[Federal Register Volume 75, Number 8 (Wednesday, January 13, 2010)]
[Proposed Rules]
[Pages 1844-2011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-31217]
[[Page 1843]]
-----------------------------------------------------------------------
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 412, et al.
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program; Proposed Rule
Federal Register / Vol. 75, No. 8 / Wednesday, January 13, 2010 /
Proposed Rules
[[Page 1844]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, 422, and 495
[CMS-0033-P]
RIN 0938-AP78
Medicare and Medicaid Programs; Electronic Health Record
Incentive Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would implement the provisions of the
American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5)
that provide incentive payments to eligible professionals (EPs) and
eligible hospitals participating in Medicare and Medicaid programs that
adopt and meaningfully use certified electronic health record (EHR)
technology. The proposed rule would specify the--initial criteria an EP
and eligible hospital must meet in order to qualify for the incentive
payment; calculation of the incentive payment amounts; payment
adjustments under Medicare for covered professional services and
inpatient hospital services provided by EPs and eligible hospitals
failing to meaningfully use certified EHR technology; and other program
participation requirements. Also, as required by ARRA the Office of the
National Coordinator for Health Information Technology (ONC) will be
issuing a closely related interim final rule that specifies the
Secretary's adoption of an initial set of standards, implementation,
specifications, and certification criteria for electronic health
records. ONC will also be issuing a notice of proposed rulemaking on
the process for organizations to conduct the certification of EHR
technology.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on March 15, 2010.
ADDRESSES: In commenting, please refer to file code CMS-0033-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the instructions on
the home page.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-0033-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-0033-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by following the
instructions at the end of the ``Collection of Information
Requirements'' section in this document.
In the event that CMS must limit the number of employees reporting
for duty during an emergency or for other reasons, submitting comments
on CMS regulations and Paperwork Reduction Act (PRA) notices via
www.regulations.gov will ensure that CMS considers the comments
promptly. Comments mailed or delivered to the CMS headquarters may not
be readily accessible for review if CMS employees are not able to
report to work at the CMS headquarters. CMS wishes to ensure that
public comments on its regulations and PRA notices are promptly
displayed on the regulations.gov Web site for the public to review. To
ensure that comments are displayed as quickly as possible, we request
that the public use only one public comment submission option. These
efforts are intended to ensure that CMS operations continue even during
an emergency and that consideration of public comments and access to
those comments occur timely.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Elizabeth Holland, (410) 786-1309, EHR
incentive program issues. Edward Gendron, (410) 786-1064, Medicaid
incentive payment issues. Jim Hart, (410) 786-9520, Medicare fee for
service payment issues. Terry Kay, (410) 786-4493, Medicare fee for
service payment issues.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this proposed rule to assist us in fully
considering issues and developing policies. You can assist us by
referencing the file code (CMS-0033-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.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
[[Page 1845]]
Acronyms
ARRA American Recovery and Reinvestment Act of 2009
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems
CCN CMS Certification Numbers
CHIP Children's Health Insurance Program
CHIPRA Children's Health Insurance Program Reauthorization Act of
2009
CMS Centers for Medicare & Medicaid Services
CY Calendar Year
EHR Electronic Health Record
EP Eligible Professionals
EPO Exclusive Provider Organization
FACA Federal Advisory Committee Act
FFP Federal Financial Participation
FFS Fee-For-Service
FQHC Federally Qualified Health Center
FTE Full-Time Equivalent
FY Fiscal Year
FFY Federal Fiscal Year
HEDIS Healthcare Effectiveness Data and Information Set
HHS Department of Health and Human Services
HIE Health Information Exchanges
HIT Health Information Technology
HIPPA Health Insurance Portability and Accountability Act of 1996
HITECH Health Information Technology for Economic and Clinical
Health Act
HMO Health Maintenance Organization
HOS Health Outcomes Survey
HPSA Health Professional Shortage Area
HRSA Health Resource Services Administration
IAPD Implementation Advanced Planning Document
IPA Independent Practice Association
IHS Indian Health Services
IT Information Technology
MA Medicare Advantage
MAC Medicare Administrative Contractor
MCO Medicaid Managed Care Organization
MITA Medicaid Information Technology Architecture
MMIS Medicaid Management Information Systems
MSA Medical Savings Account
NCQA National Committee for Quality Assurance
NCVHS National Committee on Vital and Health Statistics
NPI National Provider Identifier
ONC Office of the National Coordinator for Health Information
Technology
PAHP Prepaid Ambulatory Health Plan
PAPD Planning Advanced Planning Document
PIHP Prepaid Inpatient Health Plan
PFFS Private Fee-For-Service
PHO Physician Hospital Organization
PHS Public Health Service
POS Place of Service
PPO Preferred Provider Organization
PSO Provider Sponsored Organization
RHC Rural Health Clinic
RPPO Regional Preferred Provider Organization
SMHP State Medicaid Health Information Technology Plan
TIN Tax Identification Number
Table of Contents
I. Background
A. Overview of the HITECH Programs Created by the American
Recovery and Reinvestment Act of 2009
B. Statutory Basis for the Medicare & Medicaid EHR Incentive
Programs
II. Provisions of the Proposed Regulations
A. Definitions Across the Medicare FFS, Medicare Advantage, and
Medicaid Programs
1. Definitions
a. Certified Electronic Health Record (EHR) Technology
b. Qualified Electronic Health Record
c. Payment Year
d. First, Second, Third, Fourth, Fifth and Sixth Payment Year
e. EHR Reporting Period
f. Meaningful EHR User
2. Definition of Meaningful Use
a. Background
b. Common Definition of Meaningful Use Under Medicare and
Medicaid
c. Considerations in Defining Meaningful Use
d. Stage 1 Criteria for Meaningful Use
3. Sections 4101(a) and 4102(a)(1) of HITECH Act: Reporting on
Clinical Quality Measures Using EHR by EPs and All Eligible
Hospitals
a. General
b. Requirements for the Submission of Clinical Quality Measures
by EPs and Eligible Hospitals
c. Statutory Requirements and Other Considerations for the
Proposed Selection of Clinical Quality Measures Proposed for
Electronic Submission by EPs or Eligible Hospitals
(1) Statutory Requirements for the Selection of Clinical Quality
Measures Proposed for Electronic Submission by EPs and Eligible
Hospitals
(2) Other Considerations for the Proposed Selection of Clinical
Quality Measures for Electronic Submission by EPs and Eligible
Hospitals
d. Proposed Clinical Quality Measures for Electronic Submission
Using Certified EHR Technology by Eligible Professionals
e. Clinical Quality Measures Reporting Criteria for Eligible
Professionals
f. Proposed Clinical Quality Measures for Electronic Submission
by Eligible Hospitals
g. Request for Public Comment on Potential Measures for Eligible
Professionals and Eligible Hospitals in 2013 Payment Year and
Subsequent Years
h. Proposed Reporting Method for Clinical Quality Measures
(1) Reporting Method for 2011 Payment Year
(2) Reporting Method for 2012
i. Alternative Reporting Methods for Clinical Quality Measures
j. Proposed Reporting Criteria for Eligible Professionals and
Eligible Hospitals
k. Addressing Dually-Eligible Medicare/Medicaid Beneficiaries
Under HITECH
4. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
b. Methods for Demonstration of the Stage 1 Criteria of
Meaningful Use
5. Data Collection for Online Posting, Program Coordination and
Accurate Payments
a. Online Posting
b. Program Election Between Medicare FFS/MA and Medicaid for EPs
c. Data To Be Collected
6. Hospital-Based Eligible Professionals
7. Interaction With Other Programs
B. Medicare Fee-for-Service Incentives
1. Incentive Payments for Eligible Professionals
a. Definitions
b. Incentive Payment Limits
c. Increase in Incentive Payment for EPs who Predominantly
Furnish Services in a Geographic Health Professional Shortage Area
d. Form and Timing of Payment
e. Payment Adjustment Effective in CY 2015 and Subsequent Years
for EPs Who Are Not Meaningful Users of Certified EHR Technology
2. Incentive Payments for Hospitals
a. Definition of Eligible Hospital for Medicare
b. Incentive Payment Calculation for Eligible Hospitals
c. Medicare Share
d. Charity Care
e. Transition Factor
f. Duration and Timing of Incentive Payments
g. Incentive Payment Adjustment Effective in Federal FY 2015 and
Subsequent Years for Eligible Hospitals Who Are Not Meaningful EHR
Users
3. Incentive Payments for Critical Access Hospitals
a. Definition of CAHs for Medicare
b. Current Medicare Payment of Reasonable Cost for CAHs
c. Changes made by the HITECH Act
d. Incentive Payment Calculation for CAHs
e. Reduction of Reasonable Cost Payment in FY 2015 and
Subsequent Years for CAHs That Are Not Meaningful EHR Users
4. Process for Making Incentive Payments Under the Medicare FFS
Program
a. Incentive Payments to EPs
b. Incentive Payments to Eligible Hospitals
c. Incentive Payments to CAHs
d. Payment Accounting under Medicare
C. Medicare Advantage Organization Incentive Payments
1. Definitions
a. Qualifying MA Organization
b. Qualifying MA Eligible Professional
c. Qualifying MA-Affiliated Eligible Hospital
2. Identification of Qualifying MA Organizations, MA EPs, and
MA-Affiliated Eligible Hospitals
3. Computation of Incentives to Qualifying MA Organizations for
MA EPs and Hospitals
4. Timeframe for Payment
5. Avoiding Duplicate Payment
6. Meaningful User Attestation
7. Posting on Web site and Limitation on Review
8. Limitation on Review
9. Conforming Changes
[[Page 1846]]
10. Payment Adjustment and Future Rulemaking
D. Medicaid Incentives
1. Overview of Health Information Technology in Medicaid
2. General Medicaid Provisions
3. Identification of Qualifying Medicaid EPs and Eligible
Hospitals
a. Overview
b. Program Participation
1. Acute Care Hospitals
2. Children's Hospitals
c. Medicaid Professionals Program Eligibility
d. Calculating Patient Volume Requirements
e. Entities Promoting the Adoption of Certified EHR Technology
4. Computation of Amount Payable to Qualifying Medicaid EPs and
Eligible Hospitals
(1) General Overview
(2) Average Allowable Costs
(3) Net Average Allowable Costs
(4) Payments for Medicaid Eligible Professionals
(5) Basis for Medicaid EHR Incentive Program First Payment Year
and Subsequent Payment Years
(i) Medicaid EP Who Begins Adopting, Implementing or Upgrading
Certified EHR Technology in the First Year
(ii) Medicaid EP who has Already Adopted, Implemented or
Upgraded Certified EHR Technology and Meaningfully Uses EHR
Technology
b. Payment Methodology for Eligible Hospitals
c. Alternative and Optional Early State Implementation to Make
Incentive Payments for Adopting, Implementing or Upgrading Certified
EHR Technology
d. Process for Making and Receiving Medicaid Incentive Payments
e. Avoiding Duplicate Payment
f. Flexibility to Alternate Between Medicare and Medicaid
Incentive Payment Program One Time
g. One State Selection
5. National Level Repository and State Data Collection
6. Collection of Information Related to the Eligible
Professional's National Provider Identifier and the Tax
Identification Number (TIN)
7. Activities Required to Receive Incentive Payments
a. General Overview
b. Definitions Related to Certified EHR Technology and Adopting,
Implementing or Upgrading Such Technology
(1) Certified EHR Technology
(2) Adopting, Implementing or Upgrading
c. Other General Terminology
III. Collection of Information Requirements
A. ICRs Regarding Demonstration of Meaningful Use Criteria
(Sec. 495.8)
B. ICRs Regarding Participation Requirements for EPs, Eligible
Hospitals, and Qualifying CAHs (Sec. 495.10)
C. ICRs Regarding Identification of Qualifying MA Organizations,
MA-EPs and MA-Affiliated Eligible Hospitals (Sec. 495.202)
D. ICRs Regarding Incentive Payments to Qualifying MA
Organizations for MA-EPs and Hospitals (Sec. 495.204)
E. ICRs Regarding Meaningful User Attestation (Sec. 495.210)
F. ICRs Regarding Incentive Payments to Qualifying MA
Organizations for MA-Eligible Professionals and Hospitals (Sec.
495.220)
G. ICRs Regarding Process for Payments (Sec. 495.312)
H. ICRs Regarding Activities Required to Receive an Incentive
Payment (Sec. 495.314)
I. ICRs Regarding State Monitoring and Reporting Regarding
Activities Required To Receive an Incentive Payment (Sec. 495.316)
J. ICRs Regarding State Responsibilities for Receiving FFP
(Sec. 495.318)
K. ICRs Regarding Prior Approval Conditions (Sec. 495.324)
L. ICRs Regarding Termination of Federal Financial Participation
(FFP) for Failure To Provide Access to Information (Sec. 495.330)
M. ICRs Regarding State Medicaid Agency and Medicaid EP and
Hospital Activities (Sec. 495.332 Through Sec. 495.338)
N. ICRs Regarding Access to Systems and Records (Sec. 495.342)
O. ICRs Regarding Procurement Standards (Sec. 495.344)
P. ICRs Regarding State Medicaid Agency Attestations (Sec.
495.346)
Q. ICRs Regarding Reporting Requirements (Sec. 495.348)
R. ICRs Regarding Retroactive Approval of FFP With an Effective
Date of February 18, 2009 (Sec. 495.358)
S. ICRs Regarding Financial Oversight and Monitoring
Expenditures (Sec. 495.362)
T. ICRs Regarding Appeals Process for a Medicaid Provider
Receiving Electronic Health Record Incentive Payments (Sec.
495.366)
IV. Response to Comments
V. Regulatory Impact Analysis
A. Overall Impact
B. Regulatory Flexibility Analysis
C. Small Rural Hospitals
D. Unfunded Mandates Reform Act
E. Federalism
F. Anticipated Effects
G. HITECH Impact Analysis
H. Accounting Statement
I. Background
A. Overview of the HITECH Programs Created by the American Recovery and
Reinvestment Act of 2009
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L.
111-5) was enacted on February 17, 2009. ARRA includes many measures to
modernize our nation's infrastructure, enhance energy independence,
expand educational opportunities, provide tax relief, and preserve and
improve affordable health care. Title IV of Division B of ARRA amends
Titles XVIII and XIX of the Social Security Act (the Act) by
establishing incentive payments to eligible professionals (EPs) and
eligible hospitals to promote the adoption and meaningful use of
interoperable health information technology and qualified EHRs.
Expanded use of health information technology (HIT) and EHRs will
improve the quality and value of American health care. These
provisions, together with Title XIII of Division A of ARRA, may be
cited as the Health Information Technology for Economic and Clinical
Health Act'' or the ``HITECH Act.'' The incentive payments for adoption
and meaningful use of HIT and qualified EHRs are part of a broader
effort under the HITECH Act to accelerate the adoption of HIT and
utilization of qualified EHRs. We are developing the incentive programs
which are outlined in Division B, Title IV of the HITECH Act and these
programs are the keys to inducing providers to actively utilize HIT.
EPs and eligible hospitals qualify for the EHR incentive payments
if, among other requirements, they meaningfully use certified EHR
technology. This proposed rule sets forth a proposed definition of
``meaningful use of certified EHR technology.'' Section 13101 of the
HITECH Act adds a new section 3000 to the Public Health Service Act
(PHSA), which defines ``certified EHR technology'' as a qualified EHR
that has been properly certified as meeting standards adopted under
section 3004 of the PHSA. CMS and ONC have been working closely to
ensure that the definition of meaningful use of certified EHR
technology and the standards for certified EHR technology are
coordinated. ``Meaningful use'' is a term defined by CMS and describes
the use of HIT that furthers the goals of information exchange among
health care professionals. In an upcoming interim final rule, ONC will
identify the initial set of standards and implementation specifications
that EHR technology must implement, as well as the certification
criteria that will be used to certify EHR technology, and will further
define the term ``certified EHR technology.'' In a related proposed
rule, the Department will propose the development of a certification
program for health IT. Specifically, we have sought to ensure that the
definition of meaningful use of certified EHR technology does not
require EPs and eligible hospitals to perform functionalities for which
standards have not been recognized or established. Similarly, the
functionality of certified EHR technology should enable and advance the
definition of meaningful use.
We urge those interested in this proposed rule to also review the
ONC interim final rule with comment and the related proposed rule when
they are published later this year and to visit http://healthit.hhs.gov
and http://
[[Page 1847]]
www.cms.hhs.gov/Recovery/11_HealthIT.aspTopOfPage for more
information on the efforts at the Department of Health and Human
Services (HHS) to advance HIT initiatives.
B. Statutory Basis for the Medicare & Medicaid EHR Incentive Programs
Section 4101(a) of the HITECH Act adds a new subsection (o) to
section 1848 of the Act. Section 1848(o) of the Act establishes
incentive payments for the meaningful use of certified EHR technology
by EPs participating in the original Medicare program or hereinafter
referred to as Medicare Fee-for-Service (FFS) program beginning in
calendar year (CY) 2011. Section 4101(b) of the HITECH Act also adds a
new paragraph (7) to section 1848(a) of the Act. Section 1848(a)(7) of
the Act provides that beginning in CY 2015, EPs who are not meaningful
users of certified EHR technology will receive less than 100 percent of
the fee schedule for their professional services. Section 4101(c) of
the HITECH Act adds a new subsection (l) to section 1853 of the Act to
provide incentive payments to Medicare Advantage (MA) organizations for
their affiliated EPs who meaningfully use certified EHR technology and
meet certain other requirements, and a requirement to make a downward
adjustment to Medicare payments to MA organizations for professional
services provided by any of their affiliated EPs who are not meaningful
users of certified EHR technology, beginning in 2015, and avoids
duplicate of payments from the MA EHR incentive program under this
section and the FFS EHR incentive program under section 1848(o)(1)(A).
Section 4102(a) of the HITECH Act adds a new subsection (n) to
section 1886 of the Act. Section 1886(n) of the Act establishes
incentive payments for the meaningful use of certified EHR technology
by subsection (d) hospitals, as defined under section 1886(d)(1)(B) of
the Act, participating in Medicare FFS program beginning in Federal
fiscal year (FY) 2011. Section 4102(b)(1) of the HITECH Act amends
section 1886(b)(3)(B) of the Act to provide that, beginning in FY 2015,
subsection (d) hospitals that are not meaningful users of certified EHR
technology will receive a reduced annual payment update. Section
4102(b)(2) of the HITECH Act amends section 1814(l) of the Act to
provide an incentive payment to critical access hospitals (CAHs) who
meaningfully use certified EHR technology based on the hospitals'
reasonable cost beginning in FY 2011. In addition, section 4102(a)(2)
of the HITECH Act amends section 1814(l) of the Act to provide for a
downward payment adjustment for hospital services provided by CAHs that
are not meaningful users of certified EHR technology for cost reporting
periods beginning in FY 2015. Section 4102(c) of the HITECH Act adds a
new subsection (m) to section 1853 of the Act to provide incentive
payments to MA organizations for certain affiliated hospitals that
meaningfully use certified EHR technology to address avoidance of
duplicate payments, and to make a downward adjustment to payments to MA
organizations for inpatient hospital services provided by its
affiliated hospitals that are not meaningful users of certified EHR
technology beginning in FY 2015.
Section 4103 of the HITECH Act provides for implementation funding
for the EHR incentives program under Medicare.
Section 4201 of the HITECH Act amends section 1903 of the Act to
provide 100 percent Federal financial participation (FFP) to States for
incentive payments to certain eligible providers participating in the
Medicaid program to purchase, implement, and operate (including support
services and training for staff) certified EHR technology and 90
percent FFP for State administrative expenses related to the program
outlined in 1903(t) of the Act. Section 4201(a)(2) of the HITECH Act
adds a new subsection (t) to section 1903 of the Act to establish a
program with input from the States to provide incentives for the
adoption and subsequent meaningful use of certified EHR technology for
providers participating in the Medicaid program.
II. Provisions of the Proposed Regulations
We propose to add a new part 495 to title 42 of the Code of Federal
Regulations to implement the provisions discussed in this section of
the proposed rule related to certified EHR technology for providers
participating in either the Medicare program or the Medicaid program.
The HITECH Act creates incentives in the Medicare Fee-for-Service
(FFS), Medicare Advantage (MA), and Medicaid programs for demonstrating
meaning EHR use and payment adjustments in the Medicare FFS and MA
programs for not demonstrating meaningful EHR use. The three incentive
programs contain many common elements and certain provisions of the
HITECH Act encourage avoiding duplication of payments, reporting, and
other requirements, particularly in the area of demonstrating
meaningful use of certified EHR technology. Eligible hospitals may
participate in either one of the Medicare (FFS or MA) programs and the
Medicaid program, assuming they meet each program's eligibility
requirements, which vary across programs. In certain cases, the HITECH
Act has used nearly identical or identical language in defining terms
that are used in the Medicare FFS, MA, and Medicaid programs, including
such terms as ``hospital-based EPs'' and ``certified EHR technology.''
In these cases, we seek to create as much commonality between the three
programs as possible and have structured this proposed rule based on
that premise by beginning with those provisions that cut across the
three programs before moving on to discuss the provisions specific to
Medicare FFS, MA and Medicaid.
A. Definitions Across the Medicare FFS, Medicare Advantage, and
Medicaid Programs
Title IV, Division B of the HITECH Act establishes incentive
payments under the Medicare and Medicaid programs for certain
professionals and hospitals that meaningfully use certified EHR
technology. Under Medicare, these incentive payments may be made to
qualifying professionals, hospitals, and Medicare Advantage (MA)
organizations on behalf of certain MA affiliated physicians and
hospitals. We refer to the incentive payments made under the original
Medicare program as the Medicare FFS EHR incentive program. We refer to
the incentive payments made to qualifying MA organizations as the MA
EHR incentive program, and the incentive payments made under Medicaid
as the Medicaid EHR incentive program. When referring to Medicare EHR
incentive program, we are referring to both the Medicare FFS EHR and
the MA EHR incentive programs.
1. Definitions
Sections 4101, 4102, and 4202 of the HITECH Act use many identical
or similar terms. In this section of the preamble, we discuss terms for
which we are proposing uniform definitions for the Medicare FFS,
Medicare Advantage, and Medicaid EHR incentive programs. These
definitions would be included in part 495 subpart A of the regulations.
For definitions specific to an individual program, the definition is
set forth and discussed in the applicable EHR incentive program
section.
[[Page 1848]]
a. Certified Electronic Health Record (EHR) Technology
The incentive payments are available to EPs (non-hospital-based
physicians, as defined in section 1861(r) of the Act, who either
receive reimbursement for services under the Medicare FFS program or
have an employment or contractual relationship with a qualifying MA
organization meeting the criteria under section 1853(l)(2) of the Act;
or healthcare professionals meeting the definition of ``eligible
professional'' under section 1903(t)(3)(B) of the Act as well as the
patient-volume and non-hospital-based criteria of section 1903(t)(2)(A)
of the Act) and eligible hospitals (subsection (d) hospitals as defined
under subsection 1886(d)(1)(B) of the Act that either receive
reimbursement for services under the Medicare FFS program or are
affiliated with a qualifying MA organization as described in section
1853(m)(2) of the Act; critical access hospitals (CAHs); or acute care
or children's hospitals described under section 1903(t)(2)(B) of the
Act). Under all three EHR incentive programs, EPs and eligible
hospitals must utilize ``certified EHR technology'' if they are to be
considered eligible for the incentive payments. In the Medicare FFS EHR
incentive program this requirement for EPs is found in section
1848(o)(2)(A)(i) of the Act, as added by section 4101(a) of the HITECH
Act, and for eligible hospitals and CAHs in section 1886(3)(A)(i) of
the Act, as added by section 4102(a) of the HITECH Act. In the MA EHR
incentive program this requirement for EPs is found in section
1853(l)(1) of the Act, as added by section 4101(c) of the HITECH Act,
and for eligible hospitals and CAHs, in section 1853(m)(1) of the Act,
as added by section 4201(c) of the HITECH Act. In the Medicaid EHR
incentive program this requirement for EPs and Medicaid eligible
hospitals is found throughout section 1903(t) of the Act, including in
section 1903(t)(6)(C) of the Act, as added by section 4201(a)(2) of the
HITECH Act. While certified EHR technology is a critical component of
the EHR incentive programs, under the authority given to her in the
HITECH Act, the Secretary has charged ONC with developing the criteria
and mechanisms for certification of EHR technology. Therefore, ONC will
be defining certified EHR technology in its upcoming interim final rule
and we propose to use the definition of certified EHR technology
adopted by ONC.
b. Qualified Electronic Health Record
In order for an EHR technology to be eligible for certification it
must first meet the definition of a qualified electronic health record.
This term will be defined by ONC in its upcoming interim final rule,
and we propose to use the definition of qualified electronic health
record adopted by ONC.
c. Payment Year
Under section 1848(o)(1)(A)(i) of the Act, as added by section
4101(a) of the HITECH Act, the Medicare FFS EHR incentive payment is
available to EPs for a ``payment year.'' Section 1848(o)(1)(E) of the
Act defines the term ``payment year'' as a year beginning with 2011.
While the HITECH Act does not use the term, ``payment year,'' for the
Medicaid EHR incentive program, it does use the term ``year of
payment'' throughout section 1903(t) of the Act, for example, at
sections 1903(t)(3)(C), 1903(t)(4)(A), and 1903(t)(6)(C) of the Act.
For all EPs, we are proposing a common definition for both ``payment
year'' and ``year of payment,'' as ``any calendar year beginning with
2011'' at Sec. 495.4. (The only exception to this rule, is that in
certain cases, Medicaid EPs would be able to participate in the
Medicaid EHR incentive program starting with CY 2010, for adopting,
implementing, or upgrading certified EHR technology. For further
discussion of this early participation in the Medicaid EHR incentive
program, we refer readers to section II.D.3.c. of this proposed rule.)
This definition, which is consistent with the statutory definition
of ``payment year'' under Medicare FFS, will simplify the EHR incentive
programs for EPs. As discussed later in this preamble, EPs may have the
opportunity to participate in either the Medicare or Medicaid incentive
programs, and once an EP has picked a program, they are permitted to
make a one-time switch from one program to the other. A common
definition will allow EPs to more easily understand both programs, and
inform decisions regarding whether they are eligible for, and/or wish
to participate in either program. Under section 1886(n)(1) of the Act,
as added by section 4102(a) of the HITECH Act, the Medicare FFS EHR
incentive payment is available to eligible hospitals and CAHs for a
``payment year.'' Section 1886(n)(2)(G) of the Act defines the term
``payment year'' as a fiscal year (FY) beginning in 2011. As hospitals
are paid based on the 12-month Federal fiscal year, we believe the
reference to a ``fiscal year'' means the fiscal year beginning on
October 1 of the prior year and extending to September 30 of the
relevant year. Again, for the Medicaid EHR incentive program, the
HITECH Act uses the term, ``year of payment'' (see section
1903)(t)(5)(D)(ii) of the Act), rather than ``payment year.'' For the
same reasons expressed above for EPs, and because hospitals will have
the opportunity to simultaneously participate in both the Medicare and
Medicaid EHR incentive programs, we propose a common definition of
``payment year'' and ``year of payment'' for both programs. For
purposes of the incentive payments made to eligible hospitals under the
Medicare FFS, MA and Medicaid EHR incentive programs, we propose to
define payment year and year of payment at Sec. 495.4, consistent with
the statutory definition, as ``any fiscal year beginning with 2011''.
(The only exception to this rule, is that in certain cases, Medicaid
eligible hospitals would be able to participate in the Medicaid EHR
incentive program starting with FY 2010, for adopting, implementing, or
upgrading certified EHR technology. For further discussion of this
early participation in the Medicaid EHR incentive program, we refer
readers to section II.D.3.c of this proposed rule.)
The actual timing of the incentive payment for a given payment year
varies depending on which EHR incentive program an EP or an eligible
hospital is participating in. Details on the timing of incentive
payments for a given payment year can be found in section II.B.of the
proposed rule for Medicare FFS, section II.C. of the proposed rule for
MA and section II.D. of the proposed rule for Medicaid.
d. First, Second, Third, Fourth, Fifth, and Sixth Payment Year
For EPs and eligible hospitals that qualify for EHR incentive
payments in a payment year, the amount of the payment will depend in
part on how many previous payment years, if any, an EP or eligible
hospital received an incentive payment. We propose to define the first
payment year to mean the first calendar or Federal fiscal year for
which an EP or eligible hospital receives an incentive payment.
Likewise, we propose to define the second, third, fourth, fifth, and
sixth payment year, respectively, to mean the second, third, fourth,
fifth, and sixth calendar or Federal fiscal year, respectively, for
which an EP or eligible hospital receives an incentive payment.
e. EHR Reporting Period
In order to qualify for an incentive payment under the Medicare
incentive payment program for a payment year, an EP or eligible
hospital must meaningfully use certified EHR technology for the EHR
reporting period of the relevant payment year. Similarly, a Medicaid EP
or eligible hospital may
[[Page 1849]]
in the first payment year and must in subsequent payment years
demonstrate meaningful use of such technology, in order to receive a
payment. A Medicaid EP or eligible hospital may receive an incentive
payment in their first payment year for the adoption, implementation,
or upgrade of certified EHR technology. Although the Medicaid statute
does not specifically use the term, ``EHR reporting period,'' we
believe that the Secretary, pursuant to sections 1903(t)(6)(C) and
1903(t)(8) of the Act, has the authority to define the period that
would be used for demonstrating such adoption/implementation/upgrade or
meaningful use.
In this proposed rule, we propose a definition of EHR Reporting
Period for purposes of the Medicare and Medicaid incentive payments
under sections 1848(o), 1853(l)(3), 1886(n), 1853(m)(3), 1814(l) and
1903(t) of the Act. For these sections, the EHR reporting period may be
any continuous 90-day period within the first payment year and the
entire payment year for all subsequent payment years. In future
rulemaking, we will propose a definition of EHR Reporting Period for
purposes of Medicare incentive payment adjustments under sections
1848(a)(7), 1853(l)(4), 1886(b)(3)(B)(ix), 1853(m)(4), and 1814(l)(4)
of the Act. Unlike the former group of sections, meaningful EHR users
that would not be subject to adjustments would have to be identified
prior to the application of the latter group of sections. Therefore,
these two groups of sections may have two different definitions of EHR
Reporting Period.
For the first payment year only, we propose to define the term EHR
reporting period at Sec. 495.4 to mean any continuous 90-day period
within a payment year in which an EP or eligible hospital successfully
demonstrates meaningful use of certified EHR technology. The EHR
reporting period therefore could be any continuous period beginning and
ending within the relevant payment year. For example, for payment year
2011, an EHR reporting period of March 13, 2011 to June 11, 2011 would
be just as valid as an EHR reporting period of January 1, 2011 to April
1, 2011. An example of an unallowable EHR reporting period would be for
an EP to begin on November 1, 2011 and finish on January 31, 2012.
Starting with the second payment year and any subsequent payment years
for a given EP or eligible hospital, we propose to define the term EHR
reporting period at Sec. 495.4 to mean the entire payment year.
In defining the EHR reporting period, we considered three of its
aspects: (1) Whether it should vary from one payment year to the next;
(2) its length; and (3) starting point. We discuss these three aspects
below.
The first aspect of the EHR reporting period discussed is whether
it should be the same for each payment year. We believe that there are
considerations that distinguish the first payment year from the
remaining payment years. The foremost being that once an EP or eligible
hospital begins to meaningfully use certified EHR technology they are
unlikely to stop. As discussed below, in the first payment year a
shorter EHR reporting period would provide more flexibility for when an
EP or eligible hospital begins to meaningfully use certified EHR
technology and still qualify for the incentive in the same year.
However, in subsequent years we do not see that flexibility still being
required. Therefore, for purposes of the incentive payments under
sections 1848(o), 1853(l)(3), 1886(n), 1853(m)(3), 1814(l), and 1903(t)
of the Act, we propose that the length of the EHR reporting period be
different for the first payment year than from all other payment years.
We invite interested parties to comment on this proposal if they
believe that the EHR reporting period should vary from payment year to
payment year.
With respect to the length of the EHR reporting period, we note
that there is an inherent tradeoff between robust verification and time
available to achieve compliance. A longer EHR reporting period provides
a more robust verification that an EP or eligible hospital successfully
met the definition of meaningful use of certified EHR technology than a
shorter period. However, it reduces the time available for an EP or
eligible hospital to reach the point of complying with meaningful use
and still receive an incentive for a given payment year. For example, a
90-day period would allow an EP until October 1, 2011 to begin
meaningful use of their certified EHR technology and receive an
incentive for payment year 2011. A 180-day period (6 months) would move
the date upon which the EP must begin meaningful use of their certified
EHR technology forward to July 1, 2011. We are concerned that an EHR
reporting period that is shorter than 90 days would be insufficient
time to ensure that EPs and eligible hospitals are truly using
certified EHR technology in a meaningful manner consistent with our
proposed criteria for meaningful use. Moreover, as discussed later in
this proposed rule, we will require EPs and hospitals to demonstrate
meaningful use by meeting certain performance thresholds (for example,
EPs will need to use CPOE for 80 percent of all orders, and hospitals
for 10 percent of all orders). We believe a period of fewer than 90
days would not be adequate to create an accurate rate for a given EP or
eligible hospital. We believe that once an EP or hospital has
implemented certified EHR technology to the point of being able to
comply with our proposed meaningful use criteria for 90 days, it is
unlikely that they would adjust their behavior just because the EHR
reporting period has ended. Beginning in the second payment year, an EP
or eligible hospital will already be meaningfully using certified EHR
technology so there are no limitations on the time available for
compliance.
For the first payment year, therefore, we propose that the EHR
reporting period will be any continuous 90-day period within the first
payment year. However, beginning in the second payment year we see no
compelling reason not to seek the most robust verification possible.
Therefore for the second payment year and all subsequent payment years
we propose the EHR reporting period be the entire payment year. As the
length of the EHR reporting period is based on the discussed trade-off,
we remain open to alternative lengths of time. We invite comments on
the appropriate length for the EHR reporting period. We urge those
commenting to either endorse our proposed initial 90-day period
followed by full year EHR reporting periods or to recommend a specific
alternative.
With respect to when the EHR reporting period for a payment year
should begin, there are two considerations. The first is determining
the earliest start date available, and the second is the flexibility
given to EPs and eligible hospitals to choose their start date. This
aspect is only applicable for the 90-day EHR reporting period for the
first payment year. The length of the EHR reporting period for the
second payment year and subsequent payment years dictate that the start
date be the first day of the payment year. The earliest start date we
considered was one which would allow an EP or eligible hospital to
demonstrate successful meaningful use of certified EHR technology on
the first day of the relevant payment year. For example, allowing an
EHR reporting period to begin as early as July 3, 2010 would allow an
eligible hospital to successfully demonstrate meaningful use on October
1, 2010, the first day of FY 2011. We have chosen not to propose this
as the earliest start date. There are significant barriers created by
the timeline in the HITECH Act. We anticipate that we will not publish
a final rule until after March
[[Page 1850]]
2010, with the final rule effective 60 days after its publication. We
do not believe this allows enough time for us, the vendor community, or
the provider community to take advantage of this early start date. In
addition, as discussed at sections 1848(o)(2)(B)(iii) and
1886(n)(3)(B)(iii) of the Act, the HITECH Act directs the Secretary to
seek to avoid duplicative reporting of clinical quality and other
measures under the Medicare EHR incentive program and other Medicare
programs. If we were to allow EPs and hospitals to report these
measures to CMS prior to the beginning of the FY, this reporting may be
of questionable value to other Medicare programs requiring reporting of
the same measures. For example, if and when the demonstration of
meaningful use includes the submission of quality measures this
submission could include measures currently in the RHQDAPU program. As
discussed in section II.A.3. of this proposed rule, we do not desire to
have a hospital report the same measure twice for two different
programs. However, if a hospital reports these measures from July
through September 2010 for payment year 2011 for Medicare and/or
Medicaid EHR incentive program, they would not be relevant for FY 2011
under the RHQDAPU. Due to the operational challenges presented and the
statutory requirement to avoid duplication of payments to the extent
possible, we are proposing that the earliest start date for EHR
reporting period be the first day of the payment year. The second
consideration for when the EHR reporting period should begin is whether
to designate specific start dates. As we are not aware of any
compelling reason to limit the start dates available to EPs or eligible
hospitals within the payment year, we propose to allow EPs or eligible
hospitals to begin their EHR reporting period on any date starting with
the first day of the payment year and ending with the latest day in the
payment year that allows for the EHR reporting period to be completed
by the last day of the payment year. We believe that giving EPs and
eligible hospitals flexibility as to the start date of the EHR
reporting is important, as unforeseen circumstances, such as delays in
implementation, higher than expected training needs and other
unexpected hindrances, may cause an EP or eligible hospital to
potentially miss a target start date. We invite comments on the
proposed start dates for the EHR reporting period.
We acknowledge that all three of these aspects will be affected by
the need to determine which physicians, hospitals, critical access
hospitals and managed care plans are meaningful users before
application of the Medicare payment adjustments (provisions of sections
1848(a)(7), 1853(l)(4), 1886(b)(3)(B)(ix), 1853(m)(4), and 1814(l)(4)
of the Act). We will specify the EHR reporting periods for these
payment adjustment incentives in future rulemaking.
f. Meaningful EHR User
Section 1848(o)(1)(A)(i) of the Act, as added by section 4101(a) of
the HITECH Act, limits incentive payments in the Medicare FFS EHR
incentive program to an EP who is a ``meaningful EHR user.'' Section
1886(n)(1) of the Act, as added by section 4102(a) of the HITECH Act,
limits incentive payments in the Medicare FFS EHR incentive program to
hospitals described in section 1886(d) of the Act. Section 1814(l) of
the Act limits incentive payments in the Medicare FFS EHR incentive
program to CAHs who are ``meaningful EHR users.'' Section
1903(t)(6)(C)(i)(II) of the Act, as added by section 4201(a)(2) of the
HITECH Act, limits incentive payments for payment years other than the
first payment year to a Medicaid provider who ``demonstrates meaningful
use of certified EHR technology.'' We propose to define at Sec. 495.4
the term ``meaningful EHR user'' as an EP or eligible hospital who, for
an EHR reporting period for a payment year, demonstrates meaningful use
of certified EHR technology in the form and manner consistent with our
standards (discussed below). These standards would include use of
certified EHR technology in a manner that is approved by us.
2. Definition of Meaningful Use
a. Background
As discussed previously, an EP or eligible hospital must be a
meaningful EHR user in order to receive the incentive payments
available under the EHR incentive programs, except in the first payment
year for certain Medicaid EPs or eligible hospitals. This section
(II.A.2.) of this proposed rule discusses the definition of meaningful
use. Section II.A.3. of this proposed rule, discusses the manner for
demonstrating meaningful use. In Sections 1848(o)(2)(A) and 1886(n)(3)
of the Act, the Congress specified three types of requirements for
meaningful use: (1) Use of certified EHR technology in a meaningful
manner (for example, electronic prescribing); (2) that the certified
EHR technology is connected in a manner that provides for the
electronic exchange of health information to improve the quality of
care; and (3) that, in using certified EHR technology, the provider
submits to the Secretary information on clinical quality measures and
such other measures selected by the Secretary.
Over the last few months, CMS and ONC have solicited input on
defining meaningful use from both other government agencies and the
public through dialogue, public forums, and solicitation of written
comments. Below we describe the work of the National Committee on Vital
and Health Statistics (NCVHS), the HIT Standards Committee and the HIT
Policy Committee, as well as the public input we have received on
defining meaningful use.
The NCVHS is the Department of Health and Human Services' statutory
public advisory body on health data, statistics, and national health
information policy. NCVHS derives its authority from 42 U.S.C. 242k,
section 306(k) of the Public Health Service Act, which governs it along
with the provisions of Public Law 92-463 (5 U.S.C. App.2). The full
charter and membership of the NCVHS is available electronically at
http://www.ncvhs.hhs.gov/. The NCVHS held a public hearing on April 28
and 29, 2009 to learn from a broad spectrum of stakeholders their views
of ``meaningful use.'' The NCVHS hearing brought together key
healthcare and information technology stakeholder groups including:
Representatives of patients, and more broadly consumers; providers; the
public health community; public and private payers; vendors; and
certifying entities. The hearing agenda and testimony supplied is
available electronically at http://www.ncvhs.hhs.gov/090428ag.htm. A
report on the hearing was delivered May 15, 2009 to the ONC. The report
is available electronically at http://www.ncvhs.hhs.gov/090518rpt.pdf.
Written comments from interested stakeholders submitted timely to the
NCVHS were also considered by the NCVHS Executive Sub-Committee in the
drafting of the report. Subsequently, the National Coordinator for HIT
requested NCVHS to reflect on the testimony by supplying observations.
Those observations are available electronically at http://www.ncvhs.hhs.gov/090428rpt.pdf.
In addition to the work completed by the NCVHS, the HIT Policy
Committee, a Federal Advisory Committee to the Department of Health and
Human Services (HHS) created by the HITECH Act, also worked to inform
the definition of meaningful use. The full charter and membership of
the HIT Policy Committee can be found at
[[Page 1851]]
http://healthit.hhs.gov. The HIT Policy Committee formed a Meaningful
Use workgroup. On June 16, 2009, the HIT Policy Committee heard and
discussed the recommendations from their Meaningful Use workgroup, and
subsequently submitted its own recommendations on meaningful use to the
National Coordinator for Health IT. These recommendations are available
electronically at http://healthit.hhs.gov. At the conclusion of the
June 16 meeting, ONC announced a public comment period to solicit
stakeholder input on the recommendations and published a notice in the
Federal Register (74 FR 28937). The public comment period lasted
through June 26, 2009. Over 700 public comments were received by the
ONC. A summary, as well as the text of the comments, is available
electronically at http://healthit.hhs.gov. The Meaningful Use workgroup
presented its revised recommendations to the full committee based on
comments by the full HIT Policy Committee and by the public at the July
16, 2009 meeting. In developing its recommendations, the HIT Policy
Committee considered a report entitled ``National Priorities and
Goals'' (http://www.nationalprioritiespartnership.org/uploadedFiles/NPP/08-253-NQF%20ReportLo%5b6%5d.pdf) generated by the National
Priorities Partnership, convened by the National Quality Forum (NQF).
Of the national health care priorities set forward by the NQF report,
the HIT Policy Committee chose as priority areas patient engagement;
reduction of racial disparities; improved safety; increased efficiency;
coordination of care; and improved population health to drive their
recommendations. Those recommendations are available electronically at
http://healthit.hhs.gov.
The HIT Standards Committee, another Federal Advisory Committee
created by the HITECH Act, provided recommendations related to
meaningful use to ONC. The HIT Standards Committee work focuses
primarily on the standards surrounding certified EHR technology.
Further information on the HIT Standards Committee role and
recommendations can be found in a future rulemaking document to be
provided by ONC for certification of EHR technology (HHS-0151-IFC) and
at http://healthit.hhs.gov.
Finally, from June 22 to June 26, 2009, the ONC and CMS hosted 21
teleconference listening sessions with rural providers, small
practices, small hospitals, CAHs, and urban safety net providers to
hear their perspectives and obtain their input on the definition of
meaningful use. Because of the documentation that these types of
providers have below average adoption rates of HIT, we solicited
comments directly from these communities. Section V. of this proposed
rule discusses the current adoption rates of HIT. Over 200
representatives from these target audiences participated on the calls.
The vast majority of callers were rural providers, although
representatives from vendor organizations or provider associations also
participated. One session was held to specifically hear from national
organizations representing rural communities and providers. Summaries
of these listening sessions are available at http://healthit.hhs.gov/meaningfuluse. Both CMS and the ONC have reviewed input from these and
additional sources to help inform the definition of meaningful use.
b. Common Definition of Meaningful Use Under Medicare and Medicaid
Under sections 1848(o)(1)(A)(i) and 1886(n)(1) of the Act, as added
by sections 4101(a) and 4102(a) of the HITECH Act, respectively, an EP
or eligible hospital must be a meaningful EHR user for the relevant EHR
reporting period in order to qualify for the incentive payment for a
payment year. Sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act
provide that an EP and an eligible hospital shall be considered a
meaningful EHR user for an EHR reporting period for a payment year if
they meet the following three requirements: (1) Demonstrates use of
certified EHR technology in a meaningful manner; (2) demonstrates to
the satisfaction of the Secretary that certified EHR technology is
connected in a manner that provides for the electronic exchange of
health information to improve the quality of health care such as
promoting care coordination, in accordance with all laws and standards
applicable to the exchange of information; and (3) using its certified
EHR technology, submits to the Secretary, in a form and manner
specified by the Secretary, information on clinical quality measures
and other measures specified by the Secretary. The HITECH Act requires
that to receive a Medicaid incentive payment in the initial year of
payment, an EP or eligible hospital may demonstrate that they have
engaged in efforts to ``adopt, implement, or upgrade certified EHR
technology.'' Details, including special timeframes, on how we define
and implement ``adopt, implement, and upgrade'' are proposed in section
II.D.7.b.2 of this proposed rule. For subsequent payment years, or the
first payment year if an EP or eligible hospital chooses, section
1903(t)(6)(C)(i)(II) of the Act, as added by section 4201(a)(2) of
HITECH, prohibits receipt of an incentive payment, unless ``the
Medicaid provider demonstrates meaningful use of certified EHR
technology through a means that is approved by the State and acceptable
to the Secretary, and that may be based upon the methodologies applied
under section 1848(o) or 1886(n).'' (Sections 1848(o) and 1886(n) of
the Act refer to the Medicare incentive programs for EPs and eligible
hospitals respectively.) Under section 1903(t)(8) of the Act to the
maximum extent practicable, we are directed to avoid duplicative
requirements from Federal and State governments to demonstrate
meaningful use of certified EHR technology. Provisions included at
section 1848(o)(1)(D)(iii) of the Act also contain a Congressional
mandate to avoid duplicative requirements for meaningful use, to the
extent practicable. Finally section 1903(t)(8) of the Act allows the
Secretary to deem satisfaction of the requirements for meaningful use
of certified EHR technology for a payment year under Medicare to
qualify as meaningful use under Medicaid.
We believe that given the strong level of interaction on meaningful
use encouraged by the HITECH Act, there would need to be a compelling
reason to create separate definitions for Medicare and Medicaid. We
have found no such reasons for disparate definitions in our internal or
external discussions. To the contrary, stakeholders have expressed
strong preferences to link the Medicare and Medicaid EHR incentive
programs wherever possible. Hospitals are entitled to participate in
both programs, and we are proposing to offer EPs an opportunity to
switch between the Medicare and Medicaid EHR incentive programs.
Therefore, we propose to create a common definition of meaningful use
that would serve as the definition for providers participating in the
Medicare FFS and MA EHR incentive program, and the minimum standard for
EPs and eligible hospitals participating in the Medicaid EHR incentive
program. We clarify that under Medicaid this common definition would be
the minimum standard. While we would allow States to add additional
objectives to the definition of meaningful use or modify how the
existing objectives are measured, the Secretary would not accept any
State proposed alternative that does not further promote the use of
EHRs and healthcare quality or that would require additional
functionality beyond that of certified EHR technology. See section
[[Page 1852]]
II.D.7.b.2.of this proposed rule for further details on how a State may
propose an alternative.
For hospitals, we propose to exercise the option granted under
section 1903(t)(8) of the Act and deem any Medicare provider who is a
meaningful EHR user under the Medicare EHR incentive program and is
otherwise eligible for the Medicaid incentive payment to be classified
as a meaningful EHR user under the Medicaid EHR incentive program. This
is applicable only to eligible hospitals, as EPs cannot receive an
incentive payment under both Medicare and Medicaid.
We solicit comments as to whether there exist compelling reasons to
give the states additional flexibility in creating disparate
definitions beyond what is proposed. Also if commenting in favor of
such disparate definitions, we ask that interested parties also comment
on whether the proposal of deeming meeting Medicare as sufficient for
meeting those of Medicaid remains appropriate under the disparate
definitions. This is applicable only to hospitals eligible for both the
Medicare and Medicaid incentive programs. Furthermore, if a State has
CMS-approved additional meaningful use requirements, hospitals deemed
as meaningful users by Medicare would not have to meet the State-
specific additional meaningful use requirements in order to qualify for
the Medicaid incentive payment.
c. Considerations in Defining Meaningful Use
In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, as added by
sections 4101(a) and 4102(a) of the HITECH Act, the Congress identifies
the broad goal to be accomplished through the definition of meaningful
use of certified EHR technology for expanding the use of EHRs.
Certified EHR technology used in a meaningful way by providers is one
piece of a broader HIT infrastructure needed to reform the health care
system and improve health care quality, efficiency, and patient safety.
Our goal is for this ultimate vision to drive the definition of
meaningful use consistent with applicable provisions of Medicare and
Medicaid law.
In defining meaningful use through the creation of criteria, we
have balanced competing considerations of proposing a definition that
best ensures reform of health care and improved healthcare quality,
encourages widespread EHR adoption, promotes innovation, and avoids
imposing excessive or unnecessary burdens on healthcare providers,
while at the same time recognizing the short time-frame available under
the HITECH Act for providers to begin using certified EHR technology.
Based on public and stakeholder input, we consider a phased
approach to be most appropriate. Such a phased approach encompasses
reasonable criteria for meaningful use based on currently available
technology capabilities and provider practice experience, and builds up
to a more robust definition of meaningful use, based on anticipated
technology and capabilities development. The HITECH Act acknowledges
the need for this balance by granting the Secretary the discretion to
require more stringent measures of meaningful use over time.
Ultimately, consistent with other provisions of law, meaningful use of
certified EHR technology should result in health care that is patient-
centered, evidence-based, prevention-oriented, efficient, and
equitable.
Under this phased approach to meaningful use, we intend to update
the criteria of meaningful use through future rulemaking. We refer to
the initial meaningful use criteria as ``Stage 1.'' We currently
anticipate two additional updates, which we refer to as Stage 2 and
Stage 3, respectively. We are considering updating the meaningful use
criteria on a biennial basis, with the Stage 2 criteria proposed by the
end of 2011 and the Stage 3 definition proposed by the end of 2013. The
stages represent a graduated approach to arriving at the ultimate goal.
Thus, our goals for ``Stage 3'' meaningful use criteria represent
overarching goals which, we believe, are attainable by the end of the
EHR incentive programs. We will continue to evaluate the progression of
the meaningful use definition for consistency with legislative intent
and new statutory requirements relating to quality measurement. We
solicit comments on this proposed pathway of meaningful use.
Stage 1: The Stage 1 meaningful use criteria focuses on
electronically capturing health information in a coded format; using
that information to track key clinical conditions and communicating
that information for care coordination purposes (whether that
information is structured or unstructured, but in structured format
whenever feasible); consistent with other provisions of Medicare and
Medicaid law, implementing clinical decision support tools to
facilitate disease and medication management; and reporting clinical
quality measures and public health information.
Stage 2: Our goals for the Stage 2 meaningful use
criteria, consistent with other provisions of Medicare and Medicaid
law, expand upon the Stage 1 criteria to encourage the use of health IT
for continuous quality improvement at the point of care and the
exchange of information in the most structured format possible, such as
the electronic transmission of orders entered using computerized
provider order entry (CPOE) and the electronic transmission of
diagnostic test results (such as blood tests, microbiology, urinalysis,
pathology tests, radiology, cardiac imaging, nuclear medicine tests,
pulmonary function tests and other such data needed to diagnose and
treat disease). Additionally we may consider applying the criteria more
broadly to both the inpatient and outpatient hospital settings.
Stage 3: Our goals for the Stage 3 meaningful use criteria
are, consistent with other provisions of Medicare and Medicaid law, to
focus on promoting improvements in quality, safety and efficiency,
focusing on decision support for national high priority conditions,
patient access to self management tools, access to comprehensive
patient data and improving population health.
We will continue to evaluate the progression of the meaningful use
definition for consistency with legislative instructions and new
statutory requirements relating to quality measurement and
administrative simplification. We are aware that the appropriate
approach raises complex questions and we solicit comments on the
proposed approach and alternative possibilities. A different approach
might, for example, move aspects of Stage 2 into Stage 3 or vice versa.
We seek comments on how best to balance the relevant goals, including
promoting adoption of EHRs, avoiding excessive or unnecessary burdens,
and improving health care.
As the purpose of these incentives is to encourage the adoption and
meaningful use of certified EHR technology, we believe it is desirable
to account for whether an EP or eligible hospital is in their first,
second, third, fourth, fifth, or sixth payment year when deciding which
definition of meaningful use to apply in the beginning years of the
program. The HIT Policy Committee in its public meeting on July 16,
2009 also voiced its approval of this approach. However, we do not wish
to create an additional burden on EPs or eligible hospitals for
becoming a meaningful EHR user before 2015 by creating a higher
standard for them relative to an EP or eligible hospital who first
becomes a meaningful EHR user in
[[Page 1853]]
2015. The following paragraphs describe our intended alignment in the
beginning years that brings all EPs and eligible hospitals to the same
level of meaningful use by 2015. As we are only proposing criteria for
Stage 1 of meaningful use in this notice of proposed rulemaking, Stage
1 will be the criteria for meaningful use for all payment years until
updated by future rulemaking. Medicaid EHR incentive program EPs and
eligible hospitals have the option to earn their incentive for their
first payment year through the adoption, implementation or upgrade of
certified EHR technology. Those EPs and eligible hospitals doing so
will not have to demonstrate meaningful use in their first payment
year. We intend for their progression to be the same as those who
demonstrate meaningful use in their first payment year. In other words,
the second payment year is the second payment year regardless of how
the incentive was earned in the first payment year.
We intend that Medicaid EPs and eligible hospitals who qualify for
an incentive payment for adopting, implementing, or upgrading in their
first payment year would follow the same meaningful use progression
outlined below as if their second payment year was their first payment
year. For instance a Medicaid EP who received an incentive for his or
her first payment year in 2010 for adopting, implementing, or upgrading
would follow the same guidance starting in their second payment year
(2011) as a Medicare EP who received an incentive for their first
payment year in 2011 for meaningful use of certified EHR technology.
Another example would be a Medicaid eligible hospital that received an
incentive for its first payment year in 2012 for adopting,
implementing, and upgrading would follow the same guidance starting in
their second payment year (2013) as a Medicare eligible hospital who
received an incentive for their first payment year in 2013 for
meaningful use of certified EHR technology.
We propose that EPs and eligible hospitals whose first payment year
is 2011 must satisfy the requirements of the Stage 1 criteria of
meaningful use in their first and second payment years (2011 and 2012)
to receive the incentive payments. We anticipate updating the criteria
of meaningful use to Stage 2 in time for the 2013 payment year and
therefore anticipate for their third and fourth payment years (2013 and
2014), an EP or eligible hospital whose first payment year is 2011
would have to satisfy the Stage 2 criteria of meaningful use to receive
the incentive payments. We anticipate updating the criteria of
meaningful use to Stage 3 in time for the 2015 payment year and
therefore anticipate for their fifth payment year (2015), if
applicable, an EP or eligible hospital whose first payment year is 2011
would have to satisfy the Stage 3 criteria of meaningful use to receive
the incentive payments. For their sixth payment year (2016), if
applicable, an EP or eligible hospital whose first payment year is 2011
would have to satisfy the Stage 3 criteria of meaningful use or a
subsequent update to the criteria if one is established through
rulemaking to receive the incentive payments.
We propose that EPs and eligible hospitals whose first payment year
is 2012 must satisfy the Stage 1 criteria of meaningful use in their
first and second payment years (2012 and 2013) to receive the incentive
payments. We anticipate updating the criteria of meaningful use to
Stage 2 in time for the 2013 payment year and anticipate for their
third payment year (2014), an EP or eligible hospital whose first
payment year is 2012 would have to satisfy the Stage 2 criteria of
meaningful use to receive the incentive payments. We anticipate
updating the criteria of meaningful use to Stage 3 in time for the 2015
payment year and therefore anticipate for their fourth payment year
(2015), if applicable, an EP or eligible hospital whose first payment
year is 2012 would have to satisfy the Stage 3 criteria of meaningful
use to receive the incentive payments. For their fifth and sixth
payment years (2016 and 2017), if applicable, an EP or eligible
hospital whose first payment year is 2012 would have to satisfy the
Stage 3 criteria of meaningful use or a subsequent update to the
criteria if one is established through rulemaking to receive the
incentive payments.
We propose that EPs and eligible hospitals whose first payment year
is 2013 must satisfy the Stage 1 criteria of meaningful use in their
first payment year (2013) to receive the incentive payments. We
anticipate updating the criteria of meaningful use to Stage 2 in time
for the 2013 payment year and therefore anticipate for their second
payment year (2014), an EP or eligible hospital whose first payment
year is 2013 would have to satisfy the Stage 2 criteria of meaningful
use to receive the incentive payments. We anticipate updating the
criteria of meaningful use to Stage 3 in time for the 2015 payment year
and therefore anticipate for their third payment year (2015), if
applicable, an EP or eligible hospital whose first payment year is 2013
would have to satisfy the Stage 3 criteria of meaningful use to receive
the incentive payments. For their fourth, fifth, and sixth payment year
(2016, 2017 and 2018), if applicable, an EP or eligible hospital whose
first payment year is 2013 would have to satisfy the Stage 3 criteria
of meaningful use or a subsequent update to the criteria if one is
established through rulemaking to receive the incentive payments.
