[Federal Register: August 22, 2006 (Volume 71, Number 162)]
[Proposed Rules]
[Page 48981-49252]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22au06-20]
[[Page 48981]]
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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 405, 410, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule for Calendar Year 2007 and Other Changes to Payment Under
Part B; Proposed Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, and 424
[CMS-1321-P]
RIN 0938-AO24
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule for Calendar Year 2007 and Other Changes to
Payment Under Part B
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would address certain provisions of the
Deficit Reduction Act of 2005, as well as make other 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 also discusses geographic
practice cost indices (GPCI) changes; requests for additions to the
list of telehealth services; payment for covered outpatient drugs and
biologicals; payment for renal dialysis services; policies related to
private contracts and opt-out; policies related to bone mass
measurement services, independent diagnostic testing facilities, the
physician self-referral prohibition; laboratory billing for the
technical component (TC) of physician pathology services; the clinical
laboratory fee schedule; certification of advanced practice nurses;
health information technology, and the health care information
transparency initiative.
DATES: Comment Date: Comments will be considered if we receive them at
one of the addresses provided below, no later than 5 p.m. on October
10, 2006.
ADDRESSES: In commenting, please refer to file code CMS-1321-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (fax) transmission.
You may submit comments in one of three ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to http://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By mail. You may mail written comments (one original and two
copies) to the following address only: Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Attention: CMS-1321-
P, P.O. Box 8015, Baltimore, MD 21244-8015.
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 (one
original and two copies) to the following address only: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1321-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 (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7197 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD
21244-1850.
(Because access to the interior of the HHH 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.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Pam West, (410) 786-2302 (for issues
related to practice expense).
Stephanie Monroe, (410) 786-6864 (for issues related to the
geographic practice cost index).
Craig Dobyski, (410) 786-4584 (for issues related to list of
telehealth services).
Roberta Epps, (410) 786-4503 (for issues related to diagnostic
imaging services).
Bill Larson, (410) 786-4639 (for issues related to coverage of bone
mass measurement and addition of ultrasound screening for abdominal
aortic aneurysm to the ``Welcome to Medicare'' benefit).
Dorothy Shannon, (410) 786-3396 (for issues related to the
outpatient therapy cap).
Catherine Jansto, (410) 786-7762 (for issues related to payment for
covered outpatient drugs and biologicals).
Henry Richter, (410) 786-4562 (for issues related to payments for
end-stage renal disease facilities).
Fred Grabau, (410) 786-0206 (for issues related to private
contracts and opt-out provision).
Lisa Ohrin, (410) 786-4565 (for issues related to physician self-
referral prohibitions).
David Walczak (410) 786-4475 (for issues related to reassignment
provisions).
August Nemec (410) 786-0612 (for issues related to independent
diagnostic testing facilities).
Anita Greenberg, (410) 786-4601 (for issues related to the clinical
laboratory fee schedule).
James Menas (410) 786-4507 (for issues related to payment for
physician pathology services).
Diane Milstead, (410) 786-3355 or Gaysha Brooks (410) 786-9649 (for
all other issues).
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-1321-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
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.cms.hhs.gov/eRulemaking.
Click on the link ``Electronic Comments on
CMS Regulations'' on that Web site to view public comments.
Comments received timely will also be available for public
inspection as
[[Page 48983]]
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.
Information on the physician fee schedule can be found on the CMS
homepage. You can access this data by using the following directions:
1. Go to the following Web site: http://www.cms.hhs.gov/PhysicianFeeSched/
.
2. Select ``PFS Federal Regulation Notices.''
To assist readers in referencing sections contained in this
preamble, we are providing the following 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. Information on the regulation's impact appears throughout
the preamble and is not exclusively in section VI.
Table of Contents
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 the Fee Schedule
II. Provisions of the Proposed Rule
A. Resource-Based PE RVUs and Practice Expense Proposals for
Calendar Year 2007
B. Geographic Practice Cost Indices
C. Medicare Telehealth Services
D. Miscellaneous Coding Issues
1. Global Period for Remote Afterloading High Intensity
Brachytherapy Procedures
2. Assignment of RVUS to CPT Codes for Proton Beam Treatment
Delivery Services
E. Deficit Reduction Act (DRA) Related Proposals
1. Section 5102 of the DRA--Proposed Adjustments for Payments to
Imaging Services
2. Section 5107 of the DRA--Revisions to Payments for Therapy
Services
3. Section 5112 of the DRA--Proposed Addition of Ultrasound
Screening for Abdominal Aortic Aneurysm (AAA)
4. Section 5113 of the DRA--Proposed Non-Application of the Part
B Deductible for Colorectal Cancer Screening Tests
5. Section 5114--Proposed Addition of Diabetes Outpatient Self-
Management Training Services (DSMT) and Medical Nutrition Therapy
(MNT) for the FQHC Program
F. Proposed Payment for Covered Outpatient Drugs and Biologicals
(ASP Issues)
G. Proposed Provisions Related to Payment for Renal Dialysis
Services Furnished by End Stage Renal Disease (ESRD) Facilities
H. Private Contracts and Opt-Out Provision--Practitioner
Definition
I. Proposed Changes to Reassignment and Physician Self-Referral
Rules Relating to Diagnostic Tests
J. Supplier Access to Claims Billed on Reassignment
K. Coverage of Bone Mass Measurement Tests
L. Independent Diagnostic Testing Facility (IDTF) Issues
1. Proposed IDTF Changes in the Physician Fee Schedule Proposed
Rule
2. Proposed Performance Standards for IDTFs
3. Supervision
4. Place of Service
M. Independent Laboratory Billing for the Technical Component
(TC) of Physician Pathology Services to Hospital Patients
N. Public Consultation for Medicare Payment for New Outpatient
Clinical Diagnostic Laboratory Tests
O. Proposal To Establish Criteria for National Certifying Bodies
That Certify Advanced Practice Nurses
P. Chiropractic Services Demonstration
Q. Promoting Effective Use of Health Information Technology
R. Health Care Information Transparency Initiative
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--2007 Relative Value Units and Related Information Used
in Determining Medicare Payments for 2007
Addendum C--Codes for Which We Received Practice Expense Review
Committee (PERC) Recommendations on Practice Expense Direct Cost
Inputs
Addendum D--2007 Geographic Practice Cost Indices (GPCIs) by
Medicare Carrier and Locality
Addendum E--2007 Geographic Adjustment Factors (GAF)
Addendum F--Proposed CPT/HCPCS Imaging Codes Defined by Section
5102(b) of the DRA
In addition, because of the many organizations and terms to
which we refer by acronym in this proposed final rule, we are
listing these acronyms and their corresponding terms in alphabetical
order below:
AADA American Academy of Dermatology Association
AAH American Association of Homecare
AAP Average acquisition price
ACC American College of Cardiology
ACG American College of Gastroenterology
ACHPN Advanced Certified Hospice and Palliative Nurse
ACOG American College of Obstetrics and Gynecology
ACR American College of Radiology
ADA American Dietetic Association
AFROC Association of Freestanding Radiation Oncology Centers
AGA American Gastroenterological Association
AHRQ Agency for Healthcare Research and Quality
AMA American Medical Association
AMP Average manufacturer price
ASA American Society of Anesthesiologists
ASGE American Society of Gastrointestinal Endoscopy
ASP Average sales price
ASTRO American Society for Therapeutic Radiation Oncology
ATA American Telemedicine Association
AUA American Urological Association
AWP Average wholesale price
BBA Balanced Budget Act of 1997
BBRA Balanced Budget Refinement Act of 1999
BES (Bureau of the Census) Business Expenditure Survey
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement Protection
Act of 2000
BLS Bureau of Labor Statistics
BMD Bone mineral density
BMI Body mass index
BMM Bone mass measurement
BNF Budget neutrality factor
BP Best price
BSA Body surface area
CAH Critical access hospital
CAP College of American Pathologists
CBSA Core-Based Statistical Area
CCI Correct Coding Initiative
CF Conversion factor
CFR Code of Federal Regulations
CMA California Medical Association
CMS Centers for Medicare & Medicaid Services
CNS Clinical nurse specialist
CPEP Clinical Practice Expert Panel
CPI Consumer Price Index
CPO Care Plan Oversight
CPT (Physicians') Current Procedural Terminology (4th Edition, 2002,
copyrighted by the American Medical Association)
CRNA Certified Registered Nurse Anesthetist
CT Computed tomography
CTA Computed tomographic angiography
CY Calendar year
DHS Designated health services
DME Durable medical equipment
DMERC Durable Medical Equipment Regional Carrier
DRA Deficit Reduction Act
DSMT Diabetes outpatient self-management training services
DXA Dual energy x-ray absorptiometry
E&M Evaluation and management
EPO Erythopoeitin
ESRD End stage renal disease
FAX Facsimile
FI Fiscal intermediary
FR Federal Register
GAF Geographic adjustment factor
GAO General Accounting Office
GDP Gross domestic product
GPO Group purchasing organization
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GPCI Geographic practice cost index
HCPAC Health Care Professional Advisory Committee
HCPCS Healthcare Common Procedure Coding System
HCRIS Healthcare Cost Report Information System
HSA Health Savings Account
HHA Home health agency
HHS (Department of) Health and Human Services
HIT Health information technology
HOCM High osmolar contrast media
HPSA Health Professional Shortage Area
HRSA Health Resources Services Administration (HHS)
HUD (Department of) Housing and Urban Development
IDTF Independent diagnostic testing facility
IPF Inpatient psychiatric facility
IPPS Inpatient prospective payment system
IRF Inpatient rehabilitation facility
ISO Insurance Services Office
IVIG Intravenous immune globulin
JCAAI Joint Council of Allergy, Asthma, and Immunology
JUA Joint underwriting association
LCD Local coverage determination
LTCH Long-term care hospital
LOCM Low osmolar contrast media
LOINC[supreg] Logical Observation Identifiers Names and Codes
MA Medicare Advantage
MCAC Medicare Coverage Advisory Committee
MCG Medical College of Georgia
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003
MNT Medical nutrition therapy
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan statistical area
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NDC National drug code
NECMA New England County Metropolitan Area
NECTA New England City and Town Area
NP Nurse practitioner
NPP Nonphysician practitioners
NPWP Nonphysician Work Pool
OBRA Omnibus Budget Reconciliation Act
OIG Office of Inspector General
OMB Office of Management and Budget
OPD Outpatient Department
OPPS Outpatient prospective payment system
OSCAR Online Survey and Certification and Reporting
PA Physician assistant
PBM Pharmacy benefit managers
PC Professional component
PE Practice Expense
PEAC Practice Expense Advisory Committee
PERC Practice Expense Review Committee
PET Positron emission tomography
PFS Physician Fee Schedule
PLI Professional liability insurance
PPI Producer price index
PPO Preferred provider organization
PPS Prospective payment system
PRA Paperwork Reduction Act
PT Physical therapy
QCT Quantitative computerized tomography
RFA Regulatory Flexibility Act
RIA Regulatory impact analysis
RN Registered nurse
RUC (AMA's Specialty Society) Relative (Value) Update Committee
RVU Relative value unit
SXA Single energy x-ray absorptiometry
SPA Single photon absorptiometry
SGR Sustainable growth rate
SMS (AMA's) Socioeconomic Monitoring System
SNF Skilled Nursing Facility
SNM Society for Nuclear Medicine
TA Technology Assessment
TC Technical Component
UAF Update adjustment factor
UPIN Unique Physician Identification Number
WAC Wholesale acquisition cost
WAMP Widely available market price
I. Background
[If you choose to comment on issues in this section, please include
the caption ``BACKGROUND'' at the beginning of your comments.]
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 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
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 (HHS). 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)(A) of the Act specifies that the RVUs for
radiology services are based on relative value scale we adopted under
section 1834(b)(1)(A) of the Act, (the American College of Radiology
(ACR) relative value scale), which we integrated into the overall PFS.
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. We
established a separate conversion factor (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
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 practice
expenses.
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 physician's
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.
[[Page 48985]]
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) 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. The AMA's SMS data provided
aggregate specialty-specific information on hours worked and practice
expenses.
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 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 practice
expenses 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.
3. Resource-Based Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require us to implement resource-based malpractice RVUs for services
furnished on or after 2000. The resource-based malpractice RVUs were
implemented in the PFS final rule published November 2, 1999 (64 FR
59380). The malpractice 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 went into effect in 1997, published on November 22,
1996 (61 FR 59489). The second 5-year review went into effect in 2002,
published on November 1, 2001 (66 FR 55246). The next scheduled 5-year
review is scheduled to go into effect in 2007.
In 1999, the AMA's RUC established the Practice Expense Advisory
Committee (PEAC) for the purpose of refining the direct PE inputs.
Through March of 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).
In the November 15, 2004, PFS final rule (69 FR 66236), we
implemented the first 5-year review of the malpractice RVUs (69 FR
66263).
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.
B. Components of the Fee Schedule Payment Amounts
To calculate the payment for every physician service, the
components of the fee schedule (physician work, PE, and malpractice
RVUs) are adjusted by a geographic practice cost index (GPCI). The
GPCIs reflect the relative costs of physician work, PEs, and
malpractice insurance in an area compared to the national average costs
for each component.
Payments are converted to dollar amounts through the application of
a CF, which is calculated by the Office of the Actuary and is updated
annually for inflation.
The general formula for calculating the Medicare fee schedule
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.
(Note: As discussed in the June 29, 2006 proposed notice for the
Five-Year Review of Work Relative Value Units Under the Physician Fee
Schedule and Proposed Changes to the Practice Expense Methodology (71
FR 37170), we have proposed to establish a separate budget neutrality
adjustor that would be applied in the calculation of the work RVUs.
Application of this budget neutrality adjustor would enable us to meet
the budget neutrality provisions of section 1848(c)(2)(B)(ii) of the
Act.)
C. Most Recent Changes to the Fee Schedule
The final rule with comment period that appeared in the Federal
Register on November 21, 2005 (70 FR 70116) addressed Medicare Part B
payment policy, including the physician fee schedule, that is
applicable for calendar year (CY) 2006; and finalized certain
provisions of the interim final rule to implement the Competitive
Acquisition Program (CAP) for Part B Drugs.
It also revised Medicare Part B payment and related policies
regarding: Physician work, practice expense and malpractice RVUs;
Medicare telehealth services; multiple diagnostic imaging procedures;
covered outpatient drugs and biologicals; supplemental payments to
Federally Qualified Health Centers (FQHCs); renal dialysis services;
coverage for glaucoma screening services; National Coverage
Determination (NCD) timeframes; and physician referrals for nuclear
medicine services and supplies to health care entities with which
physicians have financial relationships.
In addition, the rule finalized the interim RVUs for CY 2005 and
issued interim RVUs for new and revised procedure codes for CY 2006.
The rule also updated the codes subject to the physician self-referral
prohibition and discussed payment policies relating to teaching
anesthesia services, therapy caps, private contracts and opt-out, and
chiropractic and oncology demonstrations.
In accordance with section 1848(d)(1)(E)(i) of the Act, we also
announced that the PFS update for CY 2006 would be -4.4 percent; the
initial estimate for the sustainable growth rate for CY 2006 would be
1.7; and the CF for CY 2006 would be $36.1770. However, subsequent to
publication of the CY 2005 PFS final rule with comment period, section
5104 of the Deficit Reduction Act (DRA) of 2005 (Pub. L. 109-171,
February 8, 2006), was enacted which amended section 1848(d)
[[Page 48986]]
of the statute to provide for a 0 percent update effective January 1,
2006.
We also note that the Five-Year Review of Work Relative Value Units
Under the Physician Fee Schedule and Proposed Changes to the Practice
Expense Methodology proposed notice appeared in the Federal Register on
June 29, 2006 (71 FR 37170). In that notice, we proposed revisions to
work RVUs affecting payment for physicians' services. The revisions
reflect changes in medical practice, coding changes, and new data on
relative value components that affect the relative amount of physician
work required to perform each service, as required by the statute. We
also proposed revisions to our methodology for calculating PE RVUs,
including changes based on supplemental survey data for PE. This
revised methodology would be used to establish payment for services
beginning January 1, 2007.
As indicated in the June 29, 2006 proposed notice, we will respond
to the comments received on that notice as part of the final Medicare
PFS rule for CY 2007 scheduled for publication this fall. If adopted,
the RVU revisions would be fully implemented for services furnished to
Medicare beneficiaries on or after January 1, 2007. The PE revisions
would be phased-in over a four-year period; although, as we gain
experience with the new methodology, we will reexamine this policy
beginning next year and propose necessary revisions through future
rulemaking.
II. Provisions of the Proposed Rule
[If you choose to comment on issues in this section, please include
the caption ``PROVISIONS'' at the beginning of your comments.]
A. Resource-Based Practice Expense (PE) RVU Proposals for CY 2007
Major changes to the PE methodology for 2007, as well as a detailed
discussion of the current PE methodology, are discussed in the June 29,
2006 proposed notice (71 FR 37170 through 37430).
This proposed rule contains proposals for direct PE including
clinical labor, medical supplies and medical equipment.
1. RUC Recommendations for Direct PE Inputs and Other PE Input Issues
The following discussions are proposals concerning direct PE
inputs.
(a) RUC Recommendations
The AMA's Relative Value Update Committee (RUC) established a new
committee, the Practice Expense Review Committee (PERC), to assist the
RUC in recommending direct PE inputs (clinical staff, supplies, and
equipment) for new and existing CPT codes.
The PERC reviewed the PE inputs for over 2000 existing codes, some
of which were unresolved PE issues from the CY 2006 PFS final rule with
comment period, at their meetings held in September 2005, February 2006
and April 2006. (A list of these reviewed codes can be found in
Addendum C of this proposed rule.)
We have reviewed the PERC-submitted recommendations and propose to
adopt all of them. We have worked with the AMA staff to make
corrections for any typographical errors and to ensure that previously
PEAC-accepted standards are incorporated in the recommendations.
The complete PERC recommendations and the revised PE database can
be found on our Web site. (See the SUPPLEMENTARY INFORMATION section of
this proposed rule for directions on accessing our Web site.)
(b) Standard Supplies and Equipment for 90-Day Global Codes
We are proposing to revise the CPEP supply and equipment inputs for
those 90-day global procedures for which the RUC has only refined the
clinical labor inputs. We are proposing to apply the standard supply
and equipment inputs for the facility setting for 90-day global
services to these remaining unrefined 90-day global procedure codes. As
recommended by the RUC, for supplies, we propose to include one minimum
supply visit package for each post-operative visit assigned to each
code and a post-surgical incision care kit (suture, staples, or both)
where appropriate, along with additional items recommended by the RUC
for certain procedures. For equipment, we are proposing to include an
exam table and light. However, there are several issues on which we
need input before we finalize the recommended standards. For example,
for many of the 90-day codes in question, the current supply input data
contain supplies in far larger quantities than are contained in either
the visit package or incision care kit. For other codes, the current
data includes items that are not contained in the package or kit. In
other cases, the recommendations from the RUC contain additional items
in quantities that appear excessive. We plan to work with all the
concerned specialties to ensure that the finalized inputs do represent
the typical supplies needed to perform each procedure.
Because the application of the 90-day global standard supplies and
equipment would result in the deletion of some original CPEP inputs, we
are requesting that all the medical specialties examine the direct PE
inputs on our Web site and let us know whether there are additional
items from the original CPEP data that are a necessary part of the
post-operative care and if the PE inputs listed are correct. (See the
SUPPLEMENTARY INFORMATION section of this proposed rule for directions
on accessing our Web site.)
2. Payment for Splint and Cast Supplies
In the PFS final rules published November 1999 (64 FR 59380) and
November 2000 (65 FR 65376), we removed splint and cast supplies from
the PE database for the CPT codes for fracture management and cast/
strapping application procedures. Because splint and cast supplies
could be separately billed using Healthcare Common Procedure Coding
System (HCPCS) codes (Q4001-Q4051) that were established for payment of
these supplies under section 1861(s)(5) of the Act, we did not want to
make duplicate payment under the PFS for these items.
In the CY 2006 PFS proposed rule (70 FR 70116), we proposed to
reinstate payment for all splints and cast supplies through the PE
component of the PFS because we believed we may have unintentionally
prohibited remuneration for these supplies when they are not used for
reduction of a fracture or dislocation (covered under section
1861(s)(5) of the Act), but rather are provided (and covered) as
``incident to'' a physician service under section 1861(s)(2)(A) of the
Act. This proposal was not finalized; however, in our final rule we
asked the medical specialties and the PERC to determine the typical
supplies for splints and casts necessary for each of the fracture
management codes and the cast/strapping application codes because we
wanted to make certain that the supply inputs were correct before we
proceeded with rulemaking for the CY 2007 PFS. At its February 2006
meeting, the PERC reviewed and approved the supply inputs submitted by
the AAOS for each CPT code for fracture management and cast/strapping
application and these were forwarded to us as PERC recommendations.
During this interim period we also reassessed the options for payment
of materials for splints and casts.
We believe that the majority of the splint and cast supplies that
are currently paid through the Q-codes are furnished in relationship to
cast/strapping procedures for the management of fractures and
dislocations. However, we did not intend for the medically necessary
[[Page 48987]]
splint and cast supplies used for other reasons (for example, serial
casting, wound care, or protection) not to be paid. Because it may be
difficult for the contractors to identify the purpose for the cast/
strapping application procedure on a claim form, we believe that
contractors may have been paying for the splint and cast supply Q-codes
when the service is performed for other purposes than treatment of
fractures and dislocations.
Since these splint and cast supplies can be covered under both
sections 1861(s)(5) and 1861(s)(2)(A) of the Act, we are proposing to
include payment for both statutory benefits using the separate HCPCS Q-
codes. This would allow for payment for these medically necessary
supplies whether based on sections 1861(s)(5) or 1861(s)(2)(A) of the
Act, while ensuring that no duplicate payments are made. Physicians
would continue to bill the HCPCS Q-codes, in addition to the cast/
strapping application procedure codes, to be paid for these materials.
The following supplies would continue to be paid separately using
the HCPCS Q-codes and would not be included in the PE database upon
adoption of this proposal:
Fiberglass roll.
Cast padding.
Cast shoe.
Stockingnet/stockinette.
Plaster bandage.
Denver splint.
Dome paste bandage.
Cast sole.
Elastoplast roll.
Fiberglass splint.
Ace wrap.
Kerlix.
Webril.
Malleable arch bars and elastics.
The splint and cast supplies would not be included in the PEs for
the following CPT codes:
24500 through 24685
25500 through 25695
26600 through 26785
27500 through 27566
27750 through 27848
28400 through 28675
29000 through 29750.
We are requesting input, specifically from medical specialties and
contractors on this proposal.
3. Medical Nutrition Therapy Services
In 2000, the Health Care Professional Advisory Committee (HCPAC)
recommended that we assign work RVUs to three new medical nutrition
therapy (MNT) CPT codes--97802 Medical nutrition therapy; initial
assessment and intervention, individual, face-to-face with the patient,
each 15 minutes at 0.45 RVUs, 97803 Medical nutrition therapy; re-
assessment and intervention, individual, face-to-face with the patient,
each 15 minutes at 0.37 RVUs, and 97804 Medical nutrition therapy;
group (two or more individuals), each 30 minutes at 0.25 RVUs. However,
during rulemaking for the CY 2001 PFS final rule, we indicated that MNT
was not covered because there was yet no statutory benefit category
that would allow medical nutritionists to bill these services. We also
did not accept the HCPAC recommendations for work RVUs for these MNT
services because the codes were designed for use only by nonphysicians.
The following year, section 105(c) of the Medicare, Medicaid, and SCHIP
Benefits Improvement Protection Act of 2000 (BIPA) provided for the
coverage of MNT services when furnished by registered dietitians or
nutritional professionals at 85 percent of the amount that a physician
would be paid for the same services. As a result, we established values
for these MNT services for the 2002 PFS. In keeping with our earlier
decision, we did not assign the HCPAC-recommended work values. However,
the associated work value for each code was utilized in the conversion
of work to clinical labor time for MNTs as part of the PE component. At
that time we received several comments, including one from the American
Dietetic Association (ADA), urging us to adopt the work values
recommended by the HCPAC.
More recently, the ADA has requested us to reconsider our decision
not to accept the HCPAC recommended work RVUs. The ADA contends that
the payment rate established by section 105(c) of BIPA, 85 percent of
the PFS amount that would be paid for the same service if furnished by
a physician, is based on the premise that work values are inherent to
these MNT services. The ADA believes that without work RVUs, the
payment for these services does not reflect 85 percent of what a
physician would be paid for performing the same service. Because these
MNT codes were created specifically for MNT professionals, the ADA
compared the work associated with their services to physician E/M
services of CPT 99203 and 99213, which have respective work RVUs of
1.34 and 0.67.
After reviewing the issues and relevant arguments raised by the
ADA, we are persuaded that it would be appropriate to include work RVUs
for the MNT services. Consequently, we are proposing to establish work
RVUs for each code at the level previously recommended by the HCPAC, as
follows:
CPT 97802 = 0.45 RVUs.
CPT 97803 = 0.37 RVUs.
CPT 97804 = 0.25.
Because we propose to add the work RVUs to these services, the MNT
clinical labor time in the direct input database would be removed with
the adoption of this proposal. Additionally, two HCPCS codes, G0270 MNT
subs tx for change dx and G0271 Group MNT 2 or more 30 mins were
created to track MNT services following the second referral in the same
year. These HCPCS codes correspond to CPT codes 97803 and 97804,
respectively. Therefore, we would also propose to add the same work
RVUs to these HCPCS codes and to delete the clinical labor inputs from
the PE database upon adoption of this policy. We encourage specialty
societies and other professional groups to comment on this proposal.
4. Surgical Pathology Codes
We heard from the College of American Pathologists (CAP) regarding
the equipment times assigned to CPT codes 88304 and 88305 in the basic
surgical pathology family of codes. While all six codes in this family
have been refined by the PEAC, this refinement occurred at 4 separate
PEAC meetings. CPT codes 88304 and 88305 were refined at the first PEAC
meeting in April 1999 before time standards were established for the
equipment at subsequent PEAC meetings when the other four CPT codes
88300, 88302, 88307, and 88309 were reviewed. Using our proposed
bottom-up PE methodology to value these codes, the lack of the
equipment time standards for CPT codes 88304 and 88305 create a rank-
order anomaly in this family. Consequently, CAP, after reviewing and
applying current standards for the equipment times, submitted suggested
revised equipment times to us. We are proposing to accept these times
and the proposed times will be reflected in the PE database on our Web
site (See the SUPPLEMENTARY INFORMATION section of this proposed notice
for directions on accessing our Web site.)
5. Other PE Issues
In the CY 2006 PFS final rule with comment period (70 FR 70116), we
explained that we were not implementing the PERC or other proposed PE
changes for CY 2006 due to issues with the PE methodology. In this
proposed rule, we are proposing that the PERC and other PE changes
originally proposed for CY 2006 would be implemented and effective with
the CY 2007 PFS. The following
[[Page 48988]]
subsections, (a) through (j), summarize the PE proposals from the CY
2006 PFS final rule with comment period that we are including in this
proposed rule. Additionally, we are including several other items which
concern inputs for PE that are discussed below in subsections (k)
through (n).
(a) PE Recommendations on CPEP Inputs for CY 2006
We are proposing to use a clinical labor time of 167 minutes for
the service period for CPT code 36522, Extracorporeal Photopheresis;
maintain the nonfacility setting PE RVUs for CPT code 78350, single
photon bone densitometry; and remove the PE inputs for the nonfacility
setting for CPT codes 76975, GI endoscopic ultrasound, and 15852,
Dressing change not for burn. (70 FR 70136 through 70137)
(b) Supply Items for CPT Code 95015 (Which Is Used for Intradermal
Allergy Tests With Drugs, Biologicals, or Venoms)
We are proposing to implement the allergy and immunology
specialty's recommendation to change the test substance in CPT code
95015 to venom, at $10.70 (from single antigen, at $5.18) and the
quantity to 0.3 ml (from 0.1 ml). (See 70 FR 70138.)
(c) Flow Cytometry Services
Based on information from the society representing independent
laboratories, we are proposing to implement the following direct PE
inputs:
Clinical Labor--We are proposing to change the staff type
in the service (intra) period in both CPT codes 88184 and 88185 to
cytotechnologist, at $0.45 per minute (currently lab technician, at
$0.33 per minute).
Supplies--We are proposing to change the antibody cost for
both CPT codes 88184 and 88185 to $8.50 (from $3.544).
Equipment--We are proposing to add the following equipment
to CPT code 88184:
+ Computer.
+ Printer.
+ Slide strainer.
+ Biohazard hood.
+ Wash assistant.
+ FAC loader.
+ We are proposing to add a computer and printer to the equipment
for CPT code 88185 (70 FR 70138).
(d) Low Osmolar Contrast Media (LOCM) and High Osmolar Contrast Media
(HOCM)
Because separate payment is available for both types of contrast
media, we are proposing to delete LOCM and HOCM from the PE database
with the CY 2007 PFS rule. (See 70 FR 70138).
(e) Imaging Rooms
We are proposing to implement the updates for the contents and
prices of 5 ``rooms'' used in imaging procedures including--
Basic radiology room;
Radiographic-fluoroscopic room;
Mammography room;
Computed tomography (CT) room; and
Magnetic resonance imaging (MRI) room (See 70 FR 70139).
(f) Equipment Pricing for Select Services and Procedures
We are proposing to accept the following equipment pricing
information provided by various specialty societies for select services
and procedures as discussed in the CY 2006 PFS final rule with comment
period. (See 70 FR 70139):
Equipment pricing for certain radiology services received
from the ACR as presented in Table 15 of the CY 2006 PFS proposed rule.
Equipment pricing on the ultrasound color doppler
transducers and vaginal probe received from the American College of
Obstetrics and Gynecology (ACOG).
For CPT 36522, extracorporeal photopheresis, equipment
pricing information specific to this procedure.
Pricing of EMG botox machine used in CPT code 92265 as
presented by the American Academy of Ophthalmology.
(g) Supply Item for In Situ Hybridization Codes (CPT Codes 88365,
88367, and 88368)
We are proposing to implement the Society for Clinical
Pathologists' request to change the probe quantity for CPT code 88367
In situ hybridization, auto to 1.5, equal to that of the other two
codes in the family.
(h) Supply Item for Percutaneous Vertebroplasty Procedures (CPT codes
22520 and 22525)
Based on documentation provided by the Society for Interventional
Radiology, we are proposing to implement a new price of $696.00 for the
vertebroplasty kit, to replace a temporary price of $660.50 that was a
placeholder price from the CY 2006 PFS final rule with comment period.
(See 70 FR 70139.)
(i) Clinical Labor for G-Codes Related to Home Health and Hospice
Physician Supervision, Certification and Recertification
We are proposing to apply the refinements made to the PE inputs to
CPT codes 99375 and 99378 for home health and hospice supervision to 4
G-codes that are related to home health and hospice physician
supervision, certification and recertification, G0179, GO180, GO181,
and GO182. These G-codes are incorrectly valued for clinical labor.
These G-codes are cross-walked from CPT codes 99375 and 99378, which
underwent PEAC refinement in January 2003 for the CY 2004 PFS. However,
at that time we inadvertently did not apply the new refinements to
these specific G-codes. (See 70 FR 70139 through 70140.)
(j) Programmers for Implantable Neurostimulators and Intrathecal Drug
Infusion Pumps
Although we had initially proposed, in the CY 2006 PFS proposed
rule, to remove two programmers from the PE database (EQ208 for
medication pump from two codes (CPT 62367 and 62368) and EQ209 for the
neurostimulator from 8 codes (CPT 95970-97979)), based on comments
received as discussed in the CY 2006 PFS final rule with comment period
(see 70 FR 70140), we determined that we will retain these programmers
in the database. In addition, we added ``with printer'' to the
description of EQ208 based on comments received. We are proposing to
implement these decisions for CY 2007.
(k) Cardiac Monitoring Services
We are requesting more specific PE information related to remote
cardiac monitoring services because these services do not fit the
direct PE model used for typical physician services. These services are
overwhelmingly performed by specialized independent diagnostic testing
facilities (IDTFs) that are paid under the PFS, but due to the
characteristics of cardiac monitoring services, frequently maintain
more extensive operating hours than the typical physician office.
Specifically, we are looking for data to indicate the typical number
and type of transmissions or other encounters per day between the
beneficiary and the IDTF for each of the remote monitoring services. We
would also like to know the number and type of clinical staff, as well
as the corresponding time, that are necessary to ensure appropriate
services are available for each patient. Additionally, we are
interested in identifying any other direct PE inputs for typical
supplies and equipment relating to these services, and any data that
would reflect indirect PEs, such as overhead and non-clinical payroll
expenses. We believe that the following codes represent atypical PE
scenarios
[[Page 48989]]
and would like to receive PE information regarding these services:
Cardiac event monitoring (CPT codes 93271, 93012 and
93270).
Pacemaker monitoring (CPT codes 93733 and 93736).
Holter monitoring (CPT codes 93232, 93226, 93231 and
93225).
INR monitoring (HCPCS codes G0248 and G0249).
(l) Clarification With Respect to Non-Facility PE RVUs
In the CY 2006 PFS final rule with comment (70 FR 70335) we
provided a clarification in Addendum A concerning use of ``NA'' in the
PE RVU columns for Addendum B. Commenters requested that further
clarification be made concerning the payment amount for procedures
performed in the non-facility setting if there is an ``NA'' in the non-
facility PE RVU column. Our policy is that if the Medicare carrier pays
for the service in the non-facility setting, the service will be paid
at the facility PE RVU rate. In this proposed rule, we are proposing
revisions to Addendum A to include this clarification.
(m) Supply for CPT Code 50384, Removal (via Snare/Capture) of
Internally Dwelling Ureteral Stent Via Percutaneous Approach, Including
Radiological Supervision and Interpretation
Upon review of the RUC-recommended direct PE inputs for CPT 50384,
a new procedure for CPT 2006, we identified the inappropriate inclusion
of a ureteral stent that we are proposing to delete for CY 2007. We
believe that the addition of the ureteral stent, valued by the
specialty at $162, to CPT code 50384, which is the procedure for the
removal of a stent, was an inadvertent error by the specialty during
the April 2005 RUC meeting.
(n) Supply and Equipment Items Needing Specialty Input
We have identified certain supply and equipment items for which we
were unable to verify the pricing information (see Table 1: Supply
Items Needing Specialty Input for Pricing and Table 2: Equipment Items
Needing Specialty Input for Pricing). During the CY 2006 rulemaking
process, we listed both supply and equipment items for which pricing
documentation was needed from the medical specialty societies and, for
many of these items, we received sufficient documentation in the form
of catalog listings, vendor Web sites, invoices, and manufacturer
quotes. We have accepted the documented prices for many of these items
and these prices are reflected in the PE RVUs in Addendum B of this
proposed rule. The items listed below in Tables 1 and 2 represent the
outstanding items from CY 2006 and new items added from the current RUC
recommendations. We are requesting that commenters provide pricing
information on items in these tables along with acceptable
documentation, as noted in the footnote to each table, to support
recommended prices. For supplies or equipment that have previously
appeared on this list, and for which we received no or inadequate
documentation, we are proposing to delete these items unless we receive
adequate information to support current pricing by the conclusion of
the comment period for this proposed rule.
BILLING CODE 4120-01-P
[[Page 48990]]
[GRAPHIC] [TIFF OMITTED] TP22AU06.000
[[Page 48991]]
[GRAPHIC] [TIFF OMITTED] TP22AU06.001
[[Page 48992]]
[GRAPHIC] [TIFF OMITTED] TP22AU06.002
BILLING CODE 4120-01-C
[[Page 48993]]
B. Geographic Practice Cost Indices (GPCI)
[If you choose to comment on issues in this section, please include
the caption ``GPCI'' at the beginning of your comments.]
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.
While requiring that the PE and malpractice GPCIs reflect the full
relative cost differences, section 1848(e)(1)(A)(iii) of 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, in consultation with
appropriate physician representatives, to review the GPCIs at least
every 3 years and allows us to make adjustments based on our review.
This section of the Act also requires us to phase-in the adjustment
over 2 years, implementing only one-half of any adjustment in the first
year if more than 1 year has elapsed since the last GPCI revision. The
GPCIs were first implemented in 1992. The first review and revision was
implemented in 1995 and the last GPCI revision was implemented in 2005.
The next update is scheduled to be implemented in January 2008.
We do not anticipate proposing significant changes to the GPCIs in
response to changes in the source data. There have been no new Census
data to affect the work GPCI, the PE GPCI will reflect any changes in
the Department of Housing and Urban Development (HUD) rental data, and
the malpractice GPCI (based on malpractice RVUs) will reflect the
national claims-based premium data for 2004 and 2005. Details of the
methodology, data sources, and adjustments to the GPCIs will be made
available for public comment in the CY 2008 PFS proposed rule.
In addition, section 412 of the MMA amended section 1848(e)(1) of
the Act to establish a floor of 1.0 for the work GPCI for any locality
where the GPCI would otherwise fall below 1.0 for purposes of payment
for services furnished on or after January 1, 2004 and before January
1, 2007. Beginning on January 1, 2007, the 1.00 floor will be removed
and the work GPCI will revert to the fully implemented value. The
values for the work GPCI and subsequent changes to the Geographic
Adjustment Factor (GAF) published in this proposed rule reflect the
removal of the 1.0 floor. For many payment localities this change had
no impact on the GAF; however, the GAFs for a number of payment
localities were reduced due to this change. The impact of this change
on the GAFs for those payment localities is shown below in Table 3.
The proposed GPCIs for 2007 are shown in Addendum D and the
proposed GAFs for 2007 are shown in Addendum E. The GPCIs shown in
Addendum D are fully implemented and reflect 2007 budget neutrality
scaling coefficients provided by the Office of the Actuary.
Table 3.--Payment Localities With Negative Percent Change in GAF 1
Between 2006 and 2007 Due to Removal of the 1.000 Work Floor
------------------------------------------------------------------------
Percent
Locality name 2006 GAF 2007 GAF change
------------------------------------------------------------------------
Fort Worth, TX......................... 0.998 0.996 -0.17
Rest of Michigan....................... 0.986 0.984 -0.20
Rest of New York....................... 0.952 0.950 -0.21
Rest of Maryland....................... 0.982 0.978 -0.36
Metropolitan St. Louis, MO............. 0.978 0.974 -0.41
Rest of Pennsylvania................... 0.950 0.946 -0.44
Ohio................................... 0.970 0.966 -0.44
Austin, TX............................. 1.020 1.015 -0.47
New Hampshire.......................... 1.010 1.005 -0.50
Minnesota.............................. 0.980 0.975 -0.53
Galveston, TX.......................... 0.991 0.986 -0.54
Metropolitan Kansas City, MO........... 0.987 0.981 -0.56
Fort Lauderdale, FL.................... 1.022 1.016 -0.59
Arizona................................ 0.999 0.993 -0.65
Wisconsin.............................. 0.956 0.950 -0.65
Colorado............................... 0.998 0.991 -0.67
East St. Louis, IL..................... 1.003 0.996 -0.68
New Orleans, LA........................ 0.984 0.977 -0.73
Rest of Washington..................... 0.984 0.976 -0.77
Indiana................................ 0.937 0.930 -0.79
Beaumont, TX........................... 0.951 0.942 -0.96
Alabama................................ 0.923 0.914 -0.99
Virginia............................... 0.958 0.948 -1.06
Southern Maine......................... 0.992 0.981 -1.09
Rest of Georgia........................ 0.943 0.932 -1.14
Tennessee.............................. 0.933 0.921 -1.27
Utah................................... 0.960 0.948 -1.30
South Carolina......................... 0.930 0.917 -1.41
Rest of Illinois....................... 0.952 0.938 -1.43
Rest of Florida........................ 0.982 0.968 -1.45
West Virginia.......................... 0.942 0.928 -1.47
North Carolina......................... 0.951 0.936 -1.55
New Mexico............................. 0.947 0.932 -1.57
Kansas*................................ 0.934 0.919 -1.60
Rest of Louisiana...................... 0.936 0.919 -1.78
Kentucky............................... 0.932 0.915 -1.80
Kansas*................................ 0.936 0.919 -1.81
Rest of Oregon......................... 0.946 0.929 -1.81
[[Page 48994]]
Vermont................................ 0.968 0.950 -1.82
Virgin Islands......................... 1.007 0.989 -1.83
Rest of Texas.......................... 0.947 0.929 -1.87
Idaho.................................. 0.922 0.904 -1.91
Iowa................................... 0.927 0.909 -1.97
Rest of Maine.......................... 0.936 0.916 -2.14
Oklahoma............................... 0.913 0.893 -2.14
Mississippi............................ 0.919 0.898 -2.31
Arkansas............................... 0.905 0.884 -2.34
Puerto Rico............................ 0.905 0.883 -2.44
Nebraska............................... 0.925 0.902 -2.44
Wyoming................................ 0.934 0.910 -2.55
Montana................................ 0.928 0.902 -2.83
Rest of Missouri *..................... 0.910 0.883 -2.97
North Dakota........................... 0.924 0.895 -3.16
South Dakota........................... 0.922 0.891 -3.35
------------------------------------------------------------------------
\1\ Calculation for the GAF: (.52466*work gpci) + (.03865*mp gpci) +
(.52466*pe gpci).
In the CY 2005 PFS proposed rule, published August 15, 2004, we
discussed the issue of changes to the GPCI payment localities (69 FR
47504). In that proposed rule, we noted that we look for the support of
a State medical society as the impetus for changes to existing payment
localities. Because the GPCIs for each locality are calculated using
the average of the county-specific data from all of the counties in the
locality, removing high cost counties from a locality will result in
lower GPCIs for the remaining counties. Therefore, because of this
redistributive impact, we have refrained, in the past, from making
changes to payment localities unless the State medical association
provides evidence that any proposed change has statewide support.
We would be interested in receiving suggestions on alternative ways
that we could administratively reconfigure payment localities that
could be developed and proposed in future rulemaking. In addition,
MEDPAC and the GAO have both expressed interest in studying the
physician payment localities. CMS intends to work with both groups to
study our current methodology and develop alternative options.
C. Medicare Telehealth Services
[If you choose to comment on issues in this section, please include
the caption ``TELEHEALTH'' at the beginning of your comments.]
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 (identified as of July 1, 2000 by CPT codes 99241 through
99275, 99201 through 99215, 90804 through 90809, and 90862) 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 office and other
outpatient visits, consultation, and office psychiatry services. In
reviewing these requests, we look for similarities between the proposed
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[pi]to[pi]face ``hands on''
delivery of the same service. Requestors should submit evidence showing
that the use of a telecommunications system does not affect the
diagnosis or treatment plan as compared to a face[pi]to[pi]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 by a physician, CNS, NP, or PA to examine the vascular access
site); and individual medical nutritional therapy.
Requests to add services to the list of Medicare telehealth
services must be submitted and received no later than December 31 of
each CY to be considered for the next proposed rule. For example,
requests submitted before the end of CY 2005 are considered for the CY
2007 proposed rule. For more information on submitting a request for an
addition to the list of Medicare telehealth services, visit our Web
site at http://www.cms.hhs.gov/telehealth.
2. Submitted Requests for Addition to the List of Telehealth Services
We received the following requests for additional approved services
in CY 2005: (1) Nursing facility care; (2) speech language pathology;
(3) audiology; and (4) physical therapy services. The following is a
discussion of the requests submitted in CY 2005.
Nursing Facility Care
The American Telemedicine Association (ATA) and an individual
practitioner submitted a request to add the following services: Initial
nursing facility care (as represented by HCPCS
[[Page 48995]]
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 as
described by HCPCS code 99318. The requestors explained that the
primary purpose of using telehealth in the Skilled Nursing Facility
(SNF) setting is to provide urgent consultation when the patient has a
sudden change in his or her condition, and to provide increased
availability to primary and specialty care on days when the physician
is not present in the SNF or when traveling is a hardship. The
requestors believe that the current list of Medicare telehealth
services is not appropriate because the list does not include codes
that are specifically intended for nursing facility residents.
CMS Review
Nursing Facility Care
Section 1834(m)(C)(ii) of the Act defines a telehealth originating
site as a physician's or practitioner's office; or a hospital, critical
access hospital (CAH), rural health clinic, or FQHC. SNFs are not
defined in the statute as originating sites.
