Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3, 16731-16804 [2015-06685]
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Vol. 80
Monday,
No. 60
March 30, 2015
Part II
Department of Health and Human Services
Centers for Medicare and Medicaid Services
42 CFR Part 495
Office of the Secretary
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45 CFR Part 170
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program—Stage 3; 2015 Edition Health Information Technology (Health IT)
Certification Criteria, 2015 Edition Base Electronic Health Record (EHR)
Definition, and ONC Health IT Certification Program Modifications;
Proposed Rules
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Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 495
[CMS–3310–P]
RIN 0938–AS26
Medicare and Medicaid Programs;
Electronic Health Record Incentive
Program—Stage 3
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This Stage 3 proposed rule
would specify the meaningful use
criteria that eligible professionals (EPs),
eligible hospitals, and critical access
hospitals (CAHs) must meet in order to
qualify for Medicare and Medicaid
electronic health record (EHR) incentive
payments and avoid downward
payment adjustments under Medicare
for Stage 3 of the EHR Incentive
Programs. It would continue to
encourage electronic submission of
clinical quality measure (CQM) data for
all providers where feasible in 2017,
propose to require the electronic
submission of CQMs where feasible in
2018, and establish requirements to
transition the program to a single stage
for meaningful use. Finally, this Stage 3
proposed rule would also change the
EHR reporting period so that all
providers would report under a full
calendar year timeline with a limited
exception under the Medicaid EHR
Incentive Program for providers
demonstrating meaningful use for the
first time. These changes together
support our broader efforts to increase
simplicity and flexibility in the program
while driving interoperability and a
focus on patient outcomes in the
meaningful use program.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on May 29, 2015.
ADDRESSES: In commenting, please refer
to file code CMS–3310–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
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SUMMARY:
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address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3310–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–3310–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
Ed Howard (CMS), (410) 786–6368,
Medicare Advantage
Deborah Krauss (CMS), (410) 786–5264,
clinical quality measures
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Alesia Hovatter (CMS), (410) 786–6861,
clinical quality measures
Elise Sweeney Anthony (ONC), (202)
475–2485, certification definition
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
API Application-Program Interface
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
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
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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
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 specify the
policies that would be applicable for
Stage 3 of the Medicare and Medicaid
EHR Incentive Programs. Under Stage 3,
we are proposing a set of requirements
that EPs, eligible hospitals, and CAHs
must achieve in order to meet
meaningful use, qualify for incentive
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payments under the Medicare and
Medicaid EHR Incentive Programs, and
avoid downward payment adjustments
under Medicare. These Stage 3
requirements focus on the advanced use
of certified EHR technology (CEHRT) to
promote health information exchange
and improved outcomes for patients.
Stage 3 of meaningful use is expected
to be the final stage and would
incorporate portions of the prior stages
into its requirements. In addition,
following a proposed optional year in
2017, beginning in 2018 all providers
would report on the same definition of
meaningful use at the Stage 3 level
regardless of their prior participation,
moving all participants in the EHR
Incentive Programs to a single stage of
meaningful use in 2018. The
incorporation of the requirements into
one stage for all providers is intended to
respond to stakeholder input regarding
the complexity of the program, the
success of certain measures which are
part of the meaningful use program to
date, and the need to set a long-term,
sustainable foundation based on a
consolidated set of key advanced use
objectives for the Medicare and
Medicaid EHR Incentive Programs.
In addition, we propose changes to
the EHR reporting period, timelines, and
structure of the Medicare and Medicaid
EHR Incentive Programs. We believe
these changes would provide a flexible,
clear framework to reduce provider
burden, streamline reporting, and
ensure future sustainability of the
Medicare and Medicaid EHR Incentive
Programs. These changes together lay a
foundation for our broader efforts to
support interoperability and quality
initiatives focused on improving patient
outcomes.
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 EPs,
eligible hospitals, and 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 critical access
hospitals (CAHs), respectively. Sections
1848(a)(7), 1853(l) and (m),
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1886(b)(3)(B), and 1814(l) of the Act also
establish downward payment
adjustments, beginning with calendar or
fiscal year (FY) 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 titled, ‘‘Medicare and
Medicaid Programs; Electronic Health
Record Incentive Program; Final Rule’’
(75 FR 44316 through 44317)).
2. Summary of Major Provisions
a. 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 their 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 Stage 1 of meaningful use,
we refer readers to the Stage 1 final rule
(75 FR 44313 through 44588).)
In the September 4, 2012 Stage 2 final
rule (77 FR 53967 through 54162), we
focused on the next step after the
foundation of data capture in Stage 1,
the exchange of that essential health
data among health care providers and
patients to improve care coordination.
To this end, we maintained the same
core-menu structure for several finalized
Stage 1 core and menu objectives. We
finalized that EPs must meet the
measure for 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 included 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. We also
finalized a set of clinical quality
measures (CQMs) for all providers
participating in any stage of the program
to report to CMS beginning in 2014. (For
a full discussion of the meaningful use
objectives and measures, and the CQMs
we finalized under Stage 2, we refer
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readers to the Stage 2 final rule at 77 FR
53967 through 54162.)
In this Stage 3 proposed rule, we
build on the groundwork established in
the Stage 1 and Stage 2 final rules,
including continuing our goal started
under Stage 2 to increase interoperable
health data sharing among providers. In
addition, this Stage 3 proposed rule
would also focus on the advanced use
of EHR technology to promote improved
patient outcomes and health
information exchange. We also propose
to continue improving program
efficiency, effectiveness, and flexibility
by making changes to the Medicare and
Medicaid EHR Incentive Programs that
simplify reporting requirements and
reduce program complexity. These
changes proposed respond to comments
received in earlier rulemaking that
expressed confusion and concerns
regarding increased reporting burden
related to the number of program
requirements, the multiple stages of
program participation, and the timing of
EHR reporting periods. In order to
address these stakeholder concerns, one
significant change we propose for Stage
3 includes establishing a single set of
objectives and measures (tailored to EP
or eligible hospital/CAH) to meet the
definition of meaningful use. This new,
streamlined definition of meaningful
use proposed for Stage 3 would be
optional for any provider who chooses
to attest to these objectives and
measures for an EHR reporting period in
2017; and would be required for all
eligible providers—regardless of prior
participation in the EHR Incentive
Program—for an EHR reporting period
in 2018 and subsequent years.
In addition to reducing program
complexity, the Stage 3 proposed rule
would further support efforts to align
the EHR Incentive Programs with other
CMS quality reporting programs that use
certified EHR technology, such as the
Hospital Inpatient Quality Reporting
(IQR) and Physician Quality Reporting
System (PQRS) programs, as well as
continue alignment across care settings
for providers demonstrating meaningful
use. This alignment would both reduce
provider burden associated with
reporting on multiple CMS programs
and enhance CMS operational
efficiency. The Stage 3 proposed rule
and ONC’s 2015 Edition of 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
elsewhere in this edition of the Federal
Register would also continue to support
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the privacy and security of patient
health information within certified
health IT.
b. Meaningful Use Requirements,
Objectives and Measures for 2017 and
Subsequent Years
Under this Stage 3 proposed rule,
with the exception of Medicaid
providers in their first year of
demonstrating meaningful use as
detailed in section II.F.1. of this
proposed rule, all providers (EPs,
eligible hospitals, and CAHs) would
report on a calendar year EHR reporting
period beginning in calendar year 2017.
This proposal builds on efforts to align
the EHR reporting period with reporting
periods for other quality reporting
programs identified in the Stage 2 final
rule (77 FR 53971 through 53975 and
54049 through 54051) and the FY 2015
Hospital Inpatient Prospective Payment
Systems (IPPS) final rule (79 FR 49854
through 50449). In addition, all
providers, other than Medicaid EPs and
eligible hospitals demonstrating
meaningful use for the first time, would
be required to attest based on a full year
of data for a single set of meaningful use
objectives and measures to demonstrate
Stage 3 of meaningful use, which is
proposed as optional for an EHR
reporting period in 2017 and mandatory
for an EHR reporting period in 2018,
and subsequent years for all providers
participating in the Medicare and
Medicaid EHR Incentive Programs.
The methodology for the selection of
the proposed Stage 3 objectives and
measures for the Medicare and
Medicaid EHR Incentive Programs
included the following:
• Review attestation data for Stages 1
and 2 of meaningful use.
• Conduct listening sessions and
interviews with providers, EHR system
developers, regional extension centers,
and health care provider associations.
• Review recommendations from
government agencies and advisory
committees focused on health care
improvement, such as the Health
Information Technology (HIT) Policy
Committee, the National Quality Forum
(NQF), and the Centers for Disease
Control (CDC).
The information we gathered from
these sources focused on analyzing
measure performance, implementing
discrete EHR functionalities and
standards, and examining objectives and
measures presenting the best
opportunity to improve patient
outcomes and enhance provider
support.
Based on this analysis, we are
proposing a set of 8 objectives with
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associated measures designed to do all
of the following:
• Align with national health care
quality improvement efforts.
• Promote interoperability and health
information exchange.
• Focus on the 3-part aim of reducing
cost, improving access, and improving
quality.
We intend to have this Stage 3
proposed rule be the last stage of the
meaningful use framework, which
leverages the structure identified in the
Stage 1 and Stage 2 final rules, while
simultaneously establishing a single set
of objectives and measures designed to
promote best practices and continued
improvement in health outcomes in a
sustainable manner. Measures in the
Stage 1 and Stage 2 final rules that
included paper-based workflows, chart
abstraction, or other manual actions
would be removed or transitioned to an
electronic format utilizing EHR
functionality for Stage 3. In addition, we
are proposing the removal of ‘‘topped
out’’ measures, or measures that are no
longer useful in gauging performance, in
order to reduce the reporting burden on
providers for measures already
achieving widespread adoption.
c. Clinical Quality Measurement
EPs, eligible hospitals, and CAHs
must report CQMs in order to qualify for
incentive payments under the Medicare
and Medicaid EHR Incentive Programs
and avoid downward payment
adjustments under Medicare.
We are committed to continuing the
electronic calculation and reporting of
key clinical data through the use of
CQMs. We are also focused on
improving alignment of reporting
requirements for CMS programs using
EHR technology, maintaining flexibility
with reporting requirements while
streamlining reporting mechanisms for
providers, and increasing quality data
integrity.
This proposed rule addresses quality
reporting alignment on several fronts.
Our long-term vision seeks to have
hospitals, clinicians, and other health
care providers report through a single,
aligned mechanism for multiple CMS
programs. In the Stage 2 final rule, we
outlined preliminary alignment options
for quality reporting programs with the
EHR Incentive Programs as the first step
toward that vision (77 FR 54053).
In order to facilitate continuous
quality improvement, we need a method
to allow changes to meaningful use
CQMs and the associated reporting
requirements on an ongoing basis. For
other CMS quality reporting programs,
changes occur through the annual
Medicare payment rules, such as the
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Physician Fee Schedule (PFS) and the
IPPS rules. Including CQMs in these
annual rules would allow us to capture
changes and updates annually.
Therefore, we intend to further support
alignment between the Medicare and
Medicaid EHR Incentive Programs and
other CMS quality reporting programs,
such as PQRS and Hospital IQR, by
including the reporting requirements for
CQMs for providers demonstrating
meaningful use in future rulemaking.
We propose to continue encouraging
CQM data submission through
electronic submission for Medicare
participants in 2017, and to require
electronic submission of CQMs where
feasible beginning in 2018 for Medicare
providers demonstrating meaningful
use. (We further discuss Medicaid CQM
submission in section II.F.3. of this
proposed rule.)
d. Payment Adjustments and Hardship
Exceptions
The statute requires Medicare
payment adjustment beginning in 2015.
For the Stage 3 proposed rule, we
propose to maintain all payment
adjustment provisions for all EPs,
eligible hospitals, and CAHs finalized in
the Stage 2 final rule (77 FR 54093
through 54113 and 54115 through
54119) except for a change to the
relationship between the EHR reporting
period year and the payment adjustment
year for CAHs. We are proposing a
change to the timing of the EHR
reporting period and related deadlines
for attestations and hardship exceptions
for CAHs in relation to the payment
adjustment year, in order to
accommodate a transition to EHR
reporting for meaningful use on the
calendar instead of the fiscal year
timeline. The payment adjustment
provisions being maintained in the
Stage 3 proposed rule include the
process we finalized in Stage 2 by
which a prior EHR reporting period
determines a payment adjustment. We
also maintain the four categories of
exceptions based on all of the following:
• The lack of availability of internet
access or barriers to obtain IT
infrastructure.
• A time-limited exception for newly
practicing EPs or new hospitals that
would not otherwise be able to avoid
payment adjustments.
• Unforeseen circumstances such as
natural disasters that would be handled
on a case-by-case basis.
• (EP only) exceptions due to a
combination of clinical features limiting
a provider’s interaction with patients or,
if the EP practices at multiple locations,
lack of control over the availability of
CEHRT at practice locations constituting
50 percent or more of their encounters.
e. Modifications to the Medicaid EHR
Incentive Program
Sections 1903(a)(3)(F) and 1903(t) of
the Act provide the statutory basis for
the Medicaid EHR Incentive Program.
For this Stage 3 proposed rule, we
propose that under the proposed
changes to EHR reporting periods that
would begin in 2017, Medicaid EPs and
eligible hospitals demonstrating
meaningful use for the first time in the
Medicaid EHR Incentive Program would
be required to attest for an EHR
reporting period of any continuous 90day period in the calendar year for
purposes of receiving an incentive, as
well as avoiding the payment
adjustment under the Medicare
Program.
We are proposing to continue to allow
states to set up a CQM submission
process that Medicaid EPs and eligible
hospitals may use to report on CQMs for
2017 and subsequent years. We also
propose amendments to state reporting
on providers who are participating in
the Medicaid EHR Incentive Program as
well as state reporting on
implementation and oversight activities.
f. Summary of Costs and Benefits
Upon finalization, the provisions in
this proposed rule are anticipated to
have an annual effect on the economy
of $100 million or more, making it an
economically significant rule under the
Executive Order and a major rule under
the Congressional Review Act.
Accordingly, we have prepared a
Regulatory Impact Analysis that to the
best of our ability presents the costs and
benefits of the final rule. The total
federal cost of the Medicare and
Medicaid EHR Incentive Programs
between 2017 and 2020 is estimated to
be $3.7 billion in transfers. In this
proposed rule we do not estimate total
costs and benefits to the provider
industry, but rather provide a possible
per EP and per eligible hospital outlay
for implementation and maintenance.
Nonetheless, we believe there are
substantial benefits that can be obtained
by society (perhaps accruing to eligible
hospitals and EPs), including cost
reductions related to improvements in
patient safety and patient outcomes and
cost savings benefits through
maximizing efficiencies in clinical and
business processes facilitated by
certified health IT.
TABLE 1—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS
OF THE HITECH EHR INCENTIVE PROGRAM
[Fiscal year—in billions]
Medicare eligible
Medicaid eligible
Fiscal year
Total
Hospitals
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2017
2018
2019
2020
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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
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Professionals
$1.6
0.0
0.0
0.0
$0.3
¥0.2
¥0.2
¥0.1
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
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Hospitals
$0.4
0.1
0.0
0.0
Professionals
$0.8
0.5
0.3
0.2
$3.1
0.4
0.1
0.1
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
Incentive Program would consist of
three different stages of meaningful use
requirements.
In the September 4, 2012 Federal
Register (77 FR 53967 through 54162),
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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
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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; Final Rule (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.
For Stages 1 and 2, CMS and ONC
worked closely to ensure that the
definition of meaningful use of CEHRT
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and the standards and certification
criteria for CEHRT were coordinated.
Current ONC regulations may be found
at 45 CFR part 170. For this Stage 3
proposed rule, CMS and ONC will again
work together to align our regulations.
We urge those interested in this Stage
3 proposed rule to also review the ONC
2015 Edition proposed rule, which is
published elsewhere in this Federal
Register. Readers may also visit:
https://www.cms.hhs.gov/
EHRincentiveprograms and https://
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. Meaningful Use Requirements,
Objectives, and Measures for 2017 and
Subsequent Years
1. Definitions Across the Medicare Feefor-Service, Medicare Advantage, and
Medicaid Programs
a. Uniform Definitions
As discussed in both the Stage 1 and
2 final 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.
We propose to maintain these
definitions, unless stated otherwise in
this proposed rule. (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).
As discussed in sections II.A.1.c.(1).
and (2). of this proposed rule, we are
proposing a single set of criteria for
meaningful use (‘‘Stage 3’’) in order to
eliminate the varying stages of the EHR
Incentive Programs. We propose that
this Stage 3 definition of meaningful use
would be optional for providers in 2017
and mandatory for all providers
beginning in 2018. To support Stage 3,
we propose revising the uniform
definitions under 42 CFR 495.4 for
‘‘EHR reporting period’’ and ‘‘EHR
reporting period for a payment
adjustment year,’’ as explained later in
this section. The proposed revisions to
these uniform definitions include
eliminating the current 90-day EHR
reporting period for EPs, eligible
hospitals, and CAHs demonstrating
meaningful use for the first time, and
instead creating a single EHR reporting
period aligned to the calendar year. The
proposed removal of the 90-day EHR
reporting period would not apply to
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Medicaid EPs and eligible hospitals
demonstrating meaningful use for the
first time. We believe eliminating the
90-day EHR reporting period for most
providers would simplify reporting, by
aligning providers on the same EHR
reporting timeline across all settings. In
addition, a single EHR reporting period
on the calendar year would align the
EHR Incentive Program with other CMS
quality reporting programs using
certified EHR technology such as the
Hospital IQR Program and PQRS.
Finally, a single EHR reporting period
based on the calendar year allows for a
single attestation period, thereby
enabling the HHS systems to better
capture data, conduct enhanced stress
testing and issue resolution, and
improve quality assurance of systems
before each deployment. We detail the
proposed revisions to each of the
uniform definitions later in this section.
b. Meaningful EHR User
In the Stage 3 proposed rule, we
propose to modify the definition of
‘‘Meaningful EHR User’’ under 42 CFR
495.4 to include the Stage 3 objectives
and measures defined at § 495.7.
The definition of a ‘‘Meaningful EHR
User’’ under the Act requires the use of
certified electronic health record
technology (CEHRT) (see, for example,
section 1848(o)(2) of the Act). We note
that the term CEHRT is a defined term
for the purpose of meeting the objectives
of the EHR Incentive Programs (defined
at § 495.4). The term references ONC’s
certification criteria for a ‘‘Base EHR,’’
other ONC certification criteria required
in the EHR Incentive Programs and the
definition of a ‘‘Meaningful EHR User.’’
References to CEHRT within this
proposed rule are to certification criteria
that are required for purposes of the
EHR Incentive Programs. We recognize
that CEHRT is just one form of health
IT. For this reason, this proposed rule
also includes references to ‘‘health IT’’
where appropriate to capture the
broader category of technologies where
applicable.
c. Definition of Meaningful Use
(1) Considerations in Defining
Meaningful Use
In sections 1848(o)(2)(A) and
1886(n)(3)(A) of the Act, the Congress
identified the broad goal of expanding
the use of EHRs through the concept of
meaningful use. Section 1903(t)(6)(C) of
the Act also requires that Medicaid
providers adopt, implement, upgrade or
meaningfully use CEHRT if they are to
receive incentives under Title XIX.
CEHRT used in a meaningful way is one
piece of the broader HIT infrastructure
needed to reform the health care system
and improve health care quality,
efficiency, and patient safety. This
vision of reforming the health care
system and improving health care
quality, efficiency, and patient safety
should inform the definition of
meaningful use.
As we explained in the Stage 1 and
Stage 2 rules, we seek to balance the
sometimes competing considerations of
health system advancement (for
example, improving health care quality,
encouraging widespread EHR adoption,
promoting innovation) and minimizing
burdens on health care providers given
the short timeframe available under the
HITECH Act.
Based on public and stakeholder
input received during our Stage 1 rule,
we laid out a phased approach to
meaningful use. Such a phased
approach encompasses reasonable
criteria for meaningful use based on
currently available technology
capabilities and provider practice
experience, and builds up to a more
robust definition of meaningful use as
technology and capabilities evolve. The
HITECH Act acknowledges the need for
this balance by granting the Secretary
the discretion to require more stringent
measures of meaningful use over time.
Ultimately, consistent with other
provisions of law, meaningful use of
CEHRT should result in health care that
is patient centered, evidence-based,
prevention-oriented, efficient, and
equitable.
As stated in the Stage 2 final rule (77
FR 53973), we anticipated the Stage 3
criteria for meaningful use would focus
on promoting improvements in quality,
efficiency, and safety leading to
improved health outcomes. We also
anticipated that Stage 3 would focus on
clinical decision support for national
high priority conditions; improving
patient access to self-management tools;
improving access to comprehensive
patient data through robust, secure,
patient-centered health information
exchange; and improvements in
population health.
For this Stage 3 proposed rule, we
seek to streamline the criteria for
meaningful use. We intend to do this
by—
• Creating a single stage of
meaningful use objectives and measures
(Stage 3), which would be optional for
all providers in 2017 and mandatory for
all providers in 2018;
• Allowing providers flexible options
for 2017;
• Changing the EHR reporting period
to a full calendar year for all providers;
and
• Aligning with other CMS quality
reporting programs using certified
health IT such as PQRS and Hospital
IQR for clinical quality measurement.
(a) Meaningful Use Stages
Under the phased approach to
meaningful use, we updated 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 under Stages 1 and 2,
including the recent final rule extending
Stage 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 is
outlined in Table 2.
TABLE 2—STAGE OF MEANINGFUL USE CRITERIA BY FIRST PAYMENT YEAR
Stage of meaningful use
First payment year
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2011
2011
2012
2013
2014
2015
2016
2017
...........................
...........................
...........................
...........................
...........................
...........................
...........................
2012
2013
2014
2015
2016
1
..............
..............
..............
..............
..............
..............
1
1
..............
..............
..............
..............
..............
1
1
1
..............
..............
..............
..............
* 1 or 2
* 1 or 2
*1
*1
..............
..............
..............
2
2
2
1
1
..............
..............
2
2
2
2
1
1
..............
2017
2018
3
3
3
2
2
1
1
2019
3
3
3
3
2
2
1
TBD
TBD
TBD
3
3
2
2
2020
TBD
TBD
TBD
TBD
3
3
2
2021
TBD
TBD
TBD
TBD
TBD
3
3
* 3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at Stage option) for Medicaid
EPs. All providers in the first year in 2014 use any continuous 90-day EHR reporting period.
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In the Stage 2 final rule (77 FR 53974),
we also stated that we would indicate in
future rulemaking our intent for the
potential development of stages or
further criteria beyond Stage 3. In this
proposed rule, we intend for Stage 3 to
be the final stage in meaningful use and
that no further stages would be
developed. However, we understand
that multiple technological and clinical
care standard changes associated with
EHR technology may result in the need
to consider changes to the objectives
and measures of meaningful use under
the EHR Incentive Programs.
Accordingly, we note that, as
circumstances warrant, we would
consider addressing such changes in
future rulemaking.
As shown in Table 2, providers in any
given year may be participating in 1 of
3 different stages of the EHR Incentive
Programs in addition to other CMS
quality reporting programs using
certified health IT such as PQRS and
Hospital IQR. Through listening
sessions, correspondence, and public
comment forums, providers expressed
frustration regarding the competing
reporting requirements of multiple CMS
programs, and the overall challenge of
planning and reporting on the complex
and numerous meaningful use
requirements, including the need to
manage changing processes, workflows,
and reporting systems. In addition,
group practices with EPs in different
stages of meaningful use have to
simultaneously support multiple stages
of the program in order to demonstrate
meaningful use for each EP. Meanwhile,
if the current 3-stage framework
continues, HHS and state systems
would be required to support all 3
stages of the EHR Incentive Programs in
perpetuity with extensive
implementation of complex processes to
accept submissions, analyze data, and
coordinate systems.
Providers have expressed ongoing
concern that the EHR Incentive
Programs are complicated, not focused
on clinical reality and workflow, and
stifling to innovation in health IT
development. Specifically, providers
have expressed concerns about the
number of Stage 1 and 2 objectives and
measures becoming obsolete or lacking
any link to improving outcomes. In
addition, providers have expressed
concern that continued focus on Stage 1
measures impedes current and potential
future innovation in advanced
utilization of health information
technology. Providers worry that Stage 3
of meaningful use would exacerbate
these existing concerns.
The certified EHR technology
requirements within the EHR Incentive
Programs and included in ONC’s Health
IT Certification Program have resulted
in considerable increases in certified
EHR technology adoption among
providers and are paving the way for
more comprehensive, patient-centered
care across the care continuum. We
recognize that while these
advancements have been beneficial
there are concerns, as stated previously,
that require careful examination to
ensure the sustainability and efficacy of
the program going forward—as HHS
moves to further encourage new uses of
health IT and support the developing
health IT infrastructure beyond the
strides already made. Therefore, we seek
to set a new foundation for this evolving
program by proposing a number of
changes to meaningful use. First, we
propose a definition of meaningful use
that would apply beginning in 2017.
This definition of meaningful use,
although referred to as ‘‘Stage 3’’, would
be the only definition for the Medicare
and Medicaid EHR Incentive Programs,
and would incorporate certain
requirements and aspects of Stages 1
and 2. Beginning with 2018, we propose
to require all EPs, eligible hospitals, and
CAHs, regardless of their prior
participation in the EHR Incentive
Program, to satisfy the requirements,
objectives, and measures of Stage 3.
However, for 2017, we propose that
Stage 3 would be optional for providers.
This option would allow for a provider
to move on to Stage 3 in 2017 or remain
at Stage 2, or for some providers to
remain at Stage 1, depending on their
participation timeline. For example,
under this proposal, a provider in Stage
2 in 2016 could choose to remain in
Stage 2 in 2017 or progress to Stage 3.
In contrast to our rulemaking in 2014 to
accommodate the use of multiple
Editions to meet the definitions of
CEHRT during the EHR reporting
periods in that year, this policy is based
on the provider selection of the
objectives and measures for their
demonstration of meaningful use in
2017. Both the EHR technology certified
to the 2014 Edition and the EHR
technology certified to the 2015 Edition
will support attestations for Stage 1 or
Stage 2 in 2017. In addition, the
development and certification process
for EHR technology products is not
dependent on this selection by
individual providers. Therefore, we do
not expect that this policy would affect
the availability of EHR technology
certified to the 2015 Edition in 2017 or
the ability of an individual provider to
implement EHR technology certified to
the 2015 Edition during the year
regardless of which stage they choose
for their EHR reporting period in 2017.
Therefore, we are proposing in section
II.A.2.b. that all providers would be
required to use EHR technology certified
to the 2015 Edition for a full calendar
year for the EHR reporting period in
2018. The revised timeline based on
these proposals is outlined in Table 3.
TABLE 3—STAGE OF MEANINGFUL USE CRITERIA BY FIRST YEAR
Stage of meaningful use
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First year as a
meaningful EHR user
2011
2012
2013
2014
2015
2016
2017
2018
.........................................
.........................................
.........................................
.........................................
.........................................
.........................................
.........................................
and future years ..............
2011
2012
2013
2014
2015
2016
2017
1
............
............
............
............
............
............
............
1
1
............
............
............
............
............
............
1
1
1
............
............
............
............
............
*2
*2
1
1
............
............
............
............
2
2
2
1
1
............
............
............
2
2
2
2
1
1
............
............
2 or 3
2 or 3
2 or 3
2 or 3
1, 2 or 3
1, 2 or 3
1, 2 or 3
..............
2018
2019
3
3
3
3
3
3
3
3
2021
and future
years
2020
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
* Please note, a provider scheduled to participate in Stage 2 in 2014, who instead elected to demonstrate stage 1 because of delays in availability of EHR technology certified to the 2014 Edition, is still considered a stage 2 provider in 2014 despite the alternate demonstration of meaningful use. In 2015, all such providers are considered to be participating in their second year of Stage 2 of meaningful use.
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Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules
Please note that the Medicare EHR
Incentive Program and the Medicaid
EHR Incentive Program have different
rules regarding the number of payment
years available, the last year for which
incentive payments may be received,
and the last year to initiate the program
and receive an incentive payment.
Medicaid EPs and eligible hospitals can
receive a Medicaid EHR incentive
payment for ‘‘adopting, implementing,
and upgrading’’ (AIU) to Certified EHR
Technology for their first payment year,
which is not reflected in Table 3. The
applicable payment years and the
incentive payments available for each
program are discussed in the Stage 1
final rule (75 FR 44318 through 44320).
Although Table 3 outlines a provider’s
progression through the stages of
meaningful use, it does not necessarily
reflect the relation to incentive
payments in the Medicare or Medicaid
EHR Incentive Programs. We note that
some providers may not ever qualify to
receive an incentive payment depending
on, among other factors, when and
whether they successfully demonstrate
meaningful use in the EHR Incentive
Programs. We intend for the timeline in
Table 3 to also apply to those EPs,
eligible hospitals, and CAHs that never
receive an incentive payment under the
EHR Incentive Programs.
We are further proposing that Stage 3
would adopt a simplified reporting
structure on a focused set of objectives
and associated measures to replace all
criteria under Stages 1 and 2.
Specifically, we are proposing criteria
for meaningful use for EPs, eligible
hospitals, and CAHs (optional in 2017
and mandatory beginning in 2018),
regardless of a provider’s prior
participation in the Medicare and
Medicaid EHR Incentive Programs, as
described in detail in section II.A.1.c. of
this proposed rule. We believe that a
single set of objectives would reduce
provider burden and allow for greater
focus on improving outcomes,
enhancing interoperability, and
increasing patient engagement. In
addition, with all providers
participating at the same level, the
impact of the scale of participation
helps to support growth in health
information exchange and patient
engagement infrastructure, as more
providers participate the ease of
participation increases. Finally, the
associated measures proposed for Stage
3 in this proposed rule would use
advanced EHR functionality and ITbased processes. The requirements,
objectives, and measures are outlined
further in sections II.A.1.c.(2). of this
proposed rule. In order to maintain
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clarity in relation to the various rules
and stages, provisions outlined in the
Stage 1 or Stage 2 final rules, and
proposals under this Stage 3 proposed
rule, we will maintain the ‘‘Stage’’
designation in order to indicate the rule
that contains the provision. The
requirements, objectives, and measures
proposed as part of this proposed
definition of meaningful use would be
referred to as ‘‘Stage 3’’.
We welcome public comment on
these proposals.
(b) EHR Reporting Period
In the Stage 1 and Stage 2 final rules,
we established that the EHR reporting
period for eligible hospitals and CAHs
is based on the federal fiscal year
(October 1 through September 30). This
fiscal year EHR reporting period
originally was designed to support
coordination between program
implementation and CMS payment
systems following the development of
the EHR Incentive Programs in 2010 to
allow for efficient payment of incentives
for eligible hospitals and CAHs.
However, as the EHR Incentive Program
evolved, we found the fiscal year EHR
reporting period resulted in varying
reporting timelines between provider
types (for example, the EHR reporting
period for EPs is based on the calendar
year) and a shortened timeline for
system developers to meet hospital and
CAH technology requirements.
Enhanced coordination between CMS
programs and other system
implementation changes have
subsequently made it unnecessary to
maintain a reporting timeframe for
eligible hospitals and CAHs based on
the federal fiscal year. Therefore, we are
proposing changes to the EHR reporting
period beginning with the EHR
reporting period in 2017 in order to do
all of the following:
• Simplify reporting for providers,
especially groups and diverse systems.
• Support further alignment of CMS
quality reporting programs using
certified health IT such as Hospital IQR
and PQRS.
• Simplify HHS system requirements
for data capture.
• Provide for greater flexibility, stress
testing, and Quality Assurance (QA) of
systems before deployment.