We propose that EPs and eligible hospitals whose first payment year
is 2014 must satisfy the Stage 1 criteria of meaningful use in their
first payment year (2014) to receive the incentive payments. We
anticipate updating the criteria of meaningful use to Stage 3 in time
for the 2015 payment year and therefore anticipate for their second
payment year (2015), if applicable, an EP or eligible hospital whose
first payment year is 2014 would have to satisfy the Stage 3 criteria
of meaningful use to receive the incentive payments. For their third,
fourth, fifth and sixth payment year (2016, 2017, 2018, and 2019), if
applicable, an EP or eligible hospital whose first payment year is 2014
would have to satisfy the Stage 3 criteria of meaningful use or a
subsequent update to the criteria if one is established through
rulemaking to receive the incentive payments.
We anticipate updating the criteria of meaningful use to Stage 3 in
time for the 2015 payment year and therefore anticipate for all their
payment years, an EP or eligible hospital whose first payment year is
2015 would have to satisfy the Stage 3 criteria of meaningful use for
2015. For all subsequent payment years, if applicable, an EP or
eligible hospital whose first payment year is 2015 would have to
satisfy the Stage 3 criteria of meaningful use or a subsequent update
to the criteria if one is established through rulemaking to receive the
incentive payments.
In addition to the equitable concerns discussed earlier in the
transition from incentive payments to payment adjustments, the primary
reasoning for developing different stages of meaningful use is the
current lack of HIT infrastructure and penetration of qualified EHRs
necessary to support the ambitious goals of the Stage 3 criteria of
meaningful use. Given the anticipated maturity of HIT infrastructure
inherent in the strengthening criteria and the increased adoption of
certified EHR technology predicted in section V. of this proposed rule,
these barriers to meeting the Stage 3 criteria of meaningful use will
be removed.
Table 1 outlines our proposal to apply the respective criteria of
meaningful use for each payment year (1st, 2nd, 3rd, etc.) for EPs and
eligible hospitals that
[[Page 1854]]
become meaningful EHR users before 2015. Please note that nothing in
this discussion limits us to proposed changes to meaningful use beyond
Stage 3 through future rulemaking.
Table 1--Stage of Meaningful Use Criteria by Payment Year
----------------------------------------------------------------------------------------------------------------
Payment year
First payment year ---------------------------------------------------------------------------------
2011 2012 2013 2014 2015 +**
----------------------------------------------------------------------------------------------------------------
2011.......................... Stage 1........ Stage 1........ Stage 2....... Stage 2....... Stage 3.
2012.......................... ............... Stage 1........ Stage 1....... Stage 2....... Stage 3.
2013.......................... ............... ............... Stage 1....... Stage 2....... Stage 3.
2014.......................... ............... ............... .............. Stage 1....... Stage 3.
2015+ *....................... ............... ............... .............. .............. Stage 3.
----------------------------------------------------------------------------------------------------------------
* Avoids payment adjustments only for EPs in the Medicare EHR Incentive Program.
** Stage 3 criteria of meaningful use or a subsequent update to the criteria if one is established through
rulemaking.
Please note that the number of payment years available and the last
payment year that can be the first payment year for an EP or eligible
hospital varies between the EHR incentive programs. The applicable
payment years for each program are discussed in section II.B. of this
proposed rule for the Medicare FFS EHR incentive program, in section
II.D. for the MA EHR incentive program, and in section II.E. for the
Medicaid EHR incentive program.
The stages of criteria of meaningful use and how they are
demonstrated are described further in this proposed rule and will be
updated in subsequent proposed rules to reflect advances in HIT
products and infrastructure. This could include updates to the Stage 1
criteria in future rulemaking.
We invite comments on our alignment between payment year and the
criteria of meaningful use particularly in regard to the need to create
alignment across all EPs and eligible hospitals in all EHR incentive
programs in 2015.
d. Stage 1 Criteria for Meaningful Use
To qualify as a meaningful EHR user for 2011, we propose that an EP
or eligible hospital must demonstrate that they meet all of the
objectives and their associated measures as set forth in Sec. 495.6.
Except as otherwise indicated, each objective must be satisfied by an
individual EP as determined by unique National Provider Identifiers
(NPIs) and an individual hospital as determined by unique CMS
certification numbers (CCN). Below we describe each objective and its
associated measures in detail. While we welcome comments on all aspects
of the Stage 1 criteria of meaningful use, we specifically encourage
comments on the following considerations.
While we believe that requiring satisfaction of all objectives is
appropriate for the majority of providers, we are concerned that
certain providers may have difficulty meeting one or more of the
proposed objectives. We solicit comments on whether this may be the
case, and invite commenters to identify the objectives and associated
measures that may prove out of reach for certain provider types or
specialties, and to suggest specific objective criteria we could use to
determine whether an objective and associated measure is appropriate
for different provider types or specialists.
In discussing the objectives that constitute the stage 1 criteria
of meaningful use, we adopted a structure derived from recommendations
of the HIT Policy Committee of grouping the objectives under care
goals, which are in turn grouped under health outcomes policy
priorities. We believe this structural grouping provides context to the
individual objectives; however, the grouping is not itself an aspect of
meaningful use. The criteria for meaningful use are based on the
objectives and their associated measures. CMS and ONC have carefully
reviewed the objectives and measures proposed by the HIT Policy
Committee. We found many objectives to be well suited to meaningful
use, while others we found to require modification or clarification. In
our discussion we will focus on those areas where our proposal is a
modification of the recommendation of the HIT Policy Committee. For
those areas where we elected not to propose a modification to the
recommendation of the HIT Policy Committee, we note that there already
has been extensive public debate and explanation of these
recommendations, which can be accessed at http://healthit.hhs.gov/meaningfuluse. Even if we do not propose to modify a specific
recommendation of the HIT Policy Committee, we nevertheless welcome
comment on whether to do so in the final rule.
(1) Objectives
The first health outcomes policy priority specified by the HIT
Policy Committee is improving quality, safety, efficiency and reducing
health disparities. The HIT Policy Committee identified the following
care goals to address this priority:
Provide access to comprehensive patient health data for
patient's healthcare team.
Use evidence-based order sets and computerized provider
order entry (CPOE).
Apply clinical decision support at the point of care.
Generate lists of patients who need care and use them to
reach out to those patients.
Report information for quality improvement and public
reporting.
With respect to this last care goal, the HIT Policy Committee proposed
a goal of ``Report to patient registries for quality improvement,
public reporting, etc.'' We propose to modify this care goal because we
believe that patient registries are too narrow a reporting requirement
to accomplish the goals of quality improvement and public reporting. We
note that the HIT Policy Committee's recommended objectives include the
reporting of quality measures to CMS. We do not believe that CMS would
normally be considered a ``patient registry.'' We also removed the
phrase ``etc.'' We believe that the level of ambiguity created by
``etc.'' is not appropriate for Federal regulations.
For EPs, we propose the following objectives in the Stage 1
criteria of meaningful use to further the care goal of improving
quality, safety, efficiency and reducing health disparities.
Use CPOE. We believe that the term ``CPOE'' requires
additional clarification. We propose to define CPOE as entailing the
provider's use of computer assistance to directly enter medical orders
(for example, medications,
[[Page 1855]]
consultations with other providers, laboratory services, imaging
studies, and other auxiliary services) from a computer or mobile
device. The order is also documented or captured in a digital,
structured, and computable format for use in improving safety and
organization. For Stage 1 criteria, we propose that it will not include
the electronic transmittal of that order to the pharmacy, laboratory,
or diagnostic imaging center. We encourage comments on whether
additional specificity is required on the types of orders encompassed
within CPOE.
Implement drug-drug, drug-allergy, drug-formulary checks.
Maintain an up-to-date problem list of current and active
diagnoses based on ICD-9-CM or SNOMED CT[supreg].
We believe the term ``problem list'' requires additional clarification.
We describe a ``problem list'' as a list of current and active
diagnoses as well as past diagnoses relevant to the current care of the
patient.
Generate and transmit permissible prescriptions
electronically (eRx).
The concept of only permissible prescriptions refers to the current
restrictions established by the Department of Justice on electronic
prescribing for controlled substances. (The restrictions can be found
at http://www.deadiversion.usdoj.gov/schedules/schedules.htm.)
Maintain active medication list.
Maintain active medication allergy list.
Record the following demographics: Preferred language,
insurance type, gender, race and ethnicity, and date of birth.
We note that race and ethnicity codes should follow current federal
standards published by the Office of Management and Budget (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr).
We do not propose to include the objective ``Record
Advance directives.''
The HIT Policy Committee recommended that EPs ``record advance
directives.'' It is unclear whether by this terminology they meant that
the contents of the advance directive be recorded or merely the fact
that a patient has an advance directive be noted. Depending on the
interpretation, this objective could interfere with current State law
which varies significantly from State to State in this matter. We also
believe that this objective is only relevant to a limited and undefined
patient population when compared to the patient populations to which
other objectives listed here apply. The limits could be based on age,
health status, whether a chronic condition is present, to patients
scheduled for certain types of procedures or a host of other factors.
Similarly, many EPs would not record this information under current
standards of practice. Dentists, pediatricians, optometrists,
chiropractors, dermatologists, and radiologists are just a few examples
of EPs who would only in rare circumstances require information about a
patient's advance directive. For these reasons, we do not propose to
include ``Record advance directives'' as an objective of the Stage 1
criteria of meaningful use for EPs.
Record and chart changes in the following vital signs:
Height, weight and blood pressure and calculate and display body mass
index (BMI) for ages 2 and over; plot and display growth charts for
children 2-20 years, including BMI.
This is a modification to the HIT Policy Committee recommendation to
require eligible professionals to record vital signs: Height, weight,
blood pressure and calculate BMI. We added ``plot and display growth
charts for children 2-20 years, including BMI'' to the objective
recommended by the HIT Policy Committee, as BMI itself does not provide
adequate information for children. Trends in height, weight, and BMI
among children must be interpreted and understood in the context of
expected parameters of children of the same age and sex to determine
whether the child is growing appropriately. For example, a BMI of 18 is
normal for a 12-year-old boy, and a marker of obesity for a 5-year-old
(http://www.cdc.gov/growthcharts/data/set1clinical/cj411023.pdf).
Record smoking status for patients 13 years old or older.
The HIT Policy Committee recommended the objective of recording smoking
status for patients. We propose to add ``for patients 13 years old or
older,'' as we do not believe this objective is applicable to patients
of all ages and there is not consensus in the health care community as
to what the appropriate cut off age may be. We encourage comments on
whether this age limit should be lowered or raised.
Incorporate clinical lab-test results into EHR as
structured data. Structured data are data that have specified data type
and response categories within an electronic record or file.
Generate lists of patients by specific conditions to use
for quality improvement, reduction of disparities, research, and
outreach.
Report ambulatory quality measures to CMS (or, for EPs
seeking the Medicaid incentive payment, the States). The HIT Policy
Committee did not include ``or the States'' in its recommended
objective. We propose to add the option to report directly to the
States for EPs participating in the Medicaid EHR incentive program.
Additional discussion of this objective can be found in section II.A.3
of this proposed rule.
Send reminders to patients per patient preference for
preventive/follow-up care. Patient preference refers to the patient's
choice of delivery method between internet based delivery or delivery
not requiring internet access.
Implement five clinical decision support rules relevant to
specialty or high clinical priority, including for diagnostic test
ordering, along with the ability to track compliance with those rules.
This is a modification to the HIT Policy Committee recommendation
to require EPs to implement one clinical decision support rule relevant
to specialty or high clinical priority. We made this change to align
with and support eligible professionals in reporting their clinical
quality measures proposed in section II.A.3. of this proposed rule. We
anticipate that EPs will report on at least five clinical quality
measures.
We propose to describe clinical decision support as health
information technology functionality that builds upon the foundation of
an EHR to provide persons involved in care processes with general and
person-specific information, intelligently filtered and organized, at
appropriate times, to enhance health and health care.
We do not propose to include the objective ``Document a
progress note for each encounter''. Documentation of progress notes is
a medical-legal requirement and a component of basic EHR functionality,
and is not directly related to advanced processes of care or
improvements in quality, safety, or efficiency.
Finally, the HIT Policy Committee further recommended the following
two objectives related to administrative simplification. Consistent
with that recommendation--and consistent with any forthcoming statutory
requirements regarding administrative simplifications--we propose the
following objectives, with slight modification.
Check insurance eligibility electronically from public and
private payers. Deleted ``where possible'' from the HIT Policy
Committee recommendation. The checking for
[[Page 1856]]
eligibility electronically is already a HIPAA Standard Exchange.
Submit claims electronically to public and private payers.
For eligible hospitals, we propose the following objectives in the
stage 1 criteria of meaningful use to further these care goals:
Use CPOE for orders (any type) directly entered by the
authorizing provider (for example, MD, DO, RN, PA, NP).
We believe that the term ``CPOE'' requires additional
clarification. We propose to define CPOE as entailing the provider's
use of computer assistance to directly enter medical orders (for
example, medications, consultations with other providers, laboratory
services, imaging studies, and other auxiliary services) from a
computer or mobile device. The order is also documented or captured in
a digital, structured, and computable format for use in improving
safety and organization. It does not include the electronic transmittal
of that order to the pharmacy, laboratory, or diagnostic imaging center
in 2011 or 2012. CPOE is the same as defined above for EPs. We welcome
comment on whether use of CPOE varies between hospitals and EPs in ways
that should be addressed.
Implement drug-drug, drug-allergy, drug-formulary checks.
Maintain an up-to-date problem list of current and active
diagnoses based on ICD-9-CM or SNOMED CT[supreg].
We believe the term ``problem list'' requires additional clarification.
We describe a ``problem list'' as a list of current and active
diagnoses, as well as past diagnoses relevant to the current care of
the patient.
Maintain active medication list.
Maintain active medication allergy list.
Record the following demographics: preferred language,
insurance type, gender, race and ethnicity, date of birth, and date and
cause of death in the event of mortality.
We are interested in public comments on how States and hospitals could
work together to facilitate linkage between the EHR and the full birth
and death certificate information that States currently require
hospitals to collect. We note that race and ethnicity codes should
follow current federal standards published by the Office of Management
and Budget (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr).
We do not propose to include the objective ``Record
Advance directives.''
The HIT Policy Committee recommended that eligible hospitals ``record
advance directives.'' It is unclear whether by this terminology they
meant that the contents of the advance directive be recorded or merely
the fact that a patient has an advance directive be noted. Depending on
the interpretation, this objective could interfere with current State
law which varies significantly from state to state in this matter. We
also believe that this objective is only relevant to a limited and
undefined patient population when compared to the patient populations
to which other objectives listed here apply. The limits could be based
on age, health status, whether a chronic condition is present, to
patients scheduled for certain types of procedures or a host of other
factors. For these reasons, we do not propose to include ``Record
advance directives'' as an objective of the Stage 1 criteria of
meaningful use for eligible hospitals.
Record the following vital signs: height, weight and blood
pressure and calculate and display body mass index (BMI) for patients 2
and over; plot and display growth charts for children 2-20 years,
including BMI.
We added ``plot and display growth charts for children 2-20 years,
including BMI'' to the objective recommended by the HIT Policy
Committee, as BMI itself does not provide adequate information for
children. Trends in height, weight, and BMI among children must be
interpreted and understood in the context of expected parameters of
children of the same age and sex to determine whether the child is
growing appropriately. For example, a BMI of 18 is normal for a 12-
year-old boy, and a marker of obesity for a 5-year-old (ref. http://www.cdc.gov/growthcharts/data/set1clinical/cj41l023.pdf).
Record smoking status for patients 13 years old or older.
We added ``for patients 13 years old or older'' as this objective is
not applicable to patients of all ages. The discussion as to why we
chose 13 can be found under the EP objective for ``Record smoking
status''.
Incorporate clinical lab-test results into EHR as
structured data. Structured data are data that have specified data type
and response categories within a record or file.
Generate lists of patients by specific conditions to use
for quality improvement, reduction of disparities, and outreach.
The HIT Policy Committee did not recommend the phrase ``to use for
quality improvement, reduction of disparities, and outreach'' for
eligible hospitals as they did for EPs. We believe this aspect of the
objective is just as relevant to eligible hospitals as EPs and
therefore includes it for both. We invite comments as to why this
phrase may not be applicable to eligible hospitals.
Report ambulatory quality measures to CMS (or, for
eligible hospitals seeking the Medicaid incentive payment, the States).
The HIT Policy Committee did not include ``or the States'' in their
recommended objective. We propose to add the option to report directly
to the States for Medicaid eligible hospitals participating in the
Medicaid EHR incentive program. Additional discussion can be found in
section II.A.3. of this proposed rule.
Implement five clinical decision support rules relevant to
specialty or high clinical priority, including for diagnostic test
ordering, along with the ability to track compliance with those rules.
This is a modification to the HIT Policy Committee recommendation
to require eligible professionals to implement one clinical decision
support rule relevant to specialty or high clinical priority. We made
this change to align with and support eligible professionals in
reporting their clinical quality measures proposed in section II.A.3.
of this proposed rule. We anticipate that most EPs will report on at
least five clinical quality measures from section II.A.3 of this
proposed rule and eligible hospitals will all report on at least five.
We believe greater clarification is required around the term
clinical decision support. We propose to describe clinical decision
support as health information technology functionality that builds upon
the foundation of an EHR to provide persons involved in care processes
with general and person-specific information, intelligently filtered
and organized, at appropriate times, to enhance health and health care.
Finally, the HIT Policy Committee further recommended the following
two objectives related to administrative simplification. Consistent
with that recommendation--and consistent with any forthcoming statutory
requirements regarding administrative simplifications--we propose the
following objectives, with slight modification.
Check insurance eligibility electronically from public and
private payers. Deleted ``where possible'' from the HIT Policy
Committee recommendation. The checking for eligibility electronically
is already a HIPAA Standard Exchange.
Submit claims electronically to public and private payers.
The second health outcomes policy priority identified by the HIT
Policy
[[Page 1857]]
Committee is to engage patients and families in their healthcare. The
following care goal for meaningful use addresses this priority:
Provide patients and families with timely access to data,
knowledge, and tools to make informed decisions and to manage their
health. We do not propose to preempt any existing Federal or State law
regarding the disclosure of information to minors, their parents, or
their guardians in setting the requirements for meaningful use. For
this reason when it comes to information provided to the family, we let
existing Federal and State laws dictate what is appropriate for
disclosure to the patient or the family. For purposes of all objectives
of the Stage 1 criteria of meaningful use involving the disclosure of
information to a patient, a disclosure made to a family member or a
patient's guardian consistent with Federal and State law may substitute
for a disclosure to the patient.
For EPs, we propose the following objectives in the stage 1
criteria of meaningful use to further this care goal:
Provide patients with an electronic copy of their health
information (including diagnostics test results, problem list,
medication lists, allergies) upon request.
Consistent with the HIT Policy Committee's recommendations, we propose
the following additional clarification of this objective. Electronic
copies may be provided through a number of secure electronic methods
(for example, personal health record (PHR), patient portal, CD, USB
drive).
Provide patients with timely electronic access to their
health information (including lab results, problem list, medication
lists, allergies) within 96 hours of the information being available to
the EP.
Also, consistent with the HIT Policy Committee recommendations, we
propose the following additional clarification of this objective.
Electronic access may be provided by a number of secure electronic
methods (for example, PHR, patient portal, CD, USB drive). Timely is
defined as within 96 hours of the information being available to the EP
either through the receipt of final lab results or a patient
interaction that updates the EP's knowledge of the patient's health. We
judge 96 hours to be a reasonable amount of time to ensure that
certified EHR technology is up to date. We welcome comment on if a
shorter or longer time is advantageous.
We do not propose to include the objective ``Provide
access to patient-specific education resources upon request.''
Providing patients with information and education that is relevant to
their condition, actionable, culturally competent, and of the
appropriate health literacy level is a critical component of patient
engagement and empowerment. Unfortunately, there is currently a paucity
of knowledge resources that are integrated within EHRs, that are widely
available, and that meet these criteria, particularly in multiple
languages. We intend to work with the policy committee, the National
Library of Medicine (provider of Medline Plus), and experts in this
area to ensure the feasibility of this measure in the future.
Provide clinical summaries for patients for each office
visit.
Changed from encounter to office visit. The HIT Policy Committee
recommended the objective ``Provide clinical summaries for patients for
each encounter.'' We believe this objective requires further
clarification in order to make the distinction that it is not meant to
apply to alternative encounters such as telephone or Web visits. As a
result, we propose to revise this objective to ``Provide clinical
summaries for patients for each office visit.''
For eligible hospitals, we propose the following objectives in the
stage 1 criteria of meaningful use to further this care goal:
Provide patients with an electronic copy of their health
information (including diagnostic test results, problem list,
medication lists, allergies, discharge summary, procedures), upon
request. Consistent with the HIT Policy Committee's recommendations, we
propose the following additional clarification of this objective.
Electronic copies may be provided through a number of secure electronic
methods (for example, Personal Health Record (PHR), patient portal, CD,
USB drive).
Provide patients with an electronic copy of their
discharge instructions and procedures at time of discharge, upon
request.
Also, consistent with the HIT Policy Committee recommendations, we
propose the following additional clarification of this objective.
Electronic access may be provided by a number of secure electronic
methods (for example, PHR, patient portal, CD, USB drive).
We do not propose to include the objective ``Provide
access to patient-specific education resources upon request.''
Providing patients with information and education that is relevant to
their condition, actionable, culturally competent, and of the
appropriate health literacy level is a critical component of patient
engagement and empowerment. Unfortunately, there is currently a paucity
of knowledge resources that are integrated within EHRs, that are widely
available, and that meet these criteria, particularly in multiple
languages. We intend to work with the policy committee, the National
Library of Medicine (provider of Medline Plus), and experts in this
area to ensure the feasibility of this measure in the future.
The third health outcomes policy priority identified by the HIT
Policy Committee is to improve care coordination. The HIT Policy
Committee recommended the following care goals to address this
priority:
Exchange meaningful clinical information among
professional health care team.
For EPs and eligible hospitals, we propose the following objectives
in the stage 1 criteria of meaningful use to further this care goal:
Capability to exchange key clinical information (for
example, problem list, medication list, allergies, and diagnostic test
results), among providers of care and patient authorized entities
electronically.
By ``diagnostic test results'' we mean all data needed to diagnose and
treat disease, such as blood tests, microbiology, urinalysis, pathology
tests, radiology, cardiac imaging, nuclear medicine tests, and
pulmonary function tests. Where available in structured electronic
format (for example, drug and clinical lab data), we expect that this
information would be exchanged in electronic format. However, where the
information is available only in unstructured electronic formats (for
example, free text and scanned images), we would allow the exchange of
unstructured information. Patient authorized entities could include any
individual or organization to which the patient has granted access to
their clinical information. Examples would include an insurance company
that covers the patient or a personal health record vendor identified
by the patient.
Perform medication reconciliation at relevant encounters
and each transition of care.
We believe greater clarification is needed around the term ``medication
reconciliation''. Public input received by the NCVHS Executive
Subcommittee and the HIT Policy Committee and our prior experiences
indicate confusion in the healthcare industry as to what constitutes
medication reconciliation. We propose to describe medication
reconciliation as the process of identifying the most accurate list of
all
[[Page 1858]]
medications that the patient is taking, including name, dosage,
frequency and route, by comparing the medical record to an external
list of medications obtained from a patient, hospital or other
provider. Also we would clarify transition of care as transfer of a
patient from one clinical setting (inpatient, outpatient, physician
office, home health, rehab, long-term care facility, etc.) to another
or from one EP or eligible hospital (as defined by CCN) to another. A
relevant encounter would be any encounter that the EP or eligible
hospital judges performs a medication reconciliation due to new
medication or long gaps in time between patient encounters or other
reasons determined by the EP or eligible hospital. We encourage
comments on whether our descriptions of ``transition of care'' and
``relevant encounter'' are sufficiently clear and medically relevant.
Provide summary care record for each transition of care or
referral.
This objective was not explicitly included in the HIT Policy
Committee's recommended objectives. However, they did include a measure
for the ``percent of transitions in care for which summary care record
is shared. We believe that in order for a measure to be relevant it
must correspond to an objective in the definition of meaningful use.
Therefore, we propose to add this objective in order to be able to
include the recommended measure. Furthermore, we add referrals because
the sharing of the patient care summary from one provider to another
communicates important information that the patient may not have been
able to provide, and can significantly improve the quality and safety
of referral care, and reduce unnecessary and redundant testing.
The fourth health outcomes policy priority identified by the HIT
Policy Committee is improving population and public health. The HIT
Policy Committee identified the following care goal to address this
priority:
The patient's health care team communicates with public
health agencies. The goal as recommended by the HIT Policy Committee is
``communicate with public health agencies.'' We found this goal to be
somewhat ambiguous, as it does not specify who must communicate with
public health agencies. We propose to specify ``the patient's health
care team'' as who would communicate with public health agencies.
For EPs, we propose the following objectives in the stage 1
criteria of meaningful use to further this care goal:
Capability to submit electronic data to immunization
registries and actual submission where possible and accepted.
Capability to provide electronic syndromic surveillance
data to public health agencies and actual transmission according to
applicable law and practice.
For eligible hospitals, we propose the following objectives in the
stage 1 criteria of meaningful use to further this care goal:
Capability to submit electronic data to immunization
registries and actual submission where required and accepted.
Capability to provide electronic submission of reportable
(as required by state or local law) lab results to public health
agencies and actual submission where it can be received.
Capability to provide electronic syndromic surveillance
data to public health agencies and actual transmission according to
applicable law and practice.
The fifth health outcomes policy priority is to ensure adequate
privacy and security protections for personal health information. The
following care goals for meaningful use address this priority:
Ensure privacy and security protections for confidential
information through operating policies, procedures, and technologies
and compliance with applicable law.
Provide transparency of data sharing to patient.
For EPs and eligible hospitals, we propose the following objective
in the stage 1 criteria of meaningful use to further these care goals:
Protect electronic health information created or
maintained by the certified EHR technology through the implementation
of appropriate technical capabilities.
This objective is different from the two objectives recommended by the
HIT Policy Committee. Those objectives were ``Compliance with HIPAA
Privacy and Security Rules'' and ``Compliance with fair data sharing
practices set forth in the Nationwide Privacy and Security Framework''.
While we presume that the HIT Policy Committee is referring to the
certified EHR technology and its use being in compliance with the HIPAA
Privacy and Security Rules, it is not explicit. Compliance with HIPAA
privacy and security rules is required for all covered entities,
regardless of whether they participate in the EHR incentive programs or
not. Furthermore, compliance constitutes a wide range of activities,
procedures, and infrastructure. We propose to rephrase the objective to
ensure that meaningful use of the certified EHR technology supports
compliance with the HIPAA Privacy and Security Rules and compliance
with fair sharing data practices outlined in the Nationwide Privacy and
Security Framework (http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848088_0_0_18/NationwidePS_Framework-5.pdf), but
do not believe meaningful use of certified EHR technology is the
appropriate regulatory tool to ensure such compliance with the HIPAA
Privacy and Security Rules.
(2) Health IT Functionality Measures
In order for an EP or an eligible hospital to demonstrate that it
meets these proposed objectives, we believe a measure is necessary for
each objective. To provide structure to these measures, we group the
measures into two categories: Health IT functionality measures and
clinical quality measures. The health IT functionality measures are
discussed in this section, while the clinical quality measures are
discussed in section II.A.3 of this proposed rule.
Without a measure for each objective, we believe that the
definition of meaningful use becomes too ambiguous to fulfill its
purpose. The use of measures also creates the flexibility to account
for realities of current HIT products and infrastructure and the
ability to account for future advances. The HIT Policy Committee did
recommend some measures; however, they did not explicitly link each
measure to an objective. Therefore, the proposed measures set forth
below are a significant departure from the recommendation of the HIT
Policy Committee.
For each of these measures utilizing a percentage and the reporting
of clinical quality measures, we propose at Sec. 495.10 that EPs and
eligible hospitals submit numerator and denominator information to CMS.
We invite comment on our burden estimates associated with reporting
these measures (see section III. of this proposed rule).
EP Objective: Use CPOE.
EP Measure: CPOE is used for at least 80 percent of all orders.
CPOE is a capability included in the certification criteria for
certified EHR technology (to be defined by the ONC in its upcoming
interim final rule). We believe it is important to ensure that this
capability is continuously utilized. Therefore, we believe in order to
meet this objective it is not sufficient to demonstrate use of this
capability once, but rather, an EP must utilize this capability as part
of his or her daily work process.
[[Page 1859]]
We consider two methods of for measuring use of the CPOE
functionality: the percentage of orders entered using CPOE or a count
of orders entered using CPOE. To illustrate the difference, an example
of measuring percentage use of the CPOE functionality would be 80
percent of all of an EP's orders were entered using the CPOE
functionality of certified EHR technology during the EHR reporting
period. An example of counting orders using the CPOE functionality
would be requiring that the EP entered at least 100 orders using CPOE
during the EHR reporting period. A count of orders entered using CPOE
would be easier to document than a percentage of orders, as an EP would
only have to count the number of times he or she entered an order using
CPOE, as opposed to tabulating both when he or she did so and when he
or she failed to do so. However, a count does not enable variations
between EPs to be accounted for. For instance, a count-based
measurement would not take into consideration differences in patient
volume among EPs, which may be a concern to those EPs with a low
patient volume. A percentage-based measurement would account for
variations in volume and would allow for a more revealing measurement
of an EP's individual performance in meeting the objective. Therefore,
we are proposing that an EP's successful completion of this objective
be based on a percentage.
To calculate the percentage, CMS and ONC have worked together to
define the following:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is orders issued by the EP entered
using the CPOE functionality of certified EHR technology during the EHR
reporting period. The denominator for this objective is all orders
issued by the EP during the EHR reporting period. These are orders
issued by an EP for both their Medicare/Medicaid population and all
other patients. We believe it is unlikely that an EP would use one
record keeping system for one patient population and another system for
another patient population at one location. Requiring reporting
differences based on payers would actually increase the burden of
meeting meaningful use. We are concerned about the application of this
denominator for EPs who see patients in multiple practices or multiple
locations. If an EP does not have certified EHR technology available at
each location/practice where they see patients it could become
impossible to reach the thresholds set for measuring the objectives. We
do not seek to exclude EPs who meaningfully use certified EHR
technology when it is available because they also provide care in
another practice where certified EHR technology is not available.
Therefore we are proposing all measures be limited to actions taken at
practices/locations equipped with certified EHR technology. A practice
is equipped if certified EHR technology is available at the beginning
of the EHR reporting period for a given location. Equipped does not
mean the certified EHR technology is functioning on any given day in
the EHR reporting period. Allowances for downtime and other technical
issues with certified EHR technology are made in the establishment of
the measure thresholds. We are concerned that seeing a patient without
certified EHR technology available does not advance the health care
policy priorities of the definition of meaningful use. We are also
concerned about possible inequality between EPs receiving the same
incentive, but using certified EHR technology for different proportions
of their patient population. We believe that an EP would have the
greatest control of whether certified EHR technology is available in
the practice in which they see the greatest proportion of their
patients. We are proposing that to be a meaningful EHR user an EP must
have 50 percent or more of their patient encounters during the EHR
reporting period at a practice/location or practices/locations equipped
with certified EHR technology. An EP for who does not conduct 50
percent of their patient encounters in any one practice/location would
have to meet the 50 percent threshold through a combination of
practices/locations. While control is less assured in this situation,
CMS still needs to advance the health care priorities of the definition
of meaningful use and provide some level of equity. We invite comments
as to whether this denominator is feasible to obtain for EPs, whether
this exclusion (the denominator for patients seen when certified EHR
technology is not available) is appropriate, whether a minimum
threshold is necessary and whether 50 percent is an appropriate
threshold. We note that in evaluating the 50 percent threshold, our
proposal is to review all locations/organizations at which an EP
practices. So, for example, if the EP practices at both an FQHC and
within his or her individual practice, we would include in our review
both of these locations.
As this objective relies solely on a capability included as part of
certified EHR technology and is not, for purposes of Stage 1 criteria,
reliant on the electronic exchange of information, we believe it would
be appropriate to set a high percentage threshold. We therefore propose
to set the percentage required for successful demonstration at 80
percent. Though full compliance (that is, 100 percent) is the ultimate
goal, 80 percent seemed an appropriate standard for Stage 1 meaningful
use as it creates a high standard, while still allowing room for
technical hindrances and other barriers to reaching full compliance.
For other objectives that are reliant on the electronic exchange of
information, we are cognizant that in most areas of the country, the
infrastructure necessary to support such exchange is not yet currently
available. We anticipate raising the threshold for these objectives in
future definitions of meaningful use as the capabilities of HIT
infrastructure increases. The intent and policy goal with raising this
threshold is to ensure that meaningful use encourages patient-centric,
interoperable health information exchange across provider organizations
regardless of provider's business affiliation or EHR platform.
Eligible Hospital Objective: Use of CPOE for orders (any type)
directly entered by authorizing provider (for example, MD, DO, RN, PA,
NP).
Eligible Hospital Measure: CPOE is used for at least 10 percent of
all orders.
To calculate the percentage, CMS and ONC have worked together to
define the following:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is orders entered in an inpatient
facility/department that falls under the eligible hospital's CCN and by
an authorized provider using CPOE functionality of certified EHR
technology during the EHR reporting period. Inpatient facility/
department is defined by the place of service code 21. Further
discussion about POS 21 is available at section II.A.6. of this
proposed rule and at http://www.cms.hhs.gov/PlaceofServiceCodes/. The
denominator for this objective is all orders entered in an inpatient
facility/department that falls under the eligible hospital's CCN and
issued by the authorized providers in the hospital during the EHR
reporting period. These are orders are those issued are for both their
Medicare/Medicaid population and all other
[[Page 1860]]
patients. The rationale for the establishment of this measure is
identical to that of the EP, except in the establishment of the
threshold percentage. In considering CPOE, the HIT Policy Committee did
specify this lower percentage (10 percent) for eligible hospitals.
Public input described previously in this proposed rule indicated that
CPOE is traditionally one of the last capabilities implemented at
hospitals. Also, many hospitals choose to implement one department at a
time. Detailed comments can be found at http://healthit.hhs.gov/meaningfuluse. For these reasons the HIT Policy Committee recommended
this lower threshold. We agree with the lower threshold for the same
reasons.
EP/Eligible Hospital Objective: Implement drug-drug, drug-allergy,
drug-formulary checks.
EP/Eligible Hospital Measure: The EP/eligible hospital has enabled
this functionality.
The capability of conducting automated drug-drug, drug-allergy, and
drug-formulary checks is included in the certification criteria for
certified EHR technology (to be determined by ONC in its upcoming
interim final rule). This automated check provides information to
advise the EP or eligible hospital's decisions in prescribing drugs to
a patient. The only action taken by the EP or eligible hospital is to
consider this information. Many current EHR technologies have the
option to disable these checks and the certification process does not
require the removal of this option. Therefore, in order to meet this
objective, an EP or eligible hospital would be required to enable this
functionality. While this does not ensure that an EP or an eligible
hospital is considering the information provided, it does ensure that
the information is available.
EP/Eligible Hospital Objective: Maintain an up-to-date problem list
of current and active diagnoses based on ICD-9-CM or SNOMED CT[supreg].
EP/Eligible Hospital Measure: At least 80 percent of all unique
patients seen by the EP or admitted to the eligible hospital have at
least one entry or an indication of none recorded as structured data.
The capability to maintain an up-to-date problem list of current
and active diagnoses based on ICD-9-CM or SNOMED CT[supreg] is included
in the certification criteria for certified EHR technology (to be
defined by ONC in its upcoming interim final rule). Meaningful use
seeks to ensure that those capabilities are utilized. Therefore, we
believe in order to meet this objective it is not sufficient to
demonstrate this capability once, but rather to comply with the
objective, an EP or an eligible hospital must utilize this capability
as part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen by an EP or admitted to an inpatient facility/department (POS 21)
that falls under the eligible hospital's CCN during the EHR reporting
period that have at least one ICD-9-CM or SNOMED CT[supreg] -coded
entry or an indication of none in the problem list. A unique patient
means that even if a patient is seen multiple times during the EHR
reporting period they are only counted once. The reason we propose to
base the measure on unique patients as opposed to every patient
encounter, is that a problem list would not necessarily have to be
updated at every visit. The denominator for this objective is the
number of unique patients seen by the EP or admitted to an inpatient
facility/department (POS 21) that falls under the eligible hospital's
CCN during the EHR reporting period. As this objective relies solely on
a capability included as part of certified EHR technology and is not
reliant on the electronic exchange of information, we propose to set
the percentage required for successful demonstration at 80 percent. The
reasoning for this is the same as under CPOE for EPs. Though full
compliance (that is, 100 percent) is the ultimate goal, 80 percent
seemed an appropriate standard for Stage 1 meaningful use as it creates
a high standard, while still allowing room for technical hindrances and
other barriers to reaching full compliance.
EP Objective: Generate and transmit permissible prescriptions
electronically (eRx).
EP Measure: At least 75 percent of all permissible prescriptions
written by the EP are transmitted electronically using certified EHR
technology.
The capability to generate and transmit permissible prescriptions
electronically is included in the certification criteria for certified
EHR technology (to be defined by ONC in its upcoming interim final
rule). Meaningful use seeks to ensure that those capabilities are
utilized. Therefore, we believe in order to meet this objective it is
not sufficient to demonstrate this capability once, but rather to
comply with the objective, an EP must utilize this capability as part
of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of prescriptions for
other than controlled substances generated and transmitted
electronically during the EHR reporting period. The denominator for
this objective is the number of prescriptions written for other than
controlled substances during the EHR reporting period. While this
measure does rely on the electronic exchange of information based on
the public input previously discussed and our own experiences with e-Rx
programs, we believe this is the most robust electronic exchange
currently occurring and propose 75 percent as an achievable threshold
for the Stage 1 criteria of meaningful use. Though full compliance
(that is, 100 percent) is the ultimate goal, 75 percent seemed an
appropriate standard for Stage 1 meaningful use as it creates a high
standard, while still allowing room for technical hindrances and other
barriers to reaching full compliance.
EP/Eligible Hospital Objective: Maintain active medication list.
EP/Eligible Hospital Measure: At least 80 percent of all unique
patients seen by the EP or admitted by the eligible hospital have at
least one entry (or an indication of ``none'' if the patient is not
currently prescribed any medication) recorded as structured data.
The capability to maintain an active medication list is included in
the certification standards for certified EHR technology (to be defined
by ONC in its upcoming interim final rule). Meaningful use seeks to
ensure that those capabilities are utilized. Therefore, we believe in
order to meet this objective it is not sufficient to demonstrate this
capability once, but rather to comply with the objective, an EP or
eligible hospital must utilize this capability as part of the daily
work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
[[Page 1861]]
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen by the EP or admitted to an inpatient facility/department (POS 21)
that falls under the eligible hospital's CCN during the EHR reporting
period who have at least one entry (or an indication of ``none'' if the
patient is not currently prescribed any medication) recorded as
structured data in their medication list. A unique patient is discussed
under the objective of maintaining an up-to-date problem list. The
denominator for this objective is the number of unique patients seen by
the EP or admitted to an inpatient facility/department (POS 21) that
falls under the eligible hospital's CCN during the EHR reporting
period. As this objective relies solely on a capability included as
part of certified EHR technology and is not reliant on the electronic
exchange of information, we propose to set the percentage required for
successful demonstration at 80 percent. The reasoning for this is the
same as under CPOE for EPs. Though full compliance (that is, 100
percent) is the ultimate goal, 80 percent seemed an appropriate
standard for Stage 1 meaningful use as it creates a high standard,
while still allowing room for technical hindrances and other barriers
to reaching full compliance.
EP/Eligible Hospital Objective: Maintain active medication allergy
list.
EP/Eligible Hospital Measure: At least 80 percent of all unique
patients seen by the EP or admitted to the eligible hospital have at
least one entry (or an indication of ``none'' if the patient has no
medication allergies) recorded as structured data.
The capability to maintain an active medication allergy list using
structured data is included in the certification standards for
certified EHR technology (to be defined by ONC in its upcoming interim
final rule). Meaningful use seeks to ensure that those capabilities are
utilized. Therefore, we believe in order to meet this objective it is
not sufficient to demonstrate this capability once, but rather to
comply with the objective, an EP or eligible hospital must utilize this
capability as part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen by the EP or admitted to an inpatient facility/department (POS 21)
that falls under the eligible hospital's CCN during the EHR reporting
period who have at least one entry (or an indication of ``none'')
recorded as structured data in their medication allergy list. A unique
patient is discussed under the objective of maintaining an up-to-date
problem list. The denominator for this objective is the number of
unique patients seen by the EP or admitted to an inpatient facility/
department (POS 21) that falls under the eligible hospital's CCN during
the EHR reporting period. As this objective relies solely on a
capability included as part of certified EHR technology and is not
reliant on the electronic exchange of information, we propose to set
the percentage required for successful demonstration at 80 percent. The
reasoning for this is the same as under CPOE for EPs. Though full
compliance (that is, 100 percent) is the ultimate goal, 80 percent
seemed an appropriate standard for Stage 1 meaningful use as it creates
a high standard, while still allowing room for technical hindrances and
other barriers to reaching full compliance.
EP/Eligible Hospital Objective: Record demographics.
EP/Eligible Hospital Measure: At least 80 percent of all unique
patients seen by the EP or admitted to the eligible hospital have
demographics recorded as structured data.
The capability to record demographics as structured data is
included in the certification standards for certified EHR technology
(to be defined by ONC in its upcoming interim final rule). Meaningful
use seeks to ensure that those capabilities are utilized. Therefore, we
believe in order to meet this objective it is not sufficient to
demonstrate this capability once, but rather to comply with the
objective, an EP or eligible hospital must utilize this capability as
part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen by the EP or admitted to an inpatient facility/department (POS 21)
that falls under the eligible hospital's CCN during the EHR reporting
period who have all required demographic elements (preferred language,
insurance type, gender, race, and ethnicity, date of birth and, for
hospitals, date and cause of death in the case of mortality) recorded
as structured data in their electronic record. A unique patient is
discussed under the objective of maintaining an up-to-date problem
list. The denominator for this objective is the number of unique
patients seen by the EP or admitted to an inpatient facility/department
(POS 21) that falls under the eligible hospital's CCN during the EHR
reporting period. As this objective relies solely on a capability
included as part of certified EHR technology and is not, for purposes
of Stage 1 criteria, reliant on the electronic exchange of information,
we propose to set the percentage required for successful demonstration
at 80 percent. The reasoning for this is the same as under CPOE for
EPs.
EP/Eligible Hospital Objective: Record and chart changes in vital
signs.
EP/Eligible Hospital Measure: For at least 80 percent of all unique
patients age 2 and over seen by the EP or admitted to the eligible
hospital, record blood pressure and BMI; additionally, plot growth
chart for children age 2 to 20.
The capability to record vital signs is included in the
certification standards for certified EHR technology (to be defined by
ONC in its upcoming interim final rule). Meaningful use seeks to ensure
that those capabilities are utilized. Therefore, we believe in order to
meet this objective it is not sufficient to demonstrate this capability
once, but rather to comply with the objective, an EP or eligible
hospital must utilize this capability as part of the daily work
process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
age 2 and over seen by the EP or admitted to an inpatient facility/
department (POS 21) that falls under the eligible hospital's CCN during
the EHR reporting period who have a record of their blood pressure, and
BMI (growth chart for children 2-20) in their record. A unique patient
is discussed under the objective of maintaining an up-to-date problem
[[Page 1862]]
list. The denominator for this objective is the number of unique
patients age 2 or over seen by the EP or admitted to an inpatient
facility/department (POS 21) that falls under the eligible hospital's
CCN during the EHR reporting period. As this objective relies solely on
a capability included as part of certified EHR technology and is not,
for purposes of Stage 1 criteria, reliant on the electronic exchange of
information, we propose to set the percentage required for successful
demonstration at 80 percent. The reasoning for this is the same as
under CPOE for EPs. Though full compliance (that is, 100 percent) is
the ultimate goal, 80 percent seemed an appropriate standard for Stage
1 meaningful use as it creates a high standard, while still allowing
room for technical hindrances and other barriers to reaching full
compliance.
EP/Eligible Hospital Objective: Record smoking status for patients
13 years old or older.
EP/Eligible Hospital Measure: At least 80 percent of all unique
patients 13 years old or older seen by the EP or admitted to the
eligible hospital have ``smoking status'' recorded.
The capability to record smoking status is included in the
certification standards for certified EHR technology (to be defined by
ONC in its upcoming interim final rule). Meaningful use seeks to ensure
that those capabilities are utilized. Therefore, we believe in order to
meet this objective it is not sufficient to demonstrate this capability
once, but rather to comply with the objective, an EP or eligible
hospital must utilize this capability as part of the daily work
process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
age 13 or older seen by the EP or admitted to an inpatient facility/
department (POS 21) that falls under the eligible hospital's CCN during
the EHR reporting period who have a record of their smoking status. A
unique patient is discussed under the objective of maintaining an up-
to-date problem list. The denominator for this objective is the number
of unique patients age 13 or older seen by the EP or admitted to an
inpatient facility/department (POS 21) that falls under the eligible
hospital's CCN during the EHR reporting period. As this objective
relies solely on a capability included as part of certified EHR
technology and is not, for purposes of Stage 1 criteria, reliant on the
electronic exchange of information, we propose to set the percentage
required for successful demonstration at 80 percent. The reasoning for
this is the same as under CPOE by the EP. Though full compliance (that
is, 100 percent) is the ultimate goal, 80 percent seemed an appropriate
standard for Stage 1 meaningful use as it creates a high standard,
while still allowing room for technical hindrances and other barriers
to reaching full compliance.
EP/Eligible Hospital Objective: Incorporate clinical lab-test
results into EHR as structured data.
EP/Eligible Hospital Measure: At least 50 percent of all clinical
lab tests results ordered by the EP or by an authorized provider of the
eligible hospital during the EHR reporting period whose results are in
either in a positive/negative or numerical format are incorporated in
certified EHR technology as structured data.
The capability to incorporate lab-test results is included in the
certification standards for certified EHR technology (to be defined by
ONC in its upcoming interim final rule). Meaningful use seeks to ensure
that those capabilities are utilized. Therefore, we believe in order to
meet this objective it is not sufficient to demonstrate this capability
once, but rather to comply with the objective, an EP or eligible
hospital must utilize this capability as part of the daily work
process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of lab tests ordered
during the EHR reporting period by the EP or authorized providers of
the eligible hospital for patients admitted to an inpatient facility/
department (POS 21) that falls under the eligible hospital's CCN whose
results are expressed in a positive or negative affirmation or as a
number and are incorporated as structured data into certified EHR
technology. The denominator for this objective is the number of lab
tests ordered during the EHR reporting period by the EP or authorized
providers of the eligible hospital for patients admitted to an
inpatient facility/department (POS 21) that falls under the eligible
hospital's CCN whose results are expressed in a positive or negative
affirmation or as a number. This objective is reliant on the electronic
exchange of information. We are cognizant that in most areas of the
country, the infrastructure necessary to support such exchange is still
being developed. Therefore, we believe that 80 percent is too high a
threshold for the Stage 1 criteria of meaningful use. We propose 50
percent as the threshold based on our discussions with EHR vendors,
current EHR users, and laboratories. We invite comment on whether this
50 percent is feasible for the Stage 1 criteria of meaningful use. We
anticipate raising the threshold for this objective in future stages of
the criteria of meaningful use as the capabilities of HIT
infrastructure increases.
EP/Eligible Hospital Objective: Generate lists of patients by
specific conditions to use for quality improvement, reduction of
disparities, research, and outreach.
EP/Eligible Hospital Measure: Generate at least one report listing
patients of the EP or eligible hospital with a specific condition.
The capability to generate lists of patients by specific conditions
is included in the certification criteria for certified EHR technology
(to be defined by ONC in its upcoming interim final rule). Meaningful
use seeks to ensure that those capabilities are utilized. Therefore, we
believe in order to meet this objective an EP or eligible hospital
should utilize this capability at least once during the EHR reporting
period so this information would be available to them for their use. An
EP or eligible hospital is best positioned to determine which reports
are most useful to their care efforts. Therefore, we do not propose to
direct certain reports be created, but rather to require EPs and
hospitals to attest to the ability of the EP or eligible hospital to do
so and to attest that they have actually done so at least once.
EP Objective: Report ambulatory quality measures to CMS or the
States.
EP Measure: For 2011, an EP would provide the aggregate numerator
and denominator through attestation as discussed in section II.A.3 of
this proposed rule. For 2012, an EP would electronically submit the
measures are discussed in section II.A.3. of this proposed rule.
Eligible Hospital Objective: Report hospital quality measures to
CMS or the States.
Eligible Hospital Measure: For 2011, an eligible hospital would
provide the aggregate numerator and denominator
[[Page 1863]]
through attestation as discussed in section II.A.3 of this proposed
rule. For 2012, an eligible hospital would electronically submit the
measures are discussed in section II.A.3. of this proposed rule.
EP Objective: Send reminders to patients per patient preference for
preventive/follow-up care.
EP Measure: Reminder sent to at least 50 percent of all unique
patients seen by the EP or admitted to the eligible hospital that are
50 and over.
The capability to generate reminders for preventive/follow-up care
is included in the certification standards for certified EHR technology
(to be defined by ONC in its upcoming interim final rule). Meaningful
use seeks to ensure that those capabilities are utilized. Therefore, we
believe in order to meet this objective it is not sufficient to
demonstrate this capability once, but rather to comply with the
objective an EP must utilize this capability as part of the daily work
process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
age 50 or over seen by the EP during the EHR reporting period who are
provided reminders. A unique patient is discussed under the objective
of maintaining an up-to-date problem list. We propose to limit the
patient population for this measure to patients age 50 or over as they
are more likely than the norm to require additional preventive or
follow-up care. The denominator for this objective is the number of
unique patients seen by the EP during the EHR reporting period. We
propose to set the percentage required for successful demonstration at
50 percent. While the objective relies on a capability included as part
of certified EHR technology there is still the added component of
determining patient preference. Also while we believe we greatly
increase the likelihood that additional preventive or follow up care
will be required by limiting the patient population to age 50 or over,
there may still be instances where there is not an additional
preventive or follow up care step needed. For these reasons, we propose
the lower threshold of 50 percent. We specifically invite comments on
whether limiting the patient population by age is the best approach.
EP/Eligible Hospital Objective: Implement five clinical decision
support rules relevant to specialty or high clinical priority,
including for diagnostic test ordering, along with the ability to track
compliance with those rules.
EP/Eligible Hospital Measure: Implement five clinical decision
support rules relevant to the clinical quality metrics the EP/Eligible
Hospital is responsible for as described further in section II.A.3.
The capability to provide clinical decision support is included in
the certification standards for certified EHR technology (to be defined
by ONC in its upcoming interim final rule). Clinical decision support
at the point of care is a critical aspect of improving quality, safety,
and efficiency. Research has shown that decision support must be
targeted and actionable to be effective, and that ``alert fatigue''
must be avoided. Establishing decision supports for a small set of high
priority conditions, ideally linked to quality measures being reported,
is feasible and desirable. Meaningful use seeks to ensure that those
capabilities are utilized. Therefore, we believe in order to meet this
objective an EP or eligible hospital should implement five clinical
decision support rules relevant to the clinical quality metrics
described in section II.A.3 before the end of the EHR reporting period
and attest to that implementation.
EP/Eligible Hospital Objective: Check insurance eligibility
electronically from public and private payers.
EP/Eligible Hospital Measure: Insurance eligibility checked
electronically for at least 80 percent of all unique patients seen by
the EP or admitted to an eligible hospital.
The capability to check insurance eligibility electronically is
included in the certification criteria for certified EHR technology (to
be defined by ONC in its upcoming interim final rule). Meaningful use
seeks to ensure that those capabilities are utilized. Therefore, we
believe in order to meet this objective it is not sufficient to
demonstrate this capability once, but rather to comply with the
objective an EP or eligible hospital must utilize this capability as
part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen by the EP or admitted to an inpatient facility/department (POS 21)
that falls under the eligible hospital's CCN during the EHR reporting
period whose insurance eligibility is checked electronically. A unique
patient is discussed under the objective of maintaining an up-to-date
problem list. The denominator for this objective is the number of
unique patients seen by the EP or admitted to an inpatient facility/
department (POS 21) that falls under the eligible hospital's CCN during
the EHR reporting period whose insurer allows for the electronic
verification of eligibility. While this objective does rely on the
electronic exchange of information this particular exchange is an
established HIPAA standard transaction, therefore we propose to set the
percentage required for successful demonstration at 80 percent. The
additional reasoning for this is the same as under CPOE for EPs. Though
full compliance (that is, 100 percent) is the ultimate goal, 80 percent
seemed an appropriate standard for Stage 1 meaningful use as it creates
a high standard, while still allowing room for technical hindrances and
other barriers to reaching full compliance.
EP/Eligible Hospital Objective: Submit claims electronically to
public and private payers.
EP/Eligible Hospital Measure: At least 80 percent of all claims
filed electronically by the EP or the eligible hospital.
The capability to submit claims electronically to public and
private payers is included in the certification criteria for certified
EHR technology (to be defined by ONC in its upcoming interim final
rule). Meaningful use seeks to ensure that those capabilities are
utilized. Therefore, we believe in order to meet this objective it is
not sufficient to demonstrate this capability once, but rather to
comply with the objective, an EP or eligible hospital must utilize this
capability as part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of claims submitted
[[Page 1864]]
electronically using certified EHR technology for patients seen by the
EP or admitted to an inpatient facility/department (POS 21) that falls
under the eligible hospital's CCN during the EHR reporting period. The
denominator for this objective is the number of claims filed seen by
the EP or admitted to an inpatient facility/department (POS 21) that
falls under the eligible hospital's CCN during the EHR reporting
period. While this objective relies on the electronic exchange of
information, nearly all public and private payers accept electronic
claims. Given the advance state of this aspect of electronic exchange
of information, we propose to set the percentage required for
successful demonstration at 80 percent. The additional reasoning for
this is the same as under CPOE for EPs. Though full compliance (that
is, 100 percent) is the ultimate goal, 80 percent seemed an appropriate
standard for Stage 1 meaningful use as it creates a high standard,
while still allowing room for technical hindrances and other barriers
to reaching full compliance.
EP Objective: Provide patients with an electronic copy of their
health information (including diagnostic test results, problem list,
medication lists, and allergies) upon request.
Eligible Hospital Objective: Provide patients with an electronic
copy of their health information (including diagnostic test results,
problem list, medication lists, allergies, discharge summary, and
procedures), upon request.
EP/Eligible Hospital Measure: At least 80 percent of all patients
who request an electronic copy of their health information are provided
it within 48 hours.
The capability to create an electronic copy of a patient's health
information is included in the certification criteria for certified EHR
technology (to be defined by ONC in its upcoming interim final rule).
Meaningful use seeks to ensure that those capabilities are utilized.
Therefore, we believe in order to meet this objective it is not
sufficient to demonstrate this capability once, but rather to comply
with the objective, an EP or eligible hospital must utilize this
capability as part of the daily work process. In addition, all patients
have a right under ARRA to an electronic copy of their health
information. This measure seeks to ensure that this requirement is met
in a timely fashion. Providing patients with an electronic copy of
their health information demonstrates one of the many benefits health
information technology can provide and we believe that it is an
important part of becoming a meaningful EHR user. We also believe that
certified EHR technology will provide EPs and eligible hospitals more
efficient means of providing copies of health information to patients
which is why we have proposed that a request for an electronic copy be
provided to the patient within 48 hours.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of patients seen by
the EP or admitted to an inpatient facility/department (POS 21) that
falls under the eligible hospital's CCN during the EHR reporting period
that request an electronic copy of their health information and receive
it within 48 hours. The denominator for this objective is the number of
patients seen by the EP or admitted to an inpatient facility/department
(POS 21) that falls under the eligible hospital's CCN who request an
electronic copy of their health information during the EHR reporting
period. As this objective relies solely on a capability included as
part of certified EHR technology and is not, for purposes of Stage 1
criteria, reliant on the electronic exchange of structured information
between health care providers, we propose to set the percentage
required for successful demonstration at 80 percent. The reasoning for
this is the same as under CPOE for EPs. Though full compliance (that
is, 100 percent) is the ultimate goal, 80 percent seemed an appropriate
standard for Stage 1 meaningful use as it creates a high standard,
while still allowing room for technical hindrances and other barriers
to reaching full compliance.
Eligible Hospital Objective: Provide patients with an electronic
copy of their discharge instructions and procedures at time of
discharge, upon request.
Eligible Hospital Measure: At least 80 percent of all patients who
are discharged from an eligible hospital and who request an electronic
copy of their discharge instructions and procedures are provided it.
