Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Modifications to Meaningful Use in 2015 Through 2017, 20345-20399 [2015-08514]
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Vol. 80
Wednesday,
No. 72
April 15, 2015
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
42 CFR Part 495
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program—Modifications to Meaningful Use in 2015 Through 2017;
Proposed Rule
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 495
[CMS–3311–P]
RIN 0938–AS58
Medicare and Medicaid Programs;
Electronic Health Record Incentive
Program—Modifications to Meaningful
Use in 2015 Through 2017
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
change the Medicare and Medicaid
Electronic Health Record (EHR)
Incentive Program EHR reporting period
in 2015 to a 90-day period aligned with
the calendar year, and also would align
the EHR reporting period in 2016 with
the calendar year. In addition, this
proposed rule would modify the patient
action measures in the Stage 2
objectives related to patient engagement.
Finally, it would streamline the program
by removing reporting requirements on
measures which have become
redundant, duplicative, or topped out
through advancements in EHR function
and provider performance for Stage 1
and Stage 2 of the Medicare and
Medicaid EHR Incentive Programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on June 15, 2015.
ADDRESSES: In commenting, please refer
to file code CMS–3311–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 https://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–
3311–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:
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SUMMARY:
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Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–
3311–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) 786–7195 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,
Medicare EHR Incentive Program and
Medicare payment adjustment.
Elisabeth Myers (CMS), (410) 786–
4751, Medicare EHR Incentive Program.
Thomas Romano (CMS), (410) 786–
0465, Medicaid EHR Incentive Program.
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: https://
www.regulations.gov. Follow the search
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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)
ACO—Accountable Care Organization
AIU—Adopt, Implement, Upgrade (certified
EHR Technology)
CAH—Critical Access Hospitals
CAHPS—Consumer Assessment of
Healthcare Providers and Systems
CCN—CMS Certification Number
CDC—Centers for Disease Control
CEHRT—Certified Electronic Health Record
Technology
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 and Medicaid
Services
CPOE—Computerized Physician Order Entry
CQM—Clinical Quality Measure
CY—Calendar Year
EHR—Electronic Health Record
EP—Eligible Professional
ePHI—Electronic Protected Health
Information
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
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 Resources and Services
Administration
IAPD—Implementation Advanced Planning
Document
ICR—Information Collection Requirement
IHS—Indian Health Service
IPA—Independent Practice Association
IPPS—Inpatient Prospective Payment System
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IQR—Inpatient Quality Reporting
IT—Information Technology
MA—Medicare Advantage
MAC—Medicare Administrative Contractor
MCO—Managed Care Organization
MITA—Medicaid Information Technology
Architecture
MMIS—Medicaid Management Information
Systems
MSA—Medical Savings Account
MU—Meaningful Use
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
NQF—National Quality Forum
ONC—Office of the National Coordinator for
Health Information Technology
PAHP—Prepaid Ambulatory Health Plan
PAPD—Planning Advanced 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
PQRS—Physician Quality Reporting System
PHI —Protected Health Information
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
I. Executive Summary and Background
A. Executive Summary
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1. Purpose of Regulatory Action
a. Need for Regulatory Action
In this proposed rule, we would
implement changes to Stage 1 and Stage
2 of the Medicare and Medicaid EHR
Incentive Programs. In the March 30,
2015 Federal Register (80 FR 16731
through 16804), we published in the
proposed rule for Stage 3 of meaningful
use which included changes to the
objectives and measures of meaningful
use for providers beginning in 2017.
These changes included removing
redundant, duplicative, and topped out
measures, and focusing the EHR
Incentive Programs on advanced use of
EHR technology. In order to reduce
reporting burden, eliminate redundant
and duplicative reporting, and to better
align the objectives and measures of
meaningful use for 2015 through 2017
with the proposed Stage 3 requirements
which would be optional in 2017 and
required beginning in 2018, we are
proposing to make similar modifications
to Stage 1 and Stage 2 of the EHR
Incentive Programs.
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In addition, in order to accommodate
these changes, we propose additional
modifications to the EHR reporting
period and timeline of the Medicare and
Medicaid EHR Incentive Programs in
2015 and 2016. We believe these
changes would better align reporting
periods for providers, support a flexible,
clear framework to reduce provider
burden, and ensure future sustainability
of 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 Technology
(CEHRT). 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, MA
organizations (for certain qualifying EPs
and hospitals that meaningfully use
CEHRT), subsection (d) hospitals, and
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 CEHRT 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 the statutory basis for the
EHR incentive payments, see the July
28, 2010 Stage 1 final rule (75 FR 44316
through 44317).)
2. Summary of Major Provisions
a. Aligning Meaningful Use in 2015
Through 2017 With the Stage 3
Proposals for Meaningful Use in 2017
and Subsequent Years
The Stage 1 final rule sets the
foundation for the Medicare and
Medicaid EHR Incentive Programs by
establishing requirements for the
electronic capture of clinical data,
including providing patients with
electronic copies of health information.
We outlined Stage 1 meaningful use
criteria, and finalized core and menu
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objectives for EPs, eligible hospitals,
and CAHs. (For a full discussion of the
objectives and measures of Stage 1, we
refer readers to the Stage 1 final rule at
75 FR 44313 through 44588.) In the
Stage 1 rulemaking, we discussed the
idea that alignment of stage of
meaningful use and payment year
should synchronize for all providers in
2015. However, while we stated a goal
to align the stages of meaningful use
across all providers in 2015 (75 FR
44322), we did not finalize such
changes in the Stage 2 final rule.
Furthermore, we stated in subsequent
rulemaking (see for example the 2014
CERHT Flexibility rule at 79 FR 52923
and 52596) that the requirements for
each stage for the program must be
informed by analysis of program data
related to performance and participation
milestones.
In the September 4, 2012 stage 2 final
rule, we maintained the same coremenu structure finalized for several
Stage 1 core and menu objectives. We
finalized that EPs must meet the
measure or qualify for an exclusion to
17 core objectives and 3 of 6 menu
objectives. We finalized that eligible
hospitals and CAHs must meet the
measure or qualify for an exclusion to
16 core objectives and 3 of 6 menu
objectives. We combined several Stage 1
measures into Stage 2. With the
experience providers gained from the
Stage 1 final rule, we also increased
functional objective measure thresholds
in Stage 2 to increase efficiency,
effectiveness, and flexibility. Also,
beginning in 2014, we finalized a set of
clinical quality measures (CQMs) for all
providers participating in any Stage of
the program to report to CMS. (For a full
discussion of the meaningful use
objectives and measures, and the CQMs
we finalized under Stage 2, we refer
readers to the Stage 2 final rule at 77 FR
53968 through 54162.)
In the Stage 3 proposed rule, we built
on the groundwork established in the
Stage 1 and Stage 2 final rules,
including continuing our goal started
under Stage 2 to increase
interoperability among providers. We
also proposed to make changes to the
Medicare and Medicaid EHR Incentive
Programs that simplify reporting
requirements and reduce program
complexity. These changes were
intended to balance the statutory
requirements in the HITECH Act with
responsiveness to providers expressing
confusion and concerns over increased
reporting burden related to the number
of program requirements, the multiple
stages of program participation, and the
timing of EHR reporting periods.
Therefore, we proposed for Stage 3 a
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single set of 8 objectives and related
measures to meet the definition of
meaningful use. We proposed that this
single set of 8 objectives would be
optional for 2017 and mandatory
beginning in 2018. Also, the Stage 3
proposed rule would move all providers
to an EHR reporting period of one full
calendar year, with a limited exception
for Medicaid providers demonstrating
meaningful use for the first time, to
support program alignment and simplify
reporting requirements among provider
types. The Stage 3 proposed rule and
the 2015 Edition Health Information
Technology (Health IT) Certification
Criteria, 2015 Edition Base Electronic
Health Record (EHR) Definition, and
ONC Health IT Certification Program
Modifications (hereinafter referenced as
the ‘‘2015 Edition proposed rule’’)
published by the Office of the National
Coordinator for Health Information
Technology (ONC) may be reviewed at
80 FR 16731 through 16804 and 80 FR
16804 through 1692, respectively. The
Stage 3 proposed rule would align the
stages of meaningful use across all
providers beginning in 2018.
In this proposed rule, we are seeking
to make changes to the requirements for
Stage 1 and Stage 2 of meaningful use
for 2015 through 2017 to align with the
approach for Stage 3 of meaningful use
in 2017 and subsequent years. The
analysis conducted during the planning
process for Stage 3 also allowed insight
into the progress toward program
milestones and provider performance on
the objectives and measures. This
analysis allowed us to identify an
approach to be responsive to
stakeholder concerns about program
complexity and revisit the consideration
that the stage of meaningful use and
EHR reporting periods should align
where possible. Therefore, we are
proposing a number of changes to both
the EHR reporting period, and to the
number of objectives and measures to
which a provider must attest to
demonstrate meaningful use.
Specifically, we are proposing to move
all providers to an EHR reporting period
based on the calendar year beginning in
2015. Also, we propose to align the
objectives and measures used in 2015
through 2017 with those identified in
the Stage 3 proposed rule for use in
2017 and subsequent years. This
includes a proposal that, beginning with
an EHR reporting period in 2015,
providers would no longer be required
to attest to certain objectives and
measures which have been identified
through our analysis to have reduced
utility because they may now be
redundant, duplicative, or ‘‘topped
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out’’. (For further discussion of this
selection process for Stage 3, we direct
readers to sections I.A.2. and II.A.2. of
the Stage 3 proposed rule at (80 FR
16733 through 16735 and 16767 through
16768, respectively). The related
selection process for the proposed
changes to meaningful use in 2015
through 2017 uses a similar approach to
reducing the reporting burden while
also seeking to meet our statutory
requirement to include more stringent
measures of meaningful use. Our
approach for applying these principals
for meaningful use in 2015 through
2017 is discussed in more detail in
section II.B.1.c. of this proposed rule.
period of any continuous 90-day period
between January 1, 2016 and December
31, 2016. However, all returning
participants would use an EHR
reporting period of a full calendar year
from January 1, 2016 through December
31, 2016. In 2017, all providers, both
new and existing participants, would
use an EHR reporting period of 1 full
calendar year as proposed in the Stage
3 proposed rule at (80 FR 16737 through
16739) with a limited exception for
Medicaid providers demonstrating
meaningful use for the first time.
b. EHR Reporting Period in 2015 and
2016
We are proposing to align the
definition of an EHR reporting period
with the calendar year for all providers
beginning in 2015 and continuing
through 2016 onward. Specifically, this
proposal would change the EHR
reporting period for eligible hospitals
and CAHs from a period based on the
fiscal year to the calendar year
beginning in 2015. This aligns with the
provision outlined in the Stage 3
proposed rule to move all providers to
an EHR reporting period of 1 full
calendar year beginning in 2017 with a
limited exception for Medicaid
providers demonstrating meaningful use
for the first time (80 FR 16734 and 80
FR 16737 through 16739). For 2015 and
2016, we are proposing to allow new
participants in the EHR Incentive
Program to attest to meaningful use for
an EHR reporting period of any
continuous 90-day period within the
calendar year. In addition, for 2015
only, we are proposing to allow all EPs
(regardless of their prior participation in
the program) to attest to an EHR
reporting period of any continuous 90day period within the calendar year. For
2015 only, we are proposing to allow
eligible hospitals and CAHs (regardless
of their prior participation in the
program) to attest to an EHR reporting
period of any continuous 90-day period
within the period beginning October 1,
2014 and the close of the 2015 calendar
year. This 90-day EHR reporting period
for 2015 would allow providers
additional time to address any
remaining issues with the
implementation of technology certified
to the 2014 Edition and to accommodate
the changes to the objectives and
measures of meaningful use proposed in
this rule.
In 2016, we propose EPs, eligible
hospitals, and CAHs that are
demonstrating meaningful use for the
first time may use an EHR reporting
In the Stage 3 proposed rule, we
outlined our method and approach for
identifying the objectives and measures
retained for Stage 3 of meaningful use
in 2017. We also identified those
objectives and measures which are now
redundant, duplicative, or topped out;
and therefore; would no longer be
required for the successful
demonstration of meaningful use for
Stage 3. For further discussion of this
approach, we refer readers to (80 FR
16733 through 16735 and 16767 through
16768).
In this proposed rule, we discuss how
we have used the same method to
identify objectives and measures from
Stages 1 and 2 of meaningful use which
we believe should no longer be required
for a provider to demonstrate
meaningful use in 2015 through 2017 as
these measures have been identified as
redundant, duplicative, or topped out.
These changes would remove the menu
and core structure of Stages 1 and 2 and
reduce the overall number of objectives
to which a provider must attest. We
discuss this approach in section II.B.1.c.
of this proposed rule.
In addition, we are proposing changes
to individual objectives and measures
for Stage 2 of meaningful use as follows:
• Changing the threshold from the
Stage 2 Objective for Patient Electronic
Access measure number 2 from ‘‘5
percent’’ to ‘‘equal to or greater than 1’’.
• Changing the threshold from the
Stage 2 Objective Secure Electronic
Messaging from being a percentagebased measure, to yes-no measure
stating the ‘‘functionality fully
enabled’’.
• Consolidating all public health
reporting objectives into one objective
with measure options following the
structure of the Stage 3 Public Health
Reporting Objective (80 FR 16745
through 16767).
• Changing the eligible hospital
electronic prescribing objective from a
‘‘menu’’ objective to a mandatory
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c. Meaningful Use Objectives and
Measures for 2015 Through 2017
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objective with an exclusion available for
certain eligible hospitals and CAHs.
These proposed changes would apply
for providers beginning with the EHR
reporting period in 2015. We note that
these proposals include provisions to
maintain the existing definitions for the
objectives and measures including
numerator and denominator calculation,
provisions to maintain measure
thresholds for 2015, and provisions to
allow exclusions for certain eligible
providers in 2015 in order to facilitate
the transition for providers already
engaged in the workflows, data capture
and measure calculation for meaningful
use for an EHR reporting period in 2015.
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d. Certification Requirements
Under this proposed rule, we are not
proposing changes to the individual
certification requirements for the
objectives and measures of meaningful
use for an EHR reporting period in 2015
through 2017. Until a transition to EHR
technology certified to the 2015 Edition
is required (proposed in the Stage 3
proposed rule beginning with an EHR
reporting period in 2018 at (80 FR 16767
and 16768), we are proposing that
providers would continue to use EHR
technology certified to the 2014 Edition
for an EHR reporting period in 2015,
2016, and 2017. As outlined in the Stage
3 proposed rule, providers may upgrade
early to EHR technology certified to the
2015 Edition for an EHR reporting
period prior to 2018. (For further
information on this, and to review the
applicable definition of CEHRT, we
direct readers to the Stage 3 proposed
rule at (80 FR 16767 and 16768).
e. Medicaid EHR Incentive Program in
2015 through 2017
The proposals included in this
proposed rule would also apply for the
Medicaid EHR Incentive Program,
including the proposed changes to the
EHR reporting period in 2015 and 2016,
and the objectives and measures
required to demonstrate meaningful use
in 2015 through 2017. Consistent with
the Stage 3 proposed rule, we propose
to continue to offer states flexibility
under the Medicaid EHR Incentive
Program for the public health reporting
objective. For meaningful use in 2015
through 2017, we would continue the
policy stated in the Stage 2 final rule (77
FR 53979) to allow states to 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
certification requirements specified
under the 2014 Edition certification
criteria). (For more information see the
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Stage 3 proposed rule (80 FR 16737
through 16739).)
and subsequent years to avoid Medicare
payment adjustments.
f. Clinical Quality Measurement
We are not proposing changes to the
CQM selection or reporting scheme (9 or
16 CQMs across at least 3 domains) from
the CQM requirements previously
established for all providers seeking to
demonstrate meaningful use in the
Medicare and Medicaid EHR Incentive
Programs defined in earlier rulemaking
(see, for example, 77 FR 54049 through
54089). For an EHR reporting period in
2015, and for providers demonstrating
meaningful use for the first time in
2016, we are proposing that providers
may—
• Attest to any continuous 90-day
period of CQM data during the calendar
year through the Medicare EHR
Incentive Program registration and
attestation site; or
• Electronically report CQM data
using the established methods for
electronic reporting.
For 2016 and subsequent years,
providers beyond their first year of
meaningful use may attest to one full
calendar year of CQM data or they may
electronically report their CQM data
using the established methods for
electronic reporting outlined in section
II.C. of this proposed rule.
h. Payment Adjustments and Hardship
Exceptions
We are proposing changes to the
definition of an EHR reporting period
for a payment adjustment at § 495.4 as
well as the attestation deadlines for
certain providers to demonstrate
meaningful use for an EHR reporting
period to avoid the Medicare payment
adjustment.
g. Demonstration of Meaningful Use
We are proposing 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 states for use in their
Medicaid programs. We are proposing to
continue the use of attestation as the
method for demonstrating that an EP,
eligible hospital, or CAH has met the
objectives and measures of meaningful
use. In lieu of individual Medicare EP
attestation through the CMS registration
and attestation system, we are proposing
to continue the existing optional batch
file process for attestation. We are
additionally proposing changes to the
attestation deadlines to accommodate
the proposed change to reporting based
on the calendar year for eligible
hospitals and CAHs beginning with an
EHR reporting period in 2015, as well as
the proposed change to a 90-day EHR
reporting period for all providers in
2015. We are proposing changes to the
attestation deadlines for new
meaningful EHR users in 2015 and 2016
to avoid the Medicare payment
adjustments in 2016 and 2017. Finally,
we are proposing an alternate attestation
option for certain Medicaid providers to
demonstrate meaningful use in 2015
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i. Summary of Cost Benefit Analysis
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). 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 regulatory impact analysis of this
proposed rule for modification to the
Medicare and Medicaid EHR Incentive
Programs from 2015 through 2017
outlines the reduction in the reporting
burden for providers demonstrating
meaningful use in 2015 and estimates
the total annual cost savings. The low
and high estimates for these total
savings are $52,547,132 and
$68,617,864 respectively. In addition to
these reductions, we believe there are
substantial cost savings accruing to
eligible hospitals and EPs related to
having additional time to achieve
meaningful use.
B. Overview of the Regulatory History
The American Recovery and
Reinvestment Act of 2009 (Pub. L. 111–
5)(ARRA) amended Titles XVIII and XIX
of the Act to authorize incentive
payments to EPs, eligible hospitals, and
CAHs, and MA organizations to promote
the adoption and meaningful use of
CEHRT. In the July 28, 2010 Federal
Register (75 FR 44313 through 44588),
we published a final rule (‘‘Medicare
and Medicaid Programs; Electronic
Health Record Incentive Program’’, or
‘‘Stage 1 final rule’’) 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. (For a full explanation of
the amendments made by ARRA, see the
Stage 1 final rule at 75 FR 44316.) In
that Stage 1 final rule, we also detailed
that the Medicare and Medicaid EHR
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Incentive Program would consist of
three different stages of meaningful use
requirements.
In the September 4, 2012 Federal
Register (77 FR 53967 through 54162),
we published a final rule (‘‘Medicare
and Medicaid Programs; Electronic
Health Record Incentive Program-Stage
2; Final Rule’’ or ‘‘Stage 2 final rule’’)
that specified the Stage 2 criteria that
EPs, eligible hospitals, and CAHs would
have to meet in order to qualify for
incentive payments. In addition, the
Stage 2 final rule finalized payment
adjustments and other program
participation requirements under
Medicare for covered professional and
hospital services provided by EPs,
eligible hospitals, and CAHs failing to
demonstrate meaningful use of CEHRT,
and finalized the revision of certain
Stage 1 criteria, and finalized criteria
that applied regardless of stage.
In the December 7, 2012 Federal
Register (77 FR 72985), CMS and ONC
jointly published an interim final rule
with comment period (IFC) titled
‘‘Health Information Technology:
Revisions to the 2014 Edition Electronic
Health Record Certification Criteria; and
Medicare and Medicaid Programs;
Revisions to the Electronic Health
Record Incentive Program’’ (December
7, 2012 IFC). The Department of Health
and Human Services (HHS) issued the
IFC to replace the Data Element Catalog
(DEC) standard and the Quality
Reporting Document Architecture
(QRDA) Category III standard adopted in
the final rule published on September 4,
2012 in the Federal Register with
updated versions of those standards.
The December 7, 2012 IFC also revised
the Medicare and Medicaid EHR
Incentive Programs by—
• Adding an alternative measure for
the Stage 2 meaningful use (MU)
objective for hospitals to provide
structured electronic laboratory results
to ambulatory providers;
• Correcting the regulation text for
the measures associated with the
objective for hospitals to provide
patients the ability to view online,
download, and transmit information
about a hospital admission; and
• Making the case number threshold
exemption for CQM reporting applicable
for eligible hospitals and CAHs
beginning with FY 2013.
The December 7, 2012 IFC also
provided notice of our intention to issue
technical corrections to the electronic
specifications for CQMs released on
October 25, 2012.
In the September 4, 2014 Federal
Register (79 FR 52910 through 52933)
CMS and ONC published a final rule
titled ‘‘Medicare and Medicaid
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Programs; Modifications to the Medicare
and Medicaid Electronic Health Record
(EHR) Incentive Program for 2014 and
Other Changes to the EHR Incentive
Program; and Health Information
Technology: Revisions to the Certified
EHR Technology Definition and EHR
Certification Changes Related to
Standards; Final Rule’’ (‘‘2014 CEHRT
Flexibility final rule’’). Due to issues
related to EHR technology certified to
the 2014 Edition availability delays, the
2014 CEHRT Flexibility final rule
included policies allowing EPs, eligible
hospitals, and CAHs that could not fully
implement EHR technology certified to
the 2014 Edition for an EHR reporting
period in 2014 to continue to use one
of the following options for reporting
periods in CY 2014 and FY 2014,
respectively—
• EHR technology certified to the
2011 Edition; or
• A combination of EHR technology
certified to the 2011 Edition and EHR
technology certified to the 2014 Edition
for the EHR reporting periods.
These CEHRT options applied only to
those providers that could not fully
implement EHR technology certified to
the 2014 Edition to meet meaningful use
for an EHR reporting period in 2014 due
to delays in 2014 Edition availability.
Although the 2014 CEHRT flexibility
final rule did not alter the attestation or
hardship exception application
deadlines for 2014, it did make changes
to the attestation process to support
these flexible options for CEHRT. This
2014 CEHRT Flexibility final rule also
discussed the provisions of the
December 7, 2012 IFC and finalized
policies relating to the provisions
contained in the December 7, 2012 IFC.
In the November 13, 2014 Federal
Register, we published an interim final
rule with comment period, under the
Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule, Clinical Laboratory Fee
Schedule, Access to Identifiable Data for
the Center for Medicare and Medicaid
Innovation Models & Other Revisions to
Part B for CY 2015 (79 FR 67976
through 67978) (‘‘November 13, 2014
IFC’’). Under this November 13, 2014
IFC, we recognized a hardship
exception for EPs and eligible hospitals
for 2014 under the established category
of extreme and uncontrollable
circumstances in accordance with the
Secretary’s discretionary authority. To
accommodate this hardship exception,
we further extended the hardship
application deadline for EPs and eligible
hospitals to November 30 for 2014 only.
We also amended the regulations to
allow CMS to specify a later hardship
application deadline for certain
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hardship categories for EPs, eligible
hospitals, and CAHs.
In the March 30, 2015 Federal
Register, we published a proposed rule
entitled ‘‘Medicare and Medicaid
Programs; Electronic Health Record
Incentive Program Stage 3’’ (80 FR
16731 through 16804). In this March 30,
2015 Stage 3 proposed rule, we
specified the proposed meaningful use
criteria that EPs, eligible hospitals, and
critical access hospitals must meet in
order to demonstrate meaningful use of
certified EHR technology for Stage 3 of
the EHR Incentive Programs. It also
specifies the proposed requirements for
electronic submission of CQMs and
creates a single set of meaningful use
requirements for Stage 3 which would
be optional for providers in 2017 and
required for all providers beginning in
2018. Finally, the Stage 3 proposed rule
would also change the EHR reporting
period so that all providers would
report under a calendar year timeline.
For Stages 1 and 2, CMS and the ONC
worked closely to ensure that the
definition of meaningful use of CEHRT
and the associated standards and
certification criteria were coordinated.
(Current ONC regulations may be found
at 45 CFR part 170.) For the Stage 3
proposed rule and the ONC 2015
Edition proposed rule, CMS and ONC
have aligned the proposed rules (80 FR
16731 through 16804 and 80 FR 16804
through 16921) and would again work
together to align the final regulations.
(Readers may also visit:
www.cms.hhs.gov/
EHRincentiveprograms and
www.healthit.gov for more information
on the efforts at the Department of
Health and Human Services (HHS) to
advance HIT initiatives.)
II. Provisions of the Proposed
Regulations
A. Introduction
When the EHR Incentive Program
began in 2011, the requirements for the
objectives and measures of meaningful
use were designed to begin a process
toward health care delivery system
transformation aligning with
foundational goals defined in the
HITECH Act. First, the statute requires
the Secretary to seek to improve the use
of EHR and health care quality over time
by requiring more stringent measures of
meaningful use (see section
1848(o)(2)(A)(iii) of the Act). To meet
this goal, we established stages of
meaningful use to move providers along
a progression from adoption to
advanced use of certified EHR
technology. Second, the statute includes
requirements for the use of EHR
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technology, which defines both the
functions that should be available
within the EHR and the purpose to
which those functions should be
applied. These requirements include
functions that are similar to the
following (see section 1848(o)(4) of the
Act)—
• The capacity to provide clinical
decision support;
• To support provider order entry;
• To capture and query information
relevant to health care quality; and
• To exchange protected health
information with, and integrate such
information from other sources.
The statute also defines key
foundational principles of meaningful
use such as electronic prescribing, the
electronic exchange of health
information to support the improvement
of care and care coordination, and the
use of EHR technology to submit
information on clinical quality measures
and other measures (see section
1848(o)(2)(A) of the Act).
Since the EHR Incentive Programs
began in 2011, a number of
environmental changes have occurred
which prompted us to reevaluate the
program requirements in relation to
progress toward goals. These changes
include a wide range of factors
including—
• Expansion of basic certified EHR
technology infrastructure;
• Advancements in EHR and related
health information technology;
• Widespread adoption of certain
standards and functionality;
• Increased use of CEHRT to support
quality improvement; and
• Performance on certain measures
reaching maximum potential.
The Certified Health IT Product List
(ONC CHPL) developed by ONC assists
providers in identifying certified EHR
technology products that have been
certified by an ONC-Authorized
Certification Body (ONC–ACB).
Certified EHR technology products,
certified to the 2014 Edition, are
required for use in the Medicare and
Medicaid EHR Incentive Programs to
meet meaningful use criteria for Stage 1
and 2 for an EHR reporting period in
2015. We reviewed data related to the
ONC CHPL as of March 20, 2015 and
found 1956 unique products that are
currently certified to the 2011 Edition
and 2157 unique products that are
certified to the 2014 Edition. A unique
product is a product that is certified and
receives a unique certification ID
(product updates and product version
changes are included in the unique
product count). Data from March 2013
to March 2015 shows an increase of 104
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percent in the total number of certified
EHR technology products and an
increase of 133 percent in total unique
certified EHR technology products in
the last 2 years alone. We believe the
increase in the number of certified EHR
technology products available is a
positive step for providers seeking to
meet meaningful use requirements and
advance EHR technology. The data
provided and additional information
related to the ONC CHPL may be found
on the HealthIT.gov Web site at https://
healthit.gov/chpl.
For a wide range of data and reports
on health IT adoption rates, use of
certification functions and standards,
updates to eCQM specifications and
testing, as well as the performance data
for providers in relation to the available
software, we direct readers to the ONC
Web site (https://www.healthit.gov), the
CMS eCQM Library (https://cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/eCQM_
Library.html), and the CMS EHR
Incentive Programs data and reports
Web site (https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAnd
Reports.html).
As the program has increased the
overall adoption of EHRs and as EHR
technology has automated certain
clinical functions and supported
standardized data capture, we propose
modifications, which would recognize
these changes and realign the program
with ongoing program goals. Our quality
reporting programs regularly reevaluate
measures based on factors like clinical
relevance, updates to electronic
specifications, and measure
performance. We consider modifications
to the objectives and measures of this
program similar to those regularly made
in our quality reporting programs.
In addition to these environmental
changes, stakeholder associations and
provider groups have through
correspondence, public forums, and
public comment requested that we
consider changes to the requirements to
demonstrate meaningful use of certified
EHR technology in the EHR Incentive
Programs which would reduce the
overall complexity of the program and
the burden on providers. We believe
some of these recommended changes
may contradict certain statutory
requirements for this program. For
example, certain provisions such as
electronic prescribing or health
information exchange cannot be fully
‘‘optional’’ because they are expressly
required under the statute (see section
1848(o)(2)(A) of the Act). The statutory
directive to require increasingly more
stringent measures of meaningful use
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20351
(see section 1848(o)(2)(A)(iii) of the Act)
prohibits the removal of all measure
thresholds. Further examples are also
discussed in the Stage 3 proposed rule
at (80 FR 16737 through 16742).
However, there are methods that
could be employed to modify Stages 1
and 2 of the program to address
stakeholder concerns, meet the statutory
requirements for the program defined in
the HITECH Act, and continue to
support progress toward the program’s
foundational goals. In addition, these
methods would move providers along a
continuum from data capture to
advanced use of certified EHR
technology including electronic
prescribing, health information
exchange, and quality improvement
with increasingly stringent measures as
identified in the Act and discussed in
section II.B.1.b. of this proposed rule.
Therefore, we are proposing
modifications to Stages 1 and 2 and are
seeking public comment on these
proposals, which are intended to be
responsive to the changing environment
and to stakeholder concern over
program complexity and redundant
reporting requirements. We propose
these modifications to address these
concerns and to continue to support the
overall goal of the widespread adoption
and meaningful use of EHR technology
in efforts to transform our health care
delivery system and improve health care
quality.
B. Meaningful Use Requirements for
EHR Reporting Periods in 2015 Through
2017
1. Definitions Across the Medicare Fee
for Service, Medicare Advantage, and
Medicaid Programs
a. Uniform Definitions
As discussed in prior rules, we
finalized several uniform definitions
applicable for the Medicare FFS,
Medicare Advantage, and Medicaid EHR
Incentive Programs. We set forth these
uniform definitions in part 495 subpart
A of the regulations. (For further
discussion of the uniform definitions
finalized previously, we refer readers to
the Stage 1 and Stage 2 final rules at 75
FR 44317 through 44321 and 77 FR
53972 respectively.) (For discussion of
the proposed changes to uniform
definitions outlined in the Stage 3
proposed rule, we refer readers to the
Stage 3 proposed rule at (80 FR 16736
through 16737).
In this proposed rule, we are
proposing to maintain the previously
finalized uniform definitions except as
stated in this proposed rule.
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b. Changes to Definitions for 2015
Through 2017
We are proposing changes to a
number of definitions previously
finalized for meaningful use in the Stage
1 and Stage 2 rules in order to modify
the program in response to the changing
health IT environment and related
stakeholder concerns. These changes
address the following:
• An overall simplification of the
program aligned to the overarching
goals of sustainability as discussed in
the Stage 3 proposed rule (80 FR 16737)
and in section II.B.1.b.(1). of this
proposed rule and a related change to
requirements necessary to accommodate
these changes outlined in section
II.B.1.b.(2) of this proposed rule.
• Moving all providers to an EHR
reporting period aligned with the
calendar year as outlined in section
II.B.1.b.(3).A. of this proposed rule.
• Providing flexibility for providers
in 2015 to accommodate the proposed
changes as outlined in section II.B.1.b of
this proposed rule.
• Removing requirements for
objectives and measures which are
redundant or duplicative or which have
‘‘topped out’’ as described at (80 FR
16767) of the Stage 3 proposed rule and
outlined in section II.B.1.c.(1). of this
proposed rule.
• Restructuring the remaining
measures and objectives to streamline
requirements for 2015 through 2017 and
to accommodate the changes for an EHR
reporting period in 2015 as outlined in
section II.B.1.c.(2). of this proposed rule.
• Refocusing the existing program on
building toward advanced use of EHR
technology, aligned with the Stage 3
proposed rule, through maintaining the
objectives and measures outlined in
section II.B.2. of this proposed rule.
(1) Stages of Meaningful Use
In the phased approach to meaningful
use, we finalized the criteria for
meaningful use through staggered
rulemaking, which covered Stages 1 and
2 of the EHR Incentive Program. (For
further explanation of the criteria we
finalized in Stages 1 and 2, we refer
readers to 75 FR 44314 through 44588,
77 FR 53968 through 54162, and 79 FR
52910 through 52933). The current
progression of the stages as finalized in
prior rulemaking is outlined in Table 1.
TABLE 1—STAGE OF MEANINGFUL USE CRITERIA BY FIRST PAYMENT YEAR
Stage of meaningful use
First payment year
2011
2011
2012
2013
2014
2015
2016
2017
......................................................................
......................................................................
......................................................................
......................................................................
......................................................................
......................................................................
......................................................................
In the Stage 3 proposed rule, we noted
our intent for Stage 3 to be the final
stage in meaningful use and that no
further stages would be developed. We
further proposed that all providers may
optionally move to Stage 3 in 2017, and
that all providers are required to move
to Stage 3 beginning in 2018 regardless
of their prior participation or stage of
meaningful use. (For further discussion
on this proposal, we direct readers to
(80 FR 16774).
In this proposed rule to modify Stages
1 and 2 for meaningful use in 2015
through 2017, we propose to further
reduce complexity in the program and
work toward this overall shift to a single
set of objectives and measures in Stage
3 in 2018. We propose to require all
providers to attest to a single set of
objectives and measures beginning with
2012
1
2013
1
1
2014
1
1
1
2015
1 or 2 * ........
1 or 2 * ........
1 * ................
1 * ................
an EHR reporting period in 2015. These
objectives and measures would leverage
existing objectives and measures of
meaningful use. Because this change
may occur after providers have already
begun their work toward meeting
meaningful use in 2015, we propose
accommodations within individual
objectives for providers in different
stages of meaningful use. These
accommodations include retaining the
different specifications between Stage 1
and Stage 2, and allowing special
exclusions for certain objectives or
measures for eligible providers
previously scheduled to participate in
Stage 1 for an EHR reporting period in
2015.
In this rule, we propose all providers
would be required to attest to certain
objectives and measures finalized in the
2016
2
2
2
1
1
2017
2
2
2
2
1
1
2018
3
3
3
2
2
1
1
2019
3
3
3
3
2
2
1
TBD
TBD
TBD
3
3
2
2
Stage 2 final rule, which would align
with those objectives and measures
proposed for Stage 3 of meaningful use.
In effect, this would create a new
progression using the existing objectives
and measures where providers attest to
a modified version of Stage 2 with
accommodations for Stage 1 providers
(equivalent to a reduced version of Stage
3) in 2015; a modified version of Stage
2 in 2016 (equivalent to a reduced
version of Stage 3); either a modified
version of Stage 2 (equivalent to a
reduced version of Stage 3) or the full
version of Stage 3 outlined in the Stage
3 proposed rule in 2017; and the full
version of Stage 3 outlined in the Stage
3 proposed rule beginning in 2018.
The revised timeline based on this
proposal and the Stage 3 proposed rule
is outlined in Table 2.
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TABLE 2—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR
First year as a
meaningful EHR
user
2011
2012
2013
2014
2015
........................
........................
........................
........................
........................
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2015
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Modified
Modified
Modified
Modified
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Stage
Stage
Stage
Stage
2016
2 ........................
2 ........................
2 ........................
2 * ......................
2 * ......................
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Modified
Modified
Modified
Modified
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Stage
Stage
Stage
Stage
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2
2
2
2
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........................
........................
........................
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Modified
Modified
Modified
Modified
Stage
Stage
Stage
Stage
Stage
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2
2
2
2
Or
Or
Or
Or
Or
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Stage
Stage
Stage
Stage
Stage
3
3
3
3
3
.....
.....
.....
.....
.....
Stage
Stage
Stage
Stage
Stage
3
3
3
3
3
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TABLE 2—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR—Continued
First year as a
meaningful EHR
user
Stage of meaningful use
2015
2016
2017
2016 ........................
- NA - ..........................................
Modified Stage 2 ........................
Modified Stage 2 Or Stage 3 .....
2018
Stage 3
* The Modifications to Stage 2 proposed in this rule include alternate exclusions and specifications for certain objectives and measures for providers that were scheduled to demonstrate Stage 1 of meaningful use in 2015.
For simplification and reader clarity,
we would therefore refer to the ‘‘Stage’’
designation in relation to the EHR
Incentive Program rules and to the
objectives and measures as follows:
• Meaningful use objectives and
measures for 2015 through 2017
• Stage 3 meaningful use objectives
and measures for 2017 and subsequent
years
This alignment of Stages 1 and 2 to
the proposals for Stage 3 essentially
creates a new paradigm for providers in
2015 through 2017. This includes a
simplified structure and focus on the
objectives and measures with
sustainable growth potential aligned to
the programs foundational goals prior to
the full implementation of Stage 3 in
2018. This change could alleviate the
need to include the option in 2017 to
allow providers to choose to
demonstrate Stage 3 of the program in
2017. To better understand the impact
and potential complexity, we seek
comment on whether or not we should
implement only the modifications
proposed in this rule from 2015 through
2017 and begin Stage 3 in 2018 without
an option year in 2017, or if we should
allow providers the option to
demonstrate Stage 3 beginning in 2017
as discussed in the Stage 3 proposed
rule (80 FR 16774).
We seek comment on these proposals.
(2) Meaningful EHR User
In the Stage 3 proposed rule (80 FR
16731 through 16804), we proposed to
modify the definition of ‘‘Meaningful
Current section designation
EHR User’’ in 42 CFR 495.4 to include
the Stage 3 objectives and measures
proposed at § 495.7. We further propose
to redesignate some of the numbering of
the regulation text under Part 495 to
more clearly identify which sections of
the regulation apply to specific years of
the program. This would allow more
direct references for the objectives and
measures, while also preserving the
content that applies for prior program
years. We note this numerical
redesignation would not affect the
content of the regulation text except
where noted in this proposed rule, nor
would it change the proposed objectives
and measures of Stage 3 of meaningful
use at (80 FR 16745 through 16767). The
redesignated numerical references for
the regulation text are as follows:
Proposed section redesignation
§ 495.6—Objectives and Measures ..........................................................
§ 495.7 *—Stage 3 Objectives and Measures ..........................................
§ 495.8—Demonstration of Meaningful Use .............................................
§ 495.10—Participation Requirements .....................................................
§ 495.20—Objectives and Measures Prior to 2015
§ 495.22—Objectives and Measures Beginning in 2015
§ 495.24—Stage 3 Objectives and Measures
§ 495.40—Demonstration of Meaningful Use
§ 495.60—Participation Requirements
* Indicates a new section that was proposed in the Stage 3 proposed rule.
In this proposed rule, we refer to
§ 495.20 for the objectives and measures
that apply for years prior to 2015,
§ 495.22 for the objectives and measures
proposed in this rule for 2015 through
2017, and § 495.24 for the objectives and
measures proposed in the Stage 3
proposed rule for 2017 and subsequent
years. Pending public comment and
agency review of these proposals, all
changes in Part 495 would be reconciled
through the final rule.
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(3) EHR Reporting Periods in 2015
Through 2017
In 42 CFR 495.4, we define an EHR
reporting period for eligible hospitals
and CAHs based on the federal fiscal
year (October 1 through September 30).
However, the fiscal year EHR reporting
period has resulted in varying reporting
timelines between provider types and a
shortened timeline for system
developers to meet hospital and CAH
technology needs. In the Stage 3
proposed rule, we outline changes to the
EHR reporting period beginning with
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the EHR reporting period in 2017 in
order to move eligible hospitals and
CAHs to EHR reporting periods based
on a calendar year. (For further
discussion of this proposal and the
relationship to program alignment with
quality reporting programs, we direct
readers to 80 FR 16739.)
In this proposed rule, our intent is to
modify the program to remove
redundant and duplicative measures;
reduce reporting burden for measures
that have ‘‘topped out’’ while preserving
the program’s foundational goals and
the requirement for stringent or robust
measurement; and better align the
existing program with other CMS
quality reporting programs. In order to
move these efforts forward and to
accommodate the proposed changes
beginning in 2015 while still allowing
providers time to complete an EHR
reporting period after the effective date
of a final rule, we are proposing changes
to the uniform definition of an ‘‘EHR
reporting period’’ in § 495.4 beginning
in 2015. We are also proposing similar
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changes to the definition of an ‘‘EHR
reporting period for a payment
adjustment year’’ in § 495.4 beginning in
2015 as discussed in section II.E.1. of
this proposed rule. We are proposing
changes to the attestation deadlines for
purposes of the incentive payments and
payment adjustments in section I.A.1.i.
of this proposed rule.
(a) Calendar Year Reporting Beginning
in 2015
Beginning in 2015, we are proposing
to change the definition of ‘‘EHR
reporting period’’ at § 495.4 for EPs,
eligible hospitals, and CAHs such that
the EHR reporting period would begin
and end in relation to a calendar year.
This change would allow eligible
hospitals and CAHs the same amount of
time as EPs from the release of a new
edition by ONC to the required date for
full implementation of the EHR
technology certified in accordance with
those criteria. In addition, this change
would allow providers additional time
to accommodate the changes proposed
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in this rule for demonstrating
meaningful use in 2015. Finally, this
change would align EHR reporting
periods for the EHR Incentive Program
with EHR reporting periods in CMS
quality reporting programs, which have
similar or related requirements.
In this proposal, all providers (EPs,
eligible hospitals, and CAHs) would be
required to complete an EHR reporting
period within January 1 and December
31 of the calendar year in order to
demonstrate meaningful use. In order to
accommodate eligible hospitals and
CAHs that may have planned their EHR
reporting period in 2015 during the
federal fiscal year and want to continue
to use that time period for reporting, we
propose for 2015 only these providers
may begin an EHR reporting period as
early as October 1 of 2014 and end by
December 31 of 2015. Beginning with
2016, the EHR reporting period must be
completed within January 1 and
December 31 of the calendar year.
We seek comment on this proposal.
(b) 90-Day EHR Reporting Period for All
Providers in 2015
In the 2014 CEHRT Flexibility rule
(79 FR 52919) we noted that many
commenters had requested a 90-day
EHR reporting period in 2015. In that
rule, we discussed the reasons we did
not propose or finalize a change to allow
for an EHR reporting period of 90 days
in 2015. We stated that we did not
finalize changes to the EHR reporting
period, because we believed such
changes were not necessary to mitigate
risk associated with the delay in the
availability of EHR technology certified
to the 2014 Edition (79 FR 52919). In
addition, we stated that such changes
would put the forward progress of the
program at risk, and potentially cause
further delay in implementing effective
health IT infrastructure and
misalignment with the CMS quality
reporting programs (79 FR 52919). We
maintain the assertion that the delay in
2014 Edition availability does not
necessitate changes to the EHR reporting
period 2015; and that the proposed
change to the EHR reporting period in
2015 in conjunction with the other
modifications to the EHR Incentive
Program proposed in this rule does
represent a potential risk to the
continued development of effective
health IT infrastructure.
Subsequent to the publication of the
2014 CEHRT Flexibility final rule, we
conducted a full analysis of provider
performance on Stage 1 and Stage 2
measures and identified areas where
measures were topped out or had
become redundant or duplicative based
on the widespread adoption of EHR
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technology certified to the 2014 Edition
and successful implementation of the
more complex Stage 2 objective
functions. We determined that there was
significant potential for a positive
impact through reducing the reporting
burden, simplifying the program, and
realigning the program with long term
goals for advanced use of EHRs.
However, in order to implement these
changes, a shortened EHR reporting
period would be necessary in 2015 to
allow both providers and CMS time to
make necessary changes to systems. We
believe the benefits to be gained from
the proposals in this rule outweigh the
potential risk of misalignment
introduced by the shortened reporting
period, if the risk is limited to only be
allowable for an EHR reporting period
in 2015. Therefore, we are proposing to
allow a 90-day EHR reporting period in
2015 only to accommodate
implementation of the other changes
proposed in this rule.
For 2015 only, we are proposing to
change the definition of ‘‘EHR reporting
period’’ at § 495.4 for EPs, eligible
hospitals, and CAHs such that the EHR
reporting period in 2015 would be any
continuous 90-day period within the
calendar year. We intend this change to
allow providers adequate time to plan
for any necessary changes to their
implementation of meaningful use
required in order to accommodate the
changes outlined in this proposed rule.
We further believe this change is
responsive to provider and stakeholder
feedback received through
correspondence, public forums, and
public comment, which requested that
we allow a 90-day EHR reporting period
in 2015 in order to provide flexibility
for continuing difficulties providers are
experiencing with successful
implementation of EHR technology
certified to the 2014 Edition.
We propose that for an EHR reporting
period in 2015, eligible professionals
may select an EHR reporting period of
any continuous 90-day period from
January 1, 2015 through December 31,
2015; while eligible hospitals and CAHs
may select an EHR reporting period of
any continuous 90-day period from
October 1, 2014 through December 31,
2015. This is intended to accommodate
the shift from reporting based on the
federal fiscal year to the calendar year
for eligible hospitals and CAHs.
In 2016, for eligible professionals,
eligible hospitals, and CAHs that have
not successfully demonstrated
meaningful use in a prior year and are
first-time participants in the program,
the EHR reporting period would be any
continuous 90-day period between
January 1, 2016 and December 31, 2016.
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However, for all returning participants
that have successfully demonstrated
meaningful use in a prior year, the EHR
reporting period would be a full
calendar year from January 1, 2016
through December 31, 2016. In 2017, the
EHR reporting period would be 1 full
calendar year for all providers, as
proposed in the Stage 3 proposed rule
(80 FR 16739).
We invite comment on these
proposals.
c. Definition of Meaningful Use
(1) Considerations in Defining
Meaningful Use
In order to update the definition of
meaningful use of certified EHR
technology and make modifications to
program requirements to reflect a
changing health IT environment, we
analyzed the existing objectives and
measures of meaningful use to consider
if they should be modified for the
program beginning in 2015. As outlined
in the Stage 3 proposed rule, we looked
at the set of potential objectives and
measures for inclusion in the program
for 2017 and subsequent years, and
sought to determine if they were
redundant, duplicative, or had reached
a performance level considered to be
‘‘topped out.’’ We stated that redundant
measures include those objectives
where there is now a viable health ITbased solution which may replace
paper-based actions and therefore a
provider should no longer be required to
also report on the objective where the
measures includes paper-based actions,
such as the Stage 2 Clinical Summary
objective (77 FR 53998 through 54002).
We stated that duplicative measures
include those objectives where a
measure which is also captured in the
course of meeting another objective,
such as recording vital signs which is
also a required part of the Consolidated
Clinical Document Architecture (C–
CDA) in the Summary of Care objective
(77 FR 54014 through 54016). Finally,
we stated that ‘‘topped out’’ measures
do not provide a meaningful gain in the
effort to improve the use of EHR and
health care quality over time by
requiring more stringent measures of
meaningful use. (For further discussion
of this approach to identifying the
objectives and measures for Stage 3, we
direct readers to (80 FR 16740 through
16744).
In this proposed rule, we have taken
a similar approach to review the current
objectives and measures of meaningful
use with a few additional
considerations. These included
reviewing the functions and standards
included the 2014 Edition when
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determining if a measure is redundant
or duplicative; and adding a review of
isolated performance rates for providers
in the first year of meaningful use in
addition to reviewing quartile
performance rates for topped out
measures. (For further discussion on
‘‘topped out’’ measures in the Stage 3
proposed rule, we direct readers to (80
FR 16741 and 16742). For further
information on the performance rates for
new participants as well as quartile
performance rates for individual
measures, we direct readers to the CMS
EHR Incentive Program Web site data
and reports page.1
Our analysis of the objectives and
measures of meaningful use Stages 1
and 2 identified a number of measures,
which meet these criteria as either
redundant, duplicative, or topped out
with new participants consistently
20355
performing at a statistically comparable
rate to returning participants. Table 3
identifies the current objectives and
measures which meet these criteria. We
are therefore proposing to no longer
require providers to attest to these
objectives and measures as currently
codified in the CFR under § 495.6 in
order to demonstrate meaningful use
beginning in 2015.
TABLE 3—OBJECTIVES AND MEASURES IDENTIFIED BY PROVIDER TYPE WHICH ARE REDUNDANT, DUPLICATIVE OR
TOPPED OUT
Provider type
Eligible Professional .............
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Eligible Hospital/CAH ...........
Objectives and measures
Record Demographics ....................................................
Record Vital Signs ..........................................................
Record Smoking Status ..................................................
Clinical Summaries .........................................................
Structured Lab Results ...................................................
Patient List ......................................................................
Patient Reminders ...........................................................
Summary of Care ............................................................
Measure 1—Any Method
Measure 3—Test
Electronic Notes ..............................................................
Imaging Results ..............................................................
Family Health History ......................................................
Record Demographics ....................................................
Record Vital Signs ..........................................................
Record Smoking Status ..................................................
Structured Lab Results ...................................................
Patient List ......................................................................
Summary of Care ............................................................
Measure 1—Any Method
Measure 3—Test
eMAR ..............................................................................
Advanced Directives .......................................................
Electronic Notes ..............................................................
Imaging Results ..............................................................
Family Health History ......................................................
Structure Labs to Ambulatory Providers .........................
42
42
42
42
42
42
42
42
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
(j)(3)(i) and (ii).
(j)(4)(i) and (ii).
(j)(5)(i) and (ii).
(j)(11)(i) and (ii).
(j)(7)(i) and (ii).
(j)(8)(i) and (ii).
(j)(9)(i) and (ii).
(j)(14)(i) and (ii).
42
42
42
42
42
42
42
42
42
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
(j)(9)(i) and (ii).
(k)(6)(i) and (ii).
(k)(2)(i) and (ii).
(l)(2)(i) and (ii).
(l)(3)(i) and (ii).
(l)(4)(i) and (ii).
(l)(6)(i) and (ii).
(l)(7)(i) and (ii).
(l)(11)(i) and (ii).
42
42
42
42
42
42
CFR
CFR
CFR
CFR
CFR
CFR
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
§ 495.6
(l)(16)(i) and (ii).
(m)(1)(i) and (ii).
(m)(2)(i) and (ii).
(m)(2)(i) and (ii).
(m)(3)(i) and (ii).
(m)(6)(i) and (ii).
We note that many of these objectives
and measures include actions that may
be valuable to providers and patients,
such as providing a clinical summary to
a patient after an office visit. We
encourage providers to continue to
conduct these activities as best suits
their practice and the preferences of
their patient population. The removal of
these measures is in no way intended as
a removal of endorsement of these best
practices or to discourage providers
from conducting and tracking these
activities for their own quality
improvement goal. Instead, we would
no longer require providers to calculate
and attest to the results of these
measures in order to demonstrate
meaningful use beginning in 2015.
We seek comment on this proposal.
(2) Changes to Definition of Meaningful
Use for 2015 Through 2017
In order to implement the proposed
changes to no longer require providers
to attest to their performance on the
identified objectives and measures and
to accomplish the related goal of
restructuring the program to align with
long-term goals, there are a number of
changes, which must be made to other
requirements of meaningful use. These
changes fall into the following two
major categories:
• Changes to streamline the structure
for 2015 through 2017 to align with the
proposed structure for Stage 3 of
meaningful use in 2017 and subsequent
years; and
• Changes to accommodate this shift
to allow providers to successfully
demonstrate meaningful use for an EHR
reporting period in 2015.
1 CMS EHR Incentive Programs Web site: ‘‘Data
and Reports’’ https://www.cms.gov/Regulations-
and-Guidance/Legislation/EHRIncentivePrograms/
DataAndReports.html.
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In addition, we have heard from
stakeholder associations and provider
representatives that providers have
faced significant challenges in
implementing the patient engagement
objectives, which require patient action.
These are outlined in the Stage 2 final
rule at 77 FR 54046 under the Health
Outcomes Policy Priority ‘‘Engage
patients and families in their care’’: The
Patient Electronic Access objective
Stage 2 measure 2 for more than 5
percent of patients to view, download or
transmit their health information; and,
the EPs secure electronic messaging
objective for more than 5 percent of
patients to send a secure message using
CEHRT. These concerns have included
both the barriers to successful
implementation of the required health
IT or CEHRT functions necessary to
support the measures and especially the
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secure transmission function; and the
challenges to effectively changing
patient behavior including patient IT
knowledge gaps, lack of widespread
access to technologies, and cultural
barriers among specific patient
populations. We recognize these
concerns and are proposing changes to
these objectives to allow providers to
focus on improvements without
jeopardizing their ability to successfully
demonstrate meaningful use. These
changes are outlined in section
II.B.1.c.(2).(c). of this proposed rule.
(a) Structural Requirements of
Meaningful Use in 2015 Through 2017
If we remove the requirement to attest
to the identified measures and
objectives, the distribution requirements
between menu and core objectives can
no longer be applicable. In addition,
stakeholder associations and provider
representatives have expressed through
correspondence, public forum, and
public comment on regulation that the
core and menu structure is
unnecessarily complex and a source of
confusion for providers. Therefore, we
propose to eliminate the distinction
between core and menu objectives, and
further propose that all retained
objectives and measures would be
required for the program. We note that
for Stage 1 providers, this means three
current menu objectives would now be
required; and for Stage 2 eligible
hospitals and CAHs, one current menu
objective would now be a required
objective. These objectives are as
follows:
• Stage 1 Menu: Perform Medication
Reconciliation
• Stage 1 Menu: Patient Specific
Educational Resources
• Stage 1 Menu: Public Health
Reporting Objectives (multiple
options)
• Stage 2 Menu Eligible Hospitals and
CAHs Only: Electronic Prescribing
We note that the objectives and
measures retained in each case for all
providers would be the Stage 2
objectives and measures; however, we
are proposing to establish alternate
exclusions and specifications to mitigate
any additional burden on providers for
an EHR reporting period in 2015. These
related proposals are discussed further
in section II.B.3.c.(2).(b). of this
proposed rule.
For the public health reporting
objectives and measures, we are
proposing to consolidate the different
Stage 2 core and menu objectives into a
single objective with multiple measure
options. We proposed this approach for
the Stage 3 public health reporting
objective as we believe it provides
greater flexibility for providers and
supports continued efforts to engage
providers and public health agencies in
the essential data capture and
information exchange which supports
quality improvement, emergency
response, and population health
management initiatives. For further
discussion of the rationale for the Stage
3 objective, we direct readers to (80 FR
16731 through 16804). We discuss the
proposal for the consolidated public
health reporting objective for
meaningful use in 2015 through 2017 in
section II.B.2.j. of this proposed rule.
We propose that EPs must select to
report on any combination of 2 of the 5
available options outlined in section
II.B.2.j. of this proposed rule and
eligible hospitals and CAHs must select
to report on any combination of 3 of the
6 available options in section II.B.2.j. of
this proposed rule. If a provider is
scheduled to attest to Stage 1 of
meaningful use in 2015, we propose to
allow these EPs in 2015 to select to
report on only 1 of the 5 available
options outlined in section II.B.2.j. of
this proposed rule and these eligible
hospitals and CAHs in 2015 to select to
report on any combination of 2 of the 6
available options in section II.B.2.j. of
this proposed rule.
Therefore, we propose that the
structure of meaningful use for 2015
through 2017 would be 9 required
objectives for EPs using the Stage 2
objectives for EPs with alternate
exclusions and specifications for Stage 1
providers in 2015. We propose that the
structure of meaningful use for 2015
through 2017 would be 8 required
objectives for eligible hospitals and
CAHs using the Stage 2 objectives for
eligible hospitals and CAHs with
alternate exclusions and specifications
for Stage 1 providers and some stage 2
providers in 2015. In addition, EPs
would be required to report on a total
of 2 measures from the public health
reporting objective or meet the criteria
for exclusion from up to 5 measures,
and eligible hospitals and CAHs would
be required to report on a total of 3
measures from the public health
reporting objective or meet the criteria
for exclusion from up to 6 measures. We
reiterate that the alternate exclusions
and specifications mentioned are further
defined in section II.B.1.c.(2).(b). of this
section of this proposed rule, and the
objectives and measures are defined in
section II.B.2. of this proposed rule.
TABLE 4—CURRENT STAGE STRUCTURE, RETAINED OBJECTIVES, AND PROPOSED STRUCTURE
Current stage 1
structure
EP .................................
EH/CAH ........................
EP .................................
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EH/CAH ........................
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Retained objectives
13 core objectives ..............................
5 of 9 menu objectives including 1
public health objective.
11 core objectives ..............................
5 of 10 menu objectives including 1
public health objective.
17 core objectives including public
health objectives.
3 of 6 menu objectives .......................
16 core objectives including public
health objectives.
3 of 6 menu objectives .......................
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6
3
2
5
3
3
9
0
4
7
1
3
core objectives ................................
menu objectives ..............................
public health objectives ...................
core objectives ................................
menu objectives ..............................
public health objectives ...................
core objectives ................................
menu objectives ..............................
public health objectives ...................
core objectives ................................
menu objective ................................
public health objectives ...................
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Proposed structure
9 core objectives.
1 public health objective
options).
8 core objectives.
1 public health objective
options).
9 core objectives.
1 public health objective
options).
8 core objectives.
1 public health objective
options).
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(b) Alternate Exclusions and
Specifications for Stage 1 Providers for
Meaningful Use in 2015
We are proposing several alternate
exclusions and specifications for
providers scheduled to demonstrate
Stage 1 of meaningful use in 2015,
which would allow these providers to
continue to demonstrate meaningful use
despite the proposals to use only the
Stage 2 objectives and measures
identified for meaningful use in 2015
through 2017. These provisions fall into
the following two major categories:
• Maintaining the specifications for
objectives and measures which have a
lower threshold or other measure
difference between Stage 1 and Stage 2.
• Establishing an exclusion for Stage
2 measures which do not have an
equivalent Stage 1 measure associated
with any Stage 1 objective or where the
provider did not plan to attest to the
menu objective which would now be
otherwise required.
For the first category, we propose that
providers who are scheduled to
demonstrate Stage 1 of meaningful use
for an EHR reporting period in 2015
may attest to meaningful use using the
specifications established for the Stage 1
objectives and measures defined at 42
CFR 495.6 for each retained objective or
measure where there is a difference in
specifications between Stages 1 and 2.
For example, in Stage 1 the electronic
prescribing objective for EPs requires
that ‘‘More than 40 percent of all
permissible prescriptions written by the
EP are transmitted electronically using
certified EHR technology’’ (75 FR
44338). While the Stage 2 electronic
prescribing objectives requires that
‘‘More than 50 percent of all permissible
prescriptions written by the EP are
compared to at least one drug formulary
and transmitted electronically using
Certified EHR Technology’’ (77 FR
53990). Therefore, we are proposing that
for an EHR reporting period in 2015,
providers scheduled to demonstrate
Stage 1 of meaningful use may attest
based on the specifications associated
with the Stage 1 measure. We note that
for an EHR reporting period beginning
in 2016, all providers must attest to the
specifications including the measure
thresholds associated with the Stage 2
measure. For an EHR reporting period in
2016, all providers, including those who
would otherwise be scheduled for Stage
1 in 2016, would be required to meet the
Stage 2 specifications with no alternate
exclusions.
For the second category, we note that
some objectives, such as the Patient
Electronic Access objective, have the
same requirements for one measure
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18:45 Apr 14, 2015
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(more than 50 percent of patients are
provided access to view, download, and
transmit their health information) for
both Stage 1 and Stage 2, but also have
an additional measure for Stage 2 (more
than 5 percent of patients view,
download, or transmit their health
information). Other objectives, such as
the Summary of Care objective, are
designated as a menu objective for Stage
1 but are a core objective for Stage 2 and
also may have additional measure
requirements in Stage 2 that are not
applicable for Stage 1 (77 FR 54013
through 54017). Finally, some objectives
consist of requirements from multiple
objectives from Stage 1 that were
consolidated into a single objective for
Stage 2 such as drug-drug and drugallergy decision support interventions.
For these consolidated objectives, all
providers would be required to attest to
the Stage 2 objective and measures. For
objectives where there is a measure that
is not equivalent between Stage 1 and
Stage 2 or where the objective moves
from menu to core between Stage 1 and
Stage 2, we propose to include an
exclusion for providers who were
scheduled to demonstrate Stage 1 of
meaningful use for the EHR reporting
period in 2015. For example, Stage 1
providers may exclude from the
requirement to send an electronic
summary of care record for more than
10 percent of transitions of care as
required in the Stage 2 Summary of Care
objective measure 2 (75 FR 44364).
These alternate exclusions and
specifications for certain objectives and
measures of meaningful use for an EHR
reporting period in 2015 are defined for
each objective and measure in the
description of each objective and
measure included in section II.B.2. of
this proposed rule.
We invite public comment on this
proposal.
(c) Changes to Patient Engagement
Requirements for 2015 Through 2017
Through correspondence, public
forums, and public comment on our
proposed regulations, stakeholders have
expressed concern that certain factors
like demographics, low utilization of
internet capable technology among their
patient population, or other external
barriers which are beyond their control
are impacting providers’ ability to meet
certain measures which require
providers to track patient action. In
addition, providers and system
developers have noted through similar
means an overall immaturity in the
market with health IT equipped with
the functions required to support the
transmission of health information by a
patient or the delivery of a secure
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20357
message from a patient to a third party.
Providers have indicated that while they
support the goal of improved patient
engagement, these issues are impacting
their ability to meet the measure
requirements. We note that data
obtained from provider attestations
shows performance on these measures is
concentrated around the median rate
(around 20 percent 2) which indicates
the potential for ongoing performance
that exceeds the existing threshold.
However, there is a wide variance at the
high and low ends, which indicates that
there may be external factors impacting
performance. Therefore, we are seeking
to mitigate these concerns by making
changes to the related measures. We
believe these changes would allow
providers the necessary time to work
toward patient education about the
availability of these resources as well as
allowing the industry as a whole time to
develop a stronger infrastructure
supporting patient engagement.
There are two objectives for EPs and
one objective for eligible hospitals and
CAHs, which specifically contain
measures requiring a provider to track
patient action. We propose to modify
these measures as follows:
• Patient Action To View, Download, or
Transmit Health Information
++ Remove the 5 percent threshold
for Measure 2 from the EP Stage 2
Patient Electronic Access (VDT)
objective. Instead require that at least 1
patient seen by the provider during the
EHR reporting period views, downloads,
or transmits his or her health
information to a third party. This would
demonstrate the capability is fully
enabled and workflows to support the
action have been established by the
provider.
++ Remove the 5 percent threshold
for Measure 2 from the eligible hospital
and CAH Stage 2 Patient Electronic
Access (VDT) objective. Instead require
that at least 1 patient discharged from
the hospital during the EHR reporting
period views, downloads, or transmits
his or her health information to a third
party. This would demonstrate the
capability is fully enabled and
workflows to support the action have
been established by the provider.
We seek comment on potential
alternate proposals for this proposed
change to the threshold for Measure 2 of
the Stage 2 Patient Electronic Access
objective. For example, we seek
2 CMS EHR Incentive Programs Web site: ‘‘Data
and Reports: Performance data through February
2015’’ https://www.cms.gov/Regulations-andGuidance/Legislation/EHRIncentivePrograms/
Downloads/AttestationPerformanceData_
Feb2015.pdf
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comment on potential alternates such as
a percentage threshold less than 5
percent, or a numerator greater than 10
patients, or another similar numerical
alternative. We further seek comment on
suggestions for other potential
alternatives which would accomplish
the goals here stated of reducing the
burden on providers to account for
patient actions while still continuing to
encourage IT supported patient
engagement.
mstockstill on DSK4VPTVN1PROD with PROPOSALS3
• Secure Electronic Messaging Using
CEHRT
++ Convert the measure for the Stage
2 EP Secure Electronic Messaging
objective from the 5 percent threshold to
a yes/no attestation to the statement:
‘‘The capability for patients to send and
receive a secure electronic message was
enabled during the EHR reporting
period’’.
These changes are reflected in the
discussion of these objectives in section
II.B.2. of this proposed rule. We note
that these changes are intended to allow
providers to work toward meaningful
patient engagement through health IT
using the methods best suited to their
practice and their patient population.
We further note that the Stage 3
proposed rule includes an objective
exclusively focused on patient
engagement with an expanded set of
measures and increased thresholds
which providers would be required to
meet beginning in 2018 (and optionally
in 2017). (For further information on
that proposed objective, we direct
readers to 80 FR 16755 through 16758.)
We invite public comment on this
proposal.