However, section 418 of the MMA required the Health Resources
Services Administration (HRSA), a component of HHS, in consultation
with CMS, to conduct an evaluation of demonstration projects under
which SNFs, as defined in section 1819(a) of the Act, are treated as
originating sites for Medicare telehealth services. The MMA also
required the Secretary to submit a report to the Congress that includes
recommendations on ``mechanisms to ensure that permitting a SNF to
serve as an originating site for the use of telehealth services or any
other service delivered via a telecommunications system does not serve
as a substitute for in-person visits furnished by a physician, or for
in-person visits furnished by a physician assistant (PA), nurse
practitioner (NP), or clinical nurse specialist (CNS), as is otherwise
required by the Secretary'' and provides the authority to include SNFs
as a Medicare telehealth originating site, if the Secretary concludes
in the report that it is advisable to do so and that mechanisms could
be established to ensure that the use of a telecommunications system
does not serve as a substitute for the required in-person physician or
practitioner SNF visits. This report is currently under review in DHHS.
Given that SNFs are not defined in the statute as a telehealth
originating site and the report to the Congress, as discussed above, is
currently being reviewed within DHHS, we cannot consider approving
nursing facility care for telehealth at this time. We will review and
consider the recommendations of the report to the Congress once it is
issued. If it is determined that SNFs should be added as an originating
site, this change will be considered in future rulemaking.
Speech Language Pathology, Audiology and Physical Therapy
The ATA and an individual practitioner submitted a request to add
various speech therapy, audiology and physical therapy services to the
list of Medicare telehealth services. The requestors also asked us to
add physical therapists, speech language pathologists and audiologists
to the list of approved telehealth practitioners.
CMS Review
Physical therapists, speech language pathologists and audiologists
are not permitted under current law to provide and receive payment for
Medicare telehealth services at the distant site. The statute permits
only a physician, as defined by section 1861(r) of the Act or a
practitioner as described in section 1842(b)(18)(C) of the Act (CNS,
NP, PA, nurse midwife, clinical psychologist, clinical social worker,
registered dietitian or other nutrition professional), to furnish
Medicare telehealth services. Since speech language pathologists,
audiologists and physical therapists are not permitted under current
law to provide and receive payment for Medicare telehealth services at
the distant site, we cannot fully consider the request to add speech
therapy, audiology services and physical therapy to the list of
Medicare telehealth services. We are exploring this issue as part of a
report to the Congress (required by section 223(d) of BIPA) on
additional sites and settings, geographic areas, and types of non-
physician practitioners that could be reimbursed for the provision of
telehealth services.
D. Miscellaneous Coding Issues
[If you choose to comment on issues in this section, please include
the caption ``Miscellaneous Coding Issues'' at the beginning of your
comments.]
The following sections address specific coding issues related to
payment for services under the PFS.
1. Global Period for Remote Afterloading High Intensity Brachytherapy
Procedures
CPT Code 77783, Remote afterloading high intensity brachytherapy;
9-12 source positions or catheters, resides in a family of codes with
varying numbers of source positions. All of the codes in the family,
CPT codes 77781-77784 are currently designated as 90-day global
services. CPT codes 77781-77784 are used to treat many clinical
conditions, but primarily patients with prostate cancer, breast cancer
and sarcoma. Patients with any of these conditions usually receive
several treatments (2-10) over a two to ten day period of time. Due to
the increasing variability in treatment regimens, it is difficult to
assign RVUs for a ``typical'' patient based on a global period of 90
days.
Therefore, we are proposing that this family of codes (CPT codes
77781, 77782, 77783 and 77784) be assigned a global period of ``XXX'',
which will permit separate payment each time the services are provided
and allow payment to be based on the actual service(s) provided. We
will request that the RUC revalue the work RVUs and the PE inputs for
these services if a change in the global period is finalized. However
we are proposing, on an interim basis, to revise the work RVUs and PE
inputs to reflect the removal of the postoperative visit, CPT code
99212, that is currently assigned to these services. The proposed
interim work RVUs for these services would be as follows:
77781 = 1.21
77782 = 2.04
77783 = 3.27
77784 = 5.15
We are also proposing to delete the registered nurse (RN) time in
the post-service period as well as the patient gowns for the post-
service visit. We would also note that, to the extent that these
services are performed as staged procedures, providers may make use of
applicable modifiers.
2. Assignment of RVUs to CPT Codes for Proton Beam Treatment Delivery
Services
We have received a request to assign PE inputs for the non-facility
setting to Proton Beam treatment delivery services represented by CPT
codes 77520 through 77525.
These services are currently carrier-priced; therefore, payment in
the facility or non-facility setting is established by each carrier. To
the extent that physicians and suppliers wish to have national RVUs
assigned for these services, there is an established process utilizing
the AMA-RUC to recommend work RVUs, as well as the direct PE inputs
used to compute the PE RVUs, to CMS. We would strongly encourage the
physicians and suppliers to use this established process, and would
also be
[[Page 48996]]
interested in receiving comments on this issue.
E. Deficit Reduction Act (DRA) Related Proposals
[If you choose to comment on issues in this section, please include
the caption ``DRA PROPOSALS'' at the beginning of your comments.]
The DRA of 2005 (Pub. L. 109-171), was enacted February 8, 2006 and
included provisions that affect the Medicare program. The following
section addresses the specific DRA provisions that are being addressed
in this proposed rule.
1. Section 5102--Proposed Adjustments for Payments to Imaging Services
Section 5102 of the DRA includes two provisions that affect payment
of imaging services under the Medicare physician fee schedule. The
first provision addresses payment for certain multiple imaging
procedures for CY 2007 and application of budget neutrality while the
second provision addresses limiting the payment amount under PFS to the
outpatient department (OPD) payment amount for the technical component
(TC) of certain imaging services.
(a) Payment for Multiple Imaging Procedures for 2007
In general, Medicare prices diagnostic imaging procedures in the
following three ways:
The professional component (PC) represents the physician's
interpretation (PC-only services are billed with the 26 modifier).
The TC represents PE and includes clinical staff,
supplies, and equipment (TC-only services are billed with the TC
modifier).
The global service represents both PC and TC.
As discussed in the CY 2006 PFS final rule with comment period (70
FR 70261), in the CY 2006 PFS proposed rule (70 FR 45764 through
46064), we had proposed to reduce payment for the TC of selected
diagnostic imaging procedures belonging to one of eleven imaging
families when the procedures are performed on contiguous body areas by
50 percent for CY 2006. However, in the final rule with comment period,
we stated that we would phase-in the 50 percent reduction over two
years, beginning with a 25 percent reduction in 2006. We also sought
additional data and comments on the appropriateness of 50 percent as
the final level of reduction. The reduction applies to the TC and the
technical portion of the global service, but does not apply to the PC
of the service. Currently, we make full payment for the highest priced
procedure and reduce payment for each additional procedure by 25
percent, when more than one procedure from the same imaging family is
performed during the same session on the same day.
As described in the CY 2006 PFS final rule with comment period, at
the time, the statute required us to make changes such as this in a
budget neutral manner, meaning that the estimated savings generated by
the application of the multiple imaging procedure payment reduction
were used to increase payment for other physician fee schedule
services. We increased the CY 2006 PE RVUs by 0.3 percent to offset the
estimated savings generated by the multiple imaging payment reduction
policy.
Subsequent to the publication of the CY 2006 PFS final rule with
comment period, section 5102(a) of the DRA (Multiple Procedure Payment
Reduction for Imaging Exempted From Budget Neutrality), required that
``effective for fee schedules established beginning with 2007, reduced
expenditures attributable to the multiple procedure payment reduction
for imaging under the final rule published by the Secretary in the
Federal Register on November 21, 2005 (42 CFR 405, et al.) insofar as
it relates to the physician fee schedules for 2006 and 2007'' are
exempted from the budget neutrality provision. As a result, we are
proposing to remove the 0.3 percent increase to the CY 2006 PE RVUs
from the CY 2007 PE RVUs in accordance with the statute.
In addition, in response to our request for data on the
appropriateness of the 50 percent reduction in the CY 2006 PFS final
rule with comment period (70 FR 70261), the ACR provided information
for 25 code combinations supporting a reduction of between 21 and 44
percent. Given the expected interaction between the multiple procedure
imaging policy and the further imaging payment reductions mandated by
section 5102(b) of the DRA described below, along with the new
information we have received from the ACR on the multiple imaging
procedure policy as it applies to common combinations of imaging
services, we believe it would be prudent to maintain the multiple
imaging payment reduction at its current 25 percent level while we
continue to examine the appropriate payment levels. Therefore, we are
proposing to continue the multiple imaging payment reduction for 2007
at the 25 percent level. We would proceed through future rulemaking in
the event we determine that revisions to the policy are warranted.
(b) Reduction in TC for Imaging Services Under the PFS to OPD Payment
Amount
Section 5102(b)(1) of the DRA amended section 1848 of the Act and
requires that, with respect to imaging services, if--
``(i) The technical component (including the technical component
portion of a global fee) of the service established for a year under
the fee schedule * * *, without application of the geographic
adjustment factor * * *, exceeds,
(ii) The Medicare OPD fee schedule amount established under the
prospective payment system for hospital outpatient department services
* * * for such service for such year, determined without regard to
geographic adjustment * * *, the Secretary shall substitute the amount
described in clause (ii), adjusted by the geographic adjustment factor
[under the PFS] * * *, for the fee schedule amount for such technical
component for such year.''
As required by the statute, for imaging services (described below)
furnished on or after January 1, 2007, we will cap the PFS payment
amount for the year (prior to geographic adjustment) by the CY 2007
outpatient prospective payment system (OPPS) payment amount (prior to
geographic adjustment). We will then apply the PFS geographic
adjustment to the capped payment amount.
Section 5102(b)(2) of the DRA exempts the estimated savings from
this provision from the PFS budget neutrality requirement. Section
5102(b)(1) of the DRA defines imaging services as ``* * * imaging and
computer-assisted imaging services, including X-ray, ultrasound
(including echocardiography), nuclear medicine (including positron
emission tomography), magnetic resonance imaging, computed tomography,
and fluoroscopy, but excluding diagnostic and screening mammography.''
In order to apply section 5102(b) of the DRA, we needed to
determine the CPT and alpha-numeric HCPCS codes that fall within the
scope of ``imaging services'' defined by the DRA provision. In general,
we believe that imaging services provide visual information regarding
areas of the body that are not normally visible, thereby assisting in
the diagnosis or treatment of illness or injury. We began by
considering the CPT 7XXXX series codes for radiology services and then
adding in other CPT codes and alpha-numeric HCPCS codes that describe
imaging services. We then excluded nuclear medicine services that were
either non-imaging diagnostic or treatment services. We also excluded
all
[[Page 48997]]
codes for unlisted procedures, since we would not know in advance of
any specific clinical scenario whether or not the unlisted procedure
was an imaging service. We excluded all mammography services,
consistent with the statute. We excluded radiation oncology services
that were not imaging or computer-assisted imaging services. We also
excluded all HCPCS codes for imaging services that are not separately
paid under the OPPS since there would be no corresponding OPPS payment
to serve as a TC cap. We excluded any service where the CPT code
describes a procedure for which fluoroscopy, ultrasound, or another
imaging modality is either included in the code whether or not it is
used or is employed peripherally in the performance of the main
procedure, for example, 31622 for bronchoscopy with or without
fluoroscopic guidance and 43242 for upper gastrointestinal endoscopy
with transendoscopic ultrasound-guided intramural or transmural fine
needle aspiration/biopsy(s). In these cases, we are unable to clearly
distinguish imaging from non-imaging services because, for example, a
specific procedure may or may not utilize an imaging modality, or the
use of an imaging technology cannot be segregated from the performance
of the main procedure. Note that we included carrier priced services
since these services are within the statutory definition of imaging
services and are also within the statutory definition of PFS services
(that is, carrier-priced TCs of PET scans).
Our proposed list of codes that identify imaging services defined
by the DRA OPPS cap provision can be found in Addendum F to this
proposed rule. Note that this is the list of imaging services for which
we propose to make the comparison between the PFS TC payment amount and
the OPPS payment amount used to establish OPD payment. Payment for an
individual service on this list would only be capped if the PFS TC
payment amount exceeds the OPPS payment amount.
To the extent changes are made to codes for services already on the
list, we propose to update the list through program instructions to our
contractors. To the extent that the same imaging service is coded
differently under the PFS and the OPPS, we propose to crosswalk the
code under the PFS to the appropriate code under the OPPS that could be
reported for the same service provided in the hospital outpatient
setting. Our proposed list of crosswalks is below:
------------------------------------------------------------------------
MFS code Descriptor OPPS code Desc
------------------------------------------------------------------------
74185........ Mri angio, abdom w or C8900....... MRA w/cont, abd.
w/o dye.
76093........ Magnetic image, C8905....... MRI w/o fol w/cont,
breast. brst, un.
76094........ Magnetic image, both C8908....... MRI w/o fol w/cont,
breasts. breast.
71555........ Mri angio chest w or C8909....... MRA w/cont, chest.
w/o dye.
73725........ Mr ang lwr ext w or w/ C8912....... MRA w/cont, lwr ext.
o dye.
72198........ Mr angio pelvis w/o & C8918....... MRA w/cont, pelvis.
w/dye.
------------------------------------------------------------------------
(c) Interaction of the Multiple Imaging Payment Reduction and the OPPS
Cap
For CY 2007 imaging services potentially subject to both the
multiple imaging reduction and the OPPS cap, we propose to first apply
the multiple imaging payment reduction and then apply the OPPS cap to
the reduced amount as illustrated in the following example.
----------------------------------------------------------------------------------------------------------------
25%
Pre-OPPS Multiple OPPS cap Final MPFS
HCPCS cap MPFS imaging rate payment
rate reduction
----------------------------------------------------------------------------------------------------------------
7XXX1....................................................... $341.89 $256.42 $316.55 $256.42
7XXX2....................................................... 552.86 414.65 391.83 391.83
----------------------------------------------------------------------------------------------------------------
We considered first applying the OPPS cap and then applying the
multiple procedure reduction. However, as indicated in the CY 2006 OPPS
final rule, we received public comments suggesting that the OPPS
payment rates may implicitly include at least some multiple imaging
discount. While we continue to examine this issue, we believe the most
appropriate policy is to apply the multiple imaging payment reduction
prior to the application of the OPPS cap.
2. Section 5107--Revisions to Payments for Therapy Services
Section 1833(g) of the Act applies an annual per beneficiary
combined cap beginning January 1, 1999, on outpatient physical therapy
and speech-language pathology services and a similar separate cap on
outpatient occupational therapy services. These caps apply to expenses
incurred for the respective therapy services under Medicare Part B,
with the exception of outpatient hospital services. The caps were in
effect from January 1, through December 31, 1999, from September 1,
2003 through December 7, 2003, and beginning January 1, 2006. In 2000
through 2002, and from December 8, 2003 through December 31, 2005, the
Congress placed moratoria on implementation of the caps. Section
1833(g)(2) of the Act provides that, for 1999 through 2001, the caps
were $1500, and for years after 2001, the caps are equal to the
preceding year's cap increased by the percentage increase in the
Medicare Economic Index (MEI) (except that if an increase for a year is
not a multiple of $10, it is rounded to the nearest multiple of $10).
We implemented the separate statutory limits of $1740 for
outpatient physical therapy and speech-language pathology services and
$1740 for occupational therapy on January 1, 2006. The DRA of 2005 was
enacted on February 8, 2006. Section 5107(a) of the DRA required the
Secretary to develop an exceptions process for the therapy caps
effective January 1, 2006. The exceptions process applies only to
expenses incurred in 2006. Details of the exceptions process were
published in a manual change on February 13, 2006 (CR4364). The change
request
[[Page 48998]]
consists of three transmittals with current numbers of--
Transmittal 855, CR 4364, Pub. L. 100-04;
Transmittal 47, CR 4365, Pub. L. 100-02; and
Transmittal 140, CR 4364, Pub. L. 100-08.
The transmittals are available on our Web site at http://www.cms.hhs.gov/Transmittals/
.
In accordance with the statute, the therapy caps will remain in
effect, but without the exceptions process, with respect to expenses
incurred beginning on January 1, 2007. The dollar amount of the therapy
caps in 2007 will be the 2006 rate ($1740) increased by the percentage
increase in the MEI. As noted above, under current law, the exceptions
process will not apply to therapy services incurred after December 31,
2006, but the therapy caps will remain inapplicable to therapy services
provided in the outpatient hospital setting as provided in section
1833(g) of the Act.
Section 5107(b) of the DRA requires the Secretary to implement, by
July 1, 2006, edits for clinically illogical combinations of procedure
codes and other edits in order to limit inappropriate payment for
therapy services. In January 2006, we implemented Correct Coding
Initiative (CCI) edits for the therapy providers that bill to the
fiscal intermediaries, thus, addressing the section 5107 of the DRA
requirement with respect to edits for clinically illogical combinations
of procedure codes. Adoption of these code edits ensures that these
providers of outpatient Part B therapy services, including SNFs,
comprehensive outpatient rehabilitation facilities, certain outpatient
physical therapy and speech-language therapy providers (rehabilitation
agencies) and home health agencies (HHAs) (where beneficiary is not
under a Part A plan of care) meet the same CCI edit requirements as
those that have been in place for physicians, private practice
therapists, and OPPS hospitals. We are considering the implementation
of other edits in the future to further address concerns about
inappropriate payment for therapy services.
3. Section 5112-Proposed Addition of Ultrasound Screening for Abdominal
Aortic Aneurysm (AAA)
Section 5112 of the DRA of 2005 amended section 1861 of the Act to
provide for coverage under Part B of ultrasound screening for AAAs,
effective for services furnished on or after January 1, 2007, subject
to certain eligibility and other limitations. This screening test will
be available even if the qualifying patient does not present signs or
symptoms of disease or illness.
To conform the regulations to the statutory requirements of section
5112 of the DRA, we are proposing to include an exception in Sec.
411.15(a)(1) to permit coverage for ultrasound screening for AAAs that
meet the conditions for coverage that we are proposing to specify under
new Sec. 410.19(b) (Conditions for coverage of an ultrasound screening
for abdominal aortic aneurysms). We are also adding a new Sec.
411.15(k)(12).
As provided in the DRA, this new coverage allows payment for a one-
time only screening examination. We are proposing to add new Sec.
410.19(b) to provide for the coverage of the screening examinations for
AAAs as specified in section 5112 of the DRA. We are also proposing to
add new Sec. 410.19(c) (Limitation on coverage of ultrasound screening
for abdominal aortic aneurysms.) to provide the limitation on coverage
for an individual who is not an eligible beneficiary as defined in
proposed new Sec. 410.19(a).
We are proposing definitions set forth in new Sec. 410.19(a) of
this proposed rule that would be included to implement the statutory
provisions and to help the reader in understanding the provisions of
this regulation. The proposed definitions include the following terms:
Eligible beneficiary.
Ultrasound screening for abdominal aortic aneurysms.
Specifically, section 5112(a)(1) of the DRA amended section 1861 of
the Act to provide that coverage of ultrasound screening for AAAs will
be available for an individual--(i) who receives a referral for such an
ultrasound screening as a result of an initial preventive physical
examination (as defined in section 1861(ww)(1) of the Act); (ii) who
has not been previously furnished such an ultrasound screening under
this title; and (iii) who has a family history of AAA or manifests risk
factors included in a beneficiary category recommended for screening by
the United States Preventive Services Task Force regarding AAAs.
Section 5112(a)(2) of the DRA also adds a definition of the term
``ultrasound screening for an Abdominal Aortic Aneurysm'' to mean,
``(1) a procedure using sound waves (or other procedures using
alternative technologies, of commensurate accuracy and cost, that the
Secretary may specify) provided for the early detection of abdominal
aortic aneurysm; and (2) includes a physician's interpretation of the
results of the procedure.''
In developing the proposed rule based on this provision, we
reviewed the 2005 United States Preventive Services Task Force (USPSTF)
recommendations and related material on ultrasound screening for AAAs.
This includes--
A recommendation for a one-time ultrasound screening for
men aged 65 to 75 who have smoked at least 100 cigarettes in their
lifetime;
No recommendation for or against ultrasound screening for
AAAs for men who have not smoked at least 100 cigarettes in their
lifetime; and
A recommendation against routine screening for AAAs in
women.
Based on the statutory language and the USPSTF recommendations
outlined above, we are proposing to define the term ``eligible
beneficiary'' for coverage of ultrasound screening examinations for AAA
to mean an individual who--
Has received a referral for an ultrasound screening as a
result of an initial preventive physical examination (as defined in
section 1861(ww)(1) of the Act);
Has not been previously furnished such a covered
ultrasound screening examination under the Medicare program; and
Is included in at least one of the following risk
categories:
+ Has a family history of an AAA; or
+ Is a man age 65 to 75 years who smoked at least 100 cigarettes in
his lifetime; or
+ Is an individual who manifests other risk factors that are
described in a benefit category recommended by the USPSTF regarding an
AAA that has been determined by the Secretary through the NCD process.
To facilitate our consideration of possible expansions of coverage
in the future for identifying (1) other risk factors in a benefit
category recommended for screening for the early detection of AAAs by
the USPSTF, and (2) alternative screening technologies to ultrasound
screening for AAAs of commensurate accuracy and cost, we are proposing
to add language to our regulations that would allow us to make
determinations through the NCD process. The NCD process would allow the
Secretary to expand coverage more quickly following an assessment of
those subjects than is possible under the standard rulemaking process.
We intend to use the NCD process, which includes an opportunity for
public comments, for evaluating the medical and scientific issues
relating to the coverage of alternative screening technologies and the
identification of other risk factors for AAAs recommended by the USPSTF
that may be brought to our attention in the future. Use of an NCD to
establish
[[Page 48999]]
a change in the scope of benefits is authorized by section 1871(a)(2)
of the Act. An aggrieved party can challenge an NCD under the
procedures established by section 1869(f) of the Act. These proposed
coverage provisions would be set forth in proposed new Sec. 410.19
(a)(1)(i) and Sec. 410.19(a)(2)(iii)(C).
Section 5112(b) of DRA also amended section 1861(ww)(2) of the Act
(the initial preventive physical examination benefit) by adding the new
ultrasound screening benefit to the list of preventive services for
which physicians and other qualified nonphysician practitioners must
provide ``education, counseling and referral'' to new beneficiaries who
take advantage of the initial preventive physical examination benefit
within the first 6 months after the effective date of their first Part
B coverage period. Therefore, we are also proposing to amend Sec.
410.16(a)(7) of the regulations so that it reflects the additional
responsibilities that physicians and qualified nonphysician
practitioners will have under the initial preventive physical
examination benefit with respect to the new ultrasound screening
benefit.
Beginning January 1, 2007, we are proposing to pay for ultrasound
screening for AAAs through the use of a new HCPCS code GXXX1,
Ultrasound, B-scan and/or real time with image documentation; for
abdominal aortic aneurysm (AAA) screening. We are proposing that
payment for this service be made at the same level as CPT code 76775
Ultrasound, retroperitoneal (e.g., renal, aorta, nodes), B-scan and/or
real time with image documentation; limited. CPT code 76775 is used to
bill for the service when it is provided as a diagnostic test, and we
believe the service associated with the proposed HCPCS code reflects
equivalent resources and work intensity to those contained in CPT code
76775.
In addition, since the DRA provides that the Medicare Part B
deductible will not apply with respect to ultrasound screening for
abdominal aortic aneurysm (as defined in section 1861(bbb) of the Act),
we are proposing to revise Sec. 410.160 to include an exception from
the Medicare Part B deductible for the ultrasound screening for
abdominal aortic aneurysm as described in proposed Sec. 410.19.
(Conditions for coverage of an ultrasound screening for abdominal
aortic aneurysms.)
4. Section 5113--Proposed Non-Application of the Part B Deductible for
Colorectal Cancer Screening Tests
Current Medicare policy requires that, with limited exceptions,
incurred expenses for covered part B services are subject to, and count
toward meeting the Part B annual deductible. Section 5113 of the DRA
amended section 1833(b) of the Act to provide for an exception to the
application of the Part B deductible with respect to colorectal cancer
screening tests. Beginning January 1, 2007, colorectal cancer screening
services, as described in section 1861(pp)(1) of the Act, are no longer
subject to the Part B deductible. The conditions for and limitations on
coverage for colorectal cancer screening tests under Medicare part B
are described in Sec. 410.37.
To conform our regulations to this statutory change, we are
proposing to revise Sec. 410.160 to include an exception from the Part
B annual deductible for the colorectal cancer screening services
described in Sec. 410.37.
5. Section 5114--Proposed Addition of Diabetes Outpatient Self-
Management Training Services (DSMT) and Medical Nutrition Therapy (MNT)
for the FQHC Program
Section 5114 of the DRA amended section 1861(aa)(3) of the Act to
add DSMT and MNT services to the list of Medicare covered and
reimbursed services under the Medicare FQHC benefit, effective for
services provided on or after January 1, 2006. Although this statutory
change has already been implemented in administrative instructions, we
are proposing to conform the regulations to the new statutory
requirement.
FQHCs certified as DSMT and MNT providers have been allowed to
bundle the cost of those services into their FQHC payment rates. But
before the enactment of the DRA, the provision of these services would
not generate a separate FQHC visit payment. Effective for services
furnished on or after January 1, 2006, FQHCs that are certified
providers of DSMT and MNT services can receive per visit payments for
covered services furnished by registered dietitians or nutrition
professionals. In other words, if all relevant program requirements are
met, these services are included under the Medicare FQHC benefit as
billable visits.
In order to conform the regulations, we are proposing to amend
Sec. 405.2446(b) to expand the scope of FQHC services to include
certified providers of DSMT and MNT services by adding a new paragraph
(10). We are also proposing to revise Sec. 405.2463 by--
Revising paragraph (a) to expand the definition of an FQHC
visit to include certified providers of DSMT and MNT services under new
sub-paragraph (a)(1)(ii)(B). We would also revise the definition of an
RHC visit in new subparagraph (a)(1)(i) to include a face-to-face
encounter between a patient and a clinical psychologist or clinical
social worker to conform to statutory language at section
1861(aa)(1)(B) of the Act. We are also proposing to redesignate and
revise paragraphs (b) and (c) as new paragraphs (a)(2) and (a)(3),
respectively.
We are proposing to incorporate paragraph (a)(2) into
(a)(1), and to redesignate and revise current paragraph (a)(3) as new
paragraph (b). We would also clarify that it is generally permissible
for both FQHCs and Rural Health Clinics to furnish, when necessary,
most types of medical and other health visits on the same day to the
same patient. We are also proposing to amend this paragraph to permit a
separate additional FQHC visit for DSMT and MNT services (which may
occur on the same date of service when the beneficiary receives care
from their FQHC physician or non-physician practitioner) when
reasonable and necessary, consistent with the Congressional mandate
under section 5114 of the DRA to provide coverage and adequate access
to these services in the FQHC setting.
We are proposing to redesignate and revise current
paragraph (a)(4) as new paragraph (c).
F. Proposed Payment for Covered Outpatient Drugs and Biologicals (ASP
Issues)
[If you choose to comment on issues in this section, please include
the caption ``ASP Issues'' at the beginning of your comments.]
Medicare Part B covers a limited number of prescription drugs and
biologicals. For the purposes of this proposed rule, the term ``drugs''
will hereafter refer to both drugs and biologicals. Medicare Part B
covered drugs not paid on a cost or prospective payment basis generally
fall into the following three categories:
Drugs furnished incident to a physician's service.
DME drugs.
Drugs specifically covered by statute (certain
immunosuppressive drugs, for example).
Beginning in CY 2005, the vast majority of Medicare Part B drugs
not paid on a cost or prospective payment basis are paid under the ASP
[[Page 49000]]
methodology. The ASP methodology is based on data submitted to us
quarterly by manufacturers. In addition to the payment for the drug,
Medicare currently pays a furnishing fee for blood clotting factors, a
dispensing fee for inhalation drugs, and a supplying fee to pharmacies
for certain Part B drugs.
In January 2006, the drug coverage available to Medicare
beneficiaries expanded with the implementation of Medicare Part D. The
Medicare Part D program does not change Medicare Part B drug coverage.
This section of the preamble discusses proposed changes and issues
related to the determination of the payment amounts for covered Part B
drugs and furnishing blood clotting factor. This section also discusses
proposed changes to how manufacturers calculate and report ASP data to
us.
1. ASP Issues
Section 303(c) of the MMA amended Title XVIII of the Act by adding
new section 1847A. This new section revised the payment methodology for
the vast majority of drugs and biologicals not paid on a cost or
prospective payment basis furnished on or after January 1, 2005. The
ASP reporting requirements are set forth in section 1927(b) of the Act.
Manufacturers must submit ASP data for each 11-digit National Drug Code
(NDC) to us quarterly. The manufacturers' submissions are due to us not
later than 30 days after the last day of each calendar quarter. The
methodology for developing Medicare drug payment allowances based on
the manufacturers' submitted ASP data is specified in the regulations
in part 414, subpart K. We update the Part B drug payment amounts
quarterly based on the data we receive.
In this section of the preamble, we discuss our intent to issue a
final rule to implement the provisions in the MMA related to the
calculation and submission of manufacturers' ASP data, and seek further
comments on specific issues related to price concessions and certain
fees.
On April 6, 2004, we published the Manufacturer's Submission of
Average Sales Price Data for Medicare Part B Drugs and Biologicals
(ASP) interim final rule with comment period (IFC) (69 FR 17935) to
implement the ASP calculation and reporting requirements. Manufacturers
were required to submit their initial quarterly ASP data to us shortly
thereafter, beginning April 30, 2004. We received comments from drug
manufacturers, pharmacies, physicians, national associations of the
pharmaceutical industry, national associations of physicians, and
consultants. These comments addressed a variety of aspects of
calculating and reporting ASPs. On September 16, 2004, we published the
Manufacturer's Submission of Average Sales Price Data for Medicare Part
B Drugs and Biologicals (ASP) final rule (69 FR 55763) addressing only
the comments pertaining to the methodology for estimating lagged price
concessions. We have also addressed ASP calculation and reporting
requirements in other proposed and final rules and information
collection notices, including rulemaking to implement the Competitive
Acquisition Program for Part B Drugs and Biologicals (CAP). (See 70 FR
39069, 70 FR 45842, 70 FR 70215, and 70 FR 70477.) In addition, we
posted official agency guidance, including responses to frequently
asked questions, on our Web site to implement the ASP provisions in
accordance with section 1847A(c)(5)(C) of the Act.
We intend to publish a final rule addressing comments on the April
6, 2004 IFC in the near future. We may publish the final rule as part
of this rulemaking, or we may publish a separate final rule, in either
case after the close of the comment period for this proposed rule.
Because the comments received during the comment period in response to
the April 6, 2004 IFC were made during the initial months of
manufacturers' experience with calculating and reporting ASPs and prior
to publication of payment amounts based on the ASP methodology, we
believe there is good reason to provide the public with the opportunity
for additional comments based on what is now more than a year and a
half of experience with the ASP reporting requirements. Therefore, we
seek comments on the ASP reporting provisions in the April 6, 2004 IFC.
In particular, we seek comments on the issues discussed in the sections
below.
We note that we received many comments in response to the April 6,
2004 interim final rule on the use and potential impacts of the ASP
payment methodology. As noted above, we are reopening the comment
period on the issue of ASP reporting. Thus, comments about the use or
appropriateness of the ASP payment methodology are outside the scope of
this rulemaking and the ASP reporting rule (CMS-1380-IFC). Therefore,
comments about the appropriateness and use of 106 percent of ASP as the
basis for the Medicare Part B drug payment rates will be outside the
scope of the comments considered for the final ASP reporting rule we
are preparing to publish.
a. Fees Not Considered Price Concessions
Section 1847A(c)(5)(A) of the Act states that the ASP is to be
calculated by the manufacturer on a quarterly basis. As a part of that
calculation, manufacturers are to take into account price concessions
such as--
Volume discounts;
Prompt pay discounts;
Cash discounts;
Free goods that are contingent on any purchase
requirement;
Chargebacks; and
Rebates (other than rebates under the Medicaid drug rebate
programs).
If the data on these price concessions are lagged, then the
manufacturer is required to estimate costs attributable to these price
concessions using the required ratio methodology as specified in 42 CFR
part 414, subpart J, Sec. 414.804(a)(3).
Among the comments from drug manufacturers and national
associations representing wholesalers and distributors, we received
requests for clarification and detailed guidance on the treatment of
administrative fees, service fees and fees paid to pharmacy benefit
managers (PBMs) in the ASP calculation. We posted guidance on our Web
site (http://questions.cms.hhs.gov/cgi-bin/ cmshhs.cfg/php/enduser/
std--adp.php?p --faqid=3323&p-- created=1095344721& p--sid=Ghuscgci&p--
accessibility=0& p--lva=&p-- sp=cF9zcmNoPTEmcF9zb3J
0X2J5PSZwX2dyaWRzb3J0 PSZwX3Jvd19jbnQ9M zEmcF9wcm9kcz04LD U2LDYwNCZwX2N
hdHM9JnBfc HY9My42MDQ mcF9jdj0mcF9zZWFyY 2hfdHlwZT1hb nN3ZXJzLnNl
YXJjaF9ubCZw X3BhZ2U9MQ**& p--li=& p--topview=1) to clarify that in the
absence of specific guidance in the Social Security Act or Federal
regulations, the manufacturer may make reasonable assumptions in its
calculations of ASP, consistent with the general requirements and
intent of the Social Security Act, Federal regulations, and its
customary business practices. These assumptions should be submitted
along with the ASP data. In December 2004, we posted further guidance
on our website addressing service fees and administrative fees paid to
buyers (http://questions.cms.hhs.gov/ cgi-bin/cmshhs.cfg/php/enduser/
std--adp.php?p-- faqid=3318&p-- created=1095343992& p--sid=a2qUcgci
&p--accessibility=0&p --lva=&p --sp=cF9zcmNoPTEmc F9zb3J0X2J5PSZ
wX2dyaWRzb3J0PSZ wX3Jvd19jbnQ9Mz EmcF9wcm9kcz04LDU2LDY wNCZwX2NhdHM9
[[Page 49001]]
JnBfcHY9 My42MDQmcF9jdj0 mcF9zZWFyY2hfdH lwZT1hbnN3ZXJzLnNlYXJ
jaF9ubCZwX3BhZ2U9MQ **&p--li=&p --topview=1 and http://questions.cms.hhs.gov/
cgi-bin/cmshhs.cfg/php/ enduser/std--adp.
php?p--faqid=4136&p --created=1109786814 &p--sid=bxw-cgci &p--
accessibility=0 &p--lva=& p--sp=cF9zcmNoPTE mcF9zb3J0X2J5PSZwX2
dyaWRzb3J0PSZwX3Jvd19jbn Q9MzEmcF9wcm9kcz04LDU2LDY
wNCZwX2NhdHM9JnBfcHY9 My42MDQmcF9jdj0mcF9zZWFyY2hfd
HlwZT1hbnN3ZXJzLnNlYXJjaF9 ubCZwX3BhZ2U9MQ**&p --li=&p--topview=1).
On July 6, 2005, we restated our guidance on service fees in the
preamble of the Competitive Acquisition of Outpatient Drugs and
Biologicals Under Part B (CAP) interim final rule with comment (70 FR
39069). Subsequently, we have received requests for clarification on
how fees paid to entities such as group purchasing organizations (GPOs)
or PBMs must be treated for purposes of the ASP calculation.
We propose to further clarify in the final ASP reporting rule that,
beginning with the ASP reporting for sales during the first calendar
quarter of 2007, bona fide service fees that are paid by a manufacturer
to an entity, whether or not the entity takes title to the drug, are
not considered price concessions under Sec. 414.804(a)(2) insofar as,
and to the extent that, they satisfy the definition of a bona fide
service fee that we are proposing at Sec. 414.802. In Sec. 414.802,
we propose to define bona fide service fees as fees paid by a
manufacturer to an entity that represent fair market value for a bona
fide, itemized service actually performed on behalf of the manufacturer
that the manufacturer would otherwise perform (or contract for) in the
absence of the service arrangement, and that are not passed on, in
whole or in part, to a client or customer of an entity, whether or not
the entity takes title to the drug. Our current guidance, which
provides that bona fide service fees means expenses that would have
generally been paid for by the manufacturer at the same rate had these
services been performed by other entities, would continue unless we
provide an alternative approach as discussed below. Further, we propose
to clarify in the final ASP reporting rule that fees, including service
fees, administrative fees and other fees, paid to GPOs or PBMs are not
considered price concessions under Sec. 414.804(a)(2) insofar as, and
to the extent that, they satisfy the definition of a bona fide service
fee that we have proposed at Sec. 414.802.
In comments on the April 6, 2004 IFC, groups representing
wholesalers, distributors and specialty pharmacies provided some
insight into the types of activities that are performed in the
distribution of drugs. These commenters suggested that costs for
handling, storage, inventory reporting, shipping, receiving, patient
education, disease management and data should be borne by manufacturers
and be excluded from the ASP calculation as bona fide services.
However, these commenters did not provide detailed information about
whether and how one would determine the extent to which these
activities are bona fide services actually performed on behalf of the
manufacturer or otherwise.
Because the scope of appropriate services may vary across
categories of drugs, we are considering providing guidance on the types
of services that may qualify as bona fide services for purposes of the
ASP calculation. We are also considering providing further guidance on
or revising the approach or methodology manufacturers must use to
determine the fair market value of bona fide services performed on
their behalf and whether the service fee paid was passed on in whole or
in part. In either case, we may implement our policy through rulemaking
or through program instruction or other guidance (consistent with our
authority under section 1847A(c)(5)(C) of the Act).
We seek comments on the specific types of services entities perform
on behalf of manufacturers that a manufacturer would otherwise perform
(or contract for) and the necessity of those services in the efficient
distribution of drugs. We also seek comments on activities that should
not be considered bona fide services performed on behalf of
manufacturers. To better understand which services may be considered
bona fide services performed on behalf of the manufacturer that the
manufacturer would otherwise perform (or contract for), we seek to
understand the bona fide services that may be appropriate for all or
specific types of products, as well as the specific services that may
be applicable to unique products or circumstances. We also seek to
understand the costs and relative costs of services performed on behalf
of manufacturers.
To exclude a bona fide service fee from the ASP calculation, a
manufacturer must determine whether the fee paid to an entity
represents fair market value for a bona fide service actually performed
on behalf of the manufacturer that the manufacturer would otherwise
perform (or contract for), and that the fee is not passed on, in whole
or in part, to a client or customer of the entity. Our current guidance
provides that bona fide service fees means expenses that would have
generally been paid for by the manufacturer at the same rate had these
services been performed by other entities. We seek comments on
appropriate additional guidance or alternative methods for determining
fair market value for purposes of identifying bona fide service fees
that are excluded from the calculation of ASP, as well as comments on
whether, and the extent to which, fees tied to performance of a
service, fixed fee, revenue generated by product sales, or other basis
may represent fair market prices for purposes of identifying bona fide
service fees that are excluded from the calculation of ASP. In
addition, we seek comments on the appropriate methods for determining
whether a fee is passed on in whole or in part. We also seek comments
on how Medicare's guidance on the treatment of service fees for ASP
calculation purposes may differ with the treatment of service fees for
financial accounting or other purposes, and any implications that this
may have for manufacturers.
b. Estimation Methodology for Lagged Exempted Sales
Section 1847A(c)(2) of the Act requires manufacturers to exclude
from the calculation of ASP those sales that are exempt from the
Medicaid best price (BP) calculation (for example, Federal sales, sales
to State pharmacy assistance programs, sales to a prescription drug
plan for use under Medicare Part D). In the comments on the April 6,
2004 IFC, commenters requested more guidance on the method
manufacturers should use to exclude exempted sales that are known on a
lagged basis. Manufacturers identify exempted sales based on direct
sales and through chargeback and rebate data that may not be
sufficiently available at the time the ASP is calculated. In the
absence of specific guidance on how to account for lagged exempted
sales (that is, exempted sales identified through chargeback or rebate
processes), manufacturers have relied upon assumptions in accordance
with their customary business practices to develop their approach for
excluding these sales from the ASP calculation. In our work with
manufacturers that submit ASP data, we understand that some
manufacturers have used a ratio methodology for estimating exempted
sales known on a lagged basis which is similar to the ratio methodology
manufacturers must use to estimate
[[Page 49002]]
price concessions known on a lagged basis.
To establish a uniform approach, in Sec. 414.804(a)(4), we propose
to require, in the final ASP reporting rule, that all manufacturers use
a 12-month (or less, if applicable) rolling average ratio methodology
to estimate exempted sales known on a lagged basis (through chargebacks
or rebates) in order to more accurately exclude these sales from the
ASP calculation. Specifically, for exempted sales known on a lagged
basis, the manufacturer sums the lagged exempted sales for the most
recent 12-month period available (or the number of months the NDC has
been sold for NDCs with less than 12 months of sales, except for
redesignated NDCs as described in section d below). The manufacturer
then calculates a percentage using this summed amount as the numerator
and the sales (the number of units after non-lagged exempted sales have
been subtracted from total sales) for the same period (12 months or
less, if applicable) as the denominator. The result is a rolling
average percentage estimate for lagged exempted sales that is applied
to the sales (the number of units after non-lagged exempted sales have
been subtracted from total sales) for the quarter being reported. The
product that results from multiplying the rolling average percentage
estimate of lagged exempted sales and sales (the number of units after
non-lagged exempted sales have been subtracted from total sales)
determines the number of lagged exempted sales (in units) to be
excluded from the denominator of the ASP calculation. Manufacturers
must make a corresponding adjustment to the numerator of the ASP
calculation to ensure that the total in dollars for the reporting
quarter does not include revenue related to lagged exempted sales
excluded from the denominator using the proposed estimation
methodology. Further, manufacturers must remove the dollar value of
lagged exempted sales from their estimates of lagged price concessions
by subtracting the dollar value of estimated lagged exempted sales from
the denominator as specified in Sec. 414.804(a)(3)(i).
Our proposed methodology for excluding lagged exempted sales is
similar to the methodology manufacturers are required to use to
estimate price concessions known on a lagged basis, and was recommended
by manufacturers. We believe requiring similar methods to estimate both
lagged exempted sales and lagged price concessions is reasonable and
reduces potential errors in the manufacturers' ASP calculations, while
ensuring that exempted sales are appropriately removed from the ASP
calculation. In addition, using an estimation methodology to remove
lagged exempted sales reduces the likelihood of quarter to quarter
variations in the ASP.
We seek comments on the proposed methodology for excluding exempted
sales known on a lagged basis from the ASP calculation and estimate of
lagged price concessions. We also solicit suggestions on appropriate
alternative methodologies that may be less complex.
c. Nominal Sales
Section 1847A(c)(2)(B) of the Act requires manufacturers to exclude
from the ASP calculation sales that are merely nominal in amount, as
applied for purposes of section 1927(c)(1)(C)(ii)(III) of the Act,
except as the Secretary may otherwise provide. Effective January 1,
2007, the DRA (Pub. L. 109-171) modifies section 1927(c)(1)(C)(ii)(III)
of the Act. Limitations on nominal sales have been added in new section
1927(c)(1)(D) of the Act. The DRA also modified the average
manufacturer price (AMP) calculation and frequency of AMP reporting.
Therefore, we are proposing to clarify the method manufacturers must
follow, beginning in 2007, to identify nominal sales for ASP reporting
purposes and to exclude nominal sales from the calculation of the ASP.
We also are seeking comments on whether we should establish an
alternative definition of nominal sales for ASP purposes.
In the preamble to the ASP reporting interim final rule, we stated
sales to an entity that are nominal in amount are defined in the
Medicaid drug rebate agreement (see sample agreement at http://www.cms.hhs.gov/MedicaidDrugRebateProgram/downloads/rebateagreement.pdf
). That is, for ASP purposes, a nominal sale is a
sale at a price less than 10 percent of the AMP in the same quarter for
which the AMP is computed. Effective January 1, 2007, the DRA revises
the AMP calculation (to omit customary prompt pay discounts extended to
wholesalers), added a monthly AMP reporting requirement, and
established limitations on nominal sales (only sales to certain
entities may qualify as nominal sales). Section 1927(c)(1)(D) of the
Act limits the nominal sales exclusion to nominal sales made to the
following entities:
340B covered entities as described in section 340B(a)(4)
of the Public Health Services Act (PHS Act).
Intermediate care facilities for the mentally retarded
(ICFs/MR).
State-owned or operated nursing facilities.
Any other facility or entity that the Secretary determines
is a safety net provider to which sales of such drugs at a nominal
price would be appropriate based on the factors described in section
1927(c)(1)(D)(ii) of the Act.