The capability to produce an electronic copy of discharge
instructions and procedures is included in the certification criteria
for certified EHR technology (to be defined by ONC in its upcoming
interim final rule). Meaningful use seeks to ensure that those
capabilities are utilized. Therefore, we believe in order to meet this
objective it is not sufficient to demonstrate this capability once, but
rather to comply with the objective an eligible hospital must utilize
this capability as part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of patients
discharged from an inpatient facility/department (POS 21) that falls
under the eligible hospital's CCN during the EHR reporting period that
request an electronic copy of their discharge instructions and
procedures and receive it. The denominator for this objective is the
number of patients discharged from an inpatient facility/department
(POS 21) that falls under the eligible hospital's CCN who request an
electronic copy of their discharge instructions and procedures during
the EHR reporting period. As this objective relies solely on a
capability included as part of certified EHR technology and is not, for
purposes of Stage 1 criteria, reliant on the electronic exchange
between health care providers of structured information, we propose to
set the percentage required for successful demonstration at 80 percent.
The reasoning for this is the same as under CPOE for EPs. Though full
compliance (that is, 100 percent) is the ultimate goal, 80 percent
seemed an appropriate standard for Stage 1 meaningful use as it creates
a high standard, while still allowing room for technical hindrances and
other barriers to reaching full compliance.
EP Objective: Provide patients with timely electronic access to
their health information (including lab results, problem list,
medication lists, allergies).
EP Measure: At least 10 percent of all unique patients seen by the
EP are provided timely electronic access to their health information
The capability to provide timely electronic access to health
information is included in the certification criteria for certified EHR
technology (to be defined by ONC in its upcoming interim final rule).
Meaningful use seeks to ensure that those capabilities are utilized.
Therefore, we believe in order to meet this objective it is not
sufficient to demonstrate this capability once, but rather to comply
with the objective, an EP must utilize this capability as part of the
daily work process.
[[Page 1865]]
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen during the EHR reporting period who have timely, electronic access
to their health information (for example, have established a user
account and password on a patient portal). A unique patient is
discussed under the objective of maintaining an up-to-date problem
list. The denominator for this objective is the number of unique
patients seen during the EHR reporting period. We recognize that many
patients may not have internet access, may not be able or interested to
use a patient portal. Health systems that have actively promoted such
technologies have been able to achieve active use by over 30 percent of
their patients, but this may not be realistic for many practices in the
short term.
EP Objective: Provide clinical summaries to patients for each
office visit.
EP Measure: Clinical summaries provided to patients for at least 80
percent of all office visits.
The capability to provide a clinical summary is included in the
certification standards for certified EHR technology (to be defined by
ONC in its upcoming interim final rule). Meaningful use seeks to ensure
that those capabilities are utilized. Therefore, we believe in order to
meet this objective it is not sufficient to demonstrate this capability
once, but rather to comply with the objective, an EP must utilize this
capability as part of the daily work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of unique patients
seen in the office during the EHR reporting period who are provided a
clinical summary of their visit. A unique patient is discussed under
the objective of maintaining an up-to-date problem list. The clinical
summary can be provided through a PHR, patient portal on the Web site,
secure e-mail, electronic media such as CD or USB fob, or printed copy.
The after-visit clinical summary contains an updated medication list,
laboratory and other diagnostic test orders, procedures and other
instructions based on clinical discussions that took place during the
office visit. The denominator for this objective is the number of
unique patients seen in the office during the EHR reporting period. As
this objective relies solely on a capability included as part of
certified EHR technology and is not, for purposes of Stage 1 criteria,
reliant on the electronic exchange of structured information, we
propose to set the percentage required for successful demonstration at
80 percent. The reasoning for this is the same as under CPOE for EPs.
Though full compliance (that is, 100 percent) is the ultimate goal, 80
percent seemed an appropriate standard for Stage 1 meaningful use as it
creates a high standard, while still allowing room for technical
hindrances and other barriers to reaching full compliance.
EP Objective: Capability to exchange key clinical information (for
example, problem list, medication list, allergies, and diagnostic test
results), among providers of care and patient authorized entities
electronically.
Eligible Hospital Objective: Capability to exchange key clinical
information (for example, discharge summary, procedures, problem list,
medication list, allergies, diagnostic test results), among providers
of care and patient authorized entities electronically.
EP/Eligible Hospital Measure: Performed at least one test of
certified EHR technology's capacity to electronically exchange key
clinical information.
The capability to send key clinical information electronically is
included in the certification criteria for certified EHR technology (to
be defined by ONC in its upcoming interim final rule). Meaningful use
seeks to ensure that those capabilities are utilized. However, this
objective is reliant on the electronic exchange of information. We are
cognizant that in most areas of the country, the infrastructure
necessary to support such exchange is still being developed. Therefore,
for the Stage 1 criteria of meaningful use we propose that EPs and
eligible hospitals test their ability to send such information at least
once prior to the end of the EHR reporting period. The testing could
occur prior to the beginning of the EHR reporting period. If multiple
EPs are using the same certified EHR technology in a shared physical
setting, the testing would only have to occur once for a given
certified EHR technology, as we do not see any value to running the
same test multiple times just because multiple EPs use the same
certified EHR technology. To be considered an ``exchange'' in this
section alone the clinical information must be sent between different
clinical entities with distinct certified EHR technology and not
between organizations that share a certified EHR.
EP/Eligible Hospital Objective: Perform medication reconciliation
at relevant encounters and each transition of care.
EP/Eligible Hospital Measure: Perform medication reconciliation for
at least 80 percent of relevant encounters and transitions of care.
The capability to perform medication reconciliation is included in
the certification standards for certified EHR technology (to be defined
by ONC in its upcoming interim final rule). Meaningful use seeks to
ensure that those capabilities are utilized. Therefore, we believe in
order to meet this objective it is not sufficient to demonstrate this
capability once, but rather to comply with the objective, an EP or
eligible hospital must utilize this capability as part of the daily
work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of relevant
encounters and transitions of care for which the EP or an inpatient
facility/department (POS 21) that falls under the eligible hospital's
CCN was a participant during the EHR reporting period where medication
reconciliation was performed. Relevant encounter and transition of care
are defined in the previous discussion of this objective in this
proposed rule. The denominator for this objective is the number of
relevant encounters and transitions of care for which the EP or an
inpatient facility/department (POS 21) that falls under the eligible
hospital's CCN was a participant during the EHR reporting period. As
this objective relies solely on a capability included as part of
certified EHR technology and is not, for the purposes of Stage 1
criteria, reliant on the electronic exchange of information, we propose
to set the percentage required for successful demonstration at 80
percent. The reasoning for this is the same as under CPOE for EPs.
Though full compliance (that is, 100 percent) is
[[Page 1866]]
the ultimate goal, 80 percent seemed an appropriate standard for Stage
1 meaningful use as it creates a high standard, while still allowing
room for technical hindrances and other barriers to reaching full
compliance.
EP/Eligible Hospital Objective: Provide summary care record for
each transition of care and referral.
EP/Eligible Hospital Measure: Provide summary of care record for at
least 80 percent of transitions of care and referrals.
The capability to provide a summary of care record is included in
the certification standards for certified EHR technology (to be defined
by ONC in its upcoming interim final rule). Meaningful use seeks to
ensure that those capabilities are utilized. Therefore, we believe in
order to meet this objective it is not sufficient to demonstrate this
capability once, but rather to comply with the objective an EP or
eligible hospital must utilize this capability as part of the daily
work process.
As discussed under CPOE, we will use a percentage. To calculate the
percentage, CMS and ONC have worked together to define the following
for this objective:
The numerator.
The denominator.
The required percentage for demonstrating successful
attainment of an objective.
The numerator for this objective is the number of transitions of
care and referrals for which the EP or an inpatient facility/department
(POS 21) that falls under the eligible hospital's CCN was the
transferring or referring provider during the EHR reporting period
where a summary of care record was provided. Summary of care record and
transitions of care are defined in the discussion of this objective in
this proposed rule. The summary of care record can be provided through
an electronic exchange, accessed through a secure portal, secure e-
mail, electronic media such as CD or USB fob, or printed copy. The
denominator for this objective is the number of transitions of care for
which the EP or an inpatient facility/department (POS 21) that falls
under the eligible hospital's CCN was the transferring or referring
provider during the EHR reporting period. As this objective can be
completed with or without the use of electronic exchange of
information, we propose to set the percentage required for successful
demonstration at 80 percent. The reasoning for this is the same as
under CPOE for EPs. Though full compliance (that is, 100 percent) is
the ultimate goal, 80 percent seemed an appropriate standard for Stage
1 meaningful use as it creates a high standard, while still allowing
room for technical hindrances and other barriers to reaching full
compliance.
EP/Eligible Hospital Objective: Capability to submit electronic
data to immunization registries and actual submission where required
and accepted.
EP/Eligible Hospital Measure: Performed at least one test of
certified EHR technology's capacity to submit electronic data to
immunization registries.
The capability to send electronic data to immunization registries
is included in the certification standards for certified EHR technology
(to be defined by ONC in its upcoming interim final rule). Meaningful
use seeks to ensure that those capabilities are utilized. However, this
objective is reliant on the electronic exchange of information. We are
cognizant that in many areas of the country, the infrastructure
necessary to support such exchange is still being developed. Therefore,
for the Stage 1 criteria of meaningful use we propose that EPs and
eligible hospitals test their ability to send such information at least
once prior to the end of the EHR reporting period. The testing could
occur prior to the beginning of the EHR reporting period. EPs in a
group setting using identical certified EHR technology would only need
to conduct a single test, not one test per EP. More stringent
requirements may be established for EPs and hospitals under the
Medicaid program in states where this capability exists. This is just
one example of a possible State proposed modification to meaningful use
in the Medicaid EHR incentive program. States may propose any
modification or addition to CMS in accordance with the discussion in
II.A.2.c. of this proposed rule.
Eligible Hospital Objective: Capability to provide electronic
submission of reportable lab results to public health agencies and
actual submission where it can be received.
Eligible Hospital Measure: Performed at least one test of certified
EHR technology capacity to provide electronic submission of reportable
lab results to public health agencies (unless none of the public health
agencies to which eligible hospital submits such information have the
capacity to receive the information electronically).
The capability to send reportable lab results is included in the
certification standards for certified EHR technology (to be defined by
ONC in its upcoming interim final rule). Meaningful use seeks to ensure
that those capabilities are utilized. However, this objective is
reliant on the electronic exchange of information. We are cognizant
that in most areas of the country, the infrastructure necessary to
support such exchange is still being developed. Therefore, for the
Stage 1 criteria of meaningful use we propose that eligible hospitals
test their ability to send such information at least once prior to the
end of the EHR reporting period. The testing could occur prior to the
beginning of the EHR reporting period. More stringent requirements may
be established for hospitals under the Medicaid program in States where
this capability exists. This is just one example of a possible State
proposed modification to meaningful use in the Medicaid EHR incentive
program. States may propose any modification or addition to CMS in
accordance with the discussion in II.A.2.c. of this proposed rule.
EP/Eligible Hospital Objective: Capability to provide electronic
syndromic surveillance data to public health agencies and actual
transmission according to applicable law and practice.
EP/Eligible Hospital Measure: Performed at least one test of
certified EHR technology's capacity to provide electronic syndromic
surveillance data to public health agencies (unless none of the public
health agencies to which an EP or eligible hospital submits such
information have the capacity to receive the information
electronically).
The capability to send electronic data to immunization registries
is included in the certification standards for certified EHR technology
(to be defined by ONC in its upcoming interim final rule). Meaningful
use seeks to ensure that those capabilities are utilized. However, this
objective is reliant on the electronic exchange of information. We are
cognizant that in most areas of the country, the infrastructure
necessary to support such exchange is still being developed. Therefore,
for the Stage 1 criteria of meaningful use we are proposing that EPs
and eligible hospitals test their ability to send such information at
least once prior to the end of the EHR reporting period. The testing
could occur prior to the beginning of the EHR reporting period. EPs in
a group setting using identical certified EHR technology would only
need to conduct a single test, not one test per EP. More stringent
requirements may be established for EPs and hospitals under the
Medicaid program in States where this capability exists. This is just
one example of a possible State proposed modification to meaningful use
in the Medicaid EHR incentive program. States may propose any
[[Page 1867]]
modification or addition to CMS in accordance with the discussion in
II.A.2.c. of this proposed rule.
EP/Eligible Hospital Objective: Protect electronic health
information maintained using certified EHR technology through the
implementation of appropriate technical capabilities.
EP/Eligible Hospital Measure: Conduct or review a security risk
analysis in accordance with the requirements under 45 CFR 164.308(a)(1)
and implement security updates as necessary.
The capability to protect electronic health information maintained
using certified EHR technology is included in the certification
standards for certified EHR technology (to be defined by ONC in its
upcoming interim final rule). Meaningful use seeks to ensure that those
capabilities are utilized. While certified EHR technology provides
tools for protecting health information, it is not a full protection
solution. Processes and possibly tools outside the scope of certified
EHR technology are required. Therefore, for the Stage 1 criteria of
meaningful use we propose that EPs and eligible hospitals conduct or
review a security risk analysis of certified EHR technology and
implement updates as necessary at least once prior to the end of the
EHR reporting period and attest to that conduct or review. The testing
could occur prior to the beginning of the EHR reporting period. This is
to ensure that the certified EHR technology is playing its role in the
overall strategy of the EP or eligible hospital in protecting health
information.
Table 2--Stage 1 Criteria for Meaningful Use
----------------------------------------------------------------------------------------------------------------
Stage 1 objectives
----------------------------------------
Health outcomes policy priority Care goals Eligible Stage 1 measures
professionals Hospitals
----------------------------------------------------------------------------------------------------------------
Improving quality, safety, Provide access to Use CPOE.......... Use of CPOE for For EPs, CPOE is
efficiency, and reducing comprehensive orders (any type) used for at least
health disparities. patient health directly entered 80% of all orders.
data for by authorizing For eligible
patient's health provider (for hospitals, CPOE is
care team. example, MD, DO, used for 10% of
RN, PA, NP). all orders.
Use evidence-based Implement drug- Implement drug- The EP/eligible
order sets and drug, drug- drug, drug- hospital has
CPOE. allergy, drug- allergy, drug- enabled this
formulary checks. formulary checks. functionality.
Apply clinical Maintain an up-to- Maintain an up-to- At least 80% of all
decision support date problem list date problem list unique patients
at the point of of current and of current and seen by the EP or
care. active diagnoses active diagnoses admitted to the
Generate lists of based on ICD-9-CM based on ICD-9-CM eligible hospital
patients who need or SNOMED or SNOMED have at least one
care and use them CT[supreg]. CT[supreg]. entry or an
to reach out to indication of none
patients. recorded as
structured data.
Report information Generate and .................. At least 75% of all
for quality transmit permissible
improvement and permissible prescriptions
public reporting. prescriptions written by the EP
electronically are transmitted
(eRx). electronically
using certified
EHR technology.
Maintain active Maintain active At least 80% of all
medication list. medication list. unique patients
seen by the EP or
admitted to the
eligible hospital
have at least one
entry (or an
indication of
``none'' if the
patient is not
currently
prescribed any
medication)
recorded as
structured data.
Maintain active Maintain active At least 80% of all
medication medication unique patients
allergy list. allergy list. seen, by the EP or
admitted to the
eligible hospital
have at least one
entry or (an
indication of
``none'' if the
patient has no
medication
allergies)
recorded as
structured data.
Record Record At least 80% of all
demographics. demographics. unique patients
[cir] preferred [cir] preferred seen by the EP or
language. language. admitted to the
[cir] insurance [cir] insurance eligible hospital
type. type. have demographics
[cir] gender...... [cir] gender...... recorded as
[cir] race........ [cir] race........ structured data.
[cir] ethnicity... [cir] ethnicity...
[cir] date of [cir] date of
birth. birth.
[cir] date and
cause of death in
the event of
mortality.
[[Page 1868]]
Record and chart Record and chart For at least 80% of
changes in vital changes in vital all unique
signs: signs: patients age 2 and
[cir] height...... [cir] height...... over seen by the
[cir] weight...... [cir] weight...... EP or admitted to
[cir] blood [cir] blood eligible hospital,
pressure. pressure. record blood
[cir] Calculate [cir] Calculate pressure and BMI;
and display: BMI.. and display: BMI.. additionally plot
[cir] Plot and [cir] Plot and growth chart for
display growth display growth children age 2-20.
charts for charts for
children 2-20 children 2-20
years, including years, including
BMI.. BMI..
Record smoking Record smoking At least 80% of all
status for status for unique patients 13
patients 13 years patients 13 years years old or older
old or older. old or older. seen by the EP or
admitted to the
eligible hospital
have ``smoking
status'' recorded.
Incorporate Incorporate At least 50% of all
clinical lab-test clinical lab-test clinical lab tests
results into EHR results into EHR ordered whose
as structured as structured results are in a
data. data. positive/negative
or numerical
format are
incorporated in
certified EHR
technology as
structured data.
Generate lists of Generate lists of Generate at least
patients by patients by one report listing
specific specific patients of the EP
conditions to use conditions to use or eligible
for quality for quality hospital with a
improvement, improvement, specific
reduction of reduction of condition.
disparities, and disparities, and
outreach. outreach.
Report ambulatory Report hospital For 2011, provide
quality measures quality measures aggregate
to CMS or the to CMS or the numerator and
States. States. denominator
through
attestation as
discussed in
section II(A)(3)
of this proposed
rule.
For 2012,
electronically
submit the
measures as
discussed in
section II(A)(3)
of this proposed
rule.
Send reminders to .................. Reminder sent to at
patients per least 50% of all
patient unique patients
preference for seen by the EP
preventive/follow that are age 50 or
up care. over.
Implement 5 Implement 5 Implement 5
clinical decision clinical decision clinical decision
support rules support rules support rules
relevant to related to a high relevant to the
specialty or high priority hospital clinical quality
clinical condition, metrics the EP/
priority, including Eligible Hospital
including diagnostic test is responsible for
diagnostic test ordering, along as described
ordering, along with the ability further in section
with the ability to track II(A)(3).
to track compliance with
compliance with those rules.
those rules.
Check insurance Check insurance Insurance
eligibility eligibility eligibility
electronically electronically checked
from public and from public and electronically for
private payers. private payers. at least 80% of
all unique
patients seen by
the EP or admitted
to the eligible
hospital.
Submit claims Submit claims At least 80% of all
electronically to electronically to claims filed
public and public and electronically by
private payers. private payers. the EP or the
eligible hospital.
Engage patients and families in Provide patients Provide patients Provide patients At least 80% of all
their health care. and families with with an with an patients who
timely access to electronic copy electronic copy request an
data, knowledge, of their health of their health electronic copy of
and tools to make information information their health
informed (including (including information are
decisions and to diagnostic test diagnostic test provided it within
manage their results, problem results, problem 48 hours.
health. list, medication list, medication
lists, lists, allergies,
allergies), upon discharge
request. summary,
procedures), upon
request.
[[Page 1869]]
Provide patients At least 80% of all
with an patients who are
electronic copy discharged from an
of their eligible hospital
discharge and who request an
instructions and electronic copy of
procedures at their discharge
time of instructions and
discharge, upon procedures are
request. provided it.
Provide patients .................. At least 10% of all
with timely unique patients
electronic access seen by the EP are
to their health provided timely
information electronic access
(including lab to their health
results, problem information.
list, medication
lists, allergies)
within 96 hours
of the
information being
available to the
EP.
Provide clinical .................. Clinical summaries
summaries for are provided for
patients for each at least 80% of
office visit. all office visits.
Improve care coordination...... Exchange Capability to Capability to Performed at least
meaningful exchange key exchange key one test of
clinical clinical clinical certified EHR
information among information (for information (for technology's
professional example, problem example, capacity to
health care team. list, medication discharge electronically
list, allergies, summary, exchange key
diagnostic test procedures, clinical
results), among problem list, information.
providers of care medication list,
and patient allergies,
authorized diagnostic test
entities results), among
electronically. providers of care
and patient
authorized
entities
electronically.
Perform medication Perform medication Perform medication
reconciliation at reconciliation at reconciliation for
relevant relevant at least 80% of
encounters and encounters and relevant
each transition each transition encounters and
of care. of care. transitions of
care.
Provide summary Provide summary Provide summary of
care record for care record for care record for at
each transition each transition least 80% of
of care and of care and transitions of
referral. referral. care and
referrals.
Improve population and public Communicate with Capability to Capability to Performed at least
health. public health submit electronic submit electronic one test of
agencies. data to data to certified EHR
immunization immunization technology's
registries and registries and capacity to submit
actual submission actual submission electronic data to
where required where required immunization
and accepted. and accepted. registries.
Capability to Performed at least
provide one test of the
electronic EHR system's
submission of capacity to
reportable lab provide electronic
results (as submission of
required by state reportable lab
or local law) to results to public
public health health agencies
agencies and (unless none of
actual submission the public health
where it can be agencies to which
received. eligible hospital
submits such
information have
the capacity to
receive the
information
electronically).
Capability to Capability to Performed at least
provide provide one test of
electronic electronic certified EHR
syndromic syndromic technology's
surveillance data surveillance data capacity to
to public health to public health provide electronic
agencies and agencies and syndromic
actual actual surveillance data
transmission transmission to public health
according to according to agencies (unless
applicable law applicable law none of the public
and practice. and practice. health agencies to
which an EP or
eligible hospital
submits such
information have
the capacity to
receive the
information
electronically).
[[Page 1870]]
Ensure adequate privacy and Ensure privacy and Protect electronic Protect electronic Conduct or review a
security protections for security health health security risk
personal health information. protections for information information analysis per 45
confidential created or created or CFR 164.308(a)(1)
information maintained by the maintained by the and implement
through operating certified EHR certified EHR security updates
policies, technology technology as necessary.
procedures, and through the through the
technologies and implementation of implementation of
compliance with appropriate appropriate
applicable law. technical technical
Provide capabilities. capabilities.
transparency of
data sharing to
patient.
----------------------------------------------------------------------------------------------------------------
e. Request for Public Comment on Potential Health IT Functionality
Measures for Eligible Professionals and Eligible Hospitals in 2013
Payment Year and Subsequent Years
As noted previously, we are cognizant that in most areas of the
country, the infrastructure necessary to support the electronic
exchange of structured information is not yet currently available. For
that reason, we excluded the electronic exchange of structured
information from many Stage 1 objectives or set relatively low
performance thresholds for measures that do rely on the electronic
exchange of structured data. For example, we set the threshold at 50
percent for the incorporation of lab data in structured format, and we
excluded other types of diagnostic test data (for example, radiology
reports, pathology reports, etc.) from that measure. We also excluded
the transmission of orders from the definition of ``CPOE use'' for
Stage 1 criteria.
In future rulemaking (for example, for Stage 2 and Stage 3
criteria), however, we anticipate raising the threshold for these
objectives as the capabilities of HIT infrastructure increases. We also
anticipate redefining our objectives to include not only the capturing
of data in electronic format but also the exchange (both transmission
and receipt) of that data in increasingly structured formats. The
intent and policy goal with raising these thresholds and expectations
is to ensure that meaningful use encourages patient-centric,
interoperable health information exchange across provider organizations
regardless of provider's business affiliation or EHR platform.
We specifically intend to build up the following health IT
functionality measures for Stage 2 meaningful use criteria:
``CPOE use'' will include not only the percentage of
orders entered directly by providers through CPOEs but also the
electronic transmission of those orders;
``Incorporate clinical lab-test results into EHR as
structured data'' will be expanded to include the full array of
diagnostic test data used for the treatment and diagnosis of disease,
where feasible, including blood tests, microbiology, urinalysis,
pathology tests, radiology, cardiac imaging, nuclear medicine tests,
and pulmonary function tests;
Measures that currently allow the provision and exchange
of unstructured data (for example, the provision of clinical care
summaries on paper) will require the provision and exchange of
electronic and structured data, where feasible;
Measures that currently require the performance of a
capability test (for example, capability to provide electronic
syndromic surveillance data to public health agencies) will be revised
to require the actual submission of that data;
We invite comment on our intent to propose the above measure for Stage
2 in future rulemaking and also invite comment on any other health IT
functionality measures not included in this list.
3. Sections 4101(a) and 4102(a)(1) of HITECH Act: Reporting on Clinical
Quality Measures Using EHRs by EPs and Eligible Hospitals
a. General
As discussed in the meaningful use background section, there are
three elements of meaningful use. In this section, we discuss the third
requirement using its certified EHR technology, the EP or eligible
hospital submits to the Secretary, in a form and manner specified by
the Secretary, information for the EHR reporting period on clinical
quality measures and other measures specified by the Secretary. The
submission of other measures is discussed in section II.A.2.d.2 of this
proposed rule and the other two requirements are discussed in section
II.A.2.d.1 of this proposed rule.
b. Requirements for the Submission of Clinical Quality Measures by EPs
and Eligible Hospitals
Sections 1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act provide
that the Secretary may not require the electronic reporting of
information on clinical quality measures unless the Secretary has the
capacity to accept the information electronically, which may be on a
pilot basis.
We do not anticipate that HHS will complete the necessary steps for
us to have the capacity to electronically accept data on clinical
quality measures from EHRs for the 2011 payment year. It is unlikely
that by 2011 there will be adequate testing and demonstration of the
ability to receive the required transmitted information on a widespread
basis. The capacity to accept information on clinical quality measures
also depends upon the Secretary promulgating technical specifications
for EHR vendors with respect to the transmission of information on
clinical quality measures sufficiently in advance of the EHR reporting
period for 2011, so that adequate time has been provided either for
such specifications to be certified, or for EHR vendors to code such
specifications into certified systems. Therefore, for 2011, we propose
that EPs and eligible hospitals use an attestation methodology to
submit summary information to CMS on clinical quality measures as a
condition of demonstrating meaningful use of certified EHR technology.
From the Medicaid perspective, delaying the onset of clinical
quality measures reporting until 2012 addresses concerns about States
having the ready infrastructure to receive and store
[[Page 1871]]
clinical quality measures data before then. More importantly, we
recognize that since Medicaid providers are eligible to receive
incentive payments for adopting, implementing, or upgrading certified
EHR technology. Medicaid EPs may not be focused on demonstrating
meaningful use until 2012 or later.
We anticipate that for the 2012 payment year we will have completed
the necessary steps to have the capacity to receive electronically
information on clinical quality measures from EHRs including the
promulgation of technical specifications for EHR vendors to use for
obtaining certification of their systems. Therefore, for the Medicare
EHR incentive program, we propose that beginning in CY 2012 an EP using
a certified EHR technology or beginning in FY 2012 an eligible hospital
using a certified EHR technology, as appropriate for clinical quality
measures, must submit information on clinical quality measures
electronically in addition to submitting other measures described in
section II.2.d.2 of this proposed rule in order for the EP or eligible
hospital to be a meaningful EHR user, regardless of whether CY 2012 is
their first or second payment year. However, if the Secretary does not
have the capacity to accept the information on clinical quality
measures electronically in 2012, consistent with sections
1848(o)(2)(B)(ii) and 1886(n)(3)(B)(ii) of the Act, we will continue to
rely on an attestation methodology for reporting of clinical quality
measures as a requirement for demonstrating meaningful use of certified
EHR technology for payment year 2012. Should we not have the capacity
to accept information on clinical quality measures electronically in
2012, we will inform the public of this fact by publishing a notice in
the Federal Register and providing instructions on how this information
should be submitted to us.
For purposes of the requirements under sections 1848(o)(2)(A)(iii)
and 1886 (n)(3)(iii) of the Act, we define ``clinical quality
measures'' to consist of measures of processes, experience, and/or
outcomes of patient care, observations or treatment that relate to one
or more quality aims for health care such as effective, safe,
efficient, patient-centered, equitable, and timely care. We note that
certain statutory limitations apply only to the reporting of clinical
quality measures, such as the requirement discussed in the previous
paragraph prohibiting the Secretary from requiring the electronic
reporting of information on clinical quality measures unless the
Secretary has the capacity to accept the information electronically, as
well as other statutory requirements for clinical quality measures that
are discussed below in section II.A.3.c.1 of this proposed rule. These
limitations apply solely to the submission of clinical quality
measures, and do not apply to other measures of meaningful EHR use. The
proposed clinical quality measures on which EPs or eligible hospitals
will be required to submit information using certified EHR technology,
the statutory requirements and other considerations that were used to
select these proposed measures, and the proposed reporting requirements
are described below.
With respect to Medicaid EPs and eligible hospitals, we note that
section 1903(t)(6) of the Act recognizes that the demonstration of
meaningful use may also include the reporting of clinical quality
measures to the States. In the interest of simplifying the program and
guarding against duplication of meaningful use criteria, we propose
that the clinical quality measures adopted for the Medicare EHR
incentive program, listed in Tables 3 and 20, will also apply to EPs
and eligible hospitals in the Medicaid EHR incentive program. However,
we are including alternative Medicaid-specific measures for use by
eligible hospitals as shown in Table 21.
Despite the statutory limitation prohibiting the Secretary from
requiring the electronic submission of clinical quality measures if HHS
does not have the capacity to accept this information electronically,
as previously discussed, the Secretary has broad discretion to
establish requirements for meaningful use of certified EHR technology
and for the demonstration of such use by EPs and eligible hospitals.
Although we propose to first require the electronic submission of
information on clinical quality measures in 2012, we do not desire this
to delay the use of certified EHR technology by EPs and eligible
hospitals to measure and improve clinical quality. Specifically, we
believe that the use of those functionalities that support measurement
of clinical quality is highly important to an overall goal of the
HITECH Act, to improve health care quality. We believe that measurement
and acting on the results of such measurement is an important aspect to
improving quality.
Accordingly, although we are not proposing under sections
1848(o)(2)(A)(iii) and 1886(n)(3)(A)(iii) of the Act to require that
for 2011 EPs and eligible hospitals report clinical quality measures to
CMS or States electronically, we propose to require as an additional
condition of demonstrating meaningful use of certified EHR technology
under sections 1848(o)(2)(A)(i) and 1886(n)(3)(A)(ii) of the Act that
EPs and eligible hospitals use certified EHR technology to capture the
data elements and calculate the results for the applicable clinical
quality measures discussed below. We further propose that EPs and
eligible hospitals demonstrate that they have satisfied this
requirement during the EHR reporting period for 2011 through
attestation. We further propose to require that Medicare EPs and
eligible hospital attest to the accuracy and completeness of the
numerators and denominators for each of the applicable measure.
Finally, in accordance with our authority under sections
1848(o)(C)(i)(V) and 1886(n)(3)(C)(i)(V) of the Act, which grants us
broad discretion to specify the means through which EPs and eligible
hospitals demonstrate compliance with the meaningful use criteria, we
propose that EPs and eligible hospitals demonstrate their use of
certified EHR technology to capture the data elements and calculate the
results for the applicable clinical quality measures by reporting the
results to CMS for all applicable patients. For the Medicaid incentive
program, States may accept provider attestations in the same manner to
demonstrate meaningful use in 2011. However, we expect that Medicaid
providers will qualify for the incentive payment by adopting,
implementing, or upgrading to certified EHR technology, and therefore;
will not need to attest to meaningful use of EHRs in 2011, for their
first payment year.
We recognize that considerable work needs to be done by measure
owners and developers with respect to the clinical quality measures
included in this proposed rule. This includes completing electronic
specifications for measures, implementing such specifications into EHR
technology to capture and calculate the results, and implementing the
systems, themselves. We also recognize that some measures are further
developed than others, as discussed in the proposed measures section.
Nevertheless, we believe that overall there is sufficient time to
complete work on measures and measures specifications to allow vendors,
and EPs and eligible hospitals to implement such systems. Should the
necessary work on measure specification not be completed for particular
measures according to the timetable we discuss below, it is our intent
not to finalize those specific measures.
[[Page 1872]]
c. Statutory Requirements and Other Considerations for the Proposed
Selection of Clinical Quality Measures Proposed for Electronic
Submission by EPs or Eligible Hospitals
(1) Statutory Requirements for the Selection of Clinical Quality
Measures Proposed for Electronic Submission by EPs and Eligible
Hospitals
Sections 1848(o)(2)(B)(i)(II) and 1886(n)(3)(B)(i) of the Act also
require that prior to any clinical quality measure being selected, the
Secretary will publish in the Federal Register such measure and provide
for a period of public comment on such measure. The proposed clinical
quality measures for EPs and eligible hospitals for 2011 and 2012
payment are listed in Tables 3 through 21.
For purposes of selecting clinical quality measures on which EPs
will be required to submit information using certified EHR technology,
section 1848(o)(2)(B)(i)(I) of the Act, as added by section 4101 of the
HITECH Act, states that the Secretary shall provide preference to
clinical quality measures that have been endorsed by the entity with a
contract with the Secretary under section1890(a) of the Act, as added
by section 183 of the Medicare Improvement for Patients and Providers
Act (MIPPA) of 2008. For submission of clinical quality measures by
eligible hospitals, section 1886(n)(3)(B)(i)(I) of the Act, as added by
section 4102(a) of the HITECH Act, requires the Secretary to provide
preference to those clinical quality measures that have been endorsed
by the entity with a contract with the Secretary under subsection
1890(a) of the Act, as added by section 183 of the MIPPA, or clinical
quality measures that have been selected for the purpose of applying
section 1886(b)(3)(B)(viii) of the Act (that is, measures that have
been selected for the Reporting Hospital Quality Data for Annual
Payment Update (RHQDAPU) program.
On January 14, 2009, the U.S. Department of Health and Human
Services awarded the contract required under section 1890(a) of the Act
to the National Quality Forum (NQF). Therefore, when selecting the
clinical quality measures EPs must report in order to demonstrate
meaningful use of certified EHR technology in accordance with section
1848(o)(2)(B)(i)(I) of the Act, we propose to give preference to the
clinical quality measures endorsed by the NQF, including NQF endorsed
measures that have previously been selected for the Physician Quality
Reporting Initiative (PQRI) program. Similarly when selecting the
clinical quality measures eligible hospitals must report in order to
demonstrate meaningful use of certified EHR technology in accordance
with section 1886(n)(3)(B)(i)(I) of the Act, we propose to give
preference to the clinical quality measures selected from those
endorsed by the NQF or that have previously been selected for the
RHQDAPU program. In some instances we have proposed measures for EPs
and eligible hospitals that are not currently NQF endorsed in an effort
to include a broader set of clinical quality measures. However, the
HITECH Act does not require the use of NQF endorsed measures, nor limit
the measures to those included in PQRI or RHQDAPU. If we, professional
societies, or other stakeholders identify clinical quality measures
which may be appropriate for the EHR incentive programs, we will
consider those measures even if they are not endorsed by the NQF or
have not been selected for the PQRI or RHQDAPU programs, subject to the
requirement to publish in the Federal Register such measure(s) for a
period of public comment.
We propose the clinical quality measures for EPs and eligible
hospitals in Tables 3 through 21 of this proposed rule for use in the
2011 and 2012 payment years for the Medicare EHR incentive program will
be effective 60 days after the publication of the final rule in the
Federal Register. No changes (that is, additions or deletions of
clinical quality measures) will be made after publication of the final
rule, except through further rulemaking. However, we may make
administrative and/or technical modifications or refinements, such as
revisions to the clinical quality measures titles and code additions,
corrections, or revisions to the detailed specifications for the 2011
and 2012 payment year measures. The 2011 specifications for user
submission of clinical quality measures will be available on our Web
site when they are sufficiently developed or finalized. Specifications
for the EHR incentive programs, even if already published as a part of
another incentive payment programs, must be obtained only from the
specifications documents for the EHR incentive program clinical quality
measures. We note also that the final clinical quality measure
specifications for eligible hospitals for any given clinical quality
measure may be different from specifications for the same clinical
quality measure used for the previously described testing of EHR-based
data submission. We are targeting finalization and publication of the
detailed specifications documents for all 2011 payment year Medicare
EHR incentive program clinical quality measures for eligible hospitals
on the CMS Web site on or before April 1, 2010. We intend that a
detailed specifications document for all 2012 payment year Medicare EHR
incentive program clinical quality measures for EPs be posted on the
our Web site on or before April 1, 2011. This would provide final
specifications documents at least 9 months in advance of the start of
the applicable payment year for clinical quality measure EHR reporting
period. We invite comments on our proposed timelines to post
specification documents for these clinical quality measures to the CMS
Web site.
(2) Other Considerations for the Proposed Selection of Clinical Quality
Measures for Electronic Submission by EPs and Eligible Hospitals
In addition to the requirements under sections 1848(o)(2)(B)(i)(I)
and 1886(n)(3)(B)(i)(I) of the Act and the other statutory requirements
described above, other considerations that we applied to the selection
of the proposed clinical quality measures for electronic submission
under the Medicare and Medicaid EHR incentive programs include the
following:
Clinical quality measures that are included in, facilitate
alignment with, or allow determination of satisfactory reporting in
other Medicare (for example, PQRI or the RHQDAPU program), Medicaid,
and Children's Health Insurance Program (CHIP) program priorities.
Clinical quality measures that are widely applicable to
EPs and eligible hospitals based on the services provided for the
population of patients seen.
Clinical quality measures that promote CMS and HHS policy
priorities related to improved quality and efficiency of care for the
Medicare and Medicaid populations that would allow us to track
improvement in care over time. These current and long term priority
topics include: Prevention; management of chronic conditions; high cost
and high volume conditions; elimination of health disparities;
healthcare-associated infections and other conditions; improved care
coordination; improved efficiency; improved patient and family
experience of care; improved end-of-life/palliative care; effective
management of acute and chronic episodes of care; reduced unwarranted
geographic variation in quality and efficiency; and adoption and use of
interoperable HIT.
Clinical quality measures that address or relate to known
gaps in the quality of care and measures that
[[Page 1873]]
through the PQRI program, performed at low or highly variable rates.
Clinical quality measures that have been recommended to
CMS for inclusion in the EHR incentive by FACA committees, such as the
HIT Policy Committee.
In addition, we note that the statutory requirements under sections
1848(o) and 1886(n) of the Act discussed above do not provide guidance
with respect to the development of the clinical quality measures which
may then be submitted to the NQF for endorsement. The basic steps for
developing clinical quality measures applicable to EPs may be carried
out by a variety of different organizations. We do not believe there
needs to be any special restrictions on the type or infrastructure of
the organizations carrying out this basic development of EP or eligible
hospital measures, such as restricting the initial development to EP or
eligible hospital organizations. Any such restriction would unduly
limit the basic development of clinical quality measures, and the scope
and utility of such measures that may be considered for NQF endorsement
as voluntary consensus standards.
With respect to the Children's Health Insurance Program
Reauthorization Act (CHIPRA) of 2009 (Pub. L. 111-3) Title IV, section
401 requires that the Secretary publish a core set of clinical quality
measures for the pediatric population. To the extent possible, we will
align the clinical quality measures selected under this Medicaid EHR
incentive program with the measures selected under the CHIPRA core
measure set. Included in the proposed definition of meaningful use are
nine proposed clinical quality measures that pertain to pediatric
providers. Four of the nine measures are also on the list of CHIPRA
initial core measures that were recommended to the Secretary by the
Subcommittee to AHRQ's National Advisory Committee (SNAC). Not all
CHIPRA initial measures recommended to the Secretary are applicable to
EHR technology or to the Medicaid EHR incentive payment program. For
example, some of the measures are population-based, survey-derived, or
not yet NQF-endorsed. New or additional measures for the next iteration
of the CHIPRA core set will have EHR-extractability as a priority. The
full CHIPRA core measure set will be published for comment in a
forthcoming Federal Register notice that is expected out before the end
of the year.
However, as many providers, including primary care professionals,
hospitals, dentists, and specialists provide care to the pediatric
population in the Medicaid and CHIP programs. We saw consistency as
paramount to avoid redundancy and duplication for these providers and
States.
Provider quality measure reporting under CHIPRA for this initial
core measure set will initially be voluntary. The intent is to begin
standardizing measurement data collection. Due to the concurrent CHIPRA
and ARRA HIT implementation activities, we believe there is an exciting
opportunity to align the two programs and strive to create efficiencies
for States and pediatric providers, where applicable. As both programs
move forward, we will continue to prioritize consistency in measure
selection for pediatric providers when possible.
We welcome comments on the inclusion or exclusion of any given
clinical quality measure or measures proposed herein in the EHR
incentive programs clinical quality measure set for EPs or eligible
hospitals for the 2011 and 2012 payment years, and to our approach in
selecting clinical quality measures. Our goal is for EPs and eligible
hospitals to use EHRs to transmit clinical quality measures to the
Secretary that would allow determination of their satisfactory
reporting under the PQRI and RHQDAPU programs. Even if the clinical
quality measures are not the same for PQRI and RHQDAPU satisfactory
reporting and EHR meaningful use, our aim is to encourage EPs and
eligible hospitals to use EHRs as the mechanism to report PQRI and
RHQDAPU measures rather than reporting measures on claims and other
reporting mechanisms. We plan to move to this approach as soon as
practicable. To the extent that the same clinical quality measures are
used in the PQRI and RHQDAPU programs and for EHR meaningful use, we
believe that this approach would be consistent with the statutory
requirement to avoid duplicate reporting to the extent practicable. We
believe that allowing the measures reporting for the PQRI and RHQDAPU
program to be reported via EHRs would provide an added incentive for
EPs and eligible hospitals to adopt EHRs.
In addition, we do not intend to use notice and comment rulemaking
as a means to update or modify clinical quality measure specifications.
A clinical quality measure that has completed the consensus process
through NQF has a designated party (usually, the measure developer/
owner) who has accepted responsibility for maintenance of the clinical
quality measure. In general, it is the role of the clinical quality
measure owner, developer, or maintainer to make basic changes to a
clinical quality measure in terms of the numerator, denominator, and
exclusions. However, the clinical quality measures selected for the
2011 and 2012 payment year will be supplemented by CMS technical
specifications for EHR submission. As discussed earlier, we propose to
post the complete clinical quality measures specifications including
technical specifications on our Web site and solicit comment on our
approach.
d. Proposed Clinical Quality Measures for Electronic Submission Using
Certified EHR Technology by EPs
For the 2011 and 2012 EHR reporting periods, based upon the
considerations for selecting clinical quality measures discussed above,
we propose the set of clinical quality measures identified in Table 3.
The Table 3 lists the applicable PQRI and NQF measure number, title,
description, the owner/developer, and a link to existing electronic
specifications where applicable. Tables 4 through 19 describes further
the reporting requirements of the Core and Specialty measure groups.
BILLING CODE 4210-01-P
[[Page 1874]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.000
[[Page 1875]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.001
[[Page 1876]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.002
[[Page 1877]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.003
[[Page 1878]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.004
[[Page 1879]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.005
[[Page 1880]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.006
[[Page 1881]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.007
[[Page 1882]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.008
[[Page 1883]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.009
[[Page 1884]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.010
[[Page 1885]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.011
[[Page 1886]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.012
[[Page 1887]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.013
[[Page 1888]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.014
[[Page 1889]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.015
BILLING CODE 4120-01-C
[[Page 1890]]
As previously stated, we believe that there is sufficient time to
implement the measures in EHR systems for 2011 through 2012. However,
we recognize also that there are measures that we propose, which are in
a lower state of readiness, for implementation in certified EHR's and
present a higher degree of risk in terms of completion of the necessary
work. We would note that the purpose of this quality reporting is to
begin the process of quality benchmarking and iterative improvements in
the ability of providers to benchmark themselves against their peers.
As part of the public comment process, we welcome comment on not only
the clinical utility of the measures we have proposed, but also their
state of readiness for use in the EHR incentive programs. For those
measures where electronic specifications do not currently exist, we
solicit comment on how quickly electronic specifications can be
developed and the period of time that might be required for effective
implementation from the time the electronic specifications of final
measures are posted and made available to vendors. We intend to publish
electronic specifications for the proposed clinical quality measures on
the CMS Web site as soon as they become available from the measure
developer(s). Electronic specifications may be developed concurrently
with the development of measures themselves and potentially with the
NQF endorsement processes.
All of the PQRI measures included in the above clinical quality
measures meet one or more of the criteria previously discussed. These
measures have been through notice and comment rulemaking for PQRI.
Nearly all proposed PQRI clinical quality measures are NQF endorsed.
Additionally, they have broad applicability to the range of Medicare
designated specialties, and the services provided by EPs who render
services to Medicare and Medicaid beneficiaries and many others.
Further, 9 of the 90 clinical quality measures listed above (PQRI
numbers 1, 2, 3, 5, 7, 110, 111, 112, and 113) have specifications for
the electronic submission of these clinical quality measures have
already been developed for the purpose of testing the electronic
submission of clinical quality data extracted from an EHR for the PQRI
program. The user specifications for the electronic submission of these
9 clinical quality measures for the most current PQRI program year can
be found on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_AlternativeReportingMechanisms.asp#TopOfPage.
In terms of CMS and HHS healthcare quality priorities, clinical
quality PQRI measures numbered 1, 2, 3, 5, and 7 address high priority
chronic conditions, namely diabetes, coronary artery disease, and heart
disease. Clinical quality PQRI measures numbered 110, 111, 112, 113,
114, 115, and 128 support prevention which is a high CMS and HHS
priority. The PQRI clinical quality measure specifications for claims-
based or registry-based submission of these clinical quality measures
for the most current PQRI program year can be found on the PQRI section
of the CMS Web site at http://www.cms.hhs.gov/PQRI/15_MeasuresCodes.asp#TopOfPage. A description of the clinical quality
measure, including the clinical quality measure's numerator and
denominator, can be found in the PQRI clinical quality measure
specifications.
The PQRI clinical quality measures that we have included largely
align with the recommendations of the HIT Standards Committee. However,
we have also included certain clinical quality measures not part of
PQRI that we believe are of high importance to the overall population.
These clinical quality measures are IVD: Use of Aspirin or another
Antithrombotic; IVD: Complete Lipid Profile; IVD: Low Density
Lipoprotein (LDL-C) Control, and Blood Pressure Management. Finally, we
have included an array of other measures which address important
aspects of clinical quality.
In summary, we believe that this initial set of clinical quality
measures is broad enough to allow for reporting for EPs and addresses
high priority conditions. We recognize the importance of integrating
the measures into certified EHR products for calculation of measures
results, and that not all measures may be feasible for 2011 and 2012.
We invite comment on the advisability of including the measures
proposed for payment years 2011 and 2012. Although we recognize many
other important clinical quality measures of health care provided by
EPs, we anticipate expanding the set of clinical quality measures in
future years and list a number of clinical quality measures for future
consideration in section II.A.3.g of this preamble, on which we also
invite comment.
We invite comments on our proposed clinical quality measures for
EPs.
e. Clinical Quality Measures Reporting Criteria for EPs
For the 2011 and 2012 EHR reporting periods, to satisfy the
requirements for reporting on clinical quality measures for Medicare
under section 1848(o)(2)(A)(i) and (iii) of the Act and for Medicaid
under section 1903(t)(6)(C) of the Act for the 2012 payment year, we
propose to require each EP submit information on two measure groups, as
shown in Table 4 and Tables 5 through 19, of this proposed rule. These
are the core measures group in Table 4, and the subset of clinical
measures most appropriate given the EPs specialty as described further
in Tables 5 through 19 specialty group measures below. For the core
measure group, in Table 4, we believe that the clinical quality
measures are sufficiently general in application and of such importance
to population health, we propose to require that all EPs treating
Medicare and Medicaid patients in the ambulatory setting report on all
of the core measures as applicable for their patients.
Table 4--Measure Group: Core for All EPs, Medicare or Medicaid
------------------------------------------------------------------------
Measure No. Clinical quality measure title
------------------------------------------------------------------------
PQRI 114.......................... Title: Preventive Care and
NQF 0028.......................... Screening: Inquiry Regarding
Tobacco Use.
NQF 0013.......................... Title: Blood pressure measurement.
NQF 0022.......................... Title: Drugs to be avoided in the
elderly:
a. Patients who receive at least one
drug to be avoided.
b. Patients who receive at least two
different drugs to be avoided.
------------------------------------------------------------------------
The second required measure set for each EP is to submit
information on at least one of the sets listed in Tables 5 and 19 as
specialty groups. The specialty groups are Cardiology, Pulmonology,
Endocrinology, Oncology,
[[Page 1891]]
Proceduralist/Surgery, Primary Care Physicians, Pediatrics, Obstetrics
and Gynecology, Neurology, Psychiatry, Ophthalmology, Podiatry,
Radiology, Gastroenterology, and Nephrology.
We recognize that clinical quality measures as specified by
measures developers and as endorsed by the NQF are not specialty
specific. Rather, the denominator of clinical quality measures and the
applicability of a measure is determined by the patient population to
whom the measure applies and the services rendered by the particular
EP.
Nevertheless, we have grouped measures according to the types of
patients commonly treated and services rendered by EPs of various
specialties. We have done this for purposes similar to measures groups
used in PQRI which, however, are based on clinical conditions, rather
than specialty types. The general purpose of each type of measures
grouping is to have standardized sets of measures all of which must be
reported by the EP in order to meet the reporting requirements. We
expect to narrow down each proposed set to a required subset of 3 to 5
measures based on the availability of electronic measure specifications
and comments received.
We propose to require for 2011 and 2012 that EP's will select a
specialty measures group, on which to report on all applicable cases
for each of the measures in the specialty group. The same specialty
measures group selected for the first payment year would be required
for reporting for the second payment year. We invite comment on whether
there are EPs who believe no specialty group will be applicable to
them. In accordance with public comments, we will specify in the final
rule which EP specialties will be exempt from selecting and reporting
on a specialty measures group. EPs that are so-designated will be
required to attest, to CMS or the State, to the inapplicability of any
of the specialty groups and will not be required to report information
on clinical quality measures from a specialty group for 2011 or 2012,
though the EP will still be required to report information on all of
the clinical quality measures listed in the core measure set in, Table
4, as applicable for their patients.
Table 5--Measure Group: Cardiology
------------------------------------------------------------------------
Measure No. Clinical quality measure title
------------------------------------------------------------------------
PQRI 5............................ Title: Heart Failure: Angiotensin-
NQF 0081.......................... Converting Enzyme (ACE) Inhibitor
or Angiotensin Receptor Blocker
(ARB) Therapy for Left Ventricular
Systolic Dysfunction (LVSD).
PQRI 6............................ Title: Coronary Artery Disease
NQF 0067.......................... (CAD): Oral Antiplatelet Therapy
Prescribed for Patients with CAD.
PQRI 7............................ Title: Coronary Artery Disease
NQF 0070.......................... (CAD): Beta-Blocker Therapy for CAD
Patients with Prior Myocardial
Infarction (MI).
PQRI 8............................ Title: Heart Failure: Beta-Blocker
NQF 0083.......................... Therapy for Left Ventricular
Systolic Dysfunction (LVSD).
PQRI 118.......................... Title: Coronary Artery Disease
NQF 0066.......................... (CAD): Angiotensin-Converting
Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB)
Therapy for Patients with CAD and
Diabetes and/or Left Ventricular
Systolic Dysfunction (LVSD).
PQRI 128.......................... Title: Preventive Care and
NQF 0421.......................... Screening: Body Mass Index (BMI)
Screening and Follow-Up.
PQRI 197.......................... Title: Coronary Artery Disease
NQF 0074.......................... (CAD): Drug Therapy for Lowering
LDL-Cholesterol.
PQRI 200.......................... Title: Heart Failure: Warfarin
NQF 0084.......................... Therapy Patients with Atrial
Fibrillation.
PQRI 204.......................... Title: Ischemic Vascular Disease
NQF 0068.......................... (IVD): Use of Aspirin or Another
Antithrombotic.
Not applicable.................... Title: Statin after Myocardial
Infarction.
------------------------------------------------------------------------
Table 6--Measure Group: Pulmonology
------------------------------------------------------------------------
Measure No. Clinical quality measure title
------------------------------------------------------------------------
PQRI 52........................... Title: Chronic Obstructive Pulmonary
NQF 0102.......................... Disease (COPD): Bronchodilator
Therapy.
PQRI 53........................... Title: Asthma: Pharmacologic
NQF 0047.......................... Therapy.
PQRI 111.......................... Title: Preventive Care and
NQF 0043.......................... Screening: Pneumonia Vaccination
for Patients 65 Years and Older.
PQRI 114.......................... Title: Preventive Care and
NQF 0028.......................... Screening: Inquiry Regarding
Tobacco Use.
PQRI 115.......................... Title: Preventive Care and
NQF 0027.......................... Screening: Advising Smokers to
Quit.
NQF 0001.......................... Title: Asthma assessment.
NQF 0036.......................... Title: Use of appropriate
medications for people with asthma.
Not applicable.................... Title: Use of CT scans.
------------------------------------------------------------------------
Table 7--Measure Group: Endocrinology
------------------------------------------------------------------------
Measure No. Clinical quality measure title
------------------------------------------------------------------------
PQRI 1............................ Title: Diabetes Mellitus: Hemoglobin
NQF 0059.......................... A1c Poor Control in Diabetes
Mellitus.
PQRI 2............................ Title: Diabetes Mellitus: Low
NQF 0064.......................... Density Lipoprotein (LDL-C) Control
in Diabetes Mellitus.
[[Page 1892]]
PQRI 3............................ Title: Diabetes Mellitus: High Blood
NQF 0061.......................... Pressure Control in Diabetes
Mellitus.
PQRI 117.......................... Title: Diabetes Mellitus: Dilated
NQF 0055.......................... Eye Exam in Diabetic Patient.
PQRI 119.......................... Title: Diabetes Mellitus: Urine
NQF 0062.......................... Screening for Microalbumin or
Medical Attention for Nephropathy
in Diabetic Patients.
PQRI 128.......................... Title: Preventive Care and
NQF 0421.......................... Screening: Body Mass Index (BMI)
Screening and Follow-Up.
PQRI 204.......................... Title: Ischemic Vascular Disease
NQF 0068.......................... (IVD): Use of Aspirin or Another
Antithrombotic.
NQF 0060.......................... Title: Hemoglobin A1c test for
pediatric patients.
Not applicable.................... Title: Comprehensive Diabetes Care:
HbA1c Control (< 8.0 percent).
------------------------------------------------------------------------
Table 8--Measure Group: Oncology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 71........................... Title: Breast Cancer: Hormonal
NQF 0387.......................... Therapy for Stage IC-IIIC Estrogen
Receptor/Progesterone Receptor (ER/
PR) Positive Breast Cancer.
PQRI 72........................... Title: Colon Cancer: Chemotherapy
NQF 0385.......................... for Stage III Colon Cancer
Patients.
PQRI 102.......................... Title: Prostate Cancer: Avoidance of
NQF 0389.......................... Overuse of Bone Scan for Staging
Low-Risk Prostate Cancer Patients.
PQRI 112.......................... Title: Preventive Care and
NQF 0031.......................... Screening: Screening Mammography.
PQRI 113.......................... Title: Preventive Care and
NQF 0034.......................... Screening: Colorectal Cancer
Screening.
NQF 0032.......................... Title: Cervical Cancer Screening.
------------------------------------------------------------------------
Table 9--Measure Group: Proceduralist/Surgery
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 20........................... Title: Perioperative Care: Timing of
NQF 0270.......................... Antibiotic Prophylaxis--Ordering
Physician.
PQRI 21........................... Title: Perioperative Care: Selection
NQF 0268.......................... of Prophylactic Antibiotic--First
OR Second Generation Cephalosporin.
PQRI 22........................... Title: Perioperative Care:
NQF 0271.......................... Discontinuation of Prophylactic
Antibiotics (Non-Cardiac
Procedures).
PQRI 23........................... Title: Perioperative Care: Venous
NQF 0239.......................... Thromboembolism (VTE) Prophylaxis
(When Indicated in ALL Patients).
NQF 0299.......................... Title: Surgical Site Infection Rate.
Not Applicable.................... Title: 30 day Readmission Rate.
------------------------------------------------------------------------
Table 10--Measure Group: Primary Care
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 114.......................... Title: Preventive Care and
NQF 0028.......................... Screening: Inquiry Regarding
Tobacco Use.
PQRI 115.......................... Title: Preventive Care and
NQF 0027.......................... Screening: Advising Smokers to
Quit.
PQRI 202.......................... Title: Ischemic Vascular Disease
NQF 0075.......................... (IVD): Complete Lipid Profile.
PQRI 203.......................... Title: Ischemic Vascular Disease
NQF 0075.......................... (IVD): Low Density Lipoprotein (LDL-
C) Control.
PQRI 204.......................... Title: Ischemic Vascular Disease
NQF 0068.......................... (IVD): Use of Aspirin or Another
Antithrombotic.
NQF 0038.......................... Title: Childhood Immunization
Status.
PQRI 112.......................... Title: Preventive Care and
NQF 0031.......................... Screening: Screening Mammography.
PQRI 113.......................... Title: Preventive Care and
NQF 0034.......................... Screening: Colorectal Cancer
Screening.
PQRI 1............................ Title: Diabetes Mellitus: Hemoglobin
NQF 0059.......................... A1c Poor Control in Diabetes
Mellitus.
NQF 0052.......................... Title: Low back pain: use of imaging
studies.
NQF 0018.......................... Title: Controlling High Blood
Pressure.
PQRI 128.......................... Title: Preventive Care and
NQF 0421.......................... Screening: Body Mass Index (BMI)
Screening and Follow-Up.
[[Page 1893]]
PQRI 65........................... Title: Treatment for Children with
NQF 0069.......................... Upper Respiratory Infection (URI):
Avoidance of Inappropriate Use.