2. Meaningful Use Objectives and
Measures for 2015, 2016, and 2017
We propose the following objectives
and measures for EPs, eligible hospitals,
and CAHs to successfully demonstrate
meaningful use for an EHR reporting
period in 2015 through 2017. We note
that there are 9 proposed objectives for
EPs plus one consolidated public health
reporting objective, and 8 proposed
objectives for eligible hospitals and
CAHs plus one consolidated public
health reporting objective which would
be required with alternate exclusions for
certain providers in 2015 and which
would be mandatory for all providers
for an EHR reporting period beginning
in 2016.
a. Protect Electronic Health Information
We are proposing to retain with
certain modifications the Stage 2
objective and measure for Protect
Electronic Health Information for
meaningful use in 2015 through 2017.
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18:45 Apr 14, 2015
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(For further information and discussion
of the existing Stage 2 Protect Electronic
Health Information objective and
measure, please refer to 77 FR 54002
and 54003).
Proposed Objective: Protect electronic
health information created or
maintained by the CEHRT through the
implementation of appropriate technical
capabilities.
In the Stage 2 final rule (77 FR 54002
through 54003), we discussed the
benefits of safeguarding electronic
protected health information (ePHI), as
doing so is essential to all other aspects
of meaningful use. Unintended and
unlawful disclosures (or both) of ePHI
could diminish consumers’ confidence
in EHRs and health information
exchange. Ensuring that ePHI is
adequately protected and secured would
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 in 45 CFR
164.308(a)(1), including addressing the
security (to include encryption) of data
stored in Certified EHR Technology in
accordance with requirements in 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 EP, eligible hospital, or CAHs risk
management process.
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 refer providers to the
requirements in 45 CFR 164.308(a)(1),
including addressing the security (to
include encryption) of data at rest in
accordance with requirements in 45
CFR 164.312(a)(2)(iv) and 45 CFR
164.306(d)(3), of the HIPAA Security
Rule for compliance. The HHS Office for
Civil Rights (OCR) has issued guidance
on conducting a security risk analysis in
accordance with the HIPAA Security
Rule (https://www.hhs.gov/ocr/privacy/
hipaa/administrative/securityrule/
rafinalguidancepdf.pdf). Other free tools
and resources available to assist
providers include a Security Risk
Assessment (SRA) Tool developed by
ONC and OCR https://www.healthit.gov/
providers-professionals/security-riskassessment-tool.
The scope of the security risk analysis
for purposes of this meaningful use
measure applies to ePHI created or
maintained by CEHRT. However, we
note that other ePHI may be subject to
the HIPPA Rules and we refer providers
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to those rules for additional security
requirements.
We invite public comment on this
proposal.
b. Clinical Decision Support
We are proposing to retain the Stage
2 objective and measures for Clinical
Decision Support (CDS) for meaningful
use in 2015 through 2017. This is a
consolidated objective, which
incorporates the Stage 1 objective to
implement drug-drug and drug-allergy
interaction checks. (For further
information and discussion of the
existing consolidated Stage 2 CDS
objective and measures, please refer to
77 FR 53995 through 53998.)
Proposed Objective: Use clinical
decision support to improve
performance on high-priority health
conditions.
We propose to retain the Stage 2
clinical decision support (CDS)
objective such that CDS would be used
to improve performance on high-priority
health conditions. It would be left to the
provider’s clinical discretion to select
the most appropriate CDS interventions
for his or her patient population. CDS
interventions selected should be related
to four or more of the clinical quality
measures (CQMs) on which providers
would be expected to report. The goal
of the proposed CDS objective is for
providers to implement improvements
in clinical performance for high-priority
health conditions that would result in
improved patient outcomes. We propose
to maintain that providers must
implement the CDS 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.
Proposed Measure: In order for EPs,
eligible hospitals, and CAHs to meet the
objective they must satisfy both of the
following measures:
• Measure 1: Implement five clinical
decision support interventions related
to four or more clinical quality measures
at a relevant point in patient care for the
entire EHR reporting period. Absent
four clinical quality measures related to
an EP, eligible hospital or CAH’s scope
of practice or patient population, the
clinical decision support interventions
must be related to high-priority health
conditions.
• Measure 2: The EP, eligible
hospital, or CAH has enabled and
implemented the functionality for drugdrug and drug allergy interaction checks
for the entire EHR reporting period.
For the first measure, it is suggested
that one of the five clinical decision
support interventions be related to
improving healthcare efficiency.
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Exclusion: For the second measure,
any EP who writes fewer than 100
medication orders during the EHR
reporting period.
Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
We propose that providers who are
scheduled to demonstrate Stage 1 of
meaningful use for an EHR reporting
period in 2015 may attest to meaningful
use using the specifications established
for the Stage 1 objectives and measures
as they are currently defined at 42 CFR
495.6 for each retained objective or
measure where there is a difference in
specifications between Stages 1 and 2.
We note that the Stage 1 Clinical
Decision Support objective has a
different requirement than the Stage 2
Clinical Decision Support objective
measure 1 defined previously. For Stage
1, the objective reads ‘‘Implement one
clinical decision support rule relevant
to specialty or high clinical priority
along with the ability to track
compliance with that rule’’ for EPs and
‘‘Implement one clinical decision
support rule related to a high priority
hospital condition along with the ability
to track compliance with that rule’’ for
eligible hospitals and CAHs (42 CFR
495.6). Therefore, for an EHR reporting
period in 2015 only, we propose that an
EP, eligible hospital or CAH who is
scheduled to participate in Stage 1 in
2015 may satisfy the following Stage 1
measure instead of the Stage 2 measure
1 stated previously:
• Alternate Objective and Measure
(For Measure 1): Objective: Implement
one clinical decision support rule
relevant to specialty or high clinical
priority, or high priority hospital
condition, along with the ability to track
compliance with that rule. Measure:
Implement one clinical decision support
rule.
We propose that for an EHR reporting
period in 2015, an EP, eligible hospital
or CAH who is scheduled to participate
in Stage 1 in 2015 must also satisfy the
Stage 2 measure 2 previously stated
because it is the same as an existing
Stage 1 measure (77 FR 53998). There
are no alternate exclusions for this
objective.
We invite public comment on this
proposal.
c. Computerized Provider Order Entry
(CPOE)
We are proposing to retain the Stage
2 objective and measures for
Computerized Provider Order Entry
(CPOE) for meaningful use in 2015
through 2017, with the modifications
proposed here as alternate exclusions
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and specifications for Stage 1 providers
for an EHR reporting period in 2015.
(For further information and discussion
of the existing Stage 2 CPOE objective
and measures, please refer to 77 FR
53985 through 53987.)
Proposed Objective: Use
computerized provider order entry 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.
We 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.
Proposed Measures: In Stage 2 of
meaningful use, we adopted three
measures for this objective:
• Measure 1: More than 60 percent of
medication orders created by the EP or
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
recorded using computerized provider
order entry.
• Measure 2: More than 30 percent of
laboratory orders created by the EP or 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
recorded using computerized provider
order entry.
• Measure 3: More than 30 percent of
radiology orders created by the EP or 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
recorded using computerized provider
order entry. We propose to retain the
three measures of this current Stage 2
objective to calculate a percentage
threshold for all three types of orders:
Medication, laboratory, and radiology.
We propose to retain exclusionary
criteria for those providers who so
infrequently issue an order type that it
is not practical to implement CPOE for
that order type. To calculate the
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percentage, CMS and ONC have worked
together to define the following for this
objective:
• Measure 1:
Denominator: Number of medication
orders created by the EP or 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 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 orders during the
EHR reporting period.
• Measure 2:
Denominator: Number of laboratory
orders created by the EP or 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 recorded using CPOE.
Threshold: The resulting percentage
must be more than 30 percent in order
for an EP, eligible hospital or CAH to
meet this measure.
Exclusion: Any EP who writes fewer
than 100 laboratory orders during the
EHR reporting period.
• Measure 3:
Denominator: Number of radiology
orders created by the EP or 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 recorded using CPOE.
Threshold: The resulting percentage
must be more than 30 percent in order
for an EP, eligible hospital or CAH to
meet this measure.
Exclusion: Any EP who writes fewer
than 100 radiology orders during the
EHR reporting period.
An EP through a combination of
meeting the thresholds and exclusions
(or both) must satisfy all three measures
for this objective. A hospital must meet
the thresholds for all three measures.
Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
We propose that providers who are
scheduled to demonstrate Stage 1 of
meaningful use for an EHR reporting
period in 2015 may attest to meaningful
use using the specifications and
thresholds established for the Stage 1
objectives and measures as they are
currently defined at 42 CFR 495.6 for
each retained objective or measure
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where there is a difference in
specifications between Stages 1 and 2.
In the Stage 1 final rule, the CPOE
measure requires that ‘‘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’’ (75 FR 44334). In addition,
in the Stage 2 final rule, we established
an optional alternative to this measure
for Stage 1 of ‘‘More than 30 percent of
medication 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.’’ (77 FR 53988).
Therefore, we are proposing that for an
EHR reporting period in 2015, providers
scheduled to demonstrate Stage 1 of
meaningful use may attest to the
specification associated with the Stage 1
measure.
We further propose that providers
scheduled to demonstrate Stage 1 of
meaningful use for an EHR reporting
period in 2015 may claim an exclusion
for any retained Stage 2 measure where
there is not an equivalent Stage 1
measure currently defined at 42 CFR
495.6. The Stage 2 CPOE objective
includes measures for laboratory and
radiology orders, whereas the Stage 1
CPOE objective does not include these
measures. Thus, we propose that for an
EHR reporting period in 2015 only,
providers scheduled to demonstrate
Stage 1 of meaningful use in 2015 may
exclude the Stage 2 CPOE measures for
laboratory and radiology orders
(measures 2 and 3 listed previously). We
propose that for an EHR reporting
period beginning in 2016, all providers
must attest to the Stage 2 objective and
measures, and meet the thresholds
associated with all three of the Stage 2
measures discussed previously in order
to successfully demonstrate meaningful
use.
Alternate Measure 1: 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; or more than 30 percent of
medication orders created by the EP
during the EHR reporting period, or
created by the authorized providers of
the eligible hospital or CAH for patients
admitted to their inpatient or emergency
departments (POS 21 or 23) during the
EHR reporting period, are recorded
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using computerized provider order
entry.
Alternate Exclusion for Measure 2:
Provider may claim an exclusion for
measure 2 (laboratory orders) of the
Stage 2 CPOE objective for an EHR
reporting period in 2015.
Alternate Exclusion for Measure 3:
Provider may claim an exclusion for
measure 3 (radiology orders) of the
Stage 2 CPOE objective for an EHR
reporting period in 2015.
We invite public comment on this
proposal.
d. Electronic Prescribing
We are proposing to retain the Stage
2 objective and measure for Electronic
Prescribing (eRx) for EPs as well as for
eligible hospitals and CAHs for
meaningful use in 2015 through 2017.
We note that the Stage 2 objective for
eligible hospitals and CAHs is currently
a menu objective, but we propose it
would be required for 2015 through
2017, with an exception for Stage 1
eligible hospitals and CAHs for an EHR
reporting period in 2015. (For further
information and discussion of the
existing Stage 2 eRx objectives and
measures, please refer to 77 FR 53989
through 53990 for EPs and 77 FR 54035
through 54036 for eligible hospitals and
CAHs.)
(1) EP Proposed Objective
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, CEHRT
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 CEHRT 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.
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Proposed EP Measure: More than 50
percent of all permissible prescriptions,
or all prescriptions, written by the EP
are queried for a drug formulary and
transmitted electronically using
Certified EHR Technology.
We propose to retain the exclusion
introduced for Stage 2 that would allow
EPs to exclude this objective if no
pharmacies within 10 miles of an EP’s
practice location at the start of his/her
EHR reporting period accept electronic
prescriptions. This is 10 miles in any
straight line from the practice location
independent of the travel route from the
practice location to the pharmacy. We
stated that EPs practicing at multiple
locations would be eligible for the
exclusion if any of their practice
locations that are equipped with CEHRT
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
10 mile radius regardless of whether
that pharmacy can accept electronic
prescriptions from EPs outside of the
organization.
We also propose to retain the
exclusion for EPs who write fewer than
100 permissible prescriptions 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
prescriptions written for drugs requiring
a prescription in order to be dispensed
other than controlled substances during
the EHR reporting period; or Number of
prescriptions written for drugs requiring
a prescription in order to be dispensed
during the EHR reporting period.
Numerator: The number of
prescriptions in the denominator
generated, queried for a drug formulary
and transmitted electronically using
CEHRT.
Threshold: The resulting percentage
must be more than 50 percent in order
for an EP to meet this measure.
Exclusions: Any EP who:
• Writes fewer than 100 permissible
prescriptions during the EHR reporting
period; or
• Does not have a pharmacy within
his or her organization and there are no
pharmacies that accept electronic
prescriptions within 10 miles of the EP’s
practice location at the start of his or her
EHR reporting period.
Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
We propose that providers who are
scheduled to demonstrate Stage 1 of
meaningful use for an EHR reporting
period in 2015 may attest to meaningful
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use using the specifications established
for the Stage 1 objectives and measures
as they are currently defined at 42 CFR
495.6 for each retained objective or
measure where there is a difference in
specifications between Stages 1 and 2.
In Stage 1, the electronic prescribing
measure for EPs requires that ‘‘More
than 40 percent of all permissible
prescriptions written by the EP are
transmitted electronically using
certified EHR technology’’ (75 FR
44338).
Therefore, we are proposing that for
an EHR reporting period in 2015, EPs
scheduled to demonstrate Stage 1 of
meaningful use may attest to the
specifications and threshold associated
with the Stage 1 measure. We note that
for an EHR reporting period beginning
in 2016, all EPs must meet the
specifications and threshold for the
retained Stage 2 measure in order to
successfully demonstrate meaningful
use.
Alternate EP Measure: More than 40
percent of all permissible prescriptions
written by the EP are transmitted
electronically using Certified EHR
Technology.
There are no alternate exclusions for
this EP objective.
(2) Eligible Hospital/CAH Proposed
Objective
Proposed Eligible Hospital/CAH
Objective: Generate and transmit
permissible discharge prescriptions
electronically (eRx).
In the Stage 2 final rule at 77 FR
54035, we describe that 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, CEHRT
can provide support for a number of
purposes such as promoting safety and
quality in the form of decision support
around adverse interactions and other
treatment possibilities; increasing 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;
and reducing communication errors by
allows the pharmacy or a third party to
automatically compare the medication
order to others they have received for
the patient. This allows for many of the
same decision support functions
enabled at the generation of the
prescription, but with access to
potentially greater information. For this
reason, we continue to support the use
of electronic prescribing for discharge
prescriptions in a hospital setting.
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Proposed Eligible Hospital/CAH
Measure: More than 10 percent of
hospital discharge medication orders for
permissible prescriptions (for new,
changed and refilled prescriptions) are
queried for a drug formulary and
transmitted electronically using
Certified EHR Technology.
We propose to retain the exclusion
that would allow a hospital to exclude
this objective if there is no internal
pharmacy that can accept electronic
prescriptions and is not located within
10 miles of any pharmacy that accepts
electronic prescriptions at the start of
their EHR reporting period.
To calculate the percentage, CMS and
ONC have worked together to define the
following for this objective:
Denominator: Number of new,
changed, or refill 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, queried for 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 is not located within
10 miles of any pharmacy that accepts
electronic prescriptions at the start of
their EHR reporting period.
Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
We propose that eligible hospitals and
CAHs scheduled to report on Stage 1
objectives for an EHR reporting period
in 2015 may claim an exclusion for the
Stage 2 eRx measure as there is not an
equivalent Stage 1 measure defined at
42 CFR 495.6. We further propose that
eligible hospitals and CAHs scheduled
to report Stage 2 objectives for an EHR
reporting period in 2015 who were not
intending to attest to the eRx menu
objective and measure may also claim
an exclusion. We note that for an EHR
reporting period beginning in 2016, all
providers must attest to the objective
and measure and meet the specifications
and threshold for the Stage 2 measure in
order to successfully demonstrate
meaningful use.
Alternate Eligible Hospital/CAH
Exclusion: Provider may claim an
exclusion for the eRx objective and
measure if for an EHR reporting period
in 2015 they were either scheduled to
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demonstrate Stage 1 which does not
have an equivalent measure, or if they
are scheduled to demonstrate Stage 2
but did not intend to select the Stage 2
eRx menu objective for an EHR
reporting period in 2015.
There are no alternate specifications
for this eligible hospital and CAH
objective.
We invite public comment on this
proposal.
e. Summary of Care
We are proposing to retain only the
second measure of the existing Stage 2
objective for Summary of Care for
meaningful use in 2015 through 2017
with the modifications discussed in this
proposed rule. (For further information
and discussion of the existing Stage 2
Summary of Care objective and
measures, we refer readers to the
discussion in the Stage 2 final rule at 77
FR 54013 through 54021.)
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.
In the Stage 2 final rule, we outlined
the following benefits of this objective.
By assuring 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 in
the care of the referring provider.
Proposed Measure: The EP, eligible
hospital or CAH that transitions or
refers their patient to another setting of
care or provider of care that—(1) uses
CEHRT to create a summary of care
record; and (2) electronically transmits
such summary to a receiving provider
for more than 10 percent of transitions
of care and referrals.
We are proposing to retain an updated
version of the second measure of the
Stage 2 Summary of Care objective with
modifications based on guidance
provided through CMS responses to
frequently asked questions we have
received since the publication of the
Stage 2 final rule. We are proposing to
retain this measure for electronic
transmittal because we believe that the
electronic exchange of health
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information between providers would
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 in creating the
summary of care record can
significantly reduce the cost and
complexity of interfaces between
different systems and promote
widespread exchange and
interoperability.
The proposed updates to this measure
reflect stakeholder input regarding
operational challenges in meeting this
measure, and seek to increase flexibility
for providers while continuing to drive
interoperability across care settings and
encouraging further innovation.
Currently, the measure specifies the
manner in which the summary of care
must be electronically transmitted.
Providers must either—(1) electronically
transmit the summary of care using
CEHRT to a recipient; or (2) where the
recipient receives the summary of care
record via exchange facilitated by an
organization that is a NwHIN Exchange
participant or in a manner that is
consistent with the governance
mechanism ONC establishes for the
nationwide health information network.
We propose to update this measure to
state simply that a provider would be
required to create the summary of care
record using CEHRT and transmit the
summary of care record electronically.
To calculate the percentage of the
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
created using Certified EHR Technology
and is exchanged electronically.
Threshold: The percentage must be
more than 10 percent in order for an EP,
eligible hospital or CAH to meet this
measure.
Exclusion: Any EP who transfers a
patient to another setting or refers a
patient to another provider less than 100
times during the EHR reporting period.
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Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
We propose that providers scheduled
to demonstrate Stage 1 of meaningful
use for an EHR reporting period in 2015
may claim an exclusion for Measure 2
of the Stage 2 Summary of Care core
objective, as there is not an equivalent
Stage 1 measure. The measure related to
the electronic transmission of a
summary of care record in the Summary
of Care core objective requires an
electronic summary of care document to
be sent for transitions and referrals and
is only applicable for Stage 2. There is
not an equivalent objective and measure
in Stage 1. We note that for an EHR
reporting period beginning in 2016, all
providers must attest to the complete
objective and meet the specifications
and threshold for the both Stage 2
measures in order to successfully
demonstrate meaningful use.
Alternate Exclusion: Provider may
claim an exclusion for the measure of
the Stage 2 Summary of Care objective
which requires the electronic
transmission of a summary of care
document if for an EHR reporting period
in 2015 they were scheduled to
demonstrate Stage 1, which does not
have an equivalent measure.
There are no alternate specifications
for this objective.
We invite public comment on this
proposal.
f. Patient Specific Education
We are proposing to retain the Stage
2 objective and measure for Patient
Specific Education for meaningful use
for 2015 through 2017. (For further
information and discussion of the
existing Stage 2 Patient Specific
Education objective and measure, please
refer to 77 FR 54011 and 54012.)
Proposed Objective: Use clinically
relevant information from Certified EHR
Technology to identify patient-specific
education resources and provide those
resources to the patient.
In the Stage 2 proposed rule, we
explained that providing clinically
relevant education resources to patients
is a priority for the meaningful use of
CEHRT. While CEHRT must be used to
identify patient-specific education
resources, these resources or materials
do not have to be stored within or
generated by the CEHRT. We are aware
that there are many electronic resources
available for patient education
materials, such as through the National
Library of Medicine’s MedlinePlus
(https://www.nlm.nih.gov/medlineplus,
that can be queried via CEHRT (that is,
specific patient characteristics are
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linked to specific consumer health
content). The EP or hospital should
utilize CEHRT in a manner where the
technology suggests patient-specific
educational resources based on the
information stored in the CEHRT.
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 CEHRT 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).
Proposed EP Measure: Patient-specific
education resources identified by
Certified EHR Technology are provided
to patients for more than 10 percent of
all unique patients with office visits
seen by the EP during the EHR reporting
period.
We propose to retain the 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. 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 unique
patients with office visits seen by the EP
during the EHR reporting period.
Numerator: Number of patients in the
denominator who were provided
patient-specific education resources
identified by the 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 department (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
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together to define the following for this
objective:
Denominator: Number of unique
patients admitted to the eligible hospital
or CAH 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 CEHRT.
Threshold: The resulting percentage
must be more than 10 percent in order
for an eligible hospital or CAH to meet
this measure.
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Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
While the Patient Specific Education
objective is designated as an optional
menu objective in Stage 1 of meaningful
use, the same objective is a mandatory
core objective in Stage 2 of meaningful
use. We expect that not all Stage 1
scheduled providers were planning to
choose this menu objective when
attesting in an EHR reporting period in
2015. Therefore, we propose that any
provider scheduled to demonstrate
Stage 1 of meaningful use for an EHR
reporting period in 2015 who was not
intending to attest to the Stage 1 Patient
Specific Education menu objective, may
claim an exclusion to the measure. We
note that for an EHR reporting period
beginning in 2016, all providers must
attest to the objective and measure and
meet the Stage 2 specifications and
threshold in order to successfully
demonstrate meaningful use.
Alternate Exclusion: Provider may
claim an exclusion for the measure of
the Stage 2 Patient Specific Education
objective if for an EHR reporting period
in 2015 they were scheduled to
demonstrate Stage 1 but did not intend
to select the Stage 1 Patient Specific
Education menu objective.
There are no alternate specifications
for this objective.
We invite public comment on this
proposal.
g. Medication Reconciliation
We are proposing to retain the Stage
2 objective and measure for Medication
Reconciliation for meaningful use in
2015 through 2017. (For further
information and discussion of the
existing Stage 2 Medication
Reconciliation objective and measure,
please refer to 77 FR 54012 and 54013.)
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.
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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 his or her direct
patient care, it also improves the
accuracy of information they provide to
others through health information
exchange.
In the Stage 2 proposed rule, we noted
that 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. We reiterated 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. We defined
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.
Proposed Measure: The EP, eligible
hospital or CAH performs medication
reconciliation for more than 50 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).
For the purposes of this measure, 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 and
referrals are cases where one provider
refers a patient to another, but the
referring provider maintains his or her
care of the patient as well.
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 50 percent in order
for an EP, eligible hospital or CAH to
meet this measure.
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Exclusion: Any EP who was not the
recipient of any transitions of care
during the EHR reporting period.
Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
While the Medication Reconciliation
objective is designated as an optional
menu objective in Stage 1 of meaningful
use, the same objective is a mandatory
core objective in Stage 2 of meaningful
use. We expect that not all Stage 1
scheduled providers were planning to
choose this menu objective when
attesting in an EHR reporting period in
2015. Therefore, we propose that any
provider scheduled to demonstrate
Stage 1 of meaningful use for an EHR
reporting period in 2015 who was not
intending to attest to the Stage 1
Medication Reconciliation menu
objective, may claim an exclusion to the
measure. We note that for an EHR
reporting period beginning in 2016, all
providers must attest to the objective
and measure and meet the Stage 2
specifications and threshold in order to
successfully demonstrate meaningful
use.
Alternate Exclusion: Provider may
claim an exclusion for the measure of
the Stage 2 Medication Reconciliation
objective if for an EHR reporting period
in 2015 they were scheduled to
demonstrate Stage 1 but did not intend
to select the Stage 1 Medication
Reconciliation menu objective.
There are no alternate specifications
for this objective.
We invite public comment on this
proposal.
h. Patient Electronic Access (VDT)
We are proposing to retain the Stage
2 objective for Patient Electronic Access
for meaningful use in 2015 through
2017. We are proposing to retain the
first measure of the Stage 2 objective
without modification. We are proposing
to retain the second measure for the
Stage 2 objective with modification to
the measure threshold. (For further
information and discussion of the
existing Stage 2 Patient Electronic
Access objective and measures, please
refer to 77 FR 54007 through 54011.)
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.
Proposed Eligible Hospital/CAH
Objective: Provide patients the ability to
view online, download, and transmit
information about a hospital admission.
In the Stage 2 proposed rule, we
stated that the goal of this objective was
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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.
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.
The patient must be able to access this
information on demand, such as
through a patient portal or personal
health record (PHR). We note that while
a covered entity may be able to fully
satisfy a patient’s request for
information through VDT, the measure
does not replace the covered entity’s
responsibilities to meet the broader
requirements under HIPAA to provide
an individual, upon request, with access
to PHI in a designated record set.
Providers should also 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. Finally, we noted that
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.
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Proposed EP Measures
• EP Measure 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.
• EP Measure 2: At least one patient
seen by the EP during the EHR reporting
period (or their authorized
representatives) views, downloads, or
transmits his or her health information
to a third party.
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.
++ Current and past problem list.
++ Procedures.
++ Laboratory test results.
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++ Current medication list and
medication history.
++ Current medication allergy list and
medication allergy history.
++ Vital signs (height, weight, blood
pressure, BMI, growth charts).
++ Smoking status.
++ Demographic information
(preferred language, sex, race, ethnicity,
date of birth).
++ Care plan field(s), including goals
and instructions.
++ Any known care team members
including the primary care provider
(PCP) of record.
As we stated in the Stage 2 proposed
rule, this is not intended to limit the
information made available by the EP.
An EP can make available additional
information and still align with the
objective. 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.
Please note that while some of the
information made available through this
measure is similar to the information
made available in the summary of care
document that must be provided
following transitions of care or referrals,
the list of information provided is
specific to the view online, download,
and transmit objective. Patients and
providers have different information
needs and contexts, so we have
established separate required fields for
each of these objectives.
We propose to retain the exclusion
that any EP who neither orders nor
creates any of the information listed for
inclusion as part of this measure may
exclude from this measure as well as the
exclusion for limited broadband access
in an EPs service area.
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:
• EP Measure 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.
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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.
Threshold: The resulting percentage
must be more than 50 percent in order
for an EP to meet this measure.
• EP Measure 2: At least one patient
seen by the EP during the EHR reporting
period (or his or her authorized
representatives) views, downloads, or
transmits his or her health information
to a third party.
• Exclusions: Any EP who—
(a) Neither orders nor creates any of
the information listed for inclusion as
part of the measures; or
(b) 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.
Proposed Eligible Hospital/CAH
Measures:
• Eligible Hospital/CAH Measure 1:
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.
• Eligible Hospital/CAH Measure 2:
At least 1 patient who is discharged
from the inpatient or emergency
department (POS 21 or 23) of an eligible
hospital or CAH (or his or her
authorized representative) views,
downloads, or transmits to a third party
his or her information during the EHR
reporting period.
The following information must be
available to satisfy the objective and
measure:
++ Patient name.
++ Admit and discharge date and
location.
++ Reason for hospitalization.
++ Care team including the attending
of record as well as other providers of
care.
++ Procedures performed during
admission.
++ Current and past problem list.
++ Vital signs at discharge.
++ Laboratory test results (available at
time of discharge).
++ Summary of care record for
transitions of care or referrals to another
provider.
++ Care plan field(s), including goals
and instructions.
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++ Discharge instructions for patient.
++ Demographics maintained by
hospital (sex, race, ethnicity, date of
birth, preferred language).
++ Smoking status.
This is not intended to limit the
information made available by the
hospital. A hospital can make available
additional information and still align
with the objective. Please note that
while some of the information made
available through this measure is similar
to the information made available in the
summary of care document that must be
provided following transitions of care or
referrals, this list of information
provided is specific to the view online,
download, and transmit objective.
Patients and providers have different
information needs and contexts, so CMS
has established separate required fields
for each of these objectives.
To calculate the percentage of the first
measure for providing patients timely
access to discharge information, CMS
and ONC have worked together to
define the following for this objective:
• Eligible Hospital/CAH Measure 1:
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.
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.
• Eligible Hospital/CAH Measure 2:
At least 1 patient who is discharged
from the inpatient or emergency
department (POS 21 or 23) of an eligible
hospital or CAH (or his or her
authorized representative) views,
downloads, or transmits to a third party
his or her information during the EHR
reporting period.
• Exclusion: Any eligible hospital or
CAH that is located 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.
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Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
The Patient Electronic Access
objective has two associated measures,
the first (provide access to view,
download, and transmit health
information) is applicable for both Stage
1 and Stage 2 while the second (patients
view, download, or transmit their health
information) is only applicable for Stage
2. Therefore, we propose that providers
scheduled to demonstrate Stage 1 of
meaningful use for an EHR reporting
period in 2015 may additionally claim
an exclusion for the second measure of
the Stage 2 Patient Electronic Access
objective as there is not an equivalent
Stage 1 measure defined at 42 CFR
495.6. We note that for an EHR reporting
period beginning in 2016, all providers
must attest to the objective and both
measures and meet the specifications
and threshold associated with the
retained Stage 2 objective and measures
in order to successfully demonstrate
meaningful use.
• Alternate Exclusion Measure 2:
Provider may claim an exclusion for the
second measure if for an EHR reporting
period in 2015 they were scheduled to
demonstrate Stage 1, which does not
have an equivalent measure.
There are no alternate specifications
for this objective.
We invite public comment on this
proposal.
i. Secure Electronic Messaging
We are proposing to retain the Stage
2 objective for secure electronic
messaging with modifications to the
measure for meaningful use in 2015
through 2017. (For further information
and discussion of the existing Stage 2
secure electronic messaging objective
and measure, please refer to 77 FR
54033.)
Proposed Objective: Use secure
electronic messaging to communicate
with patients on relevant health
information.
In the Stage 2 proposed rule, we
outlined the following benefits of using
secure electronic messaging to
communicate with patients: Electronic
messaging (for example, email) is one of
the most widespread methods of
communication for both businesses and
individuals. The ability to communicate
through forms of electronic messaging is
essential to 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. However, common email services
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20365
may not be secure enough to be
appropriate for the exchange of ePHI.
Therefore, the exchange of ePHI through
electronic messaging requires additional
security measures while maintaining its
ease of use for communication. While
secure 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 standalone secure messaging applications.
For EPs, secure electronic messaging
is critically important to two National
Quality Strategy (NQS) priorities—
• Ensuring that each person/family is
engaged as partners in their care; and
• Promoting effective communication
and coordination of care.
Secure electronic messaging could
make care more affordable by using
more efficient communication vehicles
when appropriate. Specifically, research
demonstrates that secure messaging has
improved patient adherence to
treatment plans, which reduces
readmission rates. In addition, secure
messaging has led to increased patient
satisfaction with their care and is one of
the top ranked features according to
patients. In addition, despite some
trepidation, providers have seen a
reduction in time responding to
inquiries and less time spent on the
phone.3
Proposed Measure: During the EHR
reporting period, the capability for
patients to send and receive a secure
electronic message with the provider
was fully enabled.
We propose to retain the exclusion for
EPs who have no office visits, and for
those EPs who lack the infrastructure
required for secure electronic messaging
due to being located in areas with
limited broadband availability as
identified by the FCC.
Measure: During the EHR reporting
period, the capability for patients to
send and receive a secure electronic
message with the provider was fully
enabled.
Exclusion: Any EP who has no office
visits during the EHR reporting period,
3 Rosenberg SN, Shnaiden TL, Wegh AA, Juster
IA (2008) ‘‘Supporting the patient’s role in
guideline compliance: a controlled study’’
American Journal of Managed Care 14(11):737–44;
Gustafson DH, Hawkins R, Boberg E, Pingree S,
Serlin RE, Graziano F, Chan CL (1999) ‘‘Impact of
a patient-centered, computer-based health
information/support system’’ American Journal of
Preventive Medicine 16(1):1–9. Ralston JD, Carrell
D, Reid R, Anderson M, Moran M, Hereford J (2007)
‘‘Patient web services integrated with a shared
medical record: patient use and satisfaction’’
Journal of the American Medical Informatics
Association 14(6):798–806).
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or any EP who 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.
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Alternate Exclusions and Specifications
for Stage 1 Providers for Meaningful Use
in 2015
For the secure electronic messaging
objective, there is no Stage 1 objective
or measure which relates to the
requirements of the Stage 2 objective
and measure. We therefore propose that
an EP scheduled to demonstrate Stage 1
of meaningful use for an EHR reporting
period in 2015 may claim an exclusion
for the secure electronic messaging
objective measure as there is not an
equivalent Stage 1 objective or measure
defined at 42 CFR 495.6. We note that
for an EHR reporting period beginning
in 2016, all providers must attest to the
objective and measure of the retained
Stage 2 secure electronic messaging
objective in order to successfully
demonstrate meaningful use.
• Alternate Exclusion: An EP may
claim an exclusion for the measure if for
an EHR reporting period in 2015 they
were scheduled to demonstrate Stage 1,
which does not have an equivalent
measure.
There are no alternate specifications
for this objective and there is no
equivalent objective for eligible
hospitals and CAHs in the Stage 2
objectives and measures for meaningful
use.
We invite public comment on this
proposal.
j. Public Health and Clinical Data
Registry (CDR) Reporting
As mentioned previously, we are
proposing to adopt the consolidated
Stage 3 version of the public health
reporting objectives for all providers to
demonstrate meaningful use for an EHR
reporting period in 2015 through 2017.
We note that this change does not
fundamentally change a provider’s
ability to demonstrate meeting the
requirements of meaningful use with
any actions they may have already taken
or are in the progress of taking to meet
the prior requirements of meaningful
use defined in the Stage 1 and Stage 2
rules for public health reporting. These
requirements are currently defined at
(75 FR 44325 through 44326) for EPs
and (75 FR 44364 through 44368) for
eligible hospitals and CAHs in the Stage
1 final rule. In the Stage two final rule
the requirements may be found at (77
FR 54021 through 54026) for EPs and
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(77 FR 54029 through 54031) for eligible
hospitals and CAHs. We further note
that this change does not require the
addition of any new technology or
standard not already available in
CEHRT to demonstrate meaningful use
in 2014.
This objective is designed based on
the objective proposed in the Stage 3
proposed rule at which builds on the
requirements set forth in the Stage 2
final rule (see for example 77 FR 54047
through 54048 under the Health
Outcomes Policy Priority ‘‘Improve
population and public health’’). In the
Stage 3 proposed rule, we proposed
changes to the Stage 1 and Stage 2
public health and specialty registry
objectives to consolidate the prior
objectives and measures into a single
objective in alignment with efforts to
streamline the program and support
flexibility for providers (80 FR 16739
and 16740).
Proposed Objective: The EP, eligible
hospital, or CAH is in active
engagement with a Public Health
Agency (PHA) or clinical data registry
(CDR) to submit electronic public health
data in a meaningful way using certified
EHR technology, except where
prohibited and in accordance with
applicable law and practice.
In the Stage 3 proposed rule, we
highlighted our intention to remove the
prior ongoing submission requirement
and replace it with an ‘‘active
engagement’’ requirement. We believe
that ‘‘active engagement’’ as defined in
the Stage 3 rule at (80 FR 16739 and
16740) and reiterated in this section is
more aligned with the process providers
undertake to report to a clinical registry
or to a PHA.
For purposes of meeting this new
objective, EPs, eligible hospitals and
CAHs would be required to demonstrate
that ‘‘active engagement’’ with a PHA or
CDR has occurred. Active engagement
means that the provider is in the process
of moving towards sending ‘‘production
data’’ to a PHA or CDR, or— is sending
production data to a PHA or CDR. We
note that the term ‘‘production data’’
refers to data generated through clinical
processes involving patient care, and it
is here used to distinguish between this
data and ‘‘test data’’ which may be
submitted for the purposes of enrolling
in and testing electronic data transfers.
We propose that ‘‘active engagement’’
may be demonstrated by any of the
following options:
Active Engagement Option 1—
Completed Registration to Submit Data:
The EP, eligible hospital, or CAH
registered to submit data with the PHA
or, where applicable, the CDR to which
the information is being submitted;
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registration was completed within 60
days after the start of the EHR reporting
period; and the EP, eligible hospital, or
CAH is awaiting an invitation from the
PHA or CDR to begin testing and
validation. This option allows providers
to meet the measure when the PHA or
the CDR has limited resources to initiate
the testing and validation process.
Providers that have registered in
previous years do not need to submit an
additional registration to meet this
requirement for each EHR reporting
period.
Active Engagement Option 2—Testing
and Validation: The EP, eligible
hospital, or CAH is in the process of
testing and validation of the electronic
submission of data. Providers must
respond to requests from the PHA or,
where applicable, the CDR within 30
days; failure to respond twice within an
EHR reporting period would result in
that provider not meeting the measure.
Active Engagement Option 3—
Production: The EP, eligible hospital, or
CAH has completed testing and
validation of the electronic submission
and is electronically submitting
production data to the PHA or CDR.
We note that the change in definition
is intended to better capture the
activities a provider may conduct in
order to engage with a PHA or CDR, and
that any prior action taken to meet the
non-consolidated public health
reporting objectives of meaningful use
Stages 1 and 2 would count toward
meeting the active engagement
requirement of this objective.
Proposed Measures: We are proposing
a total of 6 possible measures for this
objective. For meaningful use in 2015
through 2017, EPs would be required to
choose from Measures 1 through 5, and
would be required to successfully attest
to any combination of two measures.
For meaningful use in 2015 through
2017, eligible hospitals and CAHs
would be required to choose from
Measures 1 through 6, and would be
required to successfully attest to any
combination of three measures. In 2015
only for providers scheduled to be in
Stage 1, EPs would be required to
choose from Measures 1 through 5, but
would be permitted to successfully
attest to one measure; and eligible
hospitals and CAHs would be required
to choose from Measures 1 through 6,
but would be permitted to successfully
attest to any combination of two
measures. The measures are as shown in
Table 5. As noted, measures 4 and 5 for
Public Health Registry Reporting and
Clinical Data Registry Reporting may be
counted more than once if more than
one Public Health Registry or Clinical
Data Registry is available.
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The measures are as follows:
TABLE 5—MEASURES FOR OBJECTIVE 8—PUBLIC HEALTH AND CLINICAL DATA REGISTRY REPORTING OBJECTIVE
Maximum times
measure can count
towards objective
for EP
Measure
Measure
Measure
Measure
Measure
Measure
Measure
1—Immunization Registry Reporting ........................................................................
2—Syndromic Surveillance Reporting ......................................................................
3—Case Reporting ...................................................................................................
4—Public Health Registry Reporting * ......................................................................
5—Clinical Data Registry Reporting ** .....................................................................
6—Electronic Reportable Laboratory Results ..........................................................
1
1
1
3
3
N/A
Maximum times
measure can count
towards objective
for eligible
hospital or CAH
1
1
1
4
4
1
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* EPs, eligible hospitals, and CAHs may choose to report to more than one public health registry (measure 4) to meet the number of measures
required to meet the objective.
** EPs, eligible hospitals, and CAHs may choose to report to more than one clinical data registry (measure 5) to meet the number of measures
required to meet the objective.
For EPs, we propose that an exclusion
for a measure does not count toward the
total of two measures. Instead, in order
to meet this objective an EP would need
to meet two of the total number of
measures available to them. If the EP
qualifies for multiple exclusions and the
remaining number of measures available
to the EP is less than two, the EP can
meet the objective by meeting the one
remaining measure available to them
and claiming the applicable exclusions.
If no measures remain available, the EP
can meet the objective by claiming
applicable exclusions for all measures.
An EP who is scheduled to be in Stage
1 in 2015 must report at least one
measure unless they can exclude from
all available measures. Available
measures include ones for which the EP
does not qualify for an exclusion.
For eligible hospitals and CAHs, we
propose that an exclusion for a measure
does not count toward the total of three
measures. Instead, in order to meet this
objective an eligible hospital or CAH
would need to meet three of the total
number of measures available to them.
If the eligible hospital or CAH qualifies
for multiple exclusions and the total
number of remaining measures available
to the eligible hospital or CAH is less
than three, the eligible hospital or CAH
can meet the objective by meeting all of
the remaining measures available to
them and claiming the applicable
exclusions. If no measures remain
available, the eligible hospital or CAH
can meet the objective by claiming
applicable exclusions for all measures.
An eligible hospital or CAH that is
scheduled to be in Stage 1 in 2015 must
report at least two measures unless they
can either—(1) exclude from all but one
available measure and report that one
measure; or (2) can exclude from all
available measures. Available measures
include ones for which the eligible
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hospital or CAH does not qualify for an
exclusion.
We note that we are proposing to
allow EPs, eligible hospitals, and CAHs
to choose to report to more than one
public health registry to meet the
number of measures required to meet
the objective. We are also proposing to
allow EPs, eligible hospitals, and CAHs
to choose to report to more than one
clinical data registry to meet the number
of measures required to meet the
objective. We believe that this flexibility
allows for EPs, eligible hospitals, and
CAHs to choose reporting options that
align with their practice and that would
aid the provider’s ability to care for their
patients.
To calculate the measures:
• Measure 1—Immunization Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement with a
public health agency to submit
immunization data and receive
immunization forecasts and histories
from the public health immunization
registry/immunization information
system (IIS).
We believe the immunization registry
reporting measure remains a priority for
the EHR Incentive Programs because the
exchange of information between
certified EHR technology and
immunization registries allows a
provider to use the most complete
immunization history available to
inform decisions about the vaccines a
patient may need. Public health
agencies and providers also use
immunization information for
emergency preparedness and to estimate
population immunization coverage
levels of certain vaccines.
We propose that to successfully meet
the requirements of this measure,
bidirectional data exchange between the
provider’s certified EHR technology
system and the immunization registry/
IIS is required. We understand that
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many states and local public health
jurisdictions are exchanging
immunization data bidirectionally with
providers, and that the number of states
and localities able to support
bidirectional exchange continues to
increase. In the 2015 Edition proposed
rule (80 FR 16851), the ONC is
proposing to adopt a bidirectional
exchange standard for reporting to
immunization registries/IIS. We believe
this functionality is important for
patient safety and improved care
because it allows for the provider to use
the most complete immunization record
possible to make decisions on whether
a patient needs a vaccine. Immunization
registries and health IT systems also are
able to provide immunization
forecasting functions which can inform
discussions between providers and
patients on what vaccines they may
need in the future and the timeline for
the receipt of such immunizations.
Therefore, we believe that patients,
providers, and the public health
community would benefit from
technology that can accommodate
bidirectional immunization data
exchange.
We welcome comment on this
proposal.
Exclusion: Any EP, eligible hospital,
or CAH meeting one or more of the
following criteria may be excluded from
the immunization registry reporting
measure if the EP, eligible hospital, or
CAH:
++ Does not administer any
immunizations to any of the
populations for which data is collected
by their jurisdiction’s immunization
registry or immunization information
system during the EHR reporting period;
++ Operates in a jurisdiction for
which no immunization registry or
immunization information system is
capable of accepting the specific
standards required to meet the CEHRT
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definition at the start of the EHR
reporting period; or
++ Operates in a jurisdiction where
no immunization registry or
immunization information system has
declared readiness to receive
immunization data from the EP, eligible
hospital or CAHs at the start of the EHR
reporting period.
• Measure 2—Syndromic
Surveillance Reporting: The EP, eligible
hospital or CAH is in active engagement
with a public health agency to submit
syndromic surveillance data from a nonurgent care ambulatory setting for EPs,
or an emergency or urgent care
department for eligible hospitals and
CAHs (POS 23).
This measure remains a policy
priority for the EHR Incentive Programs
because electronic syndromic
surveillance is valuable for early
detection of outbreaks, as well as
monitoring disease and condition
trends.
We are distinguishing between EPs
and eligible hospital or CAHs reporting
locations because as discussed in the
Stage 2 final rule, few PHAs appeared
to have the ability to accept nonemergency or non-urgent care
ambulatory syndromic surveillance data
electronically (77 FR 53979). We
continue to observe differences in the
infrastructure and current environments
for supporting electronic syndromic
surveillance data submission to PHAs
between eligible hospitals or CAHs and
EPs. Because eligible hospitals and
CAHs send syndromic surveillance data
using different methods as compared to
EPs, we are defining slightly different
exclusions for each setting as described
by the following:
Exclusion for EPs: Any EP meeting
one or more of the following criteria
may be excluded from the syndromic
surveillance reporting measure if the
EP—
++ Does not treat or diagnose or
directly treat any disease or condition
associated with a syndromic
surveillance system in his or her
jurisdiction;
++ Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic
syndromic surveillance data from EPs in
the specific standards required to meet
the CEHRT definition at the start of the
EHR reporting period; or
++ Operates in a jurisdiction where
no public health agency has declared
readiness to receive syndromic
surveillance data from EPs at the start of
the EHR reporting period.
Exclusion for eligible hospitals/CAHs:
Any eligible hospital or CAH meeting
one or more of the following criteria
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may be excluded from the syndromic
surveillance reporting measure if the
eligible hospital or CAH—
++ Does not have an emergency or
urgent care department;
++ Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic
syndromic surveillance data from
eligible hospitals or CAHs in the
specific standards required to meet the
CEHRT definition at the start of the EHR
reporting period; or
++ Operates in a jurisdiction where
no public health agency has declared
readiness to receive syndromic
surveillance data from eligible hospitals
or CAHs at the start of the EHR
reporting period.
• Measure 3—Case Reporting: The
EP, eligible hospital, or CAH is in active
engagement with a public health agency
to submit case reporting of reportable
conditions.
This is a new reporting option that
was not part of Stage 2. The collection
of electronic case reporting data greatly
improves reporting efficiencies between
providers and the PHA. Public health
agencies collect ‘‘reportable conditions’’
as defined by the state, territorial, and
local PHAs to monitor disease trends
and support the management of
outbreaks. In many circumstances, there
has been low reporting compliance
because providers do not know when,
where, or how to report. In some cases,
the time burden to report can also
contribute to low reporting compliance.
Electronic case reporting, however,
presents a core benefit to public health
improvement, and a variety of
stakeholders have identified electronic
case reporting as a high value element
of patient and continuity of care.
Further, we believe that electronic case
reporting reduces burdensome paperbased and labor intensive case
reporting. Electronic reporting would
support more rapid exchange of case
reporting information between PHAs
and providers and can include
structured questions or data fields to
prompt the provider to supply
additional required or care-relevant
information.
To support case reporting, the ONC
has proposed a certification criterion
that includes capabilities to enable
certified EHR systems to send initial
case reporting data and receive a request
from the public health agency for
supplemental or ad hoc structured data
in the 2015 Edition proposed rule (80
FR 16855).
Exclusion: Any EP, eligible hospital,
or CAH meeting one or more of the
following criteria may be excluded from
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the case reporting measure if the EP,
eligible hospital, or CAH:
++ Does not treat or diagnose any
reportable diseases for which data is
collected by their jurisdiction’s
reportable disease system during the
EHR reporting period;
++ Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic case
reporting data in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period;
or
++ Operates in a jurisdiction where
no public health agency has declared
readiness to receive electronic case
reporting data at the start of the EHR
reporting period.
• Measure 4—Public Health Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement with a
public health agency to submit data to
public health registries.
In the Stage 2 final rule, we were
purposefully general in our use of the
term ‘‘specialized registry’’ (other than a
cancer registry) to encompass both
registry reporting to public health
agencies and clinical data registries in
order to prevent inadvertent exclusion
of certain registries through an attempt
to be more specific (77 FR 54030). In
response to insight gained from the
industry through listening sessions,
public forums, and responses to a
Federal Register notice soliciting public
comments on the proposed information
collections to develop a centralized
repository on public health readiness to
support meaningful use (79 FR 7461);
we propose to carry forward the concept
behind this broad category from Stage 2,
but also propose to split public health
registry reporting from clinical data
registry reporting into two separate
measures which better define the
potential types of registries available for
reporting. We propose to define a
‘‘public health registry’’ as a registry
that is administered by, or on behalf of,
a local, state, territorial, or national PHA
and which collects data for public
health purposes. While immunization
registries are a type of public health
registry, we propose to keep
immunization registry reporting
separate from the public health registry
reporting measure to retain continuity
from Stage 1 and 2 policy in which
immunization registry reporting was a
distinct and separate objective (77 FR
54023). We believe it is important to
retain the public health registry
reporting option for Stage 3 because
these registries allow the public health
community to monitor health and
disease trends, and inform the
development of programs and policy for
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population and community health
improvement.
We reiterate that any EP, eligible
hospital, or CAH may report to more
than one public health registry to meet
the total number of required measures
for the objective. For example, if a
provider meets this measure through
reporting to both the National Hospital
Care Survey and the National
Healthcare Safety Network registry, the
provider could get credit for meeting
two measures. ONC would consider the
adoption of standards and
implementation guides in future
rulemaking. Should these subsequently
be finalized, they may then be adopted
as part of the certified EHR technology
definition as it relates to meeting the
public health registry reporting measure
through future rulemaking for the EHR
Incentive Programs.
We further note that ONC adopted
standards for ambulatory cancer case
reporting in its 2014 Edition final rule
(see § 170.314(f)(6)) and CMS provided
EPs the option to select the cancer case
reporting menu objective in the Stage 2
final rule (77 FR 54029 through 54030).
We included cancer registry reporting as
a separate objective from specialized
registry reporting because it was more
mature in its development than other
registry types, not because other
reporting was intended to be excluded
from meaningful use. For the Stage 3
public health agency reporting measure,
given the desire to provide more flexible
options for providers to report to the
registries most applicable for their scope
of practice, we propose that EPs would
have the option of counting cancer case
reporting under the public health
registry reporting measure. Under this
measure, we note that cancer case
reporting is not an option for eligible
hospitals and CAHs, because hospitals
have traditionally diagnosed and treated
cancers (or both) and have the
infrastructure needed to report cancer
cases.
Exclusions: Any EP, eligible hospital,
or CAH meeting at least one of the
following criteria may be excluded from
the public health registry reporting
measure if the EP, eligible hospital, or
CAH—
++ Does not diagnose or directly treat
any disease or condition associated with
a public health registry in their
jurisdiction during the EHR reporting
period;
++ Operates in a jurisdiction for
which no public health agency is
capable of accepting electronic registry
transactions in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period;
or
++ Operates in a jurisdiction where
no public health registry for which the
EP, eligible hospital, or CAH is eligible
has declared readiness to receive
electronic registry transactions at the
beginning of the EHR reporting period.
• Measure 5—Clinical Data Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement to submit
data to a clinical data registry.
As discussed in the Public Health
Registry Reporting measure, we propose
to split specialized registry reporting
into two separate, clearly defined
measures: Public health registry
reporting and clinical data registry
reporting. In Stage 2 for EPs, reporting
to specialized registries is a menu
objective and this menu objective
includes reporting to clinical data
registries. For Stage 3, we propose to
include clinical data registry reporting
as an independent measure. The
National Quality Registry Network
defines clinical data registries as those
that record information about the health
status of patients and the health care
they receive over varying periods of
time 4. We propose to further
differentiate between clinical data
registries and public health registries as
follows: For the purposes of meaningful
use, ‘‘public health registries’’ are those
administered by, or on behalf of, a local,
state, territorial, or national public
health agencies; and, ‘‘clinical data
registries’’ are administered by, or on
behalf of, other non-public health
agency entities. We believe that clinical
data registries are important for
providing information that can inform
patients and their providers on the best
course of treatment and for care
improvements, and can support
specialty reporting by developing
reporting for areas not usually covered
by PHAs but that are important to a
specialist’s provision of care. Clinical
data registries can also be used to
monitor health care quality and resource
use.
As noted previously, we reiterate that
any EP, eligible hospital, or CAH may
report to more than 1 clinical data
registry to meet the total number of
required measures for this objective.
ONC would consider the adoption of
standards and implementation guides in
future rulemaking. Should these
subsequently be finalized, they may
then be adopted as part of the certified
EHR technology definition as it relates
to meeting the clinical data registry
reporting measure through future
rulemaking for the EHR Incentive
Programs.
Exclusion: Any EP, eligible hospital,
or CAH meeting at least one of the
following criteria may be excluded from
the clinical data registry reporting
measure if the EP, eligible hospital, or
CAH—
++ Does not diagnose or directly treat
any disease or condition associated with
a clinical data registry in their
jurisdiction during the EHR reporting
period;
++ Operates in a jurisdiction for
which no clinical data registry is
capable of accepting electronic registry
transactions in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period;
or
++ Operates in a jurisdiction where
no clinical data registry for which the
EP, eligible hospital, or CAH is eligible
has declared readiness to receive
electronic registry transactions at the
beginning of the EHR reporting period.
• Measure 6—Electronic Reportable
Laboratory Result Reporting: The
eligible hospital or CAH is in active
engagement with a public health agency
to submit electronic reportable
laboratory results. This measure is
available to eligible hospitals and CAHs
only. Electronic reportable laboratory
result reporting to PHAs is required for
eligible hospitals and CAHs in Stage 2
(77 FR 54021). We propose to retain this
measure for the EHR Incentive Programs
to promote the exchange of laboratory
results between eligible hospitals/CAHs
and PHAs for improved timeliness,
reduction of manual data entry errors,
and more complete information.
Exclusion: Any eligible hospital or
CAH meeting one or more of the
following criteria may be excluded from
the electronic reportable laboratory
result reporting measure if the eligible
hospital or CAH—
++ Does not perform or order
laboratory tests that are reportable in
their jurisdiction during the EHR
reporting period;
++ Operates in a jurisdiction for
which no public health agency is
capable of accepting the specific ELR
standards required to meet the CEHRT
definition at the start of the EHR
reporting period; or
++ Operates in a jurisdiction where
no public health agency has declared
readiness to receive electronic
reportable laboratory results from
eligible hospitals or CAHs at the start of
the EHR reporting period.
4 https://download.ama-assn.org/resources/doc/
cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf
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We seek public comment on this
proposal.
TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017
Proposed objectives
for 2015, 2016 and
2017
Proposed measures for providers in 2015,
2016 and 2017
Proposed alternate measures, exclusions
and/or specifications for certain providers in
2015 ONLY
Eligible Professional ....
CPOE .........................
• Measure 1: More than 60 percent of medication orders created by the EP or 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 recorded using computerized provider order entry.
• Measure 2: More than 30 percent of laboratory orders created by the EP or 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 recorded using computerized provider order entry.
• Measure 3: More than 30 percent of radiology orders created by the EP or 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 recorded using computerized provider order entry.
Electronic Prescribing
EP Measure: More than 50 percent of all permissible prescriptions, or all prescriptions,
written by the EP are queried for a drug
formulary and transmitted electronically
using Certified EHR Technology.
Clinical Decision Support.
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Provider type
• Measure 1: Implement five clinical decision
support interventions related to four or
more clinical quality measures at a relevant
point in patient care for the entire EHR reporting period. Absent four clinical quality
measures related to an EP, eligible hospital
or CAH’s scope of practice or patient population, the clinical decision support interventions must be related to high-priority
health conditions. It is suggested that one
of the five clinical decision support interventions be related to improving healthcare
efficiency.
• Measure 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. Exclusion: For the second
measure, any EP who writes fewer than
100 medication orders during the EHR reporting period.
• EP Measure 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.
If for an EHR reporting period in 2015, the
provider is scheduled to demonstrate Stage
1:
• Alternate Measure 1: 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; or more than
30 percent of medication orders created by
the EP during the EHR reporting period, or
created by the authorized providers of the
eligible hospital or CAH for patients admitted to their inpatient or emergency departments (POS 21 or 23) during the EHR reporting period, are recorded using computerized provider order entry.
• Alternate Exclusion for Measure 2: Provider may claim an exclusion for measure
2 (laboratory orders) of the Stage 2 CPOE
objective for an EHR reporting period in
2015.
• Alternate Exclusion for Measure 3: Provider may claim an exclusion for measure
3 (radiology orders) of the Stage 2 CPOE
objective for an EHR reporting period in
2015.
If for an EHR reporting period in 2015, the
provider is scheduled to demonstrate Stage
1:
Alternate EP Measure: More than 40 percent
of all permissible prescriptions written by
the EP are transmitted electronically using
Certified EHR Technology.
If for an EHR reporting period in 2015, the
provider is scheduled to demonstrate Stage
1:
Alternate Objective and Measure 1:
Objective: Implement one clinical decision
support rule relevant to specialty or high
clinical priority, or high priority hospital condition, along with the ability to track compliance with that rule.
Measure: Implement one clinical decision
support rule.
Patient Electronic Access (VDT).
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Alternate Exclusion Measure 2: Provider may
claim an exclusion for the second measure
if for an EHR reporting period in 2015 they
were scheduled to demonstrate Stage 1,
which does not have an equivalent measure.
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TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
Provider type
Proposed objectives
for 2015, 2016 and
2017
Protect Electronic
Health Information.
Patient Specific Education.
Medication Reconciliation.
Summary of Care .......
Secure Messaging .....
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Public Health ..............
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Proposed measures for providers in 2015,
2016 and 2017
• EP Measure 2: At least one patient seen
by the EP during the EHR reporting period
(or their authorized representatives) views,
downloads, or transmits his or her health
information to a third party.
Measure: Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including
addressing the security (to include
encryption) of ePHI data stored in Certified
EHR Technology in accordance with requirements in 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 EP, eligible hospital, or CAHs risk management process.
EP Measure: Patient-specific education resources identified by Certified EHR Technology are provided to patients for more
than 10 percent of all unique patients with
office visits seen by the EP during the EHR
reporting period.
Measure: The EP, eligible hospital or CAH
performs medication reconciliation for more
than 50 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).
Measure: The EP, eligible hospital or CAH
that transitions or refers their patient to another setting of care or provider of care (1)
uses CEHRT to create a summary of care
record; and (2) electronically transmits
such summary to a receiving provider for
more than 10 percent of transitions of care
and referrals.
Measure: During the EHR reporting period,
the capability for patients to send and receive a secure electronic message with the
provider was fully enabled.
• Measure Option 1—Immunization Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement with a public
health agency to submit immunization data
and receive immunization forecasts and
histories from the public health immunization registry/immunization information system (IIS).
• Measure Option 2—Syndromic Surveillance Reporting: The EP, eligible hospital/,
or CAH is in active engagement with a
public health agency to submit syndromic
surveillance data from a non-urgent care
ambulatory setting for EPs, or an emergency or urgent care department for eligible hospitals and CAHs (POS 23).
• Measure Option 3—Case Reporting: The
EP, eligible hospital, or CAH is in active
engagement with a public health agency to
submit case reporting of reportable conditions.
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Proposed alternate measures, exclusions
and/or specifications for certain providers in
2015 ONLY
NONE.
Alternate Exclusion: Provider may claim an
exclusion for the measure of the Stage 2
Patient Specific Education objective if for
an EHR reporting period in 2015 they were
scheduled to demonstrate Stage 1 but did
not intend to select the Stage 1 Patient
Specific Education menu objective.
Alternate Exclusion: Provider may claim an
exclusion for the measure of the Stage 2
Medication Reconciliation objective if for an
EHR reporting period in 2015 they were
scheduled to demonstrate Stage 1 but did
not intend to select the Stage 1 Medication
Reconciliation menu objective.
Alternate Exclusion: Provider may claim an
exclusion for Measure 2 of the Stage 2
Summary of Care objective if for an EHR
reporting period in 2015 they were scheduled to demonstrate Stage 1, which does
not have an equivalent measure.
Alternate Exclusion: An EP may claim an exclusion for the measure if for an EHR reporting period in 2015 they were scheduled
to demonstrate Stage 1, which does not
have an equivalent measure.
NONE.
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TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
Provider type
Eligible Hospital/CAH ..
Proposed objectives
for 2015, 2016 and
2017
CPOE .........................
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Clinical Decision Support.
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Proposed measures for providers in 2015,
2016 and 2017
• Measure Option 4—Public Health Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement with a public
health agency to submit data to public
health registries.
• Measure Option 5—Clinical Data Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement to submit
data to a clinical data registry.
• Measure 1: More than 60 percent of medication orders created by the EP or 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 recorded using computerized provider order entry.
• Measure 2: More than 30 percent of laboratory orders created by the EP or 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 recorded using computerized provider order entry.
• Measure 3: More than 30 percent of radiology orders created by the EP or 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 recorded using computerized provider order entry.
• Measure 1: Implement five clinical decision
support interventions related to four or
more clinical quality measures at a relevant
point in patient care for the entire EHR reporting period. Absent four clinical quality
measures related to an EP, eligible hospital
or CAH’s scope of practice or patient population, the clinical decision support interventions must be related to high-priority
health conditions. It is suggested that one
of the five clinical decision support interventions be related to improving healthcare
efficiency.
• Measure 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. Exclusion: For the second
measure, any EP who writes fewer than
100 medication orders during the EHR reporting period.
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Proposed alternate measures, exclusions
and/or specifications for certain providers in
2015 ONLY
If for an EHR reporting period in 2015, the
provider is scheduled to demonstrate Stage
1:
• Alternate Measure 1: 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; or more than
30 percent of medication orders created by
the EP or created by the authorized providers of the eligible hospital or CAH for
patients admitted to their inpatient or emergency departments (POS 21 or 23) during
the EHR reporting period are recorded
using computerized provider order entry.
• Alternate Exclusion for Measure 2: Provider may claim an exclusion for measure
2 (laboratory orders) of the Stage 2 CPOE
objective for an EHR reporting period in
2015.
• Alternate Exclusion for Measure 3: Provider may claim an exclusion for measure
3 (radiology orders) of the Stage 2 CPOE
objective for an EHR reporting period in
2015.
If for an EHR reporting period in 2015, the
provider is scheduled to demonstrate Stage
1:
Alternate Measure 1: Implement one clinical
decision support rule. We propose that for
an EHR reporting period in 2015, an EP,
eligible hospital or CAH who is scheduled
to participate in Stage 1 in 2015 must also
satisfy the Stage 2 measure 2 previously
stated because it is the same as an existing Stage 1 measure (77 FR 53998). There
are no alternate exclusions for this objective.
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TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
Proposed objectives
for 2015, 2016 and
2017
Proposed measures for providers in 2015,
2016 and 2017
Proposed alternate measures, exclusions
and/or specifications for certain providers in
2015 ONLY
Patient Electronic Access (VDT).
Provider type
• Eligible Hospital/CAH Measure 1: 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.
• Eligible Hospital/CAH Measure 2: At least
1 patient who is discharged from the inpatient or emergency department (POS 21 or
23) of an eligible hospital or CAH (or his or
her authorized representative) views,
downloads, or transmits to a third party his
or her information during the EHR reporting
period.
Measure: Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1), including
addressing the security (to include
encryption) of ePHI data stored in Certified
EHR Technology in accordance with requirements in 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 EP, eligible hospital, or CAHs risk management process.
Eligible Hospital/CAH Measure: More than 10
percent of all unique patients admitted to
the eligible hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23) are
provided patient specific education resources identified by Certified EHR Technology.
Measure: The EP, eligible hospital or CAH
performs medication reconciliation for more
than 50 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).
Measure: The EP, eligible hospital or CAH
that transitions or refers their patient to another setting of care or provider of care (1)
uses CEHRT to create a summary of care
record; and (2) electronically transmits
such summary to a receiving provider for
more than 10 percent of transitions of care
and referrals.
Eligible Hospital/CAH Measure: More than 10
percent of hospital discharge medication
orders for permissible prescriptions (for
new, changed and refilled prescriptions)
are queried for a drug formulary and transmitted electronically using Certified EHR
Technology.
Alternate Exclusion Measure 2: Provider may
claim an exclusion for the second measure
if for an EHR reporting period in 2015 they
were scheduled to demonstrate Stage 1,
which does not have an equivalent measure.
Protect Electronic
Health Information.
Patient Specific Education.
Medication Reconciliation.
Summary of Care .......
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Electronic Prescribing
Public Health ..............
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• Measure Option 1—Immunization Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement with a public
health agency to submit immunization data
and receive immunization forecasts and
histories from the public health immunization registry/immunization information system (IIS).
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NONE.