Because section 1847A(c)(2)(B) of the Act requires manufacturers to
exclude from the ASP calculation sales that are merely nominal in
amount, as applied for purposes of section 1927(c)(1)(C)(ii)(III) of
the Act, except as the Secretary may otherwise provide, the DRA changes
will have implications for ASP reporting beginning January 1, 2007
(unless we provide an alternative policy for determining nominal sales
as permitted under section 1847A(c)(2)(B) of the Act). One implication
is that the limitations set forth in section 1927(c)(1)(D) of the Act
will continue the exclusion of nominal sales to certain entities while
requiring that sales to entities not identified under section
1927(c)(1)(D) of the Act are included in the ASP calculation, even if
such sales are at very low prices. Another implication is the AMP
calculation will exclude customary prompt pay discounts extended to
wholesalers, yet prompt pay discounts will continue to be a type of
price concession that manufacturers must include in their ASP
calculations. The change in treatment of customary prompt pay discounts
extended to wholesalers in the AMP calculation may result in a higher
number of sales that are at less than 10 percent of the AMP than in
past ASP reporting periods (notwithstanding the new limitation on what
is considered a nominal sale under section 1927(c)(1)(D) of the Act).
Still another implication is that the frequency of AMP reporting will
include monthly reporting; thus, for ASP purposes, there is further
need to clarify how nominal sales are to be identified in 2007.
Separate Medicaid rulemaking will address the DRA provisions related to
AMP reporting.
We believe the DRA modifications to section 1927 of the Act noted
above will have minimal effect on reported ASPs. We would expect that
the exclusion of customary prompt pay discounts extended to wholesalers
from AMP would lead to a modest increase in AMP, and as a result a
modest increase in the number of sales that would qualify as nominal
under the current ASP reporting regulations. At the same time, we
anticipate that the limitation on nominal sales in section
1927(c)(1)(D) of the Act will result in a modest reduction in the
number of sales that qualify as nominal sales for
[[Page 49003]]
purposes of ASP reporting because we believe that the entities outlined
in section 1927(c)(1)(D) of the Act generally represent the types of
entities to which manufacturers may offer sales at a nominal amount.
Consequently, we would expect these two countervailing changes would
have a minimal overall impact on nominal sales that would be excluded
from the ASP calculation. For 2007 and beyond, we propose to revise
Sec. 414.804(a)(4) to clarify that manufacturers must continue to use
the Medicaid threshold (less than 10 percent of AMP) to determine
nominal sales that are excluded (subject to the limitations in section
1927(c)(1)(D) of the Act) from the ASP calculation. Further, we propose
that, in identifying nominal sales, manufacturers must use the AMP for
the calendar quarter that is the same calendar quarter for the ASP
reporting period. For these reasons, we are proposing to continue the
current methodology for identifying and excluding nominal sales (that
is, sales that are exempt from the Medicaid best price calculation
under section 1927(c)(1)(C)(ii)(III) of the Act) from the
manufacturer's calculation of the ASP. We believe this approach helps
maintain continuity in the ASP calculation and minimizes manufacturers'
reporting burden, as Medicare continues to follow the Medicaid approach
for identifying nominal sales and manufacturers can use a single method
for identifying nominal sales for both ASP and AMP purposes.
We seek comments on our proposal to continue use of the AMP as the
basis for identifying nominal sales excluded from the ASP calculation
and on whether an alternative threshold for identifying nominal sales
for ASP calculation purposes is necessary or desirable to ensure the
accuracy of the ASP payment methodology. Specifically, we seek comments
on whether sales at less than 10 percent of the ASP (instead of the
AMP) should be used to identify nominal sales for ASP purposes (with
the new requirement in section 1927(c)(1)(D) of the Act allowing only
sales to certain entities to be considered nominal sales still being
applicable). We also seek comments on our belief that the new
limitations on nominal sales and change to the AMP calculation will
have minimal impact on reported ASPs.
Subsequent to the April 6, 2004 IFC, we received requests for
clarification on a technical aspect related to the identification of
nominal sales. Specifically, some manufacturers have asked whether
nominal sales are identified by performing a series of calculations
once or whether the manufacturer repeats the series of calculations
until no remaining ASP eligible sales are below the nominal threshold.
Consistent with current Medicaid reporting, for 2005 and 2006,
manufacturers must identify nominal sales by performing the following
steps once:
The manufacturer calculates the AMP for the reporting
quarter to identify the dollar amount that represents 10 percent of the
AMP for that reporting period.
The manufacturer then identifies sales below this amount
and excludes these sales from the ASP calculation.
Beginning in 2007, the limitations in section
1927(c)(1)(D) of the Act must also be met to exclude the sale.
d. Other Price Concession Issues
In our ongoing work with manufacturers that submit ASP data, some
manufacturers have posed questions or raised concerns about how the
estimate of lagged price concessions is done prior to having 12 months
of data for a NDC and, when a product is redesignated with a new NDC,
whether price concessions from the prior NDC must be included in
calculating the ASP for the new NDC. Manufacturers and other
stakeholders have also asked us about how Medicare's ASP guidance
concerning price concessions is to be applied when drugs are sold under
bundling arrangements.
In response, we are proposing clarifications and seeking comment on
these issues.
(1) Price Concessions for NDCs With Less Than 12 Months of Sales
To address situations when a NDC with price concessions known on a
lagged basis has not been sold for a full 12 months, we propose to
revise Sec. 414.804(a)(3) to specify that the period used to estimate
lagged price concessions is the total number of months the NDC has been
sold. We propose to require that manufacturers use less than 12 months
of data in the estimation methodology for lagged price concessions for
NDCs with less than 12 months of sales (except when the manufacturer
has redesignated the product's NDC, as discussed below). Manufacturers
may include the current ASP reporting quarter in the most recent 12
month period (or less for NDCs with less than 12 months of sales) so
long as the manufacturer follows this approach in calculating the ASP
for all of its reported NDCs. Using less than 12 months in the
estimation methodology for lagged price concessions is consistent with
our proposal for estimating lagged excluded sales described in section
b. above.
(2) Redesignated NDCs
From time to time, a manufacturer may change the NDC assigned to a
specific product and package size while continuing or offering price
concessions that span across sales of the product under its prior and
redesignated NDCs. For example, an NDC may be changed to reflect a
change in the labeler code while lagged price concessions in place
under the prior NDC remain in effect and carry over to the redesignated
NDC. Another example would be a manufacturer that modifies its package
design or other non-drug feature of the NDC and assigns a new NDC to
reflect the revised packaging.
We propose to clarify in the final ASP reporting rule that, when an
NDC is changed (except when a product is repackaged or relabeled by a
different manufacturer or relabeler or is privately labeled) and lagged
price concessions offered for the prior NDC remain in effect, the
manufacturer must use 12 months (or the total number of months of sales
of the prior and redesignated NDCs if the total number of months of
sales is less than 12 months) of sales and price concession data from
the prior and redesignated NDCs to estimate lagged price concessions
applicable to the redesignated NDC. In establishing this methodology,
we are relying on our authority under section 1847A(c)(5)(A) of the
Act.
We seek comments on our proposed refinements to the estimation of
lagged price concessions for NDCs with less than 12 months of sales and
when a manufacturer redesignates the NDC assigned to a product. We also
solicit suggestions for potentially clarifying these policies further.
(3) Bundled Price Concessions
We have heard a few concerns about how Medicare's ASP guidance
concerning price concessions is to be applied when drugs are sold under
bundling arrangements (for example, when a purchaser's price for one or
more drugs is contingent upon the purchase of other drugs or items). We
would like to better understand how bundling affects sales of Part B
drugs and the ASP calculation, and any concerns stakeholders may have
on this issue. Therefore, we are soliciting comments on a number of
these issues. We note that we expect manufacturers of drugs reimbursed
by Medicare Part B to comply with all applicable laws, regulations, and
legal decisions including, but not limited to the Stark law, other
relevant anti-kickback laws,
[[Page 49004]]
antitrust laws, and laws governing fair trade practices. Our discussion
of this issue in this proposed rule should not be construed as an
endorsement or authorization of any pricing practices that contravene
any laws, legal decisions, or regulations.
Thus far, we have not provided specific guidance in the ASP context
on the issue of apportioning price concessions across drugs that are
sold under bundling arrangements. In the absence of specific guidance,
the manufacturer may make reasonable assumptions in its calculations of
ASP, consistent with the general requirements and the intent of the
Social Security Act, Federal regulations, and its customary business
practices. Manufacturers must include assumptions in their ASP
submissions. We are now considering providing guidance, through
rulemaking or through program instruction or other guidance (consistent
with our authority under section 1847A(c)(5)(C) of the Act) on the
methodology manufacturers must use for apportioning price concessions
across Part B drugs sold under bundling arrangements for purposes of
the calculation of ASP. As we consider this issue, our goal is to
ensure that the ASP is an accurate reflection of market prices for Part
B drugs and that the treatment of bundled price concessions in the ASP
calculation does not create inappropriate financial incentives.
We are soliciting comments on a number of issues, including how
frequently Part B drugs are sold under bundling arrangements, the
different structures of bundling arrangements that may exist (for
example, the number of products included in a bundling arrangement;
whether the price concessions are contingent on the purchase of only
one product, the purchase of multiple products, or the inclusion of one
or more products on a formulary; and the timing of the price
concessions), and the extent to which sales of Part B drugs are bundled
with sales of non-Part B drugs or non-drug products. We also seek
comment on what effect bundling arrangements may have on the ASP
calculation, on beneficiary access to high quality, appropriate care
(including access to drugs that may not have clinical alternatives),
and on costs to the Medicare program and beneficiaries. In addition, we
seek comments on whether additional guidance on apportioning bundled
price concessions for purposes of the calculation of ASP is needed and
potential methodologies that Medicare could consider requiring.
Furthermore, we seek comment on how variation in the structure of
bundling arrangements may affect the impact of potential apportionment
methodologies on the ASP calculation.
2. Clotting Factor Furnishing Fee
Section 303(e)(1) of the MMA added section 1842(o)(5) of the Act
which requires the Secretary, beginning in CY 2005, to pay a furnishing
fee, in an amount the Secretary determines to be appropriate, to
hemophilia treatment centers and homecare companies for the items and
services associated with the furnishing of blood clotting factor.
Section 1842(o)(5)(C) of the Act specifies that the furnishing fee for
clotting factor for years after CY 2006 and subsequent years will be
equal to the fee for the previous year increased by the percentage
increase in the consumer price index (CPI) for medical care for the 12
month period ending with June of the previous year. In the CY 2006 PFS
final rule, we announced that, based on the percentage increase in the
CPI of 4.2 percent for the 12-month period ending June 2005, the
furnishing fee is $0.146 per unit clotting factor for CY 2006.
The CPI data for the 12-month period ending in June 2006 is not yet
available. In the FY 2007 PFS final rule, we will include the actual
figure for the percent change in the CPI for medical care for the 12-
month period ending June 2006, and the updated furnishing fee for CY
2007 calculated based on that figure.
3. Widely Available Market Prices (WAMP) and AMP Threshold
Section 1847A(d)(1) of the Act states that ``the Inspector General
of HHS shall conduct studies, which may include surveys to determine
the widely available market prices (WAMP) of drugs and biologicals to
which this section applies, as the Inspector General, in consultation
with the Secretary, determines to be appropriate.'' Section 1847A(d)(2)
of the Act states that, ``Based upon such studies and other data for
drugs and biologicals, the Inspector General shall compare the ASP
under this section for drugs and biologicals with--
The widely available market price (WAMP) for these drugs
and biologicals (if any); and
The average manufacturer price (AMP) (as determined under
section 1927(k)(1) of the Act for such drugs and biologicals.''
Section 1847A(d)(3)(A) of the Act states that, ``The Secretary may
disregard the ASP for a drug or biological that exceeds the WAMP or the
AMP for such drug or biological by the applicable threshold percentage
(as defined in subparagraph (B)).'' The applicable threshold is
specified as 5 percent for CY 2005. For CY 2006 and subsequent years,
section 1847A(d)(3)(B) of the Act establishes that the applicable
threshold is ``the percentage applied under this subparagraph subject
to such adjustment as the Secretary may specify for the WAMP or the
AMP, or both.'' In CY 2006, we specified an applicable threshold
percentage of 5 percent for both the WAMP and AMP. We based this
decision on the limited data available to support a change in the
current threshold percentage.
For CY 2007, we propose to specify an applicable threshold
percentage of 5 percent for the WAMP and the AMP. At present, the OIG
is continuing its comparison of both the WAMP and the AMP. Since, at
this time we do not have data that suggest another level is more
appropriate, we believe that continuing the 5 percent applicable
threshold percentage for both the WAMP and AMP is appropriate.
There are a number of operational issues associated with Medicare's
authority to substitute a lower payment amount for a drug if the OIG
finds and informs the Secretary, at such times as the Secretary may
specify, that the ASP exceeds the WAMP or AMP by more than the
established threshold (currently 5 percent). We would welcome public
comment on operational issues such as the timing and frequency of the
ASP, AMP, and WAMP comparisons and effective date and duration of the
rate substitution.
4. Payment for Drugs Furnished During CY 2006 and Subsequent Years in
Connection With the Furnishing of Renal Dialysis Services if Separately
Billed by Renal Dialysis Facilities
In the November 21, 2005 PFS final rule (70 FR 70116), we stated
that payment for a drug furnished during CY 2006 in connection with
renal dialysis services and separately billed by freestanding renal
dialysis facilities and hospital-based facilities would be based on
section 1847A of the Act. We intended this to mean CY 2006 and
subsequent years. Therefore, in this proposed rule, we are not
proposing a policy change, but rather, we are clarifying that this
policy will apply to CY 2006 and subsequent years until otherwise
specified.
G. Proposed Provisions Related To Payment for Renal Dialysis Services
Furnished by End-Stage Renal Disease (ESRD) Facilities
[If you choose to comment on issues in this section, please include
the
[[Page 49005]]
caption ``ESRD PROVISIONS'' at the beginning of your comments.]
Since August 1, 1983, payment for dialysis services furnished by
ESRD facilities has been based on a composite rate payment system that
provides a fixed, prospectively determined amount per dialysis
treatment, adjusted for geographic differences in area wage levels. In
accordance with section 1881(b)(7) of the Act, separate composite rates
have been established for hospital-based and independent ESRD
facilities. The composite rate is designed to cover a package of goods
and services needed to furnish dialysis treatments that include certain
routinely provided drugs, laboratory tests, supplies, and equipment.
Unless specifically included in the composite rate, other injectable
drugs and laboratory tests medically necessary for the care of the
dialysis patient are separately billable. The base composite rates per
treatment, effective on August 1, 1983, were $123 for independent ESRD
facilities and $127 for hospital-based ESRD facilities. The Congress
has enacted a number of adjustments to the composite rate since that
time. The current 2006 base composite rates are $130.40 for independent
ESRD facilities and $134.53 for hospital-based ESRD facilities.
Section 623 of the MMA amended section 1881 of the Act to require
changes to the composite rate payment methodology, as well as to the
pricing methodology for separately billable drugs and biologicals
furnished by ESRD facilities.
Section 1881(b)(12) of the Act, as added by MMA, required the
establishment of a basic case-mix adjusted prospective payment system
(PPS) that would include the services comprising the composite rate and
an add-on to the composite rate component for the difference between
current payments for separately billed drugs and the revised drug
pricing specified in the statute. In addition, section 1881(b)(12) of
the Act required that the composite rate be adjusted for a limited
number of patient characteristics (case-mix) and section 1881(b)(12)(D)
of the Act gave the Secretary discretion to revise the wage indices and
the urban and rural definitions used to develop them. Finally, section
1881(b)(12)(E) of the Act imposed a budget neutrality requirement, so
that aggregate payments under the basic case-mix adjusted composite
payment system for 2005 would equal the aggregate payments that would
have been made for the same period if section 1881(b)(12) of the Act
did not apply.
Before January 1, 2005, payment to both independent and hospital-
based facilities for the anti-anemia drug, Erythropoietin (EPO) was
established pursuant to section 1881(b)(11) of the Act at $10.00 per
1,000 units. For independent ESRD facilities, payment for all other
separately billable drugs and biologicals was based on the lower of
actual charges or 95 percent of the average wholesale price (AWP).
Hospital-based ESRD facilities were paid based on the reasonable cost
methodology for separately billed drugs and biologicals (other than
EPO) furnished to dialysis patients. Changes to the payment methodology
for separately billed ESRD drugs and biologicals that were established
by the MMA and were effective January 1, 2005 are described in sections
G.1. and G.2. below. These changes affected payments in both CYs 2005
and 2006.
1. CY 2005 Revisions
On November 15, 2004, we published the CY 2005 PFS final rule with
comment period (69 FR 66319 through 66334), that revised payments to
ESRD facilities based on changes enacted by the MMA. The November 15,
2004 final rule with comment period implemented section 1881(b) of the
Act, as amended by section 623 of the MMA. Changes effective January 1,
2005, included implementation of a case-mix adjusted payment system
that incorporates services that comprise the composite rate; an update
of 1.6 percent to the composite rate component of the payment system;
and a drug add-on of 8.7 percent to the composite rate for the
difference between current payments for separately billable drugs and
payments based on the revised drug pricing for 2005 which used
acquisition costs. The final rule also implemented case-mix adjustments
to the composite rate for a limited number of patient characteristics
(age, low body mass index (BMI), and body surface area (BSA)),
effective April 1, 2005.
In addition, to implement section 1881(b)(13) of the Act, we
revised payments for drugs billed separately by independent ESRD
facilities, paying for the top 10 ESRD drugs based on acquisition costs
(as determined by the OIG) and for other separately billed drugs at the
average sales price +6 percent (hereafter referred to as ASP+6
percent). Hospital-based ESRD facilities continued to receive cost-
based payments for all separately billable drugs and biologicals except
for EPO which was paid based on average acquisition costs.
2. CY 2006 Revisions
In the November 21, 2005 Federal Register (70 FR 70161), we
published the CY 2006 PFS final rule with comment period (70 FR 70161)
implementing additional revisions to payments to ESRD facilities under
section 623 of the MMA. For CY 2006, we further revised the drug
payment methodology applicable to drugs furnished by ESRD facilities.
All separately billed drugs and biologicals furnished by both hospital-
based and independent ESRD facilities are now paid based on ASP+6
percent.
We recalculated the 2005 drug add-on adjustment to reflect the
difference in payments between the pre-MMA AWP pricing and the revised
pricing based on ASP+6 percent. The recalculation did not affect the
actual add-on adjustment applied to payments in 2005, but provided an
estimate of what the adjustment would have been had the 2006 payment
methodology been in effect in 2005. The drug add-on adjustment was then
updated to reflect the expected growth in expenditures for separately
billable drugs in CY 2006.
As of January 1, 2006, we also implemented a revised geographic
adjustment authorized by section 1881(b)(12) of the Act. As part of
that change, we--
Revised the labor market areas to incorporate the new CBSA
designations established by the Office of Management and Budget (OMB);
Eliminated the wage index ceiling and reduced the floor to
.8500; and
Revised the labor portion of the composite rate to which
the geographic adjustment is applied.
We also provided a 4-year transition from the previous wage-
adjusted composite rates to the current wage-adjusted rates. For CY
2006, only 25 percent of the payment is based on the revised geographic
adjustments, and the remaining 75 percent of payment is based on the
old Metropolitan Statistical Area-based (MSA-based) payments.
In addition, section 5106 of the DRA (Pub. L. 109-171), provided
for a 1.6 percent update to the composite rate component of the basic
case-mix adjusted payment system, effective January 1, 2006. As a
result, the current base composite rate is $130.40 for independent ESRD
facilities and $134.53 for hospital-based facilities. The drug add-on
adjustment (including the growth update) for 2006 is 14.5 percent.
3. Provisions of the Proposed Rule
For CY 2007, we are proposing the following provisions which are
described in more detail below:
[[Page 49006]]
A method to annually calculate the growth update to the
drug add-on adjustment required by section 1881(b)(12) of the Act, as
well as an estimated growth update adjustment to the add-on amount of
0.6 percent for CY 2007.
An update to the wage index adjustments to reflect the
latest hospital wage data, including a budget neutrality adjustment of
1.053069 to the wage index for CY 2007.
4. Proposed Growth Update to the Drug Add-On Adjustment to the
Composite Rates
Section 623(d) of the MMA added section 1881(b)(12)(B)(ii) of the
Act which required the establishment of an add-on to the composite rate
to account for changes in the drug payment methodology stemming from
enactment of the MMA. Section 1881(b)(12)(C) of the Act provides that
the drug add-on must reflect the difference in aggregate payments
between the revised drug payment methodology for separately billable
ESRD drugs (acquisition costs in CY 2005; ASP+6 percent in CY 2006) and
the AWP payment methodology in effect in CY 2004.
In addition, section 1881(b)(12)(F) of the Act requires that,
beginning in CY 2006, we establish an annual update to the drug add-on
to reflect estimated growth in expenditures for separately billable
drugs and biologicals furnished by ESRD facilities. This growth update
applies only to the drug add-on portion of the case-mix adjusted
payment system.
The CY 2006 drug add-on adjustment to the composite rate is 14.5
percent. The drug add-on adjustment for CY 2006 incorporates an
inflation adjustment of 1.4 percent. This computation is explained in
detail in the CY 2006 PFS final rule with comment period (70 FR 70162).
We note that the drug add-on adjustment of 14.7 percent that was
published in November 21, 2005 PFS final rule with comment period did
not account for the 1.6 percent update to the composite rate portion of
the basic case-mix adjustment payment system that was subsequently
enacted by the DRA, effective January 1, 2006. Since we compute the
drug add-on adjustment as a percentage of the weighted average base
composite rate, the drug add-on percentage was decreased to account for
the higher composite payment rate resulting in a 14.5 percent add-on
adjustment for CY 2006. This adjustment was necessary to ensure that
the total drug add-on dollars remained constant.
a. Estimating Growth in Expenditures for Drugs and Biologicals for CY
2007
In developing the growth update to the drug add-on for CY 2006 we
conducted a trend analysis of prior years' ESRD drug expenditure data
(2001 through 2004). All 4 years of data used for the trend analysis
reflected expenditures associated with payment for separately billed
drugs and biologicals under the AWP methodology. We could, therefore,
develop growth estimates for CY 2006 using comparable historical
expenditure data. To extend the trend analysis for CY 2007, we would
need to include drug expenditure data from CY 2005. However, in CY
2005, section 1881(b)(13)(A)(ii) of the Act required that we use a
different drug payment methodology, based on average acquisition costs,
rather than the AWP methodology used in prior years. Therefore, ESRD
drug expenditure data for CY 2005 are not comparable to expenditure
data for CY 2001 through CY 2004 for trend analysis purposes. This data
issue will extend to subsequent years' data as well, as we are now
paying for separately billable drugs using ASP+6 percent. Because we do
not have comparable data on which to base continuing trend analysis, we
believe it is necessary to re-evaluate our methodology for updating the
drug add-on adjustment.
In order to address the issue of data comparability described
above, we considered using available drug proxy measures to predict
growth in ESRD drug expenditures for CY 2007. We note that section
1881(b)(12)(F) of the Act specifies that the drug update must reflect
``the estimated growth in expenditures for drugs and biologicals that
are separately billable * * *.'' By referring to ``expenditures'', we
believe the statute contemplates that the update would account for both
increases in drug prices as well as increases in utilization of those
drugs.
One available proxy measure that reflects both price and
utilization is the national health expenditure projection for
prescription drugs that is developed by CMS. However, because of
uncertainties regarding the impact of the Medicare Part D prescription
drug program on expenditures, we are concerned that the current
estimates for CY 2007 will likely change, as actual Part D expenditure
data become available. Therefore, we do not believe this measure would
be an appropriate proxy measure for this purpose.
Another widely recognized proxy measure is the producer price index
(PPI) for prescription drugs. The PPI is a good measure of drug pricing
growth, but does not capture the growth in per patient drug utilization
that must also be part of an accurate estimate of growth in ESRD drug
expenditures. However, if the PPI is used in conjunction with an
estimate of per patient growth in drug utilization, we believe this
measure would provide a simple and accurate approach to updating the
drug add-on that could be readily used in subsequent years. Moreover,
using the PPI would significantly reduce any data bias that is inherent
in using historical drug expenditure data that do not reflect current
drug payment methodologies. As discussed in detail below, we are
proposing to estimate growth in per patient utilization of drugs by
using historical data from 2004 and 2005.
Another approach to estimating the growth in ESRD drug expenditures
is to continue using historical trend analysis by making adjustments to
the available data to permit year to year comparisons. This would be
accomplished by making an adjustment to the CY 2005 data based on
average acquisition price (AAP) using the weighted average difference
between AWP prices and AAP prices. We would use trend analysis to
project the growth in drug expenditures for CY 2007.
While we believe this approach is reasonably accurate for
developing the CY 2007 growth estimates, since only one year of data
would require adjustment, we are concerned about applying this
methodology to future updates. Future year updates would require
multiple year to year adjustments in prices. Moreover, historical AWP
data does not provide an accurate measure of price changes for EPO
under the revised drug payment methodology, since EPO pricing was held
constant during that historical period.
In addition, our estimate of the weighted average difference
between AAP prices and AWP prices (and ASP versus AWP prices in CY
2006) was based on a projection of price levels. It is likely that the
weighted average difference would change based on actual pricing data
for each of those years. To be consistent with the statute, we expect
to update the established adjustment to reflect estimated growth in
drug expenditures, but we do not anticipate re-computing the drug add-
on adjustment annually. Adjusting our assumptions to estimate projected
growth without changing the underlying assumptions in the add-on
adjustment would create inconsistencies between the two elements.
Therefore, we are proposing to discontinue use of older historical drug
spending data to
[[Page 49007]]
estimate the growth update to the drug add-on adjustment. We will
reconsider our methodology when we have sufficient historical data
reflecting the revised drug payment methodology using ASP pricing.
For the reasons discussed above, we are proposing to develop an
estimate of the growth in expenditures for ESRD drugs and biologicals
using the PPI for prescription drugs as a measure of price increases in
conjunction with two years of historical data from 2004 and 2005 as a
basis for estimating utilization growth at the per patient level. We
believe that this approach will best reflect the estimated growth in
expenditures for ESRD drugs and biologicals.
b. Estimating Growth in Per Patient Drug Utilization
To isolate and project the growth in per patient utilization of
ESRD drugs for CY 2007, we need to remove the enrollment and price
growth components from historical drug expenditure data and consider
the residual utilization growth. We propose to use total drug
expenditure data from CYs 2004 and 2005 to estimate per patient
utilization growth for CY 2007.
We first needed to estimate total drug expenditures. For this
proposed rule, we used the final CY 2004 ESRD claims data and the
latest available CY 2005 ESRD facility claims, updated through December
31, 2005, that is, claims with dates of service from January 1 through
December 31, 2005, that were received, processed, paid, and passed to
the National Claims History File as of December 31, 2005. For the final
rule, we will use more updated CY 2005 claims with dates of service for
the same time period. This updated CY 2005 data file will include
claims that are received, processed, paid, and passed to the National
Claims History File as of June 30, 2006.
While the December 2005 update of CY 2005 claims used in this
proposed rule is the most recently available claims data, we recognize
that it is not a fully complete year as claims with dates of service
towards the end of the year have not all been processed. To more
accurately estimate the update to the drug add-on, we need aggregate
drug expenditures. Based on an analysis of the 2004 claims data, we
inflated the CY 2005 drug expenditures to estimate the June 30, 2006
update of the 2005 claims file. We used the relationship between the
December 2004 and the June 2005 versions of 2004 claims to estimate the
more complete 2005 claims that will be available in June 2006. We
applied that ratio to the 2005 claims data from the December 2005
claims file. We did this for drug expenditures in aggregate, for each
of top ten separately billable drugs, and within each for independent
and hospital-based ESRD facilities. All components were then combined
to estimate aggregate CY 2005 ESRD drug expenditures. The net
adjustment to the CY 2005 claims data was an increase of 13 percent to
the 2005 expenditure data. This adjustment allows us to more accurately
compare the 2004 and 2005 data, to estimate utilization growth.
The next step is to remove the enrollment and price growth
components from that total. As discussed earlier in this section, in
developing the per patient utilization growth for this proposed rule,
we limited our analysis to the latest 2 years of available ESRD drug
data, that is, 2004 and 2005. We believe that per patient utilization
growth between these years would be a better proxy for future growth,
as it best represents current utilization trends. Furthermore, because
of the implementation of the new EPO utilization monitoring policy that
took effect on April 1, 2006 (Medicare Claims Processing Manual,
Chapter 8, section 60-4ff, p. 51-53), we believe that per patient
utilization of ESRD drugs will remain relatively stable or decline
slightly in future years. We note that EPO accounts for nearly 70
percent of ESRD drug expenditures.
To calculate the per patient utilization growth, we removed the
enrollment component by using the growth in enrollment data between
2004 and 2005. This was approximately 3 percent. To remove the price
effect we used a two-step process. First we calculated a weighted
average between EPO and non-EPO price growth factors to account for the
growth in pre-MMA pricing between 2004 and 2005. Since EPO was priced
at $10 per thousand units prior to the enactment of the MMA, there is
no growth for EPO. For the non-EPO drugs, we used the PPI as a proxy
for the growth between the 2 years to maintain consistency with the
established methodology for calculating the drug add-on adjustment
which used the PPI to estimate the price growth in separately billable
drugs (November 15, 2004, CY 2005 PFS final rule with comment period,
69 FR 66321). Next, we incorporated the estimated negative 13 percent
weighted price difference between 2005 AWP and 2005 AAP pricing as was
published in the CY 2005 PFS final rule with comment period (69 FR
66319 through 66334). This two-step process to account for the price
effect from 2004 to 2005 led to an overall 12 percent reduction in
price between 2004 and 2005.
After removing the enrollment and price effects from the
expenditure data, we believe the residual growth would reflect the per
patient utilization growth. To do this, we divided the product of the
enrollment growth of 3 percent (1.03) and the price reduction of 12
percent (1.00 - .12 = .88) into the total drug expenditure decrease
between 2004 and 2005 of 9 percent (1.00-.09 = .91). The result is a
utilization factor equal to 1.00 (.91/(1.03 * .88) = 1.00).
As we observed no growth in per patient utilization of drugs
between 2004 and 2005, we are, therefore, projecting no growth in per
patient utilization for CY 2007.
1. Applying the Proposed Growth Update to the Drug Add-on
Adjustment
In CY 2006, we estimated the growth update by trending drug
expenditures forward based on four years of AWP payment data (CY 2001
through CY 2004). We then applied the estimated growth update
percentage to the total amount of drug add-on dollars established for
CY 2005 to come up with a dollar amount for the CY 2006 growth update.
In addition, we projected the growth in dialysis treatments for CY 2006
based on the projected growth in ESRD enrollment. We divided the
projected total dialysis treatments for CY 2006 into the projected
dollar amount of the CY 2006 growth to develop the per treatment growth
update amount. This growth update amount, combined with the CY 2005 per
treatment drug add-on amount, resulted in an average drug add-on amount
per treatment of $18.88 (or a 14.5 percent adjustment to the composite
rate) for CY 2006.
Beginning in CY 2007, we are proposing to annually update the per
treatment drug add-on amount of $18.88 established in CY 2006 and
convert the update to an adjustment factor as stipulated in section
1881(b)(12)(F) of the Act. As explained above, we believe this approach
is more accurate than recalculating the per treatment add-on adjustment
each year using an estimate of growth in treatments. We note that we
had received comments that our projections of treatment growth used to
calculate the CY 2006 adjustment may have been overstated, however, we
believe that the use of enrollment data was and remains the best
measure available to predict treatment growth. By proposing to apply
the update to the CY 2006 per treatment add-on amount, this estimation
component is eliminated for CY 2007 and future years.
[[Page 49008]]
2. Proposed Update to the Drug Add-On Adjustment
As discussed above, we estimate no growth in per patient
utilization of ESRD drugs for CY 2007. Using the projected CY 2007 PPI
for prescription drugs of 4.9 percent, we are projecting that the
combined growth in per patient utilization and pricing for CY 2007
would result in an update equal to the PPI or 4.9 percent (1.0*1.049 =
1.049). This update factor would be applied to the CY 2006 average per
treatment drug add-on amount of $18.88 (reflecting a 14.5 percent
adjustment in CY 2006), resulting in a proposed weighted average
increase to the composite rate of $.93 for CY 2007 or a 0.6 percent
increase in the CY 2006 drug add-on percentage. Thus, the total
proposed drug add-on adjustment to the composite rate for CY 2007,
including the growth update, would be 15.2 percent (1.145*1.006 =
1.152).
In addition, we are proposing to continue to use this method to
estimate the growth update to the drug add-on component of the case-mix
adjusted payment system until we have at least three years worth of
ASP-based historical drug expenditure data that could be used to
conduct a trend analysis to estimate the growth in drug expenditures.
Given the time lag in the availability of ASP drug expenditure data, we
expect that the earliest we could consider using trend analysis to
update the drug add-on adjustment would be 2010. We propose to
reevaluate our methodology for estimating the growth update at that
time.
c. OIG Report on New Drug Codes
Section 623(c)(1) of the MMA mandated that the OIG conduct two
studies to determine the difference between the Medicare payment amount
for separately billable ESRD drugs and the facilities'' acquisition
costs for these drugs, as well as estimating the growth rate of
expenditures for these drugs. The initial study, ``Medicare
Reimbursement for Existing End Stage Renal Disease Drugs'' (OEI-03-04-
00120) was completed in May 2004, and reported on existing ESRD drugs.
This report was used to set the CY 2005 reimbursement rates for ESRD
drugs billed by independent dialysis facilities (69 FR 66322). The
second study (``Medicare Reimbursement for New ESRD Drugs'' (OEI-03-06-
00200)) focused on new drugs. New drugs for the purpose of this study
were defined as an ESRD drug that did not have a BILLING CODE prior to
January 1, 2004.
One drug, darbepoetin alfa (Aranesp) accounted for the majority of
all payments for new drugs. Therefore, this was the only new ESRD drug
studied. The OIG report found that use of this drug was limited to a
small number of facilities (only 157 facilities reported using this
drug with concentrated use in approximately 55 of these facilities).
Because of the recent changes we made to the drug payment methodology
and the lack of comparable historical data, the OIG report made no
estimate of an expenditure growth rate for this drug.
Darbepoetin alfa (Aranesp) is currently paid as a separately
billable drug at ASP+6 percent. Because of the recent (CY 2006)
implementation of the ASP+6 percent drug reimbursement methodology, the
small number of facilities using this drug for ESRD patients, and the
lack of historical data for trending purposes, we have no data to
indicate that any difference in payment methods for Aranesp (between
2004 and 2006) would affect our calculation of the drug add-on or of
the growth update. Moreover, since Aranesp was approved in 2001 for use
in ESRD patients, we believe that expenditures for Aranesp were
reflected in the historical data used to establish the 2005 drug add-on
under a generic drug code. Therefore, we are proposing to make no
additional changes to the drug add-on adjustment for CY 2007.
5. Proposed Update to the Geographic Adjustments to the Composite Rates
Section 1881(b)(12)(D) of the Act, as amended by section 623(d) of
the MMA, gave the Secretary the authority to revise the wage indexes
previously applied to the ESRD composite rates. The wage indexes are
calculated for each urban and rural area. The purpose of the wage index
is to adjust the composite rates for differing wage levels covering the
areas in which ESRD facilities are located.
a. Updates to CBSA Definitions
In the CY 2006 PFS final rule with comment period (70 FR 70167), we
announced our adoption of the OMB's CBSA-based geographic area
designations to develop revised urban/rural definitions and
corresponding wage index values for purposes of calculating ESRD
composite rates. OMB's CBSA-based geographic area designations were
described in Bulletin 03-04 originally issued June 6, 2003. On February
22, 2005 and December 5, 2005, OMB released Bulletins 05-02 and 06-01,
respectively. Those bulletins contained updates to the metropolitan and
micropolitan statistical area designations initially announced in
Bulletin 03-04. OMB's revisions had no effect on the classification of
counties which comprise the urban and rural areas used to develop the
ESRD wage index values. However, Bulletins 05-02 and 06-01 changed the
titles of several of the MSAs and Metropolitan Divisions used in
connection with the ESRD urban wage index. Table 5 below, which
contains the proposed wage index values for the ESRD urban areas,
includes all of the changes announced by OMB in the February 22, 2005
and December 5, 2005 bulletins.
b. Updated Wage Index Values
In the CY 2006 PFS final rule with comment period, we stated that
we intended to update the wage index values annually (70 FR 70167).
Current ESRD wage index values for CY 2006 were developed from FY 2002
wage and employment data obtained from the Medicare hospital cost
reports. The values are calculated without regard to geographic
reclassifications authorized under sections 1886(d)(8) and (d)(10) of
the Act and utilize pre-floor hospital data that is unadjusted for
occupational mix.
The methodology for calculating the CY 2006 wage index values was
described in the CY 2006 PFS final rule with comment period (70 FR
70168). We propose to use the same methodology for CY 2007, with the
exception that FY 2003 hospital data will be used to develop the CY
2007 ESRD wage index values. For a detailed description of the
development of the proposed CY 2007 ESRD wage index values based on FY
2003 hospital data, see the FY 2007 IPPS proposed rule entitled,
``Proposed Changes to the Hospital Inpatient Prospective Payment
Systems and Fiscal Year 2007 Rates,'' (April 25, 2006, 71 FR 24080).
Section III F. (Computation of the Proposed FY 2007 Unadjusted Wage
Index) of the preamble to that proposed rule describes the cost report
schedules, line items, data elements, adjustments, and wage index
computations. The wage index data affecting ESRD composite rates for
each urban and rural locale may also be accessed on the CMS website at:
http://www.cms.hhs.gov/AcuteInpatientPPS/WIFN/list.asp.
The wage data are located in the section entitled, ``FY 2007
Proposed Rule Occupational Mix Adjusted and Unadjusted Average Hourly
Wage and Pre-reclassified Wage Index by CBSA''.
(1) Wage Index Values for Areas With No Hospital Data
In CY 2006, while adopting the CBSA designations, we identified a
small number of ESRD facilities in both urban and rural geographic
areas where there
[[Page 49009]]
is no hospital wage data on which to base the calculations of the CY
2006 ESRD wage index values. Our CY 2005 policy and CY 2006 proposal
for each area are discussed separately below.
The first situation was rural Massachusetts. Because there were no
reasonable proxies for rural data within Massachusetts, we used the
prior year's acute care hospital wage index value for rural
Massachusetts. For CY 2007, we propose to continue to use this value
and request public input on an alternative methodology.
Since there may be additional rural areas in the future similarly
impacted by a lack of hospital wage data on which to derive a hospital
wage index, we are considering alternative methodologies for imputing a
rural wage index for areas in States where no hospital wage data are
available. We believe that an evaluation of alternative methodologies
for imputing a rural wage index in these areas should adhere to four
basic policy criteria. First, an alternative methodology should retain
our current longstanding policy to use pre-floor, pre-reclassified
hospital wage data to compute wage index values for post acute care
facilities, including ESRD facilities. Second, any methodology to
impute a rural wage index should use rural wage data to derive the
rural wage index value. Third, any methodology to impute a rural wage
index should be easy to evaluate. Fourth, any methodology to impute a
rural wage index would be able to update wage data from year-to-year.
We arrived at one alternative that meets all of the above policy
criteria. Under this alternative, we would impute a rural wage index
value by using a simple average CBSA-based rural wage index value at
the Census Division level. Census Divisions are defined by the U.S.
Census Bureau and may be found at (http://www.census.gov/geo/www/us_regdiv.pdf
). As stated above, for CY 2007, hospital wage data are not
available to compute a rural wage index for ESRD facilities in rural
Massachusetts, and this alternative methodology could be applied in
this case. Massachusetts is located in Census Division I (New England).
The States in this Census Division, and their respective rural wage
index values (using hospital cost report wage data for FY 2003)
include--
Connecticut (1.1753);
Maine (0.8410);
New Hampshire (1.0800);
Vermont (0.9944)
Rhode Island (all five counties classified as urban); and
Massachusetts.
Under this alternative methodology, the States in Census Division I
for which rural wage index values are available, as shown above, would
be used; this would result in a simple average rural wage index value
of 1.0227 (1.0770 after applying budget neutrality factor (BNF)).
Although this methodology would result in a rural Massachusetts wage
index that is currently greater than the value under the current
proposed policy (1.0216, 1.0758 after applying BNF), we believe this
methodology may be able to accurately reflect future increases or
decreases of wage data for the States within the applicable Census
Division.
Rural Puerto Rico is similar to rural Massachusetts in that there
are ESRD facilities where there are no acute care hospitals and,
therefore, no hospital data. However, the situation for facilities in
rural Puerto Rico is different in that the floor would be applied to
rural Puerto Rico ESRD facilities. All areas in Puerto Rico that have
an index are eligible for the floor because they have wage-index values
that are below .8000. For CY 2007, we propose to apply the floor to
rural Puerto Rico.
The third situation involves an urban area in Hinesville, GA (CBSA
25980). For CY 2006, we used a wage index value based on wage index
values in all of the other urban areas within the same State to serve
as a reasonable proxy for the urban areas without hospital wage index
data. Specifically, we used the average wage index value for all urban
areas within the State of Georgia as the urban wage index for purposes
of calculating the value for Hinesville for CY 2006. For CY 2007, we
are proposing to continue using this method for Hinesville, GA (CBSA
25980).
We solicit comments on maintaining our current policy for
establishing wage index values for rural and urban areas without
hospitals, the alternative approach outlined above in developing wage
index values for rural areas without hospitals for CY 2007 and
subsequent years, and other methods that meet the policy criteria for
imputing wage index values. We will also continue to evaluate existing
hospital wage data and, possibly, wage data from other sources, such as
the Bureau of Labor Statistics, to determine if other methodologies of
imputing a wage index value where hospital wage data are not available
may be feasible.
(2) Second Year of the Transition
In the CY 2006 PFS final rule with comment period, we indicated
that we would apply a 4-year transition period to mitigate the impact
on composite rates resulting from our adoption of CBSA-based geographic
designations (70 FR 70169). Beginning January 1, 2006, during each year
of the transition, an ESRD facility's wage-adjusted composite rate
(that is, without regard to any case-mix adjustments) will be a blend
of its old MSA-based wage-adjusted payment rate and its new CBSA-based
wage adjusted payment rate for the transition year involved. For each
transition year, the share of the blended wage-adjusted base payment
rate that is derived from the MSA-based and CBSA-based wage index
values is shown in Table 4 below. In CY 2006, the first year of the
transition, we implemented a 75/25 blend. CY 2007 is the second year of
the 4-year transition period. Consistent with the transition blends
announced in the November 21, 2005 PFS final rule with comment period
(70 FR 70170), we are proposing a 50/50 blend between an ESRD
facility's MSA-based composite rate, and its CY 2007 CBSA-based rate
reflecting its revised wage index values.
In CY 2006, we also eliminated the wage index cap of 1.30, and
stated that we would implement a gradual reduction in the wage index
floor of .90. Prior to January 1, 2006, the wage indexes were
restricted to values no less than .90 and no greater than 1.30, meaning
that payments to facilities in areas where labor costs fell below 90
percent of the national average, or exceeded 130 percent of that
average, were not adjusted beyond the 90 percent or 130 percent level.
Although we stated that the ESRD wage index values should not be
constrained by the application of floors and ceilings, we also
expressed concern that the immediate elimination of the floor could
adversely affect ESRD beneficiary access to care. Therefore, we reduced
the floor to .85 in CY 2006.
For CY 2007, we are proposing to reduce the wage index floor to
.80. As we stated in the CY 2006 PFS final rule with comment period, we
intend to reassess the continuing need for a wage index floor in CY
2008 and CY 2009 (CY 2006 PFS final rule with comment period, November
21, 2005, 70 FR 70169 through 70170). The proposed wage index floors,
caps, and blended shares of the composite rates applicable to all ESRD
facilities during CYs 2007 through 2009 are shown in Table 4 below.
They are identical to the values shown in Table 20 of the CY 2006 PFS
final rule with comment period (70 FR 70170) for the applicable years.
[[Page 49010]]
Table 4.--Wage Index Transition Blend
----------------------------------------------------------------------------------------------------------------
Old MSA New CBSA
CY payment Floor Ceiling (percent) (percent)
----------------------------------------------------------------------------------------------------------------
2007.............................. .80 *................ None................. 50 50
2008.............................. Reassess............. None................. 25 75
2009.............................. Reassess............. None................. 0 100
----------------------------------------------------------------------------------------------------------------
* Each wage index floor is multiplied by a budget neutrality adjustment factor. For CY 2007 the budget
neutrality adjustment is 1.053069 resulting in an actual wage index floor of 0.8425.