PQRI 66........................... Title: Appropriate Testing for
NQF 0002.......................... Children with Pharyngitis.
PQRI 110.......................... Title: Preventive Care and
NQF 0041.......................... Screening: Influenza Immunization
for Patients >= 50 Years Old.
PQRI 197.......................... Title: Coronary Artery Disease
NQF 0074.......................... (CAD): Drug Therapy for Lowering
LDL-Cholesterol.
NQF 0001.......................... Title: Asthma Assessment
NQF 0004.......................... Title: Initiation and Engagement of
Alcohol and Other Drug Dependence
Treatment:
(a) Initiation,
(b) Engagement.
NQF 0024.......................... Title: Body Mass Index (BMI) 2
through 18 years of age.
NQF 0032.......................... Title: Cervical Cancer Screening.
NQF 0036.......................... Title: Use of appropriate
medications for people with asthma.
NQF 0060.......................... Title: Hemoglobin A1c test for
pediatric patients.
NQF 0105.......................... Title: New Episode of Depression:
(a) Optimal Practitioner Contacts
for Medication Management.
(b) Effective Acute Phase
Treatment.
(c) Effective Continuation Phase
Treatment.
NQF 0106.......................... Title: Diagnosis of attention
deficit hyperactivity disorder
(ADHD) in primary care for school
age children and adolescents.
NQF 0107.......................... Title: Management of attention
deficit hyperactivity disorder
(ADHD) in primary care for school
age children and adolescents.
NQF 0108.......................... Title: ADHD: Follow-Up Care for
Children Prescribed Attention-
Deficit/Hyperactivity Disorder
(ADHD) Medication.
NQF 0110.......................... Title: Bipolar Disorder and Major
Depression: Appraisal for alcohol
or chemical substance use.
Not applicable.................... Title: Comprehensive Diabetes Care:
HbA1c Control (< 8.0 percent).
Not applicable.................... Title: Appropriate antibiotic use
for ear infections.
------------------------------------------------------------------------
Table 11--Measure Group: Pediatrics
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 66........................... Title: Appropriate Testing for
NQF 0002.......................... Children with Pharyngitis.
NQF 0060.......................... Title: Hemoglobin A1c test for
pediatric patients.
NQF 0106.......................... Title: Diagnosis of attention
deficit hyperactivity disorder
(ADHD) in primary care for school
age children and adolescents.
NQF 0107.......................... Title: Management of attention
deficit hyperactivity disorder
(ADHD) in primary care for school
age children and adolescents.
NQF 0108.......................... Title: ADHD: Follow-Up Care for
Children Prescribed Attention-
Deficit/Hyperactivity Disorder
(ADHD) Medication.
NQF 0024.......................... Title: Body Mass Index (BMI) 2
through 18 years of age.
NQF 0026.......................... Title: Measure pair--
a. Tobacco use prevention for
infants, children and
adolescents,
b. Tobacco use cessation for
infants, children and
adolescents.
NQF 0038.......................... Title: Childhood Immunization
Status.
Not applicable.................... Title: Appropriate antibiotic use
for ear infections.
------------------------------------------------------------------------
Table 12--Measure Group: Obstetrics and Gynecology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 112.......................... Title: Preventive Care and
NQF 0031.......................... Screening: Screening Mammography.
PQRI 128.......................... Title: Preventive Care and
NQF 0421.......................... Screening: Body Mass Index (BMI)
Screening and Follow-Up.
NQF 0032.......................... Title: Cervical Cancer Screening.
NQF 0033.......................... Title: Chlamydia screening in women.
NQF 0471.......................... Title: Cesarean Rate for low-risk
first birth women (aka NTSV CS
rate).
NQF 0012.......................... Title: Prenatal Screening for Human
Immunodeficiency Virus (HIV).
NQF 0014.......................... Title: Prenatal Anti-D Immune
Globulin.
Not applicable.................... Title: Hysterectomy rates.
Not applicable.................... Title: 30 Readmission Rate following
deliveries.
------------------------------------------------------------------------
[[Page 1894]]
Table 13--Measure Group: Neurology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 33........................... Title: Stroke and Stroke
NQF 0241.......................... Rehabilitation: Anticoagulant
Therapy Prescribed for Atrial
Fibrillation at Discharge.
PQRI 201.......................... Title: Ischemic Vascular Disease
NQF 0073.......................... (IVD): Blood Pressure Management
Control.
PQRI 202.......................... Title: Ischemic Vascular Disease
NQF 0075.......................... (IVD): Complete Lipid Profile.
PQRI 203.......................... Title: Ischemic Vascular Disease
NQF 0075.......................... (IVD): Low Density Lipoprotein (LDL-
C) Control.
PQRI 204.......................... Title: Ischemic Vascular Disease
NQF 0068.......................... (IVD): Use of Aspirin or Another
Antithrombotic.
------------------------------------------------------------------------
Table 14--Measure Group: Psychiatry
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 9............................ Title: Major Depressive Disorder
NQF 0105.......................... (MDD): Antidepressant Medication
During Acute Phase for Patients
with MDD.
PQRI 106.......................... Title: Major Depressive Disorder
NQF 0103.......................... (MDD): Diagnostic Evaluation.
PQRI 107.......................... Title: Major Depressive Disorder
NQF 0104.......................... (MDD): Suicide Risk Assessment.
NQF 0004.......................... Title: Initiation and Engagement of
Alcohol and Other Drug Dependence
Treatment: (a) Initiation, (b)
Engagement.
NQF 0105.......................... Title: New Episode of Depression:
(a) Optimal Practitioner Contacts
for Medication Management, (b)
Effective Acute Phase Treatment,
(c) Effective Continuation Phase
Treatment.
NQF 0110.......................... Title: Bipolar Disorder and Major
Depression: Appraisal for alcohol
or chemical substance use.
------------------------------------------------------------------------
Table 15--Measure Group: Ophthalmology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 12........................... Title: Primary Open Angle Glaucoma
NQF 0086.......................... (POAG): Optic Nerve Evaluation.
PQRI 18........................... Title: Diabetic Retinopathy:
NQF 0088.......................... Documentation of Presence or
Absence of Macular Edema and Level
of Severity of Retinopathy.
PQRI 19........................... Title: Diabetic Retinopathy:
NQF 0089.......................... Communication with the Physician
Managing On-going Diabetes Care.
------------------------------------------------------------------------
Table 16--Measure Group: Podiatry
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 127.......................... Title: Diabetes Mellitus: Diabetic
NQF 0416.......................... Foot and Ankle Care, Ulcer
Prevention--Evaluation of Footwear.
PQRI 163.......................... Title: Diabetes Mellitus: Foot Exam.
NQF 0056..........................
NQF 0519.......................... Title: Diabetic Foot Care and
Patient Education Implemented.
------------------------------------------------------------------------
Table 17--Measure Group: Radiology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 10........................... Title: Stroke and Stroke
NQF 0246.......................... Rehabilitation: Computed Tomography
(CT) or Magnetic Resonance Imaging
(MRI) Reports.
PQRI 195.......................... Title: Stenosis Measurement in
NQF 0507.......................... Carotid Imaging Studies.
PQRI 145.......................... Title: Radiology: Exposure Time
NQF 0510.......................... Reported for Procedures Using
Fluoroscopy.
PQRI 146.......................... Title: Radiology: Inappropriate Use
NQF 0508.......................... of ``Probably Benign'' Assessment
Category in Mammography Screening.
PQRI 147.......................... Title: Nuclear Medicine: Correlation
NQF 0511.......................... with Existing Imaging Studies for
All Patients Undergoing Bone
Scintigraphy.
NQF 0052.......................... Title: Low back pain: use of imaging
studies.
NQF 0513.......................... Title: Use of Contrast: Thorax CT.
------------------------------------------------------------------------
[[Page 1895]]
Table 18--Measure Group: Gastroenterology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 86........................... Title: Hepatitis C: Antiviral
NQF 0397.......................... Treatment Prescribed.
PQRI 89........................... Title: Hepatitis C: Counseling
NQF 0401.......................... Regarding Risk of Alcohol
Consumption.
PQRI 113.......................... Title: Preventive Care and
NQF 0034.......................... Screening: Colorectal Cancer
Screening.
PQRI 183.......................... Title: Hepatitis C: Hepatitis A
NQF 0399.......................... Vaccination in Patients with HCV.
PQRI 184.......................... Title: Hepatitis C: Hepatitis B
NQF 0400.......................... Vaccination in Patients with HCV.
PQRI 185.......................... Title: Endoscopy & Polyp
AQA adopted....................... Surveillance: Colonoscopy Interval
for Patients with a History of
Adenomatous Polyps--Avoidance of
Inappropriate Use.
------------------------------------------------------------------------
Table 19--Measure Group: Nephrology
------------------------------------------------------------------------
Clinical quality measure title &
Measure No. description
------------------------------------------------------------------------
PQRI 81........................... Title: End Stage Renal Disease
NQF 0323.......................... (ESRD): Plan of Care for Inadequate
Hemodialysis in ESRD Patients.
PQRI 82........................... Title: End Stage Renal Disease
NQF 0321.......................... (ESRD): Plan of Care for Inadequate
Peritoneal Dialysis.
PQRI 121.......................... Title: Chronic Kidney Disease (CKD):
AQA adopted....................... Laboratory Testing (Calcium,
Phosphorus, Intact Parathyroid
Hormone (iPTH) and Lipid Profile).
PQRI 122.......................... Title: Chronic Kidney Disease (CKD):
AQA adopted....................... Blood Pressure Management.
PQRI 123.......................... Title: Chronic Kidney Disease (CKD):
AQA adopted....................... Plan of Care--Elevated Hemoglobin
for Patients Receiving
Erythropoiesis-Stimulating Agents
(ESA).
PQRI 153.......................... Title: Chronic Kidney Disease (CKD):
AQA adopted....................... Referral for Arteriovenous (AV)
Fistula.
------------------------------------------------------------------------
With the inclusion of measures applicable to targeting children and
adolescents and the wide applicability of the measures like Blood
Pressure Management, we believe this core set of clinical quality
measures and specialty measures is broad enough to enable reporting by
all EPs. However, if the public believes that other EPs would not have
sufficient patients in the denominator of these core measures, we
encourage commenters to identify the EPs in question and propose
specific remedies.
Although we do not propose to require clinical quality measure
reporting electronically until 2012, we propose to begin clinical
quality reporting through attestation in the 2011 payment year. We
solicit comment on whether it may be more appropriate to defer some or
all clinical quality reporting until the 2012 payment year. If
reporting on some but not all measures in 2011 is feasible, we solicit
comment on which key measures should be chosen for 2011 and which
should be deferred until 2012 and why.
We further propose that starting in payment year 2012, in addition
to meeting requirements for measures on meaningful EHR use and other
requirements, EPs would be required to electronically submit this
quality reporting information directly to CMS and States using
certified EHR technology. We encourage comments on these reporting
criteria, particularly on the requirement that all EPs-would report on
the set of ``core measures.'' We are also interested in comments as to
whether some Medicare or Medicaid EPs may not be able to meet the
proposed reporting requirements, why that might be the case, and
whether commenters believe other alternative options are preferable.
f. Proposed Clinical Quality Measures for Electronic Submission by
Eligible Hospitals
Based on the considerations for clinical quality measures
previously discussed in this proposed rule, we propose that eligible
hospitals will be required to report summary data to CMS on the set of
clinical quality measures identified in Table 20 starting in the 2011
payment year. We further propose that for the 2012 payment year,
hospitals will be required to submit these measures to CMS
electronically using certified EHR technology on a set of clinical
quality measures identified in Table 20, which would be sufficient to
meet the requirements for both the Medicare and the Medicaid EHR
incentive (for hospitals eligible for both incentive programs), with
respect to the requirement to report clinical quality measures. For
hospitals eligible for only the Medicaid EHR incentive program, such
reporting will be to States. For eligible hospitals to which the
measures in Table 20 do not apply to their patient population,
hospitals have the option to select clinical quality measures
identified in Table 21 to meet the requirements for the reporting of
clinical quality measures for the Medicaid program incentive. Tables 20
and 21, convey the clinical quality measure's title, number, owner/
developer and contact information, and a link to existing electronic
specifications where applicable.
[[Page 1896]]
Table 20--Proposed Clinical Quality Measures for Electronic Submission by Eligible Hospitals for Payment Year
2011-2012
----------------------------------------------------------------------------------------------------------------
Measure title, description & measure Electronic measure
Measure No. identifier developer specifications information
----------------------------------------------------------------------------------------------------------------
ED-1.................................... Title: Emergency Department Throughput-- http://www.hitsp.org/
admitted patients. Median time from ED ConstructSet_Details.asp
arrival to ED departure for admitted x?&PrefixAlpha=5&PrefixNu
patients. meric=906.
NQF 0495................................ Description: Median time from emergency
department arrival to time of departure
from the emergency room for patients
admitted to the facility from the
emergency department.
Measure Developer: CMS/Oklahoma Foundation
for Medical Quality (OFMQC).
ED-2.................................... Title: Emergency Department Throughput-- http://www.hitsp.org/
admitted patients. Admission decision ConstructSet_Details.asp
time to ED departure time for admitted x?&PrefixAlpha=5&PrefixNu
patients. meric=906.
NQF 0497................................ Description: Median time from admit
decision time to time of departure from
the emergency department of emergency
department patients admitted to inpatient
status.
Measure Developer: CMS/OFMQ.
ED-3.................................... Title: Emergency Department Throughput--
discharged patients. Median Time from ED
Arrival to ED Departure for Discharged ED
Patients.
NQF 0496................................ Description: Median Time from ED arrival
to time of departure from the ED for
patients discharged from the ED.
Measure Developer: CMS/OFMQ.
Stroke-2................................ Title: Ischemic stroke--Discharge on anti- http://www.hitsp.org/
thrombotics. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0435................................ Description: Ischemic stroke patients
prescribed antithrombotic therapy at
hospital discharge.
Measure Developer: The Joint Commission.
Stroke-3................................ Title: Ischemic stroke--Anticoagulation http://www.hitsp.org/
for A-fib/flutter. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0436................................ Description: Ischemic stroke patients with
atrial fibrillation/flutter who are
prescribed anticoagulation therapy at
hospital discharge.
Measure Developer: The Joint Commission.
Stroke-4................................ Title: Ischemic stroke--Thrombolytic http://www.hitsp.org/
therapy for patients arriving within 2 ConstructSet_Details.asp
hours of symptom onset. x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0437................................ Description: Acute ischemic stroke
patients who arrive at this hospital
within 2 hours of time last known well
and for whom IV t-PA was initiated at
this hospital within 3 hours of time last
known well.
Measure Developer: The Joint Commission.
Stroke-5................................ Title: Ischemic or hemorrhagic stroke-- http://www.hitsp.org/
Antithrombotic therapy by day 2. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0438................................ Description: Ischemic stroke patients
administered antithrombotic therapy by
the end of hospital day 2.
Measure Developer: The Joint Commission.
Stroke-6................................ Title: Ischemic stroke--Discharge on http://www.hitsp.org/
statins. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0439................................ Description: Ischemic stroke patients with
LDL > 100 mg/dL, or LDL not measured, or,
who were on a lipid-lowering medication
prior to hospital arrival are prescribed
statin medication at hospital discharge.
Measure Developer: The Joint Commission.
Stroke-8................................ Title: Ischemic or hemorrhagic stroke-- http://www.hitsp.org/
Stroke education. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
[[Page 1897]]
NQF 0440................................ Description: Ischemic or hemorrhagic
stroke patients or their caregivers who
were given educational materials during
the hospital stay addressing all of the
following: activation of emergency
medical system, need for follow-up after
discharge, medications prescribed at
discharge, risk factors for stroke, and
warning signs and symptoms of stroke.
Measure Developer: The Joint Commission.
Stroke-10............................... Title: Ischemic or hemorrhagic stroke-- http://www.hitsp.org/
Rehabilitation assessment. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0441................................ Description: Ischemic or hemorrhagic
stroke patients who were assessed for
rehabilitation services.
Measure Developer: The Joint Commission.
VTE-1................................... Title: VTE prophylaxis within 24 hours of http://www.hitsp.org/
arrival. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0371................................ Description: This measure assesses the
number of patients who received VTE
prophylaxis or have documentation why no
VTE prophylaxis was given the day of or
the day after hospital admission or
surgery end date for surgeries that start
the day of or the day after hospital
admission.
Measure Developer: The Joint Commission.
VTE-2................................... Title: ICU VTE prophylaxis................ http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=5&PrefixNumeric=906 meric=906.
NQF 0372................................ Description: This measure assesses the
number of patients who received VTE
prophylaxis or have documentation why no
VTE prophylaxis was given the day of or
the day after the initial admission (or
transfer) to the Intensive Care Unit
(ICU) or surgery end date for surgeries
that start the day of or the day after
ICU admission (or transfer).
Measure Developer: The Joint Commission.
VTE-3................................... Title: Anticoagulation overlap therapy.... http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=5&PrefixNumeric=906 meric=906.
NQF 0373................................ Description: This measure assesses the
number of patients diagnosed with
confirmed VTE who received an overlap of
parenteral (intravenous [IV] or
subcutaneous [subcu]) anticoagulation and
warfarin therapy. For patients who
received less than five days of overlap
therapy, they must be discharged on both
medications. Overlap therapy must be
administered for at least five days with
an international normalized ratio (INR)
>= 2 prior to discontinuation of the
parenteral anticoagulation therapy or the
patient must be discharged on both
medications.
Measure Developer: The Joint Commission.
VTE-4................................... Title: Platelet monitoring on http://www.hitsp.org/
unfractionated heparin. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0374................................ Description: This measure assesses the
number of patients diagnosed with
confirmed VTE who received intravenous
(IV) UFH therapy dosages AND had their
platelet counts monitored using defined
parameters such as a nomogram or
protocol.
Measure Developer: The Joint Commission.
VTE-5................................... Title: VTE discharge instructions......... http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=5&PrefixNumeric=906 meric=906.
NQF 0375................................ Description: This measure assesses the
number of patients diagnosed with
confirmed VTE that are discharged to
home, to home with home health, home
hospice or discharged/transferred to
court/law enforcement on warfarin with
written discharge instructions that
address all four criteria: compliance
issues, dietary advice, follow-up
monitoring, and information about the
potential for adverse drug reactions/
interactions.
[[Page 1898]]
Measure Developer: The Joint Commission.
VTE-6................................... Title: Incidence of potentially http://www.hitsp.org/
preventable VTE. ConstructSet_Details.asp
x?&PrefixAlpha=5&PrefixNu
meric=906.
NQF 0376................................ Description: This measure assesses the
number of patients diagnosed with
confirmed VTE during hospitalization (not
present on arrival) who did not receive
VTE prophylaxis between hospital
admission and the day before the VTE
diagnostic testing order date.
Measure Developer: The Joint Commission.
RHQDAPU AMI-8a.......................... Title: Primary PCI Received Within 90
Minutes of Hospital Arrival.
NQF 0163................................ Description: Acute myocardial infarction
(AMI) patients with ST-segment elevation
or LBBB on the ECG closest to arrival
time receiving primary PCI during the
hospital stay with a time from hospital
arrival to PCI of 90 minutes or less.
Measure Developer: CMS/OFMQ.
RHQDAPU PN-3b........................... Title: Blood Cultures Performed in the
Emergency Department Prior to Initial
Antibiotic Received in Hospital.
NQF 0148................................ Description: Pneumonia patients whose
initial emergency room blood culture
specimen was collected prior to first
hospital dose of antibiotics. This
measure focuses on the treatment provided
to Emergency Department patients prior to
admission orders.
Measure Developer: CMS/OFMQ.
RHQDAPU AMI-2........................... Title: Aspirin Prescribed at Discharge....
NQF 0142................................ Description: Acute myocardial infarction
(AMI) patients who are prescribed aspirin
at hospital discharge.
Measure Developer: CMS/OFMQ.
RHQDAPU AMI-3........................... Title: Angiotensin Converting Enzyme
Inhibitor (ACEI) or Angiotensin Receptor
Blocker (ARB) for Left Ventricular
Systolic Dysfunction (LVSD).
NQF 0137................................ Description: Acute myocardial infarction
(AMI) patients with left ventricular
systolic dysfunction (LVSD) who are
prescribed an ACEI or ARB at hospital
discharge. For purposes of this measure,
LVSD is defined as chart documentation of
a left ventricular ejection fraction
(LVEF) less than 40% or a narrative
description of left ventricular systolic
(LVS) function consistent with moderate
or severe systolic dysfunction.
Measure Developer: CMS/OFMQ.
RHQDAPU AMI-5........................... Title: Beta-Blocker Prescribed at
Discharge.
NQF 0160................................ Description: Acute myocardial infarction
(AMI) patients who are prescribed a
betablocker at hospital discharge.
Measure Developer: CMS/OFMQ.
RHQDAPU AMI-READ........................ Title & Description: Hospital Specific 30
day Risk-Standardized Readmission Rate
following AMI admission.
NQF 0505................................ Measure Developer: CMS.
Not applicable.......................... Title: Hospital Specific 30 day Rate
following AMI admission.
RHQDAPU HF-READ......................... Title & Description: Hospital Specific 30
day Risk-Standardized Readmission Rate
following Heart Failure admission.
NQF 0330................................ Measure Developer: CMS/OFMQ.
Not applicable.......................... Title: Hospital Specific 30 day Rate
following Heart Failure admission.
RHQDAPU PNE-READ........................ Title & Description: Hospital Specific 30
day Risk-Standardized Readmission Rate
following Pneumonia admission.
NQF 0506................................ Measure Developer: CMS.
Not applicable.......................... Title: Hospital Specific 30 day Rate
following Pneumonia admission.
NQF 0528................................ Title: Infection SCIP Inf-2 Prophylactic
antibiotics consistent with current
recommendations.
Description: Surgical patients who
received prophylactic antibiotics
consistent with current guidelines
(specific to each type of surgical
procedure).
Measure Developer: CMS/OFMQ.
NQF 0302................................ Title: Ventilator Bundle.
Description: Percentage of intensive care
unit patients on mechanical ventilation
at time of survey for whom all four
elements of the ventilator bundle are
documented and in place. The ventilator
bundle elements are:
Head of bed (HOB) elevation 30
degrees or greater (unless medically
contraindicated); noted on 2 different
shifts within a 24 hour period.
[[Page 1899]]
Daily ``sedation
interruption'' and daily assessment of
readiness to extubate; process
includes interrupting sedation until
patient follow commands and patient is
assessed for discontinuation of
mechanical ventilation; Parameters of
discontinuation include: resolution of
reason for intubation; inspired oxygen
content roughly 40%; assessment of
patients ability to defend airway
after extubation due to heavy
sedation; minute ventilation less than
equal to 15 liters/minute; and
respiratory rate/tidal volume less
than or equal to 105/min/L (RR/TV <
105).
SUD (peptic ulcer disease)
prophylaxis DVT (deep venous
thrombosis) prophylaxis.
Measure Developer: IHI.
NQF 0298................................ Title: Central Line Bundle Compliance.
Description: Percentage of intensive care
patients with central lines for whom all
elements of the central line bundle are
documented and in place. The central line
bundle elements include:
Hand hygiene..................
Maximal barrier precautions
upon insertion.
Chlorhexidine skin antisepsis.
Optimal catheter site
selection, with subclavian vein as the
preferred site for non-tunneled
catheters in patients 18 years and
older.
Daily review of line necessity
with prompt removal of unnecessary
lines.
Measure Developer: IHI.
NQF 0140................................ Title: Ventilator-associated pneumonia for
ICU and high-risk nursery (HRN) patients.
Description: Percentage of ICU and HRN
patients who over a certain amount of
days have ventilator-associated
pneumonia.
Measure Developer: CDC.
NQF 0138................................ Title: Urinary catheter-associated urinary
tract infection for intensive care unit
(ICU) patients.
Description: Percentage of intensive care
unit patients with urinary catheter-
associated urinary tract infections.
Measure Developer: CDC.
NQF 0139................................ Title: Central line catheter-associated
blood stream infection rate for ICU and
high-risk nursery (HRN) patients.
Description: Percentage of ICU and high-
risk nursery patients, who over a certain
amount of days acquired a central line
catheter-associated blood stream
infections over a specified amount of
line-days.
Measure Developer: CDC.
NQF 0329................................ Title: All-Cause Readmission Index (risk
adjusted).
Description: Overall inpatient 30-day
hospital readmission rate.
Measure Developer: United Health Group.
Not applicable.......................... Title: All-Cause Readmission Index.
Description: Overall inpatient 30-day
hospital readmission rate.
----------------------------------------------------------------------------------------------------------------
Table 21--Proposed Alternative Medicaid Clinical Quality Measures for Medicaid Eligible Hospitals
----------------------------------------------------------------------------------------------------------------
Measure title, description & measure Electronic measure
NQF No. developer specifications information
----------------------------------------------------------------------------------------------------------------
0341.................................... Title: PICU Pain Assessment on Admission.
Description: Percentage of PICU patients
receiving:
a. Pain assessment on admission.
b. Periodic pain assessment.
Measure Developer: Vermont Oxford Network.
0348.................................... Title: Iotrogenic pneumothorax in non-
neonates (pediatric up to 17 years of
age).
Description: Percent of medical and
surgical discharges, age under 18 years,
with ICD-9-CM code of iatrogenic
pneumothorax in any secondary diagnosis
field.
Measure Developer: AHRQ.
0362.................................... Title: Foreign body left after procedure,
age under 18 years.
Description: Discharges with foreign body
accidentally left in during procedure per
1,000 discharges.
Measure Developer: AHRQ.
0151.................................... Title: Pneumonia Care PNE-5c Antibiotic.
Description: Percentage of pneumonia
patients 18 years of age and older who
receive their first dose of antibiotics
within 6 hours after arrival at the
hospital.
Measure Developer: CMS/OFMQ.
0147.................................... Title: Pneumonia Care PN-6 Antibiotic
selection.
Description: Percentage of pneumonia
patients 18 years of age or older
selected for initial receipts of
antibiotics for community-acquired
pneumonia (CAP).
[[Page 1900]]
Measure Developer: CMS/OFMQ.
0356.................................... Title: Pneumonia Care PN-3a Blood culture.
Description: Percent of pneumonia
patients, age 18 years or older,
transferred or admitted to the ICU within
24 hours of hospital arrival who had
blood cultures performed within 24 hours
prior to or 24 hours after arrival at the
hospital.
Measure Developer: CMS/OFMQ.
0527.................................... Title: Infection SCIP Inf-1 Prophylactic
antibiotic received within 1 hour prior
to surgical incision.
Description: Surgical patients with
prophylactic antibiotics initiated within
1 hour prior to surgical incision.
Patients who received vancomycin or a
fluoroquinolone for prophylactic
antibiotics should have the antibiotics
initiated within 2 hours prior to
surgical incision. Due to the longer
infusion time required for vancomycin or
a fluoroquinolone, it is acceptable to
start these antibiotics within 2 hours
prior to incision time.
Measure Developer: CMS/OFMQ.
0529.................................... Title: Infection SCIP Inf-3 Prophylactic
antibiotics discontinued within 24 hours
after surgery end time.
Description: Surgical patients whose
prophylactic antibiotics were
discontinued within 24 hours after
Anesthesia End Time.
Measure Developer: CMS/OFMQ.
----------------------------------------------------------------------------------------------------------------
We have included in the hospital measures set several clinical
quality measures which have undergone development of electronic
specifications. These clinical quality measures have been developed for
future RHQDAPU consideration. The electronic specifications were
developed through an interagency agreement with ONC to develop
interoperable standards for EHR submission of the ED throughput,
stroke, and VTE clinical quality measures on Table 20, to be determined
by a future rulemaking document provided by ONC. We also have planned
to test the submission of these clinical quality measures in Medicare
(see 74 FR 43893). The specifications for the RHQDAPU clinical quality
measures for eligible hospitals that are being used for testing EHR-
based submission of these clinical quality measures can be found at
http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=5&PrefixNumeric=906. A description of the
clinical quality measure, including the clinical quality measure's
numerator and denominator, can be found here as well. Other measures
are currently in the RHQDAPU program or are measures of importance for
measuring or preventing adverse outcomes. In addition to Risk
Standardized readmission clinical quality measures, we have proposed
Readmission rates to be reported which are not risk adjusted. We have
also reviewed the recommendations of the HIT Standards Committee that
apply to hospitals which include Atrial Fibrillation Receiving
Anticoagulation Therapy. We note that Atrial Fibrillation Receiving
Anticoagulation Therapy is one of the clinical quality measures
included on Table 20, identified in the table as Stroke-3. We note that
we have not included the HIT Standards Committee recommended clinical
quality measure on surgery patients who received VTE prophylaxis within
24 hours period to surgery to 24 hours after surgery end time because
it is a current clinical quality measure collected in the RHQDAPU
program through chart abstraction for all applicable patients (SCIP-
VTE-2). The VTE-2 clinical quality measure in Table 20 is a parallel
clinical quality measure to SCIP-VTE-2, includes non-surgical patients,
and is a more feasible to implement because the electronic
specifications have been completed. We have however added SCIP-VTE-2
for future consideration.
To satisfy the requirements of reporting on clinical quality
measures under sections 1886(n)(3)(A)(iii) and 1903(t)(6)(C) of the Act
for the 2011-2012 payment year, we propose to require eligible
hospitals to report on all EHR incentive clinical quality measures for
which they have applicable cases, without regard to payer. Medicare
eligible hospitals, who are also participating in the Medicaid EHR
incentive program, will also be required to report on all Medicaid
clinical quality measures for which the eligible hospital has
applicable cases. To demonstrate that it is an eligible meaningful EHR
user, the eligible hospital is required to electronically submit
information on each clinical quality measures for each patient to whom
the clinical quality measure applies, regardless of payer, discharged
from the hospital during the EHR reporting period and for whom the
clinical quality measure is applicable. Although we do not propose to
require clinical quality reporting electronically until 2012, we
propose to begin clinical quality reporting though attestation in the
2011 payment year. We solicit comment on whether it may be more
appropriate to defer some or all clinical quality reporting until the
2012 payment year. If reporting on some but not all measures in 2011 is
feasible, we solicit comment on which key measures should be chosen for
2011 and which should be deferred until 2012 and why.
We invite comments on these proposed clinical quality measures for
eligible hospitals and our proposed timelines to post specification
documents for these clinical quality measures to the CMS Web site.
g. Request for Public Comment on Potential Measures for EPs and
Eligible Hospitals in 2013 Payment Year and Subsequent Years
We expect that the number of clinical quality measures for which
EPs and eligible hospitals will be able to electronically submit
information will rapidly expand in 2013 and beyond.
We plan to consider measures from the 2010 PQRI program. These
clinical quality measures can be found at http://www.cms.hhs.gov/PQRI/05_StatuteRegulationsProgramInstructions.asp
For future considerations of clinical quality measures for 2013 and
beyond for eligible hospitals, we will also
[[Page 1901]]
consider other clinical quality measures from the RHQDAPU program which
are identified in the FY 2010 IPPS final rule (74 FR 43868 through
43882). We invite comments on inclusion of clinical quality measures
for the 2013 and beyond HITECH Act Medicare and Medicaid incentive
program, based on Stage 2 and Stage 3 meaningful use criteria.
For the 2013 payment year, we are considering expanding the
Medicaid EHR incentive programs clinical quality measure set for EPs
and eligible hospitals to include clinical quality measures that
address the following clinical areas, to address quality of care for
additional patient populations, and facilitate alignment with Medicaid
and CHIP programs:
Additional pediatrics measures (such as completed growth
charts, electronic prescriptions with weight-based dosing support and
documentation of newborn screening).
Long-term care measures.
Additional obstetrics measure.
Dental care/oral health measures.
Additional mental health and substance abuse measures.
The above lists do not constitute a comprehensive list of all clinical
quality measures that may be considered. Specific measures for payment
years 2013 and beyond will be addressed by CMS in future notice and
comment rulemaking. To assist us in identifying potential clinical
quality measures for future consideration for years 2013 and beyond, we
welcome comments on the potential topics and/or clinical quality
measures listed above as well as suggestions for additional clinical
quality measure topics and/or specific clinical quality measures.
h. Proposed Reporting Method for Clinical Quality Measures for 2011 and
2012 Payment Year
(1) Reporting Method for 2011 Payment Year
As we previously discussed, we propose to use attestation as a
means for EPs and eligible hospitals, for purposes of the Medicare
incentive program, to demonstrate the meaningful use requirement for
the calculation and submission of clinical quality measure results to
CMS.
Specifically, for 2011, we propose to require that Medicare EPs and
hospitals attest to the use of a certified EHR system to capture the
data elements and calculate the results for the applicable clinical
quality measures.
We further propose to require that Medicare EPs and eligible
hospitals attest to the accuracy and completeness of the numerators,
denominators, and exclusions submitted for each of the applicable
measures, and report the results to CMS for all applicable patients.
Attestation will utilize the same system for other attestation for
meaningful use, and we propose to require for Medicare EPs that they
attest to the following:
The information submitted with respect to clinical quality
measures was generated as output of an identified certified electronic
health record.
The information submitted is accurate to the best of the
knowledge and belief of the EP.
The information submitted includes information on all
patients to whom the clinical quality measure applies.
The NPI and TIN of the EP submitting the information, and
the specialty group of clinical quality measures that are being
submitted.
For an EP who is exempt from reporting each of the core
measures, an attestation that one or more of the core measures do not
apply to the scope of practice of the EP.
For an EP who is exempt from reporting on a specialty
group, an attestation that none of the specialty groups applies to the
scope of practice of the EP.
For an EP who does report on a specialty group, but is
exempt from reporting on each of the clinical quality measures in the
group, an attestation that the clinical quality measures not reported
do not apply to any patients treated by the EP.
The numerators, denominators, and exclusions for each
clinical quality measure result reported, providing separate
information for each clinical quality measure including the numerators,
denominators, and exclusions for all patients irrespective third party
payer or lack thereof; for Medicare FFS patients; for Medicare
Advantage patients; and for Medicaid patients.
The beginning and end dates for which the numerators,
denominators, and exclusions apply.
For eligible hospitals, we propose to require that they attest to
the following:
The information submitted with respect to clinical quality
measures was generated as output from an identified certified EHR.
The information submitted to the knowledge and belief of
the official submitting on behalf of the eligible hospital.
The information submitted includes information on all
patients to whom the measure applies.
The identifying information for the eligible hospital.
For eligible hospitals that do not report one or more
measures an attestation that the clinical quality measures not reported
do not apply to any patients treated by the eligible hospital during
the reporting period.
The numerators, denominators, and exclusions for each
clinical quality measure result reported, providing separate
information for each clinical quality measure including the numerators,
denominators, and exclusions for all patients irrespective third party
payer or lack thereof; for Medicare FFS patients; for Medicare
Advantage patients; and for Medicaid patients.
The beginning and end dates for which the numerators,
denominators, and exclusions apply.
(2) Reporting Method for 2012
In accordance with sections 1848(o)(2)(A)(iii) and
1886(n)(3)(A)(iii) of the Act, an EP or eligible hospital,
respectively, must submit summary information (that is, information
that is not personally identifiable) on the clinical quality measures
selected by the Secretary using certified EHR technology in order to
demonstrate their meaningful use of certified EHR technology.
Additionally, for the 2012 payment year, we propose that EPs and
eligible hospitals be required to electronically submit the summary
information for a selected clinical quality measure from those listed
in Tables 3 through 21 using certified EHR technology as defined in
section II.A.1.a of this proposed rule for the Medicare and Medicaid
incentives. The required Medicare incentive information will be
identified in the measures specifications, which we intend will be on
our Web site 9 months before the start of the payment year. For
Medicaid, EPs and hospitals eligible only for the Medicaid EHR
incentive program must report their clinical quality measures data to
States. States will propose to CMS how they plan to accept and validate
Medicaid providers' clinical quality measures data in their State
Medicaid HIT Plans, subject to CMS review and approval, as described in
section II.D.7. of this proposed rule.
Sections 1848(o)(A)(2)(iii) and 1886(n)(3)(A)(iii) of the Act
broadly state that as a condition of demonstrating meaningful use of
certified EHR technology, an EP, CAH or eligible hospital must ``submit
information'' for the EHR reporting period on the clinical quality or
other measures selected by the Secretary ``in a form and manner
specified by the
[[Page 1902]]
Secretary.'' This language does not limit us to collecting only that
information pertaining to Medicare and Medicaid beneficiaries.
Therefore, we believe that we have the authority to collect summarized
clinical quality measures selected by the Secretary, with respect to
all patients to whom the clinical quality measure applies, treated by
the EP or eligible hospital. We believe that it is necessary for the EP
or eligible hospital to report on all cases to which a clinical quality
measures applies in order to accurately assess the quality of care
rendered by the particular EP or eligible hospital generally. Otherwise
it would only be possible to evaluate the care being rendered for a
portion of patients and lessen the ability to improve quality
generally. We solicit comments on the impact of requiring the
submission of clinical quality measures data on all patients, not just
Medicare and Medicaid beneficiaries.
Sections 1848(o)(2)(B)(iii) and 1886(n)(3)(B)(iii) of the Act
requires that in selecting clinical quality measures, the Secretary
shall seek to avoid redundant or duplicative reporting otherwise
required, including reporting under section 1848(k)(2)(C) of the Act
(the PQRI program) and eligible reporting under section
1886(b)(3)(B)(viii) of the Act (RHQDAPU program). We interpret
``redundant or duplicative reporting'' to mean requiring the reporting
of data on the same clinical quality measure separately for two or more
quality reporting programs under Medicare. Similarly, we seek to align
clinical quality measure reporting activities under CHIPRA with those
proposed here, to avoid duplication of reporting and to strengthen the
quality reporting infrastructure more broadly. Therefore, when a
clinical quality measure is included in more than one quality reporting
incentive program, we will seek to avoid requiring EPs and eligible
hospitals to report the same clinical quality measure under separate
programs. In instances in which a particular clinical quality measure
is included in the Medicare EHR incentive program and another Medicare
quality reporting incentive program, an EP or eligible hospital would
only need to report the measure under the Medicare EHR incentive
program, and the reporting of such clinical quality measure using
certified EHR technology would be considered as the EP or eligible
hospitals having satisfied the parallel reporting requirement under all
other applicable Medicare programs. With respect to any clinical
quality measures that may be included in the measure sets for both the
Medicare EHR Incentive Programs for EPs and the PQRI, we note that
there is no existing statutory authority to make PQRI incentive
payments for services furnished in 2011 and subsequent years.
We propose that Medicare EPs and eligible hospitals would be
required to report the required clinical quality measures information
electronically using certified EHR technology via one of three methods.
The primary method would require the EP or eligible hospital to log
into a CMS-designated portal. Once the EP or eligible hospital has
logged into the portal, they would be required to submit, through an
upload process, data payload based on specified structures, such as
Clinical Data Architecture (CDA), and accompanying templates produced
as output from their certified EHR technology.
As an alternative to this data submission method, we propose to
permit Medicare EPs and eligible hospitals to submit the required
clinical quality measures data using certified EHR technology through
Health Information Exchange (HIE)/Health Information Organization
(HIO). This alternative data submission method would be dependent on
the Secretary's ability to collect data through a HIE/HIO network and
would require the EP or eligible hospital who chooses to submit data
via an HIE/HIO network to be a participating member of the HIE/HIO
network. Medicare EPs and eligible hospitals would be required to
submit their data payload based on specified structures or profiles,
such as Clinical Data Architecture (CDA), and accompanying templates.
The EP's or eligible hospital's data payload should be an output from
their respective certified EHR products, in the form and manner
specified from their HIE/HIO adopted architecture into the CMS HIE/HIO
adopted architecture.
As another potential alternative, we propose to accept submission
through registries dependent upon the development of the necessary
capacity and infrastructure to do so using certified EHRs.
We intend to post the technical requirements for portal submission
and the alternative HIE/HIO submission, the HIE/HIO participating
member definition, and other specifications for submission on our Web
site for Medicare EPs on or before July 1, 2011 and for Medicare
eligible hospitals on or before April 1, 2011 for EHR adoption and
incorporation and to accommodate EHR vendors.
We invite comments on our three proposed clinical quality measures
data submission methodologies as they pertain to CMS for Medicare and
to States for Medicaid.
i. Alternative Reporting Methods for Clinical Quality Measures
There are several alternative reporting methods we considered to
create a dataset of provider-submitted summary data. One such
alternative is the development of a distributed network of EHRs where
health information is retained locally in individual EP or eligible
hospital EHRs and only summary reports are submitted to CMS. Another
alternative is the creation of databases of patient-level EHR data
stored at the state or regional level. We invite comment on our
proposed approach, as well as our two alternatives. We also invite
comment on all other alternative reporting methods.
j. Proposed Reporting Criteria for EPs and Eligible Hospitals
Sections 1848(o)(A)(2)(iii) and 1886(n)(3)(A)(iii) of the Act state
that to demonstrate meaningful use of certified EHR technology for an
EHR reporting period, an EP and eligible hospital must submit
information ``for such period'' on the clinical quality measures and
other measures selected by the Secretary. We therefore propose that for
2011 and 2012, the reporting period for the clinical quality measures
selected by the Secretary be the EHR reporting period as previously
defined in section II.A.1.e. of this proposed rule.
Another alternative we considered was a fixed reporting period of
four quarterly reporting periods, or 2, 6-month reporting periods. In
terms of practice and precedent for other Medicare clinical quality
measure reporting programs, all submit data to us at specific reporting
intervals.
We invite industry and interested stakeholder comments on our
proposal, especially those who may feel that a fixed period would be
more advantageous.
k. Addressing Dually Eligible Medicare/Medicaid Beneficiaries Under
HITECH
Since the EHR incentives are based on Medicare or Medicaid EPs
choosing one program or the other, we are concerned that the Medicare
and Medicaid incentive programs address the HIT needs of dually
eligible program beneficiaries. Since this population requires special
coordination between the State and Federal government, we intend to
engage in new efforts to promote Medicare health information exchange
with States, as well as look for other new ways to meet the care
management objectives of this population through HIT. As such, we
[[Page 1903]]
are requesting comments on potential measures to reach our goal.
4. Demonstration of Meaningful Use
Section 1848(o)(3)(C) of the Act, as added by section 4101(a) of
the HITECH Act, requires that as a condition of eligibility for the
incentive payment, an EP must demonstrate meaningful use of certified
EHR technology (other than the reporting on clinical quality and other
measures) as discussed in section II.A.3 of this proposed rule in the
manner specified by the Secretary, which may include the following: An
attestation, the submission of claims with appropriate coding, a survey
response, reporting of clinical quality or other measures, or other
means. Similarly, section 1886(n)(3)(c) of the Act, as added by section
4102(a) of the HITECH Act, requires that hospitals seeking the
incentive payment demonstrate meaningful use of certified EHR
technology in the manner specified by the Secretary. Section
1903(t)(6)(C)(i)(II) of the Act, as added by section 4201(a)(2) under
the HITECH Act, states that a Medicaid EP or eligible hospital must
demonstrate meaningful use through a ``means that is approved by the
State and acceptable to the Secretary.'' In addition, pursuant to
section 1903(t)(9) of the Act, a State must demonstrate to the
satisfaction of the Secretary that the State is conducting adequate
oversight, including the routine tracking of meaningful use
attestations and reporting mechanisms.
a. Common Methods of Demonstration in Medicare and Medicaid
We propose to create a common method for demonstrating meaningful
use in both the Medicare and Medicaid EHR incentive programs, for the
same reasons we have proposed a uniform definition of meaningful use.
The demonstration methods we adopt for Medicare would automatically be
available to the States for use in their Medicaid programs. The
Medicare methods are segmented into two parts, as discussed below.
States seeking to modify or propose alternative demonstration methods
must submit the proposed methods for prior CMS approval. This process
is discussed more fully in Section II.D.7.b.2.c. of this proposed rule.
b. Methods for Demonstration of the Stage 1 Criteria of Meaningful Use
We are proposing at Sec. 495.8 that for CY 2011 and FY 2011, EPs
and eligible hospitals demonstrate that they satisfy each of the
proposed meaningful use objectives specified in Sec. 495.6 through
attestation. For payment years beginning in CY and FY 2012 and
subsequent years, we are proposing at Sec. 495.8 that EPs and eligible
hospitals demonstrate that they satisfy each of the proposed meaningful
use objectives other than ``Submitting quality measures to CMS or the
States'' through attestation, and demonstrate that they satisfy the
objective ``Submitting quality measure to CMS or the States'' through
electronic reporting of clinical quality measures to CMS or the States,
as specified in section II.A.3 of this proposed rule. Specifically, we
propose that EPs and eligible hospitals provide attestation through a
secure mechanism, such as through claims based reporting or an online
portal. We propose that an EP or eligible hospital would through a one-
time attestation following the completion of the EHR reporting period
for a given payment year identify the certified EHR technology they are
utilizing and the results of their performance on all the measures
associated with the objectives of meaningful use. We chose to propose
attestation through a secure mechanism because we do not believe that
HIT will advance enough from its current state to allow for more
automated and/or documented options of demonstrating meaningful use. As
HIT matures we expect to base demonstration more on automated reporting
by certified EHR technologies, such as the direct electronic reporting
of measures both clinical and non clinical and documented participation
in HIE. The first example is to the move from attestation for clinical
quality measures to direct reporting in 2012 and subsequent years for
EPs and eligible hospitals. As HIT advances we expect to move more of
the objectives away from being demonstrated through attestation.
However, given the current state of HIT, we believe that imposing such
demonstration requirements for 2011 would pose significant barriers to
participation in the EHR incentive programs.
We believe that the means by which EPs and eligible hospitals
demonstrate meaningful use should work for all provider types. We also
believe that uniform means of demonstration for EPs and eligible
hospitals are preferable and that a greater burden should not be placed
on one or the other. In addition, we do not believe that demonstration
of meaningful use should require use of certified EHR technology beyond
the capabilities certified to be determined by a future rulemaking
document provided by ONC.
In addition to requiring electronic reporting of clinical quality
measures in 2012 in Medicare and Medicaid, we also propose for CMS and/
or the States to test options to utilize existing and emerging HIT
products and infrastructure capabilities to satisfy other objectives of
the meaningful use definition. The optional testing could involve the
use of registries or the direct electronic reporting of some measures
associated with the objectives of the meaningful use definition. We do
not propose to require any EP or eligible hospital to participate in
this testing in either 2011 or 2012 in order to receive an incentive
payment. However, in order to make progress towards our goal of
meaningful use being demonstrated through the electronic exchange of
information we encourage States to explore the available options. The
state of electronic exchange varies widely across the country and is
dependent on numerous Federal, State, local, non-profit and for-profit
initiatives. Given this high state of flux, CMS and/or the States would
have to issue considerable updated guidance to EPs and eligible
hospitals who wish to join in our efforts to explore the electronic
exchange of information. Any testing should be based on the principal
of electronic exchange of information from certified EHR technology
either directly to the States or through an intermediary. For purposes
of the programs in this proposed rule it would be counterproductive for
an intermediary to collect information through paper abstraction.
We will issue further instructions on the specifics for submitting
attestation through established outreach venues.
5. Data Collection for Online Posting, Program Coordination, and
Accurate Payments
As described below, the HITECH Act requires the Secretary to post
online the names of Medicare EPs and eligible hospitals and CAHs who
are meaningful EHR users for the relevant payment year. Section
1903(t)(2) of the Act also requires us to ensure that EPs do not
receive an EHR incentive payment under both Medicare and Medicaid. To
fulfill these mandates, we must collect several data elements from EPs
and eligible hospitals. Beyond these two direct HITECH Act
requirements, CMS and the States also require certain data in order to
accurately calculate and distribute the incentive payments.
a. Online Posting
Section 1848(o)(3)(D) of the Act requires the Secretary to list in
an easily understandable format the names, business addresses, and
business phone numbers of the Medicare EPs and, as
[[Page 1904]]
determined appropriate by the Secretary, of group practices receiving
incentive payments for being meaningful EHR users under the Medicare
FFS program on our internet Web site. We do not propose to post
information on group practices because we do not propose to base
incentive payments at the group practice level. Section 1886(n)(4)(B)
of the Act, as added by section 4102(c) of the HITECH Act, requires the
Secretary to list in an easily understandable format the names and
other relevant data, as she determines appropriate, of eligible
hospitals and CAHs who are meaningful EHR users under the Medicare FFS
program, on our internet Web site. Eligible hospitals and CAHs will
have the opportunity to review the list before the list is publicly
posted. Sections 1853(m)(5) and 1853(l)(7) of the Act, as added by
sections 4101(c) and 4102(c) of the HITECH Act, require the Secretary
to post the same information for EPs and eligible hospitals in the MA
program as would be required if they were in the Medicare FFS program.
Additionally, the Secretary must post the names of the MA organizations
receiving the incentive payment or payments. We propose to collect the
information necessary to post the name, business address and business
phone numbers of all EPs, eligible hospitals and CAHs participating in
the Medicare FFS and MA EHR incentive programs, and to post this
information on our Web site.
b. Program Election Between Medicare FFS/MA and Medicaid for EPs
Section 1903(t)(2) of the Act prohibits an EP from receiving
incentive payments under the Medicaid program unless the EP has waived
any rights to incentive payments under the Medicare FFS or MA programs.
Furthermore, section 1903(t)(7) of the Act requires the Secretary to
assure no duplication of funding with respect to the Medicaid program,
and the physician and MA incentive payments under sections 1848(o) and
1853(l) of the Act. This waiver and non-duplication requirement applies
only to EPs meeting both the Medicare FFS/MA and Medicaid EHR incentive
programs eligibility criteria, and does not apply to hospitals (which
are eligible to receive incentive payments from both Medicare and
Medicaid simultaneously). Proposed Sec. 495.10 would allow an EP
meeting the eligibility criteria for both the Medicare FFS/MA and
Medicaid programs to participate in either program. Further, the EP
would be permitted to change his or her election once during the life
of the EHR incentive programs after making the initial election. We
believe this one-time election rule would allow an EP whose patient
volume no longer makes him or her eligible for the Medicaid program to
nevertheless continue to receive incentive payments that would
encourage the meaningful use of certified EHR technology. For example,
an EP who moves to a different practice or geographically relocates
practices may reduce his or her Medicaid patient volume, and therefore
become ineligible for the Medicaid incentive payments. Allowing this EP
to continue to receive incentive payments under Medicare (if eligible)
would continue the incentive for meaningfully using EHR technology, and
would allow EPs a certain amount of flexibility in their operations.
While allowing this flexibility creates administrative complexity, we
believe a significant number of EPs could have their participation in
the EHR incentive programs endangered due to changing circumstances
unrelated to the EHR incentive programs.
Under our proposal, if an EP does decide to switch programs, we
propose that the EP would continue in the next program at whichever
payment year he or she would have attained had the EP not chosen to
switch. For example, if an EP decides to switch after receiving his or
her Medicare FFS incentive payment for their second payment year, then
the EP would be in its third payment year for purposes of the Medicaid
incentive payments. Even after lining up the payment years, it is
possible for an EP to exceed the payment cap under Medicaid by
switching programs at the right time. We do not believe that the
Congress intended for the payment caps to be exceeded under any
circumstance, and therefore propose that no EP should receive more than
the maximum incentive available to them under Medicaid, which is the
higher of the two caps. The last year incentive payment would be
reduced if awarding the EP the full amount would exceed the overall
maximum available under Medicaid. This is possible if an EP receives
their first two payment years from Medicare and then the last four from
Medicaid, as the cap would be exceeded by $250. An EP who switches from
Medicaid to Medicare could exceed the Medicare threshold in a number of
circumstances; however, since they cannot exceed the Medicaid threshold
under any circumstance, we propose to pay the incentive for which they
are eligible for a given payment year in whichever program they are in
for that payment year. Finally, we propose that the last year for
making an incentive payment program switch would be CY 2014. In making
this proposal, we considered that it is both the last year an EP can
enroll in the Medicare EHR incentive program, and also the last year
before the payment adjustments under Medicare can begin. We request
comments on the necessity of the ability to switch and the allowed
timing for such switches.
c. Data To Be Collected
In addition to information regarding the demonstration of
meaningful use, in Sec. 495.10 of this proposed rule we propose to
collect the following administrative data for the Medicare and Medicaid
EHR incentive programs to fulfill our requirements of online posting,
avoidance of duplication of incentive payments, and to ensure accurate
and timely incentive payments:
Name, NPI, business address, and business phone of each EP
or eligible hospital.
Taxpayer Identification Number (TIN) to which the EP or
eligible hospital wants the incentive payment made. For Medicaid EPs
this must be consistent with assignment rules at Sec. 495.10.
For EPs, whether they elect to participate in the Medicare
EHR incentive programs or the Medicaid EHR incentive program.
For eligible hospitals, their CCN.
To coordinate with the States to avoid duplication of payments, we
further propose to make available to the States through a single
repository the following additional data:
Whether an EP or eligible hospital is a meaningful EHR
user, and
The remittance date and amount of any incentive payments
made to an EP or eligible hospital.
CMS, our contractors, and the States will have access to these six
data elements through a single repository maintained by CMS. The States
will have to provide information to us on whether EPs or eligible
hospitals are eligible for the Medicaid incentive program, whether EPs
or eligible hospitals participating in the Medicaid program are
meaningful EHR users, and when any Medicaid incentive payments are made
and the amount of the payment. We will put in place processes for an EP
or eligible hospital to change their information, including the one-
time switch in EHR incentive program election by EPs.
6. Hospital-Based Eligible Professionals
Section 1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of
the HITECH Act, states that hospital-based EPs are not eligible for the
Medicare incentive
[[Page 1905]]
payments. Similarly, the majority of hospital-based EPs will not be
eligible for Medicaid incentive payments under 1903(t)(2)(A) of the Act
(the only exception to this rule is for those practicing predominantly
in an FQHC or RHC). Section 1848(o)(1)(C)(ii) of the Act defines the
term ``hospital-based eligible professional'' to mean an EP, such as a
pathologist, anesthesiologist, or emergency physician, who furnishes
substantially all of his or her Medicare-covered professional services
during the relevant EHR reporting period in a hospital setting (whether
inpatient or outpatient) through the use of the facilities and
equipment of the hospital, including the hospital's qualified EHRs.
This section indicates that the determination of whether an EP is a
hospital-based EP shall be made on the basis of the site of service, as
defined by the Secretary, and without regard to the type of service
provided by the EP or any employment or billing arrangement between the
EP and any other provider (for example, the hospital-based
determination for an EP would not be affected by whether the EP is an
employee of the hospital, under a contractual relationship with the
hospital, or with respect to where he or she has made a reassignment to
the hospital for Part B billing purposes). Section 1903(t)(3)(D) of the
Act defines hospital-based EP in nearly identical terms.
In addition, as discussed below, section 1848(a)(7)(D) of the Act,
as added by section 4101(b) of the HITECH Act, exempts hospital-based
EPs from the downward payment adjustment applied under section
1848(a)(7)(A)(i) of the Act to covered professional services provided
during a payment year by EPs who are not meaningful EHR users for the
relevant payment year beginning in 2015.
If an EP is providing ``substantially all'' of their services in
the hospital, we believe it is reasonable to assume that the EP is also
using the facilities and equipment of the hospital, including any
qualified EHR implemented by the hospital. The statute uses
``facilities and equipment'' to determine whether an EP is a hospital-
based EP. As ``facilities and equipment'' would generally be understood
to apply to the hospital building and its medical and other equipment
that is used in furnishing medical services, we believe it is
reasonable to assume that an EP providing substantially all of their
services in a hospital is providing these services in the hospital
building and generally is also using its equipment, including qualified
EHRs, and not bringing his or her own equipment to the hospital to
provide medical services. Similarly, it seems reasonable to assume that
the statute contemplates that an EP that uses the hospital's facilities
and equipment would also be using the hospital's EHR system and should
be ineligible for an incentive payment. We seek comment as to whether
EPs are using qualified EHR of the hospital in ambulatory care
settings.
As noted previously, the statute provides that hospital-based EPs,
``such as a pathologist, anesthesiologist, or emergency physician,''
are those EPs that provide substantially all of their Medicare-covered
professional services in a ``hospital setting (whether inpatient or
outpatient).'' Because the HITECH Act does not define the term
``hospital setting,'' we looked to existing statutes and regulations
that define and describe hospital settings for guidance in defining
``hospital setting'' for purposes of this proposed rule. We welcome
comments on alternative approaches to interpreting the meaning of
``hospital setting.''
First, section 1861(e) of the Act defines the term a ``hospital''
to mean an institution that ``is primarily engaged in providing, by or
under the supervision of physicians, to inpatients (A) diagnostic
services and therapeutic services for medical diagnosis, treatment, and
care of injured, disabled, or sick persons, or (B) rehabilitation
services for the rehabilitation of injured, disabled, or sick
persons.'' Therefore, we propose that EPs that practice primarily in
inpatient hospital settings, as referenced in section 1861(e) of the
Act, be considered hospital-based EPs.