In the FY 2015 IPPS final rule (79 FR
49853 through 50449), we aligned the
reporting and submission timelines for
CQMs for the Medicare EHR Incentive
Programs for eligible hospitals and
CAHs with the reporting and
submission timelines for the Hospital
IQR Program on a calendar year basis.
This was designed to allow for better
alignment between these programs in
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16739
light of the directive in section
1886(n)(3)(B)(iii) of the Act to avoid
redundant or duplicative reporting.
Calendar year reporting on quality data
for hospitals allows for greater
efficiency in measure development, the
electronic specification of measures,
and the update and deployment of
measure logic and value sets for
electronic clinical quality measures. The
FY 2014 IPPS final rule (78 FR 50904)
clarified that eligible hospitals and
CAHs demonstrating meaningful use for
the first time in FY 2014 and reporting
on CQMs electronically must report on
a 3-month quarter in FY 2014, rather
than on a continuous 90-day period.
Such changes not only better align
program reporting but also allow for
better data integrity as previously
discussed in the Stage 2 final rule (77
FR 53974 through 53975) and further
discussed in section II.B.1.b. of this
proposed rule.
(i) Calendar Year Reporting
We are proposing to change the
definitions of ‘‘EHR reporting period’’
and ‘‘EHR reporting period for a
payment adjustment year’’ under § 495.4
for EPs, eligible hospitals, and CAHs
such that the EHR reporting period
would be one full calendar year, with a
limited exception under the Medicaid
EHR Incentive Program for providers
demonstrating meaningful use for the
first time as discussed later in this
section and in section II.A.2.b. of this
proposed rule. This would allow for the
full alignment of the EHR reporting
timeline for the meaningful use
objectives and associated measures and
the CQMs, and align the timing of
reporting by EPs, eligible hospitals, and
CAHs. We propose this change would
apply beginning in CY 2017. For
example, for the incentive payments for
the 2017 payment year, the EHR
reporting period for EPs, eligible
hospitals, and CAHs would be the full
2017 calendar year. We note that the
incentive payments under Medicare FFS
and Medicare Advantage (MA) (sections
1848(o), 1886(n), 1814(l)(3), 1853(l) and
(m) of the Act) will end before 2017.
However, under this proposed change,
EPs and eligible hospitals that seek to
qualify for an incentive payment under
Medicaid would have a full calendar
year EHR reporting period if they are
not demonstrating meaningful use for
the first time. For the payment
adjustments under Medicare, we discuss
the timing of the EHR reporting period
in relation to the payment adjustment
year in section II.D.2. of this proposed
rule.
This proposal would mean that
eligible hospitals and CAHs would have
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a reporting gap for the objectives and
measures of meaningful use consisting
of the 3-month quarter from October 1,
2016 through December 31, 2016.
Depending on future rulemaking,
eligible hospitals and CAHs may still be
required to report on CQMs over this
time. The next EHR reporting period for
eligible hospitals and CAHs to collect
data on the objectives and measures of
meaningful use would then begin on
January 1, 2017 and end on December
31, 2017. Eligible hospitals and CAHs
would then report on a full calendar
year basis from that point forward.
(ii) Eliminate 90-Day EHR Reporting
Period
We are further proposing to eliminate
the 90-day EHR reporting period for
new meaningful EHR users beginning in
2017, with a limited exception for
Medicaid EPs and eligible hospitals
demonstrating meaningful use for the
first time. This would allow for a single
EHR reporting period of a full calendar
year for all providers across all settings.
Specifically, we propose to eliminate
the EHR reporting period of any
continuous 90 days for EPs, eligible
hospitals, and CAHs that are
demonstrating meaningful use for the
first time. Those providers instead
would have an EHR reporting period of
a full calendar year, as described
previously. However, as discussed in
section II.A.2.b. of this proposed rule,
we propose to maintain the 90-day EHR
reporting period for a provider’s first
payment year based on meaningful use
for EPs and eligible hospitals
participating in the Medicaid EHR
Incentive Program. We propose
corresponding revisions to the
definitions of ‘‘EHR reporting period’’
and ‘‘EHR reporting period for a
payment adjustment year’’ under
§ 495.4. We propose these changes
would apply beginning in CY 2017.
As stated previously, all providers
would attest based on a single EHR
reporting period consisting of one full
calendar year for the applicable
objectives and measures of meaningful
use in 2017 and subsequent years. These
providers would submit their data in the
2 months following the close of the EHR
reporting period. For further
information on the submission methods,
see section II.D.9.b. of this proposed
rule.
We welcome public comment on
these proposals.
(iii) State Flexibility for Stage 3 of
Meaningful Use
Consistent with our approach under
both Stage 1 and 2, we propose to
continue to offer states flexibility under
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the Medicaid EHR Incentive Program in
Stage 3 by adding a new provision at
§ 495.316(d)(2)(iii) subject to the same
conditions and standards as the Stage 2
flexibility policy. Under Stage 3, state
flexibility would apply only with
respect to the public health and clinical
data registry reporting objective
outlined under section II.A.1.c.(1).(b).(i).
of this proposed rule.
For Stage 3 of meaningful use, we
would continue to allow states to
specify the means of transmission of the
data and otherwise change the public
health agency reporting objective as
long as it does not require functionality
greater than what is required for Stage
3 and included in the 2015 Edition
proposed rule elsewhere in this issue of
the Federal Register.
We welcome comment on this
proposal.
(2) Criteria for Meaningful Use Stage 3
In the Stage 1 and Stage 2 final rules,
meaningful use included the concept of
a core and a menu set of objectives.
Each objective had associated measures
that a provider needed to meet as part
of demonstrating meaningful use of
CEHRT. In Stage 2 of meaningful use,
we also combined some of the objectives
of Stage 1 and incorporated them into
objectives for Stage 2. For example, we
combined the objectives of maintaining
an up-to-date problem list, active
medication list, and active medication
allergy list with the objective of
providing a summary of care record for
each transition of care or referral
through required fields in the summary
of care document (77 FR 53990 through
53991 and 77 FR 54013 through 54016).
We did this to allow for the more
advanced use of EHR technology
functions to support clinical processes,
and to eliminate the need for providers
to individually report on measures that
were often already incorporated in
workflows and for which many
providers were already meeting the
threshold (known as ‘‘topping out’’). In
the Stage 2 final rule (77 FR 53973), we
signaled that the Stage 2 core and menu
objectives would all be included in the
Stage 3 proposal for meaningful use.
Since the publication of the Stage 2
final rule, we have reviewed meaningful
use performance from both a qualitative
and quantitative perspective including
analyzing performance rates, reviewing
CEHRT functionalities and standards,
and considering information gained by
engaging with providers through
listening sessions, correspondence, and
open forums like the HIT Policy
Committee. The data support a number
of key points for consideration:
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• Providers are performing higher
than the thresholds for some of the
meaningful use measures using some
EHR functionalities that—prior to the
Stage 1 and Stage 2 final rules—were
not common place (such as the
maintenance of problem lists).
• Providers in different specialties
and settings implemented CEHRT and
met objectives in different ways.
• Providers express support for
reducing the reporting burden on
measures that have ‘‘topped out.’’
• Providers expressed support for
advanced functionality that would offer
value to providers and patients.
• Providers expressed support for
flexibility regarding how objectives are
implemented in their practice settings.
• Providers in health systems and
large group practices expressed
frustration about the reporting burden of
having to compile multiple reports
spanning multiple stages and objectives.
Since the EHR Incentive Programs
began in 2011, stakeholder associations
and providers have requested that we
consider changes to the number of
objectives and measures that providers
must meet to demonstrate meaningful
use of certified EHR technology under
the EHR Incentive Programs. These
recommendations also extended to
considerations for the structure of Stage
3 of meaningful use. Many of these
recommendations include allowing a
provider to fail any two objectives (in
effect making all objectives ‘‘menu’’
objectives) and still meet meaningful
use, or to allow providers to receive an
incentive payment or avoid a downward
payment adjustment based on varied
percentages of performance, and
removing all measure thresholds. We
have reviewed these recommendations
and have declined to follow this course
for a number of reasons.
First, the statute specifically 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, for example,
section 1848(o)(2)(A)(iii) of the Act).
This is one reason why we established
stages of meaningful use to move
providers along a progression from
adoption to advanced use of certified
EHR technology. Therefore, we intend
to continue to use measure thresholds
that may increase over time, and to
incorporate advanced use functions of
certified EHR technology into
meaningful use objectives and
measures.
Second, there are certain objectives
and measures which capture policies
specifically required by the statute as
core goals of meaningful use of certified
EHR technology, such as electronic
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prescribing for EPs, health information
exchange, and clinical quality
measurement (see sections 1848(o)(2)(A)
and 1886(n)(3)(A) of the Act). Specific
to the health information exchange, the
statute requires certified EHR
technology connected in a manner that
provides for the electronic exchange of
health information to improve the
quality of health care, such as
promoting care coordination.
Further, the statute requires that the
certified EHR technology which
providers must use shall be a ‘‘qualified
EHR’’ as defined in section 3000(13) of
the Public Health Service Act as an
electronic record of health-related
information on an individual that
includes patient demographic and
clinical health information, such as
medical history and problem lists; and
has the capacity to—
• Provide clinical decision support;
• Support physician order entry;
• Capture and query information
relevant to health care quality; and
• Exchange electronic health
information with, and integrate such
information from, other sources (see
section 1848(o)(4) of the Act).
The objectives that address these
requirements are integral to the
foundational goals of the program,
which would be undermined if
providers were allowed to fail to meet
these objectives and still be considered
meaningful EHR users. For these
reasons, we intend to continue to
require providers to meet the objectives
and measures of meaningful use as
required for the program, rather than
allowing providers to fail any two
objectives of their choice or making all
objectives menu objectives.
Finally, while we understand
providers are seeking to reduce the
overall burden of reporting, we do not
believe these recommendations
accomplish that goal. Adding all
objectives and measures to the menu set
and allowing for varying degrees of
participation may add complexity for
the individual provider seeking to
determine how they can meet the
requirements and demonstrate
meaningful use of certified EHR
technology. We instead are proposing
(as discussed in sections II.A.1. and II.B.
of this proposed rule) to reduce provider
burden and simplify the program by
aligning reporting periods and CQM
reporting. In addition, the statute
provides that in selecting measures for
the EHR Incentive Program, the
Secretary shall seek to avoid redundant
or duplicative reporting otherwise
required, including reporting under the
PQRS and Hospital IQR Program (see
sections 1848(o)(2)(B)(iii) and
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1886(n)(3)(B)(iii) of the Act). Although
the statute refers to redundant or
duplicative reporting in the context of
other CMS quality reporting programs,
we believe it is also useful and
appropriate to consider whether there
are redundant or duplicative aspects of
the objectives and measures of Stages 1
and 2 of meaningful use as we develop
policies for Stage 3.
To that end, we have analyzed the
objectives and measures of meaningful
use in Stage 1 and Stage 2 of the
program to determine where measures
are redundant, duplicative, or have
‘‘topped out.’’ ‘‘Topped out’’ is the term
used to describe measures that have
achieved widespread adoption at a high
rate of performance and no longer
represent a basis upon which provider
performance may be differentiated. We
considered redundant objectives and
measures to include those where a
viable health IT-based solution may
replace paper-based actions, such as the
Stage 2 Clinical Summary objective (77
FR 54001 and 54002). We considered
duplicative objectives and measures to
include those where some aspect is also
captured in the course of meeting
another objective or measure, such as
recording vital signs which is also
required as part of the summary of care
document under the Stage 2 Summary
of Care objective (77 FR 54013 through
54021). Finally, measures which have
‘‘topped out’’ 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 as directed
in the statute (see section
1848(o)(2)(A)(iii) of the Act). For further
discussion of ‘‘topped out’’ measures,
we direct readers to section II.A.2.a. of
this proposed rule.
Therefore, our proposals for Stage 3
would continue the precedent of
focusing on the advanced use of
certified EHR technology. They would
reduce the reporting burden; eliminate
measures that are now redundant,
duplicative, and ‘‘topped out’’; create a
single set of objectives for all providers
with limited variation between EPs,
eligible hospitals, and CAHs as
necessary; and provide flexibility within
the objectives to allow providers to
focus on implementations that support
their practice.
(a) Topped Out Objectives and Measures
In other contexts and CMS programs,
CQMs are regularly evaluated to
determine whether they have ‘‘topped
out,’’ which means generally that
measure performance among providers
is so high and unvarying that
meaningful distinctions and
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16741
improvements in performance can no
longer be made. Examples of this type
of evaluation are found in the Hospital
Inpatient Quality Reporting (IQR)
program, the Hospital-Value Based
Purchasing (HVBP) program, the EndStage Renal Disease (ESRD) Quality
Initiative, and within the National
Quality Forum (NQF) endorsement and
maintenance process for CQMs. We
believe that quality measures, once
‘‘topped-out,’’ represent care standards
that have been widely adopted. We
believe such measures should be
considered for removal from program
reporting because their associated
reporting burden may outweigh the
value of the quality information they
provide and because, in some cases, the
inclusion of these measures may impact
the ability to differentiate among
provider performance as a whole for
programs which use baseline and
benchmarking based on measure
performance scores. Therefore,
measures are regularly subject to an
evaluation process to identify their
continued efficacy. This evaluation
process is used to determine whether a
measure is ‘‘topped out’’ and, if so,
whether that measure should be
removed from program reporting
requirements. We note that both the
identification and the determination of
a measure are part of the process as a
measure may be identified as topped
out, but still be determined useful as a
measure for a specific program because
of other factors that merit continued use
of the measure.
While the EHR Incentive Program
does not use a benchmarking system to
rate the overall and relative performance
of providers as part of the definitions of
meaningful use; we are proposing to
adopt an approach to evaluate whether
objectives and measures have become
‘‘topped out’’ and, if so, whether a
particular objective or measure should
be considered for removal from
reporting requirements. We propose to
apply the following two criteria, which
are similar to the criteria used in the
Hospital IQR and HVBP Programs (79
FR 50203): 1—Statistically
indistinguishable performance at the
75th and 99th percentile, and 2—
performance distribution curves at the
25th, 50th, and 75th percentiles as
compared to the required measure
threshold.
An example of a current Stage 1
objective which would be considered
‘‘topped out’’ under this approach is the
objective to record demographics (75 FR
44340 through 44343). For the record
demographics objective, we reviewed
performance data submitted by
providers through attestation and
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determined that across all years of
participation, the 75th percentile is
performing at 99.8 percent with the 99th
percentile performing at 100 percent. In
addition, the 25th, 50th, and 75th
percentiles are all performing with
minimal variance and significantly
higher than the measure threshold of 50
percent, with performance rates at 97
percent, 99 percent, and 100 percent
respectively for eligible hospitals and 92
percent, 98 percent and 100 percent
respectively for EPs in Stage 1.1 For
more information on the performance
data, please see the EHR Incentive
Programs Objective and Measure
Performance Report by Percentile
available at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/
DataAndReports.html. We further note
that this particular objective may also be
considered duplicative as further
discussed in section II.A.2.c. of this
proposed rule, as the functionality
which supports the objective within the
EHR is also used in other objectives
such as the objective to provide patientspecific education resources (77 FR
54011 through 54012) and the Stage 2
summary of care objective (77 FR 54013
through 54021). Therefore, this is an
example of an objective that we
determined is topped out and may no
longer provide value as an independent
objective in the program.
We welcome public comments on our
proposed approach for topped out
objectives and measures.
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(b) Electronic Versus Paper-Based
Objectives and Measures
In Stages 1 and 2, we require or allow
providers the option to include paperbased formats for certain objectives and
measures. For these objectives and
measures, providers would print, fax,
mail, or otherwise produce a paper
document and manually count these
actions to include in the measure
calculation. Examples of these include:
The provision of a non-electronic
summary of care document for a
transition or referral to meet the
measure at § 495.6(j)(14)(i) for EPs and
for eligible hospitals and CAHs
at§ 495.6(l)(11)(i): ‘‘The [provider] who
transitions or refers their patient to
another setting of care or provider of
care provides a summary of care record
for more than 50 percent of transitions
of care and referrals;’’ and the provision
of paper-based patient education
materials measure for at § 495.6(j)(12)(i)
1 Data may be found on the CMS Web site data
and program reports page: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html.
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for EPs and § 495.6(l)(9)(i) requiring:
‘‘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 [or
discharged from the eligible hospital or
CAH] during the EHR reporting period.’’
Each of these measures may be met
using a non-electronic format or action,
and we propose to discontinue this
policy for Stage 3. We recognize the
strides that providers have made in the
use of CEHRT and as we move forward
in MU, it is appropriate to remove the
earlier iterations of objectives and
measures that were designed to support
beginning EHR use and instead focus on
objectives that are based solely on
electronic use of data. This does not
imply that we do not support the
continued use of paper-based materials
in a practice setting. Some patients may
prefer to receive a paper version of their
clinical summary or may want to
receive education items or reminders on
paper or some other method that is not
electronic. We strongly recommend that
providers continue to provide patients
with visit summaries, patient health
information, and preventative care
recommendations in the format that is
most relevant for each individual
patient and easiest for that patient to
access. In some cases, this may include
the continued use of non-IT-based
resources. We are simply proposing that
paper-based formats would not be
required or allowed for the purposes of
the objectives and measures for Stage 3
of meaningful use. We welcome public
comments on this proposal.
(c) Advanced EHR Functions
As discussed in section II.A.1.c.(2).(a).
of this proposed rule, we are proposing
to simplify requirements for meaningful
use through an analysis of existing
objectives and measures for Stages 1 and
2 to determine if they are redundant,
duplicative, or ‘‘topped out’’. We note
that some of the objectives and
measures which meet these criteria
involve EHR functions that are required
by the statutory definition of ‘‘certified
EHR technology’’ (see section 1848(o)(4)
of the Act, which references the
definition of ‘‘qualified EHR’’ in section
3000(13) of the Public Health Service
Act) which a provider must use to
demonstrate meaningful use. The
objectives and measures proposed for
Stage 3 would include uses of these
functions in a more advanced form. For
example, patient demographic
information is included in an electronic
summary of care document called a
consolidated clinical document
architecture (CCDA) provided during a
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transition of care in the Stage 2
Summary of Care objective and
measures (77 FR 54013 through 54021),
which represents a more advanced use
of the EHR function than in the Stage 1
and 2 objective to record patient
demographic information (77 FR 53991
through 53993).
We adopted a multi-part approach to
identify the objectives and measures
which would be proposed for providers
to demonstrate meaningful use for Stage
3. This methodology included the
analysis mentioned previously of
existing Stage 1 and 2 objectives and
measures, and provider performance; a
review and consideration of the HIT
Policy Committee recommendations
(which are publically available for
review at: https://www.healthit.gov/
facas/health-it-policy-committee/healthit-policy-committee-recommendationsnational-coordinator-health-it); and an
evaluation of how the potential
objectives and measures align with the
foundational goals of the program
defined in the HITECH Act.
In the Stage 2 proposed and final
rules, we often identified the HIT Policy
Committee recommendations as part of
our discussion of the specific objectives
and measures, for example in the Stage
2 CPOE objective at 77 FR 43985. In this
proposed rule for Stage 3 of meaningful
use, although we have considered the
HIT Policy Committee’s
recommendations in developing our
proposed policies, we are not
referencing the recommendations in
each individual proposed objective and
measure as there are multiple factors
that contribute to the selection of each
proposed objective and measure. In
addition, many of the HIT Policy
Committee recommendations address
functions and standards that are part of
the advanced use of certified EHR
technology captured by one or more
objectives proposed for Stage 3 of
meaningful use. For example, the HIT
Policy Committee has recommended an
expansion of demographic data
captured as structured data as well as a
change to the related standards for use.
However, this function and standard is
required for certification of EHR
technology for meaningful use and it is
a required field for an electronic
summary of care document for health
information exchange. It is also to be
included in the information accessible
to a patient within their electronic
patient record. Therefore, to provide
clarity for readers, we provide a
notation within Table 4 to identify
alignment between the proposed Stage 3
objectives and measures and the
recommendations of the HIT Policy
Committee for Stage 3 of meaningful
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use. We direct readers to the HIT Policy
Committee recommendations available
on HealthIT.gov for further information
(https://www.healthit.gov/facas/health-itpolicy-committee/health-it-policycommittee-recommendations-nationalcoordinator-health-it).
As mentioned previously, the statute
includes certain foundational goals and
requirements for meaningful use of
certified EHR technology and the
functions of that technology. Therefore,
after review of the existing Stage 1 and
Stage 2 objectives and measures of
meaningful use, the recommendations
of the HIT Policy Committee, and the
foundational goals and requirements
under the HITECH Act; we have
identified eight key policy areas which
represent the advanced use of EHR
16743
technology and align with the program’s
foundational goals and overall national
health care improvement goals, such as
those found in the CMS National
Quality Strategy.2 These eight policy
areas provide the basis for the proposed
objectives and measures for Stage 3 of
meaningful use. They are included in
Table 4 as follows:
TABLE 4—OBJECTIVES AND MEASURES FOR MEANINGFUL USE IN 2017 AND SUBSEQUENT YEARS
Program goal/objective
Delivery system reform goal alignment
Protect Patient Health Information ...........................................................
Electronic Prescribing (eRx) .....................................................................
Clinical Decision Support (CDS) ..............................................................
Computerized Provider Order Entry (CPOE) ...........................................
Patient Electronic Access to Health Information ......................................
Coordination of Care through Patient Engagement .................................
Health Information Exchange (HIE) .........................................................
Public Health and Clinical Data Registry Reporting ................................
Foundational to Meaningful Use and Certified EHR Technology *.
Recommended by HIT Policy Committee.
Foundational to Meaningful Use.
National Quality Strategy Alignment.
Foundational to Certified EHR Technology.
Recommended by HIT Policy Committee.
National Quality Strategy Alignment.
Foundational to Certified EHR Technology.
National Quality Strategy Alignment.
Recommended by HIT Policy Committee.
National Quality Strategy Alignment.
Recommended by HIT Policy Committee.
National Quality Strategy Alignment.
Foundational to Meaningful Use and Certified EHR Technology.
Recommended by HIT Policy Committee.
National Quality Strategy Alignment.
Recommended by HIT Policy Committee.
National Quality Strategy Alignment.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
* See, for example, sections 1848(o)(2) and (4) of the Act.
These objectives build on the measures
and EHR functionalities from the Stage
1 final rule and the Stage 2 final rule to
advance the core functions of EHRs in
a clinically relevant way that benefits
providers and patients.
Under this proposal, which would
apply to Stage 3 of meaningful use in
2017 and subsequent years, providers
must successfully attest to these eight
objectives and the associated measures
(or meet the exclusion criteria for the
applicable measure). As mentioned
previously, 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). While we
are proposing to simplify the program
by removing topped-out, redundant, and
duplicative measures and aligning
reporting periods for providers; we are
maintaining the push to improve the use
of EHRs over time through these eight
objectives and the associated measures
proposed for Stage 3 of meaningful use.
These proposed objectives and measures
include advanced EHR functions, use a
wide range of structured standards in
CEHRT, employ increased thresholds
over similar Stage 1 and 2 measures,
support more complex clinical and care
coordination processes, and require
enhanced care coordination through
patient engagement through a flexibility
structure of active engagement
measures.
These proposed objectives and their
associated measures are further
discussed in section II.A.1.(c).(2). of this
proposed rule. CMS and ONC will
continue to monitor and review
performance on the objectives and
measures finalized for Stage 3 to
continue to evaluate them for rigor and
efficacy and, if necessary, propose
changes in future rulemaking.
(d) Flexibility Within Meaningful Use
Objectives and Measures
We are proposing to incorporate
flexibility within certain objectives
proposed for Stage 3 for providers to
choose the measures most relevant to
their unique practice setting. This
means that as part of successfully
demonstrating meaningful use,
providers would be required to attest to
the results for the numerators and
denominators of all measures associated
with an objective; however, a provider
would only need to meet the thresholds
for two of the three associated measures.
The proposed Stage 3 objectives
including flexible measure options are
as follows:
• Coordination of Care through
Patient Engagement—Providers must
meet the thresholds of two of three
measures and must attest to the
numerators and denominators of all
three measures.
• Health Information Exchange—
Providers must meet the thresholds of
two of three measures and must attest to
the numerators and denominators of all
three measures.
• Public Health Reporting—EPs must
report on three measures and eligible
hospitals and CAHs must report on four
measures.
We propose that if a provider meets
the exclusion criteria for a particular
measure within an objective which
allows providers to meet the thresholds
for two of three measures (namely, the
Coordination of Care through Patient
Engagement objective and the Health
Information Exchange objective), the
provider may exclude the measure and
must meet the thresholds of the
remaining two measures to meet the
2 The National Quality Strategy: ‘‘HHS National
Strategy for Quality Improvement in Health Care’’
https://www.ahrq.gov/workingforquality/about.htm.
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objective. If a provider meets the
exclusion criteria for two measures for
such an objective, the provider may
exclude those measures and must meet
the threshold of the remaining measure
to meet the objective. If a provider meets
the exclusion criteria for all three
measures for such an objective, the
provider may exclude those measures
and would be considered to have met
the objective.
We discuss the proposed policy for
exclusions for the public health
reporting objective as well as the
exclusion criteria in further detail
within the individual objectives and
measures in section II.A.1.(c).(2). of this
proposed rule.
(e) EPs Practicing in Multiple Practices/
Locations
For Stage 3, we propose to maintain
the policy from the Stage 2 final rule (77
FR 53981) which states that to be a
meaningful user, an EP must have 50
percent or more of his or her outpatient
encounters during the EHR reporting
period at a practice/location or
practices/locations equipped with
CEHRT. An EP who does not conduct at
least 50 percent of their patient
encounters in any one practice/location
would have to meet the 50 percent
threshold through a combination of
practices/locations equipped with
CEHRT. For example, if the EP practices
at a federally qualified health center
(FQHC) and within his or her individual
practice at two different locations, we
would include in our review all three of
these locations, and CEHRT would have
to be available at one location or a
combination of locations where the EP
has 50 percent or more of his or her
patient encounters. If CEHRT is only
available at one location, then only
encounters at this location would be
included in meaningful use assuming
this one location represents 50 percent
or more of the EP’s patient encounters.
If CEHRT is available at multiple
locations that collectively represent 50
percent or more of the EP’s patient
encounters, then all encounters from
those locations would be included in
meaningful use. In the Stage 2 final rule
at (77 FR 53981), we defined patient
encounter as any encounter where a
medical treatment is provided or
evaluation and management services are
provided. This includes both
individually billed events and events
that are globally billed, but are separate
encounters under our definition.
In addition, in the Stage 2 final rule
at (77 FR 53981) we defined a practice/
location as equipped with CEHRT if the
record of the patient encounter that
occurs at that practice/location is
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created and maintained in CEHRT. This
can be accomplished in the following
three ways: CEHRT could be
permanently installed at the practice/
location, the EP could bring CEHRT to
the practice/location on a portable
computing device, or the EP could
access CEHRT remotely using
computing devices at the practice/
location. We propose to maintain these
definitions for Stage 3.
(f) Denominators
The objectives for Stage 3 of
meaningful use include percentagebased measures wherever possible. In
the Stage 2 final rule, we included a
discussion of the denominators used for
the program that included the use of one
of four denominators for each of the
measures associated with the
meaningful use objectives outlined in
the Stage 2 final rule at 77 FR 53982 for
EPs and 77 FR 53983 for eligible
hospitals and CAHs. We focused on
denominators because the action that
moves something from the denominator
to the numerator requires the use of
CEHRT by the provider. For Stage 3 we
refer readers to each of the proposed
objectives and measures for Stage 3 for
the specific calculation of each
denominator for each measure. Here, we
simply outline the general proposals for
determining the scope of the measure
denominators.
For EPs, the references used to define
the scope of the potential denominators
for measures include the following:
• Unique patients seen by the EP
during the EHR reporting period. The
scope for this calculation may be
limited to only those patients whose
records are maintained in the EHR for
the denominator of the measures for
objectives other than those referencing
‘‘unique patients’’ as previously
established in the Stage 2 final rule at
(77 FR 53981). We propose to maintain
the policy that EPs who practice at
multiple locations or switch CEHRT
during the EHR reporting period may
determine for themselves the method for
counting unique patients in the
denominators to count unique patient
across all locations equipped with
different CEHRT, or to count at each
location equipped with CEHRT. In cases
where a provider switches CEHRT
products at a single location during the
EHR reporting period, they also have the
flexibility to count a patient as unique
on each side of the switch and not
across it. EPs in these scenarios must
choose one of these methods for
counting unique patients and apply it
consistently throughout the entire EHR
reporting period.
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A patient is seen by the EP when the
EP has a real time physical encounter
with the patient in which they render
any service to the patient. We also
consider a patient seen through
telehealth as a patient ‘‘seen by the EP’’
(telehealth may include the commonly
known telemedicine as well as
telepsychiatry, telenursing, and other
diverse forms of technology-assisted
health care). However, in cases where
the EP and the patient do not have a real
time physical or telehealth encounter,
but the EP renders a consultative service
for the patient, such as reading an EKG,
virtual visits, or asynchronous
telehealth, the EP may choose whether
to include the patient in the
denominator as ‘‘seen by the EP.’’ This
is necessary so that these providers can
avoid reporting a zero in the
denominator and be able to satisfy
meaningful use. However, we stress that
once providers choose, they must
maintain that denominator choice for
the entire EHR reporting period and for
all relevant meaningful use measures.
• Office visits. The denominators of
the measures that reference ‘‘office
visits’’ may be limited to only those
patients whose records are maintained
using CEHRT. An office visit is defined
as any billable visit that includes the
following:
++ Concurrent care or transfer of care
visits,
++ Consultant visits, or
++ Prolonged physician service
without direct, face-to-face patient
contact (for example, telehealth).
• All medication, laboratory, and
diagnostic imaging orders created
during the reporting period
• Transitions of care and referrals
including at least—
++ When the EP is the recipient of the
transition or referral, the first encounter
with a new patient and encounters with
existing patients where a summary of
care record (of any type) is provided to
the receiving EP; and
++ When the EP is the initiator of the
transition or referral, transitions and
referrals ordered by the EP.
Transitions of care are the movement
of a patient from one setting of care to
another. Referrals are cases where one
provider refers a patient to another, but
the referring provider maintains their
care of the patient as well. For the
purposes of distinguishing settings of
care in determining the movement of a
patient, we propose that a transition or
referral may take place when a patient
is transitioned or referred between
providers with different billing
identities, such as a different National
Provider Identifier (NPI) or hospital
CMS Certification Number (CCN). We
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also propose that in the cases where a
provider has a patient who seeks out
and receives care from another provider
without a prior referral, the first
provider may include that transition as
a referral if the patient subsequently
identifies the other provider of care.
For further explanation of the terms
‘‘unique patient,’’ ‘‘seen by the EP,’’
‘‘office visit,’’ ‘‘transitions of care,’’ and
‘‘referrals,’’ we refer readers to the
discussion at 77 FR 53982 through
53983. For eligible hospitals and CAHs,
the references used to define the scope
of the potential denominators for
measures include the following:
• Unique patients admitted to the
eligible hospital’s or CAH’s inpatient or
emergency department during the EHR
reporting period.
• All medication, laboratory, and
diagnostic imaging orders created
during the reporting period.
• Transitions of care and referrals
including at least—
++ When the hospital is the recipient
of the transition or referral: all
admissions to the inpatient and
emergency departments; and
++ When the hospital is the initiator
of the transition or referral: all
discharges from the inpatient
department; and after admissions to the
emergency department when follow-up
care is ordered by an authorized
provider.
We propose that the explanation of
the terms ‘‘unique patients,’’
‘‘transitions of care,’’ and ‘‘referrals’’
stated previously for EPs would also
apply for eligible hospitals and CAHs,
and we refer readers to the discussion
of those terms in the hospital context in
the Stage 2 final rule (77 FR 53983 and
53984). We propose for Stage 3 to
maintain the policy that admissions
may be calculated using one of two
methods (the observation services
method and the all emergency
department method), as described for
Stage 2 at 77 FR 53984. The method an
eligible hospital or CAH chooses must
be used uniformly across all measures
for all objectives.