An example of how the wage-adjusted composite rates would be
blended during CY 2007 and the two subsequent transition years follows.
Example: An ESRD facility has a wage-adjusted composite rate
(without regard to any case-mix adjustments) of $135.00 per
treatment in CY 2006. Using CBSA-based geographic area designations,
the facility's CY 2007 wage-adjusted composite rate, reflecting its
wage index value as shown in Table 5 below, would be $145.00. During
the remaining 3 years of the four-year transition period to the new
CBSA-based wage index values, this facility's blended rate through
2009 would be calculated as follows:
CY 2007 .50 x $135.00 + .50 x $145.00 = $140.00
CY 2008 .25 x $135.00 + .75 x $145.00 = $142.50
CY 2009 0 x $135.00 + 1.0 x $145.00 = $145.00
We note that this hypothetical example assumes that the calculated
wage-adjusted composite rate of $145.00 for CY 2007 does not change in
CYs 2008 and 2009. In actuality, the wage-adjusted composite rate would
change because of annual revisions to the wage index. However, the
example serves only to demonstrate the effect on the composite rate of
the CBSA-based wage index values which will be phased-in during the
remaining 3 years of the transition period.
c. Budget Neutrality Adjustment
Section 1881(b)(12)(E)(i) of the Act, as added by section 623(d) of
the MMA, requires that any revisions to the ESRD composite rate payment
system as a result of the MMA provision (including the geographic
adjustment) be made in a budget neutral manner. This means that
aggregate payments to ESRD facilities in CY 2007 should be the same as
aggregate payments that would have been made if we had not made any
changes to the geographic adjusters. We note that this budget
neutrality adjustment only addresses the impact of changes in the
geographic adjustments. A separate budget neutrality adjustment was
developed for the case-mix adjustments, currently in effect. Since we
are not proposing any changes to the case-mix measures for CY 2007, the
current case-mix budget neutrality will remain in effect for CY 2007.
For CY 2007, we again propose to apply a BNF directly to the ESRD wage
index values, as we did in CY 2006. As we explained in the CY 2006 PFS
final rule with comment period (70 FR 70170 through 70171), we believe
this is the simplest approach because it allows us to maintain our base
composite rates during the transition from the current wage adjustments
to the revised wage adjustments described earlier in this section.
Because the ESRD wage index is only applied to the labor-related
portion of the composite rate, we computed the BNF adjustment based on
that proportion (53.711 percent).
In order to compute the proposed CY 2007 wage index BNF, we used
the wage index values in Tables 5 and 6 below, 2005 outpatient claims
(paid and processed as of December 31, 2005), and geographic location
information for each facility which may be found through Dialysis
Facility Compare. Dialysis Facility Compare can be found by going to
the following Web site: http://www.cms.hhs.gov/DialysisFacilityCompare/
.
Using treatment counts from the 2005 claims and facility-specific
CY 2006 composite rates, we computed the estimated total dollar amount
each ESRD provider would have received in CY 2006 (the first year of
the 4-year transition). The total of these payments became the target
amount of expenditures for all ESRD facilities for CY 2007. Next, we
computed the estimated dollar amount that would have been paid to the
same ESRD facilities using the proposed ESRD wage index for CY 2007
(the second year of the 4-year transition). The total of these payments
became the second year new amount of wage-adjusted composite rate
expenditures for all ESRD facilities.
After comparing these two dollar amounts (target amount divided by
second year new amount), we calculated an adjustment factor that, when
multiplied by the applicable CY 2007 ESRD wage index shown in Tables 5
and 6 below, will result in payments to each facility that will remain
within the target amount of composite rate expenditures when totaled
for all ESRD facilities. The proposed budget neutrality adjustment
factor for the CY 2007 wage index is 1.053069.
To ensure budget neutrality we also must apply the BNF to the wage
index floor of 0.8000 which results in a proposed adjusted wage index
floor of 0.8425 for CY 2007.
d. ESRD Wage Index Tables
The following two tables show the proposed CY 2007 ESRD wage index,
including the BNF adjustment, for urban areas (Table 5) and rural areas
(Table 6).
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From the Federal Register Online via GPO Access [wais.access.gpo.gov]
]
[[pp. 49031-49080]] Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule for Calendar Year 2007 and Other Changes to
Payment Under Part B
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Table 6.--Proposed CY 2007 ESRD Wage Index for Rural Areas Based on CBSA
Labor Market Areas
------------------------------------------------------------------------
CBSA code Nonurban area Wage index
------------------------------------------------------------------------
1.............................. Alabama................ 0.8425
2.............................. Alaska................. 1.1247
3.............................. Arizona................ 0.9398
4.............................. Arkansas............... 0.8425
5.............................. California............. 1.1902
6.............................. Colorado............... 0.9838
7.............................. Connecticut............ 1.2377
8.............................. Delaware............... 1.0239
10............................. Florida................ 0.9051
11............................. Georgia................ 0.8425
12............................. Hawaii................. 1.1022
13............................. Idaho.................. 0.8566
14............................. Illinois............... 0.8769
15............................. Indiana................ 0.8927
16............................. Iowa................... 0.9159
17............................. Kansas................. 0.8425
18............................. Kentucky............... 0.8425
19............................. Louisiana.............. 0.8425
20............................. Maine.................. 0.8856
21............................. Maryland............... 0.9417
22............................. Massachusetts.......... 1.0758
23............................. Michigan............... 0.9532
24............................. Minnesota.............. 0.9653
25............................. Mississippi............ 0.8425
26............................. Missouri............... 0.8425
27............................. Montana................ 0.9062
28............................. Nebraska............... 0.9154
29............................. Nevada................. 0.9435
30............................. New Hampshire.......... 1.1373
31............................. \1\ New Jersey......... ..............
32............................. New Mexico............. 0.8790
33............................. New York............... 0.8688
34............................. North Carolina......... 0.9055
35............................. North Dakota........... 0.8425
36............................. Ohio................... 0.9134
37............................. Oklahoma............... 0.8425
38............................. Oregon................. 1.0288
39............................. Pennsylvania........... 0.8774
41............................. \1\ Rhode Island....... ..............
42............................. South Carolina......... 0.8425
43............................. South Dakota........... 0.9038
44............................. Tennessee.............. 0.8425
45............................. Texas.................. 0.8425
46............................. Utah................... 0.8587
47............................. Vermont................ 1.0472
48............................. Virgin Islands......... 0.8425
49............................. Virginia............... 0.8425
50............................. Washington............. 1.0827
51............................. West Virginia.......... 0.8425
52............................. Wisconsin.............. 0.9970
53............................. Wyoming................ 0.9805
------------------------------------------------------------------------
\1\ All counties in the States of New Jersey and Rhode Island are urban.
H. Private Contracts and Opt-Out Provision--Practitioner Definition
[If you choose to comment on issues in this section, please include
the caption ``PRIVATE CONTRACTS AND OPT-OUT'' at the beginning of your
comments.]
Section 4507 of the BBA of 1997 amended section 1802 of the Act to
permit certain physicians and practitioners to opt-out of Medicare if
certain conditions were met, and to provide through private contracts
services that would otherwise be covered by Medicare. Before enactment
of BIPA (Pub.L. 106-554), section 1802(b)(5)(C) of the Act, which
refers to the definition of ``practitioner'' at section 1842(b)(18)(C)
of the Act, did not include registered dietitians or nutrition
professionals among the practitioners who may choose to opt-out of
Medicare. Section 105(d) of BIPA amended the definition of practitioner
located at section 1842(b)(18)(c) of the Act to include registered
dietitians or nutrition professionals. Because section 1802(b)(5)(C) of
the Act references section 1842(b)(18)(c) of the Act in order to define
the term practitioner for purposes of opting out of Medicare, current
law permits registered dietitians or nutrition professionals to opt-out
of Medicare. Because the definition of practitioner located in the
current regulations at Sec. 405.400 does not include registered
dietitians or nutrition professionals, we are proposing to amend that
section so that it is consistent with section 1802(b)(5)(C) of the Act.
[[Page 49054]]
I. Proposed Changes to Reassignment and Physician Self-Referral Rules
Relating to Diagnostic Tests
[If you choose to comment on issues in this section, please include
the caption ``REASSIGNMENT AND PHYSICIAN SELF-REFERRAL'' at the
beginning of your comments.]
Historically, Medicare rules have prohibited the markup of the TC
of certain diagnostic tests that are performed by outside suppliers and
billed to Medicare by a different individual or entity. In addition,
Medicare rules restrict who may bill Medicare for the PC (hereafter,
also referred to as the ``interpretation'') of diagnostic tests. Recent
changes to our rules on reassignment of the right to receive Medicare
payment may have led to some confusion as to whether the anti-markup
and purchased interpretation requirements apply to certain situations
where a reassignment has occurred pursuant to a contractual
arrangement.
Likewise, we are concerned about the existence of certain
arrangements that are not within the intended purpose of our physician
self-referral rules, which allow physician group practices to bill for
services furnished by a contractor physician in a ``centralized
building.'' We are concerned that allowing physician group practices or
other suppliers to purchase or otherwise contract for the provision of
diagnostic tests and then to realize a profit when billing Medicare may
lead to patient and program abuse in the form of overutilization of
services and result in higher costs to the Medicare program.
Therefore, we are proposing to amend our reassignment regulations
to clarify how the purchased test and purchased test interpretation
rules apply in the case of a reassignment made under the contractual
arrangement exception set forth at Sec. 424.80(d)(2). Specifically, in
our reassignment regulations, we propose to incorporate provisions
similar to those that currently appear in Sec. 414.50 of our
regulations on purchased tests, and we are considering incorporating
provisions on purchased test interpretations that currently appear in
our manual instructions. In addition, we are proposing to change the
definition of ``centralized building'' at Sec. 411.351 of the
physician self-referral regulations to place certain restrictions on
what types of space ownership or leasing arrangements will qualify for
purposes of the physician self-referral in-office ancillary services
exception and physician services exception.
Our proposals regarding the reassignment regulations are based on
existing requirements for purchased tests and purchased test
interpretations. Section 1842(n) of the Act contains certain
limitations on billing for the TC of diagnostic tests described in
section 1861(s)(3) of the Act (other than clinical diagnostic
laboratory tests paid under section 1833(a)(2)(D) of the Act, which are
subject to the special rules set forth in section 1833(h)(5)(A) of the
Act). Section 1842(n)(1)(A) of the Act provides that if the test was
not performed by the billing physician and also was not performed or
supervised by a physician with whom the billing physician shares a
practice, Medicare payment is the lower of the costs (net of any
discount) charged by the performing supplier to the billing physician,
or the performing supplier's reasonable charge (or other applicable
limit). This is commonly known as the anti-markup provision. Section
1842(n)(2) of the Act further provides that a physician may not bill a
beneficiary any amount other than the amount specified in section
1842(n)(1)(A) of the Act and any applicable deductible and coinsurance.
Under section 1842(n)(3) of the Act, if a physician knowingly,
willfully, and repeatedly bills a Medicare beneficiary for more than
the amount allowed under section 1842(n)(2) of the Act, he or she is
subject to civil monetary penalties and assessments, and exclusion from
Medicare and Medicaid for up to 5 years. Our regulations implementing
section 1842(n) of the Act appear at Sec. 414.50 and Sec.
402.1(c)(15).
In addition, our Claims Processing Manual (Pub. 100-4) outlines
certain conditions regarding who can submit a claim for purchased
diagnostic test intepretations. As set forth in Chapter 1, Section
30.2.9.1 of the Claims Processing Manual, the following requirements
must be satisfied in order to submit a claim for a purchased diagnostic
test interpretation:
The test must be ordered by a physician or medical group
that is independent of the person or entity performing the TC of the
test, and also must be independent of the physician or medical group
performing the interpretations.
The physician or medical group performing the
interpretations does not see the patient.
The purchaser (or employee, partner, or owner of the
purchaser) performs the TC of the test, and the interpreting physician
must be enrolled in the Medicare program.
Section 1842(b)(6) of the Act generally prohibits Medicare payment
to anyone other than the Medicare beneficiary or the physician or other
person who performed the service for the beneficiary. However, section
1842(b)(6) of the Act, also provides exceptions, known as the
reassignment exceptions, to this general rule. These exceptions allow
us to make payment to an individual or an entity other than the
beneficiary or the physician or other person who performed the service
for the beneficiary. For example, the reassignment exceptions allow us
to make payment to an employer of a physician, such as a group practice
or a hospital, to which the physician employee has reassigned his or
her right to payment.
Prior to the MMA, a physician or other individual supplier could
reassign his or her right to bill and receive payment under a
contractual arrangement, rather than an employee-employer relationship,
only if the services being paid for were performed on the premises of
the contracting hospital, critical access hospital, clinic, or other
facility. Section 952 of the MMA, however, amended section
1842(b)(6)(A)(ii) of the Act to extend the reassignment exception to
contractual arrangements regardless of whether the services are
performed on the premises of the billing entity. Section 952 of the MMA
permits us to recognize this type of reassignment to the extent that
the contractual arrangement between the physician or other individual
supplier and the billing entity (excluding a billing agent, which
cannot receive reassigned benefits) meets program integrity and other
safeguards as the Secretary may determine to be appropriate. A
motivating factor behind the passage of section 952 of the MMA appears
to have been the desire by the Congress to permit us to allow hospital
emergency department staffing companies that employ physicians on a
contract basis to bill Medicare (if the staffing companies enroll in
Medicare).
Our proposed implementation of section 952 of the MMA appeared in
the Revisions to Payment Policies Under the Physician Fee Schedule for
Calendar Year 2005 proposed rule, 69 FR 47488, 47524 through 47525
(August 5, 2004). We proposed program safeguards, whereby the parties
to the contractual arrangement would have joint and several liability
for any Medicare overpayments, and the physician or other individual
supplier would have unrestricted access to billings submitted on his or
her behalf by the entity receiving reassigned payments. In that
proposed rule, we stated our awareness that the changes to the
reassignment rules authorized by section 952 of the MMA may create new
fraud and abuse vulnerabilities, which may not become apparent until
the program has
[[Page 49055]]
experience with new contractual arrangements. We solicited comments on
these potential program vulnerabilities and on possible additional
safeguards to protect against such vulnerabilities.
Comments submitted in response to the CY 2005 PFS proposed rule
expressed concern over the recent growth of ``pod'' or ``condo''
laboratories (hereinafter ``pod labs''). In a typical pod lab
arrangement involving pathology services, an entity leases space in a
medical building and then subdivides the space into separate areas or
cubicles, which are equipped with microscopes and a minimal amount of
other laboratory equipment. The entity subleases each space to a
physician group practice, even though the space may be located many
miles away from any medical office of the group practice and is often
located in a different state. The entity hires a histologist who
performs the TC of the pathology service, by preparing a microscopic
slide of each specimen for review by a pathologist. The entity also
makes arrangements with a pathologist, who performs the PC of the
pathology service and who also supervises the pod lab.
In one type of arrangement, the pathologist and histologist perform
their services for the different group practices by moving from cubicle
to cubicle. Each group practice pays the pathologist a fee for every
slide reviewed and pays the entity a management fee, which covers the
rental of the pod lab and the histologist's salary. The group practice
then bills Medicare for the entire pathology service, typically at a
markup from what the group practice paid the pathologist for the
professional service and the entity for its services. In another common
arrangement, the histologist performs the TC of the pathology service
for the entity and the entity bills Medicare for that service, while
the group practice bills for the interpretation that was performed by
its independent contractor pathologist, who has reassigned to the group
practice his or her right to receive Medicare payment.
The commenters stated that pod lab arrangements are subject to
fraud, waste and abuse, including, but not limited to the following:
Generation of medically unnecessary biopsies.
Kickbacks.
Fee-splitting.
Referrals that would otherwise be prohibited under the
physician self-referral statute.
The commenters provided several suggestions. One commenter
suggested that we prohibit a physician from reassigning benefits to
another physician if the physicians do not practice in substantially
the same medical specialty. Some commenters also stated that our
regulations need to state more clearly that all requirements of the
purchased diagnostic test rules and purchased test interpretation rules
need to be met.
In the CY 2005 PFS final rule, we responded that we shared the
commenters concerns, although we declined to incorporate the suggested
revisions at that time. We said that we would be paying close attention
to this issue, and that we might initiate future rulemaking to address
arrangements that are fraudulent or abusive. (See 69 FR 66316, November
15, 2004.) In that final rule, we amended our reassignment regulation
at Sec. 424.80(a) to state that nothing in Sec. 424.80 alters an
individual's or entity's obligations under other Medicare statutes or
rules, including, but not limited to, the physician self-referral law
(section 1877 of the Act), the anti-kickback statute (section
1128B(b)(1) of the Act), the regulations regarding purchased diagnostic
tests, and the regulations regarding services and supplies provided
incident to a physician's service.
At about the same time as we published our proposed rule for
implementing section 952 of the MMA, we published an IFC concerning
exceptions to the physician self-referral law in section 1877 of the
Act (69 FR 16054). Section 1877 of the Act prohibits a physician from
making referrals for DHS, as defined in section 1877(h)(6) of the Act,
payable by Medicare to an entity with which he or she (or an immediate
family member) has a financial relationship (ownership or
compensation), and it prohibits the entity from billing Medicare,
another payor, or the beneficiary for those referred services, unless
an exception applies. The statute establishes a number of specific
exceptions to these prohibitions and grants the Secretary the authority
to create regulatory exceptions for financial relationships that pose
no risk of fraud or abuse.
One significant exception is at Sec. 411.355(a) for the provision
of ``physician services'' as defined in Sec. 410.20(a). Under this
exception, professional physician services that are DHS must be
furnished personally by another physician who is a member of the
referring physician's group practice, or by a physician in the same
group practice as the referring physician, or by someone under the
supervision of one of these physicians. A ``member'' of a group
practice is a physician owner, a physician employee, a locum tenens
physician, or an on-call physician while the physician is providing on-
call services for members of the group practice. ``Physician in the
group practice'' means a member of the group practice, as well as an
independent contractor physician during the time the independent
contractor is furnishing patient care services for the group practice
to the group practice's patients in the group practice's facilities.
(See Sec. 411.351.)
Another significant exception, at Sec. 411.355(b), is for the
provision of in-office ancillary services. This exception allows group
practice physicians to refer patients for DHS to other members of their
group or to nonphysician staff, provided that certain supervision,
location, and billing requirements are satisfied. Specifically, the DHS
must be furnished personally by the referring physician, a member of
the group practice, or an individual who is supervised by the referring
physician or by a physician in the group practice. In addition, the DHS
must be furnished in--(1) the ``same building'' where group physicians
perform a certain amount of physician services (as set forth in Sec.
411.355(b)(2)), including physician services unrelated to the provision
of DHS; or (2) in a ``centralized building.'' We define ``centralized
building,'' in pertinent part, as all or part of building that is owned
or leased on a full-time basis 24 hours per day, 7 days per week. In
the ``Phase II'' physician self-referral IFC, we reaffirmed our earlier
position, set forth in the ``Phase I'' final rule with comment period
that, a group practice may have more than one centralized building (69
FR at 16075).
In response to the Phase II IFC, several commenters strongly
criticized the centralized building prong of the in-office ancillary
services exception. They requested that the rule be changed to require
full-time use of the facility and the addition of a commercially
reasonable test. According to the commenters, the Phase II IFC
encourages numerous abusive arrangements that are designed solely to
permit medical groups to bill in circumvention of the prohibition in
section 1877 of the Act. Commenters objected to medical groups
establishing satellite DHS facilities, sometimes in different States,
specifically to capture ancillary income. Several commenters identified
pod labs that rent space to urology groups as among the types of
abusive arrangements that are proliferating. Several other commenters
requested clarification that the in-office ancillary services exception
did not
[[Page 49056]]
override our policies on reassignment and purchased diagnostic tests.
According to the comments, some of the arrangements do not satisfy the
rules regarding purchased diagnostic tests. On the other hand, a
professional association complained that the requirement that the
centralized building be occupied exclusively by the medical group is
too restrictive.
As noted above, we stated, in response to the comments on the
proposed rule implementing section 952 of the MMA, that we might
address suspect arrangements in a future rulemaking. After additional
consideration, including consideration of the comments we received in
response to the Phase II IFC, we are now proposing to amend our
regulations on reassignment and physician self-referral in this
proposed rule.
We are proposing to amend Sec. 424.80 of our regulations to
clarify that any reassignment pursuant to the contractual arrangement
exception is subject to program integrity safeguards that relate to the
right to payment for diagnostic tests. First, we would amend Sec.
424.80 of our regulations to provide that if the TC of a diagnostic
test (other than clinical diagnostic laboratory tests paid under
section 1833(a)(2)(D) of the Act, which are subject to the special
rules set forth in section 1833(h)(5)(A) of the Act) is billed by a
physician or medical group (the ``billing entity'') under a
reassignment involving a contractual arrangement with a physician or
other supplier who performs the service, the amount billed to Medicare
by the billing entity, less the applicable deductibles and coinsurance,
may not exceed the lowest of the following amounts:
The physician or other supplier's net charge to the
billing physician or medical group.
The billing physician's or medical group's actual charge.
The fee schedule amount for the service that would be
allowed if the physician or other supplier billed directly.
Second, we would also require that, in order to bill for the TC,
the billing entity would be required to perform the interpretation.
Third, we are considering further amendments to Sec. 424.80(d) that
would impose certain conditions on when a physician or medical group
can bill for a reassigned PC of a diagnostic test. We are considering
the following conditions:
The test must be ordered by a physician that is
financially independent of the person or entity performing the test and
also of the physician or medical group performing the interpretation.
The physician or medical group performing the
interpretation does not see the patient.
The physician or medical group billing for the
interpretation must have performed the TC of the test.
We believe that we are comfortably within our authority to place
the proposed restrictions on reassignments made before a contractual
arrangement, in order to guard against patient and program abuse, and
we also believe that we would be within our authority to adopt the
conditions on billing for a reassigned PC before a contractual
arrangement that we continue to consider.
We note that there is no right to effect a reassignment under
section 1842(b)(6) of the Act (rather, this section allows, but does
not require us to make payment to someone other than the beneficiary or
the physician or other person who performed the service), and that
section 952 of the MMA permits us to recognize reassignments under the
contractual arrangement exception only to the extent that the
arrangement meets program integrity and other safeguards as the
Secretary may determine to be appropriate. Moreover, we believe that
our current rules on purchased diagnostic tests generally should be
applicable to both situations in which the billing entity is purchasing
the test without a formal reassignment as well as situations in which
the physician performing the test has reassigned his or her right to
Medicare payment to the billing physician or medical group.
Although we welcome comments on all aspects of our proposals, we
are particularly interested in soliciting comments on the amendments we
have proposed, as well as those we are still considering involving
reassigned interpretations, to Sec. 424.80(d). In particular, we are
soliciting comments as to whether diagnostic tests in the DHS category
of radiology and certain other imaging services should be excepted from
any those provisions; whether the proposal in whole or in part should
apply only to pathology services; whether any of these provisions
should apply to services performed on the premises of the billing
entity and if so, how to define the premises appropriately. We are also
soliciting suggested regulatory text for the proposal under
consideration involving purchased test interpretations, as well as any
other comments regarding the appropriate scope of the provisions under
consideration.
In addition, we are soliciting comments on whether an anti-markup
provision should apply to the reassignment of the PC of diagnostic
tests performed under a contractual arrangement, and if so, how to
determine the correct amount that should be billed to the Medicare
program.
In addition to our proposed changes to the reassignment rules, we
are proposing to change the definition of ``centralized building'' in
Sec. 411.351 for purposes of our physician self-referral regulations.
We are persuaded by the commenters who responded to the Phase II IFC
that our present definition may encourage the unnecessary ordering of
ancillary services. Section 1877(b)(1) of the Act, in conjunction with
section 1877(h)(4)(vi) of the Act, states that the Secretary may define
by regulation what constitutes a ``group practice'' for purposes of the
physician services exception. Similarly, section 1877(b)(2) of the Act
authorizes the Secretary to determine additional terms and conditions
relating to the supervision and location requirements of the in-office
ancillary services exception as may be necessary to prevent a risk of
program or patient abuse. Accordingly, we propose to modify the
definition of ``centralized building'' to include a minimum square
footage requirement of 350 square feet. Our modified definition would
be relevant to both the physician services exception and the in-office
ancillary services exception. That is because, under Sec. 411.351, a
``physician in the group practice'' includes an independent contractor
physician during the time he or she is providing services to the
group's patients in the group's facilities. Thus, to the extent that an
independent contractor physician would qualify as a ``physician in the
group'' on the basis of furnishing services to a group's patients in a
centralized building, the space owned or leased by the group would need
to comply with the proposed modification to the definition of
``centralized building'' in order for the group to rely on the
physician services exception or the in-office ancillary services
exception when billing Medicare for services furnished by the
independent contractor physician.
Although we believe that the arrangements we seek to address
through our proposed change to the definition of ``centralized
building'' primarily involves independent contractor physicians, the
proposed definition would also apply to services performed by
physicians who are employees of a group practice.
The proposed minimum square footage requirement would not apply to
[[Page 49057]]
space owned or rented in a building in which no more than three group
practices own or lease space in the ``same building,'' as defined in
Sec. 411.351 (that is, in a building with the same street address) and
share the same ``physician in the group practice'' (as defined in Sec.
411.351). The purpose of the square foot minimum and the exception is
to prevent abusive arrangements such as pod labs, while not
disqualifying legitimate, stand-alone physician offices that are
unusually small. The following examples are intended to illustrate how
the proposed exception might apply:
+ Example 1--A space of 200 square feet located in a building in
which only two other group practices lease space could qualify as a
centralized building, irrespective of whether all three group practices
contract with the same individual as a ``physician in the group
practice.''
+ Example 2--A space of 200 square feet is located in a building in
which seven other group practices lease space. Dr. Jones has a
contractual relationship with three group practices as a ``physician in
the group practice.'' Dr. Smith also has a contractual relationship
with three group practices. No physician has a contractual relationship
as a ``physician in the group practice'' with four or more group
practices that are located in that building. The space could qualify as
a ``centralized building.''
We would also require the space to contain, on a permanent basis,
the necessary equipment to perform substantially all of the DHS that
are performed in this space, in order to meet the definition of a
``centralized building.'' That is, we wish to prevent the situation in
which an entity would routinely move equipment as needed from one
group's space to another group's space (for example, from cubicle to
cubicle). We believe these situations are abusive and contrary to the
purpose of concept of the ``centralized building'' concept, but we
recognize that there may be an occasional need to bring specialized
equipment into the space on a temporary basis.
We believe that the proposed clarification to our reassignment
rules, in tandem with our proposed changes to the definition of
``centralized building'' for purposes of our physician self-referral
rules would prevent abusive arrangements while preserving legitimate
small physician offices. In particular, we anticipate that restrictions
on marking up the TC of diagnostic tests as well as the limits we are
considering for who can bill for the PC of diagnostic tests, combined
with square footage limits and requirements of having necessary
equipment on site would make it not financially feasible for pod labs
to exist.
With respect to our proposed change to the definition of
``centralized building,'' we seek comments on whether there should be a
minimum square foot requirement, and if so, whether the minimum should
be 350 square feet or an amount more or less than that. In addition, we
seek comments regarding whether there should be an exception to any
minimum square foot requirement, and if so, the circumstances under
which an exception should apply.
With respect to our proposal that the ``centralized building''
permanently contain the necessary equipment to perform substantially
all of the DHS that is furnished in the ``centralized building,'' we
seek comments on whether this test should be imposed, and whether at
least 90 percent or some other minimum percentage or measurement is
appropriate. We are also considering whether to require that, for space
to qualify as a ``centralized building,'' the group practice must
employ, in that space, a nonphysician employee or independent
contractor who will perform services exclusively for the group for at
least 35 hours per week. We seek comments on whether we should have
this requirement or similar requirement, or whether this requirement
would be unduly burdensome on a small group practice, and whether this
requirement would be likely to reduce the number of existing pod labs
and to discourage the development of new pod labs. Finally, we seek
comments on whether a group practice should be allowed to maintain a
``centralized building'' in a State different from the State(s) in
which it has an office that meets the criteria of Sec.
411.355(b)(2)(i), and if so, whether space that is located in a
different State must be within a certain number of miles from an office
of the group practice that meets the criteria of Sec.
411.355(b)(2)(i), in order to qualify as a ``centralized building.''
J. Supplier Access to Claims Billed on Reassignment
Section 1833(e) of the Act provides that, ``no payment shall be
made to any provider of services or other person under this part unless
there has been furnished such information as may be necessary in order
to determine the amounts due such provider or other person under this
part for the period with respect to which the amounts are being paid or
for any prior period.'' Section 1842(b)(6) of the Act generally
provides that payment may not be made to anyone other than the
beneficiary or the physician or other person who provided the service.
There are certain exceptions to this prohibition whereby payment may be
made to others. These are commonly referred to as the reassignment
exceptions and are found at section 1842(b)(6)(A) of the Act.
Taking these two statutory provisions together, we are permitted,
but not required, to make payment to someone other than the
beneficiary, or the physician or other person who furnished the
service, but only if we have determined that Medicare has received all
necessary information to determine the amounts due the provider. Where
Medicare makes payment to an entity rather than to the physician or
other person who furnished the service, there is a heightened concern
that payment may not be correct. By allowing physicians and other
individual suppliers who reassign benefits to an entity such as a group
practice to have access to the billing information concerning the
services they allegedly furnish, we believe we will reduce the risk of
inappropriate billing.
Moreover, as noted in section I.2. of this proposed rule, section
952 of the MMA amended section 1842(b)(6)(A)(ii) of the Act to allow a
physician or other person who was in a contractual arrangement rather
than in an employee-employer relationship to reassign his or her right
to bill and receive payment, irrespective of whether the services were
performed on the premises of the entity. Section 952 of the MMA permits
reassignment to the extent that the contractual arrangement between the
physician or other individual supplier and the billing entity meets
program integrity and other safeguards that the Secretary may determine
to be appropriate.
In the FY 2005 Physician Fee Schedule proposed rule, published
August 5, 2005 (69 FR 47488, 47524 through 47525), we stated our
awareness that changes in the reassignment rules based on section 952
of the MMA may create new fraud and abuse vulnerabilities, which may
not become apparent until the program has experience with new
contractual arrangements. We proposed program safeguards, whereby the
parties to the contractual arrangement would have joint and several
liability for any Medicare overpayments, and the physician or other
individual supplier would have unrestricted access to billings
submitted on their behalf by the entity receiving reassigned payments.
In response to the August 5, 2005 proposed
[[Page 49058]]
rule, we received a comment that questioned the need for the two
program integrity safeguards (joint and several liability and
unrestricted access to billing records) as a requirement for a
reassignment of claims involving a contractual arrangement. The
commenter believed that it was premature for CMS to implement these
program safeguards, that CMS already imposes joint and several
liability through Medicare participation agreements and the signing of
the enrollment form for billing reassigned claims (the CMS-855-R form),
and questioned why the program safeguards applied only to independent
contractors and not to employees. (69 FR 66316 through 66317 (November
15, 2004).)
In response to the commenter, we stated that those program
integrity safeguards were necessary to monitor the billings of entities
with which we have had billing problems (for example, billing for
services never furnished and upcoding resulting in Medicare
overpayments) in the past, and that the reason the safeguards applied
to independent contractors and not to employees, was that the billing
problems identified thus far involved certain entities (which, for the
most part, contracted with, rather than employed, emergency room (ER)
physicians). We also stated that we would study whether the same
program integrity safeguards applicable to independent contractors
should also apply to employees.
Prior to January 1, 2005, the effective date of the program
integrity safeguards for the contractual arrangement reassignment
exception, we received public inquiries asking why employees do not
have unrestricted access to billing records. Since the January 1, 2005
effective date of the program integrity safeguards, we have received an
inquiry from an ER physician employee of a medium-sized ER physician
staffing company, who was denied access to billing records for services
that he claims to have furnished, and who had his employment
terminated. We also note that the MMA Conference Report, in its
discussion of section 952 of the MMA, states that the Conference
Committee supports appropriate program integrity efforts for any
entities billing the Medicare program, including entities with
independent contractors as well as employees. Having reconsidered the
issue, we find no valid reason why an employee should not have access
to records on billings for services furnished by that employee.
Therefore, we are proposing to change the title of Sec. 424.80(d) and
amend Sec. 424.80(d)(2) of our regulations to state that the supplier
who reassigns his or her right to bill and receive Medicare payment to
an entity has unrestricted access to claims information submitted by
that entity for services supposedly furnished by the individual
supplier, irrespective of whether the supplier is an employee or
independent contractor of the entity. If adopted, our proposal would
also mean that if an entity receiving the reassigned benefits were to
refuse to provide the billing information to the employee supplier
requesting the information, the entity's right to receive reassigned
benefits may be revoked under 42 CFR 424.82(c)(3) (which is currently
the case with respect to an entity's refusal to provide billing
information to an independent contractor supplier).
K. Coverage of Bone Mass Measurement (BMM) Tests
[If you choose to comment on issues in this section, please include
the caption ``BONE MASS MEASUREMENT TESTS'' at the beginning of your
comments.]
In an IFC entitled ``Medicare Coverage of and Payment for Bone Mass
Measurements'' published in the Federal Register on June 24, 1998 (63
FR 34320), we implemented section 4106 of the BBA by establishing a new
regulatory section, 42 CFR 410.31 (Bone Mass Measurement: Conditions
for Coverage and Frequency Standards). Section 4106 of the BBA
statutorily defined BMM and individuals that are qualified to receive a
BMM. The June 24, 1998 IFC, under the ``reasonable and necessary''
provisions of 1862(a)(1)(A) of the Act, also established conditions for
coverage of the tests that must be ordered by physicians or
nonphysician practitioners. Lastly, as directed by section 4106 of the
BBA, we established frequency standards governing the time period when
qualified individuals would be eligible to receive covered BMMs.
1. Provisions of the June 24, 1998 IFC
As stated earlier in this section, the June 24, 1998 IFC
implemented section 4106 of the BBA by establishing conditions for
coverage and frequency standards for BMMs to ensure that they are paid
for uniformly throughout the Medicare program and that they are
reasonable and necessary for Medicare beneficiaries who are eligible to
receive these measurements. This section summarizes the provisions
discussed in the June 24, 1998 IFC.
a. Coverage Conditions and Frequency Standards
We established conditions for coverage and frequency standards for
medically necessary BMMs for five categories of Medicare beneficiaries
in Sec. 410.31.
In Sec. 410.31(a), we defined ``bone mass measurement'' based on
the statutory definition in section 4106 of the BBA. In accordance with
the ``reasonable and necessary'' provisions of section 1862(a)(1)(A) of
the Act, we established the conditions for coverage of BMMs in Sec.
410.31(b) of the regulations. Consistent with Sec. 410.32 (Diagnostic
x-ray tests, diagnostic laboratory tests, and diagnostic tests:
Conditions), we provided that coverage be available for the BMM only if
it is ordered by the physician or a qualified nonphysician practitioner
(as defined in Sec. 410.32(a)) treating the beneficiary following an
evaluation of the beneficiary's need for the test, including a
determination as to the medically appropriate procedure to be used for
the beneficiary. We believed that BMMs were not demonstrably reasonable
and necessary unless (among other things) they are ordered by the
physician treating the beneficiary following a careful evaluation of
the beneficiary's medical need, and they are employed to manage the
beneficiary's care.
To ensure that the BMM is performed as accurately and consistently
in accordance with appropriate quality assurance guidelines as
possible, we required that it be performed under the appropriate
supervision of a physician as defined in Sec. 410.32(b)(3). To ensure
that the BMM is medically appropriate for the five categories specified
in the law, we provided that it be reasonable and necessary for
diagnosing, treating, or monitoring the condition of the beneficiary
who meets the coverage requirements specified in Sec. 410.31(d).
Furthermore, in Sec. 410.31(c), we set forth limitations on the
frequency for covering a BMM. Generally, we cover a BMM for a
beneficiary if at least 23 months have passed since the month the last
BMM was performed. However, we allow for coverage of follow-up BMMs
performed more frequently than once every 23 months when medically
necessary. We listed the following examples of situations where more
frequent BMMs procedures may be medically necessary to include:
Monitoring beneficiaries on long-term glucocorticoid
(steroid) therapy of more than 3 months.
Allowing for a confirmatory baseline bone mass measurement
(either central or peripheral) to permit
[[Page 49059]]
monitoring of beneficiaries in the future if the initial test was
performed with a technique that is different from the proposed
monitoring method.
b. Beneficiaries Who May Be Covered
In Sec. 410.31(d), we amended our regulations to conform to the
statutory requirement that the following categories of beneficiaries
may receive Medicare coverage for a medically necessary BMM:
A woman who has been determined by the physician or a
qualified nonphysician practitioner treating her to be estrogen-
deficient and at clinical risk for osteoporosis, based on her medical
history and other findings.
An individual with vertebral abnormalities as demonstrated
by an x-ray to be indicative of osteoporosis, osteopenia, or vertebral
fracture.
An individual receiving (or expecting to receive)
glucocorticoid (steroid) therapy equivalent to 7.5 mg of prednisone, or
greater, per day, for more than 3 months.
An individual with primary hyperparathyroidism.
An individual being monitored to assess the response to or
efficacy of an FDA-approved osteoporosis drug therapy.
c. Waiver of Liability
Section 410.31(e) provides that Medicare payment would be denied
for a BMM in accordance with section 1862(a)(1)(A) of the Act if the
regulatory standards are not satisfied. Existing regulations concerning
limitation on liability are set forth in Sec. Sec. 411.400 through
411.406 and are applicable to denial of BMMs under Sec. 410.31.
d. Payments for BMMs
Medicare payments for covered BMMs are paid for under the PFS (42
CFR part 414) as required by statute. In the June 24, 1998 IFC, we
revised the definition of ``physician services'' in Sec. 414.2 to
include bone mass measurements. When BMM procedures are furnished to
hospital inpatients and outpatients, the TCs of these procedures are
payable under existing payment methods for hospital services. These
methods include payments under the prospective payment system, on a
reasonable cost basis, or under a special provision for determining
payment rates for hospital outpatient radiology services.
In the June 24, 1998 IFC, we revised Sec. 414.50(a), regarding
physician billing for purchased diagnostic tests, to clarify that the
section does not apply to payment for BMMs.
e. Conforming Changes
In the June 24, 1998 IFC, to allow for appropriate placement in the
CFR of the BMM coverage requirements, we redesignated Sec. 410.31
(Prescription drugs used in immunosuppressive therapy) as Sec. 410.30.
2. Additional Scientific Evidence
In 2004, the Surgeon General issued a report, Bone Health and
Osteoporosis (U.S. Department of Health and Human Services, Bone Health
and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S.
Department of Health and Human Services, Office of the Surgeon General,
2004). This report provides scientific evidence related to the
prevention, assessment, diagnosis, and treatment of bone disease. The
report states that identification of those at risk of bone disease and
fracture is important so that appropriate interventions can be
implemented. However, as the report states, ``Assessing the risk of
bone disease and fracture remains a challenge. Not all of the risk
factors have been identified, and the relative importance of those that
are known remains unclear.''
As bone strength is not measured directly, bone mineral density
(BMD) remains the single best predictor of fracture risk, with the most
widely accepted method for measuring BMD being the dual energy x-ray
absorptiometry (DXA) for a bone density study at the axial skeleton
(for example, hips and spine). As there are many sources of variability
in the measurement of BMD, a quality control system related to both the
methodology and reporting of test results is important to ensure the
validity of DXA analysis.
In addition to DXA of the axial skeleton, bone mass can also be
measured using other techniques. These other techniques include DXA
bone density study for the appendicular skeleton (for example, radius,
wrist, heel); quantitative computerized tomography (QCT), bone mineral
density study for the axial skeleton or appendicular skeleton;
radiographic absorptiometry (photodensitometry, radiogrammetry);
single-photon absorptiometry (SPA); single energy x-ray absorptiometry
(SXA) for the appendicular skeleton; and ultrasound bone mineral
density study for the appendicular skeleton. With regard to these
techniques (except for SPA which was not discussed), the 2004 Surgeon
General report states, ``While these methods do assess bone density and
may provide an indication of fracture risk, it is important to note
that the WHO [World Health Organization] recommendations and other
guidelines for using BMD and interpreting BMD results for diagnosis are
based on DXA measurements of the hip or spine.'' The report further
states, ``Incorporating these techniques for bone assessment into
future clinical trials and observational studies will help in better
understanding their appropriate use as a means of predicting the risk
of bone disease and fracture.''
3. Proposed Changes to the June 24, 1998 IFC
We received 18 public comments on the June 24, 1998 IFC. The
majority of the comments had specific recommendations for changes to
the IFC. In addition to responding to comments that we may receive on
our proposed revisions to Sec. 410.31, it is our intent to address all
these previous comments in the CY 2007 PFS final rule.
Based on the comments received on the IFC, the Surgeon General's
report, and other evidence, we are proposing changes to Sec. 410.31.
We encourage comments on these proposals.
a. Proposed ``BMM'' Definition (Sec. 410.31(a))
We are proposing to revise the definition of ``bone mass
measurement'' at Sec. 410.31(a)(2) to remove coverage for the use of
SPA, which uses isotope sources to measure BMD. Many medical experts
indicate that SPA has largely been replaced by the newer techniques of
DXA, which are believed to be superior in accuracy and precision.
Medicare claims data in recent years continue to show a steady decline
in the use of the SPA procedure by the beneficiary population. Further,
there is a lack of evidence to support continued use of SPA, an older
procedure where the metrics have not been correlated with fracture
rate.
We are proposing to revise the definition of a ``bone mass
measurement'' to read, ``Is performed with either a bone densitometer
(other than a single-photon or dual-photon absorptiometry) or with a
bone sonometer system that has been cleared for marketing for this use
by the FDA under 21 CFR part 807, or approved for marketing by the FDA
for this use under 21 CFR part 814.''
We are specifically requesting comments on this proposal regarding
the evidence of benefit for SPA, particularly in comparison with other
alternatives.
b. Conditions for Coverage (Sec. 410.31(b))
We are proposing to revise the conditions for coverage for BMMs in
[[Page 49060]]
Sec. 410.31(b) by requiring that for a medically necessary BMM to be
covered for an individual being monitored to assess the response to or
efficacy of an FDA-approved osteoporosis drug therapy (Sec.
410.31(d)(5)) the individual would be required to meet the present
conditions for coverage under Sec. 410.31(b), and the monitoring would
have to be performed by the use of an dual energy x-ray absorptiometry
system (axial system).
We recognize that in the June 24, 1998 IFC, we allowed the
physician or qualified nonphysician practitioner treating the
beneficiary more flexibility in ordering those diagnostic measurements,
but we are proposing to limit that flexibility with respect to the type
of BMM that is used for monitoring individuals receiving osteoporosis
drug therapy and other purposes (as discussed later in this section)
because of new evidence and other information received since
publication of the June 24, 1998 IFC that supports the need for
requiring the use of the DXA measurement (axial skeleton) in those
circumstances. In addition to the 2004 Surgeon General's Report that
recognized the superiority of the DXA (axial skeleton) for measuring
bone mass over time, the International Society for Clinical
Densitometry currently recommends that if an individual has a low bone
mass using a peripheral measurement (appendicular skeleton) he or she
should have a DXA (axial skeleton) performed for monitoring or
confirmatory diagnostic purposes.
Therefore, we are also proposing to revise Sec. 410.31(b) by
adding a requirement that in the case of any individual who qualifies
for a bone mass measurement as provided for in Sec. 410.31(d) and who
receives a confirmatory baseline BMM to permit monitoring in the
future, Medicare may cover a medically necessary BMM for that
individual, if the present conditions for coverage under Sec.
410.31(b) are met, and the BMM is performed by a dual energy x-ray
absorptiometry system (axial skeleton) (if the initial measurement was
not performed by this system).
As indicated previously, the most widely accepted method for
measuring bone mineral density (BMD) is the use of DXA (Surgeons
General's Report 2004) at axial skeletal sites. DXA (axial skeleton)
measures BMD at the hip and spine (sites likely to fracture in patients
who have osteoporosis). DXA is precise, safe, and low in radiation
exposure, and permits more accurate and reliable monitoring of
individuals over time. DXA of the femoral neck is the best validated
test to predict hip fracture and is comparable to forearm measurements
for predicting fractures at other sites (Evidence Report/Technology
Assessment No 28, Agency for Healthcare Research and Quality (AHRQ),
January 2001).
c. Bone Mass Measurement: Standards on Frequency of Coverage (Sec.