Because the parenthetical after the term ``hospital setting'' in
the statutory definition of hospital-based EP specifically refers to
both inpatient and outpatient hospital settings, we believe the term
``hospital setting'' should be defined to also include the outpatient
setting. So although a ``hospital'' is an institution that primarily
provides inpatient services, we propose to define the term ``hospital
setting'' for purposes of the Medicare and Medicaid EHR incentive
payment programs to also include all outpatient settings where hospital
care is furnished to registered hospital outpatients. For purposes of
Medicare payment and conditions of participation, it is CMS's
longstanding policy to consider as outpatient hospital settings those
outpatient settings that are owned by and integrated both operationally
and financially into the entity, or main provider, that owns and
operates the inpatient setting. For example, we consider as outpatient
hospital settings all types of outpatient care settings in the main
provider, on-campus and off-campus provider-based departments (PBDs) of
the hospital, and entities having provider-based status, as these
entities are defined in Sec. 413.65.
In accordance with our regulations at Sec. 413.65, a provider-
based department or entity must operate under the ownership and
financial and administrative control of the main provider. We also note
that the provider-based department or entity of the hospital comprises
both the physical facility where services are furnished and the
personnel and equipment used to care for patients in those settings. In
addition, Sec. 413.65(d) specifies that the financial operations of
provider-based departments or entities must be fully integrated within
the financial system of the main provider. Medicare makes payment to
the hospital under the outpatient payment system for the facility
resources required for care that is furnished to hospital outpatients
in its provider-based departments and entities, regardless of the
specific type of hospital outpatient setting. Moreover, Medicare pays
EPs for their professional services furnished to hospital outpatients
at the facility rate under the Medicare Physician Fee Schedule (MPFS),
also regardless of the specific type of hospital outpatient setting,
recognizing that in all hospital outpatient settings the hospital bears
the cost of personnel, equipment, and supplies for which payment would
otherwise be made to the EP under the MPFS for services furnished in a
non-facility setting. Section 413.65(d) also requires that the medical
records for patients treated in the provider-based department or entity
must be integrated into a unified retrieval system (or cross reference)
of the main provider. Moreover, an eligible hospital will receive an
incentive payment for its medical records system if such system is
considered certified EHR technology and is meaningfully used by the
hospital consistent with the requirements of the final rule to this
rule. Because, by definition of the requirements for provider-based
departments and entities, EPs who furnish substantially all of their
covered professional services to hospital outpatients use the
hospital's facility and equipment, including the integrated medical
record system, for which payment is made by Medicare to the hospital,
we believe these EPs should be considered hospital-based EPs, and thus
excluded from the Medicare EP EHR incentive payments. This is fully
consistent with the definition of hospital-based EPs in section
1848(o)(1)(C)(ii) of the Act.
[[Page 1906]]
In summary, we propose that EPs that provide substantially all of
their professional services in the inpatient hospital setting, in any
type of outpatient hospital setting, or in any combination of inpatient
and outpatient hospital settings, be considered hospital-based EPs.
We propose to consider the use of place of service (POS) codes on
physician claims to determine whether an EP furnishes substantially all
of their professional services in a hospital setting and is, therefore,
hospital-based. This code set is required for use in the implementation
guide adopted as the national standard for electronic transmission of
professional health care claims under the provisions of the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). HIPAA
directed the Secretary of HHS to adopt national standards for
electronic transactions. These standard transactions require all health
plans and providers to use standard code sets to populate data elements
in each transaction. The Transaction and Code Set Rule (65 FR 50312)
adopted the ASC X12N-837 Health Care Claim: Professional, volumes 1 and
2, version 4010, as the standard for electronic submission of
professional claims. This standard names the POS code set currently
maintained by CMS as the code set to be used for describing sites of
service in such claims and is available at http://www.cms.hhs.gov/PlaceofServiceCodes/Downloads/POS_09_10_07_Rev_2_508.pdf.
From this code set, we propose to consider the use of the following
POS codes indicating that the EP provided the service in an inpatient
or any type of outpatient hospital setting (including a PBD of a
hospital) to determine whether an EP is a hospital-based eligible
professional:
21--Inpatient Hospital--is a facility, other than
psychiatric, which primarily provides diagnostic, therapeutic (both
surgical and nonsurgical), and rehabilitation services by, or under,
the supervision of physicians, to patients admitted for a variety of
medical conditions.
22--Outpatient Hospital--is a portion of a hospital which
provides diagnostic, therapeutic (both surgical and nonsurgical), and
rehabilitation services to sick or injured persons who do not require
hospitalization or institutionalization.
23--Emergency Room, Hospital--is a portion of a hospital
where emergency diagnosis and treatment of illness or injury is
provided.
Place of service codes 22 (Outpatient Hospital) and 23 (Emergency
Room, Hospital) are commonly recognized to be outpatient departments of
the hospital. An outpatient department of a hospital will either meet
the definition of the ``main provider,'' a ``department of a
provider,'' or of having ``provider-based status'' as those terms are
used in Sec. 413.65. Place of service codes 22 and 23 are used to
describe hospital outpatient settings that meet these definitions under
Sec. 413.65 and are also subject to the conditions of participation
under part 482.
The statutory definition of hospital-based EP provides that to be
considered a hospital-based EP, the EP must provide ``substantially
all'' of his or her covered professional services in a hospital
setting, which we propose to encompass all hospital inpatient and
outpatient settings, including all settings that meet the definition of
the main provider, department of a provider, or of having provider-
based status. Therefore, we must identify the minimum percentage of an
EP's covered professional services that must be provided in a hospital
setting in order for the EP to be considered as providing
``substantially all'' of his or her covered professional services in a
hospital setting. We would define ``substantially all'' as furnishing
at least 90 percent of services in a hospital setting, either inpatient
or outpatient. We believe this threshold appropriately balances our
competing goals of ensuring that professionals are encouraged to
participate in the incentive program and avoid duplicate payments to a
professional who is primarily using the EHR technology of the hospital
in which he or she furnishes services. While we considered using 75
percent as a threshold for determining whether an EP is an hospital-
based EP, we are concerned that such a standard could exclude EPs from
receiving incentive payments that perform a minority but significant
percentage of their services outside of inpatient or outpatient
hospital settings and would have offices separate and independent from
the hospital where they provide patient care services and for which
they would have costs to obtain an EHR system. Based on an analysis of
2008 Medicare claims data, if we define ``substantially all'' of
covered services in a hospital setting to mean that 75 percent or more
of an EP's allowed services are associated with one of the place of
service codes listed above, we estimate that 65 percent of EPs would be
considered eligible to receive an EHR incentive payment. If we increase
this criterion to 90 percent, we estimate that 68 of percent of EPs
would be eligible for the EHR incentive payment. In other words, 3
percent fewer EPs would be ineligible for the EHR incentive payments if
we define ``substantially all'' to mean at least 90 percent rather than
at least 75 percent.
Because EPs providing 90 percent or more of their services in one
of these sites as described above are not likely to expend significant
resources related to EHRs in other, non-hospital settings, we believe
this proposal is most consistent with the law's intent of not providing
incentive payments to EPs that are providing substantially all of their
services in a hospital setting (whether inpatient or outpatient).
However, we are open to comments on other proposals that are consistent
with the law's intent of not providing incentive payments to hospital-
based physicians as defined in HITECH. In our proposed approach, a
hospital-based eligible professional would be ineligible to receive an
EHR incentive payment under either Medicare or Medicaid, regardless of
the type of service provided, if more than 90 percent of their services
are identified as being provided in places of service classified under
place of service codes 21, 22, or 23.
Accordingly, for both Medicare and Medicaid incentive payment
purposes, we propose that a hospital-based eligible professional is
defined as an EP who furnishes 90 percent or more of their covered
professional services in any of the above listed places of service. A
hospital-based EP would be ineligible to receive EHR incentive
payments. (Based on preliminary claims data from the first 9 months of
2009, CMS currently estimates that, under this proposed definition,
about 27 percent of Medicare EPs (physicians) would be considered
hospital-based and thus not eligible to receive any incentive payments.
We do not have any data on Medicaid practitioners.) We propose to make
this determination, for Medicare incentive payment purposes, as to
whether or not an EP is hospital-based by annually analyzing an EP's
claims history from the prior year. Therefore, for example, based on
such analysis, an otherwise EP would be considered a hospital-based EP
and be ineligible for incentive payments in 2011 if he/she provided 90
percent or more of his/her allowed services in one of the above listed
places of service based on their 2010 Medicare claims data. The
hospital-based status of each EP would be reassessed each year, using
claims data from the year immediately preceding the payment year. For
Medicaid purposes, we are proposing that State Medicaid agencies make
the determination about whether or not an
[[Page 1907]]
EP is hospital-based by analyzing an EP's Medicaid claims data, or in
the case of EPs who deliver care via Medicaid managed care programs, by
analyzing either encounter data or other equivalent data sources, at
the State's option. There is an interest in assuring that nearly all
primary care providers are meaningful users of EHR technology by 2014.
However, this objective may not be reached because of several factors.
Some primary care EPs who provide services to Medicare and
Medicaid beneficiaries would be ineligible for the incentive payments.
For example, we currently estimate that under this proposal, 12-13
percent of family practitioners under Medicare would be considered
hospital-based under our proposed definition of hospital-based EP, and
therefore would not be eligible for the EHR incentive payments. (Note
that we believe that these data could be applied generally to Medicaid
physicians as well. However, Medicaid EPs include other practitioners
who also must meet hospital-based eligibility requirements, some of
whom provide primary care services such as nurse practitioners.)
Although many of these family practitioners may be serving in
nonprimary care roles within the hospital setting (such as in emergency
departments or functioning as hospitalists), those EPs performing
primary care services in the hospital setting would also not be
eligible to receive EP incentive payments. If these EPs were eligible
to receive incentive payments, some might reassign them to the
hospital, and the hospital could then use the EP's incentive payments
for additional integrated outpatient EHR systems.
As will be explained in the next section of this proposed
rule, the hospital's total incentive payment is based on total
inpatient services. As result, a hospital with a large outpatient
department will not receive a higher incentive payment as a result of
their outpatient services.
Finally, as previously discussed, we are proposing that
the Stage 1 meaningful use criteria for eligible hospitals apply only
to a hospital's inpatient setting.
Because of these factors, we are concerned that hospital investment
in their outpatient primary care sites is likely to lag behind their
investment in their inpatient EHR systems. To address these concerns,
as part of future rulemaking, we plan to consider ways to realign the
meaningful use objectives and criteria to include a broader definition
of hospital care to include outpatient services. We believe this could
provide an important incentive for hospital investment in EHRs for
their outpatient primary care sites. We welcome comments on these
issues including other ways that CMS, under the current statute, could
help meet the objective that nearly all primary care providers are
meaningful users of EHR technology by 2014.
We also seek comment on the extent to which hospitals install EHRs
in their outpatient clinics as part of their adoption of EHRs. In
addition, we seek comment on the way that hospitals with provider-based
entities meet the provider-based requirements at 42 CFR 413.65(d) if
they have EHRs in any or all parts of the hospital.
Finally, we seek comment on whether we should use another method
for defining hospital-based EPs than what we have proposed here. Any
comments should address implementation based on the specific POS codes
identified, and/or any complexities that would result from not
including all outpatient settings owned and operated by and integrated
with the hospital in the determination of whether an EP is hospital-
based.
7. Interaction With Other Programs
The HITECH Act addresses interactions between the Medicare EHR
incentive program and the E-prescribing Incentive Program authorized by
MIPPA. Under section 1848(m)(2)(D) of the Act, as added by section
4101(f)(2)(B) of the HITECH Act, if a Medicare FFS or MA EP receives an
incentive payment from the Medicare EHR incentive program, the EP (or
group practice) is not eligible to also receive the incentive payment
under the E-prescribing Incentive Program created by MIPPA. Given the
payment timelines proposed in this rule for the Medicare EHR incentive
program and the existing payment timeline for the E-prescribing
Incentive Program, we will know whether an EP received a Medicare EHR
incentive payment before the E-Prescribing Incentive Program payment is
calculated. Thus we will exclude those EPs (or group practices) who
accept a Medicare EHR incentive payment for a given year from being
eligible for the E-Prescribing Incentive Program payment for that same
year. EPs receiving a Medicaid EHR incentive payment would remain
eligible for the Medicare MIPAA E-Prescribing Incentive Program
payment.
As the HITECH Act does not specify any other restrictions on
participation in other programs and participation in the Medicare and
Medicaid EHR incentive programs, we do not propose any other
restrictions. There may be opportunities to avoid duplication of
reporting requirements among our various programs. In section II.A.3.
of this proposed rule, we discuss how we will avoid duplication of
reporting requirements for clinical quality measures.
B. Medicare Fee-for-Service Incentives
1. Incentive Payments for Eligible Professionals (EP)
Section 1848(o)(1)(A) of the Act, as amended by section 4101(a) of
the HITECH Act, provides for incentive payments to EPs who are
meaningful users of certified EHR technology during the relevant EHR
reporting periods. Section 1848(o)(1)(A)(i) of the Act provides that
EPs who are meaningful EHR users during the relevant EHR reporting
period are entitled to an incentive payment amount, subject to an
annual limit, equal to 75 percent of the Secretary's estimate of the
Medicare allowed charges for covered professional services furnished by
the EP during the relevant payment year. Under section
1848(o)(1)(B)(ii)(VI) of the Act, an EP is entitled to an incentive
payment for up to 5 years. In addition, in accordance with section
1848(o)(1)(A)(ii) of the Act, there shall be no incentive payments made
with respect to a year after 2016. The incentive payments would be
disbursed from the Federal Supplementary Medical Insurance Trust Fund,
as provided for under section 1848(o)(1)(A)(i) of the Act. As noted in
section II.A. of this proposed rule, EPs who qualify for both the
Medicare and Medicaid incentive payments must elect to receive payments
from one program or the other.
a. Definitions
In accordance with section 1848(o)(5)(C) of the Act, we propose to
add a definition of the term ``eligible professional'' in our
regulations at Sec. 495.100 to mean a physician as defined under
section 1861(r) of the Act. Section 1861(r) of the Act defines the term
``physician'' to mean the following five types of professionals, each
of which must be legally authorized to practice their profession under
state law: A doctor of medicine or osteopathy, a doctor of dental
surgery or dental medicine, a doctor of podiatric medicine, a doctor of
optometry, or a chiropractor. As discussed in section II.B.1.a of this
proposed rule, in accordance with section 1848(o)(1)(C) of the Act,
hospital-based EPs are not eligible for an incentive payment.
[[Page 1908]]
Section 1848(o)(5)(A) of the Act defines covered professional
services as having the same meaning as in section 1848(k)(3) of the
Act, that is, services furnished by an eligible professional for which
payment is made under, or is based on, the Medicare physician fee
schedule.
In accordance with section 1848(a)(1) of the Act, the Medicare
allowed charge for covered professional services is the lesser of the
actual charge or the Medicare physician fee schedule amount established
in section 1848 of the Act. As specified under section
1848(o)(1)(A)(i), the Secretary's estimate of allowed charges is based
on claims submitted to Medicare no later than 2 months following the
end of the relevant payment year. We propose to codify these
specifications and definitions in our regulations at [cite proposed
regulation range].
b. Incentive Payment Limits
Section 1848(o)(1)(B)(i) of the Act sets forth the annual limits on
the EHR-related incentive payments to EPs. Specifically, section
1848(o)(1)(B) of the Act provides that the incentive payment for an EP
for a given payment year shall not exceed the following amounts:
For the EP's first payment year, for such professional,
$15,000 (or, $18,000 if the EP's first payment year is 2011 or 2012).
For the EP's second payment year, $12,000.
For the EP's third payment year, $8,000.
For the EP's fourth payment year, $4,000.
For the EP's fifth payment year, $2,000.
For any succeeding year, $0.
Under section 1848(o)(1)(B)(iv) of the Act, for EPs who
predominantly furnish services in a geographic HPSA (as designated by
the Secretary under section 332(a)(1)(A) of the Public Health Service
(PHS) Act), the incentive payment limitation amounts for each payment
year are increased by 10 percent. Section 1848(o)(1)(B)(iii) of the Act
also provides for a phased reduction in payment limits for EPs who
first demonstrate meaningful use of certified EHR technology after
2013. Specifically, if the EP's first payment year is after 2013, then
the annual limit on the incentive payment equals the annual limit
applicable to an EP whose first payment year is 2013. Accordingly, if
the EP's first payment year is 2014, the EP's maximum incentive payment
will be $12,000 in 2014, $8,000 in 2015, and $4,000 in 2016. Section
1848(o)(1)(B)(v) of the Act provides that if the EP's first payment
year is after 2014, then the applicable incentive payment limit for
such year and any subsequent year shall be $0. In other words, an EP
who does not qualify to receive an EHR-related incentive payment prior
to 2015 will not receive any of these incentive payments. Table 22
shows the maximum incentive payment amounts available to EPs under
Medicare FFS. (As noted above and discussed further below, these limits
are increased by 10 percent for EPs who predominantly furnish services
in an HPSA.)
Table 22--Maximum Total Amount of EHR Incentive Payments for a Medicare EP Who Does Not Predominantly Furnish
Services in a HPSA
----------------------------------------------------------------------------------------------------------------
First CY in which the EP receives an incentive payment
-------------------------------------------------------------------------------
Calendar year 2015-
2011 2012 2013 2014 subsequent
years
----------------------------------------------------------------------------------------------------------------
2011............................ $18,000 .............. .............. .............. ..............
2012............................ 12,000 $18,000 .............. .............. ..............
2013............................ 8,000 12,000 $15,000 .............. ..............
2014............................ 4,000 8,000 12,000 $12,000 ..............
2015............................ 2,000 4,000 8,000 8,000 $0
2016............................ .............. 2,000 4,000 4,000 0
-------------------------------------------------------------------------------
Total....................... 44,000 44,000 39,000 24,000 0
----------------------------------------------------------------------------------------------------------------
The following examples illustrate how the payment amount would be
determined:
Example 1: EP that receives the maximum
payment. For payment year 2011, the incentive payment for an EP
would be, subject to a payment limit of $18,000, equal to 75 percent
of the EP's Medicare physician fee schedule allowed charges for CY
2011 (in this case, the maximum allowed charges recognized for the
purposes of the incentive, or $24,000 x .75 = $18,000), estimated
based on claims for covered professional services furnished by the
EP from January 1, 2011 through December 31, 2011, and submitted to
the appropriate Medicare administrative contractor (MAC/carrier) on
or before February 29, 2012.
Example 2: EP that receives less than the
maximum payment. Assume for this example that the EP's estimated
total allowed charges for covered professional services are $10,000
which is less than the $24,000 maximum allowed charges that could be
recognized for purposes of this incentive. Therefore, for payment
year 2011, the incentive payment in this case would be, $10,000 x
.75 = $7,500, based on claims for covered professional services
furnished by the EP from January 1, 2011 through December 31, 2011,
and submitted to the appropriate Medicare administrative contractor
(MAC) or carrier on or before February 29, 2012.
We propose, for each subsequent payment year, to use the annual
allowed charges and claims in a similar manner to calculate the
Secretary's estimate of allowed charges for purposes of computing the
incentive payment.
Example: For payment year 2012, the incentive
payment issued to an EP would be, subject to a payment limit (that
is, $18,000 if it is the first payment year, $12,000 if it is the
second payment year), equal to 75 percent of the EP's Medicare
physician fee schedule allowed charges for CY 2012, based on claims
for covered professional services performed by the EP from January
1, 2012 through December 31, 2012, and submitted to the appropriate
Medicare administrative contractor (MAC/carrier) on or before
February 28, 2013.
c. Increase in Incentive Payment for EPs Who Predominantly Furnish
Services in a Geographic Health Professional Shortage Area (HPSA)
Section 1848(o)(1)(B)(iv) of the Act provides that the amount of
the annual incentive payment limit for each payment year be increased
by 10 percent for EPs who predominantly furnish services in an area
that is designated by the Secretary (under section 332(a)(1)(A) of the
PHS Act) as a geographic health professional shortage area (HPSA).
Section 332(a)(1)(A) of the PHS Act refers to geographic HPSAs, or
areas that have been determined to have a shortage of
[[Page 1909]]
health professionals, based on the population-to-provider ratio and
other factors. HPSAs are located in every State, and in both rural and
urban areas.
Geographic HPSAs are defined in 42 CFR Part 5 and include primary
medical care, dental, and mental health HPSAs. In accordance with the
statute, we will increase the limits per payment year by 10 percent for
EHR-related incentive payments to EPs who predominantly furnish covered
professional services in a geographic primary medical care, dental, or
mental health HPSA.
We propose that an EP be considered as ``predominantly'' furnishing
covered professional services in a geographic HPSA if more than 50
percent of the EP's Medicare covered professional services are
furnished in a geographic HPSA. Using ``more than 50 percent'' as the
criterion to define ``predominantly'' is consistent with how the term
is defined in general parlance as well as how the definition is used
for purposes of other aspects of the Medicare program.
To determine whether an EP has furnished more than 50 percent of
his/her covered professional services in a geographic HPSA, we propose
to utilize frequency of services provided over a 1-year period from
January 1 to December 31, rather than basing it on the percentage of
allowed charges. Our data indicates that most physicians either provide
all or none of their services in a geographic HPSA, so we believe that
our proposal to base eligibility for the 10 percent EHR HPSA payment
limit increase on frequency, rather than allowed charges, will have
little or no impact on the determination of whether an EP is eligible
for the EHR HPSA payment limit increase. To apply the payment limit
increase, we will first need to determine whether more than 50 percent
of an EP's covered professional services were furnished in a geographic
HPSA during a particular payment year. We propose to first make the
generally applicable incentive payment to the EP based on an EP's
estimated allowed charges for the relevant payment year.
Once we compile a full year of data, we would determine eligibility
for the EHR HPSA payment limit increase for the payment year based on
whether the EP provided more than 50 percent of his/her services in a
geographic HPSA during the payment year. The determination would be
made based on claims submitted not later than 2 months after the end of
the year. If we determine that the EP provided more than 50 percent of
his/her services in a geographic HPSA and is therefore eligible for the
EHR HPSA payment limit increase, we would then make an additional lump
sum payment to reflect that increased limit amount based on the
estimated allowable charges for that EP for the prior year. We propose
that the additional amount would be paid no later than 120 days after
the end of the prior year for which the EP was eligible for the 10
percent EHR HPSA payment limit increase.
Most physicians furnishing services in a HPSA furnish 100 percent
of their covered services in a HPSA. Based on our data, we found very
few physicians provide even a modest percentage of their services
across HPSA and non-HPSA areas. We estimate that about 17 percent of
EPs would qualify for the 10 percent EHR HPSA payment limit increase,
provided they satisfy the other requirements for the incentive payment.
Section 1848(o)(1)(B)(iv) of the Act also authorizes us to apply the
provisions of sections 1833(m) and (u) of the Act in implementing this
10 percent EHR HPSA payment limit increase, as the Secretary determines
appropriate. Section 1833(m) of the Act establishes the HPSA bonus
program, which provides a 10 percent bonus to physicians who furnish
Medicare covered professional services in a geographic HPSA. Section
1833(u) of the Act establishes the Physician Scarcity Area bonus
program, which provided a 5 percent bonus to physicians who furnish
Medicare covered professional services in areas that are determined to
physician scarcity areas. (Note: The authority for the Physician
Scarcity Area program ended on June 31, 2008.)
Section 1833(m)(1) of the Act provides that physicians who furnish
covered professional services in a year in an area that is designated
as a geographic HPSA prior to the beginning of the year are eligible to
receive the HPSA bonus for services furnished during the current year.
We have interpreted this to mean that bonus payments should continue
throughout the current year, even if the area loses its designation as
a geographic HPSA during the current year. Physicians furnishing
covered professional services in an area that is not designated as a
geographic HPSA by December 31 of the prior year are not eligible to
receive the HPSA bonus for the current year, even if the area is
subsequently designated as a geographic HPSA during the current year.
We propose to apply these same rules for the 10 percent EHR HPSA
payment limit increase provided under section 1848(o)(1)(B)(iv) of the
Act. Specifically, we propose that EPs who predominately furnish
covered professional services in an area that is designated as a
geographic HPSA as of December 31 of the prior year would be eligible
to receive the 10 percent EHR HPSA payment limit increase during the
current year, provided the EP qualifies for the EHR HPSA payment limit
for the current year. For example, an EP furnishing a covered
professional service in an area that was designated as a geographic
HPSA as of December 31, 2010, and who qualifies to receive the EHR HPSA
payment in 2011, also would receive a 10 percent EHR incentive payment
limit increase for 2011.
Section 1833(m)(2) of the Act also provides that geographic HPSAs
that consist of an entire county be identified and the bonus paid
automatically. We publish a list annually of the zip codes that are in
these areas on our Web site at http://www.cms.hhs.gov/HPSAPSAPhysicianBonuses/01_Overview.asp#TopOfPage. Physicians
furnishing Medicare covered professional services in a zip code that is
on this list automatically receive the HPSA bonus payment. Physicians
furnishing Medicare covered professional services in a zip code that is
not on this list but that was designated as a geographic HPSA as of
December 31 of the prior year must use a modifier when submitting a
Medicare claim in order to receive the HPSA bonus.
We note that we would only list a zip code on our Web site if the
entire geographic area encompassed by the zip code is designated as a
geographic HPSA. If a zip code encompasses both areas designated as a
geographic HPSA and areas that are not a geographic HPSA, we will not
list the zip code on our Web site. Our list also will not include zip
codes for areas designated as geographic HPSAs after we create the zip
code list (but before December 31). EPs furnishing Medicare covered
professional services in an area eligible for the EHR HPSA payment
limit increase that is not included in the list of zip codes for
automatic payment would need to use a modifier when submitting a claim
to identify their eligibility for the HPSA EHR payment limit increase.
Table 23 shows the maximum total EHR HPSA payment limit for an EP
who predominantly furnishes covered professional services in a HPSA as
described previously above for CYs 2011 through 2016. Table 24 shows
the maximum additional amount of incentive payments for a Medicare EP
who predominantly furnishes services in a HPSA. (That is, Table 24
shows the difference between Tables 22 and 23.)
[[Page 1910]]
Table 23--Maximum Total Amount of Incentive Payments for a Medicare EP Who Predominantly Performs Services in a
HPSA
----------------------------------------------------------------------------------------------------------------
Year that EP becomes EHR user in a HPSA 2015 and
Calendar year ---------------------------------------------------------------- subsequent
2011 2012 2013 2014 years
----------------------------------------------------------------------------------------------------------------
2011............................ $19,800 .............. .............. .............. ..............
2012............................ 13,200 $19,800 .............. .............. ..............
2013............................ 8,800 13,200 $16,500 .............. ..............
2014............................ 4,400 8,800 13,200 $13,200 ..............
2015............................ 2,200 4,400 8,800 8,800 $0
2016............................ .............. 2,200 4,400 4,400 0
-------------------------------------------------------------------------------
Total....................... 48,400 48,400 42,900 26,400 0
----------------------------------------------------------------------------------------------------------------
Table 24--Maximum Additional Amount of Incentive Payments for a Medicare EP Who Predominantly Performs Services
in a HPSA
----------------------------------------------------------------------------------------------------------------
Year that an EP first receives the incentive payment for
Medicare covered professional services furnished in a 2015 and
Calendar year geographic HPSA subsequent
---------------------------------------------------------------- years
2011 2012 2013 2014
----------------------------------------------------------------------------------------------------------------
2011............................ $1,800 .............. .............. .............. ..............
2012............................ 1,200 $1,800 .............. .............. ..............
2013............................ 800 1,200 $1,500 .............. ..............
2014............................ 400 800 1,200 $1,200 ..............
2015............................ 200 400 800 800 $0
2016............................ .............. 200 400 400 0
-------------------------------------------------------------------------------
Total....................... 4,400 4,400 3,900 2,400 0
----------------------------------------------------------------------------------------------------------------
d. Form and Timing of Payment
Section 1848(o)(1)(D)(i) of the Act, as amended by section 4101(a)
of the HITECH Act, provides that the incentive payments may be
disbursed as a single consolidated payment or in periodic installments
as the Secretary may specify. We propose to make a single,
consolidated, annual incentive payment to EPs. We believe that making a
single, consolidated payment would be the least administratively
burdensome for both CMS and most EPs. We expect that many EPs who
demonstrate meaningful use of certified EHR technology will receive the
maximum incentive payments. We propose that payments would be made on a
rolling basis, as soon as we ascertain that an EP has demonstrated
meaningful use for the applicable reporting period (that is, 90 days
for the first year or a calendar year for subsequent years), and
reached the threshold for maximum payment.
Section 1848(o)(1)(A) of the Act provides that ``with respect to
covered professional services provided by an eligible professional,''
the incentive payment ``shall be paid to the eligible professional (or
to an employer or facility in the cases described in clause (A) of
section 1842(b)(6)).'' Section 1842(b)(6)(A) of the Act allows for
reassignment to an employer or entity with which the physician has a
valid contractual arrangement allowing the entity to bill for the
physician's services. Therefore, EPs are allowed to reassign their
incentive payment to their employer or an entity which they have a
valid employment agreement or contract providing for such reassignment,
consistent with all rules governing reassignments. The statute does not
address the case where the EP has multiple employers/contractual
arrangements, and it would be difficult operationally for CMS to
allocate the incentive payment among two or more individuals/entities.
Therefore, in Sec. 495.10(e) we are proposing to preclude an EP from
reassigning the incentive payment to more than one employer or entity.
We believe that the question of whether the EP has reassigned the
incentive payment to the employer/entity under his or her contract with
the employer/entity, including any pre-existing contract between the
parties, is a matter of contract interpretation that should be resolved
by the parties themselves. We note that nothing in the statute or our
existing regulations would prohibit an EP from assigning to the
employer/entity only the allowable charges for his or her professional
services, with the EP retaining any incentive payment, or vice versa.
If an EP will reassign his or her incentive payment to an employer/
entity with which the EP has a contractual arrangement, the parties
will need to review their existing contract to determine whether it
currently provides for reassignment of the incentive payment to the
employer/entity or needs to be revised.
The statute provides that the incentive payment shall be paid to
the employer or facility in the cases described in clause (A) of
section 1842(b)(6) of the Act. This clause provides that payment for a
service provided to an individual may not be paid to anyone other than
the individual or the practitioner who provided the service, except
that the practitioner may reassign his or her right to payment to his
or her employer or an entity with whom he or she has a contractual
arrangement if certain conditions are met. Any such authorization must
be in accordance with our regulations at 42 CFR 424.73 and 42 CFR
424.80.
Section 1848(o)(1)(D)(ii) of the Act requires the Secretary to
establish rules to coordinate the incentive payments made among
practices for an EP furnishing covered professional services in more
than one practice, including the application of the limits on the
amounts of the incentive payments. To implement this requirement, we
propose to use the EP's Medicare enrollment information to determine
whether an EP belongs to more than one practice (that is, whether the
EP's National Provider Identifier (NPI) is
[[Page 1911]]
associated with more than one practice). In cases where the EP is
associated with more than one practice, we propose that EPs select one
tax identification number to receive any applicable EHR incentive
payment.
Although it would not be impossible for Medicare contractors to
make proportional EHR incentive payments to each TIN associated with a
provider, we believe this option would entail the creation of highly
complex and potentially unwieldy administrative systems. Therefore, we
believe our proposal to permit the EP to select one TIN to which we
will make any EHR incentive payment is the most efficient alternative.
We have proposed that payments would be made on a rolling basis, as
soon as we ascertain that an EP has demonstrated meaningful use for the
applicable reporting period (that is, 90 days for the first year or a
calendar year for subsequent years), and reached the threshold for
maximum payment. If we were to adopt an alternative policy, permitting
EHR incentive payments to be made to multiple TINs, we would need to
calculate the percentage of covered professional services billed by
each TIN for that EP, and the total of any incentive payment amount
would be divided and paid accordingly. Thus, a policy permitting
payment to multiple TINs would conflict with our proposal to make
payment on a rolling basis as EPs meet the criteria to receive the
maximum EHR incentive payment. An additional confounding factor is the
possibility that an EP might change group affiliations during the year.
Therefore, we believe the most judicious policy would be to permit the
EP to designate one TIN to which payment will be made.
e. Payment Adjustment Effective in CY 2015 and Subsequent Years for EPs
Who Are Not Meaningful Users of Certified EHR Technology
Section 1848(a)(7) of the Act, as amended by section 4101(b) of the
HITECH Act, provides for payment adjustments effective for CY 2015 and
subsequent years for EPs who are not meaningful EHR users during the
relevant EHR reporting period for the year. In general, beginning in
2015, if an EP is not a meaningful EHR user for any EHR reporting
period for the year, then the Medicare physician fee schedule amount
for covered professional services furnished by the EP during the year
(including the fee schedule amount for purposes of determining a
payment based on the fee schedule amount) is adjusted to equal the
`applicable percent' of the fee schedule amount (defined below) that
would otherwise apply. The HITECH Act includes a significant hardship
exception, discussed below, which, if applicable, could exempt certain
EPs from this payment adjustment. The payment adjustments will not
apply to hospital-based EPs, as defined elsewhere.
The term `applicable percent' means: ``(I) for 2015, 99 percent
(or, in the case of an EP who was subject to the application of the
payment adjustment if the EP is not a successful electronic prescriber
under section 1848(a)(5) for 2014, 98 percent);'' ``(II) for 2016, 98
percent; and (III) for 2017 and each subsequent year, 97 percent.''
In addition, section 1848(a)(7)(iii) of the Act provides that if
for 2018 and subsequent years the Secretary finds that the proportion
of EPs who are meaningful EHR users is less than 75 percent, the
applicable percent shall be decreased by 1 percentage point from the
applicable percent in the preceding year, but in no case shall the
applicable percent be less than 95 percent. Significant Hardship
Exception--Section 1848(a)(7)(B) of the Act provides that the Secretary
may, on a case-by-case basis, exempt an EP who is not a meaningful EHR
user for the year from the application of the payment adjustment if the
Secretary determines that compliance with the requirements for being a
meaningful EHR user would result in a significant hardship, such as in
the case of an EP who practices in a rural area without sufficient
Internet access. The exemption is subject to annual renewal, but in no
case may an EP be granted a hardship exemption for more than 5 years.
We will include specific proposals to implement these payment
adjustments for EPs who are not meaningful EHR users in future
rulemaking prior to the 2015 effective date. We welcome comments on
these payment adjustments and any comments received will be considered
in developing future proposals to implement these provisions, including
comments on the possible circumstances for which we should allow an EP
to qualify for the significant hardship exception.
2. Incentive Payments for Hospitals
a. Definition of Eligible Hospital for Medicare
Section 1886(n) of the Act, as amended by section 4102(a)(1) of the
HITECH Act, provides for incentive payments, beginning in FY 2011 (that
is, October 1, 2010 through September 30, 2011) for eligible hospitals
that are meaningful users of certified EHR technology during the EHR
reporting period for the payment year. We are proposing a new Sec.
495.104 to implement this provision. For purposes of this provision,
section 1886(n)(6)(B) of the Act defines ``eligible hospitals'' as
``subsection (d) hospitals,'' as that term is defined in section
1886(d)(1)(B) of the Act. Section 1886(d)(1)(B) of the Act generally
defines a ``subsection (d) hospital'' as a ``hospital located in one of
the fifty States or the District of Columbia.'' The term therefore does
not include hospitals located in the territories or hospitals located
in Puerto Rico. Section 1886(d)(9)(A) of the Act separately defines a
``subsection (d) Puerto Rico hospital'' as a hospital that is located
in Puerto Rico and that ``would be a subsection (d) hospital * * * if
it were located in one of the 50 states.'' Therefore, because section
4102(a)(1) of the HITECH Act does not refer to ``subsection (d) Puerto
Rico hospitals,'' incentive payments for meaningful users of certified
EHR technology are not available under this provision to hospitals
located in Puerto Rico. The provision does apply to inpatient, acute
care hospitals located in the State of Maryland. These hospitals are
not currently paid under the IPPS in accordance with a special waiver
provided by section 1814(b)(3) of the Act. Despite this waiver, the
Maryland hospitals continue to meet the definition of a ``subsection
(d) hospital'' because they are located in the 50 states. The statutory
definition of a subsection (d) hospital also does not apply to
hospitals and hospital units excluded under section 1886(d)(1)(B) from
the IPPS, such as psychiatric, rehabilitation, long term care,
children's, and cancer hospitals. For purposes of this provision, we
will provide incentive payments to hospitals as they are distinguished
by provider number in hospital cost reports. Incentive payments for
eligible hospitals will be calculated based on the provider number used
for cost reporting purposes, which is the CCN of the main provider
(also referred to as OSCAR number). Payments to eligible hospitals are
made to each provider of record. The criteria for being a meaningful
EHR user, and the manner for demonstrating meaningful use, are
discussed in section B.2. of this proposed rule.
b. Incentive Payment Calculation for Eligible Hospitals
Section 1886(n)(2) of the Act, as amended by 4102(a) of HITECH,
describes the methodology for determining the incentive payment amount
for eligible hospitals that are meaningful users of certified EHR
technology during the EHR reporting period for a payment year. In
general,
[[Page 1912]]
that section requires the incentive payment for each payment year to be
calculated as the product of: (1) An initial amount; (2) the Medicare
share; and (3) a transition factor applicable to that payment year.
As amended by section 4201(a) of the HITECH Act, section
1886(n)(2)(A)(i) of the Act defines the initial amount as the sum of a
``base amount,'' as defined in section 1886(n)(2)(B) of the Act, and a
``discharge related amount,'' as defined in section 1886(n)(2)(C) of
the Act. The base amount is $2,000,000, as defined in section
1886(n)(2)(B) of the Act. The term ``discharge related amount'' is
defined in section 1886(n)(2)(C) of the Act as ``the sum of the amount,
estimated based upon total discharges for the eligible hospital
(regardless of any source of payment) for the period, for each
discharge up to the 23,000th discharge as follows:
(i) For the first through the 1,149th discharge, $0.
(ii) For the 1,150th through the 23,000th discharge, $200.
(iii) For any discharge greater than the 23,000th, $0.
In addition to the base amount, the discharge related amount
provides an additional $200 for each hospital discharge during a
payment year, beginning with a hospital's 1,150th discharge of the
payment year, and ending with a hospital's 23,000th discharge of the
payment year. No additional payment is made for discharges prior to the
1,150th discharge, or for those discharges subsequent to the 23,000th
discharge.
Section 1886(n)(2)(C) of the Act, as amended by section 4102(a) of
the HITECH Act, specifies that a ``12-month period selected by the
Secretary'' may be employed for purposes of determining the discharge
related amount. While the statute specifies that the payment year is
determined based on a Federal fiscal year (FY), section 1886(n)(2)(C)
of the Act provides the Secretary with authority to determine the
discharge related amount on the basis of discharge data from a relevant
hospital cost reporting period, for use in determining the incentive
payment during a FY. FYs begin on October 1 of each calendar year, and
end on September 30 of the subsequent calendar year. Hospital cost
reporting periods can begin with any month of a calendar year, and end
on the last day of the 12th subsequent month. For purposes of
administrative simplicity and timeliness, we propose, for each eligible
hospital during each incentive payment year, to use data on the
hospital discharges from the hospital fiscal year that ends during the
FY prior to the FY that serves as the payment year as the basis for
making preliminary incentive payments. Final payments would be
determined at the time of settling the cost report for the hospital
fiscal year that ends during the payment year, and settled on the basis
of the hospital discharge data from that cost reporting period.
Example: FY 2011 begins on October 1, 2010 and ends on September
30, 2011. For an eligible hospital with a cost reporting period
running from July 1, 2010 through June 30, 2011, we would employ the
relevant data from the hospital's cost reporting period ending June
30, 2010 in order to determine the incentive payment for the
hospital during FY 2011. This timeline would allow us to have the
relevant data available for determining payments in a timely manner
for the first and subsequent payment years. This timeline would also
render it unnecessary to develop a cumbersome process to extract and
employ discharge data across more than one hospital cost reporting
period in order to determine the discharge related amount for a FY-
based payment period. However, final payments would be based on
hospital discharge data from the cost report ending June 30, 2011,
and determined at the time of settlement for that cost reporting
period.
c. Medicare Share
As previously discussed, the initial amount must be multiplied by
the Medicare share and an applicable transition factor to determine the
incentive payment to an eligible hospital for an incentive payment
year. As added by section 4102(a) of the HITECH Act, section
1886(n)(2)(D) of the Act defines the Medicare share for purposes of
calculating incentive payments as a fraction based on estimated
Medicare FFS and managed care inpatient bed days, divided by estimated
total inpatient bed-days, modified by charges for charity care. This
section specifies that the Medicare share fraction is determined for
the incentive payment year ``for an eligible hospital for a period
selected by the Secretary.'' As in the case of the discharge data
discussed above, this clause provides the Secretary with authority to
determine the Medicare share fraction on the basis of data from a
relevant hospital cost reporting period, for use in determining the
incentive payment during a FY. For purposes of administrative
simplicity and timeliness equivalent to those discussed above with
regard to discharge data, we propose, for each eligible hospital during
each incentive payment year, to employ data on the hospital's Medicare
fee-for-service and managed care inpatient bed days, total inpatient
bed-days, and charges for charity care from the hospital fiscal year
that ends during the FY prior to the FY that serves as the payment year
as the basis for preliminary payment. Final payment would be made on
the basis of the data from the hospital fiscal year that ends during
the FY that serves as the payment year at the time of the settlement of
the cost report for the latter period.
Section 1886(n)(2)(D) of the Act, as amended by section 4102 of the
HITECH Act, defines the numerator and denominator of this fraction in
terms of estimated Medicare FFS and managed care inpatient bed days,
estimated total inpatient bed-days, and charges for charity care.
Specifically, section 1886(n)(2)(D)(i) of the Act defines the numerator
of the Medicare share fraction as the sum of--
The estimated number of inpatient-bed-days (as established
by the Secretary) which are attributable to individuals with respect to
whom payment may be made under part A; and
The estimated number of inpatient-bed-days (as so
established) that are attributable to individuals who are enrolled with
a MA organization under Part C.
We propose to determine the numbers of Medicare Part A and Part C
inpatient-bed-days using the same data sources and methods for counting
those days that we employ in determining Medicare's share for purposes
of making payments for direct graduate medical education costs, as
provided under section 1886(h) of the Act and Sec. 413.75 of our
regulations. Specifically, we propose to derive ``the estimated number
of inpatient-bed-days * * * attributable to individuals with respect to
whom payment may be made under part A'' from lines 1, 6 through 9, 10
and 14 in column 4 on Worksheet S-3, Part I of the Medicare cost
report. The data entered on these lines in the cost report include all
patient days attributable to Medicare inpatients, excluding those in
units not paid under the IPPS and excluding nursery days. Similarly, we
propose to derive the ``estimated number of inpatient-bed-days
attributable * * * to individuals who are enrolled with a MA
organization under Part C'' from line 2 in column 4 on Worksheet S-3,
Part I of the Medicare cost report. The methodology and data sources
for making these bed day determinations are not only well established,
but also well known and understood within the hospital community. We
therefore see no reason to develop or propose any alternative approach
for determining the ``subsection (d) hospital'' numbers of Medicare
Part A and Part C inpatient-bed-days for purposes of calculating these
incentive payments.
[[Page 1913]]
Section 1886(n)(2)(D)(ii) of the Act defines the denominator of the
Medicare share fraction as the product of--
The estimated total number of inpatient-bed-days with
respect to the eligible hospital during such period; and
The estimated total amount of the eligible hospital's
charges during such period, not including any charges that are
attributable to charity care (as such term is used for purposes of
hospital cost reporting under Title XVIII), divided by the estimated
total amount of the hospitals charges during such period.
As in the case of Medicare Part A and Part C inpatient-bed days,
for purposes of determining total inpatient-bed days in the denominator
of the Medicare share fraction, we propose to use the same data
sources, and the same methods, that we employ in determining Medicare's
share for purposes of making payments for direct graduate medical
education costs. Specifically, we will derive the relevant data from
lines 1, 6 through 9, 10 and 14 in column 6 on Worksheet S-3, Part I of
the Medicare cost report. The data entered on these lines in the cost
report include all patient days attributable to inpatients, excluding
those in units not paid under the IPPS.
d. Charity Care
In determining the denominator of the Medicare share fraction, we
also must determine any charges that are attributable to charity care
furnished by an eligible hospital or CAH. The exclusion of charges
attributable to charity care has the effect of decreasing the
denominator of the Medicare share fraction as the proportion of charity
care (charity care charge ratio) provided by a hospital increases. This
is because the ratio of estimated total hospital charges, not including
charges attributable to charity care, to estimated total hospital
charges during a period decreases, relatively speaking, as a hospital
provides a greater proportion of charity care. The effect of this
factor on the denominator of the Medicare share fraction is therefore
to decrease the denominator (as the total number of inpatient-bed days
is multiplied by a relatively lower charity care charge ratio), as a
hospital provides a greater proportion of charity care. A smaller
denominator increases the Medicare share factor, providing for higher
incentive payments, to a hospital that provides a greater proportion of
charity care. Conversely, as a hospital provides a lower proportion of
charity care, the ratio of estimated total hospital charges, not
including charges attributable to charity care, to estimated total
hospital charges during a period increases. In this case, the effect of
this factor on the denominator of the Medicare share fraction is
therefore to increase the denominator (as the total number of
inpatient-bed days is multiplied by a relatively higher charity care
charge ratio), as a hospital provides a smaller proportion of charity
care. A larger denominator in turn decreases the Medicare share factor,
providing for lower incentive payments, as a hospital provides a lower
proportion of charity care.
The data and methods for determining this charity factor for
purposes of the Medicare share fraction warrants more extensive
discussion. Section 112 of the Medicare, Medicaid, and State Children's
Health Insurance Program (SCHIP) Balanced Budget Refinement Act of 1999
(Pub. L. 106-113) directs the Secretary to require prospective payment
system hospitals to submit data on the costs incurred by the hospitals
for providing inpatient and outpatient hospital services for which the
hospitals are not compensated, including non-Medicare bad debt, charity
care, and charges for medical and indigent care as part of the Medicare
cost report.
In the August 1, 2000 Federal Register (65 FR 47054), we published
a final rule that set forth changes to the IPPS and FY 2001 rates. In
that final rule we responded to comments on implementing section 112 of
Public Law 106-113. We informed the public that the hospital Medicare
cost report and instructions would be revised to collect uncompensated
care data. As a result of meeting with, and receiving input from,
various hospital industry groups, ``Worksheet S-10; Hospital
Uncompensated and Indigent Care Data'', was added to the Medicare cost
reporting forms to implement section 112 of Public Law 106-113. The
Worksheet S-10 was placed in effect for cost reporting periods
beginning on or after April 30, 2002.
In May 2005, the Medicare Payment Advisory Commission (MedPAC)
convened an expert panel to address concerns on the usefulness of the
Worksheet S-10 data. Based on the panel discussion, MedPAC issued a
list of recommended changes to the Worksheet S-10. In addition, in its
March 2007 report to Congress, MedPAC recommended that the Secretary
should improve the form and accompanying instructions for collecting
data on uncompensated care in the Medicare cost report; and require
hospitals to report using the revised form as soon as possible.
(Recommendation 2A-3)
In the August 22, 2007 Federal Register (72 FR 47406), we published
a final rule responding to the MedPAC recommendation. We stated in that
final rule that we were undertaking a major update to the Worksheet S-
10 form and accompanying instructions based on the panel's discussions
with MedPAC.
In the July 2, 2009 Federal Register (74 FR 31738), we accordingly
published a proposed collection to revise the Hospital and Hospital
Health Care Complex Cost Report, Form CMS-2552-10, which included a
revised Worksheet S-10 form. This worksheet may change based on public
comments. The revised cost report and accompanying instructions that
include the definition of charity care based on MedPAC's
recommendations are currently in the Paperwork Reduction Act clearance
process. We anticipate that the revised hospital cost report will be
effective for cost reporting periods beginning on or after February 1,
2010.
For the purposes of this proposed rule, we propose to define
charity care as part of uncompensated and indigent care described for
Medicare cost reporting purposes in the Medicare cost report
instructions at section 4012 of the Provider Reimbursement Manual
(PRM), Part 2; Worksheet S-10; Hospital Uncompensated and Indigent Care
Data. Subsection (d) hospitals and CAHs are required to complete the
Worksheet S-10.
As part of the Form CMS-2552-10 described above, the revised
Worksheet S-10 instructions define uncompensated care as follows: ``* *
* charity care and bad debt which includes non-Medicare bad debt and
non-reimbursable Medicare bad debt. Uncompensated care does not include
courtesy allowances or discounts given to patients.'' These
instructions further define charity care to include health services for
which a hospital demonstrates that the patient is unable to pay.
Charity care results from a hospital's policy to provide all or a
portion of services free of charge to patients who meet certain
financial criteria. For Medicare purposes, charity care is not
reimbursable, and unpaid amounts associated with charity care are not
considered as an allowable Medicare bad debt. Therefore, we are
proposing to use the charity care charges that are reported on line 19
of the revised Worksheet S-10 in the computation of the Medicare share
of the incentive payments. The revised instructions for line 19 of
Worksheet S-10 state the following:
[[Page 1914]]
Enter the total initial payment obligation of patients who are
given a full or partial discount, based on the hospital's charity
care criteria (measured at full charges), for care delivered during
this cost reporting period for the entire facility. For uninsured
patients, including patients with coverage from an entity that does
not have a contractual relationship with the provider (column 1),
this is the patient's total charges. For patients covered by a
public program or private insurer with which the provider has a
contractual relationship (column 2), this is the deductible and
coinsurance payments required by the payer. Include charity care for
all services except physician and other professional services. Do
not include charges for either uninsured patients given discounts
without meeting the hospital's charity care criteria or patients
given courtesy discounts. Charges for non-covered services provided
to patients eligible for Medicaid or other indigent care program
(including charges for days exceeding a length of stay limit) can be
included, if such inclusion is specified in the hospital's charity
care policy and the patient meets the hospital's charity care
criteria.
Under section 1886(n)(2)(D) of the Act, if the Secretary determines
that data are not available on charity care necessary to calculate the
portion of the formula specified in clause (ii)(II) of section
1886(n)(2)(D) of the Act, the Secretary shall use data on uncompensated
care and may adjust such data so as to be an appropriate proxy for
charity care including a downward adjustment to eliminate bad debt data
from uncompensated care data. In the absence of the data necessary for
the Secretary to compute the amount described in clause (ii)(II) of
section 1886(n)(2)(D) of the Act, the amount under such clause shall be
deemed to be 1.
We believe that the charity care charges reported on line 19 of the
Worksheet S-10 represent the most accurate measure of charity care
charges as part of the hospital's overall reporting of uncompensated
and indigent care for Medicare purposes. Therefore, since eligible
hospitals and CAHs are required to complete the Worksheet S-10, if a
hospital has not properly reported any charity care charges on line 19,
we may question the accuracy of the charges used for computing the
Medicare share of the incentive payments. With appropriate resources,
we believe the charity care data can be obtained by the MAC. This data
would be used to determine if the hospital's charity care criteria are
appropriate, if a hospital should have reported charity care charges,
and if the reported charges are proper. If we determine, as based on
the determination of the MAC, that the hospital did not properly report
charity care charges on the Worksheet S-10, then we propose to deem the
denominator in section 1886(n)(2)(D)(ii)(II) of the Act to be 1.
In this proposed rule, we are specifically soliciting public
comments on the charity care financial criteria established by each
hospital and reviewed by the MACs, the collection of charity care data
on the Worksheet S-10, and whether proxies for charity care may be
developed with other data available to us.
e. Transition Factor
As we have previously discussed, the initial amount must be
multiplied not only by the Medicare share fraction, but also by an
applicable transition factor in order to determine the incentive
payment to an eligible hospital for an incentive payment year. Section
1886(n)(2)(E)(i) of the Act designates that the applicable transition
factor equals 1 for the first payment year, three-fourths for the
second payment year, one-half for the third payment year, one-fourth
for the fourth payment year, and zero thereafter. However, section
1886(n)(2)(E)(ii) of the Act provides that if ``the first payment year
for an eligible hospital is after 2013, then the transition factor
specified in this subparagraph for a payment year for such hospital is
the same as the amount specified in clause (i) for such payment year
for an eligible hospital for which the first payment year is 2013.''
Accordingly, if a hospital's first payment year is FY 2014, the
applicable transition factor equals three-fourths for the first payment
year (FY 2014), one-half for the second payment year (FY 2015), one-
fourth for the third payment year (FY 2015, and zero thereafter.) If a
hospital's first payment year is FY 2015, the applicable transition
factor equals one-half for the first payment year (FY 2015), one-fourth
for the second payment year (FY 2016), and zero thereafter. As
discussed in more detail below, under section 1886(n)(2)(E)(ii) of the
Act, the transition factor for a hospital for which the first payment
year is after 2015 equals zero for all years. In other words, 2015 is
the last year for which eligible hospitals may begin participation in
the Medicare EHR Incentive Program.
Figure 1--Incentive Payment Calculation for Subsection D Hospitals
Incentive Amount = [Initial Amount] x [Medicare Share] x [Transition
Factor]
Initial Amount = $2,000,000 + [$200 per discharge for the 1,150th -
23,000th discharge]
Medicare Share = Medicare/(Total*Charity Care) = [M/(T*C)]
M = [ of Inpatient Bed Days for Part A Beneficiaries] +
[ of Inpatient Bed Days for MA Beneficiaries]
T = [ of Total Inpatient Bed Days]
C = [Total Charges - Charges for Charity Care*]/[Total Charges]
*If data on charity care is not available, then the Secretary
would use data on uncompensated care as a proxy. If the proxy data
is not also available, then ``C'' would be equal to 1.
Transition factor
------------------------------------------------------------------------
Transition
Consecutive payment year factor
------------------------------------------------------------------------
1....................................................... 1
2....................................................... \3/4\
3....................................................... \1/2\
4....................................................... \1/4\
------------------------------------------------------------------------
f. Duration and Timing of Incentive Payments
Section 1886(n)(2)(E)(i) of the Act establishes that an eligible
hospital that is a meaningful user of certified EHR technology could
receive up to 4 years of financial incentive payments. The transition
factor phases down the incentive payments over the 4-year period.
Therefore, an eligible hospital that is a meaningful user of certified
EHR technology during the relevant EHR reporting period, in payment
year FY 2011, could receive incentive payments beginning with FY 2011
(transition factor equals 1), and for FY 2012 (transition factor equals
three-fourths), 2013 (transition factor equals one-half), and 2014
(transition factor equals one-fourth) if they continue to be a
meaningful user of certified EHR technology during the relevant EHR
reporting periods.
Section 1886(n)(2)(E)(ii) of the Act establishes the range of time
during which a hospital may begin to receive incentive payments, and
the applicable transition periods for hospitals that are permitted to
begin receiving incentive payments after FY 2011. Specifically, that
section provides that if the ``first payment year for an eligible
hospital is after 2015, then the transition factor * * * for such
hospital and for such year and subsequent year shall be 0.'' This
clause in effect provides that no incentive payments will be available
to a hospital that would begin to receive such payments after FY 2015.
In other words, FY 2015 is the last FY in which a hospital can begin to
receive incentive payments. Taken together, sections 1886(n)(2)(G)(i)
and 1886(n)(2)(E)(ii) of the Act allow hospitals to begin receiving
incentive payments during FYs 2011 through 2015. Section
1886(n)(2)(E)(ii) of the Act also establishes the transition periods
and
[[Page 1915]]
factors that will be in effect for hospitals that begin to receive
transition payments during FY 2014 and 2015. As discussed previously,
that section states that if ``the first payment year for an eligible
hospital is after 2013, then the transition factor specified in this
subparagraph for a payment year for such hospital is the same as the
amount specified in clause (i) for such payment year for an eligible
hospital for which the first payment year is 2013.'' Section
1886(n)(2)(E)(ii) of the Act also establishes the transition periods
that will be in effect for hospitals that begin to receive transition
payments during FYs 2014 through 2015. That section states that if
``the first payment year for an eligible hospital is after 2013, then
the transition factor specified in this subparagraph for a payment year
for such hospital is the same as the amount specified in clause (i) for
such payment year for an eligible hospital for which the first payment
year is 2013.'' By implication, this clause establishes that, for
hospitals that begin to receive incentive payments in FYs 2012 and
2013, the transition periods are equivalent to those for hospitals that
begin to receive such payments in FY 2011. An eligible hospital that is
a meaningful user of certified EHR technology could receive incentive
payments beginning with FY 2012 (transition factor equals 1), and for
FY 2013 (transition factor equals three-fourths), FY 2014 (transition
factor equals one-half), and FY 2015 (transition factor equals one-
fourth). Similarly, an eligible hospital that is a meaningful EHR user
could receive incentive payments beginning with FY 2013 (transition
factor equals 1), and for FYs 2014 (transition factor equals \3/4\),
2015 (transition factor equals \1/2\), and 2016 (transition factor
equals \1/4\).
However, this section also specifically provides that the
transition factor is modified for those eligible hospitals that first
become meaningful users of certified EHR technology beginning in 2014
or 2015. Such hospitals would receive payments as if they became
meaningful EHR users beginning in 2013. In other words, if a hospital
were to begin to demonstrate meaningful use of EHR certified technology
in 2014, the transition factor used for that year (2014) would be \3/4\
instead of 1, \1/2\ for the second year (2015), \1/4\ for the third
year (2016), and zero thereafter. Similarly, if a hospital were to
begin meaningful use of certified EHR technology in 2015, the
transition factor used for that year would be \1/2\ instead of 1, \1/4\
for the second year (2016), and zero thereafter.
