[Federal Register Volume 74, Number 132 (Monday, July 13, 2009)]
[Proposed Rules]
[Pages 33520-33825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15835]
[[Page 33519]]
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Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 410, 411, 414, et al.
Medicare Program; Payment Policies Under the Physician Fee Schedule and
Other Revisions to Part B for CY 2010; Proposed Rule
Federal Register / Vol. 74 , No. 132 / Monday, July 13, 2009 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410, 411, 414, 415, and 485
[CMS-1413-P]
RIN 0938-AP40
Medicare Program; Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2010
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would address proposed changes to Medicare
Part B payment policy. We are proposing these changes to ensure that
our payment systems are updated to reflect changes in medical practice
and the relative value of services. This proposed rule discusses:
Refinements to resource-based work, practice expense and malpractice
relative value units (RVUs); geographic practice cost indices (GPCIs);
telehealth services; several coding issues; physician fee schedule
update for CY 2010; payment for covered part B outpatient drugs and
biologicals; the competitive acquisition program (CAP); payment for
renal dialysis services; the chiropractic services demonstration;
comprehensive outpatient rehabilitation facilities; physician self-
referral; the ambulance fee schedule; the clinical laboratory fee
schedule; durable medical equipment, prosthetics, orthotics, and
supplies (DMEPOS); and certain provisions of the Medicare Improvements
for Patients and Providers Act of 2008. (See the Table of contents for
a listing of the specific issues.)
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on Monday, August
31, 2009.
ADDRESSES: In commenting, please refer to file code CMS-1413-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the instructions under
the ``More Search Options'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1413-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1413-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT:
Rick Ensor, (410) 786-5617, for issues related to practice expense
methodology.
Craig Dobyski, (410) 786-4584, for issues related to geographic
practice cost indices.
Esther Markowitz, (410) 786-4595, for issues related to telehealth
services.
Ken Marsalek, (410) 786-4502, for issues related to the physician
practice information survey and the multiple procedure payment
reduction.
Cathleen Scally, (410) 786-5714, for issues related to the initial
preventive physical examination or consultation services.
Regina Walker-Wren, (410) 786-9160, for issues related to the phasing
out of the outpatient mental health treatment limitation.
Diane Stern, (410) 786-1133, for issues related to the physician
quality reporting initiative and incentives for e-prescribing.
Lisa Grabert, (410) 786-6827, for issues related to the Physician
Resource Use Feedback Program.
Colleen Bruce, (410) 786-5529, for issues related to value-based
purchasing.
Sandra Bastinelli, (410) 786-3630, for issues related to the
implementation of accreditation standards.
Jim Menas, (410) 786-4507, for issues related to teaching anesthesia
services.
Sarah McClain, (410) 786-2994, for issues related to the coverage of
cardiac rehabilitation services.
Dorothy Shannon, (410) 786-3396, for issues related to payment for
cardiac rehabilitation services.
Roya Lofti, (410) 786-4072, for issues related to the coverage of
pulmonary rehabilitation.
Jamie Hermansen, (410) 786-2064, for issues related to kidney disease
patient education programs.
Terri Harris, (410) 786-6830 for issues related to payment for kidney
disease patient education.
Henry Richter, (410) 786-4562, or Lisa Hubbard, (410) 786-5472, for
issues related to renal dialysis provisions and payments for end-stage
renal disease facilities.
Cheryl Gilbreath, (410) 786-5919, for issues related to payment for
covered outpatient drugs and biologicals.
Edmund Kasaitis, (410) 786-0477, or Bonny Dahm, (410) 786-4006, for
issues related to the Competitive Acquisition Program (CAP) for Part B
drugs.
Pauline Lapin, (410) 786-6883, for issues related to the chiropractic
services demonstration budget neutrality issue.
Monique Howard, (410) 786-3869, for issues related to CORF conditions
of coverage.
Roechel Kujawa, (410) 786-9111, for issues related to ambulance
services.
Anne Tayloe Hauswald, (410) 786-4546, for clinical laboratory issues.
Troy Barsky, (410) 786-8873, or Roy Albert, (410) 786-1872, for issues
related to physician self-referral.
Michelle Peterman, (410) 786-2591, or Iffat Fatima, (410) 786-6709 for
issues related to the grandfathering
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provisions of the durable medical equipment, prosthetics, orthotics,
and supplies (DMEPOS) Competitive Acquisition Program.
Ralph Goldberg, (410) 786-4870, or Heidi Edmunds, (410) 786-1781, for
issues related to the damages process caused by the termination of
contracts awarded in 2008 under the DMEPOS Competitive Bidding program.
Diane Milstead, (410) 786-3355, or Gaysha Brooks, (410) 786-9649, for
all other issues.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Table of Contents
To assist readers in referencing sections contained in this
preamble, we are providing a table of contents. Some of the issues
discussed in this preamble affect the payment policies, but do not
require changes to the regulations in the Code of Federal Regulations
(CFR). Information on the regulation's impact appears throughout the
preamble, and therefore, is not exclusively in section V. of this
proposed rule.
I. Background
A. Development of the Relative Value System
1. Work RVUs
2. Practice Expense Relative Value Units (PE RVUs)
3. Resource-Based Malpractice RVUs
4. Refinements to the RVUs
5. Adjustments to RVUs Are Budget Neutral
B. Components of the Fee Schedule Payment Amounts
C. Most Recent Changes to Fee Schedule
II. Provisions of the Proposed Regulation
A. Resource-Based Practice Expense (PE) Relative Value Units
(RVUs)
1. Current Methodology
a. Data Sources for Calculating Practice Expense
b. Allocation of PE to Services
c. Facility and Nonfacility Costs
d. Services With Technical Components (TCs) and Professional
Components (PCs)
e. Transition Period
f. PE RVU Methodology
2. PE Proposals for CY 2010
a. SMS and Supplemental Survey Background
b. Physician Practice Information Survey (PPIS)
c. Equipment Utilization Rate
d. Miscellaneous PE Issues
e. AMA RUC PE Recommendations for Direct PE Inputs
B. Geographic Practice Cost Indices (GPCIs): Locality Discussion
1. Update--Expiration of 1.0 Work GPCI Floor
2. Payment Localities
C. Malpractice RVUs
1. Background
2. Proposed Methodology for the Revision of Resource-Based
Malpractice RVUs
D. Medicare Telehealth Services
1. Requests for Adding Services to the List of Medicare
Telehealth Services
2. Submitted Requests for Addition to the List of Telehealth
Services
E. Specific Coding Issues Related to Physician Fee Schedule
1. Canalith Repositioning
2. Payment for an Initial Preventive Physical Examination (IPPE)
3. Audiology Codes: Policy Clarification of Existing CPT Codes
4. Consultation Services
F. Potentially Misvalued Codes Under the Physician Fee Schedule
1. Valuing Services Under the Physician Fee Schedule
2. High Cost Supplies
3. Review of Services Often Billed Together and the Possibility
of Expanding the Multiple Procedure Payment Reduction (MPPR) to
Additional Nonsurgical Services
4. AMA RUC Review of Potentially Misvalued Services
a. Site of Service Anomalies
b. ``23-Hour'' Stay
5. Establishing Appropriate Relative Values for Physician Fee
Schedule Services
G. Issues Related to the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA)
1. Section 102: Elimination of Discriminatory Copayment Rates
for Medicare Outpatient Psychiatric Services
2. Section 131(b): Physician Payment, Efficiency, and Quality
Improvements--Physician Quality Reporting Initiative (PQRI)
3. Section 131(c): Physician Resource Use Measurement and
Reporting Program
4. Section 131(d): Plan for Transition to Value-Based Purchasing
Program for Physicians and Other Practitioners
5. Section 132: Incentives for Electronic Prescribing (E-
Prescribing)--The E-Prescibing Incentive Program
6. Section 135: Implementation of Accreditation Standards for
Suppliers Furnishing the Technical Component (TC) of Advanced
Diagnostic Imaging Services
7. Section 139: Improvements for Medicare Anesthesia Teaching
Programs
8. Section 144(a): Payment and Coverage Improvements for
Patients With Chronic Obstructive Pulmonary Disease and Other
Conditions--Cardiac Rehabilitation Services
9. Section 144(a): Payment and Coverage Improvements for
Patients With Chronic Obstructive Pulmonary Disease and Other
Conditions--Pulmonary Rehabitation Services
10. Section 152(b): Coverage of Kidney Disease Patient Education
Services
11. Section 153: Renal Dialysis Provisions
12. Section 182(b): Revision of Definition of Medically-Accepted
Indication for Drugs; Compendia for Determination of Medically-
Accepted Indications for Off-Label Uses of Drugs and Biologicals in
an Anti-Cancer Chemotherapeutic Regimen
H. Part B Drug Payment
1. Average Sales Price (ASP) Issues
2. Competitive Acquisition Program (CAP) Issues
I. Provisions Related to Payment for Renal Dialysis Services
Furnished by End-Stage Renal Disease (ESRD) Facilities
J. Discussion of Chiropractic Services Demonstration
1. Background
2. Analysis of Demonstration
3. Payment Adjustment
K. Comprehensive Outpatient Rehabilitation Facilities (CORF) and
Rehabilitation Agency Issues
L. Ambulance Fee Schedule: Technical Correction to the Rural
Adjustment Factor Regulations (414.610)
M. Clinical Laboratory Fee Schedule: Signature on Requisition
N. Physician Self-Referral
1. General Background
2. Physician Stand in the Shoes
O. Durable Medical Equipment-Related Issues
1. Damages to Suppliers Awarded a Contract Under the Acquisition
of Certain Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (Medicare DMEPOS Competitive Bidding Program) Caused by the
Delay of the Program
2. Notification to Beneficiaries for Suppliers Regarding
Grandfathering
P. Physician Fee Schedule Update for CY 2010
III. Collection of Information Requirements
IV. Response to Comments
V. Regulatory Impact Analysis
Regulation Text
Addendum A--Explanation and Use of Addendum B
Addendum B--Proposed Relative Value Units and Related Information
Used in Determining Medicare Payments for CY 2010
Addendum C--[Reserved]
Addendum D--Proposed 2010 Geographic Adjustment Factors (GAFs)
Addendum E--Proposed 2010 Geographic Practice Cost Indices (GPCIs)
by State and Medicare Locality
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Addendum F--Proposed CY 2010 ESRD Wage Index for Urban Areas Based
on CBSA Labor Market Areas
Addendum G--Propsoed CY 2010 ESRD Wage Index Based on CBSA Labor
Market Areas for Rural Areas
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this final rule with comment period, we are
listing these acronyms and their corresponding terms in alphabetical
order below:
AACVPR American Association of Cardiovascular and Pulmonary
Rehabilitation
ACC American College of Cardiology
ACGME Accreditation Council on Graduate Medical Education
ACR American College of Radiology
AFROC Association of Freestanding Radiation Oncology Centers
AHA American Heart Association
AHRQ [HHS'] Agency for Healthcare Research and Quality
AIDS Acquired immune deficiency syndrome
AMA American Medical Association
AMP Average manufacturer price
AOA American Osteopathic Association
APA American Psychological Association
APTA American Physical Therapy Association
ASC Ambulatory surgical center
ASP Average sales price
ASRT American Society of Radiologic Technologists
ASTRO American Society for Therapeutic Radiology and Oncology
ATA American Telemedicine Association
AWP Average wholesale price
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program]
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement Protection
Act of 2000 (Pub. L. 106-554)
BLS Bureau of Labor Statistics
BN Budget neutrality
CABG Coronary artery bypass graft
CAD Coronary artery disease
CAH Critical access hospital
CAHEA Committee on Allied Health Education and Accreditation
CAP Competitive acquisition program
CBSA Core-Based Statistical Area
CCHIT Certification Commission for Healthcare Information Technology
CEAMA Council on Education of the American Medical Association
CF Conversion factor
CfC Conditions for Coverage
CFR Code of Federal Regulations
CKD Chronic kidney disease
CLFS Clinical laboratory fee schedule
CMA California Medical Association
CMHC Community mental health center
CMP Civil money penalty
CMS Centers for Medicare & Medicaid Services
CNS Clinical nurse specialist
CoP Condition of participation
COPD Chronic obstructive pulmonary disease
CORF Comprehensive Outpatient Rehabilitation Facility
COS Cost of service
CPEP Clinical Practice Expert Panel
CPI Consumer Price Index
CPI-U Consumer price index for urban customers
CPT [Physicians'] Current Procedural Terminology (4th Edition, 2002,
copyrighted by the American Medical Association)
CR Cardiac rehabilitation
CRNA Certified registered nurse anesthetist
CRP Canalith repositioning
CRT Certified respiratory therapist
CSW Clinical social worker
CY Calendar year
DHS Designated health services
DME Durable medical equipment
DMEPOS Durable medical equipment, prosthetics, orthotics, and
supplies
DOQ Doctor's Office Quality
DRA Deficit Reduction Act of 2005 (Pub. L. 109-171)
DSMT Diabetes self-management training
E/M Evaluation and management
EDI Electronic data interchange
EEG Electroencephalogram
EHR Electronic health record
EKG Electrocardiogram
EMG Electromyogram
EMTALA Emergency Medical Treatment and Active Labor Act
EOG Electro-oculogram
EPO Erythropoietin
ESRD End-stage renal disease
FAX Facsimile
FDA Food and Drug Administration (HHS)
FEV Forced expiratory volume
FFS Fee-for-service
FR Federal Register
FVC Forced expiratory vital capacity (liters)
GAF Geographic adjustment factor
GAO General Accountability Office
GEM Generating Medicare [Physician Quality Performance Measurement
Results]
GFR Glomerular filtration rate
GPO Group purchasing organization
GPCI Geographic practice cost index
HAC Hospital-acquired conditions
HBAI Health and behavior assessment and intervention
HCPAC Health Care Professional Advisory Committee
HCPCS Healthcare Common Procedure Coding System
HCRIS Healthcare Cost Report Information System
HDRT High dose radiation therapy
HH PPS Home Health Prospective Payment System
HHA Home health agency
HHRG Home health resource group
HHS [Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
(Pub. L. 104-191)
HIT Health information technology
HITECH Health Information Technology for Economic and Clinical
Health Act (Title IV of Division B of the Recovery Act, together
with Title XIII of Division A of the Recovery Act)
HITSP Healthcare Information Technology Standards Panel
HIV Human immunodeficiency virus
HOPD Hospital outpatient department
HPSA Health Professional Shortage Area
HRSA Health Resources Services Administration (HHS)
ICD International Classification of Diseases
IACS Individuals Access to CMS Systems
ICF Intermediate care facilities
ICR Intensive cardiac rehabilitation
ICR Information collection requirement
IDTF Independent diagnostic testing facility
IFC Interim final rule with comment period
IMRT Intensity-Modulated Radiation Therapy
IPPE Initial preventive physical examination
IPPS Inpatient prospective payment system
IRS Internal Revenue Service
ISO Insurance services office
IVD Ischemic Vascular Disease
IVIG Intravenous immune globulin
IWPUT Intra-service work per unit of time
JRCERT Joint Review Committee on Education in Radiologic Technology
JUA Joint underwriting association
KDE Kidney disease education
MA Medicare Advantage
MA-PD Medicare Advantage-Prescription Drug Plans
MCMP Medicare Care Management Performance
MedCAC Medicare Evidence Development and Coverage Advisory Committee
(formerly the Medicare Coverage Advisory Committee (MCAC))
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MIEA-TRHCA Medicare Improvements and Extension Act of 2006 (that is,
Division B of the Tax Relief and Health Care Act of 2006 (TRHCA)
(Pub. L. 109-432)
MIPPA Medicare Improvements for Patients and Providers Act of 2008
(Pub. L. 110-275)
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (Pub. L. 108-173)
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L.
110-173)
MNT Medical nutrition therapy
MP Malpractice
MPPR Multiple procedure payment reduction
MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102-539)
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MS-DRG Medicare Severity-Diagnosis related group
MSA Metropolitan statistical area
NCD National Coverage Determination
NCH National Claims History
NCPDP National Council for Prescription Drug Programs
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NDC National drug code
NF Nursing facility
NISTA National Institute of Standards and Technology Act
NP Nurse practitioner
NPDB National Practitioner Data Bank
NPI National Provider Identifier
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NPP Nonphysician practitioner
NPPES National Plan and Provider Enumeration System
NQF National Quality Forum
NRC Nuclear Regulatory Commission
NTTAA National Technology Transfer and Advancement Act of 1995 (Pub.
L. 104-113)
NUBC National Uniform Billing Committee
OACT [CMS'] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act
ODF Open door forum
OIG Office of Inspector General
OMB Office of Management and Budget
ONC [HHS'] Office of the National Coordinator
OPPS Outpatient prospective payment system
OSA Obstructive Sleep Apnea
OSCAR Online Survey and Certification and Reporting
P4P Pay for performance
PA Physician assistant
PBM Pharmacy benefit manager
PC Professional component
PCF Patient compensation fund
PCI Percutaneous coronary intervention
PDE Prescription drug event
PDP Prescription drug plan
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PERC Practice Expense Review Committee
PFS Physician Fee Schedule
PGP [Medicare] Physician Group Practice
PHP Partial hospitalization program
PIM [Medicare] Program Integrity Manual
PLI Professional liability insurance
POA Present on admission
POC Plan of care
PPI Producer price index
PPIS Physician Practice Information Survey
PPS Prospective payment system
PPTA Plasma Protein Therapeutics Association
PQRI Physician Quality Reporting Initiative
PRA Paperwork Reduction Act
PSA Physician scarcity areas
PSG Polysomnography
PT Physical therapy
PTCA Percutaneous transluminal coronary angioplasty
RA Radiology assistant
Recovery Act American Recovery and Reinvestment Act (Pub. L. 111-5)
ResDAC Research Data Assistance Center
RFA Regulatory Flexibility Act
RIA Regulatory impact analysis
RN Registered nurse
RNAC Reasonable net acquisition cost
RPA Radiology practitioner assistant
RRT Registered respiratory therapist
RUC [AMA's Specialty Society] Relative (Value) Update Committee
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SLP Speech-language pathology
SMS [AMA's] Socioeconomic Monitoring System
SNF Skilled nursing facility
SOR System of record
SRS Stereotactic radiosurgery
TC Technical Component
TIN Tax identification number
TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109-432)
TTO Transtracheal oxygen
UPMC University of Pittsburgh Medical Center
USDE United States Department of Education
VBP Value-based purchasing
WAMP Widely available market price
I. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The Act requires that payments under the
physician fee schedule (PFS) be based on national uniform relative
value units (RVUs) based on the relative resources used in furnishing a
service. Section 1848(c) of the Act requires that national RVUs be
established for physician work, practice expense (PE), and malpractice
expense. Before the establishment of the resource-based relative value
system, Medicare payment for physicians' services was based on
reasonable charges.
A. Development of the Relative Value System
1. Work RVUs
The concepts and methodology underlying the PFS were enacted as
part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L.
101-239), and OBRA 1990, (Pub. L. 101-508). The final rule, published
on November 25, 1991 (56 FR 59502), set forth the fee schedule for
payment for physicians' services beginning January 1, 1992. Initially,
only the physician work RVUs were resource-based, and the PE and
malpractice RVUs were based on average allowable charges.
The physician work RVUs established for the implementation of the
fee schedule in January 1992 were developed with extensive input from
the physician community. A research team at the Harvard School of
Public Health developed the original physician work RVUs for most codes
in a cooperative agreement with the Department of Health and Human
Services (DHHS). In constructing the code-specific vignettes for the
original physician work RVUs, Harvard worked with panels of experts,
both inside and outside the Federal government, and obtained input from
numerous physician specialty groups.
Section 1848(b)(2)(B) of the Act specifies that the RVUs for
anesthesia services are based on RVUs from a uniform relative value
guide, with appropriate adjustment of the conversion factor (CF), in a
manner to assure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value. We
established a separate CF for anesthesia services, and we continue to
utilize time units as a factor in determining payment for these
services. As a result, there is a separate payment methodology for
anesthesia services.
We establish physician work RVUs for new and revised codes based on
our review of recommendations received from the American Medical
Association's (AMA) Specialty Society Relative Value Update Committee
(RUC).
2. Practice Expense Relative Value Units (PE RVUs)
Section 121 of the Social Security Act Amendments of 1994 (Pub. L.
103-432), enacted on October 31, 1994, amended section
1848(c)(2)(C)(ii) of the Act and required us to develop resource-based
PE RVUs for each physician's service beginning in 1998. We were to
consider general categories of expenses (such as office rent and wages
of personnel, but excluding malpractice expenses) comprising PEs.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L.
105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay
implementation of the resource-based PE RVU system until January 1,
1999. In addition, section 4505(b) of the BBA provided for a 4-year
transition period from charge-based PE RVUs to resource-based RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published November 2, 1998 (63 FR 58814),
effective for services furnished in 1999. Based on the requirement to
transition to a resource-based system for PE over a 4-year period,
resource-based PE RVUs did not become fully effective until 2002.
This resource-based system was based on two significant sources of
actual PE data: The Clinical Practice Expert Panel (CPEP) data; and the
AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were
collected from panels of physicians, practice administrators, and
nonphysicians (for example, registered nurses (RNs)) nominated by
physician specialty societies and other groups. The CPEP panels
identified the direct inputs required for each physician's service in
both the office setting and out-of-office setting. We have since
refined and revised these inputs based on recommendations from the RUC.
The AMA's SMS data provided aggregate
[[Page 33524]]
specialty-specific information on hours worked and PEs.
Separate PE RVUs are established for procedures that can be
performed in both a nonfacility setting, such as a physician's office,
and a facility setting, such as a hospital outpatient department. The
difference between the facility and nonfacility RVUs reflects the fact
that a facility typically receives separate payment from Medicare for
its costs of providing the service, apart from payment under the PFS.
The nonfacility RVUs reflect all of the direct and indirect PEs of
providing a particular service.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)
(Pub. L. 106-113) directed the Secretary of Health and Human Services
(the Secretary) to establish a process under which we accept and use,
to the maximum extent practicable and consistent with sound data
practices, data collected or developed by entities and organizations to
supplement the data we normally collect in determining the PE
component. On May 3, 2000, we published the interim final rule (65 FR
25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the Calendar Year (CY) 2007 PFS final rule with comment period
(71 FR 69624), we revised the methodology for calculating PE RVUs
beginning in CY 2007 and provided for a 4-year transition for the new
PE RVUs under this new methodology.
3. Resource-Based Malpractice (MP) RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act
requiring us to implement resource-based malpractice (MP) RVUs for
services furnished on or after 2000. The resource-based MP RVUs were
implemented in the PFS final rule published November 2, 1999 (64 FR
59380). The MP RVUs were based on malpractice insurance premium data
collected from commercial and physician-owned insurers from all the
States, the District of Columbia, and Puerto Rico.
4. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review all
RVUs no less often than every 5 years. The first 5-Year Review of the
physician work RVUs was published on November 22, 1996 (61 FR 59489)
and was effective in 1997. The second 5-Year Review was published in
the CY 2002 PFS final rule with comment period (66 FR 55246) and was
effective in 2002. The third 5-Year Review of physician work RVUs was
published in the CY 2007 PFS final rule with comment period (71 FR
69624) and was effective on January 1, 2007. (Note: Additional codes
relating to the third 5-Year Review of physician work RVUs were
addressed in the CY 2008 PFS final rule with comment period (72 FR
66360).)
In 1999, the AMA's RUC established the Practice Expense Advisory
Committee (PEAC) for the purpose of refining the direct PE inputs.
Through March 2004, the PEAC provided recommendations to CMS for over
7,600 codes (all but a few hundred of the codes currently listed in the
AMA's Current Procedural Terminology (CPT) codes). As part of the CY
2007 PFS final rule with comment period (71 FR 69624), we implemented a
new methodology for determining resource-based PE RVUs and are
transitioning this over a 4-year period. (Note: In section II.A.2. of
this proposed rule, we are proposing to use new survey data under the
PE methodology.)
In the CY 2005 PFS final rule with comment period (69 FR 66236), we
implemented the first 5-Year Review of the MP RVUs (69 FR 66263).
(Note: In section II.C. of this proposed rule, we are proposing to
update the malpractice RVUs with the use of new data.)
5. Adjustments to RVUs are Budget Neutral
Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments
in RVUs for a year may not cause total PFS payments to differ by more
than $20 million from what they would have been if the adjustments were
not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act,
if adjustments to RVUs cause expenditures to change by more than $20
million, we make adjustments to ensure that expenditures do not
increase or decrease by more than $20 million.
As explained in the CY 2009 PFS final rule with comment period (73
FR 69730), as required by section 133(b) of the Medicare Improvements
for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), the
separate budget neutrality (BN) adjustor resulting from the third 5-
Year Review of physician work RVUs is being applied to the CF beginning
with CY 2009 rather than the work RVUs.
B. Components of the Fee Schedule Payment Amounts
To calculate the payment for every physicians' service, the
components of the fee schedule (physician work, PE, and MP RVUs) are
adjusted by a geographic practice cost index (GPCI). The GPCIs reflect
the relative costs of physician work, PE, and malpractice expense in an
area compared to the national average costs for each component.
RVUs are converted to dollar amounts through the application of a
CF, which is calculated by CMS' Office of the Actuary (OACT).
The formula for calculating the Medicare fee schedule payment
amount for a given service and fee schedule area can be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU
malpractice x GPCI malpractice)] x CF
C. Most Recent Changes to the Fee Schedule
The CY 2009 PFS final rule with comment period (73 FR 69726)
implemented changes to the PFS and other Medicare Part B payment
policies finalized the CY 2008 interim RVUs and implemented interim
RVUs for new and revised codes for CY 2009 to ensure that our payment
systems are updated to reflect changes in medical practice and the
relative value of services.
The CY 2009 PFS final rule with comment period also addressed other
policies, as well as certain provisions of the MIPPA.
As required by the statute, and based on section 131 of the MIPPA,
the CY 2009 PFS final rule with comment period also announced that the
PFS update is 1.1 percent for CY 2009, the initial estimate for the
sustainable growth rate for CY 2009 is 7.4 percent, and the conversion
factor (CF) for CY 2009 is $36.0666.
II. Provisions of the Proposed Regulation
A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)
Practice expense (PE) is the portion of the resources used in
furnishing the service that reflects the general categories of
physician and practitioner expenses, such as office rent and personnel
wages but excluding malpractice expenses, as specified in section
1848(c)(1)(B) of the Act.
Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-
432), enacted on October 31, 1994, required CMS to develop a
methodology for a resource-based system for determining
[[Page 33525]]
PE RVUs for each physician's service. Until that time, PE RVUs were
based on historical allowed charges. This legislation stated that the
revised PE methodology must consider the staff, equipment, and supplies
used in the provision of various medical and surgical services in
various settings beginning in 1998. The Secretary has interpreted this
to mean that Medicare payments for each service would be based on the
relative PE resources typically involved with furnishing the service.
The initial implementation of resource-based PE RVUs was delayed
from January 1, 1998, until January 1, 1999, by section 4505(a) of the
BBA. In addition, section 4505(b) of the BBA required that the new
payment methodology be phased in over 4 years, effective for services
furnished in CY 1999, and fully effective in CY 2002. The first step
toward implementation of the statute was to adjust the PE values for
certain services for CY 1998. Section 4505(d) of the BBA required that,
in developing the resource-based PE RVUs, the Secretary must--
Use, to the maximum extent possible, generally-accepted
cost accounting principles that recognize all staff, equipment,
supplies, and expenses, not solely those that can be linked to specific
procedures and actual data on equipment utilization.
Develop a refinement method to be used during the
transition.
Consider, in the course of notice and comment rulemaking,
impact projections that compare new proposed payment amounts to data on
actual physician PE.
In CY 1999, we began the 4-year transition to resource-based PE
RVUs utilizing a ``top-down'' methodology whereby we allocated
aggregate specialty-specific practice costs to individual procedures.
The specialty-specific PEs were derived from the American Medical
Association's (AMA's) Socioeconomic Monitoring Survey (SMS). In
addition, under section 212 of the BBRA, we established a process
extending through March 2005 to supplement the SMS data with data
submitted by a specialty. The aggregate PEs for a given specialty were
then allocated to the services furnished by that specialty on the basis
of the direct input data (that is, the staff time, equipment, and
supplies) and work RVUs assigned to each CPT code.
For CY 2007, we implemented a new methodology for calculating PE
RVUs. Under this new methodology, we use the same data sources for
calculating PE, but instead of using the ``top-down'' approach to
calculate the direct PE RVUs, under which the aggregate direct and
indirect costs for each specialty are allocated to each individual
service, we now utilize a ``bottom-up'' approach to calculate the
direct costs. Under the ``bottom up'' approach, we determine the direct
PE by adding the costs of the resources (that is, the clinical staff,
equipment, and supplies) typically required to provide each service.
The costs of the resources are calculated using the refined direct PE
inputs assigned to each CPT code in our PE database, which are based on
our review of recommendations received from the AMA's Relative Value
Update Committee (RUC). For a more detailed explanation of the PE
methodology, see the Five-Year Review of Work Relative Value Units
Under the PFS and Proposed Changes to the Practice Expense Methodology
proposed notice (71 FR 37242) and the CY 2007 PFS final rule with
comment period (71 FR 69629).
Note: In section II.A.1 of this proposed rule, we discuss the
current methodology used for calculating PE. In section II.A.2. of
this proposed rule, which contains PE proposals for CY 2010, we are
proposing to use data from the AMA Physician Practice Information
Survey (PPIS) in place of the AMA's SMS survey data and supplemental
survey data that is currently used in the PE methodology.
1. Current Methodology
a. Data Sources for Calculating Practice Expense
The AMA's SMS survey data and supplemental survey data from the
specialties of cardiothoracic surgery, vascular surgery, physical and
occupational therapy, independent laboratories, allergy/immunology,
cardiology, dermatology, gastroenterology, radiology, independent
diagnostic testing facilities (IDTFs), radiation oncology, and urology
are used to develop the PE per hour (PE/HR) for each specialty. For
those specialties for which we do not have PE/HR, the appropriate PE/HR
is obtained from a crosswalk to a similar specialty.
The AMA developed the SMS survey in 1981 and discontinued it in
1999. Beginning in 2002, we incorporated the 1999 SMS survey data into
our calculation of the PE RVUs, using a 5-year average of SMS survey
data. (See the CY 2002 PFS final rule with comment period (66 FR
55246).) The SMS PE survey data are adjusted to a common year, 2005.
The SMS data provide the following six categories of PE costs:
Clinical payroll expenses, which are payroll expenses
(including fringe benefits) for nonphysician clinical personnel.
Administrative payroll expenses, which are payroll
expenses (including fringe benefits) for nonphysician personnel
involved in administrative, secretarial, or clerical activities.
Office expenses, which include expenses for rent, mortgage
interest, depreciation on medical buildings, utilities, and telephones.
Medical material and supply expenses, which include
expenses for drugs, x-ray films, and disposable medical products.
Medical equipment expenses, which include depreciation,
leases, and rent of medical equipment used in the diagnosis or
treatment of patients.
All other expenses, which include expenses for legal
services, accounting, office management, professional association
memberships, and any professional expenses not previously mentioned in
this section.
In accordance with section 212 of the BBRA, we established a
process to supplement the SMS data for a specialty with data collected
by entities and organizations other than the AMA (that is, those
entities and organizations representing the specialty itself). (See the
Criteria for Submitting Supplemental Practice Expense Survey Data
interim final rule with comment period (65 FR 25664).) Originally, the
deadline to submit supplementary survey data was through August 1,
2001. In the CY 2002 PFS final rule (66 FR 55246), the deadline was
extended through August 1, 2003. To ensure maximum opportunity for
specialties to submit supplementary survey data, we extended the
deadline to submit surveys until March 1, 2005 in the Revisions to
Payment Policies Under the Physician Fee Schedule for CY 2004 final
rule with comment period (68 FR 63196) (hereinafter referred to as CY
2004 PFS final rule with comment period).
The direct cost data for individual services were originally
developed by the Clinical Practice Expert Panels (CPEP). The CPEP data
include the supplies, equipment, and staff times specific to each
procedure. The CPEPs consisted of panels of physicians, practice
administrators, and nonphysicians (for example, RNs) who were nominated
by physician specialty societies and other groups. There were 15 CPEPs
consisting of 180 members from more than 61 specialties and
subspecialties. Approximately 50 percent of the panelists were
physicians.
The CPEPs identified specific inputs involved in each physician's
service provided in an office or facility setting.
[[Page 33526]]
The inputs identified were the quantity and type of nonphysician labor,
medical supplies, and medical equipment. The CPEP data has been
regularly updated by various RUC committees on PE.
b. Allocation of PE to Services
The aggregate level specialty-specific PEs are derived from the
AMA's SMS survey and supplementary survey data. To establish PE RVUs
for specific services, it is necessary to establish the direct and
indirect PE associated with each service.
(i) Direct costs. The direct costs are determined by adding the
costs of the resources (that is, the clinical staff, equipment, and
supplies) typically required to provide the service. The costs of these
resources are calculated from the refined direct PE inputs in our PE
database. These direct inputs are then scaled to the current aggregate
pool of direct PE RVUs. The aggregate pool of direct PE RVUs can be
derived using the following formula: (PE RVUs x physician CF) x
(average direct percentage from SMS /(Supplemental PE/HR data)).
(ii) Indirect costs. The SMS and supplementary survey data are the
source for the specialty-specific aggregate indirect costs used in our
PE calculations. We then allocate the indirect costs to the code level
on the basis of the direct costs specifically associated with a code
and the greater of either the clinical labor costs or the physician
work RVUs. For calculation of the 2010 PE RVUs, we use the 2008
procedure-specific utilization data crosswalked to 2010 services. To
arrive at the indirect PE costs--
We apply a specialty-specific indirect percentage factor
to the direct expenses to recognize the varying proportion that
indirect costs represent of total costs by specialty. For a given
service, the specific indirect percentage factor to apply to the direct
costs for the purpose of the indirect allocation is calculated as the
weighted average of the ratio of the indirect to direct costs (based on
the survey data) for the specialties that furnish the service. For
example, if a service is furnished by a single specialty with indirect
PEs that were 75 percent of total PEs, the indirect percentage factor
to apply to the direct costs for the purposes of the indirect
allocation would be (0.75/0.25) = 3.0. The indirect percentage factor
is then applied to the service level adjusted indirect PE allocators.
We use the specialty-specific PE/HR from the SMS survey
data, as well as the supplemental surveys for cardiothoracic surgery,
vascular surgery, physical and occupational therapy, independent
laboratories, allergy/immunology, cardiology, dermatology, radiology,
gastroenterology, IDTFs, radiation oncology, and urology. (Note: For
radiation oncology, the data represent the combined survey data from
the American Society for Therapeutic Radiology and Oncology (ASTRO) and
the Association of Freestanding Radiation Oncology Centers (AFROC)). As
discussed in the CY 2008 PFS final rule with comment period (72 FR
66233), the PE/HR survey data for radiology is weighted by practice
size. We incorporate this PE/HR into the calculation of indirect costs
using an index which reflects the relationship between each specialty's
indirect scaling factor and the overall indirect scaling factor for the
entire PFS. For example, if a specialty had an indirect practice cost
index of 2.00, this specialty would have an indirect scaling factor
that was twice the overall average indirect scaling factor. If a
specialty had an indirect practice cost index of 0.50, this specialty
would have an indirect scaling factor that was half the overall average
indirect scaling factor.
When the clinical labor portion of the direct PE RVU is
greater than the physician work RVU for a particular service, the
indirect costs are allocated based upon the direct costs and the
clinical labor costs. For example, if a service has no physician work
and 1.10 direct PE RVUs, and the clinical labor portion of the direct
PE RVUs is 0.65 RVUs, we would use the 1.10 direct PE RVUs and the 0.65
clinical labor portions of the direct PE RVUs to allocate the indirect
PE for that service.
c. Facility and Nonfacility Costs
Procedures that can be furnished in a physician's office, as well
as in a hospital or facility setting have two PE RVUs: Facility and
nonfacility. The nonfacility setting includes physicians' offices,
patients' homes, freestanding imaging centers, and independent
pathology labs. Facility settings include hospitals, ambulatory
surgical centers (ASCs), and skilled nursing facilities (SNFs). The
methodology for calculating PE RVUs is the same for both facility and
nonfacility RVUs, but is applied independently to yield two separate PE
RVUs. Because the PEs for services provided in a facility setting are
generally included in the payment to the facility (rather than the
payment to the physician under the PFS), the PE RVUs are generally
lower for services provided in the facility setting.
d. Services With Technical Components (TCs) and Professional Components
(PCs)
Diagnostic services are generally comprised of two components: A
professional component (PC) and a technical component (TC), both of
which may be performed independently or by different providers. When
services have TCs, PCs, and global components that can be billed
separately, the payment for the global component equals the sum of the
payment for the TC and PC. This is a result of using a weighted average
of the ratio of indirect to direct costs across all the specialties
that furnish the global components, TCs, and PCs; that is, we apply the
same weighted average indirect percentage factor to allocate indirect
expenses to the global components, PCs, and TCs for a service. (The
direct PE RVUs for the TC and PC sum to the global under the bottom-up
methodology.)
e. Transition Period
As discussed in the CY 2007 PFS final rule with comment period (71
FR 69674), the change to the PE methodology was implemented over a 4-
year period. In CY 2010, the transition period is concluded and PE RVUs
will be calculated based entirely on the current methodology.
f. PE RVU Methodology
The following is a description of the PE RVU methodology.
(i) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific survey PE per physician hour
data.
(ii) Calculate the Direct Cost PE RVUs
Sum the Costs of Each Direct Input
Step 1: Sum the direct costs of the inputs for each service. The
direct costs consist of the costs of the direct inputs for clinical
labor, medical supplies, and medical equipment. The clinical labor cost
is the sum of the cost of all the staff types associated with the
service; it is the product of the time for each staff type and the wage
rate for that staff type. The medical supplies cost is the sum of the
supplies associated with the service; it is the product of the quantity
of each supply and the cost of the supply. The medical equipment cost
is the sum of the cost of the equipment associated with the service; it
is the product of the number of minutes each piece of equipment is used
in the
[[Page 33527]]
service and the equipment cost per minute. The equipment cost per
minute is calculated as described at the end of this section.
Apply a BN Adjustment to the Direct Inputs
Step 2: Calculate the current aggregate pool of direct PE costs. To
do this, multiply the current aggregate pool of total direct and
indirect PE costs (that is, the current aggregate PE RVUs multiplied by
the CF) by the average direct PE percentage from the SMS and
supplementary specialty survey data.
Step 3: Calculate the aggregate pool of direct costs. To do this,
for all PFS services, sum the product of the direct costs for each
service from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3 calculate a direct
PE BN adjustment so that the aggregate direct cost pool does not exceed
the current aggregate direct cost pool and apply it to the direct costs
from Step 1 for each service.
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the Medicare PFS
CF.
(iii) Create the indirect PE RVUs.
Create indirect allocators.
Step 6: Based on the SMS and supplementary specialty survey data,
calculate direct and indirect PE percentages for each physician
specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, we are calculating the direct and indirect percentages across
the global components, PCs, and TCs. That is, the direct and indirect
percentages for a given service (for example, echocardiogram) do not
vary by the PC, TC and global component.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVU, the
clinical PE RVU, and the work RVU.
For most services the indirect allocator is: indirect percentage *
(direct PE RVU/direct percentage) + work RVU.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
allocator is: Indirect percentage * (direct PE RVU/direct percentage) +
clinical PE RVU + work RVU.
If the clinical labor PE RVU exceeds the work RVU (and the
service is not a global service), then the indirect allocator is:
Indirect percentage * (direct PE RVU/direct percentage) + clinical PE
RVU.
Note: For global services, the indirect allocator is based on
both the work RVU and the clinical labor PE RVU. We do this to
recognize that, for the professional service, indirect PEs will be
allocated using the work RVUs, and for the TC service, indirect PEs
will be allocated using the direct PE RVU and the clinical labor PE
RVU. This also allows the global component RVUs to equal the sum of
the PC and TC RVUs.
For presentation purposes in the examples in the Table 1, the
formulas were divided into two parts for each service. The first part
does not vary by service and is the indirect percentage * (direct PE
RVU/direct percentage). The second part is either the work RVU,
clinical PE RVU, or both depending on whether the service is a global
service and whether the clinical PE RVU exceeds the work RVU (as
described earlier in this step.)
Apply a BN Adjustment to the Indirect Allocators
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the current aggregate pool of PE RVUs by the average
indirect PE percentage from the physician specialty survey data. This
is similar to the Step 2 calculation for the direct PE RVUs.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service. This is
similar to the Step 3 calculation for the direct PE RVUs.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8. This is similar to the Step 4
calculation for the direct PE RVUs.
Calculate the Indirect Practice Cost Index
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the physician time for the service, and the
specialty's utilization for the service.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors as under the current
methodology.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service.
Note: For services with TCs and PCs, we calculate the indirect
practice cost index across the global components, PCs, and TCs.
Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC
and global component.
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVU.
(iv) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs
from Step 17.
Step 19: Calculate and apply the final PE BN adjustment by
comparing the results of Step 18 to the current pool of PE RVUs. This
final BN adjustment is required primarily because certain specialties
are excluded from the PE RVU calculation for ratesetting purposes, but
all specialties are included for purposes of calculating the final BN
adjustment. (See ``Specialties excluded from ratesetting calculation''
below in this section.)
(v) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties
such as midlevel practitioners paid at a percentage of the PFS,
audiology, and low volume specialties from the calculation. These
specialties are included for the purposes of calculating the BN
adjustment.
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual
[[Page 33528]]
TC and 26 modifiers: Flag the services that are PC and TC services, but
do not use TC and 26 modifiers (for example, electrocardiograms). This
flag associates the PC and TC with the associated global code for use
in creating the indirect PE RVU. For example, the professional service
code 93010 is associated with the global code 93000.
Payment modifiers: Payment modifiers are accounted for in
the creation of the file. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier.
Work RVUs: The setup file contains the work RVUs from this
proposed rule.
(vi) Equipment cost per minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate) ** life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); 150,000 minutes.
usage = equipment utilization assumption; 0.9 for certain equipment
(see section II.A.2. of this proposed rule) and 0.5. for others.
price = price of the particular piece of equipment.
interest rate = 0.11.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
Note: To illustrate the PE calculation, in Table 1 we have used
the conversion factor (CF) of $36.0666 which is the CF effective
January 1, 2009 as published in CY 2009 PFS final rule with comment
period.
BILLING CODE 4120-01-P
[[Page 33529]]
[GRAPHIC] [TIFF OMITTED] TP13JY09.139
[[Page 33530]]
BILLING CODE 4120-01-C
Note: Proposed PE RVU in Table 1, row 27, may not match Addendum
B due to rounding.
* The direct adj = [current PE RVUs * CF * avg dir pct] / [sum
direct inputs] = [Step 2] / [Step 3]
** The indirect adj = [current PE RVUs * avg ind pct] / [sum of
ind allocators] = [Step 9] / [Step 10]
2. PE Proposals for CY 2010
a. SMS and Supplemental Survey Background
Currently, we use PE/HR obtained from the SMS surveys from 1995-
1999. For several specialties that collected additional PE/HR data
through a more recent supplemental survey, we accepted and incorporated
these data in developing current PE/HR values.
While the SMS survey was not specifically designed for the purpose
of establishing PE RVUs, we found these data to be the best available
at the time. The SMS was a multi-specialty survey effort conducted
using a consistent survey instrument and method across specialties. The
survey sample was randomly drawn from the AMA Physician Masterfile to
ensure national representativeness. The AMA discontinued the SMS survey
in 1999.
As required by the BBRA, we also established a process by which
specialty groups could submit supplemental PE data. In the May 3, 2000
interim final rule entitled, Medicare Program; Criteria for Submitting
Supplemental Practice Expense Survey Data, (65 FR 25664), we
established criteria for acceptance of supplemental data. The criteria
were modified in the CY 2001 and CY 2003 PFS final rules with comment
period (65 FR 65380 and 67 FR 79971, respectively). We currently use
supplemental survey data for the following specialties: Cardiology;
dermatology; gastroenterology; radiology; cardiothoracic surgery;
vascular surgery; physical and occupational therapy; independent
laboratories; allergy/immunology; independent diagnostic testing
facilities (IDTFs); radiation oncology; medical oncology; and urology.
Because the SMS data and the supplemental survey data are from
different time periods, we have historically inflated them by the MEI
to help put them on as comparable a time basis as we can when
calculating the PE RVUs. This MEI proxy has been necessary in the past
due to the lack of contemporaneous, consistently collected, and
comprehensive multispecialty survey data.
b. Physician Practice Information Survey (PPIS)
The AMA has conducted a new survey, the PPIS, which was expanded
(relative to the SMS) to include nonphysician practitioners (NPPs) paid
under the PFS. The PPIS, administered in CY 2007 and CY 2008, was
designed to update the specialty-specific PE/HR data used to develop PE
RVUs.
The AMA and our contractor, The Lewin Group (Lewin), analyzed the
PPIS data and calculated the PE/HR for physician and nonphysician
specialties, respectively. The AMA's summary worksheets and Lewin's
final report are available on the CMS Web site at http://www.cms.gov/PhysicianFeeSched/. (See AMA PPIS Worksheets 1-3 and Lewin Group Final
Report PPIS.) Table 2 shows the current indirect PE/HR based on SMS and
supplemental surveys, the PPIS indirect PE/HR, and the indirect cost
percentages of total costs.
Table 2--Indirect PE/HR and Indirect Percentages
[Current and PPIS]
----------------------------------------------------------------------------------------------------------------
Current PPIS
Specialty indirect indirect Current PPIS Current crosswalk
PE/HR PE/HR indirect % indirect %
----------------------------------------------------------------------------------------------------------------
All Physicians............... $59.04 $86.36 67 74
Allergy and Immunology....... 153.29 162.68 62 67
Anesthesiology............... 19.76 29.37 56 82
Audiology.................... 59.04 72.17 67 85 All Physicians.
Cardiology................... 131.02 88.04 56 65
Cardiothoracic Surgery....... 61.75 67.83 68 83
Chiropractor................. 49.60 65.33 69 86 Internal Medicine.
Clinical Laboratory (Billing 66.46 71.01 37 37
Independently) *.
Clinical Psychology.......... 29.07 20.07 90 93 Psychiatry.
Clinical Social Work......... 29.07 17.80 90 97 Psychiatry.
Colon & Rectal Surgery....... 53.93 90.85 77 80
Dermatology.................. 158.49 184.62 70 70
Emergency Medicine........... 36.85 38.36 88 94
Endocrinology................ 49.60 84.39 69 73
Family Medicine.............. 52.79 90.15 62 76
Gastroenterology............. 101.30 96.78 70 75
General Practice............. 52.79 78.59 62 69
General Surgery.............. 53.93 82.74 77 82
Geriatrics................... 49.60 54.14 69 74
Hand Surgery................. 98.56 148.78 72 77
Independent Diagnostic 466.16 501.45 50 50
Testing Facilities *.
Internal Medicine............ 49.60 84.03 69 76
Interventional Pain Medicine. 59.04 156.79 67 70
Interventional Radiology..... 118.48 82.55 58 81
Medical Oncology............. 141.84 129.94 59 56
Nephrology................... 49.60 66.00 69 80
Neurology.................... 66.05 110.39 74 87
Neurosurgery................. 89.64 115.76 86 87
Nuclear Medicine............. 118.48 39.80 58 77
Obstetrics/Gynecology........ 69.74 99.32 67 67
Ophthalmology................ 103.28 170.08 65 70
Optometry.................... 59.04 88.02 67 77 All Physicians.
Oral Surgery (Dentist only).. 96.01 173.19 71 65 Otolaryngology.
[[Page 33531]]
Orthopaedic Surgery.......... 98.56 131.40 72 81
Osteopathic Manipulative 59.04 53.93 67 93
Therapy.
Otolaryngology............... 96.01 141.53 71 75
Pain Medicine................ 59.04 122.41 67 70
Pathology.................... 59.80 74.98 70 74
Pediatrics................... 51.52 76.27 62 69
Physical Medicine and 84.92 110.13 71 84
Rehabilitation.
Physical Therapy............. 35.17 57.26 65 84
Plastic Surgery.............. 99.32 134.82 67 74
Podiatry..................... 59.04 74.76 67 82 All Physicians.
Psychiatry................... 29.07 30.09 90 94
Pulmonary Disease............ 44.63 55.26 76 74
Radiation Oncology (Hospital 114.00 126.66 50 56
Based & Freestanding).
Radiology.................... 118.48 95.60 58 71
Registered Dieticians........ 59.04 18.45 67 84 All Physicians.
Rheumatology................. 84.92 98.08 71 67
Urology...................... 119.57 97.02 69 73
Vascular Surgery............. 60.10 83.98 63 73
----------------------------------------------------------------------------------------------------------------
\*\ Did not participate in PPIS. Data based on Supplemental Survey.
The PPIS is a multispecialty, nationally representative, PE survey
of both physician and NPPs using a consistent survey instrument and
methods highly consistent with those used for the SMS and the
supplemental surveys. The PPIS has gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available to date.
As noted, the BBRA required us to establish criteria for accepting
supplemental survey data. Since the supplemental surveys were specific
to individual specialties and not part of a comprehensive
multispecialty survey, we had required certain precision levels be met
in order to ensure that the supplemental data was sufficiently valid,
and to be accepted for use in the development of the PE RVUs. Because
the PPIS is a contemporaneous, consistently collected, and
comprehensive multispecialty survey, we do not believe similar
precision requirements are necessary and are not proposing to establish
them for the use of the PPIS data.
For physician specialties, the survey responses were adjusted for
non-response bias. Non-response bias is the bias that results when the
characteristics of survey respondents differ in meaningful ways, such
as in the mix of practice sizes, from the general population. The non-
response adjustment was developed based on a comparison of practice
size and other characteristic information between the PPIS survey
respondents and data from the AMA Masterfile (for physician
specialties) or information from specialty societies (for non-physician
specialties). For six specialties (that is, chiropractors, clinical
social workers, nuclear medicine, osteopathic manipulative therapy,
physical therapy, and registered dietians) such an adjustment was not
possible due to a lack of available characteristic data. The AMA and
Lewin have indicated that the non-response weighting has only a small
impact on PE/HR values.
Under our current policy, various specialties without SMS or
supplemental survey data have been crosswalked to other similar
specialties to obtain a proxy PE/HR. For specialties that were part of
the PPIS for which we currently use a crosswalked PE/HR, we are
proposing instead to use the PPIS-based PE/HR. We are proposing to
continue current crosswalks for specialties that did not participate in
PPIS.
Supplemental survey data on independent labs, from the College of
American Pathologists, was implemented for payments in CY 2005.
Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing IDTFs, was blended
with supplementary survey data from the American College of Radiology
(ACR) and implemented for payments in CY 2007. Neither IDTFs nor
Independent Labs participated in PPIS. Therefore, we are proposing to
continue using the current PE/HR that was developed using their
supplemental survey data.
We are not proposing to use the PPIS data for reproductive
endocrinology, sleep medicine, and spine surgery since these
specialties are not separately recognized by Medicare and we do not
know how to blend this data with the Medicare recognized specialty
data. We seek comment on this issue.
We are not proposing changes to the manner in which the PE/HR data
are used in the current PE RVU methodology. We are merely proposing to
update the PE/HR data itself based on the new survey. We propose to
utilize the PE/HR developed using PPIS data for all Medicare recognized
specialties that participated in the PPIS for payments effective
January 1, 2010. The impact of using the new PPIS-based PE/HR is
discussed in the Regulatory Impact Analysis in section V. of this
proposed rule.
c. Equipment Utilization Rate
As part of the PE methodology associated with the allocation of
equipment costs for calculating PE RVUs, we have adopted an equipment
usage assumption of 50 percent. Most recently, we included a discussion
in the CY 2008 PFS proposed rule on this equipment usage assumption (72
FR 38132). We noted that if the assumed equipment usage percentage is
set too high, the result would be an insufficient allowance at the
service level for the practice costs associated with equipment. If the
assumed equipment usage percentage is set too low, the result would be
an excessive allowance for the practice costs of equipment at the
service level. We acknowledged that
[[Page 33532]]
the current 50 percent usage assumption does not capture the actual
usage rates for all equipment, but stated that we did not believe that
we had strong empirical evidence to justify any alternative approaches.
The commenters' recommendations about making adjustments to the 50
percent utilization rate assumption varied. Certain commenters
recommended we do nothing until stronger empirical evidence is
available, while other commenters recommended a decrease in the
utilization assumption, and some commenters recommended an increase in
the utilization assumption. The particular changes recommended in the
utilization assumption were, in most cases, directly related to a
specific code.
In the CY 2008 PFS final rule with comment period (72 FR 66232), we
agreed with commenters that the equipment utilization rate should
continue to be examined for accuracy. We reiterated our commitment to
continue to work with interested parties on this issue. We indicated
that we would continue to monitor the appropriateness of the equipment
utilization assumption, and evaluate whether changes should be proposed
in light of the data available.
Since the publication of the CY 2008 PFS final rule with comment
period, MedPAC addressed this issue again in its March 2009 Report to
Congress (see http://www.medpac.gov/documents/Mar09_EntireReport.pdf).
In part of its discussion, MedPAC stated:
``In 2006, the Commission sponsored a survey by NORC of imaging
providers in six markets, which found that MRI and CT machines are
used much more than the 25 hours per week that CMS assumes (Table
2B-6). According to data from this survey, MRI scanners are used 52
hours per week, on average (median of 46 hours), and CT machines are
operated 42 hours per week, on average (median of 40 hours) (NORC
2006).\32\ Although the survey results are not nationally
representative, they are representative of imaging providers in the
six markets included in the survey. We also analyzed data from a
2007 survey of CT providers by IMV, a market research firm (IMV
Medical Information Division 2008). IMV data are widely used in the
industry and have also appeared in published studies (Baker et al.
2008, Baker and Atlas 2004). Using IMV's data on 803 nonhospital CT
providers (imaging centers, clinics, and physician offices), we
calculated that the average provider uses its CT scanner 50 hours
per week, which is twice the number CMS assumes.\33\ The IMV survey
also found that nonhospital providers increased the average number
of procedures per CT machine by 31 percent from 2003 to 2007, which
indicates that providers either used their machines more hours per
day or performed more scans per hour (IMV Medical Information
Division 2008).'' (p. 108)
We believe the studies cited by MedPAC strongly suggest that our
current usage rate assumption is significantly understated, especially
with respect to the types of high cost equipment that were the subject
of the studies. Our current 50 percent utilization rate translates into
about 25 hours per week out of a 50 hour work week. The median value of
46 hours for MRIs from the first study cited by MedPAC is equivalent to
a utilization rate of 92 percent on a 50-hour week. For CT scanners,
averaging the value from the first study of 40 hours per week and the
value from the second study of 50 hours per week yields 45 hours and is
equivalent to a 90 percent utilization rate on a 50 hour work week. We
believe the studies cited by MedPAC suggest what we have long
suspected, that physicians and suppliers would not typically make huge
capital investments in equipment that would only be utilized 50 percent
of the time. All of the equipment cited in the MedPAC studies is priced
over $1 million. Therefore, we are proposing to change the equipment
usage assumption from the current 50 percent usage rate to a 90 percent
usage rate for equipment priced over $1 million. We will continue to
explore data sources regarding the utilization rates of equipment
priced at less than $1 million dollars, but are not proposing a change
in the usage rate for this less expensive equipment at this time.
As MedPAC indicated in its report, we do not believe this proposal
would create access issues in rural areas. MedPAC noted,
``According to our analysis of data from the American Hospital
Association's 2006 AHA annual survey of hospitals, 95% of rural
hospitals provide CT services in their community (AHA 2007).
Therefore, if rural areas do not have physician offices or
freestanding centers with MRI and CT machines, most of these
communities have access to such services through a hospital.'' (p.
110)
However, we welcome any additional analyses regarding access
issues, and, as in our CY 2008 and CY 2009 rulemaking, we welcome
additional empirical data relating to equipment utilization rates. Our
understanding is that the PPIS survey did not produce information that
can inform the utilization rate discussion, but we invite comments on
this or other data sources.
d. Miscellaneous PE Issues
As we have discussed in the past rulemaking (see the CY 2008 PFS
final rule with comment period (72 FR 66236) and the CY 2007 PFS final
rule with comment period (71 FR 69647)), we continue to have concerns
about the issue of PE RVUs for services which are utilized 24 hours a
day/7 days a week, such as certain monitoring systems. For example, the
PE equipment methodology was not developed with this type of 24/7
equipment in mind. We are continuing to analyze the issue of PEs for
services which are utilized 24 hours a day/7 days a week to identify
any modifications to our methodology that would address the specific
``constant use'' issues associated with these services. Services that
are currently contractor priced in CY 2009 would remain contractor
priced in CY 2010. Any proposed changes will be communicated through
future rulemaking.
We also received comments regarding the PE direct cost inputs (for
example, supply costs and the useful life of the renewable sources)
related to several high dose radiation therapy (HDRT) and placement CPT
codes. Based on our review of these codes and comments received, we are
requesting that the AMA RUC consider these CPT codes for additional
review.
e. AMA RUC Recommendations for Direct PE Inputs
The AMA RUC provided recommendations for PE inputs for the codes
listed in Table 3.
Table 3--Codes With AMA RUC PE Recommendations
------------------------------------------------------------------------
CPT \1\ code Description
------------------------------------------------------------------------
37183......................... Remove hepatic shunt (tips).
47382......................... Percut ablate liver rf.
50200......................... Biopsy of kidney.
55873......................... Cryoablate prostate.
93025......................... Microvolt t-wave assess.
------------------------------------------------------------------------
\1\ CPT codes and descriptions are Copyright 2009 American Medical
Association.
We are in agreement with the AMA RUC recommendations for the direct PE
inputs for the codes listed in Table 3 and propose to adopt these for
CY 2010.
B. Geographic Practice Cost Indices (GPCIs): Locality Discussion
1. Update--Expiration of 1.0 Work GPCI Floor
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure resource cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, PE and
malpractice). While requiring that the PE and malpractice GPCIs reflect
the full relative cost differences, section 1848(e)(1)(A)(iii) of
[[Page 33533]]
the Act requires that the physician work GPCIs reflect only one-quarter
of the relative cost differences compared to the national average.
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. This section also
specifies that if more than 1 year has elapsed since the last GPCI
revision, we must phase in the adjustment over 2 years, applying only
one-half of any adjustment in each year. As discussed in the CY 2009
PFS final rule with comment period (73 FR 69740), the CY 2009
adjustment to the GPCIs reflected the fully implemented fifth
comprehensive GPCI update. We also noted that section 134 of the MIPPA
extended the 1.000 work GPCI floor from July 1, 2008, through December
31, 2009. (Note: The 1.000 work GPCI floor was enacted and implemented
for CY 2006, and, prior to enactment of the MIPPA, was set to expire on
June 30, 2008.) Additionally, section 1848(e)(1)(G) of the Act, as
amended by section 134(b) of the MIPPA, set a permanent 1.5 work GPCI
floor in Alaska for services furnished beginning January 1, 2009.