410.31(c))
To conform the examples of a BMM exception to the standards on
frequency of coverage in Sec. 410.31(c)(2) to the regulation change we
are proposing in Sec. 410.31(b)(3), we are proposing to revise the
confirmatory baseline test example in Sec. 410.31(c)(2)(ii) to read,
``Allowing for a confirmatory baseline measurement to permit monitoring
of beneficiaries in the future if the requirements of paragraph (b)(3)
of this section are met.''
d. Bone Mass Measurement: Beneficiaries Who May Be Covered (Sec.
410.31(d))
The Congress has recognized that individuals receiving long-term
glucocorticoid steroid therapy are qualified individuals for purposes
of section 1861(rr)(1) of the Act. Therapy to prevent bone loss in most
patients beginning long-term therapy has been recommended at a
prednisone equivalent of >= 5 mg/day for at least 3 months (McIlwain,
2003). Based on our review of the current evidence, we are proposing to
reduce the dosage equivalent in Sec. 410.31(d)(3) from an average of
7.5 mg/day of prednisone for at least 3 months to an average of 5.0 mg/
day of prednisone for the same period.
e. Use of the NCD Process (Sec. 410.31(f))
To facilitate future consideration of coverage of additional BMM
systems for purposes of proposed paragraphs Sec. 410.31(b)(2) and
(b)(3), which would limit coverage of BMMs for monitoring individuals
receiving osteoporosis drug therapy and for performing confirmatory
baseline measurements, we are proposing to allow CMS, through the NCD
process, to identify additional BMM systems for those purposes. By
using the NCD process, we could conduct a timely assessment of FDA-
approved BMMs. Use of an NCD to add coverage of effective BMM systems
for these purposes is authorized by the reasonable and necessary
provision of sections 1862(a)(1)(A) and 1871(a)(2) of the Act.
In summary, in view of the 18 comments and our review of the post-
1998 medical literature, we have decided to propose several revisions
to Sec. 410.31 relative to the definition of the term ``Bone Mass
Measurement'' (Sec. 410.31(a)(2)), the conditions for coverage (Sec.
410.31(b)), the examples of exceptions to the standards on frequency of
coverage (Sec. 410.31(c)(2)), the category of individuals receiving
(or expecting to receive) glucocorticoid (steroid) therapy (Sec.
410.31(d)(3)), and the addition of a new subparagraph (Sec. 410.31(f))
on use of the NCD process.
L. Independent Diagnostic Testing Facility (IDTF) Issues
[If you choose to comment on issues in this section, please include
the caption ``IDTF ISSUES'' at the beginning of your comments.]
1. Proposed IDTF Changes in the Physician Fee Schedule Proposed Rule
During the course of a national review in 2003-2004, the Office of
Inspector General (OIG) found a potential $71 million in improper
payments made to IDTFs (Review of Claims Billed by Independent
Diagnostic Testing Facilities for Services Provided to Medicare
Beneficiaries During Calendar Year 2001 (A-03-03-00002)). The OIG found
that erroneous payments were made as the result of poor or missing
documentation or the lack of medical necessity. Moreover, in recent
years, CMS and its contractors have determined that a number of IDTFs
in California and other States are perpetrating schemes to defraud the
Medicare program.
Since 2000, the number of IDTFs in California has increased by 40
percent, which is a far greater percentage increase than the Medicare
population in that State. The number of IDTFs billing Medicare in
California alone increased more than 400 percent from 2000 to 2005. The
increased use of IDTF services has not lowered the use of diagnostic
testing within other settings. The increased rates of utilization
within IDTFs is likely to be unrealistic due to an increase in the need
of diagnostic testing within California's Medicare population. Also,
these IDTFs are growing at a rate faster than CMS can survey these
facilities. The actual growth of IDTFs is not a problem, however, the
results of the OIG audit make it clear that we need to closely monitor
IDTFs and establish standards to ensure quality care for Medicare
beneficiaries. To address the erroneous payments identified by the OIG
above, we are proposing to establish IDTF supplier standards similar to
those we adopted for Durable Medical Equipment, Prosthetics, Orthotics,
and Supplies (DMEPOS) Suppliers on October 11, 2000 (see 42 CFR
424.57).
We are proposing that each IDTF be required to be in compliance
with the
[[Page 49061]]
proposed fourteen suppler standards discussed in section L.2. below in
order to obtain or retain enrollment in the Medicare program.
Accordingly, at proposed Sec. 410.33(h), we are proposing that if an
IDTF fails to meet one or more of the proposed standards at the time of
enrollment or at the time of re-enrollment, then its enrollment
application would be denied. Also, if at any time we determine that an
enrolled IDTF no longer meets the proposed supplier standards, its
billing privileges would be revoked.
We believe that these supplier standards are needed to ensure that
minimum quality standards are met to protect beneficiaries as well as
the Medicare Trust Fund. These standards are merely good business
practices which will help to ensure that suppliers are providing a
quality care to Medicare beneficiaries. Examples of the kind of
standards are a primary business phone number and address. Another
example is a posting of standards for review by patients and the
public.
We are proposing to adopt, for IDTFs, a number of standards we
adopted for DMEPOS suppliers, including supplier standard number 6
which requires a supplier to maintain a comprehensive liability
insurance policy of $300,000 or 20 percent of its average annual
Medicare billings, whichever amount is greater, that covers both the
place of business and all customers and employees of the IDTF.
Furthermore, we are proposing in the new performance standard
number 7 that an IDTF agrees not to directly solicit patients. This
provision does not preclude the IDTF from public advertisement or
marketing its services to physicians and other suppliers, however it
does prohibit recruitment of beneficiaries through direct solicitation.
Additionally, the IDTF would be required to grant CMS, or its
designated fee-for-service contractors, including our agents, to have
access to the IDTF physical location, all equipment, and beneficiary
medical records during normal business hours. For portable equipment,
an IDTF would be required to maintain a catalog of portable equipment
and be able to produce the cataloged equipment within two business
days. If the IDTF denies this access, the IDTF's Medicare enrollment
would be immediately revoked.
To ensure that equipment used by an IDTF is maintained and operates
properly, we are seeking public comment regarding IDTF supplier
standard number 11, which would require that an IDTF must have its
testing equipment calibrated per equipment instructions or in
compliance with applicable industry standards. Specifically, we are
seeking public comment regarding the organizations or entities that may
currently establish testing specifications for diagnostics equipment.
Further, if these organizations or entities do not exist, we invite
public comment regarding establishment of a supplier standard that
relies on the manufacturer's maintenance and calibration standards.
While we understand that these proposed additional standards could
lead certain IDTFs to withdraw from the Medicare program rather than
comply with the new standards, we believe that legitimate businesses
would not oppose these changes. Moreover, we emphasize that services
provided by an IDTF are also readily available to beneficiaries through
other avenues such as physicians' offices, outpatient laboratories,
outpatient radiology facilities, and outpatient clinics. We believe
that the implementation of these proposed standards would improve the
quality of services provided to Medicare beneficiaries by IDTFs without
any associated access concerns.
2. Proposed Performance Standards for IDTFs
The IDTF would be required to meet the following standards as of
January 1, 2007 and any newly or reenrolling IDTF would be required to
certify in its enrollment application that it meets and would continue
to meet the standards. At Sec. 410.33, we are proposing to revise the
regulation to specify that the IDTF would be required to--
Operate its business in compliance with all applicable
Federal, State, and local licensure and regulatory requirements with
regard to the health and safety of patients;
Provide complete and accurate information on its
enrollment application as stated in the ``Requirements for Providers
and Suppliers to Establish and Maintain Enrollment final rule'' (April
21, 2006 (42 FR 20754)). Any change in enrollment information would be
required to be reported to the designated fee-for-service contractor on
the Medicare enrollment application within 30 calendar days;
Maintain a physical facility on an appropriate site. For
the purposes of this proposed standard, a post office box or commercial
mailbox would not be considered a physical facility. The physical
facility would be required to contain space for equipment appropriate
to the services designated on the enrollment application, facilities
for hand washing, adequate patient privacy accommodations, and the
storage of both business records and current medical records;
Have all applicable testing equipment available at the
physical site, excluding portable equipment. A catalog of portable
equipment, including equipment serial numbers, would be maintained at
the physical site. In addition, portable equipment would be made
available for inspection within two business days of our inspection
request. The IDTF would be required to maintain a current inventory of
the equipment (including serial/registration numbers), provide this
information to the designated fee-for-service contractor and notify the
contractor of any changes in equipment;
Maintain a primary business phone under the name of the
business. The business phone would be located at the designated site of
the business. The telephone number or toll free numbers would be
available in a local directory and through directory assistance;
Have a comprehensive liability insurance policy of at
least $300,000 or 20 percent of its average annual Medicare billings,
whichever amount is greater, that covers both the place of business and
all customers and employees of the IDTF. The insurance policy would be
carried by a non-relative owned company. The policy would be required
to list the serial numbers of any and all equipment used by the IDTF;
Agree not to directly solicit patients, which includes,
but is not limited to, a prohibition on telephone, computer, or in-
person contracts. The IDTF would accept only those patients referred
for diagnostic testing by an attending physician, who is furnishing a
consultation or treating a beneficiary for a specific medical problem
and who uses the results in the management of the beneficiary's
specific medical problem. Nonphysician practictioners may order tests
as set forth in Sec. 410.32(a)(3);
Answer beneficiaries' questions and respond to their
complaints. Documentation of those contacts would be maintained at the
physical site;
Openly post these standards for review by patients and the
public;
Disclose to the government, any person having ownership,
financial or control interest, or any other legal interest in the
supplier at the time of enrollment or within 30 days of a change;
Have its testing equipment calibrated per equipment
instructions and in compliance with applicable national standards;
[[Page 49062]]
Have technical staff on duty with the appropriate
credentials to perform tests. The IDTF would be required to produce the
applicable Federal or State licenses and/or certifications of the
individuals performing these services;
Have proper medical record storage and be able to retrieve
medical records upon request from CMS or its designated fee-for-service
contractor within 2 business days; and
Permit CMS, including its agents or its designated fee-
for-service contractors, to conduct unannounced, on-site inspections to
confirm the IDTF's compliance with these proposed standards. The IDTF
would be required to provide access, during regular business hours, to
CMS and beneficiaries, as well as maintain a visible sign posting the
normal business hours of the IDTF.
3. Supervision
To ensure quality care is provided to Medicare beneficiaries, we
are proposing to revise Sec. 410.33(b)(1) to read that physicians will
be limited to providing supervision to ``no more than three (3) IDTF
sites.''
4. Place of Service
In addition to proposing the establishment of specific supplier
standards for IDTFs, at proposed Sec. 410.33(i), we are proposing to
define the ``point of the actual delivery of service'' as the correct
``Place of Service'' for the claim form in the case of diagnostic
testing performed outside the IDTF's physical location. For example,
when an IDTF performs a diagnostic test at a beneficiary's residence,
we believe that it is reasonable to establish the beneficiary's
residence as the ``Place of Service.'' Previously, there has been no
set procedure, so therefore, we believe that the information is
gathered at the collection point from the beneficiary, and this is the
point service. While most diagnostic tests are performed in an office
setting, we are seeking public comment regarding the types of services
that can be safely and appropriately used in a residential setting.
M. Independent Laboratory Billing for the TC of Physician Pathology
Services to Hospital Patients
[If you choose to comment on issues in this section, please include
the caption ``INDEPENDENT LAB BILLING'' at the beginning of your
comments.]
The TC of physician pathology services refers to the preparation of
the slide involving tissue or cells that a pathologist will interpret.
(In contrast, the pathologist's interpretation of the slide is the PC
service. If this service is furnished by the hospital pathologist for a
hospital patient, it is separately billable. If the independent
laboratory's pathologist furnishes the PC service, it is usually billed
with the TC service as a combined service.)
In the ``Revisions to Payment Policies Under the Physician Fee
Schedule for Calendar Year 2000'' final rule published in the Federal
Register on November 2, 1999 (64 FR 59380 and 59408 through 59409), we
stated that we would implement a policy to pay only the hospital for
the TC of physician pathology services furnished to hospital patients.
Before that proposal, any independent laboratory could bill the carrier
under the PFS for the TC of physician pathology services for hospital
patients. As pointed out in the November 2, 1999 final rule, this
policy has contributed to the Medicare program paying twice for the TC
service, first through the inpatient prospective payment rate to the
hospital where the patient is an inpatient and again to the independent
laboratory that bills the carrier, instead of the hospital, for the TC
service.
Therefore, in that final rule at Sec. 415.130, we provided that,
for services furnished on or after January 11, 2001, the carriers would
no longer pay claims to the independent laboratory under the physician
fee schedule for the TC of physician pathology services for hospital
patients.
Ordinarily, the provisions in the final PFS are implemented in the
following year. However, in this case, the change to Sec. 415.130 was
delayed one year (until January 1, 2001), at the request of the
industry, to allow independent laboratories and hospitals sufficient
time to negotiate arrangements. Moreover, our full implementation of
Sec. 415.130 was further delayed through CY 2006.
We continue to believe, however, that hospital prospective payment
amounts already compensate hospitals for the TC of physician pathology
tests and that additional payment under the PFS is inappropriate.
Therefore, we are proposing to amend Sec. 415.130 to provide that, for
services furnished after December 31, 2006, an independent laboratory
may not bill the carrier for physician pathology services furnished to
a hospital inpatient or outpatient. Under proposed Sec. 415.130(d), we
would pay under the PFS for the TC of a physician pathology service
furnished by an independent laboratory for services provided to an
inpatient or outpatient of a ``covered hospital'' on or before December
31, 2006. A ``covered hospital'' is defined in Sec. 415.130(a)(1).
N. Public Consultation for Medicare Payment for New Outpatient Clinical
Diagnostic Laboratory Tests
[If you choose to comment on issues in this section, please include
the caption ``CLINICAL DIAGNOSTIC LAB TESTS'' at the beginning of your
comments.]
Section 1833(h) of the Act requires the Secretary to establish fee
schedules for clinical laboratory tests under Medicare Part B. In this
section of the preamble, we are proposing to implement section 942(b)
of the MMA which specifies annual procedures for consulting the public
on how to establish payment for new clinical laboratory test codes to
be included in the annual update of the clinical laboratory fee
schedule.
1. BIPA (Pub. L. 106-554)
Section 531(b) of BIPA mandated that we establish, no later than 1
year after the date of enactment, procedures that permit public
consultation for payment determinations for new clinical diagnostic
laboratory tests under Medicare Part B in a manner consistent with the
procedures established for implementing ICD-9-CM coding modifications.
In the November 23, 2001 Federal Register (66 FR 58743), we specified
the procedures to implement section 531(b) of BIPA.
These procedures were most recently used to determine the payments
for new 2006 clinical laboratory fee schedule codes. First, we convened
a public meeting to solicit expert input on the nature of the new tests
before rate determinations were made. We have held these meetings each
year since 2002 to receive this expert input on the next year's codes.
Our most recent meeting was announced in the Federal Register on May
27, 2005 (70 FR 30734) and occurred on July 18, 2005. In that meeting,
we requested that presenters address the new test codes, each test's
purpose, method, cost, and a recommendation for one of two methods
(crosswalking or gapfilling) for determining payment for the new
clinical laboratory codes. Crosswalking and gapfilling are discussed
below in section N.2.d.
Following the public meeting, we posted, on our Website, a summary
of the new codes and the payment recommendations that were presented
during the public meeting. The summary also displayed our tentative
payment determinations and indicated a comment period for interested
parties to submit written comments. After reviewing the comments
received, we issued Medicare Transmittal 750, 2006 Annual Update for
Clinical Laboratory
[[Page 49063 ]]
Fee Schedule, which provided all instructions and final rate
determinations for the 2006 clinical laboratory fee schedule including
the new codes and fees, on November 18, 2005.
2. Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108-173)
Further legislation affecting public consultation for new clinical
laboratory tests was enacted at section 942(b) of the MMA (Pub. L. 108-
173), which added section 1833(h)(8) to the Act. Section 1833(h)(8)(A)
of the Act requires the Secretary to establish by regulation procedures
for determining the basis for and amount of payment for a clinical
diagnostic laboratory test that is assigned a new or substantially
revised Healthcare Common Procedure Coding System (HCPCS) code on or
after January 1, 2005. We refer to these tests as ``new tests.''
Section 1833(h)(8)(B) of the Act provides that determinations of
payment amounts for new tests shall be made only after the Secretary--
Makes available to the public (through an Internet Web
site and other appropriate mechanisms) a list that includes codes for
which establishment of a payment amount is being considered for the
next calendar year;
On the same day the list of codes is made available,
publishes a Federal Register notice of a meeting to receive public
comments and recommendations (and data on which recommendations are
based) on the appropriate basis for establishing payment amounts for
the list of codes made available to the public;
Not less than 30 days after publication of the notice in
the Federal Register, convenes a meeting that includes representatives
of CMS officials involved in determining payment amounts, to receive
public comments and recommendations (and data on which the
recommendations are based); and
Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, develops and makes
available to the public (through an Internet Web site and other
appropriate mechanisms)--
+ A list of proposed determinations with respect to the appropriate
basis for establishing a payment amount for each code, together with an
explanation of the reasons for each determination, the data on which
the determinations are based, and a request for public written comments
on the proposed determination; and
+ A list of final determinations of the payment amounts for tests,
together with the rationale for each determination, the data on which
the determinations are based, and responses to comments and suggestions
from the public.
We believe that our current process for providing for public
consultation on the establishment of payment amounts for new clinical
laboratory tests is consistent with the requirements of section
1833(h)(8)(B) of the Act. We currently make available to the public
through a posting on the CMS Web site a list of new laboratory test
codes for the next calendar year. We publish a Federal Register notice
of a meeting to receive public comments and recommendations and convene
the meeting with appropriate CMS officials in attendance. We take into
account the input received at the public meeting and we make available
to the public on the CMS Web site a list of the proposed determinations
and seek comment. We then make available to the public our final
determinations in the instructions that we provide to our claims
processing contractors to implement the Medicare Part B clinical
laboratory fee schedule each year.
The most significant change required by section 1886(h)(8)(A) of
the Act with respect to our procedures for public consultation is that
we codify this process in regulations. Therefore, in this proposed
rule, we are proposing to codify our current process for public
consultation for new clinical diagnostic laboratory tests paid under
the Medicare Part B clinical laboratory fee schedule at proposed new
Subpart F--Payment for New Clinical Diagnostic Laboratory Tests (Sec.
414.402 through Sec. 414.406).
a. Proposed Basis and Scope (Sec. 414.400)
This proposed new subpart would implement provisions of section
1833(h)(8) of the Act--procedures for determining the basis for, and
amount of, payment for a new clinical diagnostic laboratory test with
respect to which a new or substantially revised Healthcare Common
Procedure Coding System code is assigned on or after January 1, 2005.
b. Proposed Definition (Sec. 414.402)
As specified in section 942(b) of the MMA, we propose to define the
term ``Substantially Revised Healthcare Common Procedure Coding System
Code'' to mean a code for which there has been a substantive change to
the definition of the test or procedure to which the code applies (such
as a new analyte or a new methodology for measuring an existing analyte
specific test).
c. Proposed Procedures for Public Consultation for Payment for a New
Clinical Diagnostic Laboratory Test (Sec. 414.406)
For a clinical laboratory test that is assigned a new or
substantially revised code on or after January 1, 2005, we would
establish a local fee schedule amount only after the following:
We make available to the public (through an Internet Web
site and other appropriate mechanisms) a list that includes codes for
which establishment of a payment amount is being considered for the
next calendar year.
We publish a Federal Register notice of a meeting to
receive public comments and recommendations (and data on which
recommendations are based) on the appropriate basis, as specified in
proposed new Sec. 414.408, for establishing payment amounts for the
list of codes made available to the public.
Not less than 30 days after publication of the notice in
the Federal Register, we convene a meeting, that includes
representatives of CMS officials involved in determining payment
amounts, to receive public comments and recommendations (and data on
which the recommendations are based).
Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, we develop and make
available to the public (through an Internet Web site and other
appropriate mechanisms)--
+ A list of proposed determinations with respect to the appropriate
basis for establishing a payment amount for each code, together with an
explanation of the reasons for each determination, the data on which
the determinations are based, and a request for public written comments
on the proposed determination within a specified time period; and
+ A list of final determinations of the payment amounts for tests,
together with the rationale for each determination, the data on which
the determinations are based, and responses to comments and suggestions
from the public.
d. Proposed Payment for a New Clinical Diagnostic Laboratory Test--
Crosswalking and Gapfilling (Sec. 414.408)
We are proposing to add a new Sec. 414.408 to indicate when, in
establishing the payment amount for a new clinical laboratory test, one
of two payment methods can be utilized. The
[[Page 49064]]
first payment method, called ``crosswalking,'' is used if a new test is
determined to be comparable to an existing test, multiple existing test
codes, or a portion of an existing test code. We propose that a new
test code would be assigned the related existing local fee schedule
amounts and national limitation amount.
In new Sec. 414.408, we propose to use the second method, called
``gapfilling,'' when no comparable, existing test is available.
Currently when using this method, manual instructions are provided to
each Medicare carrier to determine a payment amount for its geographic
area(s) for use in the first year, and the carrier-specific amounts are
used to establish a national limitation amount for following years.
Consistent with our current process, the sources of information
carriers examine in determining gapfill amounts, if available,
include--
Charges for the test and routine discounts to charges;
Resources required to perform the test;
Payment amounts determined by other payers; and
Charges, payment amounts, and resources required for other
tests that may be comparable or otherwise relevant.
Currently, our manual instructions allow carriers to consider other
sources of information as appropriate, including clinical studies and
information provided by clinicians practicing in the area,
manufacturers, or other interested parties. Carriers are also
instructed to establish carrier specific amounts on or before March 31
of the year and to revise their carrier specific amount, if necessary,
on or before September 1 of the year. In this manner, a carrier may
revise its carrier specific amount based on additional information, but
there is also a specific time frame to perform this revision so that we
have adequate time to receive and use the carrier specific amounts for
the calculation of the next year's clinical laboratory fee schedule.
Currently for new gapfilled laboratory tests, the payment amount
beginning in the second year is based on the lower of the carrier
specific amount determined in the first year or the national limitation
amount. In accordance with section 1833(h) of the Act, the national
limitation amount is set at the median of the carrier-specific amounts.
In light of new MMA provisions, however, we are proposing, in new
Sec. 414.408, to prospectively eliminate payment of new gapfilled
tests at a carrier specific amount after the first year. Section
1833(h)(8)(A) of the Act gives the Secretary authority to establish
procedures for determining the payment amount for laboratory tests for
which new or substantially revised HCPCS codes were established on or
after January 1, 2005. Under this authority, we propose, in new Sec.
414.408(b), to pay for a new gapfilled laboratory test under our
existing methodology for the first year (the carrier would establish a
gapfill amount.) Beginning in the second year, the test would be paid
at the national limitation amount. This would result in consistent
payment in geographic areas for a new test using the median of the
carrier gapfill amounts.
3. Other Laboratory Issues
This section discusses other laboratory issues related to quality
and glucose monitoring in SNFs.
a. Quality
In addition to providing payments, Medicare's clinical laboratory
fee schedule for both new and existing tests should foster the
provision of quality care and the prevention of avoidable health care
costs. We are exploring the development of measures related to the
quality and efficiency of care, including those involving clinical
laboratory fee schedule services. Physicians' decisions are central to
the health care their patients receive and are informed by appropriate
clinical laboratory testing. We want to work with physicians, providers
and the clinical laboratory community to identify ways to promote
utilization decisions that clearly increase the quality of care while
avoiding unnecessary costs for beneficiaries and the Medicare program.
As part of its strategies to improve quality of care, CMS could
require those who perform laboratory tests to submit laboratory values
using common vocabulary standards, such as those found in the Logical
Observation Identifiers Names and Codes (LOINC[supreg]) database.
The LOINC[supreg] database currently contains about 41,000
observational terms, of which nearly 31,000 are observational terms
related to laboratory testing. The laboratory subset of the
LOINC[supreg] database provides universal names and codes for
identifying the results of clinical laboratory tests and it facilitates
the exchange and pooling of clinical laboratory results for clinical
care, outcomes management and research. Note that LOINC[supreg]
describes the test result, but does not provide it. It is, therefore,
only one possible component of a comprehensive system of collecting
clinical laboratory fee test results. Each LOINC[supreg] record
corresponds to a single test result or panel. The following are some
examples of LOINC records:
LOINC code LOINC name (component: property: timing: specimen: scale)
2951-2 SODIUM:SCNC:PT:SER/PLAS:QN
2955-2 SODIUM:SCNC:PT:UR:QN
2956-1 SODIUM:SRAT:24H:UR:QN
2164-2 CREATININE RENAL CLEARANCE:VRAT:24H:UR:QN
1514-9 GLUCOSE[caret]2H POST 100 G GLUCOSE
PO:MCNC:PT:SER/PLAS:QN
3665-7 GENTAMICIN[caret] TROUGH:MCNC:PT:SER/PLAS:QN
17863-2 CALCIUM.IONIZED: MCNC:PT:SER/PLAS:QN
2863-9 ALBUMIN:MCNC:PT:SNV: QN:ELECTROPHORESIS
The parts of the LOINC[supreg] name refer to different aspects of
the test result. The component is the analyte (for example, sodium).
The property is the characteristic of the analyte that is measured,
evaluated or observed (for example SCNC = substance concentration).
Timing indicates whether the measurement is an observation at a moment
of time, or an observation integrated over an extended duration of time
(for example, PT = point in time). The specimen is the type of sample
(for example, SER/PLAS = serum or plasma). The scale is the type of
scale (for example QN = quantitative). For further detail, please see
the LOINC[supreg] Web site at http://www.loinc.org.
On September 23, 2005 (70 FR 55900-56025), we published the
proposed rule ``HIPAA Administrative Simplification: Standards for
Electronic Health Care Claims Attachments.'' This rule proposed
standards for electronically requesting and supplying particular types
of additional health care information in the form of an electronic
attachment to support submitted health care claims data. The proposed
rule specified a standard attachment form for reporting laboratory
results (among other standards) and proposed adoption of LOINC[supreg]
as the standard code set for reporting such results.
While the laboratory claims attachment standard and use of
LOINC[supreg] could provide a means for reporting test result data, we
recognize that there are significant operational and other challenges
that would need to be addressed before Medicare could begin to collect
laboratory values in a comprehensive fashion using common vocabulary
standards and that these challenges need to be met in partnership with
the clinical laboratory community. We look forward to working
[[Page 49065]]
collaboratively with the clinical laboratory community on these issues.
b. Blood Glucose Monitoring in SNFs
In response to inquiries regarding our policy on blood glucose
monitoring in SNFs, we are taking this opportunity to restate our long-
standing policy on coverage of blood glucose monitoring services and to
propose to codify physician certification requirements for blood
glucose monitoring in SNFs.
Generally, section 1862(a)(1)(A) of the Act requires that a service
be reasonable and necessary for diagnosis and treatment in order to be
eligible for coverage by Medicare. Our regulations at Sec. 410.32(a)
already require that, for any diagnostic test, including a clinical
diagnostic laboratory test, to be considered reasonable and necessary,
it must be both ordered by the physician and the ordering physician
must use the result in the management of the beneficiary's specific
medical problem. Tests not ordered by the physician who is treating the
beneficiary are not reasonable and necessary.
In the context of blood glucose monitoring, we most recently stated
this policy in Transmittal AB-00-108, ``Glucose Monitoring'', which is
available on our Web site at http://www.cms.hhs.gov/transmittals/downloads/ab00108.pdf.
This interpretation of Sec. 410.32 is also the
basis for our policy in Chapter 7 of the Medicare Claims Processing
Manual (``Skilled Nursing Facility Part B Billing'' available on our
Web site at http://www.cms.hhs.gov/manuals/downloads/clm104c07.pdf.)
In addition, section 1835(a)(2)(B) of the Act provides that, in the
case of certain ``medical and other health services'' (including
clinical diagnostic laboratory services), payment may be made for Part
B services that are furnished by a provider of services only if a
physician certifies--and recertifies where those services are furnished
over a period of time, with such frequency, and accompanied by such
supporting material, as may be provided by regulation--that those
services were medically necessary. The regulations currently
implementing this provision at Sec. 424.24 do not specifically address
the issue of blood glucose monitoring in SNFs. Therefore, we are
proposing to amend Sec. 424.24 to provide that, for each blood glucose
test furnished to a resident of a SNF, the physician must certify that
the test is medically necessary. We are also proposing to amend Sec.
424.24 to clarify that a physician's standing order is not sufficient
to order routine blood glucose monitoring.
c. Other Lab Issues--Proposed Clinical Diagnostic Laboratory Date of
Service (DOS) for Stored Specimens
We are proposing to add a new Sec. 414.410 to address concerns
that have been raised regarding the date of service of a clinical
diagnostic laboratory test that use a stored (or ``archived'')
specimen. In the final rule of coverage and administrative policies for
clinical diagnostic laboratory services that we published on November
23, 2001 (66 FR 58792), we adopted a policy under which the date of
service for clinical diagnostic laboratory services generally is the
date the specimen is collected. For laboratory tests that use an
archived specimen, however, the date of service is the date the
specimen was obtained from the storage. In 2002, we issued Program
Memorandum AB-02-134 which permitted contractors discretion in making
determinations regarding the length of time a specimen must be stored
to be considered archived. In response to comments requesting that we
issue a national standard to clarify when a stored specimen can be
considered ``archived,'' in the Procedures for Maintaining Code Lists
in the Negotiated National Coverage Determinations for Clinical
Diagnostic Laboratory Services final notice, published in the Federal
Register on February 25, 2005 (70 FR 9355), we defined an ``archived''
specimen as a specimen that is stored for more than 30 calendar days
before testing. The date of service for these archived specimens is the
date the specimen was obtained from storage. Specimens stored 30 days
or less have a date of service of the date the specimen was collected.
The February 25, 2005 final notice also clarified that the date of
service for tests when the collection spanned more than two calendar
days is the date the collection ended. Instructions that implemented
these policies were added to Chapter 16, section 40.8 of the Medicare
Claims Processing Manual (Pub. 100-04) with the issuance of Transmittal
800 (CR 4156), on December 30, 2005.
Recently, we have received correspondence that expressed concern
that our policies have created some unintended consequences, especially
in situations in which a specimen is taken in a hospital setting, but
then later used for a test after the patient has left the hospital.
Under the current manual instructions, if the specimen used for a test
ordered subsequent to the beneficiary's discharge is obtained less than
31 calendar days following the date the specimen was collected, the
date of service of the test is the date of collection. The date of
service of a test may affect payment because, if the date of service
falls during an inpatient stay or on a day on which the beneficiary had
an outpatient procedure, payment for the laboratory test usually is
bundled with the hospital service. To address these concerns, we are
proposing to change our current policy so that the date of service
would be the date the specimen is obtained from storage, even if the
specimen is obtained less than 31 days from the date it was collected,
without violating the unbundling rules as long as the following
conditions are met:
The test is ordered by the patient's physician at least 14
days following the date of the patient's discharge from the hospital.
The test could not reasonably have been ordered while the
patient was hospitalized.
The procedure performed while the beneficiary is a patient
of the hospital is for purposes other than collection of the specimen
needed for the test.
The test is reasonable and medically necessary.
These conditions are consistent with the guidance in Chapter 16,
sec 40.3 of the Claims Processing Manual, which states that ``When the
hospital obtains laboratory tests for outpatients under arrangements
with clinical laboratories or other hospital laboratories, only the
hospital can bill for the arranged services.''
In addition, Chapter 3 of the Program Integrity Manual contains
instructions for additional documentation if further development of
laboratory claims for pre-or postpay are required. Although we believe
these changes will help to maintain beneficiary access to care, we are
concerned about the potential for these policy changes creating
inappropriate incentives in the development of technology and the
implications for the unbundling of services. We solicit comment on the
proposed changes and these concerns.
O. Proposal to Establish Criteria for National Certifying Bodies That
Certify Advanced Practice Nurses
[If you choose to comment on issues in this section, please include
the caption ``Criteria for National Certifying Bodies-Advanced Practice
Nurses'' at the beginning of your comments.]
Federal regulatory qualifications for nurse practitioners (NPs) at
42 CFR 410.75 require that an individual be certified as an NP by a
recognized national certifying body that has established standards for
NPs. Similarly, Federal regulatory qualifications for clinical nurse
specialists (CNSs) at 42
[[Page 49066]]
CFR 410.76 require that an individual be certified as a CNS by a
national certifying body that has established standards for CNSs and
that is approved by the Secretary.
Currently, there is not a list of recognized or approved national
certifying bodies for NPs and CNSs in regulations. However, Chapter 15,
section 200 of the Benefit Policy Manual, Pub. 100-02 contains a list
of national certifying bodies that are recognized by Medicare as being
appropriate for certification of NPs. Although the manual provision
regarding CNS services at Chapter 15, section 210 of the Benefit Policy
Manual lists only the American Nurses Credentialing Center as an
approved national certifying body for CNSs, we indicated that the list
of recognized certifying bodies in the manual provision for NP services
would also apply for CNSs in the ``Revisions to Payment Policies Under
the CY 2003 Physician Fee Schedule and Inclusion of Registered Nurses
in the Personnel Provision of the Critical Access Hospital Emergency
Services Requirement for Frontier Areas and Remote Locations; Payment
Policies final rule (December 31, 2002, 67 FR 79987). The national
certifying bodies that are listed under the manual instruction at
section 200, and that currently apply for both NPs and CNSs
(collectively, advanced practice nurses) are as follows:
American Academy of Nurse Practitioners;
American Nurses Credentialing Center;
National Certification Corporation for Obstetric,
Gynecologic and Neonatal Nursing Specialties;
National Certification Board of Pediatric Nurse
Practitioners and Nurses;
Oncology Nurses Certification Corporation;
Critical Care Certification Corporation.
In the December 31, 2002 final rule, in response to a public
comment, we stated, ``it is not the agency's intention to be overly
restrictive in our program requirements and consequently prevent
qualified CNSs who specialize in areas of medicine other than those
certified by the American Nurses Credentialing Center (ANCC) from
participating under the CNS benefit and from rendering care to patients
in need of specialized services. Furthermore, the intent of the
revision to the certification requirement for CNSs is to recognize all
appropriate national certifying bodies for CNSs as the program does for
NPs.'' Accordingly, in an effort to recognize all appropriate national
certifying bodies for CNSs and NPs, we added, at that time, the
Oncology Nurses Certification Corporation (ONCC) and the Critical Care
Certification Corporation (CCCC) to the list of recognized national
certifying bodies for advanced practice nurses.
The National Board on Certification of Hospice and Palliative Care
Nurses (NBCHPN) has requested that we now follow the same course of
action as we did for the ONCC and the CCCC by adding its name to the
list of recognized national certifying bodies. That is, NBCHPN believes
that it is an appropriate national certifying body based on its
certification experience, principles, services, and the certification
exam that it administers to advanced practice nurses who specialize in
palliative care for hospice patients.
The NBCHPN stated in information it sent to the agency that its
organization is a well-established certification body with more than
12-years history of certification and that it has been certifying
advanced practice hospice and palliative nurses since 2003 in
partnership with the ANCC. Starting in 2005, the NBCHPN became sole
proprietor of the Advanced Certified Hospice and Palliative Nurse
(ACHPN) examination. Master's level nurse practitioners and clinical
nurse specialists sit for this ACHPN examination that is based on a
role delineation study for the advanced practice level of hospice and
palliative nursing. Additionally, the NBCHPN stated that it has met the
requirements of the American Board of Nursing Specialties and is an
active member of the Board of Specialties, as is the ANCC. The
Executive Director of the NBCHPN stated that she believes that the
absence of the NBCHPN from the current list of recognized national
certifying bodies presents a barrier for advanced practice nurses in
the hospice palliative care specialty because they are denied
enrollment on the basis that they do not meet the certification
qualification requirement. The Web site for the NBCHPN can be found at
http://www.nbchpn.com.
We are soliciting public comments on whether it would be
appropriate to include the NBCHPN under the list of recognized and
approved national certifying bodies for NPs and CNSs under manual
instructions for both NPs and CNSs. We are also soliciting public
comments on criteria or standards that we could use to determine
whether an organization is an appropriate national certifying body for
advanced practice nurses. CMS realizes that the agency may receive
other requests in the future from organizations that wish to be to be
added to the list of recognized or approved national certifying bodies.
In anticipation of those requests, the agency is interested in
developing certification standards that would facilitate the process
for making these decisions.
P. Chiropractic Services Demonstration
[If you choose to comment on issues in this section, please include
the caption ``Chiropractic Services Demonstration'' at the beginning of
your comments.]
In the FY 2006 PFS final rule (November 21, 2005), we included a
discussion of the 2-year demonstration authorized by section 651 of the
MMA to evaluate the feasibility and advisability of covering
chiropractic services under Medicare. These services extend beyond the
current coverage for manipulation to care for neuromusculoskeletal
conditions typical among eligible beneficiaries, and cover diagnostic
and other services that a chiropractor is legally authorized to perform
by the State or jurisdiction in which the treatment is provided. The
demonstration is being conducted in four sites, two rural and two
urban. The demonstration must be budget neutral as the statute requires
the Secretary to ensure that the aggregate payment made under the
Medicare program does not exceed the amount which would be paid in the
absence of the demonstration.
Ensuring budget neutrality requires that the Secretary develop a
strategy for recouping funds should the demonstration result in costs
higher than those that would occur in the absence of the demonstration.
As we stated in the FY 2006 PFS, we would make adjustments in the
national chiropractor fee schedule to recover the costs of the
demonstration in excess of the amount estimated to yield budget
neutrality. We will assess budget neutrality by determining the change
in costs based on a pre/post comparison of costs and the rate of change
for specific diagnoses that are treated by chiropractors and physicians
in the demonstration sites and control sites. We will not limit our
analysis to reviewing only chiropractor claims, because the costs of
the expanded chiropractor services may have an impact on other Medicare
costs.
Any needed reduction would be made in the 2010 and 2011 physician
fee schedules as it will take approximately 2 years to complete the
claims analysis. If we determine that the adjustment for budget
neutrality is greater than 2 percent of spending for the chiropractor
fee schedule codes (comprised of the 3
[[Page 49067]]
currently covered CPT codes 98940, 98941, and 98942), we would
implement the adjustment over a 2-year period. However, if the
adjustment is less than 2 percent of spending under the chiropractor
fee schedule codes, we would implement the adjustment over a 1-year
period. We will include the detailed analysis of budget neutrality and
the proposed offset during the 2009 rulemaking process. PT services
performed by chiropractors under the demonstration are subject to the
PT therapy cap. These services are included under the cap because
chiropractors are subject to the same rules as medical doctors for
therapy services under the demonstration.
Q. Promoting Effective Use of Health Information Technology (HIT)
(If you choose to comment on issues in this section, please include
the caption ``Promoting Effective Use of HIT'' at the beginning of your
comment.)
We recognize the potential for health information technology (HIT)
to facilitate improvements in the quality and efficiency of health care
services. One recent RAND study found that broad adoption of electronic
health records could save more than $81 billion annually and, at the
same time, improve quality of care.\1\ The largest potential savings
that the study identified was in the hospital setting because of
shorter hospital stays promoted by better coordinated care; less
nursing time spent on administrative tasks; better use of medications
in hospitals; and better utilization of drugs, laboratory services, and
radiology services in hospital outpatient settings. The study also
identified potential quality gains through enhanced patient safety,
decision support tools for evidence-based medicine, and reminder
mechanisms for screening and preventive care. Despite these large
potential benefits, the study found that only about 20 to 25 percent of
hospitals have adopted HIT systems.
---------------------------------------------------------------------------
\1\ RAND News Release: Rand Study Says Computerizing Medical
Records Could Save $81 Billion Annually and Improve the Quality of
Medical Care, September 14, 2005, available at http://rand.org/news/press.05/09.14.html
.
---------------------------------------------------------------------------
It is important to note the caveats to the RAND study. The
projected savings are across the health care sector, and any Federal
savings would be a reduced percentage. In addition, there are
significant assumptions made in the RAND study. National savings are
projected in some cases based on one or two small studies. Also, the
study assumes patient compliance, in the form of participation in
disease management programs and following medical advice. For these
reasons, extreme caution should be used in interpreting these results.
In summary, there are mixed signals about the potential of HIT to
reduce costs. Some studies have indicated that HIT adoption does not
necessarily lead to lower costs and improved quality. In addition, some
industry experts have stated that factors such as an aging population,
medical advances, and increasing provider expenses would make any
projected savings impossible.
In his 2004 State of the Union Address, the President announced a
plan to ensure that most Americans have electronic health records
within 10 years.\2\ One part of this plan involves developing voluntary
standards and promoting the adoption of interoperable HIT systems that
use these standards. The 2007 Budget states that ``The Administration
supports the adoption of health information technology (IT) as a normal
cost of doing business to ensure patients receive high quality care.''
---------------------------------------------------------------------------
\2\ Transforming Health Care: The President's Health Information
Technology Plan, available at: http://www.whitehouse.gov/infocus/technology/economic_policy200404/chap3.html
.
---------------------------------------------------------------------------
Over the past several years, we have undertaken several activities
to promote the adoption and effective use of HIT in coordination with
other Federal agencies and with the Office of the National Coordinator
for Health Information Technology. One of those activities is promotion
of data standards for clinical information, as well as for claims and
administrative data.
As noted above, the Administration supports the adoption of HIT as
a normal cost of doing business. The adoption and use of HIT may
contribute to improved processes and outcomes of care, including
shortened illnesses and the avoidance of adverse drug reactions.
R. Health Care Information Transparency Initiative
(If you choose to comment on issues in this section, please include
the caption ``Health Care Information Transparency Initiative'' at the
beginning of your comment.)
The United States (U.S.) faces a dilemma in health care. Although
the rate of increase in health care spending slowed last year, costs
are still growing at an unsustainable rate. The U.S. spends $1.9
trillion on health care, or 16 percent of the gross domestic product
(GDP). By 2015, projections are that health care will consume 20
percent of GDP. As indicated in the 2006 Annual Report of the Boards of
Trustees, the Medicare program alone consumes 3.2 percent of the GDP
and by 2040, it will consume 8.0 percent of the GDP.
Part of the reason health care costs are rising so quickly is that
most consumers of health care--the patients--are frequently not aware
of the actual cost of their care. Health insurance shields them from
the full cost of services, and they have only limited information about
the quality and costs of their care. Consequently, consumers do not
have the incentive or means to carefully shop for providers offering
the best value. Thus, providers of care are not subject to the
competitive pressures that exist in other markets for offering quality
services at the best possible price. Reducing the rate of increase in
health care prices and avoiding health services of little value could
help to stem the growth in health care spending, and potentially reduce
the number of individuals who are unable to afford health insurance.
Part of the President's health care agenda is to expand Health Savings
Accounts (HSAs), which would provide consumers with greater financial
incentives to compare providers in terms of price and quality, and
choose those that offer the best value.
In order to exercise those choices, consumers must have accessible
and useful information on the price and quality of health care items
and services. Typically, health care providers do not publicly quote or
publish their prices. Moreover, list prices, or charges, generally
differ from the actual prices negotiated and paid by different health
plans. Thus, even if consumers were financially motivated to shop for
the best price, it would be very difficult at the current time for them
to access usable information.
For these reasons, DHHS is launching a major health care
information transparency initiative in 2006. This effort builds on
steps taken by CMS to make quality and price information available. For
example, Medicare has provided unprecedented information about drug
prices in the Medicare drug benefit, and is now adding to these efforts
in other areas. Medicare payment information for common elective
procedures and other common admissions for all hospitals by county has
been posted on our Web site at: http://www.cms.hhs.gov/HealthCareConInit/01
Overview.asp#TopOfP.
We will post geographically-based Medicare payment information for
common elective procedures for ambulatory surgery centers this summer
and for common hospital outpatient and physician services this fall.
[[Page 49068]]
In addition, a number of tools providing usable healthcare
information are already available to Medicare beneficiaries. Supported
by the public-private quality alliances, consumers can access
``Compare'' Web sites through http://www.medicare.gov where they can evaluate
important aspects of their health care options for care at a hospital,
nursing home, home health agency, and dialysis facility, as well as
compare their costs and coverage when choosing a prescription drug
plan.