Table 25 shows the possible years an eligible hospital could
receive an incentive payment and the transition factor applicable to
each year.
Table 25--Transaction Factor for Medicare FFS Eligible Hospitals
----------------------------------------------------------------------------------------------------------------
Fiscal year that eligible hospital first receives the incentive payment
Fiscal year -------------------------------------------------------------------------------
2011 2012 2013 2014 2015
----------------------------------------------------------------------------------------------------------------
2011............................ 1.00 .............. .............. .............. ..............
2012............................ 0.75 1.00 .............. .............. ..............
2013............................ 0.50 0.75 1.00 .............. ..............
2014............................ 0.25 0.50 0.75 0.75 ..............
2015............................ .............. 0.25 0.50 0.50 0.50
2016............................ .............. .............. 0.25 0.25 0.25
----------------------------------------------------------------------------------------------------------------
We welcome comments from the public on our discussion of these
statutory requirements regarding the computation of the incentive
payment amounts, and the issues regarding the sources and timing of
data for use in these computations.
g. Incentive Payment Adjustment Effective in FY 2015 and Subsequent
Years for Eligible Hospitals Who Are Not Meaningful EHR Users
In addition to providing for incentive payments for meaningful use
of EHRs during a transition period, section 1886(b)(3)(B) of the Act,
as amended by section 4102(b)(1) of the HITECH Act, provides for an
adjustment to the market basket update to the IPPS payment rate for
those eligible hospitals that are not meaningful EHR users for the EHR
reporting period for a payment year, beginning in FY 2015.
Specifically, section 1886(b)(3)(B) of the Act provides that, ``for FY
2015 and each subsequent FY,'' an eligible hospital that is not ``a
meaningful EHR user * * * for an EHR reporting period'' will receive a
reduced update to the IPPS standardized amount. This reduction will
apply to ``three-quarters of the percentage increase otherwise
applicable.'' For FY 2015 and each subsequent FY, the reduction to
three-quarters of the applicable update for an eligible hospital that
is not a meaningful EHR user will be ``33\1/3\ percent for FY 2015,
66\2/3\ percent for FY 2016, and 100 percent for FY 2017 and each
subsequent FY.'' In other words, the Secretary is required to subject
eligible hospitals who are not meaningful users to one-quarter, one-
half, and three-quarters reductions of their market basket updates in
FY 2015, FY 2016, and FY 2017 and subsequent years respectively.
Section 4102(b)(1)(B) of the HITECH Act also provides that such
``reduction shall apply only with respect to the FY involved and the
Secretary shall not take into account such reduction in computing the
applicable percentage increase * * * for a subsequent FY.'' This
provision establishes a continuing incentive for hospitals to become
meaningful EHR users, because a hospital that does become a meaningful
EHR user in any year after the effective date of the update reduction
will receive the same, fully updated standardized amount for that year,
and subsequent years, as those hospitals that were already meaningful
EHR users at the time when the update reduction went into effect
(although hospitals would remain subject to a separate reduction for
failure to report quality data under RHQDAPU). In order to conform with
this new update reduction, section 4102(b)(1)(A) of the HITECH Act
revises section 1886(b)(3)(B)(viii)(1) of the Act to provide that,
beginning with FY 2015, the reduction to the IPPS applicable percentage
increase for failure to submit data on quality measures to the
Secretary shall be one-quarter of the applicable market basket update.
In this way, even the combined reductions for EHR use and quality data
reporting will not produce an update of less than zero for a hospital
in a given FY as long as the hospital market basket remains a positive
number.
The following example illustrates how this payment reduction would
work. Suppose that the market basket ``percentage increase otherwise
applicable'' to the IPPS standardized
[[Page 1916]]
amount is 2.0 percent. Of this 2.0 percent, one-quarter (0.5 percent)
of the market basket update would be subject to a reduction for any
hospital that fails to submit data on quality measures, and up to
three-quarters (1.5 percent) would be subject to a reduction for any
hospital that is not a meaningful EHR user. For FY 2015, hospitals
could receive one of four different updates, depending upon their
reporting of quality data and their use of EHRs:
A hospital that reports quality data and qualifies as a
meaningful EHR user would receive the full update of 2.0 percent.
A hospital that fails to report quality data but is a
meaningful EHR user would receive an update of 1.5 percent, which
represents the full 2.0 percent update minus the reduction of one-
quarter (0.5 percentage point) for failing to report quality data.
A hospital that reports quality data but does not qualify
as a meaningful EHR user would receive an update of 1.5 percent, which
represents the full 2.0 percent update minus 0.5 percentage point
(33\1/3\ percent of three-quarters of the full update: \1/3\ times 1.5
equals 0.5).
A hospital that fails to report quality data and does not
qualify as a meaningful EHR user would receive an update of 1.0
percent, which represents the full 2.0 percent update minus the
reduction of one-quarter (0.5 percentage point) for failing to report
quality data, and a further reduction of 0.5 percentage point (33\1/3\
percent of three-quarters of the full update: \1/3\ times 1.5 equals
0.5).
For FY 2016, hospitals could receive one of four different updates
(assuming a 2 percent update that is otherwise applicable), depending
upon their reporting of quality data and their use of EHRs:
A hospital that reports quality data and qualifies as a
meaningful EHR user would receive the full update of 2.0 percent.
A hospital that fails to report quality data, but is a
meaningful EHR user would receive an update of 1.5 percent, which
represents the full 2.0 percent update minus the reduction of one-
quarter (0.5 percentage point) for failing to report quality data.
A hospital that reports quality data, but does not qualify
as a meaningful EHR user would receive an update of 1.0 percent, which
represents the full 2.0 percent update minus 1.0 percentage point
(66\2/3\ percent of three-quarters of the full update: \2/3\ times 1.5
equals 1.0).
A hospital that fails to report quality data, and does not
qualify as a meaningful EHR user would receive an update of 0.5
percent, which represents the full 2.0 percent update minus the
reduction of one-quarter (0.5 percentage point) for failing to report
quality data, and a further reduction of 1.0 percentage point (66\2/3\
percent of three-quarters of the full update: \2/3\ times 1.5 equals
1.0).
For FYs 2017 and subsequent FYs, the possibilities (assuming a 2
percent update that is otherwise applicable) are as follows:
A hospital that reports quality data and qualifies as a
meaningful EHR user would receive the full update of 2.0 percent.
A hospital that fails to report quality data, but is a
meaningful EHR user would receive an update of 1.5 percent, which
represents the full 2.0 percent update minus the reduction of one-
quarter (0.5 percentage point) for failing to report quality data.
A hospital that reports quality data, but does not qualify
as a meaningful EHR user would receive an update of 0.5 percent, which
represents the full 2.0 percent update minus 1.5 percentage points (100
percent of three-quarters of the full update, which equals 1.5) for
failing to be a meaningful EHR user.
A hospital that fails to report quality data, and does not
qualify as a meaningful EHR user would receive an update of 0.0
percent, which represents the full 2.0 percent update minus the
reduction of one-quarter (0.5 percentage point) for failing to report
quality data, and a further reduction of 1.5 percentage points (100
percent of three-quarters of the full update, which equals 1.5) for
failing to be a meaningful EHR user.
These examples are illustrative of current law. Specific proposals
to implement these payment adjustments for subsection (d) hospitals
that are not meaningful EHR users are not being made at this time but
will be subject to future rule-making prior to the 2015 implementation
date. We welcome comments on these payment adjustments and any comments
received will be considered in developing future proposals to implement
these provisions.
3. Incentive Payments for Critical Access Hospitals (CAHs)
Section 1814(l)(3)(A) of the Act, as amended by section 4102(a)(2)
of the HITECH Act, also provides for incentive payments for CAHs that
are meaningful users of certified EHR technology during an EHR
reporting period for a cost reporting period beginning during a payment
year after FY 2010 but before FY 2016. The criteria for being a
meaningful EHR user, and the manner for demonstrating meaningful use,
are discussed in section II.A.2. of this proposed rule.
a. Definition of CAHs for Medicare
Section 1861(mm)(1) of the Act defines a CAH as a facility that has
been certified as a critical access hospital under section 1820(c).
CAHs are reimbursed for services furnished to Medicare beneficiaries
under section 1814(l) of the Act for inpatient services and section
1834(g) of the Act for outpatient services. Incentive payments for CAHs
under section 1814(l)(3)(A) of the Act will be calculated based on the
provider number used for cost reporting purposes, which is the CCN of
the main provider. The process for making incentive payments to CAHs is
discussed in section II.B.4.c. of this proposed rule.
b. Current Medicare Payment of Reasonable Cost for CAHs
For Medicare purposes, CAHs are paid for most inpatient and
outpatient services to Medicare beneficiaries on the basis of
reasonable cost under section 1814(l) and section 1834(g) of the Act,
respectively. Thus, CAHs are not subject to the IPPS and Hospital
Outpatient Prospective Payment System (OPPS).
Section 1861(v)(1)(A) of the Act is the statutory basis for
reasonable cost reimbursement in Medicare. Under the reasonable cost
reimbursement methodology, payments to providers are based on the
reasonable cost of furnishing Medicare-covered services to
beneficiaries. Reasonable cost includes all necessary and proper costs
in furnishing the services, subject to the principles of reasonable
cost reimbursement relating to certain specific items of revenue and
cost. Reasonable cost takes into account both direct and indirect costs
of providers of services, including normal standby costs. The objective
of the reasonable cost methodology is to ensure that the costs for
individuals covered by the program are not borne by others not so
covered, and the costs for individuals not so covered are not borne by
the program. The reasonable costs of services and the items to be
included are determined in accordance with the regulations at 42 CFR
part 413, manual guidance, and other CMS instructions.
Currently, under section 1814(l)(1) of the Act and Sec. 413.70(a)
of the regulations, effective for cost reporting periods beginning on
or after January 1, 2004, payment for inpatient services of a CAH,
other than services of a distinct part unit of a CAH, is 101 percent of
the reasonable costs of the CAH in providing CAH services to its
inpatients, as determined in accordance with
[[Page 1917]]
section 1861(v)(1)(A) of the Act and with the applicable principles of
cost reimbursement in Parts 413 and 415 of the regulations. However,
payment for inpatient CAH services is not subject to the reasonable
cost principles of the lesser of cost or charges, the reasonable
compensation equivalent limits for physician services to providers, the
ceilings on hospital operating costs, and the payment window provisions
for preadmission services, specified in Sec. 412.2(c)(5) and Sec.
413.40(c)(2). Section 1834(g) of the Act and Sec. 413.70(b) of the
regulations describe the payment methodology for outpatient services
furnished by a CAH.
Currently, reasonable cost reimbursement for CAHs includes payment
for depreciation of depreciable assets used in providing covered
services to beneficiaries, as described under Part 413 subpart G of our
regulations and Sec. 104 of the Medicare Provider Reimbursement Manual
(PRM). In general, the depreciation expense of an asset, representing a
portion of the depreciable asset's costs which is allocable to a period
of operation, is determined by distributing the acquisition costs of
the depreciable asset, less any salvage costs, over the estimated
useful life of the asset.
c. Changes Made by the HITECH Act
Sections 4102(a)(2) and 4102(b)(2) of the HITECH Act amended
section 1814(l) of the Act, which governs payment for inpatient CAH
services. The HITECH Act did not amend section 1834(g) of the Act,
which governs payment for outpatient CAH services.
Sections 4102(a)(2) and 4102(b)(2) of the HITECH Act amended
section 1814(l) of the Act by adding new paragraphs (3), (4), and (5)
as follows:
Section 1814(l)(3)(A) of the Act provides the following:
The following rules shall apply in determining payment and
reasonable costs * * * for a critical access hospital that would be
a meaningful EHR user (as would be determined under paragraph (3) of
section 1886(n)) for an EHR reporting period for a cost reporting
period beginning during a payment year if such critical access
hospital was treated as an eligible hospital under such section:
(i) The Secretary shall compute reasonable costs by expensing
such costs in a single payment year and not depreciating these costs
over a period of years (and shall include as costs with respect to
cost reporting periods beginning during a payment year costs from
previous cost reporting periods to the extent they have not been
fully depreciated as of the period involved).
(ii) There shall be substituted for the Medicare share that
would otherwise be applied [to CAHs under section 1814(l)(1)] a
percent (not to exceed 100 percent) equal to the sum of--
(I) the Medicare share (as would be specified under paragraph
(2)(D) of section 1886(n)) for such critical access hospital if such
critical access hospital was treated as an eligible hospital under
such section; and
(II) 20 percentage points.
Section 1814(l)(3)(B) of the Act provides that the incentive
payment for CAHs will be paid ``through a prompt interim payment
(subject to reconciliation) after submission and review of such
information (as specified by the Secretary) necessary to make such
payment.'' The provision also states that ``[i]n no case may payment
under this paragraph be made with respect to a cost reporting period
beginning during a payment year after 2015 and in no case may a
critical access hospital receive payment under this paragraph with
respect to more than 4 consecutive payment years.''
Section 1814(l)(3)(C) of the Act provides that the reasonable costs
for which a CAH may receive an incentive payment are costs for the
purchase of certified EHR technology to which purchase depreciation
(excluding interest) would otherwise apply under section 1814(l)(1) of
the Act.
Section 1814(l)(4)(A) of the Act provides for an adjustment,
subject to the hardship exemption in section 1814(l)(4)(C) of the Act,
to a CAH's reimbursement at 101 percent of its reasonable costs if the
CAH has not met the meaningful EHR user definition for an EHR reporting
period that begins in FY 2015 or a subsequent fiscal year. Section
1814(l)(4)(B) of the Act specifies that if a CAH is not a meaningful
EHR user during the cost reporting period beginning in FY 2015, its
reimbursement will be reduced from 101 percent of its reasonable costs
to 100.66 percent. For FY 2016, the percentage of reimbursement for a
CAH that is not a meaningful EHR user is reduced to 100.33 percent of
its reasonable costs. For FY 2017 and each subsequent FY, the
percentage of reimbursement is reduced to 100 percent of reasonable
costs. Section 1814(l)(4)(C) of the Act states that, as provided for
eligible subsection (d) hospitals, the Secretary may, on a case-by-case
basis, exempt a CAH from this adjustment if the Secretary determines,
subject to annual renewal, that requiring the CAH to be a meaningful
EHR user during a cost reporting period beginning in FY 2015 or a
subsequent fiscal year would result in a significant hardship, such as
in the case of a CAH in a rural area without sufficient Internet
access. However, in no case may a CAH be granted an exemption under
this provision for more than 5 years.
Section 1814(l)(5) provides that there shall be no administrative
or judicial review under sections 1869 or 1878 of the Act, or
otherwise, of: (1) The methodology and standards for determining the
amount of payment under section 1813(l)(3) and payment adjustments
under section 1814(l)(4); (2) the methodology and standards for
determining a CAH to be a meaningful EHR user; (3) the methodology and
standards for determining if the hardship exemption applies to a CAH;
(4) the specification of EHR reporting periods; and (5) the
identification of reasonable costs used to compute CAH incentive
payments.
d. Incentive Payment Calculation for CAHs
Consistent with section 1814(l)(3)(A) of the Act, we are proposing
to amend Sec. 413.70(a) to add a new paragraph (5) to provide for an
incentive payment to a qualifying CAH for the reasonable costs incurred
for the purchase of certified EHR technology in a cost reporting period
beginning during a payment year after FY 2010 but before FY 2016. We
are proposing to include a cross-reference to Sec. 495.106 which
defines the terms associated with the CAH incentive payment, including
the definition of a ``qualifying CAH'' that is eligible to receive the
CAH incentive payment, and the methodology for determining the amount
of that incentive payment. In addition, we are proposing to amend Sec.
413.70(a) to add a new paragraph (6) to provide for the adjustment of a
CAH's reasonable costs of providing inpatient services starting in FY
2015 if the CAH is not a qualifying CAH.
In computing the CAH incentive payment and applying the adjustments
to a CAH's payment if the CAH is not a qualifying CAH, we propose to
apply the definitions of certified EHR technology, EHR reporting
period, meaningful EHR user and qualified EHR in proposed Sec. 495.4
that are discussed elsewhere in this proposed rule.
In proposed Sec. 495.106(a), we are proposing to define a
qualifying CAH as a CAH that meets the meaningful EHR user definition
for eligible hospitals in Sec. 495.4, which is discussed in section II
A.1. of this proposed rule. Also in proposed Sec. 495.106(a), for the
purposes of computing the CAH incentive payment, we are proposing that
the reasonable costs for the purchase of certified EHR technology mean
the reasonable acquisition costs, excluding any depreciation and
interest expenses associated with the acquisition,
[[Page 1918]]
incurred for the purchase of depreciable assets as described at part
413 subpart G, such as computers and associated hardware and software,
necessary to administer certified EHR technology as defined in Sec.
495.4 of this proposed rule. We also propose to define payment year for
CAHs to mean a fiscal year beginning after FY 2010 but before FY 2016.
Under proposed Sec. 495.106(b), we specify that a qualifying CAH
shall receive an incentive payment for its reasonable costs incurred
for the purchase of certified EHR technology. The CAH incentive payment
will be for a cost reporting period that begins during a payment year
after FY 2010 but before FY 2016.
Consistent with section 1814(l)(3)(A) of the Act, under proposed
Sec. 495.106(c), the proposed payment methodology for computing the
incentive payment for a qualifying CAH for a cost reporting period
during a payment year is equal to the product of--(1) the reasonable
costs incurred for the purchase of certified EHR technology in that
cost reporting period and any similarly incurred costs from previous
cost reporting periods to the extent they have not been fully
depreciated as of the cost reporting period involved and (2) the CAH's
Medicare share which equals the Medicare share as computed for eligible
hospitals including the adjustment for charity care (described in
sections II.A.2.b. and A.3. of this proposed rule) plus 20 percentage
points. However, in no case will the resulting Medicare share for a CAH
exceed 100 percent. This percentage adjustment will be used in place of
the 101 percent typically applied to a CAH's reasonable costs under
section 1814(l)(1) of the Act and Sec. 413.70(a) of the regulations.
For example, a CAH first requests an incentive payment for its cost
reporting period beginning on January 1, 2012 which is in FY 2012. The
CAH incurred reasonable costs of $500,000 for the purchase of certified
EHR technology in its previous cost reporting period beginning on
January 1, 2011. This CAH is a meaningful user of certified EHR
technology during the relevant EHR reporting period and thus qualifies
for an incentive payment for FY 2012. (For illustrative purposes this
example assumes no salvage value of the assets acquired.) The CAH
depreciated $100,000 of the costs of these items in the cost reporting
period beginning on January 1, 2011. As a result, the amount used to
compute the incentive payment will be the remaining $400,000 of
undepreciated costs. The CAH's Medicare share is 90 percent (its
Medicare share of 70 percent using the methodology described in section
II.A.2.b. of this proposed rule plus 20 percentage points). Therefore,
the CAH's incentive payment for FY 2012 is $360,000 ($400,000 times 90
percent). This CAH's first payment year is FY 2012, and it can receive
incentive payments through 4 consecutive payment years which, in this
example, would be FYs 2012 through 2015.
If, in the above example, the CAH also incurred reasonable costs of
$300,000 for the purchase of certified EHR technology in its cost
reporting period beginning in FY 2012 that will not be depreciated,
then the incentive payment for FY 2012 is $630,000 ($700,000 ($400,000
in FY 2011 plus $300,000 in FY 2012) times 90 percent).
(The preceding examples are offered for illustrative purposes only
and are not intended to encompass all possible computations of the CAH
incentive payment.)
Under proposed Sec. 495.106(d)(1), the amount of the incentive
payment made to a qualifying CAH under this section represents the
expensing and payment of the reasonable costs of certified EHR
technology computed as described above in a single payment year and, as
specified in Sec. 413.70(a)(5), such payment is made in lieu of any
payment that would have been made under Sec. 413.70(a)(1) for the
reasonable costs of the purchase of certified EHR technology including
depreciation and interest expenses associated with the acquisition. The
Medicare contractor will review the CAH's current year and each
subsequent year's cost report to ensure that the assets associated with
the acquisition of certified EHR technology are expensed in a single
period and that depreciation and interest expenses associated with the
acquisition are not allowed.
Under proposed Sec. 495.106(d)(2), the amount of the incentive
payment made to a qualifying CAH under this section is paid through a
prompt interim payment for the applicable payment year after--(1) The
CAH submits the necessary documentation, as specified by CMS or its
Medicare contractor, to support the computation of the incentive
payment amount; and (2) CMS or its Medicare contractor reviews such
documentation and determines the interim amount of the incentive
payment.
Under Sec. 495.106(d)(3), the interim incentive payment is subject
to a reconciliation process as specified by CMS and the final incentive
payment as determined by CMS or its Medicare contractor is considered
payment in full for the reasonable costs incurred for the purchase of
certified EHR technology in a payment year.
Under Sec. 495.106(d)(4), we propose that an incentive payment may
be made with respect to a cost reporting period beginning during a
payment year beginning with FY 2011 (October 1, 2010 through September
30, 2011) through FY 2015 (October 1, 2014 through September 30, 2015),
but in no case may a CAH receive an incentive payment with respect to
more than four consecutive payment years. Therefore, a CAH, that is a
meaningful EHR user, may begin receiving an incentive payment for its
cost reporting period beginning in FY 2011 for the incurred reasonable
costs for the purchase of certified EHR technology during that cost
reporting period and in previous cost reporting periods to the extent
that the item or items have not been fully depreciated. These incentive
payments will continue for no more than 4 consecutive payment years and
will not be made for a cost reporting period beginning during a payment
year after 2015. As discussed in section II.B.4. of this proposed rule,
the CAH must submit supporting documentation for its incurred costs of
purchasing certified EHR technology to its Medicare contractor (Fiscal
Intermediary (FI)/MAC).
CAHs cannot receive an incentive payment for a cost reporting
period that begins in a payment year after FY 2015. If the first
payment year for a CAH is FY 2013 then the fourth consecutive payment
year would be 2016. However, the CAH cannot be paid an incentive
payment for FYs 2016 and beyond. For FY 2016 and beyond, payment to
CAHs for the purchase of additional EHR technology will be made under
Sec. 413.70(a)(1) in accordance with the reasonable cost principles,
as described above, which would include the depreciation and interest
cost associated with such purchase.
e. Reduction of Reasonable Cost Payment in FY 2015 and Subsequent Years
for CAHs That Are Not Meaningful EHR Users
Section 4102(b)(2) of the HITECH Act amends section 1814(l) to
include an adjustment to a CAH's reimbursement at 101 percent of its
reasonable costs if the CAH has not met the meaningful EHR user
definition for an EHR reporting period that begins in FY 2015, FY 2016,
FY 2017, and each subsequent FY thereafter. Consistent with this
provision, under proposed Sec. 495.106(e) and Sec. 413.70(a)(6), if a
CAH has not demonstrated meaningful use of certified EHR technology for
FY 2015, its reimbursement will be reduced from
[[Page 1919]]
101 percent of its reasonable costs to 100.66 percent. For FY 2016, its
reimbursement will be reduced to 100.33 percent of its reasonable
costs. For FY 2017 and each subsequent FY, its reimbursement will be
reduced to 100 percent of reasonable costs.
However, as provided for eligible hospitals, a CAH may, on a case-
by-case basis, be exempted from this adjustment if CMS or its Medicare
contractor determines, on an annual basis, that requiring the CAH to be
a meaningful EHR user would result in a significant hardship, such as
in the case of a CAH in a rural area without sufficient Internet
access. However, in no case may a CAH be granted an exemption under
this provision for more than 5 years.
Section 1814(l)(5) of the Act exempts the determinations made under
paragraphs (l)(3) and (l)(4) from administrative and judicial review.
Accordingly, under proposed Sec. 413.70(a)(6)(iv) and Sec.
495.106(f), we are proposing that there shall be no administrative or
judicial review under sections 1869 or 1878 of the Act, or otherwise,
of the following:
The methodology and standards for determining the amount
of payment under section 1814(l)(3) of the Act and payment adjustments
under section 1814(l)(4) of the Act for CAHs, including selection of
periods under section 1886(n)(2) of the Act for determining, and making
estimates or using proxies of, inpatient-bed-days, hospital charges,
charity charges, and the Medicare share under subparagraph (D) of
section 1886(n)(2) of the Act;
The methodology and standards for determining a CAH to be
a meaningful EHR user under section 1886(n)(3) of the Act as would
apply if the CAH was treated as an eligible hospital under section
1886(n) of the Act;
The methodology and standards for determining if the
hardship exemption under section 1814(l)(4)(C) of the Act applies to a
CAH;
The specification of EHR reporting periods under section
1886(n)(6)(B) of the Act as applied under section 1814(l)(3) and (4) of
the Act for CAHs; and
The identification of reasonable costs used to compute the
CAH incentive payment under section 1814(l)(3)(C) of the Act.
4. Process for Making Incentive Payments Under the Medicare FFS Program
As previously discussed in section II.B.1. and 2. of this proposed
rule and sections 1848(o)(1) and 1886(n)(1) of the Act, the statute
provides for incentive payments to eligible professionals, eligible
hospitals, and CAHS who are meaningful users of certified EHR
technology as early as FY 2011 for qualifying eligible hospitals and
CAHs and CY 2011 for qualifying EPs. The statute does not specify the
process for making these payments to qualifying EPs and qualifying
eligible hospitals and CAHs participating in the FFS Medicare incentive
payment program, but instead leaves the payment process to the
Secretary's discretion.
We propose that FIs, carriers, and MACs, as appropriate, would be
responsible for determining the incentive payment amounts for
qualifying EPs and qualifying eligible hospitals and CAHs in accordance
with the proposed methodology set forth in section II.B.1.b. and B.2.b.
of this proposed rule based on the previously discussed meaningful use
criteria, disbursing the incentive payments to qualifying EPs and
qualifying eligible hospitals and CAHs, and resolving any
reconciliation issues.
a. Incentive Payments to EPs
We propose that the carriers/MACs calculate incentive payment
amounts for qualifying EPs. Incentive payments will be disbursed on a
rolling basis, as soon as they ascertain that an EP has demonstrated
meaningful use for the applicable reporting period (i.e., 90 days for
the first year or a calendar year for subsequent years), and reached
the threshold for maximum payment. As discussed previously in section
II.A.1.b. of this proposed rule, once a qualifying EP's allowed charges
reach the minimum threshold of allowed charges for the payment year,
the qualifying EP is eligible to receive the maximum incentive payment;
the carrier/MAC would be authorized to disburse the full incentive
payment to that qualifying EP. If a qualifying EP's allowed charges do
not reach the minimum threshold during the payment year (including
subsequent claims submitted not later than 2 months after the end of
the payment year per statute) and if the qualifying EP is also a
qualifying MA EP, the qualifying MA organization with which the EP is
affiliated will receive the incentive payment for the EP from the MA.
If the qualifying EP does not also qualify as a MA EP, then the
carriers/MAC will calculate the amount of the qualifying EP's incentive
payment an amount determined by statute as 75 percent of the
accumulated allowed charges based on claims submitted not later than 2
months after the end of the payment year), and disburse the incentive
payment to the qualifying EP in the year following payment year. The
carriers/MACs will issue incentive payments to qualifying EPs after
ensuring payment has not already been made under the Medicaid program
for the relevant payment year. As required by section 1848(m)(2) of the
Act as amended by section 4101(f) of the HITECH Act, qualifying EPs
receiving incentive payments from the Medicare EHR incentive payment
program may not also receive an e-prescribing incentive payment. The
carriers/MACs will also track the incentive payment at the qualifying
EP's TIN level, and disburse the electronic payment to the TIN provided
by the qualifying EP indicated during the registration process;
qualifying EPs who do not have individual TINs (that is, a qualifying
EP who works solely in a group practice) will be paid at the group
practice level's TIN. Since some EPs work in multiple group practices,
we considered allowing these EPs to direct that their incentive payment
be allocated among the multiple practices based on individual and/or
group TINs. However, as discussed more fully in section II.B.1.d of
this proposed rule, we determined that this would create a significant
administrative burden for us and therefore are proposing that
qualifying EPs select one TIN for disbursement of their Medicare EHR
incentive payment. Of course, after the payment is disbursed to their
designated TIN, qualifying EPs may decide to allocate their incentive
payment among the multiple practices in which they furnish covered
professional services. subject to applicable laws, regulations and
rules, including, without limitation, those related to fraud, waste,
and abuse.
In addition, we recognize that financial relationships between
physicians and their employers/entities with which they have
contractual arrangements may implicate certain fraud, waste, and abuse
laws, regulations, and rules. Therefore, we are considering including
specific safeguards to limit the risk that the allocation/reassignment
of incentive payments could raise under those and other applicable
laws, regulations and rules; we appreciate public comments on this
consideration.
b. Incentive Payments to Eligible Hospitals
The FIs/MACs will calculate incentive payments for qualifying
eligible hospitals, and will disburse such payments on an interim basis
once the hospital has demonstrated it is a meaningful EHR user for the
EHR reporting period for the payment year. As discussed above in
section B.2.b. of the proposed rule, the formula for
[[Page 1920]]
calculating a qualifying eligible hospital's incentive payment requires
the following data: (1) An initial amount; (2) the Medicare share; and
(3) a transition factor applicable to that payment year. FIs/MACs will
use the prior-year cost report, Provider Statistical and Reimbursement
(PS&R) System data, and other estimates to calculate the interim
incentive payment. As discussed in section II.B.2.c. of this proposed
rule, beginning in 2010, cost reports will capture charity care data
which will be used in calculating the Medicare share of the payment. As
discussed in section II.B.2.b. of this proposed rule, we are proposing
to calculate a qualifying hospital's final incentive payment using data
from the cost report for the hospital's fiscal year that ends during
the FY prior to the FY that serves as the payment year. We therefore
are proposing that the FIs/MACs calculate the final incentive payment
using actual cost report data report for the hospital's fiscal year
that ends during the FY prior to the fiscal year that serves as the
payment year, and will reconcile the incentive payment as necessary at
settlement of the cost report. Incentive payments for qualifying
eligible hospitals will be calculated based on the provider number used
for cost reporting purposes, which is the CCN of the main provider.
Therefore, the FIs/MACs would disburse incentive payments to qualifying
hospitals based on the CCN rather than the TIN.
c. Incentive Payments to CAHs
CAHs are paid on a cost reimbursement basis; once a CAH incurs
actual EHR costs, it can submit supporting documentation to the FI/MAC
for review. The FIs/MACs will determine an incentive payment amount, as
previously discussed in section II.A.3. of this proposed rule by
substituting for the Medicare share amount that would otherwise be
applied under the formula used for computing payments for eligible
hospitals, a percent (not to exceed 100 percent) equal to the sum of--
(1) The Medicare share for such CAH, and (2) 20 percentage points.
The FIs/MACs will reconcile the cost report and ensure the EHR
expenses are adjusted on the cost report to avoid duplicate payments.
Incentive payments for qualifying CAHs will be calculated based on the
provider number used for cost reporting purposes, which is the CCN
number of the main provider. Therefore, the FIs/MACs will disburse
incentive payments to qualifying CAHs based on the CCN number rather
than the TIN.
d. Payment Accounting Under Medicare
We will conduct selected compliance reviews of EPs, eligible
hospitals, and qualified CAHs who register for the incentive programs
and of recipients of incentive payments for the meaningful use of
certified EHR technology. The reviews will validate provider
eligibility and their meaningful use attestations including
verification of meaningful use and would also review components of the
payment formulas.
We will identify and recoup overpayments made under the incentive
payment programs that result from incorrect or fraudulent attestations,
quality measures, cost data, patient data, or any other submission
required to establish eligibility or to qualify for a payment. The
overpayment will be recouped by CMS or its agents from the EP, eligible
hospital, MA organization, CAH, other entities to whom the right to
payment has been assigned/reassigned, or, in the case of Medicaid, from
the State Medicaid agencies. Medicare FFS EPs and eligible hospitals
will need to maintain evidence of qualification to receive incentive
payments for 10 years after the date they register for the incentive
program.
C. Medicare Advantage (MA) Organization Incentive Payments
1. Definitions
a. Qualifying MA Organization
Section 1853(l)(1) of the Act, as added by section 4101(c) of the
HITECH Act, provides for incentive payments to qualifying MA
organizations for certain of their affiliated EPs who are meaningful
users of certified EHR technology during the relevant EHR reporting
period for a payment year. Section 1853(l)(5) of the Act defines the
term ``qualifying MA organization'' as an MA organization that is
organized as a health maintenance organization (HMO) as defined in
section 2791(b)(3) of the PHS Act. Section 2791(b)(3) of the PHS Act in
turn defines a health maintenance organization as a federally qualified
HMO, an organization recognized as an HMO under State law, or a similar
organization regulated for solvency under State law in the same manner
and to the same extent as an HMO. Since there are few federally
qualified HMOs, we expect MA organizations to primarily qualify for
incentive payments as State-licensed HMOs, or as organizations
regulated for solvency under State law in the same manner and to the
same extent as HMOs. Therefore, in Sec. 495.200 we propose to define
``qualifying MA organization.''
In Sec. 495.202(a)(2), we propose to deem MA organizations
offering MA HMO plans that are not federally-qualified HMOs to meet the
definition of HMO in section 2791(b)(3) of the PHS Act, as HMOs
recognized under State law, or as entities subject to State solvency
rules in the same manner as HMOs. We believe this is reasonable because
under the MA application process, State regulators are required to
certify that MA organizations operating in their State are authorized
to offer the type of MA plan they propose to offer, and meet solvency
standards that are adequate for these purposes. For each MA
organization offering MA HMO plans, the State has thus recognized that
the organization is able to assume risk as an HMO. Therefore, we have
determined that absent evidence to the contrary, an MA organization
offering HMO plans is recognized by the State as a health maintenance
organization, or that it is subject to State solvency standards in the
same manner and to the same extent as an HMO and therefore provides
sufficient assurance that the section 2791(b)(3) of the PHS Act
definition is met.
In proposed Sec. 495.202(a)(3), for MA organizations that offer
other coordinated care MA plans (Preferred Provider Organization (PPO)
plans, Provider Sponsored Organization (PSO) plans, and Regional
Preferred Provider Organization (RPPO) plans) and for other MA
organizations offering other MA plan types (private fee-for-service
(PFFS) plans, Medical Savings Account (MSA) plans), we would require
the sponsoring MA organization to attest that the MA organization is
recognized under State law as an HMO, or that it is a similar
organization regulated under State law for solvency in the same manner
and to the same extent as an HMO before we would make a determination
that the MA organization is a qualifying MA organization for purposes
of incentive payments.
b. Qualifying MA Eligible Professional (EP)
A qualifying MA organization may receive an incentive payment only
for those EPs described under section 1853(l)(2) of the Act, as added
by section 4101(c) of the HITECH Act. Section 1853(l)(2) of the Act
provides that these EPs must be ``eligible professionals'' as defined
under section 1848(o) of the Act as added by section 4101(a) of the
HITECH Act, and must either--
Be employed by the qualifying MA organization; or
Be employed by, or be a partner of, an entity that through
contract with the
[[Page 1921]]
qualifying MA organization furnishes at least 80 percent of the
entity's Medicare patient care services to enrollees of the qualifying
MA organization.
Further, the EP must furnish at least 80 percent of his or her
professional services covered under Title XVIII (Medicare) to enrollees
of the qualifying MA organization and must furnish, on average, at
least 20 hours per week of patient care services.
As discussed in section II.A.1. of this proposed rule, an EP is
defined as a physician (under section 1861(r) of the Act).
We interpret ``employed by'' to mean that the EP is considered an
employee of a qualifying MA organization or qualifying entity under the
usual common law rules applicable in determining the employer-employee
relationship under section 3121(d)(2) of the Internal Revenue Code of
1986.
We interpret ``to be a partner of'' to mean that the qualifying MA
EP has an ownership stake in the entity. Under this proposed
interpretation, a professional that contracts with an entity, but has
no ownership stake in the entity, would not be considered a qualifying
MA EP.
We interpret ``furnishing at least 80 percent'' of the entity's
``patient care services'' to mean at least 80 percent of the qualifying
MA EP's total Medicare revenue in a year (that is, total revenue from
Medicare FFS as well as from all MA organizations) must be from a
single qualifying MA organization.
We propose to interpret the requirement that a qualifying MA EP
furnish at least 80 percent of their professional services covered
under Title XVIII means that at least 80 percent of the professional's
total Medicare revenue in a year (that is, total revenue from Medicare
FFS as well as from all MA organizations) must be from a single
qualifying MA organization. We believe that in establishing the rule
that qualifying MA EPs need to furnish at least 80 percent of the EP's
Title XVIII covered services ``to enrollees of the organization,'' the
statute limits payment related to any specific qualifying MA EP to a
single qualifying MA organization. Thus, if a qualifying MA EP provided
an average of 20 hours per week of patient care services to two
distinct qualifying MA organizations, we would pay the qualifying MA
organization for the MA EP only if such a qualifying EP provided at
least 80 percent of his or her professional services covered under
Title XVIII to enrollees of that organization.
For purposes of determining whether a qualifying MA EP furnishes,
on average, at least 20 hours per week of patient care services, we
interpret the requirement to include both Medicare and non-Medicare
patient care services. Moreover, we propose that the relevant time
period for determining whether an MA EP furnishes at least 20 hours per
week of patient care services should be the EHR reporting period. (We
discuss the proposed definition of EHR reporting period in section
II.A. 1. e. of this proposed rule.) Therefore, over the EHR reporting
period, the qualifying EP must provide on average 20 hours per week of
patient care services. Finally, we interpret ``patient care services''
to mean services that would be considered ``covered professional
services'' under sections 1848(o)(5)(A) and (k)(3) of the Act. That is,
health care services for which payment would be made under, or for
which payment would be based on, the fee schedule established under
Medicare Part B if they were furnished by an eligible professional.
We considered various methods of determining when at least 20 hours
per week, on average, of patient care services will be considered to be
provided by MA EPs. We considered methods such as defining a dollar or
service threshold, or the number of hours of direct patient care
services actually provided. After due consideration we propose to
require qualifying MA organizations to attest to the fact that MA EPs
for whom they are requesting EHR incentive payments have provided, on
average, 20 hours of patient care services during the EHR reporting
period.
As discussed in section II.B. of this proposed rule relating to
Medicare FFS EPs, a qualifying MA EP is also defined as a physician
under section 1861(r) of the Act. Section 1853(l)(1) of the Act, as
added by section 4101(c) of the HITECH Act, provides that the
provisions of sections 1848(o) and 1848(a)(7) of the Act, as amended
and added by sections 4101(a) and (b) of the HITECH Act, respectively,
which establish the incentive payments for EPs under Medicare FFS,
apply to a qualifying MA organization's qualifying MA EPs ``in a
similar manner'' as they apply to EPs under Medicare FFS. As discussed
above in section II.A.6. of this proposed rule, section
1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of the HITECH
Act, states that hospital-based EPs are not eligible for incentive
payments. Therefore, we propose that, similar to the Medicare FFS
incentive program, MA incentive payments would also not be available
for hospital-based EPs. We note that the hospital where a hospital-
based EP provides his or her Medicare covered services would be
potentially entitled to an incentive payment either through the
Medicare FFS incentive program, or through the MA-affiliated hospital
EHR incentive program. Therefore, for such a hospital-based MA EP, a
qualifying MA organization would be no more entitled to an MA EP
incentive payment under the MA EHR incentive program than a similarly
situated EP would be entitled to an incentive payment under the
Medicare FFS EHR incentive program.
As discussed previously, an MA EP must either be employed by the
qualifying MA organization, or be employed by, or be a partner of, an
entity that through contract with the qualifying MA organization
furnishes at least 80 percent of the entity's Medicare patient care
services to enrollees of the qualifying MA organization. With respect
to the later criteria, we do not propose to define the term ``entity,''
but instead recognize that there exist a range of entities with which
MA organizations contract for patient care services, including a
physician group, an Independent Practice Association (IPA), an
Exclusive Provider Organization (EPO), a Physician Hospital
Organization (PHO), or Preferred Provider Organization (PPO).
Moreover, we recognize that an EP may contract with more than one
such entity, and that these entities often contract with a number of MA
organizations and other health care insurers. An EP also may directly
contract with more than one MA organization. In general it is only when
an EP is employed by a single qualifying MA organization, or is
employed by or in partnership with an entity that contracts with a
single qualifying MA organization that an EP can satisfy the criteria
to be an MA EP.
Finally, the qualifying MA organization must attest to the fact
that each MA EP is a meaningful user of certified EHR technology in
accordance with proposed Sec. 495.4. If all of these conditions are
met, such an individual is identified as an MA EP. We propose to define
the term ``MA eligible professional (EP)'' at Sec. 495.200 as an EP
who satisfies these conditions.
Section 4101(d) of the HITECH Act directs the Secretary to study
and report on ``nearly exclusive'' physicians that primarily treat MA
enrollees and that would not otherwise qualify for incentive payments
under current law. This proposed rule does not address such
individuals, as it is limited to codifying in regulation existing
statutory language as discussed herein.
[[Page 1922]]
c. Qualifying MA-Affiliated Eligible Hospital
We propose to define ``qualifying MA-affiliated eligible hospital''
in Sec. 495.200. A qualifying MA organization may receive an incentive
payment only for a qualifying MA-affiliated eligible hospital described
under section 1853(m)(2) of the Act, as added by section 4102(c) of the
HITECH Act, that is a meaningful user of certified EHR technology as
defined in proposed Sec. 495.4 . Section 1853(m)(2) of the Act
provides that such MA-affiliated eligible hospitals are ``eligible
hospitals'' as defined under section 1886(n)(6) of the Act and must be
under common corporate governance with a qualifying MA organization
that serves individuals enrolled under MA plans offered by such
organization where more than two-thirds are Medicare individuals
enrolled under MA plans offered by such organization. As discussed in
section II.A.1. of this proposed rule, section 1886(n)(6) of the Act,
defines an ``eligible hospital'' as a subsection (d) hospital (as
defined under section 1886(d)(1)(B) of the Act). In Sec. 495.200, we
also propose to define ``under common corporate governance'', as a
qualifying MA organization and a qualifying MA-affiliated eligible
hospital that have a common parent corporation, that one is a
subsidiary of the other, or that the organization and the hospital have
a common board of directors.
Section 1853(m)(3)(B)(i) of the Act, as added by section 4101(c) of
the HITECH Act, provides that if for a payment year at least one-third
(33 percent) of a MA eligible hospital's discharges (or bed-days) of
Medicare patients are covered under Part A (rather than under Part C),
the hospital may only receive an incentive payment under section
1886(n) of the Act--the Medicare FFS incentive program.
In Sec. 495.200 we propose to define ``inpatient-bed-days'' in the
same manner as that term is defined for purposes of implementing
section 4201(a) of the HITECH Act in the preamble of this proposed
rule. The term will be used in the same way in computing incentive
payments due qualifying MA organization under the qualifying MA-
affiliated eligible hospital incentive payment program.
We note that, as discussed in section II.B.2.b. of this proposed
rule, under section 1886(n)(2)(D)(i)(II) of the Act, the portion of the
Medicare FFS hospital incentive payment comprising the discharge
related amount, or Medicare share, is based in part on the estimated
number of inpatient-bed-days attributable to individuals enrolled in MA
plans under Part C. This means that hospitals that treat individuals
enrolled in MA plans will receive a Medicare FFS hospital incentive
payment partially based on the number of MA-enrollee bed-days. To the
extent a hospital does not meet the 33 percent threshold requiring
payment through the FFS Medicare EHR hospital incentive program,
incentive payments can be made to a qualifying MA organization under
common corporate governance to the extent other requirements of the MA
EHR hospital incentive program are met. (See section II.C.3 of this
proposed rule for the computation of incentive payments to qualifying
MA organizations.)
Therefore, we propose to make EHR incentive payments to qualifying
MA-affiliated eligible hospitals under the FFS EHR incentive program.
Finally, to the extent that such data necessary to estimate the
inpatient-bed-days-related incentive payment amount are not already
available to us through the normal submission of hospital cost reports,
we propose to require that qualifying MA organizations seeking
reimbursement for qualifying MA-affiliated eligible hospitals submit
similar data.
2. Identification of Qualifying MA Organizations, MA EPs, and MA-
Affiliated Eligible Hospitals
In Sec. 495.202 we propose to require MA organizations that intend
to ask for reimbursement under the MA EHR incentive payment program to
so indicate as part of submissions of their initial bid under section
1854(a)(1)(A) of the Act, and to attest, in some cases, that they meet
the requirements of a qualifying MA organization. For MA organizations
offering an MA HMO plan type, we will deem such organizations to meet
the definition of HMO in 42 U.S.C. 300-gg(b)(3), (that is, section
2791(b)(3) of the PHS Act). As noted previously, for MA organizations
offering plan types other than HMOs, we propose to require an
attestation by the organization that the MA organization is recognized
under State law as an HMO, or that it is a similar organization
regulated under State law for solvency in the same manner and to the
same extent as an HMO before we would make a determination that the MA
organization is a qualifying MA organization for purposes of incentive
payments. We propose to require this beginning with bids due in June
2010 (for plan year 2011) for MA organizations seeking reimbursement
for MA EPs and MA-affiliated eligible hospitals.
We also propose requiring qualifying MA organizations, as part of
their initial bids starting with plan year 2011, to make a preliminary
identification of potentially qualifying MA EPs and potentially
qualifying MA-affiliated eligible hospitals for which the organizations
will seek EHR incentive payments.
In developing the preliminary and final lists of potentially
qualifying MA EPs, qualifying MA organizations must exclude hospital-
based MA EPs. We propose that qualifying MA organizations identify
hospital-based MA EPs using the same criteria outlined in section
II.A.6 of this proposed rule for identifying hospital-based EPs in the
Medicare FFS EHR incentive program.
Along with both the preliminary and final lists of potentially
qualifying MA EPs and hospitals, qualifying MA organizations must
submit an attestation that these professionals and hospitals meet the
criteria to be considered eligible. For example, for hospitals, the
qualifying MA organization must attest that they are under common
corporate governance with the qualifying MA organization. For example,
for EPs, the qualifying MA organization must attest that the list does
not include any hospital-based EPs.
We propose requiring qualifying MA organizations to provide final
identification of potentially qualifying MA EPs by the end of the MA EP
payment year (December 31), and final identification of potentially
qualifying MA-affiliated eligible hospitals by the end of the MA-
affiliated hospital payment year (the FFY ending on September 30), for
which MA EHR incentive payments will be sought. We also propose
requiring qualifying MA organizations to report the name, practice
address, and other identifying information, like NPI, for all
physicians that meet the requirements of a qualifying MA EP for which
the qualifying MA organization will be requesting payment under the MA
EHR incentive payment program.
Once a qualifying MA organization identifies potential EPs, we are
required to ensure that such EPs did not receive the maximum EHR
incentive payment for the relevant payment year under the Medicare FFS
program under section 1848(o)(1)(A) of the Act, as added by section
4101(a) of the HITECH Act, before releasing an incentive payment to a
qualifying MA organization related to such EP. (See section
1853(l)(3)(B)(i) of the Act, as added by section 4101(c) of the HITECH
Act). Therefore, in order to allow us time to determine whether an MA
EP received the maximum EHR incentive payment under the Medicare
[[Page 1923]]
FFS program, we propose not to make incentive payments to qualifying MA
organizations for the MA EPs for a payment year until after the final
computation of EP incentive payments for that year under the Medicare
FFS program. Additionally, we propose to require qualifying MA
organization to ensure that all MA EPs are enumerated through the NPI
system, in order to detect and prevent duplicate payment for EPs under
both the FFS and MA EHR incentive payment programs.
We also propose to require all qualifying MA organizations to self-
report and identify themselves, regardless of whether they have
qualifying MA EPs or MA-affiliated eligible hospitals for whom or which
the organization plans to claim incentive payments at the time the
initial bid is due (the first Monday of June, see section 1854(a)(1)(A)
of the Act) beginning in 2014 for bids related to plan year 2015. We
propose to require this reporting by all qualifying MA organizations in
years beginning with 2014 in anticipation of the statutory requirement
in sections 1853(l)(4) and 1853(m)(4) of the Act, to negatively adjust
our capitation payments to qualifying MA organizations for MA EPs and
MA-affiliated eligible hospitals that are not meaningful users of
certified EHR technology for years beginning with 2015.
3. Computation of Incentives to Qualifying MA Organizations for MA EPs
and Hospitals
In Sec. 495.204, we propose a methodology under which payments to
qualifying MA organizations for qualifying MA EPs will be computed.
Section 1853(l)(3)(A) of the Act provides that in applying section
1848(o), instead of the additional payment amount specified under
section 1848(o)(1)(A) of the Act, the Secretary may substitute an
amount determined by the Secretary, to the extent feasible and
practical, to be similar to the estimated amount in the aggregate that
would be payable under, or would be based on, the Medicare physician
fee schedule under Part B instead of Part C. Section II.B.1. of this
proposed rule discusses these provisions.
Section 1853(m)(3)(A) of the Act provides that in providing an
incentive payment to qualifying MA organizations for MA-affiliated
hospitals, we substitute for the amount specified under section
1886(n)(2) of the Act--the incentive payment amount under Medicare FFS
for qualifying eligible hospitals--an amount determined by the
Secretary to be similar to the estimated amount in the aggregate that
would be payable if payment for services furnished by such hospitals
was payable under Part A instead of Part C. (For more detailed
information see section II.B.2. of this proposed rule.)
Section 1848(o) of the Act permits us to make the incentive
payments for a year in installments, although we are proposing to make
a single lump sum payment under the Medicare FFS EHR incentive program.
We read the term ``aggregate'' to mean the aggregate installment
payments made by us under the FFS EHR incentive program to a qualifying
EP over the course of the relevant payment year.
The duplicate payment provisions in section 1853(l)(3)(B)(i)(II) of
the Act direct us to make payment for EPs ``only under'' the MA EHR
incentive program ``and not under'' the Medicare FFS EHR incentive
program to the extent any EP has earned ``less than [the] maximum
incentive payment for the same period'' under the Medicare FFS EHR
incentive program. We note that section 1853(l)(1) of the Act, provides
that section 1848(o) of the Act applies in a ``similar,'' but not the
same, manner to qualifying MA organizations as it applies to EPs under
Part B. The Medicare FFS incentive payment program under section
1848(o) does not include payment for professional services provided to
MA enrollees, but only for services paid under Part B. In a similar
manner we propose to limit payment to an MA organization to only
payment for their EPs' services to MA enrollees of plans offered by the
MA organization. We do not believe it would be appropriate to provide
an incentive payment to an MA organization for services provided to
individuals covered under Part B. Therefore, we propose, that in
calculating qualifying MA EP incentive payments, we will only consider
covered professional services provided to enrollees of MA plans offered
by qualifying MA organizations and will not include in the calculation
any services reimbursed by Medicare FFS.
Under the Medicare FFS EHR incentive program, an EP's incentive
payment may not exceed the annual limits specified under section
1848(o)(1)(B)(i) of the Act. We propose that similar payment limits
apply to qualifying MA organizations for their qualifying MA EPs.
Specifically, the incentive payment to a qualifying MA organization for
each of its qualifying MA EPs may not exceed certain limits.
Specifically, section 1848(o)(1)(B) of the Act provides that the
incentive payment for an EP for a given year shall not exceed the
following amounts:
For the EP's first payment year, $15,000 (or, if the first
payment year is 2011 or 2012, $18,000).
For the EP's second payment year, $12,000.
For the EP's third payment year, $8,000.
For the EP's fourth payment year, $4,000.
For the EP's fifth payment year, $2,000.
For any succeeding year, $0.
Note that, similar to the Medicare FFS EHR incentive program, there
will be no incentive payments made with respect to a year after 2016.
We propose similar restrictions related to qualifying MA organizations.
So, the maximum cumulative incentive payment over 5 years to a
qualifying MA organization for each of its qualifying MA EPs that
meaningfully use certified EHRs beginning on or before 2012 would be
$44,000 per qualifying MA EP. For qualifying MA organizations first
reporting the meaningful use of certified EHRs by qualifying MA EPs
after 2014, there is no incentive payment amount available. Subject to
an exception discussed below, for MA organizations first reporting the
meaningful use of certified EHRs by qualifying MA EPs in 2013 or 2014,
the maximum potential incentive payment per qualifying EP is,
respectively, $39,000 over 4 years, and $24,000 over 3 years.
As we discuss in more detail in the section II.C.4. of this
proposed rule, we propose to make MA EP incentive payments to
qualifying MA organizations on the same payment cycle for all employed/
partnering qualifying EPs of the organization. In other words, all MA
EPs of a specific qualifying MA organization will be in the same
payment year with respect to the amount of the incentive payment per
qualifying EP that we will make. So, for instance, if a qualifying MA
organization is in its second payment year in 2013 and it hires a new
EP for which the qualifying MA organization had not previously received
an EHR incentive payment, we will nevertheless make a second year
incentive payment (up to $12,000 in 2013) with respect to such an MA
EP--assuming all other conditions are met. Thus, the limits on MA EP
incentive payments discussed above are applied to the qualifying MA
organization's entire MA EP population in any specific payment year
relative to that MA organization, regardless of the length of
employment/partnership of/between that specific MA EP and that specific
qualifying MA organization.
Under section 1848(o)(1)(B)(iv) of the Act, the annual incentive
payment limit for EPs who predominantly furnish Part
[[Page 1924]]
B services in a geographic health professional shortage area (HPSA) is
increased by 10 percent. While we do not anticipate that MA EPs would
generally practice in a HPSA area, to the extent that an MA EP
practices in an area where he or she would be entitled to the 10
percent increase, that amount would apply to MA EPs as well. We
explored various ways of computing the EP-level incentive payments due
qualifying MA organizations whose qualifying MA EPs meaningfully use
certified EHR technology.
One option that we considered was using MA plan bidding and MA
payment data to estimate average annual MA revenue for qualifying MA
EPs with respect to a qualifying MA organization. So, for instance, a
qualifying MA organization that estimated MA Part B service-related
physician costs of $3 million/year in its bid for a year, and that
employed 100 qualifying MA eligible physicians, would be assumed to
have an average physician Part B charge per physician per year factor
of $30,000 ($3,000,000/100). However, we did not pursue this option
because the approach results in an average revenue amount across all
potentially qualifying MA EPs with respect to a qualifying MA
organization and, therefore, would include revenue amounts that exceed
the annual per-professional ceiling on incentive payments under FFS for
all EPs. We believe such a result is contrary to the legal requirement
that qualifying MA organizations are to incentive payments only for
qualifying MA EPs that actually provide at least 20 hours per week of
patient care services. Under this method there would also be no way to
know if the EP provided 80 percent of his/her professional Medicare
services to enrollees of the organization.
We also considered a reporting system for which qualifying MA
organizations would be required to report eligible-professional-
specific information along with MA patient encounters for nonhospital-
based office visits. Specifically, we examined requiring qualifying MA
organizations to report qualifying MA EP encounters with MA plan
enrollees based on the five levels of office visit codes recognized by
Medicare FFS.
We would use such reports to estimate the amount of compensation
that a qualifying MA EP working primarily for a qualifying MA
organization would be eligible to receive under Medicare FFS. For
example, a qualifying MA EP with a primary care specialty might have an
average of 10 MA patient low/moderate intensity office visits with
members of a qualifying MA organization per day. Such an EP would
potentially qualify for the maximum Medicare FFS EP incentive payment
in the first year based on a calculation of $63 * 10 * 52 = $32,760--
which is more than the Medicare FFS EHR incentive program threshold of
$24,000 necessary to qualify for the maximum incentive payment of
$18,000 if the fist payment year were 2011 or 2012.
We estimated the national average FFS allowed amounts for the 5
levels of office visit codes (CPT codes 99211-99215) in 2009 to be:
$20, $39, $63, $95, $129, respectively. We contemplated allowing, but
not requiring, qualifying MA organizations to report consultation codes
for specialist physicians (CPT codes 99241-99245) estimated to have
national average FFS allowed amounts of $50, $94, $129, $190, and $234,
respectively.
However, we now believe that such a process would be
administratively burdensome and difficult to operationalize. Therefore,
we are proposing an alternative approach, but seek input from
interested parties as to which of these approaches, or perhaps others,
would best address the statutory requirement to compensate qualifying
MA organizations for qualifying MA EPs the amount that would be payable
if payment for services furnished by such professionals were made under
Part B instead of Part C.
We propose an approach in which the revenue received by the
qualifying MA EP for services provided to enrollees of the qualifying
MA organization would serve as a proxy for the amount that would have
been paid if the services were payable under Part B. Under this
approach, the qualifying MA organization would report to us the
aggregate annual amount of revenue received by each qualifying MA EP
for MA plan enrollees of the MA organization. We would calculate the
incentive payment amount due the qualifying MA organization for each
qualifying MA EP as an amount equal to 75 percent of the reported
annual MA revenue of the qualifying MA EP, up to the maximum amounts
specified under section 1848(o)(1)(B) of the Act.
