[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Proposed Rules]
[Pages 13698-13829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4443]
[[Page 13697]]
Vol. 77
Wednesday,
No. 45
March 7, 2012
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 412, 413, and 495
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program--Stage 2; Proposed Rule
Federal Register / Vol. 77 , No. 45 / Wednesday, March 7, 2012 /
Proposed Rules
[[Page 13698]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 413, and 495
[CMS-0044-P]
RIN 0938-AQ84
Medicare and Medicaid Programs; Electronic Health Record
Incentive Program--Stage 2
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would specify the Stage 2 criteria that
eligible professionals (EPs), eligible hospitals, and critical access
hospitals (CAHs) must meet in order to qualify for Medicare and/or
Medicaid electronic health record (EHR) incentive payments. In
addition, it would specify payment adjustments under Medicare for
covered professional services and hospital services provided by EPs,
eligible hospitals, and CAHs failing to demonstrate meaningful use of
certified EHR technology and other program participation requirements.
This proposed rule would also revise certain Stage 1 criteria, as well
as criteria that apply regardless of Stage, as finalized in the final
rule titled Medicare and Medicaid Programs; Electronic Health Record
Incentive Program published on July 28, 2010 in the Federal Register.
The provisions included in the Medicaid section of this proposed rule
(which relate to calculations of patient volume and hospital
eligibility) would take effect shortly after finalization of this rule,
not subject to the proposed 1 year delay for Stage 2 of meaningful use
of certified EHR technology. Changes to Stage 1 of meaningful use would
take effect for 2013, but most would be optional until 2014.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 7, 2012.
ADDRESSES: In commenting, please refer to file code CMS-0044-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 ``Submit a
comment'' instructions.
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-0044-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-0044-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
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,
call telephone number (410) 786-1066 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Elizabeth Holland, (410) 786-1309, or
Robert Anthony, (410) 786-6183, EHR Incentive Program issues. Jessica
Kahn, (410) 786-9361, for Medicaid Incentive Program issues. James
Slade, (410) 786-1073, or Matthew Guerand, (410) 786-1450, for Medicare
Advantage issues. Travis Broome, (214) 767-4450, Medicare payment
adjustment issues. Douglas Brown, (410) 786-0028, or Maria Durham,
(410) 786-6978, for Clinical quality measures issues. Lawrence Clark,
(410) 786-5081, for Administrative appeals process issues.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Acronyms
ARRA--American Recovery and Reinvestment Act of 2009
AAC--Average Allowable Cost (of certified EHR technology)
AIU--Adopt, Implement, Upgrade (certified EHR technology)
CAH--Critical Access Hospital
CAHPS--Consumer Assessment of Healthcare Providers and Systems
CCN--CMS Certification Number
CFR--Code of Federal Regulations
CHIP--Children's Health Insurance Program
CHIPRA--Children's Health Insurance Program Reauthorization Act of
2009
CMS--Centers for Medicare & Medicaid Services
CPOE--Computerized Physician Order Entry
CY--Calendar Year
EHR--Electronic Health Record
EP--Eligible Professional
EPO--Exclusive Provider Organization
FACA--Federal Advisory Committee Act
FFP--Federal Financial Participation
FFY--Federal Fiscal Year
FFS--Fee-For-Service
FQHC--Federally Qualified Health Center
FTE--Full-Time Equivalent
FY--Fiscal Year
HEDIS--Healthcare Effectiveness Data and Information Set
HHS--Department of Health and Human Services
HIE--Health Information Exchange
HIT--Health Information Technology
HITPC--Health Information Technology Policy Committee
HIPAA--Health Insurance Portability and Accountability Act of 1996
[[Page 13699]]
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 and Services Administration
IAPD--Implementation Advance Planning Document
ICR--Information Collection Requirement
IHS--Indian Health Service
IPA--Independent Practice Association
IT--Information Technology
MA--Medicare Advantage
MAC--Medicare Administrative Contractor
MAO--Medicare Advantage Organization
MCO--Managed Care Organization
MITA--Medicaid Information Technology Architecture
MMIS--Medicaid Management Information Systems
MSA--Medical Savings Account
NAAC--Net Average Allowable Cost (of certified EHR technology)
NCQA--National Committee for Quality Assurance
NCVHS--National Committee on Vital and Health Statistics
NPI--National Provider Identifier
NPRM--Notice of Proposed Rulemaking
ONC--Office of the National Coordinator for Health Information
Technology
PAHP--Prepaid Ambulatory Health Plan
PAPD--Planning Advance Planning Document
PFFS--Private Fee-For-Service
PHO--Physician Hospital Organization
PHS--Public Health Service
PHSA--Public Health Service Act
PIHP--Prepaid Inpatient Health Plan
POS--Place of Service
PPO--Preferred Provider Organization
PQRI--Physician Quality Reporting Initiative
PSO--Provider Sponsored Organization
RHC--Rural Health Clinic
RPPO--Regional Preferred Provider Organization
SAMHSA--Substance Abuse and Mental Health Services Administration
SMHP--State Medicaid Health Information Technology Plan
TIN--Tax Identification Number
Table of Contents
I. Executive Summary and Overview
A. Executive Summary
1. Purpose of Regulatory Action
a. Need for the Regulatory Action
b. Legal Authority for the Regulatory Action
2. Summary of Major Provisions
a. Stage 2 Meaningful Use Objectives and Measures
b. Reporting on Clinical Quality Measures (CQMs)
c. Payment Adjustments and Exceptions
d. Modifications to Medicaid EHR Incentive Program
e. Stage 2 Timeline Delay
3. Costs and Benefits
B. Overview of the HITECH Programs Created by the American
Recovery and Reinvestment Act of 2009
II. Provisions of the Proposed Regulations
A. Definitions Across the Medicare FFS, Medicare Advantage, and
Medicaid Programs
1. Uniform Definitions
2. Meaningful EHR User
3. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
b. Changes to Stage 1 Criteria for Meaningful Use
c. State Flexibility for Stage 2 of Meaningful Use
d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
B. Reporting on Clinical Quality Measures Using Certified EHRs
Technology by Eligible Professionals, Eligible Hospitals, and
Critical Access Hospitals
1. Time Periods for Reporting Clinical Quality Measures
2. Certification Requirements for Clinical Quality Measures
3. Criteria for Selecting Clinical Quality Measures
4. Proposed Clinical Quality Measures for Eligible Professionals
a. Statutory and Other Considerations
b. Clinical Quality Measures Proposed for Eligible Professionals
for CY 2013
c. Clinical Quality Measures Proposed for Eligible Professionals
Beginning With CY 2014
5. Proposed Reporting Methods for Clinical Quality Measures for
Eligible Professionals
a. Reporting Methods for Medicaid EPs
b. Reporting Methods for Medicare EPs in CY 2013
c. Reporting Methods for Medicare EPs Beginning With CY 2014
d. Group Reporting Option for Medicare and Medicaid Eligible
Professionals Beginning With CY 2014
6. Proposed Clinical Quality Measures for Eligible Hospitals and
Critical Access Hospitals
a. Statutory and Other Considerations
b. Clinical Quality Measures Proposed for Eligible Hospitals and
CAHs for FY 2013
7. Proposed Reporting Methods for Eligible Hospitals and
Critical Access Hospitals
a. Reporting Methods in FY 2013
b. Reporting Methods Beginning With FY 2014
c. Electronic Reporting of Clinical Quality Measures for
Medicaid Eligible Hospitals
C. Demonstration of Meaningful Use and Other Issues
1. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
b. Methods for Demonstration of the Stage 2 Criteria of
Meaningful Use
c. Group Reporting Option of Meaningful Use Core and Menu
Objectives and Associated Measures for Medicare and Medicaid EPs
Beginning With CY 2014
2. Data Collection for Online Posting, Program Coordination, and
Accurate Payments
3. Hospital-Based Eligible Professionals
4. Interaction With Other Programs
D. Medicare Fee-for-Service
1. General Background and Statutory Basis
2. Payment Adjustment Effective in CY 2015 and Subsequent Years
for EPs Who Are Not Meaningful Users of Certified EHR Technology
a. Applicable Payment Adjustments for EPs Who Are Not Meaningful
Users of Certified EHR Technology in CY 2015 and Subsequent Calendar
Years
b. EHR Reporting Period for Determining Whether an EP Is Subject
to the Payment Adjustment for CY 2015 and Subsequent Calendar Years
c. Exception to the Application of the Payment Adjustment to EPs
in CY 2015 and Subsequent Calendar Years
d. Payment Adjustment Not Applicable to Hospital-Based EPs
3. Incentive Market Basket Adjustment Effective In FY 2015 and
Subsequent Years for Eligible Hospitals Who Are Not Meaningful EHR
Users
a. Applicable Market Basket Adjustment for Eligible Hospitals
Who Are Not Meaningful EHR Users for FY 2015 and Subsequent FYs
b. EHR Reporting Period for Determining Whether a Hospital Is
Subject to the Market Basket Adjustment for FY 2015 and Subsequent
FYs
c. Exception to the Application of the Market Adjustment to
Hospitals in FY 2015 and Subsequent FYs
d. Application of Market Basket Adjustment in FY 2015 and
Subsequent FYs to a State Operating Under a Payment Waiver Provided
by Section 1814(B)(3) of the Act
4. Reduction of Reasonable Cost Reimbursement in FY 2015 and
Subsequent Years for CAHs That Are Not Meaningful EHR Users
a. Applicable Reduction of Reasonable Cost Payment Reduction in
FY 2015 and Subsequent Years for CAHs That Are Not Meaningful EHR
Users
b. EHR Reporting Period for Determining Whether a CAH Is Subject
to the Applicable Reduction of Reasonable Cost Payment in FY 2015
and Subsequent Years
c. Exception to the Application of Reasonable Cost Payment to
CAHs in FY 2015 and Subsequent FYs
5. Proposed Administrative Review Process of Certain Electronic
Health Records Incentive Program Determinations
a. Permissible Appeals
b. Filing Requirements
c. Preclusion of Administrative and Judicial Review
d. Inchoate Review
e. Informal Review Process Standards
(1) Request for Supporting Documentation
b. Informal Review Decision
3. Final Reconsideration
4. Exhaustion of Administrative Review
E. Medicare Advantage Organization Incentive Payments
1. Definition (Sec. 495.200)
2. Identification of Qualifying MA Organizations, MA-EPs and MA-
Affiliated Eligible Hospitals (Sec. 495.202)
3. Incentive Payments to Qualifying MA Organizations for
Qualifying MA EPs and Qualifying MA-Affiliated Eligible Hospitals
(Sec. 495.204)
a. Amount Payable to a Qualifying MA Organization for Its
Qualifying MA EPs
b. Increase in Incentive Payment for MA EPs Who Predominantly
Furnish Services in a Geographic Health Professional Shortage Area
(HPSA)
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4. Avoiding Duplicate Payments
5. Payment Adjustments Effective in 2015 and Subsequent MA
Payment Adjustment Years for Potentially Qualifying MA EPs and
Potentially Qualifying MA-Affiliated Eligible Hospitals (Sec.
495.211)
6. Appeals Process for MA Organizations
F. Proposed Revisions and Clarifications to the Medicaid EHR
Incentive Program
1. Net Average Allowable Costs
2. Eligibility Requirements for Children's Hospitals
3. Medicaid Professionals Program Eligibility
a. Calculating Patient Volume Requirements
b. Practices Predominately
4. Medicaid Hospital Incentive Payment Calculation
a. Discharge Related Amount
b. Acute Care Inpatient Bed Days and Discharges for the Medicaid
Share and Discharge-Related Amount
c. Hospitals Switching States
5. Hospital Demonstrations of Meaningful Use--Auditing and
Appeals
6. State Medicaid Health Information Technology Plan (SMHP) and
Implementation Advance Planning Document (IAPD)
a. Frequency of Health Information Technology (HIT)
Implementation Advanced Planning Document (IAPD) Updates
b. Requirements of States Transitioning From HIT Planning
Advanced Planning Documents (P-APDs) to HIT IAPDs
III. Collection of Information Requirements
A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec.
495.8)
B. ICRs Regarding Qualifying MA Organizations (Sec. 495.210)
C. ICRs Regarding State Medicaid Agency and Medicaid EP and
Hospital Activities (Sec. 495.332 Through Sec. 495.344)
IV. Response to Comments
V. Regulatory Impact Analysis
A. Statement of Need
B. Overall Impact
C. Anticipated Effects
D. Accounting Statement
I. Executive Summary and Overview
A. Executive Summary
1. Purpose of Regulatory Action
a. Need for the Regulatory Action
In this proposed rule the Secretary of the Department of Health and
Human Services (the Secretary) would specify Stage 2 criteria EPs,
eligible hospitals, and CAHs must meet in order to qualify for an
incentive payment, as well as introduce changes to the program timeline
and detail payment adjustments. These proposed criteria were
substantially adopted from the recommendations of the Health IT Policy
Committee (HITPC), a Federal Advisory Committee that coordinates
industry and provider input regarding the Medicare and Medicaid EHR
Incentive Programs, as well as in consideration of current program data
for the Medicare and Medicaid EHR Incentive Programs.
b. Legal Authority for the Regulatory Action
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L.
111-5) amended Titles XVIII and XIX of the Social Security Act (the
Act) to authorize incentive payments to eligible professionals (EPs),
eligible hospitals, and critical access hospitals (CAHs), and Medicare
Advantage (MA) organizations to promote the adoption and meaningful use
of certified electronic health record (EHR) technology.
Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act
provide the statutory basis for the Medicare incentive payments made to
meaningful EHR users. These statutory provisions govern EPs, Medicare
Advantage (MA) organizations (for certain qualifying EPs and hospitals
that meaningfully use certified EHR technology), subsection (d)
hospitals and critical access hospitals (CAHs) respectively. Sections
1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also
establish downward payment adjustments, beginning with calendar or
fiscal year 2015, for EPs, MA organizations, subsection (d) hospitals
and CAHs that are not meaningful users of certified EHR technology for
certain associated reporting periods.
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory
basis for Medicaid incentive payments. (There are no payment
adjustments under Medicaid). For a more detailed explanation of
statutory basis, see the Stage 1 final rule (75 FR 44316 through
44317).
2. Summary of Major Provisions
a. Stage 2 Meaningful Use Objectives and Measures
In the Stage 1 final rule we outlined Stage 1 criteria, we
finalized a separate set of core objectives and menu objectives for
both EPs and eligible hospitals and CAHs. EPs and hospitals must meet
or qualify for an exclusion to all of the core objectives and 5 out of
the 10 menu measures in order to qualify for an EHR incentive payment.
In this proposed rule, we propose to maintain the same core-menu
structure for the program for Stage 2. We propose that EPs must meet or
qualify for an exclusion to 17 core objectives and 3 of 5 menu
objectives. We propose that eligible hospitals and CAHs must meet or
qualify for an exclusion to 16 core objectives and 2 of 4 menu
objectives. Nearly all of the Stage 1 core and menu objectives would be
retained for Stage 2. The ``exchange of key clinical information'' core
objective from Stage 1 would be re-evaluated in favor of a more robust
``transitions of care'' core objective in Stage 2, and the ``Provide
patients with an electronic copy of their health information''
objective would be removed because it would be replaced by an
``electronic/online access'' core objective. There are also multiple
Stage 1 objectives that would be combined into more unified Stage 2
objectives, with a subsequent rise in the measure threshold that
providers must achieve for each objective that has been retained from
Stage 1.
b. Reporting on Clinical Quality Measures (CQMs)
EPs, eligible hospitals, and CAHs are required to report on
specified clinical quality measures in order to qualify for incentive
payments under the Medicare and Medicaid EHR Incentive Programs. For
EPs, we propose a set of clinical quality measures beginning in 2014
that align with existing quality programs such as measures used for the
Physician Quality Reporting System (PQRS), CMS Shared Savings Program,
and National Council for Quality Assurance (NCQA) for medical home
accreditation, as well as those proposed under Children's Health
Insurance Program Reauthorization Act (CHIPRA) and under ACA Section
2701. For eligible hospitals and CAHs, the set of CQMs we propose
beginning in 2014 would align with the Hospital Inpatient Quality
Reporting (HIQR) and the Joint Commission's hospital quality measures.
This proposed rule also outlines a process by which EPs, eligible
hospitals, and CAHs would submit CQM data electronically, reducing the
associated burden of reporting on quality measures for providers. We
are soliciting public feedback on several mechanisms for electronic CQM
reporting, including aggregate-level electronic reporting group
reporting options; and through existing quality reporting systems.
Within these mechanisms of reporting, we outline different approaches
to CQM reporting that would require EPs to report 12 CQMs and eligible
hospitals and CAHs to report 24 CQMs in total.
c. Payment Adjustments and Exceptions
Medicare payment adjustments are required by statute to take effect
in 2015. We propose a process by which payment adjustment would be
determined by a prior reporting period. Therefore, we propose that any
successful meaningful user in 2013
[[Page 13701]]
would avoid payment adjustment in 2015. Also, any Medicare provider
that first meets meaningful use in 2014 would avoid the penalty if they
are able to demonstrate meaningful use at least 3 months prior to the
end of the calendar or fiscal year (respectively) and meet the
registration and attestation requirement by July 1, 2014 (eligible
hospitals) or October 1, 2014 (EPs).
We also propose exceptions to these payment adjustments. This
proposed rule outlines three categories of exceptions based on the lack
of availability of Internet access or barriers to obtaining IT
infrastructure, a time-limited exception for newly practicing EPs or
new hospitals who would not otherwise be able to avoid payment
adjustments, and unforeseen circumstances such as natural disasters
that would be handled on a case-by-case basis. We also solicit comment
on a fourth category of exception due to a combination of clinical
features limiting a provider's interaction with patients and lack of
control over the availability of Certified EHR technology at their
practice locations.
d. Modifications to Medicaid EHR Incentive Program
We propose to expand the definition of what constitutes a Medicaid
patient encounter, which is a required eligibility threshold for the
Medicaid EHR Incentive Programs. We propose to include encounters for
individuals enrolled in a Medicaid program, including Title XXI-funded
Medicaid expansion encounters (but not separate CHIP programs. We also
propose flexibility in the look-back period for patient volume to be
over the 12 months preceding attestation, not tied to the prior
calendar year.
We also propose to make eligible approximately 12 additional
children's hospitals that have not been able to participate to date,
despite meeting all other eligibility criteria, because they do not
have a CMS Certification Number since they do not bill Medicare.
e. Stage 2 Timeline Delay
Finally, we propose a minor delay of the implementation of the
onset of Stage 2 criteria. In the Stage 1 final rule, we established
that any provider who first attested to Stage 1 criteria for Medicare
in 2011 would begin using Stage 2 criteria in 2013. This proposed rule
delays the onset of those Stage 2 criteria until 2014, which we believe
provides the needed time for vendors to develop Certified EHR
Technology.
3. Summary of Costs and Benefits
This proposed rule is anticipated to have an annual effect on the
economy of $100 million or more, making it an economically significant
rule under the Executive Order and a major rule under the Congressional
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis
that to the best of our ability presents the costs and benefits of the
proposed rule. The total Federal cost of the Medicare and Medicaid EHR
Incentive Programs is estimated to be $14.6 billion in transfers
between 2014 and 2019. In this proposed rule we have not quantified the
overall benefits to the industry, nor to eligible hospitals, or EPs in
the Medicare and Medicaid EHR Incentive Programs. Information on the
costs and benefits of adopting systems specifically meeting the
requirements for the EHR Incentive Programs has not yet been collected
and information on costs and benefits overall is limited. Nonetheless,
we believe there are substantial benefits that can be obtained by
eligible hospitals and EPs, including reductions in medical
recordkeeping costs, reductions in repeat tests, decreases in length of
stay, increased patient safety, and reduced medical errors. There is
evidence to support the cost-saving benefits anticipated from wider
adoption of EHRs.
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Medicare eligible Medicaid eligible
Fiscal year ---------------------------------------------------------------- Total
Hospitals Professionals Hospitals Professionals
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2014............................ $1.3 $1.2 $0.4 $0.8 $3.7
2015............................ 1.2 1.1 0.5 0.9 3.7
2016............................ 0.6 0.8 0.9 1.0 3.3
2017............................ 0.0 0.2 1.0 1.0 2.2
2018............................ -0.2 -0.2 0.6 0.9 1.1
2019............................ -0.0 -0.2 0.1 0.7 0.6
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Amounts are in 2012 billions.
B. 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) amended Titles XVIII and XIX of the Social Security Act (the
Act) to authorize incentive payments to eligible professionals (EPs),
eligible hospitals, and critical access hospitals (CAHs), and Medicare
Advantage (MA) Organizations to promote the adoption and meaningful use
of certified electronic health record (EHR) technology. On July 28,
2010 we published in the Federal Register (75 FR 44313 through 44588) a
final rule titled ``Medicare and Medicaid Programs; Electronic Health
Record Incentive Program,'' that specified the Stage 1 criteria EPs,
eligible hospitals, and CAHs must meet in order to qualify for an
incentive payment, calculation of the incentive payment amounts, and
other program participation requirements (hereinafter referred to as
the Stage 1 final rule). (For a full explanation of the amendments made
by ARRA, see the final rule (75 FR 44316).) In that final rule, we also
detailed that the Medicare and Medicaid EHR Incentive Programs would
consist of 3 different stages of meaningful use requirements.
For Stage 1, CMS and the Office of the National Coordinator for
Health Information Technology (ONC) worked closely to ensure that the
definition of meaningful use of Certified EHR Technology and the
standards and certification criteria for Certified EHR Technology were
coordinated. Current ONC regulations may be found at 45 CFR part 170.
For Stage 2, CMS and ONC will again work together to align our
regulations.
We urge those interested in this proposed rule to also review the
ONC proposed rule on standards and implementation specifications for
Certified EHR Technology. Readers may also visit http://healthit.hhs.gov and http://www.cms.hhs.gov/EHRincentiveprograms for
more information on the efforts at the Department of Health and Human
Services (HHS) to advance HIT initiatives.
[[Page 13702]]
II. Provisions of the Proposed Regulations
A. Definitions Across the Medicare FFS, Medicare Advantage, and
Medicaid Programs
1. Uniform Definitions
In the Stage 1 final rule, we finalized many uniform definitions
for the Medicare FFS, MA, and Medicaid EHR incentive programs. These
definitions are set forth in part 495 subpart A of the regulations, and
we are proposing to maintain most of these definitions, including, for
example, ``Certified EHR Technology,'' ``Qualified EHR,'' ``Payment
Year,'' and ``First, Second, Third, Fourth, Fifth, and Sixth Payment
Year.'' We note that our definitions of ``Certified EHR Technology''
and ``Qualified EHR'' incorporate the definitions adopted by ONC, and
to the extent that ONC's definitions are revised, our definitions would
also incorporate those changes. For these definitions, we refer readers
to ONC's standards and certification criteria proposed rule that is
published elsewhere in this issue of the Federal Register. We are
revising the descriptions of the EHR reporting period to clarify that
for providers who are demonstrating meaningful for the first time their
EHR reporting period is 90 days regardless of payment year. We propose
to add definitions for the applicable EHR reporting period that would
be used in determining the payment adjustments, as well as a definition
of a payment adjustment year, as discussed in section II.D. of this
proposed rule.
2. Meaningful EHR User
We propose to include clinical quality measure reporting as part of
the definition of ``meaningful EHR user'' instead of as a separate
meaningful use objective under 42 CFR 495.6. This change is explained
in section II.A.3.d. in the context of the proposed Stage 2 criteria
for meaningful use.
The third paragraph of the definition of meaningful EHR user at 42
CFR 495.4 currently read as follows: ``(3) To be considered a
meaningful EHR user, at least 50 percent of an EP's patient encounters
during the EHR reporting period during the payment year must occur at a
practice/location or practices/locations equipped with certified EHR
technology.'' We propose to revise the third paragraph of the
definition of meaningful EHR user at 42 CFR 495.4 to read as follows:
``(3) To be considered a meaningful EHR user, at least 50 percent of an
EP's patient encounters during an EHR reporting period for a payment
year (or during an applicable EHR reporting period for a payment
adjustment year) must occur at a practice/location or practices/
locations equipped with Certified EHR Technology.'' This change is to
include the payment adjustment in this definition. Currently, it only
refers to the incentives.
3. Definition of Meaningful Use
a. Considerations in Defining Meaningful Use
In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, Congress
identified the broad goal of expanding the use of EHRs through the
concept of meaningful use. Section 1903(t)(6)(C) of the Act also
requires that Medicaid providers adopt, implement, upgrade or
meaningfully use Certified EHR Technology if they are to receive
incentives under Title XIX. Certified EHR Technology used in a
meaningful way is one piece of the broader HIT infrastructure needed to
reform the health care system and improve health care quality,
efficiency, and patient safety. This vision of reforming the health
care system and improving health care quality, efficiency, and patient
safety should inform the definition of meaningful use.
As we explained in our Stage 1 meaningful use rule, we seek to
balance the sometimes competing considerations of health system
advancement (for example, improving health care quality, encouraging
widespread EHR adoption, promoting innovation) and minimizing burdens
on health care providers given the short timeframe available under the
HITECH Act.
Based on public and stakeholder input received during our Stage 1
rulemaking, we laid out a phased approach to meaningful use. 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 as technology and capabilities evolve. 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 update the
criteria of meaningful use through staggered rulemaking. We published
the Stage 1 final rule July 28, 2010, and this rule outlines our
proposed Stage 2 approach. We currently anticipate at least one
additional update, and anticipate updating the Stage 3 criteria with
another proposed rule by early 2014. The stages represent an initial
graduated approach to arriving at the ultimate goal.
Stage 1: The Stage 1 meaningful use criteria, consistent
with other provisions of Medicare and Medicaid law, focused on
electronically capturing health information in a structured 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); implementing clinical decision support tools
to facilitate disease and medication management; using EHRs to engage
patients and families and reporting clinical quality measures and
public health information. Stage 1 focused heavily on establishing the
functionalities in Certified EHR Technology that will allow for
continuous quality improvement and ease of information exchange. By
having these functionalities in certified EHR technology at the onset
of the program and requiring that the EP, eligible hospital or CAH
become familiar with them through the varying levels of engagement
required by Stage 1, we believe we created a strong foundation to build
on in later years. Though some functionalities were optional in Stage
1, all of the functionalities are considered crucial to maximize the
value to the health care system provided by Certified EHR Technology.
We encouraged all EPs, eligible hospitals and CAHs to be proactive in
implementing all of the functionalities of Stage 1 in order to prepare
for later stages of meaningful use, particularly functionalities that
improve patient care, the efficiency of the health care system and
public and population health. The specific criteria for Stage 1 of
meaningful use are discussed in the Stage 1 final rule, (published on
July 28, 2010 (75 FR 44314 through 44588). We are proposing certain
changes to the Stage 1 criteria in section II.B.3.b. of this proposed
rule.
Stage 2: Our Stage 2 goals, consistent with other
provisions of Medicare and Medicaid law, expand upon the Stage 1
criteria with a focus on ensuring that the meaningful use of EHRs
supports the aims and priorities of the National Quality Strategy.
Specifically, Stage 2 meaningful use criteria encourage the use of
health IT for continuous quality improvement at
[[Page 13703]]
the point of care and the exchange of information in the most
structured format possible. Stage 2 meaningful use requirements include
rigorous expectations for health information exchange including: more
demanding requirements for e-prescribing; incorporating structured
laboratory results; and the expectation that providers will
electronically transmit patient care summaries to support transitions
in care across unaffiliated providers, settings and EHR systems.
Increasingly robust expectations for health information exchange in
Stage 2 and Stage 3 will support the goal that information follows the
patient. In addition, as we forecasted in the Stage 1 final rule, we
now consider nearly every objective that was optional for Stage 1 to be
required in Stage 2, and we reevaluated the thresholds and exclusions
of all the measures.
Stage 3: We anticipate that Stage 3 meaningful use
criteria will focus on: promoting improvements in quality, safety and
efficiency leading to improved health outcomes; focusing on decision
support for national high priority conditions; patient access to self-
management tools; access to comprehensive patient data through robust,
patient-centered health information exchange; and improving population
health. For Stage 3, we currently intend to propose higher standards
for meeting meaningful use. For example, we intend to propose that
every objective in the menu set for Stage 2 (as described later in this
section) be included in Stage 3 as part of the core set. While the use
of a menu set allows providers flexibility in setting priorities for
EHR implementation and takes into account their unique circumstances,
we maintain that all of the objectives are crucial to building a strong
foundation for health IT and to meeting the objectives of the Act. In
addition, as the capabilities of HIT infrastructure increase, we may
raise the thresholds for these objectives in both Stage 2 and Stage 3.
In the Stage 1 final rule (75 FR 44323), we published the following
table with our expected timeline for the stages of meaningful use.
Table 1--Stage of Meaningful Use Criteria by Payment Year as Finalized in 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
Payment year
First payment year --------------------------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011............................... Stage 1............... Stage 1............... Stage 2.............. Stage 2.............. TBD.
2012............................... ...................... Stage 1............... Stage 1.............. Stage 2.............. TBD.
2013............................... ...................... ...................... Stage 1.............. Stage 1.............. TBD.
2014............................... ...................... ...................... ..................... Stage 1.............. TBD.
--------------------------------------------------------------------------------------------------------------------------------------------------------
We are proposing changes to this timeline as well as its extension
beyond 2014. Under the timeline used in the Stage 1 final rule (75 FR
44323), an EP, eligible hospital, or CAH that became a meaningful EHR
user for the first time in 2011 would need to begin their EHR reporting
period for Stage 2 on January 1, 2013 or October 1, 2012, respectively.
We anticipate publishing a final rule by summer 2012. The HIT Policy
Committee recommended we delay by 1 year the start of Stage 2 for
providers who became meaningful EHR users in 2011. Stage 2 of
meaningful use requires changes to both technology and workflow that
cannot reasonably be expected to be completed in the time between the
publication of the final rule and the start of the EHR reporting
periods. We have heard similar concerns from other stakeholders and
agree that, based on our proposed definition of meaningful use for
Stage 2, providers could have difficulty implementing these changes in
time. Therefore, we are proposing a 1-year extension of Stage 1 of
meaningful use for providers who successfully demonstrated meaningful
use for 2011. Our proposed timeline through 2021 is displayed in Table
2. We refer readers to II.D.2 of this proposed rule for a discussion of
the applicable EHR reporting period that would be used to determine
whether providers are subject to payment adjustments.
Table 2--Stage of Meaningful Use Criteria by First Payment Year
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Stage of meaningful use
First payment year ------------------------------------------------------------------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2011............................... 1 1 1 2 2 3 3 TBD................... TBD................... TBD.................. TBD.
2012............................... ....... 1 1 2 2 3 3 TBD................... TBD................... TBD.................. TBD.
2013............................... ....... ....... 1 1 2 2 3 3..................... TBD................... TBD.................. TBD.
2014............................... ....... ....... ....... 1 1 2 2 3..................... 3..................... TBD.................. TBD.
2015............................... ....... ....... ....... ....... 1 1 2 2..................... 3..................... 3.................... TBD.
2016............................... ....... ....... ....... ....... ....... 1 1 2..................... 2..................... 3.................... 3.
2017............................... ....... ....... ....... ....... ....... ....... 1 1..................... 2..................... 2.................... 3.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Please note that the Medicare EHR incentive program and the
Medicaid EHR incentive program have different rules regarding the
number of payment years available, the last year for which incentives
may be received, and the last payment year for initiating the program.
Medicaid EPs and eligible hospitals can receive a Medicaid EHR
incentive payment for ``adopting, implementing, and upgrading'' (AIU)
to Certified EHR Technology for their first payment year, which is not
reflected in Table 2. For example, a Medicaid EP who earns an incentive
payment for AIU in 2013 would have to meet Stage 1 of meaningful use in
his or her next 2 payment years (2014 and 2015). The applicable payment
years and the incentive payments available for each program are
discussed in the Stage 1 final rule.
If there will be a Stage 4 of meaningful use, we expect to update
this table in the rulemaking for Stage 3.
[[Page 13704]]
b. Changes to Stage 1 Criteria for Meaningful Use
We propose the following changes to the objectives and associated
measures for Stage 1. As explained later in this proposed rule, most of
these changes would be optional for Stage 1 in 2013 and would be
required for Stage 1 beginning in 2014 (CY for EPs, FY for eligible
hospitals/CAHs). We do not believe that this creates an additional
hardship as providers would have the option of completing Stage 1 in
the same manner in 2013 as in 2011 and 2012, and in fact, the changes
we propose create flexibility for EPs, eligible hospitals, and CAHs
seeking to achieve Stage 1 meaningful use objectives.
The current denominator for the CPOE objective measure for Stage 1
is the number of unique patients with at least one medication in their
medication list seen by an EP or admitted to an eligible hospital's or
CAH's inpatient or emergency department (POS 21 or 23) during the EHR
reporting period. We created this denominator in response to comments
that our original Stage 1 proposed denominator for this measure, the
number of orders for medications, is difficult to measure. Following
publication of the final rule, we have received nearly unanimous
feedback from providers that the logical denominator for this measure
is the number of orders for medications and that it is measurable. For
more details please reference the discussion of the Stage 2 CPOE
objective. Beginning in 2013 (CY for EPs, FY for eligible hospitals/
CAHs), we propose to allow providers in Stage 1 to use the alternative
denominator of the number of medication orders created by the EP or in
the eligible hospital's or CAH's inpatient or emergency department (POS
21 or 23) during the EHR reporting period (for further explanation of
this alternative denominator, see the discussion of the proposed CPOE
objective in the Stage 2 criteria section). A provider seeking to meet
Stage 1 in 2013 could use either the current or the proposed
alternative denominator to calculate the percentage for the CPOE
measure.
Starting with the EHR reporting periods in FY/CY 2014, the proposed
``alternative denominator'' would be required for all providers in
Stage 1 and Stage 2.
For the objective of record and chart changes in vital signs, our
Stage 2 proposal would allow an EP to split the exclusion and exclude
blood pressure only or height/weight only (for more detail, see the
discussion of this objective in the Stage 2 criteria section). We
propose an identical change to the Stage 1 exclusion as well, starting
in CY 2013. We also propose changing the age limitations on vital signs
for Stage 2 (for more detail, see the discussion of this objective in
the Stage 2 criteria section). We propose identical changes to the age
limitations on vital signs for Stage 1, starting in 2013 (CY for EPs,
FY for eligible hospitals/CAHs). These changes to the exclusion and age
limitations would be an alternative in 2013 to the current Stage 1
requirements and would be required for Stage 1 beginning in 2014. We
have found the objective of ``capability to exchange key clinical
information'' to be surprisingly difficult for providers to understand,
which has made the objective considerably more difficult to achieve
than we envisioned in the Stage 1 final rule. As the measure for this
objective is simply a test with no associated requirement for follow-up
submission, we are concerned the value of this objective is not
sufficient to justify the burden of compliance. However, we also
strongly believe that meaningful use of EHRs must ultimately involve
real and ongoing electronic health information exchange to support care
coordination, as the Stage 2 objectives on this subject (described
below) make clear. We considered four options for this objective, and
welcome comment on all four, that variously reduce or eliminate the
burden of the objective or increase the value of the objective. The
first option we considered is removal of this objective. This
acknowledges our experience with Stage 1 and the limited benefit of
just a test. The second option is to require that the test be
successful. This would increase the value of the objective and
eliminate a common question we receive on what happens if the test is
unsuccessful. The third option is to eliminate the objective, but
require that providers select either the Stage 1 medication
reconciliation objective or the Stage 1 summary of care at transitions
of care and referrals from the menu set. This would eliminate the
burden and complexity of the test, but preserve the domain of care
coordination for Stage 1. The fourth option is to move from a test to
one case of actual electronic transmission of a summary of care
document for a real patient either to another provider of care at a
transition or referral or to a patient authorized entity. This would
increase the benefit of the objective and reduce the complexity of the
defining the parameters of the test, but potentially increases the real
burden of compliance significantly beyond what is currently included in
Stage 1. We are proposing the first option to remove this objective and
measure from the Stage 1 core set beginning in 2013 (CY for EPs, FY for
eligible hospitals/CAHs). In Stage 2, we propose to move to actual use
cases of electronic exchange of health information as discussed later
in this proposed rule, which would require significant testing in the
years of Stage 1. We encourage comments on all four options and will
evaluate them again in light of the public comment received.
We propose for Stage 2 a new method for making patient information
available electronically, which would enable patients to view online
and download their health information and hospital admission
information. We discuss in the Stage 2 criteria section the proposed
``view, download, and transmit'' objectives for EPs and hospitals.
Starting in 2014, Certified EHR Technology will no longer be certified
to the Stage 1 EP and hospital core objectives of providing patients
with electronic copies of their health information and discharge
instructions upon request, nor will it support the Stage 1 EP menu
objective of providing patients with timely electronic access to their
health information. Therefore starting in 2014, for Stage 1, we propose
to replace these objectives with the new ``view online, download and
transmit'' objectives. We discuss these objectives further in our
proposed Stage 2 criteria.
We are proposing a revised definition of a meaningful EHR user
which would incorporate the requirement to submit clinical quality
measures, as discussed in section II.A.2. of this proposed rule, and as
such are removing the objective to submit clinical quality measures
beginning in 2013 and the associated regulation text under 45 CFR 495.6
for Stage 1 to conform with this change in the definition of a
meaningful EHR user.
For the Stage 1 public health objectives, beginning in 2013, we
also propose to add ``except where prohibited'' to the regulation text,
because we want to encourage all EPs, eligible hospitals, and CAHs to
submit electronic immunization data, even when not required by State/
local law. Therefore, if they are authorized to submit the data, they
should do so even if it is not required by either law or practice.
There are a few instances where some EPs, eligible hospitals, and CAHs
are prohibited from submitting to a State/local immunization registry.
For example, in sovereign tribal areas that do not permit transmission
to an immunization registry or when the immunization registry only
accepts data from certain age groups (for example, adults).
[[Page 13705]]
Table 3--Changes to Stage 1
------------------------------------------------------------------------
Effective year
Stage 1 objective Proposed changes (CY/FY)
------------------------------------------------------------------------
Use CPOE for medication orders Change: Addition of an 2013-Only
directly entered by any alternative measure. (Optional).
licensed healthcare More than 30 percent
professional who can enter of medication orders
orders into the medical created by the EP or
record per State, local and authorized providers
professional guidelines. of the eligible
hospital's or CAH's
inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period are recorded
using CPOE.
Use CPOE for medication orders Change: Replacing the 2014-Onward
directly entered by any measure. (Required).
licensed healthcare More than 30 percent
professional who can enter of medication orders
orders into the medical created by the EP or
record per State, local and authorized providers
professional guidelines. of the eligible
hospital's or CAH's
inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period are recorded
using CPOE.
Record and chart changes in Change: Addition of 2013-Only
vital signs. alternative age (Optional).
limitations.
More than 50 percent
of all unique
patients seen by the
EP or admitted to the
eligible hospital's
or CAH's inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period have blood
pressure (for
patients age 3 and
over only) and height
and weight (for all
ages) recorded as
structured data.
Record and chart changes in Change: Addition of 2013-Only
vital signs. alternative (Optional).
exclusions.
Any EP who............
(1) Sees no patients 3
years or older is
excluded from
recording blood
pressure;.
(2) Believes that all
three vital signs of
height, weight, and
blood pressure have
no relevance to their
scope of practice is
excluded from
recording them;.
(3) Believes that
height and weight are
relevant to their
scope of practice,
but blood pressure is
not, is excluded from
recording blood
pressure; or.
(4) Believes that
blood pressure is
relevant to their
scope of practice,
but height and weight
are not, is excluded
from recording height
and weight..
Record and chart changes in Change: Age 2014-Onward
vital signs. Limitations on Growth (Required)
Charts and Blood
Pressure.
More than 50 percent
of all unique
patients seen by the
EP or admitted to the
eligible hospital's
or CAH's inpatient or
emergency department
(POS 21 or 23) during
the EHR reporting
period have blood
pressure (for
patients age 3 and
over only) and height
and weight (for all
ages) recorded as
structured data.
Record and chart changes in Change: Changing the 2014-Onward
vital signs. age and splitting the (Required).
EP exclusion.
Any EP who............
(1) Sees no patients 3
years or older is
excluded from
recording blood
pressure;.
(2) Believes that all
three vital signs of
height, weight, and
blood pressure have
no relevance to their
scope of practice is
excluded from
recording them;.
(3) Believes that
height and weight are
relevant to their
scope of practice,
but blood pressure is
not, is excluded from
recording blood
pressure; or.
(4) Believes that
blood pressure is
relevant to their
scope of practice,
but height and weight
are not, is excluded
from recording height
and weight..
Capability to exchange key Change: Objective is 2013-Onward
clinical information (for no longer required. (Required).
example, problem list,
medication list, medication
allergies, and diagnostic
test results), among
providers of care and patient
authorized entities
electronically.
Report ambulatory (hospital) Change: Objective is 2013-Onward
clinical quality measures to incorporated directly (Required)
CMS or the States. into the definition
of a meaningful EHR
user and eliminated
as an objective under
42 CFR 495.6.
EP Objective: Provide patients Change: Replace these 2014-Onward
with an electronic copy of three objectives with (Required).
their health information the Stage 2 objective
(including diagnostics test and one of the two
results, problem list, Stage 2 measures.
medication lists, medication EP Objective: Provide
allergies) upon request. patients the ability
to view online,
download and transmit
their health
information within 4
business days of the
information being
available to the EP.
Hospital Objective: Provide EP Measure: More than
patients with an electronic 50 percent of all
copy of their discharge unique patients seen
instructions and procedures by the EP during the
at time of discharge, upon EHR reporting period
request. are provided timely
(within 4 business
days after the
information is
available to the EP)
online access to
their health
information subject
to the EP's
discretion to
withhold certain
information.
EP Objective: Provide patients Hospital Objective:
with timely electronic access Provide patients the
to their health information ability to view
(including lab results, online, download and
problem list, medication transmit information
lists, medication allergies) about a hospital
within 4 business days of the admission.
information being available Hospital Measure: More
to the EP. than 50 percent of
all patients who are
discharged from the
inpatient or
emergency department
(POS 21 or 23) of an
eligible hospital or
CAH have their
information available
online within 36
hours of discharge.
Public Health Objectives:..... Change: Addition of 2013-Onward
``except where (Required).
prohibited'' to the
objective regulation
text for the public
health objectives
under 42 CFR 495.6.
------------------------------------------------------------------------
[[Page 13706]]
c. State Flexibility for Stage 2 of Meaningful Use
We propose to offer States flexibility with the public health
measures in Stage 2, similar to that of Stage 1, subject to the same
conditions and standards as the Stage 1 flexibility policy. This
applies to the public health measures as well as the measure to
generate lists of specific conditions to use for quality improvement,
reduction of disparities, research or outreach.
In addition, whether moved to the core or left in the menu, States
may also specify the means of transmission of the data or otherwise
change the public health measure, as long as it does not require EHR
functionality above and beyond that which is included in the ONC EHR
certification criteria as finalized for Stage 2 of meaningful use.
We solicit comment on extending State flexibility as described for
Stage 2 of meaningful use and whether this remains a useful tool for
State Medicaid agencies.
d. Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)
We are proposing to continue the Stage 1 concept of a core set of
objectives and a menu set of objectives for Stage 2. In the Stage 1
final rule (75 FR 44322), we indicated that for Stage 2, we expected to
include the Stage 1 menu set objectives in the core set. We propose to
follow that approach for our Stage 2 core set with two exceptions. We
are proposing to keep the objective of ``capability to submit
electronic syndromic surveillance data to public health agencies'' in
the menu set for EPs. Our experience with Stage 1 is that very few
public health agencies have the ability to accept ambulatory syndromic
surveillance data electronically and those that do are less likely to
support EPs than hospitals; therefore we do not believe that current
infrastructure supports moving this objective to the core set for EPs.
We are also proposing to keep the objective of ``record advance
directives'' in the menu set for eligible hospitals and CAHs. As we
stated in our Stage 1 final rule (75 FR 44345), we have continuing
concerns that there are potential conflicts between storing advance
directives and existing State laws.
We are proposing new objectives for Stage 2, some of which would be
part of the Stage 2 core set and others would make up the Stage 2 menu
set, as discussed below with each objective. We are proposing to
eliminate certain Stage 1 objectives for Stage 2, such as the objective
for testing the capability to exchange key clinical information. We are
also proposing to combine some of the Stage 1 objectives for Stage 2.
For example, the objectives of maintaining an up-to-date problem list,
active medication list, and active medication allergy list would not be
separate objectives for Stage 2. Instead, we would combine these
objectives with the objective of providing a summary of care record for
each transition of care or referral by including them as required
fields in the summary of care.
We are proposing a total of 17 core objectives and 5 menu
objectives for EPs. We propose that an EP must meet the criteria or an
exclusion for all of the core objectives and the criteria for 3 of the
5 menu objectives. This is a change from our current Stage 1 policy
where an EP could reduce by the number of exclusions applicable to the
EP the number of menu set objectives that the EP would otherwise need
to meet. We received feedback on Stage 1 that we have received from
providers and health care associations leads us to believe that most
EPs had difficulty understanding the concept of deferral of a menu
objective in Stage 1, so we are proposing this change for Stage 2, as
well as for Stage 1 beginning in 2014, to make the selection of menu
objectives easier for EPs. We are proposing this change because we are
concerned that under the current Stage 1 requirements EPs could select
and exclude menu objectives when there are other menu objectives they
can legitimately meet, thereby making it easier for them to demonstrate
meaningful use than EPs who attempt to legitimately meet the full
complement of menu objectives. Although we provided greater flexibility
to do this in the selection of Stage 1 menu objectives through 2013, we
believe that EPs participating in Stage 1 and Stage 2 starting in 2014
should focus solely on those objectives they can meet rather than those
for which they have an exclusion. In addition, we have provided
exclusions for the Stage 2 menu objectives that we believe will
accommodate EPs who are unable to meet certain objectives because of
scope of practice.
However, just as we signaled in our Stage 1 regulation, we
currently intend to propose in our next rulemaking that every objective
in the menu set for Stage 2 (as described later in this section) be
included in Stage 3 as part of the core set. In the case where an EP
meets the criteria for the exclusions for 3 or more of the Stage 2 menu
objectives, the EP would have more exclusions than the allowed
deferrals. EPs in this situation would attest to an exclusion for 1 or
more menu objectives in his or her attestation to meaningful use. In
doing so, the EP would be attesting that he or she also meets the
exclusion criteria for all of the menu objectives that he or she did
not choose. The same policy would also apply for the Stage 1 menu
objectives for EPs beginning in 2014.
We propose a total of 16 core objectives and 4 menu objectives for
eligible hospitals and CAHs for Stage 2. We propose that an eligible
hospital or CAH must meet the criteria or an exclusion for all of the
core objectives and the criteria for 2 of the 4 menu objectives. The
policy for exclusions for EPs discussed in the preceding paragraph
would also apply to eligible hospitals and CAHs for Stage 1 beginning
in 2014 and for Stage 2.
(1) Discussion of Whether Certain EPs, Eligible Hospitals or CAHs Can
Meet All Stage 2 Meaningful Use Objectives Given Established Scopes of
Practice
We do not believe that any of the proposed new objectives for Stage
2 make it impossible for any EP, eligible hospital or CAH to meet
meaningful use. Where scope of practice may prevent an EP, eligible
hospital or CAH from meeting the measure associated with an objective
we discuss the barriers and include exclusions in our descriptions of
the individual objectives later. We are proposing to include new
exclusion criteria when necessary for new objectives, continue the
Stage 1 exclusions for Stage 2, and continue the option for EPs and
hospitals to defer some of the objectives in the menu set unless they
meet the exclusion criteria for more objectives than they can defer as
explained previously.
We recognize that at the time of publication, our data (derived
internally from attestations) only reflects the meaningful use
attestation from Medicare providers. Before the publication of the
final rule, we plan on adjusting the data on the successful
attestations to date to reflect the experience of successful Medicaid
meaningful EHR users. This may result in changes to our current
assumptions based upon the data available at the time of the proposed
rule, especially given the different eligible professional types in the
Medicaid EHR Incentive Program. It may be that different eligible
professional types may have different levels of success in meeting the
meaningful use measure thresholds, given their scope of practice.
(2) EPs Practicing in Multiple Practices/Locations
We propose for Stage 2 to continue our policy that to be a
meaningful EHR user, an EP must have 50 percent or more of his or her
outpatient encounters
[[Page 13707]]
during the EHR reporting period at a practice/location or practices/
locations equipped with Certified EHR Technology. An EP who does not
conduct at least 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 equipped with Certified EHR
Technology. For example, if the EP practices at a federally qualified
health center (FQHC) and within his or her individual practice at 2
different locations, we would include in our review all 3 of these
locations, and Certified EHR Technology would have to be available at
one location or a combination of locations where the EP has 50 percent
or more of his or her patient encounters. If Certified EHR Technology
is only available at one location, then only encounters at this
location would be included in meaningful use assuming this one location
represents 50 percent or more of the EP's patient encounters. If
Certified EHR Technology is available at multiple locations that
collectively represent 50 percent or more of the EP's patient
encounters, then all encounters from those locations would be included
in meaningful use.
We have received many inquiries on this requirement since the
publication of the Stage 1 final rule. We define patient encounter as
any encounter where a medical treatment is provided and/or evaluation
and management services are provided. This includes both individually
billed events and events that are globally billed, but are separate
encounters under our definition. We have also received requests for
clarification on what it means for a practice/location to be equipped
with Certified EHR Technology. We define a practice/location as
equipped with Certified EHR Technology if the record of the patient
encounter that occurs at that practice/location is created and
maintained in Certified EHR Technology. This can be accomplished in
three ways: Certified EHR Technology could be permanently installed at
the practice/location, the EP could bring Certified EHR Technology to
the practice/location on a portable computing device, or the EP could
access Certified EHR Technology remotely using computing devices at the
practice/location. Although it is currently allowed under Stage 1 for
an EP to create a record of the encounter without using Certified EHR
Technology at the practice/location and then later input that
information into Certified EHR Technology that exists at a different
practice/location, we do not believe this process takes advantage of
the value Certified EHR Technology offers. We are proposing not to
allow this practice beginning in 2013. We have also received inquiries
whether the practice locations have to be in the same State, to which
we clarify that they do not. Finally, we received inquiries regarding
the interaction with hospital-based EP determination. There is no
interaction. The determination of whether an EP is hospital-based or
not occurs prior to the application of this policy, so only non-
hospital based eligible professionals are included. Furthermore, this
policy, like all meaningful use policies for EPs, only applies to
outpatient settings (all settings except the inpatient and emergency
department of a hospital).