Alternate Exclusion: Provider may claim an
exclusion for the measure of the Stage 2
Patient Specific Education objective if for
an EHR reporting period in 2015 they were
scheduled to demonstrate Stage 1 but did
not intend to select the Stage 1 Patient
Specific Education menu objective.
Alternate Exclusion: Provider may claim an
exclusion for the measure of the Stage 2
Medication Reconciliation objective if for an
EHR reporting period in 2015 they were
scheduled to demonstrate Stage 1 but did
not intend to select the Stage 1 Medication
Reconciliation menu objective.
Alternate Exclusion: Provider may claim an
exclusion for Measure 2 of the Stage 2
Summary of Care objective if for an EHR
reporting period in 2015 they were scheduled to demonstrate Stage 1, which does
not have an equivalent measure.
Alternate EH Exclusion: Measure Exclusion:
Provider may claim an exclusion for the
eRx objective and measure if for an EHR
reporting period in 2015 they were either
scheduled to demonstrate Stage 1 which
does not have an equivalent measure, or if
they are scheduled to demonstrate Stage 2
but did not intend to select the Stage 2
eRx menu objective for an EHR reporting
period in 2015.
NONE.
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TABLE 6—MEANINGFUL USES OBJECTIVES AND MEASURES FOR 2015 THROUGH 2017—Continued
Provider type
Proposed objectives
for 2015, 2016 and
2017
Proposed measures for providers in 2015,
2016 and 2017
Proposed alternate measures, exclusions
and/or specifications for certain providers in
2015 ONLY
• Measure Option 2—Syndromic Surveillance Reporting: The EP, eligible hospital/,
or CAH is in active engagement with a
public health agency to submit syndromic
surveillance data from a non-urgent care
ambulatory setting for EPs, or an emergency or urgent care department for eligible hospitals and CAHs (POS 23).
• Measure Option 3—Case Reporting: The
EP, eligible hospital, or CAH is in active
engagement with a public health agency to
submit case reporting of reportable conditions.
• Measure Option 4—Public Health Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement with a public
health agency to submit data to public
health registries
• Measure Option 5—Clinical Data Registry
Reporting: The EP, eligible hospital, or
CAH is in active engagement to submit
data to a clinical data registry.
• Measure Option 6—Electronic Reportable
Laboratory Result Reporting: The eligible
hospital or CAH is in active engagement
with a public health agency to submit electronic reportable laboratory results.
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3. Certified EHR Technology
Certified EHR technology is defined
for the Medicare and Medicaid EHR
Incentive Programs at 42 CFR 495.4,
which references ONC’s definition of
CEHRT in 45 CFR 170.102. The
definition establishes the requirements
for EHR technology that must be used
by providers to meet the meaningful use
objectives and measures. The Stage 2
final rule requires that CEHRT must be
used by EPs, eligible hospitals, and
CAHs to satisfy their CQM reporting
requirements in the Medicare and
Medicaid EHR Incentive Programs. In
addition, the CQM data reported to CMS
must originate from EHR technology
that is certified to ‘‘capture and export’’
in accordance with 45 CFR 170.314(c)(1)
and ‘‘electronic submission’’ in
accordance with 45 CFR 170.314(c)(3)
(77 FR 54053).
Rather than establishing a meaningful
use specific CEHRT definition for the
EHR Incentive Programs in the ONC
2015 Edition proposed rule, we instead
proposed to define the term ‘‘Certified
EHR Technology’’ in the Stage 3
proposed rule at § 495.4 (80 FR 16767
and 16768). This proposed change is
designed to simplify the overall
regulatory relationship between ONC
and CMS rules for stakeholders and to
ensure that relevant CMS policy for the
Medicare and Medicaid EHR Incentive
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Programs is clearly defined in CMS
regulations.
We are proposing no further changes
to the definition of CEHRT in this
proposed rule. We reiterate that
providers must use EHR technology
certified to the 2014 Edition for an EHR
reporting period in 2015. As proposed
in the Stage 3 proposed rule, providers
must use EHR technology certified at
least to the 2014 Edition in 2016 and
2017. Providers may adopt EHR
technology certified to the 2015 Edition
prior to the beginning of Stage 3 in 2017
or 2018, and that technology could be
used to satisfy the definition of CEHRT
under § 495.4 to demonstrate
meaningful use (80 FR 16767 through
16768).
4. Medicaid EHR Incentive Program in
2015 Through 2017
The proposals included in this
proposed rule would apply for
providers participating in the Medicaid
EHR Incentive Program in 2015 through
2017.
Consistent with both Stage 1 and 2,
we propose to continue to offer states
flexibility in the Medicaid EHR
Incentive Program for meaningful use in
2015 through 2017. This flexibility
would apply to the public health
reporting objective and measures where
we propose to continue to allow states
to specify the means of transmission of
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the data or otherwise change the public
health reporting objective and measures
as long as it does not require EHR
functionality above and beyond that
which is included in 45 CFR part 170
as stated in the Stage 2 final rule (77 FR
53979).
Finally, we propose to provide an
alternate attestation option for Medicaid
providers who are seeking to
demonstrate meaningful use to avoid
the Medicare payment adjustment and
who are prohibited from switching
between the Medicare and Medicaid
EHR incentive programs. For these
providers, we propose that they may use
the Medicare Registration and
Attestation system to attest to
meaningful use without switching
programs solely for the purposes of
avoiding the Medicare payment
adjustment. We are proposing this
alternate attestation option in response
to concerns about providers who
participate in the Medicaid EHR
Incentive Program; but, due to their
patient volume or another similar factor,
they are unable to attest to meaningful
use through their state Medicaid
program for a given year. If such a
provider uses the alternate attestation
option to demonstrate meaningful use
for an EHR reporting period, they may
avoid the Medicare payment adjustment
associated with that EHR reporting
period without switching out of the
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Medicaid EHR Incentive Program. This
option is discussed in further detail in
section II.D. of this proposed rule.
We invite public comment on these
proposals.
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C. Clinical Quality Measurement
Under sections
1848(o)(2)(A),1886(n)(3)(A), and
1814(l)(3)(A) of the Act and 42 CFR
495.4, EPs, eligible hospitals, and CAHs
must report on CQMs selected by CMS
using certified EHR technology, as part
of being a meaningful EHR user under
the Medicare and Medicaid EHR
Incentive Programs. In the Stage 2 final
rule, we outlined the CQMs available for
use in the EHR Incentive Programs
beginning in 2014 for EPs, eligible
hospitals, and CAHs at (77 FR 54057
through 54068 for EPs and 77 FR 54081
through 54087 for eligible hospitals/
CAHs) as well as the form and method
for submission at (77 FR 54076 through
54080 for EPs and 77 FR 54087 through
54089 for eligible hospitals/CAHs).
Following the publication of the Stage 2
final rule, we also established
requirements for reporting on CQMs
under the EHR Incentive Program in the
PFS and IPPS rules (see for example 79
FR 50319 through 50321 and 79 FR
67779). In sections II.B.1.a. and b. of the
preamble of the Stage 3 proposed rule,
we outlined the requirements for CQM
reporting for all providers for the EHR
Incentive Programs in 2017 and
subsequent years (80 FR 16768 and
16769) as well as the intent to continue
program alignment with other CMS
quality reporting programs in the IPPS
and PFS rules.
In this proposed rule for meaningful
use in 2015 through 2017, we are
proposing to maintain the existing
requirements established in earlier
rulemaking for the reporting of CQMs.
The options for CQM submission for
providers in the Medicare EHR
Incentive Program are as follows:
• EP Options for Medicare EHR
Incentive Program Participation (single
program participation)
++ Option 1: Attest to CQMs through
the EHR Registration & Attestation
System.
++ Option 2: Electronically report
CQMs through Physician Quality
Reporting System (PQRS) Portal.
• EP Options for Electronic Reporting
for Multiple Programs (for example:
EHR Incentive Program plus PQRS
participation)
++ Option 1: Report individual
eligible professionals’ CQMs through
PQRS Portal.
++ Option 2: Report group’s CQMs
through PQRS Portal.
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We note that under option 2, this may
include an EP reporting using the group
reporting option, either electronically
using QRDA, or via the GPRO Web
Interface through Pioneer ACO
participation.
• Eligible hospital and CAH Options
for Medicare EHR Incentive Program
Participation (single program
participation)
++ Option 1: Attest to CQMs through
the EHR Registration & Attestation
System.
++ Option 2: Electronically report
CQMs through QualityNet Portal.
• Eligible hospital and CAH Options
for Electronic Reporting for Multiple
Programs (for example: EHR Incentive
Program plus IQR participation)
++ Electronically report through
QualityNet Portal.
For the Medicaid EHR Incentive
Program, states would continue to be
responsible for determining whether
and how electronic reporting of CQMs
would occur, or if they wish to allow
reporting through attestation. Any
changes that states make to their CQM
reporting methods must be submitted
through the State Medicaid Health IT
Plan (SMHP) process for our review and
approval prior to being implemented.
We are also proposing to maintain the
existing CQM reporting requirements of
nine CQMs covering at least three NQS
domains for EPs and 16 CQMs covering
at least three NQS domains for eligible
hospitals and CAHs (77 FR 54058 for
EPs and 77 FR 54056 for eligible
hospitals and CAHs).
As discussed in section II.B.2(a) of
this proposed rule, beginning in 2015,
we are proposing to change the
definition of ‘‘EHR reporting period’’ in
§ 495.4 for eligible hospitals and CAHs
such that the EHR reporting period
would begin and end in relation to a
calendar year. In connection with this
proposal, we also propose that in 2015
and for all methods of reporting, eligible
hospitals and CAHs would be required
to complete a reporting period for
clinical quality measures aligned with
the calendar year in order to
demonstrate meaningful use. In order to
accommodate eligible hospitals and
CAHs that may have planned their
clinical quality measure reporting in
2015 based on the federal fiscal year, we
propose for 2015 only that eligible
hospitals and CAHs that are submitting
CQMs via attestation, may begin a
reporting period as early as October 1 of
2014 and end by December 31 of 2015.
Eligible hospitals and CAHs submitting
CQMs via electronic reporting must
meet the requirements established in the
FY 2015 final rule (79 FR 50319 through
50321).
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20375
As discussed in section II.B.1.b.(3). of
this proposed rule, for 2015 only, we are
proposing to change the EHR reporting
period for all EPs, eligible hospitals, and
CAHs to any continuous 90-day period
within the calendar year. In connection
with this proposal, we also propose a
90-day reporting period for clinical
quality measures for all EPs, eligible
hospitals, and CAHs that report clinical
quality measures by attestation. We are
proposing eligible professionals may
select any continuous 90-day period
from January 1, 2015 through December
31, 2015, while eligible hospitals and
CAHs may select any continuous 90-day
period from October 1, 2014 through
December 31, 2015, to report CQMs via
attestation using the EHR Incentive
Program registration and attestation
system. In accordance with our existing
policy, it is acceptable for a provider to
use a continuous 90-day reporting
period for CQMs even if it is different
from their continuous 90-day EHR
reporting period for the meaningful use
objectives and measures if that provider
is reporting via attestation. We also
propose that a provider may choose to
attest to a CQM reporting period of
greater than 90-days up to and including
1 full calendar year of data.
We further propose to continue our
existing policy that providers in any
year of participation for the EHR
Incentive Programs for 2015 through
2017 may instead electronically report
CQM data using the options previously
outlined for electronic reporting either
for single program participation in the
Medicare EHR Incentive Programs, or
for participation in multiple programs if
the requirements of the aligned quality
program are met.
We note that EPs seeking to
participate in multiple programs with a
single electronic submission would be
required to submit a full calendar year
of CQM data using the 2014 electronic
specifications for the CQMs (which are
also known as eCQMs) for a reporting
period in 2015. These specifications
include the annual updates released in
June of 2014 and are available at the
CMS eCQMs Library (https://cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/eCQM_
Library.html)
Eligible hospitals and CAHs seeking
to participate in multiple programs with
a single electronic submission for a
reporting period in 2015 would be
required to submit 1 calendar quarter of
data for 2015 from either Q1 (January 1,
2015–March 31, 2015), Q2 (April 1,
2015 June 30, 2015), or Q3 (July 1,
2015–September 30, 2015) and would
require of the use of the April 2014
release of the eCQMs available at the
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CMS eCQM Library (https://cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/eCQM_
Library.html). For further information,
we direct readers to the FY 2015 IPPS
final rule at 79 FR 50319 through 50321.
We note that an EHR certified for
CQMs under the 2014 Edition
certification criteria does not need to be
recertified each time it is updated to a
more recent version of the eCQMs. (For
further information on CQM reporting,
we direct readers to the EHR Incentive
Program Web site where guides and tip
sheets are available for each reporting
option (www.CMS.gov/
ehrincentiveprograms)).
We invite public comment on this
proposal.
D. Demonstration of Meaningful Use for
2015 Through 2017
1. Common Methods of Demonstration
in Medicare and Medicaid
We are proposing 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.
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2. Methods for Demonstration of the
Criteria for Meaningful Use in 2015
Through 2017
As mentioned previously in section
II.B.2. of this proposed rule, we are
redesignating the numbering of certain
sections of the regulation text under 42
CFR part 495. In prior rules, we defined
the criteria for the demonstration of
meaningful use at 42 CFR 495.8, which
would be redesignated as § 495.40. In
this proposed rule, we define the
criteria for the demonstration of
meaningful use at § 495.40 including
references to the objectives and
measures of meaningful use as well as
the requirement to report CQMs. In
order to demonstrate meaningful use in
2015 through 2017, we are proposing
that the requirements at § 495.40
include a reference to the objectives and
measures of meaningful use for 2015
through 2017 outlined at § 495.22 which
the provider must satisfy.
We are proposing to continue the use
of attestation as the method for
demonstrating that an EP, eligible
hospital, or CAH has met the objectives
and measures of meaningful use. Instead
of individual Medicare EP attestation
through the CMS Registration and
Attestation System, we are also
proposing to continue the existing
optional batch file process for
attestation. Further, we are proposing
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changes to the deadlines for EPs,
eligible hospitals, and CAHs to
demonstrate meaningful use in 2015
and 2016; as well as specific changes to
the deadlines for providers to
demonstrate meaningful use for the first
time in order to avoid a payment
adjustment in 2015 and 2016.
a. Attestation Deadlines for Meaningful
Use in 2015 and 2016
In order to accommodate the
proposed changes to the EHR reporting
period, we are proposing changes to the
attestation deadlines for eligible
hospitals and CAHs for 2015 and 2016.
Currently, in order to demonstrate
meaningful use, eligible hospitals and
CAHs are required to complete an EHR
reporting period within a federal fiscal
year. These providers must then attest to
that EHR reporting period by the end of
the open attestation period 2 months
after the close of the federal fiscal year.
For 2015, this means that eligible
hospitals and CAHs must complete an
EHR reporting period between October
1, 2014 and September 30, 2015 and
must attest by November 30, 2015.
However, we are proposing in section
II.B.3.a. of this proposed rule that
eligible hospitals and CAHs would
instead be required to complete an EHR
reporting period for 2015 between
October 1, 2014 and the end of the
calendar year on December 31, 2015,
and to complete an EHR reporting
period for 2016 between January 1, 2016
and December 31, 2016.
Therefore, we are proposing a change
to the attestation deadlines as follows:
• For an EHR reporting period in
2015, an eligible hospital or CAH must
attest by February 29, 2016.
• For an EHR reporting period in
2016, an eligible hospital or CAH must
attest by February 28, 2017.
In addition, despite the proposed
change to a 90-day EHR reporting period
in 2015 discussed previously in this
proposed rule, providers would not be
able to attest to meaningful use for an
EHR reporting period in 2015 prior to
January 1, 2016. This would allow us
adequate time to make the system
changes necessary to accept attestations
reflecting the proposals in this proposed
rule. This would mean that even if
providers successfully complete a
continuous 90-day EHR reporting period
in the first quarter of FY or CY 2015,
they would attest after the close of the
fourth quarter of CY 2015. This change
would not delay incentive payments for
Medicare EPs, because 2015 cannot be
an EP’s first payment year under section
1848(o)(1)(B)(v) of the Act. Thus, all EPs
who qualify for an incentive payment
for 2015 would be returning participants
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in the program and would have had the
full CY 2015 (as their EHR reporting
period under our current policy). We
understand that this may delay
incentive payments for eligible hospitals
and CAHs. However, most eligible
hospitals and CAHs in the program are
beyond their first year of demonstrating
meaningful use; thus, would not have
been attesting until after September 30,
2015 under our current policy.
Therefore, for most eligible hospitals
and CAHs, this change would shift the
incentive payment by 1 quarter within
the same federal fiscal year. Thus, we
believe the potential negative impact of
this change would be minimal and
outweighed by the opportunity to
capitalize on efficiencies created by
aligning the EHR reporting periods
across EPs, eligible hospitals, and CAHs.
We invite public comment on this
proposal.
b. New Participant Attestation
Deadlines for Meaningful Use in 2015
and 2016 To Avoid a Payment
Adjustment
In § 495.4 the definition of an EHR
reporting period for a payment
adjustment year establishes special
deadlines for attestation for EPs and
eligible hospitals that are demonstrating
meaningful use for the first time in the
year immediately preceding a payment
adjustment year. Generally stated, a
provider must complete an EHR
reporting period in the first 3 quarters
of the preceding year, and the deadlines
for attestation are October 1 for EPs and
July 1 for eligible hospitals of the
preceding year. For CAHs, the EHR
reporting period is within the federal
fiscal year that is the payment
adjustment year and the deadline for
attestation for CAHs is the same for
purposes of the incentive payment and
the payment adjustment (November 30,
2015). After the October 1 or July 1
deadlines, EPs and eligible hospitals
may still attest for an EHR reporting
period in the fourth quarter of the CY
or FY, respectively. However, if they
attest after the respective deadlines,
then they would not avoid the Medicare
payment adjustment in the subsequent
payment adjustment year.
In the Stage 2 proposed rule (77 FR
13769 for EPs and 77 FR 13773 through
13774 for eligible hospitals/CAHs), we
explained the rationale for these special
deadlines for attestation. We explained
that these EHR reporting periods
provide adequate time both for the
systems changes that will be required
for us to apply any applicable payment
adjustments and for providers to be
informed in advance of the payment
year whether a payment adjustment
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would apply. Those deadlines 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. However, we
are proposing a later deadline for
attestation only for 2015 to allow
enough time for all providers to
complete a 90-day EHR reporting period
after the anticipated effective date of the
final rule. As a result of this later
deadline, in 2016, providers that are
new participants in the EHR Incentive
Program may be subject to a payment
adjustment on claims submitted prior to
attestation to meaningful use for an EHR
reporting period in 2015. After
successful attestation, the payment
adjustment would be removed and any
adjustments previously applied to
claims in 2016 would be reprocessed
and reconciled for the provider.
However, as our policies seek to
minimize the claims reprocessing
burden, we note these are exceptional
circumstances caused by the need for a
later attestation deadline to
accommodate a 90-day EHR reporting
period in 2015 after the effective date of
the final rule, and this is not an
acceptable long-term solution. For the
reasons previously stated in the Stage 2
proposed rule, the special deadlines for
first-time meaningful EHR users
(October 1 for EPs and July 1 for eligible
hospitals) are necessary in 2016 and
subsequent years where no extenuating
circumstances exist. For these reasons,
we propose changes to the attestation
deadlines for purposes of the payment
adjustment years in section II.E.2.(a).
through (c). of this proposed rule.
We invite public comment on these
proposals.
3. Alternate Method of Demonstration
for Certain Medicaid Providers
Beginning in 2015
At 42 CFR 495.10, redesignated as
§ 495.60, we defined the requirements
for EPs switching between the Medicare
and Medicaid EHR Incentive Programs.
An EP who qualifies as both a Medicaid
EP and a Medicare EP must notify us as
to whether he or she elects to participate
in the Medicare or the Medicaid EHR
Incentive Program, and after receiving at
least one incentive payment, may
switch between the two EHR incentive
programs only one time, and only for a
payment year before 2015. For further
discussion of this policy we direct
readers to (75 FR 44324 through 44325).
We are not proposing any changes to the
switching requirements under § 495.60.
However, we note that an EP who
qualifies as both a Medicaid EP and a
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Medicare EP would be subject to the
Medicare payment adjustment if the EP
fails to demonstrate meaningful use for
the applicable EHR reporting period for
a payment adjustment year. We
recognize it is possible that an EP who
receives an incentive payment under the
Medicaid EHR Incentive Program for a
given year may fail in a subsequent year
to meet the eligibility criteria for the
Medicaid EHR Incentive Program. For
example, the EP would be unable to
qualify for a Medicaid EHR incentive
payment for 2015, if he or she receives
a Medicaid EHR incentive payment for
meaningful use for the 2013 payment
year, but does not meet the 30 percent
Medicaid patient volume requirement
for purposes of the 2015 payment year.
Under § 495.60(e), in this example in
order to avoid the Medicare payment
adjustment, the EP would be unable to
switch to the Medicare EHR Incentive
Program for the 2015 payment year;
thus, the EP would not have a way to
demonstrate meaningful use for an
applicable EHR reporting period for the
payment adjustment year. Therefore, for
purposes of avoiding the Medicare
payment adjustment, we are proposing
to establish an additional attestation
option to allow EPs who have received
at least one incentive payment under
the Medicaid EHR Incentive Program
(for either AIU or meaningful use) to
demonstrate meaningful use by
attestation using the EHR Incentive
Program Registration and Attestation
system. We note that this attestation
would not constitute a switch from the
Medicaid EHR Incentive Program to the
Medicare EHR Incentive Program, and
EPs who attest under this option would
not earn an incentive payment in either
program for the year. We are proposing
this attestation option for the purposes
of demonstrating meaningful use to
avoid the Medicare payment adjustment
only. In the prior example, the EP
whose Medicaid patient volume was
less than the required threshold would
be able to attest to meaningful use for
an EHR reporting period in 2015 to
avoid the 2017 payment adjustment.
This EP would continue to be
designated a Medicaid EHR Incentive
Program participant. In 2016 in order to
earn an incentive payment and avoid a
Medicare payment adjustment, if the EP
meets the Medicaid patient volume
threshold with regard to the 2016
payment year, then the EP would be
required to demonstrate meaningful use
in the Medicaid program for an EHR
reporting period.
As stated above, we are proposing that
EPs who have previously received an
incentive payment under Medicaid for
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adopting, implementing, or upgrading to
certified EHR technology may also use
this alternate attestation option even if
it is their first year of demonstrating
meaningful use. However, these EPs
would be required to demonstrate
meaningful use for the EHR reporting
periods established for the Medicare
EHR Incentive Program for EPs who
have never successfully demonstrated
meaningful use in a prior year. In the
Stage 3 proposed rule (80 FR 16739), we
propose that beginning in 2017, EPs
who demonstrate meaningful use for the
first time under the Medicare EHR
Incentive Program must use an EHR
reporting period of one full calendar
year. Accordingly, under our proposal
in this rule, Medicaid providers using
this alternate attestation option in 2017
or subsequent years would also be
required to use an EHR reporting period
of 1 full calendar year even if they are
demonstrating meaningful use for the
first time.
We invite public comment on this
proposal.
4. Data Collection for Online Posting,
Program Coordination, and Accurate
Payments
We propose no changes to the data
collection requirements or to the
registration requirements under
§ 495.10, redesignated as § 495.60. As
noted in section II.C.2 of the Stage 3
proposed rule, we note that we intend
to continue to post meaningful use
participation data both at an individual
and aggregate level for the purposes of
data transparency, program integrity,
and for use with aligned CMS quality
reporting programs.
5. Hospital-Based Eligible Professionals
Section 1848(o)(1)(C)(i) of the Act, as
added by section 4101(a) of the HITECH
Act, states that hospital-based EPs are
not eligible for Medicare incentive
payments. Similarly, the majority of
hospital-based EPs will not be eligible
for Medicaid incentive payments under
section 1903(t)(2)(A) of the Act (the only
exception to this rule is for those
practicing predominantly in an FQHC or
RHC). Sections 4101(a) and 4201(a) of
the HITECH Act originally defined the
term ‘‘hospital-based eligible
professional’’ to mean an EP, such as a
pathologist, anesthesiologist, or
emergency physician, who furnishes
substantially all of his or her Medicare
covered professional services during the
relevant EHR reporting period in a
hospital setting (whether inpatient or
outpatient) through the use of the
facilities and equipment of the hospital,
including the hospital’s qualified EHRs.
Following publication of the Stage 1
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proposed rule (75 FR 1844 through
2011), Congress modified the definition
of hospital-based EPs. Specifically, on
April 15, 2010, President Obama signed
into law the Continuing Extension Act
of 2010 (Pub. L. 111–157). Section 5 of
the Continuing Extension Act of 2010
(Pub. L. 111–157) made the following
changes to the Act as it applies to both
the Medicare and Medicare EHR
incentives for EPs:
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• Qualifications for Clinic-based
Physicians
++ Medicare—Section
1848(o)(1)(C)(ii) of the Act (42 U.S.C.
1395w–4(o)(1)(C)(ii)) is amended by
striking ‘‘setting (whether inpatient or
outpatient)’’ and inserting ‘‘inpatient or
emergency room setting’’.
++ Medicaid—Section 1903(t)(3)(D) of
the Act (42 U.S.C. 1396b(t)(3)(D)) is
amended by striking ‘‘setting (whether
inpatient or outpatient)’’ and inserting
‘‘inpatient or emergency room setting’’.
These amendments were effective as
if included in the enactment of the
HITECH Act. The previous sections
indicate that the determination of
whether an EP is a hospital-based EP
shall be made on the basis of the site of
service, as defined by the Secretary, and
without regard to any employment or
billing arrangement between the EP and
any other provider. For example, the
hospital-based determination for an EP
would not be affected by whether the EP
is an employee of the hospital, under a
contractual relationship with the
hospital, or with respect to whether he
or she has made a reassignment to the
hospital for Part B billing purposes. In
addition, section 1848(a)(7)(D) of the
Act, as added by section 4101(b) of the
HITECH Act, exempts hospital-based
EPs from the downward payment
adjustment applied under section
1848(a)(7)(A)(i) of the Act to covered
professional services provided during a
payment year by EPs who are not
meaningful EHR users for the relevant
payment year beginning in 2015.
Based on section 4101(a) of the
HITECH Act (and prior to the
amendments in the Continuing
Extension Act of 2010), we proposed in
the Stage 1 proposed rule (75 FR 1904
through1907) that an EP would be
considered a hospital-based EP;
therefore, ineligible to receive a
Medicare or Medicaid EHR incentive
payment if more than 90 percent of their
services are provided in the following
place of service (POS) codes for HIPAA
standard transactions—
• 21—Inpatient Hospital;
• 22—Outpatient Hospital;
• 23—Emergency Room.
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In the Stage 1 final rule (75 FR 44439
through 44442), we incorporated the
changes to the hospital-based definition,
that were included in the Continuing
Extension Act of 2010, into our
definition of ‘‘hospital-based EP’’ under
§ 495.4. We defined an EP as hospitalbased if he or she furnishes 90 percent
or more of his or her covered
professional services in sites of service
identified as an inpatient hospital (POS
21) or emergency room (POS 23) setting
in the year preceding the payment year.
We did not include POS 22 for
outpatient hospital settings in our final
definition.
As noted previously, section
1848(a)(7)(D) of the Act exempts
hospital-based EPs who are not
meaningful EHR users from the
downward payment adjustments under
Medicare. In the Stage 2 final rule (77
FR 54102), for purposes of the Medicare
payment adjustments, we amended the
definition of hospital-based EP under
§ 495.4 to define a hospital-based EP as
an EP who furnishes 90 percent or more
of his or her covered professional
services in sites of service identified as
an inpatient hospital (POS 21) or
emergency room (POS 23) setting in
either of the 2 years before the year
preceding a payment adjustment year.
However, recently several hospital
associations, individual providers, and
other stakeholders have raised concerns
with our current definition of a hospitalbased EP. Specifically, these
stakeholders asserted that the limitation
of hospital-based to POS codes 21 and
23, covering inpatient and emergency
room settings only, does not adequately
capture all settings where services might
be furnished by a hospital-based EP.
They stated that POS 22, which covers
an outpatient hospital place of service,
is also billed by hospital-based EPs,
especially in relation to certain CPT
codes. These stakeholders expressed the
belief that our current definition of
hospital-based EP in the regulations is
too narrow and will unfairly subject
many EPs who are not hospital-based
under our definition, but who
stakeholders would consider to be
hospital-based, to the downward
payment adjustment under Medicare in
2015. Accordingly, these stakeholders
recommended that we consider adding
additional place of service codes or
settings to the regulatory definition of
hospital-based EP.
We appreciate this feedback from
stakeholders and are requesting public
comment on our current definition of a
hospital-based EP under § 495.4 for the
EHR Incentive Programs.
We are seeking public comment on
whether additional place of service
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codes or settings should be included in
our definition of a hospital-based EP. As
stated previously, stakeholders
specifically identified POS 22 for
outpatient hospital settings as an area of
concern; therefore, we are especially
interested in comments on POS 22 for
outpatient hospital settings. In addition,
we seek comments on whether and how
the inclusion of additional POS codes or
settings in our definition of hospitalbased EP might affect the eligibility of
EPs for the EHR incentive payments
under Medicare or Medicaid.
We welcome public comment.
E. Payment Adjustments and Hardship
Exceptions
Sections 4101(b) and 4102(b) of the
HITECH Act, amending sections 1848,
1853, and 1886 of the Act, require
reductions in payments to EPs, eligible
hospitals, and CAHs that are not
meaningful users of certified EHR
technology, beginning in CY 2015 for
EPs, FY 2015 for eligible hospitals, and
in cost reporting periods beginning in
FY 2015 for CAHs.
1. Statutory Basis for Payment
Adjustment and Hardship Exceptions
Section 1848(a)(7) of the Act provides
for payment adjustments, effective for
CY 2015 and subsequent years, for EPs
as defined in § 495.100, who are not
meaningful EHR users during the
relevant EHR reporting period for the
year. Section 1848(a)(7) of the Act
provides that 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’’ of the fee
schedule amount that would otherwise
apply. The term ‘‘applicable percent’’ is
defined in section 1848(a)(7)(A)(ii) of
the Act as: (I) For 2015, 99 percent (or,
in the case of an EP who was subject to
the application of the payment
adjustment [if the EP was not a
successful electronic prescriber] under
section 1848(a)(5) of the Act for 2014, 98
percent); (II) for 2016, 98 percent; and
(III) for 2017 and each subsequent year,
97 percent.
In addition, section 1848(a)(7)(A)(iii)
of the Act provides that if, for CY 2018
and subsequent years, the Secretary
finds 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
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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.
We established regulations
implementing these statutory provisions
under 42 CFR 495.102. We refer readers
to the Stages 1 and 2 final rules (75 FR
44442 through 44448, 77 FR 54093
through 54102) for more information.
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 the 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 adjustment year,
beginning in FY 2015. Specifically,
section 1886(b)(3)(B)(ix)(I) of the Act
provides that, for FY 2015 and each
subsequent fiscal year, 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
applies to ‘‘three-quarters of the
percentage increase otherwise
applicable’’ prior to the application of
statutory adjustments under sections
1886(b)(3)(B)(viii), 1886(b)(3)(B)(xi), and
1886(b)(3)(B)(xii) of the Act, or threequarters of the applicable market basket
update. The reduction to three-quarters
of the applicable update for an eligible
hospital that is not a meaningful EHR
user would 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
must reduce the applicable percentage
increase (prior to the application of
other statutory adjustments) by—
• 25 percent (33 1/3 of 75 percent) in
FY 2015;
• 50 percent (66 2/3 percent of 75
percent) in FY 2016; and
• 75 percent (100 percent of 75
percent) in FY 2017 and subsequent
years.
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Section 4102(b)(1)(B) of the HITECH Act
also provides that the 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.’’
Section 412.64(d) of our regulations
sets forth the adjustment to the
percentage increase in the market basket
index for those eligible hospitals that
are not meaningful EHR users for the
EHR reporting period for a payment
year, beginning in FY 2015.
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 of the Act also
provides that such determinations are
subject to annual renewal, and that in
no case may a hospital be granted an
exception for more than 5 years.
Section 4102(b)(2) of the HITECH Act
amended section 1814(l) of the Act to
include an adjustment to a CAH’s
Medicare reimbursement for inpatient
services if the CAH is not a meaningful
EHR user for an EHR reporting period.
The adjustment would be made for cost
reporting periods that begin in FY 2015,
FY 2016, FY 2017, and each subsequent
FY thereafter. Specifically, sections
1814(l)(4)(A) and (B) of the Act provide
that, if a CAH does not demonstrate
meaningful use of CEHRT for an
applicable EHR reporting period, then
for a cost reporting period beginning in
FY 2015, the CAH’s reimbursement
shall be reduced from 101 percent of its
reasonable costs to 100.66 percent of
reasonable costs. 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 fiscal
year, 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 cases of a CAH in a rural
area without sufficient internet access.
However, in no case may a CAH be
granted this exception for more than 5
years.
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In the Stage 1 final rule (75 FR 44564
and 44574), we finalized the regulations
regarding the CAH adjustment at
§ 495.106(e) and § 413.70(a)(6).
2. EHR Reporting Period for a Payment
Adjustment Year
Section 1848(a)(7)(E)(ii) of the Act
provides the Secretary with broad
authority to choose the EHR reporting
period that would apply for purposes of
determining the payment adjustments
for EPs for CY 2015 and subsequent
years. In the Stage 2 final rule (77 FR
54095 through 54097), we adopted a
policy that the EHR reporting periods
for the payment adjustments will begin
and end prior to the year of the payment
adjustment. We stated that this is based
on our desire 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,
and the resulting implications for
beneficiary coinsurance. Specifically,
we finalized under § 495.4 of our
regulations that for EPs, the EHR
reporting period for a payment
adjustment year is the full calendar year
that is 2 years before the payment
adjustment year. For example, the full
calendar year of 2015 would be the EHR
reporting period for the CY 2017
payment adjustment year. We also
finalized an exception to this rule for
EPs who have never successfully
attested to meaningful use. Generally
stated, under this exception, for an EP
who is demonstrating meaningful use
for the first time, the EHR reporting
period for a payment adjustment year is
any continuous 90-day period. For a full
description of this exception, including
limitations on when the continuous 90day period must occur in relation to the
payment adjustment year and the
deadlines for registration and
attestation, we refer readers to the
definition of ‘‘EHR reporting period for
a payment adjustment year’’ under
§ 495.4 of our regulations and the
discussion in the Stage 2 final rule (77
FR 54095 through 54096). We
established that these policies apply for
the CY 2015 payment adjustment year
and subsequent payment adjustment
years.
Similarly, section 1886(b)(3)(B)(ix)(IV)
of the Act makes clear that the Secretary
has discretion to specify as the EHR
reporting period any period (or periods)
that will apply with respect to a fiscal
year. In the Stage 2 final rule at 77 FR
54104 through 54105, we finalized the
applicable EHR reporting period for
purposes of determining whether an
eligible hospital is subject to the
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payment adjustment. As with EPs, we
finalized that the EHR reporting period
for the payment adjustment year for
eligible hospitals will begin and end
prior to the year of the payment
adjustment. We finalized under § 495.4
of our regulations that for eligible
hospitals, the EHR reporting period for
a payment adjustment year is the full
federal fiscal year that is 2 years before
the payment adjustment year. We
established this policy beginning with
the FY 2015 payment adjustment year
and continuing in subsequent years. For
example, the full federal fiscal year of
2015 would be the EHR reporting period
for the FY 2017 payment adjustment
year. We finalized an exception to the
general rule of a full federal fiscal year
EHR reporting period for eligible
hospitals that have never successfully
attested to meaningful use. Generally
stated, under this exception, for an
eligible hospital that is demonstrating
meaningful use for the first time, the
EHR reporting period for a payment
adjustment year is any continuous 90day period. For a full description of this
exception, including limitations on
when the continuous 90-day period
must occur in relation to the payment
adjustment year and the deadlines for
registration and attestation, we refer
readers to the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ under § 495.4 of the
regulations and the discussion in the
Stage 2 final rule (77 FR 54104 through
54105).
In Stage 2, we amended the definition
of the EHR reporting period that would
apply for purposes of the payment
adjustment for CAHs under § 495.4 (77
FR 54109 and 54110). For CAHs, this is
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 EHR reporting
period within the payment adjustment
year would apply). The adjustment
applies 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 EHR user for FY 2015, and
thereafter, then the payment adjustment
is applied to the CAH’s reasonable costs
incurred in a cost reporting period that
begins in the affected FY as described in
§ 413.70(a)(6)(i). We further finalized
that CAHs 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
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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
would be made through the cost report
settlement process
In the Stage 3 proposed rule (80 FR
16774 through 16779), we proposed to
eliminate the exception discussed
previously for a 90-day EHR reporting
period for new meaningful EHR users in
the Medicare EHR Incentive Program
beginning with the EHR reporting
period in 2017, with a limited exception
for new meaningful EHR users under
the Medicaid EHR Incentive Program.
We also proposed for eligible hospitals
and CAHs to shift the EHR reporting
period for a payment adjustment year
from a fiscal year basis to a calendar
year basis. We proposed that for EPs and
eligible hospitals demonstrating
meaningful use under the Medicare EHR
Incentive Program, including those who
have successfully demonstrated
meaningful use in a prior year as well
as those who have not, the EHR
reporting period for a payment
adjustment year would be the full
calendar year that is 2 years before the
payment adjustment year. For further
information on these proposals, we
direct readers to the Stage 3 proposed
rule (80 FR 16739 and 16740).
In the Stage 3 proposed rule, we also
proposed a change to the EHR reporting
period that would apply for the
payment adjustments for CAHs,
beginning with the FY 2017 payment
adjustment year. Similar to what we
proposed for eligible hospitals, we
proposed that the EHR reporting period
for a payment adjustment year for CAHs
would be a full calendar year, rather
than a full federal fiscal year. We
proposed the EHR reporting period for
a payment adjustment year would be the
calendar year that overlaps the last 3
quarters of the federal fiscal year that is
the payment adjustment year. For
example, in order for a CAH to avoid
application of the adjustment to its
reasonable costs incurred in a cost
reporting period that begins in FY 2017,
the CAH must demonstrate it is a
meaningful EHR user for an EHR
reporting period of the full 2017
calendar year. For further information
on these proposals, we direct readers to
the Stage 3 proposed rule (80 FR 16777
through 16779).
In the Stage 3 proposed rule, we
proposed amendments to the definition
of ‘‘EHR reporting period for a payment
adjustment year’’ under § 495.4 to
reflect these proposals for EPs, eligible
hospitals, and CAHs.
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In this proposed rule, we are
proposing several changes to the
definition of the EHR reporting period
for a payment adjustment year for EPs,
eligible hospitals, and CAHs at § 495.4,
in connection with other proposals
made in this rule. Specifically, as stated
in section I.A.2.b. of this proposed rule,
we propose to change the EHR reporting
period in 2015 to 90 days for all
providers. This 90-day EHR reporting
period in 2015 would allow adequate
time to accommodate the changes to the
objectives and measures of meaningful
use proposed in this rule. We are also
proposing to move all providers to an
EHR reporting period based on the
calendar year beginning in 2015 to
support program alignment and simplify
reporting requirements among provider
types (section I.A.2.a. of this proposed
rule).
a. Changes to the EHR Reporting Period
for a Payment Adjustment Year for EPs
We propose a change to our current
policy for 2015 only. We propose that
for all EPs, including those who have
demonstrated meaningful use in a prior
year and those who have not, the EHR
reporting period for a payment
adjustment year would be any
continuous 90-day period in CY 2015
and would apply for purposes of the
payment adjustments in CY 2016 for
EPs demonstrating meaningful use for
the first time in 2015 and for purposes
of the payment adjustments in CY 2017
for both returning and new participant
EPs who demonstrate meaningful use in
2015. We propose the deadline for
attestation would be February 29, 2016.
We would maintain our current
policy for 2016. Under that policy, if an
EP is demonstrating meaningful use for
the first time in 2016, the EHR reporting
period for a payment adjustment year is
any continuous 90-day period in CY
2016 and applies for purposes of the
payment adjustments in CYs 2017 and
2018. To avoid the payment adjustment
in CY 2017, the 90-day period must
occur within the first three quarters of
CY 2016 and the EP must attest by
October 1, 2016. If an EP has previously
demonstrated meaningful use, the EHR
reporting period for a payment
adjustment year is the full CY 2016 and
applies for purposes of the payment
adjustment in CY 2018.
We invite comment on this proposal.
b. Changes to the EHR Reporting Period
for a Payment Adjustment Year for
Eligible Hospitals
We propose a change to our current
policy for 2015. We propose that for all
eligible hospitals, including those that
have demonstrated meaningful use in a
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prior year and those that have not, the
EHR reporting period for a payment
adjustment year would be any
continuous 90-day period beginning
October 1, 2014 and ending December
31, 2015. This EHR reporting period
would apply for purposes of the
payment adjustments in FY 2016 for
eligible hospitals demonstrating
meaningful use for the first time in 2015
and for purposes of the payment
adjustments in FY 2017 for both
returning and new participant eligible
hospitals that demonstrate meaningful
use in 2015. We propose the deadline
for attestation would be February 29,
2016.
We also propose to change our current
policy for 2016. We propose that if an
eligible hospital is demonstrating
meaningful use for the first time in
2016, the EHR reporting period for a
payment adjustment year would be any
continuous 90-day period in CY 2016
and apply for purposes of the payment
adjustments in FYs 2017 and 2018. To
avoid the payment adjustment in FY
2017, the 90-day period must occur
within the first three quarters of CY
2016, and the eligible hospital must
attest by October 1, 2016. If an eligible
hospital has previously demonstrated
meaningful use, the EHR reporting
period for a payment adjustment year
would be the full CY 2016, the
attestation deadline would be February
28, 2017, and this EHR reporting period
would apply for purposes of the
payment adjustment in FY 2018.
c. Changes to the EHR Reporting Period
for a Payment Adjustment Year for
CAHs
For CAHs, we are proposing to shift
the EHR reporting period for a payment
adjustment year from the federal fiscal
year that is the payment adjustment year
to the calendar year that begins on the
first day of the second quarter of the
federal fiscal year that is the payment
adjustment year. In the Stage 3 proposed
rule, we outline how CAHs are different
from EPs and eligible hospitals in that
the EHR reporting period is aligned with
the payment adjustment year, rather
than in advance of the payment
adjustment year. In the Stage 3 proposed
rule, we propose a similar change to this
definition for an EHR reporting period
for a payment adjustment year
beginning in 2017 and explain how this
change to the calendar year would work
for CAHs. For further discussion of this
proposal, we direct readers to the Stage
3 proposed rule (80 FR 16739 through
16740).
In this proposed rule, we propose a
change to our current policy for 2015.
We propose that for all CAHs, including
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those that have demonstrated
meaningful use in a prior year and those
that have not, the EHR reporting period
for a payment adjustment year would be
any continuous 90-day period beginning
October 1, 2014 and ending December
31, 2015. This EHR reporting period
would apply for purposes of the
payment adjustments for the cost
reporting period that begins in federal
FY 2015. We propose the deadline for
attestation would be February 29, 2016.
Any CAH that does not demonstrate
meaningful for an EHR reporting period
in 2015 would receive a downward
adjustment to payments for its
reasonable costs incurred in the cost
reporting period that begins in federal
FY 2015. If a CAH fails to demonstrate
meaningful use in 2015 and has a fiscal
year that ends between October 1, 2015
and March 1, 2016, then the payment
adjustment would be applied through
the cost report reconciliation process.
We also propose to change our current
policy for 2016. We propose that if a
CAH is demonstrating meaningful use
for the first time in 2016, the EHR
reporting period for a payment
adjustment year would be any
continuous 90-day period in CY 2016
and apply for purposes of the payment
adjustments for the cost reporting
period that begins in federal FY 2016.
The deadline for attestation would be
February 28, 2017. If a CAH has
previously demonstrated meaningful
use, the EHR reporting period for a
payment adjustment year would be the
full CY 2016, the attestation deadline
would be February 28, 2017, and this
EHR reporting period would apply for
purposes of the payment adjustments
for the cost reporting period that begins
in federal FY 2016.
Any CAH that does not demonstrate
meaningful for an EHR reporting period
in 2016 would receive a downward
adjustment to payments for its
reasonable costs incurred in the cost
reporting period that begins in federal
FY 2016. If a CAH fails to demonstrate
meaningful use in 2016 and has a fiscal
year that ends between October 1, 2016
and March 1, 2017, then the payment
adjustment would be applied through
the cost report reconciliation process.
3. Hardship Exceptions
As stated previously, sections
1848(a)(7)(B) and 1886(b)(3)(B)(ix)(II) of
the Act provide the Secretary with
discretionary authority to exempt, on a
case by case basis, a provider from the
application of the Medicare payment
adjustment if the Secretary determines
that compliance with the requirements
for being a meaningful EHR user would
result in a significant hardship. We have
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20381
established various types of hardship
exceptions for which providers may
apply as well as deadlines for
application. For more information, we
refer readers to the Stage 2 final rule at
77 FR 54093 through 54113.
In this proposed rule, we propose no
changes to the existing hardship
exceptions under our regulations.
III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to evaluate fairly
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
The following is a discussion of the
requirements contained in this proposed
regulation that we believe are subject to
PRA and information collection
requirements (ICRs). The projected
numbers of EPs, eligible hospitals, and
CAHs, MA organizations, MA EPs and
MA-affiliated hospitals are based on the
numbers used in the impact analysis
assumptions as well as estimated federal
costs and savings in the section IV.C.3.a.
and b. of this proposed rule. The actual
burden would remain constant for per
year as EPs, eligible hospitals, and
CAHs would need to attest that they
have successfully demonstrated
meaningful use under the proposed
definition in 2015 through 2017. For the
purposes of this analysis, we are
focusing only on 2015, the first year in
which a provider may use the proposed
definition of meaningful use. We do not
believe the burden for EPs, eligible
hospitals, and CAHs participating in
Stages 1 and 2 prior to 2015 would be
different from the Agency Information
Collection Activities (75 FR 65354)
based on this proposed rule. Beginning
in 2012, Medicare EPs, eligible
hospitals, and CAHs had the option to
electronically report their clinical
quality measures through the respective
aligned quality reporting programs;
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however, for the purposes of defining
the burden for 2015 through 2017, we
maintain the estimates for attestation to
CQM data.
In this proposed rule, the definition of
meaningful use with associated
reporting requirements would replace
all prior definitions and requirements
beginning in 2015. At that point, all
eligible providers would be required to
report meaningful use requirements on
an annual basis. For 2017, providers
may simply repeat this proposed
definition of meaningful use or move on
to Stage 3. The same reporting burden
would apply to all providers.
Consequently, the proposed ICRs reflect
the provider burden associated with
complying with and reporting of the
proposed requirements beginning in
2015 and each subsequent year. We note
that the proposals in this rule result in
a reduction of the reporting burden on
providers attesting to meaningful use as
compared to the existing program
requirements finalized in the Stage 2
final rule (77 FR 54132).
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements
(ICRs).
A. ICR Regarding Demonstration of
Meaningful Use Criteria (§ 495.20
Through § 495.60)
In § 495.40 we propose that to
successfully demonstrate meaningful
use of certified EHR technology for
meaningful use in 2015 through 2017,
an EP, eligible hospital, or CAH
(collectively referred to as ‘‘provider’’ in
this section) must attest, through a
secure mechanism in a specified
manner, to the following during the
EHR reporting period: (1) The provider
used certified EHR technology and
specified the technology was used; and
(2) the provider satisfied each of the
applicable objectives and associated
measures in § 495.22. In § 495.40, we
stipulate that providers must also
successfully report the clinical quality
measures selected by CMS to CMS or
the states, as applicable. We estimate
that the certified EHR technology
adopted by the provider captures many
of the objectives and associated
measures and generate automated
numerator and denominator information
where required, or generate automated
summary reports. We also expect that
the provider would enable the
functionality required to complete the
objectives and associated measures for
which they are required to attest.
We propose that EPs would be
required to report on a total of 10
objectives and associated measures and
eligible hospitals and CAHs would
report on a total of 9 objectives and
associated measures. In this proposed
rule, there are 6 objectives that would
require an EP to enter numerators and
denominators during attestation.
Eligible hospitals and CAHs would have
to attest that they have met 6 objectives
that require numerators and
denominators. For objectives and
associated measures requiring a
numerator and denominator, we limit
our estimates to actions taken in the
presence of certified EHR technology.
We do not anticipate a provider would
maintain 2 recordkeeping systems when
certified EHR technology is present.
Therefore, we assume that all patient
records that would be counted in the
denominator would be kept using
certified EHR technology. We expect it
would take an individual provider or
designee approximately 10 minutes to
attest to each meaningful use objective
and associated measure that requires a
numerator and denominator to be
generated, as well as approximately 1
hour 30 minutes to attest to CQM
requirements.
Additionally, providers would be
required to report they have completed
objectives and associated measures that
require a ‘‘yes’’ or ‘‘no’’ response during
attestation. For EPs, there are 3
objectives that would require a ‘‘yes’’ or
‘‘no’’ response during attestation. For
eligible hospitals and CAHs, there are 2
objectives and that would require a
‘‘yes’’ or ‘‘no’’ response during
attestation. We expect that it would take
a provider or their designee 1 minute to
attest to each objective that requires a
‘‘yes’’ or ‘‘no’’ response.
Providers would also be required to
attest that they are protecting ePHI. We
estimate completion of the analysis
required to meet successfully the
associated measure for this objective
would take approximately 6 hours,
which is identical to our estimate for the
Stage 1 and Stage 2 requirements. This
burden estimate assumes that covered
entities are already conducting and
reviewing these risk analyses under
current HIPAA regulations. Therefore,
we have not accounted for the
additional burden associated with the
conduct or review of such analyses.
Table 7 lists those objectives and
associated measures for EPs and eligible
hospitals and CAHs. We estimate the
objectives and associated measures
would take an EP 6 hours 49 minutes to
complete, and would take an eligible
hospital or CAH 6 hours 48 minutes to
complete.
In this proposed rule EPs, eligible
hospitals, and CAHs have nearly
identical reporting burdens. Eligible
hospitals and CAHs are required to
report to one additional registry than
EPs are required to report; however, EPs
have an additional objective, Secure
Electronic Messaging, which requires a
‘‘yes’’ or ‘‘no’’ response. Consequently,
we have not prepared lowest and
highest burdens. Rather, we have
computed a burden for EPs and a
burden for eligible hospitals and CAHs.
TABLE 7—BURDEN ESTIMATES
Eligible professionals
Eligible hospitals and CAHs
Burden
estimate per
respondent
(EPs)
Measures
Burden
estimate per
respondent
(hospitals)
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Objectives and Measures
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.
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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.
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More than 60% of medication, 30% of
laboratory, and 30% of 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.
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10 minutes .....
10 minutes.
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20383
TABLE 7—BURDEN ESTIMATES—Continued
Eligible professionals
Generate and transmit permissible prescriptions electronically (eRx).
Use clinical decision support to
improve performance on highpriority health conditions.
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.
mstockstill on DSK4VPTVN1PROD with PROPOSALS3
Use CEHRT to identify patientspecific education resources
and provide those resources
to the patient.
Use secure electronic messaging to communicate with
patients on relevant health information.
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Eligible hospitals and CAHs
Burden
estimate per
respondent
(EPs)
Measures
More than 50% of all permissible prescriptions, or all prescriptions written by
the EP and queried for a drug formulary and transmitted electronically
using CEHRT.
Generate and transmit permis- More than 10% of hospital discharge
sible discharge prescriptions
medication orders for permissible preelectronically (eRx).
scriptions (for new, changed, and refilled prescriptions) are queried for a
drug formulary and transmitted electronically using CEHRT.
Use clinical decision support to 1. Implement five clinical decision support
improve performance on
interventions related to four or more
high-priority health conditions.
clinical quality measures at a relevant
point in care for the entire EHR reporting period. Absent four clinical quality
measures related to an EP, eligible
hospital or CAH’s scope of practice or
patient population, the clinical decision
support interventions must be related
to improving healthcare efficiency.
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.
1. More than 50% 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. At least 1 patient seen by the EP during the EHR reporting period (or their
authorized
representatives)
views,
downloads, or transmits to a third party
their health information.
Provide patients the ability to 1. More than 50% of all patients who are
view online, download, and
discharged from the inpatient or emertransmit information about a
gency department (POS 21 or 23) of
hospital admission.
an eligible hospital or CAH have their
information available online within 36
hours of discharge.
2. At least 1 patient (or their authorized
representatives) who are discharged
from the inpatient or emergency department (POS 21 or 23) of an eligible
hospital or CAH views, downloads or
transmits to a third party their information during the reporting period.
Use CEHRT to identify patient- Patient-specific education resources idenspecific education resources
tified by CEHRT are provided to paand provide those resources
tients for more than 10% of all unique
to the patient.
patients with office visits seen by the
EP during the EHR reporting period.
More than 10% 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 CEHRT.
The secure electronic messaging function
was fully enabled for the EHR reporting
period.
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E:\FR\FM\15APP3.SGM
15APP3
Burden
estimate per
respondent
(hospitals)
10 minutes.
10 minutes.
1 minute .........
1 minute.
10 minutes.
10 minutes.
10 minutes .....
10 minutes.
10 minutes.
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Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Proposed Rules
TABLE 7—BURDEN ESTIMATES—Continued
Burden
estimate per
respondent
(EPs)
Burden
estimate per
respondent
(hospitals)
Eligible professionals
Eligible hospitals and CAHs
Measures
The EP who receives a patient
from another setting of care
or provider of care or believes
an encounter is relevant
should perform medication
reconciliation.
The 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.
The 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.
The EP, eligible hospital or CAH performs medication reconciliation for
more than 50% 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).
1. 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 10% of such transitions and
referrals either (a) electronically transmitted using CEHRT to a recipient or
(b) where the recipient receives the
summary of care record via exchange
facilitated by an organization that is a
NwHIN Exchange participant or in a
manner that is consistent with the governance mechanism ONC establishes
for the nationwide health information
network.
EPs must attest to at least 2 options out
of 5.
Eligible Hospitals and CAHs must attest
to at least 3 options out of 6.
Conduct or review a security risk analysis
in accordance with the requirements
under 45 CFR 164.308(a)(1), including
addressing the security (to include
encryption) of data stored in CEHRT 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.
10 minutes .....
10 minutes.
10 minutes .....
10 minutes.
1 minute .........
1 minute.
Time to Attest to Objectives and Measures ...........................................................................................................
6 hours 49
minutes.
1 hour 30 minutes.
6 hours 48
minutes.
1 hour 30 minutes.
8 hours 19
minutes.
8 hours 18
minutes.
The EP 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.
Active engagement with a public health agency to report
public health data.
Active engagement with a public health agency to report
public health data.
Protect electronic protected
health information created or
maintained by the CEHRT
through the implementation of
appropriate technical capabilities.
Protect electronic protected
health information created or
maintained by the CEHRT
through the implementation
of appropriate technical capabilities.
Time to Attest and Report Clinical Quality Measures ............................................................................................
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Total—Objectives + CQM Reporting ...............................................................................................................
In this proposed rule, we estimate that
it would take no longer than 6 hours 49
minutes for an EP to attest to each of the
applicable objectives and associated
measures. The total burden hours for an
EP to attest to the meaningful use
objectives and measures and to report
CQMs would be 8 hours 19 minutes. We
estimate that there could be
approximately 595,100 nonhospitalbased Medicare EPs in 2014. Based on
the historical data, we anticipate
approximately 60 percent (357,060) of
these EPs may attest to the objectives
and measures of meaningful use. In
addition, we believe approximately
30,000 Medicaid only EPs, or
approximately 51 percent of the
Medicaid-only EPs, will successfully
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demonstrate meaningful use in 2015.
The total estimated annual cost burden
for all EPs to attest to meaningful use
would be $297,076,291 (387,060 × 8
hours 19 minutes × $92.25 (mean hourly
rate for physicians based on May 2013
BLS data)). Similarly, eligible hospitals
and CAHs would attest that they have
met the meaningful use objectives and
associated measures, and would submit
the clinical quality measures. We
estimate that it would take no longer
than 6 hours 48 minutes to attest to each
of the applicable objectives and
associated measures. Therefore, the total
burden hours for an eligible hospital or
CAH to attest to the meaningful use
objectives and measures and to report
CQMs, would be 8 hours 18 minutes.
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6 hours.
We estimate that there are about 4,900
eligible hospitals and CAHs that may
attest to the aforementioned criteria in
FY 2015 of which 95 percent are
expected to successfully demonstrate
meaningful use. The total estimated
annual cost burden for all eligible
hospitals and CAHs to attest to
meaningful use would be $2,451,872
(4,655 eligible hospitals and CAHs ×
$63.46 (8 hours 18 minutes × $63.46
(mean hourly rate for lawyers based on
May 2013 BLS) data)).
We provide the estimate of the burden
for the approximately 13,635 MA EPs in
the MA organization burden section.
The total annual burden estimates for
meaningful use under this proposed
rule are shown in Table 10.
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For the purpose of this proposed
collection of information, we assumed
that all eligible providers would comply
with the requirements of Meaningful
Use as previously defined if the policies
proposed in this rule were not finalized.
Therefore, in this proposed rule, we
estimate that the policies contained
herein, once finalized, would result in
an overall reduction in the reporting
burden for providers of 1.45 hours to 1.9
hours for EPs and 2.62 hours for eligible
hospitals and CAHs per respondent.
While batch reporting for objectives and
measures, and group reporting for
CQMs, are available for EPs in the
20385
current program; the program is based
upon successful individual provider
demonstration of meaningful use and so
individual totals are used to identify the
estimated reduction in provider
reporting burden. This reduction of
burden is outlined in Table 8.
TABLE 8—REDUCTION IN REPORTING BURDEN HOURS
Burden under current program and proposed modifications
Estimated burden per respondent
EPs
Estimated burden per respondent
eligible hospitals and CAHs
Total Under Current Stage 2 Requirements at 42 CFR 495.6 ...............
Core Set (including CQMs) + Least Burdensome Menu Set Criteria .....
Total Under Current Stage 2 Requirements at 42 CFR 495.6 ...............
Core Set (including CQMs) + Most Burdensome Menu Set Criteria ......
Total Under Proposed Modifications at 495.22 ......................................
All Objectives and Measures + CQMs ....................................................
Reduction from Least Burdensome Estimate .........................................
Reduction from Most Burdensome Estimate ..........................................
9 hours 46 minutes ........................
NA.
10 hours 13 minutes ......................
10 hours 55 minutes.
8 hours 19 minutes ........................
8 hours 18 minutes.
1 hour 27 minutes .........................
1 hour 54 minutes .........................
NA.
2 hour 37 minutes.
Using the hourly costs associated with
the reporting burden as mentioned
previously, this reduction of 1.45 hours
to 1.9 hours for EPs and 2.62 hours for
eligible hospitals and CAHs represents a
per response savings of $133.76 to
$175.28 for EPs and $166.27 for eligible
hospitals and CAHs. The total cost
reduction in cost for providers
demonstrating meaningful use is
estimated at $48,534,332 at the lowest
and $63,359,464 at the highest. These
estimates are further outlined in Table
9.
TABLE 9—REDUCTION IN BURDEN COST SAVINGS
Burden reduction
hours
Number of responses
Reduction per
respondent
Hourly cost
Total cost
reduction
387,060 ............................................................................................
387,060 ............................................................................................
4,655 ................................................................................................
1.45
1.9
2.62
$92.25
92.25
63.46
$133.76
175.28
166.27
$51,773,146
67,843,877
773,987
Total Least ................................................................................
............................
............................
............................
52,547,132
Total Most ..........................................................................
............................
............................
............................
68,617,864
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B. ICRs Regarding Qualifying MA
Organizations (§ 495.210)
In this proposed rule, we estimate that
the burden would be significantly less
for qualifying MA organizations
attesting to the meaningful use of their
MA EPs, because qualifying MA EPs use
the EHR technology in place at a given
location or system, so if certified EHR
technology is in place and the
qualifying MA organization requires its
qualifying MA EPs to use the
technology, qualifying MA
organizations would be able to
determine at a faster rate than
individual FFS EPs, that its qualifying
MA EPs meaningfully used certified
EHR technology. In other words,
qualifying MA organizations can make
the determination in masse if the
certified EHR technology is required to
be used at its facilities, whereas under
FFS, each EP likely must make the
determination on an individual basis.
We further note, that these differences
also mean the total reduction in burden
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18:45 Apr 14, 2015
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for MA organizations resulting from the
proposals in this rule would be
negligible. We estimate that, on average,
it would take an individual 45 minutes
to collect information necessary to
determine if a given qualifying MA EP
has met the meaningful use objectives
and measures, and 15 minutes for an
individual to make the attestation for
each MA EP. Furthermore, the
individuals performing the assessment
and attesting would not likely be the
eligible professional, but non-clinical
staff. We believe that the individual
gathering the information could be
equivalent to a GS 11, step 1 (2015
unadjusted for locality rate), with an
hourly rate of approximately $25.00/
hour, and the person attesting (and who
may bind the qualifying MA
organization based on the attestation)
could be equivalent to a GS 15, step 1
(2015 unadjusted for locality rate), or
approximately $50.00/hour. Therefore,
for the estimated 13,635 potentially
qualifying MA EPs with assumed 100
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Fmt 4701
Sfmt 4702
percent successfully demonstrating
meaningful use, we believe it would
cost the participating qualifying MA
organizations approximately $426,050
annually to collect the required
information and make the attestations
([10,226 hours × $25.00]+[3,408 hours ×
$50.00]).
C. ICRs Regarding State Medicaid
Agency and Medicaid EP and Hospital
Activities (§ 495.332 Through § 495.344)
In this proposed rule, we are
proposing no changes to State Medicaid
Agency reporting which affect the time
and effort associated with completing
the single provider election repository
and each state’s process for the
administration of the Medicaid
incentive payments, including tracking
of attestations and oversight; the
submission of the state Medicaid HIT
Plan and the additional planning and
implementation documents; or the
enrollment or reenrollment of providers,
or for the collection and submission of
the data for providers to demonstrate
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that they have adopted, implemented, or
upgraded certified EHR technology. We
believe the burden associated with these
requirements has already been
accounted for in our discussion in the
Stage 1 and Stage 2 final rules at (75 FR
44516 through 44544 and 77 FR 54125
through 54135). For the collection and
submission of the data for providers to
demonstrate that they are meaningful
users of such technology, we believe the
burden associated with these
requirements has already been
accounted for in our discussion of the
burden for § 495.20 through § 495.60.
TABLE 10—ESTIMATED ANNUAL REPORTING BURDEN FOR MEANINGFUL USE
OMB Control
No.
Regulation section
Number of
respondents
Number of
responses
§ 495.22—Objectives/Measures/CQMs
(EPs) ........................................................
§ 495.22—Objectives/Measures/CQMs
(hospitals/CAHs) ......................................
§ 495.210—Gather Attestation Information
(MA EPs and EHs) ..................................
§ 495.210—Attest (MA EPs and EHs) ........
0938–1158
387,060
387,060
0938–1158
4,655
4,655
0938–1158
0938–1158
13,635
13,635
Total .....................................................
........................
418,985
Burden per
response
(hours)
Total annual
burden
(hours)
8.32
Hourly labor
cost of
reporting
($)
Total cost
($)
3,220,339
$92.25
$297,076,291
8.3
38,637
63.46
2,451,872
13,635
13,635
0.75
0.25
10,226
3,409
25.00
50.00
255,656
170,438
418,985
..........................
3,272,611
........................
299,954,257
* To avoid double counting, this number of respondents is only included once in the total.
** There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated
column from Table 10.
If you would like to comment on
these information collection and
recordkeeping requirements, please do
either of the following:
1. Submit your comments
electronically as specified in the
ADDRESSES section of this proposed rule;
or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: CMS Desk Officer,
[CMS–3311–P] Fax: (202) 395–6974; or
Email: OIRA_submission@omb.eop.gov.
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this proposed rule, and, when we
proceed with a subsequent document,
we will respond to the comments in the
preamble to that document.
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V. Regulatory Impact Analysis
A. Statement of Need
This proposed rule would implement
the provisions of the ARRA that provide
incentive payments to EPs, eligible
hospitals, and CAHs participating in
Medicare and Medicaid programs that
adopt and meaningfully use certified
EHR technology. The proposed rule
specifies applicable criteria for
demonstrating meaningful use for an
EHR reporting period in 2015 through
2017.
B. Overall Impact
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
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Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999) and the Congressional
Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
($100 million or more in any 1 year).