We are developing a project with the goals of providing more
comprehensive information on quality and costs, including more complete
measures of health outcomes, satisfaction, and volume of services that
matter to consumers, and more comprehensive measures of costs for
entire episodes of care, not just payments for particular services and
admissions. We intend for the project to combine public and private
health care data to measure cost and quality of care information at the
physician and hospital levels. Quality, cost, pricing, and patient
information will be reported to consumers and purchasers of health care
in a meaningful and transparent way.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:
Section 410.33 Independent Diagnostic Testing Facility
Section 410.33(e)(1) imposes a recordkeeping requirement on multi-
state entities. Specifically, an independent diagnostic testing
facility (IDTF) that operates across State boundaries must maintain
documentation that its supervising physicians and technicians are
licensed and certified in each of the States in which it operates. The
burden associated with this requirement is the time and effort it takes
the IDTF to collect and maintain the aforementioned information.
While subject to the PRA, we believe this information collection
requirement is exempt as defined in 5 CFR 1320.3(b)(2), because the
time, effort, and financial resources necessary to comply with the
requirement would be incurred by persons in the normal course of their
activities (for example, in compiling and maintaining business records)
and is considered to be usual and customary.
Section 410.33(g) discusses the application certification standards
that an IDTF must meet. An IDTF must complete an enrollment application
and certify the information contained in the application. The
certification is part of an application that is subject to the PRA. The
burden associated with this requirement is the time and effort
necessary to complete the application. This requirement is currently
approved in OMB No. 0938-0685, with a current expiration date of April
30, 2009.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Regulations Development Group, Attn:
William N. Parham, III, [CMS-1321-P], Room C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Carolyn Lovett, CMS Desk Officer, [CMS-1321-P],
carolyn_lovett@omb.eop.gov. Fax (202) 395-6974.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Analysis
[If you choose to comment on issues in this section, please include
the caption ``IMPACT'' at the beginning of your comments.]
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980 Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibilities of duties) directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis must be prepared for proposed rules with
economically significant effects (that is, a proposed rule that would
have an annual effect on the economy of $100 million or more in any one
year, or would adversely affect in a material way the economy, a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities). As indicated in more detail below, we estimate that the
PFS provisions included in this proposed rule will redistribute more
than $100 million in one year. We are considering this proposed rule to
be economically significant because its provisions are estimated to
result in an increase, decrease or aggregate redistribution of Medicare
spending that will exceed $100 million. Therefore, this proposed rule
is a major rule and we have prepared a regulatory impact analysis.
The RFA requires that we analyze regulatory options for small
businesses and other entities. We prepare a regulatory flexibility
analysis unless we certify that a rule would not have a significant
economic impact on a substantial number of small entities. The analysis
must include a justification concerning the reason action is being
taken, the kinds and number of small entities the rule affects, and an
explanation of any meaningful options that achieve the objectives with
less significant adverse economic impact on the small entities.
Section 1102(b) of the Act requires us to prepare a regulatory
impact analysis for any proposed rule that may have a significant
impact on the operations of
[[Page 49069]]
a substantial number of small rural hospitals. This analysis must
conform to the provisions of section 603 of the RFA. For purposes of
section 1102(b) of the Act, we define a small rural hospital as a
hospital that is located outside a Metropolitan Statistical Area and
has fewer than 100 beds. We have determined that this proposed rule
would have minimal impact on small hospitals located in rural areas. Of
the 222 hospital-based ESRD facilities located in rural areas, only 40
are affiliated with hospitals with fewer than 100 beds.
For purposes of the RFA, physicians, nonphysician practitioners,
and suppliers are considered small businesses if they generate revenues
of $6 million or less. Approximately 95 percent of physicians are
considered to be small entities. There are about 980,000 physicians,
other practitioners and medical suppliers that receive Medicare payment
under the PFS.
For purposes of the RFA, approximately 80 percent of clinical
diagnostic laboratories are considered small businesses according to
the Small Business Administration's size standards.
In addition, most ESRD facilities are considered small entities,
either based on nonprofit status or by having revenues of $29 million
or less in any year. We consider a substantial number of entities to be
affected if the proposed rule is estimated to impact more than 5
percent of the total number of small entities. Based on our analysis of
the 927 nonprofit ESRD facilities considered small entities in
accordance with the above definitions, we estimate that the combined
impact of the proposed changes to payment for renal dialysis services
included in this proposed rule would have a 0.9 percent increase in
overall payments relative to current overall payments.
IDTFs are suppliers under the Medicare program. For purposes of the
RFA, suppliers with annual sales of $6 million or less are considered
to be small entities. (Individuals and States are not included in the
definition of a small entity.) We believe that our proposed standards
for IDTFs will help bar fraudulent suppliers from participating in the
Medicare program and provide an added level of protection to Medicare
beneficiaries. Therefore, we expect to have an impact on an unknown
number of persons and entities who will effectively be prevented from
practicing their aberrant billing activities. The vast majority of
suppliers would not be significantly affected by this proposed rule.
The reduction in program overpayments and the added level of protection
to beneficiaries that we expect to achieve as a result of this proposed
rule justifies the relatively small burden this proposed rule would
impose on all small entities.
The analysis and discussion provided in this section, as well as
elsewhere in this proposed rule, complies with the RFA requirements.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditures in any year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $120 million. Medicare beneficiaries are considered to be
part of the private sector for this purpose.
We have examined this proposed rule in accordance with Executive
Order 13132 and have determined that this regulation would not have any
significant impact on the rights, roles, or responsibilities of State,
local, or tribal governments. A discussion concerning the impact of
this rule on beneficiaries is found later in this section.
We have prepared the following analysis, which, together with the
information provided in the rest of this preamble, meets all assessment
requirements. The analysis explains the rationale for and purposes of
this proposed rule; details the costs and benefits of the rule;
analyzes alternatives; and presents the measures we propose to use to
minimize the burden on small entities. As indicated elsewhere in this
proposed rule, we propose to change our methodology for calculating
resource-based PE RVUs and make a variety of other changes to our
regulations, payments, or payment policies to ensure that our payment
systems reflect changes in medical practice and the relative value of
services. We provide information for each of the policy changes in the
relevant sections of this proposed rule. We are unaware of any relevant
Federal rules that duplicate, overlap or conflict with this proposed
rule. The relevant sections of this proposed rule contain a description
of significant alternatives if applicable.
A. Resource Based PE RVU Proposals for CY 2007 and Section 5102 of the
DRA-Proposed Adjustments for Payments for Imaging Services
As required by section 5102(a) of the DRA and described earlier in
section II.E.1. of this proposed rule, we are removing, from the PE
RVUs under the PFS the 0.3 percent increase made to the PE RVUs in the
CY 2006 PFS final rule with comment period to ensure the budget
neutrality of the impact of the multiple imaging policy adopted for CY
2006. Section 5102(a) of the DRA exempts the CY 2006 and 2007 impact of
the multiple imaging policy from budget neutrality. Because we are
proposing to maintain the current 25 percent payment reduction for
multiple imaging procedures in CY 2007, there is no additional impact
resulting from our proposals for CY 2007. Section 5102 of the DRA also
exempts the estimated savings from the application of the OPPS-based
payment limitation on PFS imaging services from the PFS budget
neutrality requirement. We estimate that the combined impact of the
budget neutrality exemptions in section 5102 of the DRA would reduce
PFS expenditures by approximately 1.3 percent in CY 2007.
Table 7 below shows the specialty-level impact of section 5102 of
the DRA and our most recent estimate (-5.1 percent) of the CY 2007
Medicare PFS update. For reference purposes, we have also included the
specialty-level impacts using the methodology from the separate June
29, 2006 proposed notice (71 FR 37170), which solicited comments on
proposed changes to the PE methodology as well as changes to work RVUs
for certain services based on the agency's completion of a five-year
review of work RVUs. The CY 2007 impact of the PE input changes
described in section II.A. of this proposed rule that were not included
in the June 29, 2006 proposed notice are minimal at the specialty
level. Additionally, the impacts in this proposed rule reflect the use
of updated physician time data from the AMA-RUC.
Our estimates of changes in Medicare revenues for PFS services
compare payment rates for CY 2006 with proposed payment rates for CY
2007 using CY 2005 Medicare utilization for all years. We are using CY
2005 Medicare claims processed and paid through March 30, 2005, that we
estimate are 98 percent complete. To the extent that there are year-to-
year changes in the volume and mix of services provided by physicians,
the actual impact on total Medicare revenues will be different than
those shown here. The payment impacts reflect averages for each
specialty based on Medicare utilization. The payment impact for an
individual physician would be different from the average, based on the
mix of services the physician provides. The average change in total
revenues would be less than the impact displayed here because
physicians furnish services to both Medicare and non-Medicare patients
[[Page 49070]]
and specialties may receive substantial Medicare revenues for services
that are not paid under the PFS. For instance, independent laboratories
receive approximately 80 percent of their Medicare revenues from
clinical laboratory services that are not paid under the PFS.
Table 7 shows only the payment impact on PFS services. The
following is an explanation of the information represented in Table 7:
Specialty--The physician specialty or type of
practitioner/supplier.
Allowed Charges--Allowed charges are the Medicare Fee
Schedule amounts for covered services and include copayments and
deductibles (which are the financial responsibility of the
beneficiary.) These amounts have been summed across all services
provided by physicians, practitioners, or suppliers with a specialty to
arrive at the total allowed charges for the specialty.
Impact of Work and PE RVU Changes using the June 29, 2006
proposed notice methodology--For references purposes, the combined CY
2007 percentage increase or decrease in allowed charges attributed to
changes in the work and PE RVUs described in and republished from the
June 29, 2006 proposed notice methodology.
Impact of section 5102 of the DRA--The CY 2007 percentage
decrease in allowed charges attributed to section 5102 of the DRA.
Combined impact of the June 29, 2006 proposed notice
methodology and section 5102 of the DRA.
CY 2007 Update--The percentage decrease in allowed charges
attributed to the most recent estimate of the CY 2007 PFS conversion
factor update (-5.1 percent).
Combined impact with CY 2007 update--The CY 2007
percentage decrease in allowed charges attributed to the June 29, 2006
proposed notice methodology, section 5102 of the DRA, and the CY 2007
update.
[GRAPHIC] [TIFF OMITTED] TP22AU06.045
[[Page 49071]]
[GRAPHIC] [TIFF OMITTED] TP22AU06.046
Table 8 below shows the impact on total payments for selected high-
volume procedures of all of the changes previously discussed. We
selected these procedures because they are the most commonly provided
by a broad
[[Page 49072]]
spectrum of physician specialties. There are separate columns that show
the change in the facility rates and the nonfacility rates. For an
explanation of facility and nonfacility PE refer to Addendum A of this
proposed rule. If we change any of the proposed provisions following
the consideration of public comments, these figures may change.
[GRAPHIC] [TIFF OMITTED] TP22AU06.047
[[Page 49073]]
[GRAPHIC] [TIFF OMITTED] TP22AU06.048
B. Geographic Practice Cost Indices (GPCI)--Payment Localities
As discussed in section II.B. of the preamble to this proposed
rule, we are proposing new GPCIs for 2007. In the November 15, 2004 PFS
final rule, we published 2005 and 2006 GPCI and GAF values reflecting
the 2 year phase-in of updated GPCI data. In 2007, the proposed GPCI
and GAF values will reflect new budget neutrality scalers (developed by
the Office of the Actuary) and the removal of the 1.000 MMA floor from
the physician work GPCI. The negative impact of these changes on a
number of payment localities is shown in 4 of section II.B. in this
proposed rule.
C. Global Period for Remote Afterloading High Intensity Brachytherapy
Procedures
As discussed in section II.D.1. of this proposed rule, we are
proposing changes to the global period for these
[[Page 49074]]
services. We do not anticipate this proposed change will have a
significant impact on Medicare expenditures.
D. DRA 5112--Proposed Addition of the Ultrasound Screening for
Abdominal Aortic Aneurysm to Welcome to Medicare Benefit
As discussed earlier in section II.E.3. of this preamble, section
5112 of the DRA authorizes coverage of an ultrasound screening for
abdominal aortic aneurysms effective January 1, 2007, subject to
certain eligibility and other limitations. We estimate that this new
benefit would result in an increase in Medicare expenditures to
physicians and other practitioners and suppliers of ultrasound services
and related follow-up tests and treatment that may be required as a
result of the coverage of these screening examinations. However, this
is not expected to have a significant cost impact on the Medicare
program.
E. DRA 5113--Proposed Colorectal Screening Exemption From Part B
Deductible
As discussed earlier in section II.E.4. of this preamble, beginning
January 1, 2007, colorectal cancer screening services as described in
section 1861(pp)(1) of the Act are no longer subject to the Part B
deductible. While waiver of this deductible will be beneficial to
Medicare beneficiaries, we do not anticipate that this change will have
a significant cost impact on the Medicare program.
F. Section 5114--Proposed Addition of Diabetes Outpatient Self-
Management Training Services (DSMT) and Medical Nutrition Therapy (MNT)
for the FQHC Program
As discussed earlier in section E.4. of this preamble, section 5114
of the DRA amended section 1861(aa)(3) the Act to add DSMT and MNT to
the list of Medicare covered and reimbursed services under the Medicare
FQHC benefit, effective for services provided on or after January 1,
2006. Although this statutory change has already been implemented in
administrative instructions, we are proposing to conform the
regulations to meet the new statutory requirement. FQHCs certified as
DSMT and MNT providers have been allowed to bundle the cost of those
services into their FQHC payment rates. But before the enactment of the
DRA, the provision of these services would not generate a separate FQHC
visit payment. Effective for services furnished on or after January 1,
2006, FQHCs that are certified providers of DSMT and MNT services can
receive per visit payments for covered services furnished by registered
dietitians or nutrition professionals. In light of the fact there are a
limited number of qualified centers for DSMT and MNT services, the
increase in Medicare expenditures should be negligible.
G. Proposed Payment for Covered Outpatient Drugs and Biologicals (ASP
Issues)
The proposed changes discussed in section II.F. of this proposed
rule, with respect to payment for covered outpatient drugs and
biologicals, are estimated to have no impact on Medicare expenditures.
However, we believe the changes will assist in clarifying existing
policy with respect to ASP payment.
H. Proposed Provisions Related to Payment for Renal Dialysis Services
Furnished by End State Renal Disease (ESRD) Facilities
The ESRD related provisions in this proposed rule are discussed in
section II.G. of this preamble. In order to understand the impact of
the proposed changes affecting payments to different categories of ESRD
facilities, it is necessary to compare estimated payments under the
current year (current 2006 payments) to estimated payments under the
proposed revisions to the composite rate payment system as discussed in
II.G. of this proposed rule (proposed 2007 payments). To estimate the
impact among various classes of ESRD facilities, it is imperative that
the estimates of current payments and proposed payments contain similar
inputs. Therefore, we simulated payments only for those ESRD facilities
that we are able to calculate both current 2006 payments and proposed
2007 payments.
Due to data limitations, we are unable to estimate current and
proposed payments for 226 facilities that bill for ESRD dialysis
treatments. ESRD providers were grouped into the categories based on
characteristics provided in the Online Survey and Certification and
Reporting (OSCAR) file and the most recent cost report data from the
Healthcare Cost Report Information System (HCRIS). We also used the
December 2005 update of CY 2005 National Claims History file as a basis
for Medicare dialysis treatments and separately billable drugs and
biologicals. While the December 2005 update of the 2005 claims file is
not complete, we wanted to use the most recent data available, and plan
to use an updated version of the 2005 claims file for the final rule.
BILLING CODE 4120-01-P
[[Page 49075]]
[GRAPHIC] [TIFF OMITTED] TP22AU06.049
Table 9 above shows the impact of this year's proposed changes to
CY 2007 payments to hospital-based and independent ESRD facilities. The
first column of Table 9 identifies the type of ESRD provider, the
second column
[[Page 49076]]
indicates the number of ESRD facilities for each type, and the third
column indicates the number of dialysis treatments.
The fourth column shows the effect of CY 2007 proposed changes to
the ESRD wage index as it affects the composite rate payments to ESRD
facilities. The fourth column compares aggregate ESRD wage adjusted
composite rate payments in the second year of the transition (CY 2007)
to aggregate ESRD wage adjusted composite rate payments in first year
of the transition (CY 2006). In the second year of the transition (CY
2007), ESRD facilities receive 50 percent of the CBSA wage adjusted
composite rate and 50 percent of the MSA adjusted composite rate. In
the first year of the transition, ESRD facilities receive 25 percent of
the CBSA wage adjusted composite rate and 75 percent of the MSA
adjusted composite rate. The overall effect to all ESRD providers in
aggregate is zero because the proposed CY 2007 ESRD wage index has been
multiplied by a budget neutrality factor to comply with the statutory
requirement that any wage index revisions be done in a manner that
results in the same aggregate amount of expenditures as would have been
made without any changes in the wage index. The decreases shown among
census regions is primarily due to reducing the wage index floor, as
there were areas in these areas with wage index values below the
proposed floor.
The fifth column shows the overall effect of the proposed changes
in composite rate payments to ESRD providers. The overall effect is
measured as the difference between CY 2007 proposed payment with all
changes as proposed in this rule and CY 2006 current payment. This
amount is computed by multiplying the wage adjusted composite rate with
the drug add-on for each provider times dialysis treatments from 2005
claims. The CY 2007 proposed payment is transition year two wage
adjusted composite rate for each provider (with the proposed 15.2
percent drug add-on) times dialysis treatments from 2005 claims. The CY
2006 current payment is transition year one wage adjusted composite
rate for each provider (with the current 14.5 percent drug add on)
times dialysis treatments from 2005 claims.
The overall impact to ESRD providers in aggregate is 0.6 percent.
This increase corresponds to the proposed 0.6 percent increase to the
drug add-on. The variation seen in column 5 is due to variation in
change in the wage index (column 4). All provider types receive the
same 0.6 percent increase to the drug add on.
I. Private Contracts and Opt-Out Provision
The changes discussed in this proposed rule, with respect to
private contracts and the opt-out provision, are currently estimated to
have no significant impact on Medicare expenditures.
J. Proposals Related to Physician Self Referral Prohibitions
As discussed in section II.I of this proposed rule, we would
clarify in regulations at Sec. 424.80(d) under the contractual
arrangement reassignment exception that, if a physician or other
individual supplier reassigns his or her right to bill for the TC of a
diagnostic test, the entity to which the reassignment is made may not
be paid more than the physician or other individual supplier would have
been paid for the TC. In addition, in order to bill for the TC of the
diagnostic test, the entity to which the reassignment is made must
perform the PC. We also propose that, in order to bill for the PC of a
diagnostic test following a reassignment, the billing entity must meet
current requirements in our manual instructions.
In addition, as discussed in section II.I., we also propose to
revise Sec. Sec. 424.80(b) and (d) to provide that a physician or
other individual supplier who reassigns his or her right to benefits
has a right to review the bills for his or her services, irrespective
of whether the individual is an employee or an independent contractor
of the entity to which the reassignment is made.
We also propose the following changes to the physician self-
referral provisions:
A ``centralized building'' for purposes of the physician
services exception and the in-office ancillary services exception at
Sec. Sec. 411.355(a) and (b), respectively, would have to measure at
least 350 square feet and include permanent placement of the equipment
used in the provision of substantially all of the designated health
services. We believe that these changes would have little effect on
Medicare expenditures.
K. Supplier Access to Claims Billed on Reassignment
The reassignment provisions discussed in section II.J.2. of this
preamble are currently estimated to have no significant impact on
Medicare expenditures.
L. Proposed Coverage of Bone Mass Measurement
As discussed in section II.K. of this preamble, we have decided to
propose several revisions to Sec. 410.31 relative to the definition of
the term ``Bone Mass Measurement'' (Sec. 410.31(a)(2)), the conditions
for coverage (Sec. 410.31(b)), the examples of exceptions to the
standards on frequency of coverage (Sec. 410.31(c)(2)), and the
category of individuals receiving glucocorticoid (steroid) therapy
(Sec. 410.31(d)(3)). We are also proposing the addition of a new
paragraph (f) that would allow CMS, through the NCD process, to
identify additional BMM systems for monitoring individuals receiving
osteoporosis drug therapy and for performing confirmatory baseline
measurements. We do not expect that this addition would have a
significant cost impact on the Medicare program in the next several
years.
Based on the projected impact of the first three changes that would
place greater reliance on the use of the more expensive DXA (axial
skeleton) devices, we estimate that this revised benefit would result
in an increase in Medicare payments for providers who use the DXA
(axial skeleton) devices and a somewhat smaller decrease in payments to
providers who use QCT (axial skeleton) and peripheral devices. However,
we do not expect that these changes would have a significant cost
impact on the Medicare program due to the fact that at present a very
small percentage of our total Medicare payments for bone mass
measurements are being made to providers who use QCT or peripheral
devices. In addition, we estimate that lowering the eligibility
standard for coverage of individuals on steroid therapy from 7.5 mg/day
to 5.0 mg/day of prednisone (the fourth change) would result in an
increase in Medicare payment for testing of additional patients, but
this modest lowering of the steroid standard is not expected to have a
significant cost impact on the program.
M. Proposed IDTF Changes
The costs associated with these proposed changes would be as
follows:
1. Liability Insurance Requirement (Sec. 424.57(c)(10))
We estimate that only 10 percent of IDTFs do not already have
liability insurance that meets this requirement. Based on Medicare data
as of June 2005, 10 percent of the total number of IDTFs is
approximately 559 suppliers. Using the previously highest estimate
received ($1,800 annually), results in an approximate additional
liability insurance cost of $1 million annually (559 times $1,800) to
the IDTF industry due to this proposed rule.
[[Page 49077]]
2. Primary Business Telephone Listed Under the Name of the Business
Locally or Toll-free for Beneficiaries Proposed Requirement (Sec.
424.57(c)(9))
We estimate that only 1 percent of IDTFs do not already meet this
requirement. Based on Medicare data as of June 2005, we determined that
1 percent of IDTFs is approximately 56 suppliers. Therefore, 56 times
the approximate $600 annual cost of telephone service results in an
additional cost of $33,600 annually. Total Cost = $1 Million + $33,600
= approximately $1.04 million annually.
N. Independent Lab Billing for TC Component of Physician Pathology
Services for Hospital Patients
The most current information on the number of affected hospitals
and the impact on laboratories and hospitals comes from a report issued
by the General Accounting Office (GAO) in September 2003.
The GAO estimated that approximately 95 percent of the total of all
Medicare hospitals on the prospective payment system, as well as CAHs
sent the TC of physician pathology services to independent laboratories
and the independent laboratories billed the carrier under the PFS.
The GAO estimated that the median number of services sent by each
hospital to outside independent laboratories was small, approximately
81 services. The GAO was unable to identify the number of laboratories
billing for the TC service because a single laboratory may submit
claims under multiple provider numbers. In general, the impact on the
individual hospital is small; however, we do not know the impact on the
individual independent laboratory
If the independent laboratories had not received payments from the
carriers for these TC services for hospital patients, the GAO estimates
that Medicare spending would have been $42 million less in 2001 and
beneficiary cost sharing obligations for inpatient and outpatient
services would have been reduced by $2 million.
Based on what they learned from the hospital industry, the GAO
thought that Medicare beneficiaries' access to pathology services would
not likely be affected if independent laboratories could not longer
bill the carrier for these services. Hospital representatives indicated
that they would likely continue to use independent laboratories to
provide TC pathology services.
In is unclear if the hospitals contracting with independent
laboratories would pay the laboratories at the same rates that the
laboratories received by billing the Medicare carriers under the
physician fee schedule.
O. Public Consultation for Medicare Payment for New Outpatient Clinical
Diagnostic Laboratory Tests
This codification of our process for public consultation for new
clinical diagnostic laboratory tests paid under the Medicare Part B
clinical laboratory fee schedule, if adopted, would not increase or
decrease payment amounts for existing clinical diagnostic laboratory
tests because it would not alter our current methodology for
calculating payment amounts for existing clinical diagnostic laboratory
tests. For new tests, this proposal would primarily codify an existing
process for the determination of payment amounts. Because any new
laboratory tests to be gapfilled are unknown to us at the current time,
we do not have any data to estimate the impact of our proposal to pay
for new gapfilled lab tests at the median of the local carrier amounts
for all carriers rather than the lower of that amount and the local
carrier amount.
P. Alternatives Considered
This proposed rule contains a range of policies, including some
proposals related to specific MMA provisions. The preamble provides
descriptions of the statutory provisions that are addressed, identifies
those policies when discretion has been exercised, presents rationale
for our decisions and, where relevant, alternatives that were
considered.
Q. Impact on Beneficiaries
There are a number of changes made in this proposed rule that would
have an effect on beneficiaries. In general, we believe these proposed
changes, particularly the DRA provisions that provide for an exception
to the application of the Part B deductible with respect to colorectal
cancer screening tests and coverage of an ultrasound screening for the
early detection of AAAs, as part of the Initial Preventive Physical
Examination benefit (referred to as the Welcome to Medicare benefit)
would improve beneficiary access to services that are currently covered
or expand the Medicare benefit package to include new services. As
explained in more detail below, the regulatory provisions may affect
beneficiary liability in some cases. Any changes in aggregate
beneficiary liability from a particular provision would be a function
of the coinsurance (20 percent if applicable for the particular
provision after the beneficiary has met the deductible) and the effect
of the aggregate cost (savings) of the provision on the calculation of
the Medicare Part B premium rate (generally 25 percent of the
provision's cost or savings).
To illustrate this point, as shown in Table 8, the 2006 national
payment amount in the nonfacility setting for CPT code 99203 (Office/
outpatient visit, new), is $97.02 which means that currently a
beneficiary is responsible for 20 percent of this amount, or $19.40.
Based on the June 29, 2006 proposed notice (71 FR 37170) and this
proposed rule, the 2007 national payment amount in the nonfacility
setting for CPT code 99203, as shown in Table 8, is $91.71 which means
that, in 2007, the beneficiary coinsurance for this service would be
$18.34.
Very few of the changes we are proposing impact overall payments
and, therefore, would affect Medicare beneficiaries' coinsurance
liability. Proposals discussed above that do affect overall spending,
such as DRA 5102 imaging provisions, would similarly impact
beneficiaries' coinsurance.
R. Accounting Statement
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf
), in Table 10 below, we
have prepared an accounting statement showing the classification of the
expenditures associated with the provisions of this proposed rule. This
table includes the impact of the proposed changes in this rule on
providers and suppliers.
Expenditures are classified as transfers to Medicare providers/or
suppliers (that is, ESRD facilities and physicians, other
practitioners, clinical laboratories and medical suppliers that receive
payment under the physician fee schedule or Medicare Part B). Based on
the proposals contained in this proposed rule, there would be an
estimated decrease in expenditures from CY 2006 to 2007. This is a
result of the CY 2007 increased payment to ESRD facilities the
reduction to the payments for imaging services under the PFS required
by section 5102 of the DRA and the -5.1 percent Medicare PFS conversion
factor update required by the statutory update formula.
Table 10.--Accounting Statement: Classification of Estimated
Expenditures, From CY 2006 to the CY 2007 (in Millions)
------------------------------------------------------------------------
Category Transfers
------------------------------------------------------------------------
Annualized Monetized Transfers............ Estimated decrease in
expenditures of $3,600
[[Page 49078]]
From Whom To Whom? Federal Government To ESRD
Medicare Providers;
physicians, other
practitioners and suppliers
who receive payment under
the Medicare Physician Fee
Schedule; and Medicare
Suppliers billing for Part
B drugs.
------------------------------------------------------------------------
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 410
Health facilities, Health professions, Kidney diseases,
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural
areas, X-rays.
42 CFR Part 411
Kidney diseases, Medicare, Physician Referral, Reporting and
recordkeeping requirements.
42 CFR Part 414
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medicare, Reporting and recordkeeping.
42 CFR Part 415
Health facilities, Health professions, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
1. The authority citation for part 405 continues to read as
follows:
Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, 1881, and
1886(k) of the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a),
1395hh, 1395kk, 1395rr, and 1395ww(k)), and sec. 353 of the Public
Health Service Act (42 U.S.C. 263a).
Subpart D--Private Contracts
2. Section 405.400 is amended by revising the definition of
``Practitioner'' to read as follows:
Sec. 405.400 Definitions.
* * * * *
Practitioner means a physician assistant, nurse practitioner,
clinical nurse specialist, certified registered nurse anesthetist,
certified nurse midwife, clinical psychologist, clinical social worker,
registered dietitian or nutrition professional, who is currently
legally authorized to practice in that capacity by each State in which
he or she furnishes services to patients or clients.
* * * * *
Subpart X--Rural Health Clinic and Federally Qualified Health
Center Services Payment for Rural Health Clinic and Federally
Qualified Health Center Services
3. Section 405.2446 is amended by adding paragraph (b)(10) to read
as follows:
Sec. 405.2446 Scope of services.
* * * * *
(b) * * *
(10) Medical nutrition therapy services as specified in part 410,
subpart G of this chapter, and diabetes outpatient self-management
training services as specified in part 410, subpart H of this chapter.
* * * * *
4. Section 405.2463 is revised to read as follows:
Sec. 405.2463 What constitutes a visit.
(a) Visit--(1) General. (i) For RHCs, a visit is a face-to-face
encounter between a clinic or center patient and a physician, physician
assistant, nurse practitioner, nurse midwife, visiting nurse, clinical
psychologist, or clinical social worker.
(ii) For FQHCs, a visit means--
(A) A face-to-face encounter, as described in paragraph (a)(1)(i)
of this section; or
(B) A face-to-face encounter between a patient and a qualified
provider of medical nutrition therapy services as defined in part 410,
subpart G of this chapter; or a qualified provider of outpatient
diabetes self-management training services as defined in part 410,
subpart H of this chapter.
(2) Medical visit. For purposes of this section, a medical visit is
a face-to-face encounter between a clinic or center patient and a
physician, physician assistant, nurse practitioner, nurse midwife, or a
visiting nurse; and for FQHCs only, a medical visit also includes a
separately billable medical nutrition therapy visit or a diabetes
outpatient self-management training visit.
(3) Other health visit. For purposes of this section, a other
health visit is a face-to-face encounter between a clinic or center
patient and a clinical psychologist, clinical social worker, or other
health professional for mental health services.
(b) Encounters. Encounters with more than one health professional
and multiple encounters with the same health professional that take
place on the same day and at a single location constitute a single
visit, except when one of the following conditions exist:
(1) After the first encounter, the patient suffers illness or
injury requiring additional diagnosis or treatment.
(2) The patient has a medical visit and other health visit(s), as
defined in paragraph (a) of this section.
(c) Payment. Medicare pays for more than one visit per day when the
conditions in paragraph (b) of this section are met or a separate visit
under paragraph (a)(1)(ii)(B) of this section is made.
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
5. The authority citation for part 410 continues to read as
follows:
Authority: Secs. 1102, 1834, and 1871 of the Social Security Act
(42 U.S.C. 1302, 1395m, and 1395hh).
Subpart B--Medical and Other Health Services
6. Section 410.16 is amended in paragraph (a) by revising paragraph
(7) of the definition of ``Initial preventive physical examination'' to
read as follows:
Sec. 410.16 Initial preventive physical examination: Conditions for
and limitations on coverage.
(a) * * *
* * * * *
[[Page 49079]]
Initial preventive physical examination * * *
* * * * *
(7) Education, counseling, and referral, including a written plan
such as a checklist provided to the beneficiary for obtaining the
appropriate screening and other preventive services that are covered as
separate Medicare Part B benefits as described in section 1861(s)(10),
section 1861(jj), section 1861(nn), section 1861(oo), section 1861(pp),
section 1861(qq)(1), section 1861(rr), section 1861(uu), section
1861(vv), section 1861(xx)(1), section 1861(yy), and section 1861(bbb)
of the Act.
* * * * *
7. A new Sec. 410.19 is added to read as follows:
Sec. 410.19 Ultrasound screening for abdominal aortic aneurysms:
Condition for and limitation on coverage.
(a) Definitions: As used in this section, the following definitions
apply:
Eligible beneficiary means an individual who--
(1) Has received a referral for an ultrasound screening for an
abdominal aortic aneurysm as a result of an initial preventive physical
examination (as defined in section 1861(ww)(1) of the Act);
(2) Has not been previously furnished an ultrasound screening for
an abdominal aortic aneurysm under the Medicare program; and
(3) Is included in at least one of the following risk categories:
(i) Has a family history of an abdominal aortic aneurysm.
(ii) Is a man age 65 to 75 who has smoked at least 100 cigarettes
in his lifetime.
(iii) Is an individual who manifests other risk factors in a
beneficiary category recommended for screening by the United States
Preventive Services Task Force regarding abdominal aortic aneurysms, as
specified by the Secretary through a national coverage determination
process.
Ultrasound screening for abdominal aortic aneurysms means the
following services furnished to an asymptomatic individual for the
early detection of an abdominal aortic aneurysm:
(1) A procedure using soundwaves (or other procedures using
alternative technologies of commensurate accuracy and cost, as
specified by the Secretary through a national coverage determination
process) provided for the early detection of abdominal aortic
aneurysms.
(2) Includes a physician's interpretation of the results of the
procedure.
(b) Conditions for coverage of an ultrasound screening for
abdominal aortic aneurysms. Medicare Part B pays for one ultrasound
screening for an abdominal aortic aneurysm provided to eligible
beneficiaries, as described in this section, after a referral from a
physician or a qualified nonphysician practitioner as defined in Sec.
410.16(a).
(c) Limitation on coverage of ultrasound screening for abdominal
aortic aneurysms. Payment may not be made for an ultrasound screening
for an abdominal aortic aneurysm that is performed for an individual
who is not an eligible beneficiary, as described in the definition of
``Eligible beneficiary'' in this section.
8. Section 410.31 is revised to read as follows:
Sec. 410.31 Bone mass measurement: Conditions for coverage and
frequency standards.
(a) Definition. As used in this section unless specified otherwise,
the following definition applies:
Bone mass measurement means a radiologic, radioisotopic, or other
procedure that meets the following conditions:
(1) Is performed for the purpose of identifying bone mass,
detecting bone loss, or determining bone quality.
(2) Is performed with either a bone densitometer (other than
single-photon or dual-photon absorptiometry) or with a bone sonometer
system that has been cleared for marketing for this use by the FDA
under 21 CFR part 807, or approved for marketing by the FDA for this
use under 21 CFR part 814.
(3) Includes a physician's interpretation of the results of the
procedure.
(b) Conditions for coverage. (1) Medicare covers a medically
necessary bone mass measurement if the following conditions are met:
(i) Following an evaluation of the beneficiary's need for the
measurement, including a determination as to the medically appropriate
procedure to be used for the beneficiary, it is ordered by the
physician or a qualified nonphysician practitioner (as these terms are
defined in Sec. 410.32(a)) treating the beneficiary.
(ii) It is performed under the appropriate level of supervision of
a physician (as set forth in Sec. 410.32(b)).
(iii) It is reasonable and necessary for diagnosing and treating
the condition of a beneficiary who meets the conditions described in
paragraph (d) of this section.
(2) Medicare covers a medically necessary bone mass measurement for
an individual defined under paragraph (d)(5) of this section if the
conditions under paragraph (b)(1) of this section are met and the
monitoring is performed by the use of a dual energy x-ray
absorptiometry system (axial skeleton).
(3) Medicare covers a medically necessary confirmatory baseline
bone mass measurement for an individual defined under paragraph (d) of
this section, if the conditions under paragraph (b)(1) of this section
are met and the confirmatory baseline bone mass measurement is
performed by a dual energy x-ray absorptiometry system (axial skeleton)
and the initial measurement was not performed by a dual energy x-ray
absorptiometry system (axial skeleton).
(c) Standards on frequency of coverage --(1) General rule. Except
as allowed under paragraph (c)(2) of this section, Medicare may cover a
bone mass measurement for a beneficiary if at least 23 months have
passed since the month the last bone mass measurement was performed.
(2) Exception. If medically necessary, Medicare may cover a bone
mass measurement for a beneficiary more frequently than allowed under
paragraph (c)(1) of this section. Examples of situations where more
frequent bone mass measurement procedures may be medically necessary
include, but are not limited to the following medical circumstances.
(i) Monitoring beneficiaries on long-term glucocorticoid (steroid)
therapy of more than 3 months.
(ii) Allowing for a confirmatory baseline measurement to permit
monitoring of beneficiaries in the future if the requirements of
paragraph (b)(3) of this section are met.
(d) Beneficiaries who may be covered. The following categories of
beneficiaries may receive Medicare coverage for a medically necessary
bone mass measurement:
(1) A woman who has been determined by the physician (or a
qualified nonphysician practitioner) treating her to be estrogen-
deficient and at clinical risk for osteoporosis, based on her medical
history and other findings.
(2) An individual with vertebral abnormalities as demonstrated by
an x-ray to be indicative of osteoporosis, osteopenia, or vertebral
fracture.
(3) An individual receiving (or expecting to receive)
glucocorticoid (steroid) therapy equivalent to an average of 5.0 mg of
prednisone, or greater, per day for more than 3 months.
(4) An individual with primary hyperparathyroidism.
(5) An individual being monitored to assess the response to or
efficacy of an
[[Page 49080]]
FDA-approved osteoporosis drug therapy.
(e) Denial as not reasonable and necessary. If CMS determines that
a bone mass measurement does not meet the conditions for coverage in
paragraphs (b) or (d) of this section, or the standards on frequency of
coverage in paragraph (c) of this section, it is excluded from Medicare
coverage as not ``reasonable'' and ``necessary'' under section
1862(a)(1)(A) of the Act and Sec. 411.15(k) of this chapter.
(f) Use of the National Coverage Determination Process. For the
purposes of paragraphs (b)(2) and (b)(3) of this section, CMS may
determine through the National Coverage Determination process that
additional bone mass measurement systems are reasonable and necessary
under section 1862(a)(1) of the Act for monitoring and confirming
baseline bone mass measurements.
* * * * *
9. Section 410.33 is amended by--
A. Revising paragraph (b)(1).
B. Revising paragraph (e).
C. Adding paragraphs (g), (h), and (i).
The revision and additions read as follows:
Sec. 410.33 Independent diagnostic testing facility.
* * * * * *
(b) Supervising physician. (1) Each supervising physician must be
limited to providing supervision to no more than three (3) IDTF sites.
The IDTF supervising physician is responsible for the overall operation
and administration of the IDTFs, including the employment of personnel
who are competent to perform test procedures, record and report test
results promptly, accurately and proficiently, and for assuring
compliance with the applicable regulations.
* * * * *
(e) Multi-State entities. (1) An IDTF that operates across State
boundaries must--
(i) Maintain documentation that its supervising physicians and
technicians are licensed and certified in each of the States in which
it operates; and
(ii) Operate in compliance with all applicable Federal, State, and
local licensure and regulatory requirements with regard to the health
and safety of patients.
(2) The point of the actual delivery of services is the Place of
Service on the claim form. When an IDTF performs a diagnostic test at
the beneficiary's residence, the beneficiary's residence is the Place
of Service.
* * * * *
(g) Application certification standards. The IDTF must certify in
its enrollment application that it meets the following standards:
(1) Operate its business in compliance with all applicable Federal
and State licensure and regulatory requirements.
(2) Provide complete and accurate information on their enrollment
application. Any change in enrollment information must be reported to
the designated fee-for-service contractor on the Medicare enrollment
application within 30 calendar days of the change.
(3) Maintain a physical facility on an appropriate site. For the
purposes of this standard, a post office box or commercial mail box is
not considered a physical facility. The physical facility must contain
space for equipment appropriate to the services designated on the
enrollment application, facilities for hand washing, adequate patient
privacy accommodations, and the storage of both business records and
current medical records.
(4) Have all applicable testing equipment available at the physical
site excluding portable equipment. A catalog of portable equipment,
including equipment serial numbers, must be maintained at the physical
site. In addition, portable equipment must be available for inspection
within two business days of a CMS inspection request. The IDTF must
maintain a current inventory of the equipment, including serial and
registration numbers, provide this information to the designated fee-
for-service contractor upon request, and notify the contractor of any
changes in equipment within 90 days.
(5) Maintain a primary business phone under the name of the
designated business. The business phone must be located at the
designated site of the business. The telephone number or toll free
numbers must be available in a local directory and through directory
assistance.
(6) Have a comprehensive liability insurance policy of at least
$300,000 or 20 percent of its average annual Medicare billings,
whichever amount is greater, that covers both the place of business and
all customers and employees of the IDTF. The policy must be carried by
a non-relative owned company and list the serial numbers of any and all
equipment used by the IDTF.
(7) Agree not to directly solicit patients through any means
including, but not limited to, a prohibition on telephone, computer, or
in-person contacts. The IDTF must accept only those patients referred
for diagnostic testing by an attending physician, who is furnishing a
consultation or treating a beneficiary for a specific medical problem
and who uses the results in the management of the beneficiary's
specific medical problem. Nonphysician practictioners may order tests
as set forth in Sec. 410.32(a)(3).
(8) Answer beneficiaries' questions and respond to their
complaints. Documentation of those contacts must be maintained at the
physical site.
(9) Openly post these standards for review by patients and the
public.
(10) Disclose to the government any person having ownership,
financial, or control interest or any other legal interest in the
supplier.
(11) Have its testing equipment calibrated per equipment
instructions and in compliance with applicable national standards.
(12) Have technical staff on duty with the appropriate credentials
to perform tests. The IDTF must be able to produce the applicable
Federal or State licenses or certifications of the individuals
performing these services.
(13) Have proper medical record storage and be able to retrieve
medical records upon request from CMS or its fee-for-service contractor
within 2 business days.
(14) Permit CMS, including its agents, or its designated fee-for-
service contractors, to conduct unannounced, on-site inspections to
confirm the IDTF's compliance with these standards. The IDTF must be
accessible during regular business hours to CMS and beneficiaries and
must maintain a visible sign posting the normal business hours of the
IDTF.
(h) Failure to meet standards. If an IDTF fails to meet one or more
of the standards in paragraph (g) of this section at the time of
enrollment, its enrollment will be denied. CMS will revoke a supplier's
billing privileges if and IDTF is found not to meet the standards in
paragraph (g) or (b)(1) of this section.
(i) Definition. For purposes of this section, the following
definition applies:
Point of actual delivery of service. The point of the actual
delivery of service means the Place of Service on the claim form. When
an IDTF performs a diagnostic test at the beneficiary's residence, the
beneficiary's residence is the Place of Service.
Subpart I--Payment of SMI Benefits
10. Section 410.160 is amended by adding paragraphs (b)(7) and
(b)(8) to read as follows:
Sec. 410.160 Part B annual deductible.
* * * * *
[[Continued on page 49081]]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
]
[[pp. 49081-49130]] Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule for Calendar Year 2007 and Other Changes to
Payment Under Part B
[[Continued from page 49080]]
[[Page 49081]]
(b) * * *
(7) Beginning January 1, 2007, colorectal cancer screening tests as
described in Sec. 410.37.
(8) Beginning January 1, 2007, ultrasound screening for abdominal
aortic aneurysms described in Sec. 410.19.
* * * * *
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT
11. The authority citation for part 411 is amended to read as
follows:
Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877
of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).
Subpart A--General Exclusions and Exclusion of Particular Services
12. Section 411.15 is amended by--
A. Revising paragraph (a)(1).
B. Adding a new paragraph (k)(12).
C. Revising paragraph (o).
The revisions and addition read as follows:
Sec. 411.15 Particular services excluded from coverage.
* * * * *
(a) * * *
(1) Examinations performed for a purpose other than treatment or
diagnosis of a specific illness, symptoms, complaint, or injury, except
for screening mammography, colorectal cancer screening tests, screening
pelvic exams, prostate cancer screening tests, glaucoma screening
exams, initial preventive physical examinations, or ultrasound
screening for abdominal aortic aneurysms that meet the criteria
specified in paragraphs (k)(6) through (k)(12) of this section.
* * * * *
(k) * * *
(12) In the case of ultrasound screening for abdominal aortic
aneurysms, with the goal of early detection of abdominal aortic
aneurysms, subject to the conditions and limitation specified in Sec.
410.19 of this chapter.
* * * * *
(o) Experimental or investigational devices, except for certain
devices--
(1) Categorized by the FDA as a Category A or B device defined in
Sec. 405.201(b) of this chapter; and
(2) Furnished in accordance with the CMS clinical research policy.
Subpart J--Financial Relationships Between Physicians and Entities
Furnishing Designated Health Services
13. Section 411.351 is amended by--
A. Revising the definition ``Centralized building''.
B. Revising the definition ``Physician in the group practice''.
The revisions read as follows:
Sec. 411.351 Definitions.