(3) Discussion of the Reporting Requirements of the Measures Associated
With the Stage 2 Meaningful Use Objectives
In our experience with Stage 1, we found the distinction between
limiting the denominators of certain measures to only those patients
whose records are maintained using Certified EHR Technology, but
including all patients in the denominators of other measures, to be
complicated for providers to implement. We are proposing to remove this
distinction for Stage 2 and instead include all patients in the
denominators of all of the measures associated with the meaningful use
objectives for Stage 2. We believe that by the time an EP, eligible
hospital, or CAH has reached Stage 2 of meaningful use all or nearly
all of their patient population should be included in their Certified
EHR Technology, making this distinction no longer relevant.
We also continue our policy that EPs practicing in multiple
locations do not have to include patients seen at practices/locations
that are not equipped with Certified EHR Technology in the calculations
of the meaningful use measures as long as the EP has 50 percent of
their patient encounters during the EHR reporting period at locations
equipped with Certified EHR Technology.
We are proposing new objectives that could increase reporting
burden. To minimize the burden, we are proposing to create a uniform
set of denominators that would be used for all of the Stage 2
meaningful use objectives, as discussed later.
Many of our meaningful use objectives use percentage-based measures
wherever possible and if appropriate. To provide a check on the burden
of reporting of meaningful use, we propose for Stage 2 to use 1 of 4
denominators for each of the measures associated with the meaningful
use objectives. We focus on denominators because the action that moves
something from the denominator to the numerator usually requires the
use of Certified EHR Technology by the provider. These actions are
easily tracked by the technology.
The four proposed denominators for EPs:
Unique patients seen by the EP during the EHR reporting
period (stratified by age or previous office visit).
Number of orders (medication, labs, radiology).
Office visits, and
Transitions of care/referrals.
The term ``unique patient'' means that if a patient is seen or
admitted more than once during the EHR reporting period, the patient
only counts once in the denominator. Patients seen or admitted only
once during the EHR reporting period would count once in the
denominator. A patient is seen by the EP when the EP has an actual
physical encounter with the patient in which they render any service to
the patient. A patient seen through telemedicine would also still count
as a patient ``seen by the EP.'' In cases where the EP and the patient
do not have an actual physical or telemedicine encounter, but the EP
renders a minimal consultative service for the patient (like reading an
EKG), the EP may choose whether to include the patient in the
denominator as ``seen by the EP'' provided the choice is consistent for
the entire EHR reporting period and for all relevant meaningful use
measures. For example, a cardiologist may choose to exclude patients
for whom they provide a one-time reading of an EKG sent to them from
another provider, but include more involved consultative services as
long as the policy is consistent for the entire EHR reporting period
and for all meaningful use measures that include patients ``seen by the
EP.'' EPs who never have a physical or telemedicine interaction with
patients must adopt a policy that classifies at least some of the
services they render for patients as ``seen by the EP,'' and this
policy must be consistent for the entire EHR reporting period and
across meaningful use measures that involve patients ``seen by the
EP''--otherwise, these EPs would not be able to satisfy meaningful use,
as they would have denominators of zero for some measures. In cases
where the patient is seen by a member of the EP's clinical staff the EP
can include or not include those patients in their denominator at their
discretion as
[[Page 13708]]
long as the decision applies universally to all patients for the entire
EHR reporting period and the EP is consistent across meaningful use
measures. In cases where a member of the EP's clinical staff is
eligible for the Medicaid EHR incentive in their own right (for
example, nurse practitioners (NPs) and certain physician assistants
(PA)), patients seen by NPs or PAs under the EP's supervision can be
counted by both the NP or PA and the supervising EP as long as the
policy is consistent for the entire EHR reporting period.
An office visit is defined as any billable visit that includes: (1)
Concurrent care or transfer of care visits; (2) consultant visits; or
(3) prolonged physician service without direct, face-to-face patient
contact (for example, telehealth). A consultant visit occurs when a
provider is asked to render an expert opinion/service for a specific
condition or problem by a referring provider. The visit does not have
to be individually billable in instances where multiple visits occur
under one global fee. Transitions of care are the movement of a patient
from one setting of care (hospital, ambulatory primary care practice,
ambulatory specialty care practice, long-term care, home health,
rehabilitation facility) to another. Currently, the meaningful use
measures that use transitions of care require there to be a receiving
provider of care to accept the information. Therefore, a transition
home without any expectation of follow-up care related to the care
given in the prior setting by another provider is not a transition of
care for purpose of Stage 2 meaningful use measures as there is no
provider recipient. A transition within one setting of care does not
qualify as a transition of care. Referrals are cases where one provider
refers a patient to another, but the referring provider maintains their
care of the patient as well. (Please note that a ``referral'' as
defined here and elsewhere in this proposed rule is only intended to
apply to the EHR Incentive Programs and is not applicable to other
Federal regulations.)
The four proposed denominators for eligible hospitals and CAHs:
Unique patients admitted to the eligible hospital's or
CAH's inpatient or emergency department during the EHR reporting period
(stratified by age).
Number of orders (medication, labs, radiology).
Inpatient bed days.
Transitions of care.
The explanation of ``unique patients'' and ``transitions of care''
in the preceding paragraph for EPs also applies for eligible hospitals
and CAHs. Admissions to the eligible hospital or CAH can be calculated
using one of two methods currently available under Stage 1 of
meaningful use. The observation services method includes all patients
admitted to the inpatient department (POS 21) either directly or
through the emergency department and patients who initially present to
the emergency department (POS 23) and receive observation services.
Details on observation services can be found in the Medicare Benefit
Policy Manual, Chapter 6, Section 20.6. Patients who receive
observation services under both the outpatient department (POS 22) and
emergency department (POS 23) should be included in the denominator
under this method. The all emergency department method includes all
patients admitted to the inpatient department (POS 21) either directly
or through the emergency department and all patients receiving services
in the emergency department (POS 23).
Inpatient bed days are the admission day and each of the following
full 24-hour periods during which the patient is in the inpatient
department (POS 21) of the hospital. For example, a patient admitted to
the inpatient department at noon on June 5th and discharged at 2 p.m.
on June 7th would be admitted for 2-patient days: the admission day
(June 5th) and the 24 hour period from 12 a.m. on June 6th to 11:59
p.m. on June 6th.
(4) Discussion of the Relationship of Meaningful Use to Certified EHR
Technology
We propose to continue our policy of linking each meaningful use
objective to certification criteria for Certified EHR Technology. As
with Stage 1, EPs, eligible hospitals, and CAHs must use the
capabilities and standards that are certified to meet the objectives
and associated measures for Stage 2 of meaningful use. In meeting any
objective of meaningful use, an EP, eligible hospital or CAH must use
the capabilities and standards that are included in certification. In
some instances, meaningful use objectives and measures require use that
is not directly enabled by certified capabilities and/or standards. In
these cases, the EP, eligible hospital and CAH is responsible for
meeting the objectives and measures of meaningful use, but the way they
do so is not constrained by the capabilities and standards of Certified
EHR Technology. For example, in e-Rx and public health reporting,
Certified EHR Technology applies standards to the message being sent
and enables certain capabilities for transmission in 2014; however, to
actually engage in e-Rx or public health reporting many steps must be
taken despite these standards and capabilities such as contacting both
parties and troubleshooting issues that may arise through the normal
course of business.
(5) Discussion of the Relationship Between a Stage 2 Meaningful Use
Objective and its Associated Measure
We propose to continue our Stage 1 policy that regardless of any
actual or perceived gaps between the measure of an objective and full
compliance with the objective, meeting the criteria of the measure
means that the provider has met the objective for Stage 2.
(6) Objectives and Their Associated Measures
(a) Objectives and Measures Carried Over (Modified or Unmodified) From
Stage 1 Core Set to Stage 2 Core Set
Proposed Objective: Use computerized provider order entry (CPOE)
for medication, laboratory and radiology orders directly entered by any
licensed healthcare professional who can enter orders into the medical
record per State, local and professional guidelines to create the first
record of the order.
We propose to continue 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 then documented or captured in
a digital, structured, and computable format for use in improving
safety and efficiency of the ordering process.
CPOE improves quality and safety by allowing clinical decision
support at the point of the order and therefore influences the initial
order decision. CPOE improves safety and efficiency by automating
aspects of the ordering process to reduce the possibility of
communication and other errors. Consistent with the recommendations of
the HIT Policy Committee, we would expand the orders included in the
objective to medication (which was included in Stage 1), laboratory,
and radiology. We believe that the expansion to laboratory and
radiology furthers the goals of the CPOE objective, that such orders
are commonly included in CPOE roll outs and that this is a logical step
in the progression of meaningful use.
Our experience with Stage 1 of meaningful use demonstrated that our
definition of CPOE in the Stage 1 final
[[Page 13709]]
rule does not indicate when in the ordering process the CPOE function
must be utilized. We provided guidance at: https://questions.cms.hhs.gov/app/answers/detail/a_id/10134/ on the Stage 1
criteria to say that the CPOE function should be used the first time
the order becomes part of the patient's medical record and before any
action can be taken on the order. Our experience shows that the
limiting criterion is the first time the order becomes part of the
patient's medical record rather than the limitation to licensed
healthcare professionals entering the order. Our experience has also
demonstrated that each provider must make the decision of whether the
record of an order is part of the patient's medical record
independently as the possible variations in process and record keeping
are too numerous for a universal statement on when in the process an
order becomes part of the patient's medical record. To further CPOE's
ability to improve safety and efficiency and to provide greater clarity
for Stage 2 of meaningful use, we are proposing to redefine the point
in the ordering process when CPOE must be utilized. We propose that to
be considered CPOE, the CPOE function must be utilized to create the
first record of any type for the order. This removes the possibility
that a record of the order could be created prior to CPOE, but not be
part of the patient's medical record. In a practice, this means the
originating provider (the provider whose judgment creates the order)
must personally use the CPOE function, verbally communicate the order
to someone else who will use the CPOE function, or give an electronic
or written order that must not be retained in any way once the CPOE
function has been utilized. This is a meaningful use requirement and
does not affect any other legal or regulatory requirements as to what
constitutes a patient's health record or order. With this new proposal,
we invite public comment on whether the stipulation that the CPOE
function be used only by licensed healthcare professionals remains
necessary or if CPOE can be expanded to include nonlicensed healthcare
professionals such as scribes.
Proposed Measure: More than 60 percent of medication, laboratory,
and radiology orders created by the EP or authorized providers of the
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23) during the EHR reporting period are recorded using CPOE.
In Stage 1 of meaningful use, we adopted a measure of more than 30
percent of all unique patients with at least one medication in their
medication list seen by the EP or admitted to the eligible hospital's
or CAH's inpatient or emergency department (POS 21 or 23) during the
EHR reporting period have at least one medication order entered using
CPOE. In the Stage 1 final rule, we adopted a threshold of 60 percent
for this measure for Stage 2.
Our experience with Stage 1 of meaningful use has shown that a
denominator of all orders created by the EP or in the hospital would
not be unduly burdensome for providers. Many providers have voluntarily
provided information on the number of medication orders in their clinic
or hospital. However, this does not guarantee such a denominator would
be feasible for all providers. We believe the EHRs can calculate a
denominator of all orders entered into the Certified EHR Technology,
with the numerator limited to those entered into Certified EHR
Technology using CPOE. Potentially, this would exclude those orders
that are never entered into the Certified EHR Technology in any manner.
The provider would be responsible for including those orders in their
denominator. However, we believe that providers using Certified EHR
Technology use it as the patient's medical record; therefore, an order
not entered into Certified EHR Technology would be an order that is not
entered into a patient's medical record. For this reason, we expect
that orders given for patients that are never entered into the
Certified EHR Technology to be few in number or non-existent. We
encourage comments on whether a denominator other than number of
medication, laboratory, and radiology orders created by the EP or in
the hospital would be needed for EPs and/or hospitals. For example, the
HIT Policy Committee recommended a denominator of ``patients with at
least one type of order.'' We are proposing, however, a different
denominator for this measure, which we believe would be possible to
collect given our experience in Stage 1 of meaningful use and a much
more accurate measure of actual CPOE usage. The denominator of
``patients with at least one type of order'' is a proxy measure for the
number of orders issued by the EP, eligible hospital or CAH. The
accuracy of that proxy is dependent on the frequency in which an
encounter results in an order. For example, an EP whose scope of
practice is such that they order a medication on nearly every encounter
would have every encounter as an opportunity to move the patient from
the denominator to a numerator. The 2005 National Ambulatory Medical
Care Survey (referenced in the Stage 1 final rule, 75 FR 44333) found
that 66 percent of office-based visits had any type of medication
order. EPs whose office visits are consistent with the survey findings
would have a third fewer opportunities to move the patient from the
denominator to the numerator. We believe a direct measure of the number
of orders is feasible and more accurate as it is not dependent on the
frequency of orders. We encourage comments on whether the barriers to
collecting information for our proposed denominator would be greater in
a hospital or ambulatory setting. As we noted previously, the
denominator used in Stage 1 (as well as the denominator recommended by
the HIT Policy Committee) is much more representative of CPOE use in a
hospital setting than an ambulatory setting, so these settings could
require different denominators or measures. We request comment on
different denominators or measures and encourage any commenter
proposing an alternative denominator to discuss whether the proposed
threshold or an alternative threshold should be used for this measure
and to include any exclusions they believe are necessary based on their
alternative denominator.
Based on our experience with attestation data from Stage 1, we
continue to believe that the 60 percent threshold that we finalized
previously for Stage 2 is appropriate. We also believe that this
threshold translates to our new measure. The HIT Policy Committee
recommended including laboratory and radiology orders in the measure,
but as ``yes/no'' attestations of one order being entered using CPOE
rather than at the 60 percent threshold. We believe this is unnecessary
given the advance of CPOE. In our discussions with EPs, eligible
hospitals and CAHs we find that they do not roll out CPOE with only one
order type, but rather include medications, laboratory and radiology/
imaging orders as a package. We are also concerned about the
possibility that an EP, eligible hospital or CAH could create a test
environment to issue the one order and not roll out the capability
widely or at all. We welcome comment on whether laboratory and
radiology orders are sufficiently different in the use of CPOE that
they would require a different threshold and whether such a threshold
should be a lower percentage or a yes/no attestation.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of medication, radiology, and
laboratory orders created by the EP or authorized providers in the
eligible hospital's or CAH's inpatient or emergency
[[Page 13710]]
department (POS 21 or 23) during the EHR reporting period.
Numerator: The number of orders in the denominator
recorded using CPOE.
Threshold: The resulting percentage must be more than 60
percent in order for an EP, eligible hospital or CAH to meet this
measure.
Exclusion: Any EP who writes fewer than 100 medication, laboratory
and radiology orders during the EHR reporting period.
To qualify for the exclusion, an EP's total number of medication,
laboratory and radiology orders collectively must be less than 100. For
example, an EP who writes 75 medication orders, 50 laboratory orders
and no radiology orders during the EHR reporting period would not meet
the exclusion.
Consolidated Objective: Implement drug-drug and drug-allergy
interaction checks.
For Stage 2, we are proposing to make the objective for ``Implement
drug-drug and drug-allergy checks'' one of the measures of the core
objective for ``Use clinical decision support to improve performance on
high-priority health conditions.'' We continue to believe that
automated drug-drug and drug-allergy checks provide important
information to advise the provider's decisions in prescribing drugs to
a patient. Because this functionality provides important clinical
decision support that focuses on patient health and safety, we believe
it is appropriate to include this functionality as part of the
objective for using clinical decision support.
Proposed EP Objective: Generate and transmit permissible
prescriptions electronically (eRx).
The use of electronic prescribing has several advantages over
having the patient carry the prescription to the pharmacy or directly
faxing a handwritten or typewritten prescription to the pharmacy. When
the EP generates the prescription electronically, Certified EHR
Technology can recognize the information and can provide decision
support to promote safety and quality in the form of adverse
interactions and other treatment possibilities. The Certified EHR
Technology can also provide decision support that promotes the
efficiency of the health care system by alerting the EP to generic
alternatives or to alternatives favored by the patient's insurance plan
that are equally effective. Transmitting the prescription
electronically promotes efficiency and safety through reduced
communication errors. It also allows the pharmacy or a third party to
automatically compare the medication order to others they have received
for the patient. This comparison allows for many of the same decision
support functions enabled at the generation of the prescription, but
bases them on potentially greater information.
We propose to continue to define prescription as the authorization
by an EP to dispense a drug that would not be dispensed without such
authorization. This includes authorization for refills of previously
authorized drugs. We propose to define a permissible prescription as
all drugs meeting the definition of prescription not listed as a
controlled substance in Schedules II-V http://www.deadiversion.usdoj.gov/schedules/index.html. Although the Drug
Enforcement Administration's (DEA) interim final rule on electronic
prescriptions for controlled substances (75 FR 16236) removed the
Federal prohibition to electronic prescribing of controlled substances,
some challenges remain including more restrictive State law and
widespread availability of products both for providers and pharmacies
that include the functionalities required by the DEA's regulations.
However, as Stage 2 of meaningful use would not go into effect until
2014, it is possible that significant progress in the availability of
products enabling the electronic prescribing of controlled substances
may occur. We encourage comments addressing the current and expected
availability of these products and whether the availability would be
sufficient to include controlled substances in the Stage 2 measure for
e-Rx or to warrant an additional measure for EPs to choose that would
include controlled substance electronic prescriptions in the
denominator.
We do not believe that OTC medicines will be routinely
electronically prescribed and propose to continue to exclude them from
the definition of a prescription. However, we encourage public comment
on this assumption.
Several different workflow scenarios are possible when an EP
prescribes a drug for a patient. First, the EP could prescribe the drug
and provide it to the patient at the same time, and sometimes the EP
might also provide a prescription for doses beyond those provided
concurrently. Second, the EP could prescribe the drug, transmit it to a
pharmacy within the same organization, and the patient would obtain the
drug from that pharmacy. Third, the EP could prescribe the drug,
transmit it to a pharmacy independent of the EP's organization, and the
patient would obtain the drug from that pharmacy. Although each of
these scenarios would result in the generation of a prescription, the
transmission of the prescription would vary. In the first situation,
there is no transmission. In the second situation, the transmission may
be the viewing of the generation of the prescription by another person
using the same Certified EHR Technology as the EP, or it could be the
transmission of the prescription from the Certified EHR Technology used
by the EP to another system used by the same organization in the
pharmacy. In the third situation, the EP's Certified EHR Technology
transmits the prescription outside of their organization either through
a third party or directly to the external pharmacy. These differences
in transmissions create differences in the need for standards. We
propose that only the third situation would require standards to ensure
that the transmission meets the goals of electronic prescribing. In the
first two scenarios one organization has control over the whole
process. In the third scenario, the process is divided between
organizations. In that situation, standards can ensure that despite the
lack of control the whole process functions reliably. To have
successfully e-prescribed, the EP needs to use Certified EHR Technology
as the sole means of creating the prescription, and when transmitting
to an external pharmacy that is independent of the EP's organization
such transmission must use the standards included in certification of
EHRs.
We received many inquiries as to the alignment with this objective
and the eRx payment adjustment authorized by the Medicare Improvements
for Patients and Providers Act of 2008 (MIPPA). The HITECH Act phases
out the adjustment starting in CY 2015 so alignment between the
programs is no longer necessary. At the time of publication of this
proposed rule, the determination for CY 2013 MIPPA eRx payment
adjustment will have already occurred. For these reasons alignment with
Stage 2 becomes a moot point.
Proposed EP Measures: More than 65 percent of all permissible
prescriptions written by the EP are compared to at least one drug
formulary and transmitted electronically using Certified EHR
Technology.
In Stage 1 of meaningful use, we adopted a measure of more than 40
percent of all permissible prescriptions written by the EP are
transmitted electronically using Certified EHR Technology. In the Stage
1 rule (75 FR 44338), we acknowledged that there were reasons why a
patient may prefer a paper prescription. A patient could have this
preference for any number of reasons such as the desire to shop for
[[Page 13711]]
the best price (especially for patients in the Part D ``donut hole''),
the ability to obtain medications through the Department of Veterans
Affairs, lack of finances, indecision about whether to have the
prescription filled locally or by mail order, and desire to use a
manufacturer coupon to obtain a discount. We correspondingly lowered
the threshold to 40 percent from 75 percent as proposed for Stage 1 to
account for patient preference for a paper prescription. While pharmacy
acceptance of electronic prescriptions continues to accelerate, these
patient preferences remain creating a ceiling for this threshold on
which there is limited data with which to estimate.
The HIT Policy Committee recommended an increase in the threshold
of this measure from 40 percent to 50 percent. The average successful
Medicare meaningful EHR user rate currently exceeds 50 percent
demonstrating to us that 50 percent does not exceed the ceiling created
by patient preferences. We also believe that providers participating in
Stage 2 will already have significant experience with this objective
and can meet an even higher threshold. Therefore we are proposing a
threshold of 65 percent for this measure.
The ease with which an EP can meet this measure depends heavily on
the availability of pharmacies in their local area that accept
electronic prescriptions. We propose a new exclusion for Stage 2 that
would allow EPs to exclude this objective, if no pharmacies within 25
miles of an EP's practice location at the start of his/her EHR
reporting period accept electronic prescriptions. This is 25 miles in
any straight line from the practice location independent of the travel
route from the practice location to the pharmacy. For EP's practicing
at multiple locations, they are eligible for the exclusion if any of
their practice locations that are equipped with Certified EHR
Technology meet this criteria. An EP would not be eligible for this
exclusion if he or she is part of an organization that owns or operates
its own pharmacy within the 25-mile radius regardless of whether that
pharmacy can accept electronic prescriptions from EPs outside of the
organization.
We also have considered instances where an EP may prescribe
medications in a facility (such as a nursing home or ambulatory surgery
center) where they are compelled to use the facility's ordering system,
which may not be Certified EHR Technology. While we are not proposing
exclusionary criteria related to this circumstance, we encourage
comments on whether one is necessary or if the proposed 50 percent
threshold is low enough to account for this situation.
The inclusion of the comparison to at least one drug formulary
enhances the efficiency of the healthcare system when clinically
appropriate and cheaper alternatives may be available. We recognize
that not all drug formularies are linked to all Certified EHR
Technologies, so we are not requiring that the formulary be relevant
for each patient. Therefore, the comparison could return a result of
formulary unavailable for that patient and medication combination and
still allow the EP to meet the measure of this objective. This
modification of the measure replaces the Stage 1 menu objective of
``Implement drug-formulary checks'' and is intended to provide better
integration guidance for both EPs and their supporting vendors.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of prescriptions written for drugs
requiring a prescription in order to be dispensed other than controlled
substances during the EHR reporting period.
Numerator: The number of prescriptions in the denominator
generated, compared to a drug formulary and transmitted electronically.
Threshold: The resulting percentage must be more than 65
percent in order for an EP to meet this measure.
Exclusions: Any EP who writes fewer than 100 prescriptions during
the EHR reporting period or does not have a pharmacy within their
organization and there are no pharmacies that accept electronic
prescriptions within 25 miles of the EP's practice location at the
start of his/her EHR reporting period.
Consolidated Objective: Maintain an up-to-date problem list of
current and active diagnoses.
Consolidated Objective: Maintain active medication list.
Consolidated Objective: Maintain active medication allergy list.
For Stage 2, we are proposing to consolidate the objectives for
maintaining an up-to-date problem list, active medication list, and
active medication allergy list with the Stage 2 objective for providing
a summary of care for each transition of care or referral. We continue
to believe that an up-to-date problem list, active medication list, and
active medication allergy list are important elements to be maintained
in Certified EHR Technology. However, the continued demonstration of
their meaningful use in Stage 2 is required by other objectives focused
on the transitioning of care of patients removing the necessity of
measuring them separately. Providing this information is critical to
continuity of care, so we are proposing to add these as required fields
in the summary of care for the following Stage 2 objective: ``The EP,
eligible hospital or CAH who transitions their patient to another
setting of care or provider of care or refers their patient to another
provider of care should provide summary care record for each transition
of care or referral.'' EPs and hospitals would have to ensure the
accuracy of these fields when providing the summary of care, which we
believe will ensure a high level of compliance in maintaining an up-to-
date problem list, active medication list, and active medication
allergy list for patients. The required standards for these fields are
discussed in the ONC standards and certification proposed rule
published elsewhere in this issue of the Federal Register.
Proposed EP Objective: Record the following demographics: Preferred
language, gender, race and ethnicity, and date of birth.
Proposed Eligible Hospital/CAH Objective: Record the following
demographics: Preferred language, gender, race and ethnicity, date of
birth, and date and preliminary cause of death in the event of
mortality in the eligible hospital or CAH.
The recording of demographic data benefits healthcare and
population health. Gender, race, ethnicity, and age are all established
risk factors for a large number of diseases and conditions. Having this
information available to healthcare providers improves their ability to
care for individual patients. This same information combined with
preferred language and date and cause of death can create revealing
data on the health of populations as small as the population treated by
a single healthcare provider to the national population. Health
disparities can be identified and risk factors for disease and
conditions can be identified and refined, among other uses for this
data.
In order to obtain these benefits, especially for public health, it
is important that information from different sources be comparable. For
this reason, we propose to continue the use of the Office of Management
and Budget (OMB) standards for race and ethnicity (http://www.whitehouse.gov/omb/inforeg_statpolicy/#dr). As outlined in the OMB
policy, more detailed descriptions of race can be used, but ultimately
would need to be mapped to 1 of the 5 races included in the OMB
standards. Current OMB standards align race categories with
[[Page 13712]]
every geographic location in the globe so there are not barriers to
completing such mapping. We recognize that race is a social construct
that varies across cultures and time which is why we fully support the
use of other descriptions that can then be mapped using geography
constructs to the OMB standards. There must also be the option for the
selection of multiple races for a patient and an option for cases when
a patient declines to provide the information.
The recording of the cause of death raised many questions from
providers in Stage 1 of meaningful use. Some cases are referred to
medical examiners to determine the official cause of death while others
are not. Individual hospital policies and local/State laws and
regulations vary. For purposes of meaningful use, we refer to the
preliminary cause of death recorded by the hospital. This preliminary
cause is not required to be amended due to additional information, but
the hospital may amend the information if they want to maintain the
most accurate information. The recording of the preliminary cause of
death also does not have to occur within a specified timeframe from the
death. We believe these clarifications will enable hospitals to meet
this measure, but we encourage comments on our description of recording
the cause of death.
In addition, we encourage public comment on the burden and ability
of including disability status for patients as part of the data
collection for this objective. We believe that the recording of
disability status for certain patients can improve care coordination,
and so we are considering making the recording of disability status an
option for providers. We seek comment on the burden incorporating such
an option would impose on EHR vendors, as well as the burden that
collection of this data might impose on EPs, eligible hospitals, and
CAHs. In addition, we request public comment on--(1) how to define the
concept ``disability status'' in this context; and (2) whether the
option to collect disability status for patients should be captured
under the objective to record demographics, or if another objective
would be more appropriate.
We also seek comment on whether, we should also include the
recording of gender identity and/or sexual orientation. We encourage
commenters to identify the benefits of inclusion and the applicability
across providers.
Proposed Measure: More than 80 percent of all unique patients seen
by the EP or admitted to the eligible hospital's or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period
have demographics recorded as structured data.
For Stage 1 of meaningful use, we adopted a measure of more than 50
percent of all unique patients seen by the EP or admitted to the
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23) have demographics recorded as structured data. We agree with the
HIT Policy Committee recommendation to increase the threshold of this
measure and are proposing a more than 80 percent threshold for Stage 2
of meaningful use. Our experience with Stage 1 shows performance on
this measure above 80 percent.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by the EP or
admitted to an eligible hospital's or CAH's inpatient or emergency
departments (POS 21 or 23) during the EHR reporting period.
Numerator: The number of patients in the denominator who
have all the elements of demographics (or a specific notation if the
patient declined to provide one or more elements or if recording an
element is contrary to State law) recorded as structured data.
Threshold: The resulting percentage must be more than 80
percent in order for an EP, eligible hospital or CAH to meet this
measure.
If a patient declines to provide one or more demographic elements,
this can be noted in the Certified EHR Technology and the EP or
hospital may still count the patient in the numerator for this measure.
The required elements and standards for recording demographics and
noting omissions because of State law restrictions or patients
declining to provide information will be discussed in the ONC standards
and certification proposed rule, published elsewhere in this issue of
the Federal Register.
Proposed Objective: Record and chart changes in the following vital
signs: Height/length and weight (no age limit); blood pressure (ages 3
and over); calculate and display body mass index (BMI); and plot and
display growth charts for patients 0-20 years, including BMI.
Having accurate information on height/length (depending on a
patient's age), weight, and blood pressure both on the current
condition of the patient and changes over time provide context to a
large number and great variety of clinical decisions. By capturing
height, weight, and blood pressure in a structured format, EHRs can
analyze and display the information without the need for intervention
by the provider. The calculation of body mass index and plotting of
growth charts are just two examples. The provider need not do anything
to calculate BMI or plot a growth chart if height and weight are
recorded as structured data because this functionality is included
within Certified EHR Technology. Similarly, information on blood
pressure provides many opportunities for clinical decision support and
the identification of patient education materials. Again, these
automated processes can be enabled within Certified EHR Technology
simply by recording blood pressure as structured data.
We propose to continue our policy from Stage 1 that height/length,
weight, and blood pressure do not each need to be updated by a provider
at every patient encounter nor even once per patient seen during the
EHR reporting period. For this objective, we are primarily concerned
that some information is available to the EP, eligible hospital or CAH,
who can then make the determination based on the patient's individual
circumstances as to whether height/length, weight, and blood pressure
need to be updated. The information can get into the patient's medical
record as structured data in a number of ways. Some examples include
entry by the EP, eligible hospital, or CAH, entry by someone on the EP,
eligible hospital, or CAH's staff, transfer of the information
electronically or otherwise from another provider, or entered directly
by the patient through a portal or other means. Some of these methods
are more accurate than others and it is up to the EP or hospital to
determine what level of accuracy is needed for them to provide care to
the patient and how best to obtain this information. Any method of
obtaining height, weight or blood pressure is acceptable for purposes
of this objective as long as the information is recorded as structured
data.
We have received continuous feedback during Stage 1 of meaningful
use on the appropriate age for collecting these vital signs. In
particular, we have heard from numerous health care professionals and
associations and the HIT Policy Committee recommended that height/
length and weight should not be age-limited and that the limit for
blood pressure should be raised to 3 years of age and older in order to
align with guidelines and recommendations from other health care
associations. We agree with this alignment and propose to remove the
height/length and weight age limits and raise the blood pressure limit
to 3 years of age and older, but we encourage public comment on the age
limitations of vital signs. Age is
[[Page 13713]]
determined based on the date when the patient is last seen by the EP or
admitted to the inpatient or emergency department of the hospital
during the EHR reporting period.
Because we propose to remove the age restrictions on recording
height/length and weight, we also propose to remove the age
restrictions on calculating and displaying BMI and growth charts.
Proposed Measure: More than 80 percent of all unique patients seen
by the EP or admitted to the eligible hospital's or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period
have blood pressure (for patients age 3 and over only) and height/
length and weight (for all ages) recorded as structured data.
We included two exclusions for EPs for this measure in Stage 1 of
meaningful use. The first is that EPs who do not see any patients 2
years old or older (proposed to be raised to 3 years old or older
optionally in 2013 and permanently in 2014) are excluded from recording
blood pressure. The second is for EPs who believe that all 3 vital
signs of height/length, weight, and blood pressure have no relevance to
their scope of practice. We received considerable feedback on Stage 1
that many EPs believe that while they may collect weight and blood
pressure, they do not believe height/length is relevant to their scope
of practice, or that blood pressure is relevant, but not height/length
and weight, or some other combination.
Weight without height/length is not useful from a record keeping
perspective. A 225 pound man who is 5'5'' has different considerations
than a 225 pound man who is 6'5'' . Therefore, we propose to keep the
recording of height/length and weight as linked requirements. We
believe there are situations where height/length and weight may be
relevant, but blood pressure is not. We are less certain that there
would be cases where blood pressure is relevant, but height/length and
weight are not. We propose for Stage 2 to split the exclusion so that
an EP can choose to record height/length and weight only and exclude
blood pressure or record blood pressure only and exclude height/length
and weight. We encourage comments on this split and whether it should
or should not go both ways.
For Stage 1 of meaningful use, we adopted a measure of more than 50
percent of all unique patients seen by the EP or admitted to the
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23) have vital signs recorded as structured data. We agree with the
HIT Policy Committee recommendation to increase the threshold of this
measure and are proposing a more than 80 percent threshold for Stage 2
of meaningful use. Our preliminary Stage 1 data shows that the
recording of vital signs far exceeded the measure threshold of more
than 50 percent, so we are proposing a threshold of 80 percent for this
measure for Stage 2 of meaningful use. We will continue to monitor this
Stage 1 data as we solicit public comment so that we can determine if
the more than 80 percent threshold is appropriate for this measure.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by the EP or
admitted to an eligible hospital's or CAH's inpatient or emergency
department (POS 21 or 23) during the EHR reporting period.
Numerator: Number of patients in the denominator who have
at least one entry of their height/length and weight (all ages) and
blood pressure (ages 3 and over) recorded as structured data.
Threshold: The resulting percentage must be more than 80
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
Exclusions: Any EP who sees no patients 3 years or older is
excluded from recording blood pressure.
Any EP who believes that all 3 vital signs of height/length,
weight, and blood pressure have no relevance to their scope of practice
is excluded from recording them.
An EP who believes that height/length and weight are relevant to
their scope of practice, but blood pressure is not, is excluded from
recording blood pressure. An EP who believes that blood pressure is
relevant to their scope of practice, but height/length and weight are
not, is excluded from recording height/length and weight.
Proposed Objective: Record smoking status for patients 13 years old
or older.
Accurate information on smoking status provides context to a high
number and wide variety of clinical decisions, such as immediate needs
for smoking cessation or long-term outcomes for chronic obstructive
pulmonary disease. Cigarette smoking is a key component to the current
Million Hearts Initiative (http://millionhearts.hhs.gov). We do not
propose rules on who may record smoking status or how often the record
should be updated.
For Stage 2, we propose to limit this measure to those patients 13
years old and older (as we did in Stage 1). We have not observed any
significant consensus around when it is appropriate to collect smoking
status, regardless of the presence or absence of other risk factors. If
commenters disagree with our age limitation, we encourage them to
include their reasons for disagreement and any evidence that may be
available as to improved consensus among healthcare providers on what
age limit is appropriate.
In Stage 1 of meaningful use, we considered whether to expand the
collection of information from smoking status to other forms of tobacco
use. We continue to believe that there are insufficient electronic
standards for collecting information on other types of tobacco use and
that situations where a patient might use multiple types of tobacco
would damage the standardized collection of smoking data, but we
request comment on whether this is the case.
Finally, in Stage 1 of meaningful use, we considered whether to
include second hand smoke information as part of this objective. We
continue to believe that the level of complexity in introducing this
requirement is beyond a reasonable expectation of meaningful use at
this time. We believe it would be difficult to define what constitutes
a level of exposure to trigger recording second hand smoke information.
We encourage commenters to submit information to us that demonstrates
consensus and/or standards around the collection of second hand smoking
data that would provide the basis on which to create an additional
tobacco-related measure that is applicable to all EPs and hospitals.
Proposed Measure: More than 80 percent of all unique patients 13
years old or older seen by the EP or admitted to the eligible
hospital's or CAH's inpatient or emergency departments (POS 21 or 23)
during the EHR reporting period have smoking status recorded as
structured data.
In Stage 1 of meaningful use, we adopted a measure of more than 50
percent of all unique patients 13 years old or older seen by the EP or
admitted to the eligible hospital's or CAH's inpatient or emergency
departments (POS 21 or 23) have smoking status recorded as structured
data. As we discussed in the Stage 1 final rule (75 FR 44344), there
were many concerns by commenters over the appropriate age at which to
inquire about smoking status. There were also considerable differences
among commenters as to what the appropriate inquiry was and what it
should have included. Because of these comments, we adopted 50 percent
as the measure of this objective. The HIT Policy Committee recommended
an increase in the
[[Page 13714]]
threshold of this measure from more than 50 percent to more than 80
percent. Our preliminary Stage 1 data shows that the recording of
smoking status far exceeded the measure threshold of more than 50
percent, so we are proposing a threshold of 80 percent for this measure
for Stage 2 of meaningful use. We will continue to monitor this Stage 1
data as we solicit public comment so that we can determine if the more
than 80 percent threshold is appropriate for this measure.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients age 13 or older
seen by the EP or admitted to an eligible hospital's or CAH's inpatient
or emergency departments (POS 21 or 23) during the EHR reporting
period.
Numerator: The number of patients in the denominator with
smoking status recorded as structured data.
Threshold: The resulting percentage must be more than 80
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
Exclusion: Any EP, eligible hospital, or CAH that neither sees nor
admits any patients 13 years old or older.
Replaced EP Objective: Report ambulatory clinical quality measures
to CMS or, in the case of Medicaid EPs, the States.
Replaced Eligible Hospital/CAH Objective: Report hospital clinical
quality measures to CMS or, in the case of Medicaid eligible hospitals,
the States.
In addition to the meaningful use core and menu objectives, EPs and
hospitals are still required to report clinical quality measures to CMS
or the States in order to demonstrate meaningful use of Certified EHR
Technology. However, we propose to eliminate these objectives under 42
CFR 495.6 and instead include the reporting of clinical quality
measures (CQMs) as part of the definition of ``meaningful EHR user''
under 42 CFR 495.4. For more information about the requirements for
reporting clinical quality measures, see section II.B.3. of this
proposed rule. As explained in that section, we are proposing to move
to electronic reporting of clinical quality measure information.
Because the core and menu objectives under Sec. 495.6 are reported
through attestation, we believe it makes more sense to separate the
reporting of CQMs from the other meaningful use objectives and measures
for Stage 2.
Proposed Objective: Use clinical decision support to improve
performance on high-priority health conditions.
Clinical decision support at the point of care is an area of health
IT in which significant evidence exists for its substantial positive
impact on the quality, safety, and efficiency of care delivery. In
Stage 1, we specified that the clinical decision support rule should be
relevant to the provider's specialty or related to a high clinical
priority. We purposely used a description that would allow a provider
significant leeway in determining the clinical decision support
interventions that are most relevant to their scope of practice and
benefit their patients in the greatest way. Following the
recommendations of the HIT Policy Committee, we are proposing to modify
the objective for Stage 2 to using clinical decision support to improve
performance on high-priority health conditions. We believe that it is
best left to the provider's clinical discretion to determine which
clinical decision support interventions would address high-priority
conditions for their individual patient populations, but we are
requiring as a measure of this objective that the clinical decision
support intervention be related to 5 or more of the clinical quality
measures on which EPs or hospitals would be expected to report. We
define ``related'' to mean that the intervention's intent is to improve
the performance of the EP, eligible hospital, or CAH on a given
clinical quality measure. Because clinical quality measures focus on
high-priority health conditions by definition, this alignment will
ensure that clinical decision support is also focused on high-priority
health conditions and improved performance in measurable quality areas.
For Stage 2, we are also proposing to make the Stage 1 objective
for ``Implement drug-drug and drug-allergy checks'' one of the measures
of this clinical decision support objective. We continue to believe
that automated drug-drug and drug-allergy checks provide important
information to advise the provider's decisions in prescribing drugs to
a patient. Because this functionality provides important clinical
decision support that focuses on patient health and safety, we believe
it is appropriate to include this functionality as part of this
objective for using clinical decision support. Finally, we have
replaced the term ``clinical decision support rule'' used in our Stage
1 rule with the term ``clinical decision support intervention'' to
better align with, and clearly allow for, the variety of decision
support mechanisms available to help improve clinical performance and
outcomes. This mirrors an identical change in the ONC Standards and
Certification proposed rule.
Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy
both measures in order to meet the objective:
1. Implement 5 clinical decision support interventions related to 5
or more clinical quality measures at a relevant point in patient care
for the entire EHR reporting period.
2. The EP, eligible hospital, or CAH has enabled and implemented
the functionality for drug-drug and drug-allergy interaction checks for
the entire EHR reporting period.
The drug-drug and drug-allergy checks and the implementation of 5
clinical decision support interventions are separate measures for this
objective. Therefore the EP or hospital must implement clinical
decision support interventions in addition to drug-drug and drug-
allergy interaction checks.
For Stage 2 based on the HIT Policy Committee recommendations, each
clinical decision support intervention must enable the provider to
review all of the following attributes of the intervention: Developer
of the intervention, bibliographic citation, funding source of the
intervention, and release/revision date of the intervention. This will
enable providers to review complete information including any potential
conflict of interest for the decision support intervention(s), if they
so choose. Certified EHR technology will display these attributes
allowing providers to review them. Such information may be valuable so
that providers can understand whether the clinical evidence that the
intervention represents is current, and whether the development of that
intervention was sponsored by an organization that may have conflicting
business interests including, but not limited to, a pharmaceutical
company, pharmacy benefits management company, or device manufacturer.
We believe that there may be cases in which such organizations will
have interest in sponsoring clinical decision support interventions,
and such interventions may very well be in the patient's best interest.
Nonetheless, such sponsorship should be made transparent to the
provider using the system.
In addition to the review of clinical decision support attributes,
providers must implement the clinical decision support intervention at
a relevant point in patient care when the intervention can influence
clinical decision making before an action is taken on behalf of the
patient. Although we leave it to the provider's clinical discretion to
determine the relevant point in patient
[[Page 13715]]
care when such interventions will be most effective, the interventions
must be presented through Certified EHR Technology to a licensed
healthcare professional who can exercise clinical judgment about the
decision support intervention before an action is taken on behalf of
the patient.
Finally, we propose that clinical decision support intervention
must be related to 5 or more of the clinical quality measures that we
will finalize for EPs and hospitals and on which they will be expected
to report. By relating clinical decision support interventions to one
or more clinical quality measures, providers are necessarily focusing
on high-priority health conditions, as required by the objective and
recommended by the HIT Policy Committee. Providers would implement 5
clinical decision support interventions that they believe will result
in improvement in performance for 5 or more of the clinical quality
measures on which they report. For example, EPs reporting on the
clinical quality measure of ``Preventive Care and Screening: Influenza
Immunization for Patients 50 Years Old or Older'' (NQF 0041, PQRI 110)
could choose to implement a clinical decision support intervention that
triggers an alert in Certified EHR Technology prompting a licensed
healthcare professional to ask about influenza immunizations whenever a
patient 50 years old or older presents for an office visit or other
action that increases the likelihood that the patient receives an
influenza immunization.
Please note that for Stage 2, we do not propose to require the
provider to demonstrate actual improvement in performance on clinical
quality measures. Rather, the provider must use the goal of improvement
in performance for a clinical quality measure when the provider selects
a clinical decision support intervention to implement. If none of the
clinical quality measures are applicable to an EP's scope of practice,
the EP should implement a clinical decision support intervention that
he or she believes will be effective in improving the quality, safety,
or efficiency of patient care. We believe that the proposed clinical
quality measures for eligible hospitals and CAHs would provide ample
opportunity for implementing clinical decision support interventions
related to high-priority health conditions.
We do not believe that any EP, eligible hospital, or CAH would be
in a situation where they could not implement five clinical decision
support intervention as previously described. Therefore, we do not
propose any exclusions for this objective and its associated measure.
Replaced Objective: Provide patients with an electronic copy of
their health information.
Replaced Objective: Provide patients with an electronic copy of
their discharge instructions.
For Stage 2, we are not proposing the Stage 1 meaningful use
objectives for EPs and hospitals to provide patients with an electronic
copy of their health information and discharge instructions upon
request. The HIT Policy Committee recommended that these objectives be
combined with objectives for online viewing and downloading. We agree
with the HIT Policy Committee and are replacing these Stage 1
objectives with proposed objectives and measures for Stage 2 that would
enable patients to view online and download their health information
and hospital admission information (discussed later in this rule). We
believe that continued online access to such information is more useful
and provides greater accessibility over time and in different health
care environments than a single electronic transmission or a one-time
provision of an electronic copy, especially when that access is coupled
with the ability to download a comprehensive point in time record.
Proposed EP Objective: Provide clinical summaries for patients for
each office visit.
A summary of an office visit provides patients and their families
with a record of the visit. This record can prove to be a vital
reference for the patient and their caregivers about their health and
actions they should be taking to improve their health. Without this
reference, the patient must either recall each detail of the visit,
potentially missing vital information, or contact the provider after
the visit. Certified EHR technology enables the provider to create a
summary easily and in many cases instantly. This capability removes
nearly all of the barriers that exist when using paper records.
We also note that this is a meaningful use requirement, which does
not override an individual's broader right under HIPAA to access his or
her health information. Providers must continue to comply with all
applicable requirements under the HIPAA Privacy Rule, including the
access provisions of 45 CFR 164.524. However, none of the HIPAA access
requirements preclude an EP from releasing electronic copies of
clinical summaries to their patients as required by this meaningful use
provision.
Proposed EP Measure: Clinical summaries provided to patients within
24 hours for more than 50 percent of office visits.
Following the recommendation of the HIT Policy Committee, we
propose to continue the 50 percent threshold from Stage 1. Although
many EPs provide paper summaries as the patient leaves the office, we
believe that a timeframe is still needed for those EPs who provide
electronic summaries either as the provider's preferred method of
distribution or to accommodate patient requests for electronic
summaries. Because the clinical summary is intended to be a summary of
clinical information relevant to an office visit, we agree with the HIT
Policy Committee that 24 hours is a sufficient timeframe in which to
provide this summary. We note that the vast majority of information
required in the clinical summary should be immediately available upon
completion of the office visit. Although we provided 3 business days to
send the clinical summary in Stage 1, we now believe that a faster
exchange of information with patient is not only possible but also
encourages better quality of care. However, we welcome comments on this
timeframe. As in Stage 1, if a paper summary is mailed to the patient,
the timeframe relates to when the summary is mailed and not when it is
received by the patient.
Summaries of an office visit can quickly become out of date due to
information not available to the EP at the end of the visit. The most
common example of this is laboratory results. When such information
becomes available, the HIT Policy Committee recommended that the EP
have 4 business days to make the information known to the patient. We
concur that EPs should make this information known to the patient, but
do not believe that a new clinical summary must be issued in every
instance. For example, current common practice is for laboratory
results to be delivered by phone. We are proposing another objective of
meaningful use that would provide for online access to the latest
health information, whereas this clinical summary objective focuses on
a singular visit. We also are concerned with the practicality of
measuring this aspect and cannot determine how we would assign a
denominator to it. The EHR would have to be capable of recognizing that
additional information is available, link such information to a
specific office visit, time the provision of information to the
patient, and create a record that the patient was notified. We believe
that this is too burdensome. The clinical summary would include
information on pending tests, and therefore, will alert
[[Page 13716]]
patients that more information may soon be available if necessary. To
calculate the percentage, CMS and ONC have worked together to define
the following for this objective:
Denominator: Number of office visits conducted by the EP
during the EHR reporting period.
Numerator: Number of office visits in the denominator
where the patient is provided a clinical summary of their visit within
24 hours.
Threshold: The resulting percentage must be more than 50
percent in order for an EP to meet this measure.
Exclusion: Any EP who has no office visits during the EHR reporting
period.
We propose to require the following information to be part of the
clinical summary for Stage 2:
Patient Name.
Provider's name and office contact information.
Date and location of the visit.
Reason for the office visit.
Current problem list and any updates to it.
Current medication list and any updates to it.
Current medication allergy list and any updates to it.
Procedures performed during the visit.
Immunizations or medications administered during the
visit.
Vital signs and any updates.
Laboratory test results.
List of diagnostic tests pending.
Clinical instructions.
Future appointments.
Referrals to other providers.
Future scheduled tests.
Demographics maintained by EP (gender, race, ethnicity,
date of birth, preferred language). (New requirement for Stage 2.)
Smoking status (New requirement for Stage 2.)
Care plan field, including goals and instructions. (New
requirement for Stage 2.)
Recommended patient decision aids (if applicable to the
visit). (New requirement for Stage 2.)
This is not intended to limit the information made available in the
clinical summary by the EP. An EP can make available additional
information and still meet the objective. The content of the care plan
is dependent on the clinical context. We propose to describe a care
plan as the structure used to define the management actions for the
various conditions, problems, or issues. For purposes of meaningful use
measurement, we propose that a care plan must include at a minimum the
following components: Problem (the focus of the care plan), goal (the
target outcome) and any instructions that the provider has given to the
patient. A goal is a defined target or measure to be achieved in the
process of patient care (an expected outcome).
We encourage EPs to develop the most robust care plan that is
warranted by the situation. We also welcome comments on both our
description of a care plan and whether a description is necessary for
purpose of meaningful use. When an office visit lasts for several
consecutive days and/or the patient is seen by multiple EPs during one
office visit, a single consolidated summary at the end of the visit
meets this objective. An example of a multiday office visit could be an
evaluation one day, a diagnostic test the next and a follow-up
treatment the next day based on the results of the test. Even in cases
where multiple office visits occur under a global or bundled claim/fee,
each visit results in an update to the status of the health of the
patient and must be accompanied with a clinical summary.