Therefore, as required by the MIPPA, beginning on January 1, 2010, the
1.000 work GPCI floor will be removed. However, the 1.500 work GPCI
floor for Alaska will remain in place. See Addenda D and E of this
proposed rule for the GPCIs and summarized geographic adjustment
factors (GAFs), respectively.
2. Payment Localities
a. Background
As stated above in this section, section 1848(e)(1)(A) of the Act
requires us to develop separate GPCIs to measure resource cost
differences among localities compared to the national average for each
of the three fee schedule components (this is, work, PE, and
malpractice). Payments under the PFS are based on the relative
resources involved in furnishing physicians' services, and are adjusted
for differences in relative resource costs among payment localities
using the GPCIs. As a result, PFS payments vary between localities.
The current PFS locality structure was developed and implemented in
1997. There are currently 89 localities including 37 higher-cost areas;
16 Rest of State areas (comprising the remaining counties not located
in a higher-cost area within a State); 34 Statewide areas; and Puerto
Rico and the Virgin Islands which are designated as ``territory-wide''
localities. The development of the current locality structure is
described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and
the subsequent final rule (61 FR 59494).
As we have frequently noted, any changes to the locality
configuration must be made in a budget neutral manner. Therefore, any
change in localities can lead to significant redistributions in
payments. For many years, we have not considered making changes to
localities without the support of a State medical association in order
to demonstrate consensus for the change among the professionals whose
payments would be affected (with some increasing and some decreasing).
However, we have recognized that, over time, changes in demographics or
local economic conditions may lead us to conduct a more comprehensive
examination of existing payment localities.
Payment Locality Approaches Discussed in the CY 2008 PFS Proposed Rule
For the past several years, we have been involved in discussions
with California physicians and their representatives about recent
shifts in relative demographics and economic conditions among a number
of counties within the current California payment locality structure.
In the CY 2008 PFS proposed rule and final rule with comment period, we
described three potential options for changing the payment localities
in California (72 FR 38139 and 72 FR 66245, respectively).
After reviewing the comments on these options, we decided not to
proceed with implementing any of them at that time. We explained that
there was no consensus among the California medical community as to
which, if any, of the options would be most acceptable. We also
received suggestions from the Medicare Payment Advisory Commission
(MedPAC) for developing changes in payment localities for the entire
country and other States expressed interest in having their payment
localities reconfigured as well. In addition, other commenters wanted
us to consider a national reconfiguration of localities rather than
just making changes one State at a time. Because of the divergent views
expressed in comments, we explained in the CY 2008 PFS final rule with
comment period that we intended to conduct a thorough analysis of
potential approaches to reconfiguring localities and would address this
issue again in future rulemaking.
Interim Study of Alternative Payment Localities Under the PFS
As a follow-up to the CY 2008 PFS final rule with comment period,
we contracted with Acumen, LLC (Acumen), to conduct a preliminary study
of several options for revising the payment localities on a nationwide
basis. The contractor's interim report was posted on the CMS Web site
on August 21, 2008, and we requested comments from the public. The
report entitled, ``Review of Alternative GPCI Payment Locality
Structures,'' is still accessible from the CMS PFS Web page under the
heading ``Interim Study of Alternative Payment Localities under the
PFS.'' The report may also be accessed directly from the following
link: http://www.cms.hhs.gov/PhysicianFeeSched/10_Interim_Study.asp#TopOfPage. We accepted comments on the interim report through
November 3, 2008. The alternative locality configurations discussed in
the report are described briefly below in this section.
Option 1: CMS Core Based Statistical Area (CBSA) Payment Locality
Configuration
This option uses the Office of Management and Budget (OMB's)
Metropolitan Statistical Area (MSA) designations for the payment
locality configuration. MSAs would be considered as urban CBSAs.
Micropolitan Areas (as defined by OMB) and rural areas would be
considered as non-urban (rest of State) CBSAs. This approach would be
consistent with the inpatient hospital prospective payment system
(IPPS) pre-reclassification CBSA assignments and with the geographic
payment adjustments used in other Medicare payment systems. This option
would increase the number of localities from 89 to 439.
Option 2: Separate High Cost Counties From Existing Localities
(Separate Counties)
Under this approach, higher cost counties are removed from their
existing locality structure and they would each be placed into their
own locality. This option would increase the number of localities from
89 to 214 using a 5 percent GAF differential to separate high cost
counties.
Option 3: Separate MSAs From Statewide Localities (Separate MSAs)
This option begins with Statewide localities and creates separate
localities for higher cost MSAs (rather than removing higher cost
counties from their existing locality as described in option 2). This
option would increase the number of localities from 89 to 130 using a 5
percent GAF differential to separate high cost MSAs.
[[Page 33534]]
Option 4: Group Counties Within a State Into Locality Tiers Based on
Costs (Statewide Tiers)
This option creates tiers of counties (within each State) that may
or may not be contiguous but share similar practice costs. This option
would increase the number of localities from 89 to 140 using a 5
percent GAF differential to group similar counties into Statewide
tiers.
Additionally, as discussed in the interim locality study report,
our contractor, Acumen, applied a ``smoothing'' adjustment to the
current PFS locality structure, as well as to each of the alternative
locality configurations (except option 4: Statewide Tiers). The
``smoothing'' adjustment was applied to mitigate large payment
differences (or payment ``cliffs'') between adjacent counties. Since
large payment differences between adjacent counties could influence a
physician's decision on a practice location (and possibly impact access
to care), the ``smoothing'' adjustment was applied to ensure that GAF
differences between adjacent counties do not exceed 10 percent. (For
more information on the ``smoothing'' adjustment see the interim
locality study report on the PFS Web page via the link provided above.)
b. Summary of Public Comments on Interim Locality Study Report
In the CY 2009 PFS proposed rule (73 FR 38514), we encouraged
interested parties to submit comments on the options presented both in
the proposed rule and in the interim report posted on our Web site. We
also requested comments and suggestions on other potential alternative
locality configurations (in addition to the options described in the
report). Additionally, we requested comments on the administrative and
operational issues associated with the various options under
consideration. We also emphasized that we would not be proposing any
changes to the current PFS locality structure for CY 2009 and that we
would provide extensive opportunities for public comment before
proposing any change. The following is a summary of the comments
received on the alternative locality options discussed in the CY 2009
PFS proposed rule and interim locality study report.
(1) Introduction and General Support for Change
We received approximately 200 comments on the CY 2009 PFS proposed
rule and locality study report from various specialty groups, medical
societies, State medical associations, individual practitioners, and
beneficiaries. Commenters generally commended us for acknowledging the
need to reconfigure PFS payment localities and expressed support for
our study of alternative locality configurations. Many commenters urged
us to expedite changes to the current locality structure in order to
accurately reflect the geographic cost differences of operating a
medical practice. For example, the Connecticut State Medical Society
commented that the current locality configuration contributes to
medical access issues and problems with recruitment and retention of
practitioners (with an emphasis on access to primary care).
Another commenter stated that Ohio's Statewide locality
configuration needs to be changed because a Statewide locality
designation does not account for the (presumably higher) cost of
operating a medical practice in northern Ohio. The commenter also
objected to the agency's approach to requests for changes to the
current locality structure (which includes an assessment of support for
the changes by the medical community, including the relevant State
medical associations). The commenter believes the State medical
association does not represent all of the physicians in Ohio.
Another commenter stated that a change in the PFS locality
structure is long overdue. The commenter stated that San Diego County
is the most underpaid area in the nation and that grouping that county
with the Rest of California locality is erroneous. Moreover, several
commenters stated that a timely reassessment is needed and urged us to
update the locality structure every 3 years. Two commenters believe
that previous studies completed on the PFS locality structure by
MedPAC, GAO, Urban Institute, as well as the current study by Acumen,
support immediate reform to the current PFS locality structure.
We received many comments from hospitals and physicians located in
Frederick County Maryland (which is currently grouped with the Rest of
Maryland locality). The commenters support each of the alternative
locality configurations we presented because each option results in PFS
payment increases for services furnished in Frederick County. The
commenters stated that Frederick County is considered a `bedroom
community' for the DC/Northern Virginia area, has experienced the
highest growth rate in the State, and noted that the cost of living has
increased significantly. Additionally, the commenters noted that the
last economic census aligns costs in Frederick County with those in
Montgomery County (whose doctors receive higher payment amounts) and
that Frederick County competes with physician practices in Montgomery
County for professional staff. Moreover, the commenters believe that
because of inadequate PFS payment amounts, access to care is becoming a
problem and emergency room visits are on the rise.
(2) Cautious Approach
Some commenters requested that we take a cautious approach to
reconfiguring the locality structure. For instance, the Texas Medical
Association stated that because of the redistributive impact that
results from any locality reconfiguration, CMS should avoid making
large scale changes at one time. Additionally, another commenter stated
that ``stakeholders'' should be given a long advance notification
period (at least 2 full calendar years) prior to the effective date of
any changes to the PFS locality configuration. The commenter also
stated that the current locality structure should remain in place (for
each locality) unless the need for revision is strongly substantiated
because of a change in practice cost patterns. A specialty society
expressed support for postponing any adjustments for at least 1 year to
allow for more discussion between CMS and ``stakeholders''.
(3) Guiding Principles
We received several comments from California that suggested a set
of goals for reforming the PFS payment locality structure. The goals
suggested by the commenters are as follows:
Improve payment accuracy (as compared to the current
locality structure);
Move towards MSA-based localities;
Mitigate payment reductions to rural California areas (and
therefore minimize corresponding negative impact on access to care in
California); and
Promote administrative simplification by aligning
physician and hospital payment localities.
The California Medical Association (CMA) urged us to apply a
consistent methodology across all payment localities and requested that
any revision to the localities include a ``formula driven'' mechanism
that can be applied repeatedly to future revisions. A California county
medical society stated that more specific objectives for reforming PFS
payment localities should be developed. For example, the commenter
suggested that
[[Page 33535]]
payment reductions for practitioners should not exceed 1.5 percent in
any given year, GAF differentials between adjacent localities should
not exceed 10 percent, and that contiguous localities with less than a
1 percent difference in their GAF's should be combined into a single
locality.
(4) Comments on the Studied Alternative Locality Options
We received many comments on the options for reconfiguring PFS
payment localities presented in the interim locality study report. One
commenter stated that option 1 (the CMS CBSA locality configuration) is
the best option because it provides the greatest payment accuracy. The
same commenter also stated that using CBSAs as the PFS locality
definition would be similar to other Medicare payment systems (for
example, the IPPS). Therefore, the commenter believed that geographic
payment adjustments for physicians and hospitals would be consistent
for a given geographic area. The CMA and a California county medical
society stated that although option 1 would provide the greatest
payment accuracy, it would also lead to significant payment reductions
for many counties. Those same commenters expressed concern with the
negative impact of transitioning directly to the CMS CBSA locality
configuration. If adopted, the commenters suggested that the CMS CBSA
locality configuration be implemented in stages over several years. The
Texas Medical Association echoed this concern and urged us not to adopt
option 1 unless we employ a hold harmless floor along with ``material''
increases in the conversion factor.
The Texas Medical Association also stated that option 2 (Separate
High Cost Counties from Existing Localities) results in less
significant payment reductions to rural practitioners, as compared to
the reductions seen under option 1 (CMS CBSA) and option 4 (Statewide
Tiers). However, the commenter did not support option 2 because it
would create different localities within major urban areas and,
therefore, provide incentives for ``border-crossing,'' (in other words,
incentives for physicians to move their medical practice to an adjacent
urbanized county to obtain a higher payment amount). Additionally, the
Texas Medical Association stated that option 2 increases administrative
complexity due to the additional number of localities and the need to
reallocate source data into smaller (county level) areas. The CMA also
stated that option 2 results in less significant payment reductions (as
compared to the other options). However, the CMA stated that option 2
continues to produce inaccurate payments because it applies MSA-based
data to county-based localities.
Many commenters from the State of California expressed support for
option 3 (Separate High Cost MSAs from Statewide Localities) because
the commenters believed it would improve payment accuracy (over the
current locality configuration) and at the same time mitigate the
payment reductions to rural areas that would occur under option 1 (CMS
CBSA) and option 4 (Statewide Tiers). The CMA explained that selecting
an MSA-based locality approach would provide consistency with the
hospital payment system and enable physicians to better compete with
hospitals for the local work force. For example, the commenters stated
that hospitals located in the Santa Cruz MSA are some of the highest
paid in the nation. However, under the PFS locality structure, Santa
Cruz County is grouped with the Rest of California locality, which is
the lowest paid PFS locality in the State.
The Texas Medical Association suggested that we adopt option 3
because it minimizes payment reductions to lower cost rural areas. For
example, since option 3 results in the fewest payment localities (as
compared to the other alternative locality configurations), it reduces
the redistribution effects of separating higher cost areas from rural
``rest of State'' areas. The commenter also stated that option 3
(Separate MSAs) matches payment with the underlying data better than
option 2 (Separate Counties) and option 4 (Statewide Tiers). Some
commenters expressed their belief that MSAs are better basic locality
units than counties because the cost data is more reliably derived
directly from MSAs (instead of counties). Several commenters who
supported the adoption of an MSA-based PFS locality structure suggested
that option 3 could be used as a transition to the CMS CBSA locality
configuration (option 1).
With regard to option 4 (Statewide Tiers), the Texas Medical
Association stated that the Statewide Tiers locality configuration
creates payment areas that are poorly aligned with the underlying data
and results in unacceptable payment decreases to small urban and rural
areas. The Florida Medical Association explained that many localities
have experienced a shift in population and economic development since
the last PFS locality reconfiguration. The commenter stated that
counties with similar costs should be grouped together in the same
locality regardless of geographic location and that the Statewide cost
tier locality structure (option 4) would accomplish this objective. The
CMA stated that under option 4, counties are not geographically
contiguous and noted that the counties grouped together in a locality
may not be related to one another economically. The commenter suggested
that noncontiguous counties may experience more frequent economic
changes than contiguous counties. The commenter expressed concern that
option 4 would need to be updated more frequently and therefore
payments to physicians will fluctuate more often. A California county
medical society stated that option 4 creates payment errors for
counties in seven California localities that currently have accurate
payments. The Connecticut State Medical Society stated that New Haven
County would experience an increase under option 4.
(5) Smoothing Adjustment
Many commenters from the State of California did not support the
concept of ``smoothing'' because it would require payment reductions
for higher cost counties to offset the increases given to lower cost
counties (in order to achieve budget neutrality). Additionally, the
same commenters stated that physicians in ``smoothed'' counties benefit
financially from the smoothing adjustment solely because they are
located adjacent to high cost areas. They also stated that a
``smoothing'' adjustment would be complex to administer, and difficult
to understand. The CMA, a California county medical society, and
another commenter from California stated that a ``smoothing''
adjustment would require a change in the statute and that current
Medicare statute requires GPCIs to reflect the relative costs
differences among localities for work, PE, and malpractice expense.
Another commenter recommended that we study the extent to which a
``smoothing'' adjustment can be used as a temporary measure; in order
to phase-in significant changes in payment levels resulting from a PFS
locality reconfiguration.
(6) Other Alternative Options
A few commenters submitted suggestions on other potential
alternative PFS locality configurations in addition to those discussed
in the interim report. For example, one medical clinic suggested a
``market-based'' approach instead of the current ``cost-based''
methodology. Under this approach, PFS payment would be geographically
adjusted based on the ratio of Medicare participating
[[Page 33536]]
physicians to Medicare beneficiaries. The commenter suggested that
payment amounts should be increased in geographic areas with a low
physician to Medicare beneficiary ratio (for example, 1 physician for
every 3,000 beneficiaries) and decreased in areas with a higher ratio
(for example, 1 physician for every 200 beneficiaries). The commenter
stated that ``this process could be used to bring physician to patient
ratios in the United States to equilibrium.''
The CMA and a California county medical society suggested
variations of option 2 (Separate Counties) with the intention of
reducing the number of localities that would result under this option.
The commenters suggested adopting a ``basic locality unit'' (for
example, MSA) instead of a county when removing areas from an existing
locality. For example, if 5 counties are removed from a ``Rest of
State'' locality, and included within the same MSA, the 5 counties
would be grouped into a single new locality rather than 5 separate new
localities. The commenter also suggested that if removed counties are
contiguous and have similar costs (even if not part of same MSA); they
should be consolidated into one new locality instead of separate
localities. The commenters stated that either of these variations would
reduce the number of new localities created under option 2.
Additionally, the CMA and a California county medical society
suggested a variation of option 4 (Statewide Tiers). The commenters
stated that fixed cost tiers be established for each State using .05
GAF increments which would lock in the upper and lower GAF values for
each cost tier. Under this approach, the fixed cost tiers would not
change based on updates to the GPCIs; however, a county could be moved
to a lower (or higher) cost tier without the need to define new tiers
for the entire state.
(7) Redistribution of Payment
Many commenters acknowledged that a significant redistribution of
payments would occur under each alternative locality configuration
option and requested that we minimize the payment discrepancy between
urban and rural areas to ensure continued access to services.
Additionally several commenters stated that any changes to the locality
configuration should not be unfair to rural practitioners. One
specialty college noted that any new locality configuration must be
budget neutral, resulting in a shift of resources from one geographic
area to another. The commenter expressed concern that the requirement
for budget neutrality may help physicians who practice in certain
geographic areas, but will be costly to others. As such, the commenters
stated that each alternative PFS locality option could create problems
for medical access in areas where payments are reduced. As a method to
minimize payment reduction, a few commenters requested that we continue
the application of the 1.0 work GPCI floor.
The AMA stated that any proposal to reconfigure PFS payment
localities should not necessitate budget-neutral payment
redistributions. The commenter expressed the concern raised by other
commenters that some localities would receive payment increases under
some options while other localities would experience significant
payment reductions to offset these increases. The commenters requested
that if new locality definitions are proposed, new funding should be
provided to increase payments in localities that are found to be
underpaid. The commenters also stated that budget neutral
redistributions would only exacerbate an already flawed and under-
funded Medicare PFS. The AMA suggested that States with a Statewide
locality should be given the option of remaining a Statewide locality
and that CMS should continue its policy of allowing any State the
option of converting to a Statewide locality at the request of the
State Medical Association.
The Iowa Medical Society stated that Medicare PFS payment levels in
Iowa are among the lowest in the country and that the four alternative
locality configurations all appear to further reduce payments to State
physicians. As such, they requested that Iowa remain a Statewide
locality under any nationwide locality change.
Because of the redistribution effect of any locality
reconfiguration, some commenters did not find any of the potential
alternative locality configurations preferable to the current payment
locality structure. For example, one physician academy stated that all
four of the alternative locality scenarios result in disproportionately
lower GAFs for non-MSA counties. Therefore, the commenter encouraged us
to maintain the current locality structure until we identify an
alternative that decreases the number of payment localities and
supports practitioners in rural and underserved areas. The commenter
also expressed support for a locality reconfiguration that minimizes
the number of payment localities; does not exceed the current number of
89 localities and eliminates geographic payment adjustments (except
those designed to encourage physicians to practice in underserved
areas). Furthermore, the Florida Medical Association urged us to work
with Congress to remove the application of budget neutrality when
making changes to the PFS payment locality structure. The commenter
suggested that we use the current GCPI values as a ``floor'' to ensure
that future updates to the localities will not result in payment
reductions.
(8) Methodology
The CMA and a California county medical society commended the
contractor, Acumen, for the accuracy of its calculations, modeling of
the options, and observations. However, they recommended a change in
the iterative methodology used to develop option 2 and option 3. The
commenters stated that the threshold for removing high cost counties
from existing localities (option 2) and removing high cost MSAs from
Statewide localities (option 3) should be equal to or greater than 5
percent (not just greater than 5 percent) with no rounding up for GAF
differences below 5 percent. Additionally, with regard to option 2, the
commenters recommended that counties with identical GAFs to the county
being considered for a new locality should not be included in the
calculation of the ``Rest of Locality'' GAF (which is used for
comparison to the higher cost county).
Additionally, the commenters objected to the methodology used for
the ``smoothing'' adjustment. The commenters believe that a new
locality created by smoothing should not have a significantly lower GAF
than it would if the county was a single locality. For example, the
commenters noted that San Diego County (which is currently included in
the Rest of California locality) has a county-level GAF of 1.056.
However, when the smoothing adjustment is applied to the current
locality configuration, the GAF for San Diego is 1.018.
One research institute questioned why high cost counties were
separated from existing localities (option 2) and high cost MSAs were
separated from Statewide localities (option 3); instead of separating
low cost counties and low cost MSAs. The commenter stated that the CMS
CBSA methodology is not designed to be sensitive enough to detect
significant geographic differences in physician compensation and PE.
The commenter questioned whether compensation and PE costs are
correlated directly with population density.
[[Page 33537]]
Clarification on Methodology Used To Develop Alternative Locality
Configurations Discussed in the Interim Report
With regard to the iterative methodology used for option 2 and
option 3, the contractor, Acumen, analyzed these alternative locality
configurations based on its understanding of the MedPAC ideas. A
threshold of greater than 5 percent was used to separate high cost
counties from existing localities (option 2) and to separate high cost
MSAs from Statewide localities (option 3). Additionally, the contractor
compared just one county (or MSA) at a time against the weighted
average GAF of all the lower-ranked counties in the Medicare locality.
Counties with the same GAF were not treated as a group. In ranking
counties by GAF, the contractor used physician work RVUs to break
``ties.'' In other words, when two counties in a Medicare locality had
the same GAF, the county with the higher physician work RVU was ranked
as if it had the higher GAF. Keeping counties with identical GAFs
together would be another possible strategy for developing alternative
PFS payment localities. The high cost counties and MSAs were removed in
the iterative process to reflect ongoing concerns regarding individual
high cost counties (usually in ``rest of state'' areas) where the GAF
is significantly higher than the norm for the locality. Removing low
cost counties would isolate very low cost areas leading to further
reductions in PFS payment levels for physicians and practitioners in
these counties.
With regard to the sensitivity of the CBSA methodology and whether
compensation and PE cost are correlated directly to population density;
the CBSA methodology has three types of areas: MSAs, Metropolitan
Divisions within MSAs, and non-MSA areas. None of these definitions
involve population density per se, although MSAs must include core
areas with populations of 50,000 or greater. Given that the CBSA
methodology has more regions than the other alternative locality
configurations, it could potentially draw on more detailed levels of
data than the other options, and therefore, result in a more precise
reflection of geographic cost differences.
(9) Suggested Additional Topics for Review
One commenter stated that the interim locality study report should
have addressed how a change in payment locality structure might impact
a physician's choice regarding practice location and Medicare
beneficiary access to physician services.
The CMA and a California county medical society stated that the
interim locality study should have included a discussion of payment
accuracy under the current locality structure and under each potential
locality configuration. The commenters stated that a discussion of the
potential negative impact under a particular option without a
discussion of the accuracy of payment for each option is misleading.
Additionally, they suggested adding a discussion of potential methods
to mitigate payment reductions.
(10) Administrative and Operational Issues
We received few comments on administrative and operational issues
related to making changes to the PFS payment locality structure. Some
commenters stated that a locality revision would impose a minimal
amount of additional administrative burden. However, the commenters did
not specify whose administrative burden they were assessing. One
commenter stated that implementing the CMS CBSA locality configuration
(option 1) would be a significant administrative burden. Additionally,
one health care plan explained that many Medicare Advantage Plans are
based on Medicare fees in specific localities. As such, any fee
schedule locality revision would be a large scale and costly
administrative undertaking for managed care plans as well as for
``traditional'' Medicare.
(11) Underlying Data
We also received comments on the data used to develop GPCI values.
Although we appreciate these comments, the focus of the interim
locality study was not intended to be a review of the underlying data
sources used to develop GPCI values. As discussed earlier, the interim
locality study was a review of potential approaches for redefining the
Medicare PFS payment localities.
Response to Comments
We would like to thank the public for the many thoughtful comments
on the interim locality study report entitled, ``Review of Alternative
GPCI Payment Locality Structures''. As noted by the commenters and
reflected in the report, significant payment redistribution would occur
if a nationwide change in the PFS locality configuration were
undertaken. All four of the potential alternative payment locality
configurations reviewed in the report would increase the number of
localities and separate higher cost, typically urban areas from lower
cost, typically rural ``Rest of State'' areas. In general, payments to
urban areas would increase while rural areas would see a decrease in
payment under each of the options studied because they would no longer
be grouped with higher cost ``urbanized'' areas. We intend to review
the suggestions made by the commenters and consider the impact of each
of the potential alternative locality configurations. We will also
explore whether alternative underlying data sources are available
nationwide. A final report will be posted to the CMS Web site after
further review of the studied alternative locality approaches.
We are not proposing changes in the PFS locality structure at this
time. As explained in the CY 2009 PFS final rule with comment period,
in the event we decide to make a specific proposal for changing the
locality configuration, we would provide extensive opportunities for
public input (for example, town hall meetings or open door forums, as
well as opportunities for public comments afforded by the rulemaking
process).
C. Malpractice Relative Value Units (RVUs)
1. Background
Section 1848(c) of the Act requires that each service paid under
the PFS be comprised of three components: work, PE, and malpractice.
From 1992 to 1999, malpractice RVUs were charge-based, using weighted
specialty-specific malpractice expense percentages and 1991 average
allowed charges. Malpractice RVUs for new codes after 1991 were
extrapolated from similar existing codes or as a percentage of the
corresponding work RVU. Section 4505(f) of the BBA required us to
implement resource-based malpractice RVUs for services furnished
beginning in 2000. Initial implementation of resource-based malpractice
RVUs occurred in 2000. The statute also requires that we review, and if
necessary adjust, RVUs no less often than every 5 years. The first
review and update of resource based malpractice RVUs was addressed in
the CY 2005 PFS final rule (69 FR 66263). Minor modifications to the
methodology were addressed in the CY 2006 PFS final rule (70 FR 70153).
In this current rule, we are proposing to implement the second review
and update of malpractice RVUs.
[[Page 33538]]
2. Proposed Methodology for the Revision of Resource-Based Malpractice
RVUs
The proposed malpractice RVUs were developed by Acumen, LLC
(Acumen) under contract to us.
The methodology used in calculating the proposed second review and
update of resource-based malpractice RVUs largely parallels the process
used in the CY 2005 update. The calculation requires information on
malpractice premiums, linked to the physician work conducted by
different specialties that furnish Medicare services. Because
malpractice costs vary by State and specialty, the malpractice premium
information must be weighted geographically and across specialties.
Accordingly, the proposed malpractice expense RVUs are based upon three
data sources:
Actual CY 2006 and CY 2007 malpractice premium data.
CY 2008 Medicare payment data on allowed services and
charges.
CY 2008 Geographic adjustment data for malpractice
premiums.
Similar to the previous update of the resource-based malpractice
expense RVUs, we are proposing to revise the RVUs using specialty-
specific malpractice premium data because they represent the actual
malpractice expense to the physician. In addition, malpractice premium
data are widely available through State Departments of Insurance. We
propose to use actual CY 2006 and CY 2007 malpractice premium data
because they are the most current data available (CY 2008 malpractice
premium data were not consistently available during the data collection
process). Accounting for market shares, three fourths of all included
rate filings were implemented in CY 2006 and CY 2007. The remaining
rate filings were implemented in CY 2003 through CY 2005 but still
effective in CY 2006 and CY 2007. Carriers submit rate filings to their
State Departments of Insurance listing the premiums and other features
of their coverage. The rate filings include an effective date, which is
the date the premiums go into effect. Some States require premium
changes to be approved before their effective date; others just require
the rate filings to be submitted. We try to capture at least 2
companies and at least 50 percent of the market share, starting with
the largest carriers in a State.
The primary determinants of malpractice liability costs continue to
be physician specialty, level of surgical involvement, and the
physician's malpractice history. We collected malpractice premium data
from 49 States and the District of Columbia for all physician
specialties represented by major insurance providers. Rate filings were
not available through Departments of Insurance in Mississippi or Puerto
Rico. Premiums were for $1 million/$3 million, mature, claims-made
policies (policies covering claims made, rather than services furnished
during the policy term). A $1 million/$3 million liability limit policy
means that the most that would be paid on any claim is $1 million and
that the most that the policy would pay for several claims over the
timeframe of the policy is $3 million. We collected data from
commercial and physician-owned insurers and from joint underwriting
associations (JUAs). A JUA is a State government-administered risk
pooling insurance arrangement in areas where commercial insurers have
left the market. Adjustments were made to reflect mandatory surcharges
for patient compensation funds (PCFs) (funds to pay for any claim
beyond the statutory amount, thereby limiting an individual physician's
liability in cases of a large suit) in States where PCF participation
is mandatory. We sought to collect premium data representing at least
50 percent of physician malpractice premiums paid in each State as
identified by State Departments of Insurance and by the National
Association of Insurance Commissioners (NAIC).
Rather than select the top 20 physician specialties as when the
malpractice RVU were originally established and updated, we included
premium information for all physician and surgeon specialties and risk
classifications available in the collected rate filings. Most insurance
companies provided crosswalks from insurance services office (ISO)
codes to named specialties; we matched these crosswalks to CMS
specialty codes. We also preserved information obtained regarding
surgery classes, which are categorizations that affect premium rates.
For example, many insurance companies grouped general practice
physicians into nonsurgical, minor-surgical and major-surgical classes,
each with different malpractice premiums. Some companies provided
additional surgical subclasses; for example, distinguishing general
practice physicians that conducted obstetric procedures, which further
impacted malpractice rates. We standardized this information to CMS
specialty codes.
We could not identify malpractice premium rates through typical
malpractice rate filings for some physician specialties, nonphysician
practitioners (NPPs), and other entities (for example, independent
diagnostic testing facilities (IDTFs)) paid under the PFS. In the
absence of available premium data for these specialties and entities,
we took a number of steps.
We collected data from one of the largest association program
insurance brokers and administrators in the United States providing
malpractice insurance to medical physicists. We incorporated the data
into the calculation of the proposed update to the malpractice RVUs for
TC services. (See section II.C.3 of this proposed rule for a discussion
of this issue.)
We also crosswalked 13 specialties for which there was not
significant collected data available (those in less than 35 States'
malpractice premium rate filings) to similar specialties and risk
classes. The unassigned specialties and the specialty to which we are
proposing to assign them are shown in Table 4. The remaining four
specialties were dropped, meaning they were not included in the
weighted averages for calculating the malpractice RVUs.
Note: While we were able to collect data on many more
specialties on this survey than under the previous one, these four
specialties were also dropped under the previous version of the
survey because of a lack of available data. This left 44
specialties, representing 90 percent of Medicare services, for which
we used the malpractice premium data to develop risk factors.
Table 4--Crosswalk of Specialties to Similar Physician Specialties
----------------------------------------------------------------------------------------------------------------
Crosswalk
Spec. code Specialty name specialty code Crosswalk specialty
----------------------------------------------------------------------------------------------------------------
09...................... Interventional Pain 72 Pain Management.
Management.
19...................... Oral Surgery............... 03 Allergy Immunology*.
35...................... Chiropractic............... 03 Allergy Immunology*.
62...................... Psychologist............... 03 Allergy Immunology*.
65...................... Physical Therapist......... 03 Allergy Immunology*.
[[Page 33539]]
67...................... Occupational Therapist..... 03 Allergy Immunology*.
68...................... Clinical Psychologist...... 03 Allergy Immunology*.
79...................... Addiction Medicine......... 03 Allergy Immunology*.
85...................... Maxillofacial Surgery...... 03 Allergy Immunology*.
86...................... Neuropsychiatry............ 26 Psychiatry.
91...................... Surgical Oncology.......... 02 General Surgery.
94...................... Interventional Radiology... 30 Diagnostic Radiology.
98...................... Gynecological/Oncology..... 90 Medical Oncology.
99...................... Unknown Physician Specialty 01 General Practice.
----------------------------------------------------------------------------------------------------------------
* Lowest Physician Specialty.
The methodology presented in this proposed rule conceptually
follows the specialty-weighted approach used in the CY 2000 and CY 2005
PFS final rules with comment period (63 FR 59383 and 69 FR 66263,
respectively) and incorporates the minor modifications discussed in the
CY 2006 final rule with comment period (70 FR 70153). We revised the
current specialty-weighted approach to accommodate additional data
gathered during the malpractice premium data collection. The specialty-
weighted approach bases the malpractice RVUs upon a weighted average of
the risk factors of all specialties furnishing a given service. This
approach ensures that all specialties furnishing a given service are
accounted for in the calculation of the final malpractice RVUs. Our
proposed methodology is as follows:
(1) Compute a preliminary national average premium for each
specialty. Insurance rating area malpractice premiums for each
specialty were mapped to the county level. The specialty premium for
each county is then multiplied by the total county RVUs (as defined by
Medicare claims data), which had been divided by the malpractice GPCI
applicable to each county to standardize the relative values for
geographic variations. If the malpractice RVUs were not normalized for
geographic variation, the locality cost differences (as reflected by
the GPCIs) would be counted twice. The product of the malpractice
premiums and standardized RVUs is then summed across counties for each
specialty. This calculation is then divided by the total RVUs for all
counties, for each specialty, to yield a national average premium for
each specialty.
(2) Determine which risk class(es) to use within each specialty.
Many specialties had premium rates that differed for major surgery,
minor surgery, and no surgery. These surgery classes are designed to
reflect differences in risk of professional liability and the cost of
malpractice claims if they occur. The same concept applies to
procedures; some procedures carry greater liability risks. Accordingly,
we identified major, minor, nonsurgical, and obstetric procedures among
all Medicare procedures by established indicators (Global Surgery
Flags). Table 5 shows the surgery class definitions used in the
proposed methodology.
Table 5--Surgery Classes by Procedure Code
----------------------------------------------------------------------------------------------------------------
Surgery class CPT code range Global surgery flag
----------------------------------------------------------------------------------------------------------------
Major Surgery (Maj)...................... 10000-69999................. 90 Day.
Minor Surgery (Min)...................... 10000-69999................. All Other.
Obstetrics (OB).......................... 59000-59899................. N/A.
No Surgery (NS).......................... All other CPT Codes......... N/A.
----------------------------------------------------------------------------------------------------------------
To account for the presence of surgery classes in the malpractice
premium data and the task of mapping these premiums to procedures, we
sought to calculate distinct risk factors for major, minor, and
nonsurgical procedures, as well as a comparable approach for obstetric
premiums and procedures. However, the availability of data by surgery
class varied across specialties. In light of the complexity of the
surgery class data, we evaluated both the frequency with which rate
class data were reported and a preliminary set of normed national
average premiums, calculated for all classes reported in the data.
Because no single approach accurately addressed the risk weights and
value differences of various specialty/procedure combinations, we
developed five strategies for handling the surgical classes and
defining specialties. These strategies are summarized in Table 6.
(a) Substantial Data for Each Class: For 13 out of 44 specialties,
we determined that there was sufficient data for each surgical class,
as well as sufficient differences in rates between classes, to use the
surgical class data as the basis for risk factors by surgical class.
(b) Major Surgery Dominates: These 8 surgical specialties typically
had rate filings that specified major surgery as the predominate rate
reported. Filings that distinguished minor surgery or nonsurgical were
relatively rare. For most of these surgical specialties, we did not
have ``unspecified'' rate filings. When we had ``unspecified'' rate
filings, the unspecified category was sometimes above and sometimes
below the major surgery rate. For these cases, we assigned the premium
for major surgery to all procedures conducted by this specialty. (In
practice, the major surgery procedures dominate the services actually
furnished.)
(c) Little or No Data for Major Surgery: For five other
specialties, specific premiums for major surgery were uncommon, but
most States had rate filings that represented minor surgery or
nonsurgical coverage. These five specialties had unspecified rates that
were less common than the minor surgery-nonsurgery distinction and the
nonsurgery rates. Therefore, for these five specialties we assigned the
minor surgery rate filings for both major surgery and minor surgery
procedures, and the nonsurgery filings for nonsurgical procedures.
[[Page 33540]]
(d) Unspecified Dominates: Many malpractice rate filings did not
specify surgery classes for some specialties; we refer to these
instances as unspecified malpractice rates. In only two cases, we
choose the unspecified premium as the premium information to use for
the specialty. For both of these specialties, fewer than 20 States had
rate filings that distinguished by surgical classes, while more than 40
had general rate filings for the specialty.
(e) Blend All Available: For the last 16 specialties, there was
wide variation across the State filings in terms of whether or not
surgical classes were reported and which categories were reported.
Because there was no clear strategy for these remaining specialties, we
blended the rate information we collected into one general premium rate
and applied that rate for all three premiums (major, minor and
nonsurgical). For these specialties, we developed a weighted average
``blended'' premium at the national level, according to the percentage
of physician work RVUs correlated with the surgery classes within each
specialty.
Table 6--Summary of Approaches To Defining Premiums by Surgical Class
------------------------------------------------------------------------
Situation Specialty codes
------------------------------------------------------------------------
1. Substantial Data for Each Class (13) 01 (non-OB), 04, 06, 07.
08 (non-OB), 10, 13, 18.
16 (non-OB), 38, 39, 46, 93.
2. Major Surgery Dominates (8)......... 02, 14, 20, 24, 28, 33, 77, 78.
3. Little or No Data for Major Surgery 11, 22, 37, 44, 82.
(5).
4. Unspecified Dominates (2)........... 05, 72.
5. Blend All Available (16)............ 03, 25, 26, 29, 30, 34, 36, 40,
48, 66, 71, 81, 83, 84, 90,
92.
------------------------------------------------------------------------
For rarely-billed Medicare procedures, we did not apply the 5
percent threshold for inclusion of services or specialties as utilized
in previous MP RVU updates. Rather, we are proposing to use the risk
factor of the dominant specialty by services for each procedure for
which the number of allowed services is less than 100. This approach
reflects the risk factors of the specialty that most frequently
furnishes these low volume procedures.
(3) Calculate a risk factor for each specialty. Differences among
specialties in malpractice premiums are a direct reflection of the
malpractice risk associated with the services furnished by a given
specialty. The relative differences in national average premiums
between various specialties can be expressed as a specialty risk
factor. These risk factors are an index calculated by dividing the
national average premium for each specialty by the national average
premium for the specialty with the lowest average premium, allergy/
immunology. Table 7 shows the risk factors by specialty and surgery
class.
Table 7--Risk Factors by Specialty and Surgery Class
----------------------------------------------------------------------------------------------------------------
Minor-surgical Major-surgical
Medicare code Medicare name Non-surgical RF RF RF
----------------------------------------------------------------------------------------------------------------
1............................ General Practice........... 1.50 2.26 3.56
2............................ General Surgery............ 5.87 5.87 5.87
3............................ Allergy Immunology......... 1.00 1.00 1.00
4............................ Otolaryngology............. 1.44 2.37 3.55
5............................ Anesthesiology............. 2.22 2.22 2.22
6............................ Cardiology................. 1.87 2.65 6.09
7............................ Dermatology................ 1.14 2.06 3.96
8............................ Family Practice............ 1.57 2.23 3.79
10........................... Gastroenterology........... 2.03 2.48 4.09
11........................... Internal Medicine.......... 1.72 2.52 2.52
13........................... Neurology.................. 2.20 2.90 10.28
14........................... Neurosurgery............... 9.94 9.94 9.94
16........................... Obstetrics Gynecology...... 1.67 2.37 4.64
18........................... Ophthalmology.............. 1.07 1.68 1.90
19........................... Oral Surgery............... 1.00 1.00 1.00
20........................... Orthopedic Surgery......... 5.46 5.46 5.46
22........................... Pathology.................. 1.74 2.26 2.26
24........................... Plastic and Reconstructive 5.51 5.51 5.51
Surgery.
25........................... Physical Medicine and 1.14 1.14 1.14
Rehabilitation.
26........................... Psychiatry................. 1.22 1.22 1.22
28........................... Colorectal Surgery......... 3.99 3.99 3.99
29........................... Pulmonary Disease.......... 2.08 2.08 2.08
30........................... Diagnostic Radiology....... 2.62 2.62 2.62
33........................... Thoracic Surgery........... 6.51 6.51 6.51
34........................... Urology.................... 2.64 2.64 2.64
35........................... Chiropractic............... 1.00 1.00 1.00
36........................... Nuclear Medicine........... 1.55 1.55 1.55
37........................... Pediatric Medicine......... 1.49 2.41 2.41
38........................... Geriatric Medicine......... 1.43 2.23 4.22
39........................... Nephrology................. 1.61 2.27 4.17
40........................... Hand Surgery............... 3.49 3.49 3.49
44........................... Infectious Disease......... 2.09 2.52 2.52
46........................... Endocrinology.............. 1.51 2.23 4.46
[[Page 33541]]
48........................... Podiatry................... 1.98 1.98 1.98
62........................... Psychologist............... 1.00 1.00 1.00
65........................... Physical Therapist......... 1.00 1.00 1.00
66........................... Rheumatology............... 1.56 1.56 1.56
67........................... Occupational Therapist..... 1.00 1.00 1.00
68........................... Clinical Psychologist...... 1.00 1.00 1.00
71........................... Registered Dietitian/ 1.54 1.54 1.54
Nutrition Professional.
72........................... Pain Management............ 2.21 2.21 2.21
77........................... Vascular Surgery........... 6.50 6.50 6.50
78........................... Cardiac Surgery............ 6.89 6.89 6.89
79........................... Addiction Medicine......... 1.00 1.00 1.00
81........................... Critical Care 2.15 2.15 2.15
(Intensivists).
82........................... Hematology................. 1.59 2.03 2.03
83........................... Hematology/Oncology........ 1.72 1.72 1.72
84........................... Preventive Medicine........ 1.16 1.16 1.16
85........................... Maxillofacial Surgery...... 1.00 1.00 1.00
86........................... Neuropsychiatry............ 1.22 1.22 1.22
90........................... Medical Oncology........... 1.76 1.76 1.76
91........................... Surgical Oncology.......... 5.87 5.87 5.87
92........................... Radiation Oncology......... 2.30 2.30 2.30
93........................... Emergency Medicine......... 2.29 3.77 4.87
94........................... Interventional Radiology... 2.62 2.62 2.62
98........................... Gynecological/Oncology..... 1.76 1.76 1.76
99........................... Unknown Physician Specialty 1.50 2.26 3.56
----------------------------------------------------------------------------------------------------------------
One complication in the calculation of specialty risk factors is
technical component (TC) data. Many procedures are comprised of
professional components (PC) and TCs. These components are referred to
as global procedures when billed together. The TC represents the cost
of equipment, supplies, and technician/staff salaries involved in
furnishing a procedure, such as the taking of an x-ray by a technician.
The PC represents the portion of a service that is furnished by a
physician such as the interpretation of an x-ray by the physician. The
distinction is important because PCs and TCs have different associated
risk factors and face different malpractice insurance costs. The
previous update of the malpractice RVUs did not update the TCs due to
the lack of available malpractice premium data for entities providing
TC services. In the past, we were unable to obtain data concerning
malpractice costs associated with the TC, so we based the malpractice
RVUs for TC services and the TC portion of global services on
historical allowed charges.
We have had ongoing discussions with the AMA RUC and various
specialty societies about this issue. In the CY 2008 PFS proposed rule
(72 FR 38143), we noted that the Professional Liability Insurance (PLI)
workgroup, a subset of the AMA RUC brought to our attention the fact
that there are approximately 600 services that have TC malpractice RVUs
that are greater than the PC malpractice RVUs. The PLI workgroup
requested that we make changes to these malpractice RVUs and suggested
that it is illogical for the malpractice RVUs for the TC of a service
to be higher than the malpractice RVUs for the PC.
We responded that we would like to develop a resource-based
methodology for the technical portion of these malpractice RVUs; but
that we did not have data to support such a change. We asked for
information about whether, and if so, how technicians employed by
facilities purchase PLI or how their professional liability is covered.
We also asked for comments on what types of PLI are carried by entities
that furnish these technical services.
In the CY 2009 PFS proposed rule (73 FR 38515), we stated that the
issue of assigning malpractice RVUs for the TC of certain services
continues to be a source of concern for several physician associations
and for CMS. We noted that we did not receive a response to our CY 2008
request for additional data on this issue and that this issue is one of
importance to CMS. We also stated that the lack of available PLI data
affects our ability to make a resource-based evaluation of the TC
malpractice RVUs for these codes. We indicated that as part of our work
to update the malpractice RVUs in CY 2010, we would instruct our
contractor to research available data sources for the malpractice costs
associated with the TC portion of these codes and that we would also
ask the contractor to look at what is included in general liability
insurance versus PLI for physicians and other professional staff. We
also stated that if data sources were available, we would instruct the
contractor to gather the data so we will be ready to implement revised
malpractice RVUs for the TC of these codes in conjunction with the
update of malpractice RVUs for the PCs in CY 2010.
In the CY 2009 PFS final rule (73 FR 69741), we again responded to
comments on this issue. We noted that one commenter provided us with
the name of a company that provides liability insurance to imaging
facilities. We stated that we planned to share the information with our
contractor and that if premium data could be identified; it would be
incorporated into the malpractice RVU update. Our contractor, Acumen
LLC, contacted the company suggested by the commenter and obtained
medical physicist malpractice premium data from one of the largest
association program insurance brokers and administrators in the United
States providing this type of malpractice insurance. The premium data
indicate that medical physicists have very low malpractice premiums
relative to physicians.
Medical physicists are involved in complex services such as
Intensity-Modulated Radiation Therapy (IMRT). IMRT is an advanced mode
of radiotherapy that utilizes computer-controlled x-ray accelerators to
deliver radiation doses to a malignant tumor. Based on the complexity
of these services, we believe that medical
[[Page 33542]]
physicists would pay one of the highest malpractice premium rates of
the entities furnishing TC services and that using their data as a
proxy (in the absence of actual premium data) to develop malpractice
RVUs for TC services would be more realistic than our current approach
for these entities. Moreover, we believe it is unlikely that actual
malpractice premium rates for these entities would exceed those for
medical physicists. Therefore, based on this new data collection, we
are proposing to use the medical physicists' premium data as a proxy
for the malpractice premiums paid by entities providing TC services. We
believe that the use of this data will better reflect the level of
malpractice premiums paid by entities providing TC services than the
current charge-based malpractice RVUs or crosswalks to the malpractice
premium data of physician specialties.
As we have done in the past, we continue to encourage public
commenters to submit or identify alternative data that we might use for
the purpose of establishing malpractice RVUs.
(4) Calculate malpractice RVUs for each code. Resource-based
malpractice RVUs were calculated for each procedure. The first step was
to identify the percentage of services furnished by each specialty for
each respective procedure code. This percentage was then multiplied by
each respective specialty's risk factor as calculated in Step 3. The
products for all specialties for the procedure were then added
together, yielding a specialty-weighted malpractice RVU reflecting the
weighted malpractice costs across all specialties for that procedure.
This sum was then multiplied by the procedure's work RVUs to account
for differences in risk-of-service.
Certain codes have no physician work RVUs. The overwhelming
majority of these codes are the TCs of diagnostic tests, such as x-rays
and cardiac catheterization, which have a distinctly separate TC (the
taking of an x-ray by a technician) and PC (the interpretation of the
x-ray by a physician). Examples of other codes with no work RVUs are
audiology tests and injections. These services are usually furnished by
NPPs, in this example, audiologists and nurses, respectively. In many
cases, the NPP or entity furnishing the TC is distinct and separate
from the physician ordering and interpreting the test. We believe it is
appropriate for the malpractice RVUs assigned to TCs to be based on the
malpractice costs of the NPP or entity, not the professional liability
of the physician.
Our proposed methodology, however, would result in zero malpractice
RVUs for codes with no physician work, since we propose the use of
physician work RVUs to adjust for risk-of-service. We believe that zero
malpractice RVUs for reasons other than rounding would be inappropriate
because NPPs and entities such as IDTFs also have malpractice
liability.
Note that the earlier discussion above in ``(3) Calculate a risk
factor for each specialty'' addressed the proposed use of the medical
physicist premium data to develop a TC risk factor. This TC risk factor
is used in (3), as noted above, along with the global risk factor to
calculate a PC risk factor. Once the global and PC risk factors are
calculated, they are used here in step (4) to calculate the global and
PC malpractice RVUs. Once we have calculated the global and PC
malpractice RVUs, we propose to address the lack of work RVUs for TC
services by setting the TC malpractice RVUs equal to the difference
between the global malpractice RVUs and PC malpractice RVUs.
(5) Rescale for budget neutrality. The statute requires that
changes to fee schedule RVUs be budget neutral. The current resource-
based malpractice RVUs and the proposed resource-based malpractice RVUs
were constructed using entirely different malpractice premium data.
Thus, the last step is to adjust for budget neutrality by rescaling the
proposed malpractice RVUs so that the total proposed resource-based
malpractice RVUs equal the total current resource-based malpractice
RVUs.
We are requesting comments on our proposed methodology for updating
the malpractice RVUs. We are especially interested in comments on our
proposed process for revising the malpractice RVUs of the TC of codes
with no physician work. Additionally, we intend to post the Acumen
report, ``Interim Report on Malpractice RVUs for the CY 2010 Medicare
Physician Fee Schedule Proposed Rule'' on the CMS Web site in
conjunction with publication of this proposed.
D. Medicare Telehealth Services
1. Requests for Adding Services to the List of Medicare Telehealth
Services
Section 1834(m)(4)(F) of the Act defines telehealth services as
professional consultations, office visits, and office psychiatry
services, and any additional service specified by the Secretary. In
addition, the statute requires us to establish a process for adding
services to or deleting services from the list of telehealth services
on an annual basis.
In the December 31, 2002 Federal Register (67 FR 79988), we
established a process for adding services to or deleting services from
the list of Medicare telehealth services. This process provides the
public an ongoing opportunity to submit requests for adding services.
We assign any request to make additions to the list of Medicare
telehealth services to one of the following categories:
Category #1: Services that are similar to professional
consultations, office visits, and office psychiatry services. In
reviewing these requests, we look for similarities between the
requested and existing telehealth services for the roles of, and
interactions among, the beneficiary, the physician (or other
practitioner) at the distant site and, if necessary, the telepresenter.
We also look for similarities in the telecommunications system used to
deliver the proposed service, for example, the use of interactive audio
and video equipment.
Category #2: Services that are not similar to the current
list of telehealth services. Our review of these requests includes an
assessment of whether the use of a telecommunications system to deliver
the service produces similar diagnostic findings or therapeutic
interventions as compared with the face-to-face ``hands on'' delivery
of the same service. Requesters should submit evidence showing that the
use of a telecommunications system does not affect the diagnosis or
treatment plan as compared to a face-to-face delivery of the requested
service.
Since establishing the process, we have added the following to the
list of Medicare telehealth services: Psychiatric diagnostic interview
examination; ESRD services with two to three visits per month and four
or more visits per month (although we require at least one visit a
month to be furnished in-person ``hands on,'' by a physician, clinical
nurse specialist (CNS), nurse practitioner (NP), or physician assistant
(PA) to examine the vascular access site); individual medical nutrition
therapy; neurobehavioral status exam; and follow-up inpatient
telehealth consultations.
Requests to add services to the list of Medicare telehealth
services must be submitted and received no later than December 31 of
each calendar year to be considered for the next rulemaking cycle. For
example, requests submitted before the end of CY 2008 are considered
for the CY 2010 proposed rule. Each request for adding a service to the
list of Medicare telehealth
[[Page 33543]]
services must include any supporting documentation you wish us to
consider as we review the request. Because we use the annual PFS
rulemaking process as a vehicle for making changes to the list of
Medicare telehealth services, requesters should be advised that any
information submitted is subject to disclosure for this purpose. For
more information on submitting a request for an addition to the list of
Medicare telehealth services, including where to mail these requests,
visit our Web site at http://www.cms.hhs.gov/telehealth/.
2. Submitted Requests for Addition to the List of Telehealth Services
We received requests in CY 2008 to add the following services as
Medicare telehealth services effective for CY 2010: (1) Health and
behavior assessment and intervention (HBAI) procedures; and (2) nursing
facility services. In addition, we received a number of requests to add
services that we considered previously and did not approve as Medicare
telehealth services in previous PFS rules. These requested services
include critical care services; initial and subsequent hospital care;
group medical nutrition therapy; diabetes self-management training;
speech and language pathology services; and physical and occupational
therapy services. The following is a discussion of these requests.
a. Health and Behavior Assessment and Intervention (HBAI)
The American Psychological Association (APA) submitted a request to
add HBAI services (as described by HCPCS codes 96150 through 96154) to
the list of approved telehealth services. The APA asks us to evaluate
and approve HBAI services as Category 1 service because they
are comparable to the psychotherapy services currently approved for
telehealth.
CMS Review
To determine whether to assign a request to Category 1, we
look for similarities between the service that is being considered for
addition and the existing telehealth services in the roles of, and
interactions among, the beneficiary, the physician (or other
practitioner) at the distant site and, if necessary, the telepresenter.
Clinical psychologists furnish HBAI services to beneficiaries to
help them manage or improve their behavior in response to physical
problems. Elements of HBAI services typically include interviewing,
observing, and counseling beneficiaries to help them modify their
behavior. These elements are also common to the office psychiatry
services currently approved for telehealth. We believe the interaction
between a practitioner and a beneficiary receiving individual HBAI
services (as described by HCPCS codes 96150 through 96152) is similar
to the assessment and counseling elements of the individual office
psychiatry services currently approved for telehealth. Therefore, we
are proposing to revise Sec. 410.78 and Sec. 414.65 to include
individual HBAI services as Medicare telehealth services.
With regard to group HBAI (as described by HCPCS code 96153) or
family-with-patient HBAI (as described by HCPCS code 96154), we note
that no group services are currently approved as Medicare telehealth
services. Group counseling services have a different interactive
dynamic between the physician or practitioner and his or her patients
as compared to individual services. No other group counseling or other
group services are approved as telehealth services. Since the
interactive dynamic for group HBAI services is not similar to that for
individual HBAI services or any other approved telehealth services, we
do not believe that group HBAI or family-with-patient HBAI services are
properly considered as Category 1 requests. To be considered
as a Category 1 request, a service must be similar to the
current list of Medicare telehealth services. (See 70 FR 45787 and
70157, and 73 FR 38516 and 69743).
Since the interactive dynamic between practitioner and patient for
group HBAI and family-with-patient HBAI is not similar to that for
office psychiatry services or any other service currently approved for
telehealth, we believe that group HBAI and family-with-patient HBAI
must be evaluated as Category 2 services. Because we consider
group HBAI and family-with-patient HBAI to be Category 2
services, we need to evaluate whether these are services for which
telehealth can be an adequate substitute for a face-to-face encounter.
The requester did not submit evidence suggesting that the use of a
telecommunications system to deliver these services would produce
similar diagnostic findings or therapeutic interventions as compared to
the face-to-face delivery of these services. As such, we do not propose
to add group HBAI (as described by HCPCS code 96153) or family-with-
patient HBAI (as described by HCPCS code 96154) to the list of approved
telehealth services.
b. Nursing Facility Services
In 2005, we received a request to add the following nursing
facility services to the list of approved telehealth services: Initial
nursing facility care (as described by HCPCS codes 99304 through
99306); subsequent nursing facility care (HCPCS codes 99307 through
99310); nursing facility discharge services (HCPCS codes 99315 and
99316); and other nursing facility services (HCPCS code 99318). In the
CY 2007 PFS final rule with comment period, we did not add these
nursing facility care services to the list of approved telehealth
services because these procedure codes did not describe services that
were appropriate to add to the list of available telehealth originating
sites in CY 2007. At that time, skilled nursing facilities (SNFs) were
not defined in the statute as originating sites (71 FR 69657).
However, section 149 of the MIPPA added SNFs as telehealth
originating sites effective for services furnished on or after January
1, 2009. In light of this provision, the American Telemedicine
Association (ATA) urged us to add nursing facility care codes to the
list of telehealth services for CY 2009, as requested in 2005.
In the CY 2009 PFS final rule with comment period, we noted that
section 149 of the MIPPA did not add any services to the list of
Medicare telehealth services. In the CY 2009 PFS final rule with
comment period, we also responded to the ATA's comment suggesting that
we add nursing facility care codes to the list of telehealth services
for CY 2009, as requested in 2005. In our response, we noted that when
we received the 2005 request to consider the addition of nursing
facility care services for telehealth for CY 2007, we did not include a
full review of these codes in either the CY 2007 PFS proposed rule or
final rule with comment period since we believed it was not relevant to
add the nursing facility services codes when the SNFs in which these
services would be furnished were not eligible originating sites. In the
CY 2009 PFS final rule with comment period, we responded that we
believe it would be more appropriate to consider the addition of
nursing facility care services for telehealth through our existing
process, including full notice and comment procedures. We committed to
revisiting the 2005 request to add the nursing facility codes in the CY
2010 PFS proposed rule, and we noted that we would accept additional
information in support of the 2005 request if we received the
information prior to December 31, 2008 (73 FR 69747).
Subsequent to publication of the CY 2009 PFS final rule with
comment period, the ATA submitted an amended request to add subsequent
nursing facility care; nursing facility discharge
[[Page 33544]]
services; and other nursing facility services to the list of approved
telehealth services. The Center for Telehealth and e-Health Law
submitted a request to add the same nursing facility services and
indicated its support of ATA's request. We also received a request from
the Marshfield Clinic to add the same services requested by the ATA,
plus the initial nursing facility care services. The requesters drew
analogies to the evaluation and management (E/M) services currently
approved for telehealth, and they provided evidence in support of their
belief that the use of telehealth could be a reasonable surrogate for
the face-to-face delivery of this type of care.
CMS Review
The procedure codes included in these requests are used to report
E/M services furnished onsite to patients in nursing facilities. In the
context of these codes, ``nursing facility'' describes SNFs, NFs,
intermediate care facilities, and psychiatric residential treatment
centers.
Medicare telehealth services can only be furnished to beneficiaries
located at an originating site authorized by law. A SNF (as defined in
section 1819(a) of the Act) is the only type of nursing facility that
can also be considered an originating site for telehealth services.
Therefore, our review of these services focuses on the potential impact
of adding these services when furnished via telehealth to a Medicare
beneficiary located in a SNF.
Federally-Mandated Visits in Skilled Nursing Facilities
In describing our assessment, we first describe the service
requirements of a Medicare SNF stay. In response to concerns about
inadequate care provided to residents of nursing homes, the Omnibus
Budget Reconciliation Act of 1987 (OBRA '87) (Pub. L. 100-203) included
extensive revisions to the requirements for Medicare and Medicaid
certified nursing homes. These provisions were designed to
significantly improve the quality of life and the quality of care
provided to residents of nursing homes, and were a high priority for
the Department of Health and Human Services.