We reiterate that all discharges from
an inpatient setting are considered a
transition of care. We further propose
for transitions from an emergency
department, that eligible hospitals and
CAHs must count any discharge where
follow up care is ordered by an
authorized provider regardless of the
completeness of information available
on the receiving provider. The eligible
hospital or CAH should determine an
internal policy applicable for the
identification and capture of a patient’s
primary care provider or other relevant
care team members for the purposes of
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ordering potential follow-up care. This
will allow eligible hospitals and CAHs
to better differentiate between
discharges where care is ordered and
discharges to home where no follow up
care is ordered.
(g) Patient-Authorized Representatives
In the Stage 3 Coordination of Care
through Patient Engagement objective
and the Patient Electronic Access
objective outlined in section
II.A.1.c.(2).(i). of this proposed rule, we
propose the inclusion of patientauthorized representatives in the
numerators as equivalent to the
inclusion of the patient. We recognize
that patients often consult with and rely
on trusted family members and other
caregivers to help coordinate care,
understand health information, and
make health care decisions.
Accordingly, as part of these objectives,
we encourage providers to provide
access to health information to patientauthorized representatives in
accordance with all applicable laws. We
expect that patient-authorized
representatives accessing such
information under these objectives
could include a wide variety of sources,
including caregivers and various family
members. However, we expect that
patient-authorized representatives with
access to such health information will
always act on the patient’s behalf and in
the patient’s best interests, and will
remain free from any potential or actual
conflict of interest with the patient. We
further expect that the patientauthorized representatives would have
the patient’s best interests at heart and
will act in a manner protective of the
patient.
(h) Discussion of the Relationship of
Meaningful Use to CEHRT
We propose to continue our policy of
linking each meaningful use objective to
the CEHRT definition and to ONCestablished certification criteria. As
with Stage 1 and Stage 2, EPs, eligible
hospitals, and CAHs must use
technology certified to the certification
criteria in the ONC Health IT
Certification Program to meet the
objectives and associated measures for
Stage 3 of meaningful use. In some
instances, meaningful use objectives
and measures may not be directly
enabled by certification criteria of the
Health IT Certification Program. For
example, in e-Rx and public health
reporting, the CEHRT definition
requires criteria established by the
Health IT Certification Program to be
applied to the message being sent or
received and for purposes of message
transmission. However, to actually
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engage in e-Rx or public health
reporting, there are many steps that
must be taken to meet the requirements
of the measure, such as contacting both
parties and troubleshooting issues that
may arise through the normal course of
business. In these cases, the EP, eligible
hospital, and CAH remain responsible
for meeting the objectives and measures
of meaningful use, but the way they do
so is not entirely constrained by the
CEHRT definition.
(i) Discussion of the Relationship
Between a Stage 3 Meaningful Use
Objective and Its Associated Measure
We propose to continue our Stage 1
and 2 policy that regardless of any
actual or perceived gaps between the
measure of an objective and full
compliance with the objective, meeting
the criteria of the measure means that
the provider has met the objective for
meaningful use in Stage 3.
Objective 1: Protect Patient Health
Information
The Health Insurance Portability and
Accountability Act (HIPAA) was
enacted in part to provide federal
protections for individually identifiable
health information (IIHI). The Secretary
of HHS adopted what are commonly
known as the HIPAA Privacy, Security
and Breach Notification Rules (HIPAA
Rules) to implement certain aspects of
the HIPAA statute and the HITECH
statute pertaining to a patient’s IIHI. The
Privacy Rule provides protections for
most individually identifiable health
information, in any form or media,
whether electronic, paper, or oral, held
by covered entities and business
associates. The Security Rule specifies a
series of administrative, physical, and
technical standards that provide
protections for most electronic
individually identifiable health
information, held by covered entities
and business associates. Covered
entities consist of most health care
providers, health plans, and health care
clearinghouses. Business associates
consist of persons or organizations that
perform certain functions or activities
on behalf of, or provide certain services
to, covered entities or other business
associates that involve the use or
disclosure of individually identifiable
health information. Individually
identifiable health information is
information that relates to an
individual’s physical or mental health
or condition, the provision of health
care to an individual, or the payment for
the provision of health care to an
individual. Individually identifiable
health information is information that
identifies an individual directly or with
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respect to which there is a reasonable
basis to believe it can be used to identify
an individual. The individually
identifiable health information
protected by the HIPAA Rules is known
as ‘‘protected health information’’ and
that information in electronic form is
known as ‘‘electronic protected health
information’’ (ePHI). The Privacy Rule
can be found at 45 CFR Part160 and
subparts A and E of part 164 and the
Security Rule can be found at 45 CFR
Part160 and Subparts A and C of Part
164. Section 164.308(a)(1) of the
Security Rule requires covered entities
and business associates, among other
things, to conduct a security risk
analysis to assess the potential risks to
the ePHI they create, receive, maintain,
or transmit.
Consistent with HIPAA and its
implementing regulations, and as we
stated under both the Stage 1 and Stage
2 final rules (75 FR 44368 through
44369 and 77 FR 54002 through 54003),
protecting ePHI remains essential to all
aspects of meaningful use under the
EHR Incentive Programs. We remain
cognizant that unintended or unlawful
disclosures of ePHI could diminish
consumer confidence in EHRs and the
overall exchange of ePHI. Therefore, in
both the Stage 1 and 2 final rules, we
created a meaningful use core objective
aimed at protecting patients’ health care
information. Most recently, we finalized
at (77 FR 54002 and 54003), a Stage 2
meaningful use core objective requiring
providers to ‘‘protect ePHI created or
maintained by the certified EHR
technology through the implementation
of appropriate technical capabilities.’’
The measure for this objective requires
providers to 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),
implementing security updates as
necessary, and correcting identified
security deficiencies as part of the
provider’s risk management process. For
further detail on this objective, we refer
readers to the Stage 2 proposed and
final rules (77 FR 13716 through 13717
and 77 FR 54002).
In this Stage 3 proposed rule, we
continue to emphasize the importance
of protecting ePHI under the EHR
Incentive Programs. With more and
more users using electronic health
records, we believe that adequate
protection of ePHI remains instrumental
to the continued success of the EHR
Incentive Program.
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However, public comments on the
Stage 2 final rule and subsequent
comments received through public
forums, suggest some confusion remains
among providers between the
requirements of this meaningful use
objective and the requirements
established under 45 CFR 164.308(a)(1),
45 CFR 164.312(a)(2)(iv) and 45 CFR
164.306(d)(3) of the HIPAA Security
Rule. Although we stressed that the
objective and measure finalized relating
to ePHI are specific to the EHR Incentive
Programs, and further added that
compliance with the requirements in
the HIPAA Security Rule falls outside
the scope of this rulemaking, we
nonetheless continued to receive
inquiries about the relationship between
our objective and the HIPAA Rules.
Therefore, for Stage 3, in order to
alleviate provider confusion and
simplify the EHR Incentive Program, we
are proposing to maintain the
previously finalized Stage 2 objective on
protecting ePHI. However, we propose
further explanation of the security risk
analysis timing and review
requirements for purposes of meeting
this objective and associated measure
for Stage 3.
Proposed Objective: Protect electronic
protected health information (ePHI)
created or maintained by the certified
EHR technology (CEHRT) through the
implementation of appropriate
technical, administrative, and physical
safeguards.
For the proposed Stage 3 objective, we
have added language to the security
requirements for the implementation of
appropriate technical, administrative,
and physical safeguards. We propose to
include administrative and physical
safeguards because an entity would
require technical, administrative, and
physical safeguards to enable it to
implement risk management security
measures to reduce the risks and
vulnerabilities identified. Technical
safeguards alone are not enough to
ensure the confidentiality, integrity, and
availability of ePHI. Administrative
safeguards (for example, risk analysis,
risk management, training, and
contingency plans) and physical
safeguards (for example, facility access
controls, workstation security) are also
required to protect against threats and
impermissible uses or disclosures to
ePHI created or maintained by CEHRT.
Proposed Measure: Conduct or review
a security risk analysis in accordance
with the requirements under 45 CFR
164.308(a)(1), including addressing the
security (including encryption) of data
stored in CEHRT in accordance with
requirements under 45 CFR
164.312(a)(2)(iv) and 45 CFR
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164.306(d)(3), implement security
updates as necessary, and correct
identified security deficiencies as part
of the provider’s risk management
process.
Under this proposed measure, a risk
analysis must assess the risks and
vulnerabilities to ePHI created or
maintained by the CEHRT and must be
conducted or reviewed for each EHR
reporting period, which, as proposed in
this rule, would be a full calendar year,
and any security updates and
deficiencies identified should be
included in the provider’s risk
management process and implemented
or corrected as dictated by that process.
To address inquiries about the
relationship between this measure and
the HIPAA Security Rule, we explain
that the requirement of this proposed
measure is narrower than what is
required to satisfy the security risk
analysis requirement under 45 CFR
164.308(a)(1). The requirement of this
proposed measure is limited to annually
conducting or reviewing a security risk
analysis to assess whether the technical,
administrative, and physical safeguards
and risk management strategies are
sufficient to reduce the potential risks
and vulnerabilities to the
confidentiality, availability, and
integrity of ePHI created by or
maintained in CEHRT. In contrast, the
security risk analysis requirement under
45 CFR 164.308(a)(1) must assess the
potential risks and vulnerabilities to the
confidentiality, availability, and
integrity of all ePHI that an organization
creates, receives, maintains, or
transmits. This includes ePHI in all
forms of electronic media, such as hard
drives, floppy disks, CDs, DVDs, smart
cards or other storage devices, personal
digital assistants, transmission media, or
portable electronic media.
We propose that the timing or review
of the security risk analysis to satisfy
this proposed measure must be as
follows:
• EPs, eligible hospitals, and CAHs
must conduct the security risk analysis
upon installation of CEHRT or upon
upgrade to a new Edition of certified
EHR Technology. The initial security
risk analysis and testing may occur prior
to the beginning of the first EHR
reporting period using that certified
EHR technology.
• In subsequent years, a provider
must review the security risk analysis of
the CEHRT and the administrative,
physical, and technical safeguards
implemented, and make updates to its
analysis as necessary, but at least once
per EHR reporting period.
We note that providers have several
resources available for strategies and
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methods for securing ePHI. Completing
a security risk analysis requires a time
investment, and may necessitate the
involvement of security, health IT, or
system IT staff or support teams at your
facility. The Office for Civil Rights
(OCR) provides broad scale guidance on
security risk analysis requirements at:
https://www.hhs.gov/ocr/privacy/hipaa/
administrative/securityrule/
rafinalguidancepdf.pdf.
In addition, other tools and resources
are available to assist providers in the
process. For example, the Office of the
National Coordinator for Health IT
(ONC) provides guidance and a Security
Risk Assessment (SRA) tool created in
conjunction with OCR on its Web site
at: https://www.healthit.gov/providersprofessionals/security-risk-assessmenttool. The SRA Tool is a self-contained
application available at no cost to the
provider. There are a total of 156
questions and resources are included
with each question to—
• Assist in understanding the context
of the question
• Consider the potential impacts to
ePHI if the requirement is not met
• See the actual safeguard language of
the HIPAA Security Rule
In addition, the SRA Tool assists a
provider by suggesting when corrective
action may be required for a particular
item. This tool is not required by the
HIPAA Security Rule, but is one means
by which providers and professionals in
small and medium sized practices may
perform a security risk analysis.
We further note that the 2015 Edition
proposed rule published elsewhere in
this issue of the Federal Register
includes an auditable events and
tamper-resistance criterion which is
known as an ‘‘audit log’’ which can be
a valuable resource in ensuring the
protection of ePHI. While we recognize
there may be legitimate instances where
the function must be disabled for a short
time, we strongly recommend providers
ensure this function is enabled at all
times when the CEHRT is in use. The
audit log function serves to ensure
consistent protection of ePHI as well as
providing support in mitigating risk in
other areas such as patient safety,
adverse events, and in the event of any
potential breach.
We emphasize that our discussion of
this measure as it relates to 45 CFR
164.308(a)(1) is only relevant for
purposes of the meaningful use
requirements and is not intended to
supersede or satisfy the broader,
separate requirements under the HIPAA
Security Rule and other rulemaking.
Compliance with the requirements in
the HIPAA Security Rule fall outside of
the scope of this rulemaking.
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Compliance with 42 CFR part 2 and
state mental health privacy and
confidentiality laws also fall outside the
scope of this rulemaking. EPs, eligible
hospitals, or CAHs affected by 42 CFR
part 2 should consult with the
Substance Abuse and Mental Health
Services Administration (SAMHSA) or
State authorities.
We welcome public comments on this
proposal.
16747
For Stage 3, we propose to maintain
the objective and measure finalized in
the Stage 2 final rule for electronic
prescribing for EPs, with minor changes.
In the Stage 2 final rule, we included for
eligible hospitals and CAHs a menu set
objective for the electronic prescription
of discharge medications. We are
proposing to include the Stage 2 menu
objective, with a modification to
increase the threshold, as a required
objective for Stage 3 of meaningful use
for eligible hospitals and CAHs.
For a full discussion of electronic
prescribing as a meaningful use
objective in the Stage 2 final rule, we
direct readers to (77 FR 53989 through
53990 for EPs and 77 FR 54035 through
54036 for eligible hospitals and CAHs).
Proposed Objective: EPs must
generate and transmit permissible
prescriptions electronically, and eligible
hospitals and CAHs must generate and
transmit permissible discharge
prescriptions electronically (eRx).
As discussed in the Stage 2 final rule
(77 FR 53989), transmitting the
prescription electronically promotes
efficiency and patient 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 that works in conjunction
with clinical decision support
interventions enabled at the generation
of the prescription. While the EP
performance rate across all years and
stages of participation indicate wide
spread adoption, with the median rate at
89 percent for Stage 1 and 92 percent for
Stage 2 3, we believe continued support
of this objective is warranted to support
the continued development of the
ePrescribing marketplace. The
continued expansion of the number and
variety of products helps to reduce entry
barriers and proliferate important
standards for ePrescribing for a wide
range of providers beyond those eligible
for the EHR Incentive Programs. This
represents a benefit to patients and to
population health through a potential
overall reduction in the occurrence of
prescription drug related adverse
events. For eligible hospitals and CAHs,
the performance rate among Stage 2
providers selecting the measure is
higher than the 10 percent threshold
and has increased since the previous
report (median rate is 76 4 percent). This
opportunity to expand on early success,
combined with the continued expansion
of the pharmacy market acceptance of
electronic prescriptions leads CMS to
believe providers can meet an even
higher threshold and should be
encouraged to do so.
We propose to continue to define
‘‘prescription’’ as the authorization by a
provider to dispense a drug that would
not be dispensed without such
authorization. This includes
authorization for refills of previously
authorized drugs. We propose to
continue to generally define a
‘‘permissible prescription’’ as all drugs
meeting the definition of prescription
not listed as a controlled substance in
Schedules II–V (DEA Web site at
https://www.deadiversion.usdoj.gov/
schedules/ (77 FR 53989)
with a slight modification to allow for
inclusion of scheduled drugs where
such drugs are permissible to be
electronically prescribed. We note that
the electronic prescribing of controlled
substances (EPCS) is now legal in many
states. This functionality provides
prescribers with a way to manage
treatments for patients with pain
electronically and also deters creation of
fraudulent prescriptions, which is a
major concern in combating opioid
misuse and abuse. While the technology
may, in many instances, be in place to
support EPCS, workflow challenges and
additional modifications may need to
occur to meet the requirements of Drug
Enforcement Agency regulations (75 FR
16236). However, as Stage 3 would not
begin until January of 2017 and would
not be required until January of 2018, it
is possible that significant progress in
the availability of products enabling the
electronic prescribing of controlled
substances may occur. Therefore, we are
proposing that providers who practice
in a state where controlled substances
may be electronically prescribed who
wish to include these prescriptions in
the numerator and denominator may do
so under the definition of ‘‘permissible
prescriptions’’ for their practice. If a
provider chooses to include such
3 Data may be found on the CMS Web site data
and program reports page: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html.
4 Data may be found on the CMS Web site data
and program reports page: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html.
Objective 2: Electronic Prescribing
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prescriptions, they must do so
uniformly across all patients and across
all allowable schedules for the duration
of the EHR reporting period.
For Stage 2, we requested comment
on whether over-the-counter (OTC)
medicines should be included in the
definition of a prescription for this
objective and determined that they
should be excluded. For further
information on that discussion, we
direct readers to (77 FR 53989 and
53990). We maintain that OTC
medicines will not be routinely
electronically prescribed and propose to
continue to exclude them from the
definition of a prescription. However,
we encourage public comment on this
assumption and whether OTC
medicines should be included in this
objective for Stage 3.
In the Stage 2 final rule at (77 FR
53989), we discussed several different
workflow scenarios that are possible
when an EP prescribes a drug for a
patient and that these differences in
transmissions create differences in the
need for standards. We propose to
maintain this policy for Stage 3 for EPs
and extend it to eligible hospitals and
CAHs so that only a scenario in which
a provider—
• Prescribes the drug;
• Transmits it to a pharmacy
independent of the provider’s
organization; and
• The patient obtains the drug from
that pharmacy requires the use of
standards to ensure that the
transmission meets the goals of
electronic prescribing. In that situation,
standards can ensure the whole process
functions reliably. In all cases under
this objective, the provider needs to use
CEHRT as the sole means of creating the
prescription, and when transmitting to
an external pharmacy that is
independent of the provider’s
organization, such transmission must be
pursuant to ONC Health IT Certification
Program criteria.
Proposed EP Measure: More than 80
percent of all permissible prescriptions
written by the EP are queried for a drug
formulary and transmitted electronically
using CEHRT.
In Stage 1 of meaningful use, we
adopted a measure of more than 40
percent of all permissible prescriptions
written by the EP are transmitted
electronically using CEHRT. In the Stage
1 final rule (75 FR 44338), we
acknowledged that there were reasons
why a patient may prefer a paper
prescription such as the desire to shop
for the best price (especially for patients
in the Part D ‘‘donut hole’’), the
indecision about whether to have the
prescription filled locally or by mail
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order, and the desire to use a
manufacturer coupon (except in the Part
D program) to obtain a discount.
In Stage 2, we adopted a measure of
more than 50 percent of all permissible
prescriptions written by the EP are
queried for a drug formulary and
transmitted electronically using CEHRT.
Our analysis of attestation data from
Stages 1 and 2 shows that the median
performance on this measure for Stage
1 EPs is 89 percent and for Stage 2 EPs
is 92 percent, which demonstrates that
the 50 percent threshold does not
exceed the ceiling created by patient
preferences 5. We believe that with
continued experience with this
objective and the continued expansion
of the pharmacy market acceptance of
electronic prescriptions, providers can
meet an even higher threshold and
should be encouraged to do so in line
with the statutory directive to seek to
improve the use of EHRs and health care
quality over time by requiring more
stringent measures of meaningful use
(see section 1848(o)(2)(A)(iii) of the
Act). Therefore, we are proposing a
threshold of 80 percent for this measure
for Stage 3.
We propose to maintain for Stage 3
the exclusion from Stage 2 for EPs who
write fewer than 100 permissible
prescriptions during the EHR reporting
period. We also propose to maintain for
Stage 3 the exclusion from Stage 2 if no
pharmacies within a 10-mile radius of
an EP’s practice location at the start of
his or her EHR reporting period accept
electronic prescriptions (77 FR 53990).
This is 10 miles in any straight line from
the practice location independent of the
travel route from the practice location to
the pharmacy. For EPs practicing at
multiple locations, they are eligible for
the exclusion if any of their practice
locations equipped with CEHRT meet
this criterion. 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.
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
5 Data can be found on the CMS Web site data and
program reports page: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html.
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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 80 percent in order
for an EP to meet this measure.
Exclusions: Any EP who: (1) Writes
fewer than 100 permissible
prescriptions during the EHR reporting
period; or (2) does not have a pharmacy
within their 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.
Proposed Eligible Hospital/CAH
Measure: More than 25 percent of
hospital discharge medication orders for
permissible prescriptions (for new and
changed prescriptions) are queried for a
drug formulary and transmitted
electronically using CEHRT.
In the Stage 2 final rule, we included
in this measure new, changed, and refill
prescriptions ordered during the course
of treatment of the patient while in the
hospital (77 FR 54036). We are
proposing to limit this measure for Stage
3 to only new and changed
prescriptions. We believe this limitation
is appropriate because prescriptions that
originate prior to the hospital stay, and
that remain unchanged, would be
within the purview of the original
prescriber, and not hospital staff or
attending physicians. We propose to
include this limitation as we believe
that in most cases a hospital would not
issue refills for medications that were
not authorized or altered during a
patient’s hospital stay. With this new
proposal, we invite public comment on
whether a hospital would issue refills
upon discharge for medications the
patient was taking when they arrived at
the hospital and, if so, whether
distinguishing those refill prescriptions
from new or altered prescriptions is
unnecessarily burdensome for the
hospital.
Our review of the Stage 2 attestation
data for eligible hospitals and CAHs
indicates performance levels of 53
percent at the median and 31 percent for
the lowest quartile (www.cms.gov/
ehrincentiveprograms Data and
Reports). Thus, we are proposing to
increase the threshold for the measure
from 10 percent to 25 percent for Stage
3 of meaningful use for eligible
hospitals and CAHs.
We propose to maintain the Stage 2
exclusion for any eligible hospital or
CAH that does not have an internal
pharmacy that can accept electronic
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prescriptions and is not located within
10 miles of any pharmacy that accepts
electronic prescriptions at the start of
their EHR reporting period (77 FR
54036).
We recognize that not every patient
will have a formulary that is relevant for
him or her. If a relevant formulary is
available, then the information can be
provided. If there is no formulary for a
given patient, the comparison could
return a result of formulary unavailable
for that patient and medication
combination, and the provider may
count the prescription in the numerator
if they generate and transmit the
prescription electronically as required
by the measure.
To calculate the percentage, CMS and
ONC have worked together to define the
following for this objective:
Denominator: The number of new or
changed prescriptions written for drugs
requiring a prescription in order to be
dispensed other than controlled
substances for patients discharged
during the EHR reporting period.
Numerator: The number of
prescriptions in the denominator
generated, queried for a drug formulary
and transmitted electronically.
Threshold: The resulting percentage
must be more than 25 percent in order
for an eligible hospital or CAH to meet
this measure.
Exclusion: Any eligible hospital or
CAH that does not have an internal
pharmacy that can accept electronic
prescriptions and there are no
pharmacies that accept electronic
prescriptions within 10 miles at the start
of their EHR reporting period.
We invite public comment on these
proposals.
Objective 3: Clinical Decision Support
Proposed Objective: Implement
clinical decision support (CDS)
interventions focused on improving
performance on high-priority health
conditions.
Clinical decision support at the
relevant point of care is an area of
health IT in which significant evidence
exists for substantial positive impact on
the quality, safety, and efficiency of care
delivery. For Stage 2, we finalized an
objective for the use of CDS to improve
performance on high-priority health
conditions, and two associated
measures (77 FR 53995 through 53998).
The first measure requires a provider to
implement five CDS interventions
related to four or more CQMs at a
relevant point in patient care for the
entire EHR reporting period. Absent
four CQMs related to the provider’s
scope of practice or patient population,
the CDS interventions must be related to
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high-priority health conditions. At least
one of the CDS interventions should be
related to improving healthcare
efficiency. To meet the Stage 2 Clinical
Decision Support objective, 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. Although
we leave it to the provider’s clinical
discretion to determine the relevant
point in patient care when such
interventions will be most effective, the
interventions must be presented through
Certified EHR Technology to a licensed
healthcare professional who can
exercise clinical judgment about the
decision support intervention before an
action is taken on behalf of the patient.
For the second measure, we
consolidated the Stage 1 ‘‘drug-drug/
drug-allergy interaction checks’’
objective into the Stage 2 CDS objective
in the Stage 2 final rule (77 FR 53995
through 53998). The second measure
requires a provider to enable and
implement the functionality for drugdrug and drug-allergy interaction checks
for the entire EHR reporting period. We
also finalized an exclusion for the
second measure for any EP who writes
fewer than 100 medication orders
during the EHR reporting period.
For Stage 3 of meaningful use, we
propose to maintain the Stage 2
objective with slight modifications and
further explanation of the relevant point
of care, the types of CDS allowed, and
the selection of a CDS applicable to a
provider’s scope of practice and patient
population.
First, we offer further explanation of
the concept of the relevant point of care
and note that providers should
implement the CDS intervention at a
relevant point in clinical workflows
when the intervention can influence
clinical decision making before
diagnostic or treatment action is taken
in response to the intervention. Second,
many providers may associate CDS with
pop-up alerts; however, these alerts are
not the only method of providing CDS.
CDS should not be viewed as simply an
interruptive alert, notification, or
explicit care suggestion. Well-designed
CDS encompasses a variety of workflowoptimized information tools, which can
be presented to providers, clinical and
support staff, patients, and other
caregivers at various points in time.
These may include but are not limited
to: Computerized alerts and reminders
for providers and patients; information
displays or links; context-aware
knowledge retrieval specifications
which provide a standard mechanism to
incorporate information from online
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16749
resources (commonly referred to as
InfoButtons); clinical guidelines;
condition-specific order sets; focused
patient data reports and summaries;
documentation templates; diagnostic
support; and contextually relevant
reference information. These
functionalities may be deployed on a
variety of platforms (that is, mobile,
cloud-based, installed).6 We encourage
innovative efforts to use CDS to improve
care quality, efficiency, and outcomes.
HIT functionality that builds upon the
foundation of an EHR to provide
persons involved in care processes with
general and person-specific information,
intelligently filtered and organized, at
appropriate times, to enhance health
and health care. CDS is not intended to
replace clinician judgment, but rather, is
a tool to assist care team members in
making timely, informed, and higher
quality decisions.
We propose to retain both measures of
the Stage 2 objective for Stage 3 and we
are proposing that these additional
options mentioned previously on the
actions, functions, and interventions
may constitute CDS for purposes of
meaningful use would meet the measure
requirements outlined in the proposed
measures.
Proposed Measures: EPs, eligible
hospitals, and CAHs must satisfy both
measures in order to meet the objective:
Measure 1: Implement five clinical
decision support interventions related
to four or more CQMs at a relevant point
in patient care for the entire EHR
reporting period. Absent four CQMs
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.
Exclusion: For the second measure,
any EP who writes fewer than 100
medication orders during the EHR
reporting period.
We recommend that providers explore
a wide range of potential CDS
interventions and determine the best
mix for their practice and patient
population. There are a wide range of
CQMs which providers may implement
in conjunction with the CDS. We refer
readers to the CMS eCQM Library
(www.cms.gov/ehrincentiveprograms/
ecqmlibrary) for a list of the CQMs
6 FDASIA Health IT report available on the FDA
Web site at: https://www.fda.gov/downloads/
AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CDRH/
CDRHReports/UCM391521.pdf.
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currently in use and under development
for CMS programs and the associated
National Quality Strategy domain
categories.
In alignment with the HHS National
Quality Strategy goals,7 providers are
encouraged to implement CDS related to
quality measurement and improvement
goals on the following areas:
• Preventive care.
• Chronic condition management.
• Heart disease and hypertension.
• Appropriateness of diagnostic
orders or procedures such as labs,
diagnostic imaging, genetic testing,
pharmacogenetic and pharmacogenomic
test result support or other diagnostic
testing.
• Advanced medication-related
decision support, to include
pharmacogenetic and pharmacogenomic
test result support.
An example of a potential CDS a
provider may include which highlights
the proposed expansion of the variety of
workflow-optimized tools available for
providers, and the link between a CDS
and a high priority health condition,
may be found in the use of treatment
protocols and algorithms within the
Million Hearts initiative. The Million
Hearts initiative emphasizes the use of
treatment protocols which can be
embedded throughout the clinical
workflow for hypertension control to
standardize a team’s or system’s
approach to achieving outcomes of
interest. These treatment protocols or
algorithms can expand the number of
care team members that can assist in
achieving desired outcomes; lend
clarity, efficiency, and cost-effectiveness
to selection of medications; and specify
intervals and processes for patient
follow up for care related to
hypertension. For further information
on this example, we direct readers to the
Million Hearts initiative protocols
https://millionhearts.hhs.gov/resources/
protocols.html. In this example, these
CDS interventions are applied to utilize
standardized treatment approaches or
protocols specific to hypertension
control; however, we emphasize that
similar strategies and approaches to the
implementation of a variety of CDS can
be widely applied. Another relevant
example is clinical decision support in
certified EHR technology that is used for
consultation regarding appropriate use
criteria for applicable imaging services
as outlined in section 218 of the
‘‘Protecting Access to Medicare Act of
2014’’ which includes provisions
focused on promoting evidence based
7 HHS National Quality Strategy: https://
www.ahrq.gov/workingforquality/.
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care. We welcome public comments on
the proposals.
As in the Stage 2 final rule (77 FR
53997), we do not propose to require the
provider to report a change in
performance on individual CQMs either
independently or in relation to the
paired CDS. Rather, we recommend
each provider set internal goals for
improved performance using the CQM,
or related set of CQMs, as indicators for
their own reference when selecting and
implementing a CDS intervention. We
note that for CDS and CQM pairings, we
recommend providers focus on the use
of CQMs which measure patient
outcomes (also known as outcome
measures), as preferred over CQMs
which measure clinical process without
consideration of a particular outcome
(also known as process measures).
Outcome measure CQMs are designed to
provide a patient-centered and outcomefocused indicator for quality
improvement goal-setting and planning.
Where possible, we recommend
providers implement CDS interventions
which relate to care quality
improvement goals and a related
outcome measure CQM. However, for
specialty hospitals and certain EPs, if
there are no CQMs which are outcome
measures related to their scope of
practice, the provider should implement
a CDS intervention related to a CQM
process measure; or if none of the
available CQMs apply, the provider
should apply an intervention that he or
she believes will be effective in
improving the quality, safety, or
efficiency of patient care.
CMS and ONC are committed to
harmonizing the quality improvement
ecosystem, refining and developing
outcome measures, and aligning
standards for CDS and quality
measurement. Work is underway in the
ONC Standards and Interoperability
Framework to align and develop a
shared quality improvement data model
and technical expression standards for
both CDS and quality measurement.
Upon successful completion, such
standards may be considered for
inclusion in future quality measurement
and certification rulemaking.
Given the wide range of CDS
interventions currently available and
the continuing development of new
technologies, we do not believe that any
EP, eligible hospital, or CAH would be
unable to identify and implement five
CDS interventions as previously
described. Therefore, we do not propose
any exclusion for the first measure of
this objective.
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Objective 4: Computerized Provider
Order Entry
In the Stage 2 final rule, we expanded
the use of computerized provider order
entry (CPOE) from the Stage 1 objective
requiring only medication orders to be
entered using CPOE to include
laboratory orders and radiology orders.
For a full discussion of this expansion,
we direct readers to (77 FR 53985
through 53989). We maintain CPOE
continues to represent an opportunity
for providers to leverage technology to
capture these orders to reduce error and
maximize efficiencies within their
practice, therefore we are proposing to
maintain the use of CPOE for these
orders as an objective of meaningful use
for Stage 3.
Proposed Objective: Use
computerized provider order entry
(CPOE) for medication, laboratory, and
diagnostic imaging orders directly
entered by any licensed healthcare
professional, credentialed medical
assistant, or a medical staff member
credentialed to and performing the
equivalent duties of a credentialed
medical assistant; who can enter orders
into the medical record per state, local,
and professional guidelines.
We propose to continue to define
CPOE as the provider’s use of computer
assistance to directly enter clinical
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.