In relation to the existing program
requirements outlined in the Stage 2
final rule (77 FR 53967 through 54162),
we do not expect this rule to result in
more incentives paid or in more
providers failing meaningful use and
being assessed a payment adjustment.
This is due to the nature of the
modifications being proposed in this
rule, which, while they reduce the
reporting burden on providers, do not
affect the clinical processes and IT
functions required to successfully meet
the objectives and measures of
meaningful use. The proposals in this
rule do not fundamentally change the
technology required to support
participation in the meaningful use
program. Under the current program,
the requirement to report data on the
measures and objectives which have
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been identified as now redundant to
other more advanced measures being
retained, or are duplicative of other
measures using the same certified EHR
technology function, is essentially
requiring providers to report on the
same action or process twice. Therefore,
it is not the occurrence of the action or
process which is reduced by the
proposals in this rule, but the burden
associated with the duplicative and
redundant reporting. In addition, the
objectives and measures which are
considered topped out have reached
high performance and the statistical
evidence demonstrates that the expected
result of any provider attesting to
meaningful use would be a score near
the maximum. However, the analysis of
these measures and their identification
as topped out also takes into account the
statistical likelihood that the functions
of measures and the processes behind
them would continue even without a
requirement to report the results.
Therefore, while the proposals result in
a reduction in reporting requirements,
this does not correlate to a change in the
overall achievement of the measures
and objective as compared to the current
program. Finally, when compared
against historical data, the shortened
reporting period in 2015, which has
been proposed to accommodate the
implementation of the policies of this
rule, is expected to have a minimal
impact on successful demonstration of
meaningful use. This expectation of
minimal impact is based on a number of
factors:
• The shortened period is for 2015
only and not for 2016 or 2017.
• Historical data on attestations
shows no strong correlation between a
shorter reporting period and the ability
of providers to attest to a second year of
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meaningful use, no correlation for
providers returning to attest to a third or
fourth year of meaningful use, and
providers who would otherwise be in
their first year of meaningful use would
already have a 90-day reporting period.5
• Performance data shows
statistically negligible disparity among
providers attesting for a 90-day
reporting period and those attesting for
a full year reporting period on the
measures which have been identified as
redundant, duplicative, and topped
out.6
For these reasons, we do not believe
the proposals in this rule would impact
the overall estimates for incentive
payments, payment adjustments, and
the net transfer costs associated with the
program. However, these proposals do
affect the costs associated with the
reporting burden on providers. The
impacts directly attributable with the
proposals in this rule relate to both an
hourly reduction per response an
overall reduction in the cost associated
with reporting for providers
demonstrating meaningful use. The
burden analysis in this proposed rule, as
compared to the Stage 2 estimates,
reduces the reporting burden for
attestation for providers by
approximately 1.45 hours to 1.9 hours
for EPs and 2.62 hours for eligible
hospitals and CAHs per respondent.
This burden estimate and analysis of the
impact of the policies result in a total
cost reduction estimated at $48,534,332
at the lowest and $63,359,464 at the
highest. However, we believe this
proposed rule will have additional
impacts—most notably, cost savings for
hospitals and providers that would have
additional time to achieve meaningful
use—which cannot be adequately
estimated because of the wide variation
among provider types, and therefore a
designation as an economically
significant rule under the Executive
Order and a major rule under the
Congressional Review Act is still
applicable. The burden estimate and
analysis of the impact of the policies
proposed in this proposed rule are
outlined further in section III. of this
proposed rule.
5 CMS Data and Reports: Quarterly Public Use
Files for participation, Monthly Reports for
performance rates: https://www.cms.gov/
Regulations-and-Guidance/Legislation/EHR
IncentivePrograms/DataAndReports.html.
6 CMS Data and Reports: Quarterly Public Use
Files for participation, Monthly Reports for
performance rates: https://www.cms.gov/
Regulations-and-Guidance/Legislation/EHR
IncentivePrograms/DataAndReports.html.
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1. Overall Effects
a. Regulatory Flexibility Analysis and
Small Entities
The Regulatory Flexibility Act (RFA)
requires agencies to prepare an Initial
Regulatory Flexibility Analysis to
describe and analyze the impact of the
proposed rule on small entities unless
the Secretary can certify that the rule
will not have a significant impact on a
substantial number of small entities. In
the healthcare sector, Small Business
Administration (SBA) size standards
define a small entity as one with
between $7 million and $34 million in
annual revenues. For the purposes of
the RFA, essentially all non-profit
organizations are considered small
entities, regardless of size. Individuals
and states are not included in the
definition of a small entity. Since the
vast majority of Medicare providers
(well over 90 percent) are small entities
within the RFA’s definitions, it is the
normal practice of HHS simply to
assume that all affected providers are
‘‘small’’ under the RFA. In this case,
most EPs, eligible hospitals, and CAHs
are either nonprofit or meet the SBA’s
size standard for small business. We
also believe that the effects of the
incentives program on many and
probably most of these affected entities
will be economically significant.
Accordingly, this RIA section, in
conjunction with the remainder of the
preamble, constitutes the required
Initial Regulatory Flexibility Analysis
(RFA).
Data available suggests that more
providers have adopted EHR technology
since the publication of the Stage 1 final
rule. An ONC data brief (No. 16, May
2014) noted that hospital adoption of
EHR systems has increased 5 fold since
2008. Nine in ten acute care hospitals
possessed CEHRT in 2013, increasing 29
percent since 2011. As of January 1,
2015, more than 95 percent of eligible
hospitals had successfully demonstrated
meaningful use. In January 2014, a
Centers for Disease Control and
Prevention (CDC) data brief entitled,
‘‘Use and Characteristics of Electronic
Health Record Systems Among Officebased Physician Practices: United
States, 2001 through 2013 found that 78
percent of office-based used any type of
EHR systems, up from 18 percent in
2001. The majority of EPs have already
purchased certified EHR technology,
implemented this new technology, and
trained their staff on its use with over
60 percent earning an incentive
payment for participation in the
program prior to 2015.
The cost reductions provided by the
proposals in this rule offer a benefit to
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20387
these providers. Furthermore, we
believe that the combination of payment
incentives and long-term overall gains
in efficiency may compensate for some
of the initial expenditures.
(1) Small Entities
We estimate that EPs would spend
approximately $54,000 to purchase and
implement a certified EHR and $10,000
annually for ongoing maintenance
according to the Congressional Budget
Office (CBO) (75 FR 44546).
In the paper, Evidence on the Costs
and Benefits of Health Information
Technology, May 2008, in attempting to
estimate the total cost of implementing
health IT systems in office-based
medical practices, recognized the
complicating factors of EHR types,
available features and differences in
characteristics of the practices that are
adopting them. The CBO estimated a
cost range of $25,000 to $45,000 per
physician. Annual operating and
maintenance amount was estimated at
12 to 20 percent of initial costs (that is,
$3,000 to $9,000) per physician. For all
eligible hospitals, the range is from $1
million to $100 million. Though reports
vary widely, we anticipate that the
average will be $5 million for eligible
hospitals to achieve meaningful use. We
estimate $1 million for maintenance,
upgrades, and training each year per
eligible hospital. However, as stated
earlier many providers have already
purchased systems with expenditures
focused on maintenance and upgrades.
We believe that future retrospective
studies on the costs to implement and
EHR and the return on investment (ROI)
would demonstrate the actual costs
incurred by providers participating in
the EHR Incentive Programs. The
potential costs savings in this proposed
rule would benefit these providers as a
reduction in the overall cost of program
participation.
(2) Conclusion
As discussed later in this analysis, we
believe that there are many positive
effects of adopting EHR on health care
providers. Furthermore, we believe that
the proposals in this rule will result in
an overall reduction in the reporting
burden for providers of all types.
Accordingly, we believe that the object
of the RFA to minimize burden on small
entities is met by this proposed rule.
b. Small Rural Hospitals
Section 1102(b) of the Act requires us
to prepare a regulatory impact analysis
(RIA) if a rule will have a significant
impact on the operations of a substantial
number of small rural hospitals. This
analysis must conform to the provisions
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of section 603 of the RFA. For purposes
of section 1102(b) of the Act, we define
a small rural hospital as a hospital that
is located outside of a metropolitan
statistical area and has fewer than 100
beds. There is no identifiable disparity
among this group and the overall
success rates for eligible hospitals and
CAHs in demonstrating meaningful use;
furthermore, 95 percent of eligible
hospitals and CAHs have successfully
demonstrated meaningful use as of
January 1, 2015. Finally, on the whole
we anticipate an estimated reduction in
the reporting burden on eligible
hospitals as a group to be less than $1
million. Therefore, we do not believe
that this proposed rule would have a
significant impact on a substantial
number of small entities.
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c. Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates will require
spending in any 1 year $100 million in
1995 dollars, updated annually for
inflation. In 2015, that threshold is
approximately $144 million. UMRA
does not address the total cost of a rule.
Rather, it focuses on certain categories
of cost, mainly those ‘‘federal mandate’’
costs resulting from—(1) imposing
enforceable duties on state, local, or
tribal governments, or on the private
sector; or (2) increasing the stringency of
conditions in, or decreasing the funding
of, state, local, or tribal governments
under entitlement programs.
This proposed rule imposes no
substantial mandates on states. This
program is voluntary for states and
states offer the incentives at their
option. The state role in the incentive
program is essentially to administer the
Medicaid incentive program. While this
entails certain procedural
responsibilities, these do not involve
substantial state expense. In general,
each state Medicaid Agency that
participates in the incentive program
would be required to invest in systems
and technology to comply. States would
have to identify and educate providers,
evaluate their attestations and pay the
incentive. However, the federal
government would fund 90 percent of
the state’s related administrative costs,
providing controls on the total state
outlay. In addition, the changes being
made by this proposed rule have very
little impact on any state functions.
d. Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a final
rule that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has Federalism implications.
This proposed rule would not have a
substantial direct effect on state or local
governments, preempt state law, or
otherwise have a Federalism
implication.
2. Effects on EPs, Eligible Hospitals, and
CAHs
a. Background and Assumptions
There are no new costs associated
with this proposed rule. Furthermore,
the estimates for the provisions affecting
Medicare and Medicaid EPs, eligible
hospitals, and CAHs are somewhat
uncertain for the following reasons:
• The program is voluntary although
payment adjustments will be imposed
on Medicare providers if they are unable
to demonstrate meaningful use for the
applicable reporting period.
• The potential reduction in burden
for EPs rely on relate to assumptions of
what options for meaningful use they
would otherwise attest to should the
policies in this proposed rule not be
adopted.
• The net costs and savings for any
individual provider may not directly
correlate to the total for the organization
as larger organizations may employ
economies of scale in meaningful use
attestations.
However, based on the actual count of
providers eligible for the program as of
December 31, 2014 which were
identified through the process of
implementing payment adjustments for
2015, we estimated the numbers of EPs
and eligible hospitals, including CAHs
under Medicare, Medicaid, and MA for
2015 through 2017 and used the
updated estimates throughout the
analysis. These total potential eligible
providers are as follows:
• About 660,000 Medicare FFS EPs
(some of whom will also be Medicaid
EPs). About 595,100 non-hospital based
Medicare EPs.
• About 58,300 non-Medicare eligible
EPs (such as dentists, pediatricians, and
eligible non-physicians such as certified
nurse-midwives, nurse practitioners,
and physicians assistants).
• 4,900 eligible hospitals comprising
the following:
++ 3,397 acute care hospitals.
++ 1,395 CAHs.
++ 97 children’s hospitals (Medicaid
only).
++ 11 cancer hospitals (Medicaid
only).
• 16 MA organizations and 13,635
MA EPs
b. Industry Costs and Adoption Rates
In this proposed rule, we are
proposing no new policies which would
require changes to the development,
certification, and implementation of
certified EHR technology as compared
to the policies in the existing program
outlined in the Stage 2 final rule (77 FR
54136 through 54146).
3. Medicare Incentive Program Costs
As noted at the beginning of this
analysis, it is difficult to predict the
actual impacts of the policies in this
proposed rule with certainty. We
believe the assumptions and methods
described herein are reasonable for
estimating the financial impact of the
provisions on providers participating in
the Medicare and Medicaid programs,
but acknowledge the wide range of
possible outcomes.
a. Medicare Eligible Professionals (EPs)
In brief, the estimates of Medicare EP
burden reduction are based on current
participation as of January 1, 2015. We
estimate that significant cost reductions
for Medicare EPs participating in the
EHR Incentive Program will result from
the policies in this proposed rule when
compared to the requirements of the
current program. Our estimates of the
reduction in burden cost savings are
presented in Table 12. They reflect our
assumptions about the proportion of EPs
who will demonstrate meaningful use of
certified EHR technology outlined in
Table 11 based on historical data.
TABLE 11—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY
Calendar year
2015
Medicare EPs who have claims with Medicare (in thousands) ................................
Nonhospital-based Medicare EPs (in thousands) .....................................................
Percent of EPs who are Meaningful Users ...............................................................
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595.1
60
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TABLE 11—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY—Continued
Calendar year
2015
Meaningful Users (in thousands) ...............................................................................
2016
357.1
2017
391.4
426.4
TABLE 12—ESTIMATED COST REDUCTION FOR MEDICARE EPS
Calendar year
2015
Meaningful Users (in thousands) ...............................................................................
Lowest Estimated Cost Savings ................................................................................
Highest Estimated Cost Savings ...............................................................................
b. Medicare Eligible Hospitals and
CAHs
In brief, the estimates of hospital
burden reduction are based on current
participation as of January 1, 2015. We
estimate that significant cost reductions
2016
357.1
$47,760,345.60
$62,585,476.80
for Medicare eligible hospitals and
CAHs participating in the EHR Incentive
Program would result from the policies
in this proposed rule when compared to
the requirements of the current program.
Our estimates of the reduction in
burden cost savings are presented in
2017
391.4
$52,353,664.00
$68,604,592.00
426.4
$57,035,264.00
$74,739,392.00
Table 12. They reflect our assumptions
about the proportion of eligible
hospitals and CAHs that will
demonstrate meaningful use of certified
EHR technology outlined in Table 13
based on historical data.
TABLE 13—MEDICARE ELIGIBLE HOSPITALS AND CAHS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR
TECHNOLOGY
Calendar year
2015
Eligible Hospitals .............................................................................................................
CAHs ................................................................................................................................
Percent Demonstrating Meaningful Use ..........................................................................
Meaningful Users .............................................................................................................
2016
3,397
1,395
95
4,552
2017
3,397
1,395
97
4,648
3,397
1,395
99
4,744
TABLE 14—ESTIMATED COST REDUCTION FOR MEDICARE ELIGIBLE HOSPITALS AND CAHS
Calendar year
2015
Meaningful Users .......................................................................................................
Estimated Cost Savings ............................................................................................
4. Medicaid Only EPs
We estimate that significant cost
reductions for Medicaid only EPs
participating in the EHR Incentive
2016
2017
4,552
$756,861.04
4,648
$772,822.96
4,744
$788,784.88
Program will result from the policies in
this proposed rule when compared to
the requirements of the current program.
Our estimates of the reduction in
burden cost savings are presented in
Table 16. They reflect our assumptions
about the proportion of Medicaid only
EPs who will demonstrate meaningful
use of certified EHR technology outlined
in Table 15 based on historical data.
TABLE 15—MEDICAID ONLY EPS DEMONSTRATING MEANINGFUL USE
Calendar year
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2015
Medicaid only EPs .....................................................................................................
Percent of EPs who are Meaningful Users ...............................................................
Meaningful Users (in thousands) ...............................................................................
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51
30
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53
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TABLE 16—ESTIMATED COST REDUCTION FOR MEDICAID ONLY EPS
Calendar year
2015
Meaningful Users (in thousands) ...............................................................................
Lowest Estimated Cost Savings ................................................................................
Highest Estimated Cost Savings ...............................................................................
It should be noted that since the
Medicaid EHR Incentive Program
provides that a Medicaid EP can receive
an incentive payment in their first year
because he or she has demonstrated a
meaningful use or because he or she has
adopted, implemented, or upgraded
certified EHR technology, these
participation rates include only those
Medicaid providers who are expected to
demonstrate meaningful use. Providers
who are dual-eligible have been
included in the Medicare EP program
2016
30,000
$4,012,800.00
$5,258,400.00
estimates based on the total current
volume of Medicare EPs who have
demonstrated meaningful use in either
Medicare or Medicaid as of January 1,
2015.
b. Medicaid Only Hospitals
The burden reduction for Medicaid
only eligible hospitals assumes a similar
participation rate for the demonstration
of meaningful use as is applicable for
Medicare eligible hospitals. We estimate
that significant cost reductions for
2017
31,480
$4,210,764.80
$5,517,814.40
33,330
$4,458,220.80
$5,842,082.40
Medicaid only eligible hospitals
participating in the EHR Incentive
Program will result from the policies in
this proposed rule when compared to
the requirements of the current program.
Our estimates of the reduction in
burden cost savings are presented in
Table 18. They reflect our assumptions
about the proportion of Medicaid only
eligible hospitals that will demonstrate
meaningful use of certified EHR
technology outlined in Table 17 based
on historical data.
TABLE 17—MEDICAID ONLY ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY
Calendar year
2015
Eligible Hospitals .............................................................................................................
Percent Demonstrating Meaningful Use ..........................................................................
Meaningful Users .............................................................................................................
2016
108
95
103
2017
108
97
105
108
99
107
TABLE 18—ESTIMATED COST REDUCTION FOR MEDICARE ELIGIBLE HOSPITALS AND CAHS
Calendar year
2015
Meaningful Users .............................................................................................................
Estimated Cost Savings ..................................................................................................
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5. Benefits for all EPs and all Eligible
Hospitals
In this proposed rule, we have not
quantified the overall benefits to the
industry, nor to eligible hospitals or EPs
in the Medicare, Medicaid, or MA
programs. Although information on the
costs and benefits of adopting systems
that specifically meet the requirements
for the EHR Incentive Programs (for
example, certified EHR technology) has
not yet been collected, and although
some studies question the benefits of
health information technology, a 2011
study completed by ONC (Buntin et al,
2011 ‘‘The Benefits of Health
Information Technology: A Review of
the Recent Literature Shows
Predominantly Positive Results’’ Health
Affairs) found that 92 percent of articles
published from July 2007 up to
February 2010 reached conclusions that
showed the overall positive effects of
health information technology on key
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2017
4,552
$17,125.81
4,648
$17,458.35
4,744
$17,790.89
aspects of care, including quality and
efficiency of health care. Among the
positive results highlighted in these
articles were decreases in patient
mortality, reductions in staffing needs,
correlation of clinical decision support
to reduced transfusion and costs,
reduction in complications for patients
in hospitals with more advanced health
IT, and a reduction in costs for hospitals
with less advanced health IT. A
subsequent 2013 study completed by
the RAND Corporation for ONC
(Shekelle at al. 2013 ‘‘Health
Information Technology: An Updated
Systemic Review with a Focus on
Meaningful Use Functionalities) found
77 percent of articles published between
January 2010 to August 2013 that
evaluated the effects of health IT on
healthcare quality, safety, and efficiency
reported findings that were at least
partially positive. The Centers for
Disease Control and Prevention
publication in January 2014, (Hsiao et
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al, ‘‘Use and Characteristics of
Electronic Health Record Systems
Among Office-based Physician
Practices: United States, 2001–2013)
concluded that the adoption of basic
EHR systems by office-based physicians
increased 21 percent between 2012 and
2013, varying widely across the states
ranging from 21 percent in New Jersey
to 83 percent in North Dakota. Another
study, at one hospital emergency room
in Delaware, showed the ability to
download and create a file with a
patient’s medical history saved the ER
$545 per use, mostly in reduced waiting
times. A pilot study of ambulatory
practices found a positive ROI within 16
months and annual savings thereafter
(Greiger et al. 2007, A Pilot Study to
Document the Return on Investment for
Implementing an Ambulatory Electronic
Health Record at an Academic Medical
Center https://www.journalacs.org/
article/S1072-7515%2807%2900390-0/
abstract—article-footnote-1.) Another
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study compared the productivity of 75
providers within a large urban primary
care practice over a 4-year period
showed increases in productivity of 1.7
percent per month per provider after
EHR adoption (DeLeon et al. 2010, ‘‘The
business end of health information
technology’’). Some vendors have
estimated that EHRs could result in cost
savings of between $100 and $200 per
patient per year. The proposals in this
rule focus on a long term goal of moving
providers along a continuum from data
capture to advanced use of certified
EHR technology. The reduction of
reporting burden recognizes progress
toward key milestones and is intended
to allow providers to refocus on
leveraging health IT to support health
information exchange, patient
engagement, and quality improvement.
As participation and adoption increases,
there will be more opportunities to
capture and report on cost savings and
benefits.
6. Benefits to Society
According to the CBO study
‘‘Evidence on the Costs and Benefits of
Health Information Technology’’
(https://www.cbo.gov//ftpdocs/91xx/
doc9168/05-20-HealthIT.pdf) when
used effectively, EHRs can enable
providers to deliver health care more
efficiently. For example, the study states
that EHRs can reduce the duplication of
diagnostic tests, prompt providers to
prescribe cost-effective generic
medications, remind patients about
preventive care, reduce unnecessary
office visits, and assist in managing
complex care. This is consistent with
the findings in the ONC study cited
previously. Further, the CBO report
claims that there is a potential to gain
both internal and external savings from
widespread adoption of health IT,
noting that internal savings will likely
be in the reductions in the cost of
providing care, and that external savings
could accrue to the health insurance
plan or even the patient, such as the
ability to exchange information more
efficiently. However, it is important to
note that the CBO identifies the highest
gains accruing to large provider systems
and groups and claims that office-based
physicians may not realize similar
benefits from purchasing health IT
products. At this time, there is limited
data regarding the efficacy of health IT
for smaller practices and groups, and
the CBO report notes that this is a
potential area of research and analysis
that remains unexamined. The benefits
resulting specifically from this proposed
regulation are even harder to quantify
because they represent, in many cases,
the reduction in the time spent per each
individual respondent to attest to the
meaningful use objectives and
measures. While this time may
represent a reduced burden and the
opportunity to reallocate recourses,
there is no viable way to estimate that
benefit over a wide range of provider
types, practice sizes and other potential
variables. For example, the reduction of
about 2 hours per respondent for a small
practice might be insignificant;
however, for a practice of 1,000
providers it may represent as many as
2,000 man hours which could be
reallocated to making other
improvements in clinical processes and
patient outcomes. Conversely, a large
practice may instead leverage the batch
reporting option and only see an overall
reduction of 20 man hours as an
organization while a small practice may
find an even greater reduction than the
estimate which may amount to a
significantly increased benefit and more
time for the provider to spend in patient
care.
In the Stage 2 final rule, we discussed
research documenting the association of
EHRs with improved outcomes among
diabetics (Hunt, JS et al. (2009) ‘‘The
impact of a physician-directed health
information technology system on
diabetes outcomes in primary care: A
pre- and post-implementation study’’
Informatics in Primary Care 17(3):165–
74; Pollard, C et al. (2009) ‘‘Electronic
patient registries improve diabetes care
and clinical outcomes in rural
community health centers’’ Journal of
Rural Health 25(1):77–84) and trauma
patients (Deckelbaum, D. et al. (2009)
‘‘Electronic medical records and
mortality in trauma patients ‘‘The
Journal of Trauma: Injury, Infection, and
Critical Care 67(3): 634–636), enhanced
efficiencies in ambulatory care settings
(Chen, C et al. (2009) ‘‘The Kaiser
Permanente Electronic Health Record:
Transforming and Streamlining
Modalities Of Care. ‘‘Health Affairs’’
28(2):323–333), and improved outcomes
and lower costs in hospitals
(Amarasingham, R. et al. (2009)
‘‘Clinical information technologies and
inpatient outcomes: A multiple hospital
study’’ Archives of Internal Medicine
169(2):108–14). The 2013 ONC report
cited previously reported findings from
their literature review on health IT and
safety of care, health IT and quality of
care,, and health It and efficiency of care
in ambulatory and non-ambulatory care
settings. The report indicated that a
majority of studies that evaluated the
effects of health IT on healthcare
quality, safety, and efficiency reported
findings that were at least partially
positive. The report concluded that their
findings ‘‘suggested that health IT,
particularly those functionalities
included in the Meaningful Use . . . ,
can improve healthcare quality and
safety.’’
C. Accounting Statement
Whenever a rule is considered a
significant rule under Executive Order
12866, we are required to develop an
accounting statement indicating the
classification of the expenditures
associated with the provisions of this
proposed rule. This rule is considered
economically significant as mentioned
previously because the impacts directly
attributable with the proposals in this
rule would result in an overall
reduction in the reporting burden and
associated costs for providers
demonstrating meaningful use.
Monetary annualized benefits and
nonbudgetary costs are presented as
discounted flows using 3 percent and 7
percent factors.
TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COST REDUCTIONS AND BENEFITS CYS 2015
THROUGH 2017
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[In millions]
Benefits
Category
Low estimate
Annualized Monetized Cost Reductions to Private Industry
Associated with Reporting Requirements.
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2015
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High estimate
52.8
52.8
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TABLE 19—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COST REDUCTIONS AND BENEFITS CYS 2015
THROUGH 2017—Continued
[In millions]
Benefits
Category
Low estimate
High estimate
Qualitative—Other private industry and societal benefits
associated with the reduction in provider reporting burden and with having additional time to achieve meaningful use.
In this proposed rule, there is no
estimated increase in costs associated
with incentive payments or payment
adjustments for the Medicare and
Medicaid EHR Programs attributable to
the proposed policies.
D. Conclusion
The previous analysis, together with
the remainder of this preamble,
provides an RIA. We invite public
comments on the analysis and request
any additional data that will help us
determine more accurately the impact
on the EPs and eligible hospitals
affected by the proposed rule and on
Medicare and Medicaid payments to
these entities.
In accordance with the provisions of
Executive Order 12866, the Office of
Management and Budget reviewed this
rule.
List of Subjects in 42 CFR Part 495
Administrative practice and
procedure, Electronic health records,
Health facilities, Health professions,
Health maintenance organizations
(HMO), Medicaid, Medicare, Penalties,
Privacy, Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to further
amend 42 CFR part 495, as previously
proposed to be amended on March 30,
2015 (80 FR 16732), as follows:
PART 495—STANDARDS FOR THE
ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM
1. The authority citation for part 495
continues to read as follows:
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■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
§ 495.4
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Definitions.
*
2. Section 495.4 is amended as
follows:
■ A. Amend the definition of ‘‘EHR
reporting period’’ by:
■ i. In paragraph (1)(i) introductory text
removing the phrase ‘‘before CY 2017’’
and adding in its place the phrase
‘‘before CY 2015’’.
■
ii. Redesignating paragraph (1)(ii) as
paragraph (1)(iii).
■ iii. Adding a new paragraph (1)(ii).
■ iv. In paragraph (2)(i) introductory
text removing the phrase ‘‘before CY
2017’’ and adding in its place the phrase
‘‘before CY 2015’’.
■ v. Redesignating paragraph (2)(ii) as
paragraph (2)(iii).
■ vi. Adding a new paragraph (2)(ii).
■ B. Amend the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ by:
■ i. In paragraph (1)(i) introductory text
removing the phrase ‘‘before CY 2017’’
and adding in its place the phrase
‘‘before 2015’’.
■ ii. Redesignating paragraph (1)(ii) as
paragraph (1)(iii).
■ iii. Adding a new paragraph (1)(ii).
■ iv. In paragraph (2)(i) introductory
text removing the phrase ‘‘before CY
2017’’ and adding in its place the phrase
‘‘before CY 2015’’.
■ v. Redesignating paragraph (2)(ii) as
paragraph (2)(iii).
■ vi. Adding a new paragraph (2)(ii).
■ vii. In paragraph (3)(i) introductory
text removing the phrase ‘‘before CY
2017’’ and adding in its place the phrase
‘‘before CY 2015’’.
■ viii. Redesignating paragraph (3)(ii) as
paragraph (3)(iii).
■ ix. Adding a new paragraph (3)(ii).
■ C. Amend the definition of
‘‘Meaningful EHR user’’ by:
■ i. In paragraph (1), by removing the
reference ‘‘§ 495.8’’ and adding in its
place the reference ‘‘§§ 495.40’’.
■ ii. In paragraph (1), by removing the
reference ‘‘§ 495.6 or 495.7’’ and adding
in its place the reference ‘‘§§ 495.20,
495.22, and 495.24’’.
The additions read as follows:
■
*
*
*
*
EHR reporting period. * * *
(1) * * *
(ii) The following are applicable for
2015 and 2016:
(A) For the CY 2015 payment year,
any continuous 90-day period within
CY 2015.
(B) For the CY 2016 payment year:
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(1) For the EP first demonstrating he
or she is a meaningful EHR user, any
continuous 90-day period within CY
2016.
(2) For the EP who has successfully
demonstrated he or she is a meaningful
EHR user in any prior year, the CY 2016.
*
*
*
*
*
(2) * * *
(ii) The following are applicable for
2015 and 2016:
(A) For the FY 2015 payment year,
any continuous 90-day period within
the period beginning October 1, 2014
and ending December 31, 2015.
(B) For the FY 2016 payment year for
the eligible hospital or CAH—
(1) First demonstrating it is a
meaningful EHR user, any continuous
90-day period within CY 2016; or
(2) That has successfully
demonstrated it is a meaningful EHR
user in any prior year, the CY 2016.
*
*
*
*
*
EHR reporting period for a payment
adjustment year * * *
(1) * * *
(ii) The following are applicable for
2015 and 2016:
(A) For an EHR reporting period in
2015:
(1) Except as specified under
paragraph (1)(ii)(A)(2) of this definition,
any continuous 90-day period within
the calendar year that is 2 years before
the payment adjustment year.
(2) If in the calendar year that is 2
years before the payment adjustment
year and in all prior calendar years, the
EP has not successfully demonstrated he
or she is a meaningful EHR user, then
any continuous 90-day period within
the calendar year that is 1 year before
the payment adjustment year. The EP
must successfully register for and attest
to meaningful use by February 29, 2016.
(B) For an EHR reporting period in
2016:
(1) Except as specified in paragraphs
(1)(ii)(B)(2) and (3) of this definition, the
calendar year that is 2 years before the
payment adjustment year.
(2) If an EP is demonstrating he or she
is a meaningful EHR user for the first
time in the calendar year that is 2 years
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before the payment adjustment year,
then any continuous 90-day period
within such (2 years prior) calendar
year.
(3) If in the calendar year that is 2
years before the payment adjustment
year and in all prior calendar years, the
EP has not successfully demonstrated he
or she is a meaningful EHR user, then
any continuous 90-day period that both
begins in the calendar year 1 year before
the payment adjustment year and ends
at least 3 months before the end of such
prior year. The EP must successfully
register for and attest to meaningful use
by October 1, 2016.
*
*
*
*
*
(2) * * *
(ii) The following are applicable for
2015 and 2016:
(A) For an EHR reporting period in
2015:
(1) Except as specified in paragraph
(2)(ii)(A)(2) of this definition, any
continuous 90-day period within the
period beginning on October 1, 2014
and ending on the last day of the
calendar year that is 2 years before the
payment adjustment year.
(2) If in the calendar year that is 2
years before the payment adjustment
year and in all prior years, the eligible
hospital has not successfully
demonstrated it is a meaningful EHR
user, then any continuous 90-day period
within the period beginning on October
1, 2014 and ending on the last day of the
calendar year that is 1 year prior to the
payment adjustment year. The eligible
hospital must successfully register for
and attest to meaningful use by
February 29, 2016.
(B) For an EHR reporting period in
2016:
(1) Except as specified in paragraphs
(2)(ii)(B)(2) and (3) of this definition, the
calendar year that is 2 years before the
payment adjustment year.
(2) If an eligible hospital is
demonstrating that it is a meaningful
EHR user for the first time in the
calendar year that is 2 years before the
payment adjustment year, then any
continuous 90-day period within such
(2 years prior) calendar year.
(3) If in the calendar year that is 2
years before the payment adjustment
year and in all prior years, the eligible
hospital has not successfully
demonstrated it is a meaningful EHR
user, then any continuous 90-day period
that both begins in the calendar year
that is 1 year before the payment
adjustment year and ends at least 3
months before the end of such prior
calendar year. The eligible hospital
must successfully register for and attest
to meaningful use by October 1, 2016.
*
*
*
*
*
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(3) * * *
(ii) The following are applicable for
2015 and 2016:
(A) The EHR reporting period for the
FY 2015 payment adjustment year is
any continuous 90-day period within
the period beginning on October 1, 2014
and ending on December 31, 2015. The
CAH must successfully register for and
attest to meaningful use by February 29,
2016.
(B) For an EHR reporting period in
2016:
(1) Except as provided in paragraph
(3)(ii)(B)(2) of this definition, the CY
2016 is the EHR reporting period for the
FY 2016 payment adjustment year.
(2) If the CAH is demonstrating it is
a meaningful EHR user for the first time,
the EHR reporting period for the FY
2016 payment adjustment year is any
continuous 90-day period within CY
2016.
*
*
*
*
*
§ 495.6
[Redesignated as § 495.20]
3. Redesignate § 495.6 as § 495.20.
4. Newly redesignated § 495.20 is
amended by revising the section
heading and adding new introductory
text to read as follows.
■
■
§ 495.20 Meaningful use objectives and
measures for EPs, eligible hospitals, and
CAHs before 2015.
The following criteria are applicable
before 2015:
*
*
*
*
*
■ 5. Add § 495.22 to read as follows:
§ 495.22 Meaningful use objectives and
measures for EPs, eligible hospitals, and
CAHs for 2015 through 2017.
(a) General rules. (1) The criteria
specified in this section are applicable
for all EPs, eligible hospitals, and CAHs
for 2015 through 2017.
(2) For 2017 only, EPs, eligible
hospitals, and CAHs have the option to
use the criteria specified for 2018 (as
outlined at § 495.24) instead of the
criteria specified in this section.
(b) Criteria for EPs for 2015 through
2017—(1) General rule regarding criteria
for meaningful use for 2015 through
2017 for EPs. Except as specified in
paragraph (b)(2) of this section, EPs
must meet all objectives and associated
measures of the meaningful use criteria
specified under paragraph (e) of this
section to meet the definition of a
meaningful EHR user.
(2) Exclusion for nonapplicable
objectives. (i) An EP may exclude a
particular objective contained in
paragraph (e) of this section, if the EP
meets all of the following requirements:
(A) Must ensure that the objective in
paragraph (e) of this section includes an
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20393
option for the EP to attest that the
objective is not applicable.
(B) Meets the criteria in the applicable
objective that would permit the
attestation.
(C) Attests.
(ii) An exclusion will reduce (by the
number of exclusions applicable) the
number of objectives that would
otherwise apply in paragraph (e) of this
section.
(c) Criteria for eligible hospitals and
CAHs for 2015 through 2017—(1)
General rule regarding criteria for
meaningful use for 2015 through 2017
for eligible hospitals and CAHs. Except
as specified in paragraph (c)(2) of this
section, eligible hospitals and CAHs
must meet all objectives and associated
measures of the meaningful use criteria
specified under paragraph (e) of this
section to meet the definition of a
meaningful EHR user.
(2) Exclusion for nonapplicable
objectives. (i) An eligible hospital or
CAH may exclude a particular objective
contained in paragraph (e) of this
section, if the eligible hospital or CAH
meets all of the following requirements:
(A) Must ensure that the objective in
paragraph (e) of this section includes an
option for the eligible hospital or CAH
to attest that the objective is not
applicable.
(B) Meets the criteria in the applicable
objective that would permit the
attestation.
(C) Attests.
(ii) An exclusion will reduce (by the
number of exclusions applicable) the
number of objectives that would
otherwise apply in paragraph (e) of this
section.
(d) Many of the objectives and
associated measures in paragraph (e) of
this section rely on measures that count
unique patients or actions. (1) If a
measure (or associated objective) in
paragraph (e) of this section references
paragraph (d) of this section, then the
measure may be calculated by reviewing
only the actions for patients whose
records are maintained using certified
EHR technology. A patient’s record is
maintained using certified EHR
technology if sufficient data was entered
in the certified EHR technology to allow
the record to be saved, and not rejected
due to incomplete data.
(2) If the objective and associated
measure does not reference this
paragraph (d) of this section, then the
measure must be calculated by
reviewing all patient records, not just
those maintained using certified EHR
technology.
(e) Meaningful use objectives and
measures for 2015 through 2017—(1)
Protect patient health information—(i)
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Objective. Protect electronic protected
health information created or
maintained by the Certified EHR
Technology through the implementation
of appropriate technical capabilities.
(ii) Measures—(A) EP measure.
Conduct or review a security risk
analysis in accordance with the
requirements in 45 CFR 164.308(a)(1),
including addressing the security (to
include encryption) of ePHI created or
maintained in Certified EHR
Technology 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 EP’s risk management process.
(B) Eligible hospital or CAH measure.
Conduct or review a security risk
analysis in accordance with the
requirements under 45 CFR
164.308(a)(1), including addressing the
security (to include encryption) of ePHI
created or maintained in Certified EHR
Technology 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 eligible hospital’s or CAH’s risk
management process.
(2) Clinical decision support—(i)
Objective. Use clinical decision support
to improve performance on high-priority
health conditions.
(ii) EP measures—(A) Measure. In
order for EPs to meet the objective they
must satisfy both of the following
measures:
(1) Implement five clinical decision
support interventions related to four or
more clinical quality measures at a
relevant point in patient care for the
entire EHR reporting period. Absent
four clinical quality measures related to
an EP’s scope of practice or patient
population, the clinical decision
support interventions must be related to
high-priority health conditions.
(2) Enabled and implemented the
functionality for drug-drug and drugallergy interaction checks for the entire
EHR reporting period.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. An EP
who writes fewer than 100 medication
orders during the EHR reporting period
may be excluded from the measure
under paragraph (e)(2)(i)(A)(2) of this
section.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015—(1) Alternate exclusion.
An EP previously scheduled to be in
Stage 1 in 2015 may meet an alternate
measure specified in paragraph
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(e)(2)(ii)(C)(2) in place of the measure
outlined under paragraph (e)(2)(ii)(A)(1)
of this section.
(2) Alternate objective and measure—
(i) Alternate objective. Implement one
clinical decision support rule relevant
to specialty or high clinical priority
along with the ability to track
compliance with that rule.
(ii) Alternate measure. Implement one
clinical decision support rule.
(iii) Eligible hospital and CAH
measures—(A) Measure. In order for
eligible hospitals and CAHs to meet the
objective they must satisfy both of the
following measures:
(1) Implement five clinical decision
support interventions related to four or
more clinical quality measures at a
relevant point in patient care for the
entire EHR reporting period. Absent
four clinical quality measures related to
an eligible hospital or CAH’s scope of
practice or patient population, the
clinical decision support interventions
must be related to high-priority health
conditions.
(2) Enabled and implemented the
functionality for drug-drug and drugallergy interaction checks for the entire
EHR reporting period.
(B) Alternate specifications for an
EHR reporting period in 2015—(1)
Alternate objective and measure. An
eligible hospital or CAH previously
scheduled to be in Stage 1 in 2015 may
meet an alternate measure described in
paragraph (e)(2)(iii)(B)(2) of this section
in place of the measure described in
paragraph (e)(2)(iii)(A)(1) of this section.
(i) Objective. Implement one clinical
decision support rule related to a high
priority hospital condition along with
the ability to track compliance with that
rule.
(ii) Measure. Implement one clinical
decision support rule.
(3) Computerized provider order
entry—(i) Objective. Use computerized
provider order entry 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.
(ii) EP measures—(A) Measures. An
EP must meet the following 3 measures,
subject to paragraph (d) of this section:
(1) More than 60 percent of
medication orders created by the EP
during the EHR reporting period are
recorded using computerized provider
order entry.
(2) More than 30 percent of laboratory
orders created by the EP during the EHR
reporting period are recorded using
computerized provider order entry.
(3) More than 30 percent of radiology
orders created by the EP during the EHR
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reporting period are recorded using
computerized provider order entry.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. (1) For
the measure specified in paragraph
(e)(3)(ii)(A)(1) of this section, any EP
who writes fewer than 100 medication
orders during the EHR reporting period.
(2) For the measure specified in
paragraph (e)(3)(ii)(A)(2) of this section,
any EP who writes fewer than 100
laboratory orders during the EHR
reporting period.
(3) For the measure specified in
paragraph (e)(3)(ii)(A)(3) of this section,
any EP who writes fewer than 100
radiology orders during the EHR
reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015—(1) An EP previously
scheduled to be in Stage 1 in 2015 may
meet an alternate measure (e)(3)(ii)(C)(2)
in place of the measure outlined under
paragraph (e)(3)(ii)(A)(1) of this section,
and may exclude the measures outlined
under paragraphs (e)(3)(ii)(A)(2) and (3)
of this section.
(2) Subject to paragraph (d) of this
section—
(i) More than 30 percent of all unique
patients with at least one medication in
their medication list seen by the EP
during the EHR reporting period have at
least one medication order entered
using CPOE; or
(ii) More than 30 percent of
medication orders created by the EP
during the EHR reporting period are
recorded using computerized provider
order entry.
(3) Alternate exclusions. An EP
previously scheduled to be in Stage 1 in
2015 may exclude the measure—
(i) Specified in paragraph
(e)(3)(ii)(A)(2) of this section for an EHR
reporting period in 2015.
(ii) Specified in paragraph
(e)(3)(ii)(A)(3) of this section for an EHR
reporting period in 2015.
(iii) Eligible hospital and CAH
measures—(A) An eligible hospital or
CAH must meet the following 3
measures, subject to paragraph (d) of
this section:
(1) More than 60 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 recorded using
computerized provider order entry.
(2) More than 30 percent of laboratory
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 recorded using computerized
provider order entry.
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(3) More than 30 percent of radiology
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 recorded using computerized
provider order entry.
(B) Alternate exclusions and
specifications for an EHR reporting
period in 2015. (1) An eligible hospital
or CAH previously scheduled to be in
Stage 1 in 2015 may—
(i) Meet an alternate measure
specified in paragraph (e)(3)(iii)(B)(2) of
this section in place of the measure
outlined under paragraph
(e)(3)(iii)(A)(1) of this section; and
(ii) May exclude the measures
outlined under paragraphs
(e)(3)(iii)(A)(2) and (e)(3)(iii)(A)(3) of
this section.
(2) Alternate measure 1. Subject to
paragraph (d) of this section,
(i) More than 30 percent of all unique
patients with at least one medication in
their medication list admitted to the
eligible hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23)
have at least one medication order
entered using CPOE; or
(ii) More than 30 percent of
medication orders created by the
authorized providers of the eligible
hospital or CAH for patients admitted to
their inpatient or emergency
departments (POS 21 or 23) during the
EHR reporting period are recorded using
computerized provider order entry.
(3) Alternate exclusions. An eligible
hospital or CAH previously scheduled
to be in Stage 1 in 2015 may exclude the
measure specified—
(i) In paragraph (e)(3)(iii)(A)(2) of this
section for an EHR reporting period in
2015; or
(ii) In paragraph (e)(3)(iii)(A)(3) of this
section for an EHR reporting period in
2015.
(4) Electronic prescribing—(i)
Objective. For EPs, generate and
transmit permissible prescriptions
electronically (eRx); and, for eligible
hospitals and CAHs, generate and
transmit permissible discharge
prescriptions electronically (eRx).
(ii) EP measure—(A) Measure. Subject
to paragraph (d) of this section, more
than 50 percent of all permissible
prescriptions, or all prescriptions,
written by the EP are queried for a drug
formulary and transmitted electronically
using Certified EHR Technology.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. Any EP
who—
(1) Writes fewer than 100 permissible
prescriptions during the EHR reporting
period; or
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(2) Does not have a pharmacy within
his or her organization and there are no
pharmacies that accept electronic
prescriptions within 10 miles of the EP’s
practice location at the start of his or her
EHR reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
meet an alternate measure under
paragraph (e)(4)(ii)(C)(2) of this section
in place of the measure outlined under
paragraph (e)(4)(ii)(A) of this section.
(1) Alternate measure. Subject to
paragraph (d) of this section, more than
40 percent of all permissible
prescriptions written by the EP are
transmitted electronically using
Certified EHR Technology.
(2) Alternate exclusion. There are no
alternate exclusions for this measure
(iii) Eligible hospital and CAH
measure—(A) Measure. Subject to
paragraph (d) of this section, more than
10 percent of hospital discharge
medication orders for permissible
prescriptions (for new, changed, and
refilled prescriptions) are queried for a
drug formulary and transmitted
electronically using Certified EHR
Technology.
(B) Exclusion in accordance with
paragraph (c)(2) of this section. Any
eligible hospital or CAH that does not
have an internal pharmacy that can
accept electronic prescriptions and is
not located within 10 miles of any
pharmacy that accepts electronic
prescriptions at the start of their EHR
reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An eligible hospital or
CAH previously scheduled to be in—
(1) Stage 1 in 2015 may exclude the
measure specified in paragraph
(e)(4)(iii)(A) of this section for an EHR
reporting period in 2015; or
(2) Stage 2 in 2015 may exclude the
measure specified in paragraph
(e)(4)(iii)(A) of this section for an EHR
reporting period in 2015 if they did not
previously intend to select the Stage 2
Electronic Prescribing Menu Objective
for an EHR reporting period in 2015.
(5) Summary of care—(i) Objective.
The EP, eligible hospital or CAH who
transitions a patient to another setting of
care or provider of care or refers a
patient to another provider of care
provides a summary care record for each
transition of care or referral.
(ii) EP measure—(A) Measure. Subject
to paragraph (d) of this section, the EP
who transitions or refers his or her
patient to another setting of care or
provider of care must do the following:
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(1) Use CEHRT to create a summary
of care record.
(2) Electronically transmit such
summary to a receiving provider for
more than 10 percent of transitions of
care and referrals.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. Any EP
who transfers a patient to another
setting or refers a patient to another
provider less than 100 times during the
EHR reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
exclude the measure specified in
paragraph (e)(5)(ii)(A) of this section for
an EHR reporting period in 2015.
(iii) Eligible hospital and CAH
measure—(A) Measure. Subject to
paragraph (d) of this section, the eligible
hospital or CAH that transitions or
refers its patient to another setting of
care or provider of care must do the
following:
(1) Use CEHRT to create a summary
of care record.
(2) Electronically transmit such
summary to a receiving provider for
more than 10 percent of transitions of
care and referrals.
(B) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An eligible hospital or
CAH previously scheduled to be in
Stage 1 in 2015 may exclude the
measure specified in paragraph
(e)(5)(iii)(A) of this section for an EHR
reporting period in 2015.
(6) Patient specific education—(i)
Objective. Use clinically relevant
information from Certified EHR
Technology to identify patient-specific
education resources and provide those
resources to the patient.
(ii) EP measure—(A) Measure.
Patient-specific education resources
identified by Certified EHR Technology
are provided to patients for more than
10 percent of all unique patients with
office visits seen by the EP during the
EHR reporting period.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. Any EP
who has no office visits during the EHR
reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
exclude the measure specified in
paragraph (e)(6)(ii)(A) of this section for
an EHR reporting period in 2015 if the
EP did not previously intend to select
the Stage 1 Patient-Specific Education
Resources Menu Objective for an EHR
reporting period in 2015.
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(iii) Eligible hospital and CAH
measure—(A) Measure. More than 10
percent of all unique patients admitted
to the eligible hospital’s or CAH’s
inpatient or emergency department
(POS 21 or 23) are provided patientspecific education resources identified
by Certified EHR Technology.
(B) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An eligible hospital or
CAH previously scheduled to be in
Stage 1 in 2015 may exclude the
measure specified in paragraph
(e)(6)(iii)(A) of this section for an EHR
reporting period in 2015 if they did not
previously intend to select the Stage 1
Patient-Specific Education Resources
Menu Objective for an EHR reporting
period in 2015.
(7) Medication reconciliation—(i)
Objective. The EP, eligible hospital or
CAH that receives a patient from
another setting of care or provider of
care or believes an encounter is relevant
should perform medication
reconciliation.
(ii) EP measure—(A) Measure. Subject
to paragraph (d) of this section, the EP
performs medication reconciliation for
more than 50 percent of transitions of
care in which the patient is transitioned
into the care of the EP.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. Any EP
who was not the recipient of any
transitions of care during the EHR
reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
exclude the measure specified in
paragraph (e)(7)(ii)(A) of this section for
an EHR reporting period in 2015 if they
did not previously intend to select the
Stage 1 Medication Reconciliation Menu
Objective for an EHR reporting period in
2015.
(iii) Eligible hospital or CAH measure.
An eligible hospital or CAH must meet
the following measure, subject to
paragraph (d) of this section:
(A) Measure. Subject to paragraph (d)
of this section, the eligible hospital or
CAH performs medication
reconciliation for more than 50 percent
of transitions of care in which the
patient is admitted to the eligible
hospital’s or CAH’s inpatient or
emergency department (POS 21 or 23).
(B) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An eligible hospital or
CAH previously scheduled to be in
Stage 1 in 2015 may exclude the
measure specified in paragraph
(e)(7)(iii)(A) of this section for an EHR
reporting period in 2015 if they did not
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previously intend to select the Stage 1
Medication Reconciliation Menu
Objective for an EHR reporting period in
2015.
(8) Patient electronic access—(i) 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.
(A) EP measures. An EP must meet
the following 2 measures:
(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) At least 1 patient seen by the EP
during the EHR reporting period (or
their authorized representatives) views,
downloads, or transmits his or her
health information to a third party.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. (1) Any
EP who neither orders nor creates any
of the information listed for inclusion as
part of the measure in paragraph
(e)(8)(ii)(A)(1) or (2) of this section,
except for ‘‘Patient name’’ and
‘‘Provider’s name and office contact
information,’’ is excluded from both
paragraphs (e)(8)(ii)(A)(1) and (2) of this
section.
(2) Any EP who 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 Federal
Communications Commission on the
first day of the EHR reporting period is
excluded from paragraph (e)(8)(ii)(A)(2)
of this section.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
exclude the measure specified in
paragraph (e)(8)(ii)(A)(2) of this section
for an EHR reporting period in 2015.
(ii) Eligible hospital and CAH
objective. Provide patients the ability to
view online, download, and transmit
information within 36 hours of hospital
discharge .
(A) Eligible hospital and CAH
measures. An eligible hospital or CAH
must meet the following 2 measures:
(1) More than 50 percent of all unique
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.
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(2) At least 1 patient(or the patient’s
authorized representative) who is
discharged from the inpatient or
emergency department (POS 21 or 23) of
an eligible hospital or CAH views,
downloads or transmits to a third party
his or her information during the EHR
reporting period.
(B) Exclusion applicable under (c)(2)
of this section. Any eligible hospital or
CAH that is located 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
is excluded from paragraph
(e)(8)(iii)(A)(2) of this section.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An eligible hospital or
CAH previously scheduled to be in
Stage 1 in 2015 may exclude the
measure specified in paragraph
(e)(8)(iii)(A)(2) of this section for an
EHR reporting period in 2015.
(9) Secure messaging—(i) EP
objective. Use secure electronic
messaging to communicate with
patients on relevant health information.
(ii) EP measure—(A) Measure. The
capability for patients to send and
receive a secure electronic message with
the EP was fully enabled during the
EHR reporting period.
(B) Exclusion in accordance with
paragraph (b)(2) of this section. An EP
may exclude from the measure if he or
she—
(1) Has no office visits during the EHR
reporting period; or
(2) 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
Federal Communications Commission
on the first day of the EP’s EHR
reporting period.
(C) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
exclude the measure specified in
paragraph (e)(9)(ii)(A) of this section for
an EHR reporting period in 2015.
(10) Public Health and Clinical Data
Registry reporting—(i) EP Public Health
and Clinical Data Registry reporting—
(A) Objective. The EP is in active
engagement with a public health agency
or clinical data registry to submit
electronic public health data in a
meaningful way using certified EHR
technology, except where prohibited,
and in accordance with applicable law
and practice.
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(B) Measures. In order to meet the
objective under paragraph (e)(10)(i)(A)
of this section, an EP must choose from
measures 1 through 5 (as specified in
paragraphs (e)(10)(i)(B)(1) through
(e)(10)(i)(B)(5) of this section) and must
successfully attest to any combination of
two measures. These measures may be
met by any combination, including
meeting measures specified in
paragraph (e)(10)(i)(B)(4) or (5) of this
section multiple times in accordance
with applicable law and practice.
(1) Immunization registry reporting:
The EP is in active engagement with a
public health agency to submit
immunization data and receive
immunization forecasts and histories
from the public health immunization
registry/immunization information
system (IIS).
(2) Syndromic surveillance reporting.
The EP is in active engagement with a
public health agency to submit
syndromic surveillance data from a nonurgent care ambulatory setting.
(3) Case reporting. The EP is in active
engagement with a public health agency
to submit case reporting of reportable
conditions.
(4) Public health registry reporting.
The EP is in active engagement with a
public health agency to submit data to
public health registries.
(5) Clinical data registry reporting.
The EP is in active engagement to
submit data to a clinical data registry.
(C) Exclusions in accordance with
paragraph (b)(2) of this section. (1) Any
EP meeting one or more of the following
criteria may be excluded from the
immunization registry reporting
measure in paragraph (e)(10)(i)(B)(1) of
this section if the EP:
(i) Does not administer any
immunizations to any of the
populations for which data is collected
by his or her jurisdiction’s
immunization registry or immunization
information system during the EHR
reporting period.
(ii) Operates in a jurisdiction for
which no immunization registry or
immunization information system is
capable of accepting the specific
standards required to meet the CEHRT
definition at the start of his or her EHR
reporting period.
(iii) Operates in a jurisdiction where
no immunization registry or
immunization information system has
declared readiness to receive
immunization data from the EP at the
start of the EHR reporting period.
(2) Any EP meeting one or more of the
following criteria may be excluded from
the syndromic surveillance reporting
measure described in paragraph
(e)(10)(i)(B)(2) of the section if the EP:
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(i) Does not treat or diagnose or
directly treat any disease or condition
associated with a syndromic
surveillance system in his or her
jurisdiction.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic
syndromic surveillance data from EPs in
the specific standards required to meet
the CEHRT definition at the start of the
EHR reporting period.
(iii) Operates in a jurisdiction where
no public health agency has declared
readiness to receive syndromic
surveillance data from EPs at the start of
the EHR reporting period.
(3) An EP meeting one or more of the
following criteria may be excluded from
the case reporting measure at
(e)(10)(i)(B)(3) if the EP:
(i) Does not treat or diagnose any
reportable diseases for which data is
collected by his or her jurisdiction’s
reportable disease system during the
EHR reporting period.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic case
reporting data in the specific standards
required to meet the CEHRT definition
at the start of his or her EHR reporting
period.
(iii) Operates in a jurisdiction where
no public health agency has declared
readiness to receive electronic case
reporting data at the start of the EHR
reporting period.
(4) Any EP meeting at least one of the
following criteria may be excluded from
the public health registry reporting
measure specified in paragraph
(e)(10)(i)(B)(4) of this section if the EP:
(i) Does not diagnose or directly treat
any disease or condition associated with
a public health registry in his or her
jurisdiction during the EHR reporting
period.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of accepting electronic registry
transactions in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where
no public health registry for which the
EP is eligible has declared readiness to
receive electronic registry transactions
at the start of the EHR reporting period.
(5) Any EP meeting at least one of the
following criteria may be excluded from
the clinical data registry reporting
measure specified in paragraph
(e)(10)(i)(B)(5) of this section if the EP:
(i) Does not diagnose or directly treat
any disease or condition associated with
a clinical data registry in his or her
jurisdiction during the EHR reporting
period.
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(ii) Operates in a jurisdiction for
which no clinical data registry is
capable of accepting electronic registry
transactions in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where
no clinical data registry for which the
EP is eligible has declared readiness to
receive electronic registry transactions
at the start of the EHR reporting period.
(D) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An EP previously
scheduled to be in Stage 1 in 2015 may
choose from measures 1 through 5 (as
specified in paragraphs (e)(10)(i)(B)(1)
through (e)(10)(i)(B)(5) of this section)
and must successfully attest to any one
measure in accordance with applicable
law and practice for an EHR reporting
period in 2015.
(ii) Eligible hospital and CAH Public
Health and Clinical Data Registry
reporting objective—(A) Objective. The
eligible hospital or CAH is in active
engagement with a public health agency
or clinical data registry to submit
electronic public health data in a
meaningful way using certified EHR
technology, except where prohibited,
and in accordance with applicable law
and practice.
(B) Measures. In order to meet the
objective under paragraph (e)(10)(ii)(A)
of this section, an eligible hospital or
CAH must choose from measures 1
through 6 (as described in paragraphs
(e)(10)(ii)(B)(1) through (e)(10)(ii)(B)(6)
of this section) and must successfully
attest to any combination of three
measures. These measures may be met
by any combination, including meeting
the measures specified in paragraph
(e)(10)(ii)(B)(4) or (5) of this section
multiple times, in accordance with
applicable law and practice:
(1) Immunization registry reporting.
The eligible hospital or CAH is in active
engagement with a public health agency
to submit immunization data and
receive immunization forecasts and
histories from the public health
immunization registry/immunization
information system (IIS).
(2) Syndromic surveillance reporting.
The eligible hospital or CAH is in active
engagement with a public health agency
to submit syndromic surveillance data
from an emergency or urgent care
department (POS 23).
(3) Case reporting. The eligible
hospital or CAH is in active engagement
with a public health agency to submit
case reporting of reportable conditions.
(4) Public health registry reporting.
The eligible hospital or CAH is in active
engagement with a public health agency
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to submit data to public health
registries.
(5) Clinical data registry reporting.
The eligible hospital or CAH is in active
engagement to submit data to a clinical
data registry.
(6) Electronic reportable laboratory
result reporting. The eligible hospital or
CAH is in active engagement with a
public health agency to submit
electronic reportable laboratory results.
(C) Exclusions in accordance with
paragraph (c)(2) of this section. (1) Any
eligible hospital or CAH meeting one or
more of the following criteria may be
excluded from the immunization
registry reporting measure specified in
paragraph (e)(10)(ii)(B)(1) of this section
if the eligible hospital or CAH:
(i) Does not administer any
immunizations to any of the
populations for which data is collected
by its jurisdiction’s immunization
registry or immunization information
system during the EHR reporting period.
(ii) Operates in a jurisdiction for
which no immunization registry or
immunization information system is
capable of accepting the specific
standards required to meet the CEHRT
definition at the start of the EHR
reporting period.
(iii) Operates in a jurisdiction where
no immunization registry or
immunization information system has
declared readiness to receive
immunization data from the eligible
hospital or CAH at the start of the EHR
reporting period.
(2) Any eligible hospital or CAH
meeting one or more of the following
criteria may be excluded from the
syndromic surveillance reporting
measure specified in paragraph
(e)(10)(ii)(B)(2) of this section if the
eligible hospital or CAH:
(i) Does not have an emergency or
urgent care department.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic
syndromic surveillance data from
eligible hospitals or CAHs in the
specific standards required to meet the
CEHRT definition at the start of the EHR
reporting period.
(iii) Operates in a jurisdiction where
no public health agency has declared
readiness to receive syndromic
surveillance data from eligible hospitals
or CAHs at the start of the EHR
reporting period.
(3) An eligible hospital or CAH
meeting one or more of the following
criteria may be excluded from the case
reporting measure specified in
paragraph (e)(10)(ii)(B)(3) of this section
if the eligible hospital or CAH:
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(i) Does not treat or diagnose any
reportable diseases for which data is
collected by its jurisdiction’s reportable
disease system during the EHR reporting
period.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic case
reporting data in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where
no public health agency has declared
readiness to receive electronic case
reporting data at the start of the EHR
reporting period.
(4) Any eligible hospital or CAH
meeting at least one of the following
criteria may be excluded from the
public health registry reporting measure
specified in paragraph (e)(10)(ii)(B)(4) of
this section if the eligible hospital or
CAH:
(i) Does not diagnose or directly treat
any disease or condition associated with
a public health registry in their
jurisdiction during the EHR reporting
period.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of accepting electronic registry
transactions in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period
(iii) Operates in a jurisdiction where
no public health registry for which the
eligible hospital or CAH is eligible has
declared readiness to receive electronic
registry transactions at the start of the
EHR reporting period.
(5) Any eligible hospital or CAH
meeting at least one of the following
criteria may be excluded from the
clinical data registry reporting measure
specified in paragraph (e)(10)(ii)(B)(5) of
this section if the eligible hospital or
CAH:
(i) Does not diagnose or directly treat
any disease or condition associated with
a clinical data registry in their
jurisdiction during the EHR reporting
period.
(ii) Operates in a jurisdiction where
no clinical data registry for which no
clinical data registry is capable of
accepting electronic registry
transactions in the specific standards
required to meet the CEHRT definition
at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where
no clinical data registry for which the
eligible hospital or CAH is eligible has
declared readiness to receive electronic
registry transactions at the beginning of
the EHR reporting period.
(6) Any eligible hospital or CAH
meeting one or more of the following
criteria may be excluded from the
electronic reportable laboratory result
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reporting measure specified in
paragraph (d)(10)(ii)(B)(6) of this section
if the eligible hospital or CAH:
(i) Does not perform or order
laboratory tests that are reportable in the
eligible hospital’s or CAH’s jurisdiction
during the EHR reporting period
(ii) Operates in a jurisdiction for
which no public health agency that is
capable of accepting the specific ELR
standards required to meet the CEHRT
definition at the start of the EHR
reporting period.
(iii) Operates in a jurisdiction where
no public health agency has declared
readiness to receive electronic
reportable laboratory results from
eligible hospitals or CAHs at the start of
the EHR reporting period.
(D) Alternate exclusions and
specifications for an EHR reporting
period in 2015. An eligible hospital or
CAH previously scheduled to be in
Stage 1 in 2015 may choose from
measures 1 through 6 (as specified in
paragraphs (e)(10)(ii)(B)(1) through
(e)(10)(ii)(B)(6) of this section) and must
successfully attest to any 2 measures.
These measures may be met by any
combination, including meeting the
measures specified in paragraph
(e)(10)(ii)(B)(4) or (5) of this section
multiple times, in accordance with
applicable law and practice.
§ 495.7
■
[Redesginated as § 495.24]
6. Redesignate § 495.7 as § 495.24.
§ 495.8
[Redesginated as § 495.40]
7. Redesignate § 495.8 as § 495.40.
8. Newly redesignated § 495.40 is
amended by:
■ A. In paragraph (a) introductory text
by removing the cross-reference ‘‘under
§ 495.6 or § 495.7’’ and adding in its
place the cross-reference ‘‘under
§ 495.20 or § 495.24’’.
■ B. In paragraph (a)(1)(i)(B) by
removing the cross-reference ‘‘under
§ 495.6 or § 495.7’’ and adding in its
place the cross-reference ‘‘under
§ 495.20 or § 495.24’’.
■ C. In paragraph (a)(1)(iii) by removing
the cross-reference ‘‘in § 495.6 or § 495.7
and § 495.8’’ and adding in its place the
cross-reference ‘‘in § 495.20 or § 495.24
and § 495.40’’.
■ D. Revising paragraph (a)(2)(i)(B).
■ E. In paragraph (a)(2)(i)(D) by
removing the cross-reference ‘‘under
§ 495.6(a)(4) or (h)(3)’’ and adding in its
place the cross-reference ‘‘in
§ 495.20(a)(4) or (h)(3)’’.
■ F. Redesignating paragraph (a)(2)(i)(E)
as paragraph (a)(2)(i)(F).
■ G. Adding a new paragraph
(a)(2)(i)(E).
■ H. Revising newly redesignated
paragraph (a)(2)(i)(F).
■
■
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I. Adding paragraph (a)(2)(i)(G).
J. In paragraph (a)(2)(iv) by removing
the cross-reference ‘‘in § 495.6 or § 495.7
and § 495.8’’ and adding in its place the
cross-reference ‘‘in § 495.20 or § 495.24
and § 495.40’’.
■ K. In paragraph (b)(1)(i)(B) by
removing the cross-reference ‘‘under
§ 495.6 or § 495.7’’ and adding in its
place the cross-reference ‘‘under
§ 495.20 or § 495.24’’.
■ L. In paragraph (b)(1)(iii) by removing
the cross-reference ‘‘in § 495.6 or § 495.7
and § 495.8’’ and adding in its place the
cross-reference ‘‘in § 495.20 or § 495.24
and § 495.40’’.
■ M. Revising paragraph (b)(2)(i)(B).
■ N. In paragraph (b)(2)(i)(D) by
removing the cross-reference ‘‘under
§ 495.6(b)(4) or (i)(3)’’ and adding in its
place the cross-reference ‘‘in
§ 495.20(b)(4) or (h)(3)’’.