Specific requirements for assuring the quality of care that SNFs
must meet to participate in Medicare are specified in section 1819 of
the Act. In addition, section 1819(d)(4)(B) of the Act provides that
``[a] skilled nursing facility must meet such other requirements
relating to the health, safety, and well-being of residents or relating
to the physical facilities thereof as the Secretary may find
necessary.'' The provisions of 42 CFR Part 483 codify the requirements
set forth in the statute that long term care facilities are obligated
to meet in order to participate in the Medicare and/or Medicaid
program.
Section 1819(b)(6)(A) of the Act requires that the medical care of
every SNF resident must be provided under the supervision of a
physician. The requirements contained in Sec. 483.40 include a
prescribed visit schedule and specify that the physician must perform
the initial visit personally. Section 483.40(c) requires that the
resident of a SNF must be seen by a physician at least once every 30
days for the first 90 days after admission, and at least once every 60
days thereafter. As we indicated in the preamble to the February 2,
1989 final rule (54 FR 5341), and again in response to comments in the
September 26, 1991 final rule (56 FR 48826), the wording of the
regulation states that the resident ``must be seen'' by the physician
and requires an actual, face-to-face contact. Except for certain stated
exceptions, all required physician visits must be made personally by
the physician. Section 483.40(e)(2) requires that when personal
performance of a particular task by a physician is specified in the
regulations, performance of that task cannot be delegated to anyone
else. Section 483.40(c)(4) requires that the physician must perform the
initial visit personally, and Sec. 483.40(c)(5), allows the physician
the option of alternating with a qualified NPP (that is, physician
assistant, nurse practitioner, or clinical nurse specialist) in making
the subsequent required visits. These regulations ensure that at least
a minimal degree of personal contact between physician or qualified NPP
and resident is maintained, both at the point of admission to the
facility and periodically during the course of the resident's stay (54
FR 5342).
In the CY 2009 PFS final rule with comment period (73 FR 69747), we
noted that in considering nursing facility care for telehealth, we
would need to carefully evaluate the use of telehealth for the personal
visits that are currently required under Sec. 483.40. The OBRA '87 and
other long-term care legislation enacted since then require a SNF to
care for its residents ``in such a manner and in such an environment as
will promote maintenance or enhancement of the quality of life of each
resident'' as specified in section 1819(b)(1)(A) of the Act. We believe
that a minimum number of periodic, comprehensive, hands-on examinations
of a resident by a physician or a qualified NPP are necessary to ensure
that the resident receives quality care. We believe that the complexity
of care required by many residents of SNFs warrants at least a minimal
degree of direct personal contact between physicians or qualified NPPs
and SNF residents. Therefore, we believe that these Federally-mandated
visits should be conducted in-person, and not as telehealth services,
in order to provide direct personal contact between the resident and
the physician or qualified NPP.
In the MMA, the Congress recognized the importance of furnishing
the Federally-mandated visits in person, rather than via telehealth.
Section 418 of the MMA required the Secretary to submit a Report to
Congress evaluating the use of telehealth in SNFs. If the Secretary
determined that it was advisable to permit a SNF to be an originating
site for telehealth services, the MMA provided the Secretary with the
authority to expand telehealth originating sites to include SNFs. SNFs
were permitted to be added as originating sites only if the Secretary
could establish a mechanism to ensure that telehealth does not serve as
a substitute for in-person visits furnished by a physician, or for in-
person visits furnished by a physician assistant, nurse practitioner,
or clinical nurse specialist.
On November 9, 2007, the Secretary provided to Congress the report
specified under section 418 of the MMA, entitled, ``Permitting Skilled
Nursing Facilities to be Originating Telehealth Sites.'' Overall, the
Report noted that evidence concerning the net impact of allowing SNFs
to be originating telehealth sites was not conclusive and further
analysis was needed. With respect to Federally-mandated visits in SNFs,
the Report stated that the Secretary could use its authority to add
services to and delete services from the list of Medicare telehealth
services as a mechanism to ensure that Federally-mandated visits are
not furnished as a Medicare telehealth service by not adding these
visits to the lists of Medicare telehealth services.
In consideration of the history of the OBRA '87, 42 CFR part 483,
and Congressional concern expressed in section 418 of the MMA, we do
not propose to add any procedure codes that are used exclusively to
describe E/M services that fulfill Federal requirements for personal
visits under Sec. 483.40. We are proposing to revise Sec. 410.78 to
restrict physicians and practitioners from using telehealth to furnish
the physician visits required under Sec. 483.40(c).
[[Page 33545]]
In the following sections, we will separately review the use of
telehealth for each of the subcategories of nursing facility services
included in these requests. In these discussions, we will also indicate
which of these subcategories are used to describe E/M services that
fulfill Federal requirements for personal visits under Sec. 483.40.
Initial Nursing Facility Care
The initial nursing facility care procedure codes (as described by
HCPCS codes 99304 through 99306) are used to report the initial E/M
visit in a SNF or NF that fulfills Federally-mandated requirements
under Sec. 483.40(c). For survey and certification requirements, this
initial visit must occur no later than 30 days after admission. In a
SNF, a physician must furnish the initial visit.
One of the requesters noted that once the patient is transferred to
the SNF, it might be days until a physician can see a resident in-
person. The requester believes a higher quality of care would be
provided if the initial nursing facility service can be done in an
expeditious manner--via telehealth--rather than delayed until the
physician is on site.
As noted above, we are not proposing to add any procedure codes
that are used exclusively to describe E/M services that fulfill Federal
requirements for personal visits under Sec. 483.40. We believe that
these Federally-mandated visits should be conducted in-person because
this will ensure at least a minimal degree of direct personal contact
between physicians or qualified NPPs and residents. Further, we believe
it is particularly important that the Federally-mandated initial visit
should be conducted in-person because this will ensure that the
physician can comprehensively assess the resident's condition upon
admission to the SNF through a thorough hands-on examination. We
believe that even if the initial visit is delayed for a few days, it is
necessary for the resident of a SNF to have a face-to-face visit with
the physician who is developing a plan of care. Under section
1819(b)(2) of the Act, a SNF must provide services to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being of each resident. We believe that furnishing the initial
visit in a face-to-face encounter, and not via telehealth, is necessary
to assure quality care. As such, we are not proposing to add the
initial nursing facility care services (as described by HCPCS codes
99304 through 99306) to the list of approved telehealth services.
Subsequent Nursing Facility Care
The subsequent nursing facility care procedure codes (as described
by HCPCS codes 99307 through 99310) are used to report either a
Federally-mandated periodic visit under Sec. 483.40(c), or any E/M
visit, prior to and after the initial physician visit, that is
reasonable and medically necessary to meet the medical needs of the
individual resident.
The long-term care regulations at Sec. 483.40 require periodic
physician visits for residents of SNFs (and NFs) at least once every 30
days for the first 90 days after admission and at least once every 60
days thereafter. After the initial visit, Federally-mandated periodic
visits in SNFs may, at the option of the physician, alternate between
personal visits by the physician and visits by a qualified NPP (who is
under the supervision of a physician, and meets the other requirements
specified at Sec. 483.40(e)). As noted above, we are not proposing to
allow the use of telehealth to furnish these Federally-mandated
personal visits. We believe that these Federally-mandated periodic
visits should be conducted in-person because this will ensure at least
a minimal degree of direct personal contact between physicians or
qualified NPPs and residents. Under section 1819(b)(2) of the Act, a
SNF must provide services to attain or maintain the highest practicable
physical, mental, and psychosocial well-being of each resident. We
believe that furnishing the periodic personal visits in face-to-face
encounters, and not via telehealth, is necessary to assure quality
care.
We considered the possibility of approving subsequent nursing
facility care for telehealth with specific limitations, for example,
approving subsequent nursing facility care for telehealth only when the
codes are used for medically necessary E/M visits that are in addition
to Federally mandated periodic personal visits. In past years, we did
not add hospital E/M visits to the list of Medicare approved telehealth
services because of our concern regarding the use of telehealth for the
ongoing E/M of a high-acuity hospital inpatient. (See 69 FR 47511, 69
FR 66276, 72 FR 38144, 72 FR 66250, 73 FR 38517, and 73 FR 69745.) Many
residents of SNFs require medically complex care, and we have similar
concerns about allowing physicians or NPPs to furnish E/M visits via
telehealth to residents of SNFs.
Because the complexity of care required by many residents of SNFs
may be significantly greater than the complexity of care generally
associated with patients receiving the office visits approved for
telehealth, we do not consider E/M visits furnished to residents of
SNFs similar to the office visits on the current list of Medicare
telehealth services. Therefore, we believe the use of subsequent
nursing facility care for medically necessary E/M visits that are in
addition to Federally mandated periodic personal visits must be
evaluated as a Category 2 service.
Because we consider subsequent nursing facility care to be a
Category 2 request, we evaluate whether these are services for
which telehealth can be an adequate substitute for a face-to-face
encounter. The requesters submitted supporting documentation intended
to suggest that the use of telehealth could be a reasonable surrogate
for the face-to-face delivery of this type of care.
One study assessed the impact of videoconferencing (as opposed to
communication by telephone without video) on nighttime, on-call medical
decision-making in the nursing home. The comparison of
videoconferencing with telephonic communication of information by
nurses does not provide a comparative analysis demonstrating that E/M
visits furnished via telehealth to residents of SNFs is equivalent to
the face-to-face delivery of such services. As such, this study was not
relevant to this review.
Another study assessed the value of a monitoring system in reducing
falls and injuries in non-acute late-evening and nighttime situations
in a nursing home setting. The monitoring system described in this
study was comprised of sensors to alert caregivers via a silent pager
when a high-risk resident exits his or her bed, bedroom, or bathroom.
This allows caregivers to aid the resident and potentially reduce
falls. The technologies utilized in this study do not correspond with
our definitions of telehealth as specified in Sec. 410.78. In
addition, this type of resident monitoring is performed typically by
nursing staff and is not an E/M visit. As such, this study was not
relevant to this review.
A third study presented the savings achieved through avoiding
transport to emergency departments and physicians' offices by
furnishing visits via telehealth to residents in nursing facilities.
The study did not provide any comparative analysis of the services
furnished via telehealth with those furnished in person.
A fourth study evaluated the impact of telemedicine as a decision
aid for residents of long-term care SNFs with chronic wounds. The
patients selected for this study were alert and
[[Page 33546]]
intellectually interactive. The study concluded that furnishing a
telehealth consultation prior to a face-to-face consultation increased
the level of patient comfort with care-related decisions made during
the face-to-face consultation. The control group did not receive an
equivalent intermediate consultation face-to-face that could be
compared to the services furnished to the test group. We acknowledge
the study's findings that the intermediate telehealth consultation was
a useful decision aid, but we do not consider this a comparative
analysis between delivery of the same type of care via telehealth
versus face-to-face.
We received a pilot study evaluating the usefulness of E/M services
furnished via telehealth for making routine medical decisions in the
nursing home. The nursing home residents were evaluated over
videoconferencing and then evaluated immediately afterward by the same
clinician in person. On a scale of 1 to 5 (1 being the least ill), the
clinicians assessed the illness level of these residents at 3 or below,
with the illness level for over 65 percent of the encounters assessed
at ``1.'' Videoconferencing without a face-to-face examination was
sufficient for making medical decisions in most cases studied in this
pilot, although face-to-face examinations were preferred. Clinicians
generated orders in 30 percent of these paired encounters, with a
predominance of orders generated after, rather than before, the face-
to-face examination. The study also noted that even when nursing home
residents were alert, they had limited participation in the
telemedicine interactions and were not as involved in making informed
medical decisions with their clinicians, compared to face-to-face
encounters. The study suggests that remote examination by video might
serve as a substitute for some routine visits, if interspersed with
face-to-face examinations. The study concluded that videoconferencing
is feasible for making routine medical decisions in the nursing home.
We appreciate the comparative analysis provided by this study.
However, we note that this study focused on the usefulness of
telehealth for routine decision-making in the nursing home, and the
reported illness levels of the residents in these sample encounters was
relatively low to moderate. We do not consider these findings
persuasive that telehealth can, more generally, be an adequate
substitute for the face-to-face delivery of E/M visits to residents of
SNFs who might require more medically complex care.
We considered the possibility of approving the use of telehealth to
furnish E/M visits to residents of SNFs who do not require medically
complex care or approving subsequent nursing facility care for
telehealth only for medically necessary E/M visits with straightforward
or low complexity medical decision-making (as described by HCPCS codes
99307 and 99308). Although this last pilot study concluded that
videoconferencing is feasible for making routine medical decisions in
the nursing home, we are concerned with the study's finding that
residents with low to moderate levels of reported illness had limited
participation in the telemedicine interactions and less involvement in
making informed medical decisions with their clinicians, compared to
face-to-face encounters. Under section 1819(c)(1)(A) of the Act, a SNF
must protect and promote the rights of each resident, including the
right to be fully informed in advance of any changes in care or
treatment that may affect the resident's well-being, and (except with
respect to a resident adjudged incompetent) to participate in planning
care and treatment or changes in care or treatment. Under Sec.
483.10(b)(3), a resident has the right to be fully informed in language
that he or she can understand of his or her total health status,
including but not limited to his or her medical condition. If the use
of telehealth does not elicit from residents with low to moderate
reported illness adequate participation in making informed medical
decisions with their clinicians when compared to face-to-face
encounters, we believe that telehealth is not an adequate substitute
for the face-to-face delivery of E/M visits to any residents of SNFs.
After reviewing these studies, we do not have sufficient
comparative analysis or other compelling evidence to demonstrate that
furnishing E/M visits via telehealth to residents of SNFs is an
adequate substitute for the face-to-face encounter between the
practitioner and the resident, especially in cases where the resident
requires medically complex care. Therefore, we are not proposing to add
subsequent nursing facility care services (as described by HCPCS codes
99307 through 99310) to the list of approved telehealth services.
Nursing Facility Discharge Day Management
The nursing facility discharge day management codes (as described
by HCPCS codes 99315 and 99316) are used to report an E/M visit that
prepares a resident for discharge from a nursing facility. We note that
there is no Medicare Part B requirement to furnish and bill an E/M
visit in preparation for a resident's discharge from a SNF. However, if
a physician or qualified NPP bills a Nursing Facility Discharge
Services code, we believe that a face-to-face encounter will better
insure that the resident is prepared for discharge, as we do not have
evidence that nursing facility discharge services via telehealth is
adequately equivalent to face-to-face provision. As such, we are not
proposing to add the nursing facility discharge day management services
(as described by HCPCS codes 99315 and 99316) to the list of approved
telehealth services.
Other Nursing Facility Service
In 2006, CPT added a procedure code for Other Nursing Facility
Service (CPT code 99318) to describe an annual nursing facility
assessment. An annual assessment is not one of the required visits
under the long-term care regulations at Sec. 483.40. For Medicare
purposes, this code can be used in lieu of a Subsequent Nursing
Facility Care code to report a Federally-mandated periodic personal
visit furnished under Sec. 483.40(c). An annual assessment visit
billed using CPT code 99318 does not represent a distinct benefit
service for Medicare Part B physician services, and it cannot be billed
in addition to the required number of Federally-mandated periodic
personal visits. Under Medicare Part B, we cover this procedure code if
the visit fully meets the CPT code 99318 requirements for an annual
nursing facility assessment and if such an annual assessment falls on
the 60-day mandated visit cycle. We are not proposing to add the other
nursing facility care services (as described by HCPCS code 99318) to
the list of approved telehealth services because this code is payable
by Medicare only if the visit is substituted for a Federally-mandated
visit under Sec. 483.40(c). As explained above, we believe all of the
Federally-mandated periodic visits must be conducted in person.
Follow-up Inpatient Consultations
Prior to 2006, follow-up inpatient consultations (as described by
CPT codes 99261 through 99263) were approved telehealth services. In
2006, the CPT Editorial Panel of the American Medical Association (AMA)
deleted the codes for follow-up inpatient consultations. In the
hospital setting, the AMA advised practitioners to bill for services
that would previously have been billed as follow-up inpatient
consultations using the procedure codes for subsequent hospital care
(as described by CPT codes 99231 through 99233). In the nursing
facility setting,
[[Page 33547]]
the AMA advised practitioners to bill for these services using the
procedure codes for subsequent nursing facility care (as described by
CPT codes 99307 through 99310).
In the CY 2008 PFS proposed rule (72 FR 38144) and subsequent final
rule with comment period (72 FR 66250), we discussed a request from the
ATA to add subsequent hospital care to the list of approved telehealth
services. Because there was no method for practitioners to bill for
follow-up consultations delivered via telehealth to hospital
inpatients, the ATA requested that we add the subsequent hospital care
codes to the list of Medicare approved telehealth services. We
expressed our concern that subsequent hospital care codes describe a
broader range of services than follow-up consultations, including some
services that may not be appropriate to be furnished via telehealth. We
committed to continue evaluating the issues.
In the CY 2009 PFS proposed rule (73 FR 38517), we proposed to
create a new series of HCPCS codes for follow-up inpatient telehealth
consultations. In the CY 2009 PFS final rule with comment period (73 FR
69745), we finalized our proposal to create follow-up inpatient
telehealth consultation codes (as described by HCPCS codes G0406
through G0408) and added these G-codes to the list of Medicare
telehealth services. These HCPCS codes are limited to the range of
services included in the scope of the previous CPT codes for follow-up
inpatient consultations, and the descriptions limit the use of such
services for telehealth. (See the CMS Internet-Only Medicare Benefit
Policy Manual, Pub. 100-02, Chapter 15, Section 270.2.1 and the
Medicare Claims Processing Manual, Pub. 100-04, Chapter 12, Section
190.3.1 for the current definition of follow-up inpatient telehealth
consultations.)
We note that if the former codes for follow-up consultations (as
described by CPT codes 99261 through 99263) still existed, these
procedure codes would also be available to practitioners to submit
claims to their Medicare contractors for payment of follow-up
consultations provided via telehealth to patients located in SNFs.
Although we did not receive a public request to add follow-up inpatient
consultations for patients in SNFs to the list of approved Medicare
telehealth services, we recognize a similar need to establish a method
for practitioners to furnish and bill for follow-up consultations
delivered via telehealth to patients in SNFs.
We considered the possibility of approving subsequent nursing
facility care for telehealth with specific limitations, for example,
approving subsequent nursing facility care for telehealth only when the
codes are used for follow-up consultations. However, as discussed
above, we do not believe it would be appropriate for E/M visits to be
furnished via telehealth to treat residents of SNFs requiring medically
complex care. We are concerned that it could be difficult to implement
sufficient controls and monitoring to ensure that the use of the
subsequent nursing facility care codes for telehealth is limited to the
delivery of services that were formerly described as follow-up
inpatient consultations.
We considered creating new G-codes to enable practitioners to bill
for the services that were formerly described as follow-up inpatient
telehealth consultations when furnished to residents of SNFs. We
examined the feasibility of creating such codes to parallel the
subsequent nursing facility care services, which are the codes
currently used to bill these follow-up consultations in a face-to-face
encounter. We found that the elements of the four levels of subsequent
nursing facility care did not correspond to the three levels of the
deleted CPT codes previously used for follow-up inpatient
consultations. We believe that it would be administratively simpler to
utilize the three existing codes for follow-up inpatient telehealth
consultations rather than add additional G-codes. The use of the same
``follow-up inpatient telehealth consultation'' G-codes for services
furnished in both hospital inpatient and SNF settings would also
correspond to the use of the previous CPT codes for services furnished
to hospital inpatients and residents of SNFs.
For CY 2010, we are proposing to revise Sec. 410.78 to specify
that the G-codes for follow-up inpatient telehealth consultations (as
described by HCPCS codes G0406 through G0408) include follow-up
telehealth consultations furnished to beneficiaries in hospitals and
SNFs. The HCPCS codes will clearly designate these services as follow-
up consultations provided via telehealth, and not subsequent nursing
facility care used for E/M visits. Utilization of these codes for
patients in SNFs will facilitate payment for these services, as well as
enable us to monitor whether the codes are used appropriately.
As described in the CMS Internet-Only Medicare Benefit Policy
Manual, Pub. 100-02, Chapter 15, Section 270.2.1 and the Medicare
Claims Processing Manual, Pub. 100-04, Chapter 12, Section 190.3.1,
follow-up inpatient telehealth consultations include monitoring
progress, recommending management modifications, or advising on a new
plan of care in response to changes in the patient's status or no
changes on the consulted health issue. Counseling and coordination of
care with other providers or agencies is included as well, consistent
with the nature of the problem(s) and the patient's needs. The
physician or practitioner who furnishes the inpatient follow-up
consultation via telehealth cannot be the physician of record or the
attending physician, and the follow-up inpatient consultation would be
distinct from the follow-up care provided by a physician of record or
the attending physician. If a physician consultant has initiated
treatment at an initial consultation and participates thereafter in the
patient's ongoing care management, such care would not be included in
the definition of a follow-up inpatient consultation and is not
appropriate for delivery via telehealth.
Consistent with our policy for follow-up telehealth consultations
furnished to hospital inpatients, in order to bill and receive payment
for these services, physicians and practitioners must submit the
appropriate HCPCS procedure code for follow-up inpatient telehealth
consultations along with the ``GT'' modifier (``via interactive audio
and video telecommunications system''). By coding and billing the
``GT'' modifier with the follow-up inpatient telehealth consultation
codes, the distant site physician or practitioner certifies that the
beneficiary was present at an eligible originating site when the
telehealth service was furnished. (See the CMS Internet-Only Medicare
Claims Processing Manual, Pub. 100-04, Chapter 12, Section 190.6.1 for
instructions for submission of interactive telehealth claims.)
In the case of Federal telemedicine demonstration programs
conducted in Alaska or Hawaii, store and forward technologies may be
used as a substitute for an interactive telecommunications system.
Covered store and forward telehealth services are billed with the
``GQ'' modifier, ``via asynchronous telecommunications system.'' By
using the ``GQ'' modifier, the distant site physician or practitioner
certifies that the asynchronous medical file was collected and
transmitted to him or her at the distant site from a Federal
telemedicine demonstration project conducted in Alaska or Hawaii. (See
the CMS Internet-Only Medicare Claims Processing Manual, Pub. 100-04,
Chapter 12, Section 190.6.2 for instructions for submission of
telehealth store and forward claims.)
[[Page 33548]]
c. Critical Care Services
In the CY 2009 PFS proposed rule (73 FR 38517), we reviewed a
request submitted by the University of Pittsburgh Medical Center (UPMC)
to add critical care services (as described by HCPCS codes 99291 and
99292) to the list of approved telehealth services. UPMC drew analogies
to the E/M consultation services currently approved for telehealth and
described how it uses telehealth to give stroke patients timely access
to consultative input from highly specialized physicians who are not
available to furnish services face-to-face.
In the CY 2009 PFS final rule with comment period (73 FR 69744), we
did not add critical care services to the list of approved telehealth
services. This request was not considered as a category 1
request because, as we stated, we believe that remote critical care
services are a different service than the telehealth delivery of
critical care (as described by HCPCS codes 99291 and 99292). We stated
that we had no evidence suggesting that the use of telehealth could be
a reasonable surrogate for the face-to-face delivery of this type of
care, and we did not add critical care services to the list of Medicare
approved telehealth services. We noted that this decision does not
preclude physicians from providing telehealth consultations to
critically ill patients.
Following publication of the CY 2009 PFS final rule with comment
period, Philips Healthcare, the maker of a remote critical care system,
submitted an expanded request to add critical care services to the list
of Medicare approved telehealth services. The Philips Healthcare
request stated that critical care services can be approved as a
Category 1 service based on their similarity to the inpatient
consultation services currently approved for telehealth. The requester
noted that many of the components of critical care are similar to a
high-level inpatient consultation service, which is currently approved
for telehealth. Common components include obtaining a patient history,
conducting an examination, and engaging in complex medical decision-
making for patients who may be severely ill. Because we classified
critical care as a Category 2 service last year, Philips also
submitted evidence to support its belief that the use of telehealth
could be a reasonable surrogate for the face-to-face delivery of this
type of care.
CMS Review
To determine whether to assign a request to Category 1, we
look for similarities between the service that is being considered for
addition and existing telehealth services for the roles of, and
interactions among, the beneficiary, the physician (or other
practitioner) at the distant site and, if necessary, the telepresenter.
In this case, we look for such similarities between critical care and
inpatient consultations and other similar services on the current list
of approved Medicare telehealth services. Critical care (as described
by HCPCS codes 99291 and 99292) is the direct delivery by a physician
of medical care for a critically ill or critically injured patient. It
involves high complexity decision-making to assess, manipulate, and
support vital system function(s) to treat single or multiple vital
organ system failure and/or to prevent further life-threatening
deterioration of the patient's condition. Within the current standards
of practice, we believe critical care services require the physical
presence of the physician rendering the critical care services. We also
note that a number of hands-on interventions (for example, gastric
intubation and vascular access procedures), when furnished on the day a
physician bills for critical care, are included in the critical care
service and are not reported separately. Inpatient consultations
generally do not include hands-on interventions. Because we believe
that critical care services (as described by HCPCS codes 99291 and
99292) require the physical presence of a physician who is available to
furnish any necessary hands-on interventions, we do not consider
critical care services similar to any services on the current list of
Medicare telehealth services. Therefore, we believe critical care must
be evaluated as a Category 2 service.
In order to evaluate critical care services as a Category
2 service, we need to determine whether these are services for
which telehealth can be an adequate substitute for a face-to-face
encounter. In CPT 2009, the AMA defined remote critical care services
tracking codes (codes 0188T through 0189T) with cross-references to
critical care services (HCPCS codes 99291 through 99292). CPT directs
that only one physician may report either critical care services or
remote critical care services for the same period. The requester cites
this as evidence that the AMA considers the two services equivalent,
and that critical care should be approved as a Category 2
service. We do not consider the CPT coding guidance persuasive evidence
that remote critical care is the telehealth delivery of critical care,
as defined by HCPCS codes 99291 and 99292. We believe that if the AMA
valued the two services equally, they would not have created separate
tracking codes for remote critical care services.
As we noted in the CY 2009 PFS final rule with comment period,
consistent with the AMA's creation of tracking codes, we believe that
remote critical care services are different from the telehealth
delivery of critical care services (as described by HCPCS codes 99291
and 99292). Category III CPT codes track utilization of a service,
facilitating data collection on, and assessment of, new services and
procedures. We believe that the data collected for these tracking codes
will help provide useful information on how to best categorize and
value remote critical care services in the future.
The requester also submitted studies which conclude that remote
critical care services furnished by intensivists improve mortality
rates, decrease length of stay, reduce per patient costs, and improve
compliance with best practices, thereby improving patient outcomes.
These studies are similar to the ones we received and reviewed from the
CY 2009 PFS proposed rule. We maintain that remote critical care
services are not the telehealth delivery of critical care services (as
described by HCPCS codes 99291 and 99292). Therefore, we do not find
the new studies submitted with the CY 2010 request persuasive that
telehealth can be an adequate substitute for the face-to-face delivery
of critical care services (as described by HCPCS codes 99291 and
99292).
We continue to believe that remote critical care services are
different services than the telehealth delivery of critical care (as
described by HCPCS codes 99291 and 99292). As such, we are not
proposing to add critical care services (as described by HCPCS codes
99291 and 99292) to the list of approved telehealth services. We
reiterate that our decision not to add critical care services to the
list of approved telehealth services does not preclude physicians from
furnishing telehealth consultations to critically ill patients.
d. Other Requests
We received a number of requests to add services that we reviewed
and did not approve in previous PFS Rules. The following are brief
summaries and references to previous discussions regarding our
decisions not to add these procedure codes to the list of Medicare
approved telehealth services. As explained further below, we are not
reconsidering these previous decisions.
[[Page 33549]]
Initial and Subsequent Hospital Care
We received a request to add initial hospital care (as described by
HCPCS codes 99221 through 99223) and subsequent hospital care (as
described by HCPCS codes 99231 through 99233) to the list of approved
telehealth services. In response to previous requests, we did not add
initial or subsequent hospital care to the list of approved telehealth
services because of our concern regarding the use of telehealth for the
ongoing E/M of a high-acuity hospital inpatient. (See 69 FR 47510 and
66276, 72 FR 38144 and 66250, and 73 FR 38517 and 69745.) We did not
receive any new information with this request that would alter our
previous decisions. Therefore, we are not proposing to add initial
hospital care (as described by HCPCS codes 99221 through 99223) or
subsequent hospital care (as described by HCPCS codes 99231 through
99233) to the list of approved telehealth services.
Group Medical Nutrition Therapy Services
We received a request to add group medical nutrition therapy (MNT)
services (as described by HCPCS codes G0271 and 97804) to the list of
approved telehealth services. In response to a previous request, we did
not add group MNT to the list of approved telehealth services because
we believe that group services are not appropriately delivered through
telehealth. (See 70 FR 45787 and 70157.) We did not receive any new
information with this request that would alter our previous decision.
Therefore, we are not proposing to add group MNT (as described by HCPCS
codes G0271 and 97804) to the list of approved telehealth services.
Diabetes Self-Management Training (DSMT)
We received a request to add diabetes self-management training
(DSMT) (as described by HCPCS codes G0108 and G0109) to the list of
approved telehealth services. In response to previous requests, we did
not add DSMT to the list of approved telehealth services because of the
statutory requirement that DSMT include teaching beneficiaries to self-
administer injectable drugs. Furthermore, DSMT is often performed in
group settings and we believe that group services are not appropriately
delivered through telehealth. (See 70 FR 45787 and 70157, and 73 FR
38516 and 69743.) We did not receive any new information with this
request that would alter our previous decisions. Therefore, we are not
proposing to add DSMT (as described by HCPCS codes G0108 and G0109) to
the list of approved telehealth services.
Speech and Language Pathology Services
We received a request to add various speech and language pathology
services to the list of approved telehealth services. Speech-language
pathologists are not permitted under current law to furnish and receive
payment for Medicare telehealth services. Therefore, we do not propose
to add any speech and language pathology services to the list of
Medicare telehealth services. (For further discussion, see 69 FR 47512
and 66276, and 71 FR 48995 and 69657.)
Physical and Occupational Therapy Services
We received a request to add various physical and occupational
therapy services to the list of approved telehealth services. Physical
and occupational therapists are not permitted under current law to
furnish and receive payment for Medicare telehealth services.
Therefore, we are not proposing to add any physical and occupational
therapy services to the list of approved telehealth services. (For
further discussion, see 71 FR 48995 and 69657.)
E. Coding Issues
1. Canalith Repositioning
In 2008, the CPT Editorial Panel created a new code for canalith
repositioning (CRP). This procedure is a treatment for vertigo which
involves therapeutic maneuvering of the patient's body and head in
order to use the force of gravity to redeposit the calcium crystal
debris in the semicircular canal system.
In the CY 2009 PFS final rule with comment period (73 FR 69896),
new CPT code 95992, Canalith repositioning procedure(s) (eg, Epley
maneuver, Semont maneuver), per day, was assigned the bundled status
indicator (B). We explained that this procedure previously was billed
as part of an evaluation and management (E/M) service or under a number
of CPT codes, including CPT code 97112, Therapeutic procedure, one or
more areas, each 15 minutes; neuromuscular reeducation of movement,
balance, coordination, kinesthetic sense, posture, and/or
proprioception for sitting and/or standing activities. We also
explained that because neurologists and therapists are the predominant
providers of this service to Medicare patients (each at 22 percent), it
was assigned as a ``sometimes therapy'' service under the therapy code
abstract file.
We received comments on this issue from the American Physical
Therapy Association (APTA), as well as other organizations expressing
opposition to our decision to bundle the new code. Commenters stated
that they believe that our decision to bundle CPT code 95992 is flawed
since physical therapists are unable to bill E/M services. The
commenter also stated that therapists would be precluded from using
another code for billing for this service because CPT correct coding
instructions require that the provider/supplier select the procedure
that most accurately defines the service provided. Commenters also
expressed concern that this could impact beneficiary access to this
service.
Based upon the commenters' feedback, we realized that we had failed
to address how therapists would bill for the service since they cannot
bill E/M services. In order to address this situation so that access to
this service would not be impacted, we included language in a change
request (CR) (the quarterly update CR for April) and also released a
MedLearn article informing PTs to continue using one of the more
generally defined ``always therapy'' CPT codes (97112) as a temporary
measure. See http://www.cms.hhs.gov/transmittals/downloads/R1691CP.pdf
and http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6397.pdf.
In response to the concerns raised and upon additional review of
this issue for CY 2010, we are proposing to change the status indicator
from B (Bundled) to I (Invalid). We propose that physicians would
continue to be paid for CRP as a part of an E/M service. Physical
therapists would continue to use one of the more generally defined
``always therapy'' CPT codes (97112). We believe that this will enable
beneficiaries to continue to receive this service while at the same
time it will address our concerns about the potential for duplicate
billing for this service to the extent that this service is paid as a
part of an E/M service. As a result of this proposal, CPT code 95992
would be removed as a ``sometimes'' therapy code from the therapy code
list.
2. Payment for an Initial Preventive Physical Examination (IPPE)
Beginning January 1, 2010, we propose to increase the payment for
an initial preventive physical examination (IPPE) furnished face-to-
face with the patient and billed with HCPCS code G0402, Initial
preventive physical examination; face-to-face visit, services
[[Page 33550]]
limited to new beneficiary during the first 12 months of Medicare
enrollment. The IPPE service includes a broad array of components and
focuses on primary care, health promotion, and disease prevention.
Section 101(b) of the MIPPA changed the IPPE benefit by adding to
the IPPE visit the measurement of an individual's body mass index and,
upon an individual's consent, end-of-life planning. Section 101(b) of
the MIPPA also removed the screening electrocardiogram (EKG) as a
mandatory service of the IPPE.
In order to implement this MIPPA provision, in the CY 2009 PFS
final rule with comment period (73 FR 69870), we created HCPCS code
G0402 as a new HCPCS code and retained, on an interim basis, the work
RVUs of 1.34 assigned to HCPCS code G0344, the code that was previously
used to bill for the IPPE. While we did not believe the revisions to
the IPPE required by MIPPA impacted the work RVUs associated with this
service, we solicited public comments on this issue, as well as
suggested valuations of this service to reflect resources involved in
furnishing the service.
We received comments from several medical groups representing
primary care physicians and geriatricians, as well as comments from the
American Medical Association concerning this issue. The commenters
stated that the IPPE service was undervalued prior to the addition of
components by the MIPPA. Commenters also stated that the current level
of work RVUs would discourage delivery of appropriate end-of-life
planning with the beneficiary. One commenter suggested the work
associated with HCPCS code G0402 for the IPPE, as described in statute,
is captured in existing CPT code 99387, Preventive Medicine Service,
new patient, Initial comprehensive preventive medicine, 65 years and
older. (This code is not paid under the PFS.) The work RVUs for this
CPT code are 2.06.
Based on a review of the comments and upon further evaluation of
the component services of the IPPE, we believe the services, in the
context of work and intensity, contained in HCPCS code G0402 are most
equivalent to those services contained in CPT code 99204, Evaluation
and management new patient, office or other outpatient visit, and
propose increasing the work RVUs for HCPCS code G0402 to 2.30 effective
for services furnished beginning on January 1, 2010.
3. Audiology Codes: Policy Clarification of Existing CPT Codes
In the CY 2009 PFS final rule with comment period (73 FR 69890), we
noted that the RUC reviewed and recommended work RVUs for 6 audiology
codes with which we agreed (that is, CPT codes 92620, 92621, 92625,
92626, 92627, and 92640). We also noted that in the Medicare program,
audiology services are provided under the diagnostic test benefit and
that some of the work descriptors for these services include
``counseling,'' ``potential for remediation,'' and ``establishment of
interventional goals.'' We noted that we do not believe these aspects
fit within the diagnostic test benefit, and therefore, we solicited
comment on this issue.
Since audiology services fall under the diagnostic test benefit,
aspects of services that are therapeutic or management activities are
not payable to audiologists. This distinction is of particular
importance since CPT codes 92620, 92621, 92626, 92627, and 92640 are
``timed'' codes, that is, these codes are billed based on the actual
time spent furnishing the service. In response to our request, the
society that represents speech language pathologists, audiologists, and
speech and language scientists, provided the following comments.
Comment: With respect to the term ``counseling,'' the commenter
stated that ``counseling'' as used in the intraservice work description
for CPT code 92640, Diagnostic analysis with programming of auditory
brainstem implant, per hour, is used in the context of informational
rather than personal counseling. In this instance the counseling
provides information and guidance to the patient on what to expect
relative to the service (application of the electrical stimulation).
This counseling is an integral part of the diagnostic procedure and not
a means of providing therapy or active treatment.
Response: We appreciate the comments related to counseling by the
specialty society, but are not persuaded that counseling is an integral
part of a diagnostic test. Although we understand that test results are
sometimes conveyed to the patient during or at the conclusion of a
diagnostic test, counseling the patient about how to compensate for a
hearing loss is part of a therapeutic service. As such, therapeutic
and/or management of disease process counseling are not part of the
diagnostic test benefit and time attributable to such activities is not
payable to audiologists under the Medicare program.
Comment: With respect to the term ``potential for remediation,''
which is found as part of the intraservice work descriptor for CPT code
92625, Assessment of tinnitus (includes pitch, loudness matching, and
masking), the commenter states that the procedure evaluates the
frequency and intensity characteristics of the perceived tinnitus in
addition to measuring how the tinnitus responds to a masking noise. The
response to masking noise is diagnostic information that audiologists
and physicians refer to as the ``potential for remediation.'' This
assessment is thus a part of a complete diagnostic workup and is not a
treatment or therapeutic service.
Response: The intraservice work for this service includes informing
the patient of the outcome of the evaluation and the potential for
remediation. As noted above, although we understand that test results
are sometimes conveyed to the patient during or at the conclusion of a
diagnostic test, discussing therapeutic options and/or providing
therapy or management based on test results are not part of a
diagnostic test. Discussing the potential for remediation does not
appear to be part of a diagnostic test. While this service can involve
a small amount of nondiagnostic work, CPT code 92625 is not a timed
code and the bulk of the work described in the code appears to be
diagnostic in nature.
Comment: With respect to the term ``establishment of interventional
goals,'' this phrase is found in the intraservice work description of
CPT code 92626, Evaluation of auditory rehabilitation status; first
hour. The commenter states that this procedure focuses on diagnostic
information relative to the patient's ability to use residual hearing
with a hearing aid, a cochlear implant, or with no electronic device.
The intervention goals may take a variety of forms, such as the
following: Meeting audiological criteria for cochlear implantation; a
recommendation to continue use of hearing aids (that is, not a cochlear
implant candidate); and the need to coordinate with a speech-language
pathologist for auditory training. This provides the physician with a
complete diagnostic evaluation of the patient's residual hearing
status. There is no element of therapy or treatment associated with
this service.
Response: Diagnostic testing usually does not involve the
establishment of interventional goals. The test report usually contains
test findings and may suggest additional tests. While we appreciate the
comments of the specialty society, we are not persuaded that
establishing interventional goals is
[[Page 33551]]
part of a diagnostic test under Medicare. The establishment of
interventional goals is clearly a function of therapeutic management.
As such, establishment of goals is not part of the diagnostic test
benefit and time attributable to such activity is not payable to an
audiologist under the Medicare program.
We appreciate the comments we received on this issue. We want to
emphasize that therapeutic and/or management activities associated with
these audiology tests are not payable to audiologists because of the
benefit category under which these tests are covered. We may also issue
instructions to contractors to monitor these services to prevent
inappropriate payments.
4. Consultation Services
a. Background
The current physician visit and consultation codes were developed
by the American Medical Association (AMA) Current Procedural
Terminology (CPT) Editorial Panel in November 1990. A consultation
service is an evaluation and management (E/M) service furnished to
evaluate and possibly treat a patient's problem(s). It can involve an
opinion, advice, recommendation, suggestion, direction, or counsel from
a physician or qualified NPP at the request of another physician or
appropriate source. (See the Internet-Only Medicare Claims Processing
Manual, Pub. 100-04, chapter 12, Sec. 30.6.10A for more information.)
A consultation service must be documented and a written report given to
the requesting professional. Currently, consultation services are
predominantly billed by specialty physicians. Primary care physicians
infrequently furnish these services.
The required documentation supports the accuracy and medical
necessity of a consultation service that is requested and provided.
Medicare pays for a consultation service when the request and report
are documented as a consultation service, regardless of whether
treatment is initiated during the consultation evaluation service. (See
the Internet-Only Medicare Claims Processing Manual, Pub. 100-04,
chapter 12, Sec. 30.6.10B.) A consultation request between
professionals may be done orally by telephone, face-to-face, or by
written prescription brought from one professional to another by the
patient. The request must be documented in the medical record.
In the Physician Fee Schedule Final Rule issued June 5, 1991, (56
FR 25828) we stated that the agency's goal for the development of the
new visit and consultation codes was that they meet two criteria: (1)
They should be used reliably and consistently by all physicians and
carriers; that is, the same service should be coded the same way by
different physicians; and (2) they should be defined in a way that
enables us to properly crosswalk the new codes to the relative values
for the Harvard vignettes so valid RVUs for work are assigned to the
new codes.
Based on requests from the physician community to clarify our
consultation payment policy and to provide consultation examples, we
convened an internal workgroup of medical officers within CMS (then
called the Health Care Financing Administration, or HCFA) and revised
the payment policy instructions in August 1999 in the Medicare Claims
Processing Manual (at Sec. 30.6.10 as cited above). We provided
examples of consultation services and examples of clinical scenarios
that did not satisfy Medicare criteria for consultation services.
Without explicit instructions for every possible clinical scenario
outlined in national policy instructions or in AMA coding definitions
or coding instructions, the local policy interpretations by Medicare
contractors were not universally equivalent or acceptable to the
physician community and resulted in denials in different localities.
Some Medicare contractors would consider a consultation service with
treatment to be an initial visit rather than a consultation thus
resulting in a denial for the billed consultation. We clarified in the
1999 revision that Medicare would pay for a consultation whether
treatment was initiated at the consultation visit or not. The physician
community has stated that terms such as referral, transfer and
consultation, used interchangeably by physicians in clinical settings,
confuse the actual meaning of a consultation service and that
interpretation of these words varies greatly among members of that
community as some label a transfer as a referral and others label a
consultation as a referral. Although we clarified the terms referral
and consultation in the 1999 revision, there was disagreement with our
policy by physicians in the health care community and by AMA CPT staff.
We provided our documentation guidance so physicians would be in
compliance with our payment policy. The consultation definition in the
AMA CPT simply stated that the consultant's opinion or other
information must be communicated to the requesting physician.
Additional manual revisions in both January and September 2001 (at
Sec. 30.6.10 as cited above) clarified that NPPs can both request and
furnish consultation services within their scope of practice and
licensure requirements. We continued to explain our documentation
requirements to the physician community through our Medicare
contractors and in our discussions with the AMA CPT staff. Under our
current policy and in the AMA CPT definition, a consultation service
must have a request from another physician or other professional and be
followed by a report to the requesting professional. The AMA CPT
definition does not state the request must be written in the requesting
physician's medical record. However, we require the request to be
documented in the requesting physician's plan of care in the medical
record as a condition for Medicare payment. The E/M documentation
guidelines which apply to all E/M visits or consultations (http://www.cms.hhs.gov/MLNEdWebGuide/25_EMDOC.asp) clearly state that when
referrals are made, consultations are requested, or advice is sought,
the medical record should indicate to whom and where the referral or
consultation is made or from whom the advice is requested. Our Medicare
contractors are responsible for reviewing and paying consultation
claims when submitted. When there is a question that triggers a review
of a consultation service, our Medicare contractors will look at both
the requesting physician's medical record (where the request should be
noted) and the consultant's medical record where the consultation is
reported and at the report generated for the requesting physician.
Medicare contractors do not look for evidence of documentation on every
claim, only when there is a concern raised during random sampling or
during a specific audit performed by a contractor. The AMA CPT coding
manual, which is not a payment manual, does not specify these
requirements, and, therefore, as we understand it, many physicians do
not agree with the CMS policy.
In March 2006, the Office of the Inspector General (OIG) published
a report entitled, ``Consultations in Medicare: Coding and
Reimbursement'' (OEI-09-02-00030). The purpose of the report was to
assess whether Medicare's payments for consultation services were
appropriate. While the OIG study was being conducted, we continued our
ongoing discussions with the AMA CPT staff for potential changes to the
consultation definition and guidance in CPT. The findings in the OIG
report (based on claims paid by Medicare in 2001) indicated that
Medicare allowed
[[Page 33552]]
approximately $1.1 billion more in 2001 than it should have for
services that were billed as consultations. Approximately 75 percent of
services paid as consultations did not meet all applicable program
requirements (per the Medicare instructions) resulting in improper
payments. The majority of these errors (47 percent of the claims
reviewed) were billed as the wrong type or level of consultation. The
second most frequent error was for services that did not meet the
definition of a consultation (19 percent of the claims reviewed). The
third category of improperly paid claims was a lack of appropriate
documentation (9 percent of the claims reviewed). The OIG recommended
that CMS, through our Medicare contractors, should educate physicians
and other health care practitioners about Medicare criteria and proper
billing for all types and levels of consultations with emphasis on the
highest levels and follow-up inpatient consultation services.
We agreed with the OIG findings that additional education would
help physicians understand the differences in the requirements for a
consultation service from those for other E/M services. With each
additional revision from 1999 until the OIG study began, we continually
educated physicians through the guidance provided by our Medicare
contractors. However, there remained discrepancies with unclear and
ambiguous terms and instructions in the AMA CPT consultation coding
definition, transfer of care and documentation, and the feedback from
the physician community indicated they disagreed with Medicare
guidance.
Prior to the official publication of the OIG report, we issued a
Medlearn Matters article, effective January 2006, to educate the
physician community about requirements and proper billing for all types
and levels of consultation services as requested by the OIG in their
report. The Medlearn Matters article reflected the manual changes we
made in 2006 and the AMA CPT coding changes as noted below.
Our consultation policy revisions continued as a work-in-progress
over several years as disagreements were raised by the physician
community. We continued to work with AMA CPT coding staff in an attempt
to have improved guidance for consultation services in the CPT coding
definition. In looking at physician claims data (for example, the low
usage of confirmatory consultation services) and in response to
concerns from the physician community regarding how to correctly use
the follow-up consultation codes, the AMA CPT Editorial Panel chose to
delete some of the consultation codes for 2006. The Follow-Up Inpatient
Consultation codes (CPT codes 99261 through 99263) and the Confirmatory
Consultation codes (CPT codes 99271 through 99275) were deleted. During
our ongoing discussions, the AMA CPT staff, maintained that physicians
did not fully understand the use of these codes and historically
submitted them inappropriately for payment as was reflected in the OIG
study.
We issued a manual revision in the Medicare Claims Processing
Manual (at Sec. 30.6.10 as cited above) simultaneously with the
publication of AMA CPT 2006 coding changes removing the follow-up
consultation codes, and instructed physicians to use the existing
subsequent hospital care code(s) and subsequent nursing facility care
codes for visits following a consultation service. The confirmatory
consultation codes (which were typically used for second opinions) were
also removed and we instructed physicians to use the existing E/M codes
for a second opinion service. We further clarified the documentation
requirements by making it easier to document a request for a
consultation service from another physician and to submit a
consultation report to the requesting professional. Again, physicians
stated that a consultant has no control over what a requesting or
referring physician writes in a medical record, and that they should
not be penalized for the behavior of others. However, our consultation
policy instructions apply to all physicians, whether they request a
consultation or furnish a consultation. As noted above, documentation
by both the requesting physician and the physician who furnishes the
consultation, is required under the E/M documentation guidelines. The
E/M documentation guidelines have been in use since 1995. In our
discussions with the AMA CPT staff and physician groups, and national
physician open door conference calls, we have emphasized that the
requesting physician medical record is not reviewed unless there is a
specific audit or random sampling performed. The physician furnishing
the consultation service should document in the medical record from
whom a request is received.
We continue to hear from the AMA and from specific national
physician specialty representatives that physicians are dissatisfied
with Medicare documentation requirements and guidance that distinguish
a consultation service from other E/M services such as transfer of
care. CPT has not clarified transfer of care. Therefore, many physician
groups disagree with our requirements for documentation of transfer of
care. Interpretation differs from one physician to another as to
whether transfer of care should be reported as an initial E/M service
or as a consultation service.
Despite our efforts, the physician community disagrees with
Medicare interpretation and guidance for documentation of transfer of
care and consultation. The existing consultation coding definition in
the AMA CPT definition remains ambiguous and confusing for certain
clinical scenarios and without a clear definition of transfer of care.
The CPT consultation codes are used by physicians and qualified NPPs to
identify their services for Medicare payment. There is an absence of
any guidance in the AMA CPT consultation coding definition that
distinguishes a transfer of care service (when a new patient visit is
billed) from a consultation service (when a consultation service is
billed). Medicare does provide guidance although there is disagreement
with our policy from AMA CPT staff and some members of the physician
community. Because of the disparity between AMA coding guidance and
Medicare policy some physicians state they have difficulty in choosing
the appropriate code to bill. The payment for both inpatient
consultation and office/outpatient consultation services is higher than
for initial hospital care and new patient office/outpatient visits.
However, the associated physician work is clinically similar. Many
physicians contend that there is more work involved with a new patient
visit than a consultation service because of the post work involvement
with a new patient. The payment for a consultation service has been set
higher than for initial visits because a written report must be made to
the requesting professional. However, all medically necessary Medicare
services require documentation in some form in a patient's medical
record. Over the past several years, some physicians have asked CMS to
recognize the provision of the consultation report via a different form
of communication in lieu of a written letter report to the requesting
physician so as to lessen any paperwork burden on physicians. We have
eased the consultation reporting requirements by lessening the required
level of formality and permitting the report to be made in any written
form of communication, (including submission of a copy of the
evaluation examination taken directly from the medical record and
submitted without a letter format) as long as the identity of the
physician who furnished the consultation is
[[Page 33553]]
evident. Although preparation and submission of the consultant's report
is no longer the major defining aspect of consultation services, the
higher payment has remained. (See the Internet-Only Medicare Claims
Processing Manual, Pub. 100-04, chapter 12, Sec. 30.6.10 F.)
Both AMA CPT coding rules and Medicare Part B payment policy have
always required that there is only one admitting physician of record
for a particular patient in the hospital or nursing facility setting.
(AMA CPT 2009, Hospital Inpatient Services, Initial Hospital Care,
p.12) This physician has been the only one permitted to bill the
initial hospital care codes or initial nursing facility codes. All
other physicians must bill either the subsequent hospital care codes,
subsequent nursing facility care codes or consultation codes. (See the
Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter
12, Sec. 30.6.9.1 G.)
Beginning January 1, 2008, we ceased to recognize office/outpatient
consultation CPT codes for payment of hospital outpatient visits (72 FR
66790 through 66795). Instead, we instructed hospitals to bill a new or
established patient visit CPT code, as appropriate to the particular
patient, for all hospital outpatient visits. Regardless of all of our
efforts to educate physicians on Medicare guidance for documentation,
transfer of care, and consultation policy, disagreement in the
physician community prevails.
b. Proposal
Beginning January 1, 2010, we propose to budget neutrally eliminate
the use of all consultation codes (inpatient and office/outpatient
codes for various places of service except for telehealth consultation
G-codes) by increasing the work RVUs for new and established office
visits, increasing the work RVUs for initial hospital and initial
nursing facility visits, and incorporating the increased use of these
visits into our PE and malpractice RVU calculations.
We note that section 1834(m) of the Act includes ``professional
consultations'' (including the initial inpatient consultation codes
``as subsequently modified by the Secretary'') in the definition of
telehealth services. We recognize that consultations furnished via
telehealth can facilitate the provision of certain services and/or
medical expertise that might not otherwise be available to a patient
located at an originating site. Therefore, for CY 2010, if we finalize
our proposed policy to eliminate consultations from the PFS, then we
propose to create HCPCS codes specific to the telehealth delivery of
initial inpatient consultations. The purpose of these codes would be
solely to preserve the ability for practitioners to provide and bill
for initial inpatient consultations delivered via telehealth. These
codes are intended for use by practitioners when furnishing services
that meet Medicare requirements relating to coverage and payment for
telehealth services. Practitioners would use these codes to submit
claims to their Medicare contractors for payment of initial inpatient
consultations provided via telehealth. The new HCPCS codes would be
limited to the range of services included in the scope of the CPT codes
for initial inpatient consultations, and the descriptions would be
modified to limit the use of such services for telehealth. The HCPCS
codes would clearly designate these as initial inpatient consultations
provided via telehealth, and not initial hospital care or initial
nursing facility care used for inpatient visits. Utilization of these
codes would allow us to provide payment for these services, as well as
enable us to monitor whether the codes are used appropriately.
If we create HCPCS G-codes specific to the telehealth delivery of
initial inpatient consultations, then we also propose to crosswalk the
RVUs for these services from the RVUs for initial hospital care (as
described by CPT codes 99221 through 99223). We believe this is
appropriate because a physician or practitioner furnishing a telehealth
service is paid an amount equal to the amount that would have been paid
if the service had been furnished without the use of a
telecommunication system. Since physicians and practitioners furnishing
initial inpatient consultations in a face-to-face encounter to hospital
inpatients must continue to utilize initial hospital care codes (as
described by CPT codes 99221 through 99223), we believe it is
appropriate to set the RVUs for the proposed inpatient telehealth
consultation G-codes at the same level as for the initial hospital care
codes.
We considered creating separate G-codes to enable practitioners to
bill initial inpatient telehealth consultations when furnished to
residents of SNFs and crosswalking the RVUs to initial nursing facility
care (as described by CPT codes 99304 through 99306). For the sake of
administrative simplicity, if we create HCPCS G-codes specific to the
telehealth delivery of initial inpatient consultations, they will be
defined in Sec. 410.78 and in our manuals as appropriate for use to
deliver care to beneficiaries in hospitals or skilled nursing
facilities. If we adopt this proposal, then we will make corresponding
changes to our regulations at Sec. 410.78 and Sec. 414.65. In
addition, we will add the definition of these codes to the CMS
Internet-Only Medicare Benefit Policy Manual, Pub. 100-02, Chapter 15,
Section 270 and the Medicare Claims Processing Manual, Pub. 100-04,
Chapter 12, Section 190.
Outside the context of telehealth services, physicians will bill an
initial hospital care or initial nursing facility care code for their
first visit during a patient's admission to the hospital or nursing
facility in lieu of the consultation codes these physicians may have
previously reported. The initial visit in a skilled nursing facility
and nursing facility must be furnished by a physician except as
otherwise permitted as specified in Sec. 483.40(c)(4). In the nursing
facility setting, an NPP who is enrolled in the Medicare program, and
who is not employed by the facility, may perform the initial visit when
the State law permits this. (See this exception in the Internet-Only
Medicare Claims Processing Manual, Pub. 100-04, chapter 12, Sec.
30.6.13A). An NPP, who is enrolled in the Medicare program is permitted
to report the initial hospital care visit or new patient office visit,
as appropriate, under current Medicare policy. Because of an existing
CPT coding rule and current Medicare payment policy regarding the
admitting physician, we will create a modifier to identify the
admitting physician of record for hospital inpatient and nursing
facility admissions. For operational purposes, this modifier will
distinguish the admitting physician of record who oversees the
patient's care from other physicians who may be furnishing specialty
care. The admitting physician of record will be required to append the
specific modifier to the initial hospital care or initial nursing
facility care code which will identify him or her as the admitting
physician of record who is overseeing the patient's care. Subsequent
care visits by all physicians and qualified NPPs will be reported as
subsequent hospital care codes and subsequent nursing facility care
codes.
We believe the rationale for a differential payment for a
consultation service is no longer supported because documentation
requirements are now similar across all E/M services. To be consistent
with OPPS policy, as noted above, we will pay only new and established
office or other clinic visits under the PFS.
This proposed change would be implemented in a budget neutral
[[Page 33554]]
manner, meaning it would not increase or decrease PFS expenditures. We
would make this change budget neutral for the work RVUs by increasing
the work RVUs for new and established office visits by approximately 6
percent to reflect the elimination of the office consultation codes and
the work RVUs for initial hospital and facility visits by approximately
2 percent to reflect the elimination of the facility consultation
codes. We have crosswalked the utilization for the office consultation
codes into the office visits and the utilization of the hospital and
facility consultation codes into the initial hospital and facility
visits. This change would be made budget neutral in the PE and
malpractice RVU methodologies through the use of the new work RVUs and
the crosswalked utilization. The PE and malpractice RVU methodologies
are described elsewhere in this proposed rule.
We are soliciting comments on the proposal, described more fully
above, to eliminate payment for all consultation services codes under
the PFS and to allow all physicians to bill, in lieu of a consultation
service code, an initial hospital care visit or initial nursing
facility care visit for their first visit during a patient's admission
to the hospital or nursing facility. Additionally, we are soliciting
comments on the proposal to create HCPCS G-codes to identify the
telehealth delivery of initial inpatient consultations.
F. Potentially Misvalued Services Under the Physician Fee Schedule
1. Valuing Services Under the Physician Fee Schedule
The American Medical Association's (AMA) Relative Value System
Update Committee (RUC) provides recommendations to CMS for the
valuation of new and revised codes, as well as codes identified as
misvalued. On an ongoing basis, the AMA RUC's Practice Expense (PE)
Subcommittee reviews direct PE (clinical staff, medical supplies,
medical equipment) for individual services and examines the many broad
and methodological issues relating to the development of PE relative
value units (RVUs).
To address concerns expressed by stakeholders with regard to the
process we use to price services paid under the PFS, the AMA RUC
created the Five-Year Review Identification Workgroup. As we stated in
the CY 2009 PFS proposed rule (73 FR 38582), the workgroup identified
some potentially misvalued codes through several vehicles, namely,
identifying codes with site of service anomalies, high intra-service
work per unit time (IWPUT), and services with high volume growth. The
IWPUT is derived from components of the ``building-block'' approach, as
described in the CY 2007 PFS proposed rule (71 FR 37172), and is used
as a measure of service intensity. There were 204 services identified
as misvalued last year and we plan to continue working with the AMA RUC
to identify additional codes that are potentially misvalued. In the CY
2009 PFS proposed rule (73 FR 38586), we also listed approaches for the
AMA RUC to utilize, namely, the review of the fastest growing procedure
codes, review of Harvard-valued codes, and review of PE RVUs.
We plan to address the AMA RUC's recommendations from the February
and April 2009 meetings for codes with site of service anomalies in the
CY 2010 PFS final rule with comment period in a manner consistent with
the way we address other AMA RUC recommendations. Specifically, we
complete our own review of the AMA RUC recommendations; and then in the
PFS final rule with comment period, we describe the AMA RUC's
recommendations, indicate whether or not we accept them, and provide a
rationale for our decision. The values for these services will be
published as interim values for the next calendar year.
We believe that there are additional steps we can take to help
address the issue of potentially misvalued services. In the CY 2009 PFS
proposed rule, we identified approaches to address this issue including
reviewing services often billed together and the possibility of
expanding the multiple procedure payment reduction (MPPR) to additional
nonsurgical procedures and the update of high cost supplies.