We would also maintain several other policies from Stage 1. For
purposes of meaningful use, an EP may withhold information from the
clinical summary if they believe substantial harm may arise from its
disclosure through an after-visit clinical summary. An EP can choose
whether to offer the summary electronically or on paper by default, but
at the patient's request must make the other form available. The EP can
select any modality (for example, online, CD, USB) as their electronic
option and does not have to accommodate requests for different
modalities. We do not believe it would be appropriate for an EP to
charge the patient a fee for providing the summary.
When a single consolidated summary is provided for an office visit
that lasts for several consecutive days, or for an office visit where a
patient is seen by multiple EPs, that office visit must be counted only
once in both the numerator and denominator of the measure.
Removed Objective: Capability to exchange key clinical information.
In Stage 2, we propose to move to actual use cases of electronic
exchange of health information through the following objective: ``The
EP, eligible hospital or CAH who transitions their patient to another
setting of care or provider of care or refers their patient to another
provider of care should provide summary care record for each transition
of care or referral.'' We believe that this actual use case is more
beneficial and easier to understand. We also propose to remove this
objective for Stage 1 as well, but consider other option. Please refer
to the section titled ``Changes to Stage 1'' for details of the options
considered. As we propose that the EHR reporting period for Stage 2 of
meaningful use is the entire year, a prudent provider would be
preparing and testing to conduct actual exchange prior to the start of
Stage 2 during their Stage 1 EHR reporting periods.
Proposed Objective: Protect electronic health information created
or maintained by the Certified EHR Technology through the
implementation of appropriate technical capabilities.
Protecting electronic health information is essential to all other
aspects of meaningful use. Unintended and/or unlawful disclosures of
personal health information could diminish consumers' confidence in
EHRs and electronic health information exchange. Ensuring that health
information is adequately protected and secured will assist in
addressing the unique risks and challenges that may be presented by
electronic health records.
Proposed Measure: Conduct or review a security risk analysis in
accordance with the requirements under 45 CFR 164.308(a)(1), including
addressing the encryption/security of data at rest in accordance with
requirements under 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3),
and implement security updates as necessary and correct identified
security deficiencies as part of the provider's risk management
process.
This measure is the same as in Stage 1 except that we specifically
address the encryption/security of data that is stored in Certified EHR
Technology (data at rest). Due to the number of breaches reported to
HHS involving lost or stolen devices, the HIT Policy Committee
recommended specifically highlighting the importance of an entity's
reviewing its encryption practices as part of its risk analysis. We
agree that this is an area of security that appears to need specific
focus. Recent HHS analysis of reported breaches indicates that almost
40 percent of large breaches involve lost or stolen devices. Had these
devices been encrypted, their data would have been secured. It is for
these reasons that we specifically call out this element of the
requirements under 45 CFR 164.308(a)(1) for the meaningful use measure.
We do not propose to change the HIPAA Security Rule requirements, or
require any more than would be required under HIPAA. We only emphasize
the importance of an EP or hospital including in its security risk
analysis an assessment of the reasonableness and appropriateness of
encrypting electronic protected health information as a means of
securing it, and where it is not reasonable and
[[Page 13717]]
appropriate, the adoption of an equivalent alternative measure.
We propose this measure because the implementation of Certified EHR
Technology has privacy and security implications under 45 CFR
164.308(a)(1). A review must be conducted for each EHR reporting period
and any security updates and deficiencies that are identified should be
included in the provider's risk management process and implemented or
corrected as dictated by that process.
We emphasize that our discussion of this measure and 45 CFR
164.308(a)(1) is only relevant for purposes of the meaningful use
requirements and is not intended to supersede what is separately
required under HIPAA and other rulemaking. Compliance with the HIPAA
requirements is outside of the scope of this rulemaking. Compliance
with 42 CFR Part 2 and State mental health privacy and confidentiality
laws is also outside the scope of this rulemaking. EPs, eligible
hospitals or CAH affected by 42 CFR Part 2 should consult with the
Substance Abuse and Mental Health Services Administration (SAMHSA) or
State authorities.
(b) Objectives and Measures Carried Over (Modified or Unmodified)
from Stage 1 Menu Set to Stage 2 Core Set
We signaled our intent in the Stage 1 final rule to move the
objectives from the Stage 1 menu set to the Stage 2 core set. The HIT
Policy Committee also recommended that we move all of these objectives
to the core set for Stage 2. We propose to include in the Stage 2 core
set all of the objectives and associated measures from the Stage 1 menu
set, except for the objective ``capability to submit electronic
syndromic surveillance data to public health agencies'' for EPs, which
would remain in the menu set for Stage 2. As discussed later, we also
propose to modify and combine some of these objectives and associated
measures for Stage 2.
Consolidated Objective: Implement drug formulary checks.
For Stage 2, we are proposing to include this objective within the
core objective for EPs ``Generate and transmit permissible
prescriptions electronically (eRx)'' and the menu objective for
eligible hospitals and CAHs of ``Generate and transmit permissible
discharge prescriptions electronically (eRx).'' We believe that drug
formulary checks are most useful when performed in combination with e-
prescribing, where such checks can allow the EP or hospital to increase
the efficiency of care and benefit the patient financially.
Proposed Objective: Incorporate clinical lab-test results into
Certified EHR Technology as structured data.
We believe that incorporating clinical lab-test results into
Certified EHR Technology as structured data assists in the exchange of
complete information between providers of care, facilitates the sharing
of information with patients and their designated representatives, and
contributes to the improvement of health care delivery to the patient.
We encourage every EP, eligible hospital, and CAH to utilize electronic
exchange of results with laboratories in accordance with the
certification criteria in the ONC standards and certification proposed
rule published elsewhere in this issue of the Federal Register. If
results are not received through electronic exchange, then they are
presumably received in another form (such as by fax, telephone call,
mail) and would need to be incorporated into the patient's medical
record in some way. We encourage the recording of results as structured
data; however, there would be risk of recording the data twice (for
example, scanning the faxed results and then entering the results as
structured data). To reduce the risk of entry error, we highly
encourage the electronic exchange of the results with the laboratory,
instead of manual entry through typing, option selecting, scanning or
other means.
Proposed Measure: More than 55 percent of all clinical lab tests
results ordered by the EP or by authorized providers of the eligible
hospital or CAH for patients admitted to its inpatient or emergency
department (POS 21 or 23) during the EHR reporting period whose results
are either in a positive/negative or numerical format are incorporated
in Certified EHR Technology as structured data.
Although the HIT Policy Committee did not recommend an increase in
the threshold for this measure, our initial data on Stage 1 of
meaningful use shows high compliance with this measure for those
providers individually selecting the objective from the menu set.
Therefore we are proposing to increase the threshold of this objective
to 55 percent for Stage 2.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of lab tests ordered during the EHR
reporting period by the EP or by authorized providers of the eligible
hospital or CAH for patients admitted to its inpatient or emergency
department (POS 21 or 23) whose results are expressed in a positive or
negative affirmation or as a number.
Numerator: Number of lab test results whose results are
expressed in a positive or negative affirmation or as a number which
are incorporated in Certified EHR Technology as structured data.
Threshold: The resulting percentage must be more than 55
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
Exclusion: Any EP who orders no lab tests whose results are either
in a positive/negative or numeric format during the EHR reporting
period.
There is no exclusion available for eligible hospitals and CAHs
because we do not believe any hospital will ever be in a situation
where its authorized providers have not ordered any lab tests for
admitted patients during an EHR reporting period.
Reducing the risk of entry error is one of the primary reasons we
lowered the measure threshold to 40 percent for Stage 1, during which
providers are changing their workflow processes to accurately
incorporate information into EHRs through either electronic exchange or
manual entry. However, for this measure, we do not limit the EP,
eligible hospital or CAH to only counting structured data received via
electronic exchange, but count in the numerator all structured data. By
entering these results into the patient's medical record as structured
data, the EP, eligible hospital or CAH is accomplishing a task that
must be performed regardless of whether the provider is attempting to
demonstrate meaningful use or not. We believe that entering the data as
structured data encourages future exchange of information. We have
received inquiries on Stage 1 on how to account for laboratory tests
that are ordered in a group or panel. The inquiries have highlighted
several problems this creates for measurement (for example, EHR only
counting a panel as one, but the results individually creating more
than 100 percent performance, panels that include tests that are
included in the measure and other tests that are not included in the
measure, EHRs that count the entire panel if one test meets the
numerator criteria). The measure in Stage 1 and Stage 2 counts lab
tests individually, not as panels or groups in both the numerator and
the denominator for the very complications illustrated by the inquiries
that occur when this is not done. However, we solicit comment on
whether such individual accounting is infeasible. We note that this in
no way precludes the use of grouping and panels when ordering labs.
While we are not proposing to move beyond numeric and
[[Page 13718]]
yes/no tests, we request comments on whether standards and other
capabilities would allow us to expand the measure to all quantitative
results (all results that can be compared on as a ratio or on a
difference scale).
Proposed Objective: Generate lists of patients by specific
conditions to use for quality improvement, reduction of disparities,
research, or outreach.
Generating patient lists is the first step in proactive management
of populations with chronic conditions and is critical to providing
accountable care. The ability to look at a provider's entire population
or a subset of that population brings insight that is simply not
available when looking at patients individually. Small variations that
are unnoticeable or seem insignificant on an individual basis can be
magnified when multiplied across a population. A number of studies have
shown that significant improvements result merely due to provider
awareness of population level information. We believe that many EPs and
eligible hospitals would use these reports in combination with one of
the selected quality measures and decision support interventions to
improve quality for a high priority issue (for example, identify
patients who are in the denominator for a measure, but not the
numerator, and in need of an intervention). The capabilities and
variables used to generate the lists are defined in the ONC standards
and certification proposed rule published elsewhere in this issue of
the Federal Register; not all capabilities and variables must be used
for every list.
Proposed Measure: Generate at least one report listing patients of
the EP, eligible hospital, or CAH with a specific condition.
We propose to continue our Stage 1 policies for this measure. The
objective and measure do not dictate the specific report(s) that must
be generated, as the EP, eligible hospital, or CAH is best positioned
to determine which reports are most useful to their care efforts. The
report used to meet the measure can cover every patient or a subset of
patients. We believe there is no EP, eligible hospital, or CAH that
could not benefit their patient population or a subset of their patient
population by using such a report to identify opportunities for quality
improvement, reductions in disparities of patient care, or for purposes
of research or patient outreach; therefore, we do not propose an
exclusion for this measure. The report can be generated by anyone who
is on the EP's or hospital's staff during the EHR reporting period. We
are also seeking comment on whether a measure that either increases the
number and/or frequency of the patient lists would further the intent
of this objective.
Proposed EP Objective: Use clinically relevant information to
identify patients who should receive reminders for preventive/follow-up
care.
By proactively reminding patients of preventive and follow-up care
needs, EPs can increase compliance. These reminders are especially
beneficial when long time lapses may occur as with some preventive care
measures and when symptoms subside, but additional follow-up care is
still required.
In Stage 1, this objective was stated as ``Send reminders to
patients per patient preference for preventive/follow-up care.'' For
Stage 2, the HIT Policy Committee recommended that clinically relevant
information from Certified EHR Technology be used to identify patients
to whom reminders of preventive/follow-up care would be most
beneficial. We agree with this recommendation and are proposing to
modify this objective for Stage 2 as ``Use clinically relevant
information to identify patients who should receive reminders for
preventive/follow-up care.'' An EP should use clinically relevant
information stored within the Certified EHR Technology to identify
patients who should receive reminders. We believe that the EP is best
positioned to decide which information is clinically relevant for this
purpose.
Proposed EP Measure: More than 10 percent of all unique patients
who have had an office visit with the EP within the 24 months prior to
the beginning of the EHR reporting period were sent a reminder, per
patient preference.
In Stage 1, the measure of this objective was limited to more than
20 percent of all patients 65 years old or older or 5 years old or
younger. Rather than raise the threshold for this measure, the HIT
Policy Committee recommended lowering the threshold but extending the
measure to all active patients. We propose to apply the measure of this
objective to all unique patients who have had an office visit with the
EP within the 24 months prior to the beginning of the EHR reporting
period. We believe this not only identifies the population most likely
to consist of active patients, but also allows the EP flexibility to
identify patients within that population who can benefit most from
reminders. We encourage comments on the appropriateness of this
timeframe. We also recognize that some EPs may not conduct face-to-face
encounters with patients but still provide treatment to patients. These
EPs could be unintentionally prevented from meeting this core objective
under the measure requirements, so we are proposing an exclusion for
EPs who have no office visits in order to accommodate such EPs. Patient
preference refers to the method of providing the reminder.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients who have had an
office visit with the EP in the 24 months prior to the beginning of the
EHR reporting period.
Numerator: Number of patients in the denominator who were
sent a reminder per patient preference during the EHR reporting period.
Threshold: The resulting percentage must be more than 10
percent in order for an EP to meet this measure.
Exclusion: Any EP who has had no office visits in the 24 months
before the EHR reporting period.
Proposed EP Objective: Provide patients the ability to view online,
download, and transmit their health information within 4 business days
of the information being available to the EP.
The goal of this objective is to allow patients easy access to
their health information as soon as possible so that they can make
informed decisions regarding their care or share their most recent
clinical information with other health care providers and personal
caregivers as they see fit. In addition, this objective aligns with the
Fair Information Practice Principles (FIPPs),\1\ in affording baseline
privacy protections to individuals.\2\ In particular, the principles
include Individual Access (patients should be provided with a
[[Page 13719]]
simple and timely means to access and obtain their individually
identifiable information in a readable form and format). This objective
replaces the Stage 1 core objective for EPs of ``Provide patients with
an electronic copy of their health information (including diagnostic
test results, problem list, medication lists, medication allergies)
upon request'' and the Stage 1 menu objective for EPs of ``Provide
patients with timely electronic access to their health information
(including lab results, problem list, medication lists, and allergies)
within 4 business days of the information being available to the EP.''
The HIT Policy Committee recommended making this a core objective for
Stage 2 for EPs, and we agree with their recommendation consistent with
our policy of moving Stage 1 menu objectives to the core set for Stage
2. Consistent with the Stage 1 requirements, the patient must be able
to access this information on demand, such as through a patient portal
or personal health record (PHR). However, providers should be aware
that while meaningful use is limited to the capabilities of CEHRT to
provide online access there may be patients who cannot access their
EHRs electronically because of their disability. Additionally, other
health information may not be accessible. Providers who are covered by
civil rights laws must provide individuals with disabilities equal
access to information and appropriate auxiliary aids and services as
provided in the applicable statutes and regulations.
---------------------------------------------------------------------------
\1\ In 1973, the Department of Health, Education, and Welfare
(HEW) released its report, Records, Computers, and the Rights of
Citizens, which outlined a Code of Fair Information Practices that
would create ``safeguard requirements'' for certain ``automated
personal data systems'' maintained by the Federal Government. This
Code of Fair Information Practices is now commonly referred to as
fair information practice principles (FIPPs) and established the
framework on which much privacy policy would be built. There are
many versions of the FIPPs; the principles described here are
discussed in more detail in The Nationwide Privacy and Security
Framework for Electronic Exchange of Individually Identifiable
Health Information, December 15, 2008. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
\2\ The FIPPs, developed in the United States nearly 40 years
ago, are well-established and have been incorporated into both the
privacy laws of many states with regard to government-held records
\2\ and numerous international frameworks, including the development
of the OECD's privacy guidelines, the European Union Data Protection
Directive, and the Asia-Pacific Economic Cooperation (APEC) Privacy
Framework. http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
---------------------------------------------------------------------------
In the Stage 1 final rule (75 FR 44356), we indicated that
information should be available to the patient through online access
within 4 business days of the information being available to the EP
through either the receipt of final lab results or a patient encounter
that updates the EP's knowledge of the patient's health. For Stage 2,
we propose to maintain the requirement of information being made
available to the patient through online access within 4 business days
of the information being available to the EP. To that end, we propose
to continue the definition of business days as Monday through Friday
excluding Federal or State holidays on which the EP or their
administrative staff are unavailable. The HIT Policy Committee
recommended that EPs be required to make information resulting from a
patient encounter available within 24 hours instead of 4 business days.
They also recommended continuing the 4 business day timeframe for
updates following the receipt of new information. We believe that
splitting the timeframes in this manner adds unnecessary complexity to
this objective and associated measure. We believe that 4 business days
remains a reasonable timeframe and limits the needs for updating. To
the extent that Certified EHR Technologies enable a quicker posting
time we expect that this will be workflow benefit to the providers and
they will utilize this quicker time regardless of the threshold
timeline in meaningful use.
Proposed EP Measures: We propose 2 measures for this objective,
both of which must be satisfied in order to meet the objective:
1. More than 50 percent of all unique patients seen by the EP
during the EHR reporting period are provided timely (within 4 business
days after the information is available to the EP) online access to
their health information subject to the EP's discretion to withhold
certain information.
2. More than 10 percent of all unique patients seen by the EP
during the EHR reporting period (or their authorized representatives)
view, download or transmit to a third party their health information.
Transmission can be any means of electronic transmission according
to any transport standard(s) (SMTP, FTP, REST, SOAP, etc.). However,
the relocation of physical electronic media (for example, USB, CD) does
not qualify as transmission although the movement of the information
from online to the physical electronic media would be a download.
To calculate the percentage of the first measure for providing
patient with timely online access to health information, CMS and ONC
have worked together to define the following for this objective:
Denominator: Number of unique patients seen by the EP
during the EHR reporting period.
Numerator: The number of patients in the denominator who
have timely (within 4 business days after the information is available
to the EP) online access to their health information online.
Threshold: The resulting percentage must be more than 50
percent in order for an EP to meet this measure.
To calculate the percentage of the second measure for patients or
patient-authorized representatives to view, download or transmit health
information, CMS and ONC have worked together to define the following
for this objective:
Denominator: Number of unique patients seen by the EP
during the EHR reporting period.
Numerator: The number of unique patients (or their
authorized representatives) in the denominator who have viewed online
or downloaded or transmitted to a third party the patient's health
information.
Threshold: The resulting percentage must be more than 10
percent in order for an EP to meet this measure.
Exclusions: Any EP who neither orders nor creates any of the
information listed for inclusion as part of this measure may exclude
both measures. Any EP that conducts 50 percent or more of his or her
patient encounters in a county that does not have 50 percent or more of
its housing units with 4Mbps broadband availability according to the
latest information available from the FCC on the first day of the EHR
reporting period may exclude only the second measure.
The thresholds of both of these measures must be reached in order
for the EP to meet the objective. If the EP reaches one of these
thresholds but not the other, then the EP will fail to meet this
objective, unless the EP meets an applicable exclusion. An EP that
conducts the 50 percent or more of his or her patient encounters in a
county that does not have 50 percent or more of its housing units with
4Mbps broadband availability according to the latest information
available from the FCC on the first day of the EHR reporting period may
exclude the second measure. According to the FCC at the time of
formulation of this proposed rule, 370 counties in the United States
have broadband penetration of less than 50 percent (www.broadband.gov).
Further discussion of this exclusion can be found under the eligible
hospital and CAH objective of ``Provide patients the ability to view
online, download, and transmit information about a hospital
admission.'' We are also proposing that an EP who neither orders nor
creates any of the information listed for inclusion as part of these
measures may exclude both the first and second measures.
Consistent with the recommendations of the HIT Policy Committee, we
are proposing a threshold of more than 10 percent for patients (or
their authorized representatives) to view, download or transmit to a
third party health information. An EP has any number of ways to make
this information available online. The EP can host a patient portal,
contract with a vendor to host a patient portal, connect with an online
PHR or other means. As long as the patient can view, download, and
transmit the information using a standard web browser and internet
connection, the
[[Page 13720]]
means is at the discretion of the EP. We note that this new measure
does not focus solely on access and instead requires action by patients
or their authorized representatives in order for the EP to meet it. A
patient who views their information online, downloads it from the
internet or uses the internet to transmit it to a third party would
count for purposes of the numerator. While this is a departure from
most meaningful use measures, which are dependent solely on actions
taken by the EP, we believe that requiring a measurement of patient use
ensures that the EP will promote the availability and active use of
electronic health information by the patient or their authorized
representatives. Furthermore, we believe that accountable care should
extend to meaningful use objectives that encourage patient and family
engagement. We invite comment on this new measure and whether the 10
percent threshold is too high or too low given the patient's role in
achieving it.
We define patient-authorized representative as any individual to
whom the patient has granted access to their health information.
Examples would include family members, an advocate for the patient, or
other individual identified by the patient. A patient would have to
affirmatively grant access to these representatives with the exception
of minors for whom existing local, State or Federal law grants their
parents or guardians access without the need for the minor to consent
and individuals who are unable to provide consent and where the State
appoints a guardian.
In order to make the information available to patients online
consistent with the information provided during transitions of care, we
are aligning the information required to meet this objective with the
information provided in the summary of care record for each transition
of care or referral. Therefore, in order to meet this objective, the
following information must be made available to patients electronically
within 4 business days of the information being made available to the
EP:
Patient name.
Provider's name and office contact information.
Problem list.
Procedures.
Laboratory test results.
Medication list.
Medication allergy list.
Vital signs (height, weight, blood pressure, BMI, growth
charts).
Smoking status.
Demographic information (preferred language, gender, race,
ethnicity, date of birth).
Care plan field, including goals and instructions, and
Any additional known care team members beyond the
referring or transitioning provider and the receiving provider.
In circumstances where there is no information available to
populate one or more of the fields previously listed, either because
the EP can be excluded from recording such information (for example,
vital signs) or because there is no information to record (for example,
no medication allergies or laboratory tests), the EP may have an
indication that the information is not available and still meet the
objective and its associated measure.
As stated in the Stage 1 final rule (75 FR 44356), we understand
that there may be situations where a provider decides that online
posting is not the best forum to communicate results. Within the
confines of laws governing patient access to their medical records, we
defer to an EP's judgment as to whether to hold information back in
anticipation of an actual encounter or conversation between the EP or a
member of their staff and the patient. Furthermore, for purposes of
meeting this objective, an EP may withhold information from being
accessible electronically if its disclosure would cause substantial
harm to the patient or another individual. Therefore, if in the EP's
judgment substantial harm may arise from the disclosure of particular
information, an EP may choose to withhold that particular information.
Any such withholding would not affect the EP's ability to meet this
measure as that information would not be included in the percentage
calculation. However, we note that such withholding of information
would not have any effect on a provider's obligations under 45 CFR
164.524 when an individual exercises his or her right of access to
inspect and obtain a copy of protected health information about the
individual in a designated record set. We do not believe there would be
a circumstance where all information about an encounter would be
withheld from the patient and therefore some information would be
eligible for uploading for online access. If nothing else, information
that the encounter occurred should be provided. This is a meaningful
use provision, which does not override applicable federal, State or
local laws regarding patient access to health information, including
the requirements under the HIPAA Privacy Rule at 45 CFR 164.524.
As discussed earlier in this proposed rule, beginning in 2014,
Certified EHR Technology will no longer be certified for the Stage 1
objectives of providing patients with an electronic copy of their
health information upon request and providing patients with timely
electronic access to their health information. This new ``view and
download'' objective would replace those objectives, and we are
proposing to include it in the core set for Stages 1 and 2 beginning in
2014.'' However, for Stage 1, we are only proposing the first measure
of ``More than 50 percent of all unique patients seen by the EP during
the EHR reporting period are provided timely (available to the patient
within 4 business days after the information is available to the EP)
online access to their health information subject to the EP's
discretion to withhold certain information.'' Both measures would be
required for Stage 2.
Proposed Objective: Use clinically relevant information from
Certified EHR Technology to identify patient-specific education
resources and provide those resources to the patient.
Providing clinically relevant education resources to patients is a
priority for the meaningful use of Certified EHR Technology. Because of
our experience with this objective in Stage 1, we are clarifying that
while Certified EHR Technology must be used to identify patient-
specific education resources, these resources or materials do not have
to be stored within or generated by the Certified EHR Technology. We
are aware that there are many electronic resources available for
patient education materials, such as through the National Library of
Medicine, that can be queried via Certified EHR Technology (that is,
specific patient characteristics are linked to specific consumer health
content). The EP or hospital should utilize Certified EHR Technology in
a manner where the technology suggests patient-specific educational
resources based on the information stored in the Certified EHR
Technology. Certified EHR technology is certified to use the patient's
problem list, medication list, or laboratory test results to identify
the patient-specific educational resources. The EP or hospital may use
these elements or additional elements within Certified EHR Technology
to identify educational resources specific to patients' needs. The EP
or hospital can then provide these educational resources to patients in
a useful format for the patient (such as, electronic copy, printed
copy, electronic link to source materials, through a patient portal or
PHR).
[[Page 13721]]
In the Stage 1 final rule (75 FR 44359), we included the phrase
``if appropriate'' in the objective so that the EP or the authorized
provider in the hospital could determine whether the education resource
was useful and relevant to a specific patient. Consistent with the
recommendations of the HIT Policy Committee, we are proposing to remove
the phrase ``if appropriate'' from the objective for Stage 2 because we
do not believe that any EP or hospital would have difficulty
identifying appropriate patient-specific education resources for the
low percentage of patients required by the measure of this objective.
We also recognize that providing education materials at literacy
levels and cultural competency levels appropriate to patients is an
important part of providing patient-specific education. However, we
believe that there is not currently widespread availability of such
materials and that such materials could be difficult for EPs and
hospitals to identify for their patients. We are specifically inviting
comments and seeking input on whether EPs and hospitals believe that
patient-specific education resources at appropriate literacy levels and
with appropriate cultural competencies could be successfully identified
at this time through the use of Certified EHR Technology.
Proposed EP Measure: Patient-specific education resources
identified by Certified EHR Technology are provided to patients for
more than 10 percent of all office visits by the EP.
In Stage 1, the measure of this objective for EPs was ``More than
10 percent of all unique patients seen by the EP are provided patient-
specific education resources.'' Because we are proposing this as a core
objective for Stage 2, we have modified the measure for EPs to
``Patient-specific education resources identified by Certified EHR
Technology are provided to patients for more than 10 percent of all
office visits by the EP.'' We recognize that some EPs may not conduct
face-to-face encounters with patients but still provide treatment to
patients. These EPs could be prevented from meeting this core objective
under the previous measure requirements, so we are proposing to alter
the measure to account for office visits rather than unique patients
seen by the EP. We are also proposing an exclusion for EPs who have no
office visits in order to accommodate such EPs. The resources would
have to be those identified by CEHRT. If resources are not identified
by CEHRT and provided to the patient then it would not count in the
numerator. We do not intend through this requirement to limit the
education resources provided to patient to only those identified by
CEHRT. We set the threshold at only ten percent for this reason. We
believe that the 10 percent threshold both ensures that providers are
using CEHRT to identify patient-specific education resources and is low
enough to not infringe on the provider's freedom to choose education
resources and to which patients these resources will be provided. The
education resources would need to be provided prior to the calculation
and subsequent attestation to meaningful use.
To calculate the percentage for EPs, CMS and ONC have worked
together to define the following for this objective:
Denominator: Number of office visits by the EP during the
EHR reporting period.
Numerator: Number of patients who had office visits during
the EHR reporting period who were subsequently provided patient-
specific education resources identified by Certified EHR Technology.
Threshold: The resulting percentage must be more than 10
percent in order for an EP to meet this measure.
Exclusion: Any EP who has no office visits during the EHR reporting
period.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of all
unique patients admitted to the eligible hospital's or CAH's inpatient
or emergency departments (POS 21 or 23) are provided patient-specific
education resources identified by Certified EHR Technology.
To calculate the percentage for hospitals, CMS and ONC have worked
together to define the following for this objective:
Denominator: Number of unique patients admitted to the
eligible hospital's or CAH's inpatient or emergency departments (POS 21
or 23) during the EHR reporting period.
Numerator: Number of patients in the denominator who are
subsequently provided patient-specific education resources identified
by Certified EHR Technology.
Threshold: The resulting percentage must be more than 10
percent in order for an eligible hospital or CAH to meet this measure.
Our explanation of ``patient-specific education resources
identified by Certified EHR Technology'' for the EP measure also
applies for the hospital measure.
Proposed Objective: The EP, eligible hospital or CAH who receives a
patient from another setting of care or provider of care or believes an
encounter is relevant should perform medication reconciliation.
Medication reconciliation allows providers to confirm that the
information they have on the patient's medication is accurate. This not
only assists the provider in their direct patient care, it also
improves the accuracy of information they provide to others through
health information exchange.
We note that when conducting medication reconciliation during a
transition of care, the EP, eligible hospital or CAH that receives the
patient into their care should conduct the medication reconciliation.
It is for the receiving provider that up-to-date medication information
will be most crucial in order to make informed clinical judgments for
patient care. We reiterate that the measure of this objective does not
dictate what information must be included in medication reconciliation.
Information included in the process of medication reconciliation is
appropriately determined by the provider and patient. For the purposes
of this objective, we propose to maintain the definition of a
transition of care as the movement of a patient from one setting of
care (for example, a hospital, ambulatory primary care practice,
ambulatory specialty care practice, long-term care, home health,
rehabilitation facility) to another.
For Stage 2, we also propose to maintain the definition of
medication reconciliation as the process of identifying the most
accurate list of all 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. There are additional resources available that further
define medication reconciliation that while not incorporated into
meaningful use may be helpful for EPs, eligible hospitals, and CAHs.
While we believe that an electronic exchange of information following
the transition of care of a patient is the most efficient method of
performing medication reconciliation, we also realize it is unlikely
that an automated process within the EHR will fully supplant the
medication reconciliation conducted between the provider and the
patient. Therefore, the electronic exchange of information is not a
requirement for medication reconciliation.
While the objective is to conduct medication reconciliation at all
relevant encounters, determining which encounters are relevant beyond
transitions of care is too subjective to be included in the measure.
Proposed Measure: The EP, eligible hospital or CAH performs
medication
[[Page 13722]]
reconciliation for more than 65 percent of transitions of care in which
the patient is transitioned into the care of the EP or admitted to the
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23).
The HIT Policy Committee recommended maintaining this threshold at
50 percent. However, because this measure relates directly to the role
of information exchange that we seek to promote through the meaningful
use of Certified EHR Technology, we believe that a higher threshold for
this measure is appropriate. Although the majority chose to defer this
measure in Stage 1, the performance of both EPs and hospitals was well
above the Stage 1 threshold. For these reasons we are proposing to
raise the threshold of this measure to 65 percent for Stage 2.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of transitions of care during the EHR
reporting period for which the EP or eligible hospital's or CAH's
inpatient or emergency department (POS 21 or 23) was the receiving
party of the transition.
Numerator: The number of transitions of care in the
denominator where medication reconciliation was performed.
Threshold: The resulting percentage must be more than 65
percent in order for an EP, eligible hospital or CAH to meet this
measure.
Exclusion: Any EP who was not the recipient of any
transitions of care during the EHR reporting period.
Proposed Objective: The EP, eligible hospital or CAH who
transitions their patient to another setting of care or provider of
care or refers their patient to another provider of care provides a
summary care record for each transition of care or referral.
By guaranteeing lines of communication between providers caring for
the same patient, all of the providers of care can operate with better
information and more effectively coordinate the care they provide.
Electronic health records, especially when linked directly or through
health information exchanges, reduce the burden of such communication.
The purpose of this objective is to ensure a summary of care record is
provided to the receiving provider when a patient is transitioning to a
new provider or has been referred to another provider while remaining
under the care of the referring provider.
The feedback we have received from providers who have met Stage 1
meaningful use requirements has convinced us that the exchange of key
clinical information is most efficiently accomplished within the
context of providing a summary of care record during transitions of
care. Therefore, we are proposing to eliminate the objective for the
exchange of key clinical information for Stage 2 and instead include
such information as part of the summary of care when it is a part of
the patient's electronic record.
In addition the HIT Policy Committee made two separate Stage 2
recommendations for EPs, eligible hospitals, and CAHs to record
additional information--
Record care plan fields, including goals and instructions,
for at least 10 percent of transitions of care; and
Record team member, including primary care practitioner,
for at least 10 percent of patients.
We believe that this information is best incorporated as required
data within the summary of care record itself. Rather than implement
two separate objectives and measures for these recommendations, we are
establishing these as required fields along with the summary of care
information listed later. The ONC proposed rule on standards and
certification includes these as standard fields required to populate
the summary of care document so Certified EHR Technology would be able
to include this information. We also recognize that a ``care plan'' may
require further definition. The content of the care plan is dependent
on the clinical context. We propose to describe a care plan as the
structure used to define the management actions for the various
conditions, problems, or issues. For purposes of meaningful use
measurement we propose that a care plan must include at a minimum the
following components: problem (the focus of the care plan), goal (the
target outcome) and any instructions that the provider has given to the
patient. A goal is a defined target or measure to be achieved in the
process of patient care (an expected outcome).
We encourage EPs to develop the most robust care plan that is
warranted by the situation. We also welcome comments on both our
description of a care plan and whether a description is necessary for
purpose of meaningful use.
All summary of care documents used to meet this objective must
include the following:
Patient name.
Referring or transitioning provider's name and office
contact information (EP only).
Procedures.
Relevant past diagnoses.
Laboratory test results.
Vital signs (height, weight, blood pressure, BMI, growth
charts).
Smoking status.
Demographic information (preferred language, gender, race,
ethnicity, date of birth).
Care plan field, including goals and instructions, and
Any additional known care team members beyond the
referring or transitioning provider and the receiving provider.
In addition, eligible hospitals and CAHs would be required to
include discharge instructions.
In circumstances where there is no information available to
populate one or more of the fields listed previously, either because
the EP, eligible hospital or CAH can be excluded from recording such
information (for example, vital signs) or because there is no
information to record (for example, laboratory tests), the EP, eligible
hospital or CAH may leave the field(s) blank and still meet the
objective and its associated measure.
In addition, all summary of care documents used to meet this
objective must include the following:
An up-to-date problem list of current and active
diagnoses.
An active medication list, and
An active medication allergy list.
We encourage all summary of care documents to contain the most
recent and up-to-date information on all elements. In order for the
summary of care document to count in the numerator of this objective,
the EP or hospital must verify these three fields for problem list,
medication list, and medication allergy list are not blank and include
the most recent information known by the EP or hospital as of the time
of generating the summary of care document. We define problem list as a
list of current and active diagnoses. We solicit comment on whether the
problem list should be extended to include, ``when applicable,
functional and cognitive limitations'' or whether a separate list
should be included for functional and cognitive limitations. We define
an up-to-date problem list as a list populated with the most recent
diagnoses known by the EP or hospital. We define active medication list
as a list of medications that a given patient is currently taking. We
define active medication allergy list as a list of medications to which
a given patient has known allergies. We define allergy as an
exaggerated immune response or reaction to substances that are
generally not harmful. Information on problems, medications, and
medication allergies could be obtained from previous records, transfer
of information from
[[Page 13723]]
other providers (directly or indirectly), diagnoses made by the EP or
hospital, new medications ordered by the EP or in the hospital, or
through querying the patient. In the event that there are no current or
active diagnoses for a patient, the patient is not currently taking any
medications, or the patient has no known medication allergies,
confirmation of no problems, no medications, or no medication allergies
would satisfy the measure of this objective. Note that the inclusion
and verification of these elements in the summary of care record
replaces the Stage 1 objectives for ``Maintain an up-to-date problem
list,'' ``Maintain active medication list,'' and ``Maintain active
medication allergy list.''
We leave it to the provider's clinical judgment to identify any
additional clinical information that would be relevant to include in
the summary of care record.
Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy
both measures in order to meet the objective:
The EP, eligible hospital or CAH that transitions or refers their
patient to another setting of care or provider of care provides a
summary of care record for more than 65 percent of transitions of care
and referrals.
The EP, eligible hospital or CAH that transitions or refers their
patient to another setting of care or provider of care electronically
transmits a summary of care record using Certified EHR Technology to a
recipient with no organizational affiliation and using a different
Certified EHR Technology vendor than the sender for more than 10
percent of transitions of care and referrals.
Exclusion: Any EP who neither transfers a patient to
another setting nor refers a patient to another provider during the EHR
reporting period is excluded from both measures.
To calculate the percentage of the first measure, CMS and ONC have
worked together to define the following for this objective:
Denominator: Number of transitions of care and referrals
during the EHR reporting period for which the EP or eligible hospital's
or CAH's inpatient or emergency department (POS 21 or 23) was the
transferring or referring provider.
Numerator: The number of transitions of care and
referrals in the denominator where a summary of care record was
provided.
Threshold: The percentage must be more than 65
percent in order for an EP, eligible hospital, or CAH to meet this
measure.
If the provider to whom the referral is made or to whom the patient
is transitioned has access to the medical record maintained by the
referring provider, then the summary of care record would not need to
be provided and that patient should not be included in the denominators
of the measures of this objective. We believe that different settings
within a hospital using Certified EHR Technology would have access to
the same information, so providing a clinical care summary for
transfers within the hospital would not be necessary.
To calculate the percentage of the second measure, CMS and ONC have
worked together to define the following for this objective:
Denominator: Number of transitions of care and referrals
during the EHR reporting period for which the EP or eligible hospital's
or CAH's inpatient or emergency department (POS 21 or 23) was the
transferring or referring provider.
Numerator: The number of transitions of care and referrals
in the denominator where a summary of care record was electronically
transmitted using Certified EHR Technology to a recipient with no
organizational affiliation and using a different Certified EHR
Technology vendor than the sender.
Threshold: The percentage must be more than 10 percent in
order for an EP, eligible hospital or CAH to meet this measure.
For Stage 2, we are proposing the additional second measure for
electronic transmittal because we believe that the electronic exchange
of health information between providers will encourage the sharing of
the patient care summary from one provider to another and the
communication of important information that the patient may not have
been able to provide, which can significantly improve the quality and
safety of referral care and reduce unnecessary and redundant testing.
Use of common standards can significantly reduce the cost and
complexity of interfaces between different systems and promote
widespread exchange and interoperability. In acknowledgement of this,
ONC has included certain transmission protocols in proposed 2014
Edition EHR certification criteria. Please see the ONC proposed rule
published elsewhere in this issue of the Federal Register for more
details.
These protocols will allow every provider with certified electronic
health record technology to have the tools in place to share critical
information when patients are discharged or referred, representing a
critical step forward in exchange and interoperability. Accordingly, we
propose to limit the numerator for this second measure to only count
electronic transmissions which conform to the transport standards
proposed for adoption at 45 CFR 170.202 of the ONC standards and
certification criteria rule.
To meet the second measure of this objective a provider must use
Certified EHR Technology to create a summary of care document with the
required information according to the required standards and
electronically transmit the summary of care document using the
transport standards to which its Certified EHR Technology has been
certified. No other transport standards beyond those proposed for
adoption as part of certification would be permitted to be used to meet
this measure.
We acknowledge the benefits of requiring the use of consistently
implemented transport standards nationwide, but at the same time want
to be cognizant of any unintended consequences of this approach. Thus,
ONC requests comments on whether equivalent alternative transport
standards exist to the ones ONC proposes to exclusively permit for
certification. Comments on transports standards should be made to the
ONC proposed rule published elsewhere in this issue of the Federal
Register, while comments on the appropriateness of limiting this
measure to only those standards finalized by ONC should be made to this
rule. Note, the use of USB, CD-ROM, or other physical media or
electronic fax would not satisfy the measures for electronic
transmittal of a summary of care record. The required elements and
standards of the summary of care document will be discussed in the ONC
standards and certification proposed rule published elsewhere in this
issue of the Federal Register. We are considering, in lieu of requiring
solely the transmission capability and transport standard(s) included
in a provider's Certified EHR Technology to be used to meet this
measure, also permitting a provider to count electronic transmissions
in the numerator if the provider electronically transmits summary of
care records to support patient transitions using an organization that
follows Nationwide Health Information Network (NwHIN) specifications
(http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_nhin_resources/1194). This could include those organizations that
are part of the NwHIN Exchange as well as any organization that is
identified through a governance mechanism ONC would establish
[[Page 13724]]
through regulation. We request public comment on whether this
additional flexibility should be added to our proposed numerator
limitations.
Another potential concern could be that another transport standard
emerges after CMS' and ONC's rules are finalized that is not adopted in
a final rule by ONC as part of certification, but nonetheless
accomplishes the objective in the same way. To mitigate this concern,
ONC has indicated in its proposed rule that it would pursue an off-
cycle rulemaking to add as an option for certification transport
standards that emerge at any time after these proposed rules are
finalized in order to keep pace with innovation and thereby allow other
transport standards to be used and counted as part of this measure's
numerator. We solicit comments on how these standards will further the
goal of true health information exchange.
Additionally, in order to foster standards based-exchange across
organizational and vendor boundaries, we propose to further limit the
numerator by only permitting electronic transmissions to count towards
the numerator if they are made to recipients that are--(1) not within
the organization of the transmitting provider; and (2) do not have
Certified EHR Technology from the same EHR vendor.
We propose these numerator limitations because, in collaboration
with ONC, our experience has shown that one of the biggest barriers to
electronic exchange is the adoption of numerous different transmission
methods by different providers and vendors. Thus, we believe that it is
prudent for Stage 2 to include these more specific requirements and
conformance to open, national standards as it will cause the market to
converge on those transport standards that can best and most readily
support electronic health information exchange and avoid the use of
proprietary approaches that limit exchange among providers. We
recognize that because the 2011 Edition EHR certification criteria did
not include specific transport standards for transitions of care, some
providers and vendors implemented their own methods for Stage 1 to
engage in electronic health information exchange, some of which would
no longer be an acceptable means of meeting meaningful use if this
proposal were finalized.
Therefore, in order to determine a reasonable balance that makes
this measure achievable yet significantly advance interoperability and
electronic exchange, we solicit comment on the following concerns
stakeholders may have relative to the numerator limitations we proposed
previously.
We could see a potential concern related to the feasibility of
meeting this proposed measure if an insufficient number of providers in
a given geographic location (because of upgrade timing or some other
factor) have EHR technology certified to the transport standards ONC
has proposed to adopt. For example, a city might have had a widely
adopted health information exchange organization that still used
another standard that those proposed for adoption by ONC. While it is
not our intent to restrict providers who are engaged in electronic
health information exchange via other transport standards, we believe
requiring the use of a consistent transport standard could
significantly further our overarching goals for Stage 2.
We recognize that this limitation extends beyond the existing
parameters set for Stage 1, which specified that providers with access
to the same medical record do not include transitions of care or
referrals among themselves in either the denominator or the numerator.
We recognize that this limitation could severely limit the pool of
eligible recipients in areas where one vendor or one organizational
structure using the same EHR technology has a large market share and
may make measuring the numerator more difficult. We seek comment on the
extent to which this concern could potentially be mitigated with an
exclusion or exclusion criteria that account for these unique
environments. We believe the limitation on organizational and vendor
affiliations is important because even if a network or organization is
using the standards, it does not mean that a network is open to all
providers. Certain organizations may find benefits, such as competitive
advantage, in keeping their networks closed, even to those involved in
the care of the same patient. We believe this limitation will help
ensure that electronic transmission of the summary of care record can
follow the patient in every situation.
Even without the addition of exclusions Certified EHR Technology
would need to be able to distinguish between (1) electronic
transmissions sent using standards and those that are not, (2)
transmission that are sent to recipients with the same organizational
affiliation or not, and (3) transmissions that are sent to recipients
using the same EHR vendor or not, and ONC will seek comment in their
proposed certification rule as to the feasibility of this reporting
requirement for certified EHR technologies.
Despite the possible unintended consequences of the parameters we
propose for the numerator, we believe that these limitations will help
ensure that electronic health information exchange proceeds at the pace
necessary to accomplish the goals of meaningful use. We encourage
comments on all these points and particularly suggestions that would
both push electronic health information exchange beyond what is
proposed and minimize the potential concerns expressed previously.
However, we note that electronic transmittal is not a requirement
for the first measure to provide a summary of care record. For the
first measure, where the electronic transmittal of the summary of care
record is not a requirement but an option, a provider is permitted to
generate an electronic or paper copy of the summary of care record
using the Certified EHR Technology and to document that it was provided
to the patient, receiving provider or both. In this case, the use of
physical media such as a CD-ROM, a USB or hard drive, or other formats
could satisfy the measure of this objective.
The HIT Policy Committee recommended different thresholds for EPs
and hospitals for the electronic transmission measure, with a threshold
of only 25 instances for EPs. We believe a percentage-based measure is
attainable for both EPs and eligible hospitals/CAHs and better reflects
the actual meaningful use of technology. It also provides a more level
method for measurement across EPs. We encourage comment on whether
there are significant barriers in addition to those discussed above to
EPs meeting the 10 percent threshold for this measure.
In addition, the HIT Policy Committee recommended maintaining the
50 percent threshold from Stage 1. However, because this measure
relates directly to the role of information exchange that we seek to
promote through the meaningful use of Certified EHR Technology, we
believe that a higher threshold for this measure is appropriate.
Although the majority chose to defer this measure in Stage 1, the
performance of both EPs and hospitals was well above the Stage 1
threshold. For these reasons we are proposing to raise the threshold of
this measure to 65 percent for Stage 2.
The thresholds of both measures must be reached in order for the
EP, eligible hospital, or CAH to meet the objective. If the EP,
eligible hospital, or CAH reaches one of these thresholds but not the
other, then the EP, eligible hospital, or CAH will fail to meet this
objective.
[[Page 13725]]
(c) Public Health Objectives
Due to similar considerations among the public health objectives,
we are discussing them together. Some Stage 2 public health objectives
are in the core set while others are in the menu set. Each objective is
identified as either core or menu in the below discussion.
Capability to submit electronic data to immunization
registries or immunization information systems except where prohibited,
and in accordance with applicable law and practice.
Capability to submit electronic reportable laboratory
results to public health agencies, except where prohibited, and in
accordance with applicable law and practice.
Capability to submit electronic syndromic surveillance
data to public health agencies, except where prohibited, and in
accordance with applicable law and practice.
Capability to identify and report cancer cases to a State
cancer registry where authorized, and in accordance with applicable law
and practice.
Capability to identify and report specific cases to a
specialized registry (other than a cancer registry), except where
prohibited, and in accordance with applicable law and practice.
We are proposing the following requirements, which would apply to
all of the public health objectives and measures. We propose that
actual patient data is required for the meaningful use measures that
include ongoing submission of patient data.
There are a growing number of public health agencies partnering
with health information exchange (HIE) organizations to facilitate the
submission of public health data electronically from EHRs. As we stated
in guidance for Stage 1, (see FAQ at: https://questions.cms.hhs.gov/app/answers/detail/a_id/10764/kw/immunizations) we clarify that such
arrangements with HIE organizations, if serving on the behalf of the
public health agency to simply transport the data, but not transforming
content or message format (for example, HL7 format), are acceptable for
the demonstration of meaningful use. Alternatively, if the intermediary
is serving as an extension of the EP, eligible hospital or CAH's
Certified EHR Technology and performing capabilities for which
certification is required (for example, transforming the data into the
required standard), then that functionality must be certified in
accordance with the certification program established by ONC.
An eligible provider is required to utilize the transport
method or methods supported by the public health agency in order to
achieve meaningful use.
Unlike in Stage 1, a failed submission would not meet the
objective. An eligible provider must either have successful ongoing
submission or meet exclusion criteria.
We expect that CMS, CDC and public health agencies (PHA)
will establish a process where PHAs will be able to provide letters
affirming that the EP, eligible hospital or CAH was able to submit the
relevant public health data to the PHA. This affirmation letter could
then be used by the EP, eligible hospital or CAH for the Medicare and
Medicaid meaningful use attestation systems, as well as in the event of
any audit. We request comments on challenges to implementing this
strategy.
We will accept a yes/no attestation and information indicating to
which public health agency the public health data were submitted to
support each of the public health meaningful use measures.
Where a measure states ``in accordance with applicable law and
practice,'' this reflects that some public health jurisdictions may
have unique requirements for reporting and that some may not currently
accept electronic data reports. In the former case, the proposed
criteria for this objective would not preempt otherwise applicable
State or local laws that govern reporting. In the latter case, EPs,
eligible hospitals and CAHs would be excluded from reporting.
Proposed Objective: Capability to submit electronic data to
immunization registries or immunization information systems except
where prohibited, and in accordance with applicable law and practice.
This objective is in the Stage 2 core set for EPs, eligible
hospitals and CAHs. The Stage 1 objective and measure acknowledged that
our nation's public health IT infrastructure is not universally capable
of receiving electronic immunization data from Certified EHR
Technology, either due to technical or resource readiness. Immunization
programs, their reporting providers and federal funding agencies, such
as the CDC, ONC, and CMS, have worked diligently since the passage of
the HITECH Act in 2009 to facilitate EPs, eligible hospitals and CAHs
ability to meet the Stage 1 measure. We propose for Stage 2 to take the
next step from testing to requiring actual submission of immunization
data. In order to achieve improved population health, providers who
administer immunizations must share that data electronically, to avoid
missed opportunities or duplicative vaccinations. Stage 3 is likely to
enhance this functionality to permit clinicians to view the entire
immunization registry/immunization information system record and
support bi-directional information exchange.
The HIT Policy Committee recommended making this a core objective
for Stage 2 for EPs and hospitals, and we are adopting their
recommendation. We agree that the bar for Stage 2 should move from
simply testing the electronic submission of immunization data to
ongoing submission. We also agree that given the focus on upgrading and
enhancing immunization registries' capacity, under CDC's guidance, this
measure is sufficiently achievable to warrant its inclusion in the core
set of Stage 2 meaningful use measures. However, we specifically invite
comment on the challenges that moving this objective from the menu set
to the core set would present for EPs and hospitals.
We also propose to modify the Stage 1 objective to add ``except
where prohibited'' because we want to encourage all EPs, eligible
hospitals, and CAHs to submit electronic immunization data, even when
not required by State/local law. Therefore, if they are authorized to
submit the data, they should do so even if is not required by either
law or practice. There are a few instances where some EPs, eligible
hospitals, and CAHs are not authorized or cannot submit to a State/
local immunization registry. For example, in sovereign tribal areas
that do not permit transmission to an immunization registry or when the
immunization registry only accepts data from certain age groups (for
example, adults).
Proposed Measure: Successful ongoing submission of electronic
immunization data from Certified EHR Technology to an immunization
registry or immunization information system for the entire EHR
reporting period.