■ O. Redesignating paragraph (b)(2)(i)(E)
as paragraph (b)(2)(i)(F).
■ P. Adding a new paragraph
(b)(2)(i)(E).
■ Q. Revising newly redesignated
paragraph (b)(2)(i)(F).
■ R. Adding paragraph (b)(2)(i)(G).
The revisions and additions read as
follows:
■
■
§ 495.40
criteria.
Demonstration of meaningful use
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(2) * * *
(i) * * *
(B) For calendar years before 2015,
satisfied the required objectives and
associated measures under § 495.20 for
the EP’s stage of meaningful use.
*
*
*
*
*
(E) For CYs 2015 through 2017,
satisfied the required objectives and
associated measures under § 495.22(e)
for meaningful use.
(F) For CY 2017 only, an EP may
satisfy either of the following objectives
and measures for meaningful use:
(1) Objectives and measures specified
in § 495.22(e).
(2) Objectives and measures specified
in § 495.24(d)
(G) For CY 2018 and subsequent
years, satisfied the required objectives
and associated measures under
§ 495.24(d) for meaningful use.
*
*
*
*
*
(b) * * *
(2) * * *
(i) * * *
(B) For fiscal years before 2015,
satisfied the required objectives and
associated measures under § 495.20 for
the eligible hospital or CAH’s stage of
meaningful use.
*
*
*
*
*
(E) For CYs 2015 through 2017,
satisfied the required objectives and
PO 00000
Frm 00055
Fmt 4701
Sfmt 9990
20399
associated measures under § 495.22(e)
for meaningful use.
(F) For CY 2017 only, an eligible
hospital or CAH may satisfy either of
the following objectives and measures
for meaningful use:
(1) Objectives and measures specified
at § 495.22(e); or
(2) Objectives and measures specified
at § 495.24(d).
(G) For CY 2018 and subsequent
years, satisfied the required objectives
and associated measures under
§ 495.24(h) for meaningful use.
*
*
*
*
*
§ 495.10
■
[Redesginated as § 495.60]
9. Redesignate § 495.10 as § 495.60.
Dated: April 2, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: April 8, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2015–08514 Filed 4–10–15; 4:15 pm]
BILLING CODE 4120–01–P
E:\FR\FM\15APP3.SGM
15APP3
]]>Agencies
[Federal Register Volume 80, Number 72 (Wednesday, April 15, 2015)]
[Proposed Rules]
[Pages 20345-20399]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08514]
[[Page 20345]]
Vol. 80
Wednesday,
No. 72
April 15, 2015
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 495
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program--Modifications to Meaningful Use in 2015 Through 2017; Proposed
Rule
Federal Register / Vol. 80 , No. 72 / Wednesday, April 15, 2015 /
Proposed Rules
[[Page 20346]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 495
[CMS-3311-P]
RIN 0938-AS58
Medicare and Medicaid Programs; Electronic Health Record
Incentive Program--Modifications to Meaningful Use in 2015 Through 2017
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would change the Medicare and Medicaid
Electronic Health Record (EHR) Incentive Program EHR reporting period
in 2015 to a 90-day period aligned with the calendar year, and also
would align the EHR reporting period in 2016 with the calendar year. In
addition, this proposed rule would modify the patient action measures
in the Stage 2 objectives related to patient engagement. Finally, it
would streamline the program by removing reporting requirements on
measures which have become redundant, duplicative, or topped out
through advancements in EHR function and provider performance for Stage
1 and Stage 2 of the Medicare and Medicaid EHR Incentive Programs.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on June 15, 2015.
ADDRESSES: In commenting, please refer to file code CMS-3311-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 https://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-3311-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-3311-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) 786-7195 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, Medicare EHR Incentive Program
and Medicare payment adjustment.
Elisabeth Myers (CMS), (410) 786-4751, Medicare EHR Incentive
Program.
Thomas Romano (CMS), (410) 786-0465, Medicaid EHR Incentive
Program.
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: https://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)
ACO--Accountable Care Organization
AIU--Adopt, Implement, Upgrade (certified EHR Technology)
CAH--Critical Access Hospitals
CAHPS--Consumer Assessment of Healthcare Providers and Systems
CCN--CMS Certification Number
CDC--Centers for Disease Control
CEHRT--Certified Electronic Health Record Technology
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 and Medicaid Services
CPOE--Computerized Physician Order Entry
CQM--Clinical Quality Measure
CY--Calendar Year
EHR--Electronic Health Record
EP--Eligible Professional
ePHI--Electronic Protected Health Information
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
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 Resources and Services Administration
IAPD--Implementation Advanced Planning Document
ICR--Information Collection Requirement
IHS--Indian Health Service
IPA--Independent Practice Association
IPPS--Inpatient Prospective Payment System
[[Page 20347]]
IQR--Inpatient Quality Reporting
IT--Information Technology
MA--Medicare Advantage
MAC--Medicare Administrative Contractor
MCO--Managed Care Organization
MITA--Medicaid Information Technology Architecture
MMIS--Medicaid Management Information Systems
MSA--Medical Savings Account
MU--Meaningful Use
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
NQF--National Quality Forum
ONC--Office of the National Coordinator for Health Information
Technology
PAHP--Prepaid Ambulatory Health Plan
PAPD--Planning Advanced 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
PQRS--Physician Quality Reporting System
PHI --Protected Health Information
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
I. Executive Summary and Background
A. Executive Summary
1. Purpose of Regulatory Action
a. Need for Regulatory Action
In this proposed rule, we would implement changes to Stage 1 and
Stage 2 of the Medicare and Medicaid EHR Incentive Programs. In the
March 30, 2015 Federal Register (80 FR 16731 through 16804), we
published in the proposed rule for Stage 3 of meaningful use which
included changes to the objectives and measures of meaningful use for
providers beginning in 2017. These changes included removing redundant,
duplicative, and topped out measures, and focusing the EHR Incentive
Programs on advanced use of EHR technology. In order to reduce
reporting burden, eliminate redundant and duplicative reporting, and to
better align the objectives and measures of meaningful use for 2015
through 2017 with the proposed Stage 3 requirements which would be
optional in 2017 and required beginning in 2018, we are proposing to
make similar modifications to Stage 1 and Stage 2 of the EHR Incentive
Programs.
In addition, in order to accommodate these changes, we propose
additional modifications to the EHR reporting period and timeline of
the Medicare and Medicaid EHR Incentive Programs in 2015 and 2016. We
believe these changes would better align reporting periods for
providers, support a flexible, clear framework to reduce provider
burden, and ensure future sustainability of 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 Technology (CEHRT). 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, MA organizations (for
certain qualifying EPs and hospitals that meaningfully use CEHRT),
subsection (d) hospitals, and 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 CEHRT 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 the
statutory basis for the EHR incentive payments, see the July 28, 2010
Stage 1 final rule (75 FR 44316 through 44317).)
2. Summary of Major Provisions
a. Aligning Meaningful Use in 2015 Through 2017 With the Stage 3
Proposals for Meaningful Use in 2017 and Subsequent Years
The Stage 1 final rule sets the foundation for the Medicare and
Medicaid EHR Incentive Programs by establishing requirements for the
electronic capture of clinical data, including providing patients with
electronic copies of health information. We outlined Stage 1 meaningful
use criteria, and finalized core and menu objectives for EPs, eligible
hospitals, and CAHs. (For a full discussion of the objectives and
measures of Stage 1, we refer readers to the Stage 1 final rule at 75
FR 44313 through 44588.) In the Stage 1 rulemaking, we discussed the
idea that alignment of stage of meaningful use and payment year should
synchronize for all providers in 2015. However, while we stated a goal
to align the stages of meaningful use across all providers in 2015 (75
FR 44322), we did not finalize such changes in the Stage 2 final rule.
Furthermore, we stated in subsequent rulemaking (see for example the
2014 CERHT Flexibility rule at 79 FR 52923 and 52596) that the
requirements for each stage for the program must be informed by
analysis of program data related to performance and participation
milestones.
In the September 4, 2012 stage 2 final rule, we maintained the same
core-menu structure finalized for several Stage 1 core and menu
objectives. We finalized that EPs must meet the measure or qualify for
an exclusion to 17 core objectives and 3 of 6 menu objectives. We
finalized that eligible hospitals and CAHs must meet the measure or
qualify for an exclusion to 16 core objectives and 3 of 6 menu
objectives. We combined several Stage 1 measures into Stage 2. With the
experience providers gained from the Stage 1 final rule, we also
increased functional objective measure thresholds in Stage 2 to
increase efficiency, effectiveness, and flexibility. Also, beginning in
2014, we finalized a set of clinical quality measures (CQMs) for all
providers participating in any Stage of the program to report to CMS.
(For a full discussion of the meaningful use objectives and measures,
and the CQMs we finalized under Stage 2, we refer readers to the Stage
2 final rule at 77 FR 53968 through 54162.)
In the Stage 3 proposed rule, we built on the groundwork
established in the Stage 1 and Stage 2 final rules, including
continuing our goal started under Stage 2 to increase interoperability
among providers. We also proposed to make changes to the Medicare and
Medicaid EHR Incentive Programs that simplify reporting requirements
and reduce program complexity. These changes were intended to balance
the statutory requirements in the HITECH Act with responsiveness to
providers expressing confusion and concerns over increased reporting
burden related to the number of program requirements, the multiple
stages of program participation, and the timing of EHR reporting
periods. Therefore, we proposed for Stage 3 a
[[Page 20348]]
single set of 8 objectives and related measures to meet the definition
of meaningful use. We proposed that this single set of 8 objectives
would be optional for 2017 and mandatory beginning in 2018. Also, the
Stage 3 proposed rule would move all providers to an EHR reporting
period of one full calendar year, with a limited exception for Medicaid
providers demonstrating meaningful use for the first time, to support
program alignment and simplify reporting requirements among provider
types. The Stage 3 proposed rule and the 2015 Edition Health
Information Technology (Health IT) Certification Criteria, 2015 Edition
Base Electronic Health Record (EHR) Definition, and ONC Health IT
Certification Program Modifications (hereinafter referenced as the
``2015 Edition proposed rule'') published by the Office of the National
Coordinator for Health Information Technology (ONC) may be reviewed at
80 FR 16731 through 16804 and 80 FR 16804 through 1692, respectively.
The Stage 3 proposed rule would align the stages of meaningful use
across all providers beginning in 2018.
In this proposed rule, we are seeking to make changes to the
requirements for Stage 1 and Stage 2 of meaningful use for 2015 through
2017 to align with the approach for Stage 3 of meaningful use in 2017
and subsequent years. The analysis conducted during the planning
process for Stage 3 also allowed insight into the progress toward
program milestones and provider performance on the objectives and
measures. This analysis allowed us to identify an approach to be
responsive to stakeholder concerns about program complexity and revisit
the consideration that the stage of meaningful use and EHR reporting
periods should align where possible. Therefore, we are proposing a
number of changes to both the EHR reporting period, and to the number
of objectives and measures to which a provider must attest to
demonstrate meaningful use. Specifically, we are proposing to move all
providers to an EHR reporting period based on the calendar year
beginning in 2015. Also, we propose to align the objectives and
measures used in 2015 through 2017 with those identified in the Stage 3
proposed rule for use in 2017 and subsequent years. This includes a
proposal that, beginning with an EHR reporting period in 2015,
providers would no longer be required to attest to certain objectives
and measures which have been identified through our analysis to have
reduced utility because they may now be redundant, duplicative, or
``topped out''. (For further discussion of this selection process for
Stage 3, we direct readers to sections I.A.2. and II.A.2. of the Stage
3 proposed rule at (80 FR 16733 through 16735 and 16767 through 16768,
respectively). The related selection process for the proposed changes
to meaningful use in 2015 through 2017 uses a similar approach to
reducing the reporting burden while also seeking to meet our statutory
requirement to include more stringent measures of meaningful use. Our
approach for applying these principals for meaningful use in 2015
through 2017 is discussed in more detail in section II.B.1.c. of this
proposed rule.
b. EHR Reporting Period in 2015 and 2016
We are proposing to align the definition of an EHR reporting period
with the calendar year for all providers beginning in 2015 and
continuing through 2016 onward. Specifically, this proposal would
change the EHR reporting period for eligible hospitals and CAHs from a
period based on the fiscal year to the calendar year beginning in 2015.
This aligns with the provision outlined in the Stage 3 proposed rule to
move all providers to an EHR reporting period of 1 full calendar year
beginning in 2017 with a limited exception for Medicaid providers
demonstrating meaningful use for the first time (80 FR 16734 and 80 FR
16737 through 16739). For 2015 and 2016, we are proposing to allow new
participants in the EHR Incentive Program to attest to meaningful use
for an EHR reporting period of any continuous 90-day period within the
calendar year. In addition, for 2015 only, we are proposing to allow
all EPs (regardless of their prior participation in the program) to
attest to an EHR reporting period of any continuous 90-day period
within the calendar year. For 2015 only, we are proposing to allow
eligible hospitals and CAHs (regardless of their prior participation in
the program) to attest to an EHR reporting period of any continuous 90-
day period within the period beginning October 1, 2014 and the close of
the 2015 calendar year. This 90-day EHR reporting period for 2015 would
allow providers additional time to address any remaining issues with
the implementation of technology certified to the 2014 Edition and to
accommodate the changes to the objectives and measures of meaningful
use proposed in this rule.
In 2016, we propose EPs, eligible hospitals, and CAHs that are
demonstrating meaningful use for the first time may use an EHR
reporting period of any continuous 90-day period between January 1,
2016 and December 31, 2016. However, all returning participants would
use an EHR reporting period of a full calendar year from January 1,
2016 through December 31, 2016. In 2017, all providers, both new and
existing participants, would use an EHR reporting period of 1 full
calendar year as proposed in the Stage 3 proposed rule at (80 FR 16737
through 16739) with a limited exception for Medicaid providers
demonstrating meaningful use for the first time.
c. Meaningful Use Objectives and Measures for 2015 Through 2017
In the Stage 3 proposed rule, we outlined our method and approach
for identifying the objectives and measures retained for Stage 3 of
meaningful use in 2017. We also identified those objectives and
measures which are now redundant, duplicative, or topped out; and
therefore; would no longer be required for the successful demonstration
of meaningful use for Stage 3. For further discussion of this approach,
we refer readers to (80 FR 16733 through 16735 and 16767 through
16768).
In this proposed rule, we discuss how we have used the same method
to identify objectives and measures from Stages 1 and 2 of meaningful
use which we believe should no longer be required for a provider to
demonstrate meaningful use in 2015 through 2017 as these measures have
been identified as redundant, duplicative, or topped out. These changes
would remove the menu and core structure of Stages 1 and 2 and reduce
the overall number of objectives to which a provider must attest. We
discuss this approach in section II.B.1.c. of this proposed rule.
In addition, we are proposing changes to individual objectives and
measures for Stage 2 of meaningful use as follows:
Changing the threshold from the Stage 2 Objective for
Patient Electronic Access measure number 2 from ``5 percent'' to
``equal to or greater than 1''.
Changing the threshold from the Stage 2 Objective Secure
Electronic Messaging from being a percentage-based measure, to yes-no
measure stating the ``functionality fully enabled''.
Consolidating all public health reporting objectives into
one objective with measure options following the structure of the Stage
3 Public Health Reporting Objective (80 FR 16745 through 16767).
Changing the eligible hospital electronic prescribing
objective from a ``menu'' objective to a mandatory
[[Page 20349]]
objective with an exclusion available for certain eligible hospitals
and CAHs.
These proposed changes would apply for providers beginning with the
EHR reporting period in 2015. We note that these proposals include
provisions to maintain the existing definitions for the objectives and
measures including numerator and denominator calculation, provisions to
maintain measure thresholds for 2015, and provisions to allow
exclusions for certain eligible providers in 2015 in order to
facilitate the transition for providers already engaged in the
workflows, data capture and measure calculation for meaningful use for
an EHR reporting period in 2015.
d. Certification Requirements
Under this proposed rule, we are not proposing changes to the
individual certification requirements for the objectives and measures
of meaningful use for an EHR reporting period in 2015 through 2017.
Until a transition to EHR technology certified to the 2015 Edition is
required (proposed in the Stage 3 proposed rule beginning with an EHR
reporting period in 2018 at (80 FR 16767 and 16768), we are proposing
that providers would continue to use EHR technology certified to the
2014 Edition for an EHR reporting period in 2015, 2016, and 2017. As
outlined in the Stage 3 proposed rule, providers may upgrade early to
EHR technology certified to the 2015 Edition for an EHR reporting
period prior to 2018. (For further information on this, and to review
the applicable definition of CEHRT, we direct readers to the Stage 3
proposed rule at (80 FR 16767 and 16768).
e. Medicaid EHR Incentive Program in 2015 through 2017
The proposals included in this proposed rule would also apply for
the Medicaid EHR Incentive Program, including the proposed changes to
the EHR reporting period in 2015 and 2016, and the objectives and
measures required to demonstrate meaningful use in 2015 through 2017.
Consistent with the Stage 3 proposed rule, we propose to continue to
offer states flexibility under the Medicaid EHR Incentive Program for
the public health reporting objective. For meaningful use in 2015
through 2017, we would continue the policy stated in the Stage 2 final
rule (77 FR 53979) to allow states to 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 certification requirements specified under the 2014
Edition certification criteria). (For more information see the Stage 3
proposed rule (80 FR 16737 through 16739).)
f. Clinical Quality Measurement
We are not proposing changes to the CQM selection or reporting
scheme (9 or 16 CQMs across at least 3 domains) from the CQM
requirements previously established for all providers seeking to
demonstrate meaningful use in the Medicare and Medicaid EHR Incentive
Programs defined in earlier rulemaking (see, for example, 77 FR 54049
through 54089). For an EHR reporting period in 2015, and for providers
demonstrating meaningful use for the first time in 2016, we are
proposing that providers may--
Attest to any continuous 90-day period of CQM data during
the calendar year through the Medicare EHR Incentive Program
registration and attestation site; or
Electronically report CQM data using the established
methods for electronic reporting.
For 2016 and subsequent years, providers beyond their first year of
meaningful use may attest to one full calendar year of CQM data or they
may electronically report their CQM data using the established methods
for electronic reporting outlined in section II.C. of this proposed
rule.
g. Demonstration of Meaningful Use
We are proposing 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 states for use in their Medicaid
programs. We are proposing to continue the use of attestation as the
method for demonstrating that an EP, eligible hospital, or CAH has met
the objectives and measures of meaningful use. In lieu of individual
Medicare EP attestation through the CMS registration and attestation
system, we are proposing to continue the existing optional batch file
process for attestation. We are additionally proposing changes to the
attestation deadlines to accommodate the proposed change to reporting
based on the calendar year for eligible hospitals and CAHs beginning
with an EHR reporting period in 2015, as well as the proposed change to
a 90-day EHR reporting period for all providers in 2015. We are
proposing changes to the attestation deadlines for new meaningful EHR
users in 2015 and 2016 to avoid the Medicare payment adjustments in
2016 and 2017. Finally, we are proposing an alternate attestation
option for certain Medicaid providers to demonstrate meaningful use in
2015 and subsequent years to avoid Medicare payment adjustments.
h. Payment Adjustments and Hardship Exceptions
We are proposing changes to the definition of an EHR reporting
period for a payment adjustment at Sec. 495.4 as well as the
attestation deadlines for certain providers to demonstrate meaningful
use for an EHR reporting period to avoid the Medicare payment
adjustment.
i. Summary of Cost Benefit Analysis
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity).
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 regulatory impact analysis of this proposed rule for
modification to the Medicare and Medicaid EHR Incentive Programs from
2015 through 2017 outlines the reduction in the reporting burden for
providers demonstrating meaningful use in 2015 and estimates the total
annual cost savings. The low and high estimates for these total savings
are $52,547,132 and $68,617,864 respectively. In addition to these
reductions, we believe there are substantial cost savings accruing to
eligible hospitals and EPs related to having additional time to achieve
meaningful use.
B. Overview of the Regulatory History
The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-
5)(ARRA) amended Titles XVIII and XIX of the Act to authorize incentive
payments to EPs, eligible hospitals, and CAHs, and MA organizations to
promote the adoption and meaningful use of CEHRT. In the July 28, 2010
Federal Register (75 FR 44313 through 44588), we published a final rule
(``Medicare and Medicaid Programs; Electronic Health Record Incentive
Program'', or ``Stage 1 final rule'') 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. (For a full
explanation of the amendments made by ARRA, see the Stage 1 final rule
at 75 FR 44316.) In that Stage 1 final rule, we also detailed that the
Medicare and Medicaid EHR
[[Page 20350]]
Incentive Program would consist of three different stages of meaningful
use requirements.
In the September 4, 2012 Federal Register (77 FR 53967 through
54162), we published a final rule (``Medicare and Medicaid Programs;
Electronic Health Record Incentive Program-Stage 2; Final Rule'' or
``Stage 2 final rule'') that specified the Stage 2 criteria that EPs,
eligible hospitals, and CAHs would have to meet in order to qualify for
incentive payments. In addition, the Stage 2 final rule finalized
payment adjustments and other program participation requirements under
Medicare for covered professional and hospital services provided by
EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use
of CEHRT, and finalized the revision of certain Stage 1 criteria, and
finalized criteria that applied regardless of stage.
In the December 7, 2012 Federal Register (77 FR 72985), CMS and ONC
jointly published an interim final rule with comment period (IFC)
titled ``Health Information Technology: Revisions to the 2014 Edition
Electronic Health Record Certification Criteria; and Medicare and
Medicaid Programs; Revisions to the Electronic Health Record Incentive
Program'' (December 7, 2012 IFC). The Department of Health and Human
Services (HHS) issued the IFC to replace the Data Element Catalog (DEC)
standard and the Quality Reporting Document Architecture (QRDA)
Category III standard adopted in the final rule published on September
4, 2012 in the Federal Register with updated versions of those
standards. The December 7, 2012 IFC also revised the Medicare and
Medicaid EHR Incentive Programs by--
Adding an alternative measure for the Stage 2 meaningful
use (MU) objective for hospitals to provide structured electronic
laboratory results to ambulatory providers;
Correcting the regulation text for the measures associated
with the objective for hospitals to provide patients the ability to
view online, download, and transmit information about a hospital
admission; and
Making the case number threshold exemption for CQM
reporting applicable for eligible hospitals and CAHs beginning with FY
2013.
The December 7, 2012 IFC also provided notice of our intention to
issue technical corrections to the electronic specifications for CQMs
released on October 25, 2012.
In the September 4, 2014 Federal Register (79 FR 52910 through
52933) CMS and ONC published a final rule titled ``Medicare and
Medicaid Programs; Modifications to the Medicare and Medicaid
Electronic Health Record (EHR) Incentive Program for 2014 and Other
Changes to the EHR Incentive Program; and Health Information
Technology: Revisions to the Certified EHR Technology Definition and
EHR Certification Changes Related to Standards; Final Rule'' (``2014
CEHRT Flexibility final rule''). Due to issues related to EHR
technology certified to the 2014 Edition availability delays, the 2014
CEHRT Flexibility final rule included policies allowing EPs, eligible
hospitals, and CAHs that could not fully implement EHR technology
certified to the 2014 Edition for an EHR reporting period in 2014 to
continue to use one of the following options for reporting periods in
CY 2014 and FY 2014, respectively--
EHR technology certified to the 2011 Edition; or
A combination of EHR technology certified to the 2011
Edition and EHR technology certified to the 2014 Edition for the EHR
reporting periods.
These CEHRT options applied only to those providers that could not
fully implement EHR technology certified to the 2014 Edition to meet
meaningful use for an EHR reporting period in 2014 due to delays in
2014 Edition availability. Although the 2014 CEHRT flexibility final
rule did not alter the attestation or hardship exception application
deadlines for 2014, it did make changes to the attestation process to
support these flexible options for CEHRT. This 2014 CEHRT Flexibility
final rule also discussed the provisions of the December 7, 2012 IFC
and finalized policies relating to the provisions contained in the
December 7, 2012 IFC.
In the November 13, 2014 Federal Register, we published an interim
final rule with comment period, under the Medicare Program; Revisions
to Payment Policies Under the Physician Fee Schedule, Clinical
Laboratory Fee Schedule, Access to Identifiable Data for the Center for
Medicare and Medicaid Innovation Models & Other Revisions to Part B for
CY 2015 (79 FR 67976 through 67978) (``November 13, 2014 IFC''). Under
this November 13, 2014 IFC, we recognized a hardship exception for EPs
and eligible hospitals for 2014 under the established category of
extreme and uncontrollable circumstances in accordance with the
Secretary's discretionary authority. To accommodate this hardship
exception, we further extended the hardship application deadline for
EPs and eligible hospitals to November 30 for 2014 only. We also
amended the regulations to allow CMS to specify a later hardship
application deadline for certain hardship categories for EPs, eligible
hospitals, and CAHs.
In the March 30, 2015 Federal Register, we published a proposed
rule entitled ``Medicare and Medicaid Programs; Electronic Health
Record Incentive Program Stage 3'' (80 FR 16731 through 16804). In this
March 30, 2015 Stage 3 proposed rule, we specified the proposed
meaningful use criteria that EPs, eligible hospitals, and critical
access hospitals must meet in order to demonstrate meaningful use of
certified EHR technology for Stage 3 of the EHR Incentive Programs. It
also specifies the proposed requirements for electronic submission of
CQMs and creates a single set of meaningful use requirements for Stage
3 which would be optional for providers in 2017 and required for all
providers beginning in 2018. Finally, the Stage 3 proposed rule would
also change the EHR reporting period so that all providers would report
under a calendar year timeline.
For Stages 1 and 2, CMS and the ONC worked closely to ensure that
the definition of meaningful use of CEHRT and the associated standards
and certification criteria were coordinated. (Current ONC regulations
may be found at 45 CFR part 170.) For the Stage 3 proposed rule and the
ONC 2015 Edition proposed rule, CMS and ONC have aligned the proposed
rules (80 FR 16731 through 16804 and 80 FR 16804 through 16921) and
would again work together to align the final regulations.
(Readers may also visit: www.cms.hhs.gov/EHRincentiveprograms and
www.healthit.gov for more information on the efforts at the Department
of Health and Human Services (HHS) to advance HIT initiatives.)
II. Provisions of the Proposed Regulations
A. Introduction
When the EHR Incentive Program began in 2011, the requirements for
the objectives and measures of meaningful use were designed to begin a
process toward health care delivery system transformation aligning with
foundational goals defined in the HITECH Act. First, the statute
requires the Secretary to seek to improve the use of EHR and health
care quality over time by requiring more stringent measures of
meaningful use (see section 1848(o)(2)(A)(iii) of the Act). To meet
this goal, we established stages of meaningful use to move providers
along a progression from adoption to advanced use of certified EHR
technology. Second, the statute includes requirements for the use of
EHR
[[Page 20351]]
technology, which defines both the functions that should be available
within the EHR and the purpose to which those functions should be
applied. These requirements include functions that are similar to the
following (see section 1848(o)(4) of the Act)--
The capacity to provide clinical decision support;
To support provider order entry;
To capture and query information relevant to health care
quality; and
To exchange protected health information with, and
integrate such information from other sources.
The statute also defines key foundational principles of meaningful use
such as electronic prescribing, the electronic exchange of health
information to support the improvement of care and care coordination,
and the use of EHR technology to submit information on clinical quality
measures and other measures (see section 1848(o)(2)(A) of the Act).
Since the EHR Incentive Programs began in 2011, a number of
environmental changes have occurred which prompted us to reevaluate the
program requirements in relation to progress toward goals. These
changes include a wide range of factors including--
Expansion of basic certified EHR technology
infrastructure;
Advancements in EHR and related health information
technology;
Widespread adoption of certain standards and
functionality;
Increased use of CEHRT to support quality improvement; and
Performance on certain measures reaching maximum
potential.
The Certified Health IT Product List (ONC CHPL) developed by ONC
assists providers in identifying certified EHR technology products that
have been certified by an ONC-Authorized Certification Body (ONC-ACB).
Certified EHR technology products, certified to the 2014 Edition, are
required for use in the Medicare and Medicaid EHR Incentive Programs to
meet meaningful use criteria for Stage 1 and 2 for an EHR reporting
period in 2015. We reviewed data related to the ONC CHPL as of March
20, 2015 and found 1956 unique products that are currently certified to
the 2011 Edition and 2157 unique products that are certified to the
2014 Edition. A unique product is a product that is certified and
receives a unique certification ID (product updates and product version
changes are included in the unique product count). Data from March 2013
to March 2015 shows an increase of 104 percent in the total number of
certified EHR technology products and an increase of 133 percent in
total unique certified EHR technology products in the last 2 years
alone. We believe the increase in the number of certified EHR
technology products available is a positive step for providers seeking
to meet meaningful use requirements and advance EHR technology. The
data provided and additional information related to the ONC CHPL may be
found on the HealthIT.gov Web site at https://healthit.gov/chpl.
For a wide range of data and reports on health IT adoption rates,
use of certification functions and standards, updates to eCQM
specifications and testing, as well as the performance data for
providers in relation to the available software, we direct readers to
the ONC Web site (https://www.healthit.gov), the CMS eCQM Library
(https://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html), and the CMS EHR Incentive
Programs data and reports Web site (https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html).
As the program has increased the overall adoption of EHRs and as
EHR technology has automated certain clinical functions and supported
standardized data capture, we propose modifications, which would
recognize these changes and realign the program with ongoing program
goals. Our quality reporting programs regularly reevaluate measures
based on factors like clinical relevance, updates to electronic
specifications, and measure performance. We consider modifications to
the objectives and measures of this program similar to those regularly
made in our quality reporting programs.
In addition to these environmental changes, stakeholder
associations and provider groups have through correspondence, public
forums, and public comment requested that we consider changes to the
requirements to demonstrate meaningful use of certified EHR technology
in the EHR Incentive Programs which would reduce the overall complexity
of the program and the burden on providers. We believe some of these
recommended changes may contradict certain statutory requirements for
this program. For example, certain provisions such as electronic
prescribing or health information exchange cannot be fully ``optional''
because they are expressly required under the statute (see section
1848(o)(2)(A) of the Act). The statutory directive to require
increasingly more stringent measures of meaningful use (see section
1848(o)(2)(A)(iii) of the Act) prohibits the removal of all measure
thresholds. Further examples are also discussed in the Stage 3 proposed
rule at (80 FR 16737 through 16742).
However, there are methods that could be employed to modify Stages
1 and 2 of the program to address stakeholder concerns, meet the
statutory requirements for the program defined in the HITECH Act, and
continue to support progress toward the program's foundational goals.
In addition, these methods would move providers along a continuum from
data capture to advanced use of certified EHR technology including
electronic prescribing, health information exchange, and quality
improvement with increasingly stringent measures as identified in the
Act and discussed in section II.B.1.b. of this proposed rule.
Therefore, we are proposing modifications to Stages 1 and 2 and are
seeking public comment on these proposals, which are intended to be
responsive to the changing environment and to stakeholder concern over
program complexity and redundant reporting requirements. We propose
these modifications to address these concerns and to continue to
support the overall goal of the widespread adoption and meaningful use
of EHR technology in efforts to transform our health care delivery
system and improve health care quality.
B. Meaningful Use Requirements for EHR Reporting Periods in 2015
Through 2017
1. Definitions Across the Medicare Fee for Service, Medicare Advantage,
and Medicaid Programs
a. Uniform Definitions
As discussed in prior rules, we finalized several uniform
definitions applicable for the Medicare FFS, Medicare Advantage, and
Medicaid EHR Incentive Programs. We set forth these uniform definitions
in part 495 subpart A of the regulations. (For further discussion of
the uniform definitions finalized previously, we refer readers to the
Stage 1 and Stage 2 final rules at 75 FR 44317 through 44321 and 77 FR
53972 respectively.) (For discussion of the proposed changes to uniform
definitions outlined in the Stage 3 proposed rule, we refer readers to
the Stage 3 proposed rule at (80 FR 16736 through 16737).
In this proposed rule, we are proposing to maintain the previously
finalized uniform definitions except as stated in this proposed rule.
[[Page 20352]]
b. Changes to Definitions for 2015 Through 2017
We are proposing changes to a number of definitions previously
finalized for meaningful use in the Stage 1 and Stage 2 rules in order
to modify the program in response to the changing health IT environment
and related stakeholder concerns. These changes address the following:
An overall simplification of the program aligned to the
overarching goals of sustainability as discussed in the Stage 3
proposed rule (80 FR 16737) and in section II.B.1.b.(1). of this
proposed rule and a related change to requirements necessary to
accommodate these changes outlined in section II.B.1.b.(2) of this
proposed rule.
Moving all providers to an EHR reporting period aligned
with the calendar year as outlined in section II.B.1.b.(3).A. of this
proposed rule.
Providing flexibility for providers in 2015 to accommodate
the proposed changes as outlined in section II.B.1.b of this proposed
rule.
Removing requirements for objectives and measures which
are redundant or duplicative or which have ``topped out'' as described
at (80 FR 16767) of the Stage 3 proposed rule and outlined in section
II.B.1.c.(1). of this proposed rule.
Restructuring the remaining measures and objectives to
streamline requirements for 2015 through 2017 and to accommodate the
changes for an EHR reporting period in 2015 as outlined in section
II.B.1.c.(2). of this proposed rule.
Refocusing the existing program on building toward
advanced use of EHR technology, aligned with the Stage 3 proposed rule,
through maintaining the objectives and measures outlined in section
II.B.2. of this proposed rule.
(1) Stages of Meaningful Use
In the phased approach to meaningful use, we finalized the criteria
for meaningful use through staggered rulemaking, which covered Stages 1
and 2 of the EHR Incentive Program. (For further explanation of the
criteria we finalized in Stages 1 and 2, we refer readers to 75 FR
44314 through 44588, 77 FR 53968 through 54162, and 79 FR 52910 through
52933). The current progression of the stages as finalized in prior
rulemaking is outlined in Table 1.
Table 1--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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011................................... 1 1 1 1 or 2 *.................. 2 2 3 3 TBD
2012................................... 1 1 1 or 2 *.................. 2 2 3 3 TBD
2013................................... 1 1 *....................... 2 2 3 3 TBD
2014................................... 1 *....................... 1 2 2 3 3
2015................................... 1 1 2 2 3
2016................................... 1 1 2 2
2017................................... 1 1 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the Stage 3 proposed rule, we noted our intent for Stage 3 to be
the final stage in meaningful use and that no further stages would be
developed. We further proposed that all providers may optionally move
to Stage 3 in 2017, and that all providers are required to move to
Stage 3 beginning in 2018 regardless of their prior participation or
stage of meaningful use. (For further discussion on this proposal, we
direct readers to (80 FR 16774).
In this proposed rule to modify Stages 1 and 2 for meaningful use
in 2015 through 2017, we propose to further reduce complexity in the
program and work toward this overall shift to a single set of
objectives and measures in Stage 3 in 2018. We propose to require all
providers to attest to a single set of objectives and measures
beginning with an EHR reporting period in 2015. These objectives and
measures would leverage existing objectives and measures of meaningful
use. Because this change may occur after providers have already begun
their work toward meeting meaningful use in 2015, we propose
accommodations within individual objectives for providers in different
stages of meaningful use. These accommodations include retaining the
different specifications between Stage 1 and Stage 2, and allowing
special exclusions for certain objectives or measures for eligible
providers previously scheduled to participate in Stage 1 for an EHR
reporting period in 2015.
In this rule, we propose all providers would be required to attest
to certain objectives and measures finalized in the Stage 2 final rule,
which would align with those objectives and measures proposed for Stage
3 of meaningful use. In effect, this would create a new progression
using the existing objectives and measures where providers attest to a
modified version of Stage 2 with accommodations for Stage 1 providers
(equivalent to a reduced version of Stage 3) in 2015; a modified
version of Stage 2 in 2016 (equivalent to a reduced version of Stage
3); either a modified version of Stage 2 (equivalent to a reduced
version of Stage 3) or the full version of Stage 3 outlined in the
Stage 3 proposed rule in 2017; and the full version of Stage 3 outlined
in the Stage 3 proposed rule beginning in 2018.
The revised timeline based on this proposal and the Stage 3
proposed rule is outlined in Table 2.
Table 2--Stage of Meaningful Use Criteria by First Year
----------------------------------------------------------------------------------------------------------------
Stage of meaningful use
First year as a meaningful EHR -------------------------------------------------------------------------------
user 2015 2016 2017 2018
----------------------------------------------------------------------------------------------------------------
2011............................ Modified Stage 2.. Modified Stage 2.. Modified Stage 2 Stage 3
Or Stage 3.
2012............................ Modified Stage 2.. Modified Stage 2.. Modified Stage 2 Stage 3
Or Stage 3.
2013............................ Modified Stage 2.. Modified Stage 2.. Modified Stage 2 Stage 3
Or Stage 3.
2014............................ Modified Stage 2 * Modified Stage 2.. Modified Stage 2 Stage 3
Or Stage 3.
2015............................ Modified Stage 2 * Modified Stage 2.. Modified Stage 2 Stage 3
Or Stage 3.
[[Page 20353]]
2016............................ - NA -............ Modified Stage 2.. Modified Stage 2 Stage 3
Or Stage 3.
----------------------------------------------------------------------------------------------------------------
* The Modifications to Stage 2 proposed in this rule include alternate exclusions and specifications for certain
objectives and measures for providers that were scheduled to demonstrate Stage 1 of meaningful use in 2015.
For simplification and reader clarity, we would therefore refer to
the ``Stage'' designation in relation to the EHR Incentive Program
rules and to the objectives and measures as follows:
Meaningful use objectives and measures for 2015 through
2017
Stage 3 meaningful use objectives and measures for 2017
and subsequent years
This alignment of Stages 1 and 2 to the proposals for Stage 3
essentially creates a new paradigm for providers in 2015 through 2017.
This includes a simplified structure and focus on the objectives and
measures with sustainable growth potential aligned to the programs
foundational goals prior to the full implementation of Stage 3 in 2018.
This change could alleviate the need to include the option in 2017 to
allow providers to choose to demonstrate Stage 3 of the program in
2017. To better understand the impact and potential complexity, we seek
comment on whether or not we should implement only the modifications
proposed in this rule from 2015 through 2017 and begin Stage 3 in 2018
without an option year in 2017, or if we should allow providers the
option to demonstrate Stage 3 beginning in 2017 as discussed in the
Stage 3 proposed rule (80 FR 16774).
We seek comment on these proposals.
(2) Meaningful EHR User
In the Stage 3 proposed rule (80 FR 16731 through 16804), we
proposed to modify the definition of ``Meaningful EHR User'' in 42 CFR
495.4 to include the Stage 3 objectives and measures proposed at Sec.
495.7. We further propose to redesignate some of the numbering of the
regulation text under Part 495 to more clearly identify which sections
of the regulation apply to specific years of the program. This would
allow more direct references for the objectives and measures, while
also preserving the content that applies for prior program years. We
note this numerical redesignation would not affect the content of the
regulation text except where noted in this proposed rule, nor would it
change the proposed objectives and measures of Stage 3 of meaningful
use at (80 FR 16745 through 16767). The redesignated numerical
references for the regulation text are as follows:
------------------------------------------------------------------------
Current section designation Proposed section redesignation
------------------------------------------------------------------------
Sec. 495.6--Objectives and Measures.. Sec. 495.20--Objectives and
Measures Prior to 2015
Sec. 495.22--Objectives and
Measures Beginning in 2015
Sec. 495.7 *--Stage 3 Objectives and Sec. 495.24--Stage 3
Measures. Objectives and Measures
Sec. 495.8--Demonstration of Sec. 495.40--Demonstration of
Meaningful Use. Meaningful Use
Sec. 495.10--Participation Sec. 495.60--Participation
Requirements. Requirements
------------------------------------------------------------------------
* Indicates a new section that was proposed in the Stage 3 proposed
rule.
In this proposed rule, we refer to Sec. 495.20 for the objectives
and measures that apply for years prior to 2015, Sec. 495.22 for the
objectives and measures proposed in this rule for 2015 through 2017,
and Sec. 495.24 for the objectives and measures proposed in the Stage
3 proposed rule for 2017 and subsequent years. Pending public comment
and agency review of these proposals, all changes in Part 495 would be
reconciled through the final rule.
(3) EHR Reporting Periods in 2015 Through 2017
In 42 CFR 495.4, we define an EHR reporting period for eligible
hospitals and CAHs based on the federal fiscal year (October 1 through
September 30). However, the fiscal year EHR reporting period has
resulted in varying reporting timelines between provider types and a
shortened timeline for system developers to meet hospital and CAH
technology needs. In the Stage 3 proposed rule, we outline changes to
the EHR reporting period beginning with the EHR reporting period in
2017 in order to move eligible hospitals and CAHs to EHR reporting
periods based on a calendar year. (For further discussion of this
proposal and the relationship to program alignment with quality
reporting programs, we direct readers to 80 FR 16739.)
In this proposed rule, our intent is to modify the program to
remove redundant and duplicative measures; reduce reporting burden for
measures that have ``topped out'' while preserving the program's
foundational goals and the requirement for stringent or robust
measurement; and better align the existing program with other CMS
quality reporting programs. In order to move these efforts forward and
to accommodate the proposed changes beginning in 2015 while still
allowing providers time to complete an EHR reporting period after the
effective date of a final rule, we are proposing changes to the uniform
definition of an ``EHR reporting period'' in Sec. 495.4 beginning in
2015. We are also proposing similar changes to the definition of an
``EHR reporting period for a payment adjustment year'' in Sec. 495.4
beginning in 2015 as discussed in section II.E.1. of this proposed
rule. We are proposing changes to the attestation deadlines for
purposes of the incentive payments and payment adjustments in section
I.A.1.i. of this proposed rule.
(a) Calendar Year Reporting Beginning in 2015
Beginning in 2015, we are proposing to change the definition of
``EHR reporting period'' at Sec. 495.4 for EPs, eligible hospitals,
and CAHs such that the EHR reporting period would begin and end in
relation to a calendar year. This change would allow eligible hospitals
and CAHs the same amount of time as EPs from the release of a new
edition by ONC to the required date for full implementation of the EHR
technology certified in accordance with those criteria. In addition,
this change would allow providers additional time to accommodate the
changes proposed
[[Page 20354]]
in this rule for demonstrating meaningful use in 2015. Finally, this
change would align EHR reporting periods for the EHR Incentive Program
with EHR reporting periods in CMS quality reporting programs, which
have similar or related requirements.
In this proposal, all providers (EPs, eligible hospitals, and CAHs)
would be required to complete an EHR reporting period within January 1
and December 31 of the calendar year in order to demonstrate meaningful
use. In order to accommodate eligible hospitals and CAHs that may have
planned their EHR reporting period in 2015 during the federal fiscal
year and want to continue to use that time period for reporting, we
propose for 2015 only these providers may begin an EHR reporting period
as early as October 1 of 2014 and end by December 31 of 2015. Beginning
with 2016, the EHR reporting period must be completed within January 1
and December 31 of the calendar year.
We seek comment on this proposal.
(b) 90-Day EHR Reporting Period for All Providers in 2015
In the 2014 CEHRT Flexibility rule (79 FR 52919) we noted that many
commenters had requested a 90-day EHR reporting period in 2015. In that
rule, we discussed the reasons we did not propose or finalize a change
to allow for an EHR reporting period of 90 days in 2015. We stated that
we did not finalize changes to the EHR reporting period, because we
believed such changes were not necessary to mitigate risk associated
with the delay in the availability of EHR technology certified to the
2014 Edition (79 FR 52919). In addition, we stated that such changes
would put the forward progress of the program at risk, and potentially
cause further delay in implementing effective health IT infrastructure
and misalignment with the CMS quality reporting programs (79 FR 52919).
We maintain the assertion that the delay in 2014 Edition availability
does not necessitate changes to the EHR reporting period 2015; and that
the proposed change to the EHR reporting period in 2015 in conjunction
with the other modifications to the EHR Incentive Program proposed in
this rule does represent a potential risk to the continued development
of effective health IT infrastructure.
Subsequent to the publication of the 2014 CEHRT Flexibility final
rule, we conducted a full analysis of provider performance on Stage 1
and Stage 2 measures and identified areas where measures were topped
out or had become redundant or duplicative based on the widespread
adoption of EHR technology certified to the 2014 Edition and successful
implementation of the more complex Stage 2 objective functions. We
determined that there was significant potential for a positive impact
through reducing the reporting burden, simplifying the program, and
realigning the program with long term goals for advanced use of EHRs.
However, in order to implement these changes, a shortened EHR reporting
period would be necessary in 2015 to allow both providers and CMS time
to make necessary changes to systems. We believe the benefits to be
gained from the proposals in this rule outweigh the potential risk of
misalignment introduced by the shortened reporting period, if the risk
is limited to only be allowable for an EHR reporting period in 2015.
Therefore, we are proposing to allow a 90-day EHR reporting period in
2015 only to accommodate implementation of the other changes proposed
in this rule.
For 2015 only, we are proposing to change the definition of ``EHR
reporting period'' at Sec. 495.4 for EPs, eligible hospitals, and CAHs
such that the EHR reporting period in 2015 would be any continuous 90-
day period within the calendar year. We intend this change to allow
providers adequate time to plan for any necessary changes to their
implementation of meaningful use required in order to accommodate the
changes outlined in this proposed rule. We further believe this change
is responsive to provider and stakeholder feedback received through
correspondence, public forums, and public comment, which requested that
we allow a 90-day EHR reporting period in 2015 in order to provide
flexibility for continuing difficulties providers are experiencing with
successful implementation of EHR technology certified to the 2014
Edition.
We propose that for an EHR reporting period in 2015, eligible
professionals may select an EHR reporting period of any continuous 90-
day period from January 1, 2015 through December 31, 2015; while
eligible hospitals and CAHs may select an EHR reporting period of any
continuous 90-day period from October 1, 2014 through December 31,
2015. This is intended to accommodate the shift from reporting based on
the federal fiscal year to the calendar year for eligible hospitals and
CAHs.
In 2016, for eligible professionals, eligible hospitals, and CAHs
that have not successfully demonstrated meaningful use in a prior year
and are first-time participants in the program, the EHR reporting
period would be any continuous 90-day period between January 1, 2016
and December 31, 2016. However, for all returning participants that
have successfully demonstrated meaningful use in a prior year, the EHR
reporting period would be a full calendar year from January 1, 2016
through December 31, 2016. In 2017, the EHR reporting period would be 1
full calendar year for all providers, as proposed in the Stage 3
proposed rule (80 FR 16739).
We invite comment on these proposals.
c. Definition of Meaningful Use
(1) Considerations in Defining Meaningful Use
In order to update the definition of meaningful use of certified
EHR technology and make modifications to program requirements to
reflect a changing health IT environment, we analyzed the existing
objectives and measures of meaningful use to consider if they should be
modified for the program beginning in 2015. As outlined in the Stage 3
proposed rule, we looked at the set of potential objectives and
measures for inclusion in the program for 2017 and subsequent years,
and sought to determine if they were redundant, duplicative, or had
reached a performance level considered to be ``topped out.'' We stated
that redundant measures include those objectives where there is now a
viable health IT-based solution which may replace paper-based actions
and therefore a provider should no longer be required to also report on
the objective where the measures includes paper-based actions, such as
the Stage 2 Clinical Summary objective (77 FR 53998 through 54002). We
stated that duplicative measures include those objectives where a
measure which is also captured in the course of meeting another
objective, such as recording vital signs which is also a required part
of the Consolidated Clinical Document Architecture (C-CDA) in the
Summary of Care objective (77 FR 54014 through 54016). Finally, we
stated that ``topped out'' measures do not provide a meaningful gain in
the effort to improve the use of EHR and health care quality over time
by requiring more stringent measures of meaningful use. (For further
discussion of this approach to identifying the objectives and measures
for Stage 3, we direct readers to (80 FR 16740 through 16744).
In this proposed rule, we have taken a similar approach to review
the current objectives and measures of meaningful use with a few
additional considerations. These included reviewing the functions and
standards included the 2014 Edition when
[[Page 20355]]
determining if a measure is redundant or duplicative; and adding a
review of isolated performance rates for providers in the first year of
meaningful use in addition to reviewing quartile performance rates for
topped out measures. (For further discussion on ``topped out'' measures
in the Stage 3 proposed rule, we direct readers to (80 FR 16741 and
16742). For further information on the performance rates for new
participants as well as quartile performance rates for individual
measures, we direct readers to the CMS EHR Incentive Program Web site
data and reports page.\1\
---------------------------------------------------------------------------
\1\ CMS EHR Incentive Programs Web site: ``Data and Reports''
https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------
Our analysis of the objectives and measures of meaningful use
Stages 1 and 2 identified a number of measures, which meet these
criteria as either redundant, duplicative, or topped out with new
participants consistently performing at a statistically comparable rate
to returning participants. Table 3 identifies the current objectives
and measures which meet these criteria. We are therefore proposing to
no longer require providers to attest to these objectives and measures
as currently codified in the CFR under Sec. 495.6 in order to
demonstrate meaningful use beginning in 2015.
Table 3--Objectives and Measures Identified by Provider Type Which Are
Redundant, Duplicative or Topped Out
------------------------------------------------------------------------
------------------------------------------------------------------------
Provider type Objectives and measures
------------------------------------------------------------------------
Eligible Professional....... Record Demographics. 42 CFR Sec. 495.6
(j)(3)(i) and (ii).
Record Vital Signs.. 42 CFR Sec. 495.6
(j)(4)(i) and (ii).
Record Smoking 42 CFR Sec. 495.6
Status. (j)(5)(i) and (ii).
Clinical Summaries.. 42 CFR Sec. 495.6
(j)(11)(i) and
(ii).
Structured Lab 42 CFR Sec. 495.6
Results. (j)(7)(i) and (ii).
Patient List........ 42 CFR Sec. 495.6
(j)(8)(i) and (ii).
Patient Reminders... 42 CFR Sec. 495.6
(j)(9)(i) and (ii).
Summary of Care..... 42 CFR Sec. 495.6
Measure 1--Any (j)(14)(i) and
Method. (ii).
Measure 3--Test.....
Electronic Notes.... 42 CFR Sec. 495.6
(j)(9)(i) and (ii).
Imaging Results..... 42 CFR Sec. 495.6
(k)(6)(i) and (ii).
Family Health 42 CFR Sec. 495.6
History. (k)(2)(i) and (ii).
Eligible Hospital/CAH....... Record Demographics. 42 CFR Sec. 495.6
(l)(2)(i) and (ii).
Record Vital Signs.. 42 CFR Sec. 495.6
(l)(3)(i) and (ii).
Record Smoking 42 CFR Sec. 495.6
Status. (l)(4)(i) and (ii).
Structured Lab 42 CFR Sec. 495.6
Results. (l)(6)(i) and (ii).
Patient List........ 42 CFR Sec. 495.6
(l)(7)(i) and (ii).
Summary of Care..... 42 CFR Sec. 495.6
Measure 1--Any (l)(11)(i) and
Method. (ii).
Measure 3--Test.....
eMAR................ 42 CFR Sec. 495.6
(l)(16)(i) and
(ii).
Advanced Directives. 42 CFR Sec. 495.6
(m)(1)(i) and (ii).
Electronic Notes.... 42 CFR Sec. 495.6
(m)(2)(i) and (ii).
Imaging Results..... 42 CFR Sec. 495.6
(m)(2)(i) and (ii).
Family Health 42 CFR Sec. 495.6
History. (m)(3)(i) and (ii).
Structure Labs to 42 CFR Sec. 495.6
Ambulatory (m)(6)(i) and (ii).
Providers.
------------------------------------------------------------------------
We note that many of these objectives and measures include actions
that may be valuable to providers and patients, such as providing a
clinical summary to a patient after an office visit. We encourage
providers to continue to conduct these activities as best suits their
practice and the preferences of their patient population. The removal
of these measures is in no way intended as a removal of endorsement of
these best practices or to discourage providers from conducting and
tracking these activities for their own quality improvement goal.
Instead, we would no longer require providers to calculate and attest
to the results of these measures in order to demonstrate meaningful use
beginning in 2015.
We seek comment on this proposal.
(2) Changes to Definition of Meaningful Use for 2015 Through 2017
In order to implement the proposed changes to no longer require
providers to attest to their performance on the identified objectives
and measures and to accomplish the related goal of restructuring the
program to align with long-term goals, there are a number of changes,
which must be made to other requirements of meaningful use. These
changes fall into the following two major categories:
Changes to streamline the structure for 2015 through 2017
to align with the proposed structure for Stage 3 of meaningful use in
2017 and subsequent years; and
Changes to accommodate this shift to allow providers to
successfully demonstrate meaningful use for an EHR reporting period in
2015.
In addition, we have heard from stakeholder associations and
provider representatives that providers have faced significant
challenges in implementing the patient engagement objectives, which
require patient action. These are outlined in the Stage 2 final rule at
77 FR 54046 under the Health Outcomes Policy Priority ``Engage patients
and families in their care'': The Patient Electronic Access objective
Stage 2 measure 2 for more than 5 percent of patients to view, download
or transmit their health information; and, the EPs secure electronic
messaging objective for more than 5 percent of patients to send a
secure message using CEHRT. These concerns have included both the
barriers to successful implementation of the required health IT or
CEHRT functions necessary to support the measures and especially the
[[Page 20356]]
secure transmission function; and the challenges to effectively
changing patient behavior including patient IT knowledge gaps, lack of
widespread access to technologies, and cultural barriers among specific
patient populations. We recognize these concerns and are proposing
changes to these objectives to allow providers to focus on improvements
without jeopardizing their ability to successfully demonstrate
meaningful use. These changes are outlined in section II.B.1.c.(2).(c).
of this proposed rule.
(a) Structural Requirements of Meaningful Use in 2015 Through 2017
If we remove the requirement to attest to the identified measures
and objectives, the distribution requirements between menu and core
objectives can no longer be applicable. In addition, stakeholder
associations and provider representatives have expressed through
correspondence, public forum, and public comment on regulation that the
core and menu structure is unnecessarily complex and a source of
confusion for providers. Therefore, we propose to eliminate the
distinction between core and menu objectives, and further propose that
all retained objectives and measures would be required for the program.
We note that for Stage 1 providers, this means three current menu
objectives would now be required; and for Stage 2 eligible hospitals
and CAHs, one current menu objective would now be a required objective.
These objectives are as follows:
Stage 1 Menu: Perform Medication Reconciliation
Stage 1 Menu: Patient Specific Educational Resources
Stage 1 Menu: Public Health Reporting Objectives (multiple
options)
Stage 2 Menu Eligible Hospitals and CAHs Only: Electronic
Prescribing
We note that the objectives and measures retained in each case for
all providers would be the Stage 2 objectives and measures; however, we
are proposing to establish alternate exclusions and specifications to
mitigate any additional burden on providers for an EHR reporting period
in 2015. These related proposals are discussed further in section
II.B.3.c.(2).(b). of this proposed rule.
For the public health reporting objectives and measures, we are
proposing to consolidate the different Stage 2 core and menu objectives
into a single objective with multiple measure options. We proposed this
approach for the Stage 3 public health reporting objective as we
believe it provides greater flexibility for providers and supports
continued efforts to engage providers and public health agencies in the
essential data capture and information exchange which supports quality
improvement, emergency response, and population health management
initiatives. For further discussion of the rationale for the Stage 3
objective, we direct readers to (80 FR 16731 through 16804). We discuss
the proposal for the consolidated public health reporting objective for
meaningful use in 2015 through 2017 in section II.B.2.j. of this
proposed rule. We propose that EPs must select to report on any
combination of 2 of the 5 available options outlined in section
II.B.2.j. of this proposed rule and eligible hospitals and CAHs must
select to report on any combination of 3 of the 6 available options in
section II.B.2.j. of this proposed rule. If a provider is scheduled to
attest to Stage 1 of meaningful use in 2015, we propose to allow these
EPs in 2015 to select to report on only 1 of the 5 available options
outlined in section II.B.2.j. of this proposed rule and these eligible
hospitals and CAHs in 2015 to select to report on any combination of 2
of the 6 available options in section II.B.2.j. of this proposed rule.
Therefore, we propose that the structure of meaningful use for 2015
through 2017 would be 9 required objectives for EPs using the Stage 2
objectives for EPs with alternate exclusions and specifications for
Stage 1 providers in 2015. We propose that the structure of meaningful
use for 2015 through 2017 would be 8 required objectives for eligible
hospitals and CAHs using the Stage 2 objectives for eligible hospitals
and CAHs with alternate exclusions and specifications for Stage 1
providers and some stage 2 providers in 2015. In addition, EPs would be
required to report on a total of 2 measures from the public health
reporting objective or meet the criteria for exclusion from up to 5
measures, and eligible hospitals and CAHs would be required to report
on a total of 3 measures from the public health reporting objective or
meet the criteria for exclusion from up to 6 measures. We reiterate
that the alternate exclusions and specifications mentioned are further
defined in section II.B.1.c.(2).(b). of this section of this proposed
rule, and the objectives and measures are defined in section II.B.2. of
this proposed rule.
Table 4--Current Stage Structure, Retained Objectives, and Proposed Structure
----------------------------------------------------------------------------------------------------------------
Current stage 1
structure Retained objectives Proposed structure
----------------------------------------------------------------------------------------------------------------
EP................................... 13 core objectives..... 6 core objectives...... 9 core objectives.
5 of 9 menu objectives 3 menu objectives...... 1 public health
including 1 public 2 public health objective (2 measure
health objective. objectives. options).
EH/CAH............................... 11 core objectives..... 5 core objectives...... 8 core objectives.
5 of 10 menu objectives 3 menu objectives...... 1 public health
including 1 public 3 public health objective (3 measure
health objective. objectives. options).
EP................................... 17 core objectives 9 core objectives...... 9 core objectives.
including public 0 menu objectives...... 1 public health
health objectives. 4 public health objective (2 measure
3 of 6 menu objectives. objectives. options).
EH/CAH............................... 16 core objectives 7 core objectives...... 8 core objectives.
including public 1 menu objective....... 1 public health
health objectives. 3 public health objective (3 measure
3 of 6 menu objectives. objectives. options).
----------------------------------------------------------------------------------------------------------------
[[Page 20357]]
(b) Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
We are proposing several alternate exclusions and specifications
for providers scheduled to demonstrate Stage 1 of meaningful use in
2015, which would allow these providers to continue to demonstrate
meaningful use despite the proposals to use only the Stage 2 objectives
and measures identified for meaningful use in 2015 through 2017. These
provisions fall into the following two major categories:
Maintaining the specifications for objectives and measures
which have a lower threshold or other measure difference between Stage
1 and Stage 2.
Establishing an exclusion for Stage 2 measures which do
not have an equivalent Stage 1 measure associated with any Stage 1
objective or where the provider did not plan to attest to the menu
objective which would now be otherwise required.
For the first category, we propose that providers who are scheduled
to demonstrate Stage 1 of meaningful use for an EHR reporting period in
2015 may attest to meaningful use using the specifications established
for the Stage 1 objectives and measures defined at 42 CFR 495.6 for
each retained objective or measure where there is a difference in
specifications between Stages 1 and 2. For example, in Stage 1 the
electronic prescribing objective for EPs requires that ``More than 40
percent of all permissible prescriptions written by the EP are
transmitted electronically using certified EHR technology'' (75 FR
44338). While the Stage 2 electronic prescribing objectives requires
that ``More than 50 percent of all permissible prescriptions written by
the EP are compared to at least one drug formulary and transmitted
electronically using Certified EHR Technology'' (77 FR 53990).
Therefore, we are proposing that for an EHR reporting period in 2015,
providers scheduled to demonstrate Stage 1 of meaningful use may attest
based on the specifications associated with the Stage 1 measure. We
note that for an EHR reporting period beginning in 2016, all providers
must attest to the specifications including the measure thresholds
associated with the Stage 2 measure. For an EHR reporting period in
2016, all providers, including those who would otherwise be scheduled
for Stage 1 in 2016, would be required to meet the Stage 2
specifications with no alternate exclusions.
For the second category, we note that some objectives, such as the
Patient Electronic Access objective, have the same requirements for one
measure (more than 50 percent of patients are provided access to view,
download, and transmit their health information) for both Stage 1 and
Stage 2, but also have an additional measure for Stage 2 (more than 5
percent of patients view, download, or transmit their health
information). Other objectives, such as the Summary of Care objective,
are designated as a menu objective for Stage 1 but are a core objective
for Stage 2 and also may have additional measure requirements in Stage
2 that are not applicable for Stage 1 (77 FR 54013 through 54017).
Finally, some objectives consist of requirements from multiple
objectives from Stage 1 that were consolidated into a single objective
for Stage 2 such as drug-drug and drug-allergy decision support
interventions. For these consolidated objectives, all providers would
be required to attest to the Stage 2 objective and measures. For
objectives where there is a measure that is not equivalent between
Stage 1 and Stage 2 or where the objective moves from menu to core
between Stage 1 and Stage 2, we propose to include an exclusion for
providers who were scheduled to demonstrate Stage 1 of meaningful use
for the EHR reporting period in 2015. For example, Stage 1 providers
may exclude from the requirement to send an electronic summary of care
record for more than 10 percent of transitions of care as required in
the Stage 2 Summary of Care objective measure 2 (75 FR 44364).
These alternate exclusions and specifications for certain
objectives and measures of meaningful use for an EHR reporting period
in 2015 are defined for each objective and measure in the description
of each objective and measure included in section II.B.2. of this
proposed rule.
We invite public comment on this proposal.
(c) Changes to Patient Engagement Requirements for 2015 Through 2017
Through correspondence, public forums, and public comment on our
proposed regulations, stakeholders have expressed concern that certain
factors like demographics, low utilization of internet capable
technology among their patient population, or other external barriers
which are beyond their control are impacting providers' ability to meet
certain measures which require providers to track patient action. In
addition, providers and system developers have noted through similar
means an overall immaturity in the market with health IT equipped with
the functions required to support the transmission of health
information by a patient or the delivery of a secure message from a
patient to a third party. Providers have indicated that while they
support the goal of improved patient engagement, these issues are
impacting their ability to meet the measure requirements. We note that
data obtained from provider attestations shows performance on these
measures is concentrated around the median rate (around 20 percent \2\)
which indicates the potential for ongoing performance that exceeds the
existing threshold. However, there is a wide variance at the high and
low ends, which indicates that there may be external factors impacting
performance. Therefore, we are seeking to mitigate these concerns by
making changes to the related measures. We believe these changes would
allow providers the necessary time to work toward patient education
about the availability of these resources as well as allowing the
industry as a whole time to develop a stronger infrastructure
supporting patient engagement.
---------------------------------------------------------------------------
\2\ CMS EHR Incentive Programs Web site: ``Data and Reports:
Performance data through February 2015'' https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/AttestationPerformanceData_Feb2015.pdf
---------------------------------------------------------------------------
There are two objectives for EPs and one objective for eligible
hospitals and CAHs, which specifically contain measures requiring a
provider to track patient action. We propose to modify these measures
as follows:
Patient Action To View, Download, or Transmit Health
Information
++ Remove the 5 percent threshold for Measure 2 from the EP Stage 2
Patient Electronic Access (VDT) objective. Instead require that at
least 1 patient seen by the provider during the EHR reporting period
views, downloads, or transmits his or her health information to a third
party. This would demonstrate the capability is fully enabled and
workflows to support the action have been established by the provider.
++ Remove the 5 percent threshold for Measure 2 from the eligible
hospital and CAH Stage 2 Patient Electronic Access (VDT) objective.
Instead require that at least 1 patient discharged from the hospital
during the EHR reporting period views, downloads, or transmits his or
her health information to a third party. This would demonstrate the
capability is fully enabled and workflows to support the action have
been established by the provider.
We seek comment on potential alternate proposals for this proposed
change to the threshold for Measure 2 of the Stage 2 Patient Electronic
Access objective. For example, we seek
[[Page 20358]]
comment on potential alternates such as a percentage threshold less
than 5 percent, or a numerator greater than 10 patients, or another
similar numerical alternative. We further seek comment on suggestions
for other potential alternatives which would accomplish the goals here
stated of reducing the burden on providers to account for patient
actions while still continuing to encourage IT supported patient
engagement.
Secure Electronic Messaging Using CEHRT
++ Convert the measure for the Stage 2 EP Secure Electronic
Messaging objective from the 5 percent threshold to a yes/no
attestation to the statement: ``The capability for patients to send and
receive a secure electronic message was enabled during the EHR
reporting period''.