We propose to continue our policy
from the Stage 2 final rule that the
orders to be included in this objective
are medication, laboratory, and
radiology orders as such orders are
commonly included in CPOE
implementation and offer opportunity to
maximize efficiencies for providers.
However, for Stage 3, we are proposing
to expand the objective to include
diagnostic imaging, which is a broader
category including other imaging tests
such as ultrasound, magnetic resonance,
and computed tomography in addition
to traditional radiology. This change
addresses the needs of specialists and
allows for a wider variety of clinical
orders relevant to particular specialists
to be included for purposes of
measurement.
In Stage 3, we propose to continue the
policy from the Stage 2 final rule at 77
FR 53986 that orders entered by any
licensed healthcare professional or
credentialed medical assistant would
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count toward this objective. A
credentialed medical assistant may
enter orders if they are credentialed to
perform the duties of a medical assistant
by a credentialing body other than the
employer. If a staff member of the
eligible provider is appropriately
credentialed and performs assistive
services similar to a medical assistant,
but carries a more specific title due to
either specialization of their duties or to
the specialty of the medical professional
they assist, orders entered by that staff
member would be included in this
objective. We further note that medical
staff whose organizational or job title, or
the title of their credential, is other than
medical assistant may enter orders if
these staff are credentialed to perform
the equivalent duties of a credentialed
medical assistant by a credentialing
body other than their employer and
perform such duties as part of their
organizational or job title. We defer to
the provider’s discretion to determine
the appropriateness of the credentialing
of staff to ensure that any staff entering
orders have the clinical training and
knowledge required to enter orders for
CPOE. This determination must be
made by the EP or representative of the
eligible hospital or CAH based on—
• Organizational workflows;
• Appropriate credentialing of the
staff member by an organization other
than the employing organization;
• Analysis of duties performed by the
staff member in question; and
• Compliance with all applicable
federal, state, and local laws and
professional guidelines.
However, as stated in the Stage 2 final
rule at 77 FR 53986, it is apparent that
the prevalent time when CDS
interventions are presented is when the
order is entered into CEHRT, and that
not all EHRs also present CDS when the
order is authorized (assuming such a
multiple step ordering process is in
place). This means that the person
entering the order would be required to
enter the order correctly, evaluate a CDS
intervention either using their own
judgment or through accurate relay of
the information to the ordering
provider, and then either make a change
to the order based on the information
provided by the CDS intervention or
bypass the intervention. The execution
of this role represents a significant
impact on patient safety; therefore, we
continue to maintain for Stage 3 that a
layperson is not qualified to perform
these tasks. We believe that the order
must be entered by a qualified
individual. We further propose that if
the individual entering the orders is not
the licensed healthcare professional, the
order must be entered with the direct
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supervision or active engagement of a
licensed healthcare professional.
We propose to maintain for Stage 3
our existing policy for Stages 1 and 2
that the CPOE function should be used
the first time the order becomes part of
the patient’s medical record and before
any action can be taken on the order.
The numerator of this objective also
includes orders entered using CPOE
initially when the patient record became
part of the certified EHR. This does not
include paper orders entered initially
into the patient record and then
transferred to CEHRT by other
individuals at a later time, nor does it
include orders entered into technology
not compliant with the CEHRT
definition and transferred into the
CEHRT at a later time. In addition,
based on the discussion in the Stage 2
final rule (77 FR 53986), we propose to
maintain for Stage 3 that ‘‘protocol’’ or
‘‘standing’’ orders may be excluded
from this objective. The defining
characteristic of these orders is that they
are not created due to a specific clinical
determination by the ordering provider
for a given patient, but rather are
predetermined for patients with a given
set of characteristics (for example,
administer medication X and order lab
Y for all patients undergoing a certain
specific procedure or refills for given
medication). We agree that this category
of orders warrant different
considerations than orders that are due
to a specific clinical determination by
the ordering provider for a specific
patient. Therefore, we allow providers
to exclude orders that are
predetermined for a given set of patient
characteristics or for a given procedure
from the calculation of CPOE
numerators and denominators.
However, the exclusion of this type of
order may not be a blanket policy for
patients presenting with a specific
diagnosis or symptom which requires
the evaluation and determination of the
provider for the order.
We propose to maintain the Stage 2
description of ‘‘laboratory services’’ as
any service provided by a laboratory
that could not be provided by a nonlaboratory for the CPOE objective for
Stage 3 (77 FR 53984). We also propose
to maintain for Stage 3 the Stage 2
description of ‘‘radiologic services’’ as
any imaging service that uses electronic
product radiation (77 FR 53986). Even
though we are proposing to expand the
CPOE objective from radiology orders to
all diagnostic imaging orders, this
description would still apply for
radiology services within the expanded
objective.
We invite public comment on these
proposals.
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Proposed Measures: An EP, eligible
hospital or CAH must meet all three
measures.
Proposed Measure 1: More than 80
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 computerized provider
order entry;
Proposed Measure 2: More than 60
percent of laboratory 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 computerized provider
order entry; and
Proposed Measure 3: More than 60
percent of diagnostic imaging 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
computerized provider order entry.
We propose to continue a separate
percentage threshold for all three types
of orders: medication, laboratory, and
diagnostic imaging. We continue to
believe that an aggregate denominator
cannot best capture differentiated
performance on the individual order
types within the objective, and therefore
maintain a separate denominator for
each order type. We propose to retain
exclusionary criteria from Stage 2 for
those EPs who so infrequently issue an
order type specified by the measures
(write fewer than 100 of the type of
order), that it is not practical to
implement CPOE for that order type.
Based on our review of attestation
data from Stages 1 and 2 demonstrating
provider performance on the CPOE
measures, we propose to increase the
threshold for medication orders to 80
percent and to increase the threshold for
diagnostic imaging orders and
laboratory orders to 60 percent. Median
performance for Stage 1 on medication
orders is 95 percent for EPs and 93
percent foreligible hospitals and CAHs.
Stage 2 median performance on
laboratory and radiology orders is 80
percent and 83 percent for eligible
hospitals and CAHs and 100 percent for
EPs for both measures.8 We believe it is
reasonable to expect the actual use of
CPOE for medication orders to increase
from 60 percent in Stage 2 to 80 percent
in Stage 3 and the actual use of CPOE
for diagnostic imaging and laboratory
8 Data can be found on the CMS Web site data and
program reports page: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html.
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orders to increase from 30 percent in
Stage 2 to 60 percent in Stage 3. We note
that despite the expansion of the
category for radiology orders to
diagnostic imaging orders, we do not
anticipate a negative impact on the
ability of providers to meet the higher
threshold as the adoption of the
expanded functionality does not require
additional workflow implementation
and allows for inclusion of a wider
range of orders already being captured
by many providers. Therefore, for
medication orders we propose the
threshold at 80 percent and for
diagnostic imaging and laboratory
orders we propose the threshold at 60
percent for Stage 3.
In the Stage 2 final rule, we addressed
the concern posed when calculating a
denominator of all orders entered into
the CEHRT while limiting the
numerator to only those entered into
CEHRT using CPOE (77 FR 53987
through 53988). Potentially, this would
exclude those orders that are never
entered into the CEHRT in any manner.
The provider would be responsible for
including those orders in their
denominator. However, we believe that
providers using CEHRT use it as the
patient’s medical record; therefore, an
order not entered into CEHRT would be
an order that is not entered into a
patient’s medical record. For this
reason, we expect that orders given for
patients that are never entered into the
CEHRT to be few in number or nonexistent. While our experience with
both Stage 1 and Stage 2 of meaningful
use has shown that a denominator of all
orders created by the EP or in the
hospital would not be unduly
burdensome for providers and would
create a better measurement for CPOE
usage, particularly for EPs who
infrequently order medications, this
does not guarantee such a denominator
would be feasible for all providers. We
invite comments on whether to continue
to allow, but not require, providers to
limit the measure of this objective to
those patients whose records are
maintained using CEHRT.
Proposed Measure 1: To calculate the
percentage, CMS and ONC have worked
together to define the following for this
measure:
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 80 percent in order
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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.
Proposed Measure 2: To calculate the
percentage, CMS and ONC have worked
together to define the following for this
measure:
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 60 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.
Proposed Measure 3: To calculate the
percentage, CMS and ONC have worked
together to define the following for this
measure:
Denominator: Number of diagnostic
imaging 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 diagnostic imaging orders
during the EHR reporting period.
We seek comment on if there are
circumstances which might warrant an
additional exclusion for an EP such as
a situation representing a barrier to
successfully implementing the
technology required to meet the
objective. We also seek comment on if
there are circumstances where an
eligible hospital or CAH which focuses
on a particular patient population or
specialty may have an EHR reporting
period where the calculation results in
a zero denominator for one of the
measures, how often such
circumstances might occur, and whether
an exclusion would be appropriate.
An EP through a combination of
meeting the thresholds and exclusions
must satisfy all three measures for this
objective. An eligible hospital or CAH
must meet the thresholds for all three
measures.
We welcome public comment on
these proposals.
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Objective 5: Patient Electronic Access to
Health Information
The Stage 1 and Stage 2 final rules
included a number of objectives focused
on increasing patient access to health
information and supporting provider
and patient communication. These
objectives include patient reminders (77
FR 54005 through 54007), patientspecific education resources (77 FR
54011 through 54012), clinical
summaries of office visits (77 FR 53998
through 54002), secure messaging (77
FR 54031 through 54033), and the
ability for patients to view, download,
and transmit their health information to
a third party (77 FR 54007 through
54011). For Stage 3, we generally
identified two related policy goals
within the overall larger goal of
improved patient access to health
information and patient-centered
communication. The first is to ensure
patients have timely access to their full
health record and related important
health information; and the second is to
engage in patient-centered
communication for care planning and
care coordination. While these two goals
are intricately linked, we see them as
two distinct priorities requiring
different foci and measures of success.
For the first goal, we are proposing to
incorporate the Stage 2 objectives
related to providing patients with access
to health information, including the
objective for providing access for
patients (or their authorized
representatives) to view online,
download, and transmit their health
information and the objective for
patient-specific education resources,
into a new Stage 3 objective entitled,
‘‘Patient Electronic Access’’ (Objective
5), focused on using certified EHR
technology to support increasing patient
access to important health information.
For the second goal, we are proposing
an objective entitled Coordination of
Care through Patient Engagement
(Objective 6) incorporating the policy
goals of the Stage 2 objectives related to
secure messaging, patient reminders,
and the ability for patients (or their
authorized representatives) to view
online, download, and transmit their
health information using the
functionality of the certified EHR
technology.
In this Stage 3 Patient Electronic
Access Objective, we are proposing to
incorporate certain measures and
objectives from Stage 2 into a single
objective focused on providing patients
with timely access to information
related to their care. This proposed
objective is a consolidation of the first
measure of the Stage 2 Core Objective
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for EPs of ‘‘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’’ and the Stage 2
Core Objective for EPs to ‘‘Use clinically
relevant information from CEHRT to
identify patient-specific education
resources and provide those resources to
the patient.’’ For eligible hospitals and
CAHs, this proposed objective
consolidates the first measure of the
Stage 2 Core Objective for eligible
hospitals/CAHs of ‘‘Provide patients the
ability to view online, download, and
transmit information about a hospital
admission’’ and the Stage 2 Core
Objective ‘‘Use clinically relevant
information from CEHRT to identify
patient-specific education resources and
provide those resources to the patient.’’
For further discussion around the
development of the Stage 2 objectives,
we direct readers to the Stage 2 final
rule at (77 FR 53973).
In Stage 2, there are objectives that
allow providers to communicate and
provide information to patients through
paper-based means, such as clinical
summaries of office visits and patientspecific education resources. Although
these methods of communication and
information exchange are embraced by
many providers and patients and we
continue to support their use, we will
no longer require or allow providers to
capture and calculate these actions or
attest to these measures for meaningful
use Stage 3. While we believe that
providing patients access to health
information in many formats is
beneficial to patient-centered
communication, care delivery, and
quality improvement, meaningful use
Stage 3 focuses exclusively on
electronic, certified EHR technology
supported communication.
We are also proposing to expand the
options through which providers may
engage with patients under the EHR
Incentive Programs. Specifically, we are
proposing an additional functionality,
known as application-program
interfaces (APIs), which would allow
providers to enable new functionalities
to support data access and patient
exchange. An API is a set of
programming protocols established for
multiple purposes. APIs may be enabled
by a provider or provider organization
to provide the patient with access to
their health information through a thirdparty application with more flexibility
than often found in many current
‘‘patient portals.’’ From the provider
perspective, using this option would
mean the provider would not be
required to separately purchase or
implement a ‘‘patient portal,’’ nor
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would they need to implement or
purchase a separate mechanism to
provide the secure download and
transmit functions for their patients
because the API would provide the
patient the ability to download or
transmit their health information to a
third party. If the provider elects to
implement an API, the provider would
only need to fully enable the API
functionality, provide patients with
detailed instructions on how to
authenticate, and provide supplemental
information on available applications
which leverage the API. For further
discussion on the technical
requirements for APIs, we direct readers
to the 2015 Edition proposed rule
published elsewhere in this issue of the
Federal Register. The certification
criteria proposed by ONC would
establish API criteria which would
allow patients, through a third-party
application, to pull certain components
of their unique health data directly from
the provider’s CEHRT, and potentially
could—on demand—pull such
information from multiple providers
caring for a patient. Therefore, we are
proposing for the Patient Electronic
Access objective to allow providers to
enable API functionality in accordance
with the proposed ONC requirements in
the 2015 Edition proposed rule
published elsewhere in this issue of the
Federal Register.
From the patient perspective, an API
enabled by a provider will empower the
patient to receive information from their
provider in the manner that is most
valuable to that particular patient.
Patients would be able to collect their
health information from multiple
providers and potentially incorporate all
of their health information into a single
portal, application, program, or other
software. We also believe that providerenabled APIs allow patients to control
the manner in which they receive their
health information while still ensuring
the interoperability of data across
platforms. In addition, we recognize that
a large number of patients consult with
and rely on trusted family members and
other caregivers to help coordinate care,
understand health information, and
make decisions. Therefore, we
encourage providers to provide access to
health information to appropriately
authorized patient representatives.
As some low-cost and free API
functions already exist in the health IT
industry, we expect third-party
application developers to continue to
create low-cost solutions that leverage
APIs as part of their business models.
Therefore, we encourage health IT
system developers to leverage these
existing API platforms and applications
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to allow providers no-cost, or low-cost
solutions to implement and enable an
API as part of their CEHRT systems. In
addition, we do not believe it would be
appropriate for EPs and hospitals to
charge patients a fee for accessing their
information using an API.
The goal of this objective is to allow
patients easy access to their health
information as soon as possible, so that
they can make informed decisions
regarding their care and share their most
recent clinical information with other
health care providers and personal
caregivers as they see fit. We believe
this is also integral to the hospital
Partnership for Patients initiative and
reducing hospital readmissions. This
objective aligns with the Fair
Information Practice Principles
(FIPPS),9 in affording baseline privacy
protections to individuals.10
We seek comment on what additional
requirements might be needed to ensure
that if the eligible hospital, CAH or EP
selects the API option—(1) the
functionality supports a patient’s right
to have his or her protected health
information sent directly to a third party
designated by the patient; and (2)
patients have at least the same access to
and use of their health information that
they have under the view, download,
and transmit option.
Proposed Objective: The EP, eligible
hospital, or CAH provides access for
patients to view online, download, and
transmit their health information, or
retrieve their health information
through an API, within 24 hours of its
availability.
We continue to believe that patient
access to their electronic health
9 1 In 1973, the Department of Health, Education,
and Welfare (HEW) released its report, Records,
Computers, and the Rights of Citizens, which
outlined a Code of Fair Information Practices that
would create ’’safeguard requirements’’ for certain
’’automated personal data systems’’ maintained by
the Federal Government. This Code of Fair
Information Practices is now commonly referred to
as fair information practice principles (FIPPs) and
established the framework on which much privacy
policy would be built. There are many versions of
the FIPPs; the principles described here are
discussed in more detail in The Nationwide Privacy
and Security Framework for Electronic Exchange of
Individually Identifiable Health Information,
December 15, 2008. https://healthit.hhs.gov/portal/
server.pt/community/healthit_hhs_gov_privacy_
security_framework/1173.
10 The FIPPs, developed in the United States
nearly 40 years ago, are well-established and have
been incorporated into both the privacy laws of
many states with regard to government-held records
2 and numerous international frameworks,
including the development of the OECD’s privacy
guidelines, the European Union Data Protection
Directive, and the Asia-Pacific Economic
Cooperation (APEC) Privacy Framework. https://
healthit.hhs.gov/portal/server.pt/community/
healthit_hhs_gov_privacy_security_framework/
1173.
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information is a high priority for the
EHR Incentive Programs. Furthermore,
providing educational resources about a
patient’s health including
recommendations for preventative care
and screenings, identifying risk factors,
and other important health resources
can help to increase patient health
literacy, empower patients to make
more informed decisions, and support
the efforts of providers in managing a
patient care plan. We also believe that
patient access to health information
should be provided in the manner
requested by the patient when possible.
We note that for this objective, the
provider is only required to provide
access to the information through these
means; the patient is not required to
take action in order for the provider to
meet this objective. In the Patient
Electronic Access to Health Information
objective, we note that ‘‘provides
access’’ means that the patient has all
the tools they need to gain access to
their health information including any
necessary instructions, user
identification information, or the steps
required to access their information if
they have previously elected to ‘‘optout’’ of electronic access. If this
information is provided to the patient in
a clear and actionable manner, the
provider may count the patient for this
objective. Additionally, this objective
should not require the provider to make
extraordinary efforts to assist patients in
use or access of the information, but the
provider must inform patients of these
options, and provide sufficient guidance
so that all patients could leverage this
access. The providers may withhold
from online disclosure any information
either prohibited by federal, state, or
local laws or if such information
provided through online means may
result in significant harm. We also note,
as we have previously, that this is a
meaningful use requirement, which
does not affect an individual’s right
under HIPAA to access his or her health
information. Providers must continue to
comply with all applicable requirements
under the HIPAA Privacy Rule,
including the access provisions of 45
CFR 164.524.
Proposed Measures: EPs, eligible
hospitals, and CAHs must satisfy both
measures in order to meet the objective:
Proposed Measure 1: For more than
80 percent of all unique patients seen by
the EP or discharged from the eligible
hospital or CAH inpatient or emergency
department (POS 21 or 23):
(1) The patient (or patient-authorized
representative) is provided access to
view online, download, and transmit
their health information within 24 hours
of its availability to the provider; or
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(2) The patient (or patient-authorized
representative) is provided access to an
ONC-certified API that can be used by
third-party applications or devices to
provide patients (or patient-authorized
representatives) access to their health
information, within 24 hours of its
availability to the provider.
Proposed Measure 2: The EP, eligible
hospital or CAH must use clinically
relevant information from CEHRT to
identify patient-specific educational
resources and provide electronic access
to those materials to more than 35
percent of unique patients seen by the
EP or discharged from the eligible
hospital or CAH inpatient or emergency
department (POS 21 or 23) during the
EHR reporting period.
We propose that for measure 1, the
patient must be able to access this
information on demand, such as
through a patient portal, personal health
record (PHR), or API and have
everything necessary to access the
information even if they opt out. All
three functionalities (view, download,
and transmit) or an API must be present
and accessible to meet the measure. The
functionality must support a patient’s
right to have his or her protected health
information sent directly to a third party
designated by the patient consistent
with the provision of access
requirements at 45 CFR 164.524(c) of
the HIPAA Privacy Rule.
However, if the provider can
demonstrate that at least one application
that leverages the API is available
(preferably at no cost to the patient) and
that more than 80 percent of all unique
patients have been provided
instructions on how to access the
information; the provider need not
create, purchase, or implement
redundant software to enable view,
download, and transmit capability
independently of the API.
We propose to increase the threshold
for measure 1 from the Stage 1 and Stage
2 threshold of 50 percent to a threshold
of 80 percent for Stage 3. We believe
that all patients should be provided
access to their electronic health record;
however, we are setting the threshold at
80 percent based on the highest
threshold defined for measures based on
unique patients seen by the provider
during the EHR reporting period in the
Stage 2 final rule (for example see 77 FR
53993). Based on the continued progress
toward automation and standardization
of data capture supported by CEHRT
which facilitates a faster response time,
we further propose to decrease patient
wait time for the availability of
information to within 24 hours of the
office visit or of the information
becoming available to the provider for
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potential inclusion in the case of lab or
other test results which require
sufficient time for processing and
returning results.
For measure 2, we propose to increase
the threshold that was finalized in Stage
2 from 10 percent to 35 percent. We
believe that the 35 percent threshold
both ensures that providers are using
CEHRT to identify patient-specific
education resources and is low enough
to not infringe on the provider’s
freedom to choose education resources
and to which patients these resources
will be provided.
We continue to propose that both
measures for this objective must be met
using CEHRT. For the purposes of
meeting this objective, this would mean
the capabilities provided by a patient
portal, PHR, or any other means of
online access that would permit a
patient or authorized representatives to
view, download, and transmit their
personal health information and/or any
API enabled, must be certified in
accordance with the certification
requirements adopted by ONC.
We are proposing a continuation of
the exclusion in Stage 2 for both EPs
and eligible hospitals/CAHs in that any
EP, eligible hospital, or CAH would be
excluded from the first measure if it is
located in a county that does not have
50 percent or more of their housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC at
the start of the EHR reporting period.
We continue to recognize that in areas
of the country where a significant
section of the patient population does
not have access to broadband internet,
this measure may be significantly harder
or impossible to achieve. Finally, we
propose an additional exclusion for EPs
for Stage 3, that any EP who has no
office visits during the EHR reporting
period may be excluded from the
measures. We encourage comments on
these exclusions and will evaluate them
again in light of the public comments
received.
Proposed Measure 1: To calculate the
percentage, CMS and ONC have worked
together to define the following for this
measure:
Denominator: The number of unique
patients seen by the EP or the number
of unique patients discharged from an
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period.
Numerator: The number of patients in
the denominator who are provided
access to information within 24 hours of
its availability to the EP or eligible
hospital/CAH.
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Threshold: The resulting percentage
must be more than 80 percent in order
for a provider to meet this measure.
Exclusions: An EP may exclude from
the measure if they have no office visits
during the EHR reporting period.
Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude the
measure.
Any eligible hospital or CAH will be
excluded from the measure if it is
located in a county that does not have
50 percent or more of their housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC at
the start of the EHR reporting period.
Proposed Measure 2: To calculate the
percentage, CMS and ONC have worked
together to define the following for this
measure:
Denominator: The number of unique
patients seen by the EP or the number
of unique patients discharged from an
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period.
Numerator: The number of patients in
the denominator who were provided
electronic access to patient-specific
educational resources using clinically
relevant information identified from
CEHRT.
Threshold: The resulting percentage
must be more than 35 percent in order
for a provider to meet this measure.
Exclusions: An EP may exclude from
the measure if they have no office visits
during the EHR reporting period.
Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude the
measure.
Any eligible hospital or CAH will be
excluded from the measure if it is
located in a county that does not have
50 percent or more of their housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC at
the start of the EHR reporting period.
Alternate Proposals:
We note that for measure one we are
seeking comment on the following set of
alternate proposals for providers to meet
the measure using the functions of
CEHRT outlined previously in this
section. These alternate proposals
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involve the requirements to use a view,
download, and transmit function or an
API to provide patients access to their
health information. We believe the
current view, download, and transmit
functions are widely in use and
represent the current standard for
patient access to their health record.
However, we believe that the use of
APIs could potentially replace this
function and move toward a more
accessible means for patients to access
their information. Therefore, we are
seeking comment on alternatives which
would present a different mix of CEHRT
functionality for providers to use for
patients seeking to access their records.
The proposed first measure discussed
previously would allow providers the
option either to give patients access to
the view, download, and transmit
functionality, or to give patients access
to an API. Specifically, we are seeking
comment on whether the API option
should be required rather than optional
for providers, and if so, should
providers also be required to offer the
view, download, and transmit function.
Proposed Measure 1: For more than
80 percent of all unique patients seen by
the EP or discharged from the eligible
hospital or CAH inpatient or emergency
department (POS 21 or 23):
(1) The patient (or patient-authorized
representative) is provided access to
view online, download, and transmit
their health information within 24 hours
of its availability to the provider; or
(2) The patient (or the patientauthorized representative) is provided
access to an ONC-certified API that can
be used by third-party applications or
devices to provide patients (or patient
authorized representatives) access to
their health information, within 24
hours of its availability to the provider.
Alternate A: For more than 80 percent
of all unique patients seen by the EP or
discharged from the eligible hospital or
CAH inpatient or emergency department
(POS 21 or 23):
(1) The patient (or the patientauthorized representative) is provided
access to view online, download, and
transmit his or her health information
within 24 hours of its availability to the
provider; and
(2) The patient (or patient-authorized
representatives) is provided access to an
ONC-certified API that can be used by
third-party applications or devices to
provide patients (or patient authorized
representatives) access to their health
information within 24 hours of its
availability to the provider.
Alternate B: For more than 80 percent
of all unique patients seen by the EP or
discharged from the eligible hospital or
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CAH inpatient or emergency department
(POS 21 or 23):
(1) The patient (or patient-authorized
representative) is provided access to
view online, download, and transmit
their health information within 24 hours
of its availability to the provider; and
the patient (or patient-authorized
representative) is provided access to an
ONC-certified API that can be used by
third-party applications or devices to
provide patients (or patient authorized
representatives) access to their health
information within 24 hours of its
availability to the provider; or,
(2) The patient (or patient-authorized
representatives) is provided access to an
ONC-certified API that can be used by
third-party applications or devices to
provide patients (or patient authorized
representatives) access to their health
information within 24 hours of its
availability to the provider.
Alternate C: For more than 80 percent
of all unique patients seen by the EP or
discharged from the eligible hospital or
CAH inpatient or emergency department
(POS 21 or 23), the patient (or patientauthorized representative) is provided
access to an ONC-certified API that can
be used by third-party applications or
devices to provide patients (or patientauthorized representatives) access to
their health information, within 24
hours of its availability to the provider.
These three alternate proposals would
represent different use cases for the
CEHRT function to support view,
download, and transmit and/or API
functionality. We note that under these
proposed alternates the following mix of
functions would be applicable:
Alternate A would require both
functions to be available instead of
allowing the provider to choose between
the two; Alternate B would require the
provider to choose to have either both
functions, or just an API function; and
Alternate C would require the provider
to only have the API function. For
Alternate C, the use of a separate view,
download, and transmit function would
be entirely at the provider’s discretion
and not included as part of the
definition of meaningful use.
We welcome public comment on
these proposals.
Objective 6: Coordination of Care
Through Patient Engagement
As mentioned previously, the Stage 1
and Stage 2 final rules included a
number of objectives focused on patient
access to health information and
communication among providers, care
teams, and patients. These patient
engagement objectives focused on
changing behaviors among providers
and patients to promote patient
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involvement in health care. Specifically,
the objectives included supporting
provider and patient communication
about their health, improving overall
patient health literacy, and supporting
patient-driven coordination with
providers and other members of the
patient’s care team. The Stage 1 and
Stage 2 objectives included patient
reminders (77 FR 54005 through 54007),
patient-specific education resources (77
FR 54011 through 54012), clinical
summaries of office visits (77 FR 53998
through 54002), secure messaging (77
FR 54031 through 54033), and the
ability for patients to view, download,
and transmit their health information to
a third party (77 FR 54007 through
54011). For Stage 3, as mentioned
previously, we are proposing to
incorporate the Stage 2 objectives
related to providing patients with access
to health information into a new Stage
3 objective entitled, ‘‘Patient Electronic
Access’’ (Objective 5). For the proposed
objective entitled Coordination of Care
through Patient Engagement (Objective
6), we are proposing to incorporate the
policy goals of the Stage 2 objectives
related to secure messaging, patient
reminders, and the measure of patient
engagement requiring patients (or their
authorized representatives) to view,
download, and transmit their health
information using the functionality of
the certified EHR technology.
As mentioned previously, while we
believe there may be many methods of
communication and information sharing
among providers, or other care team
members, and patients (including paperbased or telephone communications),
meaningful use Stage 3 focuses
exclusively on electronic, certified EHR
technology supported communication
in the requirements outlined in this
proposed objective for Coordination of
Care through Patient Engagement.
Proposed Objective: Use
communications functions of certified
EHR technology to engage with patients
or their authorized representatives about
the patient’s care.
Specifically, this proposed rule
focuses on encouraging the use of EHR
functionality for secure dialogue and
efficient communication between
providers, care team members, and
patients about their care and health
status, as well as important health
information such as preventative and
coordinated care planning. In addition,
certified EHR technology functions
designed to support patient engagement
can be a platform to securely capture
and record patient-generated health data
and information provided in nonclinical care settings.
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We are also proposing to expand the
options through which providers may
engage with patients under the EHR
Incentive Programs including the use of
APIs as mentioned previously. An API
can enable a patient—through a thirdparty application—to access and
retrieve their health information from a
care provider in a way that is most
valuable to that particular patient.
Therefore, we are proposing a
meaningful use objective for Stage 3 to
support this provider and patient
engagement continuum based on the
foundation already created within the
EHR Incentive Programs but using new
methods and expanded options to
advance meaningful patient engagement
and patient-centered care. We also
propose that for purposes of this
objective, patient engagement may
include patient-centered
communication between and among
providers facilitated by authorized
representatives of the patient and of the
EP, eligible hospital, or CAH. As care
delivery evolves, the participation of a
diverse group of care team members
enables more robust care for the patient.
Engagement between the patient and,
for example, nutritionists, social
workers, physical therapists, or other
members of the provider’s care team is
crucial to effective patient engagement
and are therefore included in this
objective.
For Stage 3 of meaningful use, we
propose the following measures for the
Patient Engagement Objective:
Proposed Measures: We are proposing
that providers must attest to the
numerator and denominator for all three
measures, but would only be required to
successfully meet the threshold for two
of the three proposed measures to meet
the Coordination of Care through Patient
Engagement Objective. These three
measures support the communication
continuum between providers, patients,
and the patient’s authorized
representatives through the use of view,
download, and transmit functionality.
They also support using API
functionality through patient
engagement with their health data, but
also potentially through secure
messaging functions and standards, and
the capture and inclusion of data
collected from non-clinical settings,
including patient-generated health data.
Proposed Measure 1: During the EHR
reporting period, more than 25 percent
of all unique patients seen by the EP or
discharged from the eligible hospital or
CAH inpatient or emergency department
(POS 21 or 23) actively engage with the
electronic health record made accessible
by the provider. An EP, eligible hospital
or CAH may meet the measure by either:
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(1) More than 25 percent of all unique
patients (or patient-authorized
representatives) seen by the EP or
discharged from the eligible hospital or
CAH inpatient or emergency department
(POS 21 or 23) during the EHR reporting
period view, download or transmit to a
third party their health information; or
(2) More than 25 percent of all unique
patients (or patient-authorized
representatives) seen by the EP or
discharged from the eligible hospital or
CAH inpatient or emergency department
(POS 21 or 23) during the EHR reporting
period access their health information
through the use of an ONC-certified API
that can be used by third-party
applications or devices.
Proposed Measure 2: For more than
35 percent of all unique patients seen by
the EP or discharged from the eligible
hospital or CAH inpatient or emergency
department (POS 21 or 23) during the
EHR reporting period, a secure message
was sent using the electronic messaging
function of CEHRT to the patient (or the
patient’s authorized representatives), or
in response to a secure message sent by
the patient (or the patient’s authorized
representative).
Proposed Measure 3: Patientgenerated health data or data from a
non-clinical setting is incorporated into
the certified EHR technology for more
than 15 percent of all unique patients
seen by the EP or discharged by the
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period.