* * * * *
Centralized building means all or part of a building, including,
for purposes of this subpart only, a mobile vehicle, van, or trailer
that is owned or leased on a full-time basis (that is, 24 hours per
day, 7 days per week, for a term of not less than 6 months) by a group
practice and that is used exclusively by the group practice. Space in a
building or a mobile vehicle, van, or trailer that is shared by more
than one group practice, by a group practice and one or more solo
practitioners, or by a group practice and another provider or supplier
(for example, a diagnostic imaging facility) is not a centralized
building for purposes of this subpart. This definition does not
preclude a group practice from providing services to other providers or
suppliers (for example, purchased diagnostic tests) in the group
practice's centralized building. A group practice may have more than
one centralized building. A centralized building does not include space
that is owned or leased by a group practice if that space is less than
350 square feet. This limitation does not apply to space owned or
rented in a building where no more than three group practices own or
lease space in the ``same building'' (as defined in this section) and
share the same ``physician in the group practice'' (as defined in this
section). A centralized building does not include space owned or leased
by a group practice if equipment needed to perform substantially all
(at least 90 percent) of the designated health services furnished in
that space in any given calendar year is not permanently located in
that space. That is, equipment needed to perform more than 10 percent
of the designated health services furnished in that space in a calendar
year cannot be temporarily moved into that space from another space in
the ``same building'' or from outside the ``same building'' (as defined
in this section).
* * * * *
Physician in the group practice means a member of the group
practice, as well as an independent contractor physician during the
time the independent contractor is furnishing patient care services (as
defined in this section) for the group practice under a contractual
arrangement with the group practice to provide services to the group
practice's patients in the group practice's facilities. The contract
must contain the same restrictions on compensation that apply to
members of the group practice under Sec. 411.352(g) (or the contract
must fit in the personal services exception in Sec. 411.357(d)), and
the independent contractor's arrangement with the group practice and
must comply with the reassignment rules at Sec. 424.80(d)(3) of this
chapter or section 30.2.9.1 of the CMS Internet-only manual,
publication 100-04, Claims Processing Manual, chapter 1 on general
billing requirements (as amended or replaced from time to time).
Referrals from an independent contractor who is a physician in the
group practice are subject to the prohibition on referrals in Sec.
411.353(a), and the group practice is subject to the limitation on
billing for those referrals in Sec. 411.353(b).
* * * * *
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
14. The authority citation for part 414 continues to read as
follows:
Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1).
15. A new subpart F is added as follows:
Subpart F--Payment for New Clinical Diagnostic Laboratory Tests
Sec.
414.400 Basis and scope.
414.402 Definitions.
414.404 [Reserved]
414.406 Procedures for public consultation for payment for a new
clinical diagnostic laboratory test.
414.408 Payment for a new clinical diagnostic laboratory test.
414.410 Clinical Diagnostic Laboratory Date of Service for Specimens
Subpart F--Payment for New Clinical Diagnostic Laboratory Tests
Sec. 414.400 Basis and scope.
This subpart implements provisions of 1833(h)(8) of the Act
procedures for determining the basis for, and amount of, payment for a
new clinical diagnostic laboratory test with respect to which a new or
substantially revised Healthcare Common Procedure Coding System code is
assigned on or after January 1, 2005.
Sec. 414.402 Definitions.
For purposes of this subpart--
Substantially Revised Healthcare Common Procedure Coding System
Code means a code for which there has been a substantive change to the
definition of the test or procedure to which the code applies (such as
a new
[[Page 49082]]
analyte or a new methodology for measuring an existing analyte specific
test).
Sec. 414.404 [Reserved]
Sec. 414.406 Procedures for public consultation for payment for a new
clinical diagnostic laboratory test.
For a new clinical diagnostic laboratory test that is assigned a
new or substantially revised code on or after January 1, 2005, CMS
determines the payment after the performance of the following:
(a) CMS makes available to the public (through an Internet Web site
and other appropriate mechanisms) a list that includes codes for which
establishment of a payment amount is being considered for the next
calendar year.
(b) CMS publishes a Federal Register notice of a meeting to receive
public comments and recommendations (and data on which recommendations
are based) on the appropriate basis, as specified in Sec. 414.408, for
establishing payment amounts for the list of codes made available to
the public.
(c) Not fewer than 30 days after publication of the notice in the
Federal Register, CMS convenes a meeting that includes representatives
of CMS officials involved in determining payment amounts, to receive
public comments and recommendations (and data on which the
recommendations are based).
(d) Taking into account the comments and recommendations (and
accompanying data) received at the public meeting, CMS develops and
makes available to the public (through an Internet Web site and other
appropriate mechanisms)--
(1) A list of proposed determinations with respect to the
appropriate basis for establishing a payment amount for each code, with
an explanation of the reasons for each determination, the data on which
the determinations are based, and a request for public written comments
within a specified time period on the proposed determination; and
(2) A list of final determinations of the payment amounts for
tests, with the rationale for each determination, the data on which the
determinations are based, and responses to comments and suggestions
from the public.
Sec. 414.408 Payment for a new clinical diagnostic laboratory test.
For a new clinical diagnostic laboratory test that is assigned a
new or substantially revised code on or after January 1, 2005, CMS
determines the payment amount based on either of the following:
(a) Crosswalking. Crosswalking is used if it is determined that a
new test is comparable to an existing test, multiple existing test
codes, or a portion of an existing test code.
(1) CMS assigns to the new test code, the local fee schedule
amounts and national limitation amount of the existing test.
(2) Payment for the new test code is made at the lesser of the
local fee schedule amount or the national limitation amount.
(b) Gapfilling. Gapfilling is used when no comparable existing test
is available.
(1) Carrier-specific amounts are established for the new test code
for the first year using the following sources of information to
determine gapfill amounts, if available:
(i) Charges for the test and routine discounts to charges;
(ii) Resources required to perform the test;
(iii) Payment amounts determined by other payers; and
(iv) Charges, payment amounts, and resources required for other
tests that may be comparable or otherwise relevant.
(2) In the second year, the test code is paid at the national
limitation amount, which is the median of the carrier-specific amounts.
Sec. 414.410 Clinical Diagnostic Laboratory Date of Service for
Specimens.
The date of service for a laboratory test is as follows:
(a) Except as provided under paragraph (b) of this section, the
date of service of the test shall be the date the specimen was
collected.
(b)(1) If a specimen is collected over a period that spans two
calendar days, then the date of service shall be the date the
collection ended.
(2) If a specimen was stored for more than 30 calendar days before
testing (otherwise known as ``an archived specimen''), the date of
service of the test shall be the date the specimen was obtained from
storage.
(3) If a specimen was stored for less than or equal to 30 calendar
days from the date it was collected, the date of service of the test
must be the date the specimen was obtained from storage if--
(i) The test is ordered by the patient's physician at least 14 days
following the date of the patient's discharge from the hospital.
(ii) The test could not reasonably have been ordered while the
patient was hospitalized.
(iii) The procedure performed while the beneficiary is a patient of
the hospital is for purposes other than collection of the specimen
needed for the test.
(iv) The test is reasonable and medically necessary.
Subpart J--Submission of Manufacturer's Average Sales Price Data
16. Section 414.802 is amended by adding the definition of ``Bona
fide service fees'' in alphabetical order to read as follows:
Sec. 414.802 Definitions.
* * * * *
Bona fide service fees means fees paid by a manufacturer to an
entity, that represent fair market value for a bona fide, itemized
service actually performed on behalf of the manufacturer that the
manufacturer would otherwise perform (or contract for) in the absence
of the service arrangement, and that are not passed on in whole or in
part to a client or customer of an entity, whether or not the entity
takes title to the drug.
* * * * *
17. Section 414.804 is amended by revising paragraphs (a)(1),
(a)(2), (a)(3), and (a)(4).
The revisions read as follows:
Sec. 414.804 Basis of Payment.
(a) * * *
(1) The manufacturer's average sales price for a quarter for a drug
represented by a particular 11-digit National Drug Code must be
calculated as the manufacturer's sales to all purchasers in the United
States for that particular 11-digit National Drug Code (after excluding
sales as specified in paragraph (a)(4) of this section and then
deducting price concessions as specified in paragraphs (a)(2) and
(a)(3) of this section) divided by the total number of units sold by
the manufacturer in that quarter (after excluding units associated with
sales as specified in paragraph (a)(4) of this section).
(2) Price concessions. (i) In calculating the manufacturer's
average sales price, a manufacturer must deduct price concessions.
Price concessions include the following types of transactions and
items:
(A) Volume discounts.
(B) Prompt pay discounts.
(C) Cash discounts.
(D) Free goods that are contingent on any purchase requirement.
(E) Chargebacks and rebates (other than rebates under the Medicaid
program).
(ii) For the purposes of paragraph (a)(2)(i), bona fide services
fees are not considered price concessions.
(3) To the extent that data on price concessions, as described in
paragraph (a)(2) of this section, are available on a
[[Page 49083]]
lagged basis, the manufacturer must estimate this amount in accordance
with the methodology described in this paragraph.
(i)(A) For each National Drug Code with at least 12 months of sales
(including products for which the manufacturer has redesignated the
National Drug Code for the specific product and package size and has 12
months of sales across the prior and current National Drug Codes),
after adjusting for exempted sales, the manufacturer calculates a
percentage equal to the sum of the price concessions for the most
recent 12-month period available associated with sales subject to the
average sales price reporting requirement divided by the total in
dollars for the sales subject to the average sales price reporting
requirement for the same 12-month period.
(B) For each National Drug Code with less than 12 months of sales,
the calculation described in paragraph (i)(A) of this section is
performed for the time period equaling the total number of months of
sales.
(ii) The manufacturer multiplies the applicable percentage
described in paragraph (a)(3)(i)(A) or (a)(3)(i)(B) of this section by
the total in dollars for the sales subject to the average sales price
reporting requirement (after adjusting for exempted sales) for the
quarter being submitted. (The manufacturer must carry a sufficient
number of decimal places in the calculation of the price concessions
percentage in order to round accurately the net total sales amount for
the quarter to the nearest whole dollar.) The result of this
multiplication is then subtracted from the total in dollars for the
sales subject to the average sales price reporting requirement (after
adjusting for exempted sales) for the quarter being submitted.
(iii) The manufacturer uses the result of the calculation described
in paragraph (a)(3)(ii) of this section as the numerator and the number
of units sold in the quarter (after adjusting for exempted sales) as
the denominator to calculate the manufacturer's average sales price for
the National Drug Code for the quarter being submitted.
(iv) Example. After adjusting for exempted sales, the total lagged
price concessions (discounts, rebates, etc.) over the most recent 12-
month period available associated with sales for National Drug Code
12345-6789-01 subject to the ASP reporting requirement equal $200,000,
and the total in dollars for the sales subject to the average sales
price reporting requirement for the same period equals $600,000. The
lagged price concessions percentage for this period equals 200,000/
600,000 = .33333. The total in dollars for the sales subject to the
average sales price reporting requirement for the quarter being
reported, after accounting for non-lagged price concessions, equals
$50,000 for 10,000 units sold. The manufacturer's average sales price
calculation for this National Drug Code for this quarter is: $50,000 -
(0.33333 x 50,000) = $33,334 (net total sales amount); $33,334/10,000 =
$3.33 (average sales price).
(4) Exempted sales. (i) In calculating the manufacturer's average
sales price, a manufacturer must exclude sales that are exempt from the
Medicaid best price calculation under sections 1927(c)(1)(C)(i) and
1927(c)(1)(C)(ii)(III) of the Act as limited by section 1927(c)(1)(D)
of the Act.
(ii) In determining nominal sales exempted under section
1927(c)(1)(C)(ii)(III) of the Act, the manufacturer calculates the
average manufacturer price as defined in section 1927(k) of the Act and
then identifies sales that are eligible to be considered a nominal sale
under section 1927(c)(1)(D) of the Act and are at less than 10 percent
of the average manufacturer price. To identify nominal sales, the
manufacturer must use the average manufacturer price for the calendar
quarter that is the same calendar quarter as the average sales price
reporting period.
(iii) For exempted sales under section 1927(c)(1)(C)(i) of the Act
known on a lagged basis because of chargebacks or rebates,
manufacturers must estimate such lagged exempted sales using the ratio
methodology specified in this paragraph to exclude lagged exempted
sales before accounting for price concessions as specified in
paragraphs (a)(2) and (a)(3) of this section.
(A) For each National Drug Code with at least 12 months of sales
(including products for which the manufacturer has redesignated the
Nation Drug Code and has 12 months of sales across the prior and
current National Drug Codes), the manufacturer calculates a percentage
using the sum of lagged exempted sales (in units) for the most recent
12 month period available as the numerator and the sales (the number of
units after non-lagged exempted sales have been subtracted from total
sales) for the same 12 month period as the denominator. The result is a
rolling average percentage estimate of lagged exempted sales that is
applied to the sales (the number of units after non-lagged exempted
sales have been subtracted from total sales) for the quarter being
submitted. The product that results from the multiplication of the
rolling average percentage estimate of lagged exempted sales and the
sales for the quarter determines the estimated lagged exempted sales in
units to subtract from the denominator of the average sales price
calculation. Manufacturers must make a corresponding adjustment to the
numerator of the average sales price calculation to ensure that the
total in dollars for the reporting quarter does not include revenue
related to lagged exempted sales removed from the denominator using the
estimation methodology.
(B) For National Drug Codes with less than 12 months of sales, the
calculation described in paragraph (4)(iii)(A) of this section is
calculated based on the sales and exempted sales (lagged and non-
lagged) for the period equaling the total number of months of sales.
(C) Manufacturers must exclude lagged exempted sales (as calculated
using the ratio methodology in paragraph (a)(4)(iii)(A) of this
section) from their estimates of lagged price concessions described in
paragraph (a)(3) of this section.
* * * * *
Subpart K--Payment for Drugs and Biologicals Under Part B
18. Section 414.904 is amended by revising paragraphs (d)(2)(iii)
and (d)(3) to read as follows:
Sec. 414.904 Average sales price as the basis for payment.
* * * * *
(d) * * *
(2) * * *
(iii) Effective for drugs and biologicals furnished in CY 2006 and
subsequent calendar years, the payment for such drugs and biologicals
furnished in connection with renal dialysis services and separately
billed by freestanding and hospital-based renal dialysis facilities not
paid on a cost basis is 106 percent of the average sales price.
(3) Widely available market price and average manufacturer price.
If the Inspector General finds that the average sales price exceeds the
widely available market price or the average manufacturer price by 5
percent or more in CY 2007, the payment limit in the quarter following
the transmittal of this information to the Secretary is the lesser of
the widely available market price or 103 percent of the average
manufacturer price.
* * * * *
[[Page 49084]]
PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS,
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN
CERTAIN SETTINGS
19. The authority citation for part 415 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Part B Carrier Payments for Physician Services to
Beneficiaries in Providers
20. Section 415.130 is amended by revising paragraph (d) to read as
follows:
Sec. 415.130 Conditions for payment: Physician pathology services.
* * * * *
(d) Physician pathology services furnished by an independent
laboratory. The technical component of physician pathology services
furnished by an independent laboratory to a hospital inpatient or
outpatient on or before December 31, 2006 may be paid to the laboratory
by the carrier under the physician fee schedule if the Medicare
beneficiary is a patient of a covered hospital as defined in paragraph
(a)(1) of this section. For services furnished after December 31, 2006,
an independent laboratory may not bill the carrier for physician
pathology services furnished to a hospital inpatient or outpatient.
* * * * *
PART 424--CONDITIONS FOR MEDICARE PAYMENT
21. The authority citation for part 424 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Certification and Plan of Treatment Requirements
22. Section 424.24 is amended by--
A. Redesignating paragraph (f) as paragraph (g).
B. Adding a new paragraph (f).
The addition reads as follows:
Sec. 424.24 Requirements for medical and other health services
furnished by providers under Medicare Part B.
* * * * *
(f) Blood glucose monitoring in skilled nursing facilities. For
each blood glucose test furnished to a resident of a skilled nursing
facility, the physician must certify that the test is medically
necessary. A physician's standing order is not sufficient to order a
series of blood glucose tests.
* * * * *
Subpart F--Limitations on Assignment and Reassignment of Claims
23. Section 424.80 is amended by--
A. Revising the heading of paragraph (d).
B. Revising paragraph (d)(2)
C. Adding a new paragraph (d)(3).
The revisions and addition read as follows:
Sec. 424.80 Prohibition of reassignment of claims by suppliers.
* * * * *
(d) Reassignment to an entity under an employer-employee
relationship or under a contractual arrangement: Conditions and
limitations. (1) * * *
(2) Access to records. The supplier who furnishes the service has
unrestricted access to claims submitted by an entity for services
provided by that supplier. This paragraph applies irrespective of
whether the supplier is an employee or whether the service is provided
under a contractual arrangement. If an entity refuses to provide, upon
request, the billing information to the supplier performing the
service, the entity's right to receive reassigned benefits may be
revoked under Sec. 424.82(c)(3).
(3) Contractual arrangements for provision of diagnostic test
services. If a physician or medical group bills for the technical
component of a diagnostic test covered under section 1861(s)(3) of the
Act and paid for under part 414 of this chapter (other than clinical
diagnostic laboratory tests paid under section 1833(a)(2)(D) of the
Act, which are subject to the special rules set forth in section
1833(h)(5)(A) of the Act), following a reassignment involving a
contractual arrangement with the physician or other supplier who
performed the technical component, each of the following conditions
must be met:
(i) The payment to the billing physician, or medical group, less
the applicable deductibles and coinsurance, may not exceed the lowest
of the following amounts:
(A) The physician or other supplier's net charge to the billing
physician or medical group.
(B) The billing physician's or medical group's actual charge.
(C) The fee schedule amount for the service that would be allowed
if the physician or other supplier billed directly.
(ii) The physician or medical group billing for the test must
identify the physician or other supplier that performed the test and
indicate the supplier's net charge for the test. If the physician or
medical group billing for the test fails to provide this information,
CMS will not make any payment to the physician or medical group billing
for the test and the billing physician or medical group can not bill
the beneficiary.
(iii) In order to bill for the technical component of the service,
the physician or medical group must directly perform the professional
component of the service.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: June 29, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 3, 2006.
Michael O. Leavitt,
Secretary.
Note: These addenda will not appear in the Code of Federal
Regulations.
Addendum A: Explanation and Use of Addenda B
The addenda on the following pages provide various data pertaining
to the Medicare fee schedule for physicians' services furnished in
2007. Addendum B contains the RVUs for work, non-facility PE, facility
PE, and malpractice expense, and other information for all services
included in the PFS.
In previous years, we have listed many services in Addendum B that
are not paid under the PFS. To avoid publishing as many pages of codes
for these services, we are not including clinical laboratory codes or
the alphanumeric codes (Healthcare Common Procedure Coding System
(HCPCS) codes not included in CPT) not paid under the PFS in Addendum
B.
Addendum B--2007 Relative Value Units and Related Information Used in
Determining Medicare Payments for 2007
This addendum contains the following information for each CPT code
and alphanumeric HCPCS code, except for: alphanumeric codes beginning
with B (enteral and parenteral therapy), E (durable medical equipment),
K (temporary stcodes for nonphysicians' services or items), or L
(orthotics); and codes for anesthesiology. Please also note the
following:
An ``NA'' in the ``Non-facility PE RVUs'' column of
Addendum B means that CMS has not developed a PE RVU
[[Page 49085]]
in the non-facility setting for the service because it is typically
performed in the hospital (for example, an open heart surgery is
generally performed in the hospital setting and not a physician's
office). If there is an ``NA'' in the non-facility PE RVU column, and
the contractor determines that this service can be performed in the
non-facility setting, the service will be paid at the facility PE RVU
rate.
Services that have an ``NA'' in the ``Facility PE RVUs''
column of Addendum B are typically not paid using the PFS when provided
in a facility setting. These services (which include ``incident to''
services and the technical portion of diagnostic tests) are generally
paid under either the outpatient hospital prospective payment system or
bundled into the hospital inpatient prospective payment system payment.
1. CPT/HCPCS code. This is the CPT or alphanumeric HCPCS number for
the service. Alphanumeric HCPCS codes are included at the end of this
addendum.
2. Modifier. A modifier is shown if there is a technical component
(modifier TC) and a professional component (PC) (modifier -26) for the
service. If there is a PC and a TC for the service, Addendum B contains
three entries for the code. A code for: the global values (both
professional and technical); modifier -26 (PC); and, modifier TC. The
global service is not designated by a modifier, and physicians must
bill using the code without a modifier if the physician furnishes both
the PC and the TC of the service.
Modifier-53 is shown for a discontinued procedure, for example, a
colonoscopy that is not completed. There will be RVUs for a code with
this modifier.
3. Status indicator. This indicator shows whether the CPT/HCPCS
code is in the PFS and whether it is separately payable if the service
is covered.
A = Active code. These codes are separately payable under the PFS
if covered. There will be RVUs for codes with this status. The presence
of an ``A'' indicator does not mean that Medicare has made a national
coverage determination regarding the service. Carriers remain
responsible for coverage decisions in the absence of a national
Medicare policy.
B = Bundled code. Payments for covered services are always bundled
into payment for other services not specified. If RVUs are shown, they
are not used for Medicare payment. If these services are covered,
payment for them is subsumed by the payment for the services to which
they are incident (an example is a telephone call from a hospital nurse
regarding care of a patient).
C = Carriers price the code. Carriers will establish RVUs and
payment amounts for these services, generally on an individual case
basis following review of documentation, such as an operative report.
D* = Deleted/discontinued code.
E = Excluded from the PFS by regulation. These codes are for items
and services that CMS chose to exclude from the fee schedule payment by
regulation. No RVUs are shown, and no payment may be made under the PFS
for these codes. Payment for them, when covered, continues under
reasonable charge procedures.
F = Deleted/discontinued codes. (Code not subject to a 90-day grace
period.) These codes are deleted effective with the beginning of the
year and are never subject to a grace period. This indicator is no
longer effective beginning with the 2005 fee schedule as of January 1,
2005.
G = Code not valid for Medicare purposes. Medicare uses another
code for reporting of, and payment for, these services. (Codes subject
to a 90-day grace period.) This indicator is no longer effective with
the 2005 PFS as of January 1, 2005.
H* = Deleted modifier. For 2000 and later years, either the TC or
PC component shown for the code has been deleted and the deleted
component is shown in the database with the H status indicator.
I = Not valid for Medicare purposes. Medicare uses another code for
the reporting of, and the payment for these services. (Codes not
subject to a 90-day grace period.)
L = Local codes. Carriers will apply this status to all local codes
in effect on January 1, 1998 or subsequently approved by central office
for use. Carriers will complete the RVUs and payment amounts for these
codes.
M = Measurement codes, used for reporting purposes only. There are
no RVUs and no payment amounts for these codes. Medicare uses them to
aid with performance measurement. No separate payment is made. These
codes should be billed with a zero (($0.00) charge and are denied) on
the MPFSDB.
N = Non-covered service. These codes are noncovered services.
Medicare payment may not be made for these codes. If RVUs are shown,
they are not used for Medicare payment.
R = Restricted coverage. Special coverage instructions apply. If
the service is covered and no RVUs are shown, it is carrier-priced.
T = There are RVUs for these services, but they are only paid if
there are no other services payable under the PFS billed on the same
date by the same provider. If any other services payable under the PFS
are billed on the same date by the same provider, these services are
bundled into the service(s) for which payment is made.
X = Statutory exclusion. These codes represent an item or service
that is not within the statutory definition of ``physicians' services''
for PFS payment purposes. No RVUs are shown for these codes, and no
payment may be made under the PFS. (Examples are ambulance services and
clinical diagnostic laboratory services.)
4. Description of code. This is an abbreviated version of the
narrative description of the code.
5. Physician work RVUs. These are the RVUs for the physician work
for this service in 2007. As stated in the June 29, 2006 proposed
notice, the RVUs for codes with a 10- or 90-day global period reflect
the application of the RUC-recommended values for the E/M services that
are included as part of the global period for the service.
Note: The separate budget neutrality adjustor is not reflected in
these physician work RVUs.
6. Fully implemented non-facility practice expense RVUs. These are
the fully implemented resource-based PE RVUs for non-facility settings.
7. Transitional Non-facility practice expense RVUs. These are the
2007 resource-based PE RVUs for non-facility settings.
8. Fully implemented facility practice expense RVUs. These are the
fully implemented resource-based PE RVUs for facility settings.
9. Transitional facility practice expense RVUs. These are the 2007
resource-based PE RVUs for facility settings.
10. Malpractice expense RVUs. These are the RVUs for the
malpractice expense for the service for 2006.
11. Non-facility total. This is the sum of the work, fully
implemented non-facility PE, and malpractice expense RVUs.
12. Transitional non-facility total. This is the sum of the work,
2007 transitional non-facility PE, and malpractice expense RVUs.
13. Facility total. This is the sum of the work, fully implemented
facility PE, and malpractice expense RVUs.
14. Transitional facility total. This is the sum of the work, 2007
transitional facility PE, and malpractice expense RVUs.
15. Global period. This indicator shows the number of days in the
global period for the code (0, 10, or 90 days).
[[Page 49086]]
An explanation of the alpha codes follows:
MMM = Code describes a service furnished in uncomplicated maternity
cases including antepartum care, delivery, and postpartum care. The
usual global surgical concept does not apply. See the 1999 Physicians'
Current Procedural Terminology for specific definitions.
XXX = The global concept does not apply.
YYY = The global period is to be set by the carrier (for example,
unlisted surgery codes).
ZZZ = Code related to another service that is always included in
the global period of the other service. (Note: Physician work and PE
are associated with intra service time and in some instances in the
post service time.
*Codes with these indicators had a 90-day grace period before
January 1, 2005.
[[Page 49087]]
Addendum B.--Relative Value Units (RVUs) and Related Information Used In Determining Medicare Payments For 2007
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fully Fully
Implemented Year 2007 Fully Year 2007 Mal- Implemented Year 2007 Fully Year 2007
CPT\1\/ Mod Status Description Physician Non- Transitional Implemented Transitional Practice Non- Transitional Implemented Transitional Global
HCPCS\2\ Work RVUs Facility PE Non-Facility Facility PE Facility PE RVUs Facility Non-Facility Facility Facility
RVUs PE RVUs RVUs RVUs Total Total Total Total
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
0003T......... ........ C Cervicography.. 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
0008T......... ........ C Upper gi 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
endoscopy w/
suture.
0016T......... ........ C Thermotx 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
choroid vasc
lesion.
0017T......... ........ C Photocoagulat 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
macular drusen.
0018T......... ........ C Transcranial 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
magnetic
stimul.
0019T......... ........ C Extracorp shock 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
wv tx,ms nos.
0021T......... ........ C Fetal oximetry, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
trnsvag/cerv.
0024T......... ........ C Transcath 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
cardiac
reduction.
0026T......... ........ C Measure remnant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
lipoproteins.
0027T......... ........ C Endoscopic 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
epidural lysis.
0028T......... ........ C Dexa body 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
composition
study.
0029T......... ........ C Magnetic tx for 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
incontinence.
0030T......... ........ C Antiprothrombin 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
antibody.
0031T......... ........ C Speculoscopy... 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
0032T......... ........ C Speculoscopy w/ 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
direct sample.
0041T......... ........ C Detect ur 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
infect agnt w/
cpas.
0042T......... ........ C Ct perfusion w/ 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
contrast, cbf.
0043T......... ........ C Co expired gas 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
analysis.
0044T......... ........ C Whole body 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
photography.
0045T......... ........ C Whole body 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
photography.
0046T......... ........ C Cath lavage, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
mammary duct(s.
0047T......... ........ C Cath lavage, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
mammary
duct(s).
0048T......... ........ C Implant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
ventricular
device.
0049T......... ........ C External 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
circulation
assist.
0050T......... ........ C Removal 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
circulation
assist.
0051T......... ........ C Implant total 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
heart system.
0052T......... ........ C Replace 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
component
heart syst.
0053T......... ........ C Replace 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
component
heart syst.
0054T......... ........ C Bone surgery 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
using computer.
0055T......... ........ C Bone surgery 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
using computer.
0056T......... ........ C Bone surgery 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
using computer.
0058T......... ........ C Cryopreservatio 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
n, ovary tiss.
0059T......... ........ C Cryopreservatio 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
n, oocyte.
0060T......... ........ C Electrical 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
impedance scan.
0061T......... ........ C Destruction of 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
tumor, breast.
0062T......... ........ C Rep intradisc 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
annulus;1 lev.
0063T......... ........ C Rep intradisc 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
annulus;>1lev.
0064T......... ........ C Spectroscop 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
eval expired
gas.
0065T......... ........ C Ocular 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
photoscreen
bilat.
0067T......... ........ C Ct 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
colonography;d
x.
0067T......... 26...... C Ct 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
colonography;d
x.
0067T......... TC...... C Ct 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
colonography;d
x.
0068T......... ........ C Interp/rept 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
heart sound.
0069T......... ........ C Analysis only 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
heart sound.
0070T......... ........ C Interp only 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
heart sound.
0071T......... ........ C U/s leiomyomata 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
ablate < 200.
0072T......... ........ C U/s leiomyomata 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
ablate >200.
0073T......... ........ A Delivery, comp 0.00 13.02 16.77 NA NA 0.13 13.15 16.90 NA NA XXX
imrt.
0075T......... ........ C Perq stent/ 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
chest vert art.
0075T......... 26...... C Perq stent/ 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
chest vert art.
0075T......... TC...... C Perq stent/ 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
chest vert art.
0076T......... ........ C S&i stent/chest 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
vert art.
0076T......... 26...... C S&i stent/chest 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
vert art.
0076T......... TC...... C S&i stent/chest 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
vert art.
0077T......... ........ C Cereb therm 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
perfusion
probe.
0078T......... ........ C Endovasc aort 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
repr w/device.
[[Page 49088]]
0079T......... ........ C Endovasc visc 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
extnsn repr.
0080T......... ........ C Endovasc aort 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
repr rad s&i.
0081T......... ........ C Endovasc visc 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
extnsn s&i.
0082T......... ........ C Stereotactic 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
rad delivery.
0083T......... ........ C Stereotactic 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
rad tx mngmt.
0084T......... ........ C Temp prostate 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
urethral stent.
0085T......... ........ C Breath test 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
heart reject.
0086T......... ........ C L ventricle 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
fill pressure.
0087T......... ........ C Sperm eval 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
hyaluronan.
0088T......... ........ C Rf tongue base 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
vol reduxn.
0089T......... ........ C Actigraphy 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
testing, 3-day.
0090T......... ........ C Cervical 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
artific disc.
0091T......... ........ C Lumbar artific 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
disc.
0092T......... ........ C Artific disc 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
addl.
0093T......... ........ C Cervical 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
artific
diskectomy.
0094T......... ........ C Lumbar artific 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
diskectomy.
0095T......... ........ C Artific 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
diskectomy
addl.
0096T......... ........ C Rev cervical 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
artific disc.
0097T......... ........ C Rev lumbar 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
artific disc.
0098T......... ........ C Rev artific 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
disc addl.
0099T......... ........ C Implant corneal 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
ring.
0100T......... ........ C Prosth retina 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
receive&gen.
0101T......... ........ C Extracorp 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
shockwv tx,hi
enrg.
0102T......... ........ C Extracorp 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
shockwv
tx,anesth.
0103T......... ........ C Holotranscobala 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
min.
0104T......... ........ C At rest cardio 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
gas rebreathe.
0105T......... ........ C Exerc cardio 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
gas rebreathe.
0106T......... ........ C Touch quant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensory test.
0107T......... ........ C Vibrate quant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensory test.
0108T......... ........ C Cool quant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensory test.
0109T......... ........ C Heat quant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensory test.
0110T......... ........ C Nos quant 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensory test.
0111T......... ........ C Rbc membranes 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
fatty acids.
0115T......... ........ C Med tx mngmt 15 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
min.
0116T......... ........ C Med tx mngmt 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
subsqt.
0117T......... ........ C Med tx mngmt 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
addl 15 min.
0120T......... ........ C Fibroadenoma 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
cryoablate, ea.
0123T......... ........ C Scleral 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
fistulization.
0124T......... ........ C Conjunctival 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
drug placement.
0126T......... ........ C Chd risk imt 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
study.
0130T......... ........ C Chron care drug 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
investigatn.
0133T......... ........ C Esophageal 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
implant injexn.
0135T......... ........ C Perq cryoablate 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
renal tumor.
0137T......... ........ C Prostate 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
saturation
sampling.
0140T......... ........ C Exhaled breath 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
condensate ph.
0144T......... ........ C CT heart wo 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
dye; qual calc.
0144T......... 26...... C CT heart wo 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
dye; qual calc.
0144T......... TC...... C CT heart wo 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
dye; qual calc.
0145T......... ........ C CT heart w/wo 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
dye funct.
0145T......... 26...... C CT heart w/wo 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
dye funct.
0145T......... TC...... C CT heart w/wo 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
dye funct.
0146T......... ........ C CCTA w/wo dye.. 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
0146T......... 26...... C CCTA w/wo dye.. 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
0146T......... TC...... C CCTA w/wo dye.. 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
0147T......... ........ C CCTA w/wo, quan 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
calcium.
0147T......... 26...... C CCTA w/wo, quan 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
calcium.
[[Page 49089]]
0147T......... TC...... C CCTA w/wo, quan 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
calcium.
0148T......... ........ C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
strxr.
0148T......... 26...... C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
strxr.
0148T......... TC...... C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
strxr.
0149T......... ........ C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
strxr quan
calc.
0149T......... 26...... C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
strxr quan
calc.
0149T......... TC...... C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
strxr quan
calc.
0150T......... ........ C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
disease strxr.
0150T......... 26...... C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
disease strxr.
0150T......... TC...... C CCTA w/wo, 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
disease strxr.
0151T......... ........ C CT heart funct 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
add-on.
0151T......... 26...... C CT heart funct 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
add-on.
0151T......... TC...... C CT heart funct 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
add-on.
0152T......... ........ C Computer chest 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
add-on.
0153T......... ........ C Implant aneur 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensor add-on.
0154T......... ........ C Implant aneur 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
sensor study.
0155T......... ........ C Lap ins gastr 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
eltrd for mo.
0156T......... ........ C Lap redo gastr 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
eltrd for mo.
0157T......... ........ C Opn ins gastr 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
eltrd for mo.
0158T......... ........ C Opn redo gastr 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
eltrd for mo.
0159T......... ........ C Computer breast 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 ZZZ
MRI add-on.
0159T......... 26...... C Computer breast 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 ZZZ
MRI add-on.
0159T......... TC...... C Computer breast 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 ZZZ
MRI add-on.
0160T......... ........ C Transcran mag 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
stim planning.
0161T......... ........ C Transcran mag 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 XXX
stim delivery.
10021......... ........ A Fna w/o image.. 1.27 2.13 2.15 0.36 0.50 0.10 3.50 3.52 1.73 1.87 XXX
10022......... ........ A Fna w/image.... 1.27 2.13 2.44 0.38 0.41 0.08 3.48 3.79 1.73 1.76 XXX
10040......... ........ A Acne surgery... 1.18 1.26 1.07 0.93 0.83 0.05 2.49 2.30 2.16 2.06 010
10060......... ........ A Drainage of 1.17 1.50 1.28 1.08 0.97 0.12 2.79 2.57 2.37 2.26 010
skin abscess.
10061......... ........ A Drainage of 2.40 2.07 1.88 1.51 1.50 0.26 4.73 4.54 4.17 4.16 010
skin abscess.
10080......... ........ A Drainage of 1.17 2.65 2.99 1.09 1.11 0.11 3.93 4.27 2.37 2.39 010
pilonidal cyst.
10081......... ........ A Drainage of 2.45 3.49 3.93 1.44 1.49 0.24 6.18 6.62 4.13 4.18 010
pilonidal cyst.
10120......... ........ A Remove foreign 1.22 2.10 2.15 0.94 0.96 0.12 3.44 3.49 2.28 2.30 010
body.
10121......... ........ A Remove foreign 2.69 3.52 3.51 1.65 1.75 0.33 6.54 6.53 4.67 4.77 010
body.
10140......... ........ A Drainage of 1.53 2.27 1.90 1.29 1.29 0.19 3.99 3.62 3.01 3.01 010
hematoma/fluid.
10160......... ........ A Puncture 1.20 1.85 1.66 1.07 1.08 0.14 3.19 3.00 2.41 2.42 010
drainage of
lesion.
10180......... ........ A Complex 2.25 3.30 3.06 1.83 1.94 0.35 5.90 5.66 4.43 4.54 010
drainage,
wound.
11000......... ........ A Debride 0.60 0.73 0.62 0.16 0.21 0.07 1.40 1.29 0.83 0.88 000
infected skin.
11001......... ........ A Debride 0.30 0.23 0.23 0.08 0.10 0.04 0.57 0.57 0.42 0.44 ZZZ
infected skin
add-on.
11004......... ........ A Debride 10.31 NA NA 3.04 3.69 0.67 NA NA 14.02 14.67 000
genitalia &
perineum.
11005......... ........ A Debride abdom 13.75 NA NA 4.06 5.19 0.96 NA NA 18.77 19.90 000
wall.
11006......... ........ A Debride genit/ 12.61 NA NA 3.61 4.54 1.28 NA NA 17.50 18.43 000
per/abdom wall.
11008......... ........ A Remove mesh 5.00 NA NA 1.36 1.86 0.61 NA NA 6.97 7.47 ZZZ
from abd wall.
11010......... ........ A Debride skin, 4.19 6.77 6.85 2.33 2.55 0.66 11.62 11.70 7.18 7.40 010
fx.
11011......... ........ A Debride skin/ 4.94 7.09 7.89 2.04 2.27 0.74 12.77 13.57 7.72 7.95 000
muscle, fx.
11012......... ........ A Debride skin/ 6.87 9.03 11.33 3.12 3.66 1.16 17.06 19.36 11.15 11.69 000
muscle/bone,
fx.
11040......... ........ A Debride skin, 0.48 0.68 0.56 0.16 0.20 0.06 1.22 1.10 0.70 0.74 000
partial.
11041......... ........ A Debride skin, 0.60 0.73 0.68 0.19 0.30 0.10 1.43 1.38 0.89 1.00 000
full.
11042......... ........ A Debride skin/ 0.80 0.96 0.97 0.25 0.39 0.13 1.89 1.90 1.18 1.32 000
tissue.
11043......... ........ A Debride tissue/ 3.00 3.64 3.45 2.71 2.62 0.32 6.96 6.77 6.03 5.94 010
muscle.
11044......... ........ A Debride tissue/ 4.05 4.96 4.58 3.67 3.73 0.43 9.44 9.06 8.15 8.21 010
muscle/bone.
11055......... ........ R Trim skin 0.43 0.82 0.63 0.11 0.16 0.05 1.30 1.11 0.59 0.64 000
lesion.
11056......... ........ R Trim skin 0.61 0.89 0.70 0.16 0.21 0.07 1.57 1.38 0.84 0.89 000
lesions, 2 to
4.
11057......... ........ R Trim skin 0.79 1.00 0.81 0.21 0.28 0.10 1.89 1.70 1.10 1.17 000
lesions, over
4.
11100......... ........ A Biopsy, skin 0.81 1.83 1.40 0.37 0.37 0.03 2.67 2.24 1.21 1.21 000
lesion.
11101......... ........ A Biopsy, skin 0.41 0.40 0.35 0.19 0.19 0.02 0.83 0.78 0.62 0.62 ZZZ
add-on.
11200......... ........ A Removal of skin 0.77 1.20 1.08 0.88 0.79 0.04 2.01 1.89 1.69 1.60 010
tags.
11201......... ........ A Remove skin 0.29 0.16 0.16 0.11 0.12 0.02 0.47 0.47 0.42 0.43 ZZZ
tags add-on.
11300......... ........ A Shave skin 0.51 1.17 1.04 0.20 0.21 0.03 1.71 1.58 0.74 0.75 000
lesion.
11301......... ........ A Shave skin 0.85 1.47 1.20 0.37 0.38 0.04 2.36 2.09 1.26 1.27 000
lesion.
11302......... ........ A Shave skin 1.05 1.73 1.41 0.47 0.46 0.05 2.83 2.51 1.57 1.56 000
lesion.
11303......... ........ A Shave skin 1.24 1.97 1.68 0.53 0.52 0.07 3.28 2.99 1.84 1.83 000
lesion.
11305......... ........ A Shave skin 0.67 1.06 0.90 0.20 0.25 0.07 1.80 1.64 0.94 0.99 000
lesion.
11306......... ........ A Shave skin 0.99 1.39 1.17 0.37 0.41 0.07 2.45 2.23 1.43 1.47 000
lesion.
11307......... ........ A Shave skin 1.14 1.66 1.38 0.46 0.48 0.07 2.87 2.59 1.67 1.69 000
lesion.
11308......... ........ A Shave skin 1.41 1.71 1.52 0.50 0.57 0.13 3.25 3.06 2.04 2.11 000
lesion.
[[Page 49090]]
11310......... ........ A Shave skin 0.73 1.35 1.17 0.30 0.32 0.04 2.12 1.94 1.07 1.09 000
lesion.
11311......... ........ A Shave skin 1.05 1.60 1.32 0.46 0.48 0.05 2.70 2.42 1.56 1.58 000
lesion.
11312......... ........ A Shave skin 1.20 1.87 1.53 0.54 0.55 0.06 3.13 2.79 1.80 1.81 000
lesion.
11313......... ........ A Shave skin 1.62 2.13 1.88 0.71 0.72 0.10 3.85 3.60 2.43 2.44 000
lesion.
11400......... ........ A Exc tr-ext 0.85 1.86 1.96 0.92 0.89 0.06 2.77 2.87 1.83 1.80 010
b9+marg 0.5 <
cm.
11401......... ........ A Exc tr-ext 1.23 2.14 2.07 1.12 1.05 0.10 3.47 3.40 2.45 2.38 010
b9+marg 0.6-1
cm.
11402......... ........ A Exc tr-ext 1.40 2.35 2.25 1.18 1.11 0.13 3.88 3.78 2.71 2.64 010
b9+marg 1.1-2
cm.
11403......... ........ A Exc tr-ext 1.79 2.52 2.42 1.54 1.38 0.17 4.48 4.38 3.50 3.34 010
b9+marg 2.1-3
cm.
11404......... ........ A Exc tr-ext 2.06 2.84 2.74 1.61 1.45 0.21 5.11 5.01 3.88 3.72 010
b9+marg 3.1-4
cm.
11406......... ........ A Exc tr-ext 3.45 3.50 3.17 2.07 1.76 0.32 7.27 6.94 5.84 5.53 010
b9+marg > 4.0
cm.
11420......... ........ A Exc h-f-nk-sp 0.98 1.82 1.78 0.92 0.93 0.09 2.89 2.85 1.99 2.00 010
b9+marg 0.5 < .
11421......... ........ A Exc h-f-nk-sp 1.42 2.18 2.09 1.14 1.12 0.13 3.73 3.64 2.69 2.67 010
b9+marg 0.6-1.
11422......... ........ A Exc h-f-nk-sp 1.63 2.39 2.29 1.50 1.37 0.16 4.18 4.08 3.29 3.16 010
b9+marg 1.1-2.
11423......... ........ A Exc h-f-nk-sp 2.01 2.62 2.59 1.62 1.49 0.20 4.83 4.80 3.83 3.70 010
b9+marg 2.1-3.
11424......... ........ A Exc h-f-nk-sp 2.43 2.94 2.84 1.75 1.64 0.25 5.62 5.52 4.43 4.32 010
b9+marg 3.1-4.
11426......... ........ A Exc h-f-nk-sp 4.02 3.58 3.51 2.29 2.15 0.44 8.04 7.97 6.75 6.61 010
b9+marg > 4 cm.
11440......... ........ A Exc face-mm 1.00 1.99 2.15 1.30 1.31 0.08 3.07 3.23 2.38 2.39 010
b9+marg 0.5 <
cm.
11441......... ........ A Exc face-mm 1.48 2.34 2.33 1.52 1.50 0.13 3.95 3.94 3.13 3.11 010
b9+marg 0.6-1
cm.
11442......... ........ A Exc face-mm 1.72 2.59 2.55 1.62 1.58 0.16 4.47 4.43 3.50 3.46 010
b9+marg 1.1-2
cm.
11443......... ........ A Exc face-mm 2.29 2.82 2.89 1.79 1.81 0.22 5.33 5.40 4.30 4.32 010
b9+marg 2.1-3
cm.