Exclusions: Any EP, eligible hospital or CAH that meets one or more
of the following criteria may be excluded from this objective: (1) The
EP, eligible hospital or CAH does not administer any of the
immunizations to any of the populations for which data is collected by
the jurisdiction's immunization registry or immunization information
system during the EHR reporting period; (2) the EP, eligible hospital
or CAH operates in a jurisdiction for which no immunization registry or
immunization information system is capable of receiving electronic
immunization data in the specific for Certified EHR Technology at the
start of their EHR reporting period; or (3) the EP, eligible hospital
or CAH operates in a
[[Page 13726]]
jurisdiction for which no immunization registry or immunization
information system is capable of accepting the specific standards
required for Certified EHR Technology at the start of their EHR
reporting period. For the second and third scenarios, there is no
exclusion if an entity designated by the immunization registry can
receive electronic immunization data submissions. For example, if the
immunization registry cannot accept the data directly or in the version
of HL7 used by the provider's Certified EHR Technology, but has
designated a Health Information Exchange to do so on their behalf, the
provider could not claim the 2nd or 3rd exclusions previously noted.
Proposed Eligible Hospital/CAH Objective: Capability to submit
electronic reportable laboratory results to public health agencies,
except where prohibited, and in accordance with applicable law and
practice.
This objective is in the Stage 2 core set for eligible hospitals
and CAHs. The same rationale for the changes between this proposed
objective and that of Stage 1 are discussed earlier under the
immunization registry objective. Please refer to that section for
details.
Proposed Eligible Hospital/CAH Measure: Successful ongoing
submission of electronic reportable laboratory results from Certified
EHR Technology to a public health agency for the entire EHR reporting
period.
Please refer to the general public health discussion regarding use
of intermediaries.
Exclusions: The eligible hospital or CAH operates in a jurisdiction
for which no public health agency is capable of receiving electronic
reportable laboratory results in the specific standards required by ONC
for EHR certification at the start of the EHR reporting period.
Proposed Objective: Capability to submit electronic syndromic
surveillance data to public health agencies except where prohibited,
and in accordance with applicable law and practice.
This objective is in the Stage 2 core set for eligible hospitals
and CAHs and the Stage 2 menu set for EPs. The Stage 1 objective and
measure acknowledged that our nation's public health IT infrastructure
is not universally capable of receiving syndromic surveillance data
from Certified EHR Technology, either due to technical or resource
readiness. Given public health IT infrastructure improvements and new
implementation guidance, for Stage 2, we are proposing that this
objective and measure be in the core set for hospitals and in the menu
set for EPs. It is our understanding from hospitals and the CDC that
many hospitals already send syndromic surveillance data. The CDC has
issued the PHIN Messaging Guide for Syndromic Surveillance: Emergency
Department and Urgent Care Data [http://www.cdc.gov/ehrmeaningfuluse/Syndromic.html] as cited in the ONC proposed rule on EHR standards and
certification. However, per the CDC and a 2010 survey completed by the
Association of State and Territorial Health Officials (ASTHO), very few
public health agencies are currently accepting syndromic surveillance
data from ambulatory providers, and there is no corresponding
implementation guide at the time of this proposed rule. CDC is working
with the syndromic surveillance community to develop a new
implementation guide for ambulatory reporting of syndromic surveillance
information, which it expects will be available in the fall of 2012. We
anticipate that Stage 3 might include syndromic surveillance for EPs in
the core set if the collection of ambulatory syndromic data becomes a
more standard public health practice in the interim.
The HIT Policy Committee recommended making this a core objective
for Stage 2 for EPs and hospitals. However, we are not proposing to
adopt their recommendation for EPs. We specifically invite comment on
the proposal to leave syndromic surveillance in the menu set for EPs,
while requiring it in the core set for eligible hospitals and CAHs.
Proposed Measure: Successful ongoing submission of electronic
syndromic surveillance data from Certified EHR Technology to a public
health agency for the entire EHR reporting period.
Exclusions: Any EP, eligible hospital or CAH that meets one or more
of the following criteria may be excluded from this objective: (1) The
EP is not in a category of providers that collect ambulatory syndromic
surveillance information on their patients during the EHR reporting
period (we expect that the CDC will be issuing (in Spring 2013) the CDC
PHIN Messaging Guide for Ambulatory Syndromic Surveillance and we may
rely on this guide to determine which categories of EPs would not
collect such information); (2) the eligible hospital or CAH does not
have an emergency or urgent care department; (3) the EP, eligible
hospital, or CAH operates in a jurisdiction for which no public health
agency is capable of receiving electronic syndromic surveillance data
in the specific standards required by ONC for EHR certification for
2014 at the start of their EHR reporting period; or (4) the EP,
eligible hospital, or CAH operates in a jurisdiction for which no
public health agency is capable of accepting the specific standards
required for Certified EHR Technology at the start of their EHR
reporting period. As was described under the immunization registry
measure, the third and fourth exclusions do not apply if the public
health agency has designated an HIE to collect this information on its
behalf and that HIE can do so in the specific Stage 2 standards and/or
the same standard as the provider's Certified EHR Technology. An urgent
care department delivers ambulatory care, usually on an unscheduled,
walk-in basis, in a facility dedicated to the delivery of medical care,
but not classified as a hospital emergency department. Urgent care
centers are primarily used to treat patients who have an injury or
illness that requires immediate care but is not serious enough to
warrant a visit to an emergency department. Often urgent care centers
are not open on a continuous basis, unlike a hospital emergency
department which would be open at all times.
(d) New Core and Menu Set Objectives and Measures for Stage 2
We are proposing the following objectives for inclusion in the core
set for Stage 2: ``Provide patients the ability to view online,
download, and transmit information about a hospital admission'' and
``Automatically track medication orders using an electronic medication
administration record (eMAR)'' for hospitals; ``Use secure electronic
messaging to communicate with patients'' for EPs. We are proposing all
other new objectives for inclusion in the menu set for Stage 2. While
the HIT Policy Committee recommended making all objectives mandatory
and eliminating the menu option, we believe a menu set is necessary for
these new menu set objectives in order to give providers an opportunity
to implement new technologies and make changes to workflow processes
and to provide maximum flexibility for providers in specialties that
may face particular challenges in meeting new objectives.
Proposed Objective: Imaging results and information are accessible
through Certified EHR Technology.
Making the image that results from diagnostic scans and
accompanying information accessible through Certified EHR Technology
increases the utility and efficiency of both the imaging technology and
the CEHRT. The ability to share the results of imaging scans will
likewise improve the efficiency of all
[[Page 13727]]
health care providers and increase their ability to share information
with their patients. This will reduce the cost and radiation exposure
from tests that are repeated solely because a prior test is not
available to the provider.
Most of the enabling steps to incorporating imaging relate to the
certification of EHR technologies. As with the objective for
incorporating lab results, we encourage the use of electronic exchange
to incorporate imaging results into the Certified EHR Technology, but
in absence of such exchange it is acceptable to manually add the image
and accompanying information to Certified EHR Technology.
Proposed Measure: More than 40 percent of all scans and tests whose
result is one or more images ordered by the EP or by an authorized
provider of the eligible hospital or CAH for patients admitted to its
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period are accessible through Certified EHR Technology.
For Stage 2, we do not propose the image or accompanying
information (for example, radiation dose) be required to be structured
data. Images and imaging results that are scanned into the Certified
EHR Technology may be counted in the numerator of this measure. We
define accessible as either incorporation of the image and accompanying
information into Certified EHR Technology or an indication in Certified
EHR Technology that the image and accompanying information are
available for a given patient in another technology and a link to that
image and accompanying information. Incorporation of the image means
that the image and accompanying information is stored by the Certified
EHR Technology. Meaningful use does not impose any additional retention
requirements on the image. A link to the image and accompanying
information means that a link to where the image and accompanying
information is stored is available in Certified EHR Technology. This
link must conform to the certification requirements associated with
this objective in the ONC rule. We encourage comments on the necessary
level of specification and what those specifications should be to
define accessible and what constitutes a direct link.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of scans and tests whose result is one
or more image ordered by the EP or by an authorized provider on behalf
of the eligible hospital or CAH for patients admitted to its inpatient
or emergency department (POS 21 and 23) during the EHR reporting
period.
Numerator: The number of results in the denominator that
are accessible through Certified EHR Technology.
Threshold: The resulting percentage must be more than 40
percent in order to meet this measure.
Exclusion: Any EP who does not perform diagnostic interpretation of
scans or tests whose result is an image during the EHR reporting
period.
We also solicit comments on a potential second measure for this
objective that would encourage the exchange of imaging and results
between providers. We are considering a threshold of 10 percent of all
scans and tests whose result is one or more images ordered by the EP or
by an authorized provider of the eligible hospital or CAH for patients
admitted to its inpatient or emergency department (POS 21 or 23) during
the EHR reporting period and accessible through Certified EHR
Technology also be exchanged with another provider of care. However, we
are concerned that this extra measure may be difficult for some EPs to
meet and might discourage a significant number of EPs from selecting
this objective as part of their menu set. We also solicit comment on
whether an exclusion for this second measure should be included for
providers who do not typically exchange imaging scans and test results
as a normal part of their workflow, and we encourage commenters to
provide details about how such an exclusion might be included.
Proposed Objective: Record patient family health history as
structured data.
Family health history is a major risk indicator for a variety of
chronic conditions for which effective screening and prevention tools
are available. Certified EHR technology can use family health history,
if captured as structured data, to inform clinical decision support,
patient reminders, and patient education. Family health history would
also benefit from greater interoperability made possible by EHRs. A
family health history is unique to each patient and fairly static over
time. Currently, every provider requests this information from the
patient in order to obtain it; however, EHRs can allow the patient to
contribute directly to the record and allow the record to be shared
among providers, thereby greatly increasing the efficiency of
collecting family health histories.
The HIT Policy Committee recommended delaying the inclusion of this
objective until Stage 3 due to absence of available standards. However,
we believe that standards supporting family health history are
currently available. We are proposing this as a menu objective for
Stage 2.
Proposed Measure: More than 20 percent of all unique patients seen
by the EP or admitted to the eligible hospital or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period
have a structured data entry for one or more first-degree relatives.
For Stage 2, we do not propose to include the capability to
exchange family health history electronically as part of the measure.
We do not believe there is sufficient structured data capture of family
health history to support such exchange. After Stage 2 increases the
capture of family health history in EHRs, we will seek to include
exchange with other providers and the patient in Stage 3.
We propose to adopt the definition of first degree relative used by
the National Human Genome Research Institute of the National Institutes
of Health. A first degree relative is a family member who shares about
50 percent of their genes with a particular individual in a family.
First degree relatives include parents, offspring, and siblings. We
considered other definitions, including those that address both
affinity and consanguinity relationships and encourage comments on this
definition. We note that this is a minimum and not a limitation on the
health history that can be recorded. We invite comment on the utility
of expanding this definition to capture risks associated with social
and other environmental determinants.
We do not propose a time limitation on the indication that the
family health history has been reviewed. The recent nature of this
capability in EHRs will impose a de facto limitation on review to the
recent past.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by the EP or
admitted to the eligible hospital's or CAH's inpatient or emergency
departments (POS 21 or 23) during the EHR reporting period.
Numerator: The number of patients in the denominator with
a structured data entry for one or more first-degree relatives.
Threshold: The resulting percentage must be more than 20
percent in order to meet this measure.
We are concerned that certain EPs may not be able to meet this
measure either due to scope of practice constraints or lack of patient
interaction. Therefore, we are proposing an
[[Page 13728]]
exclusion to this measure for EPs who have no office visits during the
EHR reporting period. We believe that EPs who do not have office visits
would not have the face-to-face contact with patients necessary to
obtain family health history information. We also believe that EPs who
do not have office visits may be unable to obtain family health history
information from referring physicians, which could prevent them from
being able to meet the measure of this objective. While the exclusion
does not relate directly to the denominator, it represents the barriers
justifying the exclusion. Furthermore, all office visits would not
require updates to family health history.
Exclusion: Any EP who has no office visits during the EHR reporting
period.
Proposed EP Objective: Capability to identify and report cancer
cases to a State cancer registry, except where prohibited, and in
accordance with applicable law and practice.
Reporting to cancer registries by EPs would address current
underreporting of cancer, especially certain types. In the past most
cancers were diagnosed and/or treated in a hospital setting and data
were primarily collected from this source. However, medical practice is
changing rapidly and an increasing number of cancer cases are never
seen in a hospital. Data collection from EPs presents new challenges
since the infrastructure for reporting is less mature than it is in
hospitals. Certified EHR technology can address this barrier by
identifying reportable cancer cases and treatments to the EP and
facilitating electronic reporting either automatically or upon
verification by the EP. We have included this objective to provide more
flexibility in the menu objectives that EPs can choose. We believe that
cancer reporting could provide many EPs with a meaningful use public
health reporting option that is more aligned with their scope of
practice.
We include ``except where prohibited and in accordance with
applicable law'' because we want to encourage all EPs to submit cancer
cases, even in rare cases where they are not required to by State/local
law. Legislation requiring cancer reporting by EPs exists in 49 States
with some variation in specific requirements, per the 2010 Council of
State and Territorial Epidemiologists (CSTE) State Reportable
Conditions Assessment (SRCA) (http://www.cste.org/dnn/ProgramsandActivities/PublicHealthInformatics/StateReportableConditionsQueryResults/tabid/261/Default.aspx).'' If EPs
are authorized to submit, they should do so even if it is not required
by either law or practice.
``In accordance with applicable law and practice'' reflects that
some public health jurisdictions may have unique requirements for
reporting, and that some may not currently accept electronic provider
reports. In the former case, the proposed criteria for this objective
would not preempt otherwise applicable State or local laws that govern
reporting. In the latter case, eligible professionals would be exempt
from reporting.
Proposed EP Measure: Successful ongoing submission of cancer case
information from Certified EHR Technology to a cancer registry for the
entire EHR reporting period.
Exclusions: Any EP that meets at least 1 of the following criteria
may be excluded from this objective: (1) The EP does not diagnose or
directly treat cancer; or (2) the EP operates in a jurisdiction for
which no public health agency is capable of receiving electronic cancer
case information in the specific standards required under Stage 2 at
the beginning of their EHR reporting period.
An EP must either successfully submit or meet 1 of the exclusion
criteria.
Proposed EP Objective: Capability to identify and report specific
cases to a specialized registry (other than a cancer registry), except
where prohibited, and in accordance with applicable law and practice.
We believe that reporting to registries is an integral part of
improving population and public health. The benefits of this reporting
are not limited to cancer reporting. We include cancer registry
reporting as a separate objective because it is more mature in its
development than other registry types, not because other reporting is
excluded from meaningful use. We have included this objective to
provide more flexibility in the menu objectives that EPs can choose. We
believe that specialized registry reporting could provide many EPs with
meaningful use menu option that is more aligned with their scope of
practice.
Proposed EP Measure: Successful ongoing submission of specific case
information from Certified EHR Technology to a specialized registry for
the entire EHR reporting period.
Exclusions: Any EP that meets at least 1of the following criteria
may be excluded from this objective: (1) The EP does not diagnose or
directly treat any disease associated with a specialized registry; or
(2) the EP operates in a jurisdiction for which no registry is capable
of receiving electronic specific case information in the specific
standards required under Stage 2 at the beginning of their EHR
reporting period.
Proposed EP Objective: Use secure electronic messaging to
communicate with patients on relevant health information.
Electronic messaging (for example, email) is one of the most
widespread methods of communication for both businesses and
individuals. The inability to communicate through electronic messaging
may hinder the provider-patient relationship. Electronic messaging is
very inexpensive on a transactional basis and allows for communication
even when the provider and patient are not available at the same moment
in time. The use of common email services and the security measures
that may be used when they are sent may not be appropriate for the
exchange of protected health information. Therefore, the exchange of
health information through electronic messaging requires additional
security measures while maintaining its ease of use for communication.
While email with the necessary safeguards is probably the most widely
used method of electronic messaging, for the purposes of meeting this
objective, secure electronic messaging could also occur through
functionalities of patient portals, PHRs, or other stand-alone secure
messaging applications.
We are proposing this as a core objective for EPs for Stage 2. The
additional time made available for Stage 2 implementation makes
possible the inclusion of some new objectives in the core set. We chose
to identify objectives that address critical priorities of the
country's National Quality Strategy (NQS) (http://www.healthcare.gov/law/resources/reports/quality03212011a.html), with a focus on one for
EPs and one for hospitals.
For EPs, secure electronic messaging is critically important to two
NQS priorities--
Ensuring that each person/family is engaged as partners in
their care; and
Promoting effective communication and coordination of
care.
Secure messaging could make care more affordable by using more
efficient communication vehicles when appropriate. Specifically,
research demonstrates that secure messaging has been shown to improve
patient adherence to treatment plans, which reduces readmission rates.
Secure messaging has also been shown to increase patient satisfaction
with their care. Secure messaging has been named as one of the top
ranked features according to patients. Also, despite some trepidation,
providers have seen a reduction in time responding to inquires and less
time spent on the phone. We specifically seek comment on whether
[[Page 13729]]
there may be special concerns with this objective in regards to
behavioral health.
Proposed EP Measure: A secure message was sent using the electronic
messaging function of Certified EHR Technology by more than 10 percent
of unique patients seen by the EP during the EHR reporting period.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of unique patients seen by the EP
during the EHR reporting period.
Numerator: The number of patients in the denominator who
send a secure electronic message to the EP using the electronic
messaging function of Certified EHR Technology during the EHR reporting
period.
Threshold: The resulting percentage must be more than 10
percent in order for an EP to meet this measure.
Exclusion: Any EP who has no office visits during the EHR reporting
period.
We note that this new measure requires action by patients in order
for the EP to meet it. While this is a departure from most meaningful
use measures, which are dependent solely on actions taken by the EP, we
believe that requiring a measurement of patient use ensures that the EP
will promote the availability and active use of secure electronic
messaging by the patient. Furthermore, we believe that accountable care
should extend to accountability for meaningful use objectives that
encourage patient and family engagement. We invite comment on this new
measure and whether EPs believe that the 10 percent threshold is too
high or too low given the patient's role in achieving it.
We specify that the secure messages sent should contain relevant
health information specific to the patient in order to meet the measure
of this objective. We believe the EP is the best judge of what health
information should be considered relevant in this context. We do not
specifically include the term ``relevant health information'' in the
measure, not because we believe that the messages sent by the patient
to the healthcare provider do not need to contain relevant health
information, but because we believe the provider is best equipped to
determine whether such information is included. It would be too great a
burden for the certified EHR technology, or the attestation process, to
determine whether the information in the secure message has such
information. We also note that there is an expectation that the EP
would respond to electronic messages sent by the patient, although we
do not specify the method of response or require the EP to document his
or her response as a condition of meeting this measure.
To address some circumstances regarding scope of practice, we
propose an exclusion to this objective for EPs who have no office
visits during the EHR reporting period. Not having any office visits
for an entire EHR reporting period indicates that there may not be a
need for follow-up communication through secure electronic messaging.
Proposed Eligible Hospital/CAH Objective: Automatically track
medications from order to administration using assistive technologies
in conjunction with an electronic medication administration record
(eMAR).
eMAR increases the accuracy of medication administration thereby
increasing both patient safety and efficiency. The HIT Policy Committee
has recommended the inclusion of this objective for hospitals in Stage
2, and we are proposing this as a core objective for eligible hospitals
and CAHs. The additional time made available for Stage 2 implementation
makes possible the inclusion of some new objectives in the core set.
eMAR is critically important to making care safer by reducing
medication errors which may make care more affordable. eMAR has been
shown to lead to significant improvements in medication-related adverse
events within hospitals with associated decreases in cost. eMAR cuts in
half the adverse drug event (ADE) rates for non-timing medication
errors, according to a study published in the New England Journal of
Medicine (Poon et al., 2010, Effect of Bar-Code Technology on the
Safety of Medication Administration http://www.nejm.org/doi/abs/10.1056/NEJMsa0907115?query=NC). A study done to evaluate cost-benefit
of eMAR (Maviglia et al., 2007, Cost-Benefit Analysis of a Hospital
Pharmacy Bar Code Solution http://archinte.ama-assn.org/cgi/content/full/167/8/788) demonstrated that associated ADE cost savings allowed
hospitals to break even after 1 year and begin reaping cost savings
going forward.
We propose to define eMAR as technology that automatically
documents the administration of medication into Certified EHR
Technology using electronic tracking sensors (for example, radio
frequency identification (RFID)) or electronically readable tagging
such as bar coding). The specific characteristics of eMAR for the EHR
Incentive Programs will be further described in the ONC standards and
certification criteria proposed rule published elsewhere in this issue
of the Federal Register.
By its very definition, eMAR occurs at the point of care so we do
not propose additional qualifications on when it must be used or who
must use it.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of
medication orders created by authorized providers of the eligible
hospital's or CAH's inpatient or emergency department (POS 21 or 23)
during the EHR reporting period are tracked using eMAR.
This recommendation by the HIT Policy Committee was that the
measure of this objective be that eMAR is implemented and in use for
the entire EHR reporting period in at least one ward/unit of the
hospital. However, we recognize that it may be difficult to provide a
definition of ward or unit that is applicable for all eligible
hospitals and CAHs. Therefore we are proposing a percentage-based
measure that would be applicable to all medication orders created by
authorized providers of an inpatient or emergency department. We
believe the low threshold of 10 percent allows eligible hospitals and
CAHs maximum flexibility in how they choose to implement eMAR. We note
that this approach does not prevent an eligible hospital or CAH from
implementing eMAR in a single ward or unit, provided that they are able
to meet the 10 percent threshold from orders tracked through eMAR in
that unit. Eligible hospitals and CAHs might also elect to implement
eMAR more widely in order to better complement their current workflow.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of medication orders created by
authorized providers in the eligible hospital's or CAH's inpatient or
emergency department (POS 21 or 23) during the EHR reporting period.
Numerator: The number of orders in the denominator tracked
using eMAR.
Threshold: The resulting percentage must be more than 10
percent in order for an eligible hospital or CAH to meet this measure.
Proposed Eligible Hospital/CAH Objective: Generate and transmit
permissible discharge prescriptions electronically (eRx)
The use of electronic prescribing has several advantages over
having the patient carry the prescription to the pharmacy or directly
faxing a handwritten or typewritten prescription to the pharmacy. When
the hospital generates the prescription electronically, Certified EHR
Technology can recognize the information and can provide decision
[[Page 13730]]
support to promote safety and quality in the form of adverse
interactions and other treatment possibilities. The Certified EHR
Technology can also provide decision support that promotes the
efficiency of the health care system by alerting the EP to generic
alternatives or to alternatives favored by the patient's insurance plan
that are equally effective. Transmitting the prescription
electronically promotes efficiency and safety through reduced
communication errors. It also allows the pharmacy or a third party to
automatically compare the medication order to others they have received
for the patient. This comparison allows for many of the same decision
support functions enabled at the generation of the prescription, but
bases them on potentially greater information.
The HIT Policy Committee recommended the inclusion of eRx for
hospitals for discharge medications. We agree that eRx has unique
advantages for discharge medications versus medications dispensed
within the hospital. Primarily the efficiency of the transmission and
the information it provides to the external pharmacy and/or third party
to compare to other medication orders received for the patient.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of
hospital discharge medication orders for permissible prescriptions (for
new or changed prescriptions) are compared to at least one drug
formulary and transmitted electronically using Certified EHR
Technology.
The HIT Policy Committee recommended that this measure be limited
to new or changed prescriptions that were ordered during the course of
treatment of the patient while in the hospital. The limitation is
necessary because prescriptions that originate prior to the hospital
stay, and that remain unchanged, would be within the purview of the
original prescriber, and not hospital staff or attending physicians. We
propose to include this limitation as we agree with the HIT Policy
Committee that the hospital would not issue refills for medications
they did not authorize or alter during their treatment of the patient.
We ask that commenters consider whether a hospital issues refills to
patients being discharged for medications the patient was taking when
they arrived at the hospital and, if so, whether distinguishing those
prescriptions from new or altered prescriptions is unnecessarily
burdensome for the hospital.
As this would be a new menu objective for hospitals for Stage 2 and
we continue to have concerns about the effect of patient preferences,
we are proposing a threshold of 10 percent as recommended by the HIT
Policy Committee. We do not believe that an exclusion based on the
number of medications is necessary, as we cannot envision a hospital
with fewer than 100 prescriptions, but we do propose an exclusion if
there are no pharmacies that accept electronic prescriptions within 25
miles of the hospital. A hospital with an internal pharmacy that can
dispense these electronic prescriptions to patients after discharge
could not qualify for this exclusion.
The inclusion of the comparison to at least one drug formulary
enhances the efficiency of the healthcare system when clinically
appropriate and cheaper alternatives may be available. Not all drug
formularies are linked to all Certified EHR Technologies, so we do not
require that the formulary be one that is relevant for the particular
patient. Therefore, the comparison could return a result of formulary
unavailable for that patient and medication combination. This
modification of the measure replaces the Stage 1 menu objective of
``Implement drug-formulary checks'' and is intended to provide better
integration guidance both for the hospital and their supporting
vendors. To calculate the percentage, CMS and ONC have worked together
to define the following for this objective:
Denominator: Number of new or changed prescriptions
written for drugs requiring a prescription in order to be dispensed
other than controlled substances for patients discharged during the EHR
reporting period.
Numerator: The number of prescriptions in the denominator
generated, compared to a drug formulary and transmitted electronically.
Threshold: The resulting percentage must be more than 10
percent in order for an eligible hospital or CAH to meet this measure.
Exclusion: Any eligible hospital or CAH that does not have an
internal pharmacy that can accept electronic prescriptions and there
are no pharmacies that accept electronic prescriptions within 25 miles
at the start of their EHR reporting period.
Proposed Eligible Hospital/CAH Objective: Provide patients the
ability to view online, download, and transmit information about a
hospital admission.
Studies have found that patients engaged with computer based
information sources and decision support show improvement in quality of
life indicators, patient satisfaction and health outcomes. (Ralston,
Carrell, Reid, Anderson, Moran, & Hereford, 2007) (Gustafson, Hawkins,
Bober, S, Graziano, & CL, 1999) (Riggio, Sorokin, Moxey, Mather, Gould,
& Kane, 2009) (Gustafson, et al., 2001). In addition, this objective
aligns with the FIPPs,\3\ in affording baseline privacy protections to
individuals. We believe that this information is integral to the
Partnership for Patents initiative and reducing hospital readmissions.
While this objective does not require all of the information sources
and decision support used in these studies, having a set of basic
information available advances these initiatives. The ability to have
this information online means it is always retrievable by the patient,
while the download function ensures that the patient can take the
information with them when secure internet access is not available.
However, providers should be aware that while meaningful use is limited
to the capabilities of CEHRT to provide online access, there may be
patients who cannot access their EHRs electronically because of their
disability. Additionally, other health information may not be
accessible. Providers who are covered by civil rights laws must provide
individuals with disabilities equal access to information and
appropriate auxiliary aids and services as provided in the applicable
statutes and regulations.
---------------------------------------------------------------------------
\3\ Ibid.
---------------------------------------------------------------------------
We propose this as a core objective for hospitals in Stage 2 with
the following information that must be available as part of the
objective:
Admit and discharge date and location.
Reason for hospitalization.
Providers of care during hospitalization.
Problem list maintained by the hospital on the patient.
Relevant past diagnoses known by the hospital.
Medication list maintained by the hospital on the patient
(both current admission and historical).
Medication allergy list maintained by the hospital on the
patient (both current admission and historical).
Vital signs at discharge.
Laboratory test results (available at time of discharge).
Care transition summary and plan for next provider of care
(for transitions other than home).
Discharge instructions for patient, and
Demographics maintained by hospital (gender, race,
ethnicity, date of birth, preferred language, smoking status).
This is not intended to limit the information made available by the
[[Page 13731]]
hospital. A hospital can make available additional information and
still align with the objective.
A hospital has any number of ways to make this information
available online. The hospital can host a patient portal, contract with
a vendor to host a patient portal, connect with an online PHR, or other
means. As long as the patient can view and download the information
using a standard Web browser and internet connection, the means is at
the discretion of the hospital.
Proposed Measure: There are 2 measures for this objective, both of
which must be satisfied in order to meet the objective.
More than 50 percent of all patients who are discharged from the
inpatient or emergency department (POS 21 or 23) of an eligible
hospital or CAH have their information available online within 36 hours
of discharge.
More than 10 percent of all patients who are discharged from the
inpatient or emergency department (POS 21 or 23) of an eligible
hospital or CAH view, download, or transmit to a third party their
information during the EHR reporting period.
This objective replaces two Stage 1 objectives for providing
patients electronic copies of their health information upon request and
providing electronic copies of discharge instructions. In Stage 1 of
meaningful use, there was a measure of 50 percent of patients
requesting electronic copies (within 3 business days) and discharge
instructions (at time of discharge) were provided to them. The creation
of this Stage 2 combined objective creates different time constraints.
The HIT Policy Committee recommended 36 hours from discharge as an
appropriate time period to meet this measure. We see no compelling
reason to alter this recommendation; however, we encourage comment on
whether this is an appropriate time frame for this new measure.
The second measure represents a new concept for meaningful use
criteria, because it measures the hospital based upon the actions of
the patient. The HIT Policy Committee noted that providers would want
flexibility with respect to the type of guidance provided to patients.
In turn, the HIT Policy Committee recommended best practice guidance
for providers, vendors, and software developments. We believe the
hospital can sponsor education and awareness activities that result in
patients viewing their information. Also, the low threshold of 10
percent recognizes that this kind of measure is in its earlier stages.
A patient who views their information online, downloads it from the
internet or uses the internet to transmit it to a third party would
count for purposes of the numerator. However, we recognize, that in
areas of the country where a significant section of the patient
population does not have access to broadband internet, this measure may
be significantly harder or impossible to achieve. For example, for a
hospital in an area with 100 percent broadband availability, only 10
percent of the patient population must view the information. However, a
hospital in an area with 30 percent broadband availability must
essentially have a third of their patient population view the
information. In addition, areas with high broadband penetration tend to
correlate with more prolific users making it more likely that patients
will view information online. There are 2 possible solutions to this
disparity. The first is to exclude hospitals that operate in areas with
below a certain threshold of broadband penetration. The second would be
to change the measure to 10 percent of the broadband penetration.
According to the FCC, 370 counties in the United States have broadband
penetration of less than 50 percent (www.broadband.gov). Hospitals in
areas of low broadband availability tend to service large areas that
may extend beyond the county in which the hospital is located. Under
the first option we considered, if the county in which the hospital is
located has less than 50 percent of its housing units with 4Mbps
broadband availability according to the latest information available
from the FCC on the first day of the EHR reporting period, the hospital
may exclude the second measure. Under the second option, the hospital
would have to meet 10 percent of the broadband availability according
to the FCC in the county in which they are located at the beginning of
the EHR reporting period. For example, if the reported availability in
a county on October 1, 2014, for a hospital was 23 percent, the
hospital's threshold for the second measure would be 2.3 percent. There
are counties currently with zero percent availability. If there is a
hospital in a county with zero percent availability, those hospitals
would not have to meet the second measure. We propose to adopt the
first method as we believe the second method is too complex to be a
practical requirement. However, we welcome comments on both options as
well as the correct threshold for the first option.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
First Measure:
Denominator: Number of unique patients discharged from an
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23) during the EHR reporting period.
Numerator: The number of patients in the denominator whose
information is available online within 36 hours of discharge.
Threshold: The resulting percentage must be more than 50
percent in order for an eligible hospital or CAH to meet this measure.
Second Measure:
Denominator: Number of unique patients discharged from an
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23) during the EHR reporting period.
Numerator: The number of patients in the denominator who
view, download or transmit to a third party the information provided by
the eligible hospital or CAH online during the EHR reporting period.
Threshold: The resulting percentage must be more than 10
percent in order for an eligible hospital or CAH to meet this measure.
Exclusion: Any eligible hospital or CAH will be excluded from the
second measure if it is located in a county that does not have 50
percent or more of their housing units with 4Mbps broadband
availability according to the latest information available from the FCC
at the start of the EHR reporting period is excluded from the second
measure.
(e) Objective and Measure Carried Over Unmodified From Stage 1 Menu Set
to Stage 2 Menu Set
Proposed Eligible Hospital/CAH Objective: Record whether a patient
65 years old or older has an advance directive.
The HIT Policy Committee recommended making this a core objective
and also requiring eligible hospitals and CAHs to either store an
electronic copy of the advance directive in the Certified EHR
Technology or link to an electronic copy of the advance directive.
However, we propose to maintain this objective as part of the Menu Set
and we are not proposing a copy or link to the advance directive for
eligible hospitals and CAHs in Stage 2. As we stated in our Stage 1
final rule (75 FR 44345), we have continuing concerns that there are
potential conflicts between storing advance directives and existing
State laws. Also, we believe that because of State law restrictions, an
advance directive stored in an EHR may not be actionable. Finally, we
believe that eligible hospitals and CAHs may have other methods of
satisfying the intent of this objective at this time, although we
recognize that these
[[Page 13732]]
workflows may change as EHR technology develops and becomes more widely
adopted. Therefore, we do not propose to adopt the HIT Policy
Committee's recommendations to require this objective as a core
measure, to store an electronic copy of the advance directive in the
Certified EHR Technology, or to link to an electronic copy of the
advance directive.
The HIT Policy Committee has also recommended the inclusion of this
objective for EPs in Stage 2. In our Stage 1 final rule (75 FR 44345),
we indicated our belief that many EPs would not record this information
under current standards of practice and would only require information
about a patient's advance directive in rare circumstances. We continue
to believe this is the case and that creating a list of specialties or
types of EPs that would be excluded from the objective would be too
cumbersome and still might not be comprehensive. Therefore, we are not
proposing the recording of the existence of advance directives as an
objective for EPs in Stage 2. However, we invite public comment on this
decision and encourage commenters to address specific concerns
regarding scope of practice and ease of compliance for EPs. And we note
that nothing in this rule compels the use of advance directives.
Proposed Eligible Hospital/CAH Measure: More than 50 percent of all
unique patients 65 years old or older admitted to the eligible
hospital's or CAH's inpatient department (POS 21) during the EHR
reporting period have an indication of an advance directive status
recorded as structured data.
We propose that the measure of this objective would remain
unmodified from Stage 1. To calculate the percentage, CMS and ONC have
worked together to define the following for this objective:
Denominator: Number of unique patients age 65 or older
admitted to an eligible hospital's or CAH's inpatient department (POS
21) during the EHR reporting period.
Numerator: The number of patients in the denominator who
have an indication of an advance directive status entered using
structured data.
Threshold: The resulting percentage must be more than 50
percent in order for an eligible hospital or CAH to meet this measure.
Exclusion: Any eligible hospital or CAH that admits no patients age
65 years old or older during the EHR reporting period.
Please note that the calculation of the denominator for the measure
of this objective is limited to unique patients age 65 or older who are
admitted to an eligible hospital's or CAH's inpatient department (POS
21). Patients admitted to an emergency department (POS 23) should not
be included in the calculation. As we discussed in our Stage 1 final
rule (75 FR 44345), we believe that this information is a level of
detail that is not practical to collect on every patient admitted to
the eligible hospital's or CAH's emergency department, and therefore,
have limited this measure only to the inpatient department of the
hospital.
(f) Other HIT Policy Committee Recommended Objectives Not Proposed
We are not proposing these objectives for Stage 2 as explained at
each objective, but we encourage comments on whether these objectives
should be incorporated into Stage 2.
Hospital Objective: Provide structured electronic lab results to
eligible professionals.
Hospital Measure: Hospital labs send (directly or indirectly)
structured electronic clinical lab results to the ordering provider for
more than 40 percent of electronic lab orders received.
The measure for this objective recommended by the HIT Policy
Committee is that 40 percent of clinical lab test results
electronically sent by an eligible hospital or CAH would need to be
done so using the capabilities Certified EHR Technology. This measure
requires that in situations where the electronic connectivity between
an eligible hospital or CAH and an EP is established, the results
electronically exchanged are done so using Certified EHR Technology. To
facilitate the ease with which this electronic exchange may take place,
ONC has proposed that for certification, ambulatory EHR technology
would need to be able to incorporate lab test results formatted in the
same standard and implementation specifications to which inpatient EHR
technology would need to be certified as being able to create. However,
we are not proposing this objective for a variety of reasons. While ONC
is working to ease the barriers to this exchange through certification,
this assumes that over 40 percent of the ordering providers would be
utilizing Certified EHR Technology. Also, as discussed elsewhere, there
is more to exchange than the established standards. Secondly, although
hospital labs supply nearly half of all lab results to EPs, they are
not the predominant vendors for providers who do not share or cannot
access their technology. Independent and office laboratories provide
over half of the labs in this market. We are concerned that imposing
this requirement on hospital labs would unfairly disadvantage them in
this market. Furthermore, not all hospitals offer these services so it
would create a natural disparity in meaningful use between those
hospitals offering these services and those that do not. Finally, all
other aspects of meaningful use in Stage 1 and Stage 2 focuses on the
inpatient and emergency departments of a hospital. This objective is
not related to these departments, in fact, it explicitly excludes
services provided in these departments. We encourage comments on both
the pros and cons of this objective and whether it should be considered
for the final rule as recommended by the HIT Policy Committee. The HIT
Policy Committee recommended this as a core objective for Stage 2 for
eligible hospitals.
EP Objective/Measure: Record patient preferences for communication
medium for more than 20 percent of all unique patients seen during the
EHR reporting period.
We believe that this requirement is better incorporated with other
objectives that require patient communication and is not necessary as a
standalone objective.
Objective/Measure: Record care plan goals and patient instructions
in the care plan for more than 10 percent of patients seen during the
reporting period.
We believe that this requirement is better incorporated with other
objectives that require summary of care documents and is not necessary
as a standalone objective.
Objective/Measure: Record health care team members (including at a
minimum PCP, if available) for more than 10 percent of all patients
seen during the reporting period; this information can be unstructured.
We believe that this requirement is better incorporated with other
objectives that require summary of care documents and is not necessary
as a standalone objective.
Objective/Measure: Record electronic notes in patient records for
more than 30 percent of office visits.
While we believe that medical evaluation entries by providers are
an important component of patient records that can provide information
not otherwise captured within standardized fields, we believe there is
evidence to suggest that electronic notes are already widely used by
providers of Certified EHR Technology and therefore do not need to be
included as a meaningful use objective. For example, a 2008 survey of
healthcare professionals indicated that 75 percent of respondents were
already using an EHR for physician charting/
[[Page 13733]]
documentation and 74 percent were already using the EHR for nursing
charting/documentation (2008 HIMSS/HIMSS Analytics Ambulatory
Healthcare IT Survey: http://www.himss.org/content/files/2008_HA_HIMSS_ambulatory_Survey.pdf). However, we note that ONC has included
in its Stage 2 proposed rule certification capabilities that require
Certified EHR Technology to allow the inclusion of electronic notes
that are text-searchable.
Table 4 provides a summary of stage 2 objectives and measures that
we are proposing to adopt.
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B. Reporting on Clinical Quality Measures Using Certified EHR
Technology by Eligible Professionals, Eligible Hospitals, and Critical
Access Hospitals
1. Time Periods for Reporting Clinical Quality Measures
This section clarifies the time periods as they relate to reporting
clinical quality measures only. We are not proposing any changes to the
time periods for reporting clinical quality measures. The EHR reporting
period for clinical quality measures under the EHR Incentive Program is
the period during which data collection or measurement for clinical
quality measures occurs. The reporting period is consistent with our
Stage 1 final rule (75 FR 44314) and will continue to track with the
EHR reporting periods for the meaningful use criteria:
Eligible Professionals (EPs): January 1 through December
31 (calendar year).
Eligible Hospitals and Critical Access Hospitals (CAHs):
October 1 through September 30 (Federal fiscal year).
EPs, eligible hospitals, and CAHs in their first year of
meaningful use for Stage 1, the EHR reporting period would be any
continuous 90-day period within the calendar year (CY) or Federal
fiscal year (FY), respectively. To avoid a payment adjustment, Medicare
EPs and eligible hospitals that are in their first year of
demonstrating meaningful use in the year immediately preceding any
payment adjustment year would have to ensure that the 90-day EHR
reporting period ends at least three months before the end of the CY or
FY, and that all submission is completed by October 1 or July 1,
respectively. For an explanation of the applicable EHR reporting
periods for determining the payment adjustments, please see section
II.D. of this proposed rule.
Table 5--Reporting on Clinical Quality Measures Using Certified EHR Technology by Eligible Professionals,
Eligible Hospitals and Critical Access Hospitals
----------------------------------------------------------------------------------------------------------------
Reporting period Submission period
Reporting period Submission period for subsequent for subsequent
for first year of for first year of years of years of
Provider type meaningful use meaningful use meaningful use meaningful use
(Stage 1) (Stage 1) (Stage 1 and (Stage 1 and
Subsequent Stages) subsequent stages)
----------------------------------------------------------------------------------------------------------------
EP.............................. 90 consecutive Anytime 1 calendar year 2 months following
days. immediately (January 1- the end of the
following the end December 31). EHR reporting
of the 90-day period (January 1-
reporting period, February 28).
but no later than
February 28 of
the following
calendar year.
Eligible Hospital/CAH........... 90 consecutive Anytime immediate 1 fiscal year 2 months following
days. following the end (October1-Septemb the end of the
of the 90-day er 30). EHR reporting
reporting period, period (October 1-
but no later than November 30).
November 30 of
the following
fiscal year.
----------------------------------------------------------------------------------------------------------------
For example, for an EP, an EHR reporting period would be January 1,
2014 through December 31, 2014 and is the same as CY 2014. If the EP is
in his or her first year of Stage 1, the EHR reporting period could be
at the earliest from January 1, 2014 through March 31, 2014 and at the
latest from October 3, 2014 through December 31, 2014. If the EP is
demonstrating meaningful use for the first time in CY 2014, for
purposes of avoiding the payment adjustment in CY 2015, the EHR
reporting period must end by September 30, 2014.
For an eligible hospital or CAH, an EHR reporting period would be
October 1, 2013 through September 30, 2014 and is the same as FY 2014.
If the eligible hospital or CAH is in its first year of meaningful use
for Stage 1, the EHR reporting period could be at the earliest from
October 1, 2013 through December 29, 2013 and at the latest from July
3, 2014 through September 30, 2014. If an eligible hospital is
demonstrating meaningful use for the first time in FY 2014, for
purposes of avoiding the payment adjustment in FY 2015, the EHR
reporting period must end by June 30, 2014.
For EPs, eligible hospitals, and CAHs, the submission period for
clinical quality measure data to us generally would be 2 months
immediately following the end of the EHR reporting period:
Eligible Professionals: January 1 through February 28.
Eligible Hospitals and CAHs: October 1 through November
30.
EPs, eligible hospitals, and CAHs in their first year of
Stage 1 could submit clinical quality measure data anytime after their
respective 90-day EHR reporting period up to the end of the 2 months
immediately following the end of the CY or FY, respectively. However,
for purposes of avoiding the payment adjustments, Medicare EPs and
eligible hospitals that are in their first year of demonstrating
meaningful use in the year immediately preceding a payment adjustment
year must submit their clinical quality measure data no later than
October 1 (for EPs) or July 1 (for eligible hospitals) of such
preceding year.
Using the same examples for the EHR reporting periods previously
for an EP, the submission period for CY 2014 would be January 1, 2015
through February 28, 2015. If the EP is in his or her first year of
Stage 1, the submission period could begin at the earliest April 1,
2014 and would end February 28, 2015. However, if the EP is
demonstrating meaningful use for the first time in CY 2014, for
purposes of avoiding the payment adjustment in CY 2015, the clinical
quality measure data must be submitted by October 1, 2014.
Using the same examples for the EHR reporting periods previously
for an eligible hospital and CAH, the submission period for FY 2014
would be October 1, 2014 through November 30, 2014. If the eligible
hospital and CAH is in its first year of Stage 1, the submission period
could begin at the earliest December 30, 2013 and would end November
30, 2014. However, if an eligible hospital is demonstrating meaningful
use for the first time in FY 2014, for purposes of avoiding the payment
adjustment in FY 2015, the clinical quality measure data must be
submitted by July 1, 2014.
2. Certification Requirements for Clinical Quality Measures
The Office of the National Coordinator (ONC) sets the certification
[[Page 13743]]
criteria for EHR technology, which for clinical quality measures are
described in 45 CFR 170.314(c) in ONC's proposed rule published
elsewhere in this issue of the Federal Register. Certified EHR
Technology will be required for the reporting methods finalized from
this proposed rule. This may include attestation, reporting under the
PQRS EHR reporting option, the group reporting options for EPs, the
aggregate portal-based reporting methods, and the finalized reporting
method for eligible hospitals and CAHs. Readers should refer to ONC's
proposed rule for an explanation of the definition of Certified EHR
Technology that would apply beginning with 2014.
In addition, for attestation and the aggregate portal-based
reporting methods for EPs, eligible hospitals and CAHs, Certified EHR
Technology must be certified to ``incorporate and calculate'' in
accordance with 45 CFR 170.314(c)(2) for each individual clinical
quality measure that an EP, eligible hospital or CAH submits. EPs,
eligible hospitals and CAHs must only submit clinical quality measures
that their Certified EHR Technology is explicitly certified to
calculate according to 45 CFR 170.314(c)(2) in ONC's proposed rule in
order to meet the meaningful use requirement for reporting clinical
quality measures. For example, if an EP's Certified EHR Technology is
only certified to calculate clinical quality measures 1
through 12, and the EP submits clinical quality measures
1 through 11 and 37, the EP would not have
met the meaningful use requirement for reporting clinical quality
measures because his/her Certified EHR Technology was not certified to
calculate clinical quality measure 37.
Likewise, for attestation and the aggregate portal-based reporting
methods, Certified EHR Technology must be certified for ``reporting''
(please refer to the discussion of 45 CFR 170.314(c)(3) in ONC's
proposed rule), which certifies the capability to create and transmit a
standard aggregate XML-based file that can be electronically accepted
by CMS.
3. Criteria for Selecting Clinical Quality Measures
We are soliciting comment on a wide ranging list of 125 potential
measures for EPs and 49 potential measures for eligible hospitals and
CAHs. We expect to finalize only a subset of these proposed measures.
We are committed to aligning quality measurement and reporting
among our programs (for example, IQR, PQRS, CHIPRA, ACO programs). Our
alignment efforts focus on several fronts including choosing the same
measures for different program measure sets, standardizing measure
development and specification processes across CMS programs,
coordinating quality measurement stakeholder involvement efforts and
opportunities for public input, and identifying ways to minimize
multiple submission requirements and mechanisms. For example, we are
working towards allowing CQM data submitted via certified EHRs by EPs
and EHs/CAHs to apply to other CMS quality reporting programs. A longer
term vision would be hospitals and clinicians reporting through a
single, aligned mechanism for multiple CMS programs. We believe the
alignment options for PQRS/EHR Incentive Program proposed in this rule
are the first step towards such a vision. We are exploring how
intermediaries and State Medicaid Agencies could participate in and
further enable these quality measurement and reporting alignment
efforts, while meeting the needs of multiple Medicare and Medicaid
programs (for example, ACO programs, Dual Eligible initiatives,
Medicaid shared savings efforts, CHIPRA and ACA measure sets, etc).
This would lessen provider burden and harmonize with our data exchange
priorities, while also supporting our goal of the programs transforming
our system to provide higher quality care, better health outcomes, and
lower cost through improvement.
In addition to statutory requirements for EPs (section II.B.4.(a)
of this proposed rule), eligible hospitals (section II.B.6.(a) of this
proposed rule), and CAHs (section II.B.6.(a) of this proposed rule), we
relied on the following criteria to select this initial list of
proposed clinical quality measures for EPs, eligible hospitals, and
CAHs:
Measures that can be technically implemented within the
capacity of the CMS infrastructure for data collection, analysis, and
calculation of reporting and performance rates. This includes measures
that are ready for implementation, such as those with developed
specifications for electronic submission that have been used in the EHR
Incentive Program or other CMS quality reporting initiatives, or that
will be ready soon after the expected publication of the final rule in
2012. This also includes measures that can be most efficiently
implemented for data collection and submission.
Measures that support CMS and HHS priorities for improved
quality of care for people in the United States, which are based on the
March 2011 report to Congress, ``National Strategy for Quality
Improvement in Health Care'' (National Quality Strategy) (http://www.healthcare.gov/law/resources/reports/nationalqualitystrategy032011.pdf) and the Health Information
Technology Policy Committee's (HITPC's) recommendations (http://healthit.hhs.gov/portal/server.pt?open=512&objID=1815&parentname=CommunityPage&parentid=7&mode=2&in_hi_userid=11113&cached=true). These include the following 6
priorities:
++ Making care safer by reducing harm caused in the delivery of
care.
++ Ensuring that each person and family are engaged as partners in
their care.
++ Promoting effective communication and coordination of care.
++ Promoting the most effective prevention and treatment practices
for the leading causes of mortality, starting with cardiovascular
disease.
++ Working with communities to promote wide use of best practices
to enable healthy living.
++ Making quality care more affordable for individuals, families,
employers, and governments by developing and spreading new health care
delivery models.
Measures that address known gaps in quality of care, such
as measures in which performance rates are currently low or for which
there is wide variability in performance, or that address known drivers
of high morbidity and/or cost for Medicare and Medicaid.
Measures that address areas of care for different types of
eligible professionals (for example, Medicare- and Medicaid-eligible
physicians, and Medicaid-eligible nurse-practitioners, certified nurse-
midwives, dentists, physician assistants).
In an effort to align the clinical quality measures used within the
EHR Incentive Program with the goals of CMS and HHS, the National
Quality Strategy, and the HITPC's recommendations, we have assessed all
proposed measures against six domains based on the National Quality
Strategy's six priorities, which were developed by the HITPC
Workgroups, as follows:
Patient and Family Engagement. These are measures that
reflect the potential to improve patient-centered care and the quality
of care delivered to patients. They emphasize the importance of
collecting patient-reported data and the ability to impact care at the
individual patient level as well as the population level through
greater involvement of patients and
[[Page 13744]]
families in decision making, self care, activation, and understanding
of their health condition and its effective management.