For measure 1, we are proposing to
increase the threshold for the measure
from 5 percent to 25 percent based on
provider performance on the related
Stage 2 measure requiring more than 5
percent of patients to view, download,
or transmit to a third party the health
information made available to them by
the provider. Stage 2 median
performance for an EP on this measure
is 32 percent and 11 percent for eligible
hospitals.11 Therefore, we are proposing
more than 25 percent of all unique
patients (or the patient’s authorized
representatives) seen by the EP, eligible
hospital or CAH during the EHR
reporting period must view, download,
or transmit to a third party their health
information or access their health
information through the use of an ONCcertified API that can be used by thirdparty applications or devices. For the
API option, we propose that providers
must attest that they have enabled an
API and that at least one application
11 Data can be found on CMS Web site Data and
Program Reports page: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
EHRIncentivePrograms/DataAndReports.html.
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which leverages the API is available to
patients (or the patient-authorized
representatives) to retrieve health
information from the provider’s certified
EHR.
CMS recognizes that there may be
inherent challenges in measuring
patient access to CEHRT through thirdparty applications that utilize an ONCcertified API, and we solicit comment
on the nature of those challenges and
what solutions can be put in place to
overcome them. For example, are there
specific requirements around the use of
APIs or are there specific certification
requirements for APIs that could make
the measurement of this objective easier.
We also solicit comment on suggested
alternate proposals for measuring
patient access to CEHRT through thirdparty applications that utilize an API,
including the pros and cons of
measuring a minimum number of
patients (one or more) who must access
their health information through the use
of an API in order to meet the measure
of this objective.
For measure 2, the EP, eligible
hospital, CAH, or the provider’s
authorized representative must
communicate with the patient (or the
patient’s authorized representatives),
through secure electronic messaging for
more than 35 percent of the unique
patients seen by the provider during the
EHR reporting period. ‘‘Communicate’’
means when a provider sends a message
to a patient (or the patient’s authorized
representatives) or when a patient (or
the patient’s authorized representatives)
sends a message to the provider. In
patient-to-provider communication, the
provider must respond to the patient (or
the patient’s authorized representatives)
for purposes of this measure. We
propose to increase the threshold for
this measure over the threshold for the
Stage 2 measure because for Stage 3
provider initiated messages would
count toward the measure numerator.
For measure 2, we propose to include
in the measure numerator situations
where providers communicate with
other care team members using the
secure messaging function of certified
EHR technology, and the patient is
engaged in the message and has the
ability to be an active participant in the
conversation between care providers.
However, we seek comment on how this
action could be counted in the
numerator, and the extent to which that
interaction could or should be counted
for eligible providers engaged in the
communication. For example, should
only the initiating provider be allowed
to include the communication as an
action in the numerator? Or, should any
provider who contributes to such a
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message during the EHR reporting
period be allowed to count the
communication? In addition, we seek
comment on what should be considered
a contribution to the patient-centered
communication; for example, a
contribution must be active
participation or response, a contribution
may be viewing the communication, or
a contribution may be simple inclusion
in the communication.
We specify that the secure messages
sent should contain relevant health
information specific to the patient in
order to meet the measure of this
objective. We believe the provider is the
best judge of what health information
should be considered relevant in this
context. For the purposes of this
measure, we are proposing that secure
messaging content may include, but is
not limited to, questions about test
results, problems, and medications;
suggestions for follow-up care or
preventative screenings; confirmations
of diagnosis and care plan goals; and
information regarding patient progress.
However, we note that messages with
content exclusively relating to billing
questions, appointment scheduling, or
other administrative subjects should not
be included in the numerator. For care
team secure messaging with the patient
included in the conversation, we also
believe the provider may exercise
discretion if further communications
resulting from the initial action should
be excluded from patient disclosure to
prevent harm. We note that if such a
message is excluded, all subsequent
actions related to that message would
not count toward the numerator.
For measure 3, EPs, eligible hospitals,
and CAHs (or their authorized
representatives) must incorporate health
data obtained from a non-clinical setting
in a patient’s electronic health record
for more than 15 percent of unique
patients seen during the EHR reporting
period. We note that the use of the term
‘‘clinical’’ means different things in
relation to place of service for billing for
Medicare and Medicaid services.
However, for purposes of this measure
only, we are proposing that a nonclinical setting shall be defined as a
setting with any provider who is not an
EP, eligible hospital or CAH as defined
for the Medicare and Medicaid EHR
Incentive Programs. Therefore, for this
measure, a non-clinical setting is any
provider or setting of care which is not
an EP, eligible hospital, or CAH in
either the Medicare or Medicaid EHR
Incentive Programs and where the care
provider does not have shared access to
the EP, eligible hospital, or CAHs
certified EHR. This may include, but is
not limited to, health and care-related
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data from care providers such as
nutritionists, physical therapists,
occupational therapists, psychologists,
and home health care providers as well
as data obtained from patients
themselves. We specifically mention
this last item and refer to this subcategory as patient-generated health
data, which may result from patient selfmonitoring of their health (such as
recording vital signs, activity and
exercise, medication intake, and
nutrition), either on their own, or at the
direction of a member of the care team.
We are proposing this measure in
response to requests from providers to
support the capture and incorporation
of patient-generated health data, and the
capture and incorporation of data from
a non-clinical setting into an EHR.
Providers have expressed a desire to
have this information captured in a
useful and structured way and made
available in the EHR. The capture and
incorporation of this information is an
integral part of ensuring that providers
and patients have adequate information
to partner in making clinical care
decisions, especially for patients with
chronic disease and complex health
conditions for whom self-monitoring is
an important part of an ongoing care
plan.
We are seeking comment on how the
information for measure 3 could be
captured, standardized, and
incorporated into an EHR. For the
purposes of this measure, the types of
data that would satisfy the measure is
broad. It may include, but is not limited
to social service data, data generated by
a patient or a patient’s authorized
representatives, advance directives,
medical device data, home health
monitoring data, and fitness monitor
data. In addition, the sources of data
vary and may include mobile
applications for tracking health and
nutrition, home health devices with
tracking capabilities such as scales and
blood pressure monitors, wearable
devices such as activity trackers or heart
monitors, patient reported outcome
data, and other methods of input for
patient and non-clinical setting
generated health data. We emphasize
that these represent several examples of
the data types that could be covered
under this measure. We also note that
while the scope of data covered by this
measure is broad, it may not include
data related to billing, payment, or other
insurance information. As part of
determining the proper scope of this
measure, we are seeking comment on
the following questions:
• Should the data require verification
by an authorized provider?
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• Should the incorporation of the
data be automated?
• Should there be structured data
elements available for this data as fields
in an EHR?
• Should the data be incorporated in
the CEHRT with or without provider
verification?
• Should the provenance of the data
be recorded in all cases and for all types
of data?
We also seek comment on whether
this proposed measure should have a
denominator limited to patients with
whom the provider has multiple
encounters, such as unique patients
seen by the provider two or more times
during the EHR reporting period. We
also seek comment on whether this
measure should be divided into two
distinct measures. The first measure
would include only the specific subcategory of patient-generated health
data, or data generated predominantly
through patient self-monitoring rather
than by a provider. The second measure
would include all other data from a nonclinical setting. This would result in the
objective including four measures with
providers having an option of which
two measures to focus on for the EHR
reporting period.
We also seek comment on whether the
third measure should be proposed for
eligible hospitals and CAHs, or remain
an option only for eligible professionals.
For those commenters who believe it
should not be applicable for eligible
hospitals and CAHs, we seek further
comment on whether eligible hospitals
and CAHs should then choose one of
the remaining two measures or be
required to attest to both.
Providers must attest to the numerator
and denominator for all three measures,
and must meet the threshold for two of
the three measures to meet the objective
for Stage 3 of meaningful use:
Proposed Measure 1: We have
identified the following for measure 1 of
this objective:
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Option 1: View, Download, or Transmit
to a Third Party
Denominator: Number of unique
patients seen by the EP, or the number
of unique patients discharged from an
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period.
Numerator: The number of unique
patients (or their authorized
representatives) in the denominator who
have viewed online, downloaded, or
transmitted to a third party the patient’s
health information.
Threshold: The resulting percentage
must be more than 25 percent in order
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for an EP, eligible hospital, or CAH to
meet this measure.
Option 2: API
Denominator: The number of unique
patients seen by the EP or the number
of unique patients discharged from an
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period.
Numerator: The number of unique
patients (or their authorized
representatives) in the denominator who
have accessed their health information
through the use of an an ONC-certified
API.
Threshold: The resulting percentage
must be more than 25 percent in order
for an EP, eligible hospital, or CAH to
meet this measure.
Exclusions: Applicable for either
option discussed previously, the
following providers may exclude from
the measure:
Any EP who has no office visits
during the EHR reporting period may
exclude from the measure.
Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude from the
measure.
Any eligible hospital or CAH
operating in a location that does not
have 50 percent or more of its housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC on
the first day of the EHR reporting period
may exclude from the measure.
Measure 2: Denominator: Number of
unique patients seen by the EP or the
number of unique patients discharged
from an eligible hospital or CAH
inpatient or emergency department
(POS 21 or 23) during the EHR reporting
period.
Numerator: The number of patients in
the denominator for whom a secure
electronic message is sent to the patient,
the patient’s authorized representatives,
or in response to a secure message sent
by the patient.
Threshold: The resulting percentage
must be more than 35 percent in order
for an EP, eligible hospital, or CAH to
meet this measure.
Exclusion: Any EP who has no office
visits during the EHR reporting period
may exclude from the measure.
Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
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latest information available from the
FCC on the first day of the EHR
reporting period may exclude from the
measure.
Any eligible hospital or CAH
operating in a location that does not
have 50 percent or more of its housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC on
the first day of the EHR reporting period
may exclude from the measure.
Measure 3: Denominator: Number of
unique patients seen by the EP or the
number of unique patients discharged
from an eligible hospital or CAH
inpatient or emergency department
(POS 21 or 23) during the EHR reporting
period.
Numerator: The number of patients in
the denominator for whom data from
non-clinical settings, which may
include patient-generated health data, is
captured through the certified EHR
technology into the patient record.
Threshold: The resulting percentage
must be more than 15 percent in order
for an EP, eligible hospital, or CAH to
meet this measure.
Exclusion: Any EP who has no office
visits during the EHR reporting period
may exclude from the measure.
Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude from the
measure.
Any eligible hospital or CAH
operating in a location that does not
have 50 percent or more of its housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC on
the first day of the EHR reporting period
may exclude from the measure.
We seek comment on this proposed
objective and the related proposed
measures.
Objective 7: Health Information
Exchange
Improved communication between
providers caring for the same patient
can help providers make more informed
care decisions and coordinate the care
they provide. Electronic health records
and the electronic exchange of health
information, either directly or through
health information exchanges, can
reduce the burden of such
communication. The purpose of this
objective is to ensure a summary of care
record is transmitted or captured
electronically and incorporated into the
EHR for patients seeking care among
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different providers in the care
continuum, and to encourage
reconciliation of health information for
the patient. This objective promotes
interoperable systems and supports the
use of CEHRT to share information
among care teams.
Proposed Objective: The EP, eligible
hospital, or CAH provides a summary of
care record when transitioning or
referring their patient to another setting
of care, retrieves a summary of care
record upon the first patient encounter
with a new patient, and incorporates
summary of care information from other
providers into their EHR using the
functions of certified EHR technology.
In the Stage 2 final rule at 77 FR
53983, we described transitions of care
as the movement of a patient from one
setting of care (hospital, ambulatory
primary care practice, ambulatory
specialty care practice, long-term care,
home health, rehabilitation facility) to
another. Referrals are cases where one
provider refers a patient to another
provider, but the referring provider also
continues to provide care to the patient.
In this rule, we also recognize there may
be circumstances when a patient refers
himself or herself to a setting of care
without a provider’s prior knowledge or
intervention. These referrals may be
included as a subset of the existing
referral framework and they are an
important part of the care coordination
loop for which summary of care record
exchange is integral. Therefore, a
provider should include these instances
in their denominator for the measures if
the patient subsequently identifies the
provider from whom they received care.
In addition, the provider may count
such a referral in the numerator for each
measure if they undertake the action
required to meet the measure upon
disclosure and identification of the
provider from whom the patient
received care.
In the Stage 2 final rule, we indicated
that a transition or referral within a
single setting of care does not qualify as
a transition of care (77 FR 53983). We
received public comments and
questions requesting clearer
characterization of when a setting of
care can be considered distinct from
another setting of care. For example,
questions arose whether EPs who work
within the same provider practice are
considered the same or two distinct
settings of care. Similarly, questions
arose whether an EP who practices in an
outpatient setting that is affiliated with
an inpatient facility is considered a
separate entity. Therefore, for the
purposes of distinguishing settings of
care in determining the movement of a
patient, we explain that for a transition
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or referral, it must take place between
providers which have, at the minimum,
different billing identities within the
EHR Incentive Programs, such as a
different National Provider Identifiers
(NPI) or hospital CMS Certification
Numbers (CCN) to count toward this
objective.
Please note that a ‘‘referral’’ as
defined here and elsewhere in this
proposed rule only applies to the EHR
Incentive Programs and is not
applicable to other federal regulations.
We stated in the Stage 2 proposed rule
at 77 FR 13723 that if the receiving
provider has access to the medical
record maintained by the provider
initiating the transition or referral, then
the summary of care record would not
need to be provided and that patient
may be excluded from the denominators
of the measures for the objective. We
further note that this access may vary
from read-only access of a specific
record, to full access with authoring
capabilities, depending on provider
agreements and system implementation
among practice settings. In many cases,
a clinical care summary for transfers
within organizations sharing access to
an EHR may not be necessary, such as
a hospital sharing their CEHRT with
affiliated providers in ambulatory
settings who have full access to the
patient information. However, public
comments received and questions
submitted by the public on the Stage 2
Summary of Care Objective reveal that
there may be benefits to the provision of
a summary of care document following
a transition or referral of a patient, even
when access to medical records is
already available. For example, a
summary of care document would
notify the receiving provider of relevant
information about the latest patient
encounter as well as highlight the most
up-to-date information. In addition, the
‘‘push’’ of a summary of care document
may function as an alert to the recipient
provider of the transition that a patient
has received care elsewhere and would
encourage the provider to review a
patient’s medical record for follow-up
care or reconciliation of clinical
information.
Therefore, we are revising this
objective for Stage 3 to allow the
inclusion of transitions of care and
referrals in which the recipient provider
may already have access to the medical
record maintained in the referring
provider’s CEHRT, as long as the
providers have different billing
identities within the EHR Incentive
Program. We note that for a transition or
referral to be included in the numerator,
if the receiving provider already has
access to the CEHRT of the initiating
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provider of the transition or referral,
simply accessing the patient’s health
information does not count toward
meeting this objective. However, if the
initiating provider also sends a
summary of care document, this
transition can be included in the
denominator and the numerator, as long
as this transition is counted consistently
across the organization.
Proposed Measures: We are proposing
that providers must attest to the
numerator and denominator for all three
measures, but would only be required to
successfully meet the threshold for two
of the three proposed measures to meet
the Health Information Exchange
Objective.
Proposed Measure 1: For more than
50 percent of transitions of care and
referrals, the EP, eligible hospital or
CAH that transitions or refers their
patient to another setting of care or
provider of care: (1) creates a summary
of care record using CEHRT; and (2)
electronically exchanges the summary
of care record.
Proposed Measure 2: For more than
40 percent of transitions or referrals
received and patient encounters in
which the provider has never before
encountered the patient, the EP, eligible
hospital or CAH incorporates into the
patient’s EHR an electronic summary of
care document from a source other than
the provider’s EHR system.
Proposed Measure 3: For more than
80 percent of transitions or referrals
received and patient encounters in
which the provider has never before
encountered the patient, the EP, eligible
hospital, or CAH performs a clinical
information reconciliation. The provider
must implement clinical information
reconciliation for the following three
clinical information sets:
• Medication. Review of the patient’s
medication, including the name, dosage,
frequency, and route of each
medication.
• Medication allergy. Review of the
patient’s known allergic medications.
• Current Problem list. Review of the
patient’s current and active diagnoses.
For the first measure, we are
maintaining the requirements
established in the Stage 2 final rule to
capture structured data within the
certified EHR and to generate a
summary of care document using
CEHRT for purposes of this measure (77
FR 54014). For purposes of this
measure, we are requiring that the
summary of care document created by
CEHRT be sent electronically to the
receiving provider.
In the Stage 2 final rule at 77 FR
54016, we specified all summary of care
documents must include the following
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information in order to meet the
objective, if the provider knows it:
• Patient name.
• Referring or transitioning provider’s
name and office contact information (EP
only).
• Procedures.
• Encounter diagnosis.
• Immunizations.
• Laboratory test results.
• Vital signs (height, weight, blood
pressure, BMI).
• Smoking status.
• Functional status, including
activities of daily living, cognitive and
disability status.
• Demographic information
(preferred language, sex, race, ethnicity,
date of birth).
• Care plan field, including goals and
instructions.
• Care team including the primary
care provider of record and any
additional known care team members
beyond the referring or transitioning
provider and the receiving provider.
• Discharge instructions (Hospital
Only).
• Reason for referral (EP only).
For the 2015 Edition proposed rule,
ONC has proposed a set of criteria
called the Common Clinical Data Set
which include the required elements for
the summary of care document, the
standards required for structured data
capture of each, and further definition
of related terminology and use.
Therefore, for Stage 3 of meaningful use
we are proposing that summary of care
documents used to meet the Stage 3
Health Information Exchange objective
must include the requirements and
specifications included in the Common
Clinical Data Set (CCDS) specified by
ONC for certification to the 2015 Edition
proposed rule published elsewhere in
this issue of the Federal Register.
We note that ONC’s 2015 Edition
proposed rule may include additional
fields beyond those initially required for
Stage 2 of meaningful use as new
standards have been developed to
accurately capture vital information on
patient health. For example, the 2015
Edition proposed rule includes a
criterion and standard for capturing the
unique device identifier (UDI) for
implantable medical devices. The
inclusion of the UDI in the CCDS
reflects the understanding that UDIs are
an important part of patient information
that should be exchanged and available
to providers who care for patients with
implanted medical devices. Hundreds of
thousands of Medicare beneficiaries
receive some type of implantable
medical device each year. Some
implants require ongoing monitoring
and medication for the device to
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perform effectively, such as a
mechanical heart valve. Other
implanted devices are affected by
imaging procedures and are not MRI
safe such as some pace makers. Even the
variation between specific makes and
models of similar devices may impact
the clinical processes required to
mitigate against patient safety risk.
Without readily available data, the
patient is put at risk if the provider does
not have adequate knowledge of the
existence and specific details of medical
implants. Therefore, the documentation
of UDIs in a patient medical record and
the inclusion of that data field within
the CCDS requirements for the summary
of care documents is a key step toward
improving the quality of care and
ensuring patient safety. This example
highlights the importance of capturing
health data in a structured format using
specified, transferable standards.
In circumstances where there is no
information available to populate one or
more of the fields included in the CCDS,
either because the EP, eligible hospital,
or CAH can be excluded from recording
such information (for example, vital
signs) or because there is no information
to record (for example, laboratory tests),
the EP, eligible hospital, or CAH may
leave the field blank and still meet the
requirements for the measure.
However, all summary of care
documents used to meet this objective
must be populated with the following
information using the CCDS
certification standards for those fields:
• Current problem list (Providers may
also include historical problems at their
discretion).
• A current medication list.
• A current medication allergy list.
We define allergy as an exaggerated
immune response or reaction to
substances that are generally not
harmful. Information on problems,
medications, and medication allergies
could be obtained from previous
records, transfer of information from
other providers (directly or indirectly),
diagnoses made by the EP or hospital,
new medications ordered by the EP or
in the hospital, or through querying the
patient.
We propose to maintain that all
summary of care documents contain the
most recent and up-to-date information
on all elements. In the event that there
are no current diagnoses for a patient,
the patient is not currently taking any
medications, or the patient has no
known medication allergies; the EP,
eligible hospital, or CAH must record or
document within the required fields
that there are no problems, no
medications, or no medication allergies
recorded for the patient to satisfy the
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measure of this objective. The EP or
hospital must verify that the fields for
problem list, medication list, and
medication allergy list are not blank and
include the most recent information
known by the EP or hospital as of the
time of generating the summary of care
document.
For summary of care documents at
transitions of care, we encourage
providers to send a list of items that he
or she believes to be pertinent and
relevant to the patient’s care, rather than
a list of all problems, whether active or
resolved, that have ever populated the
problem list. While a current problem
list must always be included, the
provider can use his or her judgment in
deciding which items historically
present on the problem list, medical
history list (if it exists in CEHRT), or
surgical history list are relevant given
the clinical circumstances.
Similarly, for Stage 3 we have
received comments from stakeholders
and through public forums and
correspondence on the potential of
allowing only clinically relevant
laboratory test results and clinical notes
(rather than all laboratory tests results
and clinical notes) in the summary of
care document for purposes of meeting
the objective. We believe that while
there may be a benefit and efficiency to
be gained in the potential to limit
laboratory test results or clinical notes
to those most relevant for a patient’s
care; a single definition of clinical
relevance may not be appropriate for all
providers, all settings, or all individual
patient diagnosis. Furthermore, we note
that should a reasonable limitation
around a concept of ‘‘clinical relevance’’
be added; a provider must still have the
CEHRT functionality to include and
send all labs or clinical notes. Therefore,
we defer to provider discretion on the
circumstances and cases wherein a
limitation around clinical relevance
may be beneficial and note that such a
limitation would be incumbent on the
provider to define and develop in
partnership with their health IT
developer as best fits their
organizational needs and patient
population. We specify that while the
provider has the discretion to define the
relevant clinical notes or relevant
laboratory results to send as part of the
summary of care record, providers must
be able to provide all clinical notes or
laboratory results through an electronic
transmission of a summary of care
document if that level of detail is
subsequently requested by a provider
receiving a transition of care or referral
or the patient is transitioning to another
setting of care. We note that this
proposal would apply for lab results,
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clinical notes, problem lists, and the
care plan within the summary of care
document.
For the second measure, we are
proposing to address the other end of
the transition of care continuum. In the
Stage 2 rule, we limited the action
required by providers to sending an
electronic transmission of a summary of
care document. We did not have a
related requirement for the recipient of
that transmission. We did not adopt a
certification requirement for the
receiving end of a transition or referral
or for the measure related to sending the
summary, as that is a factor outside the
sending provider’s immediate control.
However, in Stage 3 of meaningful use,
we are proposing a measure for the
provider as the recipient of a transition
or referral requiring them to actively
seek to incorporate an electronic
summary of care document into the
patient record when a patient is referred
to them or otherwise transferred into
their care. This proposal is designed to
complete the electronic transmission
loop and support providers in using
CEHRT to support the multiple roles a
provider plays in meaningful health
information exchange.
For the purposes of defining the cases
in the denominator, we are proposing
that what constitutes ‘‘unavailable’’ and
therefore, may be excluded from the
denominator, will be that a provider—
• Requested an electronic summary of
care record to be sent and did not
receive an electronic summary of care
document; and
• Queried at least one external source
via HIE functionality and did not locate
a summary of care for the patient, or the
provider does not have access to HIE
functionality to support such a query.
We seek comment on whether
electronic alerts received by EPs from
hospitals when a patient is admitted,
seen in the emergency room or
discharged from the hospital—so called
‘‘utilization alerts’’—should be included
in measure two, or as a separate
measure. Use of this form of health
information exchange is increasingly
rapidly, driven by hospital and EP
efforts to improve care transitions and
reduce readmissions. We also seek
comment on which information from a
utilization alert would typically be
incorporated into a patient’s record and
how this is done today.
For both the first and second
measures, we are proposing that a
provider may use a wide range of health
IT system for health information
exchange to receive or send an
electronic summary of care document,
but must use their certified EHR
technology to create the summary of
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care document sent or to incorporate the
summary of care document received
into the patient record. We are also
proposing that the receipt of the
summary of care document (CCDA) may
be passive (provider is sent the CCDA
and incorporates it) or active (provider
requests a direct transfer of the CCDA or
provider queries an HIE for the CCDA).
In the Stage 2 proposed rule, we noted
the benefits of requiring standards for
the transport mechanism for health
information exchange consistently
nationwide (77 FR 13723). We requested
public comment in that proposed rule
on the Nationwide Health Information
Network specifications and a
governance mechanism for health
information exchange to be established
by ONC. In the final rule, a governance
mechanism option was included in the
second measure for the Stage 2
summary of care objective at 77 FR
54020. In this Stage 3 proposed rule, we
again seek comment on a health
information exchange governance
mechanism. Specifically we seek
comment on whether providers who
create a summary of care record using
CEHRT for purposes of Measure 1
should be permitted to send the created
summary of care record either—(1)
through any electronic means; or (2) in
a manner that is consistent with the
governance mechanism ONC establishes
for the nationwide health information
network. We additionally seek comment
on whether providers who are receiving
a summary of care record using CEHRT
for the purposes of Measure 2 should
have a similar requirement for the
transport of summary of care documents
requested from a transitioning provider.
Finally, we seek comment on how a
governance mechanism established by
ONC at a later date could be
incorporated into the EHR Incentive
Programs for purposes of encouraging
interoperable exchange that benefits
patients and providers, including how
the governance mechanism should be
captured in the numerator,
denominator, and thresholds for both
the first (send) and second (receive)
measures of this Health Information
exchange objective.
For the third measure, we are
proposing a measure of clinical
information reconciliation which
incorporates the Stage 2 objective for
medication reconciliation and expands
the options to allow for the
reconciliation of other clinical
information such as medication
allergies, and problems which will
allow providers additional flexibility in
meeting the measure in a way that is
relevant to their scope of practice. In the
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Stage 2 final rule, we outlined the
benefits of medication reconciliation,
which enables providers to validate that
the patient’s list of active medications is
accurate (77 FR 54011 through 54012).
This activity improves patient safety,
improves care quality, and improves the
validity of information that the provider
shares with others through health
information exchange. We believe that
reconciliation of medication allergies
and problems affords similar benefits.
For this proposed measure, we specify
that the EP, eligible hospital, or CAH
that receives the patient into their care
should conduct the clinical information
reconciliation. It is for the receiving
provider that up-to-date information
will be most crucial to make informed
clinical judgments for patient care. We
reiterate that this measure does not
dictate what subset of information must
be included in reconciliation.
Information included in the process is
determined by the provider’s clinical
judgment of what is most relevant to
patient care.
For this measure, we propose to
define clinical information
reconciliation as the process of creating
the most accurate patient-specific
information in one or more of the
specified categories by using the clinical
information reconciliation capability of
their certified EHR technology which
will compare the ‘‘local’’ information to
external/incoming information that is
being incorporated into the certified
EHR technology from any external
source. We refer providers to the
standards and certification criteria for
clinical information reconciliation
proposed in ONC’s 2015 Edition
proposed rule published elsewhere in
this issue of the Federal Register.
As with medication reconciliation, we
believe that an electronic exchange of
information following the transition of
care of a patient is the most efficient
method of performing clinical
information reconciliation.
We recognize that workflows to
reconcile clinical information vary
widely across providers and settings of
care, and we request comment on the
challenges that this objective might
present for providers, and how such
challenges might be mitigated, while
preserving the policy intent of the
measure. In particular, we solicit
comment on the following:
• Automation and Manual
Reconciliation. The Stage 2 measure
does not specify whether reconciliation
must be automated or manual. Some
providers have expressed concern over
the automatic inclusion of data in the
patient record from referring providers,
while others have indicated that
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requiring manual reconciliation imposes
significant workflow burden. We also
seek comment on whether the use and
display of meta-tagged data could
address concerns related to the origin of
data and thereby permit more
automated reconciliation of these data
elements.
• Review of Reconciled Information.
Depending on clinical setting, this
measure could be accomplished through
manual reconciliation or through
automated functionality. In either
scenario, should the reconciliation or
review of automated functionality be
performed only by the same staff
allowed under the Stage 3 requirements
for the Computerized Provider Order
Entry objective?
• What impact would the
requirement of clinical information
reconciliation have on workflow for
specialists? Are there particular
specialties where this measure would be
difficult to meet?
• What additional exclusions, if any,
should be considered for this measure?
We also encourage comment on the
proposal to require reconciliation of all
three clinical information reconciliation
data sets, or if we should potentially
require providers to choose 2 of 3
information reconciliation data sets
relevant to their specialty or patient
population. We expect that most
providers would find that conducting
clinical information reconciliation for
medications, medication allergies, and
problem lists is relevant for every
patient encountered. We solicit
examples describing challenges and
burdens that providers who deliver
specialist care or employ unique clinical
workflow practices may experience in
completing clinical information
reconciliation for all three data sets and
whether an exclusion should be
considered for providers for whom such
reconciliation may not be relevant to
their scope of practice or patient
population. Additionally, we solicit
comments around the necessity to
conduct different types of clinical
information reconciliation of data for
each individual patient. For example, it
is possible that the data for certain
patients should always be reviewed for
medication allergy reconciliation, when
it may not be as relevant to other patient
populations.
We propose that to meet this
objective, a provider must attest to the
numerator and denominator for all three
measures but would only be required to
successfully meet the threshold for two
of the three proposed measures. We
invite public comment on this proposal.
Measure 1: To calculate the
percentage of the first measure, CMS
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and ONC have worked together to
define the following for this measure:
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 exchanged electronically.
Threshold: The percentage must be
more than 50 percent in order for an EP,
eligible hospital, or CAH to meet this
measure.
Exclusion: An EP neither transfers a
patient to another setting nor refers a
patient to another provider during the
EHR reporting period.
* Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude the
measures.
Any eligible hospital or CAH will be
excluded from the measure if it is
located in a county that does not have
50 percent or more of their housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC at
the start of the EHR reporting period.
Measure 2: To calculate the
percentage of the second measure, CMS
and ONC have worked together to
define the following for this measure:
Denominator: Number of patient
encounters during the EHR reporting
period for which an EP, eligible
hospital, or CAH was the receiving party
of a transition or referral or has never
before encountered the patient and for
which an electronic summary of care
record is available.
Numerator: Number of patient
encounters in the denominator where an
electronic summary of care record
received is incorporated by the provider
into the certified EHR technology.
Threshold: The percentage must be
more than 40 percent in order for an EP,
eligible hospital, or CAH to meet this
measure.
Exclusion: Any EP, eligible hospital or
CAH for whom the total of transitions or
referrals received and patient
encounters in which the provider has
never before encountered the patient, is
fewer than 100 during the EHR
reporting period is excluded from this
measure.
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Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude the
measures.
Any eligible hospital or CAH will be
excluded from the measure if it is
located in a county that does not have
50 percent or more of their housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC at
the start of the EHR reporting period.
Measure 3: To calculate the
percentage, CMS and ONC have worked
together to define the following for this
measure:
Denominator: Number of transitions
of care or 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 recipient of the transition or
referral or has never before encountered
the patient.
Numerator: The number of transitions
of care or referrals in the denominator
where the following three clinical
information reconciliations were
performed: medication list, medication
allergy list, and current problem list.
Threshold: The resulting percentage
must be more than 80 percent in order
for an EP, eligible hospital, or CAH to
meet this measure.
Exclusion: Any EP, eligible hospital or
CAH for whom the total of transitions or
referrals received and patient
encounters in which the provider has
never before encountered the patient, is
fewer than 100 during the EHR
reporting period is excluded from this
measure.
Any EP that conducts 50 percent or
more of his or her patient encounters in
a county that does not have 50 percent
or more of its housing units with 4Mbps
broadband availability according to the
latest information available from the
FCC on the first day of the EHR
reporting period may exclude the
measure.
Any eligible hospital or CAH will be
excluded from the measure if it is
located in a county that does not have
50 percent or more of their housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC at
the start of the EHR reporting period.
We welcome comment on these
proposals.
Objective 8: Public Health and
Clinical Data Registry Reporting
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This objective builds on the
requirements set forth in the Stage 2
final rule (77 FR 54021 through 54026).