2. High Cost Supplies
In the CY 2009 PFS proposed rule (73 FR 38582), we proposed a
process to update the prices associated with high cost supplies over
$150 every 2 years. We explained that we would need the cooperation of
the medical community in obtaining typical prices in the marketplace.
We also outlined examples of acceptable documentation. Although we
received many thoughtful comments on the proposed process for updating
high-cost supplies, as stated in the CY 2009 PFS final rule with
comment period (73 FR 69882), we are continuing to examine alternatives
on the best way to obtain accurate pricing information and will propose
a revised process in future rulemaking.
3. Review of Services Often Billed Together and the Possibility of
Expanding the Multiple Procedure Payment Reduction (MPPR) to Additional
Nonsurgical Procedures
In the CY 2009 PFS final rule with comment period (73 FR 69882), we
stated that we plan to perform a data analysis of nonsurgical CPT codes
that are often billed together. This would identify whether there are
inequities in PFS payments that are a result of variations between
services in the comprehensiveness of the codes used to report the
services, or in the payment policies applied to each (for example,
global surgery and MPPRs). The rationale for the MPPR is that certain
clinical labor activities, supplies, and equipment are not performed or
furnished twice when multiple procedures are performed. We stated that
we would consider developing a proposal either to bundle additional
services or expand application of the MPPR to additional procedures.
Several specialty groups noted that the AMA RUC has already taken
action to identify frequently occurring code pairs. The commenters
support the AMA RUC's recommendation that CMS analyze data to identify
nonsurgical CPT codes that are billed together 90 to 95 percent of the
time. Additionally, the Medicare Payment Advisory Committee (MedPAC)
requested that we consider duplicative physician work, as well as PE,
in any expansion of the MPPR.
We plan to analyze codes furnished together more than 75 percent of
the time, excluding E/M codes. We will analyze both physician work and
PE inputs. If duplications are found, we will consider whether an MPPR
or bundling of services is most appropriate. Any proposed changes will
be made through rulemaking and be subject to public comment at a later
date.
4. AMA RUC Review of Potentially Misvalued Codes
a. Site of Service Anomalies
The AMA RUC created the Five-Year Review Identification Workgroup
to respond to concerns expressed by the MedPAC, the Congress, and other
stakeholders regarding accurate pricing under the PFS. The workgroup
identified potentially misvalued codes through several vehicles. For
example, the workgroup focused on codes for which there have been
shifts in the site of service (site of service anomalies), codes with a
high intra-service work per unit of time (IWPUT), and codes that were
high volume. There were 204 potentially misvalued services
[[Page 33555]]
identified in 2008 (see the CY 2009 PFS final rule with comment period
(73 FR 69883)). These codes were reviewed by the AMA RUC and
recommendations were submitted to CMS in 2008.
In the CY 2009 PFS final rule with comment period (73 FR 69883), we
noted that although we would accept the AMA RUC valuation for these
site of service anomaly codes for 2009, we recognized that many of them
included deletion or modification of certain inputs such as hospital
days, office visits, service times, and discharge day management
services in the global period. We also indicated that we had concerns
about the methodology used by the AMA RUC to review these services
which may have resulted in removal of hospital days and deletion or
reallocation of office visits without extraction of the associated RVUs
from the valuation of the code. However, we stated that we believed the
AMA RUC-recommended valuations were still a better representation of
the resources used to furnish these services than the current ones. We
also stated that we would continue to examine these codes and would
consider whether it would be appropriate to propose additional changes
in future rulemaking.
After further review of these codes, we believe it would be
appropriate to propose further changes to several of the codes where
the valuation has been adjusted to reflect changes in the site of
service. Specifically, we are proposing changes to codes for which the
AMA RUC review process deleted or reallocated pre-service and post
service times, hospital days, office visits, and discharge day
management services without the extraction of the associated RVUs.
We believe the AMA RUC-recommended values do not reflect the
extraction of the RVUs associated with deleted or reallocated pre-
service and post-service times, hospital days, office visits, and
discharge day management services. Therefore, we have recalculated the
work RVUs based upon the AMA RUC-recommended inputs (that is, changes
in pre-service and post-service times and associated E/M services). The
proposed work RVUs for each CPT code shown in Table 8 were recalculated
using the pre-AMA RUC review work RVUs as a starting point, and
adjusting them for the addition or extraction of pre-service and post-
service times, inpatient hospital days, discharge day management
services and outpatient visits as recommended by the AMA RUC. We used
the following methodology:
1. For each CPT code noted in Table 8, we separated out each
component (that is, pre-service time, intra-service time, post-service
time, inpatient hospital day, discharge day management services, and
outpatient visits) that comprised the entire work RVUs for the service.
2. We calculated the incremental difference between the pre-service
and post-service time from before and after the AMA RUC review, and
multiplied that difference by an IWPUT intensity factor of 0.0224,
which is a constant in the IWPUT equation. For example, if the pre-
service time prior to the AMA RUC review was 75 minutes and, following
its review, the AMA RUC recommended an increase in pre-service time to
85 minutes, we multiplied the difference (10 minutes) by 0.0224 to
determine the RVUs associated with the increase in pre-service time,
and then added that number of RVUs to the pre-AMA RUC evaluation work
RVU.
3. We then added or removed the work RVUs associated with the
extraction or reallocation of each inpatient hospital day, outpatient
visit or discharge day management service as appropriate. For example,
assume that prior to the AMA RUC review a code was assigned:
1 inpatient hospital day (currently billed using CPT code
99231 and assigned 0.76 work RVUs);
1 discharge day management service (currently billed using
CPT code 99238 and assigned 1.28 work RVUs); and
2 outpatient visits (currently billed using 99212 and
assigned 0.45 work RVUs).
After the AMA RUC review, the inpatient hospital day and discharge
day management service were removed. To account for the removal of
these services, we would have subtracted 0.76 work RVUs (represents the
removal of the work RVUs for 1 inpatient hospital day) and 1.28 work
RVUs (represents the removal of the work RVUs for 1 discharge day
management service) from the pre-AMA RUC review work RVUs in order to
develop the CMS proposed work RVUs.
The methodology discussed above was used for each code noted in
Table 8 and reflects the extraction of the RVUs associated with deleted
or reallocated hospital days, office visits, discharge day management
services, and pre-service and post-service times based upon the AMA RUC
recommendations.
Table 8: CY 2010 CMS Proposed Work RVUs
----------------------------------------------------------------------------------------------------------------
2009 AMA RUC 2010 CMS
CPT code \1\ Descriptor Pre-AMA RUC recommended proposed work
eval. work RVU work RVU RVU
----------------------------------------------------------------------------------------------------------------
21025........................... Excision of bone, lower jaw... 11.07 9.87 7.23
23415........................... Release of shoulder ligament.. 10.09 9.07 10.64
25116........................... Remove wrist/forearm lesion... 7.38 7.38 4.83
42440........................... Excise submaxillary gland..... 7.05 7.05 6.88
52341........................... Cysto w/ureter stricture tx... 6.11 5.35 5.20
52342........................... Cysto w/up stricture tx....... 6.61 5.85 5.63
52343........................... Cysto w/renal stricture tx.... 7.31 6.55 6.55
52344........................... Cysto/uretero, stricture tx... 7.81 7.05 6.83
52345........................... Cysto/uretero w/up stricture.. 8.31 7.55 8.51
52346........................... Cystouretero w/renal strict... 9.34 8.58 9.02
52400........................... Cystouretero w/congen repr.... 10.06 8.66 8.25
52500........................... Revision of bladder neck...... 9.39 7.99 8.49
52640........................... Relieve bladder contracture... 6.89 4.73 4.28
53445........................... Insert uro/ves nck sphincter.. 15.21 15.21 17.02
54410........................... Remove/replace penis prosth... 16.48 15.00 16.01
54530........................... Removal of testis............. 9.31 8.35 8.65
57287........................... Revise/remove sling repair.... 11.49 10.97 10.36
62263........................... Epidural lysis mult sessions.. 6.41 6.41 6.04
62350........................... Implant spinal canal cath..... 8.04 6.00 1.29
[[Page 33556]]
63650........................... Implant neuroelectrodes....... 7.57 7.15 4.18
63685........................... Insrt/redo spine n generator.. 7.87 6.00 4.27
64708........................... Revise arm/leg nerve.......... 6.22 6.22 7.36
64831........................... Repair of digit nerve......... 10.23 9.00 9.74
65285........................... Repair of eye wound........... 14.43 14.43 14.43
----------------------------------------------------------------------------------------------------------------
\1\ All CPT codes copyright 2008 American Medical Association.
Using the methodology described above, the adjustments to work RVUs
for CPT codes 62355, 62360, 62361, 62362, and 62365 would result in
negative valuation: 62355 = -1.96; 62360 = -2.31; 62361 = -2.42; 62362
= -2.46; and 62365 = -1.88. For these codes, we are requesting that the
AMA RUC re-review the entire family of associated codes and in the
interim will maintain the AMA RUC recommended values until a
methodology is developed to address codes that result in negative
valuation when the methodology described above is utilized.
In addition to the proposed revisions to the AMA RUC-recommended
RVUs described above, we encourage the AMA RUC to utilize the building
block methodology as described in the CY 2007 PFS proposed rule (71 FR
37172) in the future when revaluing codes with site of service
anomalies. We recognize that the AMA RUC looks at families of codes and
may assign RVUs based on a particular code ranking within the family.
However, the relative value scale requires each service to be valued
based on the resources used in furnishing the service.
We are also seeking public comment on alternative methodologies
that could be utilized to establish work RVUs for codes that would have
a negative valuation under the methodology we used for the proposed
revisions to the AMA RUC-recommended values described above.
b. ``23-Hour'' Stay
For services that are performed in the outpatient setting and
require a hospital stay of less than 24 hours, we consider this an
outpatient service and recognize the additional time associated with
the patient evaluation and assessment in the post-service period. We
are requesting that the AMA RUC include the additional minutes in their
recommendations to CMS. We do not believe the current minutes assigned
in the post-service period accurately reflects the total time required
for evaluation and assessment of the patient. We believe the use of E/M
codes for services rendered in the post-service period for procedures
requiring less than a 24-hour hospital stay would result in overpayment
for pre-service and intraservice work that would not be provided.
Therefore, we will not allow an additional E/M service to be billed for
care furnished during the post procedure period when care is furnished
for an outpatient service requiring less than a 24-hour hospital stay.
5. Establishing Appropriate Relative Values for Physician Fee Schedule
Services
In MedPAC's March 2006 Report to Congress, MedPAC made a number of
recommendations to improve the review of the relative values for PFS
services. Since that time, we have taken significant action to improve
the accuracy of the RVUs. As MedPAC noted in its recent March 2009
Report to Congress, ``CMS and the AMA RUC have taken several steps to
improve the review process'' in the intervening years since those
initial recommendations. Many of our efforts to improve the accuracy of
RVUs have also resulted in substantial increases in the payments for
primary care services, which was one of the motivations for MedPAC's
recommendations.
We completed the most recent Five-Year Review of work
RVUs, resulting in an increase in over 25 percent to the work RVUs for
primary care services.
We significantly revised the methodology for determining
PE RVUs, resulting in more than a 5 percent increase for primary care
services.
We improved our processes for identifying potentially
misvalued services by engaging in an ongoing review that includes
screens for rapidly growing services and services with substantial
shifts in site of service. We also identified approaches to address the
issue of potentially misvalued services including reviewing services
often billed together and the possibility of expanding the multiple
procedure payment reduction (MPPR) to additional nonsurgical procedures
and the update of high cost supplies.
As discussed elsewhere in this proposed rule, we are
proposing a number of improvements to the calculation and establishment
of the work, PE, and malpractice RVUs that would result in overall
payment increases to primary care specialties of between 6 percent and
8 percent in CY 2010. These changes include a 6 percent increase in the
work RVUs for office visits as a result of our proposal regarding
consultation services; our proposed use of more accurate specialty-
specific survey data on physician practice costs; our proposal to
revise the utilization rate assumption for certain equipment; and our
proposed use of updated and expanded malpractice premium data in the
calculation of the malpractice RVUs.
MedPAC has in the past also recommended the establishment of a
group panel of experts separate from the AMA RUC to review RVUs. This
original March 2006 recommendation was summarized in its March 2008
Report to Congress:
``We also recommended that CMS establish a group of experts,
separate from the AMA RUC, to help the agency conduct these and
other activities. This recommendation was intended not to supplant
the AMA RUC but to augment it. To that end, the panel should include
members who do not directly benefit from changes to Medicare's
payment rates, such as experts in medical economics and technology
diffusion and physicians who are employed by managed care
organizations and academic medical centers.''
The idea of a group of experts separate from the AMA RUC, to help
the agency improve the review of relative values raises a number of
issues. We seek broad public input on the following questions and other
aspects of such an approach:
How could input from a group of experts best be
incorporated into existing processes of rulemaking and agency receipt
of AMA RUC recommendations?
What specifically would be the roles of a group of experts
(for example,
[[Page 33557]]
identify potentially misvalued services, provide recommendations on
valuation of specified services, review AMA RUC recommendations
selected by the Secretary, etc.)?
What should be the composition of a group of experts? How
could such a group provide expertise on services that clinician group
members do not furnish?
How would such a group relate to the AMA RUC and existing
Secretarial advisory panels such as the Practicing Physician Advisory
Committee?
Also of interest are comments on the resources required to
establish and maintain such a group. As MedPAC noted in its March 2006
Report with respect to the group of experts ``we recognize that these
recommendations will increase demands on CMS and urge the Congress to
provide the agency with the financial resources and administrative
flexibility needed to undertake them.''
We welcome comments on these topics, as well as others of interest
to the stakeholder community. We will consider these comments as we
consider the establishment of a group of experts to assist us in our
ongoing reviews of the PFS RVUs.
G. Issues Related to the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA)
This section addresses certain provisions of the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L.
110-275). We are proposing to revise our policies and regulations as
described below in order to conform them to the statutory amendments.
1. Section 102: Elimination of Discriminatory Copayment Rates for
Medicare Outpatient Psychiatric Services
Prior to the enactment of the MIPPA, section 1833(c) of the Act
provided that for expenses incurred in any calendar year in connection
with the treatment of mental, psychoneurotic, and personality disorders
of an individual who is not an inpatient of a hospital, only 62\1/2\
percent of such expenses are considered to be incurred under Medicare
Part B when determining the amount of payment and application of the
Part B deductible in any calendar year. This provision is known as the
outpatient mental health treatment limitation (the limitation), and has
resulted in Medicare paying only 50 percent of the approved amount for
outpatient mental health treatment, rather than the 80 percent that is
paid for most other outpatient services.
Section 102 of the MIPPA amends the statute to phase out the
limitation on recognition of expenses incurred for outpatient mental
health treatment, which will result in an increase in the Medicare Part
B payment for outpatient mental health services to 80 percent by CY
2014. When this section is fully implemented in 2014, Medicare will pay
for outpatient mental health services at the same level as other Part B
services. For CY 2010, section 102 of the MIPPA provides that Medicare
will recognize 68\3/4\ percent of expenses incurred for outpatient
mental health treatment, which translates to a payment of 55 percent of
the Medicare-approved amount. Section 102 of the MIPPA specifies that
the phase out of the limitation will be implemented as shown in Table 9
(provided that the patient has satisfied his or her deductible).
Table 9--Implementation of Section 102 of the MIPPA
----------------------------------------------------------------------------------------------------------------
Recognized
incurred Patient pays Medicare pays
Calendar year expenses (in (in percent) (in percent)
percent)
----------------------------------------------------------------------------------------------------------------
CY 2009 and prior calendar years................................ 62.50 50 50
CY 2010 and CY 2011............................................. 68.75 45 55
CY 2012......................................................... 75.00 40 60
CY 2013......................................................... 81.25 35 65
CY 2014......................................................... 100.00 20 80
----------------------------------------------------------------------------------------------------------------
At present, Sec. 410.155(c) of the regulations includes examples
to illustrate application of the current limitation. We are proposing
to remove these examples from our regulations and, instead, to provide
examples in this proposed rule, in our manual, and under provider
education materials as needed. The following examples illustrate the
application of the limitation in various circumstances as it is
gradually reduced under section 102 of the MIPPA. We note that although
we have used the CY 2009 Part B deductible of $135 for purposes of the
examples below, the actual deductible amount for CY 2010 and future
years will be subject to change.
Example #1: In 2010, a clinical psychologist submits a claim for
$200 for outpatient treatment of a patient's mental disorder. The
Medicare-approved amount is $180. Since clinical psychologists must
accept assignment, the patient is not liable for the $20 in excess
charges. The patient previously satisfied the $135 annual Part B
deductible. The limitation reduces the amount of incurred expenses
to 68\3/4\ percent of the approved amount. Medicare pays 80 percent
of the remaining incurred expenses. The Medicare payment and patient
liability are computed as shown in Table 10.
Table 10--Example 1--CY 2010
------------------------------------------------------------------------
------------------------------------------------------------------------
1. Actual charges....................................... $200.00
2. Medicare-approved amount............................. 180.00
3. Medicare incurred expenses (0.6875 x line 2) *....... 123.75
4. Unmet deductible..................................... 0.00
5. Remainder after subtracting deductible (line 3 minus 123.75
line 4)................................................
6. Medicare payment (0.80 x line 5)..................... 99.00
7. Patient liability (line 2 minus line 6).............. 81.00
------------------------------------------------------------------------
* The recognized incurred expenses for 2010 are 68\3/4\ percent.
[[Page 33558]]
Example #2: In 2012, a clinical social worker submits a claim
for $135 for outpatient treatment of a patient's mental disorder.
The Medicare-approved amount is $120. Since clinical social workers
must accept assignment, the patient is not liable for the $15 in
excess charges. The limitation reduces the amount of incurred
expenses to 75 percent of the approved amount. The patient
previously satisfied $70 of the $135 annual Part B deductible,
leaving $65 unmet (see Table 11).
Table 11--Example 2--CY 2012
------------------------------------------------------------------------
------------------------------------------------------------------------
1. Actual charges....................................... $135.00
2. Medicare-approved amount............................. 120.00
3. Medicare incurred expenses (0.75 x line 2) *......... 90.00
4. Unmet deductible..................................... 65.00
5. Remainder after subtracting deductible (line 3 minus 25.00
line 4)................................................
6. Medicare payment (0.80 x line 5)..................... 20.00
7. Patient liability (line 2 minus line 6).............. 100.00
------------------------------------------------------------------------
* The recognized incurred expenses for CY 2012 are 75 percent.
Example #3: In CY 2013, a physician who does not accept
assignment submits a claim for $780 for services in connection with
the treatment of a mental disorder that did not require inpatient
hospitalization. The Medicare-approved amount is $750. Because the
physician does not accept assignment, the patient is liable for the
$30 in excess charges. The patient has not satisfied any of the $135
Part B annual deductible (see Table 12).
Table 12--Example 3--CY 2013
------------------------------------------------------------------------
------------------------------------------------------------------------
1. Actual charges....................................... $780.00
2. Medicare-approved amount............................. 750.00
3. Medicare incurred expenses (0.8125 x line 2) *....... 609.38
4. Unmet deductible..................................... 135.00
5. Remainder after subtracting deductible (line 3 minus 474.38
line 4)................................................
6. Medicare payment (0.80 x line 5)..................... 379.50
7. Patient liability (line 1 minus line 6).............. 400.50
------------------------------------------------------------------------
* The recognized incurred expenses for CY 2013 are 81\1/4\ percent.
Example #4: A patient's Part B expenses during CY 2014 are for a
physician's services in connection with the treatment of a mental
disorder that initially required inpatient hospitalization, with
subsequent physician services furnished on an outpatient basis. The
patient has not satisfied any of the $135 Part B deductible. The
physician accepts assignment and submits a claim for $780. The
Medicare-approved amount is $750. Since the limitation will be
completely phased out as of January 1, 2014, the entire $750
Medicare-approved amount is recognized as the total incurred
expenses because such expenses are no longer reduced. Also, there is
no longer any distinction between mental health services the patient
receives as an inpatient or outpatient (see Table 13).
Table 13--Example 4--CY 2014
------------------------------------------------------------------------
------------------------------------------------------------------------
1. Actual charges....................................... $780.00
2. Medicare-approved amount............................. 750.00
3. Medicare incurred expenses (1.00 x line 2) *......... 750.00
4. Unmet deductible..................................... 135.00
5. Remainder after subtracting deductible (line 3 minus 615.00
line 4)................................................
6. Medicare payment (0.80 x line 5)..................... 492.00
7. Beneficiary liability (line 2 minus line 6).......... 258.00
------------------------------------------------------------------------
* The recognized incurred expenses for CY 2014 are 100 percent.
Section 102 of the MIPPA did not make any other changes to the
outpatient mental health treatment limitation. Therefore, other aspects
of the limitation will remain unchanged during the transition period
between CYs 2010 and 2014. The limitation will continue to be applied
as it has been in accordance with our regulation at Sec. 410.155(b)
which specifies that the limitation applies to outpatient treatment of
a mental, psychoneurotic, or personality disorder, identified under the
International Classification of Diseases (ICD) diagnosis code range
290-319. We use the place of service code, and the procedure code to
identify services to which the limitation applies.
Additionally, we are proposing to make technical corrections to
Sec. 410.155(b)(2) in order to update and clarify the services to
which the limitation does not apply. Our proposed technical changes are
as follows:
Under Sec. 410.155(b)(2)(ii), revise the regulation to
specify the HCPCS code, M0064 (or any successor code), that represents
the statutory exception to the limitation for brief office visits for
the sole purpose of monitoring or changing drug prescriptions used in
mental health treatment.
At Sec. 410.155(b)(2)(iv), we are proposing to revise the
regulation to add neuropsychological tests and diagnostic psychological
tests to the examples of diagnostic services that are not subject to
the limitation when performed to establish a diagnosis.
Under Sec. 410.155(b)(2)(v), we are proposing to revise
the regulation to specify the CPT code 90862 (or any successor code)
that represents pharmacologic management services to which the
limitation does not apply when furnished to treat a patient who is
diagnosed with Alzheimer's disease or a related disorder.
[[Page 33559]]
Finally, we are proposing to add a new paragraph (c) to Sec.
410.155 that provides a basic formula for computing the limitation
during the phase-out period from CY 2010 through CY 2013, as well as
after the limitation is fully removed from CY 2014 onward.
2. Section 131: Physician Payment, Efficiency, and Quality
Improvements--Physician Quality Reporting Initiative (PQRI)
a. Program Background and Statutory Authority
The Physician Quality Reporting Initiative (PQRI) is a voluntary
reporting program that provides an incentive payment to eligible
professionals who satisfactorily report data on quality measures for
covered professional services during a specified reporting period.
Under section 1848(k)(3)(B) of the Act, the term ``eligible
professional'' means any of the following: (1) A physician; (2) A
practitioner described in section 1842(b)(18)(C); (3) A physical or
occupational therapist or a qualified speech-language pathologist; (4)
A qualified audiologist. The PQRI was first implemented in 2007 as a
result of section 101 of Division B of the Tax Relief and Health Care
Act of 2006--the Medicare Improvements and Extension Act of 2006 (Pub.
L. 109-432) (MIEA-TRHCA), which was enacted on December 20, 2006. The
PQRI was extended and further enhanced as a result of the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) (MMSEA),
which was enacted on December 29, 2007, and the MIPPA, which was
enacted on July 15, 2008. Changes to the PQRI as a result of these
laws, as well as information about the PQRI in 2007, 2008, and 2009 are
discussed in detail in the CY 2008 PFS proposed rule (72 FR 38196
through 38204), CY 2008 PFS final rule with comment period (72 FR 66336
through 66353), CY 2009 PFS proposed rule (73 FR 38558 through 38575),
and CY 2009 PFS final rule with comment period (73 FR 69817 through
69847). In addition, detailed information about the PQRI is available
on the CMS Web site at http://www.cms.hhs.gov/PQRI.
b. Incentive Payments for the 2010 PQRI
For 2010, section 1848(m)(1)(B) of the Act authorizes the Secretary
to provide an incentive payment equal to 2.0 percent of the estimated
total allowed charges (based on claims submitted not later than 2
months after the end of the reporting period) for all covered
professional services furnished during the reporting period for 2010.
Although PQRI incentive payments are only authorized through 2010 under
section 1848(m)(1)(A) of the Act, section 1848(k)(2)(C) of the Act
provides for the use of consensus-based quality measures for the PQRI
for 2010 and subsequent years.
The PQRI incentive payment amount is calculated using estimated
allowed charges for all covered professional services furnished under
the PFS, not just those charges associated with the reported quality
measures. ``Allowed charges'' refers to total charges, including the
beneficiary deductible and coinsurance, and is not limited to the 80
percent paid by Medicare or the portion covered by Medicare where
Medicare is secondary payer. Amounts billed above the PFS amounts for
assigned and non-assigned claims will not be included in the
calculation of the incentive payment amount. In addition, since, by
definition under section 1848(k)(3)(A)) of the Act, ``covered
professional services'' are limited to services for which payment is
made under, or is based on, the PFS and which are furnished by an
eligible professional, other Part B services and items that may be
billed by eligible professionals but are not paid under or based upon
the Medicare Part B PFS are not included in the calculation of the
incentive payment amount.
Under section 1848(m)(6)(C) of the Act, the ``reporting period''
for the 2008 through 2011 PQRI is defined to be the entire year, but
the Secretary is authorized to revise the reporting period for years
after 2009 if the Secretary determines such ``revision is appropriate,
produces valid results on measures reported, and is consistent with the
goals of maximizing scientific validity and reducing administrative
burden.''
We are also required by section 1848(m)(5)(F) of the Act to
establish alternative criteria for satisfactorily reporting and
alternative reporting periods for registry-based reporting and for
reporting measures groups. Therefore, eligible professionals who meet
the proposed alternative criteria for satisfactorily reporting for
registry-based reporting and for reporting measures groups for the
proposed 2010 alternative reporting periods for registry-based
reporting and for reporting measures groups would also be eligible to
earn an incentive payment equal to 2.0 percent of the estimated total
Medicare Part B PFS allowed charges for all covered professional
services furnished by the eligible professional during the proposed
alternative reporting periods for 2010 PQRI registry-based reporting or
for reporting measures groups.
The proposed PQRI reporting options for an individual eligible
professional seeking to qualify for a 2010 PQRI incentive payment (that
is, the proposed PQRI reporting mechanisms, proposed reporting periods,
and proposed criteria for satisfactory reporting, including the
proposed alternative reporting periods and alternative criteria for
satisfactorily reporting for registry-based reporting and for reporting
measures groups) are addressed in sections II.G.2.c. through II.G.2.f.
of this proposed rule. The proposed 2010 PQRI quality measures and
proposed 2010 PQRI measures groups are discussed in section II.G.2.i.
of this proposed rule.
Prior to 2010, the PQRI was an incentive program in which
determination of whether an eligible professional satisfactorily
reported quality data was made at the individual professional level,
based on the National Provider Identifier (NPI). Although the incentive
payments were made to the practice(s) represented by the Tax
Identification Number (TIN) to which payments are made for the
individual professional's services, there were no incentive payments
made to the group practice based on a determination that the group
practice, as a whole, satisfactorily reported PQRI quality measures
data. To the extent individuals (based on the individuals' NPIs)
satisfactorily reported data on PQRI quality measures that were
associated with more than one practice or TIN, the determination of
whether an eligible professional satisfactorily reported PQRI quality
measures data was made for each unique TIN/NPI combination. Therefore,
the incentive payment amount was calculated for each unique TIN/NPI
combination and payment was made to the holder of the applicable TIN.
However, section 1848(m)(3)(C)(i) of the Act requires that by
January 1, 2010, the Secretary establish and have in place a process
under which eligible professionals in a group practice (as defined by
the Secretary) shall be treated as satisfactorily submitting data on
quality measures for the PQRI for covered professional services for a
reporting period, if, in lieu of reporting measures under subsection
(k)(2)(C), the group practice reports measures determined appropriate
by the Secretary, such as measures that target high-cost chronic
conditions and preventive care, in a form and manner, and at a time,
specified by the Secretary. Therefore, beginning with the 2010 PQRI,
group practices who satisfactorily submit data on quality measures also
would be eligible to earn an incentive payment equal to 2.0 percent of
the
[[Page 33560]]
estimated total allowed charges for all covered professional services
furnished by the group practice during the applicable reporting period.
As required by section 1848(m)(3)(C)(iii) of the Act, payments to a
group practice by reason of the process described above shall be in
lieu of the PQRI incentive payments that would otherwise be made to
eligible professionals in the group practice for satisfactorily
submitting data on quality measures. Therefore, an individual eligible
professional who is participating in the group practice reporting
option as a member of a group practice would not be able to separately
earn a PQRI incentive payment as an individual eligible professional.
The process proposed to be used to determine whether a group
practice satisfactorily submits data on quality measures for the 2010
PQRI is described in section II.G.2.g. of this proposed rule. The
proposed measures on which a group practice would need to report in
order to be treated as satisfactorily submitting data on quality
measures for the 2010 PQRI are discussed in section II.G.2.j. of this
proposed rule.
c. Proposed 2010 Reporting Periods for Individual Eligible
Professionals
As we indicated above, section 1848(m)(6)(C) of the Act defines
``reporting period'' for 2010 to be the entire year. Section
1848(m)(6)(C)(ii) of the Act, however, authorizes the Secretary to
revise the reporting period for years after 2009 if the Secretary
determines such revision is appropriate, produces valid results on
measures reported, and is consistent with the goals of maximizing
scientific validity and reducing administrative burden. To be
consistent with section 1848(m)(6)(C) of the Act and with prior years,
we propose the 2010 PQRI reporting period for the reporting of
individual PQRI quality measures through claims or a qualified
electronic health record (EHR) (see section II.G.2.d. of this proposed
rule for discussion of proposed 2010 PQRI reporting mechanisms) will be
the entire year (that is, January 1, 2010 through December 31, 2010).
We also considered exercising our authority to revise the reporting
period for claims-based reporting of individual measures by proposing
to add an alternative reporting period beginning July 1, 2010 for
claims-based reporting of individual measures. Doing so would make the
reporting periods for claims-based reporting of individual measures
consistent with the alternative reporting periods for reporting
measures groups and for registry-based reporting that have been in
place since the 2008 PQRI. This would allow an eligible professional to
earn a PQRI incentive payment equal to 2.0 percent of his or her
estimated allowed charges for covered professional services furnished
for the last half of 2010 if he or she satisfactorily reports data on
individual PQRI quality measures through claims during the last half of
2010. We received input from a few stakeholders in support of a partial
year reporting period for claims-based reporting of individual measures
to give more eligible professionals the opportunity to begin reporting
later in the year. Other stakeholders recommended that we offer the
same reporting periods for all reporting mechanisms. We agree that
having the same reporting periods for all reporting mechanisms may be
less complex. We also agree that the addition of a 6-month reporting
period may facilitate participation in PQRI for certain eligible
professionals. However, we do not believe that making a 6-month
reporting period available would serve to enhance the validity of
results on measures reported or to maximize scientific validity as
required under section 1848(m)(6)(C)(ii) of the Act. In addition, given
our desire to transition from the use of the claims-based reporting
mechanism as the primary reporting mechanism for clinical quality
measures for PQRI after 2010 to rely more heavily on registry-based
reporting (see section II.G.2.d. of this proposed rule for further
discussion), we do not believe it appropriate to add a new 6-month
reporting period for claims-based reporting of individual measures.
Given the fact that we seek to lessen reliance on the claims-based
reporting mechanism for the PQRI after 2010, we believe the cost of
adding a 6-month reporting period for claims-based reporting of
individual measures outweighs any added flexibility that eligible
professionals may receive in the short-term.
Nevertheless, we invite comments on the decision to not propose a
6-month reporting period for claims-based reporting of individual PQRI
quality measures.
In addition, section 1848(m)(5)(F) of the Act requires, for 2008
and subsequent years, the Secretary to establish alternative reporting
periods for reporting groups of measures and for registry-based
reporting. To satisfy the requirements of section 1848(m)(5)(F) of the
Act and to maintain program stability, we propose to retain the 2
alternative reporting periods from the 2008 and 2009 PQRI for reporting
measures groups and for registry-based reporting: (1) The entire year;
and (2) a 6-month reporting period beginning July 1. Therefore, for
2010, the proposed alternative reporting periods for reporting measures
groups and for registry-based reporting are: (1) January 1, 2010
through December 31, 2010; and (2) July 1, 2010 through December 31,
2010. We note that the 6-month reporting period, beginning July 1,
2010, is proposed to be available for reporting on measures groups and
for reporting using the registry-based reporting mechanism only. For an
eligible professional who satisfactorily reports measures groups or
through the registry-based reporting mechanism for the 6-month
reporting period, the eligible professional would qualify to earn a
PQRI incentive payment equal to 2.0 percent of his or her total
estimated allowed charges for covered professional services furnished
between July 1, 2010 and December 31, 2010 only. The incentive payment
would not be calculated based on the eligible professional's charges
for covered professional services for the entire year.
d. Proposed 2010 PQRI Reporting Mechanisms for Individual Eligible
Professionals
When the PQRI was first implemented in 2007, there was only 1
reporting mechanism available to submit data on PQRI quality measures.
For the 2007 PQRI, the only way that eligible professionals could
submit data on PQRI quality measures was by reporting the appropriate
quality data codes on their Medicare Part B claims (claims-based
reporting). For the 2008 PQRI, we added a second reporting mechanism as
required by section 1848(k)(4) of the Act, so that eligible
professionals could submit data on PQRI quality measures to a qualified
PQRI registry and request the registry to submit PQRI quality measures
results and numerator and denominator data on the 2008 PQRI quality
measures or measures groups on their behalf (registry-based reporting).
For the 2009 PQRI, we retained the 2 reporting mechanisms used in the
2008 PQRI (that is, claims-based reporting and registry-based
reporting) for reporting individual PQRI quality measures and for
reporting measures groups.
To promote the adoption of EHRs, we also conducted limited testing
of a third reporting mechanism for the 2008 PQRI, which was the
submission of clinical quality data extracted from an EHR, or the EHR-
based reporting mechanism. No incentive payment was available to those
eligible professionals who participated in testing the EHR-based
reporting mechanism. In the CY 2009 PFS proposed rule (73 FR 38564
through 38565), we described our plans to test the submission of
clinical quality
[[Page 33561]]
data extracted from qualified EHR products for five 2008 PQRI measures
and proposed to accept PQRI data from EHRs and to pay PQRI incentive
payments based on that submission for a limited subset of the proposed
2009 PQRI quality measures. However, as described in the CY 2009 PFS
final rule with comment period (73 FR 69830), we did not finalize our
proposal to allow eligible professionals to submit clinical quality
data extracted from EHRs for purposes of receiving a PQRI incentive
payment for 2009. Since the 2008 EHR testing process was not complete
at the time of publication of the CY 2009 PFS final rule, we instead
opted to continue to test the submission of clinical quality data
extracted from EHRs in 2009 and provide no incentive payment to those
eligible professionals participating in testing the EHR-based reporting
mechanism in 2009.
For the 2010 PQRI, we are proposing to retain the claims-based
reporting mechanism and the registry-based reporting mechanism. In
addition, we are again proposing for the 2010 PQRI to accept PQRI
quality measures data extracted from a qualified EHR product for a
limited subset of the proposed 2010 PQRI quality measures, as
identified in Table 20, contingent upon the successful completion of
our 2009 EHR data submission testing process and a determination based
on that testing process that accepting data from EHRs on quality
measures for the 2010 PQRI is practical and feasible. We will make the
determination as to whether accepting data from EHRs on quality
measures is practical and feasible for the 2010 PQRI prior to
publication of the CY 2010 PFS final rule with comment period. We will
indicate in the CY 2010 PFS final rule with comment period whether we
intend to finalize this proposal. If we finalize this proposal, then,
unlike in prior years, an eligible professional would be able to earn a
PQRI incentive payment through the EHR-based reporting mechanism in
2010.
We seek to offer more reporting mechanisms because we recognize
that 1 mode of quality reporting does not suit all practices and our
experience with the registry-based reporting mechanism thus far has
been favorable. While the availability of multiple reporting mechanisms
should increase opportunities for eligible professionals to
satisfactorily report quality data for the PQRI, we also recognize that
there are a number of limitations associated with claims-based
reporting. On one hand, claims submission is available to nearly all
eligible professionals. On the other hand, submission of quality data
on claims has certain drawbacks since the claims processing system was
developed for billing purposes and not for the submission of quality
data. As we noted in the CY 2009 PFS final rule with comment period (73
FR 69833), for example, measures with complex specifications, such as
those that require multiple diagnosis codes are not as conducive to
claims-based reporting and may be associated with a greater number of
invalidly reported quality data codes. Similarly, when multiple
measures share the same codes it may be difficult to determine which
measure(s) the eligible professional intended to report through claims.
We believe that EHR-based reporting is a viable option for
overcoming the limitations associated with claims-based reporting of
quality measures. Therefore, we propose to add an EHR-based reporting
mechanism for the 2010 PQRI in order to promote the adoption and use of
EHRs and to provide both eligible professionals and CMS experience on
EHR-based quality reporting.
Furthermore, on February 17, 2009, the President signed into law
the American Recovery and Reinvestment Act (the Recovery Act) (Pub. L.
111-5). Section 4101(a) of the Health Information Technology for
Economic and Clinical Health (HITECH) Act (Title IV of Division B of
the Recovery Act, together with Title XIII of Division A of the
Recovery Act), which amends section 1848 of the Act to add new
subsection (o), authorizes incentive payments under Medicare for
certain eligible professionals who are ``meaningful EHR users''
beginning in 2011. However, the provisions in this proposed rule do not
implement any HITECH Act statutory provisions. While our efforts to
encourage the adoption and use of EHRs through testing EHR-based data
submission in the 2008 and 2009 PQRI and our proposal to add an EHR-
based reporting mechanism for the purpose of receiving a PQRI incentive
payment for the 2010 PQRI could potentially provide invaluable
experience and serve as a foundation for establishing the capacity for
eligible professionals to send, and for CMS to receive, data on quality
measures via EHRs, the provisions of the HITECH Act will be implemented
in future notice and comment rulemaking.
In summary, we propose that for 2010, an eligible professional may
choose to report data on PQRI quality measures through claims, to a
qualified registry (for the qualification requirements for registries,
see section II.G.2.i.(4) of this proposed rule), or through a qualified
EHR product (for the qualification requirements for EHR vendors and
their products, see section II.G.2.i.(5) of this proposed rule).
Depending on which PQRI individual quality measures or measures groups
an eligible professional selects, however, one or more of the proposed
reporting mechanisms may not be available for reporting a particular
2010 PQRI individual quality measure or measures group. The proposed
2010 reporting mechanisms through which each proposed 2010 PQRI
individual quality measure and measures group could be reported is
identified in Tables 14 through 15. We invite comments on the proposed
reporting mechanisms for the 2010 PQRI, including our proposal to add
an EHR-based reporting mechanism to the 2010 PQRI, contingent upon the
successful completion of our 2009 EHR data submission testing process
and a determination that accepting data from EHRs on quality measures
for the 2010 PQRI is practical and feasible.
While we propose to retain the claims-based reporting mechanism for
2010, we note that we are considering significantly limiting the
claims-based mechanism of reporting clinical quality measures for the
PQRI after 2010. This would be contingent upon there being an adequate
number and variety of registries available and/or EHR reporting
options. Potentially, we would retain claims-based reporting in years
after 2010 principally for the reporting of structural measures, such
as Measure 124 Health Information Technology (HIT): Adoption/
Use of Electronic Health Records (EHR), and circumstances where claims-
based reporting is the only available mechanism for certain categories
of eligible professionals to report on PQRI quality measures.
Reducing our reliance on the claims-based reporting mechanism after
2010 will allow us and eligible professionals to devote available
resources to maximizing the potential of registries and EHRs for
quality measurement reporting. Both mechanisms hold the promise of more
sophisticated and timely reporting on clinical quality measures.
Clinical data registries allow the collection of more detailed data,
including outcomes, without the necessity of a single submission
contemporaneously with claims billing, which overcomes some of the
limitations of the claims-based reporting mechanism. Registries can
also provide feedback and quality improvement information based on
reported data. Finally, clinical data registries can also receive data
from EHRs, and therefore, serve as an alternative means to reporting
clinical quality data extracted
[[Page 33562]]
from an EHR. As we continue to qualify additional registries, we
believe that there will be a sufficient number of qualified PQRI
registries by 2011 to make it possible to reduce or even discontinue
the claims-based reporting mechanism for most measures after 2010. We
invite comments on our intent to lessen our reliance on the claims-
based reporting mechanism for the PQRI beyond 2010.
Regardless of the reporting mechanism chosen by an eligible
professional, there is no requirement for the eligible professional to
sign up or register to participate in the PQRI. However, there may be
some requirements for participation through a specific reporting
mechanism that are unique to that particular reporting mechanism. In
addition to the criteria for satisfactory reporting of individual
measures and measures groups described in sections II.G.2.e. and
II.G.2.f., respectively, of this proposed rule, eligible professionals
must ensure that they meet all requirements for their chosen reporting
mechanism.
(1) Requirements for Individual Eligible Professionals Who Choose the
Claims-Based Reporting Mechanism
For eligible professionals who choose to participate in the PQRI by
submitting data on individual quality measures or measures groups
through the claims-based reporting mechanism, the only requirement
associated with claims-based reporting that we are proposing apart from
the proposed criteria for satisfactory reporting of individual measures
and measures described below in sections II.G.2.e. and II.G.2.f.,
respectively, of this proposed rule, is the submission of the
appropriate PQRI quality data codes on the professionals' Medicare Part
B claims. An eligible professional would be permitted to submit the
quality data codes for the eligible professional's selected individual
PQRI quality measures or measures group at any time during the 2010
reporting period. Please note, however, that as required by section
1848(m)(1)(A) of the Act, all claims for services furnished between
January 1, 2010 and December 31, 2010 must be processed by no later
than February 28, 2011 to be included in the 2010 PQRI analysis.
(2) Requirements for Individual Eligible Professionals Who Choose the
Registry-Based Reporting Mechanism
In order to report quality measures results and numerator and
denominator data on the 2010 PQRI individual quality measures or
measures group through a qualified clinical registry, we propose that
eligible professionals would need to enter into and maintain an
appropriate legal arrangement with a qualified 2010 PQRI registry. Such
arrangements would provide for the registry's receipt of patient-
specific data from the eligible professional and the registry's
disclosure of quality measures results and numerator and denominator
data on PQRI quality measures or measures groups on behalf of the
eligible professional to CMS. Thus, the registry would act as a Health
Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191)
(HIPAA) Business Associate and agent of the eligible professional. Such
agents are referred to as ``data submission vendors.'' The ``data
submission vendors'' would have the requisite legal authority to
provide clinical quality measures results and numerator and denominator
data on individual quality measures or measures groups on behalf of the
eligible professional for the PQRI. The registry, acting as a data
submission vendor, would submit registry-derived measures information
to the CMS designated database for the PQRI, using a CMS-specified
record layout. The record layout will be provided to the registry by
CMS.
To maintain compliance with applicable statutes and regulations,
our program and its data system must maintain compliance with the HIPAA
requirements for requesting, processing, storing, and transmitting
data. Eligible professionals that conduct HIPAA covered transactions
also must maintain compliance with the HIPAA requirements.
Eligible professionals choosing to participate in PQRI by
submitting quality measures results and numerator and denominator data
on PQRI individual quality measures or measures groups through the
registry-based reporting mechanism for 2010 would need to select a
qualified PQRI registry and submit information on PQRI individual
quality measures or measures groups to the selected registry in the
form and manner and by the deadline specified by the registry.
The process and requirements that we propose to use to determine
whether a registry is qualified to submit quality measures results and
numerator and denominator data on PQRI quality measures or measures
groups on an eligible professional's behalf in 2010 are described in
section II.G.2.d. of this proposed rule. We will post on the PQRI
section of the CMS Web site at http://www.cms.hhs.gov a list of
qualified registries for the 2010 PQRI, including the registry name,
contact information, and the 2010 measure(s) and/or measures group(s)
for which the registry is qualified and intends to report. We propose
to post the names of 2010 PQRI qualified registries in 2 phases. In
either event, even though a registry is listed as ``qualified,'' we
cannot guarantee or assume responsibility for the registry's successful
submission of PQRI quality measures results and numerator and
denominate data on PQRI quality measures or measures groups on behalf
of eligible professionals.
In the first phase, we anticipate that by December 31, 2009, we
will be able to, at minimum, post a list of those registries qualified
for the 2010 PQRI based on: (1) Being a qualified registry for the 2008
and 2009 PQRI that successfully submitted 2008 PQRI quality measures
results and numerator and denominator data on the quality measures; (2)
having received a letter indicating their continued interest in being a
PQRI registry for 2010; and (3) the registry's compliance with the 2010
PQRI registry requirements. By posting this first list of qualified
registries for the 2010 PQRI, we seek to make available the names of
registries that can be qualified at the start of the 2010 reporting
period. We do this to accommodate requests we have received from
eligible professionals who wish to avoid claims-based reporting pending
knowing whether a particular registry is qualified for the 2010 PQRI.
In the second phase, we anticipate to complete posting of the list
of qualified 2010 registries as soon as we have completed vetting the
registries interested in participating in the 2010 PQRI and identified
the qualified registries for the 2010 PQRI, which we anticipate will be
completed by no later than Summer 2010. An eligible professional's
ability to report PQRI quality measures results and numerator and
denominator data on PQRI quality measures or measures groups using the
registry-based reporting mechanism should not be impacted by the
complete list of qualified registries for the 2010 PQRI being made
available after the start of the reporting period. First, registries
will not begin submitting eligible professionals' PQRI quality measures
results and numerator and denominator data on the quality measures or
measures groups to CMS until 2011. Second, if an eligible professional
decides that he or she is no longer interested in submitting quality
measures results and numerator and denominator data on PQRI individual
quality measures or measures group through the registry-based reporting
mechanism after the complete list of qualified registries becomes
available, this does not preclude the eligible
[[Page 33563]]
professional from attempting to meet the criteria for satisfactory
reporting through another 2010 PQRI reporting mechanism.
In addition to meeting the above proposed requirements specific to
registry-based reporting, eligible professionals who choose to
participate in PQRI through the registry-based reporting mechanism
would need to meet the relevant criteria proposed for satisfactory
reporting of individual measures or measures groups that all eligible
professionals must meet in order to qualify to earn a 2010 PQRI
incentive payment. The criteria for satisfactory reporting of
individual measures and measures groups are described in sections
II.G.2.e. and II.G.2.f., respectively, of this proposed rule.
(3) Requirements for Individual Eligible Professionals Who Choose the
EHR-Based Reporting Mechanism
For eligible professionals who choose to participate in the 2010
PQRI by submitting data on individual quality measures through the EHR-
based reporting mechanism, the only proposed requirements associated
with EHR-based reporting other than meeting the criteria for
satisfactory reporting of individual measures described in section
II.G.2.e. of this proposed rule are to: (1) Select a qualified EHR
product and (2) submit clinical quality data extracted from the EHR to
a CMS clinical data warehouse. Provided that our 2009 EHR data
submission testing process is successful, we propose to begin accepting
submission of clinical quality data extracted from ``qualified'' EHRs
on January 1, 2010, or as soon thereafter as is technically feasible.
We propose that eligible professionals will have until March 31, 2011
to complete data submission through qualified EHRs for services
furnished during the 2010 PQRI reporting period. The process that was
used to determine whether an EHR vendor and its EHR product(s) are
qualified to submit clinical quality data extracted from EHRs for the
2010 PQRI is described in section II.G.2.d.5. of this proposed rule.
The specifications for the electronic transmission of the proposed
2010 PQRI measures identified in Table 20 (section II.G.2.i.(4) of this
proposed rule) as being under consideration for EHR-based reporting in
2010 will be posted on a public Web site when available. We will
announce the availability and exact location of these specifications
through familiar CMS communications channels, including the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI. The posting
of specifications for the electronic transmission of any particular
measure prior to publication of the final rule does not signify that
the measure will necessarily be selected for the 2010 PQRI measure set,
nor that EHR-based reporting will be accepted for that measure even if
it may otherwise be included in the 2010 PQRI. However, by posting the
specifications for electronic transmission of these measures, we seek
to allow sufficient time for EHR vendors to adapt their products to
support EHR-based capture and submission of data for these measures
prior to the start of any 2010 PQRI reporting periods.
We do not propose any option to report measures groups through EHR-
based reporting on services furnished during 2010. Because EHR-based
reporting to CMS of data on quality measures would be new to PQRI for
2010, we propose to make available only the criteria applicable to
reporting of individual PQRI measures.
We cannot assume responsibility for the successful submission of
data from eligible professionals' EHRs. Any eligible professional who
chooses to submit PQRI data extracted from an EHR should contact the
EHR product's vendor to determine if the product is qualified and has
been updated to facilitate PQRI quality measures data submission. Such
professionals also should begin attempting submission promptly after we
announce that the clinical data warehouse is ready to accept 2010 PQRI
quality measures data through the EHR mechanism in order to assure the
professional has a reasonable period of time to work with his or her
EHR and/or its vendor to correct any problems that may complicate or
preclude successful quality measures data submission through that EHR.
As we indicated above, data submission for the 2010 PQRI would need to
be completed by March 31, 2011.
(4) Qualification Requirements for Registries
In order to be ``qualified'' to submit quality measures results and
numerator and denominator data on PQRI quality measures and measures
groups on behalf of eligible professionals pursuing incentive payment
for the 2008 and 2009 PQRI, we required registries to complete a self-
nomination process and to meet certain technical and other
requirements. For the 2009 PQRI, registries that were ``qualified'' for
2008 did not need to be ``re-qualified'' for 2009 unless they were
unsuccessful at submitting 2008 PQRI data (that is, failed to submit
2008 PQRI data per the 2008 PQRI registry requirements). Registries
that were ``qualified'' for 2008 and wished to continue to participate
in 2009 were only required to communicate their desire to continue
participation for 2009 by submitting a letter to CMS indicating their
continued interest in being a PQRI registry for 2009 and their
compliance with the 2009 PQRI registry requirements by March 31, 2009.
For the 2010 PQRI, we are again proposing to require a self-
nomination process for registries wishing to submit 2010 PQRI quality
measures or measures groups on behalf of eligible professionals for
services furnished during the applicable reporting periods in 2010.
Similar to the 2008 and 2009 PQRI registry self-nomination process, the
proposed registry self-nomination process for the 2010 PQRI would be
based on a registry meeting specific technical and other requirements.
In order to be consistent with the registry requirements from prior
program years, we propose that the 2010 registry requirements be
substantially the same as for 2008 and 2009. Specifically, to be
considered a qualified registry for purposes of submitting individual
quality measures and measures groups on behalf of eligible
professionals who choose to report using this reporting mechanism under
the 2010 PQRI, we propose that a registry would need to:
Be in existence as of January 1, 2009.
Be able to collect all needed data elements and calculate
results for at least 3 measures in the 2010 PQRI program (according to
the posted 2010 PQRI Measure Specifications).
Be able to calculate and submit measure-level reporting
rates by TIN/NPI;
Be able to calculate and submit, by TIN/NPI, a performance
rate (that is, the percentage of a defined population who receive a
particular process of care or achieve a particular outcome) for each
measure on which the TIN/NPI reports;
Be able to separate out and report on Medicare Part B FFS
patients;
Provide the name of the registry;
Provide the reporting period start date the registry will
cover;
Provide the reporting period end date the registry will
cover;
Provide the measure numbers for the PQRI quality measures
on which the registry is reporting;
Provide the measure title for the PQRI quality measures on
which the registry is reporting;
Report the number of eligible instances (reporting
denominator);
Report the number of instances of quality service
performed (numerator);
[[Page 33564]]
Report the number of performance exclusions;
Report the number of reported instances, performance not
met (eligible professional receives credit for reporting, not for
performance);
Be able to transmit this data in a CMS-approved XML
format. We expect that this CMS-specified record layout will be
substantially the same as for the 2008 and 2009 PQRI. This layout will
be provided to registries in 2010;
Comply with a CMS-specified secure method for data
submission, such as submitting its data in an XML file through an
Individuals Access to CMS Systems (IACS) user account;
Submit an acceptable ``validation strategy'' to CMS by
March 31, 2010. A validation strategy ascertains whether eligible
professionals have submitted accurately and on at least the minimum
number (80 percent) of their eligible patients, visits, procedures, or
episodes for a given measure. Acceptable validation strategies often
include such provisions as the registry being able to conduct random
sampling of their participants' data, but may also be based on other
credible means of verifying the accuracy of data content and
completeness of reporting or adherence to a required sampling method;
Enter into and maintain with its participating
professionals an appropriate Business Associate agreement that provides
for the registry's receipt of patient-specific data from the eligible
professionals, as well as the registry's disclosure of quality measure
results and numerator and denominator data on behalf of eligible
professionals who wish to participate in the PQRI program;
Obtain and keep on file signed documentation that each
holder of an NPI whose data are submitted to the registry has
authorized the registry to submit quality measures results and
numerator and denominator data to CMS for the purpose of PQRI
participation. This documentation must be obtained at the time the
eligible professional signs up with the registry to submit PQRI quality
measures data to the registry and must meet any applicable laws,
regulations, and contractual business associate agreements;
Provide CMS access (if requested) to review the Medicare
beneficiary data on which 2010 PQRI registry-based submissions are
founded;
Provide the reporting option (reporting period and
reporting criteria) that the eligible professional has satisfied or
chosen; and
Provide CMS a signed, written attestation statement via
mail or e-mail which states that the quality measure results and
numerator and denominator data provided to CMS are accurate and
complete.
With respect to the submission of 2010 measure results and
numerator and denominator data on measures groups, we propose to retain
the following registry requirements from the 2009 PQRI:
Indicate the reporting period chosen for each eligible
professional who chooses to submit data on measures groups;
Base reported information on measures groups only on
patients to whom services were furnished during the 12-month reporting
period of January through December 2010 or the 6-month reporting period
of July 2010 through December 2010;
Agree that the registry's data may be inspected by CMS
under our oversight authority if non-Medicare patients are included in
the patient sample;
Be able to report data on all of the measures in a given
measures group and on either 30 patients from January 1 through
December 31, 2010 (note this patient sample must include some Medicare
Part B FFS beneficiaries) or on 80 percent of applicable Medicare Part
B FFS patients for each eligible professional (with a minimum of 15
patients during the January 1, 2010 through December 31, 2010 reporting
period or a minimum of 8 patients during the July 1, 2010 through
December 31, 2010 reporting period) (see criteria for satisfactory
reporting of measures groups described in section II.G.2.f. of this
proposed rule for further information); and
Be able to report the number of Medicare FFS patients and
the number of Medicare Advantage patients that are included in the
patient sample for a given measures group.
In addition to the above requirements, we propose the following new
requirements for registries for the 2010 PQRI:
Registries must have at least 25 participants;
Registries must provide at least 1 feedback report per
year to participating eligible professionals;
Registries must not be owned and managed by an individual
locally-owned single-specialty group (in other words, single-specialty
practices with only 1 practice location or solo practitioner practices
would be prohibited from self-nominating to become a qualified PQRI
registry);
Registries must participate in ongoing 2010 PQRI mandatory
support conference calls hosted by CMS (approximately 1 call per
month);
Registries must provide a flow and XML of a measure's
calculation process for each measure type that the registry intends to
calculate; and
Registries must use PQRI measure specifications to
calculate reporting or performance unless otherwise stated.
These proposed new requirements are intended to improve the
registry-based reporting mechanism by taking advantage of some of the
registries' existing quality improvement functions, maximizing the
registry's ability to successfully submit eligible professionals'
quality measure results and numerator and denominator data on PQRI
individual quality measures or measures groups to CMS, and discouraging
small physician offices or an individual eligible professional from
self-nominating to become a qualified registry. We are concerned that
an individual eligible professional or a small practice does not have
the resources or capabilities to successfully submit quality measures
results and numerator and denominator data on PQRI individual measures
or measures groups through the registry data submission process.
We propose to post the final 2010 PQRI registry requirements,
including the exact date by which registries that wish to qualify for
2010 must submit a self-nomination letter and instructions for
submitting the self-nomination letter, on the PQRI section of the CMS
Web site at http://www.cms.hhs.gov/PQRI by November 15, 2009. We
anticipate that new registries that wish to self-nominate for 2010 will
be required to do so by January 31, 2010.
Similar to the 2009 PQRI, we propose that registries that were
``qualified'' for 2009 and wish to continue to participate in 2010
would not need to be ``re-qualified'' for 2010 unless they are
unsuccessful at submitting 2009 PQRI data (that is, fail to submit 2009
PQRI data per the 2009 PQRI registry requirements). We further propose
that registries that were ``qualified'' for 2009, were successful in
submitting 2009 PQRI data, and wish to continue to participate in 2010
would need to indicate their desire to continue participation for 2010
by submitting a letter to CMS indicating their continued interest in
being a PQRI registry for 2010 and their compliance with the 2010 PQRI
registry requirements by no later than October 31, 2009. Instructions
regarding the procedures for submitting this letter will be provided to
qualified 2009 PQRI registries on the 2009 PQRI registry support
conference calls.
If a qualified 2009 PQRI registry fails to submit 2009 PQRI data
per the 2009 PQRI registry requirements, we propose
[[Page 33565]]
the registry would be considered unsuccessful at submitting 2009 PQRI
data and would need to go through the full self-nomination process
again to participate in the 2010 PQRI. By March 31, 2010, registries
that are unsuccessful submitting quality measures results and numerator
and denominator data for 2009 would need to be able to meet the 2010
PQRI registry requirements and go through the full vetting process
again.
Finally, as discussed further under section II.G.5.c.(1) of this
proposed rule, we propose that the above registry requirements would
apply not only for the purpose of a registry qualifying to report 2010
PQRI quality measure results and numerator and denominator data on PQRI
individual quality measures or measures groups, but also for the
purpose of a registry qualifying to submit the proposed electronic
prescribing measure for the 2010 E-Prescribing Incentive Program.
(5) Qualification Requirements for EHR Vendors and Their Products
In the CY 2009 PFS final rule with comment period (73 FR 69830), we
announced our intent to qualify EHR vendors and their specific products
to submit quality data extracted from their EHR products to the CMS
clinical quality data warehouse so that we may potentially begin to
accept data via EHRs for purposes of satisfactorily reporting data on
quality measures in future PQRI reporting. We stated that we anticipate
posting on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI, by December 31, 2008, a list of requirements that
EHR vendors must be able to meet in order to self-nominate to have
their product ``qualified'' to potentially be able to submit quality
measures data for the 2010 PQRI to CMS. We also stated that qualifying
EHR vendors ahead of actual data submission will facilitate the live
data submission process.
On December 31, 2008, the ``Requirements for Electronic Health
Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing
Program,'' was posted on the Reporting page of the PQRI section of the
CMS Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage, which described the EHR vendor requirements
and the EHR vendor self-nomination process.