Patient Safety. These are measures that reflect the safe
delivery of clinical services in both hospital and ambulatory settings
and include processes that would reduce harm to patients and reduce
burden of illness. These measures should enable longitudinal assessment
of condition-specific, patient-focused episodes of care.
Care Coordination. These are measures that demonstrate
appropriate and timely sharing of information and coordination of
clinical and preventive services among health professionals in the care
team and with patients, caregivers, and families in order to improve
appropriate and timely patient and care team communication.
Population and Public Health. These are measures that
reflect the use of clinical and preventive services and achieve
improvements in the health of the population served and are especially
focused on the leading causes of mortality. These are outcome-focused
and have the ability to achieve longitudinal measurement that will
demonstrate improvement or lack of improvement in the health of the US
population.
Efficient Use of Healthcare Resources. These are measures
that reflect efforts to significantly improve outcomes and reduce
errors. These measures also impact and benefit a large number of
patients and emphasize the use of evidence to best manage high priority
conditions and determine appropriate use of healthcare resources.
Clinical Processes/Effectiveness. These are measures that
reflect clinical care processes closely linked to outcomes based on
evidence and practice guidelines.
We welcome comments on these domains, and whether they will
adequately align with and support the breadth of CMS and HHS activities
to improve quality of care and health outcomes.
We also considered the recommendations of the Measure Applications
Partnership (MAP) for inclusion of clinical quality measures. The MAP
is a public-private partnership convened by the National Quality Forum
(NQF) for the primary purpose of providing input to HHS on selecting
performance measures for public reporting. The MAP published draft
recommendations in their Pre-Rulemaking Report on January 11, 2012
(http://www.qualityforum.org/map/), which includes a list of, and
rationales for, all the clinical quality measures that the MAP did not
support. The MAP did not review the clinical quality measures for 2011
and 2012 that were previously adopted for the EHR Incentive Program in
the Stage 1 final rule. We have included some of the clinical quality
measures not supported by the MAP in Tables 8 (EPs) and 9 (eligible
hospitals and CAHs) to ensure alignment with other CMS quality
reporting programs, address recommendations by other Federal advisory
committees such as the HITPC, and support other quality goals such as
the Million Hearts Campaign. We also included some measures to address
specialty areas that may not have had applicable measures in the Stage
1 final rule.
We anticipate that only a subset of these measures will be
finalized. When considering which measures to finalize, we will take
into account public comment on the measures themselves and the
priorities listed previously. We intend to prioritize measures that
align with and support the measurement needs of CMS program activities
related to quality of care, delivery system reform, and payment reform,
especially:
Encouraging the use of outcome measures, which provide
foundational data needed to assess the impact of these programs on
population health.
Measuring progress in preventing and treating priority
conditions, including those affecting a large number of CMS
beneficiaries or contributing to a large proportion of program costs.
Improving patient safety and reducing medical harm.
Capturing the full range of populations served by CMS
programs.
4. Measure Specification
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 has a measure
steward who has accepted responsibility for maintaining and updating
the measure. In general, it is the role of the measure steward to make
changes to a measure in terms of the initial patient population,
numerator, denominator, and potential exclusions. We recognize that it
may be necessary to update measure specifications after they have been
published to ensure their continued relevance, accuracy, and validity.
Measure specifications updates may include administrative changes, such
as adding the NQF endorsement number to a measure, correcting faulty
logic, adding or deleting codes as well as providing additional
implementation guidance for a measure. These changes would be described
in full through supplemental updates to the electronic specifications
for EHR submission provided by CMS.
The complete measure specifications would be posted on our Web site
(https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp)
at or around the time of the final rule. In order to assist the public
when considering the proposed clinical quality measures in this
proposed rule, we would publish tables titled ``Proposed Clinical
Quality Measures for 2014 CMS EHR Incentive Programs for Eligible
Professionals'' and ``Proposed Clinical Quality Measures for 2014 CMS
EHR Incentive Programs for Eligible Hospitals and CAHs'' on this Web
site at or around the time of the publication of this proposed rule.
These tables contain additional information for the EP, eligible
hospital and CAH clinical quality measures, respectively, which may not
be found on the NQF Web site. Some of these measures are still being
developed, therefore the additional descriptions provided in these
tables may still change before the final rule is published. Public
comments regarding these measures should be submitted using the same
method required for all other comments related to this proposed rule.
Please note that the titles and descriptions for the clinical quality
measures included in these tables were updated by the measure stewards
and therefore may not match the information provided on the NQF Web
site. Measures that do not have an NQF number are not currently
endorsed.
Measures would be tracked on a version basis as updates to those
measures are made. We would require all EPs, eligible hospitals, and
CAHs to submit the versions of the clinical quality measure as
identified on our Web site, and they would need to include the version
numbers when they report the measure. It is our intent to include the
version numbers with our updates to the measure specifications.
Under certain circumstances, we believe it may be necessary to
remove a clinical quality measure from the EHR Incentive Program
between rulemaking cycles. When there is reason to believe that the
continued collection of a measure as it is currently specified raises
potential patient safety concerns and/or is no longer scientifically
valid, it would be appropriate for us to take immediate action to
remove the measure from the EHR Incentive Program and not wait for the
rulemaking cycle. Likewise, if a clinical quality measure undergoes a
substantive change by the measure steward between rulemaking cycles
such that the measure's intent has
[[Page 13745]]
changed, we would expect to remove the measure immediately from the EHR
Incentive Program until the next rulemaking cycle when we could propose
the revised measure for public comment. Under this policy, we would
promptly remove such clinical quality measures from the set of measures
available for providers to report under the EHR Incentive Program,
confirm the removal (or propose the revised measure) in the next EHR
Incentive Program rulemaking cycle, and notify providers (EPs, eligible
hospitals, and CAHs) and the public of our decision to remove the
measure(s) through the usual communication channels (memos, email
notification, Web site postings).
5. Proposed Clinical Quality Measures for Eligible Professionals
(a) Statutory and Other Considerations
Sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C) of the Act provide
for the reporting of clinical quality measures by EPs as part of
demonstrating meaningful use of Certified EHR Technology. For further
explanation of the statutory requirements, we refer readers to the
discussion in our proposed and final rules for Stage 1 (75 FR 1870
through 1902 and 75 FR 44380 through 44435, respectively).
Under sections 1848(o)(1)(D)(iii) and 1903(t)(8) of the Act, the
Secretary must seek, to the maximum extent practicable, to avoid
duplicative requirements from Federal and State governments for EPs to
demonstrate meaningful use of Certified EHR Technology under Medicare
and Medicaid. Therefore, to meet this requirement, we continue our
practice from Stage 1 of proposing clinical quality measures that would
apply for both the Medicare and Medicaid EHR Incentive Programs, as
listed in sections II.B.4.(b). and II.B.4.(c). of this proposed rule.
Section 1848(o)(2)(B)(iii) of the Act requires that in selecting
measures for EPs, and in establishing the form and manner of reporting,
the Secretary shall seek to avoid redundant or duplicative reporting
otherwise required, including reporting under subsection (k)(2)(C)
(that is, reporting under the Physician Quality Reporting System).
Consistent with that requirement, we are proposing to select clinical
quality measures for EPs for the EHR Incentive Programs that align with
other existing quality programs such as the Physician Quality Reporting
System (PQRS) (76 FR 73026), the Medicare Shared Savings Program (76 FR
67802), measures used by the National Committee for Quality Assurance
(NCQA) for medical home accreditation (http://ncqa.org), the Health
Resources and Services Administration's (HRSA) Uniform Data System
(UDS) (75 FR 73170), Children's Health Insurance Program
Reauthorization Act (CHIPRA) (75 FR 44314), and the final Section 2701
adult measures under the Affordable Care Act (ACA) published in the
Federal Register on January 4, 2012 (77 FR 286). When a measure is
included in more than one CMS quality reporting program and is reported
using Certified EHR Technology, we would seek to avoid requiring EPs to
report the same clinical quality measure to separate programs through
multiple transactions or mechanisms.
Section 1848(o)(2)(B)(i)(I) of the Act requires the Secretary to
give preference to clinical quality measures endorsed by the entity
with a contract with the Secretary under section 1890(a) (namely, the
National Quality Forum (NQF)). We are proposing clinical quality
measures for EPs for 2013, 2014, and 2015 (and potentially subsequent
years) that reflect this preference, although we note that the Act does
not require the selection of NQF endorsed measures for the EHR
Incentive Programs. Measures listed in this proposed rule that do not
have an NQF identifying number are not NQF endorsed, but are included
in this proposed rule with the intent of eventually obtaining NQF
endorsement of those measures determined to be critical to our program.
Per the preamble discussion in the Stage 1 final rule regarding
measures gaps and Medicaid providers (75 FR 44506), we are proposing to
increase the total number of clinical quality measures for EPs in order
to cover areas noted by commenters such as behavioral health, dental
care, long-term care, special needs populations, and care coordination.
The new measures we are proposing beginning with CY 2014 include new
pediatric measures, an obstetric measure, behavioral/mental health
measures, and measures related to HIV medical visits and antiretroviral
therapy, as well as other measures that address National Quality
Strategy goals.
We recognize that we do not have additional measures to propose
beginning with CY 2014 in the areas of long-term and post-acute care.
Since the publication of the Stage 1 final rule, we have partnered with
the National Governor's Association to participate in a panel with
long-term care and health information exchange experts to gain insight
and consensus on possible clinical quality measures. At this time,
however, no clinical quality measures for long-term and post-acute care
have been identified as being ready (electronically specified)
beginning with CY 2014. We expect to continue to develop or identify
clinical quality measures for these areas with our partners and
stakeholders for future years.
We are pleased to propose two oral health measures beginning with
CY 2014. In the past year, we partnered with Agency for Healthcare
Research and Quality (AHRQ) to solicit input from a technical expert
panel to identify barriers to the adoption and use of health IT for
oral health care providers. A final report titled ``Quality Oral Health
Care in Medicaid Through Health IT'' is available at http://healthit.ahrq.gov/portal/server.pt/community/ahrq-fundedprojects/654/medicaid-schip/14760. CMS, the American Dental Association, and the
Dental Quality Alliance have all strategized ways to encourage and
support the use of EHRs for oral health providers. We expect to
continue to develop or identify clinical quality measures for dental/
oral health care with our partners and stakeholders that could be ready
for future years.
(b) Proposed Clinical Quality Measures for Eligible Professionals for
CY 2013
We propose that for the EHR reporting periods in CY 2013, EPs must
submit data for the clinical quality measures that were finalized in
the Stage 1 final rule for CYs 2011 and 2012 (75 FR 44398 through
44411, Tables 6 and 7). Updates to these clinical quality measures'
electronic specifications are expected to be posted on the EHR
Incentive Program Web site at least 6 months prior to the start of CY
2013 (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp). As required by the Stage 1 final rule,
EPs must report on three core or alternate core measures, plus three
additional measures. We refer readers to the discussion in the Stage 1
final rule for further explanation of the requirements for reporting
those clinical quality measures (75 FR 44398 through 44411). The
proposed reporting methods for EPs for CY 2013 are discussed in
sections II.B.5.(a). and II.B.5.(b). of this proposed rule.
(c) Proposed Clinical Quality Measures for Eligible Professionals
Beginning With CY 2014
We are proposing two reporting options that would begin in CY 2014
for Medicare and Medicaid EPs, as described below: Options 1 and 2. For
Options 1, we are proposing the following two alternatives, but intend
to finalize only a single method:
[[Page 13746]]
Option 1a: EPs would report 12 clinical quality measures
from those listed in Table 8, including at least 1 measure from each of
the 6 domains.
Option 1b: EPs would report 11 ``core'' clinical quality
measures listed in Table 6 plus 1 ``menu'' clinical quality measure
from Table 8.
We welcome comment regarding the advantages and disadvantages of
Options 1a and 1b, including EP preference, the appropriateness of the
domains, the number of clinical quality measures required, and the
appropriate split between ``core'' and ``menu'' clinical quality
measures. It is our intent to finalize the most operationally viable
and appropriate option or combination of options in our final rule. As
an alternative to Options 1a or 1b, Medicare EPs who participate in
both the Physician Quality Reporting System and the EHR Incentive
Program may choose Option 2, as described below (the Physician Quality
Reporting System EHR Reporting Option).
We are proposing clinical quality measures in Table 8 that would
apply to all EPs for the EHR reporting periods in CYs 2014 and 2015
(and potentially subsequent years), regardless of whether an EP is in
Stage 1 or Stage 2 of meaningful use. For Medicaid EPs, the reporting
method for clinical quality measures may vary by State. However, the
set of clinical quality measures from which to select (Table 8) would
be the same for both Medicaid EPs and Medicare EPs. Medicare EPs who
are in their first year of Stage 1 of meaningful use may report
clinical quality measures through attestation during the 2 months
immediately following the end of the 90-day EHR reporting period as
described in section II.B.1. of this proposed rule. Readers should
refer to the discussion in the Stage 1 final rule for more information
about reporting clinical quality measures through attestation (75 FR
44430 through 44431). We expect that by CY 2016, we will have engaged
in another round of rulemaking for the EHR Incentive Programs. However,
in the unlikely event such rulemaking does not occur, the clinical
quality measures proposed for CYs 2014 and 2015 would continue to apply
for the EHR reporting periods in CY 2016 and subsequent years.
Therefore, we refer to clinical quality measures that apply ``beginning
with'' or ``beginning in'' CY 2014.
Option 1a: Select and submit 12 clinical quality measures
from Table 8, including at least 1 measure from each of the 6 domains.
We are proposing that EPs must report 12 clinical quality measures
from those listed in Table 8, which must include at least one measure
from each of the following 6 domains, which are described in section
II.B.3. of this proposed rule:
Patient and Family Engagement.
Patient Safety.
Care Coordination.
Population and Public Health.
Efficient Use of Healthcare Resources.
Clinical Process/Effectiveness.
EPs would select the clinical quality measures that best apply to
their scope of practice and/or unique patient population. If an EP's
Certified EHR Technology does not contain patient data for at least 12
clinical quality measures, then the EP must report the clinical quality
measures for which there is patient data and report the remaining
required clinical quality measures as ``zero denominators'' as
displayed by the EPs Certified EHR Technology. If there are no clinical
quality measures applicable to the EP's scope of practice or unique
patient populations, EPs must still report 12 clinical quality measures
even if zero is the result in either the numerator and/or the
denominator of the measure. If all applicable clinical quality measures
have a value of zero from their Certified EHR Technology, then EPs must
report any 12 of the clinical quality measures. For this option, the
clinical quality measures data would be submitted in an XML-based
format on an aggregate basis reflective of all patients without regard
to payer. One advantage of this approach is that EPs can choose
measures that best fit their practice and patient populations. However,
because of the large number of measures to choose from, this approach
would result in fewer EPs reporting on any given measure, and likely
only a small sample of patient data represented in each measure.
Option 1b: Submit 12 clinical quality measures composed of
all 11 of the core clinical quality measures in Table 6 plus 1 menu
clinical quality measure from Table 8.
We are considering a ``core'' clinical quality measure set that all
EPs must report, which will reflect the national priorities outlined in
section II.B.3. of this proposed rule. In addition to the core clinical
quality measure set, we are considering a ``menu'' set from which EPs
would select 1 clinical quality measure to report based on their
respective scope of practice and/or unique patient population. One
advantage of this approach is that quality data would be collected on a
smaller set of measures, so the resulting data for each measure would
represent a larger number of patients and therefore could be more
accurate. However, this approach could mean that more measures are
reported with zero denominators (if they are not applicable to certain
practices or populations), making the data less comprehensive. The menu
set would consist of the measures in Table 8 that are not part of the
core clinical quality measure set. The core clinical quality measure
set for EPs consists of the following measures in Table 6 (these
clinical quality measures are also in Table 8):
Table 6--Potential Core Clinical Quality Measure Set To Be Reported by Eligible Professionals Beginning in CY
2014
----------------------------------------------------------------------------------------------------------------
Clinical quality
Measure Number Clinical quality measure measure steward & Domain
title & description contact information
----------------------------------------------------------------------------------------------------------------
TBD................................ Title: Closing the referral Centers for Medicare Care Coordination.
loop: receipt of and Medicaid Services
specialist report (CMS).
Description: Percentage of 1-888-734-6433 or
patients regardless of age http://
with a referral from a questions.cms.hhs.gov/
primary care provider for app/ask/p/21,26,1139;
whom a report from the Quality Insights of
provider to whom the Pennsylvania (QIP)
patient was referred was Contact Information:
received by the referring www.usqualitymeasures
provider. .org.
[[Page 13747]]
TBD................................ Title: Functional status CMS 1-888-734-6433 or Patient and Family
assessment for complex http:// Engagement.
chronic conditions; questions.cms.hhs.gov/
Description: Percentage of app/ask/p/21,26,1139.
patients aged 65 years and
older with heart failure
and two or more high
impact conditions who
completed initial and
follow-up (patient-
reported) functional
status assessments.
NQF 0018........................... Title: Controlling High NCQA Contact Clinical Process/
Blood Pressure; Information: Effectiveness.
Description: Percentage of www.ncqa.org.
patients 18-85 years of
age who had a diagnosis of
hypertension and whose
blood pressure was
adequately controlled
during the measurement
year.
NQF 0097........................... Title: Medication AMA-PCPI Contact Patient Safety.
Reconciliation; Information: cpe@ama-
Description: Percentage of assn.org; National
patients aged 65 years and Committee for Quality
older discharged from any Assurance (NCQA)
inpatient facility (e.g. Contact information:
hospital, skilled nursing www.ncqa.org.
facility, or
rehabilitation facility)
and seen within 60 days
following discharge in the
office by the physician
providing on-going care
who had a reconciliation
of the discharge
medications with the
current medication list in
the medical record
documented.
NQF 0418........................... Title: Screening for CMS 1-888-734-6433 or Population/Public
Clinical Depression; http:// Health.
Description: Percentage of questions.cms.hhs.gov/
patients aged 12 years and app/ask/p/21,26,1139.
older screened for
clinical depression using
an age appropriate
standardized tool and
follow up plan documented.
NQF 0028........................... Title: Preventive Care and AMA-PCPI Contact Population/Public
Screening: Tobacco Use: Information: cpe@ama- Health.
Screening and Cessation assn.org.
Intervention; Description:
Percentage of patients
aged 18 years and older
who were screened for
tobacco use one or more
times within 24 months AND
who received cessation
counseling intervention if
identified as a tobacco
user.
TBD................................ Title: Preventive Care and CMS 1-888-734-6433 or Clinical Process/
Screening: Cholesterol-- http:// Effectiveness.
Fasting Low Density questions.cms.hhs.gov/
Lipoprotein (LDL) Test app/ask/p/21,26,1139;
Performed AND Risk- QIP Contact
Stratified Fasting LDL; Information:
Description: Percentage of www.usqualitymeasures
patients aged 20 through .org.
79 years whose risk
factors * have been
assessed and a fasting LDL
test has been performed.
Percentage of patients
aged 20 through 79 years
who had a fasting LDL test
performed and whose risk-
stratified* fasting LDL is
at or below the
recommended LDL goal.
NQF 0068........................... Title: Ischemic Vascular NCQA Contact Clinical Process/
Disease (IVD): Use of Information: Effectiveness.
Aspirin or Another www.ncqa.org.
Antithrombotic;
Description: Percentage of
patients 18 years of age
and older who were
discharged alive for acute
myocardial infarction
(AMI), coronary artery
bypass graft (CABG) or
percutaneous transluminal
coronary angioplasty
(PTCA) from January 1-
November 1 of the year
prior to the measurement
year, or who had a
diagnosis of ischemic
vascular disease (IVD)
during the measurement
year and the year prior to
the measurement year and
who had documentation of
use of aspirin or another
antithrombotic during the
measurement year.
NQF 0024........................... Title: Weight Assessment NCQA Contact Population/Public
and Counseling for information: Health.
Nutrition and Physical www.ncqa.org.
Activity for Children and
Adolescents; Description:
Percentage of patients 3-
17 years of age who had an
outpatient visit with a
Primary Care Physician
(PCP) or OB/GYN and who
had evidence of body mass
index (BMI) percentile
documentation, counseling
for nutrition and
counseling for physical
activity during the
measurement year.
NQF 0022........................... Title: Use of High-Risk NCQA Contact Patient Safety.
Medications in the Information:
Elderly; Description: www.ncqa.org.
Percentage of patients
ages 65 years and older
who received at least one
high-risk medication.
Percentage of patients 65
years of age and older who
received at least two
different high-risk
medications.
TBD................................ Title: Adverse Drug Event CMS 1-888-734-6433 or Patient Safety.
(ADE) Prevention: http://
Outpatient therapeutic questions.cms.hhs.gov/
drug monitoring; app/ask/p/21,26,1139.
Description: Percentage of
patients 18 years of age
and older receiving
outpatient chronic
medication therapy who had
the appropriate
therapeutic drug
monitoring during the
measurement year.
----------------------------------------------------------------------------------------------------------------
We selected these measures for the proposed core set based upon
analysis of several factors that include: conditions that contribute
the most to Medicare and Medicaid beneficiaries' morbidity and
mortality; conditions that represent national public/population health
priorities; conditions that are common to health disparities; those
conditions that disproportionately drive healthcare costs that could
improve with better quality measurement; measures that would enable
CMS, States, and the provider community to measure quality of care in
new dimensions with a stronger focus on parsimonious measurement; and
those measures that include patient and/or caregiver engagement.
We request public comment on the core and menu set reporting schema
[[Page 13748]]
described as well as the number and appropriateness of the core set
listed in Table 6. We are considering that all identified core clinical
quality measures must be reported by all EPs in addition to a menu set
clinical quality measure. The policy on reporting ``zeros'' discussed
previously under Option 1a would also apply for this core and menu
option. In this option, an EP who does not report all of the identified
core clinical quality measures, plus a menu set clinical quality
measure, would have not met the requirements for submitting the
clinical quality measures.
Option 2: Submit and satisfactorily report clinical
quality measures under the Physician Quality Reporting System's EHR
Reporting Option.
We propose an alternative option for Medicare EPs who participate
in both the Physician Quality Reporting System and the EHR Incentive
Program. As an alternative to reporting the 12 clinical quality
measures as described under Options 1a and 1b, and in order to
streamline quality reporting options for participating providers,
Medicare EPs who submit and satisfactorily report Physician Quality
Reporting System clinical quality measures under the Physician Quality
Reporting System's EHR reporting option using Certified EHR Technology
would satisfy their clinical quality measures reporting requirement
under the Medicare EHR Incentive Program. For more information about
the requirements of the Physician Quality Reporting System, we refer
readers to 42 CFR 414.90 and the CY 2012 Medicare Physician Fee
Schedule final rule with comment period (76 FR 73314). EPs who choose
this option to satisfy their clinical quality measures reporting
obligation under the Medicare EHR Incentive Program would be required
to comply with any changes to the requirements of the Physician Quality
Reporting System that may apply in future years.
Table 7 lists the clinical quality measures that were finalized in
the Stage 1 final rule (75 FR 44398 through 44408) that we are
proposing to eliminate beginning with CY 2014.
Table 7--Clinical Quality Measures Included in the Stage 1 Final Rule
That Are Proposed To Be Eliminated Beginning in CY 2014
------------------------------------------------------------------------
Clinical quality
Clinical quality measure
Measure No. measure title & developer * &
description contact
information
------------------------------------------------------------------------
NQF 0013............. Title: Hypertension: AMA-PCPI Contact
Blood Pressure Information:
Management; cpe@ama-
Description: assn.org.
Percentage of patient
visits aged 18 years
and older with a
diagnosis of
hypertension who have
been seen for at
least 2 office
visits, with blood
pressure (BP)
recorded.
NQF 0027............. Title: Smoking and NCQA Contact
Tobacco Use Information:
Cessation, Medical www.ncqa.org.
Assistance: a.
Advising Smokers and
Tobacco Users to
Quit, b. Discussing
Smoking and Tobacco
Use Cessation
Strategies.
NQF 0084............. Title: Heart Failure AMA-PCPI Contact
(HF): Warfarin Information:
Therapy Patients with cpe@ama-
Atrial Fibrillation; assn.org.
Description:
Percentage of all
patients aged 18
years and older with
a diagnosis of heart
failure and
paroxysmal or chronic
atrial fibrillation
who were prescribed
warfarin therapy.
------------------------------------------------------------------------
*AMA-PCPI = American Medical Association-Physician Consortium for
Performance Improvement.
NCQA = National Committee for Quality Assurance.
Based in part on the feedback received throughout Stage 1, we
propose to eliminate these three clinical quality measures beginning
with CY 2014 for EPs at all Stages for the following reasons:
NQF 0013--The measure steward did not submit
this measure to the National Quality Forum for continued endorsement.
We have included other measures that address high blood pressure and
hypertension in Table 8.
NQF 0027--We determined this measure is very
similar to NQF 0028 a and b; therefore, to avoid duplication
of measures, we propose to only retain NQF 0028 a and b.
NQF 0084--The measure steward did not submit this
measure to the National Quality Forum for continued endorsement.
Additionally, CMS has decided to remove this measure because there are
other FDA-approved anticoagulant therapies available in addition to
Warfarin. We are proposing to replace this measure, pending
availability of electronic specifications, with NQF 1525--
Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation
Therapy.
Table 8 lists all of the clinical quality measures that we are
considering for EPs to report for the EHR Incentive Programs beginning
with CY 2014. However, we expect to finalize only a subset of these
proposed measures based on public comment and the priorities listed in
section II.B.3. of this proposed rule. The measures titles and
descriptions in Table 8 reflect the most current updates, as provided
by the measure stewards who are responsible for maintaining and
updating the measure specifications,; and therefore, may not reflect
the title and/or description as presented on the NQF Web site. Measures
which are designated as ``New'' in the ``New Measures'' column were not
finalized in the Stage 1 final rule. Please note that measures which
are listed as also being part of the ``ACO'' program in the ``Other
Quality Programs that Use the Same Measure'' column of Table 8 are
Medicare Shared Savings Program measures. Some of the clinical quality
measures in Table 8 will require the development of electronic
specifications. Therefore, we propose to consider these measures for
inclusion beginning with CY 2014 based on our expectation that their
electronic specifications will be available at the time of or within a
reasonable period after the publication of the final rule.
Additionally, some of these measures have not yet been submitted
for consensus endorsement consideration or are currently under review
for endorsement consideration by the National Quality Forum. We expect
that any measure proposed in Table 8 for inclusion beginning with CY
2014 will be submitted for endorsement consideration by the measure
steward. The finalized list of measures that would apply for EPs
beginning with CY 2014 will be published in the final rule. Because
measure specifications may need to be updated more frequently than our
expected rulemaking cycle would allow for, we would provide updates to
the specifications at least 6 months prior to the beginning of the
calendar year for which the measures would be required, and we expect
to update specifications annually. All clinical quality measure
specification updates, including a schedule for updates to electronic
specifications,
[[Page 13749]]
would be posted on the EHR Incentive Program Web site (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp), and we
would notify the public of the posting.
TABLE 8--Clinical Quality Measures Proposed for Medicare and Medicaid Eligible Professionals Beginning With Cy 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinical quality Other quality measure
Measure No. Clinical quality measure measure steward & programs that use the New measure Domain
title & description contact information same measure**
--------------------------------------------------------------------------------------------------------------------------------------------------------
NQF 0001.......................... Title: Asthma: Assessment American Medical EHR PQRS............. .................... Clinical Process/
of Asthma Control. Association- Effectiveness.
Description: Percentage of Physician Consortium
patients aged 5 through for Performance
50 years with a diagnosis Improvement (AMA-
of asthma who were PCPI).
evaluated at least once Contact Information:
for asthma control assn.org">cpe@ama-assn.org.
(comprising asthma
impairment and asthma
risk).
NQF 0002.......................... Title: Appropriate Testing National Committee EHR PQRS, CHIPRA..... .................... Efficient Use of
for Children with for Quality Healthcare
Pharyngitis. Assurance (NCQA). Resources.
Description: Percentage of Contact Information:
children 2-18 years of www.ncqa.org..
age who were diagnosed
with pharyngitis,
dispensed an antibiotic
and received a group A
streptococcus (strep)
test for the episode.
NQF 0004.......................... Title: Initiation and NCQA................. EHR PQRS, HEDIS, .................... Clinical Process/
Engagement of Alcohol and Contact Information: State use, ACA 2701, Effectiveness.
Other Drug Dependence www.ncqa.org.. NCQA-PCMH
Treatment: (a) Accreditation.
Initiation, (b)
Engagement.
Description: The
percentage of adolescent
and adult patients with a
new episode of alcohol
and other drug (AOD)
dependence who initiate
treatment through an
inpatient AOD admission,
outpatient visit,
intensive outpatient
encounter or partial
hospitalization within 14
days of the diagnosis and
who initiated treatment
and who had two or more
additional services with
an AOD diagnosis within
30 days of the initiation
visit.
NQF 0012.......................... Title: Prenatal Care: AMA-PCPI............. EHR PQRS............. .................... Population/Public
Screening for Human Contact Information: Health.
Immunodeficiency Virus assn.org">cpe@ama-assn.org.
(HIV).
Description: Percentage of
patients, regardless of
age, who gave birth
during a 12-month period
who were screened for HIV
infection during the
first or second prenatal
care visit.
NQF 0014.......................... Title: Prenatal Care: Anti- AMA-PCPI............. EHR PQRS, NCQA-PCMH .................... Patient Safety.
D Immune Globulin. Contact Information: Accreditation.
Description: Percentage of assn.org">cpe@ama-assn.org.
D (Rh) negative,
unsensitized patients,
regardless of age, who
gave birth during a 12-
month period who received
anti-D immune globulin at
26-30 weeks gestation.
NQF 0018.......................... Title: Controlling High NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Blood Pressure. Contact Information: Reporting PQRS, UDS. Effectiveness.
Description: Percentage of www.ncqa.org..
patients 18-85 years of
age who had a diagnosis
of hypertension and whose
blood pressure was
adequately controlled
during the measurement
year.
NQF 0022.......................... Title: Use of High-Risk NCQA................. PQRS................. New................. Patient Safety.
Medications in the Contact Information:
Elderly. www.ncqa.org..
Description: Percentage of
patients ages 65 years
and older who received at
least one high-risk
medication. Percentage of
patients 65 years of age
and older who received at
least two different high-
risk medications.
NQF 0024.......................... Title: Weight Assessment NCQA................. EHR PQRS, UDS........ .................... Population/Public
and Counseling for Contact Information: Health.
Nutrition and Physical www.ncqa.org..
Activity for Children and
Adolescents.
Description: Percentage of
patients 3-17 years of
age who had an outpatient
visit with a Primary Care
Physician (PCP) or OB/GYN
and who had evidence of
body mass index (BMI)
percentile documentation,
counseling for nutrition
and counseling for
physical activity during
the measurement year.
NQF 0028.......................... Title: Preventive Care and AMA-PCPI............. EHR PQRS, ACO, Group .................... Population/Public
Screening: Tobacco Use: Contact Information: Reporting PQRS, UDS. Health.
Screening and Cessation assn.org">cpe@ama-assn.org.
Intervention.
Description: Percentage of
patients aged 18 years
and older who were
screened for tobacco use
one or more times within
24 months AND who
received cessation
counseling intervention
if identified as a
tobacco user.
NQF 0031.......................... Title: Breast Cancer NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Screening. Contact Information: Reporting PQRS, ACA Effectiveness.
Description: Percentage of www.ncqa.org.. 2701, HEDIS, State
women 40-69 years of age use, NCQA-PCMH
who had a mammogram to Accreditation.
screen for breast cancer.
NQF 0032.......................... Title: Cervical Cancer NCQA................. EHR PQRS, ACA 2701, .................... Clinical Process/
Screening. Contact Information: HEDIS, State use, Effectiveness.
Description: Percentage of www.ncqa.org.. NCQA-PCMH
women 21-64 years of age, Accreditation, UDS.
who received one or more
Pap tests to screen for
cervical cancer.
NQF 0033.......................... Title: Chlamydia Screening NCQA................. EHR PQRS, CHIPRA, ACA .................... Population/Public
in Women. Contact Information: 2701, HEDIS, State Health.
Description: Percentage of www.ncqa.org.. use, NCQA-PCMH
women 16-24 years of age Accreditation.
who were identified as
sexually active and who
had at least one test for
Chlamydia during the
measurement year.
NQF 0034.......................... Title: Colorectal Cancer NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Screening. Contact Information: Reporting PQRS, NCQA- Effectiveness.
Description: Percentage of www.ncqa.org.. PCMH Accreditation.
adults 50-75 years of age
who had appropriate
screening for colorectal
cancer.
NQF 0036.......................... Title: Use of Appropriate NCQA................. EHR PQRS............. .................... Clinical Process/
Medications for Asthma. Contact Information: Effectiveness.
Description: Percentage of www.ncqa.org..
patients 5-50 years of
age who were identified
as having persistent
asthma and were
appropriately prescribed
medication during the
measurement year. Report
three age stratifications
(5-11 years, 12-50 years,
and total).
NQF 0038.......................... Title: Childhood NCQA................. EHR PQRS, UDS........ .................... Population/Public
Immunization Status. Contact Information: Health.
Description: Percentage of www.ncqa.org..
children 2 years of age
who had four diphtheria,
tetanus and acellular
pertussis (DTaP); three
polio (IPV), one measles,
mumps and rubella (MMR);
two H influenza type B
(HiB); three hepatitis B
(Hep B); one chicken pox
(VZV); four pneumococcal
conjugate (PCV); two
hepatitis A (Hep A); two
or three rotavirus (RV);
and two influenza (flu)
vaccines by their second
birthday. The measure
calculates a rate for
each vaccine and nine
separate combination
rates.
NQF 0041.......................... Title: Preventative Care AMA-PCPI............. EHR PQRS, ACO, Group .................... Population/Public
and Screening: Influenza Contact Information: Reporting PQRS. Health.
Immunization. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 6 months
and older seen for a
visit between October 1
and March 31 who received
an influenza immunization
OR who reported previous
receipt of an influenza
immunization.
[[Page 13750]]
NQF 0043.......................... Title: Pneumonia NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Vaccination Status for Contact Information: Reporting PQRS, NCQA- Effectiveness.
Older Adults. www.ncqa.org.. PCMH Accreditation.
Description: Percentage of
patients 65 years of age
and older who have ever
received a pneumococcal
vaccine.
NQF 0045.......................... Title: Osteoporosis: NCQA................. PQRS, NCQA-PCMH New................. Care Coordination.
Communication with the Contact Information: Accreditation.
Physician Managing www.ncqa.org..
Ongoing Care Post-
Fracture.
Description: Percentage of
patients aged 50 years
and older treated for a
hip, spine, or distal
radial fracture with
documentation of
communication with the
physician managing the
patient's on-going care
that a fracture occurred
and that the patient was
or should be tested or
treated for osteoporosis.
NQF 0046.......................... Title: Osteoporosis: NCQA................. PQRS, NCQA-PCMH New................. Clinical Process/
Screening or Therapy for Contact Information: Accreditation. Effectiveness.
Osteoporosis for Women www.ncqa.org..
Aged 65 Years and Older.
Description: Percentage of
female patients aged 65
years and older who have
a central dual-energy X-
ray absorptiometry
measurement ordered or
performed at least once
since age 60 or
pharmacologic therapy
prescribed within 12
months.
NQF 0047.......................... Title: Asthma AMA-PCPI............. EHR PQRS, UDS........ .................... Clinical Process/
Pharmacologic Therapy for Contact Information: Effectiveness.
Persistent Asthma. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 5 through
50 years with a diagnosis
of persistent asthma and
at least one medical
encounter for asthma
during the measurement
year who were prescribed
long-term control
medication.
NQF 0048.......................... Title: Osteoporosis: NCQA................. PQRS................. New................. Clinical Process/
Management Following Contact Information: Effectiveness.
Fracture of Hip, Spine or www.ncqa.org..
Distal radius for Men and
Women Aged 50 Years and
Older.
Description: Percentage of
patients aged 50 years or
older with fracture of
the hip, spine or distal
radius that had a central
dual-energy X-ray
absorptiometry
measurement ordered or
performed or
pharmacologic therapy
prescribed.
NQF 0050.......................... Title: Osteoarthritis AMA-PCPI............. PQRS................. New................. Patient and Family
(OA): Function and Pain Contact Information: Engagement.
Assessment. assn.org">cpe@ama-assn.org.
Description: Percentage of
patient visits for
patients aged 21 years
and older with a
diagnosis of OA with
assessment for function
and pain.
NQF 0051.......................... Title: Osteoarthritis AMA-PCPI............. PQRS................. New................. Clinical Process/
(OA): assessment for use Contact Information: Effectiveness.
of anti-inflammatory or assn.org">cpe@ama-assn.org.
analgesic over-the-
counter (OTC) medications.
Description: Percentage of
patient visits for
patients aged 21 years
and older with a
diagnosis of OA with an
assessment for use of
anti-inflammatory or
analgesic OTC medications.
NQF 0052.......................... Title: Use of Imaging NCQA................. EHR PQRS............. .................... Efficient Use of
Studies for Low Back Pain. Contact Information: Healthcare
Description: Percentage of www.ncqa.org.. Resources.
patients with a primary
diagnosis of low back
pain who did not have an
imaging study (plain x-
ray, MRI, CT scan) within
28 days of diagnosis.
NQF 0055.......................... Title: Diabetes: Eye Exam. NCQA................. EHR PQRS, Group .................... Clinical Process/
Description: Percentage of Contact Information: Reporting PQRS. Effectiveness.
patients 18-75 years of www.ncqa.org..
age with diabetes (type 1
or type 2) who had a
retinal or dilated eye
exam or a negative
retinal exam (no evidence
of retinopathy) by an eye
care professional.
NQF 0056.......................... Title: Diabetes: Foot Exam NCQA................. EHR PQRS, Group .................... Clinical Process/
Description: The Contact Information: Reporting PQRS. Effectiveness.
percentage of patients www.ncqa.org..
aged 18-75 years with
diabetes (type 1 or type
2) who had a foot exam
(visual inspection,
sensory exam with
monofilament, or pulse
exam).
NQF 0058.......................... Title: Avoidance of NCQA................. PQRS................. New................. Efficient Use of
Antibiotic Treatment in Contact Information: Healthcare
Adults with Acute www.ncqa.org.. Resources.
Bronchitis.
Description: Percentage of
adults ages 18 through 64
years with a diagnosis of
acute bronchitis who were
not dispensed an
antibiotic prescription
on or within 3 days of
the initial date of
service.
NQF 0059.......................... Title: Diabetes: NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Hemoglobin A1c Poor Contact Information: Reporting PQRS, UDS. Effectiveness.
Control. www.ncqa.org..
Description: Percentage of
patients 18-75 years of
age with diabetes (type 1
or type 2) who had
hemoglobin A1c >9.0%.
NQF 0060.......................... Title: Hemoglobin A1c Test NCQA................. ..................... New................. Clinical Process/
for Pediatric Patients. Contact Information: Effectiveness.
Description: Percentage of www.ncqa.org..
pediatric patients with
diabetes with an HbA1c
test in a 12-month
measurement period.
NQF 0061.......................... Title: Diabetes: Blood NCQA................. EHR PQRS, Group .................... Clinical Process/
Pressure Management. Contact Information: Reporting PQRS. Effectiveness.
Description: Percentage of www.ncqa.org..
patients 18-75 years of
age with diabetes (type 1
or type 2) who had blood
pressure <140/90 mmHg.
NQF 0062.......................... Title: Diabetes: Urine NCQA................. EHR PQRS, Group .................... Clinical Process/
Screening. Contact Information: Reporting PQRS. Effectiveness.
Description: Percentage of www.ncqa.org..
patients 18-75 years of
age with diabetes (type 1
or type 2) who had a
nephropathy screening
test or evidence of
nephropathy.
NQF 0064.......................... Title: Diabetes: Low NCQA................. PQRS, Group Reporting .................... Clinical Process/
Density Lipoprotein (LDL) Contact Information: PQRS. Effectiveness.
Management and Control. www.ncqa.org..
Description: Percentage of
patients 18-75 years of
age with diabetes (type 1
or type 2) who had LDL-C
<100 mg/dL.
NQF 0066.......................... Title: Coronary Artery AMA-PCPI............. ACO, Group Reporting New................. Clinical Process/
Disease (CAD): Contact Information: PQRS. Effectiveness.
Angiotensin-converting assn.org">cpe@ama-assn.org.
Enzyme (ACE) Inhibitor or
Angiotensin Receptor
Blocker (ARB) Therapy-
Diabetes or Left
Ventricular Systolic
Dysfunction (LVEF <40%).
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of coronary
artery disease seen
within a 12 month period
who also have diabetes OR
a current or prior Left
Ventricular Ejection
Fraction (LVEF) <40% who
were prescribed ACE
inhibitor or ARB therapy.
NQF 0067.......................... Title: Coronary Artery AMA-PCPI............. EHR PQRS, Group .................... Clinical Process/
Disease (CAD): Contact Information: Reporting PQRS. Effectiveness.
Antiplatelet Therapy. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of coronary
artery disease seen
within a 12 month period
who were prescribed
aspirin or clopidogrel.
[[Page 13751]]
NQF 0068.......................... Title: Ischemic Vascular NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Disease (IVD): Use of Contact Information: Reporting PQRS. Effectiveness.
Aspirin or Another www.ncqa.org..
Antithrombotic.
Description: Percentage of
patients 18 years of age
and older who were
discharged alive for
acute myocardial
infarction (AMI),
coronary artery bypass
graft (CABG) or
percutaneous transluminal
coronary angioplasty
(PTCA) from January 1-
November 1 of the year
prior to the measurement
year, or who had a
diagnosis of ischemic
vascular disease (IVD)
during the measurement
year and the year prior
to the measurement year
and who had documentation
of use of aspirin or
another antithrombotic
during the measurement
year.
NQF 0069.......................... Title: Appropriate NCQA................. PQRS, NCQA-PCMH New................. Efficient Use of
Treatment for Children Contact Information: Accreditation. Healthcare
with Upper Respiratory www.ncqa.org.. Resources.
Infection (URI).
Description: Percentage of
children who were given a
diagnosis of URI and were
not dispensed an
antibiotic prescription
on or three days after
the episode date.
NQF 0070.......................... Title: Coronary Artery AMA-PCPI............. EHR PQRS, NCQA-PCMH .................... Clinical Process/
Disease (CAD): Beta- Contact Information: Accreditation. Effectiveness.
Blocker Therapy- Prior assn.org">cpe@ama-assn.org.
Myocardial Infarction
(MI) or Left Ventricular
Systolic Dysfunction
(LVEF <40%).
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of coronary
artery disease seen
within a 12 month period
who also have a prior MI
or a current or prior
LVEF <40% who were
prescribed beta-blocker
therapy.
NQF 0073.......................... Title: Ischemic Vascular NCQA................. EHR PQRS............. .................... Clinical Process/
Disease (IVD): Blood Contact Information: Effectiveness.
Pressure Management. www.ncqa.org..
Description: Percentage of
patients 18 years of age
and older who were
discharged alive for
acute myocardial
infarction (AMI),
coronary artery bypass
graft (CABG) or
percutaneous transluminal
coronary angioplasty
(PTCA) from January 1-
November 1 of the year
prior to the measurement
year, or who had a
diagnosis of ischemic
vascular disease (IVD)
during the measurement
year and the year prior
to the measurement year
and whose recent blood
pressure is in control
(<140/90 mmHg).
NQF 0074.......................... Title: Coronary Artery AMA-PCPI............. PQRS, ACO, Group .................... Clinical Process/
Disease (CAD): Lipid Contact Information: Reporting PQRS. Effectiveness.
Control. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of coronary
artery disease seen
within a 12 month period
who have a LDL-C result
<100mg/dL OR patients who
have a LDL-C result
>=100mg/dL and have a
documented plan of care
to achieve LDL-C <100mg/
dL, including at a
minimum the prescription
of a statin.
NQF 0075.......................... Title: Ischemic Vascular NCQA................. EHR PQRS, ACO, Group .................... Clinical Process/
Disease (IVD): Complete Contact Information: Reporting PQRS. Effectiveness.
Lipid Panel and LDL www.ncqa.org..
Control.
Description: Percentage of
patients 18 years of age
and older who were
discharged alive for
acute myocardial
infarction (AMI),
coronary artery bypass
graft (CABG) or
percutaneous transluminal
angioplasty (PTCA) from
January 1-November 1 of
the year prior to the
measurement year, or who
had a diagnosis of
ischemic vascular disease
(IVD) during the
measurement year and the
year prior to the
measurement year and who
had a complete lipid
profile performed during
the measurement year and
whose LDL-C<100 mg/dL.
NQF 0081.......................... Title: Heart Failure (HF): AMA-PCPI............. EHR PQRS, Group .................... Clinical Process/
Angiotensin-Converting Contact Information: Reporting PQRS, NCQA- Effectiveness.
Enzyme (ACE) Inhibitor or assn.org">cpe@ama-assn.org. PCMH Accreditation.
Angiotensin Receptor
Blocker (ARB) Therapy for
Left Ventricular Systolic
Dysfunction (LVSD).
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of heart
failure (HF) with a
current or prior left
ventricular ejection
fraction (LVEF) <40% who
were prescribed ACE
inhibitor or ARB therapy
either within a 12 month
period when seen in the
outpatient setting OR at
each hospital discharge.
NQF 0083.......................... Title: Heart Failure (HF): AMA-PCPI............. EHR PQRS, ACO, Group .................... Clinical Process/
Beta-Blocker Therapy for Contact Information: Reporting PQRS. Effectiveness.
Left Ventricular Systolic assn.org">cpe@ama-assn.org.
Dysfunction (LVSD).
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of heart
failure (HF) with a
current or prior left
ventricular ejection
fraction (LVEF) <40% who
were prescribed beta-
blocker therapy either
within a 12 month period
when seen in the
outpatient setting OR at
each hospital discharge.
NQF 0086.......................... Title: Primary Open Angle AMA-PCPI............. EHR PQRS............. .................... Clinical Process/
Glaucoma (POAG): Optic Contact Information: Effectiveness.
Nerve Evaluation. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of POAG who
have an optic nerve head
evaluation during one or
more office visits within
12 months.
NQF 0088.......................... Title: Diabetic AMA-PCPI............. EHR PQRS............. .................... Clinical Process/
Retinopathy: Contact Information: Effectiveness.
Documentation of Presence assn.org">cpe@ama-assn.org.
or Absence of Macular
Edema and Level of
Severity of Retinopathy.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of diabetic
retinopathy who had a
dilated macular or fundus
exam performed which
included documentation of
the level of severity of
retinopathy and the
presence or absence of
macular edema during one
or more office visits
within 12 months.
NQF 0089.......................... Title: Diabetic AMA-PCPI............. EHR PQRS............. .................... Clinical Process/
Retinopathy: Contact Information: Effectiveness.
Communication with the assn.org">cpe@ama-assn.org.
Physician Managing
Ongoing Diabetes Care.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of diabetic
retinopathy who had a
dilated macular or fundus
exam performed with
documented communication
to the physician who
manages the ongoing care
of the patient with
diabetes mellitus
regarding the findings of
the macular or fundus
exam at least once within
12 months.
[[Page 13752]]
NQF 0097.......................... Title: Medication AMA-PCPI............. ACO, Group Reporting New................. Patient Safety.
Reconciliation. Contact Information: PQRS, NCQA-PCMH
Description: Percentage of assn.org">cpe@ama-assn.org; Accreditation.
patients aged 65 years NCQA Contact
and older discharged from Information:
any inpatient facility www.ncqa.org.
(e.g. hospital, skilled
nursing facility, or
rehabilitation facility)
and seen within 60 days
following discharge in
the office by the
physician providing on-
going care who had a
reconciliation of the
discharge medications
with the current
medication list in the
medical record documented.
NQF 0098.......................... Title: Urinary NCQA................. PQRS................. New................. Clinical Process/
Incontinence: Assessment Contact Information: Effectiveness.
of Presence or Absence of www.ncqa.org..
Urinary Incontinence in
Women Age 65 Years and
Older.
Description: Percentage of
female patients aged 65
years and older who were
assessed for the presence
or absence of urinary
incontinence within 12
months.
NQF 0100.......................... Title: Urinary AMA-PCPI............. PQRS................. New................. Patient and Family
Incontinence: Plan of Contact Information: Engagement.
Care for Urinary assn.org">cpe@ama-assn.org;
Incontinence in Women NCQA Contact
Aged 65 Years and Older. Information:
Description: Percentage of www.ncqa.org.
female patients aged 65
years and older with a
diagnosis of urinary
incontinence with a
documented plan of care
for urinary incontinence
at least once within 12
months.
NQF 0101.......................... Title: Falls: Screening AMA-PCPI............. PQRS, ACO, Group New................. Patient Safety.
for Falls Risk. Contact Information: Reporting PQRS.
Description: Percentage of assn.org">cpe@ama-assn.org;
patients aged 65 years NCQA Contact
and older who were Information:
screened for future fall www.ncqa.org.
risk (patients are
considered at risk for
future falls if they have
had 2 or more falls in
the past year or any fall
with injury in the past
year) at least once
within 12 months.
NQF 0102.......................... Title: Chronic Obstructive AMA-PCPI............. PQRS, Group Reporting New................. Clinical Process/
Pulmonary Disease (COPD): Contact Information: PQRS. Effectiveness.
Bronchodilator Therapy. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of COPD and who
have FEV1/FVC less than
70% and have symptoms who
were prescribed an
inhaled bronchodilator.
NQF 0103.......................... Title: Major Depressive AMA-PCPI............. PQRS................. New................. Clinical Process/
Disorder (MDD): Contact Information: Effectiveness.