These changes are reflected in the discussion of these objectives
in section II.B.2. of this proposed rule. We note that these changes
are intended to allow providers to work toward meaningful patient
engagement through health IT using the methods best suited to their
practice and their patient population. We further note that the Stage 3
proposed rule includes an objective exclusively focused on patient
engagement with an expanded set of measures and increased thresholds
which providers would be required to meet beginning in 2018 (and
optionally in 2017). (For further information on that proposed
objective, we direct readers to 80 FR 16755 through 16758.)
We invite public comment on this proposal.
2. Meaningful Use Objectives and Measures for 2015, 2016, and 2017
We propose the following objectives and measures for EPs, eligible
hospitals, and CAHs to successfully demonstrate meaningful use for an
EHR reporting period in 2015 through 2017. We note that there are 9
proposed objectives for EPs plus one consolidated public health
reporting objective, and 8 proposed objectives for eligible hospitals
and CAHs plus one consolidated public health reporting objective which
would be required with alternate exclusions for certain providers in
2015 and which would be mandatory for all providers for an EHR
reporting period beginning in 2016.
a. Protect Electronic Health Information
We are proposing to retain with certain modifications the Stage 2
objective and measure for Protect Electronic Health Information for
meaningful use in 2015 through 2017. (For further information and
discussion of the existing Stage 2 Protect Electronic Health
Information objective and measure, please refer to 77 FR 54002 and
54003).
Proposed Objective: Protect electronic health information created
or maintained by the CEHRT through the implementation of appropriate
technical capabilities.
In the Stage 2 final rule (77 FR 54002 through 54003), we discussed
the benefits of safeguarding electronic protected health information
(ePHI), as doing so is essential to all other aspects of meaningful
use. Unintended and unlawful disclosures (or both) of ePHI could
diminish consumers' confidence in EHRs and health information exchange.
Ensuring that ePHI is adequately protected and secured would 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 in 45 CFR 164.308(a)(1), including
addressing the security (to include encryption) of data stored in
Certified EHR Technology in accordance with requirements in 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 EP, eligible hospital, or CAHs risk management process.
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 refer providers to the
requirements in 45 CFR 164.308(a)(1), including addressing the security
(to include encryption) of data at rest in accordance with requirements
in 45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3), of the HIPAA
Security Rule for compliance. The HHS Office for Civil Rights (OCR) has
issued guidance on conducting a security risk analysis in accordance
with the HIPAA Security Rule (https://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf). Other free tools
and resources available to assist providers include a Security Risk
Assessment (SRA) Tool developed by ONC and OCR https://www.healthit.gov/providers-professionals/security-risk-assessment-tool.
The scope of the security risk analysis for purposes of this
meaningful use measure applies to ePHI created or maintained by CEHRT.
However, we note that other ePHI may be subject to the HIPPA Rules and
we refer providers to those rules for additional security requirements.
We invite public comment on this proposal.
b. Clinical Decision Support
We are proposing to retain the Stage 2 objective and measures for
Clinical Decision Support (CDS) for meaningful use in 2015 through
2017. This is a consolidated objective, which incorporates the Stage 1
objective to implement drug-drug and drug-allergy interaction checks.
(For further information and discussion of the existing consolidated
Stage 2 CDS objective and measures, please refer to 77 FR 53995 through
53998.)
Proposed Objective: Use clinical decision support to improve
performance on high-priority health conditions.
We propose to retain the Stage 2 clinical decision support (CDS)
objective such that CDS would be used to improve performance on high-
priority health conditions. It would be left to the provider's clinical
discretion to select the most appropriate CDS interventions for his or
her patient population. CDS interventions selected should be related to
four or more of the clinical quality measures (CQMs) on which providers
would be expected to report. The goal of the proposed CDS objective is
for providers to implement improvements in clinical performance for
high-priority health conditions that would result in improved patient
outcomes. We propose to maintain that providers must implement the CDS
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.
Proposed Measure: In order for EPs, eligible hospitals, and CAHs to
meet the objective they must satisfy both of the following measures:
Measure 1: Implement five clinical decision support
interventions related to four or more clinical quality measures at a
relevant point in patient care for the entire EHR reporting period.
Absent four clinical quality measures related to an EP, eligible
hospital or CAH's scope of practice or patient population, the clinical
decision support interventions must be related to high-priority health
conditions.
Measure 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.
For the first measure, it is suggested that one of the five
clinical decision support interventions be related to improving
healthcare efficiency.
[[Page 20359]]
Exclusion: For the second measure, any EP who writes fewer than 100
medication orders during the EHR reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
We propose that providers who are scheduled to demonstrate Stage 1
of meaningful use for an EHR reporting period in 2015 may attest to
meaningful use using the specifications established for the Stage 1
objectives and measures as they are currently defined at 42 CFR 495.6
for each retained objective or measure where there is a difference in
specifications between Stages 1 and 2. We note that the Stage 1
Clinical Decision Support objective has a different requirement than
the Stage 2 Clinical Decision Support objective measure 1 defined
previously. For Stage 1, the objective reads ``Implement one clinical
decision support rule relevant to specialty or high clinical priority
along with the ability to track compliance with that rule'' for EPs and
``Implement one clinical decision support rule related to a high
priority hospital condition along with the ability to track compliance
with that rule'' for eligible hospitals and CAHs (42 CFR 495.6).
Therefore, for an EHR reporting period in 2015 only, we propose that an
EP, eligible hospital or CAH who is scheduled to participate in Stage 1
in 2015 may satisfy the following Stage 1 measure instead of the Stage
2 measure 1 stated previously:
Alternate Objective and Measure (For Measure 1):
Objective: Implement one clinical decision support rule relevant to
specialty or high clinical priority, or high priority hospital
condition, along with the ability to track compliance with that rule.
Measure: Implement one clinical decision support rule.
We propose that for an EHR reporting period in 2015, an EP,
eligible hospital or CAH who is scheduled to participate in Stage 1 in
2015 must also satisfy the Stage 2 measure 2 previously stated because
it is the same as an existing Stage 1 measure (77 FR 53998). There are
no alternate exclusions for this objective.
We invite public comment on this proposal.
c. Computerized Provider Order Entry (CPOE)
We are proposing to retain the Stage 2 objective and measures for
Computerized Provider Order Entry (CPOE) for meaningful use in 2015
through 2017, with the modifications proposed here as alternate
exclusions and specifications for Stage 1 providers for an EHR
reporting period in 2015. (For further information and discussion of
the existing Stage 2 CPOE objective and measures, please refer to 77 FR
53985 through 53987.)
Proposed Objective: Use computerized provider order entry 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.
We 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.
Proposed Measures: In Stage 2 of meaningful use, we adopted three
measures for this objective:
Measure 1: More than 60 percent of medication orders
created by the EP or 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 recorded using computerized provider order
entry.
Measure 2: More than 30 percent of laboratory orders
created by the EP or 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 recorded using computerized provider order
entry.
Measure 3: More than 30 percent of radiology orders
created by the EP or 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 recorded using computerized provider order
entry. We propose to retain the three measures of this current Stage 2
objective to calculate a percentage threshold for all three types of
orders: Medication, laboratory, and radiology. We propose to retain
exclusionary criteria for those providers who so infrequently issue an
order type that it is not practical to implement CPOE for that order
type. To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Measure 1:
Denominator: Number of medication orders created by the EP or
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 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 orders
during the EHR reporting period.
Measure 2:
Denominator: Number of laboratory orders created by the EP or
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 recorded using
CPOE.
Threshold: The resulting percentage must be more than 30 percent in
order for an EP, eligible hospital or CAH to meet this measure.
Exclusion: Any EP who writes fewer than 100 laboratory orders
during the EHR reporting period.
Measure 3:
Denominator: Number of radiology orders created by the EP or
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 recorded using
CPOE.
Threshold: The resulting percentage must be more than 30 percent in
order for an EP, eligible hospital or CAH to meet this measure.
Exclusion: Any EP who writes fewer than 100 radiology orders during
the EHR reporting period.
An EP through a combination of meeting the thresholds and
exclusions (or both) must satisfy all three measures for this
objective. A hospital must meet the thresholds for all three measures.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
We propose that providers who are scheduled to demonstrate Stage 1
of meaningful use for an EHR reporting period in 2015 may attest to
meaningful use using the specifications and thresholds established for
the Stage 1 objectives and measures as they are currently defined at 42
CFR 495.6 for each retained objective or measure
[[Page 20360]]
where there is a difference in specifications between Stages 1 and 2.
In the Stage 1 final rule, the CPOE measure requires that ``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'' (75 FR 44334). In addition, in the Stage 2 final
rule, we established an optional alternative to this measure for Stage
1 of ``More than 30 percent of medication 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.'' (77 FR 53988). Therefore, we are proposing that
for an EHR reporting period in 2015, providers scheduled to demonstrate
Stage 1 of meaningful use may attest to the specification associated
with the Stage 1 measure.
We further propose that providers scheduled to demonstrate Stage 1
of meaningful use for an EHR reporting period in 2015 may claim an
exclusion for any retained Stage 2 measure where there is not an
equivalent Stage 1 measure currently defined at 42 CFR 495.6. The Stage
2 CPOE objective includes measures for laboratory and radiology orders,
whereas the Stage 1 CPOE objective does not include these measures.
Thus, we propose that for an EHR reporting period in 2015 only,
providers scheduled to demonstrate Stage 1 of meaningful use in 2015
may exclude the Stage 2 CPOE measures for laboratory and radiology
orders (measures 2 and 3 listed previously). We propose that for an EHR
reporting period beginning in 2016, all providers must attest to the
Stage 2 objective and measures, and meet the thresholds associated with
all three of the Stage 2 measures discussed previously in order to
successfully demonstrate meaningful use.
Alternate Measure 1: 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; or more than 30 percent of
medication orders created by the EP during the EHR reporting period, or
created by the authorized providers of the eligible hospital or CAH for
patients admitted to their inpatient or emergency departments (POS 21
or 23) during the EHR reporting period, are recorded using computerized
provider order entry.
Alternate Exclusion for Measure 2: Provider may claim an exclusion
for measure 2 (laboratory orders) of the Stage 2 CPOE objective for an
EHR reporting period in 2015.
Alternate Exclusion for Measure 3: Provider may claim an exclusion
for measure 3 (radiology orders) of the Stage 2 CPOE objective for an
EHR reporting period in 2015.
We invite public comment on this proposal.
d. Electronic Prescribing
We are proposing to retain the Stage 2 objective and measure for
Electronic Prescribing (eRx) for EPs as well as for eligible hospitals
and CAHs for meaningful use in 2015 through 2017. We note that the
Stage 2 objective for eligible hospitals and CAHs is currently a menu
objective, but we propose it would be required for 2015 through 2017,
with an exception for Stage 1 eligible hospitals and CAHs for an EHR
reporting period in 2015. (For further information and discussion of
the existing Stage 2 eRx objectives and measures, please refer to 77 FR
53989 through 53990 for EPs and 77 FR 54035 through 54036 for eligible
hospitals and CAHs.)
(1) EP Proposed Objective
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, CEHRT 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 CEHRT 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.
Proposed EP Measure: More than 50 percent of all permissible
prescriptions, or all prescriptions, written by the EP are queried for
a drug formulary and transmitted electronically using Certified EHR
Technology.
We propose to retain the exclusion introduced for Stage 2 that
would allow EPs to exclude this objective if no pharmacies within 10
miles of an EP's practice location at the start of his/her EHR
reporting period accept electronic prescriptions. This is 10 miles in
any straight line from the practice location independent of the travel
route from the practice location to the pharmacy. We stated that EPs
practicing at multiple locations would be eligible for the exclusion if
any of their practice locations that are equipped with CEHRT 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 10 mile radius regardless of whether that pharmacy can
accept electronic prescriptions from EPs outside of the organization.
We also propose to retain the exclusion for EPs who write fewer
than 100 permissible prescriptions 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 prescriptions written for drugs requiring a
prescription in order to be dispensed other than controlled substances
during the EHR reporting period; or Number of prescriptions written for
drugs requiring a prescription in order to be dispensed during the EHR
reporting period.
Numerator: The number of prescriptions in the denominator
generated, queried for a drug formulary and transmitted electronically
using CEHRT.
Threshold: The resulting percentage must be more than 50 percent in
order for an EP to meet this measure.
Exclusions: Any EP who:
Writes fewer than 100 permissible prescriptions during the
EHR reporting period; or
Does not have a pharmacy within his or her organization
and there are no pharmacies that accept electronic prescriptions within
10 miles of the EP's practice location at the start of his or her EHR
reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
We propose that providers who are scheduled to demonstrate Stage 1
of meaningful use for an EHR reporting period in 2015 may attest to
meaningful
[[Page 20361]]
use using the specifications established for the Stage 1 objectives and
measures as they are currently defined at 42 CFR 495.6 for each
retained objective or measure where there is a difference in
specifications between Stages 1 and 2.
In Stage 1, the electronic prescribing measure for EPs requires
that ``More than 40 percent of all permissible prescriptions written by
the EP are transmitted electronically using certified EHR technology''
(75 FR 44338).
Therefore, we are proposing that for an EHR reporting period in
2015, EPs scheduled to demonstrate Stage 1 of meaningful use may attest
to the specifications and threshold associated with the Stage 1
measure. We note that for an EHR reporting period beginning in 2016,
all EPs must meet the specifications and threshold for the retained
Stage 2 measure in order to successfully demonstrate meaningful use.
Alternate EP Measure: More than 40 percent of all permissible
prescriptions written by the EP are transmitted electronically using
Certified EHR Technology.
There are no alternate exclusions for this EP objective.
(2) Eligible Hospital/CAH Proposed Objective
Proposed Eligible Hospital/CAH Objective: Generate and transmit
permissible discharge prescriptions electronically (eRx).
In the Stage 2 final rule at 77 FR 54035, we describe that 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, CEHRT can provide
support for a number of purposes such as promoting safety and quality
in the form of decision support around adverse interactions and other
treatment possibilities; increasing 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; and
reducing communication errors by allows the pharmacy or a third party
to automatically compare the medication order to others they have
received for the patient. This allows for many of the same decision
support functions enabled at the generation of the prescription, but
with access to potentially greater information. For this reason, we
continue to support the use of electronic prescribing for discharge
prescriptions in a hospital setting.
Proposed Eligible Hospital/CAH Measure: More than 10 percent of
hospital discharge medication orders for permissible prescriptions (for
new, changed and refilled prescriptions) are queried for a drug
formulary and transmitted electronically using Certified EHR
Technology.
We propose to retain the exclusion that would allow a hospital to
exclude this objective if there is no internal pharmacy that can accept
electronic prescriptions and is not located within 10 miles of any
pharmacy that accepts electronic prescriptions at the start of their
EHR reporting period.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: Number of new, changed, or refill 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, queried for 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 is not
located within 10 miles of any pharmacy that accepts electronic
prescriptions at the start of their EHR reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
We propose that eligible hospitals and CAHs scheduled to report on
Stage 1 objectives for an EHR reporting period in 2015 may claim an
exclusion for the Stage 2 eRx measure as there is not an equivalent
Stage 1 measure defined at 42 CFR 495.6. We further propose that
eligible hospitals and CAHs scheduled to report Stage 2 objectives for
an EHR reporting period in 2015 who were not intending to attest to the
eRx menu objective and measure may also claim an exclusion. We note
that for an EHR reporting period beginning in 2016, all providers must
attest to the objective and measure and meet the specifications and
threshold for the Stage 2 measure in order to successfully demonstrate
meaningful use.
Alternate Eligible Hospital/CAH Exclusion: Provider may claim an
exclusion for the eRx objective and measure if for an EHR reporting
period in 2015 they were either scheduled to demonstrate Stage 1 which
does not have an equivalent measure, or if they are scheduled to
demonstrate Stage 2 but did not intend to select the Stage 2 eRx menu
objective for an EHR reporting period in 2015.
There are no alternate specifications for this eligible hospital
and CAH objective.
We invite public comment on this proposal.
e. Summary of Care
We are proposing to retain only the second measure of the existing
Stage 2 objective for Summary of Care for meaningful use in 2015
through 2017 with the modifications discussed in this proposed rule.
(For further information and discussion of the existing Stage 2 Summary
of Care objective and measures, we refer readers to the discussion in
the Stage 2 final rule at 77 FR 54013 through 54021.)
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.
In the Stage 2 final rule, we outlined the following benefits of
this objective. By assuring 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 in the care of the referring provider.
Proposed Measure: The EP, eligible hospital or CAH that transitions
or refers their patient to another setting of care or provider of care
that--(1) uses CEHRT to create a summary of care record; and (2)
electronically transmits such summary to a receiving provider for more
than 10 percent of transitions of care and referrals.
We are proposing to retain an updated version of the second measure
of the Stage 2 Summary of Care objective with modifications based on
guidance provided through CMS responses to frequently asked questions
we have received since the publication of the Stage 2 final rule. We
are proposing to retain this measure for electronic transmittal because
we believe that the electronic exchange of health
[[Page 20362]]
information between providers would 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 in creating the summary of care record can
significantly reduce the cost and complexity of interfaces between
different systems and promote widespread exchange and interoperability.
The proposed updates to this measure reflect stakeholder input
regarding operational challenges in meeting this measure, and seek to
increase flexibility for providers while continuing to drive
interoperability across care settings and encouraging further
innovation. Currently, the measure specifies the manner in which the
summary of care must be electronically transmitted. Providers must
either--(1) electronically transmit the summary of care using CEHRT to
a recipient; or (2) where the recipient receives the summary of care
record via exchange facilitated by an organization that is a NwHIN
Exchange participant or in a manner that is consistent with the
governance mechanism ONC establishes for the nationwide health
information network. We propose to update this measure to state simply
that a provider would be required to create the summary of care record
using CEHRT and transmit the summary of care record electronically.
To calculate the percentage of the 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 created using Certified
EHR Technology and is exchanged electronically.
Threshold: The percentage must be more than 10 percent in order for
an EP, eligible hospital or CAH to meet this measure.
Exclusion: Any EP who transfers a patient to another setting or
refers a patient to another provider less than 100 times during the EHR
reporting period.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
We propose that providers scheduled to demonstrate Stage 1 of
meaningful use for an EHR reporting period in 2015 may claim an
exclusion for Measure 2 of the Stage 2 Summary of Care core objective,
as there is not an equivalent Stage 1 measure. The measure related to
the electronic transmission of a summary of care record in the Summary
of Care core objective requires an electronic summary of care document
to be sent for transitions and referrals and is only applicable for
Stage 2. There is not an equivalent objective and measure in Stage 1.
We note that for an EHR reporting period beginning in 2016, all
providers must attest to the complete objective and meet the
specifications and threshold for the both Stage 2 measures in order to
successfully demonstrate meaningful use.
Alternate Exclusion: Provider may claim an exclusion for the
measure of the Stage 2 Summary of Care objective which requires the
electronic transmission of a summary of care document if for an EHR
reporting period in 2015 they were scheduled to demonstrate Stage 1,
which does not have an equivalent measure.
There are no alternate specifications for this objective.
We invite public comment on this proposal.
f. Patient Specific Education
We are proposing to retain the Stage 2 objective and measure for
Patient Specific Education for meaningful use for 2015 through 2017.
(For further information and discussion of the existing Stage 2 Patient
Specific Education objective and measure, please refer to 77 FR 54011
and 54012.)
Proposed Objective: Use clinically relevant information from
Certified EHR Technology to identify patient-specific education
resources and provide those resources to the patient.
In the Stage 2 proposed rule, we explained that providing
clinically relevant education resources to patients is a priority for
the meaningful use of CEHRT. While CEHRT must be used to identify
patient-specific education resources, these resources or materials do
not have to be stored within or generated by the CEHRT. We are aware
that there are many electronic resources available for patient
education materials, such as through the National Library of Medicine's
MedlinePlus (https://www.nlm.nih.gov/medlineplus, that can be queried
via CEHRT (that is, specific patient characteristics are linked to
specific consumer health content). The EP or hospital should utilize
CEHRT in a manner where the technology suggests patient-specific
educational resources based on the information stored in the CEHRT.
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 CEHRT 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).
Proposed EP Measure: Patient-specific education resources
identified by Certified EHR Technology are provided to patients for
more than 10 percent of all unique patients with office visits seen by
the EP during the EHR reporting period.
We propose to retain the 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. 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 unique patients with office visits seen by
the EP during the EHR reporting period.
Numerator: Number of patients in the denominator who were provided
patient-specific education resources identified by the 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 department (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
[[Page 20363]]
together to define the following for this objective:
Denominator: Number of unique patients admitted to the eligible
hospital or CAH 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 CEHRT.
Threshold: The resulting percentage must be more than 10 percent in
order for an eligible hospital or CAH to meet this measure.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
While the Patient Specific Education objective is designated as an
optional menu objective in Stage 1 of meaningful use, the same
objective is a mandatory core objective in Stage 2 of meaningful use.
We expect that not all Stage 1 scheduled providers were planning to
choose this menu objective when attesting in an EHR reporting period in
2015. Therefore, we propose that any provider scheduled to demonstrate
Stage 1 of meaningful use for an EHR reporting period in 2015 who was
not intending to attest to the Stage 1 Patient Specific Education menu
objective, may claim an exclusion to the measure. We note that for an
EHR reporting period beginning in 2016, all providers must attest to
the objective and measure and meet the Stage 2 specifications and
threshold in order to successfully demonstrate meaningful use.
Alternate Exclusion: Provider may claim an exclusion for the
measure of the Stage 2 Patient Specific Education objective if for an
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1
but did not intend to select the Stage 1 Patient Specific Education
menu objective.
There are no alternate specifications for this objective.
We invite public comment on this proposal.
g. Medication Reconciliation
We are proposing to retain the Stage 2 objective and measure for
Medication Reconciliation for meaningful use in 2015 through 2017. (For
further information and discussion of the existing Stage 2 Medication
Reconciliation objective and measure, please refer to 77 FR 54012 and
54013.)
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 his or her direct patient care, it also
improves the accuracy of information they provide to others through
health information exchange.
In the Stage 2 proposed rule, we noted that 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. We reiterated 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. We defined 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.
Proposed Measure: The EP, eligible hospital or CAH performs
medication reconciliation for more than 50 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).
For the purposes of this measure, 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 and referrals are cases
where one provider refers a patient to another, but the referring
provider maintains his or her care of the patient as well.
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 50 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.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
While the Medication Reconciliation objective is designated as an
optional menu objective in Stage 1 of meaningful use, the same
objective is a mandatory core objective in Stage 2 of meaningful use.
We expect that not all Stage 1 scheduled providers were planning to
choose this menu objective when attesting in an EHR reporting period in
2015. Therefore, we propose that any provider scheduled to demonstrate
Stage 1 of meaningful use for an EHR reporting period in 2015 who was
not intending to attest to the Stage 1 Medication Reconciliation menu
objective, may claim an exclusion to the measure. We note that for an
EHR reporting period beginning in 2016, all providers must attest to
the objective and measure and meet the Stage 2 specifications and
threshold in order to successfully demonstrate meaningful use.
Alternate Exclusion: Provider may claim an exclusion for the
measure of the Stage 2 Medication Reconciliation objective if for an
EHR reporting period in 2015 they were scheduled to demonstrate Stage 1
but did not intend to select the Stage 1 Medication Reconciliation menu
objective.
There are no alternate specifications for this objective.
We invite public comment on this proposal.
h. Patient Electronic Access (VDT)
We are proposing to retain the Stage 2 objective for Patient
Electronic Access for meaningful use in 2015 through 2017. We are
proposing to retain the first measure of the Stage 2 objective without
modification. We are proposing to retain the second measure for the
Stage 2 objective with modification to the measure threshold. (For
further information and discussion of the existing Stage 2 Patient
Electronic Access objective and measures, please refer to 77 FR 54007
through 54011.)
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.
Proposed Eligible Hospital/CAH Objective: Provide patients the
ability to view online, download, and transmit information about a
hospital admission.
In the Stage 2 proposed rule, we stated that the goal of this
objective was
[[Page 20364]]
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.
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. The patient must be able to access this
information on demand, such as through a patient portal or personal
health record (PHR). We note that while a covered entity may be able to
fully satisfy a patient's request for information through VDT, the
measure does not replace the covered entity's responsibilities to meet
the broader requirements under HIPAA to provide an individual, upon
request, with access to PHI in a designated record set. Providers
should also 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. Finally, we noted that 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.
Proposed EP Measures
EP Measure 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.
EP Measure 2: At least one patient seen by the EP during
the EHR reporting period (or their authorized representatives) views,
downloads, or transmits his or her health information to a third party.
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.
++ Current and past problem list.
++ Procedures.
++ Laboratory test results.
++ Current medication list and medication history.
++ Current medication allergy list and medication allergy history.
++ Vital signs (height, weight, blood pressure, BMI, growth
charts).
++ Smoking status.
++ Demographic information (preferred language, sex, race,
ethnicity, date of birth).
++ Care plan field(s), including goals and instructions.
++ Any known care team members including the primary care provider
(PCP) of record.
As we stated in the Stage 2 proposed rule, this is not intended to
limit the information made available by the EP. An EP can make
available additional information and still align with the objective. 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. Please note that while some of the information made
available through this measure is similar to the information made
available in the summary of care document that must be provided
following transitions of care or referrals, the list of information
provided is specific to the view online, download, and transmit
objective. Patients and providers have different information needs and
contexts, so we have established separate required fields for each of
these objectives.
We propose to retain the exclusion that any EP who neither orders
nor creates any of the information listed for inclusion as part of this
measure may exclude from this measure as well as the exclusion for
limited broadband access in an EPs service area.
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:
EP Measure 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.
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.
Threshold: The resulting percentage must be more than 50 percent in
order for an EP to meet this measure.
EP Measure 2: At least one patient seen by the EP during
the EHR reporting period (or his or her authorized representatives)
views, downloads, or transmits his or her health information to a third
party.
Exclusions: Any EP who--
(a) Neither orders nor creates any of the information listed for
inclusion as part of the measures; or
(b) 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.
Proposed Eligible Hospital/CAH Measures:
Eligible Hospital/CAH Measure 1: 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.
Eligible Hospital/CAH Measure 2: At least 1 patient who is
discharged from the inpatient or emergency department (POS 21 or 23) of
an eligible hospital or CAH (or his or her authorized representative)
views, downloads, or transmits to a third party his or her information
during the EHR reporting period.
The following information must be available to satisfy the
objective and measure:
++ Patient name.
++ Admit and discharge date and location.
++ Reason for hospitalization.
++ Care team including the attending of record as well as other
providers of care.
++ Procedures performed during admission.
++ Current and past problem list.
++ Vital signs at discharge.
++ Laboratory test results (available at time of discharge).
++ Summary of care record for transitions of care or referrals to
another provider.
++ Care plan field(s), including goals and instructions.
[[Page 20365]]
++ Discharge instructions for patient.
++ Demographics maintained by hospital (sex, race, ethnicity, date
of birth, preferred language).
++ Smoking status.
This is not intended to limit the information made available by the
hospital. A hospital can make available additional information and
still align with the objective. Please note that while some of the
information made available through this measure is similar to the
information made available in the summary of care document that must be
provided following transitions of care or referrals, this list of
information provided is specific to the view online, download, and
transmit objective. Patients and providers have different information
needs and contexts, so CMS has established separate required fields for
each of these objectives.
To calculate the percentage of the first measure for providing
patients timely access to discharge information, CMS and ONC have
worked together to define the following for this objective:
Eligible Hospital/CAH Measure 1: 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.
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.
Eligible Hospital/CAH Measure 2: At least 1 patient who is
discharged from the inpatient or emergency department (POS 21 or 23) of
an eligible hospital or CAH (or his or her authorized representative)
views, downloads, or transmits to a third party his or her information
during the EHR reporting period.
Exclusion: Any eligible hospital or CAH that is located 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.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
The Patient Electronic Access objective has two associated
measures, the first (provide access to view, download, and transmit
health information) is applicable for both Stage 1 and Stage 2 while
the second (patients view, download, or transmit their health
information) is only applicable for Stage 2. Therefore, we propose that
providers scheduled to demonstrate Stage 1 of meaningful use for an EHR
reporting period in 2015 may additionally claim an exclusion for the
second measure of the Stage 2 Patient Electronic Access objective as
there is not an equivalent Stage 1 measure defined at 42 CFR 495.6. We
note that for an EHR reporting period beginning in 2016, all providers
must attest to the objective and both measures and meet the
specifications and threshold associated with the retained Stage 2
objective and measures in order to successfully demonstrate meaningful
use.
Alternate Exclusion Measure 2: Provider may claim an
exclusion for the second measure if for an EHR reporting period in 2015
they were scheduled to demonstrate Stage 1, which does not have an
equivalent measure.
There are no alternate specifications for this objective.
We invite public comment on this proposal.
i. Secure Electronic Messaging
We are proposing to retain the Stage 2 objective for secure
electronic messaging with modifications to the measure for meaningful
use in 2015 through 2017. (For further information and discussion of
the existing Stage 2 secure electronic messaging objective and measure,
please refer to 77 FR 54033.)
Proposed Objective: Use secure electronic messaging to communicate
with patients on relevant health information.
In the Stage 2 proposed rule, we outlined the following benefits of
using secure electronic messaging to communicate with patients:
Electronic messaging (for example, email) is one of the most widespread
methods of communication for both businesses and individuals. The
ability to communicate through forms of electronic messaging is
essential to 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. However, common email services may not be secure enough to be
appropriate for the exchange of ePHI. Therefore, the exchange of ePHI
through electronic messaging requires additional security measures
while maintaining its ease of use for communication. While secure 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.
For EPs, secure electronic messaging is critically important to two
National Quality Strategy (NQS) priorities--
Ensuring that each person/family is engaged as partners in
their care; and
Promoting effective communication and coordination of
care.
Secure electronic messaging could make care more affordable by
using more efficient communication vehicles when appropriate.
Specifically, research demonstrates that secure messaging has improved
patient adherence to treatment plans, which reduces readmission rates.
In addition, secure messaging has led to increased patient satisfaction
with their care and is one of the top ranked features according to
patients. In addition, despite some trepidation, providers have seen a
reduction in time responding to inquiries and less time spent on the
phone.\3\
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\3\ Rosenberg SN, Shnaiden TL, Wegh AA, Juster IA (2008)
``Supporting the patient's role in guideline compliance: a
controlled study'' American Journal of Managed Care 14(11):737-44;
Gustafson DH, Hawkins R, Boberg E, Pingree S, Serlin RE, Graziano F,
Chan CL (1999) ``Impact of a patient-centered, computer-based health
information/support system'' American Journal of Preventive Medicine
16(1):1-9. Ralston JD, Carrell D, Reid R, Anderson M, Moran M,
Hereford J (2007) ``Patient web services integrated with a shared
medical record: patient use and satisfaction'' Journal of the
American Medical Informatics Association 14(6):798-806).
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Proposed Measure: During the EHR reporting period, the capability
for patients to send and receive a secure electronic message with the
provider was fully enabled.
We propose to retain the exclusion for EPs who have no office
visits, and for those EPs who lack the infrastructure required for
secure electronic messaging due to being located in areas with limited
broadband availability as identified by the FCC.
Measure: During the EHR reporting period, the capability for
patients to send and receive a secure electronic message with the
provider was fully enabled.
Exclusion: Any EP who has no office visits during the EHR reporting
period,
[[Page 20366]]
or any EP who 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.
Alternate Exclusions and Specifications for Stage 1 Providers for
Meaningful Use in 2015
For the secure electronic messaging objective, there is no Stage 1
objective or measure which relates to the requirements of the Stage 2
objective and measure. We therefore propose that an EP scheduled to
demonstrate Stage 1 of meaningful use for an EHR reporting period in
2015 may claim an exclusion for the secure electronic messaging
objective measure as there is not an equivalent Stage 1 objective or
measure defined at 42 CFR 495.6. We note that for an EHR reporting
period beginning in 2016, all providers must attest to the objective
and measure of the retained Stage 2 secure electronic messaging
objective in order to successfully demonstrate meaningful use.
Alternate Exclusion: An EP may claim an exclusion for the
measure if for an EHR reporting period in 2015 they were scheduled to
demonstrate Stage 1, which does not have an equivalent measure.
There are no alternate specifications for this objective and there
is no equivalent objective for eligible hospitals and CAHs in the Stage
2 objectives and measures for meaningful use.
We invite public comment on this proposal.
j. Public Health and Clinical Data Registry (CDR) Reporting
As mentioned previously, we are proposing to adopt the consolidated
Stage 3 version of the public health reporting objectives for all
providers to demonstrate meaningful use for an EHR reporting period in
2015 through 2017. We note that this change does not fundamentally
change a provider's ability to demonstrate meeting the requirements of
meaningful use with any actions they may have already taken or are in
the progress of taking to meet the prior requirements of meaningful use
defined in the Stage 1 and Stage 2 rules for public health reporting.
These requirements are currently defined at (75 FR 44325 through 44326)
for EPs and (75 FR 44364 through 44368) for eligible hospitals and CAHs
in the Stage 1 final rule. In the Stage two final rule the requirements
may be found at (77 FR 54021 through 54026) for EPs and (77 FR 54029
through 54031) for eligible hospitals and CAHs. We further note that
this change does not require the addition of any new technology or
standard not already available in CEHRT to demonstrate meaningful use
in 2014.
This objective is designed based on the objective proposed in the
Stage 3 proposed rule at which builds on the requirements set forth in
the Stage 2 final rule (see for example 77 FR 54047 through 54048 under
the Health Outcomes Policy Priority ``Improve population and public
health''). In the Stage 3 proposed rule, we proposed changes to the
Stage 1 and Stage 2 public health and specialty registry objectives to
consolidate the prior objectives and measures into a single objective
in alignment with efforts to streamline the program and support
flexibility for providers (80 FR 16739 and 16740).
Proposed Objective: The EP, eligible hospital, or CAH is in active
engagement with a Public Health Agency (PHA) or clinical data registry
(CDR) to submit electronic public health data in a meaningful way using
certified EHR technology, except where prohibited and in accordance
with applicable law and practice.
In the Stage 3 proposed rule, we highlighted our intention to
remove the prior ongoing submission requirement and replace it with an
``active engagement'' requirement. We believe that ``active
engagement'' as defined in the Stage 3 rule at (80 FR 16739 and 16740)
and reiterated in this section is more aligned with the process
providers undertake to report to a clinical registry or to a PHA.
For purposes of meeting this new objective, EPs, eligible hospitals
and CAHs would be required to demonstrate that ``active engagement''
with a PHA or CDR has occurred. Active engagement means that the
provider is in the process of moving towards sending ``production
data'' to a PHA or CDR, or-- is sending production data to a PHA or
CDR. We note that the term ``production data'' refers to data generated
through clinical processes involving patient care, and it is here used
to distinguish between this data and ``test data'' which may be
submitted for the purposes of enrolling in and testing electronic data
transfers. We propose that ``active engagement'' may be demonstrated by
any of the following options:
Active Engagement Option 1--Completed Registration to Submit Data:
The EP, eligible hospital, or CAH registered to submit data with the
PHA or, where applicable, the CDR to which the information is being
submitted; registration was completed within 60 days after the start of
the EHR reporting period; and the EP, eligible hospital, or CAH is
awaiting an invitation from the PHA or CDR to begin testing and
validation. This option allows providers to meet the measure when the
PHA or the CDR has limited resources to initiate the testing and
validation process. Providers that have registered in previous years do
not need to submit an additional registration to meet this requirement
for each EHR reporting period.
Active Engagement Option 2--Testing and Validation: The EP,
eligible hospital, or CAH is in the process of testing and validation
of the electronic submission of data. Providers must respond to
requests from the PHA or, where applicable, the CDR within 30 days;
failure to respond twice within an EHR reporting period would result in
that provider not meeting the measure.
Active Engagement Option 3--Production: The EP, eligible hospital,
or CAH has completed testing and validation of the electronic
submission and is electronically submitting production data to the PHA
or CDR.
We note that the change in definition is intended to better capture
the activities a provider may conduct in order to engage with a PHA or
CDR, and that any prior action taken to meet the non-consolidated
public health reporting objectives of meaningful use Stages 1 and 2
would count toward meeting the active engagement requirement of this
objective.
Proposed Measures: We are proposing a total of 6 possible measures
for this objective. For meaningful use in 2015 through 2017, EPs would
be required to choose from Measures 1 through 5, and would be required
to successfully attest to any combination of two measures. For
meaningful use in 2015 through 2017, eligible hospitals and CAHs would
be required to choose from Measures 1 through 6, and would be required
to successfully attest to any combination of three measures. In 2015
only for providers scheduled to be in Stage 1, EPs would be required to
choose from Measures 1 through 5, but would be permitted to
successfully attest to one measure; and eligible hospitals and CAHs
would be required to choose from Measures 1 through 6, but would be
permitted to successfully attest to any combination of two measures.
The measures are as shown in Table 5. As noted, measures 4 and 5 for
Public Health Registry Reporting and Clinical Data Registry Reporting
may be counted more than once if more than one Public Health Registry
or Clinical Data Registry is available.
[[Page 20367]]
The measures are as follows:
Table 5--Measures for Objective 8--Public Health and Clinical Data Registry Reporting Objective
----------------------------------------------------------------------------------------------------------------
Maximum times measure
Maximum times measure can count towards
Measure can count towards objective for eligible
objective for EP hospital or CAH
----------------------------------------------------------------------------------------------------------------
Measure 1--Immunization Registry Reporting.................... 1 1
Measure 2--Syndromic Surveillance Reporting................... 1 1
Measure 3--Case Reporting..................................... 1 1
Measure 4--Public Health Registry Reporting *................. 3 4
Measure 5--Clinical Data Registry Reporting **................ 3 4
Measure 6--Electronic Reportable Laboratory Results........... N/A 1
----------------------------------------------------------------------------------------------------------------
* EPs, eligible hospitals, and CAHs may choose to report to more than one public health registry (measure 4) to
meet the number of measures required to meet the objective.
** EPs, eligible hospitals, and CAHs may choose to report to more than one clinical data registry (measure 5) to
meet the number of measures required to meet the objective.
For EPs, we propose that an exclusion for a measure does not count
toward the total of two measures. Instead, in order to meet this
objective an EP would need to meet two of the total number of measures
available to them. If the EP qualifies for multiple exclusions and the
remaining number of measures available to the EP is less than two, the
EP can meet the objective by meeting the one remaining measure
available to them and claiming the applicable exclusions. If no
measures remain available, the EP can meet the objective by claiming
applicable exclusions for all measures. An EP who is scheduled to be in
Stage 1 in 2015 must report at least one measure unless they can
exclude from all available measures. Available measures include ones
for which the EP does not qualify for an exclusion.
For eligible hospitals and CAHs, we propose that an exclusion for a
measure does not count toward the total of three measures. Instead, in
order to meet this objective an eligible hospital or CAH would need to
meet three of the total number of measures available to them. If the
eligible hospital or CAH qualifies for multiple exclusions and the
total number of remaining measures available to the eligible hospital
or CAH is less than three, the eligible hospital or CAH can meet the
objective by meeting all of the remaining measures available to them
and claiming the applicable exclusions. If no measures remain
available, the eligible hospital or CAH can meet the objective by
claiming applicable exclusions for all measures. An eligible hospital
or CAH that is scheduled to be in Stage 1 in 2015 must report at least
two measures unless they can either--(1) exclude from all but one
available measure and report that one measure; or (2) can exclude from
all available measures. Available measures include ones for which the
eligible hospital or CAH does not qualify for an exclusion.
We note that we are proposing to allow EPs, eligible hospitals, and
CAHs to choose to report to more than one public health registry to
meet the number of measures required to meet the objective. We are also
proposing to allow EPs, eligible hospitals, and CAHs to choose to
report to more than one clinical data registry to meet the number of
measures required to meet the objective. We believe that this
flexibility allows for EPs, eligible hospitals, and CAHs to choose
reporting options that align with their practice and that would aid the
provider's ability to care for their patients.
To calculate the measures:
Measure 1--Immunization Registry Reporting: The EP,
eligible hospital, or CAH is in active engagement with a public health
agency to submit immunization data and receive immunization forecasts
and histories from the public health immunization registry/immunization
information system (IIS).
We believe the immunization registry reporting measure remains a
priority for the EHR Incentive Programs because the exchange of
information between certified EHR technology and immunization
registries allows a provider to use the most complete immunization
history available to inform decisions about the vaccines a patient may
need. Public health agencies and providers also use immunization
information for emergency preparedness and to estimate population
immunization coverage levels of certain vaccines.
We propose that to successfully meet the requirements of this
measure, bidirectional data exchange between the provider's certified
EHR technology system and the immunization registry/IIS is required. We
understand that many states and local public health jurisdictions are
exchanging immunization data bidirectionally with providers, and that
the number of states and localities able to support bidirectional
exchange continues to increase. In the 2015 Edition proposed rule (80
FR 16851), the ONC is proposing to adopt a bidirectional exchange
standard for reporting to immunization registries/IIS. We believe this
functionality is important for patient safety and improved care because
it allows for the provider to use the most complete immunization record
possible to make decisions on whether a patient needs a vaccine.
Immunization registries and health IT systems also are able to provide
immunization forecasting functions which can inform discussions between
providers and patients on what vaccines they may need in the future and
the timeline for the receipt of such immunizations. Therefore, we
believe that patients, providers, and the public health community would
benefit from technology that can accommodate bidirectional immunization
data exchange.
We welcome comment on this proposal.
Exclusion: Any EP, eligible hospital, or CAH meeting one or more of
the following criteria may be excluded from the immunization registry
reporting measure if the EP, eligible hospital, or CAH:
++ Does not administer any immunizations to any of the populations
for which data is collected by their jurisdiction's immunization
registry or immunization information system during the EHR reporting
period;
++ Operates in a jurisdiction for which no immunization registry or
immunization information system is capable of accepting the specific
standards required to meet the CEHRT
[[Page 20368]]
definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no immunization registry or
immunization information system has declared readiness to receive
immunization data from the EP, eligible hospital or CAHs at the start
of the EHR reporting period.
Measure 2--Syndromic Surveillance Reporting: The EP,
eligible hospital or CAH is in active engagement with a public health
agency to submit syndromic surveillance data from a non-urgent care
ambulatory setting for EPs, or an emergency or urgent care department
for eligible hospitals and CAHs (POS 23).
This measure remains a policy priority for the EHR Incentive
Programs because electronic syndromic surveillance is valuable for
early detection of outbreaks, as well as monitoring disease and
condition trends.
We are distinguishing between EPs and eligible hospital or CAHs
reporting locations because as discussed in the Stage 2 final rule, few
PHAs appeared to have the ability to accept non-emergency or non-urgent
care ambulatory syndromic surveillance data electronically (77 FR
53979). We continue to observe differences in the infrastructure and
current environments for supporting electronic syndromic surveillance
data submission to PHAs between eligible hospitals or CAHs and EPs.
Because eligible hospitals and CAHs send syndromic surveillance data
using different methods as compared to EPs, we are defining slightly
different exclusions for each setting as described by the following:
Exclusion for EPs: Any EP meeting one or more of the following
criteria may be excluded from the syndromic surveillance reporting
measure if the EP--
++ Does not treat or diagnose or directly treat any disease or
condition associated with a syndromic surveillance system in his or her
jurisdiction;
++ Operates in a jurisdiction for which no public health agency is
capable of receiving electronic syndromic surveillance data from EPs in
the specific standards required to meet the CEHRT definition at the
start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has
declared readiness to receive syndromic surveillance data from EPs at
the start of the EHR reporting period.
Exclusion for eligible hospitals/CAHs: Any eligible hospital or CAH
meeting one or more of the following criteria may be excluded from the
syndromic surveillance reporting measure if the eligible hospital or
CAH--
++ Does not have an emergency or urgent care department;
++ Operates in a jurisdiction for which no public health agency is
capable of receiving electronic syndromic surveillance data from
eligible hospitals or CAHs in the specific standards required to meet
the CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has
declared readiness to receive syndromic surveillance data from eligible
hospitals or CAHs at the start of the EHR reporting period.
Measure 3--Case Reporting: The EP, eligible hospital, or
CAH is in active engagement with a public health agency to submit case
reporting of reportable conditions.
This is a new reporting option that was not part of Stage 2. The
collection of electronic case reporting data greatly improves reporting
efficiencies between providers and the PHA. Public health agencies
collect ``reportable conditions'' as defined by the state, territorial,
and local PHAs to monitor disease trends and support the management of
outbreaks. In many circumstances, there has been low reporting
compliance because providers do not know when, where, or how to report.
In some cases, the time burden to report can also contribute to low
reporting compliance. Electronic case reporting, however, presents a
core benefit to public health improvement, and a variety of
stakeholders have identified electronic case reporting as a high value
element of patient and continuity of care. Further, we believe that
electronic case reporting reduces burdensome paper-based and labor
intensive case reporting. Electronic reporting would support more rapid
exchange of case reporting information between PHAs and providers and
can include structured questions or data fields to prompt the provider
to supply additional required or care-relevant information.
To support case reporting, the ONC has proposed a certification
criterion that includes capabilities to enable certified EHR systems to
send initial case reporting data and receive a request from the public
health agency for supplemental or ad hoc structured data in the 2015
Edition proposed rule (80 FR 16855).
Exclusion: Any EP, eligible hospital, or CAH meeting one or more of
the following criteria may be excluded from the case reporting measure
if the EP, eligible hospital, or CAH:
++ Does not treat or diagnose any reportable diseases for which
data is collected by their jurisdiction's reportable disease system
during the EHR reporting period;
++ Operates in a jurisdiction for which no public health agency is
capable of receiving electronic case reporting data in the specific
standards required to meet the CEHRT definition at the start of the EHR
reporting period; or
++ Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic case reporting data at the
start of the EHR reporting period.
Measure 4--Public Health Registry Reporting: The EP,
eligible hospital, or CAH is in active engagement with a public health
agency to submit data to public health registries.
In the Stage 2 final rule, we were purposefully general in our use
of the term ``specialized registry'' (other than a cancer registry) to
encompass both registry reporting to public health agencies and
clinical data registries in order to prevent inadvertent exclusion of
certain registries through an attempt to be more specific (77 FR
54030). In response to insight gained from the industry through
listening sessions, public forums, and responses to a Federal Register
notice soliciting public comments on the proposed information
collections to develop a centralized repository on public health
readiness to support meaningful use (79 FR 7461); we propose to carry
forward the concept behind this broad category from Stage 2, but also
propose to split public health registry reporting from clinical data
registry reporting into two separate measures which better define the
potential types of registries available for reporting. We propose to
define a ``public health registry'' as a registry that is administered
by, or on behalf of, a local, state, territorial, or national PHA and
which collects data for public health purposes. While immunization
registries are a type of public health registry, we propose to keep
immunization registry reporting separate from the public health
registry reporting measure to retain continuity from Stage 1 and 2
policy in which immunization registry reporting was a distinct and
separate objective (77 FR 54023). We believe it is important to retain
the public health registry reporting option for Stage 3 because these
registries allow the public health community to monitor health and
disease trends, and inform the development of programs and policy for
[[Page 20369]]
population and community health improvement.
We reiterate that any EP, eligible hospital, or CAH may report to
more than one public health registry to meet the total number of
required measures for the objective. For example, if a provider meets
this measure through reporting to both the National Hospital Care
Survey and the National Healthcare Safety Network registry, the
provider could get credit for meeting two measures. ONC would consider
the adoption of standards and implementation guides in future
rulemaking. Should these subsequently be finalized, they may then be
adopted as part of the certified EHR technology definition as it
relates to meeting the public health registry reporting measure through
future rulemaking for the EHR Incentive Programs.
We further note that ONC adopted standards for ambulatory cancer
case reporting in its 2014 Edition final rule (see Sec. 170.314(f)(6))
and CMS provided EPs the option to select the cancer case reporting
menu objective in the Stage 2 final rule (77 FR 54029 through 54030).
We included cancer registry reporting as a separate objective from
specialized registry reporting because it was more mature in its
development than other registry types, not because other reporting was
intended to be excluded from meaningful use. For the Stage 3 public
health agency reporting measure, given the desire to provide more
flexible options for providers to report to the registries most
applicable for their scope of practice, we propose that EPs would have
the option of counting cancer case reporting under the public health
registry reporting measure. Under this measure, we note that cancer
case reporting is not an option for eligible hospitals and CAHs,
because hospitals have traditionally diagnosed and treated cancers (or
both) and have the infrastructure needed to report cancer cases.
Exclusions: Any EP, eligible hospital, or CAH meeting at least one
of the following criteria may be excluded from the public health
registry reporting measure if the EP, eligible hospital, or CAH--
++ Does not diagnose or directly treat any disease or condition
associated with a public health registry in their jurisdiction during
the EHR reporting period;
++ Operates in a jurisdiction for which no public health agency is
capable of accepting electronic registry transactions in the specific
standards required to meet the CEHRT definition at the start of the EHR
reporting period; or
++ Operates in a jurisdiction where no public health registry for
which the EP, eligible hospital, or CAH is eligible has declared
readiness to receive electronic registry transactions at the beginning
of the EHR reporting period.
Measure 5--Clinical Data Registry Reporting: The EP,
eligible hospital, or CAH is in active engagement to submit data to a
clinical data registry.
As discussed in the Public Health Registry Reporting measure, we
propose to split specialized registry reporting into two separate,
clearly defined measures: Public health registry reporting and clinical
data registry reporting. In Stage 2 for EPs, reporting to specialized
registries is a menu objective and this menu objective includes
reporting to clinical data registries. For Stage 3, we propose to
include clinical data registry reporting as an independent measure. The
National Quality Registry Network defines clinical data registries as
those that record information about the health status of patients and
the health care they receive over varying periods of time \4\. We
propose to further differentiate between clinical data registries and
public health registries as follows: For the purposes of meaningful
use, ``public health registries'' are those administered by, or on
behalf of, a local, state, territorial, or national public health
agencies; and, ``clinical data registries'' are administered by, or on
behalf of, other non-public health agency entities. We believe that
clinical data registries are important for providing information that
can inform patients and their providers on the best course of treatment
and for care improvements, and can support specialty reporting by
developing reporting for areas not usually covered by PHAs but that are
important to a specialist's provision of care. Clinical data registries
can also be used to monitor health care quality and resource use.
---------------------------------------------------------------------------
\4\ https://download.ama-assn.org/resources/doc/cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf
---------------------------------------------------------------------------
As noted previously, we reiterate that any EP, eligible hospital,
or CAH may report to more than 1 clinical data registry to meet the
total number of required measures for this objective. ONC would
consider the adoption of standards and implementation guides in future
rulemaking. Should these subsequently be finalized, they may then be
adopted as part of the certified EHR technology definition as it
relates to meeting the clinical data registry reporting measure through
future rulemaking for the EHR Incentive Programs.
Exclusion: Any EP, eligible hospital, or CAH meeting at least one
of the following criteria may be excluded from the clinical data
registry reporting measure if the EP, eligible hospital, or CAH--
++ Does not diagnose or directly treat any disease or condition
associated with a clinical data registry in their jurisdiction during
the EHR reporting period;
++ Operates in a jurisdiction for which no clinical data registry
is capable of accepting electronic registry transactions in the
specific standards required to meet the CEHRT definition at the start
of the EHR reporting period; or
++ Operates in a jurisdiction where no clinical data registry for
which the EP, eligible hospital, or CAH is eligible has declared
readiness to receive electronic registry transactions at the beginning
of the EHR reporting period.
Measure 6--Electronic Reportable Laboratory Result
Reporting: The eligible hospital or CAH is in active engagement with a
public health agency to submit electronic reportable laboratory
results. This measure is available to eligible hospitals and CAHs only.
Electronic reportable laboratory result reporting to PHAs is required
for eligible hospitals and CAHs in Stage 2 (77 FR 54021). We propose to
retain this measure for the EHR Incentive Programs to promote the
exchange of laboratory results between eligible hospitals/CAHs and PHAs
for improved timeliness, reduction of manual data entry errors, and
more complete information.
Exclusion: Any eligible hospital or CAH meeting one or more of the
following criteria may be excluded from the electronic reportable
laboratory result reporting measure if the eligible hospital or CAH--
++ Does not perform or order laboratory tests that are reportable
in their jurisdiction during the EHR reporting period;
++ Operates in a jurisdiction for which no public health agency is
capable of accepting the specific ELR standards required to meet the
CEHRT definition at the start of the EHR reporting period; or
++ Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic reportable laboratory results
from eligible hospitals or CAHs at the start of the EHR reporting
period.
[[Page 20370]]
We seek public comment on this proposal.
Table 6--Meaningful Uses Objectives and Measures for 2015 Through 2017
----------------------------------------------------------------------------------------------------------------
Proposed alternate
Proposed measures, exclusions
Provider type objectives for Proposed measures for providers in and/or specifications
2015, 2016 and 2015, 2016 and 2017 for certain providers
2017 in 2015 ONLY
----------------------------------------------------------------------------------------------------------------
Eligible Professional.......... CPOE.............. Measure 1: More than 60 If for an EHR
percent of medication orders reporting period in
created by the EP or by authorized 2015, the provider is
providers of the eligible scheduled to
hospital's or CAH's inpatient or demonstrate Stage 1:
emergency department (POS 21 or Alternate
23) during the EHR reporting Measure 1: More than
period are recorded using 30 percent of all
computerized provider order entry. unique patients with
Measure 2: More than 30 at least one
percent of laboratory orders medication in their
created by the EP or by authorized medication list seen
providers of the eligible by the EP or admitted
hospital's or CAH's inpatient or to the eligible
emergency department (POS 21 or hospital's or CAH's
23) during the EHR reporting inpatient or
period are recorded using emergency department
computerized provider order entry. (POS 21 or 23) during
Measure 3: More than 30 the EHR reporting
percent of radiology orders period have at least
created by the EP or by authorized one medication order
providers of the eligible entered using CPOE;
hospital's or CAH's inpatient or or more than 30
emergency department (POS 21 or percent of medication
23) during the EHR reporting orders created by the
period are recorded using EP during the EHR
computerized provider order entry. reporting period, or
created by the
authorized providers
of the eligible
hospital or CAH for
patients admitted to
their inpatient or
emergency departments
(POS 21 or 23) during
the EHR reporting
period, are recorded
using computerized
provider order entry.
Alternate
Exclusion for Measure
2: Provider may claim
an exclusion for
measure 2 (laboratory
orders) of the Stage
2 CPOE objective for
an EHR reporting
period in 2015.
Alternate
Exclusion for Measure
3: Provider may claim
an exclusion for
measure 3 (radiology
orders) of the Stage
2 CPOE objective for
an EHR reporting
period in 2015.
Electronic EP Measure: More than 50 percent of If for an EHR
Prescribing. all permissible prescriptions, or reporting period in
all prescriptions, written by the 2015, the provider is
EP are queried for a drug scheduled to
formulary and transmitted demonstrate Stage 1:
electronically using Certified EHR Alternate EP Measure:
Technology. More than 40 percent
of all permissible
prescriptions written
by the EP are
transmitted
electronically using
Certified EHR
Technology.
Clinical Decision Measure 1: Implement five If for an EHR
Support. clinical decision support reporting period in
interventions related to four or 2015, the provider is
more clinical quality measures at scheduled to
a relevant point in patient care demonstrate Stage 1:
for the entire EHR reporting Alternate Objective
period. Absent four clinical and Measure 1:
quality measures related to an EP, Objective: Implement
eligible hospital or CAH's scope one clinical decision
of practice or patient population, support rule relevant
the clinical decision support to specialty or high
interventions must be related to clinical priority, or
high-priority health conditions. high priority
It is suggested that one of the hospital condition,
five clinical decision support along with the
interventions be related to ability to track
improving healthcare efficiency. compliance with that
Measure 2: The EP, rule.
eligible hospital, or CAH has Measure: Implement one
enabled and implemented the clinical decision
functionality for drug-drug and support rule.
drug allergy interaction checks
for the entire EHR reporting
period. Exclusion: For the second
measure, any EP who writes fewer
than 100 medication orders during
the EHR reporting period.
Patient Electronic EP Measure 1: More than 50 Alternate Exclusion
Access (VDT). percent of all unique patients Measure 2: Provider
seen by the EP during the EHR may claim an
reporting period are provided exclusion for the
timely (within 4 business days second measure if for
after the information is available an EHR reporting
to the EP) online access to their period in 2015 they
health information subject to the were scheduled to
EP's discretion to withhold demonstrate Stage 1,
certain information. which does not have
an equivalent
measure.
[[Page 20371]]
EP Measure 2: At least one
patient seen by the EP during the
EHR reporting period (or their
authorized representatives) views,
downloads, or transmits his or her
health information to a third
party.
Protect Electronic Measure: Conduct or review a NONE.
Health security risk analysis in
Information. accordance with the requirements
in 45 CFR 164.308(a)(1), including
addressing the security (to
include encryption) of ePHI data
stored in Certified EHR Technology
in accordance with requirements in
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 EP,
eligible hospital, or CAHs risk
management process.
Patient Specific EP Measure: Patient-specific Alternate Exclusion:
Education. education resources identified by Provider may claim an
Certified EHR Technology are exclusion for the
provided to patients for more than measure of the Stage
10 percent of all unique patients 2 Patient Specific
with office visits seen by the EP Education objective
during the EHR reporting period. if for an EHR
reporting period in
2015 they were
scheduled to
demonstrate Stage 1
but did not intend to
select the Stage 1
Patient Specific
Education menu
objective.
Medication Measure: The EP, eligible hospital Alternate Exclusion:
Reconciliation. or CAH performs medication Provider may claim an
reconciliation for more than 50 exclusion for the
percent of transitions of care in measure of the Stage
which the patient is transitioned 2 Medication
into the care of the EP or Reconciliation
admitted to the eligible objective if for an
hospital's or CAH's inpatient or EHR reporting period
emergency department (POS 21 or in 2015 they were
23). scheduled to
demonstrate Stage 1
but did not intend to
select the Stage 1
Medication
Reconciliation menu
objective.
Summary of Care... Measure: The EP, eligible hospital Alternate Exclusion:
or CAH that transitions or refers Provider may claim an
their patient to another setting exclusion for Measure
of care or provider of care (1) 2 of the Stage 2
uses CEHRT to create a summary of Summary of Care
care record; and (2) objective if for an
electronically transmits such EHR reporting period
summary to a receiving provider in 2015 they were
for more than 10 percent of scheduled to
transitions of care and referrals. demonstrate Stage 1,
which does not have
an equivalent
measure.
Secure Messaging.. Measure: During the EHR reporting Alternate Exclusion:
period, the capability for An EP may claim an
patients to send and receive a exclusion for the
secure electronic message with the measure if for an EHR
provider was fully enabled. reporting period in
2015 they were
scheduled to
demonstrate Stage 1,
which does not have
an equivalent
measure.
Public Health..... Measure Option 1-- NONE.
Immunization Registry Reporting:
The EP, eligible hospital, or CAH
is in active engagement with a
public health agency to submit
immunization data and receive
immunization forecasts and
histories from the public health
immunization registry/immunization
information system (IIS).
Measure Option 2--
Syndromic Surveillance Reporting:
The EP, eligible hospital/, or CAH
is in active engagement with a
public health agency to submit
syndromic surveillance data from a
non-urgent care ambulatory setting
for EPs, or an emergency or urgent
care department for eligible
hospitals and CAHs (POS 23).
Measure Option 3--Case
Reporting: The EP, eligible
hospital, or CAH is in active
engagement with a public health
agency to submit case reporting of
reportable conditions.
[[Page 20372]]
Measure Option 4--Public
Health Registry Reporting: The EP,
eligible hospital, or CAH is in
active engagement with a public
health agency to submit data to
public health registries.
Measure Option 5--Clinical
Data Registry Reporting: The EP,
eligible hospital, or CAH is in
active engagement to submit data
to a clinical data registry.
Eligible Hospital/CAH.......... CPOE.............. Measure 1: More than 60 If for an EHR
percent of medication orders reporting period in
created by the EP or by authorized 2015, the provider is
providers of the eligible scheduled to
hospital's or CAH's inpatient or demonstrate Stage 1:
emergency department (POS 21 or Alternate
23) during the EHR reporting Measure 1: More than
period are recorded using 30 percent of all
computerized provider order entry. unique patients with
Measure 2: More than 30 at least one
percent of laboratory orders medication in their
created by the EP or by authorized medication list seen
providers of the eligible by the EP or admitted
hospital's or CAH's inpatient or to the eligible
emergency department (POS 21 or hospital's or CAH's
23) during the EHR reporting inpatient or
period are recorded using emergency department
computerized provider order entry. (POS 21 or 23) during
Measure 3: More than 30 the EHR reporting
percent of radiology orders period have at least
created by the EP or by authorized one medication order
providers of the eligible entered using CPOE;
hospital's or CAH's inpatient or or more than 30
emergency department (POS 21 or percent of medication
23) during the EHR reporting orders created by the
period are recorded using EP or created by the
computerized provider order entry. authorized providers
of the eligible
hospital or CAH for
patients admitted to
their inpatient or
emergency departments
(POS 21 or 23) during
the EHR reporting
period are recorded
using computerized
provider order entry.
Alternate
Exclusion for Measure
2: Provider may claim
an exclusion for
measure 2 (laboratory
orders) of the Stage
2 CPOE objective for
an EHR reporting
period in 2015.
Alternate
Exclusion for Measure
3: Provider may claim
an exclusion for
measure 3 (radiology
orders) of the Stage
2 CPOE objective for
an EHR reporting
period in 2015.
Clinical Decision Measure 1: Implement five If for an EHR
Support. clinical decision support reporting period in
interventions related to four or 2015, the provider is
more clinical quality measures at scheduled to
a relevant point in patient care demonstrate Stage 1:
for the entire EHR reporting Alternate Measure 1:
period. Absent four clinical Implement one
quality measures related to an EP, clinical decision
eligible hospital or CAH's scope support rule. We
of practice or patient population, propose that for an
the clinical decision support EHR reporting period
interventions must be related to in 2015, an EP,
high-priority health conditions. eligible hospital or
It is suggested that one of the CAH who is scheduled
five clinical decision support to participate in
interventions be related to Stage 1 in 2015 must
improving healthcare efficiency. also satisfy the
Measure 2: The EP, Stage 2 measure 2
eligible hospital, or CAH has previously stated
enabled and implemented the because it is the
functionality for drug-drug and same as an existing
drug allergy interaction checks Stage 1 measure (77
for the entire EHR reporting FR 53998). There are
period. Exclusion: For the second no alternate
measure, any EP who writes fewer exclusions for this
than 100 medication orders during objective.
the EHR reporting period.
[[Page 20373]]
Patient Electronic Eligible Hospital/CAH Alternate Exclusion
Access (VDT). Measure 1: More than 50 percent of Measure 2: Provider
all patients who are discharged may claim an
from the inpatient or emergency exclusion for the
department (POS 21 or 23) of an second measure if for
eligible hospital or CAH have an EHR reporting
their information available online period in 2015 they
within 36 hours of discharge. were scheduled to
Eligible Hospital/CAH demonstrate Stage 1,
Measure 2: At least 1 patient who which does not have
is discharged from the inpatient an equivalent
or emergency department (POS 21 or measure.
23) of an eligible hospital or CAH
(or his or her authorized
representative) views, downloads,
or transmits to a third party his
or her information during the EHR
reporting period.
Protect Electronic Measure: Conduct or review a NONE.
Health security risk analysis in
Information. accordance with the requirements
in 45 CFR 164.308(a)(1), including
addressing the security (to
include encryption) of ePHI data
stored in Certified EHR Technology
in accordance with requirements in
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 EP,
eligible hospital, or CAHs risk
management process.
Patient Specific Eligible Hospital/CAH Measure: More Alternate Exclusion:
Education. than 10 percent of all unique Provider may claim an
patients admitted to the eligible exclusion for the
hospital's or CAH's inpatient or measure of the Stage
emergency department (POS 21 or 2 Patient Specific
23) are provided patient specific Education objective
education resources identified by if for an EHR
Certified EHR Technology. reporting period in
2015 they were
scheduled to
demonstrate Stage 1
but did not intend to
select the Stage 1
Patient Specific
Education menu
objective.
Medication Measure: The EP, eligible hospital Alternate Exclusion:
Reconciliation. or CAH performs medication Provider may claim an
reconciliation for more than 50 exclusion for the
percent of transitions of care in measure of the Stage
which the patient is transitioned 2 Medication
into the care of the EP or Reconciliation
admitted to the eligible objective if for an
hospital's or CAH's inpatient or EHR reporting period
emergency department (POS 21 or in 2015 they were
23). scheduled to
demonstrate Stage 1
but did not intend to
select the Stage 1
Medication
Reconciliation menu
objective.