The vendor's EHR system must be updated according to the Draft 2009
EHR specifications posted on the QualityNet Web site at http://www.qualitynet.org in order for an EHR vendor and its product to
qualify to submit test information on 2009 PQRI measures, and for
possible EHR data submission for future PQRI reporting years. In
addition, the 2009 PQRI EHR test-vendors must meet the following
requirements:
Be able to collect and transmit all required data elements
according to the 2009 EHR Specifications.
Be able to separate out and report on Medicare Part B FFS
patients only.
Be able to include TIN/NPI information submitted with an
eligible professional's quality data.
Be able to transmit this data in the CMS-approved format.
Comply with a secure method for data submission.
Enter into and maintain with its participating
professionals an appropriate legal arrangement that provides for the
EHR vendor to receive patient-specific data from the eligible
professional, as well as the EHR vendor's disclosure of protected
health information on behalf of eligible professionals who wish to
participate in the 2009 PQRI EHR test program.
Obtain and keep on file signed documentation that each NPI
whose data is submitted to the EHR vendor has authorized the EHR vendor
to submit patient data to CMS for the purpose of PQRI testing. This
documentation must meet the standards of applicable law, regulations,
and contractual or business associate agreements.
As described in the ``Requirements for Electronic Health Record
(EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program,''
which is posted on the Reporting page of the PQRI section of the CMS
Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage,
EHR vendors who wish to qualify to participate in the 2009 PQRI EHR
test program were required to submit a self-nomination letter
requesting inclusion in the 2009 EHR testing process by February 13,
2009. All nominees would then go through a vetting process. Those
nominees passing this vetting process would be asked to submit test
data (that is, mock-up data) or to submit live test data from some of
their clients (users) with their permission. Vendors who successfully
submit their test data would also need to be able to adapt their system
to any changes in the measure specifications that may arise due to
Healthcare Information Technology Standards Panel (HITSP) or
Certification Commission for Healthcare Information Technology (CCHIT)
adoption of quality measure data reporting criteria.
It is expected that the process for qualifying self-nominated EHR
vendors may conclude in 2009. At the conclusion of this process, we
propose that those EHR products that meet all of the EHR vendor
requirements will be listed on the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI as a ``qualified'' EHR product (that is,
the name of the vendor software product and the version that is
qualified), which indicates that the product's users may submit quality
data to CMS (either directly from their system or through the vendor--
which is yet to be determined) for the 2010 PQRI, if and when, EHR
submission is included in the 2010 PQRI as a PQRI reporting mechanism.
As discussed further under section II.G.5.c.(1) of this proposed
rule, we propose that the above EHR vendor requirements would apply not
only for the purpose of a vendor's EHR product being qualified for the
purpose of the product's users being able to submit data extracted from
the EHR for the 2010 PQRI, but also for the purpose of a vendor's EHR
product being qualified for the purpose of the product's users being
able to electronically submit data extracted from the EHR for the
electronic prescribing measure for the 2010 E-Prescribing Incentive
Program.
During 2010, we expect to use the self-nomination process described
in the ``Requirements for Electronic Health Record (EHR) Vendors to
Participate in the 2009 PQRI EHR Testing Program'' posted on the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage, to qualify additional EHR vendors and their
EHR products to submit quality data extracted from their EHR products
to the CMS clinical quality data warehouse for program years after
2010. We anticipate that the requirements will be similar to those used
to qualify EHR products for the 2009 PQRI EHR testing, but they may be
modified based on the results of our 2009 EHR testing. At the
conclusion of this process, sometime in late 2010, those EHR products
that meet all of the EHR vendor requirements will be listed on the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI as a
``qualified'' EHR product, which indicates that the product's users may
submit quality data to CMS (either directly from their system or
through the vendor--which is yet to be determined) for the 2011 PQRI or
subsequent years, if and when, EHR submission is included as a PQRI
reporting mechanism for years after 2010.
e. Proposed Criteria for Satisfactory Reporting of Individual Quality
Measures for Individual Eligible Professionals
Under section 1848(m)(3)(A) of the Act, the criteria for
satisfactorily
[[Page 33566]]
submitting data on individual quality measures through claims-based
reporting require the reporting of at least 3 applicable measures in at
least 80 percent of the cases in which the measure is reportable. If
fewer than 3 measures are applicable to the services of the
professional, the professional may meet the criteria by reporting on
all applicable measures (that is, 1 to 2 measures) for at least 80
percent of the cases where the measures are reportable. It is assumed
that if an eligible professional submits quality data codes for a
particular measure, the measure applies to the eligible professional.
In prior program years, when we were required, under section
1848(m)(5)(F) of the Act, to establish alternative criteria for
satisfactorily reporting using the registry-based reporting mechanism,
we decided that the criteria for registry-based reporting of individual
measures should be consistent with the criteria for claims-based
reporting of individual measures. Thus, we adopted the same criteria
for satisfactory reporting of individual measures through registry-
based reporting as the criteria for satisfactory reporting of
individual measures through claims-based reporting except that an
eligible professional could choose to report through the registry-based
reporting mechanism only if there are at least 3 PQRI quality measures
applicable to the services of the professional. For the 2008 or 2009
PQRI, eligible professionals could not satisfactorily report PQRI
measures through the registry-based reporting mechanism by reporting on
fewer than 3 measures.
For years after 2009, section 1848(m)(3)(D) of the Act authorizes
the Secretary, in consultation with stakeholders and experts, to revise
the criteria for satisfactorily reporting data on quality measures.
Based on this authority and the input we have received from
stakeholders via the invitation to submit suggestions for the 2010 PQRI
reporting options posted on the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI in April 2009, we propose 3 criteria for
satisfactory reporting of individual PQRI quality measures for 2010. In
an effort to continue to be consistent with the criteria of
satisfactory reporting used in prior PQRI program years, we propose to
retain the following 2 criteria with respect to satisfactorily
reporting data on individual quality measures in circumstances where 3
or more individual quality measures apply to the services furnished by
an eligible professional:
Report on at least 3 2010 PQRI measures (unless fewer than
3 2010 PQRI measures apply to the services furnished by the eligible
professional); and
Report each measure for at least 80 percent of the
eligible professional's Medicare Part B FFS patients for whom services
were furnished during the reporting period to which the measure
applies.
These criteria would apply to all proposed 2010 PQRI reporting
mechanisms available for reporting individual PQRI quality measures
(that is, claims-based reporting, registry-based reporting, and EHR-
based reporting).
If an eligible professional has fewer than 3 PQRI measures that
apply to the professional's services, then the professional would be
able to meet the criteria for satisfactorily reporting data on
individual quality measures by meeting the following 2 proposed
criteria:
Reporting on all measures that apply to the services
furnished by the professional (that is 1 to 2 measures); and
Reporting each measure for at least 80 percent of the
eligible professional's Medicare Part B FFS patients for whom services
were furnished during the reporting period to which the measure
applies.
We propose that, as in previous years, these criteria for
satisfactorily reporting data on fewer than 3 individual quality
measures would be available for the claims-based reporting mechanism
only. An eligible professional who has fewer than 3 PQRI measures that
apply to the professional's services would not be able to meet the
criteria for satisfactory reporting by reporting on all applicable
measures (that is, 1 or 2 measures) through the registry-based
reporting mechanism.
While we have received input from several stakeholders requesting
that we permit an eligible professional to report fewer than 3 measures
through the registry-based reporting mechanism if fewer than 3 measures
apply to him or her, doing so would be inefficient. First, in addition
to needing to analyze the data submitted to us by the registry, we
would have to analyze the claims data to ensure that no additional
measures are applicable to the eligible professional, much like what we
do under the Measure Applicability Validation process for claims-based
reporting. Second, we would also have to analyze the claims data to
ensure that the eligible professional had not attempted to report
additional measures through claims. For these reasons, we are not
proposing to permit eligible professionals who choose the registry-
based or EHR-based reporting mechanism to report on individual quality
measures to report on fewer than 3 measures if only 1 or 2 measures
apply to the services they furnish.
Based on the previously stated assumption that a measure applies to
the eligible professional if an eligible professional submits quality
data codes for a particular measure, we propose that an eligible
professional who reports on fewer than 3 measures through the claims-
based reporting mechanism in 2010 may be subject to the Measure
Applicability Validation process, which allows us to determine whether
an eligible professional should have reported quality data codes for
additional measures. This process was applied in the 2007 and 2008
PQRI. When an eligible professional reports on fewer than 3 measures,
we propose to review whether there are other closely related measures
(such as those that share a common diagnosis or those that are
representative of services typically provided by a particular type of
professional). If an eligible professional who reports on fewer than 3
measures in 2010 reports on a measure that is part of an identified
cluster of closely related measures and did not report on any other
measure that is part of that identified cluster of closely related
measures, then the professional would not qualify to receive a 2010
PQRI incentive payment. Additional information on the Measure
Applicability Validation process can be found on the Analysis and
Payment page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.
In addition to the above criteria related to the number of measures
on which an eligible professional would be required to report and the
frequency of reporting, we propose a third criterion for satisfactory
reporting of individual measures. Based on our authority to revise the
criteria for satisfactory reporting under section 1848(m)(3)(D) of the
Act, we propose that an eligible professional also be required to
report data on at least one individual measure on a minimum number of
Medicare Part B FFS patients seen during the reporting period, as
detailed below. Establishing a minimum patient sample size requirement
would enhance the scientific validity of eligible professionals'
performance results and encourage eligible professionals to select to
report only measures that are representative of the types of services
they typically provide in their practice. If, for example, an eligible
professional selects 3 patient-level measures (that is, measures in
which the required
[[Page 33567]]
reporting frequency is a minimum of once per reporting period per
individual eligible professional) where only one of his or her Medicare
Part B FFS patients are eligible for the measures and there is no
minimum patient sample size requirement, then the eligible professional
currently could qualify to earn a PQRI incentive payment by reporting
PQRI quality measures data only 3 times during the entire reporting
period. We believe that information on such a small sample of cases
would be insufficient to do any meaningful analysis of the eligible
professional's performance on the reported measure. We also believe
that a minimum patient sample size requirement would prevent an
eligible professional from purposely selecting measures that apply to
only a few of their patients.
Regardless of the reporting mechanism chosen by the eligible
professional, we propose that the minimum patient sample size for
reporting individual quality measures be 15 Medicare Part B FFS
patients for the 12-month reporting period. An eligible professional
would need to meet this minimum patient sample size requirement for at
least one measure on which the eligible professional chooses to report.
This proposed number is based on our experience with the 2007 PQRI and
the limited information we have available regarding the 2008 PQRI
reporting experience. For the 2007 PQRI measures, where the only
reporting period was a 6-month reporting period beginning July 1, 2007,
the median number of instances in which an eligible professional could
have reported a 2007 PQRI measure was, on average, 9 eligible instances
per measure. If we assume that the number of eligible instances for the
first half of 2007 were similar to the number of eligible instances in
the second half of 2007, then we can assume that the median number of
eligible instances was an average of 18 instances per measure for the
entire year. Preliminary information from the 2008 PQRI, based on data
through September 2008, indicate that the median number of instances in
which an eligible professional could have reported a 2008 PQRI measure
was, on average, 18 eligible instances per measure. Since eligible
professionals are not required to report a measure for all eligible
cases, we based the proposed minimum patient sample size threshold on
80 percent of 18 eligible instances, which is 14.4.
Similarly, for the 6-month reporting period (available for
registry-based reporting only), we propose that the minimum patient
sample size for reporting on individual quality measures be 8 Medicare
Part B FFS patients seen during the 6-month reporting period. An
eligible professional would need to meet this minimum patient sample
size requirement for at least one measure on which the eligible
professional chooses to report. We welcome comments on the proposal to
add a minimum patient sample size criterion to the criteria for
satisfactory reporting of data on individual quality measures. In
addition, we invite comments on the specific thresholds proposed for
the 12-month reporting period (available for claims-based, registry-
based, and EHR-based reporting) and for the 6-month reporting period
(available for registry-based reporting only) for reporting individual
quality measures.
The proposed 2010 criteria for satisfactory reporting of data on
individual PQRI quality measures are summarized in Table 14 and are
arranged by reporting mechanism and reporting period.
Table 14--Proposed 2010 Criteria for Satisfactory Reporting of Data on Individual PQRI Quality Measures, by
Reporting Mechanism and Reporting Period
----------------------------------------------------------------------------------------------------------------
Reporting mechanism Reporting criteria Reporting period
----------------------------------------------------------------------------------------------------------------
Claims-based reporting................ Report at least 3 PQRI January 1, 2010-December 31,
measures, or 1-2 measures if less than 2010.
3 measures apply to the eligible
professional;
Report each measure for at
least 80% of the eligible
professional's Medicare Part B FFS
patients seen during the reporting
period to whom the measure applies; and
Report at least 1 PQRI measure
on at least 15 Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
Registry-based reporting.............. Report at least 3 PQRI January 1, 2010-December 31,
measures; 2010.
Report each measure for at
least 80% of the eligible
professional's Medicare Part B FFS
patients seen during the reporting
period to whom the measure applies; and.
Report at least 1 PQRI measure
on at least 15 Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
Registry-based reporting.............. Report at least 3 PQRI July 1, 2010-December 31,
measures; 2010.
Report each measure for at
least 80% of the eligible
professional's Medicare Part B FFS
patients seen during the reporting
period to whom the measure applies; and.
Report at least 1 PQRI measure
on at least 8 Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
EHR-based reporting................... Report at least 3 PQRI January 1, 2010-December 31,
measures; 2010.
Report each measure for at
least 80% of the eligible
professional's Medicare Part B FFS
patients seen during the reporting
period to whom the measure applies; and.
Report at least 1 PQRI measure
on at least 15 Medicare Part B FFS
patients seen during the reporting
period to which the measure applies.
----------------------------------------------------------------------------------------------------------------
[[Page 33568]]
As illustrated in Table 14, there are a total of 4 proposed
reporting options, or ways in which an eligible professional may meet
the criteria for satisfactory reporting on individual quality measures
for the 2010 PQRI. Each reporting option consists of the criteria for
satisfactorily reporting such data and results on individual quality
measures relevant to a given reporting mechanism and reporting period.
While eligible professionals may potentially qualify as satisfactorily
reporting individual quality measures under more than one of the
proposed reporting criteria, proposed reporting mechanisms, and/or for
more than one proposed reporting period, only one incentive payment
would be made to an eligible professional based on the longest
reporting period for which the eligible professional satisfactorily
reports.
f. Proposed Criteria for Satisfactory Reporting Measures Groups for
Individual Eligible Professionals
As described above, section 1848(m)(5)(F) of the Act requires that,
for 2008 and subsequent years, the Secretary establish alternative
reporting periods and alternative criteria for satisfactorily reporting
groups of measures. In establishing these alternatives in prior years,
we have labeled these groups of measures ``measures groups.'' We have
previously defined ``measures groups'' as a subset of four or more PQRI
measures that have a particular clinical condition or focus in common.
The denominator definition and coding of the measures group identifies
the condition or focus that is shared across the measures within a
particular measures group.
In the 2008 and 2009 PQRI, measures groups were reportable through
claims-based or registry-based reporting. For the 2008 and 2009 PQRI,
there were 2 basic sets of criteria for satisfactory reporting measures
groups through claims-based or registry-based reporting: (1) The
reporting of at least 1 measures group for at least 80 percent of
patients to whom the measures group applies during the reporting
period; or (2) the reporting of at least 1 measures group for a
specified number of consecutive patients to whom the measures group
applies during the reporting period. For registry-based reporting in
the 2008 and 2009 PQRI, we allowed eligible professionals to include
some non-Medicare Part B FFS patients in the consecutive patient sample
under the second set of criteria. For registry-based reporting quality
measures results and numerator and denominator data on measures groups
in 2009, we also added to the first set of criteria a requirement to
report the measures group on a minimum number of patients commensurate
with the reporting period duration.
For the 2010 PQRI, we again propose 2 basic sets of criteria for
satisfactory reporting on measures group. Both sets of criteria would
apply to the claims-based and registry-based reporting mechanism. As
discussed in section II.G.2.d.(3) of this proposed rule, we are not
proposing to make the EHR-based reporting mechanism available for
reporting on measures groups in 2010.
The first set of proposed criteria, which we propose to make
available for either the 12-month or 6-month reporting period in 2010,
would be consistent with the 2009 criteria for satisfactory reporting
of measures groups through registry-based reporting, which require the
reporting of at least 1 measures group for at least 80 percent of
patients to whom the measures group applies during the applicable
reporting period (with reporting required on a minimum number of
Medicare Part B FFS patients commensurate with the reporting period
duration). In the 2009 PQRI, there was a requirement under these
criteria to report each measures group on at least 30 Medicare Part B
FFS patients for the 12-month reporting period and at least 15 Medicare
Part B FFS patients for the 6-month reporting period for registry-based
reporting of measures groups. For the 2010 PQRI, we propose to revise
the requirement by making these criteria applicable to both registry-
based and claims-based reporting and to change the number of Medicare
Part B FFS patients on which an eligible professional would be required
to report a measures group. We propose to require an eligible
professional who chooses to report on measures groups based on
reporting on 80 percent of applicable patients to report on a minimum
of 15 Medicare Part B FFS patients for the 12-month reporting period
and a minimum of 8 Medicare Part B FFS patients for the 6-month
reporting period, regardless of whether the eligible professional
chooses to report the measures group through claims-based reporting or
registry-based reporting. We propose to revise the required minimum
sample size to make the proposed 2010 criteria for satisfactory
reporting of measures groups consistent with the proposed 2010 criteria
for satisfactory reporting of individual measures. We invite comments
on our proposal to make the criteria for satisfactory reporting of
measures groups more consistent with those proposed for reporting
individual measures. We especially would be interested in comments with
respect to our proposal to revise the minimum sample size requirement
related to satisfactory reporting on measures group through the
registry-based reporting mechanism so that the criteria for
satisfactory reporting of measures groups, regardless of reporting
mechanism, would be identical to those proposed for reporting
individual measures.
The second set of proposed criteria, which we propose to make
available for the 12-month reporting period only, would be based on
reporting on a measures group on a specified minimum number of
patients. The second set of criteria would require reporting on at
least 1 measures group for at least 30 patients seen between January 1,
2010 and December 31, 2010 to whom the measures group applies. Unlike
the 2009 PQRI, which required that eligible professionals report on
consecutive patients (that is, patients seen in order, by date of
service), the 30 patients on which an eligible professional would need
to report a measures group for 2010 would not need to be consecutive
patients. The eligible professional would be able to report on any 30
patients seen during the reporting period to which the measures group
applies. We propose to remove the requirement to report on patients
seen consecutively by date of service because our preliminary analysis
of the 2008 PQRI claims-based reporting experience through September
2008 suggests that this requirement is difficult for professionals to
apply accurately to meet the criteria for satisfactory reporting of
measures groups. In addition, the questions we receive from eligible
professionals indicate that many eligible professionals are not clear
on how to determine which patients are ``consecutive'' and should be
included in the patient sample. We believe that any adverse effect on
the reliability or validity of the quality information received as a
result of the removal of the requirement to report on patients seen
consecutively and allowing eligible professionals to report on any 30
patients would be minimal. When eligible professionals report measures
groups, they are required to report on multiple measures for a given
clinical condition or focus, which makes it harder for them to
selectively choose patients in an attempt to improve their performance
results. We invite comments on our proposal to allow eligible
professionals to report on measures groups on any 30 patients rather
than a consecutive patient sample.
As in previous years, we propose that for 2010, the patients, for
claims-based
[[Page 33569]]
reporting, would be limited to Medicare Part B FFS patients. We receive
claims on Medicare patients only. For registry-based reporting,
however, we propose that the patients could include some, but not be
exclusively, non-Medicare Part B FFS patients.
The proposed 2010 criteria for satisfactory reporting on measures
groups are summarized in Table 15, which is arranged by reporting
mechanism and reporting period.
Table 15--Proposed 2010 Criteria for Satisfactory Reporting on Measures Groups, by Reporting Mechanism and
Reporting Period
----------------------------------------------------------------------------------------------------------------
Reporting mechanism Reporting criteria Reporting period
----------------------------------------------------------------------------------------------------------------
Claims-based reporting........... Report at least 1 PQRI measures group; January 1, 2010-
December 31, 2010.
Report each measures group for at least 30
Medicare Part B FFS patients.
Claims-based reporting........... Report at least 1 PQRI measures group; January 1, 2010-
December 31, 2010.
Report each measures group for at least 80% of
the eligible professional's Medicare Part B FFS
patients seen during the reporting period to whom the
measures group applies; and
Report each measures group on at least 15
Medicare Part B FFS patients seen during the reporting
period to which the measures group applies.
Claims-based reporting........... Report at least 1 PQRI measures group; July 1, 2010-
December 31, 2010.
Report each measures group for at least 80% of January 1, 2010-
the eligible professional's Medicare Part B FFS December 31, 2010.
patients seen during the reporting period to whom the
measures group applies; and
Report each measures group on at least 8
Medicare Part B FFS patients seen during the reporting
period to which the measures group applies.
Registry-based reporting......... Report at least 1 PQRI measures group; January 1, 2010-
December 31, 2010.
Report each measures group for at least 30
patients. Patients may include, but may not be
exclusively, non-Medicare Part B FFS patients.
Registry-based reporting......... Report at least 1 PQRI measures group; January 1, 2010-
December 31, 2010.
Report each measures group for at least 80% of
the eligible professional's Medicare Part B FFS
patients seen during the reporting period to whom the
measures group applies; and
Report each measures group on at least 15
Medicare Part B FFS patients seen during the reporting
period to which the measures group applies.
Registry-based reporting......... Report at least 1 PQRI measures group; July 1, 2010-
December 31, 2010.
Report each measures group for at least 80 %
of the eligible professional's Medicare Part B FFS
patients seen during the reporting period to whom the
measures group applies; and
Report each measures group on at least 8
Medicare Part B FFS patients seen during the reporting
period to which the measures group applies.
----------------------------------------------------------------------------------------------------------------
As illustrated in Table 15, there are a total of 6 proposed
reporting options, or ways in which an eligible professional may meet
the proposed criteria for satisfactory reporting of measures groups for
the 2010 PQRI. Each reporting option consists of the criteria for
satisfactory reporting relevant to a given reporting mechanism and
reporting period. As stated previously, while eligible professionals
may potentially qualify as satisfactorily reporting on measures groups
under more than one of the proposed reporting criteria, proposed
reporting mechanisms, and/or for more than one proposed reporting
period, only one incentive payment would be made to an eligible
professional based on the longest reporting period for which the
eligible professional satisfactorily reports.
g. Proposed Reporting Option for Satisfactory Reporting on Quality
Measures by Group Practices
As stated previously, section 1848(m)(3)(C)(i) of the Act requires
the Secretary to establish and have in place a process by January 1,
2010 under which eligible professionals in a group practice (as defined
by the Secretary) shall be treated as satisfactorily submitting data on
quality measures under PQRI if, in lieu of reporting measures under
PQRI, the group practice reports measures determined appropriate by the
Secretary, such as measures that target high-cost chronic conditions
and preventive care, in a form and manner, and at a time specified by
the Secretary. Section 1848(m)(3)(C)(ii) of the Act requires that this
process provide for the use of a statistical sampling model to submit
data on measures, such as the model used under the Medicare Physician
Group Practice (PGP) demonstration project under section 1866A of the
Act.
In addition, payments to a group practice under section 1848(m) of
the Act by reason of the process proposed herein shall be in lieu of
the PQRI incentive payments that would otherwise be made to eligible
professionals in the group practice for satisfactorily submitting data
on quality measures (that is, prohibits double payments). Therefore, in
addition to making incentive payments for 2010 to group practices based
on separately analyzing whether the individual eligible professionals
within the group practice (that is, for each TIN/NPI combination)
satisfactorily reported on PQRI quality measures, we will begin making
incentive payments to group practices based on the determination that
the group practice, as a whole (that is, for the TIN), satisfactorily
reports on
[[Page 33570]]
PQRI quality measures for 2010. In addition, an individual eligible
professional who is affiliated with a group practice participating in
the group practice reporting option that satisfactorily reports under
the proposed group practice reporting option would not be eligible to
earn a separate PQRI incentive payment for 2010 on the basis of his or
her satisfactorily reporting PQRI quality measures data at the
individual level.
(1) Definition of ``Group Practice''
As stated above, section 1848(m)(3)(C)(i) of the Act authorizes the
Secretary to define ``group practice.'' For purposes of determining
whether a group practice satisfactorily submits PQRI quality measures
data, we propose that a ``group practice'' would consist of a physician
group practice, as defined by a TIN, with at least 200 or more
individual eligible professionals (or, as identified by NPIs) who have
reassigned their billing rights to the TIN.
Generally, our intent is to build on an existing quality reporting
program that group practices may already be familiar with by modeling
the PQRI group practice reporting option after the PGP demonstration.
Since the PGP demonstration is a demonstration program for large group
practices, one of the requirements for group practices participating in
the PGP demonstration is for each practice to have 200 or more members.
To be consistent with the PGP demonstration, we also propose to limit
initial implementation of the PQRI group practice reporting option for
2010 to similar large group practices. As we gain more experience with
the group practice reporting option, we may consider lowering the group
size threshold in the future. We invite comments on the proposed
definition of ``group practice'' and our proposal to limit initial
implementation of the PQRI group practice reporting option in 2010 to
practices with 200 or more individual eligible professionals.
In order to participate in the 2010 PQRI through the group practice
reporting option, we propose to require group practices to complete a
self-nomination process and to meet certain technical and other
requirements. Group practices interested in participating in the 2010
PQRI through the group practice reporting option would be required to
submit a self-nomination letter to CMS or a CMS designee requesting to
participate in the 2010 PQRI group practice reporting option. We
propose that each group practice would be required to meet the
following requirements:
Have an active Individuals Access to CMS Systems (IACS)
user account;
Provide CMS or a CMS designee with the group practice's
TIN and the NPI numbers and names of all eligible professionals who
will be participating as part of the group practice (that is, all
individual NPI numbers associated with the group practice's TIN). This
information must be provided in an electronic format specified by CMS,
such as in an Excel spreadsheet; and
Agree to have the group practice's PQRI quality
measurement performance rates for each measure publicly reported by
posting of the results on a CMS Web site.
We propose to post the final participation requirements for group
practices, including the exact date by which group practices that wish
to participate in the 2010 PQRI through the group practice reporting
option must submit a self-nomination letter and other instructions for
submitting the self-nomination letter, on the PQRI section of the CMS
Web site at http://www.cms.hhs.gov/PQRI by November 15, 2009. We
anticipate that group practices that wish to self-nominate for 2010
will be required to do so by the end of the first quarter of 2010, but
not later than the end of the second quarter of 2010. Upon receipt of
the self-nomination letters we will assess whether the participation
requirements proposed above have been met by each self-nominated group
practice.
(2) Process for Physician Group Practices To Participate as Group
Practices and Criteria for Satisfactory Reporting Data on Quality
Measures by Group Practices
For physician groups selected to participate in the PQRI group
practice reporting option for 2010, we propose the reporting period
would be the 12-month reporting period beginning January 1, 2010. We
propose that group practices would be required to submit information on
these measures using a data collection tool based on the data
collection tool used in CMS' Medicare Care Management Performance
(MCMP) demonstration and the quality measurement and reporting methods
used in CMS' PGP demonstration. We propose that physician groups
selected to participate in the 2010 PQRI through the group practice
reporting option would be required to report on a common set of 26 NQF-
endorsed quality measures that are based on measures currently used in
the MCMP and/or PGP demonstration and that target high-cost chronic
conditions and preventive care. These quality measures are identified
in Table 34. Additional information on the MCMP and PGP demonstrations
is posted on the Medicare Demonstrations section of the CMS Web site at
http://www.cms.hhs.gov/DemoProjectsEvalRpts/MD/list.asp#TopOfPage.
Although our proposed process for physician groups to participate in
PQRI as a group practice incorporates some characteristics and methods
from the PGP demonstration and the MCMP demonstration, the PQRI group
practice reporting option will be a separate program with its own
specifications and methodology from the PGP and MCMP demonstration
programs.
The proposed quality measures identified in Table 34 are based on a
subset of the Doctor's Office Quality (DOQ) quality measures set
developed and specified under the direction of CMS and which are used
in the PGP and/or MCMP demonstration programs. Contributors to the
development of the DOQ measure set included the American Medical
Association's Physician Consortium for Performance Improvement (AMA-
PCPI), the American College of Cardiology (ACC), the American Heart
Association (AHA), the National Diabetes Quality Improvement Alliance,
the National Committee for Quality Assurance (NCQA), and the Veterans
Health Administration (VA) and, in most instances, overlap with
proposed 2010 PQRI measures. These quality measures are grouped into
four disease modules: diabetes; heart failure; coronary artery disease;
and preventive care services.
As part of the data submission process, we propose that, beginning
in 2011, each group practice would be required to report quality
measures with respect to services furnished during the 2010 reporting
period (that is, January 1, 2010 through December 31, 2010) on an
assigned sample of Medicare beneficiaries. We propose to analyze the
January 1, 2010 through October 29, 2010 (that is, the last business
day of October 2010) National Claims History (NCH) file to assign
Medicare beneficiaries to each physician group practice using the same
patient assignment methodology used in the PGP demonstration. Assigned
beneficiaries are limited to those Medicare FFS beneficiaries with
Medicare Parts A and B for whom Medicare is the primary payer. Assigned
beneficiaries do not include Medicare Advantage enrollees. Essentially,
a beneficiary would be assigned to the physician group that provides
the plurality of a beneficiary's office or other outpatient E/M allowed
charges (based on Medicare Part B claims submitted for the beneficiary
for dates of services between January 1, 2010 and October 29, 2010).
Beneficiaries with
[[Page 33571]]
only 1 visit to the group practice between January 1, 2010 and October
29, 2010 would be eliminated from the group practice's assigned patient
sample. Once the beneficiary assignment has been made for each
physician group, each physician group would be required to report the
quality measures on a random sample of the assigned beneficiaries per
disease module or preventive care measure. For each disease module or
preventive care measure, the physician group would be required to
report information on the assigned patients in the order in which they
appear in the group's sample (that is, consecutively). In the fourth
quarter of 2010, we would pull a random sample of assigned
beneficiaries for each disease module or preventive care measure and
provide the sample to the physician group consistent with the methods
used in the PGP demonstration. Identical to the sampling method used in
the PGP demonstration, the random sample must consist of at least 411
assigned beneficiaries. If the pool of eligible assigned beneficiaries
is less than 411, then the group practice must report on 100 percent of
the assigned beneficiaries to participate in the group practice
reporting option.
We propose a unique reporting mechanism for the group practice
reporting option that would not be available to individual eligible
professionals participating in the 2010 PQRI. We propose that each
physician group selected to participate in the group practice reporting
option would have access to a database (that is, a data collection
tool) that would include the assigned beneficiary sample and the
quality measures. This data collection tool was originally developed
for use in the PGP demonstration, updated for use in the MCMP
demonstration, and would be updated as needed for use in the PQRI. The
assigned beneficiaries' demographic and utilization information would
be prepopulated based on claims data. We anticipate being able to
provide the selected physician groups with access to this prepopulated
database by the fourth quarter of 2010. The physician group would be
required to populate the remaining data fields necessary for capturing
quality measure information on each of the assigned beneficiaries.
Numerators for each of the quality measures would include all
beneficiaries in the denominator population who also satisfy the
quality performance criteria for that measure. Denominators for each
quality measure would include a sample of the assigned beneficiaries
who meet the eligibility criteria for that quality measure module or
preventive care measure.
We invite comments on our proposal to adopt the PGP demonstration's
quality measurement and reporting methods for the PQRI group practice
reporting option. We specifically request comments on the proposed
patient assignment methodology and our proposal to use a data
collection tool based on the one used in the MCMP demonstration as the
reporting mechanism for physician groups selected to participate in the
PQRI group practice reporting option.
We propose 2 criteria for satisfactory reporting of quality
measures by a physician group. First, the physician group would be
required to report completely on all of the proposed modules and
measures listed in Table 34. Second, the physician group would be
required to report on the first 411 consecutively assigned Medicare
beneficiaries per disease module or preventive care measure. This is
identical to the reporting criteria used in the PGP demonstration. By
building on an existing demonstration program that large group
practices may already have experience with, we hope to minimize burden
on both group practices and CMS. The sample that we pull for and
provide to each physician group would include more than the 411
assigned beneficiaries (the sample would include an over sample of
approximately 50 percent). More beneficiaries are provided in the
sample than the group practice is required to report on in order to
account for beneficiaries included in the sample who cannot be
confirmed with the diagnosis for a particular disease module or whose
medical information may not be able to be located within the physician
group's systems.
h. Statutory Requirements and Other Considerations for Measures
Proposed for Inclusion in the 2010 PQRI
(1) Statutory Requirements for Measures Proposed for Inclusion in the
2010 PQRI
As a result of section 131(b) of the MIPPA, the statutory
requirements with respect to the use of quality measures for the 2010
PQRI are different from the statutory requirements for previous program
years. For the 2007 PQRI, section 1848(k)(2)(A)(i) of the Act required
the Secretary to generally select the quality measures identified as
2007 physician quality measures under the Physician Voluntary Reporting
Program. For the 2008 and 2009 PQRI, section 1848(k)(2)(B) of the Act
required that the quality measures be measures that have been adopted
or endorsed by a consensus organization (such as the National Quality
Forum or AQA), that include measures that have been submitted by a
physician specialty, and that the Secretary identifies as having used a
consensus-based process for developing such measures. For purposes of
reporting data on quality measures for covered professional services
furnished during 2010 and subsequent years for the PQRI, subject to the
exception noted below, section 1848(k)(2)(C)(i) of the Act, as added by
MIPPA, requires that the quality measures shall be such measures
selected by the Secretary from measures that have been endorsed by the
entity with a contract with the Secretary under subsection 1890(a) of
the Act, as added by section 183 of the MIPPA. On January 14, 2009, the
U.S. Department of Health and Human Services awarded the contract
required under section 1890(a) of the Act to the National Quality Forum
(NQF).
In the case of a specified area or medical topic determined
appropriate by the Secretary for which a feasible and practical measure
has not been endorsed by the NQF, however, section 1848(k)(2)(C)(ii) of
the Act authorizes the Secretary to specify a measure that is not so
endorsed as long as due consideration is given to measures that have
been endorsed or adopted by a consensus organization identified by the
Secretary, such as the AQA alliance. In light of these statutory
requirements, we believe that, except in certain specified
circumstances, each proposed 2010 PQRI quality measure would need to be
endorsed by the NQF by July 1, 2009. In those circumstances in which a
feasible and practical measure has not been endorsed by the NQF, we
believe that all other proposed 2010 PQRI quality measures would need
to have at least been adopted by the AQA or another organization with
comparable consensus-organization characteristics. However, in January
2009, the AQA announced that it will no longer be adopting measures and
we are not aware of any other organizations with consensus-organization
characteristics (see 73 FR 38565 through 38566 for discussion of the
considerations applied in determining whether an entity is a consensus
organization). Therefore, our policy with respect to identifying
exceptions under section 1848(k)(2)(C)(ii) of the Act would be to give
due consideration to measures that have been endorsed by the NQF. As a
result, in reviewing measures for possible inclusion in the 2010 PQRI
quality measure set, we propose that any new quality measures proposed
for the 2010 PQRI must be NQF-endorsed
[[Page 33572]]
by July 1, 2009, while any proposed 2010 PQRI quality measures selected
from the 2009 PQRI quality measure set would need to have been adopted
by the AQA as of January 31, 2009, if the measure still is not endorsed
by the NQF by July 1, 2009.
In addition, section 1848(k)(2)(D) of the Act requires that for
each 2010 PQRI quality measure, ``the Secretary shall ensure that
eligible professionals have the opportunity to provide input during the
development, endorsement, or selection of measures applicable to
services they furnish.'' Measure developers generally include a public
comment phase in their measure development process. As part of the
measure development process, measure developers typically solicit
public comments on measures that they are testing in order to determine
whether additional refinement of the measure(s) is needed prior to
submission for consensus endorsement. For example, information on the
measure development process employed by us when CMS or a CMS contractor
is the measure developer is available in the ``Measures Management
System Blueprint'' found on the CMS Web site at http://www.cms.hhs.gov/apps/QMIS/mmsBlueprint.asp.
Eligible professionals also have the opportunity to provide input
on a measure as the measure is being vetted through the NQF consensus
endorsement process (and previously, the AQA consensus adoption
process). In particular, the NQF employs a public comment period for
measures vetted through its consensus endorsement process (and
previously, for the AQA, its consensus adoption process).
Finally, eligible professionals have an opportunity to provide
input on the measures proposed for inclusion in the 2010 PQRI through
this proposed rule, which provides a 60-day comment period.
Accordingly, with regard to the 2010 PQRI, we believe we have satisfied
this requirement in multiple ways.
(2) Other Considerations for Measures Proposed for Inclusion in the
2010 PQRI
Consistent with the statutory requirements described in section
II.G.2.h.(1) of this proposed rule, we propose to apply the following
considerations with respect to the selection of 2009 PQRI quality
measures proposed for inclusion in the 2010 PQRI quality measure set:
Where some 2009 PQRI quality measures have been endorsed
by the NQF and others have not, those 2009 PQRI quality measures that
have been specifically considered by NQF for possible endorsement, but
NQF has declined to endorse it, are not proposed for inclusion in the
2010 PQRI quality measure set (that is, we propose to retire the
measure for 2010).
In circumstances where no NQF-endorsed measure is
available, we propose to exercise the exception under section
1848(k)(2)(C)(ii) of the Act. Under these circumstances, a 2009 PQRI
quality measure that previously (that is, prior to January 31, 2009)
has been adopted by the AQA would meet the requirements under the Act
and we propose that it would be appropriate for eligible professionals
to use the measure to submit quality measures data and/or quality
measures results and numerator and denominator data on quality
measures, as appropriate.
Although we do not propose to include any 2009 PQRI
measures that have not been endorsed by the NQF or adopted by the AQA
in the final 2010 PQRI quality measure set, we acknowledge that section
1848(k)(C)(ii) of the Act provides an exception to the requirement that
the Secretary select measures that have been endorsed by the entity
with a contract under section 1890(a) of the Act (that is, the NQF) as
long as an area or medical topic for which a feasible and practical
NQF-endorsed measure is not available has been identified and due
consideration has been given to measures that have been endorsed by the
NQF and/or, prior to January 31, 2009, adopted by the AQA.
The statutory requirements under section 1848(k)(2)(C) of
the Act, subject to the exception noted above, require only that the
measures be selected from measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) (that
is, the NQF) and are silent with respect to how the measures that are
submitted to the NQF for endorsement were developed. The basic steps
for developing measures applicable to physicians and other eligible
professionals prior to submission of the measures for endorsement may
be carried out by a variety of different organizations. We do not
believe there needs to be any special restrictions on the type or make
up of the organizations carrying out this basic development of
physician measures, such as restricting the initial development to
physician-controlled organizations. Any such restriction would unduly
limit the basic development of quality measures and the scope and
utility of measures that may be considered for endorsement as voluntary
consensus standards.
2009 PQRI measures that were part of the 2007 and/or 2008
PQRI in which the 2007 and 2008 PQRI analytics indicate a lack of
significant reporting and usage were not considered for inclusion in
the 2010 PQRI.
In addition to reviewing the 2009 PQRI measures and previously
retired measures, for purposes of developing the proposed 2010 PQRI
measures, we have reviewed and considered measure suggestions including
comments received in response to the CY 2009 PFS proposed rule and
final rule with comment period. Additionally, suggestions and input
received through other venues, such as an invitation for measures
suggestions posted on the PQRI section of the CMS Web site in February
2009 were also reviewed and considered for purposes of our development
of the list of proposed 2010 PQRI quality measures.
With respect to the selection of new measures (that is, measures
that have never been selected as part of a PQRI quality measure set for
2009 or any prior year), we propose to apply the following
considerations, which include many of the same considerations applied
to the selection of 2009 PQRI quality measures for proposed inclusion
in the 2010 PQRI quality measure set described above:
High Impact on Healthcare.
Measures that are high impact and support CMS and HHS
priorities for improved quality and efficiency of care for Medicare
beneficiaries. These current and long term priority topics include:
Prevention; chronic conditions; high cost and high volume conditions;
elimination of health disparities; healthcare-associated infections and
other conditions; improved care coordination; improved efficiency;
improved patient and family experience of care; improved end-of-life/
palliative care; effective management of acute and chronic episodes of
care; reduced unwarranted geographic variation in quality and
efficiency; and adoption and use of interoperable HIT.
Measures that are included in, or facilitate alignment
with, other Medicare, Medicaid, and CHIP programs in furtherance of
overarching healthcare goals.
NQF Endorsement.
+ Measures must be NQF-endorsed by July 1, 2009 in order to be
considered for inclusion in the 2010 PQRI quality measure set.
+ Although we do not propose to include any new measures that are
not endorsed by the NQF by July 1, 2009 in the final 2010 PQRI quality
measure set, we acknowledge that section (k)(2)(C)(ii) of the Act
provides an exception to the requirement that the Secretary select
measures that have been endorsed by the entity with a contract under
section 1890(a) of the Act (that is, the NQF). As
[[Page 33573]]
long as an area or medical topic for which a feasible and practical
NQF-endorsed measure is not available has been identified and due
consideration has been given to measures that have been adopted by the
AQA or other consensus organization identified by Secretary.
+ The statutory requirements under section 1848(k)(2)(C) of the
Act, subject to the exception noted above, require only that the
measures be selected from measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) (that
is, the NQF) and are silent with respect to how the measures that are
submitted to the NQF for endorsement were developed. The basic steps
for developing measures applicable to physicians and other eligible
professionals prior to submission of the measures for endorsement may
be carried out by a variety of different organizations. We do not
believe there needs to be any special restrictions on the type or make
up of the organizations carrying out this basic development of
physician measures, such as restricting the initial development to
physician-controlled organizations. Any such restriction would unduly
limit the basic development of quality measures and the scope and
utility of measures that may be considered for endorsement as voluntary
consensus standards. The requirements under section 1848(k)(2)(C) of
the Act pertain only to the selection of measures and not to the
development of measures.
Address Gaps in PQRI Measure Set.
+ Measures that increase the scope of applicability of the PQRI
measures to services furnished to Medicare beneficiaries and expand
opportunities for eligible professionals to participate in PQRI. We
seek to achieve broad ability to assess the quality of care furnished
to Medicare beneficiaries, and ultimately to compare performance among
professionals. We seek to increase the circumstances where eligible
professionals have at least 3 measures applicable to their practice and
measures that help expand the number of measures groups with at least
four measures in a group.
Measures of various aspects of clinical quality including
outcome measures, where appropriate and feasible, process measures,
structural measures, efficiency measures, and measures of patient
experience of care.
Other considerations that we propose to apply to the selection of
measures for 2010, regardless of whether the measure is a 2009 PQRI
measure or not, are:
Measures that are functional, which is to say measures
that can be technically implemented within the capacity of the CMS
infrastructure for data collection, analysis, and calculation of
reporting and performance rates. This leads to preference for measures
that reflect readiness for implementation, such as those that are
currently in the 2009 PQRI program or have been through testing. The
purpose of measure testing is to reveal the measure's strengths and
weaknesses so that the limitations can be addressed and the measure
refined and strengthened prior to implementation. For new measures,
preference is given to those that can be most efficiently implemented
for data collection and submission. Therefore, any measures that have
been found to be technically impractical to report because they are
analytically challenging due to any number of factors, including those
that are claims-based, have not been included in the 2010 PQRI. For
example, in some cases, we have proposed to replace existing 2009 PQRI
measures with updated and improved measures that are less technically
challenging to report.
For some measures that are useful, but where data
submission is not feasible through all otherwise available PQRI
reporting mechanisms, a measure may be included for reporting solely
through specific reporting mechanism(s) in which its submission is
feasible. For example, we are proposing to limit reporting of some
measures that previously were available for claims-based reporting and
registry-based reporting to registry-based reporting only because they
were technically challenging to report and/or analyze through the
claims-based reporting mechanism. For further discussion of the
proposed reporting mechanisms, see section II.G.2.d. of this proposed
rule.
We also reviewed 33 measures that have been retired from the PQRI
in previous years using the considerations for selecting proposed
measures for the 2010 PQRI discussed above. None were found to be
eligible for inclusion in the 2010 PQRI quality measure set because
they did not meet the criteria described above.
We welcome comments on the implication of including or excluding
any given measure or measures proposed herein in the final 2010 PQRI
quality measure set and on our approach in selecting measures. We
recognize that some commenters may also wish to recommend additional
measures for inclusion in the 2010 PQRI measures that we have not
herein proposed. While we welcome all constructive comments and
suggestions, and may consider such recommended measures for inclusion
in future measure sets for PQRI and/or other programs to which such
measures may be relevant, we will not be able to consider such
additional measures for inclusion in the 2010 measure set.
As discussed above, section 1848(k)(2)(D) of the Act requires that
the public have the opportunity to provide input during the selection
of measures. We also are required by other applicable statutes to
provide opportunity for public comment on provisions of policy or
regulation that are established via notice and comment rulemaking.
Measures that were not included in this proposed rule for inclusion in
the 2010 PQRI that are recommended to CMS via comments on this proposed
rule have not been placed before the public with opportunity for the
public to comment on the selection of those measures within the
rulemaking process. Even when measures have been published in the
Federal Register, but in other contexts and not specifically proposed
as PQRI measures, such publication does not provide true opportunity
for public comment on those measures' potential inclusion in PQRI.
Thus, such additional measures recommended for selection for the 2010
PQRI via comments on this proposed rule cannot be included in the 2010
measure set. However, as discussed above, we will consider comments and
recommendations for measures, which may not be applicable to the final
set of 2010 PQRI measures, for purposes of identifying measures for
possible use in future years' PQRI or other initiatives to which those
measures may be pertinent.
In addition, as in prior years, we note that we do not use notice
and comment rulemaking as a means to update or modify measure
specifications. Quality measures that have completed the consensus
process have a designated party (usually, the measure developer/owner)
who has accepted responsibility for maintaining the measure. In
general, it is the role of the measure owner, developer, or maintainer
to make changes to a measure. Therefore, comments requesting changes to
a specific proposed PQRI measure's title, definition, and detailed
specifications or coding should be directed to the measure developer
identified in Tables 16 through 34. Contact information for the 2009
PQRI measure developers is listed in the ``2009 PQRI Quality Measures
List,'' which is available on the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI.
[[Page 33574]]
i. Proposed 2010 PQRI Quality Measures for Individual Eligible
Professionals
As stated previously, individual eligible professionals have the
choice of reporting PQRI quality measures data on either individual
quality measures or on measures groups.
Consistent with the statutory requirements for measures included in
the 2010 PQRI and other considerations for identifying proposed 2010
quality measures discussed in section II.G.2.h.(1) and II.G.2.h.(2),
respectively, of this proposed rule, the individual quality measures
identified for use in the 2010 PQRI will be selected from those we
propose in this rule and will be finalized as of the date the CY 2010
PFS final rule with comment period goes on display at the Office of the
Federal Register. No changes (that is, additions or deletions of
measures) will be made after publication of the CY 2010 PFS final rule
with comment period. However, as was the case for 2008 and 2009, we may
make modifications or refinements, such as revisions to measures titles
and code additions, corrections, or revisions to the detailed
specifications for the 2010 measures until the beginning of the
reporting period. Such specification modifications may be made through
the last day preceding the beginning of the reporting period. The 2010
measures specifications for individual quality measures will be
available on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI when they are sufficiently developed or finalized.
We are targeting finalization and publication of the detailed
specifications for all 2010 PQRI measures on the PQRI section of the
CMS Web site by November 15, 2009 and will, in no event, publish these
specifications later than December 31, 2009. The detailed
specifications will include instructions for reporting and identify the
circumstances in which each measure is applicable.
For 2010, we are proposing that final PQRI quality measures will be
selected from 153 of the 2009 PQRI measures and 149 measure suggestions
received in response to the February 2009 invitation to submit
suggestions for measures and measures groups for possible inclusion in
the 2010 PQRI (that is, the ``Call for 2010 Measure Suggestions''). We
propose to include a total of 168 measures (this includes both
individual measures and measures that are part of a proposed 2010
measures group) on which individual eligible professionals can report
for the 2010 PQRI. The individual PQRI quality measures proposed for
the 2010 PQRI are listed in Tables 17 through 20 and fall into four
broad categories as set forth below in this section. The four
categories are the following:
(1) Proposed 2010 Individual Quality Measures Selected From the
2009 PQRI Quality Measures Set Available for Claims-based Reporting and
Registry-Based Reporting;
(2) Proposed 2010 Individual Quality Measures Selected From the
2009 PQRI Quality Measures Set Available for Registry-based Reporting
Only;
(3) New Individual Quality Measures Proposed for 2010; and
(4) Proposed 2010 Measures Available for EHR-based Reporting.
In addition, we propose 13 measures groups for 2010. The measures
proposed for inclusion in each of the proposed 2010 measures groups are
listed in Tables 21 through 33.
(1) Proposed 2010 Individual Quality Measures Selected From the
2009 PQRI Quality Measures Set Available for Claims-based Reporting and
Registry-based Reporting
After careful consideration of 2009 PQRI measures, we propose to
retire 7 measures because they did not meet one or more of the
considerations for selection of proposed 2010 measures discussed in
section II.G.2.h. of this proposed rule. The measures, including their
Measure Number and Measure Title, and the specific reason(s) we are
using as the basis for our proposal to retire the measures are
identified in Table 16.
Table 16--2009 PQRI Quality Measures Not Proposed for Inclusion in the
2010 PQRI
------------------------------------------------------------------------
Measure no. Measure title Reason for retirement
------------------------------------------------------------------------
11.................. Stroke and Stroke Analytically challenging
Rehabilitation: Carotid / Replaced with another
Imagining Reporting. measure.
34.................. Stroke and Stroke Analytically challenging
Rehabilitation: Tissue / Replaced with another
Plasminogen Activator. measure.
94.................. Otitis Media with Lack of significant
Effusion (OME): reporting.
Diagnostic Evaluation.
95.................. Otitis Media with Lack of significant
Effusion (OME): Hearing reporting.
Test.
143................. Oncology: Medical and Analytically
Radiation--Pain challenging.
Intensity Quantified.
144................. Oncology: Medical and Analytically
Radiation--Plan of Care challenging.
for Pain.
152................. Coronary Artery Disease Declined for NQF
(CAD): Lipid Profile in Endorsement.
Patients with CAD.
------------------------------------------------------------------------
We propose to include in the 2010 PQRI quality measure set 116 of
the 2009 PQRI measures, which would be available for either claims-
based reporting or registry-based reporting as individual quality
measures. We note that one of these proposed measures, Measure
46 Medication Reconciliation: Reconciliation After Discharge
from an Inpatient Facility, is reportable through the registry-based
reporting mechanism only in the 2009 PQRI. However, for the 2010 PQRI,
we propose to make this measure available for either claims-based
reporting or registry-based reporting. For the 2009 PQRI, registries
have reported difficulty capturing the required information since the
measure requires the inpatient discharge to be correlated to the
outpatient visit. Therefore, for the 2010 PQRI we propose to make this
measure available for both claims-based and registry-based reporting.
These 116 proposed measures do not include any measures that are
proposed to be included as part of the 2010 Back Pain measures group.
Similar to the 2009 PQRI, we propose that any 2010 PQRI measure that is
included in the Back Pain measures group would not be reportable as
individual measures through claims-based reporting or registry-based
reporting.
The 116 individual 2009 PQRI measures proposed for inclusion in the
2010 PQRI quality measure set as individual quality measures for either
claims-based reporting or registry-based reporting are listed by their
Measure Number and Title in Table 17, along with the name of the
measure's developer/owner, their NQF endorsement status as of May 1,
2009, and their AQA adoption status as of January 31, 2009. The PQRI
Measure Number is a unique identifier assigned by CMS to all measures
in the PQRI measure set. Once a PQRI Measure Number is assigned to a
measure, it will not be used again to identify a different
[[Page 33575]]
measure, even if the original measure to which the number was assigned
is subsequently retired from the PQRI measure set. A description of the
proposed measures listed in Table 17 can be found in the ``2009 PQRI
Quality Measures List,'' which is available on the Measures and Codes
page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.
The 2009 measures that are proposed to be available for registry-
based reporting only for the 2010 PQRI are discussed and identified in
section II.G.2.i.(2) of this proposed rule.
Table 17--Proposed 2010 Measures Selected From the 2009 PQRI Quality Measure Set Available for Either Claims-
Based Reporting or Registry-Based Reporting
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure No. Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
1................... Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Hemoglobin A1c
Poor Control in
Diabetes Mellitus.
2................... Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Low Density
Lipoprotein (LDL-
C) Control in
Diabetes Mellitus.
3................... Diabetes Mellitus: Yes..................... No..................... NCQA.
High Blood
Pressure Control
in Diabetes
Mellitus.
6................... Coronary Artery Yes..................... Yes.................... AMA-PCPI.
Disease (CAD):
Oral Antiplatelet
Therapy Perscribed
for Patients with
CAD.
9................... Major Depressive Yes..................... Yes.................... NCQA.
Disorder (MDD):
Antidepressant
Medication During
Acute Phase for
Patients with MDD.
10.................. Stroke and Stroke Yes..................... Yes.................... AMA-PCPI/NCQA.
Rehabilitation:
Computed
Tomography (CT) or
Magnetic Resonance
Imaging (MRI)
Reports.
12.................. Primary Open Angle Yes..................... Yes.................... AMA-PCPI/NCQA.
Glaucoma (POAG):
Optic Nerve
Evaluation.
14.................. Age-Related macular Yes..................... Yes.................... AMA-PCPI/NCQA.
Degeneration
(AMD): Dilated
Macular
Examination.
18.................. Diabetic Yes..................... Yes.................... AMA-PCPI/NCQA.
Retinopathy:
Documentation of
Presence or
Absence of Macular
Edema and Level of
Severity of
Retinopathy.
19.................. Diabetic Yes..................... Yes.................... AMA-PCPI/NCQA.
Retinopathy:
Communication with
the Physician
Managing On-going
Diabetes Care.
20.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Timing of
Antibiotic
Prophylaxis--Order
ing Physician.
21.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Selection of
Prophylactic
Antibiotic--First
OR Second
Generation
Cephalosporin.
22.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Discontinuation of
Prophylactic
Antibiotics (Non-
Cardiac
Procedures).
23.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Venous
Thromboembolism
(VTE) Prophylaxis
(When Indicated in
ALL Patients).
24.................. Osteoporosis: Yes..................... Yes.................... AMA-PCPI/NCQA.
Communication with
the Physician
Managing On-going
Care Post Fracture.
28.................. Aspirin at Arrival Yes..................... Yes.................... AMA-PCPI/NCQA.
for Acute
Myocardial
Infarction (AMI).
30.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Timing of
Prophylactic
Antibiotics--Admin
istering Physician.
31.................. Stroke and Stroke Yes..................... Yes.................... AMA-PCPI/NCQA.
Rehabilitation:
Deep Vein
Thrombosis
Prophylaxis (DVT)
for Ischemic
Stroke or
Intracranial
Hemorrhage.
32.................. Stroke and Stroke Yes..................... Yes.................... AMA-PCPI/NCQA.
Rehabilitation:
Discharged on
Antiplatelet
Therapy.
35.................. Stroke and Stroke Yes..................... Yes.................... AMA-PCPI/NCQA.
Rehabilitation:
Screening for
Dysphagia.
36.................. Stroke and Stroke Yes..................... Yes.................... AMA-PCPI/NCQA.
Rehabilitation:
Consideration for
Rehabilitation
Services.
39.................. Screening or Yes..................... Yes.................... AMA-PCPI/NCQA.
Therapy for
Osteoporosis for
Women Aged 65
Years and Older.
40.................. Osteoporosis: Yes..................... Yes.................... AMA-PCPI/NCQA.
Management
Following Fracture.
41.................. Osteoporosis: Yes..................... Yes.................... AMA-PCPI/NCQA.
Pharmacologic
Therapy.
43.................. Coronary Artery Yes..................... Yes.................... Society of
Bypass Graft Thoracic Surgeons
(CABG): Use of (STS).
Internal Mammary
Artery (IMA) in
Patients with
Isolated CABG
Surgery.
[[Page 33576]]
44.................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG):
Preoperative Beta-
Blocker in
Patients with
Isolated CABG
Surgery.
45.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Discontinuation of
Prophylactic
Antiobitics
(Cardiac
Procedures).
46.................. Medication Yes..................... Yes.................... AMA-PCPI/NCQA.
Reconciliation:
Reconciliation
After Discharge
from an Inpatient
Facility.
47.................. Advance Care Plan.. Yes..................... Yes.................... AMA-PCPI/NCQA.
48.................. Urinary Yes..................... Yes.................... AMA-PCPI/NCQA.
Incontinence:
Assessment of
Presence or
Absence of Urinary
Incontinence in
Women Aged 6 Years
and Older.
49.................. Urinary Yes..................... Yes.................... AMA-PCPI/NCQA.
Incontinence:
Characterization
of Urinary
Incontinence in
Women Aged 65
Years and Older.
50.................. Urinary Yes..................... Yes.................... AMA-PCPI/NCQA.
Incontinence: Plan
of Care for
Urinary
Incontinence in
Women Aged 65
Years and Older.
51.................. Chronic Obstructive Yes..................... No..................... AMA-PCPI.
Pulmonary Disease
(COPD): Spirometry
Evaluation.
52.................. Chronic Obstructive Yes..................... No..................... AMA-PCPI.
Pulmonary Disease
(COPD):
Bronchodilator
Therapy.
53.................. Asthma: Yes..................... Yes.................... AMA-PCPI.
Pharmacologic
Therapy.
54.................. 12-Lead Yes..................... Yes.................... AMA-PCPI/NCQA.
Electrocardiogram
(ECG) Performed
for Non-Traumatic
Chest Pain.
55.................. 12-Lead Yes..................... Yes.................... AMA-PCPI/NCQA.
Electrocardiogram
(ECG) Performed
for Syncope.
56.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Vital Signs.
57.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Assessment of
Oxygen Saturation.
58.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Assessment of
Mental Status.
59.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Empiric Antibiotic.
64.................. Asthma: Asthma Yes..................... Yes.................... AMA-PCPI.
Assessment.
65.................. Treatment for Yes..................... Yes.................... NCQA.
Children with
Upper Respiratory
Infection (URI):
Avoidance of
Inappropriate Use.
66.................. Appropriate Testing Yes..................... Yes.................... NCQA.
for Children with
Pharyngitis.
67.................. Myelodysplastic Yes..................... Yes.................... AMA-PCPI/American
Syndrome (MDS) and Society of
Acute Leukemias: Hematology (ASH).
Baseline
Cytogenetic
Testing Performed
on Bone Marrow.
68.................. Myelodysplastic Yes..................... Yes.................... AMA-PCPI/ASH.