Diagnostic Evaluation. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a new
diagnosis or recurrent
episode of MDD who met
the DSM-IV criteria
during the visit in which
the new diagnosis or
recurrent episode was
identified during the
measurement period.
NQF 0104.......................... Title: Major Depressive AMA-PCPI............. PQRS................. New................. Clinical Process/
Disorder (MDD): Suicide Contact Information: Effectiveness.
Risk Assessment. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a new
diagnosis or recurrent
episode of MDD who had a
suicide risk assessment
completed at each visit
during the measurement
period.
NQF 0105.......................... Title: Anti-depressant NCQA................. EHR PQRS, HEDIS, .................... Clinical Process/
Medication Management: Contact Information: State use, ACA 2701. Effectiveness.
(a) Effective Acute Phase www.ncqa.org..
Treatment, (b) Effective
Continuation Phase
Treatment.
Description: The
percentage of patients 18
years of age and older
who were diagnosed with a
new episode of major
depression, treated with
antidepressant
medication, and who
remained on an
antidepressant medication
treatment.
NQF 0106.......................... Title: Diagnosis of Institute for ..................... New................. Care Coordination.
attention deficit Clinical Systems
hyperactivity disorder Improvement (ICSI).
(ADHD) in primary care Contact Information:
for school age children www.icsi.org.
and adolescents.
Description: Percentage of
patients newly diagnosed
with ADHD whose medical
record contains
documentation of DSM-IV-
TR or DSM-PC criteria.
NQF 0107.......................... Title: Management of ICSI................. ..................... New................. Clinical Process/
attention deficit Contact Information: Effectiveness.
hyperactivity disorder www.icsi.org.
(ADHD) in primary care
for school age children
and adolescents.
Description: Percentage of
patients treated with
psychostimulant
medication for the
diagnosis of ADHD whose
medical record contains
documentation of a follow-
up visit at least twice a
year.
NQF 0108.......................... Title: ADHD: Follow-Up NCQA................. ..................... New................. Clinical Process/
Care for Children Contact Information: Effectiveness.
Prescribed Attention- www.ncqa.org..
Deficit/Hyperactivity
Disorder (ADHD)
Medication.
Description: (a)
Initiation Phase:
Percentage of children 6-
12 years of age as of the
Index Prescription
Episode Start Date with
an ambulatory
prescription dispensed
for ADHD medication and
who had one follow-up
visit with a practitioner
with prescribing
authority during the 30-
Day Initiation Phase.
(b) Continuation and
Maintenance (C&M) Phase:
Percentage of children 6-
12 years of age as of the
Index Prescription
Episode Start Date with
an ambulatory
prescription dispensed
for ADHD medication who
remained on the
medication for at least
210 days and who, in
addition to the visit in
the Initiation Phase, had
at least two additional
follow-up visits with a
practitioner within 270
days (9 months) after the
Initiation Phase ended.
NQF 0110.......................... Title: Bipolar Disorder Center for Quality NCQA-PCMH New................. Clinical Process/
and Major Depression: Assessment and Accreditation. Effectiveness.
Appraisal for alcohol or Improvement in
chemical substance use. Mental Health
Description: Percentage of (CQAIMH).
patients with depression Contact Information:
or bipolar disorder with www.cqaimh.org;
evidence of an initial [email protected].
assessment that includes
an appraisal for alcohol
or chemical substance use.
NQF 0112.......................... Title: Bipolar Disorder: CQAIMH............... ..................... New................. Clinical Process/
Monitoring change in Contact Information: Effectiveness.
level-of-functioning. www.cqaimh.org;
Description: Percentage of [email protected].
patients aged 18 years
and older with an initial
diagnosis or new episode/
presentation of bipolar
disorder.
NQF 0239.......................... Title: Perioperative Care: AMA-PCPI............. PQRS................. New................. Patient Safety.
Venous Thromboembolism Contact Information:
(VTE) Prophylaxis (when assn.org">cpe@ama-assn.org.
indicated in ALL
patients).
Description: Percentage of
patients aged 18 years
and older undergoing
procedures for which VTE
prophylaxis is indicated
in all patients, who had
an order for Low
Molecular Weight Heparin
(LMWH), Low-Dose
Unfractionated Heparin
(LDUH), adjusted-dose
warfarin, fondaparinux or
mechanical prophylaxis to
be given within 24 hours
prior to incision time or
within 24 hours after
surgery end time.
[[Page 13753]]
Formerly NQF 0246, Title: Stroke and Stroke AMA-PCPI............. PQRS................. New................. Clinical Process/
no longer endorsed................ Rehabilitation: Computed Contact Information: Effectiveness.
Tomography (CT) or assn.org">cpe@ama-assn.org;
Magnetic Resonance NCQA Contact
Imaging (MRI) Reports. Information:
Description: Percentage of www.ncqa.org.
final reports for CT or
MRI studies of the brain
performed either:.
In the hospital
within 24 hours of
arrival, OR.
In an outpatient
imaging center to confirm
initial diagnosis of
stroke, transient
ischemic attack (TIA) or
intracranial hemorrhage..
For patients aged 18 years
and older with either a
diagnosis of ischemic
stroke, TIA or
intracranial hemorrhage
OR at least one
documented symptom
consistent with ischemic
stroke, TIA or
intracranial hemorrhage
that includes
documentation of the
presence or absence of
each of the following:
hemorrhage, mass lesion
and acute infarction.
NQF 0271.......................... Title: Perioperative Care: AMA-PCPI............. PQRS, NCQA-PCMH New................. Patient Safety.
Discontinuation of Contact Information: Accreditation.
Prophylactic Antibiotics assn.org">cpe@ama-assn.org.
(Non-Cardiac Procedures).
Description: Percentage of
non-cardiac surgical
patients aged 18 years
and older undergoing
procedures with the
indications for
prophylactic parenteral
antibiotics AND who
received a prophylactic
parenteral antibiotic,
who have an order for
discontinuation of
prophylactic parenteral
antibiotics within 24
hours of surgical end
time.
NQF 0312.......................... Title: Lower Back Pain: NCQA................. ..................... New................. Efficient Use of
Repeat Imaging Studies. Contact Information: Healthcare
Description: Percentage of www.ncqa.org.. Resources.
patients with back pain
who received
inappropriate imaging
studies in the absence of
red flags or progressive
symptoms (overuse
measure, lower
performance is better).
NQF 0321.......................... Title: Adult Kidney AMA-PCPI............. PQRS................. New................. Care Coordination.
Disease: Peritoneal Contact Information:
Dialysis Adequacy: Solute. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of ESRD
receiving peritoneal
dialysis who have a Kt/
V>= 1.7 per week measured
once every 4 months.
NQF 0322.......................... Title: Back Pain: Initial NCQA................. PQRS................. New................. Efficient Use of
Visit Contact Information: Healthcare
Description: The www.ncqa.org.. Resources.
percentage of patients
with a diagnosis of back
pain who have medical
record documentation of
all of the following on
the date of the initial
visit to the physician:.
1. Pain assessment........
2. Functional status......
3. Patient history,
including notation of
presence or absence of
``red flags''.
4. Assessment of prior
treatment and response,
and.
5. Employment status......
NQF 0323.......................... Title: Adult Kidney AMA-PCPI............. PQRS................. New................. Care Coordination.
Disease: Hemodialysis Contact Information:
Adequacy: Solute. assn.org">cpe@ama-assn.org.
Description: Percentage of
calendar months within a
12-month period during
which patients aged 18
years and older with a
diagnosis of end-stage
renal disease (ESRD)
receiving hemodialysis
three times a week have a
spKt/V>=1.2.
NQF 0382.......................... Title: Oncology: Radiation AMA-PCPI............. PQRS................. New................. Patient Safety.
Dose Limits to Normal Contact Information:
Tissues. assn.org">cpe@ama-assn.org;.
Description: Percentage of
patients, regardless of
age, with a diagnosis of
pancreatic or lung cancer
receiving 3D conformal
radiation therapy with
documentation in medical
record that radiation
dose limits to normal
tissues were established
prior to the initiation
of a course of 3D
conformal radiation for a
minimum of two tissues.
NQF 0383.......................... Title: Oncology: Measure AMA-PCPI............. PQRS................. New................. Patient and Family
Pair: Oncology: Medical Contact Information: Engagement.
and Radiation--Plan of assn.org">cpe@ama-assn.org.
Care for Pain.
Description: Percentage of
patient visits,
regardless of patient
age, with a diagnosis of
cancer currently
receiving chemotherapy or
radiation therapy who
report having pain with a
documented plan of care
to address pain.
NQF 0384.......................... Title: Oncology: Measure AMA-PCPI............. PQRS................. New................. Patient and Family
Pair: Oncology: Medical Contact Information: Engagement.
and Radiation- Pain assn.org">cpe@ama-assn.org.
Intensity Quantified.
Description: Percentage of
patient visits,
regardless of patient
age, with a diagnosis of
cancer currently
receiving chemotherapy or
radiation therapy in
which pain intensity is
quantified.
NQF 0385.......................... Title: Colon Cancer: AMA-PCPI............. EHR PQRS............. .................... Clinical Process/
Chemotherapy for Stage Contact Information: Effectiveness.
III Colon Cancer Patients. assn.org">cpe@ama-assn.org;
Description: Percentage of American Society of
patients aged 18 years Clinical Oncology
and older with Stage IIIA (ASCO):
through IIIC colon cancer www.asco.org;
who are referred for National
adjuvant chemotherapy, Comprehensive Cancer
prescribed adjuvant Network (NCCN):
chemotherapy, or have www.nccn.org.
previously received
adjuvant chemotherapy
within the 12-month
reporting period.
NQF 0387.......................... Title: Breast Cancer: AMA-PCPI............. EHR PQRS............. .................... Clinical Process/
Hormonal Therapy for Contact Information: Effectiveness.
Stage IC-IIIC Estrogen assn.org">cpe@ama-assn.org;
Receptor/Progesterone ASCO: www.asco.org;
Receptor (ER/PR) Positive NCCN: www.nccn.org.
Breast Cancer.
Description: Percentage of
female patients aged 18
years and older with
Stage IC through IIIC, ER
or PR positive breast
cancer who were
prescribed tamoxifen or
aromatase inhibitor (AI)
during the 12-month
reporting period.
NQF 0388.......................... Title: Prostate Cancer: AMA-PCPI............. PQRS................. New................. Patient Safety.
Three Dimensional (3D) Contact Information:
Radiotherapy. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients, regardless of
age, with a diagnosis of
clinically localized
prostate cancer receiving
external beam
radiotherapy as a primary
therapy to the prostate
with or without nodal
irradiation (no
metastases; no salvage
therapy) who receive
three-dimensional
conformal radiotherapy
(3D-CRT) or intensity
modulated radiation
therapy (IMRT).
[[Page 13754]]
NQF 0389.......................... Title: Prostate Cancer: AMA-PCPI............. EHR PQRS............. .................... Efficient Use of
Avoidance of Overuse of Contact Information: Healthcare
Bone Scan for Staging Low assn.org">cpe@ama-assn.org. Resources.
Risk Prostate Cancer
Patients.
Description: Percentage of
patients, regardless of
age, with a diagnosis of
prostate cancer at low
risk of recurrence
receiving interstitial
prostate brachytherapy,
OR external beam
radiotherapy to the
prostate, OR radical
prostatectomy, OR
cryotherapy who did not
have a bone scan
performed at any time
since diagnosis of
prostate cancer.
NQF 0399.......................... Title: Hepatitis C: AMA-PCPI............. PQRS, NCQA-PCMH New................. Population/Public
Hepatitis A Vaccination Contact Information: Accreditation. Health.
in Patients with HCV. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of hepatitis C
who have received at
least one injection of
hepatitis A vaccine, or
who have documented
immunity to hepatitis A.
NQF 0400.......................... Title: Hepatitis C: AMA-PCPI............. PQRS, NCQA-PCMH New................. Population/Public
Hepatitis B Vaccination Contact Information: Accreditation. Health.
in Patients with HCV. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of hepatitis C
who have received at
least one injection of
hepatitis B vaccine, or
who have documented
immunity to hepatitis B.
NQF 0401.......................... Title: Hepatitis C: AMA-PCPI............. PQRS, NCQA-PCMH New................. Clinical Process/
Counseling Regarding Risk Contact Information: Accreditation. Effectiveness.
of Alcohol Consumption. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of hepatitis C
who were counseled about
the risks of alcohol use
at least once within 12
months.
NQF 0403.......................... Title: Medical Visits..... AMA-PCPI............. ..................... New................. Clinical Process/
Description: Percentage of Contact Information: Effectiveness.
patients regardless of assn.org">cpe@ama-assn.org;
age, with a diagnosis of NCQA Contact
HIV/AIDS with at least Information:
one medical visit in each www.ncqa.org.
6 month period with a
minimum of 60 days
between each visit.
NQF 0405.......................... Title: Pneumocystitis AMA-PCPI............. PQRS, NCQA-PCMH New................. Clinical Process/
jiroveci pneumonia (PCP) Contact Information: Accreditation. Effectiveness.
Prophylaxis. assn.org">cpe@ama-assn.org;
Description: Percentage of NCQA Contact
patients with HIV/AIDS Information:
who were prescribed www.ncqa.org.
Pneumocystis jiroveci
pneumonia (PCP)
prophylaxis.
NQF 0406.......................... Title: Patients with HIV/ AMA-PCPI............. PQRS, NCQA-PCMH New................. Clinical Process/
AIDS Who Are Prescribed Contact Information: Accreditation. Effectiveness.
Potent Antiretroviral assn.org">cpe@ama-assn.org;
Therapy. NCQA Contact
Description: Percentage of Information:
patients who were www.ncqa.org.
prescribed potent
antiretroviral therapy.
NQF 0407.......................... Title: HIV RNA control NCQA................. PQRS................. New................. Clinical Process/
after six months of Contact Information: Effectiveness.
potent antiretroviral www.ncqa.org..
therapy.
Description: Percentage of
patients aged 13 years
and older with a
diagnosis of HIV/AIDS who
had at least two medical
visits during the
measurement year, with at
least 60 days between
each visit, who are
receiving potent
antiretroviral therapy,
who have a viral load
below limits of
quantification after at
least 6 months of potent
antiretroviral therapy OR
whose viral load is not
below limits of
quantification after at
least 6 months of potent
antiretroviral therapy
and has a documented plan
of care.
NQF 0418.......................... Title: Screening for Centers for Medicare EHR PQRS, ACO........ New................. Population/Public
Clinical Depression. and Medicaid Health.
Description: Percentage of Services (CMS).
patients aged 12 years 1-888-734-6433 or
and older screened for http://
clinical depression using questions.cms.hhs.go
an age appropriate v/app/ask/p/
standardized tool and 21,26,1139;.
follow up plan documented. Quality Insights of
Pennsylvania (QIP).
Contact Information:
www.usqualitymeasures.org.
NQF 0419.......................... Title: Documentation of Centers for Medicare PQRS, EHR PQRS, Group New................. Patient Safety.
Current Medications in and Medicaid Reporting PQRS.
the Medical Record. Services (CMS) 1-888-
Description: Percentage of 734-6433 or http://
specified visits as questions.cms.hhs.go
defined by the v/app/ask/p/
denominator criteria for 21,26,1139; QIP.
which the eligible Contact Information:
professional attests to www.usqualitymeasure
documenting a list of s.org.
current medications to
the best of his/her
knowledge and ability.
This list must include
ALL prescriptions, over-
the-counters, herbals,
vitamin/mineral/dietary
(nutritional) supplements
AND must contain the
medications' name,
dosage, frequency and
route.
NQF 0421.......................... Title: Adult Weight Centers for Medicare EHR PQRS, ACO, Group .................... Population/Public
Screening and Follow-Up. and Medicaid Reporting PQRS, UDS. Health.
Description: Percentage of Services (CMS) 1-888-
patients aged 18 years 734-6433 or http://
and older with a questions.cms.hhs.go
calculated body mass v/app/ask/p/
index (BMI) in the past 21,26,1139;.
six months or during the QIP..................
current visit documented Contact Information:
in the medical record AND www.usqualitymeasure
if the most recent BMI is s.org.
outside of normal
parameters, a follow-up
plan is documented.
Normal Parameters: Age 65
years and older BMI >=23
and <30.
Age 18-64 years BMI >=18/5
and <25.
NQF 0507.......................... Title: Radiology: Stenosis AMA-PCPI............. PQRS................. New................. Clinical Process/
Measurement in Carotid Contact Information: Effectiveness.
Imaging Studies. assn.org">cpe@ama-assn.org.
Description: Percentage of
final reports for all
patients, regardless of
age, for carotid imaging
studies (neck magnetic
resonance angiography
[MRA], neck computer
tomography angiography
[CTA], neck duplex
ultrasound, carotid
angiogram) performed that
include direct or
indirect reference to
measurements of distal
internal carotid diameter
as the denominator for
stenosis measurement.
NQF 0508.......................... Title: Radiology: AMA-PCPI............. PQRS................. New................. Efficient Use of
Inappropriate Use of Contact Information: Healthcare
``Probably Benign'' assn.org">cpe@ama-assn.org. Resources.
Assessment Category in
Mammography Screening.
Description: Percentage of
final reports for
screening mammograms that
are classified as
``probably benign.''.
NQF 0510.......................... Title: Radiology: Exposure AMA-PCPI............. PQRS................. New................. Patient Safety.
Time Reported for Contact Information:
Procedures Using assn.org">cpe@ama-assn.org.
Fluoroscopy.
Description: Percentage of
final reports for
procedures using
fluoroscopy that include
documentation of
radiation exposure or
exposure time.
[[Page 13755]]
NQF 0513.......................... Title: Thorax CT: Use of CMS.................. ..................... New................. Efficient Use of
Contrast Material. Contact Information: Healthcare
Description: This measure 1-888-734-6433 or Resources.
calculates the percentage http://
of thorax studies that questions.cms.hhs.go
are performed with and v/app/ask/p/
without contrast out of 21,26,1139.
all thorax studies
performed (those with
contrast, those without
contrast, and those with
both).
NQF 0519.......................... Title: Diabetic Foot Care CMS.................. ..................... New................. Care Coordination.
and Patient/Caregiver Contact Information:
Education Implemented 1-888-734-6433 or
During Short Term http://
Episodes of Care. questions.cms.hhs.go
Description: Percentage of v/app/ask/p/
short term home health 21,26,1139.
episodes of care during
which diabetic foot care
and education were
included in the physician-
ordered plan of care and
implemented for patients
with diabetes.
NQF 0561.......................... Title: Melanoma: AMA-PCPI............. PQRS................. New................. Care Coordination.
Coordination of Care. Contact Information:
Description: Percentage of assn.org">cpe@ama-assn.org;
patient visits, NCQA Contact
regardless of patient Information:
age, with a new www.ncqa.org.
occurrence of melanoma
who have a treatment plan
documented in the chart
that was communicated to
the physicians(s)
providing continuing care
within one month of
diagnosis.
NQF 0562.......................... Title: Melanoma: AMA-PCPI............. PQRS................. New................. Efficient Use of
Overutilization of Contact Information: Healthcare
Imaging Studies in assn.org">cpe@ama-assn.org; Resources.
Melanoma. NCQA Contact
Description: Percentage of Information:
patients, regardless of www.ncqa.org.
age, with a current
diagnosis of stage 0
through IIC melanoma or a
history of melanoma of
any stage, without signs
or symptoms suggesting
systemic spread, seen for
an office visit during
the one-year measurement
period, for whom no
diagnostic imaging
studies were ordered.
NQF 0564.......................... Title: Cataracts: AMA-PCPI............. PQRS................. New................. Patient Safety.
Complications within 30 Contact Information:
Days Following Cataract assn.org">cpe@ama-assn.org;
Surgery Requiring NCQA Contact
Additional Surgical Information:
Procedures. www.ncqa.org.
Description: Percentage of
patients aged 18 years
and older with a
diagnosis of
uncomplicated cataract
who had cataract surgery
and had any of a
specified list of
surgical procedures in
the 30 days following
cataract surgery which
would indicate the
occurrence of any of the
following major
complications: retained
nuclear fragments,
endophthalmitis,
dislocated or wrong power
IOL, retinal detachment,
or wound dehiscence.
NQF 0565.......................... Title: Cataracts: 20/40 or AMA-PCPI............. PQRS................. New................. Clinical Process/
Better Visual Acuity Contact Information: Effectiveness.
within 90 Days Following assn.org">cpe@ama-assn.org;
Cataract Surgery. NCQA Contact
Description: Percentage of Information:
patients aged 18 years www.ncqa.org.
and older with a
diagnosis of
uncomplicated cataract
who had cataract surgery
and no significant ocular
conditions impacting the
visual outcome of surgery
and had best-corrected
visual acuity of 20/40 or
better (distance or near)
achieved within 90 days
following the cataract
surgery.
NQF 0575.......................... Title: Diabetes: NCQA................. EHR PQRS, Group .................... Clinical Process/
Hemoglobin A1c Control Contact Information: Reporting PQRS, UDS. Effectiveness.
(<8.0%). www.ncqa.org..
Description: The
percentage of patients 18-
75 years of age with
diabetes (type 1 or type
2) who had hemoglobin A1c
<8.0%.
NQF 0608.......................... Title: Pregnant women that Ingenix.............. ..................... New................. Clinical Process/
had HBsAg testing. Contact Information: Effectiveness.
Description: This measure www.ingenix.com.
identifies pregnant women
who had a HBsAg
(hepatitis B) test during
their pregnancy.
NQF 0710.......................... Title: Depression Minnesota Community ..................... New................. Clinical Process/
Remission at Twelve Measurement (MNCM). Effectiveness.
Months. Contact Information:
Description: Adult www.mncm.org;
patients age 18 and older [email protected].
with major depression or
dysthymia and an initial
PHQ-9 score >9 who
demonstrate remission at
twelve months defined as
PHQ-9 score less than 5.
This measure applies to
both patients with newly
diagnosed and existing
depression whose current
PHQ-9 score indicates a
need for treatment.
NQF 0711.......................... Title: Depression MNCM................. ..................... New................. Clinical Process/
Remission at Six Months. Contact Information: Effectiveness.
Description: Adult www.mncm.org;
patients age 18 and older [email protected].
with major depression or
dysthymia and an initial
PHQ-9 score >9 who
demonstrate remission at
six months defined as PHQ-
9 score less than 5. This
measure applies to both
patients with newly
diagnosed and existing
depression whose current
PHQ-9 score indicates a
need for treatment.
NQF 0712.......................... Title: Depression MNCM................. ..................... New................. Clinical Process/
Utilization of the PHQ-9 Contact Information: Effectiveness.
Tool. www.mncm.org;
Description: Adult [email protected].
patients age 18 and older
with the diagnosis of
major depression or
dysthymia who have a PHQ-
9 tool administered at
least once during a 4
month period in which
there was a qualifying
visit.
NQF 1335.......................... Title: Children who have Maternal and Child ..................... New................. Clinical Process/
dental decay or cavities. Health Bureau, Effectiveness.
Description: Assesses if Health Resources and
children aged 1-17 years Services
have had tooth decay or Adminstration http://
cavities in the past 6 mchb.hrsa.gov/.
months.
NQF 1365.......................... Title: Child and AMA-PCPI............. ..................... New................. Patient Safety.
Adolescent Major Contact Information:
Depressive Disorder: assn.org">cpe@ama-assn.org.
Suicide Risk Assessment.
Description: Percentage of
patient visits for those
patients aged 6 through
17 years with a diagnosis
of major depressive
disorder with an
assessment for suicide
risk.
NQF 1401.......................... Title: Maternal depression NCQA................. ..................... New................. Population/Public
screening Description: Contact Information: Health.
The percentage of www.ncqa.org..
children who turned 6
months of age during the
measurement year who had
documentation of a
maternal depression
screening for the mother.
NQF 1419.......................... Title: Primary Caries University of ..................... New................. Clinical Process/
Prevention Intervention Minnesota. Effectiveness.
as Part of Well/Ill Child Contact Information:
Care as Offered by www.umn.edu.
Primary Care Medical
Providers.
Description: The measure
will a) track the extent
to which the PCMP or
clinic (determined by the
provider number used for
billing) applies FV as
part of the EPSDT
examination and b) track
the degree to which each
billing entity's use of
the EPSDT with FV codes
increases from year to
year (more children
varnished and more
children receiving FV
four times a year
according to ADA
recommendations for high-
risk children).
[[Page 13756]]
NQF 1525.......................... Title: Atrial Fibrillation AMA-PCPI............. ..................... New................. Clinical Process/
and Atrial Flutter: Contact Information: Effectiveness.
Chronic Anticoagulation assn.org">cpe@ama-assn.org;
Therapy. American College of
Description: Percentage of Cardiology
patients aged 18 years Foundation (ACCF)
and older with www.cardiosource.org
nonvalvular AF or atrial ; American Heart
flutter at high risk for Association (AHA)
thromboembolism, www.heart.org.
according to CHADS2 risk
stratification, who were
prescribed warfarin or
another oral
anticoagulant drug that
is FDA approved for the
prevention of
thromboembolism during
the 12-month reporting
period.
TBD............................... Title: Preventive Care and CMS.................. EHR PQRS............. New................. Clinical Process/
Screening: Cholesterol-- 1-888-734-6433 or Effectiveness.
Fasting Low Density http://
Lipoprotein (LDL) Test questions.cms.hhs.go
Performed AND Risk- v/app/ask/p/
Stratified Fasting LDL. 21,26,1139; QIP
Description: Percentage of Contact Information:
patients aged 20 through www.usqualitymeasure
79 years whose risk s.org.
factors* have been
assessed and a fasting
LDL test has been
performed. Percentage of
patients aged 20 through
79 years who had a
fasting LDL test
performed and whose risk-
stratified* fasting LDL
is at or below the
recommended LDL goal.
TBD............................... Title: Falls: Risk AMA-PCPI............. PQRS................. New................. Patient Safety.
Assessment for Falls. Contact Information:
Description: Percentage of assn.org">cpe@ama-assn.org;
patients aged 65 years NCQA Contact
and older with a history Information:
of falls who had a risk www.ncqa.org.
assessment for falls
completed within 12
months.
TBD............................... Title: Falls: Plan of Care AMA-PCPI............. PQRS................. New................. Patient Safety.
for Falls. Contact Information:
Description: Percentage of assn.org">cpe@ama-assn.org;
patients aged 65 years NCQA Contact
and older with a history Information:
of falls who had a plan www.ncqa.org.
of care for falls
documented within 12
months.
TBD............................... Title: Adult Kidney AMA-PCPI............. ..................... New................. Clinical Process/
Disease: Blood Pressure Contact Information: Effectiveness.
Management. assn.org">cpe@ama-assn.org.
Description: Percentage of
patient visits for those
patients aged 18 years
and older with a
diagnosis of CKD (stage
3, 4, or 5 not receiving
RRT) and proteinuria with
a blood pressure <130/80
mmHg or >=130/80 mmHg
with documented plan of
care.
TBD............................... Title: Adult Kidney AMA-PCPI............. ..................... New................. Efficient Use of
Disease: Patients on Contact Information: Healthcare
Erythropoiesis assn.org">cpe@ama-assn.org. Resources.
Stimulating Agent (ESA)-
Hemoglobin Level >12.0 g/
dL.
Description: Percentage of
calendar months within a
12-month period during
which a hemoglobin (Hgb)
level is measured for
patients aged 18 years
and older with a
diagnosis of advanced CKD
(stage 4 or 5, not
receiving RRT) or end-
stage renal disease
(ESRD) (who are on
hemodialysis or
peritoneal dialysis) who
are also receiving ESA
therapy have a hemoglobin
(Hgb) level >12.0 g/dL.
TBD............................... Title: Chronic Wound Care: AMA-PCPI............. PQRS................. New................. Patient Safety.
Use of wet to dry Contact Information:
dressings in patients assn.org">cpe@ama-assn.org;
with chronic skin ulcers NCQA Contact
(overuse measure). Information:
Description: Percentage of www.ncqa.org.
patient visits for those
patients aged 18 years
and older with a
diagnosis of chronic skin
ulcer without a
prescription or
recommendation to use wet
to dry dressings.
TBD............................... Title: Dementia: Staging AMA-PCPI............. PQRS................. New................. Clinical Process/
of Dementia. Contact Information: Effectiveness.
Description: Percentage of assn.org">cpe@ama-assn.org.
patients, regardless of
age, with a diagnosis of
dementia whose severity
of dementia was
classified as mild,
moderate, or severe at
least once within a 12
month period.
TBD............................... Title: Dementia: Cognitive AMA-PCPI............. PQRS................. New................. Clinical Process/
Assessment. Contact Information: Effectiveness.
Description: Percentage of assn.org">cpe@ama-assn.org.
patients, regardless of
age, with a diagnosis of
dementia for whom an
assessment of cognition
is performed and the
results reviewed at least
once within a 12 month
period.
TBD............................... Title: Dementia: AMA-PCPI............. PQRS................. New................. Patient and Family
Functional Status Contact Information: Engagement.
Assessment. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients, regardless of
age, with a diagnosis of
dementia for whom an
assessment of functional
status is performed and
the results reviewed at
least once within a 12
month period.
TBD............................... Title: Dementia: AMA-PCPI............. PQRS................. New................. Patient and Family
Counseling Regarding Contact Information: Engagement.
Safety Concerns. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients, regardless of
age, with a diagnosis of
dementia or their
caregiver(s) who were
counseled or referred for
counseling regarding
safety concerns within a
12 month period.
TBD............................... Title: Dementia: AMA-PCPI............. PQRS................. New................. Patient Safety.
Counseling Regarding Contact Information:
Risks of Driving. assn.org">cpe@ama-assn.org.
Description: Percentage of
patients, regardless of
age, with a diagnosis of
dementia or their
caregiver(s) who were
counseled regarding the
risks of driving and the
alternatives to driving
at least once within a 12
month period.
TBD............................... Title: Dementia: Caregiver AMA-PCPI............. PQRS................. New................. Patient and Family
Education and Support. Contact Information: Engagement.
Description: Percentage of assn.org">cpe@ama-assn.org.
patients, regardless of
age, with a diagnosis of
dementia whose
caregiver(s) were
provided with education
on dementia disease
management and health
behavior changes AND
referred to additional
resources for support
within a 12-month period.
TBD............................... Title: Chronic Wound Care: AMA-PCPI............. ..................... New................. Patient and Family
Patient education Contact Information: Engagement.
regarding long term assn.org">cpe@ama-assn.org;
compression therapy. NCQA Contact
Description: Percentage of Information:
patients aged 18 years www.ncqa.org.
and older with a
diagnosis of venous ulcer
who received education
regarding the need for
long term compression
therapy including
interval replacement of
compression stockings
within the 12 month
reporting period.
TBD............................... Title: Rheumatoid AMA-PCPI............. PQRS................. New................. Patient and Family
Arthritis (RA): Contact Information: Engagement.
Functional Status assn.org">cpe@ama-assn.org;
Assessment. NCQA Contact
Description: Percentage of Information:
patients aged 18 years www.ncqa.org.
and older with a
diagnosis of RA for whom
a functional status
assessment was performed
at least once within 12
months.
TBD............................... Title: Glaucoma Screening NCQA................. ..................... New................. Clinical Process/
in Older Adults. Contact Information: Effectiveness.
Description: Percentage of www.ncqa.org..
patients 65 years and
older, without a prior
diagnosis of glaucoma or
glaucoma suspect, who
received a glaucoma eye
exam by an eye-care
professional for early
identification of
glaucomatous conditions.
[[Page 13757]]
TBD............................... Title: Chronic Wound Care: AMA-PCPI............. ..................... New................. Patient and Family
Patient Education Contact Information: Engagement.
regarding diabetic foot assn.org">cpe@ama-assn.org;
care. NCQA Contact
Description: Percentage of Information:
patients aged 18 years www.ncqa.org.
and older with a
diagnosis of diabetes and
foot ulcer who received
education regarding
appropriate foot care AND
daily inspection of the
feet within the 12 month
reporting period.
TBD............................... Title: Hypertension: CMS.................. ..................... New................. Clinical Process/
Improvement in blood 1-888-734-6433 or Effectiveness.
pressure. http://
Description: Percentage of questions.cms.hhs.go
patients aged 18 years v/app/ask/p/
and older with 21,26,1139.
hypertension whose blood
pressure improved during
the measurement period.
TBD............................... Title: Closing the CMS.................. ..................... New................. Care Coordination.
referral loop: receipt of 1-888-734-6433 or
specialist report. http://
Description: Percentage of questions.cms.hhs.go
patients regardless of v/app/ask/p/
age with a referral from 21,26,1139.
a primary care provider
for whom a report from
the provider to whom the
patient was referred was
received by the referring
provider.
TBD............................... Title: Functional status CMS.................. ..................... New................. Patient and Family
assessment for knee 1-888-734-6433 or Engagement.
replacement. http://
Description: Percentage of questions.cms.hhs.go
patients aged 18 years v/app/ask/p/
and older with primary 21,26,1139.
total knee arthroplasty
(TKA) who completed
baseline and follow-up
(patient-reported)
functional status
assessments.
TBD............................... Title: Functional status CMS.................. ..................... New................. Patient and Family
assessment for hip 1-888-734-6433 or Engagement.
replacement. http://
Description: Percentage of questions.cms.hhs.go
patients aged 18 years v/app/ask/p/
and older with primary 21,26,1139.
total hip arthroplasty
(THA) who completed
baseline and follow-up
(patient-reported)
functional status
assessments.
TBD............................... Title: Functional status CMS.................. ..................... New................. Patient and Family
assessment for complex 1-888-734-6433 or Engagement.
chronic conditions. http://
Description: Percentage of questions.cms.hhs.go
patients aged 65 years v/app/ask/p/
and older with heart 21,26,1139.
failure and two or more
high impact conditions
who completed initial and
follow-up (patient-
reported) functional
status assessments.
TBD............................... Title: Adverse Drug Event CMS.................. ..................... New................. Patient Safety.
(ADE) Prevention: 1-888-734-6433 or
Outpatient therapeutic http://
drug monitoring. questions.cms.hhs.go
Description: Percentage of v/app/ask/p/
patients 18 years of age 21,26,1139.
and older receiving
outpatient chronic
medication therapy who
had the appropriate
therapeutic drug
monitoring during the
measurement year.
TBD............................... Title: Preventive Care and CMS.................. PQRS, Group Reporting New................. Population/Public
Screening: Screening for 1-888-734-6433 or PQRS, ACO. Health.
High Blood Pressure. http://
Description: Percentage of questions.cms.hhs.go
patients aged 18 years v/app/ask/p/
and older who are 21,26,1139;.
screened for high blood QIP..................
pressure. Contact Information:
www.usqualitymeasures.org.
TBD............................... Title: Hypertension: Blood AMA-PCPI............. ..................... New................. Clinical Process/
Pressure Management. Contact Information: Effectiveness.
Description: Percentage of assn.org">cpe@ama-assn.org.
patients aged 18 years
and older with a
diagnosis of hypertension
seen within a 12 month
period with a blood
pressure <140/90mmHg OR
patients with a blood
pressure >=140/90mmHg and
prescribed 2 or more anti-
hypertensive medications
during the most recent
office visit.
--------------------------------------------------------------------------------------------------------------------------------------------------------
** PQRS = Physician Quality Reporting System.
EHR PQRS = Physician Quality Reporting System's Electronic Health Record Reporting Option.
CHIPRA = Children's Health Insurance Program Reauthorization Act.
HEDIS = Healthcare Effectiveness Data and Information Set.
ACA 2701 = Affordable Care Act section 2701.
NCQA-PCMH = National Committee for Quality Assurance--Patient Centered Medical Home.
Group Reporting PQRS = Physician Quality Reporting System's Group Reporting Option.
UDS = Uniform Data System (Health Resources Services Administration).
ACO = Accountable Care Organization (Medicare Shared Savings Program).
6. Proposed Reporting Methods for Clinical Quality Measures for
Eligible Professionals
(a) Proposed Reporting Methods for Medicaid EPs
For Medicaid EPs, States are, and will continue in Stage 2 to be,
responsible for determining whether and how electronic reporting would
occur, or whether they wish to allow reporting through attestation. If
a State does require such electronic reporting, the State is
responsible for sharing the details on the process with its provider
community. We anticipate that whatever means States have deployed for
capturing Stage 1 clinical quality measures electronically would be
similar for reporting in CY 2013. However, we note that subject to our
prior approval, this is within the States' purview. Beginning in CY
2014, the States will establish the method and requirements, subject to
CMS prior approval, for electronically reporting.
(b) Proposed Reporting Methods for Medicare EPs in CY 2013
In the CY 2012 Medicare Physician Fee Schedule final rule, we
established a pilot program for Medicare EPs for CY 2012 that is
intended to test and demonstrate our capacity to accept electronic
reporting of Stage 1 clinical quality measure data (76 FR 73422 through
73425). The title of this pilot program is the Physician Quality
Reporting System--Medicare EHR Incentive Pilot, and it capitalizes on
existing quality measures reporting infrastructure. The EHR Incentive
Program Registration and Attestation System is located at https://ehrincentives.cms.gov/hitech/login.action.
(c) Proposed Reporting Methods for Medicare EPs Beginning With CY 2014
Under section 1848(o)(2)(A)(iii) of the Act, EPs must submit
information on the clinical quality measures selected by the Secretary
``in a form and manner specified by the Secretary'' as part of
demonstrating meaningful use of Certified EHR Technology. As discussed
in section II.B.4.b. of this proposed rule, Medicare EPs who are in
their first year of Stage 1 may report clinical quality measures
through attestation for a continuous 90-day EHR reporting period (for
an explanation of reporting through attestation, see the discussion in
the Stage 1 final rule (75 FR 44430 through 44431)).
Medicare EPs who choose to report 12 clinical quality measures as
described in Options 1.a. and 1.b. in section II.B.4.c. of this
proposed rule would submit
[[Page 13758]]
through an aggregate reporting method, which would require the EP to
log into a CMS-designated portal. Once the EP has logged into the
portal, they would be required to submit through an upload process,
data produced as output from their Certified EHR Technology in an XML-
based format specified by CMS.
We are considering an ``interim submission'' option for Medicare
EPs who are in their first year of Stage 1 and who participate in the
Physician Quality Reporting System. Under this option, EPs would submit
the Physician Quality Reporting System clinical quality measures data
for a continuous 90-day EHR reporting period, and the data must be
received no later than October 1 to meet the requirements of the EHR
Incentive Program. The EP would report the remainder of his/her
clinical quality measures data by the deadline specified for the
Physician Quality Reporting System to meet the requirements of the
Physician Quality Reporting System. We request public comment on this
potential option. Medicare EPs who are beyond their first year of Stage
1 and who choose the Physician Quality Reporting System EHR reporting
option (Option 2 in section II.B.4.(c). of this proposed rule) must
report in the form and manner specified for the Physician Quality
Reporting System (for more information on current reporting
requirements, see the CY 2012 Medicare Physician Fee Schedule final
rule with comment period (76 FR 73314)).
(d) Group Reporting Option for Medicare and Medicaid Eligible
Professionals Beginning With CY 2014
For Stage 1, EPs were required to report the clinical quality
measures on an individual basis and did not have an option to report
the measures as part of a group practice. Under section 1848(o)(2)(A)
of the Act, the Secretary may provide for the use of alternative means
for eligible professionals furnishing covered professional services in
a group practice (as defined by the Secretary) to meet the requirements
of meaningful use. Beginning with CY 2014, we are proposing three group
reporting options to allow eligible professionals within a single group
practice to report clinical quality measure data on a group level. All
three methods would be available for Medicare EPs, while only the first
one would be possible for Medicaid EPs, at States' discretion.
We are proposing each of these options as an alternative to
reporting clinical quality measure data as an individual eligible
professional under the proposed options and reporting methods discussed
earlier in this rule. These group reporting options would only be
available for reporting clinical quality measures for purposes of the
EHR Incentive Program and only if all EPs in the group are beyond the
first year of Stage 1. EPs would not be able to use these group
reporting options for any of the other meaningful use objectives and
associated measures in the EHR Incentive Programs.
The three group reporting options that we propose for EPs are as
follows:
Two or more EPs, each identified with a unique NPI
associated with a group practice identified under one tax
identification number (TIN) may be considered an EHR Incentive Group
for the purposes of reporting clinical quality measures for the
Medicare EHR Incentive Program. This group reporting option is only
available for electronic reporting of clinical quality measures and is
not available for those EPs in their first year of Stage 1. The
clinical quality measures reported under this option would represent
all EPs within the group. EPs who choose this group reporting option
for clinical quality measures must still individually satisfy the
objectives and associated measures for their respective stage of
meaningful use. CMS proposes that States may also choose this option to
accept group reporting for clinical quality measures, based upon a pre-
determined definition of a ``group practice,'' such as sharing one TIN.
Medicare EPs participating in the Medicare Shared Savings
Program and the testing of the Pioneer Accountable Care Organization
(ACO) model who use Certified EHR Technology to submit ACO measures in
accordance with the requirements of the Medicare Shared Savings Program
would be considered to have satisfied their clinical quality measures
reporting requirement as a group for the Medicare EHR Incentive
Program. The Medicare Shared Savings Program does not require the use
of Certified EHR Technology. However, all clinical quality measures
data must be extracted from Certified EHR Technology in order for the
EP to qualify for the Medicare EHR Incentive Program if an EP intends
to use this group reporting option. EPs must still individually satisfy
the objectives and associated measures for their respective stage of
meaningful use, in addition to submitting clinical quality measures as
part of an ACO. EPs who are part of an ACO but do not enter the data
used for reporting the clinical quality measures (which excludes the
survey tool or claims-based measures that are collected to calculate
the quality performance score in the Medicare Shared Savings Program)
into Certified EHR Technology would not be able to meet meaningful use
requirements. (For more information about the requirements of the
Medicare Shared Savings Program, see 42 CFR part 425 and the final rule
published at 76 FR 67802). EPs who use this group reporting option for
the Medicare EHR Incentive Program would be required to comply with any
changes to the Medicare Shared Savings Program that may apply in the
future. EPs must be part of a group practice (that is, two or more
eligible professionals, each identified with a unique NPI associated
with a group practice identified under one TIN) to be able to use this
group reporting option.
Medicare EPs who satisfactorily report Physician Quality Reporting
System clinical quality measures using Certified EHR Technology under
the Physician Quality Reporting System Group Practice Reporting Option,
would be considered to have satisfied their clinical quality measures
reporting requirement as a group for the Medicare EHR Incentive
Program. For more information about the Physician Quality Reporting
System Group Practice Reporting Option, see 42 CFR 414.90 and the CY
2012 Medicare Physician Fee Schedule final rule (76 FR 73314). EPs who
use this group reporting option for the Medicare EHR Incentive Program
would be required to comply with any changes to the Physician Quality
Reporting System Group Practice Reporting Option that may apply in the
future and must still individually satisfy the objectives and
associated measures for their respective stage of meaningful use.
States would have the option to allow group reporting of clinical
quality measures based upon the first option previously described,
through an update to their State Medicaid HIT Plan, and would have to
address how they would address the issue of EPs who switch group
practices during an EHR reporting period.
7. Proposed Clinical Quality Measures for Eligible Hospitals and
Critical Access Hospitals
(a) Statutory and Other Considerations
Sections 1886(n)(3)(A)(iii) and 1903(t)(6)(C) of the Act provide
for the reporting of clinical quality measures by eligible hospitals
and CAHs as part of demonstrating meaningful use of Certified EHR
Technology. For further explanation of the statutory requirements, we
refer readers to the discussion in our Stage 1 proposed and final rules
(75 FR 1870 through 1902 and 75 FR 44380 through 44435, respectively).
[[Page 13759]]
Section 1886(n)(3)(B)(i)(I) of the Act requires the Secretary to
give preference to 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 Hospital Inpatient
Quality Reporting (IQR) Program) or that have been endorsed by the
entity with a contract with the Secretary under section 1890(a)
(namely, the NQF). We are proposing clinical quality measures for
eligible hospitals and CAHs for 2013, 2014, and 2015 (and potentially
subsequent years) that reflect this preference, although we note that
the Act does not require the selection of such measures for the EHR
Incentive Programs. Measures listed in this proposed rule that do not
have an NQF identifying number are not NQF endorsed.
Under section 1903(t)(8) of the Act, the Secretary must seek, to
the maximum extent practicable, to avoid duplicative requirements from
Federal and State governments for eligible hospitals and CAHs to
demonstrate meaningful use of Certified EHR Technology under Medicare
and Medicaid. Therefore, to meet this requirement, we continue our
practice from Stage 1 of proposing clinical quality measures that would
apply for both the Medicare and Medicaid EHR Incentive Programs, as
listed in sections II.B.6.(b). and II.B.6.(c). of this proposed rule.
In accordance with CMS and HHS quality goals as well as the HHS
National Quality Strategy recommendations, the hospital clinical
quality measures that we are proposing beginning with FY 2014 can be
categorized into the following six domains, which are described in
section II.B.3. of this proposed rule:
Clinical Process/Effectiveness.
Patient Safety.
Care Coordination.
Efficient Use of Healthcare Resources.
Patient & Family Engagement.
Population & Public Health.
The selection of clinical quality measures we are proposing for
eligible hospitals and CAHs was based on statutory requirements, the
HITPC's recommendations, alignment with other CMS and national hospital
quality measurement programs such as the Joint Commission, the Medicare
Hospital Inpatient Quality Reporting Program and Hospital Value-Based
Purchasing Program, the National Quality Strategy, and other
considerations discussed in sections II.B.6.(b). and II.B.6.(c). of
this proposed rule. The proposed reporting methods for Medicare
eligible hospitals and CAHs are described in sections II.B.7.(a). and
II.B.7.(b). of this proposed rule. The proposed reporting methods for
Medicaid-only eligible hospitals are described in section II.B.7.(c).
of this proposed rule.
Section 1886(n)(3)(B)(iii) of the Act requires that in selecting
measures for eligible hospitals and CAHs, and in establishing the form
and manner of reporting, the Secretary shall seek to avoid redundant or
duplicative reporting with reporting otherwise required. In
consideration of the importance of alignment with other measure sets
that apply to eligible hospitals and CAHs, we have analyzed the
Hospital IQR Program, hospital measures used by State Medicaid
agencies, and the Joint Commission's hospital quality measures when
selecting the measures to be reported under the EHR Incentive Program.
Furthermore, we have placed emphasis on those measures that are in line
with the National Quality Strategy and the HITPC's recommendations.
(b) Proposed Clinical Quality Measures for Eligible Hospitals and CAHs
for FY 2013
For the EHR reporting periods in FY 2013, we propose that the
eligible hospitals and CAHs would be required to submit information on
each of the 15 clinical quality measures that were finalized for FYs
2011 and 2012 in the Stage 1 final rule (75 FR 44418 through 44420,
Table 10). We refer readers to the discussion in the Stage 1 final rule
for further explanation of the requirements for reporting those
clinical quality measures (75 FR 44411 through 44422).
(c) Clinical Quality Measures Proposed for Eligible Hospitals and CAHs
Beginning With FY 2014
We are proposing to change the reporting requirement beginning with
FY 2014 to require eligible hospitals and CAHs to report 24 clinical
quality measures from a menu of 49 clinical quality measures, including
at least 1 clinical quality measure from each of the 6 domains. The 49
clinical quality measures would include the current set of 15 clinical
quality measures that were finalized for FYs 2011 and 2012 in the Stage
1 final rule as well as additional pediatric measures, an obstetric
measure, and cardiac measures.
Our experience from Stage 1 in implementing the current set of 15
clinical quality measures in specialty and low volume eligible
hospitals has illuminated several challenges. For example, children's
hospitals rarely see patients 18 years or older. One of the exceptions
to this generality is individuals with sickle cell disease. National
Institutes of Health Guidelines (NIH Publication 02-2117) list the
conditions under which thrombolytic therapy cannot be recommended for
adults or children with sickle cell disease. This, plus the fact that
children's hospitals have on average two or fewer cases of stroke per
year, have created workflow, cost, and clinical barriers to
demonstrating meaningful use as it relates to the clinical quality
measures for stroke and VTE. We are considering whether a case number
threshold would be appropriate, given the apparent burden on hospitals
that very seldom have the types of cases addressed by certain measures.
Hospitals that do not have enough cases to exceed the threshold would
be exempt from reporting certain clinical quality measures. We solicit
comments on what the numerical range of threshold should be, how
hospitals would demonstrate to CMS or State Medicaid agencies that they
have not exceeded this threshold, whether it should apply to only
certain hospital clinical quality measures (and if so, which ones), and
the extent of the burden on hospitals if a case number threshold is not
adopted (given that they are allowed to report ``zeros'' for the
measures). We are also soliciting comment on limiting the case
threshold exemption to only children's, cancer hospitals, and a subset
of hospitals in the Indian health system as they have a much more
narrow patient base than acute care and critical access hospitals.
Comments are solicited for application of the thresholds to Stage 1 of
meaningful use in 2013, as the issue would be mitigated for Stages 1
and 2 by a beginning in 2014 proposed menu set of hospital clinical
quality measures.
Aside from the previous threshold discussion, we are proposing
clinical quality measures in Table 9 that would apply for all eligible
hospitals and CAHs beginning with FY 2014, regardless of whether an
eligible hospital or CAH is in Stage 1 or Stage 2 of meaningful use. We
propose that eligible hospitals and CAHs must report a total of 24
clinical quality measures from those listed in Table 9. Eligible
hospitals and CAHs would have to select and report at least 1 measure
from each of the following 6 domains:
Patient and Family Engagement.
Patient Safety.
Care Coordination.
Population and Public Health.
Efficient Use of Healthcare Resources.
Clinical Process/Effectiveness.
For the remaining clinical quality measures, eligible hospitals and
CAHs
[[Page 13760]]
would select and report the measures from Table 9 that best apply to
their patient mix. We are soliciting comment on the number of measures
and the appropriateness of the measures and domains for eligible
hospitals and CAHs.