Summary of Care... Measure: The EP, eligible hospital Alternate Exclusion:
or CAH that transitions or refers Provider may claim an
their patient to another setting exclusion for Measure
of care or provider of care (1) 2 of the Stage 2
uses CEHRT to create a summary of Summary of Care
care record; and (2) objective if for an
electronically transmits such EHR reporting period
summary to a receiving provider in 2015 they were
for more than 10 percent of scheduled to
transitions of care and referrals. demonstrate Stage 1,
which does not have
an equivalent
measure.
Electronic Eligible Hospital/CAH Measure: More Alternate EH
Prescribing. than 10 percent of hospital Exclusion: Measure
discharge medication orders for Exclusion: Provider
permissible prescriptions (for may claim an
new, changed and refilled exclusion for the eRx
prescriptions) are queried for a objective and measure
drug formulary and transmitted if for an EHR
electronically using Certified EHR reporting period in
Technology. 2015 they were either
scheduled to
demonstrate Stage 1
which does not have
an equivalent
measure, or if they
are scheduled to
demonstrate Stage 2
but did not intend to
select the Stage 2
eRx menu objective
for an EHR reporting
period in 2015.
Public Health..... Measure Option 1-- NONE.
Immunization Registry Reporting:
The EP, eligible hospital, or CAH
is in active engagement with a
public health agency to submit
immunization data and receive
immunization forecasts and
histories from the public health
immunization registry/immunization
information system (IIS).
[[Page 20374]]
Measure Option 2--
Syndromic Surveillance Reporting:
The EP, eligible hospital/, or CAH
is in active engagement with a
public health agency to submit
syndromic surveillance data from a
non-urgent care ambulatory setting
for EPs, or an emergency or urgent
care department for eligible
hospitals and CAHs (POS 23).
Measure Option 3--Case
Reporting: The EP, eligible
hospital, or CAH is in active
engagement with a public health
agency to submit case reporting of
reportable conditions.
Measure Option 4--Public
Health Registry Reporting: The EP,
eligible hospital, or CAH is in
active engagement with a public
health agency to submit data to
public health registries
Measure Option 5--Clinical
Data Registry Reporting: The EP,
eligible hospital, or CAH is in
active engagement to submit data
to a clinical data registry.
Measure Option 6--
Electronic Reportable Laboratory
Result Reporting: The eligible
hospital or CAH is in active
engagement with a public health
agency to submit electronic
reportable laboratory results.
----------------------------------------------------------------------------------------------------------------
3. Certified EHR Technology
Certified EHR technology is defined for the Medicare and Medicaid
EHR Incentive Programs at 42 CFR 495.4, which references ONC's
definition of CEHRT in 45 CFR 170.102. The definition establishes the
requirements for EHR technology that must be used by providers to meet
the meaningful use objectives and measures. The Stage 2 final rule
requires that CEHRT must be used by EPs, eligible hospitals, and CAHs
to satisfy their CQM reporting requirements in the Medicare and
Medicaid EHR Incentive Programs. In addition, the CQM data reported to
CMS must originate from EHR technology that is certified to ``capture
and export'' in accordance with 45 CFR 170.314(c)(1) and ``electronic
submission'' in accordance with 45 CFR 170.314(c)(3) (77 FR 54053).
Rather than establishing a meaningful use specific CEHRT definition
for the EHR Incentive Programs in the ONC 2015 Edition proposed rule,
we instead proposed to define the term ``Certified EHR Technology'' in
the Stage 3 proposed rule at Sec. 495.4 (80 FR 16767 and 16768). This
proposed change is designed to simplify the overall regulatory
relationship between ONC and CMS rules for stakeholders and to ensure
that relevant CMS policy for the Medicare and Medicaid EHR Incentive
Programs is clearly defined in CMS regulations.
We are proposing no further changes to the definition of CEHRT in
this proposed rule. We reiterate that providers must use EHR technology
certified to the 2014 Edition for an EHR reporting period in 2015. As
proposed in the Stage 3 proposed rule, providers must use EHR
technology certified at least to the 2014 Edition in 2016 and 2017.
Providers may adopt EHR technology certified to the 2015 Edition prior
to the beginning of Stage 3 in 2017 or 2018, and that technology could
be used to satisfy the definition of CEHRT under Sec. 495.4 to
demonstrate meaningful use (80 FR 16767 through 16768).
4. Medicaid EHR Incentive Program in 2015 Through 2017
The proposals included in this proposed rule would apply for
providers participating in the Medicaid EHR Incentive Program in 2015
through 2017.
Consistent with both Stage 1 and 2, we propose to continue to offer
states flexibility in the Medicaid EHR Incentive Program for meaningful
use in 2015 through 2017. This flexibility would apply to the public
health reporting objective and measures where we propose to continue to
allow states to specify the means of transmission of the data or
otherwise change the public health reporting objective and measures as
long as it does not require EHR functionality above and beyond that
which is included in 45 CFR part 170 as stated in the Stage 2 final
rule (77 FR 53979).
Finally, we propose to provide an alternate attestation option for
Medicaid providers who are seeking to demonstrate meaningful use to
avoid the Medicare payment adjustment and who are prohibited from
switching between the Medicare and Medicaid EHR incentive programs. For
these providers, we propose that they may use the Medicare Registration
and Attestation system to attest to meaningful use without switching
programs solely for the purposes of avoiding the Medicare payment
adjustment. We are proposing this alternate attestation option in
response to concerns about providers who participate in the Medicaid
EHR Incentive Program; but, due to their patient volume or another
similar factor, they are unable to attest to meaningful use through
their state Medicaid program for a given year. If such a provider uses
the alternate attestation option to demonstrate meaningful use for an
EHR reporting period, they may avoid the Medicare payment adjustment
associated with that EHR reporting period without switching out of the
[[Page 20375]]
Medicaid EHR Incentive Program. This option is discussed in further
detail in section II.D. of this proposed rule.
We invite public comment on these proposals.
C. Clinical Quality Measurement
Under sections 1848(o)(2)(A),1886(n)(3)(A), and 1814(l)(3)(A) of
the Act and 42 CFR 495.4, EPs, eligible hospitals, and CAHs must report
on CQMs selected by CMS using certified EHR technology, as part of
being a meaningful EHR user under the Medicare and Medicaid EHR
Incentive Programs. In the Stage 2 final rule, we outlined the CQMs
available for use in the EHR Incentive Programs beginning in 2014 for
EPs, eligible hospitals, and CAHs at (77 FR 54057 through 54068 for EPs
and 77 FR 54081 through 54087 for eligible hospitals/CAHs) as well as
the form and method for submission at (77 FR 54076 through 54080 for
EPs and 77 FR 54087 through 54089 for eligible hospitals/CAHs).
Following the publication of the Stage 2 final rule, we also
established requirements for reporting on CQMs under the EHR Incentive
Program in the PFS and IPPS rules (see for example 79 FR 50319 through
50321 and 79 FR 67779). In sections II.B.1.a. and b. of the preamble of
the Stage 3 proposed rule, we outlined the requirements for CQM
reporting for all providers for the EHR Incentive Programs in 2017 and
subsequent years (80 FR 16768 and 16769) as well as the intent to
continue program alignment with other CMS quality reporting programs in
the IPPS and PFS rules.
In this proposed rule for meaningful use in 2015 through 2017, we
are proposing to maintain the existing requirements established in
earlier rulemaking for the reporting of CQMs. The options for CQM
submission for providers in the Medicare EHR Incentive Program are as
follows:
EP Options for Medicare EHR Incentive Program
Participation (single program participation)
++ Option 1: Attest to CQMs through the EHR Registration &
Attestation System.
++ Option 2: Electronically report CQMs through Physician Quality
Reporting System (PQRS) Portal.
EP Options for Electronic Reporting for Multiple Programs
(for example: EHR Incentive Program plus PQRS participation)
++ Option 1: Report individual eligible professionals' CQMs through
PQRS Portal.
++ Option 2: Report group's CQMs through PQRS Portal.
We note that under option 2, this may include an EP reporting using the
group reporting option, either electronically using QRDA, or via the
GPRO Web Interface through Pioneer ACO participation.
Eligible hospital and CAH Options for Medicare EHR
Incentive Program Participation (single program participation)
++ Option 1: Attest to CQMs through the EHR Registration &
Attestation System.
++ Option 2: Electronically report CQMs through QualityNet Portal.
Eligible hospital and CAH Options for Electronic Reporting
for Multiple Programs (for example: EHR Incentive Program plus IQR
participation)
++ Electronically report through QualityNet Portal.
For the Medicaid EHR Incentive Program, states would continue to be
responsible for determining whether and how electronic reporting of
CQMs would occur, or if they wish to allow reporting through
attestation. Any changes that states make to their CQM reporting
methods must be submitted through the State Medicaid Health IT Plan
(SMHP) process for our review and approval prior to being implemented.
We are also proposing to maintain the existing CQM reporting
requirements of nine CQMs covering at least three NQS domains for EPs
and 16 CQMs covering at least three NQS domains for eligible hospitals
and CAHs (77 FR 54058 for EPs and 77 FR 54056 for eligible hospitals
and CAHs).
As discussed in section II.B.2(a) of this proposed rule, beginning
in 2015, we are proposing to change the definition of ``EHR reporting
period'' in Sec. 495.4 for eligible hospitals and CAHs such that the
EHR reporting period would begin and end in relation to a calendar
year. In connection with this proposal, we also propose that in 2015
and for all methods of reporting, eligible hospitals and CAHs would be
required to complete a reporting period for clinical quality measures
aligned with the calendar year in order to demonstrate meaningful use.
In order to accommodate eligible hospitals and CAHs that may have
planned their clinical quality measure reporting in 2015 based on the
federal fiscal year, we propose for 2015 only that eligible hospitals
and CAHs that are submitting CQMs via attestation, may begin a
reporting period as early as October 1 of 2014 and end by December 31
of 2015. Eligible hospitals and CAHs submitting CQMs via electronic
reporting must meet the requirements established in the FY 2015 final
rule (79 FR 50319 through 50321).
As discussed in section II.B.1.b.(3). of this proposed rule, for
2015 only, we are proposing to change the EHR reporting period for all
EPs, eligible hospitals, and CAHs to any continuous 90-day period
within the calendar year. In connection with this proposal, we also
propose a 90-day reporting period for clinical quality measures for all
EPs, eligible hospitals, and CAHs that report clinical quality measures
by attestation. We are proposing eligible professionals may select any
continuous 90-day period from January 1, 2015 through December 31,
2015, while eligible hospitals and CAHs may select any continuous 90-
day period from October 1, 2014 through December 31, 2015, to report
CQMs via attestation using the EHR Incentive Program registration and
attestation system. In accordance with our existing policy, it is
acceptable for a provider to use a continuous 90-day reporting period
for CQMs even if it is different from their continuous 90-day EHR
reporting period for the meaningful use objectives and measures if that
provider is reporting via attestation. We also propose that a provider
may choose to attest to a CQM reporting period of greater than 90-days
up to and including 1 full calendar year of data.
We further propose to continue our existing policy that providers
in any year of participation for the EHR Incentive Programs for 2015
through 2017 may instead electronically report CQM data using the
options previously outlined for electronic reporting either for single
program participation in the Medicare EHR Incentive Programs, or for
participation in multiple programs if the requirements of the aligned
quality program are met.
We note that EPs seeking to participate in multiple programs with a
single electronic submission would be required to submit a full
calendar year of CQM data using the 2014 electronic specifications for
the CQMs (which are also known as eCQMs) for a reporting period in
2015. These specifications include the annual updates released in June
of 2014 and are available at the CMS eCQMs Library (https://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html)
Eligible hospitals and CAHs seeking to participate in multiple
programs with a single electronic submission for a reporting period in
2015 would be required to submit 1 calendar quarter of data for 2015
from either Q1 (January 1, 2015-March 31, 2015), Q2 (April 1, 2015 June
30, 2015), or Q3 (July 1, 2015-September 30, 2015) and would require of
the use of the April 2014 release of the eCQMs available at the
[[Page 20376]]
CMS eCQM Library (https://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html). For further information, we
direct readers to the FY 2015 IPPS final rule at 79 FR 50319 through
50321.
We note that an EHR certified for CQMs under the 2014 Edition
certification criteria does not need to be recertified each time it is
updated to a more recent version of the eCQMs. (For further information
on CQM reporting, we direct readers to the EHR Incentive Program Web
site where guides and tip sheets are available for each reporting
option (www.CMS.gov/ehrincentiveprograms)).
We invite public comment on this proposal.
D. Demonstration of Meaningful Use for 2015 Through 2017
1. Common Methods of Demonstration in Medicare and Medicaid
We are proposing 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.
2. Methods for Demonstration of the Criteria for Meaningful Use in 2015
Through 2017
As mentioned previously in section II.B.2. of this proposed rule,
we are redesignating the numbering of certain sections of the
regulation text under 42 CFR part 495. In prior rules, we defined the
criteria for the demonstration of meaningful use at 42 CFR 495.8, which
would be redesignated as Sec. 495.40. In this proposed rule, we define
the criteria for the demonstration of meaningful use at Sec. 495.40
including references to the objectives and measures of meaningful use
as well as the requirement to report CQMs. In order to demonstrate
meaningful use in 2015 through 2017, we are proposing that the
requirements at Sec. 495.40 include a reference to the objectives and
measures of meaningful use for 2015 through 2017 outlined at Sec.
495.22 which the provider must satisfy.
We are proposing to continue the use of attestation as the method
for demonstrating that an EP, eligible hospital, or CAH has met the
objectives and measures of meaningful use. Instead of individual
Medicare EP attestation through the CMS Registration and Attestation
System, we are also proposing to continue the existing optional batch
file process for attestation. Further, we are proposing changes to the
deadlines for EPs, eligible hospitals, and CAHs to demonstrate
meaningful use in 2015 and 2016; as well as specific changes to the
deadlines for providers to demonstrate meaningful use for the first
time in order to avoid a payment adjustment in 2015 and 2016.
a. Attestation Deadlines for Meaningful Use in 2015 and 2016
In order to accommodate the proposed changes to the EHR reporting
period, we are proposing changes to the attestation deadlines for
eligible hospitals and CAHs for 2015 and 2016. Currently, in order to
demonstrate meaningful use, eligible hospitals and CAHs are required to
complete an EHR reporting period within a federal fiscal year. These
providers must then attest to that EHR reporting period by the end of
the open attestation period 2 months after the close of the federal
fiscal year. For 2015, this means that eligible hospitals and CAHs must
complete an EHR reporting period between October 1, 2014 and September
30, 2015 and must attest by November 30, 2015. However, we are
proposing in section II.B.3.a. of this proposed rule that eligible
hospitals and CAHs would instead be required to complete an EHR
reporting period for 2015 between October 1, 2014 and the end of the
calendar year on December 31, 2015, and to complete an EHR reporting
period for 2016 between January 1, 2016 and December 31, 2016.
Therefore, we are proposing a change to the attestation deadlines
as follows:
For an EHR reporting period in 2015, an eligible hospital
or CAH must attest by February 29, 2016.
For an EHR reporting period in 2016, an eligible hospital
or CAH must attest by February 28, 2017.
In addition, despite the proposed change to a 90-day EHR reporting
period in 2015 discussed previously in this proposed rule, providers
would not be able to attest to meaningful use for an EHR reporting
period in 2015 prior to January 1, 2016. This would allow us adequate
time to make the system changes necessary to accept attestations
reflecting the proposals in this proposed rule. This would mean that
even if providers successfully complete a continuous 90-day EHR
reporting period in the first quarter of FY or CY 2015, they would
attest after the close of the fourth quarter of CY 2015. This change
would not delay incentive payments for Medicare EPs, because 2015
cannot be an EP's first payment year under section 1848(o)(1)(B)(v) of
the Act. Thus, all EPs who qualify for an incentive payment for 2015
would be returning participants in the program and would have had the
full CY 2015 (as their EHR reporting period under our current policy).
We understand that this may delay incentive payments for eligible
hospitals and CAHs. However, most eligible hospitals and CAHs in the
program are beyond their first year of demonstrating meaningful use;
thus, would not have been attesting until after September 30, 2015
under our current policy. Therefore, for most eligible hospitals and
CAHs, this change would shift the incentive payment by 1 quarter within
the same federal fiscal year. Thus, we believe the potential negative
impact of this change would be minimal and outweighed by the
opportunity to capitalize on efficiencies created by aligning the EHR
reporting periods across EPs, eligible hospitals, and CAHs.
We invite public comment on this proposal.
b. New Participant Attestation Deadlines for Meaningful Use in 2015 and
2016 To Avoid a Payment Adjustment
In Sec. 495.4 the definition of an EHR reporting period for a
payment adjustment year establishes special deadlines for attestation
for EPs and eligible hospitals that are demonstrating meaningful use
for the first time in the year immediately preceding a payment
adjustment year. Generally stated, a provider must complete an EHR
reporting period in the first 3 quarters of the preceding year, and the
deadlines for attestation are October 1 for EPs and July 1 for eligible
hospitals of the preceding year. For CAHs, the EHR reporting period is
within the federal fiscal year that is the payment adjustment year and
the deadline for attestation for CAHs is the same for purposes of the
incentive payment and the payment adjustment (November 30, 2015). After
the October 1 or July 1 deadlines, EPs and eligible hospitals may still
attest for an EHR reporting period in the fourth quarter of the CY or
FY, respectively. However, if they attest after the respective
deadlines, then they would not avoid the Medicare payment adjustment in
the subsequent payment adjustment year.
In the Stage 2 proposed rule (77 FR 13769 for EPs and 77 FR 13773
through 13774 for eligible hospitals/CAHs), we explained the rationale
for these special deadlines for attestation. We explained that these
EHR reporting periods provide adequate time both for the systems
changes that will be required for us to apply any applicable payment
adjustments and for providers to be informed in advance of the payment
year whether a payment adjustment
[[Page 20377]]
would apply. Those deadlines 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. However, we are proposing
a later deadline for attestation only for 2015 to allow enough time for
all providers to complete a 90-day EHR reporting period after the
anticipated effective date of the final rule. As a result of this later
deadline, in 2016, providers that are new participants in the EHR
Incentive Program may be subject to a payment adjustment on claims
submitted prior to attestation to meaningful use for an EHR reporting
period in 2015. After successful attestation, the payment adjustment
would be removed and any adjustments previously applied to claims in
2016 would be reprocessed and reconciled for the provider. However, as
our policies seek to minimize the claims reprocessing burden, we note
these are exceptional circumstances caused by the need for a later
attestation deadline to accommodate a 90-day EHR reporting period in
2015 after the effective date of the final rule, and this is not an
acceptable long-term solution. For the reasons previously stated in the
Stage 2 proposed rule, the special deadlines for first-time meaningful
EHR users (October 1 for EPs and July 1 for eligible hospitals) are
necessary in 2016 and subsequent years where no extenuating
circumstances exist. For these reasons, we propose changes to the
attestation deadlines for purposes of the payment adjustment years in
section II.E.2.(a). through (c). of this proposed rule.
We invite public comment on these proposals.
3. Alternate Method of Demonstration for Certain Medicaid Providers
Beginning in 2015
At 42 CFR 495.10, redesignated as Sec. 495.60, we defined the
requirements for EPs switching between the Medicare and Medicaid EHR
Incentive Programs. An EP who qualifies as both a Medicaid EP and a
Medicare EP must notify us as to whether he or she elects to
participate in the Medicare or the Medicaid EHR Incentive Program, and
after receiving at least one incentive payment, may switch between the
two EHR incentive programs only one time, and only for a payment year
before 2015. For further discussion of this policy we direct readers to
(75 FR 44324 through 44325). We are not proposing any changes to the
switching requirements under Sec. 495.60.
However, we note that an EP who qualifies as both a Medicaid EP and
a Medicare EP would be subject to the Medicare payment adjustment if
the EP fails to demonstrate meaningful use for the applicable EHR
reporting period for a payment adjustment year. We recognize it is
possible that an EP who receives an incentive payment under the
Medicaid EHR Incentive Program for a given year may fail in a
subsequent year to meet the eligibility criteria for the Medicaid EHR
Incentive Program. For example, the EP would be unable to qualify for a
Medicaid EHR incentive payment for 2015, if he or she receives a
Medicaid EHR incentive payment for meaningful use for the 2013 payment
year, but does not meet the 30 percent Medicaid patient volume
requirement for purposes of the 2015 payment year. Under Sec.
495.60(e), in this example in order to avoid the Medicare payment
adjustment, the EP would be unable to switch to the Medicare EHR
Incentive Program for the 2015 payment year; thus, the EP would not
have a way to demonstrate meaningful use for an applicable EHR
reporting period for the payment adjustment year. Therefore, for
purposes of avoiding the Medicare payment adjustment, we are proposing
to establish an additional attestation option to allow EPs who have
received at least one incentive payment under the Medicaid EHR
Incentive Program (for either AIU or meaningful use) to demonstrate
meaningful use by attestation using the EHR Incentive Program
Registration and Attestation system. We note that this attestation
would not constitute a switch from the Medicaid EHR Incentive Program
to the Medicare EHR Incentive Program, and EPs who attest under this
option would not earn an incentive payment in either program for the
year. We are proposing this attestation option for the purposes of
demonstrating meaningful use to avoid the Medicare payment adjustment
only. In the prior example, the EP whose Medicaid patient volume was
less than the required threshold would be able to attest to meaningful
use for an EHR reporting period in 2015 to avoid the 2017 payment
adjustment. This EP would continue to be designated a Medicaid EHR
Incentive Program participant. In 2016 in order to earn an incentive
payment and avoid a Medicare payment adjustment, if the EP meets the
Medicaid patient volume threshold with regard to the 2016 payment year,
then the EP would be required to demonstrate meaningful use in the
Medicaid program for an EHR reporting period.
As stated above, we are proposing that EPs who have previously
received an incentive payment under Medicaid for adopting,
implementing, or upgrading to certified EHR technology may also use
this alternate attestation option even if it is their first year of
demonstrating meaningful use. However, these EPs would be required to
demonstrate meaningful use for the EHR reporting periods established
for the Medicare EHR Incentive Program for EPs who have never
successfully demonstrated meaningful use in a prior year. In the Stage
3 proposed rule (80 FR 16739), we propose that beginning in 2017, EPs
who demonstrate meaningful use for the first time under the Medicare
EHR Incentive Program must use an EHR reporting period of one full
calendar year. Accordingly, under our proposal in this rule, Medicaid
providers using this alternate attestation option in 2017 or subsequent
years would also be required to use an EHR reporting period of 1 full
calendar year even if they are demonstrating meaningful use for the
first time.
We invite public comment on this proposal.
4. Data Collection for Online Posting, Program Coordination, and
Accurate Payments
We propose no changes to the data collection requirements or to the
registration requirements under Sec. 495.10, redesignated as Sec.
495.60. As noted in section II.C.2 of the Stage 3 proposed rule, we
note that we intend to continue to post meaningful use participation
data both at an individual and aggregate level for the purposes of data
transparency, program integrity, and for use with aligned CMS quality
reporting programs.
5. Hospital-Based Eligible Professionals
Section 1848(o)(1)(C)(i) of the Act, as added by section 4101(a) of
the HITECH Act, states that hospital-based EPs are not eligible for
Medicare incentive payments. Similarly, the majority of hospital-based
EPs will not be eligible for Medicaid incentive payments under section
1903(t)(2)(A) of the Act (the only exception to this rule is for those
practicing predominantly in an FQHC or RHC). Sections 4101(a) and
4201(a) of the HITECH Act originally defined the term ``hospital-based
eligible professional'' to mean an EP, such as a pathologist,
anesthesiologist, or emergency physician, who furnishes substantially
all of his or her Medicare covered professional services during the
relevant EHR reporting period in a hospital setting (whether inpatient
or outpatient) through the use of the facilities and equipment of the
hospital, including the hospital's qualified EHRs. Following
publication of the Stage 1
[[Page 20378]]
proposed rule (75 FR 1844 through 2011), Congress modified the
definition of hospital-based EPs. Specifically, on April 15, 2010,
President Obama signed into law the Continuing Extension Act of 2010
(Pub. L. 111-157). Section 5 of the Continuing Extension Act of 2010
(Pub. L. 111-157) made the following changes to the Act as it applies
to both the Medicare and Medicare EHR incentives for EPs:
Qualifications for Clinic-based Physicians
++ Medicare--Section 1848(o)(1)(C)(ii) of the Act (42 U.S.C. 1395w-
4(o)(1)(C)(ii)) is amended by striking ``setting (whether inpatient or
outpatient)'' and inserting ``inpatient or emergency room setting''.
++ Medicaid--Section 1903(t)(3)(D) of the Act (42 U.S.C.
1396b(t)(3)(D)) is amended by striking ``setting (whether inpatient or
outpatient)'' and inserting ``inpatient or emergency room setting''.
These amendments were effective as if included in the enactment of
the HITECH Act. The previous sections indicate that the determination
of whether an EP is a hospital-based EP shall be made on the basis of
the site of service, as defined by the Secretary, and without regard to
any employment or billing arrangement between the EP and any other
provider. For example, the hospital-based determination for an EP would
not be affected by whether the EP is an employee of the hospital, under
a contractual relationship with the hospital, or with respect to
whether he or she has made a reassignment to the hospital for Part B
billing purposes. In addition, section 1848(a)(7)(D) of the Act, as
added by section 4101(b) of the HITECH Act, exempts hospital-based EPs
from the downward payment adjustment applied under section
1848(a)(7)(A)(i) of the Act to covered professional services provided
during a payment year by EPs who are not meaningful EHR users for the
relevant payment year beginning in 2015.
Based on section 4101(a) of the HITECH Act (and prior to the
amendments in the Continuing Extension Act of 2010), we proposed in the
Stage 1 proposed rule (75 FR 1904 through1907) that an EP would be
considered a hospital-based EP; therefore, ineligible to receive a
Medicare or Medicaid EHR incentive payment if more than 90 percent of
their services are provided in the following place of service (POS)
codes for HIPAA standard transactions--
21--Inpatient Hospital;
22--Outpatient Hospital;
23--Emergency Room.
In the Stage 1 final rule (75 FR 44439 through 44442), we incorporated
the changes to the hospital-based definition, that were included in the
Continuing Extension Act of 2010, into our definition of ``hospital-
based EP'' under Sec. 495.4. We defined an EP as hospital-based if he
or she furnishes 90 percent or more of his or her covered professional
services in sites of service identified as an inpatient hospital (POS
21) or emergency room (POS 23) setting in the year preceding the
payment year. We did not include POS 22 for outpatient hospital
settings in our final definition.
As noted previously, section 1848(a)(7)(D) of the Act exempts
hospital-based EPs who are not meaningful EHR users from the downward
payment adjustments under Medicare. In the Stage 2 final rule (77 FR
54102), for purposes of the Medicare payment adjustments, we amended
the definition of hospital-based EP under Sec. 495.4 to define a
hospital-based EP as an EP who furnishes 90 percent or more of his or
her covered professional services in sites of service identified as an
inpatient hospital (POS 21) or emergency room (POS 23) setting in
either of the 2 years before the year preceding a payment adjustment
year.
However, recently several hospital associations, individual
providers, and other stakeholders have raised concerns with our current
definition of a hospital-based EP. Specifically, these stakeholders
asserted that the limitation of hospital-based to POS codes 21 and 23,
covering inpatient and emergency room settings only, does not
adequately capture all settings where services might be furnished by a
hospital-based EP. They stated that POS 22, which covers an outpatient
hospital place of service, is also billed by hospital-based EPs,
especially in relation to certain CPT codes. These stakeholders
expressed the belief that our current definition of hospital-based EP
in the regulations is too narrow and will unfairly subject many EPs who
are not hospital-based under our definition, but who stakeholders would
consider to be hospital-based, to the downward payment adjustment under
Medicare in 2015. Accordingly, these stakeholders recommended that we
consider adding additional place of service codes or settings to the
regulatory definition of hospital-based EP.
We appreciate this feedback from stakeholders and are requesting
public comment on our current definition of a hospital-based EP under
Sec. 495.4 for the EHR Incentive Programs.
We are seeking public comment on whether additional place of
service codes or settings should be included in our definition of a
hospital-based EP. As stated previously, stakeholders specifically
identified POS 22 for outpatient hospital settings as an area of
concern; therefore, we are especially interested in comments on POS 22
for outpatient hospital settings. In addition, we seek comments on
whether and how the inclusion of additional POS codes or settings in
our definition of hospital-based EP might affect the eligibility of EPs
for the EHR incentive payments under Medicare or Medicaid.
We welcome public comment.
E. Payment Adjustments and Hardship Exceptions
Sections 4101(b) and 4102(b) of the HITECH Act, amending sections
1848, 1853, and 1886 of the Act, require reductions in payments to EPs,
eligible hospitals, and CAHs that are not meaningful users of certified
EHR technology, beginning in CY 2015 for EPs, FY 2015 for eligible
hospitals, and in cost reporting periods beginning in FY 2015 for CAHs.
1. Statutory Basis for Payment Adjustment and Hardship Exceptions
Section 1848(a)(7) of the Act provides for payment adjustments,
effective for CY 2015 and subsequent years, for EPs as defined in Sec.
495.100, who are not meaningful EHR users during the relevant EHR
reporting period for the year. Section 1848(a)(7) of the Act provides
that 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'' of the fee schedule
amount that would otherwise apply. The term ``applicable percent'' is
defined in section 1848(a)(7)(A)(ii) of the Act as: (I) For 2015, 99
percent (or, in the case of an EP who was subject to the application of
the payment adjustment [if the EP was not a successful electronic
prescriber] under section 1848(a)(5) of the Act for 2014, 98 percent);
(II) for 2016, 98 percent; and (III) for 2017 and each subsequent year,
97 percent.
In addition, section 1848(a)(7)(A)(iii) of the Act provides that
if, for CY 2018 and subsequent years, the Secretary finds 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
[[Page 20379]]
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.
We established regulations implementing these statutory provisions
under 42 CFR 495.102. We refer readers to the Stages 1 and 2 final
rules (75 FR 44442 through 44448, 77 FR 54093 through 54102) for more
information.
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 the
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 adjustment year, beginning in FY
2015. Specifically, section 1886(b)(3)(B)(ix)(I) of the Act provides
that, for FY 2015 and each subsequent fiscal year, 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 applies to ``three-quarters of the percentage increase
otherwise applicable'' prior to the application of statutory
adjustments under sections 1886(b)(3)(B)(viii), 1886(b)(3)(B)(xi), and
1886(b)(3)(B)(xii) of the Act, or three-quarters of the applicable
market basket update. The reduction to three-quarters of the applicable
update for an eligible hospital that is not a meaningful EHR user would
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
must reduce the applicable percentage increase (prior to the
application of other statutory adjustments) by--
25 percent (33 1/3 of 75 percent) in FY 2015;
50 percent (66 2/3 percent of 75 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 the
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.''
Section 412.64(d) of our regulations sets forth the adjustment to
the percentage increase in the market basket index for those eligible
hospitals that are not meaningful EHR users for the EHR reporting
period for a payment year, beginning in FY 2015.
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 of the Act also provides that such determinations are subject
to annual renewal, and that in no case may a hospital be granted an
exception for more than 5 years.
Section 4102(b)(2) of the HITECH Act amended section 1814(l) of the
Act to include an adjustment to a CAH's Medicare reimbursement for
inpatient services if the CAH is not a meaningful EHR user for an EHR
reporting period. The adjustment would be made for cost reporting
periods that begin in FY 2015, FY 2016, FY 2017, and each subsequent FY
thereafter. Specifically, sections 1814(l)(4)(A) and (B) of the Act
provide that, if a CAH does not demonstrate meaningful use of CEHRT for
an applicable EHR reporting period, then for a cost reporting period
beginning in FY 2015, the CAH's reimbursement shall be reduced from 101
percent of its reasonable costs to 100.66 percent of reasonable costs.
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 fiscal year,
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 cases of a CAH in a rural
area without sufficient internet access. However, in no case may a CAH
be granted this exception for more than 5 years.
In the Stage 1 final rule (75 FR 44564 and 44574), we finalized the
regulations regarding the CAH adjustment at Sec. 495.106(e) and Sec.
413.70(a)(6).
2. EHR Reporting Period for a Payment Adjustment Year
Section 1848(a)(7)(E)(ii) of the Act provides the Secretary with
broad authority to choose the EHR reporting period that would apply for
purposes of determining the payment adjustments for EPs for CY 2015 and
subsequent years. In the Stage 2 final rule (77 FR 54095 through
54097), we adopted a policy that the EHR reporting periods for the
payment adjustments will begin and end prior to the year of the payment
adjustment. We stated that this is based on our desire 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, and the resulting
implications for beneficiary coinsurance. Specifically, we finalized
under Sec. 495.4 of our regulations that for EPs, the EHR reporting
period for a payment adjustment year is the full calendar year that is
2 years before the payment adjustment year. For example, the full
calendar year of 2015 would be the EHR reporting period for the CY 2017
payment adjustment year. We also finalized an exception to this rule
for EPs who have never successfully attested to meaningful use.
Generally stated, under this exception, for an EP who is demonstrating
meaningful use for the first time, the EHR reporting period for a
payment adjustment year is any continuous 90-day period. For a full
description of this exception, including limitations on when the
continuous 90-day period must occur in relation to the payment
adjustment year and the deadlines for registration and attestation, we
refer readers to the definition of ``EHR reporting period for a payment
adjustment year'' under Sec. 495.4 of our regulations and the
discussion in the Stage 2 final rule (77 FR 54095 through 54096). We
established that these policies apply for the CY 2015 payment
adjustment year and subsequent payment adjustment years.
Similarly, section 1886(b)(3)(B)(ix)(IV) of the Act makes clear
that the Secretary has discretion to specify as the EHR reporting
period any period (or periods) that will apply with respect to a fiscal
year. In the Stage 2 final rule at 77 FR 54104 through 54105, we
finalized the applicable EHR reporting period for purposes of
determining whether an eligible hospital is subject to the
[[Page 20380]]
payment adjustment. As with EPs, we finalized that the EHR reporting
period for the payment adjustment year for eligible hospitals will
begin and end prior to the year of the payment adjustment. We finalized
under Sec. 495.4 of our regulations that for eligible hospitals, the
EHR reporting period for a payment adjustment year is the full federal
fiscal year that is 2 years before the payment adjustment year. We
established this policy beginning with the FY 2015 payment adjustment
year and continuing in subsequent years. For example, the full federal
fiscal year of 2015 would be the EHR reporting period for the FY 2017
payment adjustment year. We finalized an exception to the general rule
of a full federal fiscal year EHR reporting period for eligible
hospitals that have never successfully attested to meaningful use.
Generally stated, under this exception, for an eligible hospital that
is demonstrating meaningful use for the first time, the EHR reporting
period for a payment adjustment year is any continuous 90-day period.
For a full description of this exception, including limitations on when
the continuous 90-day period must occur in relation to the payment
adjustment year and the deadlines for registration and attestation, we
refer readers to the definition of ``EHR reporting period for a payment
adjustment year'' under Sec. 495.4 of the regulations and the
discussion in the Stage 2 final rule (77 FR 54104 through 54105).
In Stage 2, we amended the definition of the EHR reporting period
that would apply for purposes of the payment adjustment for CAHs under
Sec. 495.4 (77 FR 54109 and 54110). For CAHs, this is 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 EHR reporting period within the payment adjustment
year would apply). The adjustment applies 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 EHR user for FY 2015,
and thereafter, then the payment adjustment is applied to the CAH's
reasonable costs incurred in a cost reporting period that begins in the
affected FY as described in Sec. 413.70(a)(6)(i). We further finalized
that CAHs 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 would be made through the cost report settlement process
In the Stage 3 proposed rule (80 FR 16774 through 16779), we
proposed to eliminate the exception discussed previously for a 90-day
EHR reporting period for new meaningful EHR users in the Medicare EHR
Incentive Program beginning with the EHR reporting period in 2017, with
a limited exception for new meaningful EHR users under the Medicaid EHR
Incentive Program. We also proposed for eligible hospitals and CAHs to
shift the EHR reporting period for a payment adjustment year from a
fiscal year basis to a calendar year basis. We proposed that for EPs
and eligible hospitals demonstrating meaningful use under the Medicare
EHR Incentive Program, including those who have successfully
demonstrated meaningful use in a prior year as well as those who have
not, the EHR reporting period for a payment adjustment year would be
the full calendar year that is 2 years before the payment adjustment
year. For further information on these proposals, we direct readers to
the Stage 3 proposed rule (80 FR 16739 and 16740).
In the Stage 3 proposed rule, we also proposed a change to the EHR
reporting period that would apply for the payment adjustments for CAHs,
beginning with the FY 2017 payment adjustment year. Similar to what we
proposed for eligible hospitals, we proposed that the EHR reporting
period for a payment adjustment year for CAHs would be a full calendar
year, rather than a full federal fiscal year. We proposed the EHR
reporting period for a payment adjustment year would be the calendar
year that overlaps the last 3 quarters of the federal fiscal year that
is the payment adjustment year. For example, in order for a CAH to
avoid application of the adjustment to its reasonable costs incurred in
a cost reporting period that begins in FY 2017, the CAH must
demonstrate it is a meaningful EHR user for an EHR reporting period of
the full 2017 calendar year. For further information on these
proposals, we direct readers to the Stage 3 proposed rule (80 FR 16777
through 16779).
In the Stage 3 proposed rule, we proposed amendments to the
definition of ``EHR reporting period for a payment adjustment year''
under Sec. 495.4 to reflect these proposals for EPs, eligible
hospitals, and CAHs.
In this proposed rule, we are proposing several changes to the
definition of the EHR reporting period for a payment adjustment year
for EPs, eligible hospitals, and CAHs at Sec. 495.4, in connection
with other proposals made in this rule. Specifically, as stated in
section I.A.2.b. of this proposed rule, we propose to change the EHR
reporting period in 2015 to 90 days for all providers. This 90-day EHR
reporting period in 2015 would allow adequate time to accommodate the
changes to the objectives and measures of meaningful use proposed in
this rule. We are also proposing to move all providers to an EHR
reporting period based on the calendar year beginning in 2015 to
support program alignment and simplify reporting requirements among
provider types (section I.A.2.a. of this proposed rule).
a. Changes to the EHR Reporting Period for a Payment Adjustment Year
for EPs
We propose a change to our current policy for 2015 only. We propose
that for all EPs, including those who have demonstrated meaningful use
in a prior year and those who have not, the EHR reporting period for a
payment adjustment year would be any continuous 90-day period in CY
2015 and would apply for purposes of the payment adjustments in CY 2016
for EPs demonstrating meaningful use for the first time in 2015 and for
purposes of the payment adjustments in CY 2017 for both returning and
new participant EPs who demonstrate meaningful use in 2015. We propose
the deadline for attestation would be February 29, 2016.
We would maintain our current policy for 2016. Under that policy,
if an EP is demonstrating meaningful use for the first time in 2016,
the EHR reporting period for a payment adjustment year is any
continuous 90-day period in CY 2016 and applies for purposes of the
payment adjustments in CYs 2017 and 2018. To avoid the payment
adjustment in CY 2017, the 90-day period must occur within the first
three quarters of CY 2016 and the EP must attest by October 1, 2016. If
an EP has previously demonstrated meaningful use, the EHR reporting
period for a payment adjustment year is the full CY 2016 and applies
for purposes of the payment adjustment in CY 2018.
We invite comment on this proposal.
b. Changes to the EHR Reporting Period for a Payment Adjustment Year
for Eligible Hospitals
We propose a change to our current policy for 2015. We propose that
for all eligible hospitals, including those that have demonstrated
meaningful use in a
[[Page 20381]]
prior year and those that have not, the EHR reporting period for a
payment adjustment year would be any continuous 90-day period beginning
October 1, 2014 and ending December 31, 2015. This EHR reporting period
would apply for purposes of the payment adjustments in FY 2016 for
eligible hospitals demonstrating meaningful use for the first time in
2015 and for purposes of the payment adjustments in FY 2017 for both
returning and new participant eligible hospitals that demonstrate
meaningful use in 2015. We propose the deadline for attestation would
be February 29, 2016.
We also propose to change our current policy for 2016. We propose
that if an eligible hospital is demonstrating meaningful use for the
first time in 2016, the EHR reporting period for a payment adjustment
year would be any continuous 90-day period in CY 2016 and apply for
purposes of the payment adjustments in FYs 2017 and 2018. To avoid the
payment adjustment in FY 2017, the 90-day period must occur within the
first three quarters of CY 2016, and the eligible hospital must attest
by October 1, 2016. If an eligible hospital has previously demonstrated
meaningful use, the EHR reporting period for a payment adjustment year
would be the full CY 2016, the attestation deadline would be February
28, 2017, and this EHR reporting period would apply for purposes of the
payment adjustment in FY 2018.
c. Changes to the EHR Reporting Period for a Payment Adjustment Year
for CAHs
For CAHs, we are proposing to shift the EHR reporting period for a
payment adjustment year from the federal fiscal year that is the
payment adjustment year to the calendar year that begins on the first
day of the second quarter of the federal fiscal year that is the
payment adjustment year. In the Stage 3 proposed rule, we outline how
CAHs are different from EPs and eligible hospitals in that the EHR
reporting period is aligned with the payment adjustment year, rather
than in advance of the payment adjustment year. In the Stage 3 proposed
rule, we propose a similar change to this definition for an EHR
reporting period for a payment adjustment year beginning in 2017 and
explain how this change to the calendar year would work for CAHs. For
further discussion of this proposal, we direct readers to the Stage 3
proposed rule (80 FR 16739 through 16740).
In this proposed rule, we propose a change to our current policy
for 2015. We propose that for all CAHs, including those that have
demonstrated meaningful use in a prior year and those that have not,
the EHR reporting period for a payment adjustment year would be any
continuous 90-day period beginning October 1, 2014 and ending December
31, 2015. This EHR reporting period would apply for purposes of the
payment adjustments for the cost reporting period that begins in
federal FY 2015. We propose the deadline for attestation would be
February 29, 2016.
Any CAH that does not demonstrate meaningful for an EHR reporting
period in 2015 would receive a downward adjustment to payments for its
reasonable costs incurred in the cost reporting period that begins in
federal FY 2015. If a CAH fails to demonstrate meaningful use in 2015
and has a fiscal year that ends between October 1, 2015 and March 1,
2016, then the payment adjustment would be applied through the cost
report reconciliation process.
We also propose to change our current policy for 2016. We propose
that if a CAH is demonstrating meaningful use for the first time in
2016, the EHR reporting period for a payment adjustment year would be
any continuous 90-day period in CY 2016 and apply for purposes of the
payment adjustments for the cost reporting period that begins in
federal FY 2016. The deadline for attestation would be February 28,
2017. If a CAH has previously demonstrated meaningful use, the EHR
reporting period for a payment adjustment year would be the full CY
2016, the attestation deadline would be February 28, 2017, and this EHR
reporting period would apply for purposes of the payment adjustments
for the cost reporting period that begins in federal FY 2016.
Any CAH that does not demonstrate meaningful for an EHR reporting
period in 2016 would receive a downward adjustment to payments for its
reasonable costs incurred in the cost reporting period that begins in
federal FY 2016. If a CAH fails to demonstrate meaningful use in 2016
and has a fiscal year that ends between October 1, 2016 and March 1,
2017, then the payment adjustment would be applied through the cost
report reconciliation process.
3. Hardship Exceptions
As stated previously, sections 1848(a)(7)(B) and
1886(b)(3)(B)(ix)(II) of the Act provide the Secretary with
discretionary authority to exempt, on a case by case basis, a provider
from the application of the Medicare payment adjustment if the
Secretary determines that compliance with the requirements for being a
meaningful EHR user would result in a significant hardship. We have
established various types of hardship exceptions for which providers
may apply as well as deadlines for application. For more information,
we refer readers to the Stage 2 final rule at 77 FR 54093 through
54113.
In this proposed rule, we propose no changes to the existing
hardship exceptions under our regulations.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to evaluate fairly whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
The following is a discussion of the requirements contained in this
proposed regulation that we believe are subject to PRA and information
collection requirements (ICRs). The projected numbers of EPs, eligible
hospitals, and CAHs, MA organizations, MA EPs and MA-affiliated
hospitals are based on the numbers used in the impact analysis
assumptions as well as estimated federal costs and savings in the
section IV.C.3.a. and b. of this proposed rule. The actual burden would
remain constant for per year as EPs, eligible hospitals, and CAHs would
need to attest that they have successfully demonstrated meaningful use
under the proposed definition in 2015 through 2017. For the purposes of
this analysis, we are focusing only on 2015, the first year in which a
provider may use the proposed definition of meaningful use. We do not
believe the burden for EPs, eligible hospitals, and CAHs participating
in Stages 1 and 2 prior to 2015 would be different from the Agency
Information Collection Activities (75 FR 65354) based on this proposed
rule. Beginning in 2012, Medicare EPs, eligible hospitals, and CAHs had
the option to electronically report their clinical quality measures
through the respective aligned quality reporting programs;
[[Page 20382]]
however, for the purposes of defining the burden for 2015 through 2017,
we maintain the estimates for attestation to CQM data.
In this proposed rule, the definition of meaningful use with
associated reporting requirements would replace all prior definitions
and requirements beginning in 2015. At that point, all eligible
providers would be required to report meaningful use requirements on an
annual basis. For 2017, providers may simply repeat this proposed
definition of meaningful use or move on to Stage 3. The same reporting
burden would apply to all providers. Consequently, the proposed ICRs
reflect the provider burden associated with complying with and
reporting of the proposed requirements beginning in 2015 and each
subsequent year. We note that the proposals in this rule result in a
reduction of the reporting burden on providers attesting to meaningful
use as compared to the existing program requirements finalized in the
Stage 2 final rule (77 FR 54132).
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs).
A. ICR Regarding Demonstration of Meaningful Use Criteria (Sec. 495.20
Through Sec. 495.60)
In Sec. 495.40 we propose that to successfully demonstrate
meaningful use of certified EHR technology for meaningful use in 2015
through 2017, an EP, eligible hospital, or CAH (collectively referred
to as ``provider'' in this section) must attest, through a secure
mechanism in a specified manner, to the following during the EHR
reporting period: (1) The provider used certified EHR technology and
specified the technology was used; and (2) the provider satisfied each
of the applicable objectives and associated measures in Sec. 495.22.
In Sec. 495.40, we stipulate that providers must also successfully
report the clinical quality measures selected by CMS to CMS or the
states, as applicable. We estimate that the certified EHR technology
adopted by the provider captures many of the objectives and associated
measures and generate automated numerator and denominator information
where required, or generate automated summary reports. We also expect
that the provider would enable the functionality required to complete
the objectives and associated measures for which they are required to
attest.
We propose that EPs would be required to report on a total of 10
objectives and associated measures and eligible hospitals and CAHs
would report on a total of 9 objectives and associated measures. In
this proposed rule, there are 6 objectives that would require an EP to
enter numerators and denominators during attestation. Eligible
hospitals and CAHs would have to attest that they have met 6 objectives
that require numerators and denominators. For objectives and associated
measures requiring a numerator and denominator, we limit our estimates
to actions taken in the presence of certified EHR technology. We do not
anticipate a provider would maintain 2 recordkeeping systems when
certified EHR technology is present. Therefore, we assume that all
patient records that would be counted in the denominator would be kept
using certified EHR technology. We expect it would take an individual
provider or designee approximately 10 minutes to attest to each
meaningful use objective and associated measure that requires a
numerator and denominator to be generated, as well as approximately 1
hour 30 minutes to attest to CQM requirements.
Additionally, providers would be required to report they have
completed objectives and associated measures that require a ``yes'' or
``no'' response during attestation. For EPs, there are 3 objectives
that would require a ``yes'' or ``no'' response during attestation. For
eligible hospitals and CAHs, there are 2 objectives and that would
require a ``yes'' or ``no'' response during attestation. We expect that
it would take a provider or their designee 1 minute to attest to each
objective that requires a ``yes'' or ``no'' response.
Providers would also be required to attest that they are protecting
ePHI. We estimate completion of the analysis required to meet
successfully the associated measure for this objective would take
approximately 6 hours, which is identical to our estimate for the Stage
1 and Stage 2 requirements. This burden estimate assumes that covered
entities are already conducting and reviewing these risk analyses under
current HIPAA regulations. Therefore, we have not accounted for the
additional burden associated with the conduct or review of such
analyses.
Table 7 lists those objectives and associated measures for EPs and
eligible hospitals and CAHs. We estimate the objectives and associated
measures would take an EP 6 hours 49 minutes to complete, and would
take an eligible hospital or CAH 6 hours 48 minutes to complete.
In this proposed rule EPs, eligible hospitals, and CAHs have nearly
identical reporting burdens. Eligible hospitals and CAHs are required
to report to one additional registry than EPs are required to report;
however, EPs have an additional objective, Secure Electronic Messaging,
which requires a ``yes'' or ``no'' response. Consequently, we have not
prepared lowest and highest burdens. Rather, we have computed a burden
for EPs and a burden for eligible hospitals and CAHs.
Table 7--Burden Estimates
----------------------------------------------------------------------------------------------------------------
Eligible Burden estimate Burden estimate
Eligible professionals hospitals and Measures per respondent per respondent
CAHs (EPs) (hospitals)
----------------------------------------------------------------------------------------------------------------
Objectives and Measures
----------------------------------------------------------------------------------------------------------------
Use computerized provider Use computerized More than 60% of 10 minutes......... 10 minutes.
order entry (CPOE) for provider order medication, 30% of
medication, laboratory and entry (CPOE) laboratory, and 30%
radiology orders directly for medication, of radiology orders
entered by any licensed laboratory and created by the EP or
healthcare professional who radiology authorized providers
can enter orders into the orders directly of the eligible
medical record per state, entered by any hospital's or CAH's
local and professional licensed inpatient or
guidelines. healthcare emergency department
professional (POS 21 or 23)
who can enter during the EHR
orders into the reporting period are
medical record recorded using CPOE.
per state,
local and
professional
guidelines.
[[Page 20383]]
Generate and transmit More than 50% of all 10 minutes.........
permissible prescriptions permissible
electronically (eRx). prescriptions, or
all prescriptions
written by the EP
and queried for a
drug formulary and
transmitted
electronically using
CEHRT.
Generate and More than 10% of 10 minutes.
transmit hospital discharge
permissible medication orders
discharge for permissible
prescriptions prescriptions (for
electronically new, changed, and
(eRx). refilled
prescriptions) are
queried for a drug
formulary and
transmitted
electronically using
CEHRT.
Use clinical decision support Use clinical 1. Implement five 1 minute........... 1 minute.
to improve performance on decision clinical decision
high-priority health support to support
conditions. improve interventions
performance on related to four or
high-priority more clinical
health quality measures at
conditions. a relevant point in
care for the entire
EHR reporting
period. Absent four
clinical quality
measures related to
an EP, eligible
hospital or CAH's
scope of practice or
patient population,
the clinical
decision support
interventions must
be related to
improving healthcare
efficiency.
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.
Provide patients the ability 1. More than 50% of 10 minutes.........
to view online, download, all unique patients
and transmit their health seen by the EP
information within 4 during the EHR
business days of the reporting period are
information being available provided timely
to the EP. (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. At least 1 patient
seen by the EP
during the EHR
reporting period (or
their authorized
representatives)
views, downloads, or
transmits to a third
party their health
information.
Provide patients 1. More than 50% of 10 minutes.
the ability to all patients who are
view online, discharged from the
download, and inpatient or
transmit emergency department
information (POS 21 or 23) of an
about a eligible hospital or
hospital CAH have their
admission. information
available online
within 36 hours of
discharge.
2. At least 1 patient
(or their authorized
representatives) who
are discharged from
the inpatient or
emergency department
(POS 21 or 23) of an
eligible hospital or
CAH views, downloads
or transmits to a
third party their
information during
the reporting period.
Use CEHRT to identify patient- Use CEHRT to Patient-specific 10 minutes......... 10 minutes.
specific education resources identify education resources
and provide those resources patient- identified by CEHRT
to the patient. specific are provided to
education patients for more
resources and than 10% of all
provide those unique patients with
resources to office visits seen
the patient. by the EP during the
EHR reporting period.
More than 10% 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 CEHRT.
Use secure electronic The secure electronic 10 minutes.........
messaging to communicate messaging function
with patients on relevant was fully enabled
health information. for the EHR
reporting period.
[[Page 20384]]
The EP who receives a patient The eligible The EP, eligible 10 minutes......... 10 minutes.
from another setting of care hospital or CAH hospital or CAH
or provider of care or who receives a performs medication
believes an encounter is patient from reconciliation for
relevant should perform another setting more than 50% of
medication reconciliation. of care or transitions of care
provider of in which the patient
care or is transitioned into
believes an the care of the EP
encounter is or admitted to the
relevant should eligible hospital's
perform or CAH's inpatient
medication or emergency
reconciliation. department (POS 21
or 23).
The EP who transitions their The eligible 1. The EP, eligible 10 minutes......... 10 minutes.
patient to another setting hospital or CAH hospital or CAH that
of care or provider of care who transitions transitions or
or refers their patient to their patient refers their patient
another provider of care to another to another setting
provides a summary care setting of care of care or provider
record for each transition or provider of of care provides a
of care or referral. care or refers summary of care
their patient record for more than
to another 10% of such
provider of transitions and
care provides a referrals either (a)
summary care electronically
record for each transmitted using
transition of CEHRT to a recipient
care or or (b) where the
referral. recipient receives
the summary of care
record via exchange
facilitated by an
organization that is
a NwHIN Exchange
participant or in a
manner that is
consistent with the
governance mechanism
ONC establishes for
the nationwide
health information
network.
Active engagement with a Active EPs must attest to at 1 minute........... 1 minute.
public health agency to engagement with least 2 options out
report public health data. a public health of 5.
agency to Eligible Hospitals
report public and CAHs must attest
health data. to at least 3
options out of 6.
Protect electronic protected Protect Conduct or review a 6 hours............
health information created electronic security risk
or maintained by the CEHRT protected analysis in
through the implementation health accordance with the
of appropriate technical information requirements under
capabilities. created or 45 CFR
maintained by 164.308(a)(1),
the CEHRT including addressing
through the the security (to
implementation include encryption)
of appropriate of data stored in
technical CEHRT in accordance
capabilities. 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.
----------------------------------------------------------------------------------------------------------------
Time to Attest to Objectives and Measures............................. 6 hours 49 minutes. 6 hours 48 minutes.
Time to Attest and Report Clinical Quality Measures................... 1 hour 30 minutes.. 1 hour 30 minutes.
----------------------------------------------------------------------------------
Total--Objectives + CQM Reporting................................. 8 hours 19 minutes. 8 hours 18 minutes.
----------------------------------------------------------------------------------------------------------------
In this proposed rule, we estimate that it would take no longer
than 6 hours 49 minutes for an EP to attest to each of the applicable
objectives and associated measures. The total burden hours for an EP to
attest to the meaningful use objectives and measures and to report CQMs
would be 8 hours 19 minutes. We estimate that there could be
approximately 595,100 nonhospital-based Medicare EPs in 2014. Based on
the historical data, we anticipate approximately 60 percent (357,060)
of these EPs may attest to the objectives and measures of meaningful
use. In addition, we believe approximately 30,000 Medicaid only EPs, or
approximately 51 percent of the Medicaid-only EPs, will successfully
demonstrate meaningful use in 2015. The total estimated annual cost
burden for all EPs to attest to meaningful use would be $297,076,291
(387,060 x 8 hours 19 minutes x $92.25 (mean hourly rate for physicians
based on May 2013 BLS data)). Similarly, eligible hospitals and CAHs
would attest that they have met the meaningful use objectives and
associated measures, and would submit the clinical quality measures. We
estimate that it would take no longer than 6 hours 48 minutes to attest
to each of the applicable objectives and associated measures.
Therefore, the total burden hours for an eligible hospital or CAH to
attest to the meaningful use objectives and measures and to report
CQMs, would be 8 hours 18 minutes. We estimate that there are about
4,900 eligible hospitals and CAHs that may attest to the aforementioned
criteria in FY 2015 of which 95 percent are expected to successfully
demonstrate meaningful use. The total estimated annual cost burden for
all eligible hospitals and CAHs to attest to meaningful use would be
$2,451,872 (4,655 eligible hospitals and CAHs x $63.46 (8 hours 18
minutes x $63.46 (mean hourly rate for lawyers based on May 2013 BLS)
data)).
We provide the estimate of the burden for the approximately 13,635
MA EPs in the MA organization burden section. The total annual burden
estimates for meaningful use under this proposed rule are shown in
Table 10.
[[Page 20385]]
For the purpose of this proposed collection of information, we
assumed that all eligible providers would comply with the requirements
of Meaningful Use as previously defined if the policies proposed in
this rule were not finalized. Therefore, in this proposed rule, we
estimate that the policies contained herein, once finalized, would
result in an overall reduction in the reporting burden for providers of
1.45 hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals
and CAHs per respondent. While batch reporting for objectives and
measures, and group reporting for CQMs, are available for EPs in the
current program; the program is based upon successful individual
provider demonstration of meaningful use and so individual totals are
used to identify the estimated reduction in provider reporting burden.
This reduction of burden is outlined in Table 8.
Table 8--Reduction in Reporting Burden Hours
------------------------------------------------------------------------
Estimated burden
Burden under current program and Estimated burden per respondent
proposed modifications per respondent EPs eligible hospitals
and CAHs
------------------------------------------------------------------------
Total Under Current Stage 2 9 hours 46 minutes NA.
Requirements at 42 CFR 495.6.
Core Set (including CQMs) +
Least Burdensome Menu Set
Criteria.
Total Under Current Stage 2 10 hours 13 10 hours 55
Requirements at 42 CFR 495.6. minutes. minutes.
Core Set (including CQMs) + Most
Burdensome Menu Set Criteria.
Total Under Proposed 8 hours 19 minutes 8 hours 18
Modifications at 495.22. minutes.
All Objectives and Measures +
CQMs.
Reduction from Least Burdensome 1 hour 27 minutes. NA.
Estimate.
Reduction from Most Burdensome 1 hour 54 minutes. 2 hour 37 minutes.
Estimate.
------------------------------------------------------------------------
Using the hourly costs associated with the reporting burden as
mentioned previously, this reduction of 1.45 hours to 1.9 hours for EPs
and 2.62 hours for eligible hospitals and CAHs represents a per
response savings of $133.76 to $175.28 for EPs and $166.27 for eligible
hospitals and CAHs. The total cost reduction in cost for providers
demonstrating meaningful use is estimated at $48,534,332 at the lowest
and $63,359,464 at the highest. These estimates are further outlined in
Table 9.
Table 9--Reduction in Burden Cost Savings
----------------------------------------------------------------------------------------------------------------
Burden reduction Reduction per Total cost
Number of responses hours Hourly cost respondent reduction
----------------------------------------------------------------------------------------------------------------
387,060................................. 1.45 $92.25 $133.76 $51,773,146
387,060................................. 1.9 92.25 175.28 67,843,877
4,655................................... 2.62 63.46 166.27 773,987
-----------------------------------------------------------------------
Total Least......................... ................ ................ ................ 52,547,132
-----------------------------------------------------------------------
Total Most...................... ................ ................ ................ 68,617,864
----------------------------------------------------------------------------------------------------------------
B. ICRs Regarding Qualifying MA Organizations (Sec. 495.210)
In this proposed rule, we estimate that the burden would be
significantly less for qualifying MA organizations attesting to the
meaningful use of their MA EPs, because qualifying MA EPs use the EHR
technology in place at a given location or system, so if certified EHR
technology is in place and the qualifying MA organization requires its
qualifying MA EPs to use the technology, qualifying MA organizations
would be able to determine at a faster rate than individual FFS EPs,
that its qualifying MA EPs meaningfully used certified EHR technology.
In other words, qualifying MA organizations can make the determination
in masse if the certified EHR technology is required to be used at its
facilities, whereas under FFS, each EP likely must make the
determination on an individual basis. We further note, that these
differences also mean the total reduction in burden for MA
organizations resulting from the proposals in this rule would be
negligible. We estimate that, on average, it would take an individual
45 minutes to collect information necessary to determine if a given
qualifying MA EP has met the meaningful use objectives and measures,
and 15 minutes for an individual to make the attestation for each MA
EP. Furthermore, the individuals performing the assessment and
attesting would not likely be the eligible professional, but non-
clinical staff. We believe that the individual gathering the
information could be equivalent to a GS 11, step 1 (2015 unadjusted for
locality rate), with an hourly rate of approximately $25.00/hour, and
the person attesting (and who may bind the qualifying MA organization
based on the attestation) could be equivalent to a GS 15, step 1 (2015
unadjusted for locality rate), or approximately $50.00/hour. Therefore,
for the estimated 13,635 potentially qualifying MA EPs with assumed 100
percent successfully demonstrating meaningful use, we believe it would
cost the participating qualifying MA organizations approximately
$426,050 annually to collect the required information and make the
attestations ([10,226 hours x $25.00]+[3,408 hours x $50.00]).
C. ICRs Regarding State Medicaid Agency and Medicaid EP and Hospital
Activities (Sec. 495.332 Through Sec. 495.344)
In this proposed rule, we are proposing no changes to State
Medicaid Agency reporting which affect the time and effort associated
with completing the single provider election repository and each
state's process for the administration of the Medicaid incentive
payments, including tracking of attestations and oversight; the
submission of the state Medicaid HIT Plan and the additional planning
and implementation documents; or the enrollment or reenrollment of
providers, or for the collection and submission of the data for
providers to demonstrate
[[Page 20386]]
that they have adopted, implemented, or upgraded certified EHR
technology. We believe the burden associated with these requirements
has already been accounted for in our discussion in the Stage 1 and
Stage 2 final rules at (75 FR 44516 through 44544 and 77 FR 54125
through 54135). For the collection and submission of the data for
providers to demonstrate that they are meaningful users of such
technology, we believe the burden associated with these requirements
has already been accounted for in our discussion of the burden for
Sec. 495.20 through Sec. 495.60.
Table 10--Estimated Annual Reporting Burden for Meaningful Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per Hourly labor
Regulation section OMB Control Number of Number of response Total annual cost of Total cost ($)
No. respondents responses (hours) burden (hours) reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 495.22--Objectives/Measures/CQMs 0938-1158 387,060 387,060 8.32 3,220,339 $92.25 $297,076,291
(EPs)..................................
Sec. 495.22--Objectives/Measures/CQMs 0938-1158 4,655 4,655 8.3 38,637 63.46 2,451,872
(hospitals/CAHs).......................
Sec. 495.210--Gather Attestation 0938-1158 13,635 13,635 0.75 10,226 25.00 255,656
Information (MA EPs and EHs)...........
Sec. 495.210--Attest (MA EPs and EHs). 0938-1158 13,635 13,635 0.25 3,409 50.00 170,438
---------------------------------------------------------------------------------------------------------------
Total............................... .............. 418,985 418,985 .............. 3,272,611 .............. 299,954,257
--------------------------------------------------------------------------------------------------------------------------------------------------------
* To avoid double counting, this number of respondents is only included once in the total.
** There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the
associated column from Table 10.
If you would like to comment on these information collection and
recordkeeping requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
[CMS-3311-P] Fax: (202) 395-6974; or Email:
OIRA_submission@omb.eop.gov.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this proposed
rule, and, when we proceed with a subsequent document, we will respond
to the comments in the preamble to that document.
V. Regulatory Impact Analysis
A. Statement of Need
This proposed rule would implement the provisions of the ARRA that
provide incentive payments to EPs, eligible hospitals, and CAHs
participating in Medicare and Medicaid programs that adopt and
meaningfully use certified EHR technology. The proposed rule specifies
applicable criteria for demonstrating meaningful use for an EHR
reporting period in 2015 through 2017.
B. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
In relation to the existing program requirements outlined in the
Stage 2 final rule (77 FR 53967 through 54162), we do not expect this
rule to result in more incentives paid or in more providers failing
meaningful use and being assessed a payment adjustment. This is due to
the nature of the modifications being proposed in this rule, which,
while they reduce the reporting burden on providers, do not affect the
clinical processes and IT functions required to successfully meet the
objectives and measures of meaningful use. The proposals in this rule
do not fundamentally change the technology required to support
participation in the meaningful use program. Under the current program,
the requirement to report data on the measures and objectives which
have been identified as now redundant to other more advanced measures
being retained, or are duplicative of other measures using the same
certified EHR technology function, is essentially requiring providers
to report on the same action or process twice. Therefore, it is not the
occurrence of the action or process which is reduced by the proposals
in this rule, but the burden associated with the duplicative and
redundant reporting. In addition, the objectives and measures which are
considered topped out have reached high performance and the statistical
evidence demonstrates that the expected result of any provider
attesting to meaningful use would be a score near the maximum. However,
the analysis of these measures and their identification as topped out
also takes into account the statistical likelihood that the functions
of measures and the processes behind them would continue even without a
requirement to report the results. Therefore, while the proposals
result in a reduction in reporting requirements, this does not
correlate to a change in the overall achievement of the measures and
objective as compared to the current program. Finally, when compared
against historical data, the shortened reporting period in 2015, which
has been proposed to accommodate the implementation of the policies of
this rule, is expected to have a minimal impact on successful
demonstration of meaningful use. This expectation of minimal impact is
based on a number of factors:
The shortened period is for 2015 only and not for 2016 or
2017.