11444......... ........ A Exc face-mm 3.14 3.23 3.41 2.04 2.15 0.30 6.67 6.85 5.48 5.59 010
b9+marg 3.1-4
cm.
11446......... ........ A Exc face-mm 4.73 4.01 4.03 2.62 2.73 0.43 9.17 9.19 7.78 7.89 010
b9+marg > 4 cm.
11450......... ........ A Removal, sweat 3.11 5.19 5.07 2.44 2.13 0.34 8.64 8.52 5.89 5.58 090
gland lesion.
11451......... ........ A Removal, sweat 4.32 6.17 6.49 2.79 2.60 0.53 11.02 11.34 7.64 7.45 090
gland lesion.
11462......... ........ A Removal, sweat 2.89 5.33 5.17 2.47 2.13 0.32 8.54 8.38 5.68 5.34 090
gland lesion.
11463......... ........ A Removal, sweat 4.32 6.64 6.78 2.98 2.76 0.54 11.50 11.64 7.84 7.62 090
gland lesion.
11470......... ........ A Removal, sweat 3.63 5.61 5.20 2.70 2.37 0.40 9.64 9.23 6.73 6.40 090
gland lesion.
11471......... ........ A Removal, sweat 4.78 6.48 6.65 2.99 2.82 0.58 11.84 12.01 8.35 8.18 090
gland lesion.
11600......... ........ A Exc tr-ext 1.56 2.71 2.65 1.12 1.01 0.10 4.37 4.31 2.78 2.67 010
mlg+marg 0.5 <
cm.
11601......... ........ A Exc tr-ext 2.00 3.37 2.87 1.47 1.28 0.12 5.49 4.99 3.59 3.40 010
mlg+marg 0.6-1
cm.
11602......... ........ A Exc tr-ext 2.20 3.74 3.05 1.63 1.35 0.12 6.06 5.37 3.95 3.67 010
mlg+marg 1.1-2
cm.
11603......... ........ A Exc tr-ext 2.75 3.95 3.29 1.81 1.45 0.16 6.86 6.20 4.72 4.36 010
mlg+marg 2.1-3
cm.
11604......... ........ A Exc tr-ext 3.10 4.26 3.59 1.88 1.51 0.20 7.56 6.89 5.18 4.81 010
mlg+marg 3.1-4
cm.
11606......... ........ A Exc tr-ext 4.95 5.41 4.40 2.41 1.90 0.36 10.72 9.71 7.72 7.21 010
mlg+marg > 4
cm.
11620......... ........ A Exc h-f-nk-sp 1.57 2.81 2.65 1.17 1.01 0.09 4.47 4.31 2.83 2.67 010
mlg+marg 0.5 < .
11621......... ........ A Exc h-f-nk-sp 2.01 3.42 2.88 1.49 1.30 0.12 5.55 5.01 3.62 3.43 010
mlg+marg 0.6-1.
11622......... ........ A Exc h-f-nk-sp 2.34 3.80 3.17 1.69 1.47 0.14 6.28 5.65 4.17 3.95 010
mlg+marg 1.1-2.
11623......... ........ A Exc h-f-nk-sp 3.04 4.03 3.51 1.90 1.66 0.20 7.27 6.75 5.14 4.90 010
mlg+marg 2.1-3.
11624......... ........ A Exc h-f-nk-sp 3.55 4.35 3.89 2.03 1.84 0.27 8.17 7.71 5.85 5.66 010
mlg+marg 3.1-4.
11626......... ........ A Exc h-f-nk-sp 4.54 4.90 4.70 2.28 2.36 0.45 9.89 9.69 7.27 7.35 010
mlg+mar > 4 cm.
11640......... ........ A Exc face-mm 1.60 3.00 2.74 1.26 1.15 0.11 4.71 4.45 2.97 2.86 010
malig+marg 0.5
< .
11641......... ........ A Exc face-mm 2.10 3.55 3.15 1.56 1.54 0.16 5.81 5.41 3.82 3.80 010
malig+marg 0.6-
1.
11642......... ........ A Exc face-mm 2.55 3.93 3.53 1.78 1.73 0.19 6.67 6.27 4.52 4.47 010
malig+marg 1.1-
2.
11643......... ........ A Exc face-mm 3.35 4.18 3.90 2.04 1.98 0.26 7.79 7.51 5.65 5.59 010
malig+marg 2.1-
3.
11644......... ........ A Exc face-mm 4.27 4.95 4.75 2.38 2.43 0.37 9.59 9.39 7.02 7.07 010
malig+marg 3.1-
4.
11646......... ........ A Exc face-mm 6.19 5.76 5.75 3.03 3.36 0.61 12.56 12.55 9.83 10.16 010
mlg+marg > 4
cm.
11719......... ........ R Trim nail(s)... 0.17 0.38 0.28 0.04 0.06 0.02 0.57 0.47 0.23 0.25 000
11720......... ........ A Debride nail, 1- 0.32 0.47 0.37 0.08 0.11 0.04 0.83 0.73 0.44 0.47 000
5.
11721......... ........ A Debride nail, 6 0.54 0.55 0.47 0.14 0.19 0.07 1.16 1.08 0.75 0.80 000
or more.
11730......... ........ A Removal of nail 1.10 1.35 1.11 0.29 0.40 0.14 2.59 2.35 1.53 1.64 000
plate.
11732......... ........ A Remove nail 0.57 0.55 0.47 0.15 0.20 0.07 1.19 1.11 0.79 0.84 ZZZ
plate, add-on.
11740......... ........ A Drain blood 0.37 0.80 0.61 0.44 0.37 0.04 1.21 1.02 0.85 0.78 000
from under
nail.
11750......... ........ A Removal of nail 2.36 2.98 2.37 1.89 1.79 0.22 5.56 4.95 4.47 4.37 010
bed.
11752......... ........ A Remove nail bed/ 3.42 4.12 3.27 2.82 2.95 0.35 7.89 7.04 6.59 6.72 010
finger tip.
11755......... ........ A Biopsy, nail 1.31 2.02 1.68 0.76 0.77 0.14 3.47 3.13 2.21 2.22 000
unit.
11760......... ........ A Repair of nail 1.58 3.45 2.83 1.44 1.70 0.21 5.24 4.62 3.23 3.49 010
bed.
[[Page 49091]]
11762......... ........ A Reconstruction 2.89 3.72 3.09 1.69 2.18 0.36 6.97 6.34 4.94 5.43 010
of nail bed.
11765......... ........ A Excision of 0.69 2.69 2.01 1.01 0.82 0.08 3.46 2.78 1.78 1.59 010
nail fold, toe.
11770......... ........ A Removal of 2.61 3.49 3.48 1.53 1.51 0.33 6.43 6.42 4.47 4.45 010
pilonidal
lesion.
11771......... ........ A Removal of 5.91 6.72 5.91 3.74 3.42 0.74 13.37 12.56 10.39 10.07 090
pilonidal
lesion.
11772......... ........ A Removal of 7.15 8.06 7.64 5.56 5.19 0.89 16.10 15.68 13.60 13.23 090
pilonidal
lesion.
11900......... ........ A Injection into 0.52 0.89 0.71 0.24 0.22 0.02 1.43 1.25 0.78 0.76 000
skin lesions.
11901......... ........ A Added skin 0.80 0.98 0.74 0.38 0.36 0.03 1.81 1.57 1.21 1.19 000
lesions
injection.
11920......... ........ R Correct skin 1.61 2.40 3.38 1.12 1.10 0.24 4.25 5.23 2.97 2.95 000
color defects.
11921......... ........ R Correct skin 1.93 2.67 3.64 1.26 1.27 0.29 4.89 5.86 3.48 3.49 000
color defects.
11922......... ........ R Correct skin 0.49 0.93 1.09 0.22 0.24 0.07 1.49 1.65 0.78 0.80 ZZZ
color defects.
11950......... ........ R Therapy for 0.84 0.86 1.07 0.35 0.38 0.06 1.76 1.97 1.25 1.28 000
contour
defects.
11951......... ........ R Therapy for 1.19 1.18 1.41 0.53 0.52 0.11 2.48 2.71 1.83 1.82 000
contour
defects.
11952......... ........ R Therapy for 1.69 1.71 1.82 0.81 0.71 0.16 3.56 3.67 2.66 2.56 000
contour
defects.
11954......... ........ R Therapy for 1.85 1.76 2.27 0.76 0.87 0.25 3.86 4.37 2.86 2.97 000
contour
defects.
11960......... ........ A Insert tissue 10.85 NA NA 10.58 10.44 1.31 NA NA 22.74 22.60 090
expander(s).
11970......... ........ A Replace tissue 7.80 NA NA 6.20 6.15 1.05 NA NA 15.05 15.00 090
expander.
11971......... ........ A Remove tissue 3.13 7.42 8.69 4.01 3.85 0.32 10.87 12.14 7.46 7.30 090
expander(s).
11975......... ........ N Insert 1.48 1.55 1.45 0.34 0.51 0.17 3.20 3.10 1.99 2.16 XXX
contraceptive
cap.
11976......... ........ R Removal of 1.78 1.71 1.72 0.47 0.63 0.21 3.70 3.71 2.46 2.62 000
contraceptive
cap.
11977......... ........ N Removal/ 3.30 2.00 2.20 0.77 1.14 0.37 5.67 5.87 4.44 4.81 XXX
reinsert
contra cap.
11980......... ........ A Implant hormone 1.48 1.17 1.10 0.55 0.54 0.13 2.78 2.71 2.16 2.15 000
pellet(s).
11981......... ........ A Insert drug 1.48 1.92 1.76 0.59 0.66 0.12 3.52 3.36 2.19 2.26 XXX
implant device.
11982......... ........ A Remove drug 1.78 2.05 1.97 0.71 0.80 0.17 4.00 3.92 2.66 2.75 XXX
implant device.
11983......... ........ A Remove/insert 3.30 2.67 2.38 1.34 1.44 0.23 6.20 5.91 4.87 4.97 XXX
drug implant.
12001......... ........ A Repair 1.70 1.73 1.92 0.72 0.76 0.15 3.58 3.77 2.57 2.61 010
superficial
wound(s).
12002......... ........ A Repair 1.86 1.79 1.98 0.83 0.88 0.17 3.82 4.01 2.86 2.91 010
superficial
wound(s).
12004......... ........ A Repair 2.24 2.07 2.26 0.92 0.99 0.21 4.52 4.71 3.37 3.44 010
superficial
wound(s).
12005......... ........ A Repair 2.86 2.52 2.75 1.06 1.17 0.27 5.65 5.88 4.19 4.30 010
superficial
wound(s).
12006......... ........ A Repair 3.66 3.03 3.30 1.30 1.46 0.35 7.04 7.31 5.31 5.47 010
superficial
wound(s).
12007......... ........ A Repair 4.11 3.40 3.72 1.49 1.73 0.45 7.96 8.28 6.05 6.29 010
superficial
wound(s).
12011......... ........ A Repair 1.76 1.89 2.07 0.75 0.77 0.16 3.81 3.99 2.67 2.69 010
superficial
wound(s).
12013......... ........ A Repair 1.99 2.05 2.22 0.88 0.92 0.18 4.22 4.39 3.05 3.09 010
superficial
wound(s).
12014......... ........ A Repair 2.46 2.28 2.50 0.97 1.04 0.23 4.97 5.19 3.66 3.73 010
superficial
wound(s).
12015......... ........ A Repair 3.19 2.76 3.04 1.11 1.22 0.29 6.24 6.52 4.59 4.70 010
superficial
wound(s).
12016......... ........ A Repair 3.92 3.16 3.45 1.29 1.46 0.37 7.45 7.74 5.58 5.75 010
superficial
wound(s).
12017......... ........ A Repair 4.70 NA NA 1.48 1.79 0.47 NA NA 6.65 6.96 010
superficial
wound(s).
12018......... ........ A Repair 5.52 NA NA 1.96 2.18 0.64 NA NA 8.12 8.34 010
superficial
wound(s).
12020......... ........ A Closure of 2.62 3.75 3.80 1.77 1.88 0.30 6.67 6.72 4.69 4.80 010
split wound.
12021......... ........ A Closure of 1.84 1.86 1.83 1.33 1.39 0.24 3.94 3.91 3.41 3.47 010
split wound.
12031......... ........ A Layer closure 2.15 3.82 2.67 1.73 1.15 0.17 6.14 4.99 4.05 3.47 010
of wound(s).
12032......... ........ A Layer closure 2.47 5.08 4.15 2.21 1.90 0.16 7.71 6.78 4.84 4.53 010
of wound(s).
12034......... ........ A Layer closure 2.92 4.50 3.52 1.93 1.57 0.25 7.67 6.69 5.10 4.74 010
of wound(s).
12035......... ........ A Layer closure 3.42 5.25 5.21 2.08 2.13 0.39 9.06 9.02 5.89 5.94 010
of wound(s).
12036......... ........ A Layer closure 4.04 5.38 5.51 2.22 2.46 0.55 9.97 10.10 6.81 7.05 010
of wound(s).
12037......... ........ A Layer closure 4.66 5.94 6.05 2.59 2.87 0.66 11.26 11.37 7.91 8.19 010
of wound(s).
12041......... ........ A Layer closure 2.37 3.77 2.85 1.72 1.28 0.19 6.33 5.41 4.28 3.84 010
of wound(s).
12042......... ........ A Layer closure 2.74 4.36 3.54 2.04 1.61 0.17 7.27 6.45 4.95 4.52 010
of wound(s).
12044......... ........ A Layer closure 3.14 5.27 3.73 1.89 1.67 0.27 8.68 7.14 5.30 5.08 010
of wound(s).
12045......... ........ A Layer closure 3.63 5.07 5.21 2.06 2.23 0.41 9.11 9.25 6.10 6.27 010
of wound(s).
12046......... ........ A Layer closure 4.24 5.64 6.29 2.27 2.63 0.54 10.42 11.07 7.05 7.41 010
of wound(s).
12047......... ........ A Layer closure 4.64 6.16 6.30 2.51 2.94 0.58 11.38 11.52 7.73 8.16 010
of wound(s).
12051......... ........ A Layer closure 2.47 4.01 3.46 1.86 1.55 0.20 6.68 6.13 4.53 4.22 010
of wound(s).
12052......... ........ A Layer closure 2.77 4.69 3.59 2.44 1.68 0.17 7.63 6.53 5.38 4.62 010
of wound(s).
12053......... ........ A Layer closure 3.12 5.23 3.74 2.05 1.66 0.23 8.58 7.09 5.40 5.01 010
of wound(s).
12054......... ........ A Layer closure 3.45 5.30 4.00 2.01 1.73 0.30 9.05 7.75 5.76 5.48 010
of wound(s).
12055......... ........ A Layer closure 4.42 6.00 4.86 2.10 2.12 0.45 10.87 9.73 6.97 6.99 010
of wound(s).
12056......... ........ A Layer closure 5.23 6.21 6.62 2.38 2.88 0.59 12.03 12.44 8.20 8.70 010
of wound(s).
12057......... ........ A Layer closure 5.95 7.45 6.46 2.79 3.51 0.56 13.96 12.97 9.30 10.02 010
of wound(s).
13100......... ........ A Repair of wound 3.12 4.32 4.12 2.39 2.32 0.26 7.70 7.50 5.77 5.70 010
or lesion.
13101......... ........ A Repair of wound 3.91 5.79 4.94 2.88 2.73 0.26 9.96 9.11 7.05 6.90 010
or lesion.
13102......... ........ A Repair wound/ 1.24 1.34 1.21 0.52 0.56 0.13 2.71 2.58 1.89 1.93 ZZZ
lesion add-on.
13120......... ........ A Repair of wound 3.30 4.46 4.22 2.50 2.38 0.26 8.02 7.78 6.06 5.94 010
or lesion.
13121......... ........ A Repair of wound 4.32 6.47 5.26 3.46 2.96 0.25 11.04 9.83 8.03 7.53 010
or lesion.
13122......... ........ A Repair wound/ 1.44 1.37 1.48 0.58 0.62 0.15 2.96 3.07 2.17 2.21 ZZZ
lesion add-on.
13131......... ........ A Repair of wound 3.78 4.86 4.49 2.78 2.71 0.26 8.90 8.53 6.82 6.75 010
or lesion.
13132......... ........ A Repair of wound 6.44 7.64 6.34 4.77 4.31 0.32 14.40 13.10 11.53 11.07 010
or lesion.
[[Page 49092]]
13133......... ........ A Repair wound/ 2.19 1.82 1.70 0.94 1.01 0.18 4.19 4.07 3.31 3.38 ZZZ
lesion add-on.
13150......... ........ A Repair of wound 3.80 4.59 4.80 2.64 2.73 0.34 8.73 8.94 6.78 6.87 010
or lesion.
13151......... ........ A Repair of wound 4.44 5.35 4.94 3.11 3.13 0.31 10.10 9.69 7.86 7.88 010
or lesion.
13152......... ........ A Repair of wound 6.32 7.31 6.35 3.77 3.97 0.40 14.03 13.07 10.49 10.69 010
or lesion.
13153......... ........ A Repair wound/ 2.38 1.98 1.94 0.98 1.10 0.24 4.60 4.56 3.60 3.72 ZZZ
lesion add-on.
13160......... ........ A Late closure of 11.76 NA NA 7.07 7.14 1.54 NA NA 20.37 20.44 090
wound.
14000......... ........ A Skin tissue 6.76 8.78 8.08 5.92 5.58 0.59 16.13 15.43 13.27 12.93 090
rearrangement.
14001......... ........ A Skin tissue 9.52 10.90 9.78 7.40 7.15 0.82 21.24 20.12 17.74 17.49 090
rearrangement.
14020......... ........ A Skin tissue 7.58 9.79 8.91 6.70 6.57 0.64 18.01 17.13 14.92 14.79 090
rearrangement.
14021......... ........ A Skin tissue 11.10 12.13 10.52 8.40 8.31 0.81 24.04 22.43 20.31 20.22 090
rearrangement.
14040......... ........ A Skin tissue 8.36 9.92 9.08 6.77 7.09 0.62 18.90 18.06 15.75 16.07 090
rearrangement.
14041......... ........ A Skin tissue 12.59 13.17 11.24 9.03 8.76 0.73 26.49 24.56 22.35 22.08 090
rearrangement.
14060......... ........ A Skin tissue 8.99 9.40 8.94 6.94 7.31 0.68 19.07 18.61 16.61 16.98 090
rearrangement.
14061......... ........ A Skin tissue 13.58 14.41 12.30 9.84 9.59 0.76 28.75 26.64 24.18 23.93 090
rearrangement.
14300......... ........ A Skin tissue 13.17 13.26 11.66 9.24 9.19 1.16 27.59 25.99 23.57 23.52 090
rearrangement.
14350......... ........ A Skin tissue 10.73 NA NA 6.92 7.09 1.34 NA NA 18.99 19.16 090
rearrangement.
15000......... ........ A Wound prep, 1st 3.99 4.24 3.90 1.73 2.07 0.54 8.77 8.43 6.26 6.60 000
100 sq cm.
15001......... ........ A Wound prep, 1.00 0.56 1.15 0.35 0.40 0.14 1.70 2.29 1.49 1.54 ZZZ
addl 100 sq cm.
15040......... ........ A Harvest 2.00 3.86 4.39 1.03 1.11 0.24 6.10 6.63 3.27 3.35 000
cultured skin
graft.
15050......... ........ A Skin pinch 5.29 7.65 7.10 5.02 5.09 0.57 13.51 12.96 10.88 10.95 090
graft.
15100......... ........ A Skin splt grft, 9.66 9.84 11.90 6.73 7.55 1.28 20.78 22.84 17.67 18.49 090
trnk/arm/leg.
15101......... ........ A Skin splt grft 1.72 2.51 3.43 0.87 1.10 0.24 4.47 5.39 2.83 3.06 ZZZ
t/a/l, add-on.
15110......... ........ A Epidrm autogrft 10.82 8.92 10.23 6.50 6.88 1.31 21.05 22.36 18.63 19.01 090
trnk/arm/leg.
15111......... ........ A Epidrm autogrft 1.85 0.89 1.19 0.64 0.75 0.26 3.00 3.30 2.75 2.86 ZZZ
t/a/l add-on.
15115......... ........ A Epidrm a-grft 11.13 9.16 9.21 6.68 7.18 1.15 21.44 21.49 18.96 19.46 090
face/nck/hf/g.
15116......... ........ A Epidrm a-grft f/ 2.50 1.22 1.49 0.89 1.06 0.33 4.05 4.32 3.72 3.89 ZZZ
n/hf/g addl.
15120......... ........ A Skn splt a-grft 10.88 11.18 10.84 7.32 7.67 1.16 23.22 22.88 19.36 19.71 090
fac/nck/hf/g.
15121......... ........ A Skn splt a-grft 2.67 3.47 4.24 1.33 1.71 0.36 6.50 7.27 4.36 4.74 ZZZ
f/n/hf/g add.
15130......... ........ A Derm autograft, 7.33 8.03 9.40 5.64 6.17 0.97 16.33 17.70 13.94 14.47 090
trnk/arm/leg.
15131......... ........ A Derm autograft 1.50 0.70 0.98 0.52 0.61 0.21 2.41 2.69 2.23 2.32 ZZZ
t/a/l add-on.
15135......... ........ A Derm autograft 10.83 9.41 9.76 6.98 7.84 1.23 21.47 21.82 19.04 19.90 090
face/nck/hf/g.
15136......... ........ A Derm autograft, 1.50 0.68 0.84 0.53 0.64 0.20 2.38 2.54 2.23 2.34 ZZZ
f/n/hf/g add.
15150......... ........ A Cult epiderm 9.24 7.22 8.15 5.92 6.31 1.14 17.60 18.53 16.30 16.69 090
grft t/arm/leg.
15151......... ........ A Cult epiderm 2.00 0.90 1.21 0.70 0.81 0.28 3.18 3.49 2.98 3.09 ZZZ
grft t/a/l
addl.
15152......... ........ A Cult epiderm 2.50 1.08 1.44 0.87 1.01 0.35 3.93 4.29 3.72 3.86 ZZZ
graft t/a/l +%.
15155......... ........ A Cult epiderm 9.99 7.60 7.77 6.25 6.78 1.05 18.64 18.81 17.29 17.82 090
graft, f/n/hf/
g.
15156......... ........ A Cult epidrm 2.75 1.18 1.47 0.98 1.18 0.36 4.29 4.58 4.09 4.29 ZZZ
grft f/n/hfg
add.
15157......... ........ A Cult epiderm 3.00 1.37 1.67 1.07 1.28 0.39 4.76 5.06 4.46 4.67 ZZZ
grft f/n/hfg
+%.
15170......... ........ A Acell graft 5.99 3.65 3.79 2.36 2.36 0.55 10.19 10.33 8.90 8.90 090
trunk/arms/
legs.
15171......... ........ A Acell graft t/ 1.55 0.65 0.67 0.51 0.59 0.19 2.39 2.41 2.25 2.33 ZZZ
arm/leg add-on.
15175......... ........ A Acellular 7.99 5.24 5.38 3.75 3.94 0.82 14.05 14.19 12.56 12.75 090
graft, f/n/hf/
g.
15176......... ........ A Acell graft, f/ 2.45 1.07 1.10 0.81 0.95 0.29 3.81 3.84 3.55 3.69 ZZZ
n/hf/g add-on.
15200......... ........ A Skin full 8.90 9.85 9.51 6.29 6.22 0.98 19.73 19.39 16.17 16.10 090
graft, trunk.
15201......... ........ A Skin full graft 1.32 2.11 2.45 0.56 0.61 0.19 3.62 3.96 2.07 2.12 ZZZ
trunk add-on.
15220......... ........ A Skin full graft 7.86 10.21 9.44 6.51 6.64 0.84 18.91 18.14 15.21 15.34 090
sclp/arm/leg.
15221......... ........ A Skin full graft 1.19 2.01 2.24 0.50 0.55 0.16 3.36 3.59 1.85 1.90 ZZZ
add-on.
15240......... ........ A Skin full grft 10.03 11.73 10.58 8.64 8.12 0.92 22.68 21.53 19.59 19.07 090
face/genit/hf.
15241......... ........ A Skin full graft 1.86 2.51 2.46 0.79 0.88 0.23 4.60 4.55 2.88 2.97 ZZZ
add-on.
15260......... ........ A Skin full graft 11.29 12.63 10.82 9.02 8.69 0.69 24.61 22.80 21.00 20.67 090
een & lips.
15261......... ........ A Skin full graft 2.23 2.91 2.75 1.12 1.33 0.21 5.35 5.19 3.56 3.77 ZZZ
add-on.
15300......... ........ A Apply 4.65 3.36 3.24 2.10 2.20 0.49 8.50 8.38 7.24 7.34 090
skinallogrft,
t/arm/lg.
15301......... ........ A Apply 1.00 0.47 0.47 0.34 0.39 0.14 1.61 1.61 1.48 1.53 ZZZ
sknallogrft t/
a/l addl.
15320......... ........ A Apply skin 5.36 3.75 3.65 2.32 2.48 0.58 9.69 9.59 8.26 8.42 090
allogrft f/n/
hf/g.
15321......... ........ A Aply 1.50 0.68 0.69 0.50 0.57 0.21 2.39 2.40 2.21 2.28 ZZZ
sknallogrft f/
n/hfg add.
15330......... ........ A Aply acell 3.99 3.14 3.18 1.90 2.14 0.49 7.62 7.66 6.38 6.62 090
alogrft t/arm/
leg.
15331......... ........ A Aply acell grft 1.00 0.46 0.46 0.34 0.39 0.14 1.60 1.60 1.48 1.53 ZZZ
t/a/l add-on.
[[Page 49093]]
15335......... ........ A Apply acell 4.50 3.40 3.45 2.06 2.35 0.55 8.45 8.50 7.11 7.40 090
graft, f/n/hf/
g.
15336......... ........ A Aply acell grft 1.43 0.72 0.70 0.48 0.55 0.20 2.35 2.33 2.11 2.18 ZZZ
f/n/hf/g add.
15340......... ........ A Apply cult skin 3.72 3.79 3.95 2.72 2.74 0.41 7.92 8.08 6.85 6.87 010
substitute.
15341......... ........ A Apply cult skin 0.50 0.72 0.64 0.17 0.19 0.06 1.28 1.20 0.73 0.75 ZZZ
sub add-on.
15360......... ........ A Apply cult derm 3.87 4.31 4.43 3.11 3.09 0.43 8.61 8.73 7.41 7.39 090
sub, t/a/l.
15361......... ........ A Aply cult derm 1.15 0.57 0.58 0.38 0.44 0.14 1.86 1.87 1.67 1.73 ZZZ
sub t/a/l add.
15365......... ........ A Apply cult derm 4.15 4.35 4.50 3.19 3.19 0.46 8.96 9.11 7.80 7.80 090
sub f/n/hf/g.
15366......... ........ A Apply cult derm 1.45 0.69 0.70 0.48 0.56 0.17 2.31 2.32 2.10 2.18 ZZZ
f/hf/g add.
15400......... ........ A Apply skin 4.32 4.91 4.24 3.69 3.93 0.47 9.70 9.03 8.48 8.72 090
xenograft, t/a/
l.
15401......... ........ A Apply skn 1.00 1.02 1.67 0.35 0.42 0.14 2.16 2.81 1.49 1.56 ZZZ
xenogrft t/a/l
add.
15420......... ........ A Apply skin 4.83 5.04 4.85 3.86 3.81 0.52 10.39 10.20 9.21 9.16 090
xgraft, f/n/hf/
g.
15421......... ........ A Apply skn xgrft 1.50 1.20 1.29 0.52 0.60 0.21 2.91 3.00 2.23 2.31 ZZZ
f/n/hf/g add.
15430......... ........ A Apply acellular 5.75 7.01 6.93 6.44 6.57 0.66 13.42 13.34 12.85 12.98 090
xenograft.
15431......... ........ C Apply acellular 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 ZZZ
xgraft add.
15570......... ........ A Form skin 9.94 10.36 11.07 6.46 6.69 1.34 21.64 22.35 17.74 17.97 090
pedicle flap.
15572......... ........ A Form skin 9.88 9.74 9.55 6.62 6.49 1.20 20.82 20.63 17.70 17.57 090
pedicle flap.
15574......... ........ A Form skin 10.48 10.36 10.60 6.89 7.57 1.20 22.04 22.28 18.57 19.25 090
pedicle flap.
15576......... ........ A Form skin 9.18 9.50 9.69 6.39 6.76 0.87 19.55 19.74 16.44 16.81 090
pedicle flap.
15600......... ........ A Skin graft..... 1.91 5.28 7.02 2.71 2.97 0.27 7.46 9.20 4.89 5.15 090
15610......... ........ A Skin graft..... 2.42 5.55 4.91 3.03 3.32 0.35 8.32 7.68 5.80 6.09 090
15620......... ........ A Skin graft..... 3.57 6.33 7.42 3.80 3.86 0.35 10.25 11.34 7.72 7.78 090
15630......... ........ A Skin graft..... 3.90 6.89 7.00 4.18 4.16 0.34 11.13 11.24 8.42 8.40 090
15650......... ........ A Transfer skin 4.59 7.02 7.11 4.20 4.21 0.42 12.03 12.12 9.21 9.22 090
pedicle flap.
15732......... ........ A Muscle-skin 19.62 14.71 17.21 11.13 11.94 1.99 36.32 38.82 32.74 33.55 090
graft, head/
neck.
15734......... ........ A Muscle-skin 19.52 15.75 17.52 11.89 12.25 2.61 37.88 39.65 34.02 34.38 090
graft, trunk.
15736......... ........ A Muscle-skin 16.86 13.77 17.12 9.95 10.90 2.45 33.08 36.43 29.26 30.21 090
graft, arm.
15738......... ........ A Muscle-skin 18.86 14.03 16.99 10.41 11.39 2.65 35.54 38.50 31.92 32.90 090
graft, leg.
15740......... ........ A Island pedicle 11.48 13.10 10.87 9.05 8.46 0.63 25.21 22.98 21.16 20.57 090
flap graft.
15750......... ........ A Neurovascular 12.64 NA NA 8.80 8.98 1.42 NA NA 22.86 23.04 090
pedicle graft.
15756......... ........ A Free myo/skin 36.64 NA NA 18.38 20.02 4.61 NA NA 59.63 61.27 090
flap microvasc.
15757......... ........ A Free skin flap, 36.85 NA NA 16.63 20.35 3.89 NA NA 57.37 61.09 090
microvasc.
15758......... ........ A Free fascial 36.60 NA NA 16.47 20.30 4.23 NA NA 57.30 61.13 090
flap,
microvasc.
15760......... ........ A Composite skin 9.61 10.14 10.05 6.84 7.16 0.85 20.60 20.51 17.30 17.62 090
graft.
15770......... ........ A Derma-fat- 8.64 NA NA 6.56 6.65 1.05 NA NA 16.25 16.34 090
fascia graft.
15775......... ........ R Hair transplant 3.95 3.50 4.05 1.70 1.40 0.52 7.97 8.52 6.17 5.87 000
punch grafts.
15776......... ........ R Hair transplant 5.53 3.98 5.01 1.61 2.50 0.72 10.23 11.26 7.86 8.75 000
punch grafts.
15780......... ........ A Abrasion 8.41 11.65 11.55 6.74 7.87 0.67 20.73 20.63 15.82 16.95 090
treatment of
skin.
15781......... ........ A Abrasion 4.84 8.43 7.29 5.47 5.39 0.34 13.61 12.47 10.65 10.57 090
treatment of
skin.
15782......... ........ A Abrasion 4.31 9.44 9.75 5.43 6.27 0.34 14.09 14.40 10.08 10.92 090
treatment of
skin.
15783......... ........ A Abrasion 4.28 7.83 7.11 4.89 4.36 0.28 12.39 11.67 9.45 8.92 090
treatment of
skin.
15786......... ........ A Abrasion, 2.03 3.76 3.45 1.22 1.30 0.11 5.90 5.59 3.36 3.44 010
lesion, single.
15787......... ........ A Abrasion, 0.33 0.83 1.03 0.10 0.15 0.04 1.20 1.40 0.47 0.52 ZZZ
lesions, add-
on.
15788......... ........ R Chemical peel, 2.09 8.43 7.14 3.66 3.23 0.11 10.63 9.34 5.86 5.43 090
face, epiderm.
15789......... ........ R Chemical peel, 4.91 9.00 8.32 5.56 4.99 0.20 14.11 13.43 10.67 10.10 090
face, dermal.
15792......... ........ R Chemical peel, 1.86 6.85 7.03 3.46 4.20 0.13 8.84 9.02 5.45 6.19 090
nonfacial.
15793......... ........ A Chemical peel, 3.73 5.54 6.10 3.27 4.10 0.19 9.46 10.02 7.19 8.02 090
nonfacial.
15819......... ........ A Plastic 10.37 NA NA 6.67 7.05 0.97 NA NA 18.01 18.39 090
surgery, neck.
15820......... ........ A Revision of 6.02 6.47 6.85 5.25 5.48 0.40 12.89 13.27 11.67 11.90 090
lower eyelid.
15821......... ........ A Revision of 6.59 6.73 7.20 5.41 5.64 0.45 13.77 14.24 12.45 12.68 090
lower eyelid.
15822......... ........ A Revision of 4.44 5.34 5.71 4.18 4.41 0.37 10.15 10.52 8.99 9.22 090
upper eyelid.
15823......... ........ A Revision of 8.04 7.59 7.79 6.29 6.40 0.50 16.13 16.33 14.83 14.94 090
upper eyelid.
15831......... ........ A Excise 13.57 NA NA 8.73 8.30 1.75 NA NA 24.05 23.62 090
excessive skin
tissue.
15832......... ........ A Excise 12.57 NA NA 8.30 8.33 1.66 NA NA 22.53 22.56 090
excessive skin
tissue.
15833......... ........ A Excise 11.62 NA NA 7.09 7.93 1.49 NA NA 20.20 21.04 090
excessive skin
tissue.
15834......... ........ A Excise 11.89 NA NA 7.73 7.70 1.61 NA NA 21.23 21.20 090
excessive skin
tissue.
15835......... ........ A Excise 12.71 NA NA 7.81 7.61 1.60 NA NA 22.12 21.92 090
excessive skin
tissue.
15836......... ........ A Excise 10.33 NA NA 7.02 6.84 1.34 NA NA 18.69 18.51 090
excessive skin
tissue.
15837......... ........ A Excise 9.30 8.79 8.61 5.78 6.97 1.18 19.27 19.09 16.26 17.45 090
excessive skin
tissue.
15838......... ........ A Excise 8.00 NA NA 4.88 5.77 0.58 NA NA 13.46 14.35 090
excessive skin
tissue.
15839......... ........ A Excise 10.25 9.40 8.97 6.19 6.34 1.22 20.87 20.44 17.66 17.81 090
excessive skin
tissue.
15840......... ........ A Graft for face 14.67 NA NA 8.55 9.62 1.32 NA NA 24.54 25.61 090
nerve palsy.
15841......... ........ A Graft for face 25.57 NA NA 13.05 14.51 2.54 NA NA 41.16 42.62 090
nerve palsy.
15842......... ........ A Flap for face 40.55 NA NA 21.01 22.44 4.93 NA NA 66.49 67.92 090
nerve palsy.
15845......... ........ A Skin and muscle 13.93 NA NA 8.77 9.17 0.81 NA NA 23.51 23.91 090
repair, face.
15850......... ........ B Removal of 0.78 1.21 1.47 0.18 0.27 0.05 2.04 2.30 1.01 1.10 XXX
sutures.
15851......... ........ A Removal of 0.86 1.33 1.59 0.24 0.29 0.06 2.25 2.51 1.16 1.21 000
sutures.
[[Page 49094]]
15852......... ........ A Dressing change 0.86 1.62 1.79 0.25 0.31 0.09 2.57 2.74 1.20 1.26 000
not for burn.
15860......... ........ A Test for blood 1.95 NA NA 0.70 0.76 0.27 NA NA 2.92 2.98 000
flow in graft.
15920......... ........ A Removal of tail 8.06 NA NA 5.83 5.62 1.04 NA NA 14.93 14.72 090
bone ulcer.
15922......... ........ A Removal of tail 10.13 NA NA 7.01 7.16 1.42 NA NA 18.56 18.71 090
bone ulcer.
15931......... ........ A Remove sacrum 9.89 NA NA 5.55 5.65 1.25 NA NA 16.69 16.79 090
pressure sore.
15933......... ........ A Remove sacrum 11.49 NA NA 7.34 7.72 1.52 NA NA 20.35 20.73 090
pressure sore.
15934......... ........ A Remove sacrum 13.45 NA NA 7.61 7.93 1.78 NA NA 22.84 23.16 090
pressure sore.
15935......... ........ A Remove sacrum 15.45 NA NA 10.14 10.28 2.09 NA NA 27.68 27.82 090
pressure sore.
15936......... ........ A Remove sacrum 12.96 NA NA 7.49 8.04 1.76 NA NA 22.21 22.76 090
pressure sore.
15937......... ........ A Remove sacrum 14.91 NA NA 8.96 9.61 2.06 NA NA 25.93 26.58 090
pressure sore.
15940......... ........ A Remove hip 10.05 NA NA 5.84 6.09 1.31 NA NA 17.20 17.45 090
pressure sore.
15941......... ........ A Remove hip 12.13 NA NA 8.51 9.22 1.66 NA NA 22.30 23.01 090
pressure sore.
15944......... ........ A Remove hip 12.16 NA NA 8.24 8.51 1.65 NA NA 22.05 22.32 090
pressure sore.
15945......... ........ A Remove hip 13.45 NA NA 9.15 9.52 1.84 NA NA 24.44 24.81 090
pressure sore.
15946......... ........ A Remove hip 23.72 NA NA 13.95 14.27 3.16 NA NA 40.83 41.15 090
pressure sore.
15950......... ........ A Remove thigh 7.83 NA NA 5.40 5.41 1.04 NA NA 14.27 14.28 090
pressure sore.
15951......... ........ A Remove thigh 11.30 NA NA 8.00 7.90 1.49 NA NA 20.79 20.69 090
pressure sore.
15952......... ........ A Remove thigh 12.03 NA NA 7.77 7.76 1.60 NA NA 21.40 21.39 090
pressure sore.
15953......... ........ A Remove thigh 13.27 NA NA 9.10 9.02 1.79 NA NA 24.16 24.08 090
pressure sore.
15956......... ........ A Remove thigh 16.46 NA NA 9.66 10.49 2.21 NA NA 28.33 29.16 090
pressure sore.
15958......... ........ A Remove thigh 16.42 NA NA 10.28 10.85 2.25 NA NA 28.95 29.52 090
pressure sore.
15999......... ........ C Removal of 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 YYY
pressure sore.
16000......... ........ A Initial 0.89 0.73 0.83 0.24 0.26 0.08 1.70 1.80 1.21 1.23 000
treatment of
burn(s).
16020......... ........ A Dress/debrid p- 0.80 1.11 1.25 0.56 0.58 0.08 1.99 2.13 1.44 1.46 000
thick burn, s.
16025......... ........ A Dress/debrid p- 1.85 1.61 1.72 0.88 0.94 0.19 3.65 3.76 2.92 2.98 000
thick burn, m.
16030......... ........ A Dress/debrid p- 2.08 1.98 2.12 0.96 1.08 0.24 4.30 4.44 3.28 3.40 000
thick burn, l.
16035......... ........ A Incision of 3.74 NA NA 1.27 1.50 0.46 NA NA 5.47 5.70 090
burn scab,
initi.
16036......... ........ A Escharotomy; 1.50 NA NA 0.49 0.57 0.20 NA NA 2.19 2.27 ZZZ
addIl incision.
17000......... ........ A Destroy benign/ 0.60 1.36 1.07 0.71 0.58 0.03 1.99 1.70 1.34 1.21 010
premlg lesion.
17003......... ........ A Destroy 0.07 0.10 0.11 0.03 0.06 0.01 0.18 0.19 0.11 0.14 ZZZ
lesions, 2-14.
17004......... ........ A Destroy 1.58 2.23 2.28 1.20 1.49 0.11 3.92 3.97 2.89 3.18 010
lesions, 15 or
more.
17106......... ........ A Destruction of 4.58 4.56 4.59 3.18 3.29 0.35 9.49 9.52 8.11 8.22 090
skin lesions.
17107......... ........ A Destruction of 9.15 7.08 7.17 5.01 5.34 0.63 16.86 16.95 14.79 15.12 090
skin lesions.
17108......... ........ A Destruction of 13.18 9.19 9.24 6.64 7.41 0.54 22.91 22.96 20.36 21.13 090
skin lesions.
17110......... ........ A Destruct 0.65 1.74 1.65 0.85 0.74 0.05 2.44 2.35 1.55 1.44 010
lesion, 1-14.
17111......... ........ A Destruct 0.92 2.23 1.81 1.09 0.88 0.05 3.20 2.78 2.06 1.85 010
lesion, 15 or
more.
17250......... ........ A Chemical 0.50 1.32 1.25 0.38 0.35 0.06 1.88 1.81 0.94 0.91 000
cautery,
tissue.
17260......... ........ A Destruction of 0.91 1.37 1.30 0.68 0.67 0.04 2.32 2.25 1.63 1.62 010
skin lesions.
17261......... ........ A Destruction of 1.17 2.42 1.81 1.02 0.88 0.05 3.64 3.03 2.24 2.10 010
skin lesions.
17262......... ........ A Destruction of 1.58 2.74 2.10 1.22 1.07 0.06 4.38 3.74 2.86 2.71 010
skin lesions.
17263......... ........ A Destruction of 1.79 2.97 2.28 1.31 1.15 0.07 4.83 4.14 3.17 3.01 010
skin lesions.
17264......... ........ A Destruction of 1.94 3.17 2.46 1.38 1.19 0.08 5.19 4.48 3.40 3.21 010
skin lesions.
17266......... ........ A Destruction of 2.34 3.42 2.73 1.54 1.30 0.09 5.85 5.16 3.97 3.73 010
skin lesions.
17270......... ........ A Destruction of 1.32 2.36 1.87 1.05 0.92 0.05 3.73 3.24 2.42 2.29 010
skin lesions.
17271......... ........ A Destruction of 1.49 2.58 1.97 1.17 1.03 0.06 4.13 3.52 2.72 2.58 010
skin lesions.
17272......... ........ A Destruction of 1.77 2.88 2.21 1.31 1.16 0.07 4.72 4.05 3.15 3.00 010
skin lesions.
17273......... ........ A Destruction of 2.05 3.12 2.43 1.43 1.27 0.08 5.25 4.56 3.56 3.40 010
skin lesions.
17274......... ........ A Destruction of 2.59 3.50 2.80 1.68 1.50 0.10 6.19 5.49 4.37 4.19 010
skin lesions.
17276......... ........ A Destruction of 3.20 3.78 3.15 1.91 1.74 0.16 7.14 6.51 5.27 5.10 010
skin lesions.
17280......... ........ A Destruction of 1.17 2.29 1.78 0.99 0.86 0.05 3.51 3.00 2.21 2.08 010
skin lesions.
17281......... ........ A Destruction of 1.72 2.65 2.09 1.28 1.14 0.07 4.44 3.88 3.07 2.93 010
skin lesions.
17282......... ........ A Destruction of 2.04 3.04 2.37 1.43 1.29 0.08 5.16 4.49 3.55 3.41 010
skin lesions.
17283......... ........ A Destruction of 2.64 3.45 2.77 1.70 1.54 0.11 6.20 5.52 4.45 4.29 010
skin lesions.
17284......... ........ A Destruction of 3.21 3.86 3.16 1.95 1.80 0.13 7.20 6.50 5.29 5.14 010
skin lesions.
17286......... ........ A Destruction of 4.43 4.28 3.82 2.38 2.43 0.23 8.94 8.48 7.04 7.09 010
skin lesions.
17304......... ........ A 1 stage mohs, 7.59 11.63 9.09 3.58 3.57 0.30 19.52 16.98 11.47 11.46 000
up to 5 spec.
[[Page 49095]]
17305......... ........ A 2 stage mohs, 2.85 6.74 4.60 1.34 1.34 0.11 9.70 7.56 4.30 4.30 000
up to 5 spec.
17306......... ........ A 3 stage mohs, 2.85 6.99 4.68 1.33 1.35 0.11 9.95 7.64 4.29 4.31 000
up to 5 spec.
17307......... ........ A Mohs addl stage 2.85 6.74 4.36 1.34 1.36 0.11 9.70 7.32 4.30 4.32 000