In addition, this objective includes
improvements to the Stage 2 measures,
supports innovation that has occurred
since the Stage 2 rule was released, and
adds flexibility in the options that an
eligible provider has to successfully
report.
Further, this objective places
increased focus on the importance of the
ongoing lines of communication that
should exist between providers and
public health agencies (PHAs) or as
further discussed later in this section,
between providers and clinical data
registries (CDRs). Providers’ use of
certified EHR technology can increase
the flow of secure health information
and reduce the burden that otherwise
could attach to these important
communications. The purpose of this
Stage 3 objective is to further advance
communication between providers and
PHAs or CDRs, as well as strengthen the
capture and transmission of such health
information within the care continuum.
In this Stage 3 proposed rule, we are
proposing 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. We
propose to include a new measure for
case reporting to reflect the diverse
ways that providers can electronically
exchange data with PHAs and CDRs. In
addition, we are using new terms such
as public health registries and clinical
data registries to incorporate the Stage 2
designations for cancer registries and
specialized registries under these
categories which are used in the health
care industry to designate a broader
range of registry types. We further
explain the use of these terms within
the specifications outlined for each
applicable measure.
Proposed Objective: The EP, eligible
hospital, or CAH is in active
engagement with a PHA or 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.
For Stage 3, we are proposing to
remove the prior ‘‘ongoing submission’’
requirement and replace it with an
‘‘active engagement’’ requirement.
Depending on the measure, the ongoing
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submission requirement from the Stage
1 and Stage 2 final rules required the
successful ongoing submission of
applicable data from certified EHR
technology to a PHA or CDR for the
entire EHR reporting period. As part of
the Stage 2 final rule, we provided
examples demonstrating how ongoing
submission could satisfy the measure
(77 FR 54021). However, stakeholders
noted that the ongoing submission
requirement does not accurately capture
the nature of communication between
providers and a PHA or CDR, and does
not consider the many steps necessary
to arrange for registry submission to a
PHA or CDR. Given this feedback, we
believe that ‘‘active engagement’’ as
defined later in this section is more
aligned with the process providers
undertake to report to a CDR 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
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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 also propose to provide support to
providers seeking to meet the
requirements of this objective by
creating a centralized repository of
national, state, and local PHA and CDR
readiness. In the Stage 2 final rule (77
FR 54021), we noted the benefits of
developing a centralized repository
where a PHA could post readiness
updates regarding their ability to accept
electronic data using specifications
prescribed by ONC for the public health
objectives. We also published, pursuant
to the Paperwork Reduction Act of 1995,
a notice in the Federal Register on
February 7, 2014 soliciting public
comment on the proposed information
collection required to develop the
centralized repository on public health
readiness (79 FR 7461). We considered
the comments and we now propose
moving forward with the development
of the centralized repository. The
centralized repository is integral to
meaningful use and is expected to be
available by the start of CY 2017. We
expect that the centralized repository
will include readiness updates for PHAs
and CDRs at the state, local, and
national level. We welcome your
comments on the use and structure of
the centralized repository.
Proposed Measures: We are proposing
a total of six possible measures for this
objective. EPs would be required to
choose from measures 1 through 5, and
would be required to successfully attest
to any combination of three measures.
Eligible hospitals and CAHs would be
required to choose from measures one
through six, and would be required to
successfully attest to any combination of
four measures. The measures are as
shown in Table 5. As noted, measures
four and five 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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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
Maximum
times measure
can count towards objective for eligible
hospital or
CAH
1
1
1
3
3
N/A
1
1
1
4
4
1
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 ..........................................................................................
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* EPs, eligible hospitals, and CAHs may choose to report to more than one public health registry 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 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 three measures. Instead, in order
to meet this objective, an EP would need
to meet three 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 three, the EP can
meet the objective by meeting all of the
remaining measures available to them
and claiming the applicable exclusions.
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 four
measures. Instead, in order to meet this
objective an eligible hospital or CAH
would need to meet four 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 four, the eligible hospital or CAH
can meet the objective by meeting all of
the remaining measures available to
them and claiming the applicable
exclusions. 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 will
aid the provider’s ability to care for their
patients.
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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
Stage 3 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 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 published by ONC elsewhere in
this issue of the Federal Register, 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 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
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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 for Measure 1: 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: (1) 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; (2) 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; or (3) operates in a
jurisdiction where no immunization
registry or immunization information
system has declared readiness to receive
immunization data 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 Stage 3 because
electronic syndromic surveillance is
valuable for early detection of
outbreaks, as well as monitoring disease
and condition trends. We are
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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
later in this section.
Exclusion for EPs for Measure 2: Any
EP meeting one or more of the following
criteria may be excluded from the
syndromic surveillance reporting
measure if the EP: (1) Does not treat or
diagnose or directly treat any disease or
condition associated with a syndromic
surveillance system in their jurisdiction;
(2) 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 (3) 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
for Measure 2: 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:
(1) Does not have an emergency or
urgent care department; (2) 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 (3) 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
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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. However,
electronic case reporting 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 laborintensive case reporting. Electronic
reporting will 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,
published elsewhere in this issue of the
Federal Register.
Exclusion for Measure 3: 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: (1) 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; (2) 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 (3) 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
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to be more specific (77 FR 54030). In
response to insight gained from the
industry through listening sessions,
public forums, and reponses to the
February 2014 Public Health Reporting
RFI; 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
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 will 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 final rule ‘‘2014 Edition,
Release 2 EHR Certification Criteria and
the ONC HIT Certification Program;
Regulatory Flexibilities, Improvements,
and Enhanced Health Information
Exchange’’ (79 FR 54468) and we
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
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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 registry 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. We note that
cancer case reporting is not an option
for eligible hospitals and CAHs under
this measure because hospitals have
traditionally diagnosed or treated
cancers and have the infrastructure
needed to report cancer cases.
Exclusions for Measure 4: 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: (1) Does not
diagnose or directly treat any disease or
condition associated with a public
health registry in their jurisdiction
during the EHR reporting period; (2)
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 (3) 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.12 We propose to further
differentiate between clinical data
registries and public health registries as
12 https://download.ama-assn.org/resources/doc/
cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf.
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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 one clinical data
registry to meet the total number of
required measures for this objective.
ONC will 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.
Exclusions for Measure 5: 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: (1) Does not
diagnose or directly treat any disease or
condition associated with a clinical data
registry in their jurisdiction during the
EHR reporting period; (2) 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 (3) 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 Stage 3 to promote the
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exchange of laboratory results between
eligible hospitals/CAHs and PHAs for
improved timeliness, reduction of
manual data entry errors, and more
complete information.
Exclusion for Measure 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 if the eligible
hospital or CAH: (1) Does not perform
or order laboratory tests that are
reportable in their jurisdiction during
the EHR reporting period; (2) 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 (3) operates in
a jurisdiction where no public health
agency has declared readiness to receive
electronic reportable laboratory results
from an eligible hospital or CAH at the
start of the EHR reporting period.
The Use of CEHRT for the Public
Health and Clinical Data Registry
Reporting Objective
As proposed previously, the Public
Health and Clinical Data Registry
Reporting objective requires active
engagement with a public health agency
to submit electronic public health data
from certified EHR technology. ONC
defined the standards and certification
criteria to meet the definition of CEHRT
in its 2011, 2014, and 2014 Release 2
Edition EHR certification criteria rules
(see section II.B. of the ‘‘2014 Edition,
Release 2 EHR Certification Criteria and
the ONC HIT Certification Program;
Regulatory Flexibilities, Improvements,
and Enhanced Health Information
Exchange’’ for a full description of
ONC’s regulatory history; (79 FR
54434)). For example, ONC adopted
standards for immunization reporting
(see § 170.314(f)(1) and (f)(2)), inpatient
syndromic surveillance (see
§ 170.314(f)(3) and (f)(7)), ELR (see
§ 170.314(f)(4)), and cancer case
reporting (see § 170.314(f)(5) and (f)(6))
in its 2014 Edition final rule.
We support ONC’s intent to promote
standardized and interoperable
exchange of public health data across
the country. Therefore, to meet all of the
measures within this public health
objective EPs, eligible hospitals, and
CAHs must use CEHRT as we propose
to define it under § 495.4 in this
proposed rule and use the standards
included in the 2015 Edition proposed
rule published elsewhere in this edition
of the Federal Register. We anticipate
that as new public health registries and
clinical data registries are created, ONC
and CMS will work with the public
health community and clinical specialty
societies to develop ONC-certified
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electronic reporting standards for those
registries so that providers have the
option to count participation in those
registries under the measures of this
objective. ONC will look to adopt such
standards, as appropriate, in future rules
published by ONC.
We welcome public comment on
these proposals.
II. Provisions of the Proposed
Regulations
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A. Meaningful Use Requirements,
Objectives and Measures
2. Certified EHR Technology (CEHRT)
Requirements
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 under 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 under 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).
On September 4, 2014, CMS and ONC
published a final rule in the Federal
Register (79 FR 52910 through 52933)
that, among other things, modified the
meaningful use requirements for 2014
and the CEHRT definition.
First, we granted flexibility to
providers who experienced product
availability issues that affected their
ability to fully implement EHR
technology certified to the 2014 Edition
of certification criteria (79 FR 52913
through 52926). We allowed those EPs,
eligible hospitals, and CAHs to continue
using either EHR technology certified to
the 2011 Edition, or a combination of
EHR technology certified to the 2011
Edition and 2014 Edition, for the EHR
reporting periods in CY 2014 and FY
2014. EPs, eligible hospitals, and CAHs
could take one of these approaches if
they were unable to fully implement
EHR technology certified to the 2014
Edition for an EHR reporting period in
2014 due to delays in the availability of
EHR technology certified to the 2014
Edition.
Second, we established that in order
to receive an incentive payment for
2014 under Medicaid for adopting,
implementing, or upgrading CEHRT, a
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provider must adopt, implement, or
upgrade to EHR technology certified to
the 2014 Edition and meet the CEHRT
definition (79 FR 52925 through 52926).
Finally, ONC revised the CEHRT
definition under 45 CFR 170.102 to
align with our policy allowing for the
use of EHR technology certified to the
2011 Edition, or a combination of EHR
technology certified to the 2011 Edition
and 2014 Edition, in 2014 (79 FR
52930).
For further detail on the changes to
the requirements for 2014 and CEHRT
definition, we refer readers to the 2014
CEHRT Flexibility final rule (79 FR
52910 through 52933).
a. CEHRT Definition for the EHR
Incentive Programs
As we have stated previously in
rulemaking, the statute and regulations
require EPs, eligible hospitals, and
CAHs to use ‘‘Certified EHR
Technology’’ if they are to be considered
meaningful EHR users and eligible for
incentive payments under Medicare or
Medicaid, and to avoid payment
adjustments under Medicare (for
example, see section 1848(o)(2)(A)(i) of
the Act, and 42 CFR 495.4). However, in
contrast to prior rulemaking cycles
where ONC has established a
meaningful-use-specific CEHRT
definition for the EHR Incentive
Programs that CMS has adopted by
cross-reference under 42 CFR 495.4, we
propose to take a different approach
under which we would define the term
‘‘Certified EHR Technology,’’ and that
definition would be specific to the EHR
Incentive Programs.
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 EHR
Incentive Programs is clearly referenced
in CMS regulations. For example, ONC’s
definition of CEHRT under 45 CFR
170.102 includes the compliance dates
for EPs, eligible hospitals, and CAHs to
use EHR technology certified to a
particular edition of certification criteria
to meet the CEHRT definition and for
purposes of the EHR Incentive
Programs, such as the requirement to
use EHR technology certified to the
2014 Edition beginning in 2015. Under
the proposed new approach, we would
establish through rulemaking for the
EHR Incentive Programs (either with
stand-alone rulemaking or through other
vehicles such as the annual Medicare
payment rules) the compliance dates by
which providers must use EHR
technology certified to a particular
edition of certification criteria to meet
the CEHRT definition, which would be
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reflected in our regulations under 42
CFR part 495 rather than ONC’s
regulations under 45 CFR part 170.
b. Defining CEHRT for 2015 Through
2017 and for 2018 and Subsequent
Years
In adopting a CEHRT definition
specific for the EHR Incentive Programs,
we propose to include, as currently for
the ONC CEHRT definition under 45
CFR 170.102, the relevant Base EHR
definitions adopted by ONC in 45 CFR
170.102 and other ONC certification
criteria relevant to the EHR Incentive
Programs. We refer readers to ONC’s
2015 Edition proposed rule published
elsewhere in this issue of the Federal
Register for the proposed 2015 Edition
Base EHR definition and discussion of
the 2014 Edition Base EHR definition.
We are including the Base EHR
definition(s) because as ONC explained
in the 2014 Edition final rule ‘‘2014
Edition, Release 2 EHR Certification
Criteria and the ONC HIT Certification
Program; Regulatory Flexibilities,
Improvements, and Enhanced Health
Information Exchange’’ (77 FR 54443
through 54444) the ‘‘Base EHR’’
essentially serves as a substitute for the
term ‘‘Qualified EHR’’ in the definition
of CEHRT. The term ‘‘Qualified EHR’’ is
defined in section 3000(13) of the
PHSA, to include certain capabilities
listed in that section, and is included in
the statutory definition of ‘‘certified
EHR technology’’ for the EHR Incentive
Programs (for example, see section
1848(o)(4) of the Act). The Base EHR
definition(s) also include additional
capabilities as proposed by ONC that we
agree all providers should have that are
participating in the EHR Incentive
Programs to support their attempts to
meet meaningful use objectives and
measures as well as interoperable health
information exchange.
We propose to define the editions of
certification criteria that may be used
for years 2015 through 2017 to meet the
CEHRT definition. At a minimum, EPs,
eligible hospitals, and CAHs would be
required to use EHR technology certified
to the 2014 Edition certification criteria
for their respective EHR reporting
periods in 2015 through 2017. A
provider may also upgrade to the 2015
Edition prior to 2018 to meet the
required certified EHR technology
definition for the EHR reporting periods
in 2015, 2016, or 2017, or they may use
a combination of 2014 and 2015
Editions prior to 2018 if they have
modules from both Editions which meet
the requirements for the objectives and
measures or if they fully upgrade during
an EHR reporting period.
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Based on experience with delays in
the availability of EHR technology
certified to the 2014 Edition for
providers to implement and use to meet
meaningful use for an EHR reporting
period in 2014, we propose to include
as part of the CEHRT definition a longer
period of time for providers to use
technology certified to the 2014 Edition
in an effort to give providers more time
in updating their technology to the 2015
Edition before the EHR reporting period
in 2018. We also propose to make the
use of a combination of technology
certified to the 2014 Edition and 2015
Edition to meet the CEHRT definition
more flexible in 2015 through 2017 by
taking into account ONC’s proposed
new privacy and security certification
approach for health IT (see ONC’s 2015
Edition proposed rule published
elsewhere in this issue of the Federal
Register). Specifically, as a provider
updates to technology certified to the
2015 Edition, the provider would not
necessarily need to continue to meet the
privacy and security capability
requirements of the 2014 Edition Base
EHR definition because the technology
they adopt certified to the 2015 Edition
would include necessary privacy and
security capabilities. Additionally,
because ONC is proposing, for the 2015
Edition, to no longer require
certification of Health IT Modules to
capabilities that support meaningful use
objectives with percentage-based
measures, we propose to include these
capabilities (45 CFR 170.314(g)(1) or (2)
or 45 CFR 170.315(g)(1) or (2)), as
applicable, in the CEHRT definition for
2015 through 2017 so that providers
have technology that can appropriately
record and calculate meaningful use
measures. We note that there are many
combinations of 2014 and 2015 Edition
certified technologies that could be used
to successfully meet the transitions of
care requirements included in the 2014
and 2015 Edition Base EHR definitions
for the purposes of meeting meaningful
use objectives and measures. We believe
we have identified all combinations in
the proposed regulation text under
§ 495.4 that could be used to meet the
CEHRT definition through 2017 and be
used for the purposes of meeting
meaningful use objectives and
measures. We welcome comments on
the accuracy of the identified available
options.
We propose that starting with 2018,
all EPs, eligible hospitals, and CAHs
would be required to use technology
certified to the 2015 Edition to meet the
CEHRT definition and demonstrate
meaningful use for an EHR reporting
period in 2018 and subsequent years.
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The CEHRT definition would include,
for the reasons discussed previously,
meeting the 2015 Edition Base EHR
definition and having other important
capabilities, that include the capabilities
to—
• Record or create and incorporate
family health history;
• Capture patient health information
such as advance directives;
• Record numerators and
denominators for meaningful use
objectives with percentage-based
measures and calculate the percentages;
• Calculate and report clinical quality
measures; and
• Any other capabilities needed to be
a Meaningful EHR User.
For information on 2015 Edition
certification criteria that include these
capabilities and are associated with
proposed Meaningful Use objectives for
Stage 3, please see the 2015 Edition
proposed rule published elsewhere in
this issue of the Federal Register. We
expect that the certification criteria with
capabilities that support CQM
calculation and reporting would be
jointly proposed with CQM reporting
requirements in a separate rulemaking.
c. Proposed Definition for CEHRT
For the reasons stated previously, we
propose to adopt a definition of
Certified EHR Technology under 42 CFR
495.4 for the Medicare and Medicaid
EHR Incentive Programs that would
apply for the EHR reporting periods in
2015 up to and including 2017 and for
the EHR reporting periods in 2018 and
subsequent years. We refer readers to
ONC’s 2015 Edition proposed rule
published elsewhere in this issue of the
Federal Register for further explanation
of the concepts and terms used in our
proposed definition of Certified EHR
Technology, including the 2014 Edition
Base EHR definition, 2015 Edition Base
EHR definition, certification criteria,
and the regulation text under 45 CFR
part 170.
B. Reporting on Clinical Quality
Measures Using Certified EHR
Technology by EPs, Eligible Hospitals,
and Critical Access Hospitals
1. Clinical Quality Measure (CQM)
Requirements for Meaningful Use in
2017 and Subsequent Years
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.
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In regard to the selection of CQMs, we
expect to continue to include CQMs that
align with the National Quality Strategy;
as well as, the our Quality Strategy. We
also expect to consider programmatic
goals and outcome measures that would
advance patient and population health.
a. Clinical Quality Measure Reporting
Requirements for EPs
Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting measures for
EPs for the Medicare EHR Incentive
Program, and in establishing the form
and manner of reporting, the Secretary
shall seek to avoid redundant or
duplicative reporting, including
reporting under subsection (k)(2)(C) for
the Physician Quality Reporting System
(PQRS). Consistent with that
requirement, in the Stage 2 final rule,
we finalized a policy to align certain
aspects of reporting CQMs for the
Medicare EHR Incentive Program for
EPs with reporting under the PQRS.
Specifically, we stated that Medicare
EPs who participate in both the PQRS
and the Medicare EHR Incentive
Program will satisfy the CQM reporting
component of meaningful use if they
submit and satisfactorily report PQRS
CQMs under the PQRS’s EHR reporting
option using CEHRT (77 FR 54058).
Section 1848(m)(7) of the Act requires
the Secretary to develop a plan to
integrate reporting on quality measures
under the PQRS with reporting
requirements under the Medicare EHR
Incentive Program relating to the
meaningful use of electronic health
records. Therefore, it is our goal to align
the reporting requirements for the CQM
component of meaningful use under the
Medicare EHR Incentive Program and
for PQRS wherever possible.
Historically, most requirements for the
Medicare and Medicaid EHR Incentive
Programs have been established through
stand-alone rulemaking, such as the
rules for Stage 1 (75 FR 44314 through
44588) and Stage 2 (77 FR 53968
through 54162), which span multiple
program years. This limited our ability
to align the EHR Incentive Program with
the requirements established in the
annual Medicare payment rules for
other CMS quality programs affecting
physicians and other EPs.
To further our goals of alignment and
avoiding redundant or duplicative
reporting across the various CMS
quality reporting programs, we intend to
address CQM reporting requirements for
the Medicare and Medicaid EHR
Incentive Program for EPs for 2017 and
subsequent years in the Medicare
Physician Fee Schedule (PFS)
rulemaking, which also establishes the
requirements for PQRS and other
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quality programs affecting EPs. We note
that the form and manner of reporting
of CQMs for Medicare EPs would also
be included in the PFS, while for
Medicaid we would continue to allow
the states to determine form and method
requirements subject to CMS approval.
We propose to continue the policy of
establishing certain CQM requirements
that apply for both the Medicare and
Medicaid EHR Incentive Programs
including a common set of CQMs and
the reporting periods for CQMs in the
EHR Incentive Programs. However, we
believe that receiving and reviewing
public comments for various CMS
quality programs at one time (for
example, EHR Incentive Program, PQRS,
Physician Compare); and finalizing the
requirements for these programs
simultaneously, would allow us to
better align these programs for EPs to
support streamlined reporting and
program efficacy. We propose to
continue to support active
communication with providers to
facilitate the sharing of information
related to CQM selection and reporting,
the announcement of opportunities for
public comment on CQM selection and
reporting, and upcoming or relevant
CQM program milestones in partnership
with state Medicaid programs and the
Medicare quality reporting programs.
We propose to continue to post the
defined CQM sets and the published
electronic specifications for CQM that
are in use for all aligned programs on
the CMS Web site as currently posted on
the eCQM Library page: https://
www.cms.gov/Regulations-andGuidance/Legislation/
EHRIncentivePrograms/eCQM_
Library.html.
b. CQM Reporting Requirements for
Eligible Hospitals and Critical Access
Hospitals
Section 1886(n)(3)(B)(iii) of the Act
requires that, in selecting measures for
eligible hospitals for the Medicare EHR
Incentive Program, and establishing the
form and manner for reporting
measures, the Secretary shall seek to
avoid redundant or duplicative
reporting with reporting otherwise
required, including reporting under
section 1886(b)(3)(B)(viii) of the Act, the
Hospital IQR Program.
Similar to our intentions for EPs
discussed previously, and to further our
alignment goal among CMS quality
reporting programs for eligible hospitals
and CAHs, and avoid redundant or
duplicative reporting among hospital
programs, we intend to address CQM
reporting requirements for the Medicare
and Medicaid EHR Incentive Program
for eligible hospitals and CAHs for 2016,
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2017, and future years, in the Inpatient
Prospective Payment System (IPPS)
rulemaking. IPPS rulemaking also
establishes the requirements for the
Hospital IQR Program and other quality
programs affecting hospitals. We intend
to include all Medicare EHR Incentive
Program requirements related to CQM
reporting in the IPPS rulemaking
including, but not limited to, new
program requirements, reporting
requirements, reporting and submission
periods, reporting methods, and
information regarding the CQMs. As
with EPs, for the Medicaid EHR
Incentive Program we would continue
to allow the states to determine form
and method requirements subject to
CMS approval. However, as previously
noted, this proposal would continue the
policy of establishing certain CQM
requirements that apply for both the
Medicare and Medicaid EHR Incentive
Programs including a common set of
CQMs and the reporting periods for
CQMs in the EHR Incentive Programs.
We believe that receiving and reviewing
public comments for various CMS
quality programs at one time and
finalizing the requirements for these
programs simultaneously would allow
us to better align these programs for
eligible hospitals and CAHs, allow more
flexibility into the Medicare and
Medicaid EHR Incentive Programs, and
add overall value and consistency by
providing us the opportunity to address
public comments that affect multiple
programs at one time. We propose to
continue to support active
communication with providers to
facilitate the sharing of information
related to CQM selection and reporting,
the announcement of opportunities for
public comment on CQM selection and
reporting, and upcoming or relevant
CQM program milestones in partnership
with state Medicaid programs and the
Medicare quality reporting programs.
We propose to continue to post the
defined CQM sets and the published
electronic specifications for CQM that
are in use for all aligned programs on
the CMS Web site as currently posted on
the eCQM Library page: https://
www.cms.gov/Regulations-andGuidance/Legislation/
EHRIncentivePrograms/eCQM_
Library.html.
2. CQM Reporting Period
In the Stage 2 final rule, we finalized
a reporting period for CQMs for EPs,
eligible hospitals, and CAHs (see 77 FR
54049 through 54051). In the FY 2015
IPPS final rule, we began to shift CQM
reporting to a calendar year basis for
eligible hospitals and CAHs for the
Medicare EHR Incentive Program (79 FR
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16769
50319 through 50321). We established
that for eligible hospitals and CAHs that
submit CQMs electronically in 2015, the
reporting period is one calendar quarter
from Q1, Q2, or Q3 of CY 2015 (79 FR
50321).
As discussed in sections
II.A.1.c.(1).(b).(i). and II.F. of this
proposed rule, we are proposing to
require an EHR reporting period of 1 full
calendar year for meaningful use for
providers participating in the Medicare
EHR Incentive Program, with a limited
exception for Medicaid providers
demonstrating meaningful use for the
first time. We are proposing to require
the same length for the CQM reporting
period for EPs, eligible hospitals, and
CAHs beginning in 2017. As noted, we
are proposing a limited exception for
Medicaid providers demonstrating
meaningful use for the first time who
would have a CQM reporting period of
any continuous 90 days that is the same
90-day period as their EHR Reporting
Period.
We believe full year reporting would
allow for the collection of more
comparable data across CMS quality
programs and increase alignment across
those programs. The more robust data
set provided by a full year reporting
period offers more opportunity for
alignment than the data set provided by
a shorter reporting period, especially
compared across years. We further
believe this full calendar year reporting
period for CQMs would reduce the
complexity of reporting requirements
for the Medicare EHR Incentive Program
by streamlining the reporting timeline
for providers for CQMs and meaningful
use objectives and measures. We
welcome comment on the following
proposals.
a. CQM Reporting Period for EPs
With the previously stated
considerations in mind, and in an effort
to align with other CMS quality
reporting programs such as the PQRS,
we propose to require for CQM
reporting under the EHR Incentive
Program a reporting period of one full
calendar year for all EPs participating in
the Medicare and Medicaid EHR
Incentive Program, with a limited
exception for Medicaid providers
demonstrating meaningful use for the
first time who would have a CQM
reporting period of any continuous 90
days that is the same 90-day period as
their EHR Reporting Period. These
reporting periods would apply
beginning in CY 2017 for all EPs
participating in the EHR Incentive
Program.
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b. CQM Reporting Period for Eligible
Hospital/CAH
For eligible hospitals and CAHs in
2017 and subsequent years, we are
proposing to require a reporting period
of 1 full calendar year which consists of
4 quarterly data reporting periods for
providers participating in the Medicare
and Medicaid EHR Incentive Program,
with a limited exception for Medicaid
providers demonstrating meaningful use
for the first time who would have a
CQM reporting period of any
continuous 90 days that is the same 90day period as their EHR Reporting
Period. More details of the form and
manner will be provided in the IPPS
rulemaking cycle.
c. Reporting Flexibility EPs, Eligible
Hospitals, CAHs 2017
In order to align with the flexibility
option of participation in Meaningful
Use in 2017 (see section II.C.1.b. of this
proposed rule), we are proposing that
EPs, eligible hospitals, and CAHs would
be able to have more flexibility to report
CQMs in one of two ways in 2017—via
electronic reporting or attestation. First
EPs, eligible hospitals, and CAHs may
choose to report eCQMs electronically
using the CQMs finalized for use in
2017 using the most recent version of
the eCQMs (electronic specifications),
which would be the electronic
specifications of the CQMs published by
CMS in 2016. Alternately, a provider
may choose to continue to attest also
using the most recent (2016 version)
eCQM electronic specifications. We note
that the intent to allow attestation in
2017 is to provide flexibility for
providers transitioning between
versions of CEHRT in 2017 and believe
that requiring the most recent version of
the annual updates should not be a
significant burden given that developers
do not need to recertify a product each
time CQM specifications are updated.
However, we seek comment on if CMS
should consider allowing providers to
report using another earlier version of
the specifications.
We note that, unlike the flexible
options established in rulemaking in
2014 (79 FR 52927 through 52930),
providers may select the CQMs they
choose to report separately from the
Stage objectives and measures of
meaningful use for their EHR reporting
period in 2017.
We invite public comment on our
proposals.
3. Reporting Methods for CQMs
In the Stage 2 final rule, we finalized
the reporting methods for CQMs for EPs
(77 FR 54075 through 54078), eligible
hospitals, and CAHs (77 FR 54087
through 54089) for the Medicare EHR
Incentive Program, which included
reporting electronically, where feasible,
or by attestation. To further align the
Medicare and Medicaid EHR Incentive
Programs with programs such as PQRS
and the Hospital IQR program, starting
in 2017, we propose to continue to
encourage electronic submission of
CQM data for all EPs, eligible hospitals,
and CAHs where feasible; however, as
outlined in section II.C.1.b. of this
proposed rule, we would allow
attestation for CQMs in 2017. For 2018
and subsequent years, we are proposing
that providers participating in the
Medicare program must electronically
report where feasible and that
attestation to CQMs would no longer be
an option except in certain
circumstances where electronic
reporting is not feasible. This would
include providers facing circumstances
which render them unable to
electronically report (such as a data
submission system failure, natural
disaster, or certification issue outside
the control of the provider) who may
attest to CQMs if they also attest that
electronically reporting was not feasible
for their demonstration of meaningful
use for a given year. We believe that the
collection and electronic reporting of
data through health information
technology would greatly simplify and
streamline reporting for many CMS
quality reporting programs and reduce
the burden of quality measure reporting
for providers who participate in these
programs. We also believe this would
further encourage the adoption and use
of certified EHR technology by allowing
EPs, eligible hospitals, and CAHs to
report data for multiple programs
through a single electronic submission.
Through electronic reporting, EPs,
eligible hospitals, and CAHs would be
able to leverage EHRs to capture,
calculate, and electronically submit
quality data to CMS for the Medicare
EHR Incentive Program. We note that
we intend to address the form and
manner of electronic reporting in future
Medicare payment rules.
For the Medicaid EHR Incentive
Program, as in the Stage 2 rulemaking
(77 FR 54089), we propose that states
would continue in Stage 3 to be
responsible for determining whether
and how electronic reporting of CQMs
would occur, or whether they wish to
continue to allow reporting through
attestation. If a state does require such
electronic reporting, the state is
responsible for sharing the details of the
process with its provider community.
We anticipate that whatever means
states have deployed for capturing
CQMs electronically for Stages 1 and 2
would be similar for reporting in Stage
3. However, we note that subject to our
prior approval, this is within the states’
purview. We propose for Stage 3 that
the states would establish the method
and requirements, subject to our prior
approval, for the electronic capture and
reporting of CQMs from CEHRT.
PROPOSED eCQM REPORTING TIMELINES FOR MEDICARE & MEDICAID EHR INCENTIVE PROGRAM
2017 only ..........................
2017 only ..........................
Reporting Method Available.
Provider Type who May
Use Method.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
Year ...................................
Attestation .........................
Electronic Reporting ..........
All Medicare providers ......
All Medicare Providers ......
Medicaid providers must
refer to state requirements for reporting.
1 CY for Medicare .............
1 CY for returning Medicaid.
90 days for first time
meaningful user Medicaid.
Medicaid providers must
refer to state requirements for reporting.
1 CY for Medicare .............
1 CY for returning Medicaid.
90 days for first time
meaningful user Medicaid.
CQM Reporting Period ......
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2018 and subsequent
years.
Attestation .........................
2018 and subsequent
years.
Electronic Reporting.
Medicare Providers with
circumstances rendering
them unable to eReport.
Medicaid providers must
refer to state requirements for reporting.
1 CY for Medicare .............
1 CY for returning Medicaid.
90 days for first time
meaningful user Medicaid.
All Medicare Providers.
E:\FR\FM\30MRP2.SGM
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Medicaid providers must
refer to state requirements for reporting.
1 CY for Medicare.
1 CY for returning Medicaid.
90 days for first time
meaningful user Medicaid.
Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules
16771
PROPOSED eCQM REPORTING TIMELINES FOR MEDICARE & MEDICAID EHR INCENTIVE PROGRAM—Continued
eCQM Version Required
(CQM electronic specifications update).
CEHRT Edition Required ..
2016 Annual Update .........
2016 Annual Update .........
2016 Annual Update or
more recent version.
2017 Annual Update.
2014 Edition ......................
Or
2015 Edition
2014 Edition ......................
Or
2015 Edition
2015 Edition ......................
2015 Edition.
We invite public comments on our
proposals.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
a. Quality Reporting Data Architecture
Category III (QRDA–III) Option for
Eligible Hospitals and CAHs
In the Stage 2 final rule (77 FR 54088),
we finalized two options for eligible
hospitals and CAHs to electronically
submit CQMs beginning in FY 2014
under the Medicare EHR Incentive
Program. Option 1 was to submit
aggregate level CQM data using QRDA–
III electronically. Option 2 was to
submit data electronically using a
method similar to the 2012 and 2013
Medicare EHR Incentive Program
electronic reporting pilot for eligible
hospitals and CAHs, which used
QRDA–I (patient-level data).
We noted in the FY 2014 and 2015
IPPS/LTCH PPS final rules (78 FR 50904
through 50905 and 79 FR 50321 through
50322) that we had determined that the
electronic submission of aggregate-level
data using QRDA–III would not be
feasible in 2014 or 2015 for eligible
hospitals and CAHs under the Medicare
EHR Incentive Program. We stated that
we would reassess this policy for future
reporting periods.
In this proposed rule, we are
proposing to remove the QRDA–III
option for eligible hospitals and CAHs,
as we have found this is not an option
for electronic reporting as we move
forward with the EHR Incentive
Program, we believe the calculations,
per the QRDA–III, are not advantageous
to quality improvement. As the EHR
Incentive Program further aligns with
the Hospital IQR program, we intend to
continue utilizing the electronic
reporting standard of QRDA–I patient
level data that we finalized in the FY
2015 IPPS rule (79 FR 50322), which
will allow the same level of CQM
reporting, and use and analysis of these
data for quality improvement initiatives.
As we understand the need to support
state flexibility, we are also proposing
that states would continue to have the
option, subject to our prior approval, to
allow or require QRDA–III for CQM
reporting.
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4. CQM Specification and Changes to
the Annual Update
In the Stage 2 final rule, we stated that
we do not intend to use notice and
comment rulemaking as a means to
update or modify electronic CQM
(eCQM) specifications (77 FR 54055). In
general, it is the role of the measure
steward to make changes to a CQM in
terms of the initial patient population,
numerator, denominator, potential
exclusions, logic, and value sets. We
recognize that it may be necessary to
update CQM specifications after they
have been published to ensure their
continued clinical relevance, accuracy,
and validity. CQM specification updates
may include administrative changes,
such as adding the NQF endorsement
number to a CQM, correcting faulty
logic, adding or deleting codes as well
as providing additional implementation
guidance for a CQM.
These changes are described through
the annual updates to the electronic
specifications for EHR submission
published by CMS. CQMs are currently
tracked on a version basis as updates are
made and we require EPs, eligible
hospitals, and CAHs to submit the
versions of the CQMs as identified on
our Web site. The Web site contains all
versions of the CQMs since reporting via
attestation does not require the most
recent version of the CQMs, but
electronic reporting of the CQMs does
require the most recent version to be
reported. Because we require the most
recent version of the CQM specifications
to be used for electronic reporting
methods, we understand that EHR
vendors must make CQM updates on an
annual basis. We also understand that
providers must regularly implement
those updates to stay current with the
most recent CQM version.
We continue to evaluate the CQM
update timeline and look for ways to
provide CQM updates timely, so that
vendors can develop, test, and deploy
these updates and providers can
implement those updates as necessary.
We have the flexibility to update CQMs
so they remain clinically relevant,
accurate, and valid. While we are not
proposing any change to our policy on
updating CQM specifications in this
proposed rule, we seek comment on our
annual update timeline and suggestions
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for how to improve the CQM update
process.
5. EHR Technology Certification
Requirements for Reporting of CQMs
In the 2014 Edition EHR Certification
Criteria Final Rule, ONC finalized
certain certification criteria to support
the MU objectives and CQMs set forth
by CMS. In that rule, ONC also specified
that in order for an EP, eligible hospital,
or CAH to have EHR technology that
meets the Base EHR definition, the EHR
technology must be certified to a
minimum of nine CQMs for EPs or 16
CQMs for eligible hospitals and CAHs
(77 FR 54264 through 54265; see also 45
CFR 170.102). This is the same number
required for quality reporting to the
Medicare and Medicaid EHR Incentive
Programs, the PQRS EHR reporting and,
beginning in 2015, the electronic
reporting option under the Hospital IQR
Program. In certain cases, an EP, eligible
hospital or CAH may purchase an EHR
product that is certified to the minimum
number of CQMs and discover that, for
at least one of those CQMs, they do not
have data on which to report. In these
cases, the EP (77 FR 54058 through
54059), eligible hospital or CAH (77 FR
54051) would report a zero denominator
for one or more CQMs.
We believe EHRs should be certified
to more than the minimum number of
CQMs required by one or more CMS
quality reporting programs so that EPs,
eligible hospitals, and CAHs have a
choice of which CQMs to report, and
could therefore choose to report on
CQMs most applicable to their patient
population or scope of practice.
We realize that requiring EHRs to be
certified to more than the minimum
number of CQMs required by the
Medicare and Medicaid EHR Incentive
Programs may increase the burden on
EHR vendors. However, in the interest
of EPs, eligible hospitals, and CAHs
being able to choose to report eCQMs
that represent their patient populations,
we would like to see EP vendors certify
to all eCQMs that are in the EP selection
list, or eligible hospital/CAH vendors
certify to all eCQMs in the selection list
for those stakeholders.
We are also considering a phased
approach such that the number of CQMs
required for the vendors to have
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certified would increase each year until
EHR products are required to certify all
CQMs required for reporting by EPs,
eligible hospitals, and CAHs. For
example, in year one of this phased
plan, we might require that EHRs be
certified to at least 18 of 64 available
CQMs for EPs and 22 of 29 available
CQMs for eligible hospitals and CAHs;
in year two, we might require at least 36
CQMs for EPs and all 29 CQMs for
eligible hospitals and CAHs; in
subsequent years of the plan, we would
increase the number of required CQMs
for EPs until the EHR is certified to all
applicable CQMs for EPs, eligible
hospitals, and CAHs.
We have also considered alternate
plans that would require EHRs to be
certified to more than the minimum
number of CQMs required for reporting,
but would not require the EHR to be
certified to all available CQMs. For
example, we might require that EHRs be
certified to a certain core set of CQMs
plus an additional 9 CQMs for EPs, and
a certain core set of CQMs plus an
additional 16 CQMs for eligible
hospitals and CAHs, which the EHR
vendor could choose from the list of
available CQMs.
We note that the specifics of this plan
would be outlined in separate noticeand-comment rulemaking such as the
PFS or IPPS rules. We specifically seek
comment on this issue of a plan to
increase the number of CQMs to which
an EHR is certified.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
6. Electronic Reporting of CQMs
As previously stated in the Medicare
and Medicaid EHR Incentive Programs
Stage 2 final rule (77 FR 54051 through
54053), CQM data submitted by EPs,
eligible hospitals, and CAHs are
required to be captured, calculated and
reported using certified EHR
technology. We received numerous
questions from stakeholders expressing
confusion over what it means to capture
data in certified EHR technology.
Specifically, stakeholders question
whether they may manually abstract
data into the EHR from a patient’s chart.
We do not consider the manual
abstraction of data from the EHR to be
capturing the data using certified EHR
technology. We believe that electronic
information interfaced or electronically
transmitted from non-certified EHR
technology, such as lab information
systems, automated blood pressure
cuffs, and electronic scales, into the
certified EHR, would satisfy the
‘‘capture’’ requirement, as long as that
data is visible to providers in the EHR.
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C. Demonstration of Meaningful Use
and Other Issues
1. Demonstration of Meaningful Use
a. 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.
b. Methods for Demonstration of the
Stage 3 Criteria of Meaningful Use for
2017 and Subsequent Years
We are proposing to continue the use
of attestation as the method for
demonstrating that an EP, eligible
hospital, or CAH has met the Stage 3
objectives and measures of meaningful
use. We are proposing to continue the
existing optional batch file process for
attestation in lieu of individual
Medicare EP attestation through our
registration and attestion system. This
batch reporting process ensures that
meaningful use of certified EHR
technology continues to be measured at
the individual level, while promoting
efficiencies for group practices that
must submit attestations on large groups
of individuals (77 FR 54089).
We would continue to leave open the
possibility for CMS and the states to test
options for demonstrating meaningful
use that utilize existing and emerging
HIT products and infrastructure
capabilities. These options could
involve the use of registries or the direct
electronic reporting of measures
associated with the objectives of
meaningful use. We would not require
any EP, eligible hospital, or CAH to
participate in this testing in order to
receive an incentive payment or avoid
the payment adjustment.
For 2017 only, we are proposing
changes to the attestation process for the
meaningful use objectives and
measures, which would allow flexibility
for providers during this transitional
year. These proposals are supported by
a similar flexibility proposed in the
requirements for the Edition of CEHRT
a provider may use in 2017 as further
discussed in section II.A.I.C.(1).(b).(3).
of this proposed rule. In addition, we
discuss the attestation changes proposed
for CQM reporting in detail under
section II.B.2.a. of this proposed rule.
(1) Meaningful Use Objective and
Measures in 2017
In order to allow all providers to
successfully transition to Stage 3 of
meaningful use for a full year-long EHR
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reporting period in 2018, we are
proposing to allow flexibility for the
EHR Incentive Programs in 2017. This
transition period would allow providers
to establish and test their processes and
workflows for Stage 3 of meaningful use
prior to 2018. Specifically, for 2017, we
are proposing that providers may either
repeat a year at their current stage or
move up stage levels. However, for
2017, a provider may not move
backward in their progression. Under
this proposal, providers who
participated in Stage 1 in 2016 may
choose to attest to the Stage 1 objective
and measures, or they may move on to
Stage 2 or Stage 3 objectives and
measures for an EHR reporting period in
2017. Providers who participated in
Stage 2 in 2016 may choose to attest to
the Stage 2 objectives and measures or
move on to Stage 3 objectives and
measures for an EHR reporting period in
2017. However, under no
circumstances, may providers return to
Stage 1. In 2018, all providers,
regardless of their prior participation or
the stage level chosen in 2017, would be
required to attest to Stage 3 objectives
and measures for an EHR reporting
period in 2018.
(2) CEHRT and Stage Flexibility in 2017
Based on the delays providers
experienced with fully implementing
the EHR technology certified to the 2014
Edition (as further described in the 2014
CEHRT Flexibility final rule (79 FR
52910 through 52933) we believe it is
necessary to preemptively prepare for
the upgrade to EHR technology certified
to the 2015 Edition and the transition to
Stage 3. Preparation for the upgrade
would ensure that providers and
developers have adequate time to
certify, install, fully implement the
software, and establish the processes
and workflows for the objectives and
measures for providers moving to the
next stage of the EHR Incentive
Programs. Accordingly, we propose
allowing providers flexible CEHRT
options for 2017. These options may
impact the selection of objectives and
measures to which a provider can attest.
Specifically, under the CEHRT options
for 2017, we propose that providers
would have the option to continue to
use EHR technology certified to the
2014 Edition, in whole or in part, for an
EHR reporting period in 2017. We note
that providers who use only the EHR
technology certified to the 2014 Edition
for an EHR reporting period in 2017
may not choose to attest to the Stage 3
objectives and measures as those
objectives and measures require the
support of EHR technology certified to
the 2015 Edition.
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Providers using only EHR technology
certified in whole or in relevant part to
the 2014 Edition certification criteria
may attest to the objectives and
measures of meaningful use in the
following manner:
• If a provider first demonstrated
meaningful use in 2015 or 2016, they
may attest to Stage 1 objectives and
measures or Stage 2 objectives and
measures.
• If a provider first demonstrated
meaningful use in any year prior to
2015, they may attest to the Stage 2
objectives and measures.
Providers using EHR technology
certified in whole or in relevant part to
the 2015 Edition certification criteria
may elect to attest to the objectives and
measures of meaningful use in the
following manner:
• If a provider first demonstrated
meaningful use in 2015 or 2016, they
may attest to Stage 1 objectives and
measures, Stage 2 objectives and
measures, or Stage 3 objectives and
measures if they have all the 2015
Edition functionality required to meet
all Stage 3 objectives.
• If a provider first demonstrated
meaningful use in any year prior to
2015, they may attest to Stage 2
objectives and measures, or Stage 3
objectives and measures if they have all
the 2015 Edition functionality required
to meet all Stage 3 objectives.
We note that all providers would be
required to fully upgrade to EHR
technology certified to the 2015 Edition
for the EHR reporting period in 2018.
We also reiterate that providers may
elect to attest to Stage 3 of the program
using EHR technology certified to the
2015 Edition beginning in 2017. We
further stress that the use of 2011
CEHRT, although an option under the
2014 CEHRT Flexibility final rule (79
FR 52913 through 52914), is not an
option under this proposal. However, as
part of this proposal, we would like to
seek comment on alternate flexibility
options. Specifically, we are seeking
comment on whether the flexible option
to attest to Stages 1 or 2 should be
limited to only those providers who
could not fully implement EHR
technology certified to the 2015 Edition
in 2017. We are also seeking comment
on whether those providers with fully
implemented EHR technology certified
to the 2015 Edition in 2017 should be
required to attest to Stage 3 only in
2017. Finally, we seek comment on
whether providers should not have the
option to attest to Stage 3 in 2017
regardless of an upgrade to EHR
technology certified to the 2015 Edition
in 2017, and should instead be required
to wait to demonstrate Stage 3 until
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2018 using EHR technology certified to
the 2015 Edition.
We welcome comments on these
proposals.
(3) CQM Flexibility in 2017
In the 2014 CEHRT Flexibility final
rule, we did not allow providers to
separate their CQM reporting selection
from the year of meaningful use
objectives they reported on. We did not
allow this reporting for a number of
reasons including how we defined
CQMs, as well as the number of CQMs
reporting changes occurring between
Stage 1 in 2011 through 2013, and Stage
1 and 2 in 2014. For further discussion,
we direct readers to 79 FR 52927
through 52930.
To report CQMs for 2017, we propose
to allow greater flexibility by proposing
to split the use of CEHRT for CQM
reporting from the use of CEHRT for the
objectives and measures. This means
that providers would be able to
separately report CQMs using EHR
technology certified to the 2015 Edition
even if they use EHR technology
certified to the 2014 Edition for the
meaningful use objectives and measures
for an EHR reporting period in 2017.
Providers may also use EHR technology
certified to the 2015 Edition for their
meaningful use objectives and measures
in 2017 and use EHR technology
certified to the 2014 Edition for their
CQM reporting for an EHR reporting
period in 2017.
For an EHR reporting period in 2017,
EPs, eligible hospitals, and CAHs may
choose to report eCQMs electronically
using the CQMs finalized for use in
2017 using the most recent version of
the eCQMs (electronic specifications),
which would be the electronic
specifications of the CQMs published by
CMS in 2016. Alternately, a provider
may choose to continue to attest to the
CQMs established for use in 2017 also
using the most recent (2016 version)
eCQM electronic specifications. These
options are available for provider using
either EHR technology certified to the
2014 Edition or EHR technology
certified to the 2015 Edition. These
flexible options for an EHR reporting
period in 2017 are further discussed in
sections II.B.2.a. of this proposed rule.
An EP, eligible hospital, or CAH must
use certified EHR technology,
successfully attest to the meaningful use
objectives and measures, and
successfully submit CQMs to be a
meaningful EHR user. We note that
states may determine the form and
method of CQM submission for
participants in the Medicaid program
subject to our approval as outline in
sections II.B.3 and II.F.3. of this
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proposed rule. However, the selection of
CQMs and the minimum reporting
period are the same for providers in
both Medicare and Medicaid as outlined
in section II.B.3. of this proposed rule.
Similar to our rationale under the
2014 CEHRT Flexibility final rule (79
FR 52910 through 52933), we believe
the proposals outlined for attestation in
2017 would allow providers the
flexibility to choose the option which
applies to their particular circumstances
and use of CEHRT. Upon attestation,
providers may select one of the
proposed options available for their
participation year and EHR Edition. The
EHR Incentive Program Registration and
Attestation System would then prompt
the provider to attest to meeting the
objectives, measures, and CQMs
applicable under that option. We further
propose that auditors would be
provided guidance related to reviewing
attestations associated with the options
for using CEHRT in 2017, as was done
for 2014.
We welcome comment on this
proposal.
c. EHR Reporting Period in 2017 and
Subsequent Years
We are proposing, with limited
exceptions outlined in section II.F.1. of
this proposed rule, that the EHR
reporting period in 2017 would be a full
calendar year for all providers. We
encourage providers to begin Stage 3 in
2017. However, under the current
timeline shown in Table 3, we recognize
that providers first demonstrating
meaningful use under Stage 1 in 2016 or
2017 or under Stage 2 in 2016 or 2017
must begin Stage 3 in 2018. We further
recognize providers scheduled to begin
Stage 3 in 2017 that instead choose to
meet the Stage 2 criteria in 2017 must
begin Stage 3 in 2018. However, in
2018, all providers, except as outlined
in section II.F.1. of this proposed rule,
must report based on a full calendar
year EHR reporting period for the Stage
3 objectives and measures. In addition,
in 2018, all providers must use EHR
technology certified to the 2015 Edition
for the full EHR reporting period in
order to successfully demonstrate
meaningful use.
For CQM reporting in 2018 and
subsequent years, as outlined in section
II.B.3 of this proposed rule, we are
proposing that providers participating
in the Medicare program must
electronically report, where feasible,
and that attestation to CQMs would no
longer be an option except in
circumstances where electronic
reporting is not feasible. This would
include providers facing circumstances
which render them unable to
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electronically report (such as a data
submission system failure, natural
disaster, or certification issue outside
the control of the provider) who may
attest to CQMs if they also attest that
electronically reporting was not feasible
for their demonstration of meaningful
use for a given year.
We welcome public comment on this
proposal.
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2. Data Collection for Online Posting,
Program Coordination, and Accurate
Payments
We propose to continue posting Stage
1 and Stage 2 aggregate and individual
performance and participation data
resulting from the EHR Incentive
programs online regularly for public
use. We further note our intent to
potentially publish the performance and
participation data on Stage 3 objectives
and measures of meaningful use in
alignment with quality programs which
utilize publicly available performance
data such as physician compare.
In addition to the data already being
collected under our regulations, as
outlined in section III. of this proposed
rule, we propose to collect the following
information from providers to ensure
providers keep their information up-todate through the system of record for
their National Provider Identifier (NPI)
in the National Plan & Provider
Enumeration System:
• Primary Practice Address (address,
city, state zip, country code, etc.).
• Primary Business/Billing Address
(address, city, state, zip, country code,
etc.).
• Primary License information (for
example, provide medical license in at
least one state (or territory)).
• Contact Information (phone
number, fax number, and contact email
address).
• Health Information Exchange
Information:
++ Such as DIRECT address required
(if available).
++ If DIRECT address is not available,
Electronic Service Information is
required.
++ If DIRECT address is available,
Electronic Service Information is
optional in addition to DIRECT address.
We do not propose any changes to the
registration for the Medicare and
Medicaid EHR Incentive Programs.
3. Interaction With Other Programs
There are no proposed changes to the
ability of providers to participate in the
Medicare and Medicaid EHR Incentive
Programs and other CMS programs. We
continue to work on aligning the data
collection and reporting of the various
CMS programs, especially in the area of
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clinical quality measurement. See
sections II.B.1. through II.B.6. of this
proposed rule for the proposed
alignment initiatives for CQMs.
D. 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
for EPs
Section 1848(a)(7) of the Act provides
for payment adjustments, effective for
CY 2015 and subsequent years, for EPs
as defined in 42 CFR 495.100, who are
not meaningful EHR users during the
relevant EHR reporting period for the
year. Section 1848(a)(7) 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
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
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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 final rules for Stages 1 and 2 (75
FR 44442 through 44448 and 77 FR
54093 through 54102) for more
information.
2. EHR Reporting Period for
Determining Whether an EP Is Subject
to the Payment Adjustment for CY 2018
and Subsequent Calendar Years
Section 1848(a)(7)(E)(ii) of the Act
provides the Secretary with broad
authority to choose the EHR reporting
period that will apply for purposes of
determining the payment adjustments
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 the 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. Stated
generally, 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 the regulations and the
discussion in the Stage 2 final rule (77
FR 54095 through 54096). We
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established that these policies apply for
the CY 2015 payment adjustment year
and subsequent payment adjustment
years.
However, in this Stage 3 proposed
rule, we propose to eliminate the
exception discussed previously for a 90day EHR reporting period for new
meaningful EHR users beginning with
the EHR reporting period in 2017, with
a limited exception for Medicaid EPs
demonstrating meaningful use for the
first time. We propose that for EPs 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 example,
for all EPs demonstrating meaningful
use, the full CY 2017 would be the EHR
reporting period for the CY 2019
payment adjustment year. To avoid a
payment adjustment in CY 2019, EPs
must demonstrate meaningful use of
certified EHR technology for an EHR
reporting period of the entire CY 2017.
This policy would continue to apply in
subsequent years.
As discussed in sections II.A.1.a. and
II.F.1. of this proposed rule, we are
proposing to maintain a 90-day EHR
reporting period for the first payment
year based on meaningful use for
Medicaid EPs demonstrating meaningful
use for the first time. We recognize that
these EPs may be subject to payment
adjustments under Medicare if they fail
to demonstrate meaningful use, and
thus we propose that the same 90-day
EHR reporting period used for the
Medicaid incentive payment would also
apply for purposes of the Medicare
payment adjustment for the payment
adjustment year two years after the
calendar year in which the provider
demonstrates meaningful use. We note
under our current policy, if an EP has
never successfully demonstrated
meaningful use, the EHR reporting
period for a payment adjustment year is
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. We do not propose to
maintain this policy, and thus for
Medicaid EPs who are new meaningful
EHR users, the 90-day EHR reporting
period for a payment adjustment year
must occur within the calendar year that
is 2 years before the payment
adjustment year. These proposals for
Medicaid EPs would apply beginning
with the EHR reporting period in CY
2017.
We provide the following example:
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Example A: If an EP has never
successfully demonstrated meaningful
use prior to CY 2017 and demonstrates
under the Medicaid EHR Incentive
Program that he or she is a meaningful
EHR user for the first time in CY 2017,
the EHR reporting period for the
Medicaid incentive payment would be
any continuous 90-day period within
CY 2017. The same 90-day period
would also serve as the EHR reporting
period for the CY 2019 payment
adjustment year under Medicare. This
90-day period would not serve as the
EHR reporting period for the CY 2018
payment adjustment year under
Medicare even if the EP registers for and
attests to meaningful use by October 1,
2017. The EP would have to
demonstrate meaningful use for an EHR
reporting period of the full CY 2018 to
earn an incentive payment under
Medicaid for the CY 2018 payment year
and avoid the payment adjustment
under Medicare for the CY 2020
payment adjustment year.
We propose these changes to further
our goal to align reporting requirements
under the EHR Incentive Program and
the reporting requirements for various
CMS quality reporting programs, to
respond to stakeholders who cited
difficulty with following varying
reporting requirements, and to simplify
HHS system requirements for data
capture. We further note that newly
practicing EPs have the ability to apply
for a hardship exception from the
Secretary under § 495.102(d)(4)(ii),
which provides for an exception from
the payment adjustments for the 2 years
after they begin practicing. We propose
amendments to the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ under § 495.4 to
reflect these proposals. We welcome
public comments on this proposal.
3. Exception to the Application of the
Payment Adjustment to EPs in CY 2017
and Subsequent Years
As previously discussed, sections
1848(a)(7)(B) of the Act provides that
the Secretary may, on a case-by-case
basis, exempt an EP from the
application of the payment adjustment
in CY 2015 and subsequent calendar
years if the Secretary determines that
compliance with the requirements for
being a meaningful EHR user will result
in a significant hardship, such as an EP
who practices in a rural area without
sufficient internet access. As provided
by the statute, the exception is subject
to annual renewal, but in no case may
an EP be granted an exception for more
than 5 years. The statute does not
require the Secretary to grant
exceptions. However, as we stated in the
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16775
Stage 2 final rule at 77 FR 54097, we
believe that certain circumstances
evidence the existence of a hardship,
thereby justifying the need for an
exception by the Secretary. Therefore, in
the Stage 2 final rule, we finalized
various types of hardship exceptions
that EPs could apply for, which
included insufficient internet access,
newly practicing EPs, extreme
circumstances outside of an EP’s
control, lack of control over the
availability of CEHRT for EPs practicing
in multiple locations, lack of face-toface patient interactions and lack of
need for follow-up care, and certain
primary specialties. For further
discussion of the hardship exceptions,
we refer readers to the Stage 2 final rule
at 77 FR 54097 through 54101 and 42
CFR 495.102(d)(4).
In this Stage 3 proposed rule, we
propose no changes to the types of
exceptions previously finalized for EPs,
nor do we propose any new types of
exceptions for 2017 and subsequent
years. Accordingly, we propose that the
exceptions continue as previously
finalized.
4. Statutory Basis for Payment
Adjustments and Hardship Exceptions
for Eligible Hospitals
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 will be ‘‘331⁄3 percent for FY 2015,
662⁄3 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 (331⁄3 of 75 percent) in FY 2015,
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50 percent (662⁄3 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 fiscal year involved and
the Secretary shall not take into account
such reduction in computing the
applicable percentage increase for a
subsequent fiscal year.
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
will result in a significant hardship,
such as in the case of a hospital in a
rural area without sufficient internet
access. This section also provides that
such determinations are subject to
annual renewal, and that in no case may
a hospital be granted an exception for
more than 5 years.
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5. Applicable Market Basket Update
Adjustment for Eligible Hospitals That
Are Not Meaningful EHR Users for FY
2019 and Subsequent Fiscal Years
Section 412.64(d) of the 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.
6. EHR Reporting Period for
Determining Whether a Hospital Is
Subject to the Market Basket Update
Adjustment for FY 2018 and Subsequent
Fiscal Years
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 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 the 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
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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. However, in this Stage 3 proposed
rule, beginning in 2017, we propose to
change the EHR reporting period for a
payment adjustment year for eligible
hospitals from a fiscal year basis to a
calendar year basis. Specifically, we
propose to revise the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ under § 495.4 such
that the EHR reporting period for a
payment adjustment year for an eligible
hospital would be the full calendar year
that is 2 years before the payment
adjustment year. For example, the entire
CY 2017 would be the EHR reporting
period used to determine whether the
payment adjustment would apply for an
eligible hospital for FY 2019. This
change would apply beginning with the
CY 2017 EHR reporting period for
purposes of the FY 2019 payment
adjustment year, and continue to apply
in subsequent years. We note that
eligible hospitals would have ample
time to adjust to the new calendar year
reporting timeframe given that under
our current policy, the EHR reporting
period occurs prior to the payment
adjustment year. We further believe that
aligning all providers, including eligible
hospitals, to a calendar year EHR
reporting timeframe for purposes of the
payment adjustment, would simplify
reporting for all providers, especially for
larger providers with diverse systems
and groups. In addition, placing all
providers, including eligible hospitals,
onto a calendar year timeframe would
further simplify HHS system
requirements for data capture and
would move the EHR Incentive Program
another step closer to alignment with
various CMS quality reporting
programs. We welcome comments on
this proposal.
Further, in the Stage 2 final rule, 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. Stated generally, 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 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
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§ 495.4 of the regulations and the
discussion in the Stage 2 final rule (77
FR 54104 and 54105).
However, in this Stage 3 proposed
rule, we propose to eliminate this
exception for eligible hospitals that are
new meaningful EHR users beginning
with the EHR reporting period in 2017,
with a limited exception for Medicaid
eligible hospitals demonstrating
meaningful use for the first time. As
explained previously, we propose that
for eligible hospitals that have
successfully demonstrated meaningful
use in a prior year as well as those that
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
example, for all eligible hospitals, the
full CY 2017 would be the EHR
reporting period for the FY 2019
payment adjustment year. This policy
would continue to apply in subsequent
years.
Though, as discussed in sections
II.A.1.a. and II.F.1. of this proposed rule,
for Medicaid eligible hospitals
demonstrating meaningful use for the
first time, we are proposing to maintain
a 90-day EHR reporting period for the
first payment year based on meaningful
use. We recognize that these eligible
hospitals may be subject to payment
adjustments under Medicare if they fail
to demonstrate meaningful use, and
thus we propose that the same 90-day
EHR reporting period used for the
Medicaid incentive payment would also
apply for purposes of the Medicare
payment adjustment for the payment
adjustment year 2 years after the
calendar year in which the provider
demonstrates meaningful use. We note
under our current policy, if an eligible
hospital has never successfully
demonstrated meaningful use, the EHR
reporting period for a payment
adjustment year is any continuous 90day period that both begins in the
federal fiscal year 1 year before the
payment adjustment year and ends at
least 3 months before the end of such
prior year. We do not propose to
maintain this policy, and thus for
Medicaid eligible hospitals that are new
meaningful EHR users, the 90-day EHR
reporting period for a payment
adjustment year must occur within the
calendar year that is 2 years before the
payment adjustment year. These
proposals for Medicaid eligible
hospitals would apply beginning with
the EHR reporting period in CY 2017.
We provide the following example:
Example A: If an eligible hospital has
never successfully demonstrated
meaningful use prior to CY 2017 and
demonstrates under the Medicaid EHR
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Incentive Program that it is a
meaningful EHR user for the first time
in CY 2017, the EHR reporting period
for the Medicaid incentive payment
would be any continuous 90-day period
within CY 2017. The same 90-day
period would also serve as the EHR
reporting period for the FY 2019
payment adjustment year under
Medicare. This 90-day period would not
serve as the EHR reporting period for
the FY 2018 payment adjustment year
under Medicare even if the eligible
hospital registers for and attests to
meaningful use by July 1, 2017. The
eligible hospital would have to
demonstrate meaningful use for an EHR
reporting period of the full CY 2018 to
earn an incentive payment under
Medicaid for the 2018 payment year and
avoid the payment adjustment under
Medicare for the FY 2020 payment
adjustment year.
Like our proposal to move eligible
hospitals to a calendar year timeframe,
we believe that removing the
continuous 90-day EHR reporting period
for most eligible hospitals would
simplify reporting for providers,
especially those hospitals with diverse
groups and systems. In addition,
eliminating the 90-day EHR reporting
period would move the EHR Incentive
Program one step closer to alignment
within the program and with CMS
quality reporting programs and would
simplify HHS system requirements for
data capture. Therefore, moving eligible
hospitals to a calendar year EHR
reporting period for the payment
adjustment years, as well as requiring
all providers (EPs and hospitals) to
report based on the same full year
calendar timeframe would accomplish
these goals and be responsive to prior
public comments asking us to simplify
the EHR Incentive Program.
We propose amendments to the
definition of ‘‘EHR reporting period for
a payment adjustment year’’ under
§ 495.4 to reflect these proposals.
We note that hospitals that are eligible
under both the Medicaid and Medicare
incentive programs, and that are
attesting for the Medicaid program, do
not need to separately attest in the
Medicare program in 2017 and
subsequent years, because the statute
does not allow for Medicare EHR
incentive payments to eligible hospitals
after FY 2016. If a hospital eligible
under both programs is demonstrating
meaningful use for the first time, and
using a continuous 90-day EHR
reporting period under the Medicaid
program, it could attest for the Medicaid
program only, and still avoid the
Medicare payment adjustment that is 2
years after the calendar year in which
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the EHR reporting period occurs.