Historical data on attestations shows no strong
correlation between a shorter reporting period and the ability of
providers to attest to a second year of
[[Page 20387]]
meaningful use, no correlation for providers returning to attest to a
third or fourth year of meaningful use, and providers who would
otherwise be in their first year of meaningful use would already have a
90-day reporting period.\5\
---------------------------------------------------------------------------
\5\ CMS Data and Reports: Quarterly Public Use Files for
participation, Monthly Reports for performance rates: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------
Performance data shows statistically negligible disparity
among providers attesting for a 90-day reporting period and those
attesting for a full year reporting period on the measures which have
been identified as redundant, duplicative, and topped out.\6\
---------------------------------------------------------------------------
\6\ CMS Data and Reports: Quarterly Public Use Files for
participation, Monthly Reports for performance rates: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------
For these reasons, we do not believe the proposals in this rule
would impact the overall estimates for incentive payments, payment
adjustments, and the net transfer costs associated with the program.
However, these proposals do affect the costs associated with the
reporting burden on providers. The impacts directly attributable with
the proposals in this rule relate to both an hourly reduction per
response an overall reduction in the cost associated with reporting for
providers demonstrating meaningful use. The burden analysis in this
proposed rule, as compared to the Stage 2 estimates, reduces the
reporting burden for attestation for providers by approximately 1.45
hours to 1.9 hours for EPs and 2.62 hours for eligible hospitals and
CAHs per respondent. This burden estimate and analysis of the impact of
the policies result in a total cost reduction estimated at $48,534,332
at the lowest and $63,359,464 at the highest. However, we believe this
proposed rule will have additional impacts--most notably, cost savings
for hospitals and providers that would have additional time to achieve
meaningful use--which cannot be adequately estimated because of the
wide variation among provider types, and therefore a designation as an
economically significant rule under the Executive Order and a major
rule under the Congressional Review Act is still applicable. The burden
estimate and analysis of the impact of the policies proposed in this
proposed rule are outlined further in section III. of this proposed
rule.
1. Overall Effects
a. Regulatory Flexibility Analysis and Small Entities
The Regulatory Flexibility Act (RFA) requires agencies to prepare
an Initial Regulatory Flexibility Analysis to describe and analyze the
impact of the proposed rule on small entities unless the Secretary can
certify that the rule will not have a significant impact on a
substantial number of small entities. In the healthcare sector, Small
Business Administration (SBA) size standards define a small entity as
one with between $7 million and $34 million in annual revenues. For the
purposes of the RFA, essentially all non-profit organizations are
considered small entities, regardless of size. Individuals and states
are not included in the definition of a small entity. Since the vast
majority of Medicare providers (well over 90 percent) are small
entities within the RFA's definitions, it is the normal practice of HHS
simply to assume that all affected providers are ``small'' under the
RFA. In this case, most EPs, eligible hospitals, and CAHs are either
nonprofit or meet the SBA's size standard for small business. We also
believe that the effects of the incentives program on many and probably
most of these affected entities will be economically significant.
Accordingly, this RIA section, in conjunction with the remainder of the
preamble, constitutes the required Initial Regulatory Flexibility
Analysis (RFA).
Data available suggests that more providers have adopted EHR
technology since the publication of the Stage 1 final rule. An ONC data
brief (No. 16, May 2014) noted that hospital adoption of EHR systems
has increased 5 fold since 2008. Nine in ten acute care hospitals
possessed CEHRT in 2013, increasing 29 percent since 2011. As of
January 1, 2015, more than 95 percent of eligible hospitals had
successfully demonstrated meaningful use. In January 2014, a Centers
for Disease Control and Prevention (CDC) data brief entitled, ``Use and
Characteristics of Electronic Health Record Systems Among Office-based
Physician Practices: United States, 2001 through 2013 found that 78
percent of office-based used any type of EHR systems, up from 18
percent in 2001. The majority of EPs have already purchased certified
EHR technology, implemented this new technology, and trained their
staff on its use with over 60 percent earning an incentive payment for
participation in the program prior to 2015.
The cost reductions provided by the proposals in this rule offer a
benefit to these providers. Furthermore, we believe that the
combination of payment incentives and long-term overall gains in
efficiency may compensate for some of the initial expenditures.
(1) Small Entities
We estimate that EPs would spend approximately $54,000 to purchase
and implement a certified EHR and $10,000 annually for ongoing
maintenance according to the Congressional Budget Office (CBO) (75 FR
44546).
In the paper, Evidence on the Costs and Benefits of Health
Information Technology, May 2008, in attempting to estimate the total
cost of implementing health IT systems in office-based medical
practices, recognized the complicating factors of EHR types, available
features and differences in characteristics of the practices that are
adopting them. The CBO estimated a cost range of $25,000 to $45,000 per
physician. Annual operating and maintenance amount was estimated at 12
to 20 percent of initial costs (that is, $3,000 to $9,000) per
physician. For all eligible hospitals, the range is from $1 million to
$100 million. Though reports vary widely, we anticipate that the
average will be $5 million for eligible hospitals to achieve meaningful
use. We estimate $1 million for maintenance, upgrades, and training
each year per eligible hospital. However, as stated earlier many
providers have already purchased systems with expenditures focused on
maintenance and upgrades. We believe that future retrospective studies
on the costs to implement and EHR and the return on investment (ROI)
would demonstrate the actual costs incurred by providers participating
in the EHR Incentive Programs. The potential costs savings in this
proposed rule would benefit these providers as a reduction in the
overall cost of program participation.
(2) Conclusion
As discussed later in this analysis, we believe that there are many
positive effects of adopting EHR on health care providers. Furthermore,
we believe that the proposals in this rule will result in an overall
reduction in the reporting burden for providers of all types.
Accordingly, we believe that the object of the RFA to minimize burden
on small entities is met by this proposed rule.
b. Small Rural Hospitals
Section 1102(b) of the Act requires us to prepare a regulatory
impact analysis (RIA) if a rule will have a significant impact on the
operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions
[[Page 20388]]
of section 603 of the RFA. For purposes of section 1102(b) of the Act,
we define a small rural hospital as a hospital that is located outside
of a metropolitan statistical area and has fewer than 100 beds. There
is no identifiable disparity among this group and the overall success
rates for eligible hospitals and CAHs in demonstrating meaningful use;
furthermore, 95 percent of eligible hospitals and CAHs have
successfully demonstrated meaningful use as of January 1, 2015.
Finally, on the whole we anticipate an estimated reduction in the
reporting burden on eligible hospitals as a group to be less than $1
million. Therefore, we do not believe that this proposed rule would
have a significant impact on a substantial number of small entities.
c. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates will require spending in any 1 year
$100 million in 1995 dollars, updated annually for inflation. In 2015,
that threshold is approximately $144 million. UMRA does not address the
total cost of a rule. Rather, it focuses on certain categories of cost,
mainly those ``federal mandate'' costs resulting from--(1) imposing
enforceable duties on state, local, or tribal governments, or on the
private sector; or (2) increasing the stringency of conditions in, or
decreasing the funding of, state, local, or tribal governments under
entitlement programs.
This proposed rule imposes no substantial mandates on states. This
program is voluntary for states and states offer the incentives at
their option. The state role in the incentive program is essentially to
administer the Medicaid incentive program. While this entails certain
procedural responsibilities, these do not involve substantial state
expense. In general, each state Medicaid Agency that participates in
the incentive program would be required to invest in systems and
technology to comply. States would have to identify and educate
providers, evaluate their attestations and pay the incentive. However,
the federal government would fund 90 percent of the state's related
administrative costs, providing controls on the total state outlay. In
addition, the changes being made by this proposed rule have very little
impact on any state functions.
d. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has Federalism implications. This
proposed rule would not have a substantial direct effect on state or
local governments, preempt state law, or otherwise have a Federalism
implication.
2. Effects on EPs, Eligible Hospitals, and CAHs
a. Background and Assumptions
There are no new costs associated with this proposed rule.
Furthermore, the estimates for the provisions affecting Medicare and
Medicaid EPs, eligible hospitals, and CAHs are somewhat uncertain for
the following reasons:
The program is voluntary although payment adjustments will
be imposed on Medicare providers if they are unable to demonstrate
meaningful use for the applicable reporting period.
The potential reduction in burden for EPs rely on relate
to assumptions of what options for meaningful use they would otherwise
attest to should the policies in this proposed rule not be adopted.
The net costs and savings for any individual provider may
not directly correlate to the total for the organization as larger
organizations may employ economies of scale in meaningful use
attestations.
However, based on the actual count of providers eligible for the
program as of December 31, 2014 which were identified through the
process of implementing payment adjustments for 2015, we estimated the
numbers of EPs and eligible hospitals, including CAHs under Medicare,
Medicaid, and MA for 2015 through 2017 and used the updated estimates
throughout the analysis. These total potential eligible providers are
as follows:
About 660,000 Medicare FFS EPs (some of whom will also be
Medicaid EPs). About 595,100 non-hospital based Medicare EPs.
About 58,300 non-Medicare eligible EPs (such as dentists,
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners, and physicians assistants).
4,900 eligible hospitals comprising the following:
++ 3,397 acute care hospitals.
++ 1,395 CAHs.
++ 97 children's hospitals (Medicaid only).
++ 11 cancer hospitals (Medicaid only).
16 MA organizations and 13,635 MA EPs
b. Industry Costs and Adoption Rates
In this proposed rule, we are proposing no new policies which would
require changes to the development, certification, and implementation
of certified EHR technology as compared to the policies in the existing
program outlined in the Stage 2 final rule (77 FR 54136 through 54146).
3. Medicare Incentive Program Costs
As noted at the beginning of this analysis, it is difficult to
predict the actual impacts of the policies in this proposed rule with
certainty. We believe the assumptions and methods described herein are
reasonable for estimating the financial impact of the provisions on
providers participating in the Medicare and Medicaid programs, but
acknowledge the wide range of possible outcomes.
a. Medicare Eligible Professionals (EPs)
In brief, the estimates of Medicare EP burden reduction are based
on current participation as of January 1, 2015. We estimate that
significant cost reductions for Medicare EPs participating in the EHR
Incentive Program will result from the policies in this proposed rule
when compared to the requirements of the current program. Our estimates
of the reduction in burden cost savings are presented in Table 12. They
reflect our assumptions about the proportion of EPs who will
demonstrate meaningful use of certified EHR technology outlined in
Table 11 based on historical data.
Table 11--Medicare EPs Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
Calendar year
--------------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Medicare EPs who have claims with Medicare (in 660.0 667.8 675.5
thousands)............................................
Nonhospital-based Medicare EPs (in thousands).......... 595.1 602.1 609.1
Percent of EPs who are Meaningful Users................ 60 65 70
[[Page 20389]]
Meaningful Users (in thousands)........................ 357.1 391.4 426.4
----------------------------------------------------------------------------------------------------------------
Table 12--Estimated Cost Reduction for Medicare EPs
----------------------------------------------------------------------------------------------------------------
Calendar year
--------------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users (in thousands)........................ 357.1 391.4 426.4
Lowest Estimated Cost Savings.......................... $47,760,345.60 $52,353,664.00 $57,035,264.00
Highest Estimated Cost Savings......................... $62,585,476.80 $68,604,592.00 $74,739,392.00
----------------------------------------------------------------------------------------------------------------
b. Medicare Eligible Hospitals and CAHs
In brief, the estimates of hospital burden reduction are based on
current participation as of January 1, 2015. We estimate that
significant cost reductions for Medicare eligible hospitals and CAHs
participating in the EHR Incentive Program would result from the
policies in this proposed rule when compared to the requirements of the
current program. Our estimates of the reduction in burden cost savings
are presented in Table 12. They reflect our assumptions about the
proportion of eligible hospitals and CAHs that will demonstrate
meaningful use of certified EHR technology outlined in Table 13 based
on historical data.
Table 13--Medicare Eligible Hospitals and CAHs Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
Calendar year
-----------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Eligible Hospitals........................................ 3,397 3,397 3,397
CAHs...................................................... 1,395 1,395 1,395
Percent Demonstrating Meaningful Use...................... 95 97 99
Meaningful Users.......................................... 4,552 4,648 4,744
----------------------------------------------------------------------------------------------------------------
Table 14--Estimated Cost Reduction for Medicare Eligible Hospitals and CAHs
----------------------------------------------------------------------------------------------------------------
Calendar year
--------------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users....................................... 4,552 4,648 4,744
Estimated Cost Savings................................. $756,861.04 $772,822.96 $788,784.88
----------------------------------------------------------------------------------------------------------------
4. Medicaid Only EPs
We estimate that significant cost reductions for Medicaid only EPs
participating in the EHR Incentive Program will result from the
policies in this proposed rule when compared to the requirements of the
current program. Our estimates of the reduction in burden cost savings
are presented in Table 16. They reflect our assumptions about the
proportion of Medicaid only EPs who will demonstrate meaningful use of
certified EHR technology outlined in Table 15 based on historical data.
Table 15--Medicaid Only EPs Demonstrating Meaningful Use
----------------------------------------------------------------------------------------------------------------
Calendar year
--------------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Medicaid only EPs...................................... 58.3 59.4 60.6
Percent of EPs who are Meaningful Users................ 51 53 55
Meaningful Users (in thousands)........................ 30 31.48 33.33
----------------------------------------------------------------------------------------------------------------
[[Page 20390]]
Table 16--Estimated Cost Reduction for Medicaid Only EPs
----------------------------------------------------------------------------------------------------------------
Calendar year
--------------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users (in thousands)........................ 30,000 31,480 33,330
Lowest Estimated Cost Savings.......................... $4,012,800.00 $4,210,764.80 $4,458,220.80
Highest Estimated Cost Savings......................... $5,258,400.00 $5,517,814.40 $5,842,082.40
----------------------------------------------------------------------------------------------------------------
It should be noted that since the Medicaid EHR Incentive Program
provides that a Medicaid EP can receive an incentive payment in their
first year because he or she has demonstrated a meaningful use or
because he or she has adopted, implemented, or upgraded certified EHR
technology, these participation rates include only those Medicaid
providers who are expected to demonstrate meaningful use. Providers who
are dual-eligible have been included in the Medicare EP program
estimates based on the total current volume of Medicare EPs who have
demonstrated meaningful use in either Medicare or Medicaid as of
January 1, 2015.
b. Medicaid Only Hospitals
The burden reduction for Medicaid only eligible hospitals assumes a
similar participation rate for the demonstration of meaningful use as
is applicable for Medicare eligible hospitals. We estimate that
significant cost reductions for Medicaid only eligible hospitals
participating in the EHR Incentive Program will result from the
policies in this proposed rule when compared to the requirements of the
current program. Our estimates of the reduction in burden cost savings
are presented in Table 18. They reflect our assumptions about the
proportion of Medicaid only eligible hospitals that will demonstrate
meaningful use of certified EHR technology outlined in Table 17 based
on historical data.
Table 17--Medicaid Only Eligible Hospitals Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
Calendar year
-----------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Eligible Hospitals........................................ 108 108 108
Percent Demonstrating Meaningful Use...................... 95 97 99
Meaningful Users.......................................... 103 105 107
----------------------------------------------------------------------------------------------------------------
Table 18--Estimated Cost Reduction for Medicare Eligible Hospitals and CAHs
----------------------------------------------------------------------------------------------------------------
Calendar year
-----------------------------------------------------
2015 2016 2017
----------------------------------------------------------------------------------------------------------------
Meaningful Users.......................................... 4,552 4,648 4,744
Estimated Cost Savings.................................... $17,125.81 $17,458.35 $17,790.89
----------------------------------------------------------------------------------------------------------------
5. Benefits for all EPs and all Eligible Hospitals
In this proposed rule, we have not quantified the overall benefits
to the industry, nor to eligible hospitals or EPs in the Medicare,
Medicaid, or MA programs. Although information on the costs and
benefits of adopting systems that specifically meet the requirements
for the EHR Incentive Programs (for example, certified EHR technology)
has not yet been collected, and although some studies question the
benefits of health information technology, a 2011 study completed by
ONC (Buntin et al, 2011 ``The Benefits of Health Information
Technology: A Review of the Recent Literature Shows Predominantly
Positive Results'' Health Affairs) found that 92 percent of articles
published from July 2007 up to February 2010 reached conclusions that
showed the overall positive effects of health information technology on
key aspects of care, including quality and efficiency of health care.
Among the positive results highlighted in these articles were decreases
in patient mortality, reductions in staffing needs, correlation of
clinical decision support to reduced transfusion and costs, reduction
in complications for patients in hospitals with more advanced health
IT, and a reduction in costs for hospitals with less advanced health
IT. A subsequent 2013 study completed by the RAND Corporation for ONC
(Shekelle at al. 2013 ``Health Information Technology: An Updated
Systemic Review with a Focus on Meaningful Use Functionalities) found
77 percent of articles published between January 2010 to August 2013
that evaluated the effects of health IT on healthcare quality, safety,
and efficiency reported findings that were at least partially positive.
The Centers for Disease Control and Prevention publication in January
2014, (Hsiao et al, ``Use and Characteristics of Electronic Health
Record Systems Among Office-based Physician Practices: United States,
2001-2013) concluded that the adoption of basic EHR systems by office-
based physicians increased 21 percent between 2012 and 2013, varying
widely across the states ranging from 21 percent in New Jersey to 83
percent in North Dakota. Another study, at one hospital emergency room
in Delaware, showed the ability to download and create a file with a
patient's medical history saved the ER $545 per use, mostly in reduced
waiting times. A pilot study of ambulatory practices found a positive
ROI within 16 months and annual savings thereafter (Greiger et al.
2007, A Pilot Study to Document the Return on Investment for
Implementing an Ambulatory Electronic Health Record at an Academic
Medical Center https://www.journalacs.org/article/S1072-
7515%2807%2900390-0/abstract--article-footnote-1.) Another
[[Page 20391]]
study compared the productivity of 75 providers within a large urban
primary care practice over a 4-year period showed increases in
productivity of 1.7 percent per month per provider after EHR adoption
(DeLeon et al. 2010, ``The business end of health information
technology''). Some vendors have estimated that EHRs could result in
cost savings of between $100 and $200 per patient per year. The
proposals in this rule focus on a long term goal of moving providers
along a continuum from data capture to advanced use of certified EHR
technology. The reduction of reporting burden recognizes progress
toward key milestones and is intended to allow providers to refocus on
leveraging health IT to support health information exchange, patient
engagement, and quality improvement. As participation and adoption
increases, there will be more opportunities to capture and report on
cost savings and benefits.
6. Benefits to Society
According to the CBO study ``Evidence on the Costs and Benefits of
Health Information Technology'' (https://www.cbo.gov//ftpdocs/91xx/doc9168/05-20-HealthIT.pdf) when used effectively, EHRs can enable
providers to deliver health care more efficiently. For example, the
study states that EHRs can reduce the duplication of diagnostic tests,
prompt providers to prescribe cost-effective generic medications,
remind patients about preventive care, reduce unnecessary office
visits, and assist in managing complex care. This is consistent with
the findings in the ONC study cited previously. Further, the CBO report
claims that there is a potential to gain both internal and external
savings from widespread adoption of health IT, noting that internal
savings will likely be in the reductions in the cost of providing care,
and that external savings could accrue to the health insurance plan or
even the patient, such as the ability to exchange information more
efficiently. However, it is important to note that the CBO identifies
the highest gains accruing to large provider systems and groups and
claims that office-based physicians may not realize similar benefits
from purchasing health IT products. At this time, there is limited data
regarding the efficacy of health IT for smaller practices and groups,
and the CBO report notes that this is a potential area of research and
analysis that remains unexamined. The benefits resulting specifically
from this proposed regulation are even harder to quantify because they
represent, in many cases, the reduction in the time spent per each
individual respondent to attest to the meaningful use objectives and
measures. While this time may represent a reduced burden and the
opportunity to reallocate recourses, there is no viable way to estimate
that benefit over a wide range of provider types, practice sizes and
other potential variables. For example, the reduction of about 2 hours
per respondent for a small practice might be insignificant; however,
for a practice of 1,000 providers it may represent as many as 2,000 man
hours which could be reallocated to making other improvements in
clinical processes and patient outcomes. Conversely, a large practice
may instead leverage the batch reporting option and only see an overall
reduction of 20 man hours as an organization while a small practice may
find an even greater reduction than the estimate which may amount to a
significantly increased benefit and more time for the provider to spend
in patient care.
In the Stage 2 final rule, we discussed research documenting the
association of EHRs with improved outcomes among diabetics (Hunt, JS et
al. (2009) ``The impact of a physician-directed health information
technology system on diabetes outcomes in primary care: A pre- and
post-implementation study'' Informatics in Primary Care 17(3):165-74;
Pollard, C et al. (2009) ``Electronic patient registries improve
diabetes care and clinical outcomes in rural community health centers''
Journal of Rural Health 25(1):77-84) and trauma patients (Deckelbaum,
D. et al. (2009) ``Electronic medical records and mortality in trauma
patients ``The Journal of Trauma: Injury, Infection, and Critical Care
67(3): 634-636), enhanced efficiencies in ambulatory care settings
(Chen, C et al. (2009) ``The Kaiser Permanente Electronic Health
Record: Transforming and Streamlining Modalities Of Care. ``Health
Affairs'' 28(2):323-333), and improved outcomes and lower costs in
hospitals (Amarasingham, R. et al. (2009) ``Clinical information
technologies and inpatient outcomes: A multiple hospital study''
Archives of Internal Medicine 169(2):108-14). The 2013 ONC report cited
previously reported findings from their literature review on health IT
and safety of care, health IT and quality of care,, and health It and
efficiency of care in ambulatory and non-ambulatory care settings. The
report indicated that a majority of studies that evaluated the effects
of health IT on healthcare quality, safety, and efficiency reported
findings that were at least partially positive. The report concluded
that their findings ``suggested that health IT, particularly those
functionalities included in the Meaningful Use . . . , can improve
healthcare quality and safety.''
C. Accounting Statement
Whenever a rule is considered a significant rule under Executive
Order 12866, we are required to develop an accounting statement
indicating the classification of the expenditures associated with the
provisions of this proposed rule. This rule is considered economically
significant as mentioned previously because the impacts directly
attributable with the proposals in this rule would result in an overall
reduction in the reporting burden and associated costs for providers
demonstrating meaningful use. Monetary annualized benefits and
nonbudgetary costs are presented as discounted flows using 3 percent
and 7 percent factors.
Table 19--Accounting Statement: Classification of Estimated Cost Reductions and Benefits CYs 2015 Through 2017
[In millions]
----------------------------------------------------------------------------------------------------------------
Benefits
Category -----------------------------------------------------------------------------------
Low estimate High estimate
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Cost 2015 52.8 68.9 7% CY 2015
Reductions to Private .............. 52.8 68.9 3%
Industry Associated with
Reporting Requirements.
[[Page 20392]]
Qualitative--Other private
industry and societal
benefits associated with
the reduction in provider
reporting burden and with
having additional time to
achieve meaningful use.
----------------------------------------------------------------------------------------------------------------
In this proposed rule, there is no estimated increase in costs
associated with incentive payments or payment adjustments for the
Medicare and Medicaid EHR Programs attributable to the proposed
policies.
D. Conclusion
The previous analysis, together with the remainder of this
preamble, provides an RIA. We invite public comments on the analysis
and request any additional data that will help us determine more
accurately the impact on the EPs and eligible hospitals affected by the
proposed rule and on Medicare and Medicaid payments to these entities.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget reviewed this rule.
List of Subjects in 42 CFR Part 495
Administrative practice and procedure, Electronic health records,
Health facilities, Health professions, Health maintenance organizations
(HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to further amend 42 CFR part 495, as
previously proposed to be amended on March 30, 2015 (80 FR 16732), as
follows:
PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY
INCENTIVE PROGRAM
0
1. The authority citation for part 495 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. Section 495.4 is amended as follows:
0
A. Amend the definition of ``EHR reporting period'' by:
0
i. In paragraph (1)(i) introductory text removing the phrase ``before
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
ii. Redesignating paragraph (1)(ii) as paragraph (1)(iii).
0
iii. Adding a new paragraph (1)(ii).
0
iv. In paragraph (2)(i) introductory text removing the phrase ``before
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
v. Redesignating paragraph (2)(ii) as paragraph (2)(iii).
0
vi. Adding a new paragraph (2)(ii).
0
B. Amend the definition of ``EHR reporting period for a payment
adjustment year'' by:
0
i. In paragraph (1)(i) introductory text removing the phrase ``before
CY 2017'' and adding in its place the phrase ``before 2015''.
0
ii. Redesignating paragraph (1)(ii) as paragraph (1)(iii).
0
iii. Adding a new paragraph (1)(ii).
0
iv. In paragraph (2)(i) introductory text removing the phrase ``before
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
v. Redesignating paragraph (2)(ii) as paragraph (2)(iii).
0
vi. Adding a new paragraph (2)(ii).
0
vii. In paragraph (3)(i) introductory text removing the phrase ``before
CY 2017'' and adding in its place the phrase ``before CY 2015''.
0
viii. Redesignating paragraph (3)(ii) as paragraph (3)(iii).
0
ix. Adding a new paragraph (3)(ii).
0
C. Amend the definition of ``Meaningful EHR user'' by:
0
i. In paragraph (1), by removing the reference ``Sec. 495.8'' and
adding in its place the reference ``Sec. Sec. 495.40''.
0
ii. In paragraph (1), by removing the reference ``Sec. 495.6 or
495.7'' and adding in its place the reference ``Sec. Sec. 495.20,
495.22, and 495.24''.
The additions read as follows:
Sec. 495.4 Definitions.
* * * * *
EHR reporting period. * * *
(1) * * *
(ii) The following are applicable for 2015 and 2016:
(A) For the CY 2015 payment year, any continuous 90-day period
within CY 2015.
(B) For the CY 2016 payment year:
(1) For the EP first demonstrating he or she is a meaningful EHR
user, any continuous 90-day period within CY 2016.
(2) For the EP who has successfully demonstrated he or she is a
meaningful EHR user in any prior year, the CY 2016.
* * * * *
(2) * * *
(ii) The following are applicable for 2015 and 2016:
(A) For the FY 2015 payment year, any continuous 90-day period
within the period beginning October 1, 2014 and ending December 31,
2015.
(B) For the FY 2016 payment year for the eligible hospital or CAH--
(1) First demonstrating it is a meaningful EHR user, any continuous
90-day period within CY 2016; or
(2) That has successfully demonstrated it is a meaningful EHR user
in any prior year, the CY 2016.
* * * * *
EHR reporting period for a payment adjustment year * * *
(1) * * *
(ii) The following are applicable for 2015 and 2016:
(A) For an EHR reporting period in 2015:
(1) Except as specified under paragraph (1)(ii)(A)(2) of this
definition, any continuous 90-day period within the calendar year that
is 2 years before the payment adjustment year.
(2) If in the calendar year that is 2 years before the payment
adjustment year and in all prior calendar years, the EP has not
successfully demonstrated he or she is a meaningful EHR user, then any
continuous 90-day period within the calendar year that is 1 year before
the payment adjustment year. The EP must successfully register for and
attest to meaningful use by February 29, 2016.
(B) For an EHR reporting period in 2016:
(1) Except as specified in paragraphs (1)(ii)(B)(2) and (3) of this
definition, the calendar year that is 2 years before the payment
adjustment year.
(2) If an EP is demonstrating he or she is a meaningful EHR user
for the first time in the calendar year that is 2 years
[[Page 20393]]
before the payment adjustment year, then any continuous 90-day period
within such (2 years prior) calendar year.
(3) If in the calendar year that is 2 years before the payment
adjustment year and in all prior calendar years, the EP has not
successfully demonstrated he or she is a meaningful EHR user, then any
continuous 90-day period that both begins in the calendar year 1 year
before the payment adjustment year and ends at least 3 months before
the end of such prior year. The EP must successfully register for and
attest to meaningful use by October 1, 2016.
* * * * *
(2) * * *
(ii) The following are applicable for 2015 and 2016:
(A) For an EHR reporting period in 2015:
(1) Except as specified in paragraph (2)(ii)(A)(2) of this
definition, any continuous 90-day period within the period beginning on
October 1, 2014 and ending on the last day of the calendar year that is
2 years before the payment adjustment year.
(2) If in the calendar year that is 2 years before the payment
adjustment year and in all prior years, the eligible hospital has not
successfully demonstrated it is a meaningful EHR user, then any
continuous 90-day period within the period beginning on October 1, 2014
and ending on the last day of the calendar year that is 1 year prior to
the payment adjustment year. The eligible hospital must successfully
register for and attest to meaningful use by February 29, 2016.
(B) For an EHR reporting period in 2016:
(1) Except as specified in paragraphs (2)(ii)(B)(2) and (3) of this
definition, the calendar year that is 2 years before the payment
adjustment year.
(2) If an eligible hospital is demonstrating that it is a
meaningful EHR user for the first time in the calendar year that is 2
years before the payment adjustment year, then any continuous 90-day
period within such (2 years prior) calendar year.
(3) If in the calendar year that is 2 years before the payment
adjustment year and in all prior years, the eligible hospital has not
successfully demonstrated it is a meaningful EHR user, then any
continuous 90-day period that both begins in the calendar year that is
1 year before the payment adjustment year and ends at least 3 months
before the end of such prior calendar year. The eligible hospital must
successfully register for and attest to meaningful use by October 1,
2016.
* * * * *
(3) * * *
(ii) The following are applicable for 2015 and 2016:
(A) The EHR reporting period for the FY 2015 payment adjustment
year is any continuous 90-day period within the period beginning on
October 1, 2014 and ending on December 31, 2015. The CAH must
successfully register for and attest to meaningful use by February 29,
2016.
(B) For an EHR reporting period in 2016:
(1) Except as provided in paragraph (3)(ii)(B)(2) of this
definition, the CY 2016 is the EHR reporting period for the FY 2016
payment adjustment year.
(2) If the CAH is demonstrating it is a meaningful EHR user for the
first time, the EHR reporting period for the FY 2016 payment adjustment
year is any continuous 90-day period within CY 2016.
* * * * *
Sec. 495.6 [Redesignated as Sec. 495.20]
0
3. Redesignate Sec. 495.6 as Sec. 495.20.
0
4. Newly redesignated Sec. 495.20 is amended by revising the section
heading and adding new introductory text to read as follows.
Sec. 495.20 Meaningful use objectives and measures for EPs, eligible
hospitals, and CAHs before 2015.
The following criteria are applicable before 2015:
* * * * *
0
5. Add Sec. 495.22 to read as follows:
Sec. 495.22 Meaningful use objectives and measures for EPs, eligible
hospitals, and CAHs for 2015 through 2017.
(a) General rules. (1) The criteria specified in this section are
applicable for all EPs, eligible hospitals, and CAHs for 2015 through
2017.
(2) For 2017 only, EPs, eligible hospitals, and CAHs have the
option to use the criteria specified for 2018 (as outlined at Sec.
495.24) instead of the criteria specified in this section.
(b) Criteria for EPs for 2015 through 2017--(1) General rule
regarding criteria for meaningful use for 2015 through 2017 for EPs.
Except as specified in paragraph (b)(2) of this section, EPs must meet
all objectives and associated measures of the meaningful use criteria
specified under paragraph (e) of this section to meet the definition of
a meaningful EHR user.
(2) Exclusion for nonapplicable objectives. (i) An EP may exclude a
particular objective contained in paragraph (e) of this section, if the
EP meets all of the following requirements:
(A) Must ensure that the objective in paragraph (e) of this section
includes an option for the EP to attest that the objective is not
applicable.
(B) Meets the criteria in the applicable objective that would
permit the attestation.
(C) Attests.
(ii) An exclusion will reduce (by the number of exclusions
applicable) the number of objectives that would otherwise apply in
paragraph (e) of this section.
(c) Criteria for eligible hospitals and CAHs for 2015 through
2017--(1) General rule regarding criteria for meaningful use for 2015
through 2017 for eligible hospitals and CAHs. Except as specified in
paragraph (c)(2) of this section, eligible hospitals and CAHs must meet
all objectives and associated measures of the meaningful use criteria
specified under paragraph (e) of this section to meet the definition of
a meaningful EHR user.
(2) Exclusion for nonapplicable objectives. (i) An eligible
hospital or CAH may exclude a particular objective contained in
paragraph (e) of this section, if the eligible hospital or CAH meets
all of the following requirements:
(A) Must ensure that the objective in paragraph (e) of this section
includes an option for the eligible hospital or CAH to attest that the
objective is not applicable.
(B) Meets the criteria in the applicable objective that would
permit the attestation.
(C) Attests.
(ii) An exclusion will reduce (by the number of exclusions
applicable) the number of objectives that would otherwise apply in
paragraph (e) of this section.
(d) Many of the objectives and associated measures in paragraph (e)
of this section rely on measures that count unique patients or actions.
(1) If a measure (or associated objective) in paragraph (e) of this
section references paragraph (d) of this section, then the measure may
be calculated by reviewing only the actions for patients whose records
are maintained using certified EHR technology. A patient's record is
maintained using certified EHR technology if sufficient data was
entered in the certified EHR technology to allow the record to be
saved, and not rejected due to incomplete data.
(2) If the objective and associated measure does not reference this
paragraph (d) of this section, then the measure must be calculated by
reviewing all patient records, not just those maintained using
certified EHR technology.
(e) Meaningful use objectives and measures for 2015 through 2017--
(1) Protect patient health information--(i)
[[Page 20394]]
Objective. Protect electronic protected health information created or
maintained by the Certified EHR Technology through the implementation
of appropriate technical capabilities.
(ii) Measures--(A) EP measure. Conduct or review a security risk
analysis in accordance with the requirements in 45 CFR 164.308(a)(1),
including addressing the security (to include encryption) of ePHI
created or maintained in Certified EHR Technology 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 EP's risk management process.
(B) Eligible hospital or CAH measure. Conduct or review a security
risk analysis in accordance with the requirements under 45 CFR
164.308(a)(1), including addressing the security (to include
encryption) of ePHI created or maintained in Certified EHR Technology
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 eligible
hospital's or CAH's risk management process.
(2) Clinical decision support--(i) Objective. Use clinical decision
support to improve performance on high-priority health conditions.
(ii) EP measures--(A) Measure. In order for EPs to meet the
objective they must satisfy both of the following measures:
(1) Implement five clinical decision support interventions related
to four or more clinical quality measures at a relevant point in
patient care for the entire EHR reporting period. Absent four clinical
quality measures related to an EP's scope of practice or patient
population, the clinical decision support interventions must be related
to high-priority health conditions.
(2) Enabled and implemented the functionality for drug-drug and
drug-allergy interaction checks for the entire EHR reporting period.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
An EP who writes fewer than 100 medication orders during the EHR
reporting period may be excluded from the measure under paragraph
(e)(2)(i)(A)(2) of this section.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015--(1) Alternate exclusion. An EP previously scheduled to
be in Stage 1 in 2015 may meet an alternate measure specified in
paragraph (e)(2)(ii)(C)(2) in place of the measure outlined under
paragraph (e)(2)(ii)(A)(1) of this section.
(2) Alternate objective and measure--(i) Alternate objective.
Implement one clinical decision support rule relevant to specialty or
high clinical priority along with the ability to track compliance with
that rule.
(ii) Alternate measure. Implement one clinical decision support
rule.
(iii) Eligible hospital and CAH measures--(A) Measure. In order for
eligible hospitals and CAHs to meet the objective they must satisfy
both of the following measures:
(1) Implement five clinical decision support interventions related
to four or more clinical quality measures at a relevant point in
patient care for the entire EHR reporting period. Absent four clinical
quality measures related to an eligible hospital or CAH's scope of
practice or patient population, the clinical decision support
interventions must be related to high-priority health conditions.
(2) Enabled and implemented the functionality for drug-drug and
drug-allergy interaction checks for the entire EHR reporting period.
(B) Alternate specifications for an EHR reporting period in 2015--
(1) Alternate objective and measure. An eligible hospital or CAH
previously scheduled to be in Stage 1 in 2015 may meet an alternate
measure described in paragraph (e)(2)(iii)(B)(2) of this section in
place of the measure described in paragraph (e)(2)(iii)(A)(1) of this
section.
(i) Objective. Implement one clinical decision support rule related
to a high priority hospital condition along with the ability to track
compliance with that rule.
(ii) Measure. Implement one clinical decision support rule.
(3) Computerized provider order entry--(i) Objective. Use
computerized provider order entry 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.
(ii) EP measures--(A) Measures. An EP must meet the following 3
measures, subject to paragraph (d) of this section:
(1) More than 60 percent of medication orders created by the EP
during the EHR reporting period are recorded using computerized
provider order entry.
(2) More than 30 percent of laboratory orders created by the EP
during the EHR reporting period are recorded using computerized
provider order entry.
(3) More than 30 percent of radiology orders created by the EP
during the EHR reporting period are recorded using computerized
provider order entry.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
(1) For the measure specified in paragraph (e)(3)(ii)(A)(1) of this
section, any EP who writes fewer than 100 medication orders during the
EHR reporting period.
(2) For the measure specified in paragraph (e)(3)(ii)(A)(2) of this
section, any EP who writes fewer than 100 laboratory orders during the
EHR reporting period.
(3) For the measure specified in paragraph (e)(3)(ii)(A)(3) of this
section, any EP who writes fewer than 100 radiology orders during the
EHR reporting period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015--(1) An EP previously scheduled to be in Stage 1 in 2015
may meet an alternate measure (e)(3)(ii)(C)(2) in place of the measure
outlined under paragraph (e)(3)(ii)(A)(1) of this section, and may
exclude the measures outlined under paragraphs (e)(3)(ii)(A)(2) and (3)
of this section.
(2) Subject to paragraph (d) of this section--
(i) More than 30 percent of all unique patients with at least one
medication in their medication list seen by the EP during the EHR
reporting period have at least one medication order entered using CPOE;
or
(ii) More than 30 percent of medication orders created by the EP
during the EHR reporting period are recorded using computerized
provider order entry.
(3) Alternate exclusions. An EP previously scheduled to be in Stage
1 in 2015 may exclude the measure--
(i) Specified in paragraph (e)(3)(ii)(A)(2) of this section for an
EHR reporting period in 2015.
(ii) Specified in paragraph (e)(3)(ii)(A)(3) of this section for an
EHR reporting period in 2015.
(iii) Eligible hospital and CAH measures--(A) An eligible hospital
or CAH must meet the following 3 measures, subject to paragraph (d) of
this section:
(1) More than 60 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 recorded
using computerized provider order entry.
(2) More than 30 percent of laboratory 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 recorded
using computerized provider order entry.
[[Page 20395]]
(3) More than 30 percent of radiology 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 recorded
using computerized provider order entry.
(B) Alternate exclusions and specifications for an EHR reporting
period in 2015. (1) An eligible hospital or CAH previously scheduled to
be in Stage 1 in 2015 may--
(i) Meet an alternate measure specified in paragraph
(e)(3)(iii)(B)(2) of this section in place of the measure outlined
under paragraph (e)(3)(iii)(A)(1) of this section; and
(ii) May exclude the measures outlined under paragraphs
(e)(3)(iii)(A)(2) and (e)(3)(iii)(A)(3) of this section.
(2) Alternate measure 1. Subject to paragraph (d) of this section,
(i) More than 30 percent of all unique patients with at least one
medication in their medication list admitted to the eligible hospital's
or CAH's inpatient or emergency department (POS 21 or 23) have at least
one medication order entered using CPOE; or
(ii) More than 30 percent of medication orders created by the
authorized providers of the eligible hospital or CAH for patients
admitted to their inpatient or emergency departments (POS 21 or 23)
during the EHR reporting period are recorded using computerized
provider order entry.
(3) Alternate exclusions. An eligible hospital or CAH previously
scheduled to be in Stage 1 in 2015 may exclude the measure specified--
(i) In paragraph (e)(3)(iii)(A)(2) of this section for an EHR
reporting period in 2015; or
(ii) In paragraph (e)(3)(iii)(A)(3) of this section for an EHR
reporting period in 2015.
(4) Electronic prescribing--(i) Objective. For EPs, generate and
transmit permissible prescriptions electronically (eRx); and, for
eligible hospitals and CAHs, generate and transmit permissible
discharge prescriptions electronically (eRx).
(ii) EP measure--(A) Measure. Subject to paragraph (d) of this
section, more than 50 percent of all permissible prescriptions, or all
prescriptions, written by the EP are queried for a drug formulary and
transmitted electronically using Certified EHR Technology.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
Any EP who--
(1) Writes fewer than 100 permissible prescriptions during the EHR
reporting period; or
(2) Does not have a pharmacy within his or her organization and
there are no pharmacies that accept electronic prescriptions within 10
miles of the EP's practice location at the start of his or her EHR
reporting period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
meet an alternate measure under paragraph (e)(4)(ii)(C)(2) of this
section in place of the measure outlined under paragraph (e)(4)(ii)(A)
of this section.
(1) Alternate measure. Subject to paragraph (d) of this section,
more than 40 percent of all permissible prescriptions written by the EP
are transmitted electronically using Certified EHR Technology.
(2) Alternate exclusion. There are no alternate exclusions for this
measure
(iii) Eligible hospital and CAH measure--(A) Measure. Subject to
paragraph (d) of this section, more than 10 percent of hospital
discharge medication orders for permissible prescriptions (for new,
changed, and refilled prescriptions) are queried for a drug formulary
and transmitted electronically using Certified EHR Technology.
(B) Exclusion in accordance with paragraph (c)(2) of this section.
Any eligible hospital or CAH that does not have an internal pharmacy
that can accept electronic prescriptions and is not located within 10
miles of any pharmacy that accepts electronic prescriptions at the
start of their EHR reporting period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An eligible hospital or CAH previously scheduled to be
in--
(1) Stage 1 in 2015 may exclude the measure specified in paragraph
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015; or
(2) Stage 2 in 2015 may exclude the measure specified in paragraph
(e)(4)(iii)(A) of this section for an EHR reporting period in 2015 if
they did not previously intend to select the Stage 2 Electronic
Prescribing Menu Objective for an EHR reporting period in 2015.
(5) Summary of care--(i) Objective. The EP, eligible hospital or
CAH who transitions a patient to another setting of care or provider of
care or refers a patient to another provider of care provides a summary
care record for each transition of care or referral.
(ii) EP measure--(A) Measure. Subject to paragraph (d) of this
section, the EP who transitions or refers his or her patient to another
setting of care or provider of care must do the following:
(1) Use CEHRT to create a summary of care record.
(2) Electronically transmit such summary to a receiving provider
for more than 10 percent of transitions of care and referrals.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
Any EP who transfers a patient to another setting or refers a patient
to another provider less than 100 times during the EHR reporting
period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
exclude the measure specified in paragraph (e)(5)(ii)(A) of this
section for an EHR reporting period in 2015.
(iii) Eligible hospital and CAH measure--(A) Measure. Subject to
paragraph (d) of this section, the eligible hospital or CAH that
transitions or refers its patient to another setting of care or
provider of care must do the following:
(1) Use CEHRT to create a summary of care record.
(2) Electronically transmit such summary to a receiving provider
for more than 10 percent of transitions of care and referrals.
(B) Alternate exclusions and specifications for an EHR reporting
period in 2015. An eligible hospital or CAH previously scheduled to be
in Stage 1 in 2015 may exclude the measure specified in paragraph
(e)(5)(iii)(A) of this section for an EHR reporting period in 2015.
(6) Patient specific education--(i) Objective. Use clinically
relevant information from Certified EHR Technology to identify patient-
specific education resources and provide those resources to the
patient.
(ii) EP measure--(A) Measure. Patient-specific education resources
identified by Certified EHR Technology are provided to patients for
more than 10 percent of all unique patients with office visits seen by
the EP during the EHR reporting period.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
Any EP who has no office visits during the EHR reporting period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
exclude the measure specified in paragraph (e)(6)(ii)(A) of this
section for an EHR reporting period in 2015 if the EP did not
previously intend to select the Stage 1 Patient-Specific Education
Resources Menu Objective for an EHR reporting period in 2015.
[[Page 20396]]
(iii) Eligible hospital and CAH measure--(A) Measure. More than 10
percent of all unique patients admitted to the eligible hospital's or
CAH's inpatient or emergency department (POS 21 or 23) are provided
patient-specific education resources identified by Certified EHR
Technology.
(B) Alternate exclusions and specifications for an EHR reporting
period in 2015. An eligible hospital or CAH previously scheduled to be
in Stage 1 in 2015 may exclude the measure specified in paragraph
(e)(6)(iii)(A) of this section for an EHR reporting period in 2015 if
they did not previously intend to select the Stage 1 Patient-Specific
Education Resources Menu Objective for an EHR reporting period in 2015.
(7) Medication reconciliation--(i) Objective. The EP, eligible
hospital or CAH that receives a patient from another setting of care or
provider of care or believes an encounter is relevant should perform
medication reconciliation.
(ii) EP measure--(A) Measure. Subject to paragraph (d) of this
section, the EP performs medication reconciliation for more than 50
percent of transitions of care in which the patient is transitioned
into the care of the EP.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
Any EP who was not the recipient of any transitions of care during the
EHR reporting period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
exclude the measure specified in paragraph (e)(7)(ii)(A) of this
section for an EHR reporting period in 2015 if they did not previously
intend to select the Stage 1 Medication Reconciliation Menu Objective
for an EHR reporting period in 2015.
(iii) Eligible hospital or CAH measure. An eligible hospital or CAH
must meet the following measure, subject to paragraph (d) of this
section:
(A) Measure. Subject to paragraph (d) of this section, the eligible
hospital or CAH performs medication reconciliation for more than 50
percent of transitions of care in which the patient is admitted to the
eligible hospital's or CAH's inpatient or emergency department (POS 21
or 23).
(B) Alternate exclusions and specifications for an EHR reporting
period in 2015. An eligible hospital or CAH previously scheduled to be
in Stage 1 in 2015 may exclude the measure specified in paragraph
(e)(7)(iii)(A) of this section for an EHR reporting period in 2015 if
they did not previously intend to select the Stage 1 Medication
Reconciliation Menu Objective for an EHR reporting period in 2015.
(8) Patient electronic access--(i) 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.
(A) EP measures. An EP must meet the following 2 measures:
(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) At least 1 patient seen by the EP during the EHR reporting
period (or their authorized representatives) views, downloads, or
transmits his or her health information to a third party.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
(1) Any EP who neither orders nor creates any of the information listed
for inclusion as part of the measure in paragraph (e)(8)(ii)(A)(1) or
(2) of this section, except for ``Patient name'' and ``Provider's name
and office contact information,'' is excluded from both paragraphs
(e)(8)(ii)(A)(1) and (2) of this section.
(2) Any EP who 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 Federal Communications Commission on the
first day of the EHR reporting period is excluded from paragraph
(e)(8)(ii)(A)(2) of this section.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
exclude the measure specified in paragraph (e)(8)(ii)(A)(2) of this
section for an EHR reporting period in 2015.
(ii) Eligible hospital and CAH objective. Provide patients the
ability to view online, download, and transmit information within 36
hours of hospital discharge .
(A) Eligible hospital and CAH measures. An eligible hospital or CAH
must meet the following 2 measures:
(1) More than 50 percent of all unique 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.
(2) At least 1 patient(or the patient's authorized representative)
who is discharged from the inpatient or emergency department (POS 21 or
23) of an eligible hospital or CAH views, downloads or transmits to a
third party his or her information during the EHR reporting period.
(B) Exclusion applicable under (c)(2) of this section. Any eligible
hospital or CAH that is located 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 is excluded from paragraph
(e)(8)(iii)(A)(2) of this section.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An eligible hospital or CAH previously scheduled to be
in Stage 1 in 2015 may exclude the measure specified in paragraph
(e)(8)(iii)(A)(2) of this section for an EHR reporting period in 2015.
(9) Secure messaging--(i) EP objective. Use secure electronic
messaging to communicate with patients on relevant health information.
(ii) EP measure--(A) Measure. The capability for patients to send
and receive a secure electronic message with the EP was fully enabled
during the EHR reporting period.
(B) Exclusion in accordance with paragraph (b)(2) of this section.
An EP may exclude from the measure if he or she--
(1) Has no office visits during the EHR reporting period; or
(2) 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 Federal Communications Commission on the first day
of the EP's EHR reporting period.
(C) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
exclude the measure specified in paragraph (e)(9)(ii)(A) of this
section for an EHR reporting period in 2015.
(10) Public Health and Clinical Data Registry reporting--(i) EP
Public Health and Clinical Data Registry reporting-- (A) Objective. The
EP is in active engagement with a public health agency or clinical data
registry to submit electronic public health data in a meaningful way
using certified EHR technology, except where prohibited, and in
accordance with applicable law and practice.
[[Page 20397]]
(B) Measures. In order to meet the objective under paragraph
(e)(10)(i)(A) of this section, an EP must choose from measures 1
through 5 (as specified in paragraphs (e)(10)(i)(B)(1) through
(e)(10)(i)(B)(5) of this section) and must successfully attest to any
combination of two measures. These measures may be met by any
combination, including meeting measures specified in paragraph
(e)(10)(i)(B)(4) or (5) of this section multiple times in accordance
with applicable law and practice.
(1) Immunization registry reporting: The EP is in active engagement
with a public health agency to submit immunization data and receive
immunization forecasts and histories from the public health
immunization registry/immunization information system (IIS).
(2) Syndromic surveillance reporting. The EP is in active
engagement with a public health agency to submit syndromic surveillance
data from a non-urgent care ambulatory setting.
(3) Case reporting. The EP is in active engagement with a public
health agency to submit case reporting of reportable conditions.
(4) Public health registry reporting. The EP is in active
engagement with a public health agency to submit data to public health
registries.
(5) Clinical data registry reporting. The EP is in active
engagement to submit data to a clinical data registry.
(C) Exclusions in accordance with paragraph (b)(2) of this section.
(1) Any EP meeting one or more of the following criteria may be
excluded from the immunization registry reporting measure in paragraph
(e)(10)(i)(B)(1) of this section if the EP:
(i) Does not administer any immunizations to any of the populations
for which data is collected by his or her jurisdiction's immunization
registry or immunization information system during the EHR reporting
period.
(ii) Operates in a jurisdiction for which no immunization registry
or immunization information system is capable of accepting the specific
standards required to meet the CEHRT definition at the start of his or
her EHR reporting period.
(iii) Operates in a jurisdiction where no immunization registry or
immunization information system has declared readiness to receive
immunization data from the EP at the start of the EHR reporting period.
(2) Any EP meeting one or more of the following criteria may be
excluded from the syndromic surveillance reporting measure described in
paragraph (e)(10)(i)(B)(2) of the section if the EP:
(i) Does not treat or diagnose or directly treat any disease or
condition associated with a syndromic surveillance system in his or her
jurisdiction.
(ii) Operates in a jurisdiction for which no public health agency
is capable of receiving electronic syndromic surveillance data from EPs
in the specific standards required to meet the CEHRT definition at the
start of the EHR reporting period.
(iii) Operates in a jurisdiction where no public health agency has
declared readiness to receive syndromic surveillance data from EPs at
the start of the EHR reporting period.
(3) An EP meeting one or more of the following criteria may be
excluded from the case reporting measure at (e)(10)(i)(B)(3) if the EP:
(i) Does not treat or diagnose any reportable diseases for which
data is collected by his or her jurisdiction's reportable disease
system during the EHR reporting period.
(ii) Operates in a jurisdiction for which no public health agency
is capable of receiving electronic case reporting data in the specific
standards required to meet the CEHRT definition at the start of his or
her EHR reporting period.
(iii) Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic case reporting data at the
start of the EHR reporting period.
(4) Any EP meeting at least one of the following criteria may be
excluded from the public health registry reporting measure specified in
paragraph (e)(10)(i)(B)(4) of this section if the EP:
(i) Does not diagnose or directly treat any disease or condition
associated with a public health registry in his or her jurisdiction
during the EHR reporting period.
(ii) Operates in a jurisdiction for which no public health agency
is capable of accepting electronic registry transactions in the
specific standards required to meet the CEHRT definition at the start
of the EHR reporting period.
(iii) Operates in a jurisdiction where no public health registry
for which the EP is eligible has declared readiness to receive
electronic registry transactions at the start of the EHR reporting
period.
(5) Any EP meeting at least one of the following criteria may be
excluded from the clinical data registry reporting measure specified in
paragraph (e)(10)(i)(B)(5) of this section if the EP:
(i) Does not diagnose or directly treat any disease or condition
associated with a clinical data registry in his or her jurisdiction
during the EHR reporting period.
(ii) Operates in a jurisdiction for which no clinical data registry
is capable of accepting electronic registry transactions in the
specific standards required to meet the CEHRT definition at the start
of the EHR reporting period.
(iii) Operates in a jurisdiction where no clinical data registry
for which the EP is eligible has declared readiness to receive
electronic registry transactions at the start of the EHR reporting
period.
(D) Alternate exclusions and specifications for an EHR reporting
period in 2015. An EP previously scheduled to be in Stage 1 in 2015 may
choose from measures 1 through 5 (as specified in paragraphs
(e)(10)(i)(B)(1) through (e)(10)(i)(B)(5) of this section) and must
successfully attest to any one measure in accordance with applicable
law and practice for an EHR reporting period in 2015.
(ii) Eligible hospital and CAH Public Health and Clinical Data
Registry reporting objective--(A) Objective. The eligible hospital or
CAH is in active engagement with a public health agency or clinical
data registry to submit electronic public health data in a meaningful
way using certified EHR technology, except where prohibited, and in
accordance with applicable law and practice.
(B) Measures. In order to meet the objective under paragraph
(e)(10)(ii)(A) of this section, an eligible hospital or CAH must choose
from measures 1 through 6 (as described in paragraphs (e)(10)(ii)(B)(1)
through (e)(10)(ii)(B)(6) of this section) and must successfully attest
to any combination of three measures. These measures may be met by any
combination, including meeting the measures specified in paragraph
(e)(10)(ii)(B)(4) or (5) of this section multiple times, in accordance
with applicable law and practice:
(1) Immunization registry reporting. The eligible hospital or CAH
is in active engagement with a public health agency to submit
immunization data and receive immunization forecasts and histories from
the public health immunization registry/immunization information system
(IIS).
(2) Syndromic surveillance reporting. The eligible hospital or CAH
is in active engagement with a public health agency to submit syndromic
surveillance data from an emergency or urgent care department (POS 23).
(3) Case reporting. The eligible hospital or CAH is in active
engagement with a public health agency to submit case reporting of
reportable conditions.
(4) Public health registry reporting. The eligible hospital or CAH
is in active engagement with a public health agency
[[Page 20398]]
to submit data to public health registries.
(5) Clinical data registry reporting. The eligible hospital or CAH
is in active engagement to submit data to a clinical data registry.
(6) Electronic reportable laboratory result reporting. The eligible
hospital or CAH is in active engagement with a public health agency to
submit electronic reportable laboratory results.
(C) Exclusions in accordance with paragraph (c)(2) of this section.
(1) Any eligible hospital or CAH meeting one or more of the following
criteria may be excluded from the immunization registry reporting
measure specified in paragraph (e)(10)(ii)(B)(1) of this section if the
eligible hospital or CAH:
(i) Does not administer any immunizations to any of the populations
for which data is collected by its jurisdiction's immunization registry
or immunization information system during the EHR reporting period.
(ii) Operates in a jurisdiction for which no immunization registry
or immunization information system is capable of accepting the specific
standards required to meet the CEHRT definition at the start of the EHR
reporting period.
(iii) Operates in a jurisdiction where no immunization registry or
immunization information system has declared readiness to receive
immunization data from the eligible hospital or CAH at the start of the
EHR reporting period.
(2) Any eligible hospital or CAH meeting one or more of the
following criteria may be excluded from the syndromic surveillance
reporting measure specified in paragraph (e)(10)(ii)(B)(2) of this
section if the eligible hospital or CAH:
(i) Does not have an emergency or urgent care department.
(ii) Operates in a jurisdiction for which no public health agency
is capable of receiving electronic syndromic surveillance data from
eligible hospitals or CAHs in the specific standards required to meet
the CEHRT definition at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where no public health agency has
declared readiness to receive syndromic surveillance data from eligible
hospitals or CAHs at the start of the EHR reporting period.
(3) An eligible hospital or CAH meeting one or more of the
following criteria may be excluded from the case reporting measure
specified in paragraph (e)(10)(ii)(B)(3) of this section if the
eligible hospital or CAH:
(i) Does not treat or diagnose any reportable diseases for which
data is collected by its jurisdiction's reportable disease system
during the EHR reporting period.
(ii) Operates in a jurisdiction for which no public health agency
is capable of receiving electronic case reporting data in the specific
standards required to meet the CEHRT definition at the start of the EHR
reporting period.
(iii) Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic case reporting data at the
start of the EHR reporting period.
(4) Any eligible hospital or CAH meeting at least one of the
following criteria may be excluded from the public health registry
reporting measure specified in paragraph (e)(10)(ii)(B)(4) of this
section if the eligible hospital or CAH:
(i) Does not diagnose or directly treat any disease or condition
associated with a public health registry in their jurisdiction during
the EHR reporting period.
(ii) Operates in a jurisdiction for which no public health agency
is capable of accepting electronic registry transactions in the
specific standards required to meet the CEHRT definition at the start
of the EHR reporting period
(iii) Operates in a jurisdiction where no public health registry
for which the eligible hospital or CAH is eligible has declared
readiness to receive electronic registry transactions at the start of
the EHR reporting period.
(5) Any eligible hospital or CAH meeting at least one of the
following criteria may be excluded from the clinical data registry
reporting measure specified in paragraph (e)(10)(ii)(B)(5) of this
section if the eligible hospital or CAH:
(i) Does not diagnose or directly treat any disease or condition
associated with a clinical data registry in their jurisdiction during
the EHR reporting period.
(ii) Operates in a jurisdiction where no clinical data registry for
which no clinical data registry is capable of accepting electronic
registry transactions in the specific standards required to meet the
CEHRT definition at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where no clinical data registry
for which the eligible hospital or CAH is eligible has declared
readiness to receive electronic registry transactions at the beginning
of the EHR reporting period.
(6) Any eligible hospital or CAH meeting one or more of the
following criteria may be excluded from the electronic reportable
laboratory result reporting measure specified in paragraph
(d)(10)(ii)(B)(6) of this section if the eligible hospital or CAH:
(i) Does not perform or order laboratory tests that are reportable
in the eligible hospital's or CAH's jurisdiction during the EHR
reporting period
(ii) Operates in a jurisdiction for which no public health agency
that is capable of accepting the specific ELR standards required to
meet the CEHRT definition at the start of the EHR reporting period.
(iii) Operates in a jurisdiction where no public health agency has
declared readiness to receive electronic reportable laboratory results
from eligible hospitals or CAHs at the start of the EHR reporting
period.
(D) Alternate exclusions and specifications for an EHR reporting
period in 2015. An eligible hospital or CAH previously scheduled to be
in Stage 1 in 2015 may choose from measures 1 through 6 (as specified
in paragraphs (e)(10)(ii)(B)(1) through (e)(10)(ii)(B)(6) of this
section) and must successfully attest to any 2 measures. These measures
may be met by any combination, including meeting the measures specified
in paragraph (e)(10)(ii)(B)(4) or (5) of this section multiple times,
in accordance with applicable law and practice.
Sec. 495.7 [Redesginated as Sec. 495.24]
0
6. Redesignate Sec. 495.7 as Sec. 495.24.
Sec. 495.8 [Redesginated as Sec. 495.40]
0
7. Redesignate Sec. 495.8 as Sec. 495.40.
0
8. Newly redesignated Sec. 495.40 is amended by:
0
A. In paragraph (a) introductory text by removing the cross-reference
``under Sec. 495.6 or Sec. 495.7'' and adding in its place the cross-
reference ``under Sec. 495.20 or Sec. 495.24''.
0
B. In paragraph (a)(1)(i)(B) by removing the cross-reference ``under
Sec. 495.6 or Sec. 495.7'' and adding in its place the cross-
reference ``under Sec. 495.20 or Sec. 495.24''.
0
C. In paragraph (a)(1)(iii) by removing the cross-reference ``in Sec.
495.6 or Sec. 495.7 and Sec. 495.8'' and adding in its place the
cross-reference ``in Sec. 495.20 or Sec. 495.24 and Sec. 495.40''.
0
D. Revising paragraph (a)(2)(i)(B).
0
E. In paragraph (a)(2)(i)(D) by removing the cross-reference ``under
Sec. 495.6(a)(4) or (h)(3)'' and adding in its place the cross-
reference ``in Sec. 495.20(a)(4) or (h)(3)''.
0
F. Redesignating paragraph (a)(2)(i)(E) as paragraph (a)(2)(i)(F).
0
G. Adding a new paragraph (a)(2)(i)(E).
0
H. Revising newly redesignated paragraph (a)(2)(i)(F).
[[Page 20399]]
0
I. Adding paragraph (a)(2)(i)(G).
0
J. In paragraph (a)(2)(iv) by removing the cross-reference ``in Sec.
495.6 or Sec. 495.7 and Sec. 495.8'' and adding in its place the
cross-reference ``in Sec. 495.20 or Sec. 495.24 and Sec. 495.40''.
0
K. In paragraph (b)(1)(i)(B) by removing the cross-reference ``under
Sec. 495.6 or Sec. 495.7'' and adding in its place the cross-
reference ``under Sec. 495.20 or Sec. 495.24''.
0
L. In paragraph (b)(1)(iii) by removing the cross-reference ``in Sec.
495.6 or Sec. 495.7 and Sec. 495.8'' and adding in its place the
cross-reference ``in Sec. 495.20 or Sec. 495.24 and Sec. 495.40''.
0
M. Revising paragraph (b)(2)(i)(B).
0
N. In paragraph (b)(2)(i)(D) by removing the cross-reference ``under
Sec. 495.6(b)(4) or (i)(3)'' and adding in its place the cross-
reference ``in Sec. 495.20(b)(4) or (h)(3)''.
0
O. Redesignating paragraph (b)(2)(i)(E) as paragraph (b)(2)(i)(F).
0
P. Adding a new paragraph (b)(2)(i)(E).
0
Q. Revising newly redesignated paragraph (b)(2)(i)(F).
0
R. Adding paragraph (b)(2)(i)(G).
The revisions and additions read as follows:
Sec. 495.40 Demonstration of meaningful use criteria.
(a) * * *
(2) * * *
(i) * * *
(B) For calendar years before 2015, satisfied the required
objectives and associated measures under Sec. 495.20 for the EP's
stage of meaningful use.
* * * * *
(E) For CYs 2015 through 2017, satisfied the required objectives
and associated measures under Sec. 495.22(e) for meaningful use.
(F) For CY 2017 only, an EP may satisfy either of the following
objectives and measures for meaningful use:
(1) Objectives and measures specified in Sec. 495.22(e).
(2) Objectives and measures specified in Sec. 495.24(d)
(G) For CY 2018 and subsequent years, satisfied the required
objectives and associated measures under Sec. 495.24(d) for meaningful
use.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(B) For fiscal years before 2015, satisfied the required objectives
and associated measures under Sec. 495.20 for the eligible hospital or
CAH's stage of meaningful use.
* * * * *
(E) For CYs 2015 through 2017, satisfied the required objectives
and associated measures under Sec. 495.22(e) for meaningful use.
(F) For CY 2017 only, an eligible hospital or CAH may satisfy
either of the following objectives and measures for meaningful use:
(1) Objectives and measures specified at Sec. 495.22(e); or
(2) Objectives and measures specified at Sec. 495.24(d).
(G) For CY 2018 and subsequent years, satisfied the required
objectives and associated measures under Sec. 495.24(h) for meaningful
use.
* * * * *
Sec. 495.10 [Redesginated as Sec. 495.60]
0
9. Redesignate Sec. 495.10 as Sec. 495.60.
Dated: April 2, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: April 8, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-08514 Filed 4-10-15; 4:15 pm]
BILLING CODE 4120-01-P