Syndrome (MDS):
Documentation of
Iron Stores in
Patients Receiving
Erythropoietin
Therapy.
69.................. Multiple Myeloma: Yes..................... Yes.................... AMA-PCPI/ASH.
Treatment with
Bisphosphonates.
70.................. Chronic Lymphocytic Yes..................... Yes.................... AMA-PCPI/ASH.
Leukemia (CLL):
Baseline Flow
Cytometry.
71.................. Breast Cancer: Yes..................... Yes.................... AMA-PCPI/American
Hormonal Therapy Society of
for Stage IC-IIIC Clinical Oncology
Estrogen Receptor/ (ASCO)/National
Progesterone Comprehensive
Receptor (ER/PR) Cancer Network
Positive Breast (NCCN).
Cancer.
72.................. Colon Cancer: Yes..................... Yes.................... AMA-PCPI/ASCO/
Chemotherapy for NCCN.
Stage III Colon
Cancer Patients.
76.................. Prevention of Yes..................... Yes.................... AMA-PCPI.
Catheter-Related
Bloodstream
Infections
(CRBSI): Central
Venous Catheter
(CVC) Insertion
Protocol.
79.................. End Stage Renal Yes..................... Yes.................... AMA-PCPI.
Disease (ESRD):
Influenza
Immunization with
Patients in ESRD.
84.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Ribonucleic Acid
(RNA) Testing
Before Initiating
Treatment.
85.................. Hepatitis C: HCV Yes..................... Yes.................... AMA-PCPI.
Genotype Testing
Prior to Treatment.
86.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Antiviral
Treatment
Prescribed.
87.................. Hepatitis C: HCV Yes..................... Yes.................... AMA-PCPI.
Ribonucleic Acid
(RNA) Testing at
Week 12 of
Treatment.
89.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Counseling
Regarding Risk of
Alcohol
Consumption.
[[Page 33577]]
90.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Counseling
Regarding Use of
Contraception
Prior to Antiviral
Therapy.
91.................. Acute Otitis No...................... Yes.................... AMA-PCPI.
Externa (ACE):
Topical Therapy.
92.................. Acute Otitis No...................... Yes.................... AMA-PCPI.
Externa (ACE):
Pain Assessment.
93.................. Acute Otitis No...................... Yes.................... AMA-PCPI.
Externa (ACE):
Systemic
Antimicrobial
Therapy--Avoidance
of Inappropriate
Use.
99.................. Breast Cancer Yes..................... Yes.................... AMA-PCPI/College
Resection of American
Pathology Pathologists
Reporting: pT (CAP).
Category (Primary
Tumor) and pN
Category (Regional
Lymph Nodes) with
Histologic Grade.
100................. Colorectal Cancer Yes..................... Yes.................... AMA-PCPI/CAP.
Resection
Pathology
Reporting: pT
Category (Primary
Tumor) and pN
Category (Regional
Lymph Nodes) with
Histologic Grace.
102................. Prostate Cancer: Yes..................... Yes.................... AMA-PCPI.
Avoidance of
Overuse of Bone
Scan for Staging
Low-Risk Prostate
Cancer Patients.
104................. Prostate Cancer: Yes..................... Yes.................... AMA-PCPI.
Adjuvant Hormonal
Therapy for High-
Risk Prostate
Cancer Patients.
105................. Prostate Cancer: Yes..................... Yes.................... AMA-PCPI.
Three-Dimensional
(3D) Radiotherapy.
106................. Major Depressive Yes..................... No..................... AMA-PCPI.
Disorder (MDD):
Diagnostic
Evaluation.
107................. Major Depressive Yes..................... No..................... AMA-PCPI.
Disorder (MDD):
Suicide Risk
Assessment.
108................. Rheumatoid Yes..................... No..................... NCQA.
Arthritis (RA):
Disease Modifying
Anti-Rheumatic
Drug (DMARD)
Therapy.
109................. Osteoarthritis: Yes..................... No..................... AMA-PCPI.
Function and Pain
Assessment.
110................. Preventive Care and Yes..................... No..................... AMA-PCPI.
Screening:
Influenza
Immunization for
Patients >=50
Years Old.
111................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Pneumonia
Vaccination for
Patients 65 Years
and Older.
112................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Screening
Mammography.
113................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Colorectal Cancer
Screening.
114................. Preventive Care and Yes..................... Yes.................... AMA-PCPI.
Screening: Inquiry
Regarding Tobacco
Use.
115................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Advising Smokers
to Quit.
116................. Antibiotic Yes..................... No..................... NCQA.
Treatment for
Adults with Acute
Bronchitis:
Avoidance of
Inappropriate Use.
117................. Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Dilated Eye Exam
in Diabetic
Patient.
119................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Urine Screening
for Microalbumin
or Medical
Attention for
Nephropathy in
Diabetic Patients.
121................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Laboratory Testing
(Calcium,
Phosphorous,
Intact Parathyroid
Hormone (iPTH) and
Lipid Profile).
122................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Blood Pressure
Management.
123................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Plan of Care--
Elevated
Hemoglobin for
Patients Receiving
Erythropoiesis-
Stimulating Agents
(ESA).
124................. Health Information Yes..................... Yes.................... CMS/Quality
Technology (HIT): Insights of
Adoption/Use of Pennsylvania
Electronic Health (QIP).
Records (EHR).
[[Page 33578]]
126................. Diabetes Mellitus: Yes..................... Yes.................... American Podiatric
Diabetic Foot and Medical
Ankle Care, Association
Peripheral (APMA).
Neuropathy--Neurol
ogical Evaluation.
127................. Diabetes Mellitus: Yes..................... Yes.................... APMA.
Diabetic Foot and
Ankle Care, Ulcer
Prevention--Evalua
tion of Footwear.
128................. Preventive Care and Yes..................... Yes.................... CMS/QIP.
Screening: Body
Mass Index (BMI)
Screening and
Follow-Up.
130................. Documentation and Yes..................... Yes.................... CMS/QIP.
Verification of
Current
Medications in the
Medical Record.
131................. Pain Assessment Yes..................... Yes.................... CMS/QIP.
Prior to
Initiation of
Patient Therapy
and Follow-Up.
134................. Screening for Yes..................... Yes.................... CMS/QIP.
Clinical
Depression and
Follow-Up Plan.
135................. Chronic Kidney Yes..................... Yes.................... AMA-PCPI.
Disease (CKD):
Influenza
Immunization.
140................. Age-Related Macular No...................... Yes.................... AMA-PCPI/NCQA.
Degeneration
(AMD): Counseling
on Antioxidant
Supplement.
142................. Osteoarthritis Yes..................... Yes.................... AMA-PCPI.
(OA): Assessment
for Use of Anti-
Inflammatory or
Analgesic Over-the-
Counter (OTC)
Medications.
145................. Radiology: Exposure Yes..................... Yes.................... AMA-PCPI/NCQA.
Time Reported for
Procedures Using
Fluoroscopy.
146................. Radiology: Yes..................... Yes.................... AMA-PCPI/NCQA.
Inappropriate Use
of ``Probably
Benign''
Assessment
Category in
Mammography
Screening.
147................. Nuclear Medicine: Yes..................... Yes.................... AMA-PCPI.
Correlation with
Existing Imaging
Studies for All
Patients
Undergoing Bone
Scintigraphy.
153................. Chronic Kidney Yes..................... Yes.................... AMA-PCPI.
Disease (CKD):
Referral for
Arteriovenous (AV)
Fistula.
154................. Falls: Risk No...................... Yes.................... AMA-PCPI/NCQA.
Assessment.
155................. Falls: Plan of Care No...................... Yes.................... AMA-PCPI/NCQA.
156................. Oncology: Radiation Yes..................... Yes.................... AMA-PCPI.
Dose Limits to
Normal Tissues.
157................. Thoracic Surgery: Yes..................... Yes.................... STS.
Recording of
Clinical Stage for
Lung Cancer and
Esophageal Cancer
Resection.
158................. Endarterectomy: Use Yes..................... No..................... Society of
of Patch During Vascular Surgeons
Conventional (SVS).
Endarterectomy.
163................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Foot Exam.
172................. Hemodialysis Yes..................... No..................... SVS.
Vascular Access
Decision-Making by
Surgeon to
Maximize Placement
of Autogenous
Arterial Venous
(AV) Fistula.
173................. Preventive Care and No...................... Yes.................... AMA-PCPI.
Screening:
Unhealthy Alcohol
Use--Screening.
175................. Pediatric End Stage No...................... Yes.................... AMA-PCPI.
Renal Disease
(ESRD): Influenza
Immunization.
176................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Tuberculosis
Screening.
177................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Periodic
Assessment of
Disease Activity.
178................. Rhuematoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Functional Status
Assessment.
179................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Assessment and
Classification of
Disease Prognosis.
180................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Glucocorticoid
Management.
181................. Elder Maltreatment No...................... Yes.................... CMS/QIP.
Screen and Follow-
Up Plan.
182................. Functional Outcome No...................... Yes.................... CMS/QIP.
Assessment in
Chiropractic Care.
183................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Hepatitis A
Vaccination in
Patients with HCV.
184................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Hepatatis B
Vaccination in
Patients with HCV.
[[Page 33579]]
185................. Endoscopy & Polyp No...................... Yes.................... AMA-PCPI/NCQA.
Surveillance:
Colonoscopy
Interval for
Patients with a
History of
Adenomatous
Polyps--Avoidance
of Inappropriate
Use.
186................. Wound Care: Use of No...................... Yes.................... AMA-PCPI/NCQA.
Compression System
in Patients with
Venous Ulcers.
----------------------------------------------------------------------------------------------------------------
Please note that detailed measure specifications for 2009
individual PQRI quality measures may have been updated or modified
during the NQF endorsement process or for other reasons prior to 2010.
The 2010 PQRI quality measure specifications for any given individual
quality measure may, therefore, be different from specifications for
the same quality measure used for 2009. Specifications for all 2010
individual PQRI quality measures, whether or not included in the 2009
PQRI program, must be obtained from the specifications document for
2010 individual PQRI quality measures, which will be available on the
PQRI section of the CMS Web site on or before December 31, 2009.
(2) Proposed 2010 Individual Quality Measures Selected From the 2009
PQRI Quality Measures Set Available for Registry-Based Reporting Only
In the 2008 PQRI, all 2008 PQRI quality measures were reportable
through either claims-based reporting or registry-based reporting. In
the CY 2009 PFS final rule with comment period (73 FR 69833), we noted
that some measures are not as conducive to claims-based reporting and
indicated that 18 of the 2009 PQRI quality measures are not currently
reportable through claims-based reporting due to their complexity.
Instead, these 18 measures must be reported through a qualified PQRI
registry for the 2009 PQRI. We referred to these measures as
``registry-only'' measures. As discussed further in section II.G.2.d.
of this proposed rule, registry-based reporting overcomes some of the
limitations of claims-based reporting.
For the 2010 PQRI, we again propose to include registry-only
individual measures. For 2010, we propose to select 26 registry-only
individual measures from the 2009 PQRI.
As we noted previously, 1 measure (measure 46) that was a
registry-only measure for the 2009 PQRI is now proposed to be available
for either claims-based reporting or registry-based reporting in the
2010 PQRI. Therefore, this measure is not included among these 26
proposed registry-only individual measures. These 26 proposed measures
do include 9 measures that are available for either claims-based
reporting or registry-based reporting in the 2009 PQRI and are now
proposed to be included in the 2010 PQRI as registry-only measures. We
are proposing to make more 2009 measures registry-only to relieve some
analytical difficulties encountered during the 2009 PQRI.
Although we are designating certain measures as registry-only
measures, we cannot guarantee that there will be a registry qualified
to submit each registry-only measure for 2010. We rely on registries to
self-nominate and identify the types of measures for which they would
like to be qualified to submit quality measures results and numerator
and denominator data on quality measures. If no registry self-nominates
to submit measure results and numerator and denominator data on a
particular type of measure for 2010, then an eligible professional
would not be able to report that particular measure type. We invite
comments on our proposal to increase the number of registry-only
measures for the 2010 PQRI.
The Measure Number and Measure Title for these proposed registry-
only measures are listed in Table 18 along with the name of each
measure's developer, the measure's NQF endorsement status as of May 1,
2009, and the measure's AQA adoption status as of January 31, 2009. A
description of the proposed measures listed in Table 18 can be found in
the ``2009 PQRI Quality Measures List,'' which is available on the
Measures and Codes page of the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI. Measures that were available for either
claims-based reporting or registry-based reporting in the 2009 PQRI but
are proposed to be available for registry-based reporting only in the
2010 PQRI are identified by an asterisk (*) in Table 18.
Table 18--Proposed 2010 Measures Selected From the 2009 PQRI Quality Measure Set Available for Registry-Based
Reporting Only
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure No. Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
5................... Heart Failure: Yes..................... Yes.................... AMA-PCPI.
Angiotensin-
Converting Enzyme
(ACE) Inhibitor or
Angiotensin
Receptor Blocker
(ARB) Therapy for
Left Ventricular
Systolic
Dysfunction
(LVSD)*.
7................... Coronary Artery Yes..................... Yes.................... AMA-PCPI.
Disease (CAD):
Beta-Blocker
Therapy for CAD
Patients with
Prior Myocardial
Infarction (MI).
8................... Heart Failure: Beta- Yes..................... Yes.................... AMA-PCPI.
Blocker Therapy
for Left
Ventricular
Systolic
Dysfunction
(LVSD)*.
[[Page 33580]]
33................. Stroke and Stroke Yes..................... Yes.................... AMA-PCPI/NCQA.
Rehabilitation:
Anticoagulant
Therapy Prescribed
for Atrial
Fibrillation at
Discharge.
81.................. End Stage Renal Yes..................... Yes.................... AMA-PCPI.
Disease (ESRD):
Plan of Care for
Inadequate
Hemodialysis in
ESRD Patients.
82.................. End Stage Renal Yes..................... Yes.................... AMA-PCPI.
Disease (ESRD):
Plan of Care for
Inadequate
Peritoneal
Dialysis.
83.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Testing for
Chronic Hepatitis
C--Confirmation of
Hepatitis C
Viremia*.
118................. Coronary Artery Yes..................... No..................... AMA-PCPI.
Disease (CAD):
Angiotensin-
Converting Enzyme
(ACE) Inhibitor or
Angiotensin
Receptor Blocker
(ARB) Therapy for
Patients with CAD
and Diabetes and/
or Left
Ventricular
Systolic
Dysfunction
(LSVD)*.
136................. Melanoma: Follow-Up No...................... Yes.................... AMA-PCPI/NCQA.
Aspects of Care*.
137................. Melanoma: No...................... Yes.................... AMA-PCPI/NCQA.
Continuity of
Care--Recall
System*.
138................. Melanoma: No...................... Yes.................... AMA-PCPI/NCQA.
Coordination of
Care*.
139................. Cataracts: No...................... Yes.................... AMA-PCPI/NCQA.
Comprehensive
Preoperative
Assessment for
Cataract Surgery
with Intraocular
Lens (IOL)
Placement*.
141................. Primary Open-Angle No...................... Yes.................... AMA-PCPI/NCQA.
Glaucoma (POAG):
Reduction of
Intraocular
Pressure (IOP) by
15% OR
Documentation of a
Plan of Care*.
159................. HIV/AIDS: CD4+ Cell Yes..................... No..................... AMA-PCPI/NCQA.
Count or CD4+
Percentage.
160................. HIV/AIDS: Yes..................... No..................... AMA-PCPI/NCQA.
Pneumocystis
Jiroveci Pneumonia
(PCP) Prophylaxis.
161................. HIV/AIDS: Yes..................... No..................... AMA-PCPI/NCQA.
Adolescent and
Adult Patients
with HIV/AIDS Who
Are Prescribed
Potent
Antiretroviral
Therapy.
162................. HIV/AIDS: HIV RNA Yes..................... No..................... AMA-PCPI/NCQA.
Control After Six
Months of Potent
Antiretroviral
Therapy.
164................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Prolonged
Intubation
(Ventilation).
165................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Deep
Sternal Wound
Infection Rate.
166................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Stroke/
Cerebrovascular
Accident (CVA).
167................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG):
Postoperative
Renal
Insufficiency.
168................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Surgical
Re-exploration.
169................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG):
Antiplatelet
Medications at
Discharge.
170................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Beta-
Blockers
Administered at
Discharge.
171................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Lipid
Management and
Counseling.
174................. Pediatric End Stage No...................... Yes.................... AMA-PCPI.
Renal Disease
(ESRD): Plan of
Care for
Inadequate
Hemodialysis.
----------------------------------------------------------------------------------------------------------------
* Individual 2009 PQRI measures that were available for both claims-based and registry-based reporting but
proposed to be available for registry-based reporting only for the 2010 PQRI.
Please note that detailed measure specifications for 2009 PQRI
quality measures may have been updated or modified during the NQF
endorsement process or for other reasons prior to 2010. Therefore, the
2010 PQRI quality measure specifications for any given quality measure
may be different from specifications for the same quality measure used
for 2009. Specifications for all 2010 individual PQRI quality measures,
whether or not included in the 2009 PQRI program, must be obtained from
the specifications document for 2010 individual PQRI quality measures,
which will be available on the PQRI section of the CMS Web site on or
before December 31, 2009.
(3) New Individual Quality Measures Proposed for 2010
We propose to include in the 2010 PQRI quality measure set 22
measures that were not included in the 2009 PQRI quality measures
provided that each
[[Page 33581]]
measure obtains NQF endorsement by July 1, 2009 and its detailed
specifications are completed and ready for implementation in PQRI by
August 15, 2009. Besides having NQF endorsement, the development of a
measure is considered complete for the purposes of the 2010 PQRI if by
August 15, 2009--(1) The final, detailed specifications for use in data
collection for PQRI have been completed and are ready for
implementation, and (2) all of the Category II Current Procedural
Terminology (CPT II) codes required for the measure have been
established and will be effective for CMS claims data submission on or
before January 1, 2010. The titles of these proposed additional, or
new, measures are listed in Table 19 along with the name of the measure
developer and the proposed reporting mechanism (that is, whether the
measure is proposed to be reportable using claims, registries, or
both). For these 22 proposed measures, a PQRI Measure Number will be
assigned to a measure if and when the measure is included in the final
set of 2010 PQRI measures.
Due to the complexity of their measure specifications, we propose
that 16 of these 22 measures would be available as registry-only
measures for the 2010 PQRI. We do not believe that these 16 measures
are conducive to the claims-based reporting mechanism. The remaining 6
measures would be available for reporting through either claims-based
reporting or registry-based reporting.
Table 19--New Individual Quality Measures Proposed for 2010
----------------------------------------------------------------------------------------------------------------
NQF endorsement
Measure title status as of 5/ AQA adoption status Measure Reporting mechanism(s)
1/09 as of 1/31/09 developer
----------------------------------------------------------------------------------------------------------------
Thrombolytic Therapy Yes............. No.................. American Heart Registry.
Administered. Association
(AHA)/American
Stroke
Association
(ASA).
Referral for Otologic Pending NQF No.................. Audiology Claims, Registry.
Evaluation for Patients with review. Quality
Visible Congenital or Consortium
Traumatic Deformity of the (AQC).
Ear.
Referral for Otologic Pending NQF No.................. AQC............ Claims, Registry.
Evaluation for Patients with review.
History of Active Drainage
from the Ear within the
Previous 90 days.
Referral for Otologic Pending NQF No.................. AQC............ Claims, Registry.
Evaluation for Patients with review.
a History of Sudden or
Rapidly Progressive Hearing
Loss within the Previous 90
days.
Cataracts: 20/40 or Better Pending NQF Yes................. American Registry.
Visual Acuity within 90 days review. Academy of
Following Cataract Surgery. Ophthalmology
(AAO)/AMA-PCPI/
NCQA.
Cataracts: Complications Pending NQF Yes................. AAO/AMA-PCPI/ Registry.
within 30 Days Following review. NCQA.
Cataract Surgery Requiring
Additional Surgical
Procedures.
Perioperative Temperature Yes............. Yes................. AMA-PCPI....... Claims, Registry.
Management.
Cancer Stage Documented...... Yes............. Yes................. AMA-PCPI....... Claims, Registry.
Stenosis Measurement in Yes............. Yes................. American Claims, Registry.
Carotid Imaging Studies. College of
Radiology
(ACR)/AMA-PCPI/
NCQA.
Coronary Artery Disease Yes............. No.................. ACC/AHA/AMA- Registry.
(CAD): Symptom and Activity PCPI.
Assessment.
Coronary Artery Disease Yes............. No.................. ACC/AHA/AMA- Registry.
(CAD): Drug Therapy for PCPI.
Lowering LDL-Cholesterol.
Heart Failure (HF): Left Yes............. No.................. ACC/AHA/AMA- Registry.
Ventricular Function PCPI.
Assessment.
Heart Failure (HF): Patient Yes............. No.................. ACC/AHA/AMA- Registry.
Education. PCPI.
Heart Failure (HF): Warfarin Yes............. No.................. ACC/AHA/AMA- Registry.
Therapy Patients with Atrial PCPI.
Fibrillation.
Blood Pressure Management: Yes............. No.................. NCQA........... Registry.
Control.
Complete Lipid Profile....... Yes............. No.................. NCQA........... Registry.
Cholesterol Count............ Yes............. No.................. NCQA........... Registry.
Use of Aspirin or Another Yes............. No.................. NCQA........... Registry.
Anti-Thrombotic.
HIV/AIDS: Sexually Yes............. No.................. AMA-PCPI/NCQA.. Registry.
Transmitted Diseases--
Chlamydia and Gonorrhea
Screenings.
HIV/AIDS: Screening for High Yes............. No.................. AMA-PCPI/NCQA.. Registry.
Risk Sexual Behaviors.
HIV/AIDS: Screening for Yes............. No.................. AMA-PCPI/NCQA.. Registry.
Injection Drug Use.
HIV/AIDS: Sexually Yes............. No.................. AMA-PCPI/NCQA.. Registry.
Transmitted Diseases--
Syphilis Screening.
----------------------------------------------------------------------------------------------------------------
[[Page 33582]]
(4) Proposed 2010 Individual Quality Measures Available for EHR-Based
Reporting
As discussed in section II.G.2.d.(3) of this proposed rule, we
propose to accept PQRI data from EHRs for a limited subset of the
proposed 2010 PQRI quality measures, contingent upon the successful
completion of our 2009 EHR data submission testing process and a
determination that accepting data from EHRs on quality measures for the
2010 PQRI is practical and feasible. The 10 proposed 2010 PQRI quality
measures on which we propose to accept clinical quality data extracted
from EHRs are identified in Table 20. We propose to make these measures
available for electronic submission via an EHR because these measures
target preventive care or common chronic conditions. In addition, 4 of
these proposed measures overlap with measures used in the Medicare
Quality Improvement Organization program's 9th Statement of Work.
Finally, it is much less burdensome for an eligible professional to
report Measure 124, which assesses adoption and use of EHRs,
through an EHR than through claims.
Table 20--Proposed 2010 Measures Available for EHR-based Reporting
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
1................... Diabetes Mellitus: Yes..................... Yes.................... NCQA
Hemoglobin A1c
Poor Control in
Diabetes Mellitus.
2................... Diabetes Mellitus: Yes..................... Yes.................... NCQA
Low Density
Lipoprotein (LDL-
C) Control in
Diabetes Mellitus.
3................... Diabetes Mellitus: Yes..................... No..................... NCQA
High Blood
Pressure Control
in Diabetes
Mellitus.
5................... Heart Failure: Yes..................... Yes.................... AMA-PCPI
Angiotensin-
Converting Enzyme
(ACE) Inhibitor or
Angiotensin
Receptor Blocker
(ARB) Therapy for
Left Ventricular
Systolic
Dysfunction (LVSD).
7................... Coronary Artery Yes..................... Yes.................... AMA-PCPI
Disease (CAD):
Beta-Blocker
Therapy for CAD
Patients with
Prior Myocardial
Infarction (MI).
110................. Preventive Care and Yes..................... No..................... AMA-PCPI
Screening:
Influenza
Immunization for
Patients >= 50
Years Old.
111................. Preventive Care and Yes..................... Yes.................... NCQA
Screening:
Pneumonia
Vaccination for
Patients 65 Years
and Older.
112................. Preventive Care and Yes..................... Yes.................... NCQA
Screening:
Screening
Mammography.
113................. Preventive Care and Yes..................... Yes.................... NCQA
Screening:
Colorectal Cancer
Screening.
124................. Health Information Yes..................... Yes.................... CMS/QIP
Technology (HIT):
Adoption/Use of
Electronic Health
Records (EHR).
----------------------------------------------------------------------------------------------------------------
(5) Measures Proposed for Inclusion in 2010 Measures Groups
We propose to retain the 7 2009 PQRI measures groups for the 2010
PQRI: (1) Diabetes Mellitus; (2) CKD; (3) Preventive Care; (4) CABG;
(5) Rheumatoid Arthritis; (6) Perioperative Care; and (7) Back Pain.
These measures groups were selected for inclusion in the 2010 PQRI
because they each contain at least 4 PQRI quality measures that share a
common denominator definition.
Except for the CABG measures group, all 2009 measures groups are
reportable either through claims-based reporting or registry-based
reporting. The CABG measures group, for the 2009 PQRI, is reportable
through the registry-based reporting mechanism only since some measures
included in the 2009 CABG measures group are registry-only individual
PQRI measures. For this reason, we propose the CABG measures group
would be reportable through the registry-based reporting mechanism only
for 2010 while the remaining 6 2009 PQRI measures groups would be
reportable through either claims-based reporting or registry-based
reporting for the 2010 PQRI.
Except for the measures included in the Back Pain measures group,
the measures included in a 2009 PQRI measures group are reportable
either as individual measures or as part of a measures group. As stated
in the CY 2009 PFS final rule with comment period (73 FR 69843 through
69844), as individual measures, the measures in the Back Pain measures
group are too basic. However, taken together they are meaningful
indicators of quality of care for back pain. For this reason, for the
2010 PQRI, we propose that except for the measures included in the Back
Pain measures group, the measures included in a 2009 PQRI measures
group that we propose to carry forward for the 2010 PQRI would be
reportable either as individual measures or as part of a measures
group.
The measures proposed for inclusion in the 2010 measures groups
that are based on the measures groups from 2009 are identified in
Tables 21 through 27. Some measures proposed for inclusion in some of
these measures groups for 2010 were not included in the measures groups
in 2009. The 2009 measures proposed for inclusion in a 2010 measures
group that were not included in the measures group for 2009 are
identified with an asterisk (*).
As with measures group reporting in the 2008 and 2009 PQRI, we
propose that each eligible professional electing to report a group of
measures for 2010 must report all measures in the group that are
applicable to each patient or encounter to which the measures group
applies at least up to the minimum number of patients required by
applicable reporting criteria (described above in section II.G.2.f. of
this proposed rule). The individual measures included in the final 2010
PQRI measures groups will be limited to
[[Page 33583]]
those measures which will be identified in the CY 2010 PFS final rule
with comment period as final 2010 PQRI measures
Table 21--Measures Proposed for 2010 Diabetes Mellitus Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
1................... Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Hemoglobin A1c
Poor Control in
Diabetes Mellitus.
2................... Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Low Density
Lipoprotein (LDL-
C) Control in
Diabetes Mellitus.
3................... Diabetes Mellitus: Yes..................... No..................... NCQA.
High Blood
Pressure Control
in Diabetes
Mellitus.
117................. Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Dilated Eye Exam
in Diabetic
Patient.
119................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Urine Screening
for Microalbumin
or Medical
Attention for
Nephropathy in
Diabetic Patients.
163................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Foot Exam *.
----------------------------------------------------------------------------------------------------------------
* This 2009 PQRI measure was not part of this measures group for 2009, but is proposed for inclusion in this
measures group for 2010.
Table 22--Measures Proposed for 2010 CKD Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
121................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Laboratory Testing
(Calcium,
Phosphorus, Intact
Parathyroid
Hormone (iPTH) and
Lipid Profile).
122................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Blood Pressure
Management.
123................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Plan of Care--
Elevated
Hemoglobin for
Patients Receiving
Erythropoiesis-
Stimulating Agents
(ESA).
135................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Influenza
Immunization.
153................. Chronic Kidney No...................... Yes.................... AMA-PCPI.
Disease (CKD):
Referral for
Arteriovenous (AV)
Fistula.
----------------------------------------------------------------------------------------------------------------
Table 23--Measures Proposed for 2010 Preventive Care Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
39.................. Screening or Yes..................... Yes.................... AMA-PCPI/NCQA.
Therapy for
Osteoporosis for
Women Aged 65
Years and Older.
48.................. Urinary Yes..................... Yes.................... AMA-PCPI/NCQA.
Incontinence:
Assessment of
Presence or
Absence of Urinary
Incontinence in
Women Aged 65
Years and Older.
110................. Preventive Care and Yes..................... No..................... AMA-PCPI.
Screening:
Influenza
Immunization for
Patients >= 50
Years Old.
111................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Pneumonia
Vaccination for
Patients 65 Years
and Older.
112................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Screening
Mammography.
113................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Colorectal Cancer
Screening.
114................. Preventive Care and Yes..................... Yes.................... AMA-PCPI.
Screening: Inquiry
Regarding Tobacco
Use.
115................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Advising Smokers
to Quit.
128................. Preventive Care and Yes..................... Yes.................... CMS/QIP.
Screening: Body
Mass Index (BMI)
Screening and
Follow-Up.
173................. Preventive Care and No...................... Yes.................... AMA-PCPI.
Screening:
Unhealthy Alcohol
Use--Screening *.
----------------------------------------------------------------------------------------------------------------
* This 2009 PQRI measure was not part of this measures group for 2009, but is proposed for inclusion in this
measures group for 2010.
[[Page 33584]]
Table 24--Measures Proposed for 2010 CABG Measures Group +
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
43.................. Coronary Artery Yes..................... Yes.................... Society of
Bypass Graft Thoracic Surgeons
(CABG): Use of (STS).
Internal Mammary
Artery (IMA) in
Patients with
Isolated CABG
Surgery.
44.................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG):
Preoperative Beta-
Blocker in
Patients with
Isolated CABG
Surgery.
164................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Prolonged
Intubation
(Ventilation).
165................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Deep
Sternal Wound
Infection Rate.
166................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Stroke/
Cerebrovascular
Accident (CVA).
167................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG):
Postoperative
Renal
Insufficiency.
168................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Surgical
Re-exploration.
169................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG):
Antiplatelet
Medications at
Discharge.
170................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Beta-
Blockers
Administered at
Discharge.
171................. Coronary Artery Yes..................... Yes.................... STS.
Bypass Graft
(CABG): Lipid
Management and
Counseling.
----------------------------------------------------------------------------------------------------------------
+ This measures group is proposed to be reportable through registry-based reporting only.
Table 25--Measures Proposed for 2010 Rheumatoid Arthritis Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
108................. Rheumatoid Yes..................... No..................... NCQA.
Arthritis (RA):
Disease Modifying
Anti-Rheumatic
Drug (DMARD)
Therapy.
176................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Tuberculosis
Screening.
177................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Periodic
Assessment of
Disease Activity.
178................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Functional Status
Assessment.
179................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Assessment and
Classification of
Disease Prognosis.
180................. Rheumatoid No...................... Yes.................... AMA-PCPI/NCQA.
Arthritis (RA):
Glucocorticoid
Management.
----------------------------------------------------------------------------------------------------------------
Table 26--Measures Proposed for 2010 Perioperative Care Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
20.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Timing of
Antibiotic
Prophylaxis--Order
ing Physician.
21.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Selection of
Prophylactic
Antibiotic--First
OR Second
Generation
Cephalosporin.
22.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Discontinuation of
Prophylactic
Antibiotics (Non-
Cardiac
Procedures).
23.................. Perioperative Care: Yes..................... Yes.................... AMA-PCPI/NCQA.
Venous
Thromboembolism
(VTE) Prophylaxis
(When Indicated in
ALL Patients).
----------------------------------------------------------------------------------------------------------------
[[Page 33585]]
Table 27--Measures Proposed for 2010 Back Pain Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
148................. Back Pain: Initial Yes..................... Yes.................... NCQA.
Visit.
149................. Back Pain: Physical Yes..................... Yes.................... NCQA.
Exam.
150................. Back Pain: Advice Yes..................... Yes.................... NCQA.
for Normal
Activities.
151................. Back Pain: Advice Yes..................... Yes.................... NCQA.
Against Bed Rest.
----------------------------------------------------------------------------------------------------------------
In addition to the 7 measures groups that we propose to retain from
the 2009 PQRI, we propose 6 new measures groups for the 2010 PQRI, for
a total of 13 CY 2010 measures groups. The 6 new measures groups
proposed for the 2010 PQRI are: (1) Coronary Artery Disease (CAD); (2)
Heart Failure (HF); (3) Ischemic Vascular Disease (IVD); (4) Hepatitis
C; (5) Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency
Syndrome (AIDS); and (6) Community Acquired Pneumonia (CAP). Many of
the 6 new measures groups proposed for 2010 contain proposed new
registry-only measures, which would make them reportable through
registry-based reporting only. Therefore, only 8 proposed 2010 measures
groups would be reportable through either claims-based reporting or
registry-based reporting: Diabetes Mellitus; CKD; Preventive Care;
Perioperative Care; Rheumatoid Arthritis; Back Pain; Hepatitis C; and
Community Acquired Pneumonia. We invite comments on our proposal to
limit claims-based reporting of measures groups in 2010.
New measures groups are proposed for the 2010 PQRI in order to
address gaps in quality reporting and are those that have a high impact
on HHS and CMS priority topics for improved quality and efficiency for
Medicare beneficiaries (such as prevention, chronic conditions, high
cost/high volume conditions, improved care coordination, improved
efficiency, improved patient and family experience of care, and
effective management of acute and chronic episodes of care). Groups
were identified in topical areas where: (1) 4 or more proposed 2010
measures are available; (2) the measures are NQF endorsed; and (3) they
address a gap in quality reporting. The measures proposed for inclusion
in these new 2010 measures groups are identified in Tables 28 through
33.
Some measures proposed for inclusion in these 6 measures group are
current 2009 individual PQRI measures. The title of each such measure
is preceded with its PQRI Measure Number in Tables 28 through 33. As
stated previously, the PQRI Measure Number is a unique identifier
assigned by CMS to all measures in the PQRI measure set. Once a PQRI
Measure Number is assigned to a measure, it will not be used again,
even if the measure is subsequently retired from the PQRI measure set.
Measures that are not preceded by a number (in other words, those
preceded by ``TBD'') in Tables 28 through 33 have never been part of a
PQRI measure set until being proposed now. A number will be assigned to
such measures if we include them in the final set of 2010 PQRI measures
groups.
Table 28--Measures Proposed for 2010 CAD Measures Group +
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
6................... Coronary Artery Yes..................... Yes.................... AMA-PCPI.
Disease (CAD):
Oral Antiplatelet
Therapy Prescribed
for Patients with
CAD.
114................. Preventive Care and Yes..................... Yes.................... AMA-PCPI.
Screening: Inquiry
Regarding Tobacco
Use.
115................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Advising Smokers
to Quit.
TBD................. Coronary Artery Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Disease (CAD):
Symptom and
Activity
Assessment.
TBD................. Coronary Artery Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Disease (CAD):
Drug Therapy for
Lowering LDL-
Cholesterol.
----------------------------------------------------------------------------------------------------------------
+ This measures group is proposed to be reportable through registry-based reporting only.
Table 29--Measures Proposed for 2010 HF Measures Group +
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
5................... Heart Failure: Yes..................... Yes.................... AMA-PCPI.
Angiotensin-
Converting Enzyme
(ACE) Inhibitor or
Angiotensin
Receptor Blocker
(ARB) Therapy for
Left Ventricular
Systolic
Dysfunction (LVSD).
8................... Heart Failure: Beta- Yes..................... Yes.................... AMA-PCPI.
Blocker Therapy
for Left
Ventricular
Systolic
Dysfunction (LVSD).
114................. Preventive Care and Yes..................... Yes.................... AMA-PCPI.
Screening: Inquiry
Regarding Tobacco
Use.
115................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Advising Smokers
to Quit.
[[Page 33586]]
TBD................. Heart Failure (HF): Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Left Ventricular
Function
Assessment.
TBD................. Heart Failure (HF): Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Patient Education.
TBD................. Heart Failure (HF): Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Warfarin Therapy
Patients with
Atrial
Fibrillation.
----------------------------------------------------------------------------------------------------------------
+ This measures group is proposed to be reportable through registry-based reporting only.
Table 30--Measures Proposed for 2010 IVD Measures Group +
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure number Measure title as of 5/1/09 of 1/31/09 Measure Developer
----------------------------------------------------------------------------------------------------------------
114................. Preventive Care and Yes..................... Yes.................... AMA-PCPI.
Screening: Inquiry
Regarding Tobacco
Use.
115................. Preventive Care and Yes..................... Yes.................... NCQA.
Screening:
Advising Smokers
to Quit.
TBD................. Blood Pressure Yes..................... No..................... NCQA.
Management:
Control.
TBD................. Complete Lipid Yes..................... No..................... NCQA.
Profile.
TBD................. Cholesterol Control Yes..................... No..................... NCQA.
TBD................. Use of Aspirin or Yes..................... No..................... NCQA.
Another Anti-
Thrombotic.
----------------------------------------------------------------------------------------------------------------
+ This measures group is proposed to be reportable through registry-based reporting only.
Table 31--Measures Proposed for 2010 Hepatitis C Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure No. Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
84.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Ribonucleic Acid
(RNA) Testing
Before Initiating
Treatment.
85.................. Hepatitis C: HCV Yes..................... Yes.................... AMA-PCPI.
Genotype Testing
Prior to Treatment.
86.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Antiviral
Treatment
Prescribed.
87.................. Hepatitis C: HCV Yes..................... Yes.................... AMA-PCPI.
Ribonucleic Acid
(RNA) Testing at
Week 12 of
Treatment.
89.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Counseling
Regarding Risk of
Alcohol
Consumption.
90.................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Counseling
Regarding Use of
Contraception
Prior to Antiviral
Therapy.
183................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Hepatitis A
Vaccination in
Patients with HCV.
184................. Hepatitis C: Yes..................... Yes.................... AMA-PCPI.
Hepatitis B
Vaccination in
Patients with HCV.
----------------------------------------------------------------------------------------------------------------
Table 32--Measures Proposed for 2010 HIV/AIDS Measures Group +
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure No. Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
159................. HIV/AIDS: CD4+ Cell Yes..................... No..................... AMA-PCPI/NCQA.
Count or CD4+
Percentage.
160................. HIV/AIDS: Yes..................... No..................... AMA-PCPI/NCQA.
Pneumocystis
Jiroveci Pneumonia
(PCP) Prophylaxis.
161................. HIV/AIDS: Yes..................... No..................... AMA-PCPI/NCQA.
Adolescent and
Adult Patients
with HIV/AIDS Who
Are Prescribed
Potent
Antiretroviral
Therapy.
162................. HIV/AIDS: HIV RNA Yes..................... Yes.................... AMA-PCPI/NCQA.
Control After Six
Months of Potent
Antiretroviral
Therapy.
TBD................. HIV/AIDS: Sexually Yes..................... Yes.................... AMA-PCPI/NCQA.
Transmitted
Diseases--Chlamydi
a and Gonorrhea
Screenings.
TBD................. HIV/AIDS: Screening Yes..................... Yes.................... AMA-PCPI/NCQA.
for High Risk
Sexual Behaviors.
TBD................. HIV/AIDS: Screening Yes..................... Yes.................... AMA-PCPI/NCQA.
for Injection Drug
Use.
[[Page 33587]]
TBD................. HIV/AIDS: Sexually Yes..................... No..................... AMA-PCPI/NCQA.
Transmitted
Diseases--Syphilis
Screening.
----------------------------------------------------------------------------------------------------------------
+ This measures group is proposed to be reportable through registry-based reporting only.
Table 33--Measures Proposed for 2010 Community-Acquired Pneumonia Measures Group
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure No. Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
56.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Vital Signs.
57.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Assessment of
Oxygen Saturation.
58.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Assessment of
Mental Status.
59.................. Community-Acquired Yes..................... Yes.................... AMA-PCPI/NCQA.
Pneumonia (CAP):
Empiric Antibiotic.
----------------------------------------------------------------------------------------------------------------
We note that the specifications for measures groups do not
necessarily contain all the specification elements of each individual
measure making up the measures group. This is based on the need for a
common set of denominator specifications for all the measures making up
a measures group in order to define the applicability of the measures
group. Therefore, the specifications and instructions for measures
groups will be provided separately from the specifications and
instructions for the individual 2010 PQRI measures. We will post the
detailed specifications and specific instructions for reporting
measures groups on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI by no later than December 31, 2008.
Additionally, the detailed measure specifications and instructions
for submitting data on those proposed 2010 measures groups that were
also included as 2009 PQRI measures groups may be updated or modified
prior to 2010. Therefore, the 2010 PQRI measure specifications for any
given measures group could be different from specifications and
submission instructions for the same measures group used for 2009.
These measure specification changes do not materially impact the
intended meaning of the measures or the strength of the measures.
(6) Request for Public Comment on Measure Suggestions for Future PQRI
Quality Measure Sets
As stated above, on February 1, 2009, we posted a ``Call for 2010
PQRI Measure Suggestions'' on the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI. The ``Call for 2010 PQRI Measure
Suggestions'' invited the public to submit suggestions for individual
quality measures and measures groups (that is, suggestions for new
measures groups and/or suggestions for the composition of existing
measures groups) for consideration for possible inclusion in the
proposed set of quality measure for use in the 2010 PQRI. To facilitate
our evaluation of the suggested measures, we asked individuals or
organizations submitting suggestions to provide us with the following
information:
Requestor contact information, such as name and title,
organization/practice name, phone number and e-mail address;
Measure title;
Measure description;
Measure owner/developer;
NQF endorsement status, including the date of endorsement
or anticipated endorsement (if not NQF-endorsed) and type of
endorsement (for example, time-limited endorsement);
AQA adoption status, including date of AQA adoption or
anticipated AQA adoption;
Preferred PQRI reporting option for the suggested
measure(s) (that is, claims, registry, registry-only, measures group,
measures group only, EHRs); and
The measure specifications.
In lieu of posting a call for 2011 PQRI measure suggestions on the
PQRI section of the CMS Web site in 2010, we invite commenters to
submit suggestions for individual quality measures and measures groups
(that is, suggestions for new measures groups and/or suggestions for
the composition of proposed 2010 measures groups) for consideration for
possible inclusion in the proposed set of quality measures for use in
the 2011 PQRI. When submitting suggestions for future PQRI quality
measure sets as part of the comment period for this proposed rule,
commenters should submit all the information requested above for the
``Call for 2010 PQRI Measure Suggestions.''
Please note that suggesting individual measures or measures for a
new or proposed measures group does not mean that the measure(s) will
be included in the proposed or final sets of measures of any proposed
or final rules that address the 2011 PQRI. We will determine what
individual measures and measures group(s) to include in the proposed
set of quality measures, and after a period of public comment, we will
make the final determination with regard to the final set of quality
measures for the 2011 PQRI.
j. Proposed 2010 PQRI Quality Measures for Physician Groups Selected to
Participate in the Group Practice Reporting Option
As discussed in section II.G.2.g. of this proposed rule, we propose
that physician groups selected to participate in the 2010 PQRI group
practice reporting option would be required to report on 26 measures.
These measures are NQF-endorsed measures currently collected as part of
the PGP and/or MCMP demonstrations and are identified in Table 34. To
the extent that a measure is an existing PQRI measure, the Measure
Title is preceded by the measure's PQRI Measure Number. If there is no
number in the Measure Number column of the table, then the
[[Page 33588]]
measure is not an existing PQRI measure and will be added to the 2010
PQRI for purposes of the group practice reporting option.
Table 34--Measures Proposed for Physician Groups Participating in the 2010 PQRI Group Practice Reporting Option
----------------------------------------------------------------------------------------------------------------
NQF endorsement status AQA adoption status as
Measure No. Measure title as of 5/1/09 of 1/31/09 Measure developer
----------------------------------------------------------------------------------------------------------------
1................... Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Hemoglobin A1c
Poor Control.
2................... Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Low Density
Lipoprotein
Control.
3................... Diabetes Mellitus: Yes..................... No..................... NCQA.
High Blood
Pressure Control.
5................... Heart Failure: ACE Yes..................... Yes.................... AMA-PCPI.
Inhibitor or ARB
Therapy for LVSD.
6................... Coronary Artery Yes..................... Yes.................... AMA-PCPI.
Disease: Oral Anti-
platelet Therapy.
7................... Coronary Artery Yes..................... Yes.................... AMA-PCPI.
Disease:Beta-
blocker Therapy
for CAD Patients
with Prior MI.
8................... Heart Failure: Beta- Yes..................... Yes.................... AMA-PCPI.
blocker Therapy
for LVSD.
110................. Preventive Care: Yes..................... No..................... AMA-PCPI.
Influenza
Vaccination for
Patients > 50
years.
111................. Preventive Care: Yes..................... Yes.................... NCQA.
Pneumonia
Vaccination for
Patients 65+ years.
112................. Preventive Care: Yes..................... Yes.................... NCQA.
Screening
Mammography.
113................. Preventive Care: Yes..................... Yes.................... NCQA/AMA-PCPI.
Screening
Colorectal Cancer.
117................. Diabetes Mellitus: Yes..................... Yes.................... NCQA.
Dilated Eye Exam.
118................. Coronary Artery Yes..................... No..................... AMA-PCPI.
Disease: ACE/ARB
for Patients with
CAD and Diabetes
and/or LVSD.
119................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Urine Screening
for Microalbumin
or Medical
Attention for
Nephropathy.
163................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Foot Exam.
TBD................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Hemoglobin A1c
Testing.
TBD................. Diabetes Mellitus: Yes..................... No..................... NCQA.
Lipid Profile.
TBD................. Heart Failure: Left Yes..................... Yes.................... CMS.
Ventricular
Function Testing.
TBD................. Heart Failure: Left Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Ventricular
Function
Assessment.
TBD................. Heart Failure: Yes..................... No..................... ACC/AHA/AMA-PCPI.
Weight Measurement.
TBD................. Heart Failure: Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Patient Education.
TBD................. Heart Failure: Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Warfarin Therapy
for Patients with
Atrial
Fibrillation.
TBD................. Coronary Artery Yes..................... Yes.................... ACC/AHA/AMA-PCPI.
Disease: Drug
Therapy for
Lowering LDL-
Cholesterol.
TBD................. Preventive Care: Yes..................... No..................... ACC/AHA/AMA-PCPI.
Blood Pressure
Management.
TBD................. Hypertension: Blood Yes..................... No..................... CMS/NCQA.
Pressure Control.
TBD................. Hypertension: Plan Yes..................... No..................... ACC/AHA/AMA-PCPI.
of Care.
----------------------------------------------------------------------------------------------------------------
k. Public Reporting of PQRI Data
Section 1848(m)(5)(G) of the Act, as added by the MIPPA, requires
the Secretary to post on the CMS Web site, in an easily understandable
format, a list of the names of eligible professionals (or group
practices) who satisfactorily submitted data on quality measures for
the PQRI and the names of the eligible professionals (or group
practices) who are successful electronic prescribers as defined and
discussed further in section II.G.5. of this proposed rule. In
accordance with section 1848(m)(5)(G) of the Act, we indicated in the
CY 2009 PFS final rule with comment period (73 FR 69846 through 69847)
our intent, in 2010, to enhance the current Physician and Other Health
Care Professionals directory at http://www.medicare.gov with the names
of eligible professionals that satisfactorily submit quality data for
the 2009 PQRI. In December 2008, we listed, by State, the names of
eligible professionals who participated in the 2007 PQRI on the
Physician and Other Health Care Professionals Directory.
As required by section 1848(m)(5)(G) of the Act, we intend to make
public the names of eligible professionals and group practices that
satisfactorily submit quality data for the 2010 PQRI on the Physician
and Other Health Care Professionals Directory. We anticipate that the
names of individual eligible professionals and group practices that
satisfactorily submit quality data for the 2010 PQRI will be available
in 2011 after the 2010 incentive payments are paid.
For purposes of publicly reporting the names of eligible
professionals, on the Physician and Other Health Care Professionals
Directory, we propose to post the names of eligible professionals who:
(1) Submit data on the 2010 PQRI quality measures through one of the
[[Page 33589]]
reporting mechanisms available for the 2010 PQRI; (2) meet one of the
proposed satisfactory reporting criteria of individual measures or
measures groups for the 2010 PQRI described above in section II.G.2.e.
and II.G.2.f., respectively of this proposed rule; and (3) qualify to
earn a PQRI incentive payment for covered professional services
furnished during the applicable 2010 PQRI reporting period.
Similarly, for purposes of publicly reporting the names of group
practices, on the Physician and Other Health Care Professionals
Directory, we propose to post the names of group practices who: (1)
Submit data on the 2010 PQRI quality measures through the proposed
group practice reporting option described in section II.G.2.g. of this
proposed rule; (2) meet the proposed criteria for satisfactory
reporting under the group practice reporting option; and (3) qualify to
earn a PQRI incentive payment for covered professional services
furnished during the applicable 2010 PQRI reporting period for group
practices.
In addition to posting the information required by section
1848(m)(5)(G) of the Act, for those group practices that are selected
to participate in PQRI under the group practice reporting option, we
also propose to make the group practices' PQRI performance rates
publicly available, for each of the measures. As we stated in the CY
2009 PFS proposed rule (73 FR 38574 through 38575), it is our goal to
make the quality of care for services furnished to Medicare
beneficiaries publicly available by making physician quality measure
performance rates, either at the individual practitioner level or
physician group level, publicly available. While we currently have Web
pages at http://www.medicare.gov for the public reporting of
performance results on standardized quality measures for hospitals
(Hospital Compare), dialysis facilities (Dialysis Facility Compare),
nursing homes (Nursing Home Compare), and home health facilities (Home
Health Compare), we do not have a similar Compare Web site for
information on the quality of care for services furnished by physicians
and other professionals to Medicare beneficiaries.
Public reporting of group practices' PQRI performance results at
the group practice level would allow us to move toward our goal of
making information on physician performance publicly available. We
believe that the way we have proposed to design the group practice
reporting option (see section II.G.2.g. of this proposed rule)
facilitates public reporting of the groups' performance results. Group
practices participating in the group practice reporting option would
have already agreed in advance to have their performance results
publicly reported. All groups participating in the group practice
reporting option would be reporting on identical measures, which
facilitate comparison of the results across groups. In addition, as a
result of the proposed reporting criteria, no performance results would
be calculated based on small denominator sizes. Finally, because we
intend to modify the data collection tool will provide each group
practice with numerator, denominator, and performance rates for each
measure at the time of tool submission, the group practice will have
had an opportunity to review their performance results before they are
made public.
In making performance rates for group practices publicly available,
we will attribute the group practice's performance to the entire group.
We will not post information with respect to the performance of
individual physicians or other eligible professionals associated with
the group. However, we may identify the individual eligible
professionals who were associated with the group during the reporting
period. We invite comments regarding our proposal to publicly report
group practices' PQRI performance results.
3. Section 131(c): Physician Resource Use Measurement and Reporting
Program
a. Statutory Authority
As required under section 1848(n) of the Act, as added by section
131(c) of the MIPPA, we established and implemented by January 1, 2009,
a Physician Feedback Program using Medicare claims data and other data
to provide confidential feedback reports to physicians (and as
determined appropriate by the Secretary, to groups of physicians) that
measure the resources involved in furnishing care to Medicare
beneficiaries. Section 1848(n) of the Act authorizes us, as we
determine appropriate, to include information on the quality of care
furnished to Medicare beneficiaries by the physician (or group of
physicians) in the reports. Although we initially called this effort
the Physician Resource Use Feedback Program, we are renaming this
initiative the ``Physician Resource Use Measurement and Reporting
Program'' (hereinafter referred to as ``Program'').
b. Background
As we stated in the CY 2009 PFS final rule with comment period (73
FR 69866), the Program would consist of multiple phases. We included a
summary of the activities of phase I of the Program in the CY 2009 PFS
final rule with comment period (73 FR 69866 through 69869). In addition
to discussing phase I of the Program, we also highlighted the
activities of several other initiatives, including Medicare Value-Based
Purchasing (VBP) programs and demonstrations and related activities
undertaken by the MedPAC and the Government Accountability Office
(GAO). We refer readers to the CY 2009 PFS final rule with comment
period (73 FR 69866 through 69869) for a detailed discussion of these
activities.
In the CY 2009 PFS final rule with comment period (73 FR 69866
through 69869), we finalized, on an interim basis, the following
parameters for phase I of the Program: (1) Use of both per capita and
episode of care methodologies for resource use measurement; (2) cost of
service category analysis (for example, imaging services or inpatient
admissions); (3) use of 4 calendar years of claims data; (4) focus on
high cost and/or high volume conditions; (5) reporting to physician
specialties relevant to the selected focal conditions; (6) focus on
physicians practicing in certain geographic areas, and (7) low, median,
and high cost benchmarks. We intend to finalize these parameters in the
CY 2010 PFS final rule with comment period.
c. Summary of Comments From the CY 2009 PFS Final Rule With Comment
Period
Section 1848(n)(1)(B) of the Act requires that the Program measures
resources based on the following: (1) An episode basis; (2) a per
capita basis; or (3) both an episode and a per capita basis. We
solicited public comments on the use of each of these measurement
methodologies (73 FR 69868).
Comment: Commenters were in favor of using both the per capita and
the per episode measurement methodologies.
Response: We agree with commenters that both the per capita and per
episode methodologies are appropriate measures of cost for the Program.
Each methodology offers distinct advantages. For a further discussion
regarding the advantages, we refer readers to CMS' Medicare Resource
Use Measurement Plan Web site at http://www.cms.hhs.gov/QualityInitiativesGenInfo/downloads/ResourceUse_Roadmap_OEA_1-15_508.pdf. We intend to finalize both
[[Page 33590]]
methodologies as options for use in future phases of the Program in the
CY 2010 PFS final rule with comment period.
In phase I of the Program, we included cost of service (COS)
category information from aggregated Medicare FFS claims data. We
solicited public comment on which COS categories are most meaningful
and actionable (73 FR 69868).
Comment: Commenters were overwhelmingly in favor of including E/M
services and imaging services as meaningful and actionable COS
categories. Further, commenters supported including laboratory
services, outpatient services, procedures, and post-acute services as
COS categories. No commenters raised specific categories that should be
excluded.
Response: We appreciate the comments in support of the COS category
analysis. We intend to finalize the option to include information on
all of these COS categories in future phases of the Program in the CY
2010 PFS final rule with comment period.
Section 1848(n)(3) of the Act requires that, to the extent
practicable, the data for the reports shall be based on the most recent
data available. In phase I of the Physician Resource Use Feedback
Program, we used Medicare FFS claims data from CY 2004 through CY 2007.
We solicited public comment on this approach (73 FR 69868).
Comment: The majority of commenters stated that 3 calendar years of
data is sufficient for calculating resource use measures. Further,
commenters emphasized, to the extent practicable, CMS should use the
most recent three years of data available for the Program.
Response: We agree with commenters that 3 years of Medicare FFS
claims data are sufficient for calculating resource use measures. We
intend to finalize the use of the most recent 3 years of data available
for the Program in the CY 2010 PFS final rule with comment period.
Under section 1848(n)(4)(B) of the Act, the Secretary may focus the
Program as appropriate, including focusing on physicians who treat
conditions that are high cost, high volume, or both. We finalized on an
interim basis for phase I of the Program, the following conditions: (1)
Congestive heart failure; (2) chronic obstructive pulmonary disease;
(3) prostate cancer; (4) cholecystitis; (5) coronary artery disease
with acute myocardial infarction; (6) hip fracture; (7) community-
acquired pneumonia; and (8) urinary tract infection (73 FR 69868). We
solicited public comments on the use of these high cost/high volume
conditions (73 FR 69868).
Comment: Commenters strongly supported these conditions as
appropriate for measuring the resources furnished to Medicare
beneficiaries. In addition, several commenters suggested that we
include diabetes among the priority conditions for the Program.
Response: We agree with commenters that diabetes is an important
condition to capture in the Program. We intend to finalize the option
to include: (1) Congestive heart failure; (2) chronic obstructive
pulmonary disease; (3) prostate cancer; (4) cholecystitis; (5) coronary
artery disease with acute myocardial infarction; (6) hip fracture; (7)
community-acquired pneumonia; (8) urinary tract infection; and (9)
diabetes, in the Program in the CY 2010 PFS final rule with comment
period.
Under section 1848(n)(4)(A) of the Act, we are permitted to focus
reporting on physician specialties that account for a certain
percentage of spending for physicians' services. Based on the high cost
and high volume conditions selected above, we included the following
physician specialties in phase I of the Program: General internal
medicine, family practice, gastroenterology, cardiology, general
surgery, infectious disease, neurology, orthopedic surgery, physical
medicine and rehabilitation, pulmonology, and urology (73 FR 69868). We
solicited public comments on the inclusion of these physician
specialties (73 FR 69868).
Comment: Commenters supported including all of the physician
specialties listed above as appropriate for measurement and reporting
based on the selected conditions.
Response: We agree with commenters that the physician specialties
listed above should be included in the Program. We intend to finalize
the option to include these physician specialties in the Program in the
CY 2010 PFS final rule with comment period.
Section 1848(n)(4)(D) of the Act permits us to focus the Program on
physicians practicing in certain geographic areas. In the CY 2009 PFS
final rule with comment period (73 FR 69866 through 69869) we
referenced two geographic sites (Baltimore, MD and Boston, MA) for
phase I of the Program, which we generally selected based on close
proximity to the CMS central office and due to high per capita Medicare
costs, respectively. Since the final rule was published, we have also
mailed reports to physicians in the following sites:
Greenville, SC;
Indianapolis, IN;
Northern New Jersey;
Orange County, CA;
Seattle, WA;
Syracuse, NY;
Boston, MA;
Cleveland, OH;
East Lansing, MI;
Little Rock, AR;
Miami, FL; and
Phoenix, AZ.
Comment: Commenters were in favor of including a limited number of
sites representing a wide range of geographic locations to facilitate a
phased implementation. No commenters submitted specific areas that
should be excluded.
Response: We appreciate the comments in support of including a
limited number of sites. We intend to continue to include the
geographic sites listed above, and identify a limited number of new
locations, in the Program in the CY 2010 PFS final rule with comment
period.
Section 1848(n)(4)(C) of the Act also permits us to focus the
program on physicians who use a high amount of resources compared to
other physicians. The resource use reports disseminated in phase I of
the Program defined peer groups of physicians by focusing on one
condition, one specialty, and one of the geographic locations mentioned
above. Within each peer group, the resource use reports indicated
whether the physician fell over the 90th percentile (high cost
benchmark), below the 10th percentile (low cost benchmark), or over the
50th percentile (median cost benchmark). We solicited public comments
on which cost benchmarks make the resource use reports meaningful,
actionable, and fair (73 FR 69869).