If an eligible hospital's or CAH's Certified EHR Technology does
not contain patient data for at least 24 measures, including a minimum
of at least 1 from each domain, then the eligible hospital or CAH must
report the measures for which there is patient data and report the
remaining required measures as ``zero denominators'' through the form
and manner specified by the Secretary. In the unlikely event that there
are no measures applicable to the eligible hospital's or CAH's patient
mix, eligible hospitals or CAHs must still report 24 measures even if
zero is the result in either the numerator or the denominator of the
measure. If all measures have a value of zero from their Certified EHR
Technology, then eligible hospitals or CAHs must report any 24 of the
measures.
In the Stage 1 final rule (75 FR 44418), the title for the clinical
quality measure NQF 438 was listed as ``Ischemic or
hemorrhagic stroke--Antithrombotic therapy by day 2.'' The corrected
measure title, which is also included in Table 9 is ``Stroke-5 Ischemic
stroke--Antithrombotic therapy by day 2.''
Table 9 lists all of the clinical quality measures that we are
proposing for eligible hospitals and CAHs to report for the EHR
Incentive Programs beginning with FY 2014. The measures titles and
descriptions in Table 9 reflect the most current updates, as provided
by the measure stewards who are responsible for maintaining and
updating the measure specifications, and therefore may not reflect the
title and/or description as presented on the NQF Web site. Measures
which are designated as ``New'' in the ``New Measures'' column were not
finalized in the Stage 1 final rule. Some of the clinical quality
measures in this table will require the development of electronic
specifications. Therefore, we propose to consider these clinical
quality measures for possible inclusion beginning with FY 2014 based on
our expectation that their electronic specifications will be available
at the time of or within a reasonable period the publication of the
final rule. All clinical quality measure specification updates,
including a schedule for updates to electronic specifications, would be
posted on the EHR Incentive Program Web site (https://www.cms.gov/QualityMeasures/03_ElectronicSpecifications.asp), and we would notify
the public.
Additionally, some of these measures have been submitted by the
measure steward and are currently under review for endorsement
consideration by the National Quality Forum. The finalized list of
clinical quality measures that would apply for eligible hospitals and
CAHs beginning with FY 2014 will be published in the final rule.
Table 9--Clinical Quality Measures Proposed for Eligible Hospitals and Critical Access Hospitals Beginning With FY 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other quality measure
NQF Title Measure steward and programs that use the New measure Domain
contact information same measure ***
--------------------------------------------------------------------------------------------------------------------------------------------------------
0495.............................. Title: Emergency Oklahoma Foundation IQR.................. Patient and Family
Department (ED)-1 for Medical Quality Engagement.
Emergency Department (OFMQ) www.ofmq.com
Throughput--Median time and click on
from ED arrival to ED ``Contact''.
departure for admitted ED
patients.
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..
0497.............................. Title: ED-2 Emergency Oklahoma Foundation IQR.................. Patient and Family
Department Throughput-- for Medical Quality Engagement.
admitted patients--Admit (OFMQ) www.ofmq.com
decision time to ED and click on
departure time for ``Contact''.
admitted patients.
Description: Median time
from admit decision time
to time of departure from
the emergency department
for emergency department
patients admitted to
inpatient status.
0435.............................. Title: Stroke-2 Ischemic The Joint Commission IQR.................. Clinical Process/
stroke--Discharged on www.jointcommission. Effectiveness.
anti-thrombotic therapy. org and click on
Description: Ischemic ``Contact Us''.
stroke patients
prescribed antithrombotic
therapy at hospital
discharge.
0436.............................. Title: Stroke-3 Ischemic The Joint Commission IQR.................. Clinical Process/
stroke--Anticoagulation www.jointcommission. Effectiveness.
Therapy for Atrial org and click on
Fibrillation/Flutter. ``Contact Us''.
Description: Ischemic
stroke patients with
atrial fibrillation/
flutter who are
prescribed
anticoagulation therapy
at hospital discharge.
0437.............................. Title: Stroke-4 Ischemic The Joint Commission IQR.................. Clinical Process/
stroke--Thrombolytic www.jointcommission. Effectiveness.
Therapy. org and click on
Description: Acute ``Contact Us''.
ischemic stroke patients
who arrive at this
hospital within 2 hours
(120 minutes) of time
last known well and for
whom IV t-PA was
initiated at this
hospital within 3 hours
(180 minutes) of time
last known well.
0438.............................. Title: Stroke-5 Ischemic The Joint Commission IQR.................. Clinical Process/
stroke--Antithrombotic www.jointcommission. Effectiveness.
therapy by end of org and click on
hospital day two. ``Contact Us''.
Description: Ischemic
stroke patients
administered
antithrombotic therapy by
the end of hospital day
two.
0439.............................. Title: Stroke-6 Ischemic The Joint Commission IQR.................. Clinical Process/
stroke--Discharged on www.jointcommission. Effectiveness.
Statin Medication. org and click on
Description: Ischemic ``Contact Us''.
stroke patients with LDL
greater than or equal to
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.
0440.............................. Title: Stroke-8 Ischemic The Joint Commission IQR.................. Patient & Family
or hemorrhagic stroke-- www.jointcommission. Engagement.
Stroke education. org and click on
Description: Ischemic or ``Contact Us''.
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.
0441.............................. Title: Stroke-10 Ischemic The Joint Commission IQR.................. Care Coordination.
or hemorrhagic stroke-- www.jointcommission.
Assessed for org and click on
Rehabilitation. ``Contact Us''.
Description: Ischemic or
hemorrhagic stroke
patients who were
assessed for
rehabilitation services.
0371.............................. Title: Venous The Joint Commission IQR.................. Patient Safety.
Thromboembolism (VTE)-1 www.jointcommission.
VTE prophylaxis. org and click on
Description: This measure ``Contact Us''.
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.
[[Page 13761]]
0372.............................. Title: VTE-2 Intensive The Joint Commission IQR.................. Patient Safety.
Care Unit (ICU) VTE www.jointcommission.
prophylaxis. org and click on
Description: This measure ``Contact Us''.
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).
0373.............................. Title: VTE-3 VTE Patients The Joint Commission IQR.................. New................. Clinical Process/
with Overlap of www.jointcommission. Effectiveness.
Anticoagulation Therapy. org and click on
Description: This measure ``Contact Us''.
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.
0374.............................. Title: VTE Patients The Joint Commission IQR.................. New................. Clinical Process/
Unfractionated Heparin www.jointcommission. Effectiveness.
(UFH) Dosages/Platelet org and click on
Count Monitoring by ``Contact Us''.
Protocol (or Nomogram)
Receiving Unfraction-ated
Heparin (UFH) with
Dosages/Platelet Count
Monitored by Protocol (or
Nomogram).
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.
0375.............................. Title: VTE-5 VTE discharge The Joint Commission IQR.................. New................. Patient and Family
instructions. www.jointcommission. Engagement.
Description: This measure org and click on
assesses the number of ``Contact Us''.
patients diagnosed with
confirmed VTE that are
discharged to home, to
home with home health, or
home hospice 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.
0376.............................. Title: VTE-6 Incidence of The Joint Commission IQR.................. New................. Patient Safety.
potentially preventable www.jointcommission.
VTE. org and click on
Description: This measure ``Contact Us''.
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.
0132.............................. Title: AMI-1-Aspirin at The Joint Commission IQR, TJC............. New................. Clinical Process/
arrival for acute (TJC) Effectiveness.
myocardial infarction www.jointcommission.
(AMI). org and click on
Description: Percentage of ``Contact Us''.
acute myocardial
infarction (AMI) patients
without aspirin
contraindications who
received aspirin within
24 hours before or after
hospital arrival.
0142.............................. Title: AMI-2-Aspirin The Joint Commission IQR.................. New................. Clinical Process/
Prescribed at Discharge (TJC) Effectiveness.
for AMI. www.jointcommission.
Description: Percentage of org and click on
acute myocardial ``Contact Us''.
infarction (AMI) patients
without aspirin
contraindications who are
prescribed aspirin at
hospital discharge.
0469.............................. Title: Elective Delivery The Joint Commission TJC.................. Clinical Process/
Prior to 39 Completed (TJC) Effectiveness.
Weeks Gestation. www.jointcommission.
Description: Percentage of org and click on
babies electively ``Contact Us''.
delivered prior to 39
completed weeks gestation.
0137.............................. Title: AMI-3-ACEI or ARB The Joint Commission IQR.................. New................. Clinical Process/
for Left Ventricular (TJC) Effectiveness.
Systolic Dysfunction- www.jointcommission.
Acute Myocardial org and click on
Infarction (AMI) Patients. ``Contact Us''.
Description: Percentage of
acute myocardial
infarction (AMI) patients
with left ventricular
systolic dysfunction
(LVSD) and without both
Angiotensin converting
enzyme inhibitor (ACEI)
and Angiotensin receptor
blocker (ARB)
contraindications 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.
0160.............................. Title: AMI-5-Beta Blocker The Joint Commission IQR.................. New................. Clinical Process/
Prescribed at Discharge (TJC) Effectiveness.
for AMI. www.jointcommission.
Description: Percentage of org and click on
acute myocardial ``Contact Us''.
infarction (AMI) patients
without beta blocker
contraindications who are
prescribed a beta blocker
at hospital discharge.
0164.............................. Title: AMI-7a-Fibrinolytic The Joint Commission IQR, HVBP............ New................. Clinical Process/
Therapy received within (TJC) Effectiveness.
30 minutes of hospital www.jointcommission.
arrival. org and click on
Description: Percentage of ``Contact Us''.
acute myocardial
infarction (AMI) patients
receiving fibrinolytic
therapy during the
hospital stay and having
a time from hospital
arrival to fibrinolysis
of 30 minutes or less.
0163.............................. Title: AMI-8a-Primary The Joint Commission IQR, HVBP............ New................. Clinical Process/
Percutaneous Coronary (TJC) Effectiveness.
Intervention (PCI). www.jointcommission.
Description: Percentage of org and click on
acute myocardial ``Contact Us''.
infarction (AMI) patients
receiving percutaneous
coronary intervention
(PCI) during the hospital
stay with a time from
hospital arrival to PCI
of 90 minutes or less.
0639.............................. Title: AMI-10 Statin The Joint Commission IQR.................. New................. Clinical Process/
Prescribed at Discharge. (TJC) Effectiveness.
Description: Percent of www.jointcommission.
acute myocardial org and click on
infarction (AMI) patients ``Contact Us''.
18 years of age or older
who are prescribed a
statin medication at
hospital discharge.
0148.............................. Title: PN-3b-Blood The Joint Commission IQR, HVBP............ New................. Efficient Use of
Cultures Performed in the (TJC) Healthcare
Emergency Department www.jointcommission. Resources.
Prior to Initial org and click on
Antibiotic Received in ``Contact Us''.
Hospital.
Description: Percentage of
pneumonia patients 18
years of age and older
who have had blood
cultures performed in the
emergency department
prior to initial
antibiotic received in
hospital.
0147.............................. Title: PN-6-Initial The Joint Commission IQR, HVBP............ New................. Efficient Use of
Antibiotic Selection for (TJC) Healthcare
Community-Acquired www.jointcommission. Resources.
Pneumonia (CAP) in org and click on
Immunocompetent Patients. ``Contact Us''.
Description: Percentage of
pneumonia patients 18
years of age or older
selected for initial
receipts of antibiotics
for community-acquired
pneumonia (CAP).
[[Page 13762]]
0527.............................. Title: SCIP-INF-1 The Joint Commission IQR, HVBP............ New................. Patient Safety.
Prophylactic Antibiotic (TJC)
Received within 1 Hour www.jointcommission.
Prior to Surgical org and click on
Incision. ``Contact Us''.
Description: Surgical
patients with
prophylactic antibiotics
initiated within one 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.
0528.............................. Title: SCIP-INF-2- The Joint Commission IQR, HVBP............ New................. Efficient Use of
Prophylactic Antibiotic (TJC) Healthcare
Selection for Surgical www.jointcommission. Resources.
Patients. org and click on
Description: Surgical ``Contact Us''.
patients who received
prophylactic antibiotics
consistent with current
guidelines (specific to
each type of surgical
procedure).
0529.............................. Title: SCIP-INF-3- The Joint Commission IQR, HVBP, State use. New................. Efficient Use of
Prophylactic Antibiotics (TJC) Healthcare
Discontinued Within 24 www.jointcommission. Resources.
Hours After Surgery End org and click on
Time. ``Contact Us''.
Description: Surgical
patients whose
prophylactic antibiotics
were discontinued within
24 hours after Anesthesia
End Time. The Society of
Thoracic Surgeons (STS)
Practice Guideline for
Antibiotic Prophylaxis in
Cardiac Surgery (2006)
indicates that there is
no reason to extend
antibiotics beyond 48
hours for cardiac surgery
and very explicitly
states that antibiotics
should not be extended
beyond 48 hours even with
tubes and drains in place
for cardiac surgery.
0300.............................. Title: SCIP-INF-4-Cardiac The Joint Commission IQR, HVBP............ New................. Clinical Process/
Patients with Controlled (TJC) Effectiveness.
6 AM Postoperative Serum www.jointcommission.
Glucose. org and click on
Description: Percentage of ``Contact Us''.
cardiac surgery patients
with controlled 6 a.m.
serum glucose (=200 mg/
dl) on postoperative day
(POD) 1 and POD 2.
0301.............................. Title: SCIP-INF-6-Surgery The Joint Commission IQR.................. New................. Patient Safety.
patients with appropriate (TJC)
hair removal. www.jointcommission.
Description: Percentage of org and click on
surgery patients with ``Contact Us''.
surgical hair site
removal with clippers or
depilatory or no surgical
hair site removal.
0453.............................. Title: SCIP-INF-9-Urinary The Joint Commission IQR, TJC............. New................. Patient Safety.
catheter removed on (TJC)
Postoperative Day 1 www.jointcommission.
(POD1) or Postoperative org and click on
Day 2 (POD2) with day of ``Contact Us''.
surgery being day zero.
Description: Surgical
patients with urinary
catheter removed on
Postoperative Day 1 or
Postoperative Day 2 with
day of surgery being day
zero.
0136.............................. Title: HF-1 Heart Failure The Joint Commission IQR, HVBP............ New................. Patient & Family
(HF): Detailed Discharge (TJC) Engagement.
Instructions. www.jointcommission.
Description: Percentage of org and click on
heart failure patients ``Contact Us''.
discharged home with
written instructions or
educational material
given to patient or
caregiver at discharge or
during the hospital stay
addressing all of the
following: Activity
level, diet, discharge
medications, follow-up
appointment, weight
monitoring, and what to
do if symptoms worsen.
0434.............................. Title: Stroke-1 Venous The Joint Commission IQR.................. New................. Patient Safety.
Thromboembolism (VTE) (TJC)
Prophylaxis. www.jointcommission.
Description: Ischemic or a org and click on
hemorrhagic stroke ``Contact Us''.
patients who received VTE
prophylaxis or have
documentation why no VTE
prophylaxis was given the
day of or the day after
hospital admission.
0284.............................. Title: SCIP-Card-2 Surgery The Joint Commission IQR, HVBP............ New................. Clinical Process/
Patients on a Beta (TJC) Effectiveness.
Blocker Therapy Prior to www.jointcommission.
Admission Who Received a org and click on
Beta Blocker During the ``Contact Us''.
Perioperative Period.
Description: Percentage of
patients on beta blocker
therapy prior to
admission who received a
beta blocker during the
perioperative period.
0218.............................. Title: SCIP-VTE-2 Surgery The Joint Commission IQR, HVBP............ New................. Patient Safety.
Patients Who Received (TJC)
Appropriate Venous www.jointcommission.
Thromboembolism (VTE) org and click on
Prophylaxis Within 24 ``Contact Us''.
hours Prior to Surgery to
24 Hours After Surgery
End Time.
Description: Percentage of
surgery patients who
received appropriate
Venous Thromboembolism
(VTE) prophylaxis within
24 hours prior to surgery
to 24 hours after surgery
end time.
0496.............................. Title: ED-3 Description: Oklahoma Foundation OQR.................. New................. Care Coordination.
Median time from ED for Medical Quality
arrival to ED departure (OFMQ) www.ofmq.com
for discharged ED and click on
patients. ``Contact''.
Description: Median time
from emergency department
arrival to time of
departure from the
emergency room for
patients discharged from
the emergency department.
0338.............................. Title: Home Management The Joint Commission State use............ New................. Patient & Family
Plan of Care Document (TJC) Engagement.
Given to Patient/ www.jointcommission.
Caregiver. org and click on
Description: Documentation ``Contact Us''.
exists that the Home
Management Plan of Care
(HMPC) as a separate
document, specific to the
patient, was given to the
patient/caregiver, prior
to or upon discharge.
0341.............................. Title: PICU Pain National Association State use............ New................. Patient & Family
Assessment on Admission. of Children's Engagement.
Description: Percentage of Hospitals and
PICU patients receiving: Related Institutions
a. Pain assessment on (NACHRI)
admission, b. Periodic www.nachri.org and
pain assessment. click on ``Contact
Us''.
0342.............................. Title: PICU Periodic Pain National Association State use............ New................. Patient & Family
Assessment. of Children's Engagement.
Description: Percentage of Hospitals and
PICU patients receiving: Related Institutions
a. Pain assessment on (NACHRI)
admission, b. Periodic www.nachri.org and
pain assessment. click on ``Contact
Us''.
[[Page 13763]]
0480.............................. Title: Exclusive California Maternal State use............ New................. Clinical Process/
Breastfeeding at Hospital Quality Care Effectiveness.
Discharge. Collaborative
Description: Exclusive www.cmqcc.org and
Breastfeeding (BF) for click on ``Contact
the first 6 months of Us''.
neonatal life has long
been the expressed goal
of WHO, DHHS, APA, and
ACOG. ACOG has recently
reiterated its position
(ACOG 2007). A recent
Cochrane review
substantiates the
benefits (Kramer, 2002).
Much evidence has now
focused on the prenatal
and intrapartum period as
critical for the success
of exclusive (or any) BF
(Shealy, 2005; Taveras,
2004; Petrova, 2007; CDC-
MMWR, 2007). Exclusive
Breastfeeding rate during
birth hospital stay has
been calculated by the
California Department of
Public Health for the
last several years using
newborn genetic disease
testing data. HP2010 and
the CDC have also been
active in promoting this
measure. Holding prenatal
and intrapartum providers
accountable is an
important way to incent
greater efforts during
the critical prenatal and
immediate postpartum
periods where BF
attitudes are solidified.
0481.............................. Title: First temperature Vermont Oxford State use............ New................. Clinical Process/
measured within one hour Network Effectiveness.
of admission to the NICU. www.vtoxford.org and
Description: Percent of click on ``Contact
NICU admissions with a Us''.
birth weight of 501-1500g
with a first temperature
taken within 1 hour of
NICU admission.
0482.............................. Title: First NICU Vermont Oxford State use............ New................. Clinical Process/
Temperature < 36 degrees Network Effectiveness.
C. www.vtoxford.org and
Description: Percent of click on ``Contact
all NICU admissions with Us''.
a birth weight of 501-
1500g whose first
temperature was measured
within one hour of
admission to the NICU and
was below 36 degrees
Centigrade.
0143.............................. Title: Use of relievers The Joint Commission State use............ New................. Clinical Process/
for inpatient asthma. (TJC) Effectiveness.
Description: Percentage of www.jointcommission.
pediatric asthma org and click on
inpatients, age 2-17, who ``Contact Us''.
were discharged with a
principal diagnosis of
asthma who received
relievers for inpatient
asthma.
0144.............................. Title: Use of systemic The Joint Commission State use............ New................. Clinical Process/
corticosteroids for (TJC) Effectiveness.
inpatient asthma. www.jointcommission.
Description: Percentage of org and click on
pediatric asthma ``Contact Us''.
inpatients (age 2-17
years) who were
discharged with principal
diagnosis of asthma who
received systemic
corticosteroids for
inpatient asthma.
0484.............................. Title: Proportion of Vermont Oxford State use............ New................. Clinical Process/
infants 22 to 29 weeks Network Effectiveness.
gestation treated with www.vtoxford.org and
surfactant who are click on ``Contact
treated within 2 hours of Us''.
birth.
Description: Number of
infants 22 to 29 weeks
gestation treated with
surfactant within 2 hours
of birth.
0716.............................. Title: Healthy Term California Maternal State use............ New................. Patient Safety.
Newborn. Quality Care
Description: Percent of Collaborative
term singleton livebirths www.cmqcc.org and
(excluding those with click on ``Contact
diagnoses originating in Us''.
the fetal period) who DO
NOT have significant
complications during
birth or the nursery care.
1354.............................. Title: Hearing screening CDC www.cdc.gov and State use............ New................. Clinical Process/
prior to hospital click on ``Contact Effectiveness.
discharge (EHDI-1a). CDC``.
Description: This measure
assesses the proportion
of births that have been
screened for hearing loss
before hospital discharge.
1653.............................. Title: IMM-1 Pneumococcal Oklahoma Foundation IQR.................. New................. Population/Public
Immunization (PPV23). for Medical Quality Health.
Description: This (OFMQ) www.ofmq.com
prevention measure and click on
addresses acute care ``Contact''.
hospitalized inpatients
65 years of age and older
(IMM-1b) AND inpatients
aged between 6 and 64
years (IMM-1c) who are
considered high risk and
were screened for receipt
of 23-valent pneumococcal
polysaccharide vaccine
(PPV23) and were
vaccinated prior to
discharge if indicated.
The numerator captures
two activities; screening
and the intervention of
vaccine administration
when indicated. As a
result, patients who had
documented
contraindications to
PPV23, patients who were
offered and declined
PPV23 and patients who
received PPV23 anytime in
the past are captured as
numerator events.
1659.............................. Title: IMM-2 Influenza Oklahoma Foundation IQR.................. New................. Population/Public
Immunization. for Medical Quality Health.
Description: This (OFMQ) www.ofmq.com
prevention measure and click on
addresses acute care ``Contact''.
hospitalized inpatients
age 6 months and older
who were screened for
seasonal influenza
immunization status and
were vaccinated prior to
discharge if indicated.
The numerator captures
two activities: Screening
and the intervention of
vaccine administration
when indicated. As a
result, patients who had
documented
contraindications to the
vaccine, patients who
were offered and declined
the vaccine and patients
who received the vaccine
during the current year's
influenza season but
prior to the current
hospitalization are
captured as numerator
events.
Influenza (flu) is an
acute, contagious, viral
infection of the nose,
throat and lungs
(respiratory illness)
caused by influenza
viruses. Outbreaks of
seasonal influenza occur
annually during late
autumn and winter months
although the timing and
severity of outbreaks can
vary substantially from
year to year and
community to community.
Influenza activity most
often peaks in February,
but can peak rarely as
early as November and as
late as April. In order
to protect as many people
as possible before
influenza activity
increases, most flu-
vaccine is administered
in September through
November, but vaccine is
recommended to be
administered throughout
the influenza season as
well. Because the flu
vaccine usually first
becomes available in
September, health systems
can usually meet public
and patient needs for
vaccination in advance of
widespread influenza
circulation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
***
IQR = Inpatient Quality Reporting.
TJC = The Joint Commission.
HVBP = Hospital Value-Based Purchasing.
OQR = Outpatient Quality Reporting.
[[Page 13764]]
8. Proposed Reporting Methods for Eligible Hospitals and Critical
Access Hospitals
(a) Reporting Methods in FY 2013
In the CY 2012 Hospital Outpatient Prospective Payment System
(OPPS) final rule with comment period (76 FR 74122), we implemented a
pilot program for Medicare eligible hospitals and CAHs for 2012 that is
intended to test and demonstrate our capacity to accept electronic
reporting of clinical quality measure information. The title of this
pilot program is the 2012 Medicare EHR Incentive Program Electronic
Reporting Pilot for Eligible Hospitals and CAHs. The EHR Incentive
Program Registration and Attestation System is located at https://ehrincentives.cms.gov/hitech/login.action.
(b) Reporting Methods Beginning With FY 2014
Under section 1886(n)(3)(A)(iii) of the Act, eligible hospitals and
CAHs must submit information on the clinical quality measures selected
by the Secretary ``in a form and manner specified by the Secretary'' as
part of demonstrating meaningful use of Certified EHR Technology.
Medicare eligible hospitals and CAHs that are in their first year of
Stage 1 of meaningful use may report the 24 clinical quality measures
from Table 9 through attestation for a continuous 90-day EHR reporting
period as described in section II.B.1. of this proposed rule. Readers
should refer to the discussion in the Stage 1 final rule for more
information about reporting clinical quality measures through
attestation (75 FR 44430 through 44431). Medicare eligible hospitals
and CAHs would select one of the following two options for submitting
clinical quality measures electronically.
Option 1: Submit the selected 24 clinical quality measures
through a CMS-designated portal.
For this option, the clinical quality measures data would be
submitted in an XML-based format on an aggregate basis reflective of
all patients without regard to payer. This method would require the
eligible hospitals and CAHs to log into a CMS-designated portal. Once
the eligible hospitals and CAHs have logged into the portal, they would
be required to submit through an upload process, data that is based on
specified structures produced as output from their Certified EHR
Technology.
Option 2: Submit the selected 24 clinical quality measures
in a manner similar to the 2012 Medicare EHR Incentive Program
Electronic Reporting Pilot for Eligible Hospitals and CAHs using
Certified EHR Technology.
We propose that, as an alternative to the aggregate-level reporting
schema described previously under Option 1, Medicare eligible hospitals
and CAHs that successfully report measures in an electronic reporting
method similar to the 2012 Medicare EHR Incentive Program Electronic
Reporting Pilot for Eligible Hospitals and CAHs using Certified EHR
Technology would satisfy their clinical quality measures reporting
requirement under the Medicare EHR Incentive Program. Please refer to
the CY 2012 OPPS final rule (76 FR 74489 through 74492) for details on
the pilot. We are considering an ``interim submission'' option for
Medicare eligible hospitals and CAHs that are in their first year of
Stage 1 beginning in FY 2014 and available in subsequent years through
an electronic reporting method similar to the 2012 Medicare EHR
Incentive Program Electronic Reporting Pilot for Eligible Hospitals and
CAHs. Under this option, eligible hospitals and CAHs would submit
clinical quality measures data for a continuous 90-day EHR reporting
period, and the data must be received no later than July 1 to meet the
requirements of the EHR Incentive Program. We request public comment on
this potential option.
We are considering the following 4 options of patient population--
payer data submission characteristics:
All patients--Medicare only.
All patients--all payer.
Sampling--Medicare only, or
Sampling--all payer.
Currently, the Hospital IQR program uses the ``sampling--all
payer'' data submission characteristic. We request public comment on
each of these 4 sets of characteristics and the impact they may have to
vendors and hospitals, including but not limited to potential issues
with the respective size of data files for each characteristic. We
intend to select 1 of the 4 sets as the data submission characteristic
for the electronic reporting method for eligible hospitals and CAHs
beginning in FY 2014.
We note that the Hospital IQR program does not currently have an
electronic reporting mechanism. We invite comment on whether an
electronic reporting option would be appropriate for the Hospital IQR
Program and whether it would provide further alignment with the EHR
Incentive Program.
(c) Electronic Reporting of Clinical Quality Measures for Medicaid
Eligible Hospitals
States that have launched their Medicaid EHR Incentive Programs
plan to collect clinical quality measures electronically from Certified
EHR Technology used by eligible hospitals. Each State is responsible
for sharing the details on the process for electronic reporting with
its provider community. We anticipate that whatever means States have
deployed for capturing Stage 1 clinical quality measures electronically
will be similar for Stage 2. However, we note that subject to our prior
approval, the process, requirements, and the timeline is within the
States' purview.
C. Demonstration of Meaningful Use and Other Issues
1. Demonstration of Meaningful Use
a. Common Methods of Demonstration in Medicare and Medicaid
We propose to continue our common method for demonstrating
meaningful use in both the Medicare and Medicaid EHR incentive
programs. 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 clinical quality
measures and meaningful use objectives.
b. Methods for Demonstration of the Stage 2 Criteria of Meaningful Use
We do not propose changes to the attestation process for Stage 2
meaningful use objectives, except the group reporting option discussed
in section II.C.1.c. of this proposed rule. Several changes are
proposed for clinical quality measure reporting, as discussed in
section II.B.3. of this proposed rule. An EP, eligible hospital or CAH
must successfully attest to the Stage 2 meaningful use objectives and
successfully submit clinical quality measures to be a meaningful EHR
user. We would revise Sec. 495.8 to accommodate the Stage 2 objective
and measures, as well as changes we are making to Stage 1.
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 nonclinical and documented
participation in HIE. As HIT advances we expect to move more of the
objectives away from being demonstrated through attestation. However,
at this time we do not believe that the advances in HIT and the
certification of EHR technologies allow us to propose an alternative to
attestation in this proposed rule. We continue to evaluate the possible
alternatives to attestation and the changes to certification and/or
[[Page 13765]]
meaningful use. As discussed later, while we would continue to require
analysis of all meaningful use measures at the individual EP, eligible
hospital or CAH level, we are proposing a batch file process in lieu of
individual Medicare EP attestation through the CMS Attestation Web site
beginning with CY 2014. This batch reporting process will ensure that
meaningful use of certified EHR technology continues to be measured at
the individual level, while promoting efficiencies for group practices
that must submit attestations on large groups of individuals.
We would continue to leave open the possibility 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
would not require any EP, eligible hospital or CAH to participate in
this testing in either 2013 or 2014 in order to receive an incentive
payment or avoid the payment adjustment.
c. Group Reporting Option of Meaningful Use Core and Menu Objectives
and Associated Measures for Medicare and Medicaid EPs Beginning With CY
2014
For Stage 1, EPs were required to attest and report on core and
menu objectives on an individual basis and did not have an option to
report collectively with other EPs in the same group practice. Under
section 1848(o)(2)(A) of the Act, the Secretary may provide for the use
of alternative means for eligible professionals furnishing covered
professional services in a group practice (as defined by the Secretary)
to meet the requirements of meaningful use. For EHR reporting periods
occurring in CY 2014 and subsequent years, we are proposing a group
reporting option to allow Medicare EPs within a single group practice
to report core and menu objective data through a batch file process in
lieu of individual Medicare EP attestation through the CMS Attestation
Web site. The purpose of proposing a group reporting option is to
provide administrative relief to group practices that have large
numbers of EPs who need to attest to meaningful use. This option is
intended to allow a batch reporting of each individual EP's core and
menu objective data, and each EP would still have to meet the required
meaningful use thresholds independently. This option does not permit
any EP to meet the required meaningful use thresholds through the use
of a group average or any other method of group demonstration.
We would establish a file format in which groups would be required
to submit core and menu objective information for individual Medicare
EPs (including the stage of meaningful use the individual EP is in,
numerator, denominator, exclusion, and yes/no information for each core
and menu objective) and also establish a process through which groups
would submit this batch file for upload.
States would have the option of offering batch reporting of
meaningful use data for Medicaid EPs. States would need to outline
their approach in their State Medicaid HIT Plan.
For purposes of this group reporting option, we propose to define a
Medicare EHR Incentive Group as 2 or more EPs, each identified with a
unique NPI associated with a group practice identified under one tax
identification number (TIN) through the Provider Enrollment, Chain, and
Ownership System (PECOS). This is the same definition as one proposed
in the group reporting option of clinical quality measures. States
choosing to exercise this option would have to clearly define a
Medicaid EHR Incentive Group via their State Medicaid HIT Plan. None of
the EPs in either a Medicare or Medicaid EHR Incentive Group could be
hospital-based according to the definition for these programs (see 42
CFR 495.4). Any EP that successfully attests as part of one Medicare
EHR Incentive Group would not be permitted to also attest individually
or attest as part of a batch report for another Medicare EHR Incentive
Group. Because EPs can only participate in either the Medicare or
Medicaid incentive programs in the same payment year, an EP that is
part of a Medicare EHR Incentive Group would not be able to receive a
Medicaid EHR incentive payment or be included as part of a batch report
for a Medicaid EHR Incentive Group.
This group reporting option would be limited to data for the core
and menu objectives, but it would not include the reporting of clinical
quality measures, which is also required in order to demonstrate
meaningful use and receive an EHR incentive payment. Clinical quality
measures must be reported separately through one of the electronic
submission options that are described in section II.B. of this proposed
rule. Because we are proposing multiple group reporting methods for
clinical quality measures, EPs would not have to report core and menu
objective data in the same EHR Incentive Group as they report their
clinical quality measures. An EP would be able to submit the core and
menu objectives as part of a group and the clinical quality measures as
an individual or vice versa (that is, use clinical quality group
reporting, while using individual reporting for the core/menu
objectives).Please note that EPs would not be required to batch report
as part of a group, and would still be permitted to attest individually
through the CMS Attestation Web site (as long as they did not also
report as part of a group). In order to demonstrate meaningful use and
avoid any payment adjustments applicable under the Medicare EHR
Incentive Program, EPs would be required to individually meet all of
the thresholds of the core and menu objectives. In other words, an EP
cannot avoid payment adjustments through the use of a group average or
any other method of group demonstration. Payment adjustments would be
applied to individual EPs, as described in section II.C. of this
proposed rule and not to Medicare EHR Incentive Groups.
An EP's incentive payment would not be automatically assigned to
the Medicare EHR Incentive Group with which they batch report under
this option. The EP would still have to select the payee TIN during the
registration process.
EPs that practice in multiple practices or locations would be
responsible for submitting complete information for all actions taken
at practices/locations equipped with Certified EHR Technology. Under 42
CFR 495.4, to be considered a meaningful EHR user, an EP must have 50
percent or more of their patient encounters in practice(s) or
location(s) where Certified EHR Technology is available. In the July
28, 2010 final rule (75 FR 44329), we also made clear that an EP must
include encounters for all locations equipped with Certified EHR
Technology. We are not proposing to change these requirements in this
rulemaking. Therefore, an EP who chooses the group reporting option
would be required to include in such reporting core and menu objective
information on all encounters where Certified EHR Technology is
available, even if some encounters occurred at locations not associated
with the EP's Medicare EHR Incentive Group. We are not proposing a
minimum participation threshold for reporting as part of an EHR
Incentive Group; in other words, an EP who is able to meet the 50
percent threshold of patient encounters in locations equipped with
Certified EHR Technology could report all of their core
[[Page 13766]]
and menu objective data as part of an EHR Incentive Group in which they
had only 5 percent of their patient encounters, provided they report
all of the data from the other locations through the batch reporting
process.
We also seek public comment on a group reporting option that allows
groups an additional reporting option in which groups report for their
EPs a whole rather than broken out by individual EP.
In the January 18, 2011 Federal Register (76 FR 2910), the Health
IT Policy Committee published a request for comment, to which 422
organizations and individuals submitted comments. In it, the committee
invited comment on the following question, ``Should Stage 2 allow for a
group reporting option to allow group practices to demonstrate
meaningful use at the group level for all EPs in that group?''
The majority of those responding to this question supported this
approach as one reporting option for EPs. Commenters often cited that a
group reporting option will reduce administrative burden. Many
commenters expressed an opinion that permitting group reporting may
harness EP competition that will improve performance with peers within
the group practice. Furthermore, commenters also stated that this
option would: Facilitate physician teamwork and care coordination, be
helpful for specialists and community health centers, and highlight
system-level performance, thus creating incentives to invest in system-
wide improvement programs.
When commenting on the group reporting option we are providing the
following list of suggested topics, but this list is by no means
exhaustive:
What should the definition of a group be for the exercise
of group reporting? For example, under the PQRS Group Reporting Option,
a group is defined as a physician group practice, as defined by a
single Tax Payer Identification Number, with 25 or more individual
eligible professionals who have reassigned their billing rights to the
TIN. We could adopt this definition or an alternative definition.
Should there be a self nomination process for groups as in
PQRS or an alternative process for identifying groups?
Regarding the availability of Certified EHR Technology
across the group, should the group be required to utilize the same
Certified EHR Technology?
Should a group be eligible if Certified EHR Technology
(same or different) is not available to all associated EPs at all
locations?
Should a group be eligible if they use multiple Certified
EHR Technologies that cannot share data easily?
With respect to EPs who practice in multiple groups or in
a group and practice individually, how should meaningful use activities
be calculated?
As the HITECH Act requires all meaningful users to be paid
75 percent of all covered services, how should the covered services
performed by EPs in another practice be assigned to the group TIN?
How will meaningful use activities performed at other
groups be included?
Should these services be included in the attesting group,
or should CMS just ignore this information or account for it in other
ways?
How should the government address an EPs failure to meet a
measure individually?
If an EP chooses not to participate in a particular
objective should they be a meaningful EHR user under the group if their
non-participation still allows group compliance with a percentage
threshold?
How should yes/no objectives be handled in this situation?
Some EPs in a group participate in Medicaid while others
participate in Medicare; what covered services should the meaningful
use calculation capture?
Incentive payment assignment.
Should the incentive payment be reassigned to the group
automatically or does the EP still need to assign it to the group at
registration?
Should the same policy exist if the EP has covered
services billed to other TINs?
How should covered services for EPs who leave a group
during an active EHR reporting period be handled?
How should payment adjustments for Group reporting be
handled?
What alternative options should be considered for
reporting meaningful use, while capturing necessary data?
For options presented, please share how each would be effectively
implemented while meeting the objectives of the statute. For example,
should EPs continue to report individually, use the batch file process
proposed in this proposed rule or be included in a report of all EP
data combined under one TIN?
2. Data Collection for Online Posting, Program Coordination, and
Accurate Payments
In addition to the data already being collected under our
regulations (Sec. 495.10), we propose to collect the business email
address of EPs, eligible hospitals and CAHs to facilitate communication
with providers. We do not propose to post this information online. We
propose to amend Sec. 495.10 accordingly. We propose to begin
collection as soon as the registration system can be updated following
the publication of this final rule for both the Medicare and Medicaid
EHR incentive programs.
We do not propose any changes to the registration for the Medicare
and Medicaid EHR incentive programs, to the rules on EPs switching
between programs, or to the record retention requirements in Sec.
495.10.
3. Hospital-Based Eligible Professionals
We propose changes to the definition of a hospital-based eligible
professional only to recognize the determination of hospital-based once
Medicare providers are subject to payment adjustments. We refer readers
to section II.D.2. of this proposed rule for that discussion.
While we are not proposing changes to the definition, we do seek
comments on the following discussion. The definition of ``hospital-
based'' in the Social Security Act discusses the eligible professional
furnishing professional services ``through the use of the facilities
and equipment, including qualified electronic health records, of the
hospital'' (section 1903(t)(3)(D) and 1848(o)(1)(C)(ii) of the Act). In
the Stage 1 final rule, we addressed comments on this portion of the
definition (75 FR 44441). Nevertheless, during implementation of Stage
1, we have been asked about situations where clinicians may work in
specialized hospital units, the clinicians have independently procured
and utilize EHR technology that is completely distinct from that of the
hospital, and the clinicians are capable, without the facilities and
equipment of the hospital, of meeting the eligible professional (for
example ambulatory, not in-patient) definition of meaningful use. These
inquiries point out that such situations are uncommon and might not be
generalized under the uniform definition used by place of service
codes.
We solicit comments on this issue. Specifically, comments should
address and provide documentation supporting whether specialized
hospital units are using stand-alone certified EHR technology separate
from that of the hospital. In addition, the comments should address
(and we would request documentation on) whether EPs are using the
facilities and equipment of the hospital. We consider hospital
facilities and equipment to refer to the physical
[[Page 13767]]
environment needed to support the necessary hardware; internet access
and firewalls; the hardware itself, including servers; and system
interfaces necessary for demonstrating meaningful use, for example, to
health information exchanges, laboratory information systems, or
pharmacies.
Thus, comments should address whether EPs using stand-alone
certified EHR technology separate from that of the hospital, are truly
not accessing the facilities and equipment of the hospitals. We would
appreciate discussions of EP workflow to demonstrate how the EPs avoid
use of such facilities and equipment.
Were we to adopt a policy on this issue, we believe additional
attestation elements would need to be added to the determination of
whether an EP is hospital-based. Such attestations would be subject to
audit and the False Claims Act. In addition, were we to adopt a policy
on this issue, EPs found not to be hospital-based would not only be
potentially eligible for incentive payments, but also subject to
payment adjustments under Medicare.
We also request comments on whether the criteria for ambulatory
EHRs and the meaningful use criteria that apply to EPs could be met in
cases where EPs are primarily providing inpatient or Emergency
Department services. By definition, the EPs affected by this issue are
those who provide 90 percent or more of their services in the inpatient
or emergency department, and who provide less than 10 percent of their
services, and possibly none, in outpatient settings. However, since the
beginning of the program, we have been clear that for EPs, meaningful
use measures would not include patient encounters that occur within the
inpatient or emergency departments (POS 21 or 23). See for example, FAQ
10068, 10466, and FAQ 10462.
We reiterate this policy in section II.A.3.d.(2). of this proposed
rule, where we explain that all meaningful use policies for EPs apply
only to outpatient settings (all settings except the inpatient and
emergency department of a hospital). Some of our meaningful use
criteria for EPs are measured based on office visits (clinical
summaries) and others assume an outpatient type of setting (patient
reminders). The certification rules at 45 CFR part 170 differentiate
between ambulatory and inpatient EHRs, and it is unclear whether the
EPs in this case would have inpatient or ambulatory technology. We
request comments on this issue. Finally, we request comments as to
whether patients affected by this situation would essentially be
``double-counted;'' once for the hospital's EHR incentive payment, and
once for the EP's incentive payment, and whether and how this issue
should be addressed, such as potentially excluding discharges
associated with EPs who receive an incentive payment based upon the
same inpatient.
4. Interaction With Other Programs
There are no proposed changes to the ability of providers to
participate in the Medicare and Medicaid EHR incentive programs and
other CMS programs. We continue to work on aligning the data collection
and reporting of the various CMS programs, especially in the area of
clinical quality measurement. See section II.B. of this proposed rule
for the proposed alignment initiatives for clinical quality measures.
D. Medicare Fee-for-Service
1. General Background and Statutory Basis
As we discussed in the Stage 1 final rule (75 FR 44447), sections
4101(a) and 4102(a) of the HITECH Act amended sections 1848, 1886, and
1814(l) of the Act to provide for incentive payments to EPs, hospitals,
and CAHs that are meaningful users of certified EHR technology.
Depending upon when the EP, hospital, or CAH first qualifies as a
meaningful user of EHR technology, these incentive payments could begin
as early as CY 2011 for EPs, FY 2011 for hospitals, or a cost reporting
period beginning during FY 2011 for CAHs. In no case may these
incentive payments be made later than CY 2016 for EPs, FY 2016 for
hospitals or a cost reporting period beginning after the end of FY 2015
for CAHs.
As we also discussed in the Stage 1 final rule, sections 4101(b)
and 4102(b) of the HITECH Act provide as well for reductions in
payments to EPs, hospitals, and CAHs that are not meaningful users of
certified EHR technology, beginning in CY 2015 for EPs, FY 2015 for
hospitals, and in cost reporting periods beginning in FY 2015 for CAHs.
We discuss the specific statutory requirements for each of these
payment reductions in the following three sections. In these sections,
we also present our specific proposals for implementing these mandatory
payment reductions.
2. 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. (As defined in Sec.
495.100 of the regulations, for these purposes an EP is a physician,
which includes a doctor of medicine or osteopathy, a doctor of dental
surgery or medicine, a doctor of podiatric medicine, a doctor of
optometry, or a chiropractor.) In general, beginning in 2015, if an EP
is not a meaningful EHR user for the EHR reporting period for the year,
then the Medicare physician fee schedule (PFS) 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'' (defined later) of the fee schedule amount that would
otherwise apply. As we also discuss later, the HITECH Act includes an
exception, which, if applicable, could exempt certain EPs from this
payment adjustment. The payment adjustments do not apply to hospital-
based EPs.
The term ``applicable percent'' is defined in the statute to mean:
``(1) 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 in section 1848(a)(5) of the Act for 2014, 98
percent); (2) for 2016, 98 percent; and (3) for 2017 and each
subsequent year, 97 percent.''
In addition, section 1848(a)(7)(iii) of the Act provides that if,
for CY 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 for EPs
who are not meaningful EHR users from the applicable percent in the
preceding year, but that in no case shall the applicable percent be
less than 95 percent.
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 reporting period 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 exception is subject
to annual renewal, but in no case may an EP be granted an exception for
more than 5 years.
[[Page 13768]]
a. Applicable Payment Adjustments for EPs Who Are Not Meaningful Users
of Certified EHR Technology in CY 2015 and Subsequent Calendar Years
Consistent with these provisions, in the Stage 1 final rule (75 FR
44572), we provided in Sec. 495.102(d)(1) and (2) that, beginning in
CY 2015, if an EP is not a meaningful EHR user for an EHR reporting
period for the year, then the Medicare PFS amount that would otherwise
apply for covered professional services furnished by the EP during the
year will be adjusted by the following percentages: for 2015, 99
percent (or, in the case of an EP who was subject to the application of
the payment adjustment for e-prescribing under section 1848(a)(5) of
the Act for 2014, 98 percent); (2) for 2016, 98 percent; and (3) for
2017 and each subsequent year, 97 percent.
However, while we discussed the application of the additional
adjustment for CY 2018 and subsequent years if the Secretary finds that
the proportion of EPs who are meaningful EHR users is less than 75
percent in the preamble to the final rule (75 FR 44447), we did not
include a specific provision for this adjustment in the regulations
text. Therefore, we are proposing to revise the current regulations, to
provide specifically that, beginning with CY 2018 and subsequent years,
if the Secretary has found that the proportion of EPs who are
meaningful EHR users under Sec. 495.8 is less than 75 percent, the
applicable percent is decreased by 1 percentage point for EPs who are
not meaningful EHR users from the applicable percent in the preceding
year, but that in no case is the applicable percent less than 95
percent. We expect to base the determination each year on the most
recent CY for which we have sufficient data. The computation would be
based on the ratio of EPs who have qualified as meaningful users in the
numerator, to Medicare-enrolled EPs in the denominator. We note that
the statute requires us to base this determination on ``the proportion
of eligible professionals who are meaningful EHR users (as determined
under subsection (o)(2).'' Both hospital-based EPs and EPs who have
been granted any of the exceptions that we are proposing remain EPs
within the statutory definition of the term, as implemented in our
regulations in Sec. 495.100 of our regulations. However, hospital-
based EPs and EPs granted a exception would not be subject to the
determination of meaningful use status ``under subsection (o)(2).''
Therefore, we are proposing to exclude from the denominator of the
requisite ratio both the total number of EPs granted an exception in
the most recent CY for which we have sufficient data, and all hospital-
based EPs from the relevant period. We anticipate that we would compute
the requisite ratio of EPs who are meaningful EHR users based on the
data available as of October 1, 2017, as this is the last date for EPs
to register and attest to meaningful use to avoid a payment adjustment
in CY 2018. We would provide more specific detail on this computation
in future guidance after the final regulation is published. We note
that, in general terms, these two provisions for payment adjustments to
EPs who are not meaningful users of EHR technology have the following
effects for CY 2015 and subsequent years. The adjustment to the
Medicare PFS amount that would otherwise apply for covered professional
services furnished by the EP will be 99 percent in CY 2015. However,
for CY 2015 the adjustment for an EP who, in CY 2014, was also subject
to the application of the payment adjustment for e-prescribing under
section 1848(a)(5) of the Act would be 98 percent of the Medicare PFS
amount. In CY 2016, the adjustment to the Medicare PFS amount that
would otherwise apply will be 98 percent. Similarly, the adjustment to
the Medicare PFS amount that would otherwise apply would be 97 percent
in CY 2017. Depending on whether the proportion of EPs who are
meaningful EHR users is less than 75 percent, the adjustment to the
Medicare PFS amount can be as low as 96 percent in CY 2018, and 95
percent in CY 2019 and subsequent years.
It is important to note that some eligible professionals may be
eligible for both the Medicare and Medicaid EHR incentives, and have
opted for the Medicaid EHR incentive. Under that program, in the first
year of their participation, EPs may be eligible for an incentive
payment for having adopted, implemented, or upgraded (AIU) to certified
EHR technology, as provided in Sec. 495.8(a)(2)(iv). However, AIU does
not constitute meaningful use of certified EHR technology. Therefore,
those EPs who receive an incentive payment for AIU would not be
considered meaningful EHR users for purposes of determining whether EPs
are subject to the Medicare payment adjustment. Medicaid EPs who meet
the first year requirements through AIU in either 2013 or 2014 will
still be subject to the payment adjustment in 2015 if they are not
meaningful EHR users for the applicable reporting period. However,
Medicaid EPs can, avoid this consequence by making sure that they meet
meaningful use in 2013 (or 2014 if this is the first year of
participation). Since the Medicaid EHR Incentive Program allows EPs to
initiate as late as 2016, AIU can still be an important initial step
for providers who missed the window to avoid the Medicare penalties,
assuming they then demonstrate meaningful use in the subsequent year.
Table 10--Percent Adjustment for CY 2015 and Subsequent Years, Assuming That the Secretary Finds That Less Than
75 Percent of EPs Are Meaningful EHR Users for CY 2018 and Subsequent Years
----------------------------------------------------------------------------------------------------------------
2015 2016 2017 2018 2019 2020+
----------------------------------------------------------------------------------------------------------------
EP is not subject to the payment adjustment for e- 99 98 97 96 95 95
prescribing in 2014......................................
EP is subject to the payment adjustment for e-prescribing 98 98 97 96 95 95
in 2014..................................................
----------------------------------------------------------------------------------------------------------------
Table 11--Percent Adjustment for CY 2015 and Subsequent Years, Assuming That the Secretary Always Finds That at
Least 75 Percent of EPs Are Meaningful EHR Users for CY 2018 and Subsequent Years
----------------------------------------------------------------------------------------------------------------
2015 2016 2017 2018 2019 2020+
----------------------------------------------------------------------------------------------------------------
EP is not subject to the payment adjustment for e- 99 98 97 97 97 97
prescribing in 2014......................................
EP is subject to the payment adjustment for e-prescribing 98 98 97 97 97 97
in 2014..................................................