For qualifying MA EPs who are compensated on a salaried basis, we
propose requiring the qualifying MA organization to develop a
methodology for estimating the portion of the qualifying MA EP's salary
attributable to providing services that would otherwise be covered as
professional services under Part B of Medicare to MA plan enrollees of
the MA organization. The methodology, which would require review and
approval by us, could be based on the relative share of patient care
hours spent with MA enrollees of the organization or another reasonable
method. So, for instance, if a qualifying MA EP spends 30 percent of
his or her time providing covered Part B physician office services to
MA plan enrollees, then the qualifying MA organization would report 30
percent of the qualifying MA EP's salary as annual revenue, which would
be used to compute the amount of the MA incentive payment due to the
qualifying MA organization for the qualifying MA EP. Thus, if the
qualifying MA EP had a base salary of $150,000, 30 percent would be
$45,000--which is well over the threshold of $24,000 needed by the MA
organization to qualify for a maximum incentive payment of up to
$18,000 (70 percent of $24,000) for such a qualifying MA EP in any
year. We also propose to require that salaries be prorated to ensure
that the amount reported reflects the salary paid for the applicable
year.
Salaried physicians' compensation typically does not include an
allowance for administrative practice costs. Given that Part B allowed
amounts do include practice expense costs, we propose allowing
qualifying MA organizations to identify, where appropriate, an
additional amount related to overhead that would be added to the
qualifying MA EP's estimated Part B compensation. To the extent
Medicare FFS compensation to physicians includes an amount for office
space rental, office staffing, and equipment, we believe that
qualifying MA organizations should also be permitted to include an
amount for overhead related to such costs not directly experienced by
salaried qualifying MA EPs. In Sec. 495.204(b)(4)(ii), we propose
requiring qualifying MA organizations to develop a methodology for
estimating the additional amount related to overhead attributable to
providing services that would otherwise be covered under Part B of
Medicare. The methodology would require review and approval by us.
For qualifying MA EPs who are not salaried (that is, who are paid
on a capitated or fee-for-service basis), we propose in Sec.
495.204(b)(5) to require qualifying MA organizations to obtain
attestations from such EPs and to submit to CMS information from the
attestations as to the amount of compensation received by the EPs for
MA plan enrollees of the MA organization. We are proposing such
attestations because many EPs are not paid directly by MA
organizations, but rather by intermediary contracting entities, such as
physician groups, and as a result the qualifying MA
[[Page 1925]]
organization may not otherwise know how much compensation is received
by each qualifying MA EP. In reporting compensation, we are proposing
that the EPs include only those amounts for professional services that
would otherwise be payable under Part B and for which payment would be
made under, or would be based on, the Medicare physician fee schedule.
As mentioned previously, in applying the instruction in section
1853(m)(3)(A) of the Act to substitute for the amount specified under
section 1886(n)(2) of the Act an amount similar to the estimated amount
in the aggregate that would be payable if payment for the hospitals'
services were made under Part A instead of Part C, we read the term
``aggregate'' to mean the aggregate installment payments made by us if
EHR incentive payments were made under Part A instead of Part C.
Incentive payments to eligible hospitals under the Medicare FFS EHR
incentive program are comprised of three components: (1) An initial
amount composed of a base incentive payment of $2,000,000 and a second
incentive payment amount of $200 per discharge for discharges 1,150-
23,000 during a 12-month period selected by the Secretary; (2) the
Medicare share; and (3) a transition factor. As discussed in the
preamble related to proposed Sec. 495.104(c), for purposes of
calculating incentive payments to eligible hospitals under the Medicare
FFS EHR incentive program, we are proposing that the 12-month period be
based on the FFY. For the purpose of calculating incentive payments for
qualifying MA-affiliated eligible hospitals, we similarly are proposing
that the 12-month period be based on the FFY.
Section II.B. of this proposed rule discusses our proposed
methodology for calculating the incentive payment for qualifying
eligible hospitals under the Medicare FFS EHR program. As set forth in
proposed Sec. 495.204(c)(2), we propose to use the FFS EHR hospital
incentive program for purposes of calculating and making the incentive
payment for qualifying MA-affiliated hospitals. To the extent data are
not available to reimburse MA-affiliated hospitals through the FFS
hospital incentive program, we propose to require submission of such
data to us and adopt the same definition of ``inpatient-bed-days'' and
other terms proposed under the Medicare FFS EHR hospital incentive
program specified in Sec. 495.104 of this proposed rule. In such a
case we propose in Sec. 495.204(c)(1) to make payment for such MA-
affiliated eligible hospitals to the qualifying MA organization.
The formula for calculating the hospital incentive payment under
the Medicare FFS hospital incentive program is an initial amount of the
sum of the base amount of $2,000,000 per hospital plus an additional
$200 per discharge for discharges 1,150 through 23,000 for that
hospital in that payment year. This initial amount is then multiplied
by a transition factor and then again by the Medicare share. These last
two numbers are fractions and will tend to reduce the initial amount
computed in the first step.
Similar to the Medicare FFS EHR hospital incentive program, we
propose to use inpatient-bed-day data, discharges, and other components
of the FFS calculation for each qualifying MA-affiliated eligible
hospital from the hospital-specific fiscal year that ends during the
FFY prior to the FFY that serves as the payment year. To the extent
such data are not already available to us through the normal submission
of hospital cost reporting data, we propose requiring qualifying MA
organizations seeking reimbursement for their qualifying MA-affiliated
eligible hospitals to submit similar data.
We can only pay for qualifying MA-affiliated eligible hospitals
under common corporate governance based on inpatient-bed-days computed
on a fiscal year basis where less than one-third of the inpatient-bed-
days of Medicare patients are covered under Medicare FFS--Part A.
However, it does not appear that reimbursement only under the MA EHR
incentive program is required for qualifying MA-affiliated eligible
hospitals that are under common corporate governance. Rather, section
1853(m)(3)(B), of the Act only prohibits payment under the MA EHR
incentive program when Medicare hospital inpatient-bed-days covered
under Part A exceed 33 percent of all Medicare inpatient-bed-days.
Although eligibility under the MA EHR hospital incentive program is not
available to qualifying MA organizations for any specific hospital when
FFS inpatient-bed-days exceed 33 percent of the Medicare total, a
qualifying MA organization could be reimbursed through the Medicare FFS
EHR hospital incentive payment program for qualifying hospitals under
common corporate governance even for hospitals with very low ratios of
FFS to MA inpatient-bed days.
Given that the hospital incentive payment methodology and payment
amount will be identical under the Medicare FFS EHR incentive program
and the MA EHR incentive program, and given that there is no statutory
prohibition on reimbursing a qualifying MA-affiliated eligible hospital
through the Medicare FFS EHR incentive program, for purposes of
administrative efficiency, and pursuant to our authority under section
1857(e) of the Act to add new ``appropriate'' contract terms
(incorporated for Part D by section 1860D-12(b)(3)(D) of the Act), we
propose requiring that qualifying MA organizations receive incentive
payments for qualifying MA-affiliated eligible hospitals through their
affiliated hospitals under the Medicare FFS EHR incentive program if
they are eligible for such payments, rather than through the MA EHR
incentive program. We believe this is the most efficient way in which
to administer the MA EHR hospital incentive program in light of the
expected low volume of MA-affiliated eligible hospitals (approximately
50 hospitals), and in light of preliminary data which indicates that
MA-affiliated eligible hospitals already submit Medicare cost reporting
data to us from which we can compute hospital incentive payments due.
To the extent sufficient data do not exist to make such payments under
the Medicare FFS EHR incentive program, qualifying MA organizations
will be required to submit additional data to us.
Finally, to the extent payments are made to qualifying MA
organizations for qualifying MA EPs or qualifying MA-affiliated
eligible hospitals, we propose to conduct selected compliance reviews
to ensure that EPs and eligible hospitals for which such organizations
received incentive payments were actually meaningful users of certified
EHR technology, in accordance with our existing authority in section
1857(d) of the Act and 42 CFR 422.504 of the regulations related to
protections against fraud. The reviews would include validation of
meaningful user attestations, the status of the organization as a
qualifying MA organization, and verification of both meaningful use and
data used to calculate incentive payments. We propose requiring MA
organizations to maintain evidence of compliance with all aspects of
the MA EHR incentive payment program for 10 years after the date
payment is made with respect to a given payment year. Payments that
result from incorrect or fraudulent attestations, cost data, or any
other submission required to establish eligibility or to qualify for a
payment, will be recouped by CMS from the MA organization.
4. Timeframe for Payment
For payments to qualifying MA EPs, in Sec. 495.206 we propose the
time frame
[[Page 1926]]
for payment to be after the Medicare FFS program computes incentive
payments due under the Medicare FFS EHR incentive program--so the first
possible incentive payments would be made sometime in early 2012. We
propose that payments for qualifying MA-affiliated eligible hospitals
under common corporate governance occur in the same manner and in the
same time frame as payments made under the Medicare FFS EHR incentive
program to ``subsection (d)'' hospitals as discussed in section
II.B.2.d. of this proposed rule.
We propose to define ``payment year'' with respect to qualifying MA
EPs in Sec. 495.200. Section 1853(l)(3)(C) of the Act directs us to
establish the same first payment year for all EPs with respect to any
specific qualifying MA organization. Consistent with the statute, we
propose to pay a qualifying MA organization on the same schedule for
all of its qualifying MA EPs. In other words, the first year during
which the qualifying MA organization receives an incentive payment for
its qualifying EPs will be considered the first payment year for all of
its qualifying EPs. Accordingly, for purposes of determining the
applicable incentive payment limits, the second, third, fourth, and
fifth years during which the qualifying MA organization receives an
incentive payment for its qualifying EPs will be considered the second,
third, fourth, and fifth payments years for each of its qualifying EPs,
regardless of whether the MA organization claimed an incentive payment
for a particular EP for a prior payment year. Such a consistent payment
cycle relative to qualifying MA organizations and qualifying MA EPs
obviates the need to track payment years and payment adjustment years
based on prior payments or adjustments with respect to any individual
qualifying MA EP. Rather, for purposes of payment years and payment
adjustment years, any EP employed by or partnering with any specific MA
organization will be on the same cycle with respect to that
organization.
Similar to the Medicare FFS EHR incentive program, payment to
qualifying MA organizations for qualifying MA EPs and payment for
qualifying MA-affiliated eligible hospitals is available only for a
finite number of years. As previously discussed in the section on the
calculation of MA incentive payments, above, a qualifying MA
organization can receive an incentive payment of up to $18,000 for each
of its qualifying MA EPs for its first payment year if its first
payment year is 2011 or 2012, or up to $15,000, if its first payment
year is 2013, or up to $12,000, if its first payment year is 2014. Note
that, similar to the Medicare FFS EHR incentive program, there would be
no incentive payments made with respect to a year after 2016.
We propose to define ``payment year'' with respect to qualifying
MA-affiliated eligible hospitals in Sec. 495.200. For incentive
payments for qualifying MA-affiliated eligible hospitals, the first
year for which an MA organization may claim payment is FY 2011. Similar
to the Medicare FFS EHR hospital incentive program, we propose to use
the hospital inpatient-bed-days data from the hospital fiscal year that
ends during the FFY prior to the fiscal year that serves as the payment
year. For qualifying MA-affiliated eligible hospitals, we propose to
compute hospital EHR incentive payments due in the same manner as they
are being computed in the Medicare FFS hospital incentive payment
program. For qualifying MA-affiliated eligible hospitals for which the
first payment year is 2011 through 2013, up to 3 additional years of
incentive payments are available. For qualifying MA-affiliated eligible
hospitals for which the first payment year is after 2015, no EHR
payment incentive can be made for that year or any subsequent year.
Finally, for qualifying MA-affiliated eligible hospitals for which the
first payment year is 2014 or 2015, only 2 (or 1) more year(s) of
hospital incentive payments will be available.
Unlike the fixed schedule for application of limitation on
incentive payments for MA EPs discussed previously in this section of
the proposed rule in which all employed/partnering MA EPs will be paid
on the same schedule (first payment year, second payment year, etc.)
with respect to any specific qualifying MA organization, we propose to
make payments to MA organizations for MA-affiliated eligible hospitals
on a hospital-specific basis. In other words, if a qualifying MA
organization has some MA-affiliated eligible hospitals with a first
payment year of FY 2011, it may have other MA-affiliated eligible
hospitals with a first payment year of FYs 2012 through 2015.
5. Avoiding Duplicate Payment
We propose duplicate payment avoidance provisions in Sec. 495.208.
Section 1853(l)(3)(B) of the Act, as added by the HITECH Act, is
entitled ``Avoiding Duplication of Payments.'' Subclause (I) of the Act
states that to the extent an MA EP is entitled to the maximum incentive
payment under section 1848(o)(1)(A) of the Act, the Medicare FFS EHR
incentive payment program--such incentive payment will only be made
under the Medicare FFS EHR incentive program. Therefore, before
payments can be made to qualifying MA organizations for MA EPs, we must
first determine if a maximum incentive payment under the Medicare FFS
program has been previously earned by potential MA EPs. Under the
Medicare FFS incentive payment program, incentive payment calculations
will not be completed for the first payment year, 2011, until the early
part of 2012. Therefore, we would not be able to make payments to
qualifying MA organizations for MA EPs until claims submissions counted
for Medicare FFS incentive payments for CY 2011 have been closed, and
payment calculations for participating EP under the Medicare FFS EHR
incentive program have been completed in the early part of CY 2012. We
will follow the same practice--first computing Medicare FFS incentive
payments for EPs and then computing and paying MA incentive payments,
where appropriate--in all subsequent payment years.
Subclause (II) of section 1853(l)(3)(B)(i) of the Act further
states that to the extent an MA EP is entitled to less than the maximum
incentive payment under the Medicare FFS EHR incentive program, that
payment is to be made solely under the MA provision. In other words, we
will need to withhold Medicare FFS incentive payments from EPs of less
than the maximum to the extent such professionals are also identified
as MA EPs under section 1853(l)(2) of the Act. Again, we would need to
await the computation of payments due EPs under the Medicare FFS EHR
incentive program before we can determine whether the EP is entitled to
less than the maximum payment amount under the Medicare FFS EHR
program, in which case any incentive payment for the EP will only be
made to the qualifying MA organization under the MA EHR program, and
not to the EP under the Medicare FFS EHR program.
Section 1853(m)(3)(B) of the Act, states that incentive payments
for qualifying MA-affiliated eligible hospitals are to be made under
either the Medicare FFS hospital incentive payment program, or under
the MA hospital incentive payment program. If more than 33 percent of
discharges or bed-days of all Medicare patients for a year are covered
under Part A, then payment for that year is to only be made under
section 1886(n) of the Act--the Medicare FFS EHR incentive program--and
no payment is to be made under the MA hospital incentive payment
[[Page 1927]]
program. Otherwise, to the extent less than 33 percent of bed days of
all Medicare patients for an incentive payment year are covered under
Part A, then payment for that incentive payment year may be made under
the MA EHR incentive payment program.
Unlike the process we propose to follow related to qualifying EPs
(where we will wait for the Medicare FFS incentive payment program to
compute eligible physician incentive payments due under that program
before determining the amount due under the MA EHR incentive program),
we would not need to rely on Medicare FFS EHR incentive payment program
calculations before determining eligibility for MA-affiliated hospital
incentive payments. We would reimburse all hospitals, including MA-
affiliated eligible hospitals, under the Medicare FFS hospital
incentive program. We believe that by doing so, we will prevent
duplicate payments being made for the same hospitals by Medicare FFS
and the MA incentive payment programs. To the extent that qualifying MA
organizations are to receive incentive payments through the MA program
rather than through their hospitals under the Medicare FFS EHR
incentive program due to a lack of sufficient data to make payments
under the FFS program, we would identify and reimburse only appropriate
qualifying MA organizations for qualifying MA-affiliated eligible
hospitals. Such reimbursement will be in a manner similar to the manner
in which the Medicare FFS EHR incentive program will reimburse eligible
hospitals due an incentive payment under the Medicare FFS EHR incentive
program.
In order to avoid duplicate payments and in accordance with section
1853(m)(3)(B)(ii)(II) of the Act, we will not make MA EHR hospital
incentive payments to qualifying MA organizations for MA-affiliated
eligible hospitals other than through the Medicare FFS EHR hospital
incentive payment program without first ensuring that no such payments
under the Medicare FFS EHR hospital incentive payments were made.
We invite industry and public comment on our proposed process to
eliminate duplicate payments to EPs and MA-affiliated eligible
hospitals under the Medicare FFS and MA incentive payment programs.
6. Meaningful User Attestation
We propose meaningful user attestation requirements in Sec.
495.210. For each MA EP and MA-affiliated hospital for which a
qualified MA organization seeks an incentive payment, the organization
must attest, in a form and manner specified by us, that its MA EPs and
MA-affiliated eligible hospitals are meaningful EHR users, as required
by sections 1853(l)(6) and 1853(m)(1) of the Act. We further propose to
adopt the definitions of meaningful user proposed under the Medicare
FFS program related to EPs and hospitals in proposed Sec. 495.4. We
propose to require qualifying MA organizations to attest each payment
year whether each of its MA EPs and MA-affiliated eligible hospitals
for which it is seeking an incentive payment was a meaningful EHR user
for the EHR reporting period for a payment year. A qualifying MA
organization must make this attestation for each payment year for which
it is seeking an incentive payment for MA EPs and MA-affiliated
eligible hospitals. We believe attestations should occur toward the end
of a year with respect to that year, since qualifying MA organizations
will need to attest to, based on our proposed rule, meaningful use for
the appropriate duration and during the appropriate period related to
MA EPs and MA-affiliated eligible hospitals before claiming incentive
payments for them.
Note that unlike the Medicare FFS EHR incentive program, where we
will require the reporting of clinical quality measures--see Sec.
495.8--we will not require qualifying MA organizations to submit
clinical quality measures per section 1848(o)(2)(B) of the Act, with
respect to EPs, and section 1886(n)(3)(B) of the Act, with respect to
eligible hospitals. Consistent with sections 1848(o)(2)(B)(iii) and
1886(n)(3)(B)(iii) of the Act, we note that qualifying MA organizations
sponsoring coordinated care MA plans are already required to submit
Healthcare Effectiveness Data and Information Set (HEDIS), Health
Outcomes Survey (HOS), and Consumer Assessment of Healthcare Providers
and Systems (CAHPS) measures per Sec. 422.152 and Sec. 422.516.
Coordinated care MA plans include HMO, PPO and RPPO (Regional PPO)
plans. Beginning with CY 2010, PFFS and MSA plans will also be required
to begin collecting and submitting administrative HEDIS measures.
We believe that all qualifying MA organizations will be
organizations offering MA coordinated care plans, and therefore; those
MA organizations from which we routinely receive complete HEDIS dataset
reporting. Pursuant to sections 1848(o)(2)(B)(iii) and
1886(n)(3)(B)(iii) of the Act, for clinical quality measures which
overlap between the existing MA quality reporting program and under the
HITECH program, we propose to allow qualifying MA organizations to
continue reporting under the existing MA quality reporting program. For
those HITECH clinical quality measures that do not overlap and that are
appropriate for the MA program, we are considering requiring that
qualifying MA organizations that receive an incentive payment report
those measures to CMS. This would ensure that clinical quality measure
reporting under HITECH is consistent between the FFS program and MA. An
alternative approach would be to require that qualifying MA
organizations that receive an incentive payment report all of the
HITECH clinical quality measures under section II.A.2 of this proposed
rule that are appropriate for the MA program directly to CMS, while
also reporting those HEDIS, HOS, and CAHPS measures under the existing
MA quality program. This may result in duplicative reporting under the
HITECH program and current MA quality reporting, but may provide us
with more direct access to quality data under the HITECH program. We
invite public comment on these approaches, including alternative
methods to consistently treat MA-affiliated providers and FFS providers
under the HITECH Medicare incentive program.
Therefore, we propose requiring qualifying MA organizations to
submit attestations to us related to meaningful use by MA-affiliated
hospitals within 30 days of the close of the FFY--which is the payment
year for MA-affiliated hospitals--by October 30. We also propose
requiring qualifying MA organization to submit attestations to us
related to meaningful use by MA EPs within 30 days of the close of the
MA EP payment year--which is a CY--by January 30.
7. Posting Information on the CMS Web Site
Sections 1853(l)(7) and 1853(m)(5) of the Act, require us to post
information on an Internet Web site related to the receipt of incentive
payments under the MA EHR incentive program. Information would include
the names, business addresses, and business phone numbers of each
qualifying MA organization receiving an incentive payment under this
section for qualifying MA EPs and hospitals. A list of the names of
each qualifying MA EP and qualifying MA-affiliated eligible hospital
for which an incentive payment has been made would also be posted.
Since this requirement is applicable to other Medicare EPs and eligible
hospitals, we have included this requirement in proposed Sec. 495.108.
[[Page 1928]]
8. Limitation on Review
Section 1853(l)(8) of the Act states that there shall be no
administrative or judicial review under section 1869 of the Act,
section 1878 of the Act, or otherwise of the methodology and standards
for determining payment amounts and payment adjustments under the MA
EHR EP incentive program. This includes provisions related to
duplication of payment avoidance and rules developed related to the
fixed schedule for application of limitation on incentive payments for
all qualifying MA EPs related to a specific qualifying MA organization.
This also includes the methodology and standards developed for
determining qualifying MA EPs and the methodology and standards for
determining a meaningful EHR user, including the means of demonstrating
meaningful use and the selection of measures. We propose to codify
these requirements in Sec. 495.212(b).
Section 1853(m)(6) of the Act, as added by the HITECH Act, states
that there shall be no administrative or judicial review under section
1869, section 1878, or otherwise of the methodology and standards for
determining payment amounts and payment adjustments under the MA EHR
hospital incentive program. This includes provisions related to
duplication of payment. This also includes the methodology and
standards developed for determining qualifying MA hospitals and the
methodology and standards for determining a meaningful EHR user,
including the means of demonstrating meaningful use and the selection
of measures. We propose to codify these requirements in Sec.
495.212(c).
9. Conforming Changes
Sections 4101(e) and 4201(d)(2) and (3) of the HITECH Act provide
conforming amendments to Part C of the Social Security Act. Therefore,
we are proposing the following conforming changes to the regulations
text:
Revising Sec. 422.304 by adding a new paragraph (f) to
account for the amendment to section 1853(a)(1)(A) of the Act
referencing the additional EHR incentive payments that may be made to
qualifying MA organizations in the section of the statute that provides
for monthly capitation payments to MA organizations. (This addition
would also act as a cross-reference to MA EHR incentive payment rules
in proposed subpart C of part 495 of this chapter.)
Revising Sec. 422.306(b)(2) by adding a new paragraph
(iv) to address the amendments to section 1853(c)(1)(D)(i) of the Act
which exclude the EHR incentive payments made to EPs and hospitals
under the Medicare FFS program from the computation of FFS costs in a
year for the purpose of computing MA monthly capitation amounts.
Revising Sec. 422.308 by adding a new paragraph (a)(1) to
address the amendments to section 1853(c)(1)(D)(1) and (c)(6)(A) of the
Act regarding the exclusion of FFS Medicare EHR incentive payments and
adjustments from the calculation of the national per capita growth
percentage.
Revising Sec. 422.322 by adding a new paragraph (a)(3) to
account for the amendments to section 1853(c)(6)(A) and (f) of the Act
specifying that the source of EHR incentive payments to qualifying MA
organizations are from the Federal Hospital Insurance Trust Fund or the
Supplementary Medical Insurance Trust Fund.
Revising Sec. 422.322(b) by adding a reference to Sec.
495.204 to address the amendment to section 1851(i)(1) of the Act that
indicates that EHR incentive payments are instead of incentive payments
that would otherwise be payable under original Medicare.
10. Payment Adjustment and Future Rulemaking
In future rulemaking we will develop standards related to payment
adjustments to qualifying MA organizations related to MA EPs and MA-
affiliated eligible hospitals that are not meaningful users of
certified EHR technology. We solicit comment on how we can most
effectively and efficiently apply payment adjustments to qualifying MA
organizations whose MA eligible EPs and hospitals have not successfully
meaningfully used certified EHR technology.
The statutory requirement related to imposition of payment
adjustments with respect to MA EPs is set forth in section 1853(l) of
the Act. Specifically, section 1853(l)(4) of the Act requires that
instead of applying the payment adjustment in section 1848(a)(7) of the
Act, we apply the payment adjustment to the Medicare physician
expenditure proportion. This is our estimate of the proportion of the
expenditures under Parts A and B paid to the qualifying MA organization
in the form of capitation payments under section 1853 of the Act that
are not attributable to the EHR incentive payment program, that are
attributable to expenditures for physician services. In the case of a
qualifying MA organization that attests that not all MA EPs of the
organization are meaningful EHR users with respect to years beginning
with 2015, we are directed to apply the payment adjustment on the
proportion of the capitation payment with respect to all such EPs of
the organization that are not meaningful users for such year. The
adjustment amount is 1 percent for 2015, 2 percent in 2016, and 3
percent in 2017 and subsequent years.
The statutory requirement related to imposition of payment
adjustments with respect to MA-affiliated eligible hospitals is
provided in section 1853(m) of the Act. Specifically, section
1853(m)(4) of the Act requires us to apply the adjustment to the
hospital expenditure proportion, which is our estimate of the
proportion of the expenditures under Parts A and B paid to the
qualifying MA organization in the form of capitation payments under
section 1853 of the Act that are not attributable to the EHR incentive
payment program, that are attributable to expenditures for inpatient
hospital services. In the case of a qualifying MA organization that
attests that not all MA-affiliated eligible hospitals of the
organization are meaningful EHR users with respect to years beginning
with 2015, we are directed to apply the payment adjustment on the
proportion of all such MA-affiliated eligible hospitals of the
organization that are not meaningful users for such year. The
adjustment amount is of three-fourths of the market basket increase
related to a hospital by a 33\1/3\ percent reduction in 2015, by a
66\2/3\ percent reduction in 2016, and by a 100 percent reduction in
2017 and all subsequent years. Effectively, the reduction is of all but
25 percent of the market basket increase for a specific hospital in
years after 2016.
We welcome comments on these incentive payment adjustments and on
how we can most effectively and efficiently apply payment adjustments
to qualifying MA organizations whose EPs and MA-affiliated hospitals
have not successfully meaningfully used certified EHR technology. Any
comments received will be considered in developing future rulemaking.
D. Medicaid Incentives
1. Overview of Health Information Technology in Medicaid
Under the HITECH Act, State Medicaid programs, at their option, may
receive Federal financial participation (FFP) for expenditures for
incentive payments to certain Medicaid providers to adopt, implement,
upgrade, and meaningfully use certified EHR technology. Additionally,
FFP is available to States for administrative expenses related to
administration of those incentive payments as long as the
[[Page 1929]]
State meets certain conditions. Section 1903(a)(3)(F)(i) of the Act, as
amended by section 4201 of the HITECH Act, establishes 100 percent FFP
to States for providing incentive payments to eligible Medicaid
providers (described in section 1903(t)(2) of the Act) to adopt,
implement, upgrade, and meaningfully use certified EHR technology. The
incentive payments are not direct reimbursement for the purchase and
acquisition of such technology, but rather are intended to serve as
incentives for EPs and eligible hospitals to adopt and meaningfully use
certified EHR technology.
Section 1903(a)(3)(F)(ii) of the Act, as amended by section 4201 of
the HITECH Act, also establishes 90 percent FFP to States for
administrative expenses related to carrying out the substantive
requirements associated with the incentive payments. As discussed later
in this proposed rule, we interpret these administrative expenses as
including approvable expenses related to oversight activities and
promotion of health information exchange.
It is important to note that we do not believe that the Medicaid
incentive and administrative payments authorized under section 4201 of
the HITECH Act should be viewed in isolation. Rather, we encourage
States, providers, and other stakeholders to view these new programs in
concert with the numerous other initiatives recently undertaken and
currently being promoted by both CMS and the Department to encourage
advancements in health care technology and health information exchange.
These initiatives include the following:
The establishment of the Office of the National
Coordinator (first through executive order in 2004 and then as
legislatively mandated in the HITECH Act);
The Medicaid Transformation Grant program authorized by
section 6081 of the Deficit Reduction Act of 2005 (Pub. L. 109-171).
This program provided $150 million in grants in FY 2007 through FY 2008
to States to support innovative methods for transforming Medicaid
programs. Twenty-two States focused on HIT, with initiatives ranging
from the use of statewide EHRs for beneficiaries, to mechanized
clinical decision support, to e-prescribing, to electronic health
information exchange. For more information on the program, we refer
readers to: http://www.cms.hhs.gov/MedicaidTransGrants.
The Medicaid Information Technology Architecture (MITA)
initiative and framework. MITA is a plan to promote improvements in the
Medicaid enterprise and the systems that support it through
collaboration between CMS and the States. The MITA framework consists
of models, guidelines, and principles for States to use as they plan
and implement business and technology enterprise solutions. Integral to
the MITA is the State's Medicaid Management Information System (MMIS).
The MMIS contains a great deal of claims data and other Medicaid
programmatic information that we believe should be used by States in
analyzing their current HIT environments. Once States establish a
baseline assessment, they can then plan the steps necessary to
transition towards achieving some of the objectives of the HITECH Act,
such as improving both quality of care and health care outcomes. In
addition, the MITA framework is CMS's initiative that will allow States
to modernize and transform their MMIS to improve the administration of
the Medicaid program, while supporting the States' need for
flexibility, adaptability, and rapid response to changes in the unique
aspects of their individual Medicaid programs. The ultimate goal of
MITA is to develop seamless and integrated systems that communicate
effectively and that are interoperable, both within and across States
as well as with other health care entities and payers, such as public
health departments and non-Medicaid payers. For more information on
MITA, we refer readers to: http://www.cms.hhs.gov/MedicaidInfoTechArch/
.
We believe that the HITECH Act incentives create a unique
opportunity for States and Medicaid providers to build upon prior and
current efforts in HIT in order to help achieve interoperable health
information exchange in health care. We believe that States should
build upon the lessons learned from these initiatives in order to
ensure that the incentive and administrative payments are leveraged in
a way that maximizes the role of HIT in enhancing quality and access,
reducing costs, and improving health care outcomes.
We also plan to ensure public involvement as the HIT environment
evolves, both as a result of the HITECH Act incentives, as well as a
result of other Departmental HIT initiatives. We have already convened
several State calls on the HITECH Act, including discussing the
definition of meaningful use of certified EHR technology, and the
impact the definition would have on specific provider groups. More
information on the content of these calls can be found in section
II.A.2.a of this proposed rule. We convened additional calls with State
staffs on the Medicaid EHR incentives leading up to our development of
this proposed rule. Issues addressed include policies such as State
oversight of adopting, implementing, and upgrading certified EHR
technology; alternative fiscal agents under consideration; and
validating data to establish program eligibility.
We also released a State Medicaid Director's letter on September 1,
2009. This letter outlines steps State Medicaid agencies can take to
assess the current status of their HIT efforts; develop a roadmap for
achieving their HIT objectives in support of the Medicaid EHR incentive
program; set Medicaid-specific performance goals and incentives for
provider adoption of HIT; and partner with a broad range of
stakeholders. Furthermore, we conducted a follow-up technical
assistance call with State Medicaid Directors and their staffs to
provide an overview and answer questions.
Finally, as required by section 1903(t)(10) of the Act, we will be
reporting to Congress on the status, progress, and oversight of the
overall EHR incentive program. These reports will discuss steps taken
to avoid duplicate Medicare and Medicaid incentive payments to EPs, the
extent to which Medicaid EPs and hospitals have adopted certified EHR
technology as a result of the incentive payments, and any improvements
in health outcomes, clinical quality, or efficiency resulting from the
adoption of such technology.
2. General Medicaid Provisions
In the proposed Sec. 495.342 and Sec. 495.344 we provide the
general rule that States, at their option, may receive: (1) 90 percent
FFP for State expenditures related to the administration of an EHR
incentive program for certain Medicaid providers that are adopting,
implementing, or upgrading and meaningfully using certified EHR
technology; and (2) 100 percent FFP for State expenditures for those
incentive payments.
3. Identification of Qualifying Medicaid EPs and Eligible
Hospitals
a. Overview
As specified in section 1903(t)(2) of the Act, only certain
Medicaid providers will be eligible for incentive payments. This
section of the preamble discusses some of these eligibility
requirements, including requirements relating to patient volume,
whether a provider is hospital-based, and whether an EP is practicing
predominantly in a federally-qualified health center (FQHC) or a rural
health clinic (RHC). Proposed
[[Page 1930]]
regulations relating to these requirements may be found at Sec.
495.304 through Sec. 495.306.
b. Program Participation
As specified under section 1903(t)(2)(A) of the Act, Medicaid
participating providers who wish to receive a Medicaid incentive
payment must meet the definition of a ``Medicaid EP.'' This definition
(1903(t)(3)(B) of the Act) lists five types of Medicaid professionals:
Physicians, dentists, certified nurse-midwives, nurse practitioners,
and physician assistants practicing in an FQHC or RHC that is so led by
a physician assistant.
Additionally, to qualify for incentives, most Medicaid EPs cannot
be ``hospital-based.'' We propose to use the same definition of
``hospital-based'' as used in the Medicare EHR incentive program, as
sections 1848(o)(1)(C) and 1903(t)(3)(D) of the Act use almost
identical definitions of the term. We refer readers to section II.A. of
this preamble for a proposed definition of ``hospital-based,'' and for
a thorough discussion of our proposed methodology.
The only exception to this rule is that Medicaid EPs practicing
predominantly in an FQHC or RHC are not subject to the hospital-based
exclusion.
Medicaid EPs must also meet the other criteria for Medicaid
incentive payment eligibility, such as the patient volume thresholds or
practicing predominantly in an FQHC or RHC, as described in this
subpart. Since the statute at 1903(t)(2)(iii) of the Act does not
define ``practices predominantly,'' we propose that an eligible
professional practices predominantly at an FQHC or an RHC when the
clinical location for over 50 percent of his or her total patient
encounters over a period of 6 months occurs at an FQHC or RHC.
Acute care and children's hospitals are listed in section
1903(t)(2) of the Act as the only two types of institutional providers
potentially eligible for Medicaid incentive payments. These terms are
specific to the Medicaid EHR incentive program and are not currently
defined in the Medicaid regulations. Consequently, we propose to define
these terms in Sec. 495.302.
As specified under section 1903(t)(2)(B) of the Act, to qualify for
incentive payments acute care hospitals also must meet patient volume
threshold requirements, as specified in proposed Sec. 495.306.
Children's hospitals do not have patient volume requirements for
Medicaid incentive program participation.
(1) Acute Care Hospitals
``Acute care'' is defined as the necessary treatment of a disease
or injury for only a short period of time in which a patient is treated
for a brief but severe episode of illness.\1\ Many hospitals can be
considered acute care facilities if they provide both inpatient and
outpatient services with the goal of discharging the patient as soon as
the patient is deemed stable, with appropriate discharge instructions.
We are proposing that for purposes of Medicaid incentive payments, an
``acute care hospital'' is defined as: A health care facility where the
average length of patient stay is 25 days or fewer. For purposes of
participation in the Medicaid EHR incentive program, this proposed
definition ensures that hospitals are designated as acute care
hospitals based on the level and nature of care they provide. This
definition also includes some specialty hospitals where the average
length of stay is 25 days or fewer. This definition of acute care
hospitals will exclude specialty providers and long-term care
facilities where the average patients' length of stay exceeds 25 days.
To further refine the definition, we reviewed the Medicare-issued CCN.
CCNs are issued to categories of providers who meet Federal
requirements (known as conditions of participation) to participate in
the Medicare program. State Medicaid agencies look to Medicare's
conditions of participation when deciding whether to issue provider
agreements to many categories of providers. In the case of inpatient
hospital services Sec. 440.10(a)(3)(iii) requires that for inpatient
hospital services provided to Medicaid beneficiaries to be eligible for
FFP, those services must be provided in an institution that meets the
requirements for participation in Medicare as a hospital, and such
hospitals receive CCNs.
---------------------------------------------------------------------------
\1\ State of Connecticut, Office of Health Care Access, ``The
Health of Connecticut's Hospitals,'' report released January 16,
2001, page 17.
---------------------------------------------------------------------------
Hospital CCNs are structured such that the first two digits
represent the State in which the hospital is located, and the next four
digits identify the type of facility and are assigned sequentially from
the appropriate block of numbers. Short-stay general hospitals receive
CCNs whose number range is 0001 through 0879. The 11 cancer hospitals
in the United States also are issued CCNs within that number range. To
allow some flexibility for hospital participation in the Medicaid EHR
incentive program, we are proposing to define acute care hospitals for
purposes of this Medicaid EHR incentive program as those with an
average patient length of stay of 25 days or fewer and with a CCN that
has the last four digits in the series 0001 through 0879 (that is,
short-term general hospitals and the 11 cancer hospitals in the United
States).
We also recognize a category of long-term care hospitals, which we
are planning to exclude from the definition. Long term acute care
hospitals are defined for Medicare purposes in regulations at 42 CFR
412.23(e). Specifically Sec. 412.23(e)(2)(i) states that the hospital
must have an average Medicare inpatient length of stay of greater than
25 days (which includes all covered and non-covered days of stay of
Medicare patients).
We considered allowing both short-term and long-term acute care
hospitals to meet the definition of acute care hospital for purposes of
the Medicaid incentive payments. However, we are not proposing a
definition that encompasses both types of acute care hospitals because
CMS' interpretation was that long-term acute care hospitals did not
satisfy the intent of the statute, which we believe intends to include
general acute care hospitals. In addition, CMS knew of at least one
State that does not recognize long-term acute care hospitals as a
Medicaid provider type. We therefore drew the line at 25 days, the cut-
off between short-term general and specialty hospitals and long-term
acute care hospitals. We used this cut-off in conjunction with the list
of CMS CCNs (which also distinguish between short-term and long-term
hospitals (see CMS State Operations Manual Section 2779A1, as revised
on April 20, 2007 and effective on October 1, 2007) in order to be as
inclusive as possible within statute. Since Congress specifically
singled out children's hospitals in addition to acute care hospitals,
we believe that if Congress intended to include long-term care
hospitals, it would have similarly given them separate mention. In
addition, Congress specifically did not include nursing facilities,
another category of long-term care provider (and an important source of
Medicaid care) as a provider type eligible for incentive payments. CMS
read this as further evidence that the statute did not intend inclusion
of long-term care facilities.
(2) Children's Hospitals
The statute also does not include a definition for ``children's
hospitals.'' To assist with the development of a definition of
``children's hospitals'' for purposes of the Medicaid EHR incentive
program, we convened teleconferences with States to gather input on
topics
[[Page 1931]]
that should be defined in this proposed rule. Participants noted that
one critical issue is whether a children's wing of a general hospital
could be considered a children's hospital for purposes of qualifying
for a Medicaid incentive payment.
As with the acute care hospital definition, we again looked to
Medicare-issued CCNs and recognized that numbers whose last four digits
are in the 3300 to 3399 series are assigned to children's hospitals.
Currently in the United States there are 78 certified children's
hospitals, including both freestanding and hospital-within-hospital
facilities.
For purposes of the Medicaid EHR incentive program, we propose one
definition to include only separately certified children's hospitals,
with CCNs in the 3300-3399 series in the definition of eligible
``children's hospital.'' By proposing to define ``children's hospital''
in this way, CMS would (1) prevent general acute care hospitals, which
cannot themselves qualify for the incentive because they do not meet
the 10 percent Medicaid patient volume, from using the fact that they
have a pediatric wing as justification for requesting a Medicaid
incentive payment; (2) exclude many of the facilities that are
perceived by the public as children's hospitals, but do not meet the
Medicare standards as either freestanding or hospital-within-hospital
children's hospitals; and (3) exclude some pediatric specialty
hospitals which have CCNs as psychiatric or rehabilitation hospitals.
An alternative proposed definition of a ``children's hospital''
would include those hospitals with Medicare provider numbers in the
following series:
0001 through 0879--Short-term (General and Specialty)
Hospitals.
3025 through 3099--Rehabilitation Hospitals (Excluded from
Prospective Payment Systems).
3300 through 3399--Children's Hospitals (Excluded from
Prospective Payment Systems).
4000 through 4499--Psychiatric Hospitals (Excluded from
Prospective Payment Systems).
This definition, for the purposes of the Medicaid HIT Incentive
payments, would apply only to those freestanding hospitals within the
above mentioned series that exclusively furnish services to individuals
under age 21.
This broader definition would (1) still prevent acute care
hospitals that cannot independently qualify for the incentive because
they do not meet the 10 percent Medicaid patient volume from using the
fact that they have a pediatric wing as justification for requesting an
HIT incentive payment; (2) allow for participation in the incentive
program by the greatest number of children's hospitals, including
rehabilitative and psychiatric specialty hospitals; and (3) align with
Federal efforts aimed at improving healthcare quality for all children,
including those with physical and mental diseases/disabilities.
We are soliciting comment on the proposed definitions of
``children's hospital'' as it applies to the Medicaid EHR incentive
program recognizing that there may be additional alternative
definitions that could have a positive impact on the health care
received by children.
c. Medicaid Professionals Program Eligibility
For Medicaid EPs, the general rule (subject to the two exceptions
listed below) is that the EP must have at least 30 percent patient
volume attributable to those who are receiving Medicaid. Section
1903(t)(2)(A)(i) of the Act provides authority to the Secretary to
establish the methodology by which such patient volume will be
estimated. We propose that to establish such patient volume, the EP
must have a minimum of 30 percent of all patient encounters
attributable to Medicaid over any continuous 90-day period within the
most recent calendar year prior to reporting. There are two exceptions
to the general 30 percent rule discussed previously. The first
exception is that a pediatrician may have at least 20 percent patient
volume attributable to those who are receiving health care services
under the Medicaid program, as estimated in accordance with a
methodology established by the Secretary (section 1903(t)(2)(A)(ii) of
the Act). Again, the method we propose to use is that the pediatrician
must have a minimum 20 percent of all patient encounters attributable
to Medicaid over any continuous 90-day period within the most recent
calendar year prior to reporting.
The second exception is that Medicaid EPs practicing predominantly
in an FQHC or RHC must have a minimum of 30 percent patient volume
attributable to ``needy individuals.'' Again, the method we propose to
use is that 30 percent of all patient encounters be attributable to
needy individuals over any continuous 90-day period within the most
recent calendar year prior to reporting.
Section 1903(t)(3)(F) of the Act defines needy individuals as
individuals meeting any of the following three criteria: (1) They are
receiving medical assistance from Medicaid or the Children's Health
Insurance Program (CHIP); (2) they are furnished uncompensated care by
the provider; or (3) they are furnished services at either no cost or
reduced cost based on a sliding scale determined by the individual's
ability to pay. An explanation of how we propose to apply each of these
criteria is described in detail in this section of the proposed rule.
We propose this flexible patient volume methodology in order to
capture the highest number of true Medicaid practitioners potentially
eligible for the EHR incentive program. We believe Congress set the
high patient volume thresholds in order to offer these incentives to
the practitioners whose practices are open and accessible to Medicaid
beneficiaries. We noted that many Medicaid eligible individuals, such
as children, may seek care at specified times of the year, such as the
beginning of the school-year for required immunizations. Since there
are five different types of providers, varying from specialty to
primary care, we thought the flexibility would capture any seasonal
encounter adjustments in the year, while still honoring Congress'
intent to reward higher-volume Medicaid practitioners.
d. Calculating Patient Volume Requirements
As required by section 1903(t)(2) of the Act and discussed in the
previous section, all EPs and the vast majority of hospitals will need
to meet certain patient volume thresholds in order to be eligible for
incentive payments. (The only exception to this rule is for children's
hospitals, which have no patient volume threshold requirement).
In addition, where patient volume is a criterion, most providers
will be evaluated according to their ``Medicaid'' patient volume, while
some professionals (those practicing predominantly in an FQHC or RHC)
will be evaluated according to their ``needy individual'' patient
volume.
We propose to define ``patient volume'' in Sec. 495.302 to be a
minimum participation threshold for each individual Medicaid provider
(with the exception of children's hospitals).
For the Medicaid patient volume, this threshold (represented below)
is calculated using as the numerator the individual hospital's or EP's
total number of Medicaid patient encounters in any representative
continuous 90-day period in the preceding calendar year and the
denominator is all patient encounters for the same individual
professional or hospital over the same 90-day period. We are not
prescribing standards for what is a ``representative''
[[Page 1932]]
period, but we intend to apply a plain meaning test. In other words, if
a reasonable person would not consider the selected period to be
representative (for example, because the selected period included a
short-term temporary Medicaid outreach program), then it would not
support a threshold calculation.
[Total (Medicaid) patient encounters in any 90-day period in the
preceding calendar year/Total patient encounters in that same 90-day
period] * 100
For the needy individual patient volume, the threshold (represented
below) is calculated in the same manner, but with the numerator equal
to the EP's total number of needy individual patient encounters in any
representative 90-day period in the preceding calendar year.
[Total (Needy Individuals) patient encounters in any continuous 90-
day period in the preceding calendar year/Total patient encounters in
that same 90-day period] * 100
Medicaid EPs and eligible hospitals would be required to annually
re-attest to patient volume thresholds to continue to qualify for
Medicaid incentive payments. Table 26 demonstrates the above-referenced
patient volume thresholds per provider type.
Table 26--Qualifying Patient Volume Threshold for Medicaid EHR Incentive
Program
------------------------------------------------------------------------
Minimum 90-day
Medicaid patient
Entity volume threshold
(percent)
------------------------------------------------------------------------
Physicians.................... 30 Or the Medicaid EP
practices
predominantly in an
FQHC or RHC--30%
``needy individual''
patient volume
threshold.
Pediatricians................. 20
Dentists...................... 30
Certified nurse midwives...... 30
Physician Assistants when 30
practicing at an FQHC/RHC led
by a physician assistant.
Nurse Practitioner............ 30
Acute care hospital........... 10 .....................
Children's hospital........... ................. .....................
------------------------------------------------------------------------
If a State has an alternative approach to the established timeframe
for measuring patient volume, it may propose it to us for review
through the State Medicaid HIT Plan (SMHP) (discussed later) and we
would make a determination of whether it is an acceptable alternative.
To be considered for approval, the alternative approach would require a
verifiable data source and justification. In defining the way in which
patient volume is established, we provide for a consistent methodology
per the statute, but also allow for the possibility that States may
propose acceptable alternatives that synchronize with existing data
sources, which could decrease State data burdens. This alternative
approach must provide an auditable record (that is, a record of how the
professional demonstrated patient volume) for CMS to monitor the
States' oversight of the Medicaid EHR incentive program implementation.
In determining the ``needy individual'' patient volume threshold
that applies to EPs practicing predominantly in FQHCs or RHCs, section
1902(t)(2) of the Act authorizes the Secretary to make a downward
adjustment to the uncompensated care figure to eliminate bad debt data.
We interpret bad debt to be consistent with the Medicare definition, as
specified at Sec. 413.89(b)(1). Under Medicare, bad debts are amounts
considered to be uncollectible from accounts and notes receivable that
were created or acquired in providing services. ``Accounts receivable''
and ``notes receivable'' are designations for claims arising from the
furnishing of services, and are collectible in money in the relatively
near future. Providers should be required to use cost reports (for
FQHCs and clinics this would be the Medicare 222-92 cost report, or the
most recent version of the 222), or other auditable records to identify
bad debts. All information under attestation is subject to audit. Our
proposed regulations on calculating the needy individual patient volume
can be found at Sec. 495.302 and Sec. 495.306.
Further, in establishing the Medicaid patient volume thresholds for
EPs and acute care hospitals, section 1902(t)(2) of the Act requires
that individuals enrolled in Medicaid managed care organizations
(MCOs), prepaid inpatient health plans (PIHPs), or prepaid ambulatory
health plans (PAHPs), under 42 CFR Part 438 be included in the
calculation. Therefore, in determining patient volume, providers and
States should be aware that individuals enrolled in such plans will be
included in the patient volume calculation. Acute care hospitals have
to meet the 10 percent Medicaid volume threshold.
We also note that although Sec. 438.60 of our regulations would
generally prohibit a State from making a direct payment to a provider
for services that are included under a contract with an MCO, PIHP, or
PAHP, providers contracted with these managed care plans will
nevertheless be eligible for Medicaid EHR incentive payments because
those payments are not for services that are included in such a
contract. The fact that Congress directed that individuals enrolled in
managed care be included in the patient volume calculation demonstrates
an intent to allow qualified providers to receive incentive payments,
whether they provided their services through capitated care
arrangements or fee-for-service. Over 70 percent of Medicaid
beneficiaries receive care in a managed care delivery system, and we do
not believe that the intent of Congress in creating the incentives
program was to remove the providers treating these individuals from the
incentives program.
e. Entities Promoting the Adoption of Certified EHR Technology
We are proposing to define ``promoting the adoption of certified
EHR technology'' in Sec. 495.302. Under section 1903(t)(6)(A)(i),
incentive payments must generally be made directly to the EP. Section
1903(t)(6)(A)(ii) of the Act provides an exception to permit payment of
incentive payments to ``entities promoting the adoption of certified
EHR technology,'' as designated by the State, if participation in the
payment arrangement is voluntary for the EP involved. Additionally, the
entity must not retain more than 5 percent of the payment for costs
unrelated to certified
[[Page 1933]]
EHR technology (and support services including maintenance and
training) that is for, or is necessary for, the operation of the
technology. While the Act authorizes States to designate these
entities, the Secretary nevertheless retains authority to define what
it means to be ``promoting the adoption of certified EHR technology,''
as specified in section 1903(t)(6)(A)(ii) of the Act. Section 1102 of
the Act authorizes the Secretary to ``make and publish such rules and
regulations, not inconsistent with this Act, as may be necessary to the
efficient administration of the functions with which he or she is
charged under this Act.'' Since one of our functions is to approve
Title XIX plans under sections 1902(b) and 1116 of the Act, and States
would need to submit plans as to how they would spend section 4201 of
the HITECH Act funds, we have the authority to determine whether a
State's plan for allowing EPs to assign their Medicaid incentive
payments to these entities is in compliance with our interpretation of
the Act.
We propose to define ``promoting'' certified EHR adoption to mean
the enabling and oversight of the business, operational and legal
issues involved in the adoption and implementation of EHR and/or
exchange and use of electronic health information between participating
providers, in a secure manner, including maintaining the physical and
organizational relationship integral to the adoption of certified EHR
technology by EPs. For example, health information exchanges have the
potential to transform the healthcare system by facilitating timely,
accurate, and portable health information on each patient at the point
of service. Health Information Exchanges (HIEs), are one type of entity
that we believe would meet the definition of an entity that is
promoting the adoption of certified EHR technology. HIEs provide the
capability to move clinical information electronically between
disparate health care information systems while maintaining the meaning
of the information being exchanged. HIEs also provide the
infrastructure for secondary use of clinical data for purposes such as
public health, clinical, biomedical, and consumer health informatics
research as well as institution and provider quality assessment and
improvement, where permissible under HIPAA and other requirements
included in the HITECH Act. In addition, use of health information
exchange models can reduce the need for costly point-to-point
interfaces between different EHR tools, as used in laboratories and
pharmacies, thus providing a more scalable model of interoperable
health information exchange. HIEs promote adoption of certified EHR
technology by providing the infrastructure for providers' EHRs to reach
outside of their clinical practice sites and connect with other points
of care. Providers report that having a more complete picture of their
patients' healthcare data from other providers and care settings is one
of the primary appeals to using EHRs. Without health information
exchange, electronic health records are simply digitized filing
cabinets and will not achieve their quality of care or cost containment
potential. Furthermore, given the proposed definition of meaningful
use, HIEs can significantly help Medicaid providers adopt and use EHR
in such a way that the goals of the incentive program are met. The
inclusion in HITECH of HIE grants to be awarded to States or State-
designated Entities by ONC are an additional indication of the
symbiotic relationship between health information exchanges and optimal
use of EHRs.
Under 1903(t)(6)(A)(ii) of the Act and as proposed in Sec.
495.354, States must establish verification procedures that enable
Medicaid EPs to voluntarily assign payments to entities promoting EHR
technology. States must guarantee that the assignment is voluntary and
that the entity does not retain more than 5 percent of those assigned
Medicaid incentive payments for costs unrelated to certified EHR
technology. We propose requiring States to publish and make available
to all Medicaid EPs the procedures they developed for assigning
incentive payments to the third party entities before payments can be
assigned. Such publication must also include information about the
State's verification mechanism. The State's method must assure
compliance with the requirement that no more than 5 percent of the
Medicaid EP's annual incentive payment is retained by the entity for
costs not related to certified EHR technology.
Although section 1903(t)(6)(A)(ii) of the Act allows assignment of
payment to entities promoting the adoption of EHR technology, we wish
to clarify that such assignment would not remove the responsibility of
the Medicaid EP to individually demonstrate meaningful use of the EHR
technology (as discussed in greater detail below). Therefore, entities
promoting the adoption would not receive the assigned payments unless
the Medicaid EP meets all eligibility criteria. Our proposed definition
for promoting the adoption of certified EHR technology is in Sec.
495.302.
4. Computation of Amount Payable to Qualifying Medicaid EPs and
Eligible Hospitals
The statute, at sections 1903(t)(1), (t)(4), and (t)(5) of the Act,
creates different payment formulas for Medicaid EPs versus hospitals.
The payment methodology for Medicaid hospitals shares many aspects of
the methodology used for Medicare hospitals.
a. Payment Methodology for EPs
(1) General Overview
Pursuant to section 1903(t)(1)(A) of the Act, payment for EPs
equals 85 percent of ``net average allowable costs.'' While the
Secretary is directed to determine ``average allowable costs'' based
upon studies of the average costs of both purchasing and using EHR
technology, the net average allowable costs that set payment are capped
by statute. As discussed in more detail further on, generally stated,
these caps equal $25,000 in the first year, and $10,000 for each of 5
subsequent years (there is an exception for pediatricians with under 30
percent Medicaid patient volume, whose caps are two-thirds of these
amounts). Thus, the maximum incentive payment an EP could receive from
Medicaid equals 85 percent of $75,000, or $63,750, over a period of 6
years. EPs must begin receiving incentive payments no later than CY
2016.
(2) Average Allowable Costs
Section 1903(t)(4)(C) of the Act gives the Secretary the authority
to determine average allowable costs. Specifically, the Secretary is
directed to study the average costs associated with the purchase,
initial implementation, and upgrade of certified EHR technology,
including support services, and integral related training. The
Secretary also is directed to study the average costs of operating,
maintaining, and using certified EHR technology. The statute permits
the Secretary to use studies submitted by the States.
We conducted a literature review of recent studies on EHR
technology to determine the average allowable cost of implementing and
using such technology. We reviewed the results from four recent,
comprehensive studies. Specifically, HHS' Office of the Assistant
Secretary for Planning and Evaluation commissioned a study by Moshman
Associates, Inc., Booz Allen Hamilton, in September 2006--Assessing the
Economics of EMR Adoption and Successful Implementation in Physical
Small Practice Settings. In this study, EHRs
[[Page 1934]]
consisted of a core group of functions that, in various permutations,
are often associated with an electronic medical record and frequently
include the capacity to: Capture and display clinical notes, display
laboratory results, display diagnostic imaging results or reports,
order drugs or diagnostic tests, and generate reports.\2\
---------------------------------------------------------------------------
\2\ Moshman Associates, Inc., Booz Allen Hamilton, in September
2006--Assessing the Economics of EMR Adoption and Successful
Implementation in Physical Small Practice Settings, p. 40.
---------------------------------------------------------------------------
The study found that EHR adoption is influenced by a variety of
factors, including hardware costs, software costs, the costs of
implementation and training, and costs associated with productivity
that occur in the early stages of implementation. While there are
challenges in making cost comparisons across different studies and
across different functionalities (that is, EMRs versus EHRs), the costs
per physician ranged between $33,000 and $50,000.\3\
---------------------------------------------------------------------------
\3\ Moshman Associates Inc., Booz, Allen, Hamilton, p. 50.
---------------------------------------------------------------------------
In reviewing Market Watch, The Value of Electronic Health Records
in Community Health Centers: Policy Implications by Robert H. Miller
and Christopher E. West, the cost and benefits of electronic health
records is reported in six community health centers (CHCs) that serve
disadvantaged patients.\4\ Robert Miller and Christopher West report
that initial EHR costs per full-time-equivalent (FTE) billing provider
averaged almost $54,000, with much variation across CHCs and within
each cost category, including hardware, software, installation,
training, etc. and ongoing costs per FTE provider, per year, averaged
$20,610.\5\
---------------------------------------------------------------------------
\4\ Market Watch, The Value of Electronic Health Records in
Community Health Centers: Policy Implications by Robert H. Miller
and Christopher E. West, p. 206.
\5\ Market Watch, The Value of Electronic Health Records in
Community Health Centers: Policy Implications by Robert H. Miller
and Christopher E. West, p. 208.