Comment: Commenters supported the use of high, median, and low cost
benchmarks because the benchmarks highlight useful cost categories
within a given peer group.
Response: We agree with commenters that the high, median, and low
cost benchmarks are appropriate. We intend to finalize these cost
benchmarks as options to include in the Program in the CY 2010 PFS
final rule with comment period.
Comment: A few commenters expressed support for including small
geographic areas for benchmarking.
Response: Though we recognize that a small geographic benchmark may
capture a more homogenous beneficiary population for comparison,
smaller sample sizes may adversely affect the statistical precision of
the comparison. A larger sample captured through broader geographic
benchmarks makes
[[Page 33591]]
it less likely that physicians will be erroneously identified as high
or low cost outliers.
In addition to commenting on specific statutory parameters,
commenters also provided feedback on other general topics. Those
comments and responses are included below.
Comment: A few commenters mentioned the use of proprietary
commercial episode grouper software as a barrier to transparency within
the Program. These commenters indicated that in order to understand and
validate the resource use reports, physicians would need additional
information about how the proprietary commercial software allocated
costs to episodes.
Response: One of the primary goals of CMS' VBP initiatives is to
implement performance-based incentive payment programs with transparent
methodologies. We note that the Program is currently limited under
section 1848(n)(1)(A) of the Act to confidential reporting. Use of
physician resource use information for other purposes, such as payment
or public reporting, would likely require a higher level of
transparency than confidential reporting.
We note that we have previously discussed the use of proprietary
products for payment purposes in previous rules published in the
Federal Register. For example, we discussed the use of a proprietary
product prior to implementation of the MS-DRGs in the FY 2007 IPPS
final rule (72 FR 47171).
We recognize the efforts of episode grouper vendors toward improved
transparency. For more information on episode groupers that is publicly
available, we refer readers to the following Web sites: http://www.ingenix.com/ThoughtLeadership/ETG/EtgRegistration/ and http://www.thomsonreuters.com/business_units/healthcare/.
We are soliciting public comment on the use of proprietary products
to measure episodes of the care in the Program.
Comment: Some commenters expressed that the best method for
dissemination of resource use reports is paper copies distributed via
the mail. Others favored an electronic mechanism for dissemination.
Some commenters expressed that resource use reports should be made
available in both paper format and electronically.
Response: For phase I of the Program, we disseminated reports in
paper form via mail. We agree with commenters that electronic
dissemination would also be desirable. Pending resource availability,
we will consider this suggestion in a future phase of the Program.
d. Phase I of the Program
As indicated above, the Program consists of multiple phases. Under
this approach, each phase of the Program will inform future phases of
the Program. We refer readers to the CY 2009 PFS final rule with
comment period (73 FR 69866 through 69869) for a description of phase I
Program activities. Using the parameters that were finalized on an
interim basis, we have disseminated approximately 230 resource use
reports to physicians in each of the 12 geographic regions listed above
in this section. We refer readers to the following Web site to review a
de-identified sample of the resource use reports disseminated to
physicians: http://rurinfo.mathematica-mpr.com/. We are soliciting
public comment on the design and elements of the sample resource use
report used in phase I of the Program. We are particularly interested
in receiving comment on the usefulness of the cost of service category
drill-down analysis included on pages 10, 16, 20, 24, 28, 32, and 36 of
the sample resource use report. These comments will inform future
phases of the Program.
e. Phase II of the Program
For phase II, we are proposing to expand the Program in ways that
will make the information more meaningful and actionable for
physicians. We are proposing to add reporting to groups of physicians
recognizing that physicians practice in various arrangements. Group
level reporting provides a mechanism for addressing sample size issues
that arise when individual physicians have too few Medicare
beneficiaries with specific conditions to generate statistically
significant reports. We are also proposing to add quality measurement
information as context for interpreting comparative resource use. These
proposals are addressed in greater detail below in this section.
Phase I of the Program focused on providing confidential feedback
on resource use measures to individual physicians. Section
1848(n)(1)(A) of the Act states that the Secretary may also provide
confidential feedback reports to groups of physicians. Many physicians
practice in groups. Recognizing groups of physicians within the Program
is consistent with other CMS VBP initiatives and demonstrations under
the Medicare program.
We are proposing to provide reports to groups of physicians, in
addition to providing reports to individual physicians, for the
Program. In December 2008, CMS posted an Issues Paper on the
Development of a Transition to a Medicare Physician Value-Based
Purchasing Program for Physician and Other Professional Services.\1\
The Issues paper describes cost of care measurement, the focus of Phase
I of this Program, as one of the central tenets of Physician Value-
Based Purchasing (see section II.G.4. of this proposed rule). Further,
the Issues Paper referenced possible groups of physicians under
consideration including: (1) Formally established single or multi-
specialty group practices; (2) physicians practicing in defined
geographic regions; and (3) physicians practicing within facilities or
larger systems of care. We are soliciting public comments on the
appropriateness of resource use measurement and reporting for these and
other groups of physicians.
---------------------------------------------------------------------------
\1\ http://www.cms.hhs.gov/PhysicianFeeSched/downloads/PhysicianVBP-Plan-Issues-Pape.pdf.s
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Phase I of the Program focused on providing confidential feedback
on resource use measures. Section 1848(n)(1)(A) of the Act states that
the Secretary may also include information on quality of care furnished
to Medicare beneficiaries by the physician. Providing physicians with
feedback on both quality and cost of care better captures the value of
the care provided. Including quality measures in the Program is
consistent with the direction for other CMS VBP initiatives.
We are proposing the use of quality measures, in addition to
resource use measures, for the Program. Possible sources of quality
measures include the Physician Quality Reporting Initiative (PQRI) (see
section II.G.2. of this proposed rule) and the Generating Medicare
Physician Quality Performance Measurement Results (referred to as GEM)
Project.\2\ We refer readers to the Issues Paper, mentioned above,\3\
for additional discussion on how CMS would use quality measures in this
Program and for Physician Value-Based Purchasing (see section II.G.4.
of this proposed rule). We are soliciting public comments on the use of
PQRI, GEM, and other broader aggregate quality measures to be used to
capture value for the groups proposed above in the Physician Resource
Use Measurement and Reporting Program.
---------------------------------------------------------------------------
\2\ http://www.cms.hhs.gov/GEM/.
\3\ http://www.cms.hhs.gov/PhysicianFeeSched/downloads/PhysicianVBP-Plan-Issues-Pape.pdf.
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[[Page 33592]]
4. Section 131(d): Plan for Transition to Value-Based Purchasing
Program for Physicians and Other Practitioners
a. Background
Value-based purchasing uses payment incentives and transparency to
increase the value of care by rewarding providers for higher quality
and more efficient services and for publicly reporting performance
information. Section 131(d) of the MIPPA requires the Secretary to
develop a plan to transition to a value-based purchasing (VBP) program
for Medicare payment for covered professional services made under, or
based on, the PFS. Section 131(d) of the MIPPA also states that by May
1, 2010, the Secretary shall submit a report to the Congress,
containing the plan, together with recommendations for such legislation
and administrative action as the Secretary determines appropriate. The
Secretary, through the Physician and Other Health Professional VBP
(PVBP) Workgroup, submitted a progress letter to Congress on January 8,
2009 detailing the progress made on the VBP plan for physicians and
other professionals.
Currently, Medicare health professional payments are based on
quantity of services and procedures provided, without recognition of
quality or efficiency. Under various authorities, we have pursued the
implementation of building blocks to support the establishment of a VBP
program for health professionals. These include initiatives in the
following major topic areas: Quality and efficiency measurement and
reporting, approaches for aligning incentives with providing higher
quality care instead of higher volume of care, care coordination,
prevention, and health information technology (HIT). The following is a
list of examples of the initiatives specifically relevant to physicians
and other health professionals:
Pay for reporting of quality measurement data instituted
under the Physician Quality Reporting Initiative (PQRI);
Resource use reports comparing overall costs, as well as
costs for treatment across episodes of care, as part of, as required by
the Physician Resource Use Feedback Program (See section II.G.3. of
this proposed rule); and
Demonstration projects, including the Physician Group
Practice demonstration of a shared savings model, gainsharing
demonstrations, medical home and other care coordination and disease
management demonstrations, and the Acute Care Episodes demonstration of
a bundled payment model.
We are fully committed to implementing VBP incentives to drive
quality improvement and greater efficiency for services furnished to
Medicare beneficiaries.
b. Approach to Plan Development
We have created an internal cross-component team, the PVBP
Workgroup, to lead development of the PVBP Plan. Four Subgroups were
established to address the major sections of the Plan: Measures;
incentives; data strategy and infrastructure; and public reporting. The
PVBP Workgroup was tasked with reviewing the state-of-the-art in
performance-based payment for physicians, including relevant Medicare
programs and demonstrations and private sector initiatives; preparing
an Issues Paper to present program objectives and design principles;
engaging stakeholders and obtaining input on program design; and
developing the PVBP Plan and Report to Congress. A similar approach was
used in the development of the CMS Hospital VBP Plan.
To guide the planning process, the PVBP Workgroup adopted the
following goal to improve Medicare beneficiary health outcomes and
experience of care by using payment incentives and transparency to
encourage higher quality, more efficient professional services. In
pursuit of this goal, the Workgroup has defined the following
objectives:
Promote evidence-based medicine through measurement,
payment incentives, and transparency.
Reduce fragmentation and duplication through
accountability across settings, alignment of measures and incentives
across settings, better care coordination for smoother transitions, and
attention to episodes of care.
Encourage effective management of chronic disease by
improving early detection and prevention, focusing on preventable
hospital readmissions, and emphasizing the importance of advanced care
planning and appropriate end-of-life care.
Accelerate the adoption of effective, interoperable HIT,
including clinical registries, e-prescribing, and electronic health
records.
Empower consumers to make value-based health care choices
and encourage health professionals to improve the value of care by
disseminating actionable performance information.
The goal and objectives were captured in an Issues Paper that was
posted on the CMS Web site on November 24, 2008, in preparation for the
December 9, 2008 Listening Session which was held at CMS headquarters.
The Issues Paper included questions seeking public input on key design
considerations. The Issues Paper is available on the CMS Web site at
http://www.cms.hhs.gov/PhysicianFeeSched/downloads/PhysicianVBP-Plan-Issues-Paper.pdf. Nearly 500 stakeholders participated in the day-long
Listening Session. We received both verbal and written comments that
are informing the design of the PVBP Plan.
c. Stakeholder Input From the Listening Session
Both at the Listening Session, and in written comments received
following the Session, we obtained input from a wide range of diverse
stakeholders. A large portion of the comments were received from
physician and other professional specialty societies. Commenters also
included consumer advocates, health care consulting firms, and health
IT vendors, and individual practicing physicians.
(1) Overarching Issues
Commenters generally affirmed the goal and objectives presented in
the Issues Paper. Commenters encouraged the consideration of new
payment approaches that cut across settings of care to align Medicare
Part A and Part B payment incentives. Many commenters stated that the
current Medicare payment system for health professionals is flawed in
that it fails to align incentives for high-value care across providers
and settings and that this cannot be fixed solely by a VBP program.
Commenters agreed with the Issues Paper assumption that the Plan will
need to contain more than one approach to accommodate different
practice arrangements. Several commenters praised the attention given
in the Issues Paper to addressing disparities and pointed out the
necessity of adequate risk adjustment and proper use of measures,
incentives, and program evaluation to protect vulnerable populations.
Commenters also urged careful attention to the operational transition
from the current payment system to VBP to minimize care delivery
disruptions.
(2) Measurement
Commenters emphasized the importance of aligning measures across
payment settings and applying measures consistently across payers. Many
commenters stressed the need for valid, reliable, nationally-recognized
measures, particularly in the areas of outcomes, care coordination,
patient
[[Page 33593]]
experience, and the effective use of HIT. Adequate risk adjustment was
raised as a paramount issue for outcomes and resource use measures.
Regarding resource use measures, several commenters noted that quality
and cost measures should be reported together and that CMS should get
experience with confidential feedback reporting of resource use before
using the information for incentives or public reporting (See section
II.G.3. of this proposed rule). A few commenters suggested avoidable
readmission rates as a good measure of both cost and quality of care.
Commenters emphasized the importance of CMS working with health
professionals on the selection of quality and cost measures.
Commenters generally agreed with the Issues Paper assumption that
the Plan should address multiple levels of accountability, including
individual health professionals, care teams, group practices, and
accountable care entities. A few commenters mentioned that performance
measurement at the regional level could help address regional
variation. Consumer advocates made strong arguments for individual
accountability, while noting that care delivery is ultimately a team
effort. Others noted that measurement is more difficult at the
individual level and that accountability at more aggregated levels
could support promising payment models like bundled payment,
gainsharing, and shared savings.
(3) Incentives
Commenters noted that incentive payments should be large enough to
be meaningful, be made timely, and at least cover the cost of
participating in the program. Commenters encouraged us to coordinate
the incentives, as well as measures, with other payers. Many commenters
stated that incentives should reward both improvement and attainment,
and not be based on a ranking system that rewards only high attainers;
instead, all who perform above a certain prospective benchmark should
earn the incentive. Several commenters indicated that use of incentives
could be an effective way to promote the use of effective HIT. Most
commenters agreed that more than one incentive structure would be
necessary to address different practice arrangements and to focus
effort on specific objectives (for example, care coordination).
(4) Data Strategy and Infrastructure
Commenters emphasized that the administrative burden of data
exchange, for both health professionals and CMS, should be minimized.
Several commenters noted that clinical data registries and direct
reporting from electronic health records were superior approaches to
claims-based reporting for gathering clinical data. Commenters
indicated that feedback on performance should be timely and detailed
enough to be actionable. Commenters also asked for the opportunity to
review and appeal the accuracy of their performance assessments prior
to use of that information for payment incentives or public reporting.
(5) Public Reporting
Consumer advocates highlighted the importance of transparency while
professional associations urged caution to assure that publicly
reported information not be inaccurate or misleading for consumers.
Several commenters noted that public reporting should address multiple
levels of accountability, including individual health professionals,
the care delivery team, group practices, and at the regional level. All
agreed that publicly reported information should be user-friendly.
d. Next Steps in Plan Development
Building on input from the Listening Session on the Issues Paper
topics, the PVBP Workgroup has begun to develop potential
recommendations for inclusion in the Report to Congress. The first step
is to design various approaches for performance-based payment that will
address the planning goal and objectives for different practice
arrangements. This design process will include identifying appropriate
measures and incentive structures, considering the necessary data
infrastructure, and addressing public reporting options. Consideration
will be given to approaches that:
(1) Overlay the current PFS, such as differential fee schedule
payments based on measured performance or for providing a medical home;
(2) Address multiple levels of accountability, including individual
health professionals, as well as larger teams or organizations; and
(3) Promote more integrated care through shared savings models and
bundled payment arrangements.
We are seeking further public comment on the development of the
PVBP plan and Report to Congress. Comments already submitted by
participating in person at the December 9, 2008 Listening Session or as
written comments following the Session, do not need to be resubmitted.
At this time, we are soliciting original comments that were not
previously submitted. Particularly, we are interested in the comments
further discussing the issues of the appropriate level of
accountability (for example, group practice, individual, region), and
appropriate data submission mechanisms. The PVBP Workgroup will use
public comment to inform its development of the Plan and Report to
Congress.
5. Section 132: Incentives for Electronic Prescribing (E-Prescribing)--
The E-Prescribing Incentive Program
a. Program Background and Statutory Authority
As defined in Sec. 423.159(a), e-prescribing is the transmission
using electronic media, of prescription or prescription-related
information between a prescriber, dispenser, pharmacy benefit manager
(PBM), or health plan, either directly or through an intermediary,
including an e-prescribing network. E-prescribing includes, but is not
limited to, two-way transmissions between the point of care and the
dispenser.
As discussed in the CY 2009 PFS final rule with comment period (73
FR 69847), there are many potential advantages to e-prescribing. Yet,
there has been limited adoption and use of electronic prescribing by
physicians and other professionals who prescribe medications. It is
estimated that only 12 percent of office-based prescribers currently
use e-prescribing (Surescripts. ``National Progress Report on E-
Prescribing.'' Welcome to the E-Prescribing Resource Center. 2008.
Surescripts. 15 May 2009. http://www.surescripts.com/downloads/NPR/national-progress-report.pdf).
As described in the CY 2009 PFS final rule with comment period (73
FR 69847 through 69848), the MMA and the creation of the Medicare
Prescription Drug Benefit Program (Part D) promoted the use of e-
prescribing by requiring the adoption of uniform standards for the
Medicare Part D electronic prescribing (``e-prescribing'') program. As
required by section 1860D-4(e) of the Act, ``foundation standards''
were adopted on November 7, 2005 (70 FR 67568) and additional Part D e-
prescribing standards were adopted on April 7, 2008, and were
implemented April 1, 2009 (73 FR 18918). Section 1848(m) of the Act, as
amended by section 132 of the MIPPA, further promotes the use of e-
prescribing by authorizing incentive payments to eligible professionals
or group practices who are ``successful electronic prescribers.'' This
E-Prescribing Incentive Program is expected to encourage significant
expansion of the use of e-prescribing by
[[Page 33594]]
authorizing a combination of financial incentives and payment
adjustment and is separate from, and in addition to, any incentive
payment that eligible professionals may earn through the PQRI program
discussed in section II.G.2. of this proposed rule. Eligible
professionals do not have to participate in PQRI to participate in the
E-Prescribing Incentive Program (and vice versa).
For 2010, which is the second year of the E-Prescribing Incentive
Program, the Secretary is authorized to provide successful e-
prescribers, as defined in section 1848(m)(3)(B) of the Act and further
discussed below in this section, an incentive payment equal to 2.0
percent of the total estimated (based on claims submitted not later
than 2 months after the end of the reporting period) allowed charges
for all covered professional services furnished during the 2010
reporting period. Covered professional services are defined under the
statute to be services for which payment is made under, or is based on,
the PFS and which are furnished by an eligible professional. The
applicable electronic prescribing percent (2 percent) authorized for
the 2010 E-Prescribing Incentive Program is the same as that authorized
for the 2009 E-Prescribing Incentive Program.
Subject to section 1848(m)(2)(D) of the Act, as added by section
4101(f)(2)(B) of the HITECH Act (Title IV of Division B of the Recovery
Act, together with Title XIII of Division A of the Recovery Act) (Pub.
L. 111-5), which was enacted on February 17, 2009, the incentive
payments for successful electronic prescribers for future years are
authorized under section 1848(b)(2)(C) of the Act as follows:
1.0 percent for 2011.
1.0 percent for 2012.
0.5 percent for 2013.
Section 1848(m)(2)(D) of the Act, as added by section 4001(f)(2)(B)
of the Recovery Act, specifies a limitation to the e-prescribing
incentive in relation to whether the EHR incentive authorized by the
Recovery Act is earned. Section 1848(m)(2)(D) of the Act specifically
provides that the e-prescribing incentive does not apply to an eligible
professional (or group practice), if, for the EHR reporting period, the
eligible professional (or group practice) earns an incentive payment
under the new Health Information Technology (HIT) incentive program
authorized by the Recovery Act for eligible professionals who are
meaningful EHR users. The new HIT incentive program for meaningful EHR
users begins in 2011. Therefore, beginning in 2011, eligible
professionals who earn an incentive under the new HIT incentive program
for meaningful EHR users, with respect to a certified EHR technology
that has e-prescribing capabilities, would not be eligible to earn a
separate incentive payment for being a successful electronic prescriber
under the E-prescribing Incentive Program.
In addition, under section 1848(a)(5)(A) of the Act, as added by
section 132(b) of the MIPPA and amended by section 4001(f)(1) of the
Recovery Act, a PFS payment adjustment applies beginning in 2012 to
those who are not successful electronic prescribers. Specifically, for
2012, 2013, and 2014, if the eligible professional is not a successful
electronic prescriber for the reporting period for the year, the fee
schedule amount for covered professional services furnished by such
professionals during the year shall be less than the fee schedule
amount that would otherwise apply by:
1.0 percent for 2012.
1.5 percent for 2013.
2.0 percent for 2014.
We note that the criteria for determination of successful
electronic prescriber proposed herein may not necessarily be the
criteria that will be used to determine the applicability of the
payment adjustment in the future. Policy considerations underlying the
application of the incentive payment are not necessarily the same as
those in applying a payment adjustment. In general, we believe that an
incentive should be broadly available to encourage the widest possible
adoption of e-prescribing, even for low volume prescribers. On the
other hand, a payment adjustment should be applied primarily to assure
that those who have a large volume of prescribing do so electronically,
without penalizing those for whom the adoption and use of an e-
prescribing system may be impractical given the low volume of
prescribing. We will discuss the application of the payment adjustment
in future notice and comment rulemaking, but prior to the beginning of
the reporting period that will be used to determine the applicability
of the payment adjustment.
Under section 1848(m)(6)(A) of the Act, the definition of
``eligible professional'' for purposes of eligibility for the E-
Prescribing Incentive Program is identical to the definition of
``eligible professional'' for the PQRI under section 1848(k)(3)(B) of
the Act. In other words, eligible professionals include physicians,
other practitioners as described in section 1842(b)(18)(C) of the Act,
physical and occupational therapists, qualified speech-language
pathologists, and qualified audiologists. However, for purposes of the
E-prescribing Incentive Program, eligibility is further restricted by
scope of practice to those professionals who have prescribing
authority. Detailed information about the types of professionals that
are eligible to participate in the E-Prescribing Incentive Program is
available on the ``Eligible Professionals'' page of the E-Prescribing
Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive.
Similar to the PQRI, the E-Prescribing Incentive Program, in 2009,
is an incentive program in which determination of whether an eligible
professional is a successful electronic prescriber will be made at the
individual professional level, based on the NPI. Inasmuch as some
individuals (identified by NPIs) may be associated with more than one
practice or TIN, the determination of whether an eligible professional
is a successful electronic prescriber will be made to the holder of
each unique TIN/NPI combination. Then, payment will be made to the
applicable holder of the TIN. For 2010, the determination of whether an
eligible professional is a successful electronic prescriber will
continue to be made for each unique TIN/NPI combination. However,
section 1848(m)(3)(C) of the Act requires the Secretary by January 1,
2010 to establish and have in place a process under which eligible
professionals in a group practice (as defined by the Secretary) shall
be treated as meeting the requirements for submitting data on
electronic prescribing quality measures for covered professional
services for a reporting period (or, for purposes of the payment
adjustment under section 1848(a)(5) of the Act, for a reporting period
for a year) if, in lieu of reporting the electronic prescribing
measure, the group practice reports measures determined appropriate by
the Secretary, such as measures that target high-cost chronic
conditions and preventive care, in a form and manner, and at a time
specified by the Secretary. Therefore, in addition to making incentive
payments for 2010 to group practices based on separately analyzing
whether the individual eligible professionals within the group practice
are successful electronic prescribers, we will also begin making
incentive payments to group practices based on the determination that
the group practice, as a whole, is a successful electronic prescriber.
b. The Proposed 2010 Reporting Period for the E-Prescribing Incentive
Program
Section 1848(m)(6)(C)(i)(II) of the Act defines ``reporting
period'' for the 2010
[[Page 33595]]
E-Prescribing Incentive Program to be the entire year. Section
1848(m)(6)(C)(ii) of the Act, as added by the MIPPA, however,
authorizes the Secretary to revise the reporting period for years after
2009 if the Secretary determines such revision is appropriate, produces
valid results on measures reported, and is consistent with the goals of
maximizing scientific validity and reducing administrative burden. We
propose the 2010 E-Prescribing Incentive Program reporting period will
be the entire year (January 1, 2010-December 31, 2010). We believe that
keeping the 2010 E-Prescribing Incentive Program reporting period
consistent with the 2009 E-Prescribing Incentive Program reporting
period will help to maintain program stability and be less confusing
for eligible professionals.
Successful electronic prescribers would be eligible to receive an
incentive payment equal to 2.0 percent of the total estimated allowed
charges (based on claims submitted by no later than February 28, 2011)
for all covered professional services furnished January 1, 2010 through
December 31, 2010.
c. Proposed Criteria for Determination of Successful E-Prescriber for
Eligible Professionals
Under section 1848(m)(3)(B) of the Act, in order to qualify for the
incentive payment, an eligible professional must be a ``successful
electronic prescriber,'' which the Secretary is authorized to identify
using 1 of 2 possible criteria. One criterion, under section
1848(m)(3)(B)(ii) of the Act, is based on the eligible professional's
reporting, in at least 50 percent of the reportable cases, on any e-
prescribing quality measures that have been established under the
physician reporting system under subsection 1848(k) (which, as noted
previously, we have named ``PQRI'' for ease of reference) and are
applicable to services furnished by the eligible professional during a
reporting period. The second criterion, under section
1848(m)(3)(B)(iii) of the Act, is based on the electronic submission by
the eligible professional of a sufficient number (as determined by the
Secretary) of prescriptions under Part D during the reporting period.
If the Secretary decides to use the latter standard, then, in
accordance with section 1848(m)(3)(B)(iv) of the Act, the Secretary is
authorized to use Part D drug claims data to assess whether a
``sufficient'' number of prescriptions has been submitted by eligible
professionals. However, under section 1848(m)(3)(B)(i) of the Act, if
the standard based on a sufficient number (as determined by the
Secretary) of electronic Part D prescriptions is applied for a
particular reporting period, then the standard based on the reporting
on e-prescribing measures would no longer apply.
For 2009, as described in the CY 2009 PFS final rule with comment
period (73 FR 69847 through 69852), we required eligible professionals
to report on the e-prescribing measure that had been previously used in
the 2008 PQRI. For 2010, we propose to continue to require eligible
professionals to report on the electronic prescribing measure used in
the 2009 E-Prescribing Incentive Program to determine whether an
eligible professional is a successful e-prescriber, but we propose to
use modified reporting criteria.
As we stated in the CY 2009 PFS final rule with comment period (73
FR 69848), we intend to consider the use of a certain number of Part D
prescribing events as the basis for the incentive payment in future
years. However, we do not believe that it is feasible to move to this
substitute requirement in 2010. The accuracy and completeness of the
Part D data with respect to whether a prescription was submitted
electronically is unknown. Information on whether a prescription was
submitted electronically by an individual eligible professional will
not be collected on the Part D claims, or prescription drug event (PDE)
data, until 2010. Also, prescription drug plan sponsors were not
required to send PDE data with an individual prescriber's NPI until
April 1, 2009. We currently have no information on the accuracy and
completeness of the NPI data that is submitted with the PDE data. The
NPI is needed in order for us to be able to link an eligible
professional's PDE data to his or her Medicare Part B claims to
calculate the incentive payment amount. During 2010, we expect to
evaluate the adequacy of Part D data to determine the feasibility of
its use for determining whether an eligible professional qualifies as a
successful e-prescriber in future years.
(1) Reporting the Electronic Prescribing Measure
For 2009, we limited the reporting mechanism for the electronic
prescribing measure to claims-based reporting. For 2010, we propose 3
reporting mechanisms for individual eligible professionals. First, we
propose to retain the claims-based reporting mechanism that is used in
the 2009 E-Prescribing Incentive Program. In addition, similar to the
PQRI, for the E-prescribing Incentive Program, we propose to implement
a registry-based reporting mechanism and, depending on whether we
finalize the proposed EHR-based reporting mechanism for PQRI, we are
also proposing that an EHR-based reporting mechanism be available for
the electronic prescribing measure. In other words, eligible
professionals would be able to choose whether to submit data on the
electronic prescribing measure through claims, a qualified registry, or
a qualified EHR product. As we stated in our discussion of the proposed
PQRI reporting mechanisms for 2010 in section II.G.2.d. of this
proposed rule, we recognize that one mode of quality reporting does not
suit all practices. Similar to the PQRI, we believe that having
multiple reporting mechanisms for the reporting of the electronic
prescribing measure should increase opportunities for eligible
professionals to successfully report the electronic prescribing
measure. We invite comments on our proposal to provide alternatives to
the claims-based reporting mechanism for reporting the electronic
prescribing measure.
We propose that only registries qualified to submit quality measure
results and numerator and denominator data on quality measures on
behalf of eligible professionals for the 2010 PQRI would be qualified
to submit measure results and numerator and denominator data on the
electronic prescribing measure on behalf of eligible professionals for
the 2010 E-Prescribing Incentive Program. We note that not all
registries qualified to submit quality measure results and numerator
and denominator data on quality measures on behalf of eligible
professionals for the 2010 PQRI would be qualified to submit quality
measure results and numerator and denominator data on the e-prescribing
measure. PQRI qualified registries will be qualified to submit specific
types of measures. The electronic prescribing measure is reportable by
an eligible professional any time he or she bills for one of the
procedure codes for Part B services included in the measure's
denominator. Some registries who self-nominate to become a qualified
registry for PQRI may not choose to self-nominate to become a qualified
registry for submitting measures that require reporting at each
eligible visit. Registries will need to indicate their desire to
qualify to submit measure results and numerator and denominator data on
the electronic prescribing measure for the 2010 E-Prescribing Incentive
Program at the time that they submit their self-nomination letter for
the 2010 PQRI. The self-nomination process and
[[Page 33596]]
requirements for registries for the PQRI, which also would apply to the
registries for the 2010 E-Prescribing Incentive Program, are discussed
in section II.G.2.d.(4) of this proposed rule. We will post a list of
qualified registries for the 2010 E-Prescribing Incentive Program on
the E-Prescribing Incentive Program section of the CMS Web site at
http://www.cms.hhs.gov/ERXIncentive when we post the list of qualified
registries for the 2010 PQRI on the PQRI section of the CMS Web site.
Similarly, we propose that only EHR products ``qualified'' to
potentially be able to submit clinical quality data extracted from the
EHR to CMS for the 2010 PQRI would be considered ``qualified'' for the
purpose of an eligible professional potentially being able to submit
data on the electronic prescribing measure for the 2010 E-Prescribing
Incentive Program. The self-nomination process and requirements for EHR
vendors for the PQRI, which also would apply to the EHR vendors for the
2010 E-Prescribing Incentive Program are discussed in section
II.G.2.d.(5) of this proposed rule. EHR vendors will need to indicate
their desire to have one or more of their EHR products qualified for
the purpose of an eligible professional potentially being able to
submit data on the electronic prescribing measure for the 2010 E-
Prescribing Incentive Program at the time that they submit their self-
nomination letter for the 2010 PQRI. If we finalize the EHR-based
reporting mechanism for the 2010 PQRI, we will post a list of qualified
EHR vendors and their products (including the version that is
qualified) for the 2010 E-Prescribing Incentive Program, on the E-
Prescribing Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive when we post the list of qualified EHR
products for the 2010 PQRI on the PQRI section of the CMS Web site. We
welcome comments on our proposal to limit the registries and EHR
products qualified to submit the electronic prescribing measure for the
2010 E-Prescribing Incentive Program to those that are qualified
registries and EHR products, respectively, for the 2010 PQRI.
(2) The Reporting Denominator for the Electronic Prescribing Measure
The electronic prescribing measure, similar to the PQRI measures,
has 2 basic elements. These include: (1) A reporting denominator that
defines the circumstances when the measure is reportable; and (2) a
reporting numerator.
The denominator for the electronic prescribing measure consists of
specific billing codes for professional services. The measure becomes
reportable when any one of these procedure codes is billed by an
eligible professional as Part B covered professional services. For
2009, the codes included in the measure's denominator were codes that
are typically billed for services in the office or outpatient setting
furnished by physicians or other eligible professionals. There are no
diagnosis codes or age/gender requirements in order to be included in
the measure's denominator (that is, reporting of the e-prescribing
measure is not further limited to certain ages or a specific gender).
However, as discussed further under section II.G.5.c.(5) of this
proposed rule, eligible professionals are not required to report this
measure in all cases in which the measure is reportable. Physicians and
other eligible professionals who do not bill for one of the procedure
codes for Part B covered professional services included in the
measure's denominator will have no occasion to report the electronic
prescribing measure.
Currently, the denominator codes for the electronic prescribing
measure consist of the following CPT and G-codes: 90801; 90802; 90804;
90805; 90806; 90807; 90808; 90809; 92002; 92004; 92012; 92014; 96150;
96151; 96152; 99201; 99202; 99203; 99204; 99205; 99211; 99212; 99213;
99214; 99215; 99241; 99242; 99243; 99244; 99245; G0101; G0108; G0109.
As initially required under section 1848(k)(2)(A)(ii) of the Act,
and further established through rulemaking and under section
1848(m)(2)(B) of the Act, however, we may modify the codes making up
the denominator of the electronic prescribing measure. As such, we
propose, in response to public comments received, to expand the scope
of the denominator codes for 2010 to professional services outside the
professional office and outpatient setting, such as professional
services furnished in skilled nursing facilities or the home care
setting. We propose to add the following CPT codes to the denominator
of the electronic prescribing measure for 2010: 99304; 99305; 99306;
99307; 99308; 99309; 99310; 99315; 99316; 99341; 99342; 99343; 99344;
99345; 99347; 99348; 99349; 99350; and 90862. The proposed expansion of
the electronic prescribing measure denominator is expected to provide
more eligible professionals the opportunity to report the measure, and
thus, provide more opportunities for eligible professionals to
participate in the E-Prescribing Incentive Program. We invite comments
on the proposed changes to codes identified for the electronic
prescribing measure denominator.
By December 31, 2009, we will post the final specifications of the
measure on the ``E-Prescribing Measure'' page of the E-Prescribing
Incentive Program section of the CMS Web site at http://www.cms.hhs.gov/ERXIncentive.
(3) Qualified Electronic Prescribing System--Required Functionalities
and Part D E-Prescribing Standards
To report the electronic prescribing measure in 2010, we propose
that the eligible professional must report 1 of 3 ``G'' codes, as will
be discussed below. However, in reporting any of the G-codes and
thereby qualifying for the incentive payment for e-prescribing in 2010,
the professional must have and regularly use a ``qualified'' electronic
prescribing system as defined in the electronic prescribing measure
specifications. If the professional does not have general access to an
e-prescribing system in the practice setting, there is nothing to
report. Required Functionalities for a ``Qualified'' Electronic
Prescriber System. What constitutes a ``qualified'' electronic
prescribing system is based upon certain required functionalities that
the system can perform. As currently specified in the measure, a
``qualified'' electronic prescribing system is one that can:
(a) Generate a complete active medication list incorporating
electronic data received from applicable pharmacies and PBMs, if
available.
(b) Allow eligible professionals to select medications, print
prescriptions, electronically transmit prescriptions, and conduct
alerts (written or acoustic signals to warn the prescriber of possible
undesirable or unsafe situations including potentially inappropriate
dose or route of administration of a drug, drug-drug interactions,
allergy concerns, or warnings and cautions). This functionality must be
enabled.
(c) Provide information related to lower cost, therapeutically
appropriate alternatives (if any). The ability of an electronic
prescribing system to receive tiered formulary information, if
available, would suffice for this requirement for 2010 and until this
function is more widely available in the marketplace.
(d) Provide information on formulary or tiered formulary
medications, patient eligibility, and authorization requirements
received electronically from the patient's drug plan (if available).
[[Page 33597]]
Part D E-Prescribing Standards. Section 1848(m)(3)(B)(v) of the
Act, to the extent practicable, in determining whether an eligible
professional is a successful e-prescriber, ``the Secretary shall ensure
that eligible professionals utilize electronic prescribing systems in
compliance with standards established for such systems pursuant to the
Part D Electronic Prescribing Program under section 1860D-4(e)'' of the
Act. The Part D standards for electronic prescribing systems establish
which electronic standards Part D sponsors, providers, and dispensers
must use when they electronically transmit prescriptions and certain
prescription related information for Part D covered drugs that are
prescribed for Part D eligible individuals. To be a qualified
electronic prescribing system under the E-prescribing Incentive
Program, electronic systems must convey the information listed above
under (a) through (d) using the standards currently in effect for the
Part D e-prescribing program. Additional Part D e-prescribing standards
were implemented April 1, 2009. These latest Part D e-prescribing
standards, and those that had previously been adopted, can be found on
the CMS Web site at http://www.cms.hhs.gov/eprescribing.
To ensure that eligible professionals utilize electronic
prescribing systems that meet these requirements, the electronic
prescribing measure requires that those functionalities required for a
``qualified'' electronic prescribing system must utilize the adopted
Part D e-prescribing standards. The Part D e-prescribing standards
relevant to the four functionalities for a ``qualified'' system in the
electronic prescribing measure, described above and listed as (a), (b),
(c), and (d), are:
(a) Generate medication list--Use the National Council for
Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface
SCRIPT Standard, Implementation Guide, Version 8, Release 1, October
2005 (hereinafter ``NCPDP SCRIPT 8.1'') Medication History Standard;
(b) Transmit prescriptions electronically--Use the NCPDP SCRIPT 8.1
for the transactions listed at Sec. 423.160(b)(2);
(c) Provide information on lower cost alternatives--Use the NCPDP
Formulary and Benefits Standard, Implementation Guide, Version 1,
Release 0 (Version 1.0), October 2005 (hereinafter ``NCPDP Formulary
and Benefits 1.0'');
(d) Provide information on formulary or tiered formulary
medications, patient eligibility, and authorization requirements
received electronically from the patient's drug plan--use:
(1) NCPDP Formulary and Benefits 1.0 for communicating formulary
and benefits information between prescribers and plans.
(2) Accredited Standards Committee (ASC) X12N 270/271--Health Care
Eligibility Benefit Inquiry and Response, Version 4010, May 2000,
Washington Publishing Company, 004010X092 and Addenda to Health Care
Eligibility Benefit Inquiry and Response, Version 4010A1, October 2002,
Washington Publishing Company, 004010X092A1 for communicating eligibly
information between the plan and prescribers.
(3) NCPDP Telecommunication Standard Specification, Version 5,
Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch
Standard Batch Implementation Guide, Version 1, Release 1 (Version
1.1), January 2000 for communicating eligibility information between
the plan and dispensers.
There are, however, Part D e-prescribing standards that are in
effect for functionalities that are not commonly utilized at this time.
Such functionalities are not currently required for a ``qualified''
system under the electronic prescribing measure. One example is Rx Fill
Notification, which is discussed in the Part D e-prescribing final rule
(73 FR 18918, 18926). For purposes of the 2010 Electronic Prescribing
Program and incentive payments, it is not required that the electronic
prescribing system contain all functionalities for which there are
available Part D e-prescribing standards. Rather, the only required
functionalities are those stated in the measure and described above in
the section entitled ``Required Functionalities for a `Qualified'
Electronic Prescribing System.'' For those required functionalities
described above, we propose that a ``qualified'' system must use the
adopted Part D e-prescribing standards for electronic messaging.
There are other aspects of the functionalities for a ``qualified''
system that are not dependent on electronic messaging and are part of
the software of the electronic prescribing system, for which Part D
standards for electronic prescribing do not pertain. For example, the
requirements in qualification (b) listed above that require the system
to allow professionals to select medications, print prescriptions, and
conduct alerts are functions included in the particular software, for
which Part D standards for electronic messaging do not apply.
We are aware that there are significant numbers of eligible
professionals who are interested in earning the incentive payment, but
currently do not have an electronic prescribing system. The electronic
prescribing measure does not require the use of any particular system
or transmission network; only that the system be a ``qualified'' system
having the functionalities described above based on Part D e-
prescribing standards.
(4) The Reporting Numerator for the Electronic Prescribing Measure
Currently, to report for an applicable case where 1 of the
denominator codes is billed for Part B services, an eligible
professional must report one of 3 G-codes specified in the electronic
prescribing measure. Currently, the G-codes are the following:
One G-code is used to report that all prescriptions in
connection with the visit billed were electronically prescribed
(G8443);
Another G-code indicates that no prescriptions were
generated during the visit (G8445); and
A third G-code is used when some or all prescriptions were
written or phoned in due to patient request, State or Federal law, the
pharmacy's system being unable to receive the data electronically or
because the prescription was for a narcotic or other controlled
substance (G8446).
However, for 2010, we propose to modify the first G-code (G8443) to
indicate that at least 1 prescription in connection with the visit
billed was electronically prescribed. In addition, we propose to
eliminate the 2 remaining G-codes from the measure's numerator: G8445;
and G8446. We believe these modifications to the electronic prescribing
measure will simplify reporting of the measure because the measure will
only be reportable when an eligible professional has electronically
prescribed. We invite comments on the proposed modifications to the
electronic prescribing measure numerator.
The e-prescribing quality measure would not apply unless an
eligible professional furnishes services indicated by one of the codes
included in the measure's denominator. Therefore, for claims-based
reporting, for example, it is not necessary for an eligible
professional to report G-codes for the electronic prescribing measure
on claims not containing one of the denominator codes. However, if
reporting a G-code, the G-code data submission will only be considered
valid if it appears on the same Part B claim containing one of the e-
prescribing quality measure's denominator codes.
[[Page 33598]]
(5) Criteria for Successful Reporting of the Electronic Prescribing
Measure
As discussed above, section 1848(m)(3)(B)(ii) of the Act specifies
that an eligible professional shall be treated as a successful
electronic prescriber for a reporting period based on the eligible
professional's reporting of the electronic prescribing measure in at
least 50 percent of applicable cases. However, section 1848(m)(3)(D) of
the Act permits the Secretary in consultation with stakeholders and
experts to revise the criteria for submitting data on electronic
prescribing measures under section 1848(3)(B)(ii) of the Act for years
after 2009. Therefore, we propose to revise the criteria for submitting
data on the electronic prescribing measure. For 2010, rather than
requiring that the electronic prescribing measure be reported for a
certain proportion of reportable cases, we propose to make the
determination of whether an eligible professional is a successful
electronic prescriber based on a count of the number of times an
eligible professional reports that at least one prescription created
during the encounter was generated using a qualified e-prescribing
system (that is, reports the modified G8443 code). We believe that
modifying the criteria for submitting the electronic prescribing
measure in this manner will bring us closer to our stated intention to
transition to using a certain number of electronic Part D prescribing
events as the basis for the incentive payment in future years. In
proposing to revise the criteria for successful reporting of the
electronic prescribing measure in this manner, we also assume that once
an eligible professional has invested in an e-prescribing system,
integrated the use of the e-prescribing system into the practice's work
flows, and has used the system to some extent, he or she is likely to
continue to use the e-prescribing system for most of the prescriptions
he or she generates.
Preliminary data from the 2008 PQRI through September 2008 indicate
that half of the eligible professionals who were eligible to report the
electronic prescribing measure under the 2008 PQRI (measure
125) had 132 or more instances in which they were eligible to
report the measure, with a maximum of 12,655 reporting instances.
Therefore, in order to successfully report the measure under the 2009
criteria for successful e-prescribing (that is, reporting the measure
for at least 50 percent of applicable cases), half of eligible
professionals would have had to report measure 125 66 times or
more (that is, 50 percent of 132 reporting instances), with a maximum
of 6,328 times (that is, 50 percent of 12,655 reporting instances). For
structural measures such as the electronic prescribing measure, once an
eligible professional has demonstrated that he or she has integrated
use of an e-prescribing system into his or her practice's work flow,
requiring the eligible professional to continue to report the measure
represents an administrative burden with little added benefit to the
reliability and validity of the data being reported. In contrast, for
clinical quality measures, the reliability and validity of the
performance rates depends on the adequacy of the sample. Therefore, we
propose that an eligible professional would be required to report that
at least 1 prescription for a Medicare Part B FFS patient created
during an encounter that is represented by 1 of the codes in the
denominator of the electronic prescribing measure was generated using a
qualified e-prescribing system for at least 25 times during the 2010
reporting period.
The proposed minimum reporting threshold of 25 is based on the
notion that an eligible professional would need to e-prescribe, on
average, for approximately 2 Medicare Part B FFS patient encounters per
month during the reporting period in order to be considered a
successful e-prescriber. The proposed reporting threshold of 25 also
takes into consideration that prescriptions are not generated with
every Medicare Part B FFS patient encounter and some prescriptions,
such as narcotics, cannot be prescribed electronically.
We welcome comments on the proposed criteria for determination of
successful electronic prescriber. We are particularly interested in
comments related to the following:
Our proposal to change the criteria for determining
whether an eligible professional is a successful e-prescriber from
requiring reporting of the electronic prescribing measure in 50 percent
of applicable cases to a count of the number of times the eligible
professional electronically prescribed; and
The proposed threshold number of 25 times in which an
eligible professional would be required to report that he or she
electronically prescribed during the reporting period.
d. Determination of the 2010 Incentive Payment Amount for Individual
Eligible Professionals Who Are Successful E-Prescribers
Section 1848(m)(2)(B) of the Act imposes a limitation on the E-
prescribing incentive payment. The Secretary is authorized to choose 1
of 2 possible criteria for the limitation. The first criterion, under
section 1848(m)(2)(B)(i) of the Act, is based upon whether the Medicare
Part B allowed charges for covered professional services to which the
electronic prescribing quality measure applies are less than 10 percent
of the total Part B allowed charges for all covered professional
services furnished by the eligible professional during the reporting
period. The second criterion, under section 1848(m)(2)(B)(ii) of the
Act, is based on whether the eligible professional submits (both
electronically and nonelectronically) a sufficient number (as
determined by the Secretary) of prescriptions under Part D (which can,
again, be assessed using Part D drug claims data). If the Secretary
decides to use the latter criterion, then, in accordance with section
1848(m)(2)(B) of the Act, the criterion based on the reporting on
electronic prescribing measures would no longer apply. The statutory
limitation also applies to the future application of the payment
adjustment.
As discussed above, for 2010, we propose to make the determination
of whether an eligible professional is a ``successful e-prescriber''
based on submission of the electronic prescribing measure. As a result,
we propose to apply the criterion under section 1848(m)(2)(B)(i) for
the limitation for the 2010 E-Prescribing Incentive Program. Therefore,
in determining whether an eligible professional will receive an e-
prescribing incentive payment for 2010, we would determine whether the
10 percent threshold is met based on the claims submitted by the
eligible professional at the TIN/NPI level. This calculation is
expected to take place in the first quarter of 2011 and would be
performed by dividing the individual's total 2010 allowed charges for
all such covered professional services submitted for the measure's
HCPCS codes by the individual's total allowed charges for all covered
professional services (as assessed at the TIN/NPI level). If the result
is 10 percent or more, then the statutory limitation will not apply and
a successful e-prescriber would earn the e-prescribing incentive
payment. If the result is less than 10 percent, then the statutory
limitation will apply and the eligible professional would not earn an
e-prescribing incentive payment--even if he or she electronically
prescribes and reports G8443 at least 25 times for those eligible cases
that occur during the 2010 reporting period. Although an individual
eligible professional may
[[Page 33599]]
decide to conduct his or her own assessment of how likely this
statutory limitation is expected to apply to him or her before deciding
whether or not to report the electronic prescribing measure, an
individual eligible professional may report the electronic prescribing
measure without regard to the statutory limitation for the incentive
payment.
e. Proposed Reporting Option for Satisfactory Reporting of the E-
Prescribing Measure by Group Practices
As discussed previously, section 1848(m)(3)(C)(i) requires that by
January 1, 2010, the Secretary shall establish and have in place a
process under which eligible professionals in a group practice (as
defined by the Secretary) shall be treated as meeting the requirements
for submitting data on electronic prescribing quality measures for
covered professional services for a reporting period (or, for purposes
of the payment adjustment under subsection (a)(5), for a reporting
period for a year) if, in lieu of reporting the electronic prescribing
measure, the group practice reports measures determined appropriate by
the Secretary, such as measures that target high-cost chronic
conditions and preventive care, in a form and manner, and at a time
specified by the Secretary.
Section 1848(m)(3)(C)(ii) of the Act requires that the process
established under section 1848(m)(3)(C)(i) of the Act provide for the
use of a statistical sampling model to submit data on measures, such as
the model used under the Physician Group Practice demonstration project
under section 1866A of the Act. In addition, section 1848(m)(3)(C)(iii)
of the Act specifies that payments to a group practice by reason of the
process established under section 1848(m)(3)(C)(ii) of the Act shall be
in lieu of the payments that would otherwise be made under this
subsection to eligible professionals in the group practice for being a
successful e-prescriber. Therefore, while we will be making incentive
payments to group practices based on the determination that the group
practice, as a whole, is a successful e-prescriber for 2010, an
individual eligible professional who is affiliated with a group
practice participating in the group practice reporting option that
successfully meets the proposed requirements for group practices would
not be eligible to earn a separate e-prescribing incentive payment for
2010 on the basis of his or her successfully reporting the electronic
prescribing measure at the individual level.
(1) Definition of ``Group Practice''
As stated above, section 1848(m)(3)(C)(i) of the Act authorizes the
Secretary to define ``group practice.'' For purposes of determining
whether a group practice is a successful e-prescriber, we propose that
a ``group practice'' would consist of a physician group practice, as
defined by a TIN, with at least 200 or more individual eligible
professionals (or, NPIs) who have reassigned their billing rights to
the TIN to be consistent with definition of ``group practice'' proposed
for the PQRI group practice reporting option.
However, we propose to limit the group practices eligible to
participate in the 2010 E-Prescribing Incentive Program through the
group practice reporting option to those group practices selected to
participate in the PQRI group practice reporting option. At this time,
we would like to limit the number of groups participating in the group
practice reporting option until we get further experience with the
group practice reporting option. Therefore, unlike individual eligible
professionals who are not required to participate in the PQRI to be
eligible to earn an e-prescribing incentive and vice versa, group
practices would be required to participate in both PQRI and the E-
Prescribing Incentive Program. As discussed in section II.G.2.g. of
this proposed rule, group practices interested in participating in the
2010 PQRI through the group practice reporting option would be required
to submit a self-nomination letter to CMS or a CMS designee requesting
to participate in the 2010 PQRI group practice reporting option.
Instructions for submitting the self-nomination letter will be posted
on the PQRI section of the CMS Web site by November 15, 2009. In
addition to meeting the eligibility requirements proposed in section
II.G.2.g.(1) of this proposed rule, a group practice would also have to
indicate how they intend to report the electronic prescribing measure
(that is, which proposed reporting mechanism the group practice intends
to use) for purposes of participating in the 2010 E-Prescribing
Incentive Program group practice reporting option.
(2) Process for Group Practices to Participate as Group Practices and
Criteria for Successful Reporting of the E-Prescribing Measure by Group
Practices
For group practices selected to participate in the e-prescribing
group practice reporting option for 2010, we propose the reporting
period would be January 1, 2010 to December 31, 2010.
We propose that physician groups selected to participate in the
2010 E-Prescribing Incentive Program through the group practice
reporting option would be able to choose to report the electronic
prescribing measure through the claims-based, the registry-based, or,
contingent upon us finalizing this reporting mechanism for the 2010
PQRI, the EHR-based reporting mechanism. As we proposed for individual
eligible professionals, only registries and EHR products qualified to
participate in the 2010 PQRI would be qualified for purposes of the
2010 e-prescribing group practice reporting option.
In order for a group practice to be considered a successful e-
prescriber, we propose the group practice would have to report that at
least 1 prescription during an encounter was generated using a
qualified e-prescribing system in at least 2,500 instances during the
reporting period.
In the absence of information about the composition of the group
practices that may wish to participate in the E-Prescribing Incentive
Program through the group practice reporting option rather than as
individual eligible professionals, we assumed that the average group
practice consists of 200 eligible professionals and that as many as
half of the members of an average group practice do not furnish the
services represented by the electronic prescribing measure's
denominator codes, and thus, would not have an opportunity to report
the electronic prescribing measure. Second, to be consistent with the
proposed reporting criteria for individual eligible professionals, we
also believe that each eligible professional in a group practice should
be required to report that at least 1 prescription generated during an
encounter that is represented by 1 of the electronic prescribing
measure's denominator codes was generated electronically at least 25
times. Thus, for a group of 200 eligible professionals, we could
extrapolate from our assumption that only half of the eligible
professionals in an average practice of 200 eligible professionals
would have the opportunity to report the electronic prescribing measure
per group practice, the total number of reporting instances for the 100
remaining eligible professionals would be 2,500. We invite comments on
the proposed criteria for determining whether a group practice is a
successful e-prescriber. We also invite feedback on our underlying
assumptions.
Section 1848(m)(2)(B) of the Act specifies that the limitation on
the applicability of the e-prescribing incentive discussed in section
II.G.5.d.
[[Page 33600]]
of this proposed rule applies to group practices as well as individual
eligible professionals. Therefore, in determining whether a group
practice will receive an e-prescribing incentive payment for 2010 by
meeting the proposed reporting criteria described above, we would
determine whether the 10 percent threshold is met based on the claims
submitted by the group practice. This calculation is expected to take
place in the first quarter of 2011 and would be determined by dividing
the group practice's total 2010 allowed charges for all covered
professional services submitted for the measure's HCPCS codes by the
group practice's total Medicare Part B allowed charges for all covered
professional services. If the result is 10 percent or more, then the
statutory limitation will not apply and a group practice that is
determined to be a successful e-prescriber would qualify to earn the e-
prescribing incentive payment. If the result is less than 10 percent,
then the statutory limitation will apply and the group practice would
not qualify to earn the e-prescribing incentive payment.
f. Public Reporting of Names of Successful E-Prescribers
As discussed in section II.G.2.k. of this proposed rule, section
1848(m)(5)(G) of the Act requires the Secretary to post on the CMS Web
site, in an easily understandable format, a list of the names of
eligible professionals (or group practices) who satisfactorily submit
data on quality measures for the PQRI and the names of the eligible
professionals (or group practices) who are successful e-prescribers. In
accordance with section 1848(m)(5)(G) of the Act, we indicated in the
CY 2009 PFS final rule with comment period (73 FR 69851 through 69852)
our intent, in 2010, to post the names of eligible professionals who
are successful e-prescribers for the 2009 E-Prescribing Incentive
Program at http://www.medicare.gov.
As required by section 1848(m)(5)(G) of the Act, we propose to make
public the names of eligible professionals and group practices who are
successful electronic prescribers for the 2010 E-Prescribing Incentive
Program on the Physician and Other Health Care Professionals Directory.
The names of individual eligible professionals and group practices who
are successful electronic prescribers for the 2010 E-Prescribing
Incentive Program will be available in 2011 after the 2010 incentive
payments are paid.
For purposes of publicly reporting the names of individual eligible
professionals on the Physician and Other Health Care Professionals
Directory, we propose to post the names of individual eligible
professionals: (1) Whose 2010 PFS allowed charges make up at least 10
percent of the eligible professional's Medicare Part B charges for
2010; (2) who report that at least 1 prescription generated during an
encounter included in the electronic prescribing measure denominator
was generated electronically (that is, who reported the G8443 code) at
least 25 times during the 2010 reporting period; and (3) who receive an
e-prescribing incentive payment for covered professional services
furnished January 1, 2010 through December 31, 2010. Since the PQRI and
the E-Prescribing Incentive Program are two separate incentive programs
and individual eligible professionals are not required to participate
in both programs to earn an incentive under either program, it is
possible for an eligible professional who participates in both
incentive programs to be listed both as an individual eligible
professional who satisfactorily submits data on quality measures for
the PQRI and a successful electronic prescriber if he or she meets the
criteria for both incentive programs.
For purposes of publicly reporting the names of group practices on
the Physician and Other Health Care Professionals Directory, we propose
to post the names of group practices who: (1) Report that at least 1
prescription generated during an encounter included in the electronic
prescribing measure denominator was generated electronically (that is,
who reported the G8443 code) at least 2500 times during the 2010
reporting period; and (2) receive an e-prescribing incentive payment
for covered professional services furnished January 1, 2010 through
December 31, 2010. Although group practices would be required to
participate in both programs to earn an incentive under either program,
the criteria for satisfactory reporting of PQRI measures for group
practices are different from the criteria for successful reporting of
the electronic prescribing measure by group practices. Therefore, it is
possible for a group practice to be listed as a group practice that
satisfactorily submits data on quality measures for the PQRI but not as
a successful electronic prescriber or vice versa.
6. Section 135: Implementation of Accreditation Standards for Suppliers
Furnishing the Technical Component (TC) of Advanced Diagnostic Imaging
Services
Section 1834(e) of the Act, as added by section 135(a) of the
MIPPA, requires that beginning January 1, 2012, Medicare payment may
only be made for the technical component (TC) of advanced diagnostic
imaging services for which payment is made under the fee schedule
established in section 1848(b) of the Act to a supplier who is
accredited by an accreditation organization designated by the
Secretary.
a. Accreditation Requirement
This proposed rule would set forth the criteria for designating
organizations to accredit suppliers furnishing the technical component
(TC) of advanced diagnostic imaging services as specified in section
1834(c) of the Act. In addition, it would set forth the required
procedures to ensure that the criteria used by an accreditation
organization meet minimum standards for each imaging modality. These
statutory requirements would be codified in Sec. 414.68 of the payment
rules for physicians and other practitioners.
The CMS-designated accreditation organization would apply standards
that set qualifications for medical personnel who are not physicians
but who furnish the TC. The standards would describe the qualifications
and responsibilities of medical directors and supervising physicians
including the following: Recognizing whether a particular medical
director or supervising physician received training in advanced imaging
services in a residency program; and has attained, through experience,
the necessary expertise to be a medical director or supervising
physician; has completed any continuing medical education courses
related to advanced imaging services; or has met such other standards
as the Secretary determines appropriate. In addition, the standards
would require suppliers to: (1) Establish and maintain a quality
control program to ensure the technical quality of diagnostic images
produced by the supplier; (2) ensure the equipment used meets
performance specifications; and (3) ensure safety of personnel. While
the statute authorizes the Secretary to establish as criteria for
accreditation any other standards or procedures the Secretary
determines appropriate, we are not proposing to establish other
standards or procedures at this time.
We expect to publish a notice to solicit applications from entities
for the purposes of becoming a designated accreditation organization
the same day that this proposed rule's subsequent final rule is issued,
on or before November 1, 2009. Due to the tight timeframe, we expect to
meet the January 1, 2010 statutory deadline in
[[Page 33601]]
order to designate organizations to accredit suppliers furnishing the
TC of advanced diagnostic imaging services by waiving the 60-day delay
in the imaging accreditation provisions of the final rule.
b. Accreditation for Suppliers
Section 1834(e) of the Act requires the Secretary to designate and
approve accreditation organizations to accredit suppliers of the TC of
advanced diagnostic imaging services. To promote consistency in
accrediting providers and suppliers throughout the Medicare program, we
are proposing to use existing procedures for the application,
selection, and oversight of accreditation organizations detailed at 42
CFR part 488, subparts A and D and apply them to organizations
accrediting suppliers of the TC of advanced diagnostic imaging
services. We are proposing modifications to the existing part 488
requirements to meet the specialized needs of the advanced imaging
industry. These modifications will require an independent accreditation
organization applying for approval as a designated accreditation
organization to include in their application:
A detailed description of how the organization's
accreditation criteria satisfy the statutory standards at section
1834(e)(3) of the Act, specifically:
+ Qualifications of medical personnel who are not physicians and
who furnish the TC of advanced diagnostic imaging services;
+ Qualifications and responsibilities of medical directors and
supervising physicians, such as training in advanced diagnostic imaging
services in a residency program, expertise obtained through experience,
or continuing medical education courses;
+ Procedures to ensure the safety of persons who furnish the TC of
advanced diagnostic imaging services and individuals to whom such
services are furnished;
+ Procedures to ensure the reliability, clarity, and accuracy of
the technical quality of diagnostic images produced by the supplier.