----------------------------------------------------------------------------------------------------------------
[[Page 13769]]
b. EHR Reporting Period for Determining Whether an EP Is Subject to the
Payment Adjustment for CY 2015 and Subsequent Calendar Years
In the Stage 1 final rule, we did not specifically discuss the EHR
reporting periods that would apply for purposes of determining whether
an EP is subject to the payment adjustments for CY 2015 and subsequent
years. Section 1848(a)(7)(E)(ii) of the Act provides broad authority
for the Secretary to choose the EHR reporting period for this purpose.
Specifically, this section provides that ``term `EHR reporting period'
means, with respect to a year, a period (or periods) specified by the
Secretary.'' Thus, the statute neither requires that such reporting
period fall within the year of the payment adjustment, nor precludes
the reporting period from falling within the year of the payment
adjustment.
In the case of EPs, we have sought to establish appropriate
reporting periods for purposes of the payment adjustments in CY 2015
and subsequent years to avoid creating a situation in which it might be
necessary either to recoup overpayments or make additional payments
after a determination is made about whether the payment adjustment
should apply. This consideration is especially important in the case of
EPs because, unlike the case with eligible hospitals and CAHs, there is
not an existing mechanism for reconciliation or settlement of final
payments subsequent to a payment year, based on the final data for the
payment year. (Although, as we discuss in the separate sections later
on the payment adjustments for eligible hospitals in CY 2015 and
subsequent years, this consideration also carries significant weight
even where such a reconciliation or settlement mechanism is available.)
Similarly, we do not want to create any scenarios under which providers
would be required either to refund money, or to seek additional payment
from beneficiaries, due to the need to recalculate beneficiary
coinsurance after a determination of whether the payment adjustment
should apply. If we were to establish EHR reporting periods that run
concurrently with the payment adjustment year, we would not be able to
safeguard against such retroactive adjustments (potentially including
adjustments to beneficiary copayments, which are determined as a
percentage of the Medicare PFS amount).
Therefore, we are proposing that EHR reporting periods for payment
adjustments would begin and end prior to the year of the payment
adjustment. Furthermore, we are proposing that the EHR reporting
periods for purposes of such determinations will be far enough in
advance of the payment adjustment year to give us sufficient time to
implement the system edits necessary to apply any required adjustments
correctly, and that EPs will know in advance of the payment adjustment
year whether or not they are subject to the adjustments that we have
discussed. Specifically, we believe that the following rules should
apply for establishing the appropriate reporting periods for purposes
of determining whether EPs are subject to the payment adjustments in CY
2015 and subsequent years:
Except as provided in the second bulleted paragraph, we propose
that the EHR reporting period for the 2015 payment adjustment would be
the same EHR reporting period that applies in order to receive the
incentive for payment year 2013. This proposal would align reporting
periods for multiple physician reporting programs. For EPs this would
generally be a full calendar year (unless 2013 is the first year of
demonstrating meaningful use, in which case a 90-day EHR reporting
period would apply). Under this proposed policy, an EP who receives an
incentive for payment year 2013 would be exempt from the payment
adjustment in 2015. An EP who received an incentive for payment years
in 2011 or 2012 (or both), but who failed to demonstrate meaningful use
for 2013 would be subject to a payment adjustment in 2015. (As all of
these years will be for Stage 1 of meaningful use, we do not believe
that it is necessary to create a special process to accommodate
providers that miss the 2013 year for meaningful use). For each year
subsequent to CY 2015, the EHR reporting period for the payment
adjustment would continue to be the calendar year 2 years prior to the
payment adjustment period, subject again to the special exception for
new meaningful users of the Certified EHR Technology as follows:
We would create an exception for those EPs who have never
successfully attested to meaningful use in the past nor during the
regular EHR reporting period we are proposing in the first bulleted
paragraph. For these EPs, as it is their first year of demonstrating
meaningful use, for the 2015 payment adjustment, we propose to allow a
continuous 90-day reporting period that begins in 2014 and that ends at
least 3 months before the end of CY 2014. In addition, the EP would
have to actually successfully register for and attest to meaningful use
no later than the date that occurs 3 months before the end of CY 2014.
For EPs, this means specifically that the latest day the EP must
successfully register for the incentive program and attest to
meaningful use, and thereby avoid application of the adjustment in CY
2015, is October 1, 2014. Thus, the EP's EHR reporting period must
begin no later than July 3, 2014 (allowing the EP a 90-day EHR
reporting period, followed by 1 extra day to successfully submit the
attestation and any other information necessary to earn an incentive
payment). This policy would continue to apply in subsequent years for
EPs who are in their first year of demonstrating meaningful use in the
year immediately preceding the payment adjustment year.
We believe that these proposed EHR reporting periods provide
adequate time both for the systems changes that will be required for us
to apply any applicable payment adjustments in CY 2015 and subsequent
years, and for EPs to be informed in advance of the payment year
whether any adjustment(s) will apply. They also provide appropriate
flexibility by allowing more recent adopters of EHR technology a
reasonable opportunity to establish their meaningful use of the
technology and to avoid application of the payment adjustments. We
welcome comments on this proposal.
c. Exception to the Application of the Payment Adjustment to EPs in CY
2015 and Subsequent Calendar Years
As previously discussed, section 1848(a)(7)(B) of the Act provides
that the Secretary may, on a case-by-case basis, exempt an EP from the
application of the payment adjustments in CY 2015 and subsequent CYs 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. As provided in the statute, the exception
is subject to annual renewal, but in no case may an EP be granted an
exception for more than 5 years. We note that the HITECH Act does not
obligate the Secretary to grant exceptions. Nonetheless, we believe
that given the timeframes of the HITECH Act payment adjustments there
are hardships for which an exception should be granted. We propose
three types of exceptions in this proposed rule and are considering a
potential fourth. We request public comments on all four exception
options. Three types are by definition time limited and should not be
at risk of existing for more than 5 years. The
[[Page 13770]]
potential fourth refers to barriers facing EPs as discussed further. We
believe that these barriers will be lowered over time as internet
access, health information exchange and Certified EHR Technology itself
becomes available more widely. However, we note that the 5 year
limitation is statutory and cannot be altered by regulations.
In the Stage 1 final rule, we provided for this exception in our
regulations at Sec. 495.102(d)(3). However, we did not specify the
specific circumstances, process, or period for which an exception would
be granted. We therefore propose to modify the provision (in a
renumbered Sec. 495.102(d)(4)) to specify the circumstances under
which an exception would be granted.
First, we propose that the Secretary may grant an exception to EPs
who practice in areas without sufficient Internet access. This is in
keeping with the language at section 1848(a)(7)(B) of the Act that a
significant hardship may exist ``in the case of an eligible
professional who practices in a rural area without sufficient Internet
access.'' It also recognizes that a non-rural area may also lack
sufficient Internet access to make complying with the requirements for
being a meaningful EHR user a significant hardship for an EP.
Because exceptions on the basis of insufficient Internet
connectivity must intrinsically be considered on a case-by-case basis,
we believe that it is appropriate to require EPs to demonstrate
insufficient Internet connectivity to qualify for the exception through
an application process. As we have noted, the rationale for this
exception is that lack of sufficient Internet connectivity renders
compliance with the meaningful EHR use requirements a hardship,
particularly for meeting those meaningful use objectives requiring
internet connectivity, summary of care documents, electronic
prescribing, making health information available online and submission
of public health information. Therefore, we believe that the
application must demonstrate insufficient Internet connectivity to
comply with the meaningful use objectives listed previously and
insurmountable barriers to obtaining such infrastructure, such as a
high cost of extending the Internet infrastructure to their facility.
The hardship would be shown for the year that is 2 years prior to the
payment adjustment year. We would require applications to be submitted
no later than July 1 of the calendar year before the payment adjustment
year in order to provide sufficient time for a determination to be made
and for the EP to be notified about whether an exception has been
granted prior to the payment adjustment year. This timeline for
submission and consideration of hardship applications also allows for
sufficient time to adjust our payment systems so that payment
adjustments are not applied to EPs who have received an exception for a
specific payment adjustment year.
We are proposing to establish the hardship period 2 years prior to
the payment adjustment year because, by definition, the majority of EPs
without sufficient Internet connectivity would not have previously been
meaningful EHR users. EPs who have never demonstrated meaningful use
would generally have a short (90-day) EHR reporting period that occurs
in the year before the payment adjustment year. However, if there is
insufficient Internet connectivity in the year prior to that reporting
period, we believe it is reasonable to assume that the EP would face
hardships during the reporting period year, if the EP acquired Internet
connectivity and then were required to obtain Certified EHR Technology,
implement it, and become a meaningful EHR user all in the same year.
We also encourage EPs to apply for the exception as soon as
possible, which would be after the first 90 days (the earliest EHR
reporting period) of CY 2013. If applications are submitted close to or
on the latest date possible (that is, July 1, 2014 for the 2015 payment
adjustment year), then the applications could not be processed in
sufficient time to conduct an EHR reporting period in CY 2014 in the
event that the application is denied.
Secondly, we propose to provide an exception for new EPs for a
limited period of time after the EP has begun practicing. Newly
practicing EPs would not be able to demonstrate that they are
meaningful EHR users for a reporting period that occurs prior to the
payment adjustment year. Therefore, we are proposing that for 2 years
after they begin practicing, EPs could receive an exception from the
payment adjustments that would otherwise apply in CY 2015 and
thereafter. We note that, for purposes of this exception, an EP who
switches specialties and begins practicing under a new specialty would
not be considered newly practicing. For example, an EP who begins
practicing in CY 2015 would receive an exception from the payment
adjustments in CYs 2015 and 2016. However, as discussed previously, the
new EP would still be required to demonstrate meaningful use in CY 2016
in order to avoid being subject to the payment adjustment in CY 2017.
In the absence of demonstrating meaningful use in CY 2016, an EP who
had begun practicing in CY 2015 would be subject to the payment
adjustment in CY 2017. We will employ an application process for
granting this exception, and will provide additional information on the
timeline and form of the application in guidance subsequent to the
publication of the final rule.
Thirdly, we are proposing an additional exception in this proposed
rule for extreme circumstances that make it impossible for an EP to
demonstrate meaningful use requirements through no fault of her own
during the reporting period. Such circumstances might include: A
practice being closed down; a hospital closed; a natural disaster in
which an EHR system is destroyed; EHR vendor going out of business; and
similar circumstances. Because exceptions on extreme, uncontrollable
circumstances must be evaluated on a case-by-case basis, we believe
that it is appropriate to require EPs to qualify for the exception
through an application process.
We would require applications to be submitted no later than July 1
of the calendar year before the payment adjustment year in order to
provide sufficient time for a determination to be made and for the EP
to be notified about whether an exception has been granted prior to the
payment adjustment year. This timeline for submission and consideration
of hardship applications also allows for sufficient time to adjust our
payment systems so that payment adjustments are not applied to EPs who
have received an exception for a specific payment adjustment year. The
purpose of this exception is for EPs who would have otherwise be able
to become meaningful EHR users and avoid the payment adjustment for a
given year. Therefore, it is not necessary to account for circumstances
that arise during a payment adjustment year, but rather those that
arise in the two years prior to the payment adjustment year (that is in
the calendar year immediately prior to the payment adjustment year, or
the calendar year that is 2 years prior).
Finally, we are soliciting comments on the appropriateness of
granting an exception for EPs meeting certain criteria. These include--
Lack of face-to-face or telemedicine interaction with
patients, thereby making compliance with meaningful use criteria more
difficult. Meaningful use requires that a provider is able to transport
information online (to a PHR, to another provider, or to a patient) and
is significantly easier if the provider has direct contact with the
patient and a need for follow up care or contact.
[[Page 13771]]
Certain physicians often do not have a consultative interaction with
the patient. For example, pathologist and radiologists seldom have
direct consultations with patients. Rather, they typically submit
reports to other physicians who review the results with their patients;
Lack of follow up with patients. Again, the meaningful use
requirements for transporting information online are significantly
easier to meet if a provider immediate contact with or follows up with
or contact patients; and
Lack of control over the availability of Certified EHR
Technology at their practice locations.
We do not believe that any one of these barriers taken
independently constitutes an insurmountable hardship; however, our
experience with Stage 1 of meaningful use suggests that, taken
together, they may pose a substantial obstacle to achieving meaningful
use. One option is to provide a time-limited, two year payment
adjustment exception for all EPs who meet the previous criteria. This
approach would allow us to reconsider this issue in future rulemaking.
Another option is to provide such an exception with no specific time
limit. However, we note that even under this less restrictive option,
by statute no individual EP can receive an exception for more than five
years. As discussed earlier, we believe the proliferation of both
Certified EHR Technology and health information exchange will reduce
the barriers faced by specialties with less CEHRT adoption over time as
other providers may be providing the necessary data for these
specialties to meet meaningful use. We particularly request comment on
how soon EPs who meet the previous criteria would reasonably be able to
achieve meaningful use.
We believe that EPs who meet the criteria listed previously face
unique challenges in trying to successfully achieve meaningful use.
However, we encourage comment on whether these criteria, or additional
criteria not accounted for in the meaningful use exclusions constitute
a significant hardship to meeting meaningful use. For the final rule,
we will consider whether to adopt an exception based on these or
similar criteria, and, if so, whether such an an exception should apply
to individual EPs or across-the-board based on specialty or other
groupings that generally meet the appropriate criteria.
The following table summarizes the timeline for EPs to avoid the
applicable payment adjustment by demonstrating meaningful use or
qualifying for an exception from the application of the penalty:
Table 12--Timeline For Eligible Professionals (Other Than Hospital-Based) To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
For an EP
demonstrating
meaningful use for
the first time in
Establish the year prior to Apply for an
EP Payment adjustment year meaningful use for OR the payment OR exception no later
(calendar year) the full calendar adjustment year in than:
year 2 years prior: a continuous 90-day
reporting period
beginning no later
than:
----------------------------------------------------------------------------------------------------------------
2015............................. CY 2013 (with July 3, 2014 (with July 1, 2014.
submission period submission no
the 2 months later than October
following the end 1, 2014).
of the reporting
period).
2016............................. CY 2014 (with July 3, 2015 (with July 1, 2015.
submission period submission no
the 2 months later than October
following the end 1, 2015).
of the reporting
period).
2017............................. CY 2015 (with July 3, 2016 (with July 1, 2016.
submission period submission no
the 2 months later than October
following the end 1, 2016).
of the reporting
period).
2018............................. CY 2016 (with July 3, 2017 (with July 1, 2017.
submission period submission no
the 2 months later than October
following the end 1, 2017).
of the reporting
period).
2019............................. CY 2017(with July 3, 2018 (with July 1, 2018.
submission period submission no
the 2 months later than October
following the end 1, 2018).
of the reporting
period).
----------------------------------------------------------------------------------------------------------------
Notes: (CY refers to the calendar year, January 1 through December 31 each year.)
The timelines for CY 2020 and subsequent calendar years will follow the same pattern.
d. Payment Adjustment Not Applicable To Hospital-Based EPs
Section 1848(a)(7)(D) of the Act provides that no EHR payment
adjustments otherwise applicable for CY 2015 and subsequent years ``may
be made * * * in the case of a hospital-based eligible professional (as
defined in subsection (o)(1)(C)(ii)) of the Act.'' We believe the same
definition of hospital-based should apply during the incentive and
payment adjustment phases of the Medicare EHR incentive program (that
is, those eligible to receive incentives would also be subject to
adjustments). Therefore, our regulations at Sec. 495.100 and Sec.
495.102(d) would retain, during the payment adjustment phase of the EHR
Incentive Program, the definition of hospital-based eligible
professional at Sec. 495.4. Section 495.4 defines a hospital-based EP
as ``an EP who furnishes 90 percent or more of his or her covered
professional services in a hospital setting in the year preceding the
payment year. A setting is considered a hospital setting if it is a
site of service that would be identified by the codes used in the HIPAA
standard transactions as an inpatient hospital, or emergency room
setting.'' We further specified in the definition of hospital-based
eligible professional that, for purposes of the Medicare EHR incentive
payment program, the determination of whether an EP is hospital-based
is made on the basis of data from ``the Federal FY prior to the payment
year.'' In the preamble to that final rule (75 FR 44442), we also
stated that ``in order to provide information regarding the hospital-
based status of each EP at the beginning of each payment year, we will
need to use claims data from an earlier period. Therefore, we will use
claims data from the prior fiscal year (October through September).
Under this approach, the hospital-based status of each EP would be
reassessed each year, using claims data from the fiscal year preceding
the payment year. The hospital-based status will be available for
viewing beginning in January of each payment year.'' We will retain the
concept established in the stage 1 final rule (75 FR 44442) of making
hospital-based determinations
[[Page 13772]]
based upon a prior fiscal year of data. However, we are concerned about
ensuring that EPs are aware of their hospital-based status in time to
purchase EHR technology and meaningfully use it during the EHR
reporting period that applies to a payment adjustment year. While EPs
who believe that they are not hospital based will have already either
worked towards becoming meaningful EHR users or planned for the payment
adjustment, EPs who believe that they will be determined hospital based
may not have done so. EPs in these circumstances would need to know
they are not hospital-based in time to become a meaningful EHR user for
a 90-day EHR reporting period in the year prior to the payment
adjustment year. To use the example of the CY 2015 payment adjustment
year, a determination based on FY 2013 data would allow an EP to know
whether he or she is hospital-based by January 1, 2014. This timeline
would give the EP approximately 6 months to begin the EHR reporting
period, which could last from July through September of 2014. We do not
believe this is sufficient time for the EP to implement Certified EHR
Technology. Therefore, we are proposing to base the hospital based
determination for a payment adjustment year on determinations made 2
years prior. Again using CY 2015 payment adjustment year as an example,
the determination would be available on January 1, 2013 based on FY
2012 data. This proposed determination date will give the EP up to 18
months to implement Certified EHR Technology and begin the EHR
reporting period to avoid the CY 2015 payment adjustment. We consider
this a reasonable time frame to accommodate a difficult situation for
some EPs. However, we also are aware that there may be EPs who are
determined non-hospital-based under this ``2 years prior'' policy when
they would be determined hospital-based if we made the determination
just 1 year prior. Again, using the example of the CY 2015 payment
adjustment year, an EP determined non-hospital-based as of January 1,
2013 (using FY 2012 data) may be found to be hospital-based as of
January 1, 2014 (using FY 2013 data). In this situation, we do not
believe the EP should be penalized for having been non-hospital based
as of January 1, 2013, especially if the EP has never demonstrated
meaningful use, and the EP's first EHR reporting period would have
fallen within CY 2014. Therefore, for the final rule, we are
considering expanding the hospital-based determination to encompass
determinations made either 1 or 2 years prior. Under this alternative,
if the EP were determined hospital-based as of either one of those
dates, then the EP would be exempt from the payment adjustments in the
corresponding payment adjustment year. This would mean that for the CY
2015 payment adjustment year, an EP determined hospital-based as of
either January 1, 2013 (using FY 2012 data) or January 1, 2014 (using
FY 2013 data) would not be subject to the payment adjustment. In all
cases, we would need to know that the EP is considered hospital-based
in sufficient time for the payment adjustment year.
3. Incentive Market Basket Adjustment Effective in FY 2015 and
Subsequent Years for Eligible Hospitals That Are Not Meaningful EHR
Users
In addition to providing for incentive payments for meaningful use
of EHRs, section 1886(b)(3)(B)(ix)(I) of the Act, as amended by section
4102(b)(1) of the HITECH Act, provides for an adjustment to applicable
percentage increase to the IPPS payment rate for those eligible
hospitals that are not meaningful EHR users for the associated EHR
reporting period for a payment year, beginning in FY 2015.
Specifically, section 1886(b)(3)(B)(ix)(I) 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.'' 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, for eligible hospitals that are not meaningful EHR users, the
Secretary is required to reduce the percentage increases otherwise
applicable by 25 percent (33\1/3\ percent of 75 percent) in 2015, 50
(66\2/3\ percent of 75 percent) percent in FY 2016, and 75 percent (100
percent of 75 percent) in FY 2017 and subsequent years. 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.''
Table 13--Percentage Decrease in Applicable Hospital Percentage Increase
for Hospitals That Are Not Meaningful EHR Users
------------------------------------------------------------------------
2015 2016 2017+
------------------------------------------------------------------------
Hospital is subject to EHR payment adjustment 25% 50% 75%
------------------------------------------------------------------------
Section 1886(b)(3)(B)(ix)(II) of the Act, as amended by section
4102(b)(1) of the HITECH Act, provides that the Secretary may, on a
case-by-case basis exempt a hospital from the application of the
percentage increase adjustment for a fiscal year if the Secretary
determines that requiring such hospital to be a meaningful EHR user
would result in a significant hardship, such as in the case of a
hospital in a rural area without sufficient Internet access. This
section also provides that such determinations are subject to annual
renewal, and that in no case may a hospital be granted such an
exemption for more than 5 years.
Finally section 1886(b)(3)(B)(ix)(III) of the Act, as amended by
section 4102(b)(1) of the HITECH Act, provides that, for FY 2015 and
each subsequent FY, a State in which hospitals are paid for services
under section 1814(b)(3) of the Act shall adjust the payments to each
eligible hospital in the State that is not a meaningful EHR user in a
manner that is designed to result in an aggregate reduction in payments
to hospitals in the State that is equivalent to the aggregate reduction
that would have occurred if payments had been reduced to each eligible
hospital in the State in a manner comparable to the reduction in
section 1886(b)(3)(B)(ix)(I) of the Act. This section also requires
that the State shall report to the Secretary the method it will use to
make the required payment adjustment. (At present, section 1814(b)(3)
of the Act applies to the State of Maryland.) As we discussed in the
Stage 1 final rule establishing the EHR incentive program (75 FR
44448), for purposes of determining whether hospitals are eligible for
receiving EHR incentive payments, we employ the CMS Certification
Number (CCN). We will also use CCNs to identify hospitals for purposes
of determining whether the reduction to the percentage increase
otherwise applicable for FY 2015 and subsequent years applies. (In
other words, whether a hospital was a meaningful EHR user for the
applicable EHR reporting period will be dependent on the CCN for the
hospital.). It is important to note the results of this policy for
certain cases in which
[[Page 13773]]
hospitals change ownership, merge, or otherwise reorganize and the
applicable CCN changes. In cases where a single hospital changes
ownership, we determine whether to retain the previous CCN or to assign
a new CCN depending upon whether the new owner accepts assignment of
the provider's prior participation agreement. Where a change of
ownership has occurred, and a new CCN is assigned due to the new
owner's decision not to accept assignment of the prior provider
agreement, we would not recognize a meaningful use determination that
was established under the prior CCN for purposes of determining whether
the payment adjustment applies. Where the new owner accepts the prior
provider agreement and we thus continues to assign the same CCN, we
would continue to recognize the demonstration of meaningful use under
that CCN. The same policy would apply to merging hospitals that use a
single CCN. For example, if hospital A is not a meaningful EHR user
(for the applicable reporting period), and it absorbs hospital B, which
was a meaningful EHR user, then the entire hospital will be subject to
a payment adjustment if hospital A's CCN is the surviving identifier.
The converse is true as well--if it were hospital B's CCN that
survived, the entire merged hospital would not be subject to a payment
adjustment. (The guidelines for determining CCN assignment in the case
of merged hospitals are described in the State Operations Manual,
sections 2779A ff.) We advise hospitals that are changing ownership,
merging, or otherwise reorganizing to take this policy into account.
a. Applicable Market Basket Adjustment for Eligible Hospitals Who Are
Not Meaningful EHR Users for FY 2015 and Subsequent FYs
In the stage 1 final rule on the Medicare and Medicaid Electronic
Health Record Incentive Payment Programs, we revised Sec. 412.64 of
the regulations to provide for an adjustment to the applicable
percentage increase 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, Sec.
412.64(d)(3) now provides that--
Beginning in fiscal year 2015, in the case of a ``subsection (d)
hospital,'' as defined under section 1886(d)(1)(B) of the Act, that
is not a meaningful electronic health record (EHR) user as defined
in part 495 of this chapter, three-fourths of the applicable
percentage change specified in paragraph (d)(1) of this section is
reduced--
(i) For fiscal year 2015, by 33\1/3\ percent;
(ii) For fiscal year 2016, by 66\2/3\ percent; and
(iii) For fiscal year 2017 and subsequent fiscal years, by 100
percent.
In order to conform with this new update reduction, as required in
section 4102(b)(1)(A) of the HITECH Act, we also revised Sec.
412.64(d)(2)(C) of our regulations 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 percentage increase, rather than the 2
percentage point reduction that applies for FYs 2007 through 2014 in
Sec. 412.64(d)(2)(B). The effect of this revision is that the combined
reductions to the applicable percentage increase 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 applicable percentage
increase remains a positive number.
In this proposed rule, we have no further proposals specifically
regarding the establishment of the applicable percentage increase
adjustment for eligible hospitals who are not meaningful EHR users for
FY 2015 and subsequent FYs beyond the provisions we have just cited.
However, we believe that the existing regulatory provisions
establishing the applicable percentage increase adjustment need to be
supplemented to ensure that it is clear that the applicable EHR
reporting period, for purposes of determining whether a hospital is
subject to the applicable percentage increase adjustment for FY 2015
and subsequent FYs, will be a prior EHR reporting period (as defined in
Sec. 495.4 of the regulations). We have also proposed an amendment to
Sec. 412.64(d) to recognize the availability of the exception, as well
as the application of the applicable percentage increase adjustment in
FY 2015 and subsequent FYs to a State operating under a payment waiver
provided by section 1814(b)(3) of the Act. We discuss these issues and
present our proposals relating to them in the following sections of
this preamble.
b. EHR Reporting Period for Determining Whether a Hospital is Subject
to the Market Basket Adjustment for FY 2015 and Subsequent FYs
Section 1886(b)(3)(B)(ix)(IV) of the Act makes clear that the
Secretary has discretion to ``specify'' the EHR reporting period that
will apply ``with respect to a [calendar or fiscal] year.''
Thus, as in the case of designating the EHR reporting period for
purposes of the EP payment adjustment, the statute governing the
applicable percentage increase adjustment for hospitals that are not
meaningful users of EHR technology neither requires that such reporting
period fall within the year of the payment adjustment, nor precludes
the reporting period from falling within the year of the payment
adjustment.
As in the case of EPs, we wish to avoid creating a situation in
which it might be necessary to make large payment adjustments, either
to lower or to increase payments to a hospital, after a determination
is made about whether the applicable percentage increase adjustment
should apply. We believe that this consideration remains compelling in
the case of hospitals, despite the fact that the IPPS for acute care
hospitals provides, unlike the case of EPs, a mechanism to make
appropriate changes to hospital payments for a payment year through the
cost reporting process. Despite the availability of the cost reporting
process as a mechanism for correcting over- and underpayments made
during a payment year, we seek to avoid wherever possible circumstances
under which it may be necessary to make large adjustments to the rate-
based payments that hospitals receive under the IPPS. As a matter of
course in the rate-setting system, the basic rates and applicable
percentage increase updates are fixed in advance and are not matters
that affect the settlement of final payment amounts under the cost
report reconciliation process. Since the EHR payment adjustment in FYs
2015 and subsequent years is an adjustment to the applicable percentage
increase, we believe that it is far preferable to determine whether the
adjustment applies on the basis of an EHR reporting period before the
payment period, rather than to make the adjustment (where necessary) in
a settlement process after the payment period on the basis of a
determination concerning whether the hospital was a meaningful user
during the payment period.
Therefore, we are proposing, for purposes of determining whether
the relevant applicable percentage increase adjustment applies to
hospitals who are not meaningful users of EHR technology in FY 2015 and
subsequent years, that we will establish EHR reporting periods that
begin and end prior to the year of the payment adjustment. Furthermore,
we are proposing that the EHR reporting periods for purposes of such
determinations will be far enough in
[[Page 13774]]
advance of the payment year that we have sufficient time to implement
the system edits necessary to apply any required applicable percentage
increase adjustment correctly, and that hospitals will know in advance
of the payment year whether or not they are subject to the applicable
percentage increase adjustment. Specifically, we believe that the
following rules should apply for establishing the appropriate reporting
periods for purposes of determining whether hospitals are subject to
the applicable percentage increase adjustment in FY 2015 and subsequent
years (parallel to the rules that we proposed previously for
determining whether EPs are subject to the payment adjustments in CY
2015 and subsequent years):
Except as provided in second bulleted paragraph, we
propose that the EHR reporting period for the FY 2015 applicable
percentage increase adjustment would be the same EHR reporting period
that applies in order to receive the incentive for FY 2013. For
hospitals this would generally be the full fiscal year (unless FY 2013
is the first year of demonstrating meaningful use, in which case a 90-
day EHR reporting period would apply). Under this proposed policy, a
hospital that receives an incentive for FY 2013 would be exempt from
the payment adjustment in FY 2015. A hospital that received an
incentive for FYs 2011 or 2012 (or both), but that failed to
demonstrate meaningful use for FY 2013 would be subject to a payment
adjustment in FY 2015. (As all of these years will be for Stage 1 of
meaningful use, we do not believe that it is necessary to create a
special process to accommodate providers that miss the 2013 year for
meaningful use). For each year subsequent to FY 2015, the EHR reporting
period payment adjustment would continue to be the FY 2 years before
the payment period, subject again to the special provision for new
meaningful users of certified EHR technology.
We would create an exception for those hospitals that have
never successfully attested to meaningful use in the past nor during
the regular EHR reporting period we are proposing in the first bulleted
paragraph previously. For these hospitals, as it is their first year of
demonstrating meaningful use, we propose to allow a continuous 90-day
reporting period that begins in 2014 and that ends at least 3 months
prior to the end of FY 2014. In addition, the hospital would have to
actually successfully register for and attest to meaningful use no
later than the date that occurs 3 months before the end of the year.
For hospitals, this means specifically that the latest day the hospital
must successfully register for the incentive program and attest to
meaningful use, and thereby avoid application of the adjustment in FY
2015, is July 1, 2014. Thus, the hospital's EHR reporting period must
begin no later than April 3, 2014 (allowing the hospital a 90-day EHR
reporting period, followed by one extra day to successfully submit the
attestation and any other information necessary to earn an incentive
payment). This policy would continue to apply in subsequent years. If a
hospital is demonstrating meaningful use for the first time for the
fiscal year immediately before the applicable percentage increase
adjustment year, then the reporting period would be a continuous 90-day
period that begins in such prior fiscal year and ends at least 3 months
before the end of such year. In addition all attestation, registration,
and any other details necessary to determine whether the hospital is
subject to a applicable percentage increase adjustment for the upcoming
year would need to be completed by July 1. (As we discuss later,
exception requests would be due by the April 1 before the beginning of
the next fiscal year.)
In conjunction with adopting these rules for determining the EHR
Reporting Period for determining whether a hospital is subject to the
applicable percentage increase adjustment for FY 2015 and subsequent
FYs, we are specifically proposing to revise Sec. 412.64(d)(3) of our
regulations to insert the phrase ``for the applicable EHR reporting
period,'' so that it is clear that the EHR reporting period will not
fall within the year of the market basket adjustment.
We believe that these proposed EHR reporting periods provide
adequate time both for the systems changes that will be required for
CMS to apply any applicable percentage increase adjustments in FY 2015
and subsequent years, and for hospitals to be informed in advance of
the payment year whether any adjustment(s) will apply. They also
provide appropriate flexibility by allowing more recent adopters of EHR
technology a reasonable opportunity to establish their meaningful use
of the technology and to avoid application of the payment adjustments.
We welcome comments on this proposal.
c. Exception to the Application of the Market Basket Adjustment to
Hospitals in FY 2015 and Subsequent FYs
As mentioned previously, section 1886(b)(3)(B)(ix)(II) of the Act,
as amended by section 4102(b)(1) of the HITECH Act, provides that the
Secretary may, on a case-by-case basis exempt a hospital from the
application of the applicable percentage increase adjustment for a
Fiscal year if the Secretary determines that requiring such hospital to
be a meaningful EHR user would result in a significant hardship, such
as in the case of a hospital in a rural area without sufficient
Internet access. This section also provides that such determinations
are subject to annual renewal, and that in no case may a hospital be
granted such an exception for more than 5 years.
In this proposed rule we are proposing to add a newSec.
412.64(d)(4), specifying the circumstances under which we would exempt
a hospital from the application of the applicable percentage increase
adjustment for a fiscal year. To be considered for an exception, a
hospital must submit an application demonstrating that it meets one or
both of the following criteria.
As noted previously, the statute does not mandate the circumstances
under which an exception must be granted, but (as in the case of a
similar exception provided under the statute for EPs) it does state
that the exception may be granted when ``requiring such hospital to be
a meaningful EHR user during such fiscal year would result in a
significant hardship, such as in the case of a hospital in a rural area
without sufficient Internet access.'' We are therefore proposing to
provide in new Sec. 412.64(d)(4) that the Secretary may grant an
exception to a hospital that is located in an area without sufficient
Internet access. Furthermore, while the statute specifically states
that such an exception may be granted to hospitals in ``a rural area
without sufficient Internet access,'' it does not require that such an
exception be restricted only to rural areas without such access. While
we believe that a lack of sufficient Internet access will rarely be an
issue in an urban or suburban area, we do not believe that it is
necessary to preclude the possibility that, in very rare and
exceptional cases, a non-rural area may also lack sufficient Internet
access to make complying with meaningful use requirements a significant
hardship for a hospital. Therefore, we are providing that the Secretary
may grant such an exception to a hospital in any area without
sufficient Internet access.
Because exceptions on the basis of insufficient Internet
connectivity must intrinsically be considered on a case-by-case basis,
we believe that it is appropriate to require hospitals to demonstrate
insufficient Internet connectivity to qualify for the exception through
an application process. The
[[Page 13775]]
rationale for this exception is that lack of sufficient Internet
connectivity renders compliance with the meaningful EHR use
requirements a hardship particularly those objectives requiring
internet connectivity, summary of care documents, electronic
prescribing, making health information available online and submission
of public health information. Therefore, we believe that such an
application must demonstrate insufficient Internet connectivity to
comply with the meaningful use objectives listed previously and
insurmountable barriers to obtaining such internet connectivity such as
high cost to build out Internet to their facility. As with EPs, the
hardship would be demonstrated for period that is 2 years prior to the
payment adjustment year (for example, FY 2013 for the payment
adjustment in FY 2015). As with EPs, we would require applications to
be submitted 6 months before the beginning of the payment adjustment
year (that is, by April 1 before the FY to which the adjustment would
apply) in order to provide sufficient time for a determination to be
made and for the hospital to be notified about whether an exception has
been granted. This timeline for submission and consideration of
hardship applications also allows for sufficient time to adjust our
payment systems so that payment adjustments are not applied to
hospitals who have received an exception for a specific FY. (Please
also see our previous discussion of the parallel exception for EPs,
with respect to encouraging providers to file these applications as
early as possible, and the likelihood that there will not be an
opportunity to subsequently demonstrate meaningful use if hospitals
file close to or at the application deadline of April 1.)
For the same reasons we are proposing an exception for new EPs, we
propose an exception for a new hospital for a limited period of time
after it has begun services. We would allow new hospitals an exception
for at least 1 full year cost reporting period after they accept their
first patient. For example, a hospital that accepted its first patient
in March of 2015, but with a cost reporting period from July 1 through
June 30, would receive an exception from payment adjustment for FY
2015, as well as for FY 2016. However, the new hospital would be
required to demonstrate meaningful use within the 9 months of FY 2016
(register and attest by July 1, 2016) to avoid being subject to the
payment adjustment in FY 2017.
In proposing such an exception for new hospitals, however, it is
important to ensure that the exception is not available to hospitals
that have already been in operation in one form or another, perhaps
under a different owner or merely in a different location, and thus
have in fact had an opportunity to demonstrate meaningful use of EHR
technology. Therefore, for purposes of qualifying for this exception,
the following hospitals would not be considered new hospitals
exception:
A hospital that builds new or replacement facilities at
the same or another location even if coincidental with a change of
ownership, a change in management, or a lease arrangement.
A hospital that closes and subsequently reopens.
A hospital that has been in operation for more than 2
years but has participated in the Medicare program for less than 2
years.
A hospital that changes its status from a CAH to a
hospital that is subject to the Medicare hospital in patient
prospective payment systems.
It is important to note that we would consider a hospital that
changes its status from a hospital (other than a CAH) that is excluded
from the Medicare hospital inpatient prospective payment system (IPPS)
to a hospital that is subject to the IPPS to be a new hospital for
purposes of qualifying for this proposed exception. These IPPS-exempt
hospitals, such as long-term care hospitals, inpatient psychiatric
facilities, inpatient rehabilitation facilities children's hospitals,
and cancer hospitals, are excluded from the definition of ``eligible
hospital'' for purposes of the Medicare EHR Incentive Program and have
not necessarily had an opportunity to demonstrate meaningful use. On
the other hand, CAHs are eligible for incentive payments and subject to
payment adjustments. Under the guidelines for assigning CCNs to
Medicare providers, a CAH that changes status to an IPPS hospital would
necessarily receive a new CCN. This is because several digits of the
CCN encode the provider's status (for example, IPPS, CAH) under the
Medicare program. However, we would allow the CAH to register its
meaningful use designation obtained under its previous CCN in order to
avoid being subject the hospital payment adjustment. It is worth noting
that we have adapted the proposed definition of ``new hospital'' for
these purposes from similar rules that have been employed in the
capital prospective payment system in Sec. 412.300(b) of our
regulations. We welcome comment concerning the appropriateness of
adapting these rules to the exception under the EHR program, and about
whether modifications or other revisions to these rules would be
appropriate in the EHR context.
Finally, we are proposing an additional exception in this proposed
rule for extreme circumstances that make it impossible for a hospital
to demonstrate meaningful use requirements through no fault of its own
during the reporting period. Such circumstances might include: a
hospital closed; a natural disaster in which an EHR system is
destroyed; EHR vendor going out of business; and similar circumstances.
Because exceptions on extreme, uncontrollable circumstances must be
evaluated on a case-by-case basis, we believe that it is appropriate to
require hospitals to qualify for the exception through an application
process.
We would require applications to be submitted no later than April 1
of the year before the payment adjustment year in order to provide
sufficient time for a determination to be made and for the hospital to
be notified about whether an exception has been granted prior to the
payment adjustment year. This timeline for submission and consideration
of hardship applications also allows for sufficient time to adjust our
payment systems so that payment adjustments are not applied to
hospitals who have received an exception for a specific payment
adjustment year. The purpose of this exception is for hospitals who
would have otherwise be able to become meaningful EHR users and avoid
the payment adjustment for a given year. Therefore, it is not necessary
to account for circumstances that arise during a payment adjustment
year, but rather those that arise in the 2 years prior to the payment
adjustment year.
The following table summarizes the timeline for hospitals to avoid
the applicable payment adjustment by demonstrating meaningful use or
qualifying for an exception from the application of the adjustment.
[[Page 13776]]
Table 14--Timeline for Eligible Hospitals To Avoid Payment Adjustment
----------------------------------------------------------------------------------------------------------------
For an eligible
hospital
demonstrating
meaningful use for
Establish the first time in
Hospital payment adjustment year meaningful use the the year prior to Apply for an
(fiscal year) full fiscal year 2 OR the payment OR exception no later
years prior: adjustment year use than:
a continuous 90-
day reporting
period beginning no
later than:
----------------------------------------------------------------------------------------------------------------
2015............................. FY 2013 (with April 3, 2014 (with April 1, 2014.
submission period submission no
the 2 months later than July 1,
following the end 2014).
of the reporting
period).
2016............................. FY 2014 (with April 3, 2015 (with April 1, 2015.
submission period submission no
the 2 months later than July 1,
following the end 2015).
of the reporting
period).
2017............................. FY 2015 (with April 3, 2016 (with April 1, 2016.
submission period submission no
the 2 months later than July 1,
following the end 2016).
of the reporting
period).
2018............................. FY 2016 (with April 3, 2017 (with April 1, 2017.
submission period submission no
the 2 months later than July 1,
following the end 2017).
of the reporting
period).
2019............................. FY 2017 (with April 3, 2018 (with April 1, 2018.
submission period submission no
the 2 months later than July 1,
following the end 2014).
of the reporting
period).
----------------------------------------------------------------------------------------------------------------
Notes: (FY refers to the Federal fiscal year: October 1 to September 30. For example, FY 2015 is October 1, 2014
through September 30, 2015.)
The timelines for FY 2020 and subsequent fiscal years follow the same pattern.
d. Application of Market Basket Adjustment in FY 2015 and Subsequent
FYs to a State Operating Under a Payment Waiver Provided by Section
1814(b)(3) of the Act
As discussed previously, the statute requires payment adjustments
for eligible hospitals in States where hospitals are paid under section
1814(b)(3) of the Act. Such adjustments shall be designed to result in
an aggregate reduction in payments equivalent to the aggregate
reduction that would have occurred if payments had been reduced under
section 1886(b)(3)(B)(ix)(I) of the Act. In this context, we would
consider that an aggregate reduction in payments would mean the same
dollar amount in reduced Medicare payments that that would have
occurred if payments had been reduced to each eligible hospital in the
State in a manner comparable to the reduction under Sec. 412.64(d)(3).
To implement this provision, we propose a new Sec. 412.64(d)(5)
that includes this statutory requirement. States operating under a
payment waiver under section 1814(b)(3) of the Act must provide to the
Secretary, no later than January 1, 2013, a report on the method that
it proposes to employ in order to make the requisite payment
adjustment.
In this context, we are also proposing that an aggregate reduction
in payments would mean the same dollar amount in reduced Medicare
payments that that would have occurred if payments had been reduced to
each eligible hospital in the State in a manner comparable to the
reduction under Sec. 412.64(d)(3).
4. Reduction of Reasonable Cost Reimbursement 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) of the
Act to include an adjustment to a CAH's Medicare reimbursement for
inpatient services if the CAH has not met the meaningful EHR user
definition for an EHR reporting period. The adjustment would be made
for a cost reporting period that begins in FY 2015, FY 2016, FY 2017,
and each subsequent FY thereafter. Specifically, sections 1814(l)(4)(A)
and (B) of the Act now provide that, if a CAH has not demonstrated
meaningful use of certified EHR technology for an applicable reporting
period, then for a cost reporting period that begins in FY 2015, its
reimbursement would be reduced from 101 percent of its reasonable costs
to 100.66 percent. For a cost reporting period beginning in FY 2016,
its reimbursement would be reduced to 100.33 percent of its reasonable
costs. For a cost reporting period beginning in FY 2017 and each
subsequent FY, its reimbursement would be reduced to 100 percent of
reasonable costs.
However, as provided for eligible hospitals, a CAH may, on a case-
by-case basis, be granted an exception from this adjustment if CMS or
its Medicare contractor determines, on an annual basis, that a
significant hardship exists, 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 exception under this provision for more than 5 years.
a. Applicable Reduction of Reasonable Cost Payment Reduction in FY 2015
and Subsequent Years for CAHs That Are Not Meaningful EHR Users
In the stage 1 final rule (75 FR 44564), we finalized the
regulations regarding the CAH adjustment at Sec. 495.106(e) and Sec.
413.70(a)(6).
b. EHR Reporting Period for Determining Whether a CAH is Subject to the
Applicable Reduction of Reasonable Cost Payment in FY 2015 and
Subsequent Years
For CAHs we propose an EHR reporting period that is aligned with
the payment adjustment year. For example, if a CAH is not a meaningful
EHR user in FY 2015, then its Medicare reimbursement will be reduced to
100.66 for its cost reporting period that begins in FY 2015. This
differs from what is being proposed for eligible hospitals where the
EHR reporting period will be prior to the market basket adjustment
year. We believe the Medicare cost report process would allow us to
make the CAH reduction for the cost reporting period that begins in the
payment adjustment year, with minimal disruptions to the CAH's cash
flow and minimal administrative burden on the Medicare contractors as
discussed later.
CAHs are required to file an annual Medicare cost report that is
typically for a consecutive 12-month period. The cost report reflects
the inpatient statistical and financial data that forms the basis
[[Page 13777]]
of the CAH's Medicare reimbursement. Interim Medicare payments may be
made to the CAH during the cost reporting period based on the previous
year's data. Cost reports are filed with the CAH's Medicare contractor
after the close of the cost reporting period and the data on the cost
report are subject to reconciliation and a settlement process prior to
a final Medicare payment being made.
We have proposed an amended definition of the EHR reporting period
that will apply for purposes of payment adjustments under Sec. 495.4.
For CAHs this will be the full Federal fiscal year that is the same as
the payment adjustment year (unless a CAH is in its first year of
demonstrating meaningful use, in which case a continuous 90-day
reporting period within the payment adjustment year would apply). The
adjustment would then apply based upon the cost reporting period that
begins in the payment adjustment year (that is, FY 2015 and
thereafter). Thus, if a CAH is not a meaningful user for FY 2015, and
thereafter, then the adjustment would be applied to the CAH's
reasonable costs incurred in a cost reporting period that begins in
that affected FY as described in Sec. 413.70(a)(6)(i).
CAHs are required to submit their attestations on meaningful use by
November 30th of the following FY. For example, if a CAH is attesting
that it was a meaningful EHR user for FY 2015, the attestation must be
submitted no later than November 30, 2015. Such an attestation (or lack
thereof) would then affect interim payments to the CAH made after
December 1st of the applicable FY. If the cost reporting period ends
prior to December 1st of the applicable FY then any applicable payment
adjustment will be made through the cost report settlement process.
c. Exception to the Application of Reasonable Cost Payment Reductions
to CAHs in FY 2015 and Subsequent FYs
As discussed previously, CAHs may receive exceptions from the
payment adjustments for significant hardship. While our current
regulations, in Sec. 413.70(a)(6)(ii) and (iii) contain this hardship
provision we are proposing to revise these regulations to align them
with the exceptions being proposed for EPs and subsection (d)
hospitals. As with EPs and subsection (d) hospitals CAHs could apply
for an exception on the basis of lack of sufficient Internet
connectivity. Applications would be required to demonstrate
insufficient Internet connectivity to comply with the meaningful use
objectives requiring internet connectivity (that is, summary of care
documents, electronic prescribing, making health information available
online and submission of public health information) and insurmountable
barriers to obtaining such internet connectivity. As CAHS will have an
EHR reporting period aligned with the payment adjustment year, the
insufficient Internet connectivity would need to be demonstrated for
each applicable payment adjustment year. For example, to avoid a
payment adjustment for cost reporting periods that begin during FY
2015, the hardship would need to be demonstrated for FY 2015. For each
year subsequent to FY 2015, the basis for an exception would continue
to be for the hardship in the FY in which the affected cost reporting
period begins. As stated in Sec. 413.70(a)(6)(iii), any exception
granted may not exceed 5 years. After 5 years, the exception will
expire and the appropriate adjustment will apply if the CAH has not
become a meaningful EHR user.
As with new EPs and new eligible hospitals, we are also proposing
an exception for a new CAH for a limited period of time after it has
begun services. We would allow an exception for 1 year after they
accept their first patient. For example, a CAH that is established in
FY 2015 would be exempt from the penalty through its cost reporting
period ending at least one year after the CAH accepts its first
patient. If the CAH is established March 15 of 2015 and its first cost
reporting period is less than 12 months (for example, from March 15
through June 30, 2015), the exception would exist for both the short
cost reporting period and the following 12-month cost reporting period
lasting from July 1, 2015 through June 30, 2016. However, the new CAH
would be required to submit its attestation that it was a meaningful
EHR user for FY 2016 no later than November 30 of 2016, in order to
avoid being subject to the payment adjustment for the cost reporting
period that begins in FY 2016 (in the previous example from July 1,
2016 through June 30, 2017).
In proposing such an exception for newly established CAHs, it is
important to ensure that the exception is not available to CAHs that
have already been in operation in one form or another, perhaps under a
different ownership or merely in a different location, and thus have in
fact had an opportunity to demonstrate meaningful use of EHR
technology. Therefore, for the purposes of qualifying for this
exception, a new CAH means a CAH that has operated (under previous or
present ownership) for less than 1 year.
In some cases an eligible hospital may convert to a CAH. An
eligible hospital is a subsection (d) hospital that is a meaningful
user and is paid under the inpatient hospital prospective payment
systems as described in subpart A of Part 412 of the regulations. In
these cases, eligible hospitals were able to qualify for purposes of
the EHR hospital incentive payments by establishing meaningful use, and
(as discussed previously) are also subject to a payment penalty
provision in FY 2015 and subsequent years if they fail to demonstrate
meaningful use of EHR technology during an applicable reporting period.
Therefore, we are proposing not to treat a CAH that has converted from
an eligible hospital as a newly established CAH for the purposes of
this exception.
On the other hand, other types of hospitals such as long-term care
hospitals, psychiatric hospitals, and inpatient rehabilitation
facilities are not subsection (d) hospitals. These other types of
hospitals do not meet the definition of an ``eligible hospital'' for
purposes of the Medicare EHR hospital incentive payments and the
application of the proposed hospital market basket adjustment in FY
2015 and subsequent years under section 1886(n)(6)(B) of the Act. In
some instances, a CAH may be converted from one of these types of
hospitals. In that case, the CAH would not have had an opportunity to
demonstrate meaningful use, and it is therefore appropriate to treat
them as newly established CAHs if they convert from one of these other
types of hospitals to a CAH for purposes of determining whether they
should qualify for an exception from the application of the adjustment
in FY 2015 and subsequent years. Thus, we are proposing to consider a
CAH that converts from one of these other types of hospitals to be a
newly established CAH for the purposes of qualifying for this proposed
exception from the application of the adjustment in FY 2015 and
subsequent years.
In summary, we propose for purposes of qualifying for the exception
to revise Sec. 413.70(a)(6)(ii) to state that a newly established CAH
means a CAH that has operated (under previous or present ownership) for
less than 1 year. We also propose to revise Sec. 413.70(a)(6)(ii) to
state that the following CAHs are not newly established CAHs for
purposes of this exception:
A CAH that builds new or replacement facilities at the
same or another location even if coincidental
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with a change of ownership, a change in management, or a lease
arrangement.