---------------------------------------------------------------------------
A Congressional Budget Office (CBO) Paper: Evidence on the Costs
and Benefits of Health Information Technology from May 2008 indicates
that estimating the total cost of implementing HIT systems in office-
based medical practices is complicated by differences in the types and
available features of the systems now being sold, as well as
differences in characteristics of the practices that adopt them. The
CBO paper goes further to say that few detailed studies available
report that total costs for office-based EHRs are about $25,000--
$45,000 per physician \6\ and estimates for annual costs for operating
and maintaining the system, which include software licensing fees,
technical support, and updating and replacing used equipment range
between $3,000 to $9,000 per physician per year.\7\
---------------------------------------------------------------------------
\6\ A CBO Paper, Evidence on the Costs and Benefits of Health
Information Technology, May 2008, p. 17.
\7\ A CBO Paper, Evidence on the Costs and Benefits of Health
Information Technology, May 2008, p. 18.
---------------------------------------------------------------------------
An article written by the Agency for Healthcare Research and
Quality (AHRQ), Research Activities, September 2005, Health Information
Technology, adoption rates of electronic health records are low among
physician groups--indicates that the average purchase and
implementation cost of an EHR was $32,606 per FTE physician. The
article indicates that maintenance costs were an additional $1,500 per
physician, per month and smaller practices had the highest
implementation costs per physician at $37,204.\8\
---------------------------------------------------------------------------
\8\ Agency for Healthcare Research and Quality, Research
Activities, September 2005, Health Information Technology, Adoption
rates of electronic health records are low among physician groups.
---------------------------------------------------------------------------
In conducting a review of the data, we determined that the studies
demonstrate a cross-sectional view of small and large practices and
community health centers. There was adequate data to support a
depiction of costs across multiple provider types.
To summarize, we determined that the average costs of EHRs vary
greatly because of the size and type of provider practices, the
differences in available features of systems, and the additional costs
associated with licensing, support, training, and maintenance. However,
based on the information reviewed, we determined that the average costs
for initial EHR systems currently can range from $25,000 to $54,000 in
the implementation year, per professional. Since the average costs of
EHR technology in the first year can be as much as $54,000 and no less
than $25,000, and since we believe the costs of such technology will be
increasing, we are proposing to set the average allowable cost at
$54,000. We believe that to establish this average allowable cost at
the high end of the range is reasonable since the data we reviewed is
based on certification standards that may not be appropriate moving
forward. Specifically, since the ONC will be establishing new
certification standards for EHR technology in the coming months, we
believe the average cost of certified EHR technology incorporating the
new standards will be higher than the current costs of EHR technology.
It is our assumption that making improvements to incorporate the new
certification standards into current EHR technology will be costly.
Thus, we believe that establishing the average allowable cost at
$54,000 is reasonable.
Additionally, our analysis determined that the range for subsequent
incentive payment year costs for most providers will fall into a large
range, based on a number of factors. On one end of the range, costs
related to maintenance could be as low as $3,000 to $9,000 per
provider, where other studies state that maintenance will be as high as
$18,000 to $20,610 per provider. Given the expectations in the ONC
interim final rule for system performance, interoperability, and the
health measures data discussed in this proposed rule that CMS and the
States will need to collect from professionals, we believe that the
costs for maintaining certified EHR technology will also be on the
higher end of the range at $20,610.
(3) Net Average Allowable Costs
As required by section 1903(t)(3)(E) of the Act, in order to
determine ``net'' average allowable costs, average allowable costs for
each provider must be adjusted in order to subtract any payment that is
made to Medicaid EPs and is directly attributable to payment for
certified EHR technology or support services of such technology. The
only exception to this requirement is that payments from State or local
governments do not reduce the average allowable costs. The resulting
figure is the ``net'' average allowable cost; that is, average
allowable cost minus payments from other sources (other than State or
local governments). The statute indicates that EPs may receive 85
percent of a maximum net average allowable cost in the first year of
$25,000 and a maximum net average allowable cost of $10,000 in
subsequent years. This would mean that, as required by the statute, the
net average allowable costs are capped at these amounts.
Since we have proposed that the average allowable cost is $54,000
in the first year, EPs could receive as much as $29,000 in funding from
sources (other than from State or local governments) as contributions
to the certified EHR technology and the incentive payment would still
be based on 85 percent of the maximum net average allowable cost of
$25,000 (or $21,250). This is appropriate since $54,000 (the average
allowable cost) minus $29,000 (contributing sources of funding from
other than State or local governments) equals $25,000.
[[Page 1935]]
Since $25,000 is equal to the level of the maximum net average
allowable cost or capped amount discussed above, providers could
receive 85 percent of $25,000 or $21,250 in year one as a Medicaid
incentive payment.
The same logic would hold true for subsequent years. Specifically,
if in the following years an eligible professional received as much as
$10,610 in contributing funds from sources other than State or local
governments, the maximum incentive payment of $8,500 would be
unaffected in such subsequent years. This result is due to the fact
that the average allowable costs of $20,610 for maintaining EHR
technology minus the $10,610 received would still equal $10,000, the
maximum net average allowable costs permitted under the statute.
In reviewing whether a reduction in the net average allowable cost
was warranted based on other contributions to EHR technology, we
considered the situation of EPs who may have been provided with the
actual certified EHR technology, as well as training, support services,
and other services that would promote the implementation and meaningful
use of such technology. In some cases, we do not believe the
contribution would reduce average allowable costs at all. For example,
if an FQHC or RHC has provided technology to its staff EPs to use, we
do not believe that such technology provision would be considered a
``payment'' from another source that would reduce average allowable
costs. Moreover, we believe the situations in which an EP has been
provided with the actual technology, support service, or training from
another source are extremely limited in light of the statutory
prohibitions on ``kickbacks'' at Section 1128B(b) of the Act.
(4) Payments for Medicaid Eligible Professionals
One important difference we propose between the payments to
Medicaid EPs and hospitals is that States would disburse the payments
to EPs in alignment with the calendar year, whereas hospitals will
receive payments in alignment with the fiscal year, as described in
section II.D.4.b. of this proposed rule. There are two primary reasons
for this. The first is to align Medicaid incentive payment
disbursements with that of the Medicare program, in order to support
consistency between the two programs, as well as among the States. We
will undertake national outreach activities to encourage provider EHR
adoption and to align the annual payment periods. Since meaningful use
of the certified EHR technology is the driver of the incentives, we
believe that a cooperative approach between CMS, ONC, and the States
would be realized with more providers participating in the program.
As previously discussed in this proposed rule, based on the 85
percent threshold applied to the net average allowable costs, we
propose that most Medicaid EPs may receive up to a maximum incentive
payment of $21,250 in the first payment year.
In subsequent years of payment, Medicaid EPs' incentive payments
will be limited to 85 percent of the $10,000 cap on net average
allowable cost, or up to a maximum of $8,500 annually for most Medicaid
EPs.
Since pediatricians are qualified to participate in the Medicaid
EHR incentive program as physicians, and therefore classified as
Medicaid EPs, they may qualify to receive the full incentive (that is,
the 85 percent threshold applied to the net average allowable cost) if
the pediatrician is not hospital-based and can demonstrate that they
meet the minimum 30 percent Medicaid patient volume requirements
discussed in this subpart.
Pediatricians who are not hospital-based, and have a minimum of 20
percent of their patient encounters paid by Medicaid are also
encouraged to participate in the Medicaid EHR incentive program. The
maximum payment amount for these pediatricians, who meet the 20 percent
Medicaid patient volume, but fall short of the 30 percent patient
volume, is reduced to two-thirds of the net average allowable cost,
subject to the 85 percent threshold. The reduction accounts for the
reduced patient volume, but the intent is to offer an incentive to
attract pediatricians to participate. This means pediatricians with a
minimum 20 percent patient volume may qualify for up to a maximum of
$14,167 in the first incentive payment year and up to a maximum of
$5,667 in the 5 subsequent incentive payment years, or no more than
$42,500 over the maximum 6 year period.
Table 27 demonstrates the various maximum incentive payment amounts
for Medicaid professionals.
Table 27--Maximum Incentive Payment Amount for Medicaid Professionals
----------------------------------------------------------------------------------------------------------------
85 percent allowed Maximum cumulative
Cap on net average allowable costs, per the HITECH Act for eligible incentive over
professionals 6[dash]year period
----------------------------------------------------------------------------------------------------------------
$25,000 in Year 1 for most professionals............................ $21,250 ....................
$10,000 in Years 2-6 for most professionals......................... 8,500 $63,750
$16,667 in Year 1 for pediatricians with a minimum 20 percent 14,167 ....................
patient volume, but less than 30 percent patient volume, Medicaid
patients...........................................................
$6,667 in Years 2-6 for pediatricians with a minimum 20 percent 5,667 42,500
patient volume, but less than 30 percent patient volume, Medicaid
patients...........................................................
----------------------------------------------------------------------------------------------------------------
(5) Basis for Medicaid EHR Incentive Program First Payment Year and
Subsequent Payment Years
(i) Medicaid EP Who Begins Adopting, Implementing or Upgrading
Certified EHR Technology in the First Year
A Medicaid EP who begins by adopting, implementing, or upgrading
certified EHR technology in the first year will be eligible for the
incentive payments not in excess of the maximum amount. Under section
1903(t)(4) of the Act he or she is eligible to receive up to the
maximum first year Medicaid incentive payments discussed in the
previous sections, plus additional incentive payments for up to 5 years
for demonstrating meaningful use of certified EHR technology. In other
words, these providers may participate in the Medicaid EHR incentive
program for up to 6 years.
Table 28 demonstrates the payment scenarios available to a Medicaid
EP who begins in their first year by adopting, implementing, or
upgrading certified EHR technology. As can be seen from the table, the
EP can begin receiving payments as late as 2016, and still receive up
to the maximum payments under the program.
[[Page 1936]]
Table 28--Payment Scenarios for Medicaid EPs Who Begin Adoption in the First Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid EPs who begin adoption in
Calendar year -----------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.................................................... $21,250 .............. .............. .............. .............. ..............
2012.................................................... 8,500 $21,250 .............. .............. .............. ..............
2013.................................................... 8,500 8,500 $21,250 .............. .............. ..............
2014.................................................... 8,500 8,500 8,500 $21,250 .............. ..............
2015.................................................... 8,500 8,500 8,500 8,500 $21,250 ..............
2016.................................................... 8,500 8,500 8,500 8,500 8,500 $21,250
2017.................................................... .............. 8,500 8,500 8,500 8,500 8,500
2018.................................................... .............. .............. 8,500 8,500 8,500 8,500
2019.................................................... .............. .............. .............. 8,500 8,500 8,500
2020.................................................... .............. .............. .............. .............. 8,500 8,500
2021.................................................... .............. .............. .............. .............. .............. 8,500
-----------------------------------------------------------------------------------------------
Total............................................... 63,750 63,750 63,750 63,750 63,750 63,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
(ii) Medicaid EP Who Has Already Adopted, Implemented or Upgraded
Certified EHR Technology and Meaningfully Uses EHR Technology
For a Medicaid EP who has already adopted, implemented, or upgraded
certified EHR technology and can meaningfully use this technology in
the first incentive payment year, we propose that the Medicaid EP be
permitted to receive the same maximum payments, for the same period of
time, as the Medicaid EP who merely adopted, implemented or upgraded
certified EHR technology in the first year. Section 1903(t)(6)(C)(ii)
of the Act states that for a Medicaid EP or hospital who has completed
``adopting, implementing, or upgrading'' certified EHR technology
``prior to the first year of payment. * * * clause (i)(I) shall not
apply and clause (i)(II) [discussing the demonstration of meaningful
use] shall apply to each year of payment to the Medicaid provider under
this subsection, including the first year of payment.'' We believe this
provision supports an interpretation that a Medicaid EP who has already
adopted certified EHR technology, would still receive a ``first year''
of payment under section 1903(t)(4) of the Act, and like all other
first years of payment, this payment could not exceed $21,250. Then,
under section 1903(t)(4)(A)(ii) and (iii) of the Act, such Medicaid EPs
could receive an additional 5 years of payment for subsequent years of
payment, with payments not exceeding $8,500 in each of these 5
subsequent years. This approach allows early adopters of certified EHR
to begin meaningfully using technology, without being at a competitive
disadvantage, and without losing incentive payments for the previous
costs associated with adopting, implementing, or upgrading certified
EHR technology.
Thus, the maximum incentive payments for Medicaid EPs demonstrating
that they are meaningful users in the first payment year, would be
identical to the maximum payments available to those demonstrating
adoption, implementation, or upgrading certified EHR technology in the
first year, as depicted in Table 29.
Table 29--Maximum Incentive Payments for Medicaid EPs Who Are Meaningful Users in the First Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid EPs who begin meaningful use of certified EHR technology in
Calendar year -----------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.................................................... $21,250 .............. .............. .............. .............. ..............
2012.................................................... 8,500 $21,250 .............. .............. .............. ..............
2013.................................................... 8,500 8,500 $21,250 .............. .............. ..............
2014.................................................... 8,500 8,500 8,500 $21,250 .............. ..............
2015.................................................... 8,500 8,500 8,500 8,500 $21,250 ..............
2016.................................................... 8,500 8,500 8,500 8,500 8,500 $21,250
2017.................................................... .............. 8,500 8,500 8,500 8,500 8,500
2018.................................................... .............. .............. 8,500 8,500 8,500 8,500
2019.................................................... .............. .............. .............. 8,500 8,500 8,500
2020.................................................... .............. .............. .............. .............. 8,500 8,500
2021.................................................... .............. .............. .............. .............. .............. 8,500
-----------------------------------------------------------------------------------------------
Total............................................... 63,750 63,750 63,750 63,750 63,750 63,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
An alternative approach we request comment on would be to limit the
incentive payment for Medicaid EPs who have already adopted,
implemented, or upgraded certified EHR technology to 5 years of
payment, at a maximum payment of $8,500 per year. This approach would
interpret section 1903(t)(4)(A) of the Act, which states that the
$25,000 cap on net average allowable costs is intended to cover the
costs of implementing or adopting certified EHR technology, as limiting
the $21,250 payment only to those actually adopting the technology in
their first year of payment. While early adopters would still be
eligible to receive incentive payments, the payment totals would be
lower, because such adopters would not need an incentive payment in
order to actually implement, adopt, or upgrade certified EHR
technology. This alternative approach is depicted in Table 30.
[[Page 1937]]
Table 30--Alternative Incentive Payment Scenario for Medicaid EPs Who Have Adopted EHR Technology Before the First Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid EPs who begin meaningful use in
Calendar year -----------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.................................................... $8,500 .............. .............. .............. .............. ..............
2012.................................................... 8,500 $8,500 .............. .............. .............. ..............
2013.................................................... 8,500 8,500 $8,500 .............. .............. ..............
2014.................................................... 8,500 8,500 8,500 $8,500 .............. ..............
2015.................................................... 8,500 8,500 8,500 8,500 $8,500 ..............
2016.................................................... .............. 8,500 8,500 8,500 8,500 $8,500
2017.................................................... .............. .............. 8,500 8,500 8,500 8,500
2018.................................................... .............. .............. .............. 8,500 8,500 8,500
2019.................................................... .............. .............. .............. .............. 8,500 8,500
2020.................................................... .............. .............. .............. .............. .............. 8,500
2021.................................................... .............. .............. .............. .............. .............. ..............
-----------------------------------------------------------------------------------------------
Total............................................... 42,500 42,500 42,500 42,500 42,500 42,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medicaid EPs are not required to participate on a consecutive
annual basis. The tables in this section demonstrate how a Medicaid EP
would maximize the aggregate incentive under different scenarios,
considering that a Medicaid EP may initiate participation in 2011
through 2016. Additionally, these tables do not include the alternative
Medicaid maximum incentive payment for pediatricians discussed in the
previous section, which is two-thirds of the total amount listed in
Tables 27 through 30. Finally, these tables do not represent EPs whose
incentive payments may be reduced because net average allowable costs
may actually be lower than $25,000 in the first year, or $10,000 in
subsequent years, due to payments from other, non-State/local sources.
b. Payment Methodology for Eligible Hospitals
Statutory parameters placed on Medicaid incentive payments to
hospitals are largely based on the methodology applied to Medicare
incentive payments. The specifications described in this section are
limits to which States must adhere when developing aggregate EHR
hospital incentive amounts for Medicaid-eligible hospitals. States will
calculate hospitals' aggregate EHR hospital incentive amounts on the
FFY to align with hospitals participating in the Medicare EHR incentive
program.
States may pay children's hospitals and acute care hospitals up to
100 percent of an aggregate EHR hospital incentive amount provided over
a minimum of a 3-year period and a maximum of a 6-year period. The
maximum incentive amounts for these providers are statutorily defined
by a formula at section 1903(t)(5)(B) of the Act. The statute requires
that Medicaid refer, with some adjustments, to the calculation for the
Medicare hospital incentive payment described at sections
1886(n)(2)(A), 1886(n)(2)(C), and 1886(n)(2)(D) of the Act, to
determine the aggregate EHR amount allowable for individual hospitals.
The aggregate EHR hospital incentive amount is calculated using an
overall EHR amount multiplied by the Medicaid share. The aggregate EHR
hospital incentive amount is the total amount the hospital could
receive in Medicaid payments over 4 years of the program.
States are responsible for using auditable data sources to
calculate Medicaid EPs' aggregate EHR hospital incentive amounts, as
well as determining Medicaid incentive payments to those providers.
Auditable data sources include--
Providers' Medicare cost reports;
State-specific Medicaid cost reports;
Payment and utilization information from the State's MMIS
(or other automated claims processing systems or information retrieval
systems); and
Hospital financial statements and hospital accounting
records.
All State Medicaid EHR incentive program calculations, payments,
and limits under this section are subject to our review.
For purposes of the Medicaid EHR incentive program, the overall EHR
amount is equal to the sum over 4 years of (I)(a) the base amount
(defined by statute as $2,000,000); plus (b) the discharge related
amount defined as $200 for the 1,150th through the 23,000th discharge
for the first payment year (for subsequent payments years, States must
assume discharges increase by the provider's average annual rate of
growth for the most recent 3 years for which data are available per
year): multiplied by (II) the transition factor for each year equals 1
in year 1, \3/4\ in year 2, \1/2\ in year 3, and \1/4\ in year 4.
The statute specifies that the payment year is determined based on
a Federal fiscal year. Section 1886(n)(2)(C) of the Act provides the
Secretary with authority to determine the discharge related amount on
the basis of discharge data from a relevant hospital cost reporting
period, for use in determining the incentive payment during a Federal
fiscal year. Federal fiscal years begin on October 1 of each calendar
year, and end on September 30 of the subsequent calendar year. Hospital
cost reporting periods can begin with any month of a calendar year, and
end on the last day of the 12th subsequent month in the next calendar
year. For purposes of administrative simplicity and timeliness, we
propose that States, for each eligible hospital during each incentive
payment year, use data on the hospital discharges from the hospital
fiscal year that ends during the Federal fiscal year prior to the
fiscal year that serves as the payment year.
Example: FY 2011 begins on October 1, 2010 and ends on September
30, 2011. For an eligible hospital with a cost reporting period
running from July 1, 2010 through June 30, 2011, we would employ the
relevant data from the hospital's cost reporting period ending June
30, 2010 in order to determine the incentive payment for the
hospital during Federal fiscal year 2011. This timeline would allow
States to have the relevant data available for determining the
aggregate EHR hospital incentive amount in a timely manner for the
first and subsequent payment years.
The discharge-related amount is $200 per discharge for
discharges 1,150 through 23,000. To determine the discharge-related
amount for the 3 subsequent payment years that are included in
determining the overall EHR amount, States should assume discharges
for an individual hospital have increased by the average annual
growth rate for an individual hospital over the most
[[Page 1938]]
recent 3 years of available data from an auditable data source. Note
that if a hospital's average annual rate of growth is negative over
the 3 year period, it should be applied as such.
We have provided a sample calculation for review that assumes
the following:
An individual provider had 20,000 discharges in the
first FY (2011).
The most recent annual growth data available are as
follows:
++ FY 2005 (.028 annual growth rate)
++ FY 2006 (.013 annual growth rate)
++ FY 2007 (.027 annual growth rate)
The average annual growth rate over 3 years = (.028 x .013 x
.027)/3 = .0227.
Year 1
2011 discharge related amount equals:
(20,000 - 1149) x $200 = $3,770,200
Year 2
2012 discharge related amount equals:
20,000 x 1.0227 = 20,454
(20,454 - 1149) x $200 = $3,861,000
Year 3
2013 discharge related amount equals:
20,454 x 1.0227 = 20,918
(20,918 - 1149) x $200 = $3,953,800
Year 4
2014 discharge related amount equals:
20,918 x 1.0227 = 21,393
(21,393 - 1149) x $200 = $4,048,800
The overall hospital EHR amount requires that a transition
factor be applied to each year. This transition factor equals 1 for
year 1, \3/4\ for year 2, \1/2\ for year 3, and \1/4\ for year 4, as
provided for in sections 1886(n)(2)(A) and 1886(n)(2)(E) of the Act,
and as incorporated through section 1902(t)(5)(B) of the Act. We
note that although, for purposes of the Medicare incentives, section
1886(n)(2)(E)(ii) of the Act requires a transition factor of 0, if
the first payment year is after 2013, we do not believe this rule
would apply in the context of the Medicaid incentive payments.
Nothing in section 1903(t) of the Act specifically cross references
this 0 transition factor, and, notably, section 1903(t) of the Act
allows Medicaid incentive payments to begin as late as 2016.
The ``Medicaid Share,'' against which the overall EHR amount is
multiplied, is essentially the percentage of a hospital's inpatient,
non-charity care days that are attributable to Medicaid inpatients.
More specifically, the Medicaid share is a fraction expressed as--
Estimated Medicaid inpatient-bed-days plus estimated
Medicaid managed care inpatient-bed-days;
Divided by;
Estimated total inpatient-bed days multiplied by
((estimated total charges minus charity care charges) divided by
estimated total charges).
As indicated in the above formula, the Medicaid share includes both
Medicaid inpatient-bed-days and Medicaid managed care inpatient-bed-
days. This is in keeping with section 1903(t)(5)(C) of the Act, which
provides that in computing inpatient-bed-days, the Secretary shall take
into account inpatient-bed-days that are paid for individuals enrolled
in a Medicaid managed care plan under sections 1903(m) or 1932 of the
Act. We interpret these managed care individuals to be individuals
enrolled in a managed care organization (MCO), prepaid inpatient health
plan (PIHP), or prepaid ambulatory health plan (PAHP) under 42 CFR part
438.
Some Medicaid managed care entities (that is, MCOs, PIHPs, and
PAHPs with risk contracts) provide substitute services (or, ``in-lieu-
of services'') in more cost effective or efficient settings than the
State plan services in the managed care contract. For example, in a
hospital inpatient setting, these services could be in a different
unit, such as a subacute wing or skilled nursing wing, so long as
States and contracting entities are in compliance with the actuarial
soundness rules at 42 CFR 438.6(c), provision of substitute services is
allowed. Although we understand that these substitute service days may
be used to achieve efficiency and cost effectiveness, we do not believe
such substitute service days should count as ``inpatient-bed-days'' in
the hospital EHR incentive payment calculation. The statute requires us
to calculate the Medicaid share ``in the same manner'' as the Medicare
share under section 1886(n)(2)(D) of the Act and such substitute
service days would not be considered ``in the same manner.'' Thus, we
propose that for purposes of the Medicaid formula, we would count only
those days that would count as inpatient-bed-days for Medicare purposes
under section 1886(n)(2)(D) of the Act.
In addition, because the formula for calculating the Medicaid share
requires a determination of charity care charges, States should use the
revised Medicare 2552-10, Worksheet S-10 or another auditable data
source to determine the charity care portion of the formula. In the
absence of sufficient charity care data to complete the calculation,
section 1886(n)(2)(D) of the Act, requires the use of uncompensated
care data to derive an appropriate estimate of charity care, including
a downward adjustment for bad debts. We interpreted bad debt to be
consistent with the Medicare definition of bad debt as promulgated at
42 CFR 413.89(b)(1).
Finally, per section 1886(n)(2)(D) of the Act, to the extent there
is simply not sufficient data that would allow the State to estimate
the inpatient bed-days attributable to Medicaid managed care patients,
the statute directs that such figure is deemed to equal 0. Likewise, if
there is simply not sufficient data for the State to estimate the
percentage of inpatient bed days that are not charity care (that is,
[estimated total charges--charity care charges]/estimated total
charges), the statute directs that such figure is deemed to equal 1.
The aggregate EHR incentive calculation for Medicaid eligible
hospitals is represented mathematically as follows:
(Overall EHR Amount) * (Medicaid Share) or
{Sum over 4 year of [(Base Amount + Discharge Related Amount Applicable
for Each Year) * Transition Factor Applicable for Each Year]{time} *
{(Medicaid inpatient-bed-days + Medicaid managed care inpatient-bed-
days)/[(total inpatient-bed days) * (estimated total charges-charity
care charges)/(estimated total charges)]{time}
To achieve the aggregate EHR hospital incentive amount at
1903(t)(5)(a), the calculation must be aggregated over 4 years. For
further clarification, we have provided a sample calculation of the
aggregate EHR hospital amount.
Assume the following as constant over 4 years except where noted:
20,000 discharges (Note: This calculation assumes the same
averaging data calculated in the average annual growth example above.)
34,000 inpatient Medicaid bed-days (including fee-for-
service and managed care days)
100,000 total inpatient bed-days
$1,000,000,000 in total charges
$200,000,000 in charity care
Overall EHR amount = Sum (Year 1, Year 2, Year 3, Year 4)
= $14,655,050
Year 1: {$2,000,000 + ((20,000 - 1,149) x 200){time} x 1 x 1 =
$5,770,200
Year 2: {$2,000,000 + ((20,454 - 1,149) x 200){time} x 1 x .75 =
$4,395,750
Year 3: {$2,000,000 + ((20,918 - 1,149) x 200){time} x 1 x .50 =
$2,976,900
Year 4: {$2,000,000 + ((21,393 - 1,149) x 200){time} x 1 x .25 =
$1,512,200
Medicaid Share: 34,000/(100,000 x (($1,000,000,000--$200,000,000)/
1,000,000,000) = 0.425
Overall EHR Amount x Medicaid Share = Medicaid aggregate EHR incentive
amount $14,655,050 x 0.425 = $6,228,396
Unlike Medicaid EPs, who must waive rights to duplicative Medicare
incentive payments, hospitals may receive incentive payments from both
Medicare and Medicaid, contingent on successful demonstration of
meaningful use and other requirements under both programs.
[[Page 1939]]
The last year that a hospital may begin receiving Medicaid
incentive payments is FY 2016. States must make payments over a minimum
of 3 years and a maximum of 6 years. Additionally, in any given payment
year, no annual Medicaid incentive payment to a hospital may exceed 50
percent of the hospital's aggregate incentive payment. Likewise, over a
2-year period, no Medicaid payment to a hospital may exceed 90 percent
of the aggregate incentive.
Table 31 demonstrates several scenarios for Medicaid hospitals.
However, there are other scenarios not included here. For example, this
table assumes that a hospital would participate on a consecutive annual
basis until the incentive is exhausted. The purpose of Table 31 is to
illustrate the general timeline for Medicaid hospital incentives.
[GRAPHIC] [TIFF OMITTED] TP13JA10.016
c. Alternative and Optional Early State Implementation to Make
Incentive Payments for Adopting, Implementing, or Upgrading Certified
EHR Technology
Unlike Medicare, Medicaid has no statutory implementation date for
making EHR incentive payments. We believe that some States may be
prepared to implement their program and make EHR incentive payments to
Medicaid providers in 2010 for adopting, implementing, or upgrading
certified EHR technology. We propose to allow States to initiate
implementation of these payments to Medicaid EPs and hospitals after
promulgation of the final rule if they successfully demonstrate to CMS
that they are ready to make timely and accurate payments through the
SMHP. States should include an additional attestation for providers
assuring that they are not accepting payment in any other State.
In order for us to approve a State for early implementation, we are
proposing that a State would have an electronic system for provider
registration capable of collecting the relevant information identified
in section II.A.5.c of this proposed rule, where we describe the data
collection requirements. This includes the following:
Name, National Provider Identifier (NPI), business address
and business phone of each EP or eligible hospital;
Taxpayer Identification Number to which the EP or eligible
hospital wants the incentive payment made;
For eligible hospitals, their CMS Certification Number
(CCN);
The remittance date and amount of any incentive payments
made to an EP or eligible hospital.
Participating States would be responsible for transmitting this
data to CMS so that CMS can ensure that no duplicate payments will be
made to providers. We would use the single provider election repository
described in section II.A.5.c. of this proposed rule to assure no
duplicative payments were made between States.
We are not proposing that States would be able to make early
payments to meaningful users. This opportunity is intended to offer
Medicaid providers an early opportunity for capital so that they are
more likely to have the certified EHR
[[Page 1940]]
technology required to demonstrate meaningful use in successive
periods. Since hospitals may qualify under both programs, we hope that
they will use the capital and qualify as a meaningful user under the
Medicare program in the first year. We are requesting comments on this
proposed approach.
d. Process for Making and Receiving Medicaid Incentive Payments
The process for making payments involves coordination between
Medicare and State Medicaid agencies to avoid duplication of payments,
prevent fraud and abuse, and create program efficiencies to encourage
adoption. While we have responsibility regarding payments to Medicare
EPs and hospitals, State Medicaid agencies (or their contractors) are
fully responsible for administering and disbursing the incentive
payments to Medicaid providers.
We will require that EPs make a selection between receiving
incentive payments through either the Medicare or Medicaid EHR
incentive programs. Medicaid EPs who practice in multiple states will
be required to choose only one state from which to receive Medicaid
incentive payments. The issues related to these decisions are discussed
here, as well as in section II.A of this proposed rule.
In this section, we describe the steps Medicaid EPs will take to
receive an incentive payment. Due to the inter-dependencies of multiple
issues, we refer the reader to other sections of this proposed rule.
Specifically, section II.A of this proposed rule solicits comments for
a proposed reporting period in the first payment year of any continuous
90-day period that starts and ends within the calendar year. In
addition, such 90-day period would apply in both the first and second
payments years (that is, 2010 and 2011) for States approved for early
implementation in 2010. Section II.A. also solicits comments on full
annual reporting periods for all payment years other than the first
payment year (except in the case of States approved for 2010
implementation, for which the full annual reporting period would begin
in the third year). We also discuss the proposed single provider
election repository and other issues impacting both programs.
It is important to note that there is a very clear intent in the
statute that there is coordination between the EHR incentive programs
to reduce or eliminate duplicate payments between Medicare and
Medicaid. Additionally, Medicare requirements under section
1848(o)(1)(B) of the Act require that payments begin no earlier than
2011. While the Medicaid provisions have no statutory start date,
before States may begin implementing the Medicaid EHR incentives, CMS,
and ONC need to provide guidance to States in the form of rulemaking
and other policy guidance. To that end, Medicaid will not begin to
provide 100 percent FFP for incentive payments any earlier than FY 2011
for hospitals and CY 2011 for EPs, (except in the case of incentive
payments for adopting, implementing, or upgrading, which could begin in
2010. See discussion in section II.D.4.b.(5).(c). of this proposed
rule. This also gives CMS, ONC, and States an opportunity to coordinate
between Medicare and Medicaid, which we hope will simplify
administrative complexity in the EHR incentive program and facilitate
provider adoption.
We believe that by aligning the EHR incentive programs where
possible, Medicaid EHR incentive program administration could be more
efficient for the States, and provider communication about the program
could be less ambiguous. This will be of particular benefit to the
providers who serve both Medicare and Medicaid program beneficiaries,
and will be eligible for participation in both incentive programs.
Also, we believe that the incidence of fraud and abuse could be
curtailed, and the potential for duplication of payments could be
decreased.
Under this proposed rule we are proposing that Medicaid EPs, as
discussed in section II.D.5 and II.A.5.c of this proposed rule, will
enroll in the program through the single provider election repository.
Once an EP selects the Medicaid EHR incentive program, we propose that
States must have a system for reporting and tracking necessary
information to qualify an EP for an incentive payment. In addition, as
detailed in Sec. 495.316 States will be required to submit data to CMS
including data for the number, type and practice location(s) of
providers who qualified for an incentive payment on the basis of having
adopted, implemented, or upgraded certified EHR technology or who
qualified for an incentive payment on the basis of having meaningfully
used such technology as well as aggregate de-identified data on
meaningful use. States' systems and processes will be submitted by the
States to CMS for prior approval, concurrent with the requirements
described in section II.D.8 of this proposed rule for review and
approval of the SMHP.
The specific timeframes for EPs and eligible hospitals to report
and submit the required information in order to demonstrate they have
adopted, implemented, or upgraded certified EHR technology, as well as
meaningful use of such EHR technology are proposed for comment at
section II.A.1.e of this preamble. As discussed in that section of this
proposed rule, for the first payment year (as well as the second
payment year for those hospitals that are able to begin receiving
payments for FY 2010), the reporting periods for eligible hospitals
will be on a continuous 90-day basis, in the sense that as long as the
start and end dates occur within the payment year and as long as the
period spans the proposed 90-day consecutive period, the period can
begin at any time during the payment year. States will then be expected
to process payments, also on a rolling basis. In the subsequent payment
years, the reporting period will be a full annual period (that is, a
full payment period).
e. Avoiding Duplicate Payment
At section 1903(t)(7) of the Act, the statute requires that the
Medicare and Medicaid programs coordinate payments to avoid
duplication. This section further specifies that CMS and the States
should coordinate payments through a data matching process, utilizing
NPIs to the extent practicable. Additionally, section 1903(t)(2) of the
Act states that Medicaid EPs must waive rights to Medicare incentive
payments under sections 1848(o) and 1853(l) of the Act. As previously
noted, hospitals may qualify for incentives under both programs. We
also propose requirements under the review and approval of SMHPs in
proposed part 495 subpart D for States to verify that providers meet
these requirements.
As discussed in section II.A of this proposed rule, we considered
what information will be necessary to eliminate duplicative incentive
payments to providers between the Medicare and Medicaid programs. In
order to ensure against duplicate incentive payments, we believe three
conditions are required: (1) Knowing which EHR incentive program a
provider has selected, (2) uniquely identifying each provider
participating in each incentive program; and (3) ensuring that each
State has access to the information on which EPs or hospitals intend to
receive incentive payments from another State, or from the Medicare
program.
To achieve all three of these conditions, as discussed in section
II.A.5.c of this proposed rule, we propose to collect this data in a
single provider election repository. Next, in administering each State
Medicaid EHR incentive program, we propose that
[[Page 1941]]
States would cross-check for potential duplicative payments through the
data available to them through the single provider election repository,
which is based on the NPIs. We believe that this coordinates with our
proposed requirements that a State must have an approved SMHP which
will include a mechanism for cross-checking this information prior to
payment.
f. Flexibility To Alternate Between Medicare and Medicaid EHR Incentive
Programs One Time
We refer readers to section II.A.5.b of this proposed rule, where
we discuss our proposal to allow Medicare and Medicaid EPs to make one
EHR incentive program election change prior to 2015, and not to permit
any switching after the year 2014. Under such a proposal, even if an EP
initially received incentive payments under the Medicare program, such
an EP could still switch to the Medicaid program one time prior to
2015. Similarly, an EP who initially selected the Medicaid EHR
incentive program could switch to the Medicare program one time prior
to 2015.
g. One State Selection
We propose that for EPs and hospitals with multi-state Medicaid
practice locations, that the provider may annually pick only one State
from which to receive incentive payments. In other words, a provider
would not be able to receive incentive payments from more than one
State in the same year. For example, a provider may be licensed to
practice in Illinois as well as in Iowa, particularly in the area known
as the Quad Cities because of the multiple cities in proximity to the
Illinois and Iowa borders. There are numerous situations like this
throughout the country for States sharing borders. Medicaid EPs and
hospitals may change the State that they select annually when they re-
attest to the program requirements.
Since qualifying for the Medicaid incentive payments is not a
claims accrual process, as it is in Medicare, allowing providers to
include multiple practice sites across State boundaries would create
enormous administrative complexity for both CMS and State Medicaid
agencies. For example, States would have to collect and verify Medicaid
patient volume across more than one State, then divide and administer
payments based on a methodology suitable between the State Medicaid
agencies and the providers. Given that the providers qualifying for the
Medicaid incentive program will receive the same incentive payment
dollar amount regardless of whether payments are made by one, or more
than one, State, we believe it would not be worth the resulting
administrative complexity to allow payments from multiple States.
We considered the possible impact of this proposed approach with
respect to patient volume calculations on Medicaid EPs and hospitals in
border State areas. While we addressed the administrative complexity of
this issue here, we recommend that States consider these border State
providers when developing their policies and attestation methodology.
We afforded additional flexibility in the patient volume at proposed
Sec. 495.306 to account for unique circumstances and data collection.
5. Single Provider Election Repository and State Data Collection
We refer readers to section II.A.5.c of this proposed rule for a
discussion of the single provider election repository. As discussed in
that section, the repository will collect a minimum amount of
information on all EPs and hospitals to prevent duplicative payments
and coordinate technical assistance.
6. Collection of Information Related to the Eligible Professional's
National Provider Identifier and the Tax Identification Number
Similar to the policy proposed where Medicaid EPs and hospitals
must select one State, for those EPs in multiple group practices or
multiple types of practice locations, we propose to require such
professionals to select one TIN for Medicaid EHR payment disbursement.
In other words, such EPs could not require a State to divide payments
among different practices or practice locations based upon group TINs.
Requiring EPs to use only one TIN would reduce administrative
complexity, as it would ensure that States are not put in the position
of dividing payments in any way an EP requests (such as by patient
encounters or amount contributed to EHR technology). We also believe
that requiring reimbursement to be made to one TIN would reduce
opportunities for fraud or abuse, as States will be able to cross-check
EP and TIN combinations more easily to verify EP attestations.
Although the State would not divide payments among the various TINs
of an individual EP, Medicaid EPs could decide to divide payment
themselves, and distribute funds among their respective group practices
or practice locations after the initial disbursement from the State to
their designated TIN.
7. Activities Required To Receive Incentive Payments
a. General Overview.
As previously discussed, for Medicaid providers (including both EPs
and eligible hospitals) to qualify to receive a first year Medicaid
incentive payment, section 1903(t)(6)(C)(i) of the Act indicates that
the provider must demonstrate that they are ``engaged in efforts to
adopt, implement, or upgrade certified EHR technology.'' For providers
who meet this standard in their first year of participation in the
Medicaid incentive program, in subsequent years of participation, they
must then demonstrate ``meaningful use of certified EHR technology
through a means that is approved by the State and acceptable to the
Secretary,'' and that may be based upon the methods employed under the
Medicare incentive payments to physicians and hospitals, per sections
1848(o) or 1886(n) of the Act.
b. Definitions Related to Certified EHR Technology and
Adopting, Implementing or Upgrading Such Technology.
(1) Certified EHR Technology
As noted previously, in order to receive a Medicaid incentive
payment the EHR technology must be ``certified.'' Section 1903(t)(3) of
the Act defines ``certified EHR technology'' as a qualified electronic
health record (as defined in section 3000(13) of the PHS Act) that is
certified pursuant to section 3001(c)(5) of the PHS Act as meeting
standards adopted under section 3004 of the PHS Act that are applicable
to the type of record involved (as determined by the Secretary), such
as an ambulatory electronic health record for office-based physicians
or an inpatient hospital electronic health record for hospitals). In
section I.A of this proposed rule, for both Medicare and Medicaid, we
discussed incorporating ONC's definition of certified EHR technology.
(2) Adopting, Implementing or Upgrading
Unlike the Medicare incentive programs, the Medicaid program allows
eligible providers to receive an incentive payment even before they
have begun to meaningfully use certified EHR technology. These
providers may receive a first year of payment if they are engaged in
efforts to ``adopt, implement, or upgrade'' to certified EHR
technology. In proposed Sec. 495.302, we define adopting, implementing
or upgrading certified EHR technology as the process by which providers
have installed and commenced utilization of certified EHR
[[Page 1942]]
technology capable of meeting meaningful use requirements; or expanded
the available functionality and commenced utilization of certified EHR
technology capable of meeting meaningful use requirements at the
practice site, including staffing, maintenance, and training.
For the purposes of demonstrating that providers adopted,
implemented, or upgraded certified EHR technology, Medicaid EPs and
hospitals would have to attest to having adopted, (that is, acquired
and installed) or commenced utilization of (that is, implemented)
certified EHR technology; or expanded (that is, upgraded) the available
functionality of certified EHR technology and commenced utilization at
their practice site. States would be responsible for ensuring that
processes are in place to verify that providers have actually adopted,
implemented or upgraded certified EHR technology, patient volume, as
well as other requirements in this section, including verifying that
attestations are consistent with methodologies to combat fraud and
abuse (see proposed Sec. 495.366 through 370, Financial Oversight,
Program Integrity, and Provider Appeals). The State's SMHP must detail
these processes.
The CMS Medicaid Transformation Grants have demonstrated the many
challenges that exist to adopting EHR technology. EHR system
availability is not the same as EHR system utilization. It is for that
reason that we propose to include staff training and efforts to
redesign provider workflow under the definition of implementing
certified EHR technology. Success is not simply defined by the
acquisition and installation of new or upgraded certified EHR
technology, but more importantly by providers demonstrating progress
towards the integration of EHRs into their routine health care
practices to improve patient safety, care, and outcomes.
In establishing criteria for the ``adoption'' portion of the
``adopt, implement, or upgrade'' requirement, we propose that there be
evidence that a provider demonstrate actual installation prior to the
incentive, rather than ``efforts'' to install. This evidence will serve
to differentiate between activities that may not result in installation
(for example, researching EHRs or interviewing EHR vendors) and actual
purchase/acquisition or installation. It is the States' responsibility
to verify this evidence of EHR adoption. As these Medicaid incentive
payments are intended to stimulate meaningful use of EHR technology,
they need to result in tangible adoption, implementation, or upgrading
of certified EHR technology.
In establishing criteria for the ``implementation'' portion of
``adopt, implement or upgrade'' requirement, we are proposing that
``implementation'' mean that the provider has installed certified EHR
technology and has started using the certified EHR technology in his or
her clinical practice. Implementation activities would include staff
training in the certified EHR technology, the data entry of their
patients' demographic and administrative data into the EHR, or
establishing data exchange agreements and relationships between the
provider's certified EHR technology and other providers, such as
laboratories, pharmacies, or HIEs.
In establishing the criteria for the ``upgrade'' portion of
``adopt, implement or upgrade'' requirement, we propose ``upgrade'' to
mean the expansion of the functionality of the certified EHR
technology, such as the addition of clinical decision support, e-
prescribing functionality, CPOE or other enhancements that facilitate
the meaningful use of certified EHR technology. States must describe
the process that would be in place in the SMHP for ensuring that
providers have actually adopted, upgraded or implemented certified EHR
technology. We encourage States to consider the submission of a vendor
contract from providers to ensure the existence of EHR technology.
In listening sessions with State Medicaid Agencies' staff and
Governors' offices staffs, States suggested verifying providers'
adoption, implementation, or upgrading of certified EHR technology
through system enhancements that track and audit providers' written or
electronic attestations, through surveys, or through new claims codes
that would serve as attestations. Additional suggestions from State
staff included using EHR vendor audit logs for Medicaid EPs rendering
service through the FQHCs and tracking EHR reporting of the Health
Resources and Services Administration (HRSA)-mandated quality
indicators. More information on feedback received as a result of these
listening sessions can be found in section II.A. of this proposed rule.
These suggestions may be relevant to the discussion below concerning
the States process for developing a SMHP, verifying attestations and
ensuring that providers are eligible to participate in the incentive
payments program.
c. Other General Terminology
``EHR reporting period'' and ``payment period'' relate to the
requirements for Medicaid EPs participating in the Medicaid EHR
incentive program. As discussed previously, the reporting period is
significant for EPs and eligible hospitals because it will define the
period during which the provider must establish efforts to adopt,
implement, or upgrade certified EHR technology, or demonstrate
meaningful use of, such technology. The reporting period also is
significant for States, because States will refer to such reporting
periods in assuring us that providers are eligible to participate in
the Medicaid EHR incentive program. (Requirements relating to the
components that must be included in the SMHP are specified in proposed
Sec. 495.354). States will need to refer to the providers' reports of
the activities that establish their efforts to adopt, implement, or
upgrade certified EHR technology. Similarly, once meaningful use of EHR
technology is required to include the reporting of clinical quality
measures, States will need to ensure such measures are reported in
accordance with the appropriate period. States could not appropriately
make incentive payments in the absence of such reporting.
As discussed in section II.A of this proposed rule and elsewhere in
this section, we propose that the EHR reporting period would occur on a
rolling basis during the first payment year (and also in 2010 for
States approved for early implementation). For subsequent payment
years, the EHR reporting period will be on an annual basis (that is,
for the entire payment year).
States would be required to validate to us that the Medicaid EPs
and hospitals meet all of the eligibility criteria to qualify for
Medicaid incentive payments, including the applicable patient volume
thresholds, hospital-based requirements, and all of the requirements
described in this section. States would develop their own
administration, payment and audit processes, and as described in Sec.
495.332, we would require that States include in their SMHPs how they
would obtain Medicaid EPs' and hospitals' attestations of eligibility
to qualify for the Medicaid incentive payments. Permissible means for
ensuring patient volume and all of the requirements described in this
section include survey, attestation, or the creation of special codes
on claims, subject to our prior approval.
Additionally, we may require a more robust method for ensuring
compliance with the requirements listed in this section beyond
attestation as this program matures. Therefore, we are soliciting
comments, including the
[[Page 1943]]
impact that an alternative method may have on providers and States if
an alternative method that is not attestation is required.
Section 1903(t)(6)(C)(ii) of the Act also indicates that in the
case of an early adopter, that is, a Medicaid EP or eligible hospital
that has already adopted certified EHR technology, such provider would
receive payment in the first year and all subsequent years of the
incentive program by demonstrating meaningful use. In other words, such
a provider would not need to demonstrate that it has adopted,
implemented, or upgraded certified EHR technology in year one of the
program, if they can already demonstrate meaningful use of such
technology. In the case of Medicaid EPs, we discuss our proposal
approach to paying early adopters in section II.D.4.5.
It is expected that the bar for demonstrating meaningful use of
certified EHR technology will rise in years to come, as discussed in
section II.A. States have offered their suggestions to us as to how
they would verify providers' meaningful use of certified EHR
technology, including participation in the exchange of clinical and
administrative data; National Committee for Quality Assurance (NCQA)
certification as an advanced medical home (which includes an EHR
requirement); e-prescribing, and conducting security and privacy
audits. Many of these elements are discussed in the definition of
``meaningful use'' noted in section II.A.2. of this proposed rule. For
purposes of participation in the Medicaid EHR incentive program, the
specific definition of ``meaningful use'' in section II.A.2. of this
proposed rule is what providers must demonstrate to the States, and
what States must track and validate. States wishing to ask providers to
demonstrate additional objectives to the definition of ``meaningful
use'' as noted in this proposed rule would need to request our prior
approval of such a revised definition in their SMHP, as described in
section II.D.8 of this proposed rule.
We do not wish to see the bar for demonstration of meaningful use
set so high, especially in the early years of this program that, it
becomes a deterrent for broad provider participation. Examples of how
States may consider adding to the Federal definition of meaningful use
include requiring providers to participate in a health information
exchange, and requiring that providers link to immunization, lead
screening, or newborn screening registries. These mechanisms must be
readily available to providers, and not represent a financial burden
for participation. For example, States are discouraged from proposing
additional meaningful use measures that would require providers to
assume additional financial costs in order to qualify to participate in
the Medicaid EHR incentive program.
States should carefully consider how to build upon their existing
EHR activities and infrastructure without deterring eligible Medicaid
providers from participating by compelling them to use a particular
system. We encourage States that were awarded Federal HIT/EHR grants,
such as the Medicaid Transformation Grants, to work to connect the
tools and infrastructure developed under their Federal grant funds with
providers' efforts to adopt, implement, and upgrade certified EHR
technology and to become meaningful users of certified EHR technology.
We would be evaluating States' HIT Planning Advanced Planning Documents
(PAPDs) and SMHP with this objective in mind, as described section
II.D.8 of this proposed rule.
The requirements to which States would hold eligible Medicaid
providers accountable would vary based upon the number of years an
eligible Medicaid provider participates in the program. In other words,
regardless of the calendar year, a provider's first year as a
participant in the Medicaid EHR incentive program is when that provider
must demonstrate either adoption, implementation, upgrading or
meaningful use of certified EHR technology. States' systems must be
able to track providers' year of entry into the Medicaid EHR incentive
program to determine the correct eligibility criteria and generate the
appropriate Medicaid incentive payments.
In Table 32, we depict the requirements for eligible Medicaid
professionals and hospitals that either adopt, implement, or upgrade
certified EHR technology or that move directly to meaningful use of
such technology. Additionally, we refer readers to Table 1 since the
table references the stages of meaningful use. Readers may find this
information helpful when considering the information in Table 32.
[[Page 1944]]
[GRAPHIC] [TIFF OMITTED] TP13JA10.017
As previously noted, States would be required to verify providers'
meaningful use of certified EHR technology. We also expect to test the
reporting of additional clinical quality measures that may be used in
future definitions of meaningful use. States may wish to participate in
this testing and seek out eligible Medicaid providers to report on
specific clinical quality measures, extractable from EHRs. States would
be able to use this reporting to pilot-test requirements that could be
included in future definitions of meaningful use.
Once States are giving providers the Medicaid HIT incentive
payments for being meaningful users of EHRs, and starting in 2012 are
collecting those providers' clinical quality measures data, States will
be required to share any such reported data with CMS in an aggregated,
de-identified manner, on an annual basis. The timetable and format for
sharing the clinical quality measurement data would be provided to
States in future policy guidance issued by CMS. States' failure to
submit these required reports to us could result in discontinued
funding or disallowances. See the discussion below regarding the SMHP
and the State reporting requirements. We would use the States' reports,
including data on meaningful use and clinical quality measures, in
order for the Secretary to fulfill her responsibilities to Congress
under section 1903(t)(10) of the Act. This provision requires that the
Secretary report to Congress on the improvement of health outcomes,
clinical quality, or efficiency as a result of implementing this
program. For hospitals eligible for both Medicare and Medicaid EHR
incentive programs, where hospitals are reporting meaningful use
measures to CMS, we will make quality data on Medicaid eligible
hospitals available to States.
d. Quality Measures
We refer readers to section II.A.3 of this proposed rule for a
discussion of the clinical quality measure reporting required for
demonstrating meaningful use of certified EHR technology. As discussed
in that section we have proposed in II.A.3 of this proposed rule,
additional clinical quality measures that could be used by Medicaid
providers to meet the quality reporting aspect of meaningful use. These
additional indicators address key Medicaid services, such as
pediatrics, obstetrical/gynecologic, mental health and substance abuse
services. Medicaid providers could report on these clinical quality
indicators in lieu of the quality indicators that are listed in Table
3. We recognize that quality measures associated with the Stage 1
definition of meaningful use contain certain gaps for Medicaid
providers, including in the areas of oral health, long-term care,
newborn screening, and other areas of pediatric care. As discussed
previously, we intend to update our definition of meaningful use
biannually, and we expect that our updated, Stage 2 definition would
include additional Medicaid clinical quality measures to be reported
from EHRs. We intend to work with the quality measurement community to
develop these Stage 2
[[Page 1945]]
quality measures (see section II.B.1.d. of this proposed rule).
8. Overview of Conditions for States To Receive Federal Financial
Participation (FFP) for Incentive Payments and Implementation Funding
Section 1903(a)(3)(F) of the Act provides that States are eligible
for 100 percent FFP for direct payment expenditures to certain Medicaid
EPs and eligible hospitals to encourage the adoption and use of
certified EHR technology. States are also eligible for 90 percent FFP
for reasonable administrative expenses, contingent on State compliance
with the following requirements: (1) Using the funds to administer
Medicaid incentive payments for certified EHR technology, including
tracking of meaningful use by Medicaid EPs and eligible hospitals; (2)
conducting oversight of the Medicaid EHR incentive program, including
routine tracking of meaningful use attestations and reporting
mechanisms; and (3) pursuing initiatives to encourage the adoption of
certified EHR technology for the promotion of health care quality and
the exchange of health care information.
This section of the proposed rule discusses the requirements for
States to request FFP from CMS for the Medicaid EHR incentive program.
Additionally, this section is closely connected to the requirements
outlined in Financial Oversight, Program Integrity and Providers
Appeals for purposes of oversight and accountability.
In proposed Sec. 495.302, we define terms used in the Medicaid
subpart of the regulations governing State requests for FFP. Although
some of these terms have been defined in other portions of our
regulations, for ease of reference, and in order to define the terms in
this specific context, we have separately included definitions in part
495. Other terms such as ``HIT PAPD,'' ``IAPD,'' ``SMHP'' are new terms
which would be used in approving State plans for FFP.
Acceptance Documents: The term ``acceptance document''
refers to written evidence of satisfactory completion of an approved
phase or work or contract related to information technology projects
for which approved Federal funding is utilized. The term is commonly
used in information technology projects and is defined in this proposed
rule to ensure that we are able to receive information from the State
necessary to evaluate and monitor the progress of HIT projects
requested or approved under this proposed rule.
Acquisition: The term ``acquisition'' is defined in this
proposed rule to indicate a State's intent to acquire health
information technology equipment or services for the purpose of
implementation and administration of the provisions under this proposed
rule from commercial sources or from State or local government
resources. We define and utilize this term in the context of HIT
planning and implementation activities that will enable States to
implement existing Federal requirements for competitive procurement of
equipment or services.
Service Oriented Architecture: The term ``service oriented
architecture'' is defined in this proposed rule as a means of
organizing and developing information technology capabilities as
collaborating services that interact with each other based on open
standards. We are defining this term in the context of HIT projects
authorized under the HITECH Act to ensure that different systems and
programming languages provide the basis for interoperability among and
between applications that may reside on different platforms through a
communication protocol to achieve health information exchange required
under ARRA.
State Self-Assessment: The term ``State self assessment''
uses a standard methodology and tools to document the way a State
conducts business now and plans to conduct business in the future.
Medicaid information technology architecture (MITA) is
both an initiative and a framework. It is a national framework to
support improved systems development and health care management for the
Medicaid enterprise. It is an initiative to establish national
guidelines for technologies and processes that enable improved program
administration for the Medicaid enterprise. The MITA initiative
includes an architecture framework, models, processes, and planning
guidelines for enabling State Medicaid enterprises to meet common
objectives with the framework while supporting unique local needs.
Medicaid management information system (MMIS) means a
mechanized claims processing and information retrieval system--referred
to as Medicaid Management Information Systems (MMIS)--that meets
specified requirements and that the Department has found (among other
things) is compatible with the claims processing and information
retrieval systems used in the administration of the Medicare program.
The objectives of the MMIS are to include claims processing and
retrieval of utilization and management information necessary for
program administration and audit and must coordinate with other
mechanized systems and subsystems that perform other functions, such as
eligibility determination.
We are defining the ``Medicaid Management Information System'' as
it relates to the mechanized claims processing systems at 42 CFR 433,
Subpart C, since this term has not previously been codified in
regulations and we are requiring that in implementing this program
under the authority of section 1903(t)(6)(D) of the Act, certified EHR
technology must be compatible with the MMIS. Additionally, we expect
States would align their Medicaid EHR initiatives with those envisioned
under MITA, in order to fully support the meaningful use of EHR
envisioned under this new program. As part of their SMHP, States will
be required to map different IT solutions to their existing Medicaid
enterprise business requirements using the MITA business areas and
processes list when preparing a baseline State self-assessment. Using
the MITA State self-assessment provides a baseline that will facilitate
collaboration between the States and CMS, between the State and
industry and among the States themselves. The MITA ``State self-
assessment'' process uses a standard methodology and tools to document
the way a State conducts business now, and plans to conduct business in
the future. The purpose of the SMHP is to identify the ``As Is'' state
and ``To Be'' (target) state of a State's Medicaid business enterprise
and to align business areas and processes in the user community. Once
this alignment is complete, States may then add other Medicaid business
processes by extending the MITA model during implementation to
ultimately facilitate the EHR program. The State self-assessment would
help to identify duplicative and overlapping business areas and
processes and to identify gaps by adopting new business areas and
processes needed to complete the EHR enterprise. Using an incremental
approach and setting achievable goals for the near and mid term, would
help the State assess its progress and identify targets of opportunity
critical to achieving the long-term ``To Be'' vision for HIT by 2014.
Further, the Medicaid enterprise is comprised of internal and
external communities of common business areas that share an interest in
seeing that the mission and goals of the Medicaid program and improved
health outcomes are achieved. These communities include the EPs and
hospitals that would be receiving incentive payments. MITA's principles
and tools fosters nationally integrated business and IT transformation.
It does this by demonstrating that planned
[[Page 1946]]
enhancements support State and Medicaid strategic goals and how intra-
state systems other than the MMIS have been considered in developing
the solutions. By documenting the analysis of alternative solutions,
particularly a review of solutions in other States or a description of
data sharing components and the reasons to include them or exclude them
at this time can then be considered in its solution.
As such, the MITA process establishes the guidelines necessary for
EHRs implemented as a result of the Medicaid EHR incentive program to
be interoperable with State Medicaid systems, and we believe that as
States and providers implement EHRs, it is essential to plan technology
upgrades that would facilitate health information exchange with
Medicaid providers receiving incentive funding.