An agreement to conform accreditation requirements to any
changes in Medicare statutory requirements in section 1834(e) of the
Act.
Information to demonstrate the accreditation
organization's knowledge and experience in the advanced diagnostic
imaging arena.
The organization's proposed fees for accreditation for
each modality in which the organization intends to offer accreditation
and any plans for reducing the burden and cost of accreditation to
small and rural suppliers.
Any specific documentation requirements and attestations
requested by CMS as a condition of designation under this part.
If, after review of an accreditation organization's submission of
information, we determine that additional information is necessary to
make a determination for approval or denial of the accreditation
organization's application to be designated as an accreditation
organization for suppliers of the TC of advanced diagnostic imaging
services, the organization will be notified and afforded an opportunity
to provide the additional information. We may visit the organization's
offices to verify representations made by the organization in its
application, including, but not limited to, review of documents and
interviews with the organization's staff. The accreditation
organization will receive a formal notice from CMS stating whether the
request for designation has been approved or denied. If approval was
denied, the notice will include the basis for denial and outline the
reconsideration procedures. We will make every effort to issue a final
decision no more than 30 calendar days from the time the completed
reapplication is received by CMS. An accreditation organization may
withdraw its application for designation under section 1834(e) of the
Act at any time before the formal notice of approval is received. An
accreditation organization that has been notified that its request for
designation has been denied may request reconsideration in accordance
with Sec. 488.201 through Sec. 488.211 in Subpart D. Any
accreditation organization whose request for designation has been
denied may resubmit its application if the organization (1) revises its
accreditation program to address the rationale for denial of its
previous request; (2) provides reasonable assurance that its accredited
companies meet applicable Medicare requirements; and (3) resubmits the
application in its entirety. If an accreditation organization has
requested a reconsideration of our determination that its request for
designation under section 1834(e) of the Act is denied, it may not
submit a new application for the type of modality that is at issue in
the reconsideration until the reconsideration is final.
A panel will evaluate all proposals from accreditation
organizations seeking designation under section 1834(e) of the Act
using existing CMS survey and certification processes as established in
Sec. 488.4.
c. Payment Rules for Suppliers of the TC of Advanced Diagnostic Imaging
Services (Sec. 414.68)
We would specify in Sec. 414.68 the statutory requirement of
section 1834(e) of the Act that all suppliers of the TC of advanced
diagnostic imaging services be accredited by a CMS-designated
accreditation organization by January 1, 2012 for payments made under
the fee schedule established under section 1848(b). In Sec. 414.68(a),
we are proposing to define the following:
``Accredited supplier'' as a supplier that has been
accredited by a CMS-approved accreditation organization.
``Advanced Diagnostic Imaging Services'' as diagnostic
magnetic resonance imaging, computed tomography, nuclear medicine, and
positron emission tomography. We are not proposing at this time to
include other diagnostic imaging services in this definition under
section 1834(e)(1)(B)(ii) of the Act.
``CMS-approved accreditation organization'' as an
independent accreditation organization designated by CMS to perform the
accreditation function established in section 1834(e) of the Act.
d. Ongoing Responsibilities of CMS-Approved Accreditation Organizations
We are proposing to require a CMS-approved accreditation
organization to perform the following activities on an ongoing basis.
Provide to CMS in written form and on an ongoing basis all of the
following:
Copies of all accreditation surveys of specific suppliers
along with any survey-related information that we may require
(including corrective action plans and summaries of CMS requirements
that were not met).
Notice of all accreditation decisions.
Notice of all complaints related to suppliers of the TC of
advanced diagnostic imaging service.
Information about any suppliers of the TC of advanced
diagnostic imaging service for which the accrediting organization has
denied the supplier's accreditation status.
Notice of any proposed changes in its accreditation
standards or requirements or survey process. If the organization
implemented the changes before or without CMS approval, we could
withdraw approval of the accreditation organization.
Permit its surveyors to serve as witnesses if CMS takes an
adverse action based on accreditation findings.
Provide CMS with written notice of any deficiencies and
adverse actions
[[Page 33602]]
implemented by the CMS-approved accreditation organization against an
accredited supplier of the TC of advanced diagnostic imaging within 2
days of identifying such deficiencies, if the deficiencies pose
immediate jeopardy to a beneficiary or to the general public.
Provide written notice of the withdrawal to all accredited
suppliers within 10 days of CMS' notice to withdraw approval of the
accreditation organization.
Provide, on an annual basis, summary data specified by CMS
that are related to the past year's accreditation activities and
trends.
e. Continuing CMS Oversight of CMS-Approved Accreditation Organizations
We are proposing to add Sec. 414.68 to establish specific criteria
and procedures for continuing oversight and for withdrawing approval of
an approved accreditation organization.
(1) Validation Audits
We are proposing to audit the accredited organizations in order to
validate the survey accreditation process of approved accreditation
organizations in the TC of advanced imaging. The audits would be
conducted on a representative sample of suppliers who have been
accredited by a particular accrediting organization or in response to
allegations of supplier noncompliance with the standards. When
conducted on a representative sample basis, we are proposing that the
audit would be comprehensive and address all of the standards or would
focus on a specific standard in issue. When conducted in response to an
allegation, we will specify that the CMS team or our contractor would
audit for any standard that we determined was related to the
allegations. We are proposing to require a supplier selected for a
validation audit to authorize the validation audit to occur and
authorize the CMS team or our contractor to monitor the correction of
any deficiencies found through the validation audit. If a supplier
selected for a validation audit failed to comply with the requirements
at Sec. 414.68, the supplier would no longer meet the Medicare
requirements and, under this proposal, the supplier's accreditation for
the TC of the advanced medical imaging would be revoked.
We are proposing that a CMS team or our contractor would conduct an
audit of an accredited organization, examine the results of the
accreditation organization's own survey procedure onsite, or observe
the accreditation organization's survey, in order to validate the
organization's accreditation process. At the conclusion of the review,
we would identify any accreditation programs for which validation audit
results indicated the following:
A 10 percent rate of disparity between findings by the
accreditation organization and findings by CMS or our contractor on
standards that did not constitute immediate jeopardy to patient health
and safety if not met;
Any disparity between findings by the accreditation
organization and findings by CMS or our contractor on standards that
constituted immediate jeopardy to patient health and safety if not met;
or
There were widespread or systemic problems in the
organization's accreditation process such that the accreditation no
longer provided assurance that suppliers met or exceeded the Medicare
requirements, irrespective of the rate of disparity.
(2) Notice of Intent To Withdraw Approval for Designating Authority
If a validation audit, onsite observation, or our concerns with the
ethical conduct (that impacts the health and safety of the beneficiary)
of an accreditation organization suggest that the accreditation
organization is not meeting the requirements of proposed Sec. 414.68,
we would provide the organization written notice of its intent to
withdraw approval of the accreditation organization's designating
authority.
(3) Withdrawal of Approval for Designating Authority
We are proposing to withdraw approval of an accreditation
organization at any time if we determine that:
Accreditation by the organization no longer provides
sufficient assurance that the suppliers of the TC of advanced imaging
meet the requirements of section 1834(e) of the Act and the failure to
meet those requirements could pose an immediate jeopardy to the health
and safety of Medicare beneficiaries;
Constitutes a significant hazard to the public health; or
The accreditation organization failed to meet its
obligations for application and reapplication procedures.
(4) Reconsideration
We are proposing to implement requirements under part 488 without
substantive changes as the requirements have been utilized for the
health care providers covered under part 488 since 1992. We are
proposing that an accreditation organization dissatisfied with a
determination that its accreditation requirements did not provide or do
not continue to provide reasonable assurance that the suppliers
accredited by the accreditation organization met the applicable
standards would be entitled to a reconsideration. We are also proposing
to reconsider any determination to deny, remove, or not renew the
approval of the designating authority to accreditation organizations if
the accreditation organization filed a written request for
reconsideration through its authorized officials or through its legal
representative.
We are proposing to require the accreditation organization to file
the request within 30 calendar days of the receipt of CMS notice of an
adverse determination or non-renewal. We propose to require the request
for reconsideration to specify the findings or issues with which the
accreditation organization disagreed and the reasons for the
disagreement. A requestor could withdraw its request for
reconsideration at any time before the issuance of a reconsideration
determination. In response to a request for reconsideration, we would
provide the accrediting organization the opportunity for an informal
hearing that would be conducted by a hearing officer appointed by the
CMS Administrator and provide the accrediting organization the
opportunity to present, in writing and in person, evidence or
documentation to refute the determination to deny approval, or to
withdraw or not renew its designating authority.
We would provide written notice of the time and place of the
informal hearing at least 10 business days before the scheduled date.
The informal reconsideration hearing would be open to CMS and the
organization requesting the reconsideration, including authorized
representatives, technical advisors (individuals with knowledge of the
facts of the case or presenting interpretation of the facts), and legal
counsel. The hearing would be conducted by the hearing officer who
would receive testimony and documents related to the proposed action.
Testimony and other evidence could be accepted by the hearing officer.
However, it would be inadmissible under the usual rules of court
procedures. The hearing officer would not have the authority to compel
by subpoena the production of witnesses, papers, or other evidence.
Within 45 calendar days of the close of the hearing, the hearing
officer would
[[Page 33603]]
present the findings and recommendations to the accrediting
organization that requested the reconsideration. The written report of
the hearing officer would include separate numbered findings of fact
and the legal conclusions of the hearing officer. The hearing officer's
decision would be final.
We are interested in obtaining additional information on the role
of radiology assistants (RA) and radiology practitioner assistants
(RPA), including the level of physician supervision that would be
appropriate when RAs and RPAs are involved in the performance of the TC
of advanced medical imaging, whether the role varies by State, and
related information. It would be particularly helpful for the commenter
to identify specific clinical scenarios with associated CPT codes that
would represent such services involving RAs and RPAs.
7. Section 139: Improvements for Medicare Anesthesia Teaching Programs
Section 139 of the MIPPA establishes a ``special payment rule for
teaching anesthesiologists'' and provides a directive to the Secretary
regarding payments for the services of ``teaching certified registered
nurse anesthetists'' (teaching CRNAs). It also specifies the periods
when the teaching anesthesiologist must be present during the procedure
in order to receive payment for the case at 100 percent of the fee
schedule amount (the regular fee schedule rate). These provisions are
effective for services furnished on or after January 1, 2010.
a. Teaching Anesthesiologists: Special Payment Rule
The criteria for the payment of teaching anesthesiology services
and the special rule for the teaching anesthesiologist are similar to
the current criteria for payment of teaching surgeon services and the
payment rule for the teaching surgeon involved in overlapping resident
cases. Thus, there is a similarity in the payment rules for these
physician specialties who work closely together.
(1) Payment for Anesthesia Services Furnished by a Physician
If the physician, usually an anesthesiologist, is involved in
furnishing anesthesia services to a patient, the services can be
furnished under one of three different scenarios. The anesthesiologist
may--
Personally perform the anesthesia services alone;
Be involved in the case as a teaching anesthesiologist
with an anesthesia resident; or
Provide medical direction of the performance of anesthesia
services for two, three or four concurrent cases involving a qualified
individual (who may be a CRNA, an anesthesiologist assistant (AA), an
anesthesia resident, or a student nurse anesthetist under certain
circumstances).
Under the statute and CMS policy, if the anesthesiologist
personally performs the anesthesia service alone or is involved in the
case as a teaching anesthesiologist with an anesthesia resident,
payment for the anesthesiologist's service is made at the regular fee
schedule rate.
If the anesthesiologist furnishes medical direction for two, three
or four concurrent anesthesia procedures, then payment for the
anesthesiologist's service is made, in accordance with section
1848(a)(4)(B) of the Act, at 50 percent of the otherwise applicable fee
schedule amount.
(2) Methodology for Payment of Anesthesia Services
Payment for anesthesia services furnished by a physician is made
under the PFS, under section 1848(b)(2)(B) of the Act. The methodology
for the calculation of the allowable amount is unique to anesthesia
service only. Payment is made on the basis of anesthesia base units and
time units, calculated from the actual anesthesia time of the case,
instead of on the basis of work, PE, and malpractice RVUs. Payment for
anesthesia services is also based on the anesthesia CF instead of the
general PFS CF.
(3) Section 139(a) of the MIPPA
Section 139(a) of the MIPPA adds a new paragraph at section
1848(a)(6) of the Act to establish a ``special payment rule for
teaching anesthesiologists''. This provision allows payment to be made
at the regular fee schedule rate for the teaching anesthesiologist's
involvement in the training of residents in either a single anesthesia
case or in two concurrent anesthesia cases furnished on or after
January 1, 2010. We will refer to anesthesia cases involving the
training of residents as ``resident cases'' below in this section.
(4) Discussion
The Accreditation Council on Graduate Medical Education (ACGME) is
a branch of the AMA, and it accredits allopathic residency programs. In
order for a hospital to receive Medicare graduate medical education
payments for its training programs, the residents must be in an
``approved medical residency program'' Under Sec. 413.75(b), an
approved medical residency program is one approved by one of the
national organizations listed in Sec. 415.152. One of the national
organizations is the ACGME.
ACGME's policies and procedures require that each accredited
residency program comply with the institutional requirements and the
specialty program requirements. For approved anesthesia residency
programs, ACGME requirements for faculty supervision and training of
anesthesia residents specify that faculty members not direct anesthesia
at more than two anesthetizing locations in the clinical setting. (See
the ACGME Web site at http://www.acgme.org.)
Consistent with this requirement, the American Society of
Anesthesiologists (ASA) has advised us that, when providing services in
two concurrent cases, a teaching anesthesiologist might be engaged in
two concurrent anesthesia resident cases, or in two mixed concurrent
cases, one a resident case and the other a CRNA or AA case.
The statute applies the special payment rule for teaching
anesthesiologists to the single resident case or two concurrent cases
involving anesthesia residents as long as the teaching anesthesiologist
meets the requirements in sections 1848(6)(A) and 1848(6)(B) of the
Act. However, the statute does not directly address a single resident
case that is concurrent to another case involving a CRNA, AA, or other
qualified individual who can be medically directed. The issue is
whether the medical direction payment rules apply to each of these
cases or whether an alternative payment policy may apply.
One option in implementing this provision would be to strictly
limit the special payment rule for teaching anesthesiologists to the
single resident case (which is not concurrent to any other case) or the
two concurrent resident cases (which are not concurrent to any other
cases). For the mixed concurrent case, we could continue to apply our
current medical direction payment policy to both the resident case and
the other concurrent case. This would represent a continuation of our
current medical direction payment policy, and would be predicated on
the assumption that this is consistent with Congressional intent since
the medical direction payment provisions at section 1848(a)(4) of the
Act were left largely unchanged by section 139(a) of the MIPPA.
The other option would be to apply the special payment rule for
teaching
[[Page 33604]]
anesthesiologists to the resident case when it is concurrent to a
medically directed case, and to apply the medical direction payment
policy to the medically directed case. While this represents a broader
interpretation, it still limits the applicability of the special
payment rule for teaching anesthesiologists to resident cases
consistent with the terms of section 139 of the MIPPA.
The special payment rule under section 1848(a)(6) of the Act
clearly applies for two concurrent anesthesia resident cases. The ACGME
requirements also allow the supervision of two concurrent cases, but
are not specific regarding whether the requirements relate only to two
resident cases, or also to mixed concurrent cases. However, both the
statute and ACGME requirements seem amenable to a policy that would
allow the special teaching payment rule to apply in mixed concurrent
cases, that is, the single resident case that is concurrent to another
case not involving a resident. Additionally, we are concerned that if
we continued to apply the medical direction payment policy to mixed
concurrent cases, then financial differences in payment policy might
cause teaching anesthesiologists to make changes in the scheduling of
mixed resident and CRNA cases. This might limit the utilization of
CRNAs in certain scenarios.
Accordingly, we are proposing to delete the current regulatory
language at Sec. 414.46(e) (which is no longer relevant) and add new
language to specify that the special payment rule for teaching
anesthesiologists applies to resident cases under the following
scenarios:
The teaching anesthesiologist is involved in one resident
case (which is not concurrent to any other anesthesia case);
The teaching anesthesiologist is involved in each of two
concurrent resident cases (which are not concurrent to any other
anesthesia case); or
The teaching anesthesiologist is involved in one resident
case that is concurrent to another case paid under medical direction
payment rules.
Other than the application of the special payment rule for teaching
anesthesiologists in the mixed concurrent case described above, we are
not proposing any other revisions to our medical direction payment
policies.
b. Teaching Anesthesiologists: Criteria for Payment
(1) Criteria for Payment of Teaching Anesthesiologists
Currently, the teaching anesthesiologist can be paid at the regular
fee schedule rate for his or her involvement in a single resident case.
As specified in Sec. 415.178, the teaching anesthesiologist must be
present with the anesthesia resident during all critical portions of
the anesthesia procedure and be immediately available to furnish
services during the entire procedure. Our manual instructions permit
different physicians in the same anesthesia group to provide parts of
the anesthesia service, and for the group to bill for the single
anesthesia service. We refer to this practice as an ``anesthesia
handoff.'' (See Medicare Claims Processing Manual 100-04, Chapter 12,
Section 50 C.) Of course, the medical record must document those
individual physicians who furnished the services.
This manual instruction is not limited in scope to nonteaching
hospitals. Thus, it is possible that teaching anesthesiologists have
interpreted it to permit handoffs during resident cases.
Our manual instructions state that for two overlapping surgeries,
the teaching surgeon must be present during the critical or key
portions of both operations (See Medicare Claims Processing Manual 100-
04, Chapter 12, Section 100.1.2). It is our understanding that teaching
surgeons do not hand off to another teaching surgeon during a key or
critical portion of the surgical resident case.
(2) Section 139(a)(2) of the MIPPA
This section adds a new paragraph at section 1848(a)(6) of the Act
which requires, in order for the special payment rule for teaching
anesthesiologists to apply, that the teaching anesthesiologist is
present during all critical or key portions of the anesthesia service
or procedure and the teaching anesthesiologist (or another
anesthesiologist with whom the teaching anesthesiologist has entered
into an arrangement) is immediately available to furnish anesthesia
services during the entire procedure. The new MIPPA provision regarding
payment for services of a teaching anesthesiologist for two concurrent
resident cases is similar to our current policy regarding payment for
services of a teaching surgeon for two overlapping surgical resident
cases.
(3) Discussion
The ASA has informed us that teaching anesthesiologists who work in
the same anesthesia group sometimes provide different parts of the key
or critical portions of a single anesthesia procedure. This type of a
handoff situation might occur within an anesthesia group practice when
there is an anesthesia procedure of long duration, but would not be
limited to that circumstance.
From a quality standpoint, we do not believe multiple handoffs
among teaching anesthesiologists during a case that involves the
training of an anesthesia resident would be optimal. We do not have
data on the extent to which anesthesia handoffs occur during resident
or other cases, or whether quality of anesthesia care is affected. We
note that section 1848(a)(6)(A) of the Act refers only to ``the''
teaching anesthesiologist, and requires that the teaching
anesthesiologist be present during all critical or key portions of the
service. However, section 1848(a)(6)(B) of the Act seems to contemplate
some level of handoffs between teaching anesthesiologists, at least
between those who have entered into an arrangement for such handoffs.
One option would be to permit different anesthesiologists in the
same anesthesia group practice to be considered ``the teaching
physician'' for purposes of being present at the key or critical
portions of the anesthesia case. (These physicians must have reassigned
their benefits to the group practice in order for the group to bill.)
Although this option would be less disruptive to the current anesthesia
practice arrangements (as reported by the ASA), it would establish
rules for teaching anesthesiologists that are different from those for
teaching surgeons.
Another option would be to require that, in order to meet the
requirement of section 1848(a)(6)(A) of the Act, only one individual
teaching anesthesiologist must be present during all of the key or
critical portions of the procedure. However, another teaching
anesthesiologist with whom ``the teaching anesthesiologist'' under
subparagraph (A) has an arrangement could be immediately available to
furnish services during a non-critical or non-key portion of the
procedure in order to meet the requirement under subparagraph (B). We
believe this is the most logical reading of the statute and would be
consistent with the way the teaching surgeon payment policy is applied
for overlapping surgical cases.
In addition to explaining available options for implementing this
provision, we are also soliciting specific comments on how the
continuity of care and the quality of anesthesia care are preserved
during handoffs. We are interested in whether there is an accepted
maximum number of handoffs and whether there are any industry studies
that have examined this issue. We would like to hear from anesthesia
practices that do not use handoffs and what procedures they have
implemented to achieve this
[[Page 33605]]
result. Finally, we would like to know what factors or variables are
contributing to anesthesia handoffs and what short term adjustments can
be made to affect these factors.
Although we are interested in receiving comments on these topics,
we are proposing to more narrowly interpret the law and require that
only one individual teaching anesthesiologist be present during all of
the key or critical portions of the anesthesia procedure. We are also
proposing that another teaching anesthesiologist with whom the teaching
anesthesiologist has an arrangement could be immediately available to
furnish services during a non-critical or non-key portion of the
procedure.
c. Teaching CRNAs
(1) Payment for Anesthesia Services Furnished by a CRNA
Currently, a CRNA who provides anesthesia services while under the
medical direction of an anesthesiologist is paid at 50 percent of the
regular fee schedule rate as specified in section 1833(l)(4)(B)(iii) of
the Act. A CRNA who provides anesthesia services without the medical
direction of a physician is paid the regular fee schedule rate as
specified in section 1833(l)(4)(A) of the Act.
(2) Payment for Anesthesia Services Furnished by a Teaching CRNA With a
Student Nurse Anesthetist
The legislation that created the CRNA fee schedule payment system
(that is, section 9320 of the Omnibus Budget Reconciliation Act of 1986
(Pub. L. 99-509)) did not address payment for services furnished by
teaching CRNAs involved in the training of student nurse anesthetists.
In the preamble to the CRNA fee schedule final rule published in
the July 31, 1992 Federal Register (57 FR 33888), we stated that we
would pay the teaching CRNA who is not medically directed by a
physician at the regular fee schedule rate for his or her involvement
in a single case with a student nurse anesthetist as long as he or she
was present with the student throughout the anesthesia case. No payment
would be made if the teaching CRNA divided his or her time between two
concurrent cases involving student nurse anesthetists.
In August 2002, based on the recommendations of the American
Association of Nurse Anesthetists (AANA), we modified our policy to
allow the teaching CRNA not medically directed by a physician to be
paid a portion of the regular fee schedule rate for each of two
concurrent cases involving student nurse anesthetists. If the teaching
CRNA is present with the student nurse anesthetist during the pre- and
post-anesthesia care for each of the cases involving student nurse
anesthetists, the teaching CRNA can bill the full base units (comprised
of pre- and post-anesthesia services not included in the anesthesia
time units) for each case and the actual amount of anesthesia time per
case. The resulting payment for each of these anesthesia cases is
greater than 50 percent, but less than 100 percent, of the regular fee
schedule amount because the full base units plus the actual anesthesia
time units spent by the teaching CRNA in each of the two cases yields a
payment that is greater than 50 percent of the regular fee schedule
amount.
(3) Comparison of Payment Policies for Teaching CRNAs and Teaching
Anesthesiologists
For several years, the American Society of Anesthesiologists (ASA)
requested that we revise our payment regulations to allow the teaching
anesthesiologist to be paid the regular fee schedule amount for each of
two concurrent resident cases. In the CY 2004 PFS final rule with
comment period (68 FR 63224), we finalized a policy to permit the
teaching anesthesiologist to be paid similarly to a teaching CRNA for
each of two concurrent resident cases. This policy took effect for
services furnished on or after January 1, 2004.
Thus, the payment policy is the same for a teaching CRNA for each
of two concurrent student nurse anesthetist cases, and for a teaching
anesthesiologist for each of two concurrent resident cases. The policy
is that the anesthesia provider is paid the full base units plus time
units, based on the actual anesthesia time, relating to each of two
concurrent cases.
(4) Payment Policy for an Anesthesiologist, or an Anesthesiologist and
CRNA Jointly, With a Student Nurse Anesthetist
Currently, there are circumstances where an anesthesiologist may be
involved in the training of student nurse anesthetists in two
concurrent anesthesia cases. These anesthesia cases are not paid under
the teaching anesthesiologist payment policy, but are paid under the
usual medical direction payment policy. Payment can be made for the
physician's medical direction (that is, 50 percent of the regular fee
schedule amount) for each of two concurrent cases.
If an anesthesiologist is medically directing two concurrent cases
involving student nurse anesthetists and a CRNA is also jointly
involved with the two student nurse anesthetist cases, then the
physician service, in each case, can be paid under the medical
direction rules at 50 percent of the regular fee schedule. Payment for
the CRNA services would also be made at the medically directed rate
(that is, 50 percent of the regular fee schedule) for CRNA services,
but the time units used to compute the anesthesia fee would be based on
the actual time the CRNA is involved in each case.
(5) Section 139(b) of the MIPPA
Section 139(b) of the MIPPA instructs the Secretary to make
appropriate adjustments to Medicare teaching CRNA payment policy so
that it--
Is consistent with the adjustments made by the special
payment rule for teaching anesthesiologists under section 139(a) of the
MIPPA; and
Maintains the existing payment differences between
teaching anesthesiologists and teaching CRNAs.
We are proposing to implement the first directive (under section
139(b)(1) of the MIPPA) by establishing a new payment policy for
teaching CRNAs that is similar to the special payment rule for teaching
anesthesiologists, and to limit applicability of the rule to teaching
CRNAs who are not medically directed. We are proposing to add a new
regulation at Sec. 414.61 to explain the conditions under which the
special payment rule will apply and the method for calculating the
amount of payment for anesthesia services furnished on or after January
1, 2010, by teaching CRNAs involved in the training of student nurse
anesthetists. Under this proposal, we would pay the teaching CRNA at
the regular fee schedule rate for each of two concurrent student nurse
anesthetist cases. Our medical direction payment policy would continue
to apply if both an anesthesiologist and a CRNA are involved in a
student nurse anesthetist case that is concurrent to other anesthesia
cases.
We believe the second directive in section 139(b)(2) of the MIPPA
will be satisfied as a result of these proposals. Section 139(b)(1) of
the MIPPA instructs CMS to make appropriate adjustments to implement a
payment policy for teaching CRNAs that is consistent with the special
payment rule for teaching anesthesiologists. Section 139(b)(2) of the
MIPPA instructs CMS to maintain the existing payment differences
between teaching anesthesiologists and teaching CRNAs. There currently
are no substantive differences in payment
[[Page 33606]]
between teaching anesthesiologists and teaching CRNAs, and there would
continue to be no such differences under our proposed policies.
(6) Payment for Teaching CRNAs Involved in Anesthesia Cases With
Student Nurse Anesthetists
Under current policy, when a CRNA is involved in a single student
nurse anesthetist case, the teaching CRNA must be present with the
student throughout the case in order to be paid at the regular fee
schedule rate. We are not proposing any change to this policy.
When the teaching CRNA is involved in two concurrent student nurse
anesthetist cases, payment is based on the amount of anesthesia time
the teaching CRNA spends with the student in each case. For example, if
the teaching CRNA spends 40 percent of his or her time in concurrent
case 1 and 60 percent of his or her time in concurrent case
2, and the total anesthesia time in both cases is 3 hours (or
180 minutes), then we would currently pay as follows:
Case 1: (Base units + (0.4 x 180/15)) x
Anesthesia CF
Case 2: (Base units + (0.6 x 180/15)) x
Anesthesia CF
The current payment policy has been predicated on paying the
teaching CRNA for his or her actual time spent in the student nurse
anesthetist case. We are now proposing to pay the teaching CRNA at the
regular fee schedule rate for his or her involvement in two concurrent
cases. If our goal is to minimize the effect of this change on teaching
CRNAs' practice arrangements and time devoted to cases, then we would
propose that the teaching CRNA continue to devote 100 percent of his or
her time to the two concurrent cases. The teaching CRNA would decide
how to allocate his or her time to optimize patient care in the two
cases based on the complexity of the anesthesia case, the experience
and skills of the student nurse anesthetist, the patient's health
status, and other factors.
An alternative to this policy would be to apply the same criteria
for teaching CRNAs as we use in Sec. 415.178 with respect to teaching
anesthesiologists. These criteria require the teaching anesthesiologist
to be present during all critical or key portions of the anesthesia
service. However, we believe these criteria are relevant and
appropriate only for teaching anesthesiologists due to significant
differences in experience, education and other qualifications between
anesthesia residents and student nurse anesthetists. The anesthesia
resident has completed medical school and is typically a licensed
physician. In contrast, the student nurse anesthetist is an RN who
usually has some clinical experience in ICU or critical care nursing
prior to starting the CRNA training program. Thus, we believe the
resident is more qualified through medical training and education than
the student nurse anesthetist to provide elements of the anesthesia
service without the immediate presence of the teaching
anesthesiologist. Therefore, we propose to retain our current policy.
We note that the Congress did not amend the statutory provisions
relating to medical direction at section 1848(a)(4) of the Act. We do
not believe the directives at section 139(b) of the MIPPA extend to
other arrangements in which anesthesiologists alone or both
anesthesiologists and CRNAs jointly supervise student nurse
anesthetists during concurrent anesthesia cases. Therefore, we are not
proposing any changes to our current payment policies for anesthesia
services furnished under other circumstances. We are proposing that
when an anesthesia provider (physician or CRNA) furnishes anesthesia
services in concurrent cases under other circumstances, the current
policies regarding medical direction will continue to apply.
8. Section 144(a): Payment and Coverage Improvements for Patients With
Chronic Obstructive Pulmonary Disease and Other Conditions--Cardiac
Rehabilitation Services
Section 144(a) of the MIPPA amended Title XVIII of the Act, in
pertinent part, to provide for coverage of cardiac rehabilitation (CR)
and intensive cardiac rehabilitation (ICR) under Medicare Part B. The
statute specifies certain conditions for these services, with coverage
to begin on January 1, 2010. The addition of the new CR and ICR
programs is designed to improve the health care of Medicare
beneficiaries with cardiovascular disease. This proposed rule
implements these MIPPA provisions in order to ensure services enhance
the patient's clinical outcomes.
a. Background
Intensive cardiac rehabilitation (ICR) is a relatively new practice
that is also commonly referred to as a ``lifestyle modification''
program. These programs typically involve the same elements as general
CR programs, but are furnished in highly structured environments in
which sessions of the various components may be combined for longer
periods of CR and also may be more rigorous.
b. Cardiac Rehabilitation Coverage Under Medicare
One mechanism we use to establish coverage for certain items and
services is the national coverage determination (NCD) process. An NCD
is a determination by the Secretary with respect to whether or not a
particular item or service is covered nationally under Title XVIII.
Since 1982, Medicare has covered, under an NCD, cardiac
rehabilitation for patients who experience stable angina, have had
coronary artery bypass grafts, or have had an acute myocardial
infarction within the past 12 months. The NCD is located in the
Medicare NCD Manual (Pub. 100-03), section 20.10. Effective March 22,
2006, we modified the NCD language to cover comprehensive cardiac
rehabilitation programs for patients who experience one of the
following:
A documented diagnosis of acute myocardial infarction
within the preceding 12 months.
A coronary bypass surgery.
Stable angina pectoris.
A heart valve repair/replacement.
A percutaneous transluminal coronary angioplasty (PTCA) or
coronary stenting.
A heart or heart-lung transplant.
Comprehensive programs must include a medical evaluation, a program
to modify cardiac risk factors, prescribed exercise, education, and
counseling and may last for up to 36 sessions over 18 weeks or no more
than 72 sessions over 36 weeks if determined appropriate by the local
Medicare contractors. Facilities furnishing cardiac rehabilitation must
have immediately available necessary cardio-pulmonary, emergency,
diagnostic, and therapeutic life-saving equipment and be staffed with
personnel necessary to conduct the program safely and effectively who
are trained in advanced life support techniques and exercise therapy
for coronary disease. The program must also be under the direct
supervision of a physician. Until section 144(a) of the MIPPA is
effective, ICR programs are covered under this NCD and are subject to
the same coverage requirements.
We are proposing to implement section 144(a) of the MIPPA and
refine coverage for CR and ICR through this rulemaking process. When
the rulemaking is completed, we will take the necessary steps to
withdraw and/or modify the NCD.
c. Statutory Authority
Section 144(a) of the MIPPA amended the Medicare Part B program by
adding new sections 1861(s)(2)(CC) and
[[Page 33607]]
1861(s)(2)(DD) of the Act to include items and services furnished under
a ``cardiac rehabilitation program'' and an ``intensive cardiac
rehabilitation program,'' respectively. A cardiac rehabilitation
program is defined in new section 1861(eee)(1) of the Act and an
intensive cardiac rehabilitation program is defined in new section
1861(eee)(4)(A) of the Act.
A cardiac rehabilitation program is a physician-supervised program
that furnishes the following: Physician-prescribed exercise; cardiac
risk factor modification, including education, counseling, and
behavioral intervention; psychosocial assessment; outcomes assessment;
and other items or services as determined by the Secretary under
certain conditions. These items and services must be furnished in a
physician's office, in a hospital on an outpatient basis, or in other
settings as determined appropriate by the Secretary. A physician must
be immediately available and accessible for medical consultation and
emergencies at all times items and services are being furnished in a CR
program except when provided in a hospital setting where such
availability is presumed. The items and services furnished by a CR
program are individualized and set forth in written treatment plans
that describe the patient's individual diagnosis; the type, amount,
frequency, and duration of items and services furnished under the plan;
and the goals set for the individual under the plan. These written
plans must be established, reviewed, and signed by a physician every 30
days.
We are proposing that ICR programs must provide the same items and
services under the same conditions as CR programs but must demonstrate,
as shown in peer-reviewed published research, that they have
accomplished one or more of the following: Positively affected the
progression of coronary heart disease, or reduced the need for coronary
bypass surgery, or reduced the need for percutaneous coronary
interventions (PCIs). The peer-reviewed published research must also
show that the ICR program has resulted in a statistically significant
reduction in 5 or more measures from their levels before ICR services
to their levels after receipt of such services. These measures include
low density lipoprotein; triglycerides; body mass index; systolic blood
pressure; diastolic blood pressure; or the need for cholesterol, blood
pressure, and diabetes medications.
Beneficiaries eligible for ICR must have experienced the following:
An acute myocardial infarction within the preceding 12 months; a
coronary bypass surgery; current stable angina pectoris; a heart valve
repair or replacement; a PTCA or coronary stenting; or a heart or
heart-lung transplant. Section 1861(eee)(4)(C) of the Act, as added by
section 144(a)(1)(B) of the MIPPA, states that an ICR program may be
provided in a series of 72, 1-hour sessions (as defined in section
1848(b)(5) of the Act), up to 6 sessions per day, over a period of up
to 18 weeks.
The statute directs the Secretary to establish standards for the
physician(s) supervising the ICR and/or CR programs to ensure that the
physician has expertise in the management of individuals with cardiac
pathophysiology and is licensed by the State in which the CR program
(or ICR program) is offered. These standards ensure that the physician
is responsible for the program and, in consultation with appropriate
staff, is involved substantially in directing the progress of
individuals in the program.
d. Proposals for Implementation
We are proposing to create new Sec. 410.49, ``Cardiac
Rehabilitation Program and Intensive Cardiac Rehabilitation Program:
Conditions of Coverage.''
(1) Definitions
In this section, we are proposing several definitions for the terms
used with respect to the programs and services required by section
144(a) of the MIPPA. These terms include the following:
Cardiac rehabilitation program.
Individualized treatment plan.
Intensive cardiac rehabilitation.
Physician.
Physician-prescribed exercise
Psychosocial assessment.
Outcomes assessment.
(2) Covered Beneficiaries
In Sec. 410.49, we are proposing to establish coverage for CR and
ICR programs for beneficiaries who have experienced any of the
following: An acute myocardial infarction within the preceding 12
months; a coronary bypass surgery; current stable angina pectoris; a
heart valve repair or replacement; a PTCA or coronary stenting; or a
heart or heart-lung transplant. We are proposing to maintain and refine
coverage of general CR programs for beneficiaries with these six
conditions as originally established in Pub. 100-03, section 20.10 as
this coverage was determined to be reasonable and necessary under
section 1862(a)(1)(A) of the Act due to a high level of supporting
clinical evidence. We are also proposing through this rulemaking to use
the NCD process in the future to identify additional medical
indications for patients who could obtain CR under Medicare Part B.
While CR programs include certain mandatory services, the written plans
are highly individualized, and we propose to allow some flexibility in
the type, amount, frequency, and duration of services provided in each
session. However, as supported by medical literature and statements of
the American Heart Association (AHA) and the American Association of
Cardiovascular and Pulmonary Rehabilitation (AACVPR),\4\ aerobic
exercise training using the muscles of ambulation is a mandatory
component of any CR or ICR program. We recommend both low- and high-
intensity exercise to produce optimal benefits, and suggest a
combination of endurance, strengthening and stretching exercises.
Patients in general CR programs must participate in a minimum of 2, 1-
hour CR sessions a week, and a maximum of 2, 1-hour sessions a day.
Patients in ICR programs may participate in up to 6, 1-hour sessions
per day not to exceed 72, 1-hour sessions over an 18-week period. By a
1-hour session, we mean that each session must last a minimum of 60
minutes. Each day CR or ICR items and services are provided to a
patient, aerobic exercises along with other exercises must be included
(that is, a patient must exercise aerobically every day he or she
attends a CR or ICR session). Exercise may include the use of
treadmills, bicycles, light weights or other equipment, and should be
intended to improve cardiovascular function, strength, endurance, and
flexibility.
---------------------------------------------------------------------------
\4\ Balady G, Williams M, Ades P, et al. Core Components of
Cardiac Rehabilitation/Secondary Prevention Programs: 2007 Update. A
Scientific Statement From the American Heart Association Exercise,
Cardiac Rehabilitation, and Prevention Committee, the Council on
Clinical Cardiology; the Councils on Cardiovascular Nursing,
Epidemiology and Prevention, and Nutrition, Physical Activity, and
Metabolism; and the American Association of Cardiovascular and
Pulmonary Rehabilitation. Journal of Cardiopulmonary Rehabilitation
and Prevention 2007;27:121-129.
---------------------------------------------------------------------------
Section 144(a) of the MIPPA requires CR and ICR programs to furnish
items and services including ``cardiac risk factor modification.'' This
includes education, counseling, and behavioral intervention to the
extent these services are closely related to the individual's care and
treatment and tailored to patients' individual needs. We are proposing
that patients must be provided with the information and tools to
improve their overall cardiovascular health. Items and services
furnished as part of the risk factor modification component should be
highly
[[Page 33608]]
individualized as multiple risk factors contribute to poor
cardiovascular health. For example, these items and services may
include smoking cessation counseling or referral, nutritional education
and meal planning, stress management, prescription drug education and
management information, disease history education in order to foster a
better understanding of disease origins and disease symptomatology, and
any other education, counseling and behavioral intervention deemed
appropriate in each patient's individualized treatment plan.
The MIPPA provisions require a psychosocial assessment as part of
the CR and ICR programs defined above. We are proposing that the
initial assessment by program staff evaluate aspects of the
individual's family and home situation that may affect their treatment,
and consider at the outset if referrals to support groups, community
and/or home care services are necessary. Prior to each 30-day review of
the individualized treatment plan, the supervising physician or program
staff will conduct an evaluation of the individual's response to, and
rate of progress under, the treatment plan and make recommendations to
the physician as necessary. While the individualized treatment plan
discussed below will assist in ensuring that patients begin CR with a
program tailored to their needs, a periodic re-evaluation is necessary
to ensure that their psychosocial needs are in fact being met.
The MIPPA provisions also require that CR and ICR programs include
outcomes assessment. Professional groups, such as the AHA and AACVPR,
recognize a number of relevant patient outcomes that may be expected to
accrue from the various components of cardiac rehabilitation.\5\ We
propose to define outcomes assessment as an evaluation of the patient's
progress in the program using assessments from the commencement and
conclusion of CR and ICR programs that are based upon patient centered
outcomes. Patient centered outcomes must be measured at the beginning
of the CR program, prior to each 30-day review of the individualized
treatment plan, and at the end of the CR program. All assessments are
considered part of the CR program and, as such, are conducted in the
appropriate settings and not billed separately. These measures should
include resting and exercising heart rate, resting and exercising
systolic and diastolic blood pressure, weight, BMI, amount and dosage
of medications required, self-reported quality of life, and behavioral
measures (for example, smoking cessation, increased activity levels,
change in exercise levels during CR). As CR programs must be highly
individualized, alternate or additional measures may be appropriate.
Patients' individualized treatment plans should be altered accordingly
with changes and/or progress in each of the outcome measurements.
Programs may also develop performance standards which measure the
overall quality of the program, by assessing the group as a whole.
---------------------------------------------------------------------------
\5\ Balady G, Williams M, Ades P, et al. Core Components of
Cardiac Rehabilitation/Secondary Prevention Programs: 2007 Update. A
Scientific Statement From the American Heart Association Exercise,
Cardiac Rehabilitation, and Prevention Committee, the Council on
Clinical Cardiology; the Councils on Cardiovascular Nursing,
Epidemiology and Prevention, and Nutrition, Physical Activity, and
Metabolism; and the American Association of Cardiovascular and
Pulmonary Rehabilitation. Journal of Cardiopulmonary Rehabilitation
and Prevention 2007;27:121-129.
---------------------------------------------------------------------------
The MIPPA provisions require that CR services be provided under
written individualized treatment plans. As CR programs are highly
individualized, we propose that the physician define and set the
parameters, including the individual's diagnosis, the types of services
appropriate, and the treatment goals. The MIPPA provisions require the
physician to establish the written individualized treatment plan and
conduct subsequent reviews every 30 days. This plan may initially be
developed by the referring physician or the CR physician. If the plan
is developed by the referring physician who is not the CR physician,
the CR physician must also review and sign the plan prior to initiation
of CR. Direct physician contact is not always required to meet the 30-
day review standards, but might be necessary depending upon specific
patient factors. Regardless, CR staff must provide both outcome and
psychosocial assessments to the supervising physician prior to the 30-
day deadline and the physician must evaluate the information provided
by the CR staff. The CR staff may make recommendations for
modifications to the program, but the physician will still modify the
plan as needed, and review and sign the plan. The MIPPA provisions
require written specificity relating to the type, amount, frequency,
and duration of the items and services furnished under the individual's
plan. As CR patients have had or may develop disabling cardiovascular
disease, they require individual attention and assessments that address
their individualized needs and meet realistic individualized goals
through a specifically designed treatment plan. The individualized
treatment plan should specify the combination of services necessary to
address the patient's needs, as identified through the initial
assessment and based upon changes in the patient's condition. It must
include measurable and expected outcomes and estimated timetables to
achieve these outcomes. The outcomes specified in the individualized
treatment plan should be consistent with current evidence-based
professionally-accepted clinical practice standards such as those
identified by the AHA and AACVPR.
The MIPPA provisions also authorize the Secretary to include other
mandatory items and services within the scope of the CR program under
certain conditions. We are not proposing to require any other items and
services at the present time. If the Secretary determines that the
addition of any other items and services is appropriate, additions will
be made and implemented through future rulemaking.
Section 144(a) of the MIPPA provides for coverage of CR and ICR
services in various settings which include a physician's office, a
hospital on an outpatient basis or other settings determined
appropriate by the Secretary. We are not proposing to cover CR or ICR
in other settings at this time. If the Secretary determines that the
addition of settings is appropriate, additions will be made through
rulemaking. All settings should have all equipment and staff necessary,
consistent with cardiac rehabilitation professional society
recommendations, to provide statutorily-mandated items and services.
Section 144 of the MIPPA includes requirements for immediate and
ongoing physician availability and accessibility for both medical
consultations and medical emergencies at all times items and services
are being furnished under the program. Professional groups such as the
AHA and AACVPR recognize the need to provide appropriate patient
supervision and, where appropriate, monitoring. We are proposing that
such availability be met through existing definitions for direct
physician supervision in physician offices and hospital outpatient
departments at Sec. 410.26(a)(2) (defined through cross reference to
Sec. 410.32(b)(3)(ii)) and Sec. 410.27(f), respectively. Direct
supervision, as defined in the regulations, is consistent with the
language of the MIPPA because the physician must be present and
immediately available where the services are being furnished. The
physician must also be able to furnish
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assistance and direction throughout the performance of the services,
which would include medical consultations and medical emergencies.
For CR and ICR services provided in physicians' offices and other
Part B settings paid under the PFS, the physician must be present in
the office suite and immediately available to furnish assistance and
direction throughout the performance of the service or procedure in
accordance with the Sec. 410.26(b)(5). This does not mean that the
physician must be in the room when the service or procedure is
performed. For CR and ICR services provided to hospital outpatients,
direct physician supervision is the standard set forth in the April 7,
2000 OPPS final rule with comment period (68 FR 18524 through 18526)
for supervision of hospital outpatient therapeutic services covered and
paid by Medicare in hospitals and provider-based departments of
hospitals. We currently define and specify the requirement for direct
supervision for services furnished in provider-based departments of
hospitals at Sec. 410.27(f). For this purpose, the physician must be
on the premises of the location (meaning the provider-based department)
and immediately available to furnish assistance and direction
throughout the performance of the procedure. This does not mean that
the physician must be present in the room when the procedure is
furnished. If we were to propose future changes to the physician office
or hospital outpatient policies for direct physician supervision, we
would provide our assessment of the implications of those proposals for
the supervision of cardiac rehabilitation services at that time.
The MIPPA provisions state that in the case of items and services
furnished under such a program in a hospital, physician availability
shall be presumed. As we have stated in the CY 2009 OPPS/ASC final rule
with comment period (73 FR 68702 through 68704), the longstanding
presumption relating to direct physician supervision for hospital
outpatient services means that direct physician supervision is the
standard for supervision of hospital outpatient therapeutic services
covered and paid by Medicare in hospitals and provider-based
departments of hospitals, and we expect that hospitals are providing
services in accordance with this standard.
New section 1861(eee)(4) of the Act requires ICR programs, to be
qualified for Medicare coverage, to meet several standards. To become
qualified, an ICR program must demonstrate through peer-reviewed,
published research that it has accomplished one or more of the
following: (1) Positively affected the progression of coronary heart
disease; (2) reduced the need for coronary bypass surgery; or (3)
reduced the need for percutaneous coronary interventions (PCIs). A
qualified ICR program must also demonstrate through peer-reviewed
published research that the ICR program accomplished a statistically
significant reduction for patients in 5 or more specific measures from
the individual's levels before ICR services to their levels after
receipt of such services. These measures include: (1) Low density
lipoproteins; (2) triglycerides; (3) body mass index; (4) systolic
blood pressure; (5) diastolic blood pressure; and (6) the need for
cholesterol, blood pressure, and diabetes medications. To ensure that
ICR programs in fact meet these standards, we are proposing that
programs intending to operate as ICR programs apply to CMS to receive
designation as qualified ICR programs. Only designated programs would
then be eligible for Medicare coverage and would be required to undergo
regular re-evaluation to maintain such status. We are requesting public
comments on establishing an annual re-evaluation process.
We are proposing that programs may apply to CMS to be designated
qualified programs to provide ICR. To meet this designation, programs
must submit to CMS detailed literature describing the program and the
precise manner in which the program meets MIPPA provisions. Each
program must also submit peer-reviewed, published research specific to
the actual program applying for approval. The research must clearly
demonstrate that the program under examination accomplishes at least
the minimum outcomes as defined above. We are proposing, based on our
general rulemaking authority that each ICR program must submit a
detailed description of the items and services available to ICR
patients and the capabilities of the facility in which the program
takes place as well as the responsibilities of program staff. All
materials shall be submitted to: Director, Coverage and Analysis Group,
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail
Stop C1-09-06, Baltimore, Maryland 21244.
Following CMS review, ICR programs will either be notified of any
missing information or inadequacies in their submissions (so they may
resubmit in the future) or be notified of CMS designation as an ICR
program. Designated programs will be identified in a list of ICR
programs posted on the CMS Web site and in the Federal Register. We are
proposing that all designated programs must demonstrate continued
compliance with MIPPA standards every year in order to maintain
qualified status.
We are proposing that for an ICR program to maintain its
designation by CMS as a qualified ICR program, the program must submit
specific outcomes assessment information. Programs shall submit
information for all patients who initiated and completed the full ICR
program during the initial year-long CMS designation. For each patient,
programs must identify the following: (1) The medical condition
qualifying the patient for eligibility to participate in ICR; (2) the
patient's improvement in coronary heart disease, reduced need for
coronary bypass surgery, and/or reduced need for PCIs; and (3) the
levels of the 5 or more measures identified above at the beginning and
end of the program. Programs must also submit average beginning and
ending levels of at least those 5 measures for the program as a whole.
If any changes are made to the ICR program during the initial year-long
CMS designation, such changes must be documented and submitted with the
outcomes assessment information. Programs will have 30 days to submit
this information to CMS following the end of the initial approval
period. In the month following receipt, we will review the submitted
information and determine whether the program continues to meet the
payment standards. We believe that re-evaluations of designated
programs will assist CMS in ensuring that programs continue to
demonstrate the outcome measures identified for initial designation. We
are requesting public comments on annual program re-evaluations
requirements, the required information for re-evaluation proposed above
and if an administrative appeals process should be established for ICR
programs that no longer meet outcomes standards. We are also asking for
public comments on the time period for re-evaluations of ICR programs.
Section 144(a)(1)(B) of the MIPPA requires CR and ICR programs to
be physician-supervised. In addition, section 144(a)(5) of the MIPPA
requires the Secretary to establish standards to ensure that the
physician, who has the appropriate expertise in the management of
individuals with cardiac pathophysiology and is licensed to practice
medicine in the State in which the CR or ICR program is offered, is
responsible for the CR or ICR program. We propose to identify this
physician who oversees or supervises the CR and ICR program in its
entirety as the Medical Director. As required by
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144(a)(5), we are proposing that the Medical Director must have
training and proficiency in cardiovascular disease management and
exercise training of heart disease patients. We also propose that the
Medical Director, in consultation with other staff, must be involved
substantially in directing the progress of individuals in the program.
We are expressly seeking public comments on the precise level of
expertise that is necessary for the Medical Director.
As discussed above, section 144(a)(2)(B) of MIPAA requires that a
physician must be immediately available and accessible for medical
consultations and medical emergencies at all times items and services
are being furnished under the program. For purposes of this proposed
rule we are identifying this physician as the supervising physician
(that is, the physician that must be immediately available to furnish
assistance and direction throughout the performance of CR and ICR
services); we believe this physician also requires expertise in cardiac
pathophysiology resulting from training or experience in cardiovascular
disease management and exercise training of heart disease patients.
This includes a physician billing Medicare Part B for providing
services directly to a patient during a CR or ICR session. We are
proposing standards for these physicians based on our general
rulemaking authority which include expertise in the management of
individuals with cardiac pathophysiology and licensure to practice
medicine in the State in which the CR or ICR program is offered. We are
expressly inviting public comments about the precise level of expertise
that is necessary.
Please note that the program Medical Director may fulfill both
roles of Medical Director and supervising physician (of individual CR
and ICR services furnished to patients) provided that the requirements
for direct physician supervision as required in Sec. Sec. 410.26 and
410.27 are met when CR or ICR items and services are furnished, as
discussed above.
We are requesting public comments regarding whether specific
training and expertise standards are needed for the cardiac
rehabilitation staff.
Section 1861(eee)(4)(C) of the Act provides for coverage of ICR
programs that are provided in a series of 72 1-hour sessions (as
defined in section 1848(b)(5) of the Act), up to 6 sessions per day,
over a period of up to 18 weeks. Specific provisions for the number,
duration, and time period for general CR programs are not identified in
the MIPPA; however we propose to maintain, with slight refinements,
coverage requirements previously established in Pub. L. 100-03, section
20.10 through this rulemaking process. For eligible beneficiaries,
general CR is provided for up to 36 1-hour sessions, up to 2 sessions
per day with no fewer than 2 sessions per week, over up to 18 weeks,
with contractor discretion to expand these limitations to not exceed 72
sessions for 36 weeks. This is based on section 1862(a)(1)(A) of the
Act and our general rulemaking authority. By 1-hour session, we mean
that each session must last a minimum of 60 minutes.
e. Coding and Payment
(1) CR Payment
Currently, the following CPT codes are used for CR services
described in section 144(a) of the MIPPA: CPT code 93797, Physician
services for outpatient cardiac rehabilitation; without continuous ECG
monitoring (per session); and CPT code 93798, Physician services for
outpatient cardiac rehabilitation; with continuous ECG monitoring (per
session). We are not proposing to revise these codes under the PFS
because the CR program authorized by the existing NCD is essentially
the same as that included in the MIPPA.
(2) ICR Payment
The statute requires that the hospital Outpatient Prospective
Payment System (OPPS) payment amount for CR services be substituted for
ICR under the PFS, specifically the payment for CPT codes 93797 and
93798 or any succeeding HCPCS codes for CR. We are proposing to create
two new HCPCS codes for ICR services. These codes may only be billed by
ICR programs that have been approved by CMS. The proposed codes are as
follows:
GXX28, Intensive cardiac rehabilitation; with or without
continuous ECG monitoring with exercise, per session.
GXX29, Intensive cardiac rehabilitation; with or without
continuous ECG monitoring; without exercise, per session.
These HCPCS codes will be recognized under the PFS and the OPPS.
Under the OPPS the existing CR HCPCS codes, CPT codes 93797 and 93798,
are assigned to APC 0095 (Cardiac Rehabilitation) for CY 2009. Because
the payment under the PFS for the two proposed ICR G-codes is required
to be the same as the payment for CR services under OPPS, we are
proposing to pay the same amount as will be established through
rulemaking for CY 2010. The proposed OPPS payment amount for CR
services will be announced in the CY 2010 OPPS/ASC proposed rule. We
are proposing that this amount will be adjusted for the appropriate
locality by applying the GPCI under the PFS. The CY 2010 proposed APC
assignments and payment rates for these two ICR G-codes will be
published in the CY 2010 OPPS/ASC proposed rule. The proposed payment
rate for the associated APC(s) will be included in Addendum A to the CY
2010 OPPS/ASC proposed rule.
We note that when a CR/ICR service is furnished in a hospital
outpatient department, a physician cannot bill the Medicare contractor
for CR/ICR unless the physician personally performs the CR/ICR service.
To personally perform the CR/ICR service, the physician would provide
direct care to a single patient for the entire session of CR/ICR that
is being reported. In this case, the hospital would report the CR/ICR
service and be paid the OPPS payment for the facility services
associated with the CR/ICR session and the physician would report and
be paid the PFS amount for the CR/ICR service. A physician cannot bill
under the PFS for CR/ICR services furnished in a hospital for which the
physician furnishes only supervision or for services furnished in part
by others. If the physician furnishes no direct CR/ICR services for a
given session or on a given day or provides direct CR/ICR services for
less than the full session, then only the hospital would report the CR/
ICR services and these services would be paid under the OPPS.
9. Section 144(a): Payment and Coverage Improvements for Patients With
Chronic Obstructive Pulmonary Disease and Other Conditions--Pulmonary
Rehabilitation Services
Section 144 of the MIPPA amended Title XVIII of the Act to provide
for coverage of pulmonary rehabilitation (PR) under Part B, under
certain conditions, for services furnished on or after January 1, 2010.
This proposed rule would implement the new Medicare pulmonary
rehabilitation program and establish the requirements for providing
such services to Medicare beneficiaries with a diagnosis of moderate to
severe chronic obstructive pulmonary disease (COPD). COPD is not only
one of the more common of the diseases in the category of chronic
respiratory diseases, it is one of the more severely debilitating,
characterized by chronic bronchitis and emphysema. Other diseases and
conditions in this category include persistent asthma, bronchiectasis,
primary pulmonary hypertension, obesity-related respiratory
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disease, and ventilator dependency. This rule provides direction in
implementing the MIPPA in order to ensure services are covered and
enhance the patient's clinical outcomes.
a. Background
A PR program is typically a multidisciplinary program of care for
patients with chronic respiratory impairment that is individually
tailored and designed to optimize physical and social performance and
autonomy. The main goal of an individualized PR training program is to
empower and facilitate the individuals' ability to exercise
independently; exercise is the cornerstone of the PR program. Exercise
is combined with other training and support mechanisms necessary to
integrate prevention and encourage long-term adherence to the treatment
plan. The appropriate PR program will train and motivate the patient to
his or her maximum potential in self-care, and improve his or her
overall quality of life.
b. Provisions of Section 144 of the MIPPA
In pertinent part, section 144 of the MIPPA amended section
1861(s)(2) of the Act to add a new subparagraph (CC) establishing
coverage of items and services furnished under a ``pulmonary
rehabilitation program.'' Pulmonary rehabilitation program is defined
in new subsection (fff)(1) to mean a physician supervised program that
furnishes several specific items and services. These include all of the
following:
Physician-prescribed exercise.
Education or training (to the extent that the education
and training is closely and clearly related to the individual's care
and treatment and is tailored to such individual's needs).
Psychosocial assessment.
Outcomes assessment.
Other items and services determined by the Secretary to be
appropriate under certain conditions.
These components are to be provided in physicians' offices,
hospital outpatient settings, and other settings determined appropriate
by the Secretary. A physician must be immediately available and
accessible for medical consultation and medical emergencies at all
times when PR items and services are being furnished under the program.
The individual's treatment is furnished under a written treatment plan
that is developed by the physician for each beneficiary participating
in a PR program. A physician must establish and review the plan and it
must be signed by the physician every 30 days. This plan must include
the individual's diagnosis, the scope of services to be provided in
terms of type, amount, frequency and duration, and the goals set for
the individual. To be covered and paid by Medicare, the PR program must
provide all of the specified mandatory items and services. With respect
to the Secretary's authority to require additional items and services,
we are not proposing any additional services at the present time;
however, we may propose additional items and services in the future.
c. Proposals
Under section 144 of the MIPPA, we are proposing to create a new
Sec. 410.47, ``Pulmonary Rehabilitation Program: Conditions for
Coverage'' under Part B to add the PR program as a Medicare-covered
service. The new section 1861(fff) of the Act outlines the mandatory
components of a PR program. In accordance with this new section, any
facility providing a PR program must meet all of the requirements
outlined herein. The MIPPA provides for coverage of PR services in two
specific settings (physician's office, hospital outpatient) and
authorized the agency to consider the addition of other settings. We
are not proposing any other settings at the present time.
The PR provisions defined by section 144 of the MIPPA are effective
January 1, 2010.
(1) Definitions
We are proposing the following definitions for the programs and
services required by MIPPA as related to PR provisions.