However, if a hospital eligible under
both programs chooses also to attest for
the Medicare program, it would be
required to complete an EHR reporting
period of 1 full calendar year to avoid
the Medicare payment adjustment that
is 2 years after that calendar year.
We welcome public comments on
these proposals.
7. Exception to the Application of the
Market Basket Update Adjustment to
Hospitals in FY 2019 and Subsequent
Fiscal Years
As stated previously, section
1886(b)(3)(B)(ix)(II) of the Act, as
amended by section 4102(b)(1) of the
HITECH Act, provides that the
Secretary, may, on a case-by-case basis,
exempt a hospital from the application
of the applicable percentage increase
payment adjustment for a fiscal year if
the Secretary determines that
compliance with the requirements for
being a meaningful EHR user will result
in a significant hardship, such as an
eligible hospital located in a rural area
without sufficient internet access.
Section 1886(b)(3)(B)(ix)(III) also
provides that the exception is subject to
annual renewal, but in no case may a
hospital be granted an exception for
more than 5 years. The Secretary’s
hardship exception authority is
discretionary.
As we explained in the Stage 2 final
rule at 77 FR 54105 through 54106, we
believe that certain circumstances may
constitute a hardship that would
warrant the Secretary’s use of the
exception authority. Therefore, in the
Stage 2 final rule, we finalized various
types of hardship exceptions for which
eligible hospitals may apply, which
included lack of insufficient internet
access, extreme circumstances outside
of a hospital’s control, and the
establishment of new hospitals. For
further discussion of the hardship
exceptions, we refer readers to the Stage
2 final rule at 77 FR 54105 through
54108 as well as 42 CFR 412.64(d)(4).
In this Stage 3 proposed rule, we
propose no changes to the types of
exceptions previously finalized for
eligible hospitals, nor do we propose
any new exceptions for eligible
hospitals. Accordingly, for Stage 3, we
propose to continue the hardship
exceptions for 2017 and subsequent
years as previously finalized.
8. Statutory Basis for Payment
Adjustments to CAHs
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
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services if the CAH is not a meaningful
EHR user for an EHR reporting period.
The adjustment will 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 case 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.
9. Reduction of Reasonable Cost
Reimbursement in FY 2015 and
Subsequent Years for CAHs That Are
Not Meaningful EHR Users
a. Applicable Reduction of Reasonable
Cost Payment Reduction in FY 2015 and
Subsequent Years for CAHs That Are
Not Meaningful EHR Users
In the Stage 1 final rule (75 FR 44564),
we finalized the regulations regarding
the CAH adjustment at § 495.106(e) and
§ 413.70(a)(6).
b. EHR Reporting Period for
Determining Whether a CAH Is Subject
to the Applicable Reduction of
Reasonable Cost Payment in FY 2015
and Subsequent Years
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
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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 fiscal year as
described in § 413.70(a)(6)(i). We further
finalized that CAHs submit their
attestations on meaningful use by
November 30 of the following fiscal
year. 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, will then affect interim
payments to the CAH made after
December 1 of the applicable fiscal year.
If the cost reporting period ends prior to
December 1 of the applicable fiscal year,
then any applicable payment
adjustment will be made through the
cost report settlement process.
Under this Stage 3 proposed rule, we
are proposing a change to the EHR
reporting period that would apply for
the payment adjustments for CAHs,
beginning with the FY 2017 payment
adjustment year. First, similar to what
we proposed for eligible hospitals
previously, we propose 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 propose 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
CY 2017. This proposed change would
mean that the EHR reporting period
would no longer precisely align with the
payment adjustment year. We propose
amendments to the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ under § 495.4 to
reflect these proposals.
In the Stage 2 final rule, we note the
process for the implementation of a
payment adjustment to CAH cost reports
in relation to the EHR reporting period
attestation deadline (77 FR 54109 and
54110). Under our Stage 3 proposal, we
would need to move the CAH attestation
deadline in order to accommodate the
change to a calendar year-based EHR
reporting period. Therefore, we propose
to move the CAH attestation deadline to
the last day in February following the
end of the EHR reporting period as we
currently allow for EPs. Any accounting
shifts that occur as a result from the
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change to a calendar year-based EHR
reporting period can be accommodated
through the cost reporting and
settlement process. The CAH must attest
no later than 2 months (February 28 or
February 29 if applicable) following the
close of the EHR reporting period at the
end of each calendar year to avoid the
payment adjustment. Such an
attestation or lack thereof, will then
affect interim payments to the CAH
made after March 1 of the applicable
federal fiscal year. If the cost reporting
period ends prior to March 1 of the
applicable fiscal year, then any
applicable payment adjustment will be
made through the cost report settlement
process.
We are proposing this change to the
EHR reporting period for the payment
adjustment year to further align most
providers to a calendar year-based EHR
reporting period. We believe that the
change to calendar year reporting for
CAHs is feasible given that the cost
reporting and cost settlement processes
is unique to CAHs under the Medicare
EHR Incentive Program. Unlike eligible
hospitals or EPs, who use a claims
processing system to determine the
payment adjustment under the Medicare
EHR Program, CAHs are required to file
an annual Medicare cost report that is
typically for a consecutive 12-month
period. The cost report reflects the
inpatient statistical and financial data
that forms the basis of the CAH’s
Medicare reimbursement. Interim
Medicare payment may be made to the
CAH during the cost reporting period
based on the previous year’s data. Cost
reports are filed with the CAH’s
Medicare contractor after the close of
the cost reporting period, and the data
on the cost report are subject to the
reconciliation and settlement process
prior to a final Medicare payment being
made. The proposed change to a
calendar year EHR reporting period for
CAHs would not significantly impact
the ability to implement the payment
adjustments in the cost report
reconciliation process for either CAHs
or CMS. It would only shift the potential
date where the reconciliation of any
payment adjustment in the cost
reporting process may occur. These
payments would still be subject to the
reconciliation and settlement process
prior to a final Medicare payment being
made.
For example, currently CAHs must
file their attestations on meaningful use
by November 30 of the federal fiscal
year following the close of the federal
fiscal year in which the EHR reporting
period occurs. Under our current
system, if a CAH is attesting that it was
a meaningful EHR user for FY 2015, the
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attestation must be submitted not later
than November 30, 2015. A payment
adjustment applied if the CAH does not
successfully attest would affect interim
payment to the CAH made after
December 1 of 2015. If the cost reporting
period ends prior to December 1, 2015,
then any applicable payment
adjustment will be made under the cost
reporting settlement process.
In an example of a similar scenario
under the new proposal, a CAH that
does not successfully demonstrate
meaningful use based on a calendar year
EHR reporting period in 2017 (January
1, 2017 through December 31, 2017)
would be subject to a payment
adjustment applied to its reasonable
costs incurred in the cost reporting
period beginning in FY 2017 (October 1,
2017 through September 30, 2018). To
avoid the payment adjustment in this
example, the CAH must attest no later
than February 28, 2018 to demonstrate
meaningful use for an EHR reporting
period in 2017. If the CAH does not
attest by February 28, 2018, a payment
adjustment would then affect interim
payments to the CAH made after March
1, 2018. If the cost reporting period ends
prior to March 1, 2018, then any
applicable payment adjustment would
be made through the cost report
settlement process. We note that this is
reflective of a similar policy in the Stage
2 final rule addressing the process for
CAH payment adjustments with an
attestation deadline of November 30 in
a given year and direct readers to 77 FR
54110 for further information on this
policy.
Second, as noted previously, and
outlined in the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ under § 495.4, we
established an exception for first-time
CAH meaningful EHR users. Under our
current policy, if a CAH is
demonstrating it is a meaningful EHR
user for the first time in the payment
adjustment year, the applicable EHR
reporting period is any continuous 90day period within the federal fiscal year
that is the payment adjustment year.
For this Stage 3 proposed rule, we
propose to eliminate this exception for
CAHs that are new meaningful EHR
users beginning with the EHR reporting
period in 2017, with a limited exception
for CAHs demonstrating meaningful use
for the first time under the Medicaid
EHR Incentive Program. As discussed in
II.A.1.a. and II.F.1. of this proposed rule,
for CAHs that demonstrate meaningful
use for the first time under Medicaid,
we are proposing to maintain a 90-day
EHR reporting period for the first
payment year based on meaningful use.
We recognize that these CAHs may be
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subject to payment adjustments under
Medicare if they fail to demonstrate
meaningful use, and thus we propose
that the same 90-day EHR reporting
period used for the Medicaid incentive
payment would also apply for purposes
of the Medicare payment adjustment.
We propose amendments to the
definition of ‘‘EHR reporting period for
a payment adjustment year’’ under
§ 495.4 to reflect these proposals.
Example A: If a CAH has never
successfully demonstrated meaningful
use prior to CY 2017 and demonstrates
under the Medicaid EHR Incentive
Program that it is a meaningful EHR
user for the first time in CY 2017, the
EHR reporting period for the Medicaid
incentive payment would be any
continuous 90-day period within CY
2017. The same 90-day period would
also serve as the EHR reporting period
for the FFY 2017 payment adjustment
year under Medicare.
Like our proposal to move CAHs to a
calendar year timeframe, we believe that
removing the continuous 90-day EHR
reporting period for most CAHs would
simplify reporting for providers,
especially those CAHs with diverse
groups and systems. In addition,
eliminating the 90-day EHR reporting
period would move the EHR Incentive
Program one step closer to alignment
within the program and with CMS
quality reporting programs, and would
simplify HHS system requirements for
data capture. Therefore, moving CAHs
to a calendar year EHR reporting period
for the payment adjustment year, as well
as requiring most providers (EPs, CAHs,
and eligible hospitals) to report based
on the same full year calendar
timeframe would accomplish these
goals and be responsive to prior public
comments asking us to simplify the EHR
Incentive Program.
We welcome public comments on
these proposals.
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10. Administrative Review Process of
Certain Electronic Health Record
Incentive Program Determinations
In the Stage 2 final rule (77 FR 54112
through 54113), we discussed an
administrative appeals process for both
Stages 1 and 2 of meaningful use. We
believe this appeals process is primarily
procedural and does not need to be
specified in regulation. We have
developed guidance on the appeals
process, which is available on our Web
site at www.cms.gov/
EHRIncentivePrograms. We propose no
changes in this proposed rule and
intend to continue to specify the
appeals process in guidance available
on our Web site.
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E. Medicare Advantage Organization
Incentive Payments
We are not proposing any changes to
the existing policies and regulations for
Medicare Advantage (MA)
organizations. Our existing policies and
regulations include provisions
concerning the EHR incentive payments
to qualifying MA organizations and the
payment adjustments for 2015 and
subsequent MA payment adjustment
years. (For more information on MA
organization incentive payments, we
refer readers to the final rules for Stages
1 and 2 (75 FR 44468 through 44482 and
77 FR 54113 through 54119).)
F. The Medicaid EHR Incentive Program
The proposals discussed in sections
II.F.1. through II.F.3. of this proposed
rule would be applicable upon the
effective date of the final rule, not when
Stage 3 of meaningful use of certified
EHR technology begins, unless
otherwise indicated.
1. EHR Reporting Period for First Year
of Meaningful Use
We are proposing amendments to the
definitions of ‘‘EHR reporting period’’
and ‘‘EHR reporting period for a
payment adjustment year’’ in § 495.4 to
shift the EHR reporting periods for
eligible hospitals and CAHs to periods
that are based on the calendar year, not
the federal fiscal year, and to establish
a full calendar year as the EHR reporting
period or EHR reporting period for a
payment adjustment year for almost all
providers beginning in 2017. However,
we are also proposing a limited
exception under which Medicaid EPs
and eligible hospitals demonstrating
meaningful use for the first time could
use any continuous 90-day EHR
reporting period within the calendar
year. This EHR reporting period for
Medicaid providers demonstrating
meaningful use for the first time would
apply both for purposes of receiving an
incentive payment in the Medicaid
program and for purposes of avoiding
the payment adjustment under the
Medicare program for the payment
adjustment year that is two years after
the calendar year in which the provider
first demonstrates meaningful use for an
EHR reporting period. Under this
proposal, Medicaid EPs and eligible
hospitals would have an EHR reporting
period of any continuous 90-day period
in the calendar year that is the payment
year, for their first payment year based
on meaningful use, beginning in 2017.
We note that hospitals that are eligible
under both the Medicaid and Medicare
incentive programs, and that are
attesting for the Medicaid program, do
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not need to separately attest in the
Medicare program in 2017 and
subsequent years, because the statute
does not allow for Medicare EHR
incentive payments to eligible hospitals
after FY 2016. If a hospital eligible
under both programs is demonstrating
meaningful use for the first time, and
using a continuous 90-day EHR
reporting period under the Medicaid
program, it could attest for the Medicaid
program only, and still avoid the
Medicare payment adjustment that is 2
years after the calendar year in which
the EHR reporting period occurs.
However, if a hospital eligible under
both programs chooses also to attest for
the Medicare program, it would be
required to complete an EHR reporting
period of 1 full calendar year to avoid
the Medicare payment adjustment that
is 2 years after that calendar year. We
note that, consistent with the other
proposed amendments to § 495.4
discussed previously, this proposal
would change the EHR reporting period
for eligible hospitals from one that is
based on the federal fiscal year to one
that is based on the calendar year,
beginning in 2017. For further
discussion of the relationship between
the 90-day EHR reporting period under
the Medicaid EHR Incentive Program
and the payment adjustments under
Medicare, we refer readers to section
II.D. of this proposed rule.
This policy would allow Medicaid
providers flexibility in their first year of
demonstrating meaningful use. It also
would reduce the burden on states to
implement significant policy and
system changes in preparation for Stage
3, as the 90-day period for the first year
of meaningful use is consistent with our
previous policies and meaningful use
timelines.
2. Reporting Requirements
a. State Reporting on Program Activities
As discussed in section
II.A.1.c.(1).(b).(iii). of this proposed rule,
we are adding a new provision at
§ 495.316(d)(2)(iii) to provide states
with flexibility regarding the Stage 3
public health and clinical data registry
reporting objective.
We also propose to amend
§ 495.316(c), as well as add a new
paragraph § 495.316(f), to formalize the
process of how states report to us
annually on the providers that have
attested to adopt, implement, or upgrade
(AIU), or that have attested to
meaningful use. Under this proposal,
states would follow a structured
submission process, in the manner
prescribed by CMS, which would
include a new annual reporting
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deadline. We propose to require states
to submit annual reports to CMS within
45 days of the end of the second quarter
of each federal fiscal year.
We propose to regularize the timing of
the annual reporting process described
in § 495.316 to ensure more timely
annual reports and allow for clearer
communication to states on when the
reports should be submitted to CMS. In
addition, CMS and states would be able
to more effectively track the progress of
states’ incentive program
implementation and oversight as well as
provider progress in achieving
meaningful use. Predictable deadlines
for annual reporting would permit CMS
and the states to more quickly compare
and assess overall program impact each
year.
We are also considering changes to
the data that the annual reporting
requirements outlined in § 495.316(d)
require states to include in their annual
reports. Specifically, we are considering
whether to remove the requirement that
states report information about practice
location for providers that qualify for
incentive payments on the basis of
having adopted, implemented, or
upgraded certified EHR technology or
on the basis of demonstrating they are
meaningful users of certified EHR
technology. While we believe that this
data is useful to both CMS and the states
for program implementation purposes,
we believe the benefits of including it in
state reports might be outweighed by the
burdens to states of reporting it.
Therefore, we are seeking more
information on state burdens and costs
associated with complying with this
requirement. We solicit comments both
on the burdens associated with the
requirement to report practice location
information for providers that receive
incentive payments through the
Medicaid EHR Incentive Program, and
on the benefits of including this
information in state reports.
We propose to amend § 495.352 to
formalize the process of how states
submit quarterly progress reports on
implementation and oversight activities
and to specify the elements that should
be included in the quarterly reports.
Under this proposal, states would
follow a structured submission process,
in the manner prescribed by CMS. We
propose that states would report on the
following activities: State system
implementation dates; provider
outreach; auditing; state-specific SMHP
tasks; state staffing levels and changes;
the number and type of providers that
qualified for an incentive payment on
the basis of demonstrating that they are
meaningful EHR users of certified EHR
technology and the amounts of
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incentive payments; and the number
and type of providers that qualified for
an incentive payment on the basis of
having adopted, implemented, or
upgraded certified EHR technology and
the amounts of incentive payments.
We propose these changes to the
quarterly reporting process described in
§ 495.352 so that CMS and states can
better track state implementation and
oversight activity progress in a way that
would permit CMS and the states to
compare overall programmatic and
provider progress. We also expect that
streamlined and enhanced quarterly
progress reporting would lead to an
improvement in overall data quality that
would help inform future meaningful
use activity across states.
We would like to include a deadline
for states’ quarterly reporting under the
proposed amendments to § 495.352, and
are considering requiring states to
submit quarterly progress reports to
CMS within 30 days after the end of
each federal fiscal year quarter. We
believe that a set deadline would
improve timeliness and communication,
but we do not want to set a deadline
that is overly burdensome for a report
that must be submitted quarterly. We
seek public comment on the deadline
we are considering.
b. State Reporting on Meaningful EHR
Users
Starting in FY 2015 for eligible
hospitals and CY 2015 for EPs,
providers that fail to demonstrate
meaningful use for an applicable EHR
reporting period will be subject to
downward payment adjustments under
Medicare. As discussed in the Stage 2
final rule (77 FR 54094), EPs who are
meaningful EHR users under the
Medicaid EHR Incentive Program for an
applicable EHR reporting period will be
considered meaningful EHR users for
that period for purposes of avoiding the
Medicare payment adjustments.
Currently, hospitals eligible for both
Medicaid and Medicare incentive
payments attest in both the Medicare
and Medicaid systems to earn an
incentive payment in both programs.
The statute does not authorize Medicare
EHR incentive payments to eligible
hospitals after FY 2016. To avoid
duplicative reporting, hospitals eligible
under both programs will not be
required to attest in both programs
beginning in 2017. Therefore, we must
have accurate and timely data from
states regarding both EPs and eligible
hospitals that have successfully
demonstrated meaningful use for each
payment year to ensure that meaningful
EHR users in the Medicaid EHR
Incentive Program are appropriately
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exempted from the Medicare payment
adjustment for the applicable payment
adjustment year. This additional
reporting is necessary because the
electronic data currently contained in
the National Level Repository are
insufficient to determine which
Medicaid providers should be exempted
from the Medicare payment adjustments
in an accurate and timely manner.
Accordingly, we propose to add new
paragraphs (g) and (h) to § 495.316 to
require that states submit reports on a
quarterly basis that identify certain
providers that attested to meaningful
use through the Medicaid EHR Incentive
Program for each payment year. Under
this proposal, states would submit
quarterly reports for Medicaid EPs and
eligible hospitals that successfully attest
to meaningful use for each payment
year.
We propose that states would report
quarterly, in the manner prescribed by
CMS, information on each provider that
successfully attests to meaningful use,
regardless of whether the provider has
been paid yet. The report would be
required to specify the Medicaid state
and payment year. For each EP or
eligible hospital listed in the report, the
state would also specify the Payment
Year Number, the NPI for EPs and the
CCN for eligible hospitals, the
Attestation Submission Date, the State
Qualification (as either meaningful use
or blank), and the State Qualification
Date (the beginning date of the reporting
period in which successful meaningful
use attestation was achieved by the EP
or eligible hospital). The EP or eligible
hospital’s ‘‘payment year number’’
refers to the number of years that the
provider has been paid in the EHR
Incentive Program; so, for example, this
would be ‘‘2’’ for the 2014 payment year
if the provider received payments for
2013 and 2014. States would have this
data, even for providers that have
previously received an incentive
payment through the Medicare EHR
Incentive Program. If the state is
reporting a disqualification, then the
state would leave the State Qualification
field blank. If applicable, in the cases of
EPs or eligible hospitals previously
identified as meaningful EHR users, the
state would be required to specify the
State Disqualification and State
Disqualification Date (that is, the
beginning date of the EHR reporting
period during which an EP or eligible
hospital was found not to meet the
definition of a meaningful EHR user).
Under this proposal, states would
submit this information beginning with
payment year 2013 data. The reports
would cover back to the 2013 payment
year because that would be the EHR
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reporting period for the 2015 Medicare
payment adjustment year under § 495.4.
Providers that successfully attested to
meaningful use for 2013 would be
exempt from the Medicare payment
adjustment in 2015.
Under this proposal, states would not
be required to include information
about certain providers in their reports.
We recognize that several provider types
that are eligible for the Medicaid EHR
Incentive Program are not subject to the
Medicare payment adjustments.
Accordingly, states would not be
required to report on those EPs who are
eligible for the Medicaid EHR Incentive
Program on the basis of being a nurse
practitioner, certified nurse-midwife, or
physician assistant.
3. Clinical Quality Measurement for the
Medicaid Program
States are, and will continue in Stage
3 to be, responsible for determining
whether and how electronic reporting of
CQMs would occur, or whether they
wish to allow reporting through
attestation. This is consistent with our
policy in the Stage 2 final rule (77 FR
54075). If a state does require electronic
reporting, the state is responsible for
sharing the details on the process with
its provider community. We anticipate
that whatever means states have
deployed for capturing Stages 1 and 2
clinical quality measures electronically
would be similar for reporting in 2017
and subsequent years. However, we note
that subject to our prior approval, this
is within the states’ purview. States that
wish to establish the method and
requirements for electronically reporting
would continue to be required to do so
through the SMHP submission, subject
to our prior approval.
To further our goals of alignment and
avoiding duplicative reporting across
quality reporting programs, we would
recommend that states include a
narrative in their SMHP for CY 2017
describing how their proposed
meaningful use CQM data submission
strategy aligns with their State Medicaid
Quality Strategy and report which
certified EHR technology requirements
they mandate for eCQM reporting.
For more information on requirements
around the State Medicaid Quality
Strategy, see https://medicaid.gov/
Federal-Policy-Guidance/Downloads/
SHO-13-007.pdf.
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
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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 collection of information
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 V.C. of
this proposed rule. The actual burden
would remain constant for all of Stage
3 as EPs, eligible hospitals, and CAHs
would only need to attest that they have
successfully demonstrated meaningful
use in 2017 and annually thereafter. The
only variable from year-to-year in Stage
3 would be the number of respondents,
as noted in the impact analysis
assumptions. For the purposes of this
analysis, we are focusing only on 2017,
the first year in which a provider may
participate in Stage 3 of the Medicare
EHR Incentive Program. We do not
believe the burden for EPs, eligible
hospitals, and CAHs participating in
Stages 1 and 2 prior to 2017 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 have the option to
electronically report their clinical
quality measures through the respective
electronic reporting pilots. For eligible
hospitals and CAHs, the burden is
discussed in the CY 2012 Hospital
Outpatient Prospective Payment System
final rule with comment period (76 FR
73450 through 73451).
As discussed in section I.A.1.a. of this
proposed rule, Stage 3 is intended to
build on Stages 1 and 2 with a focus on
advanced use of certified EHR
technology to promote improved patient
outcomes while assuring that the
framework is flexible and does not
hinder innovation. In this proposed
rule, the definition of meaningful use
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16781
with associated reporting requirements
would replace all prior definitions and
requirements beginning in 2018. At that
point, all eligible providers would be
required to report only Stage 3
requirements on an annual basis. For
2017, providers may simply repeat their
current status at Stage 1 or Stage 2, or
move on to Stage 3. The same reporting
time would apply to all providers.
Consequently, the proposed ICRs reflect
the provider burden associated with
complying with and reporting of Stage
3 requirements beginning in 2017 and
each subsequent year.
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 (§ 495.6, § 495.7
and § 495.8)
In § 495.7 we propose that to
successfully demonstrate meaningful
use of certified EHR technology for
Stage 3, 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—
• The provider used certified EHR
technology and specified the technology
was used; and
• The provider satisfied each of the
applicable objectives and associated
measures in § 495.7.
In § 495.8, 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
that require the provider to attest that
they have done so.
We propose that there would be 5
objectives and 10 measures that would
require an EP to enter numerators and
denominators during attestation.
Eligible hospitals and CAHs would have
to attest they have met 5 objectives and
10 measures that would require
numerators and denominators. For
objectives and associated measures
requiring a numerator and denominator
in this proposed rule, we limit our
estimates to actions taken in the
presence of certified EHR technology.
We do not anticipate a provider would
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maintain two 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. The security risk assessment
and its associated measure would not
require a numerator and denominator
and we would expect it would take an
individual provider or designee
approximately 6 hours to complete. The
clinical decision support and active
engagement with a public health agency
measures would take an eligible
professional, eligible hospital or critical
access hospital 1 minute each to report
each CDS intervention or registry.
We propose that EPs would be
required to report on a total of 8
objectives and 16 associated measures.
For the purpose of this proposed
collection of information, we assumed
that all eligible providers would comply
with the requirements of meaningful use
Stage 3. We propose that eligible
hospitals and CAHs would be required
to report on a total of 8 objectives and
17 associated measures. We estimated
the total annual cost burden for all
eligible hospitals and CAHs to attest to
EHR technology, meaningful use
objectives and associated measures, and
electronically submit the clinical quality
measures would be $2,135,204 (4,900
eligible hospitals and CAHs × 6 hours
52 minutes × $63.46 (mean hourly rate
for lawyers based on May 2013 BLS)
data)). We estimate the total annual cost
burden for all EPs to attest to EHR
technology, meaningful use objectives
and associated measures, and
electronically submit the clinical quality
measures would be $385,834,395
(609,100 EPs × 6 hours 52 minutes ×
$92.25 (mean hourly rate for physicians
based on May 2013 BLS) data).
In this proposed rule, there are 5
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 five 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 two
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 each CQM for
providers attesting in their first year of
the program.
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 three
objectives that would require a ‘‘yes’’ or
‘‘no’’ response during attestation. As
discussed previously, the associated
measures are that EPs are required to
conduct a security risk analysis, report
to three registries to fulfil the public
health objective, and must implement at
least five clinical decision support
interventions. For eligible hospitals and
CAHs, there are three objectives that
would require a ‘‘yes’’ or ‘‘no’’ response
during attestation. The associated
measures for eligible hospitals and
CAHs require the provider to conduct a
security risk analysis, report to four
registries to fulfill the public health
objective and must implement at least
five clinical decision support
interventions. We estimate each of these
measures would take 1 minute to report.
Providers would also be required to
attest that they are protecting electronic
health information. 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 6 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 52 minutes to
complete, and would take an eligible
hospital or CAH 6 hours 52 minutes to
complete.
In this proposed rule EPs, eligible
hospitals, and CAHs have virtually
identical burdens. Eligible hospitals and
CAHs are required to report to one
additional registry than EPs are required
to report. 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 6—BURDEN ESTIMATES
Burden estimate
per respondent
(EPs)
Objectives—Eligible hospitals/CAHs
Measures
Protect electronic protected health information (ePHI) created or maintained
by the CEHRT through the implementation of appropriate technical, administrative and physical safeguards.
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Objectives—Eligible professionals
Protect electronic protected health information (ePHI) created or maintained
by the CEHRT through the implementation of appropriate technical, administrative and physical safeguards.
Generate and transmit permissible prescriptions electronically (eRx.).
Generate and transmit permissible discharge prescriptions electronically
(eRx).
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), implement
security updates as necessary, and
correct identified security deficiencies
as part of the provider’s risk management process.
1. EP Measure: More than 80% of all
permissible prescriptions written by
the EP are queried for a drug formulary and transmitted electronically
using CEHRT.
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Burden estimate
per respondent
(hospitals)
6 hours .............
6 hours.
10 minutes ........
10 minutes.
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16783
TABLE 6—BURDEN ESTIMATES—Continued
Objectives—Eligible professionals
Objectives—Eligible hospitals/CAHs
.............................................................
Implement clinical decision support
(CDS) interventions focused on improving performance on high-priority
health conditions.
Implement clinical decision support
(CDS) interventions focused on improving performance on high-priority
health conditions.
.............................................................
Use computerized provider order entry
(CPOE) for medication, laboratory,
and diagnostic imaging orders directly
entered by any licensed healthcare
professional, credentialed medical
assistant, or a medical staff member
credentialed to and performing the
equivalent duties of a credentialed
medical assistant; who can enter orders into the medical record per state,
local, and professional guidelines.
Use computerized provider order entry
(CPOE) for medication, laboratory,
and diagnostic imaging orders directly
entered by any licensed healthcare
professional, credentialed medical assistant, or a medical staff member
credentialed to and performing the
equivalent duties of a credentialed
medical assistant; who can enter orders into the medical record per state,
local, and professional guidelines.
.............................................................
.............................................................
The EP provides access for patients to
view online, download, and transmit
their health information, or retrieve
their health information through an
API, within 24 hours of its availability.
The eligible hospital or CAH provides
access for patients to view online,
download, and transmit their health information, or retrieve their health information through an API, within 24
hours of its availability.
.............................................................
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Burden estimate
per respondent
(EPs)
Measures
2. Eligible Hospital Measure: More than
25% of hospital discharge medication
orders for permissible prescriptions
(for new and changed prescriptions)
are queried for a drug formulary and
transmitted
electronically
using
CEHRT.
Measure 1: The EP, eligible hospital and
CAH must implement five clinical decision support interventions related to
four or more CQMs at a relevant point
in patient care for the entire EHR reporting period. Absent four CQMs 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.
Measure 1: More than 80 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 computerized provider
order entry..
Measure 2: More than 60 percent of laboratory 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 computerized provider
order entry
Measure 3: More than 60 percent of
diagnostic imaging 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 computerized provider order entry.
Measure 1: For more than 80 percent of
all unique patients seen by the EP or
discharged from the eligible hospital
or CAH inpatient or emergency department (POS 21 or 23):
(1) The patient (or the patient authorized
representative) is provided access to
view online, download, and transmit
his or her health information within 24
hours of its availability to the provider;
or
(2) The patient (or the patient authorized
representative) is provided access to
an ONC-certified API that can be used
by third-party applications or devices
to provide patients (or patient authorized representatives) access to their
health information, within 24 hours of
its availability to the provider
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Burden estimate
per respondent
(hospitals)
1 minute ............
1 minute.
10 minutes ........
10 minutes.
10 minutes ........
10 minutes.
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TABLE 6—BURDEN ESTIMATES—Continued
Objectives—Eligible professionals
Objectives—Eligible hospitals/CAHs
.............................................................
Use communications functions of certified EHR technology to engage with
patients or their authorized representatives about the patient’s care.
Use communications functions of certified EHR technology to engage with
patients or their authorized representatives about the patient’s care
.............................................................
.............................................................
.............................................................
.............................................................
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The EP provides a summary of care
record when transitioning or referring
their patient to another setting of care,
retrieves a summary of care record
upon the first patient encounter with a
new patient, and incorporates summary of care information from other
providers into their EHR using the
functions of certified EHR technology.
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The eligible hospital or CAH provides a
summary of care record when
transitioning or referring their patient
to another setting of care, retrieves a
summary of care record upon the first
patient encounter with a new patient,
and incorporates summary of care information from other providers into
their EHR using the functions of certified EHR technology.
.............................................................
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Burden estimate
per respondent
(EPs)
Measures
Measure 2: The EP, eligible hospital or
CAH must use clinically relevant information from CEHRT to identify patient-specific educational resources
and provide electronic access to those
materials to more than 35 percent of
unique patients seen by the EP or discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Measure 1: During the EHR reporting
period, more than 25 percent of all
unique patients seen by the EP or discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) actively engage
with the electronic health record made
accessible by the provider. An EP
may meet the measure by either—.
(1) More than 25 percent of all unique
patients (or patient-authorized representatives) seen by the EP or discharged from the eligible hospital or
CAH during the EHR reporting period
view, download or transmit to a third
party their health information; or
(2) More than 25 percent of all unique
patients (or patient-authorized representatives) seen by the EP or discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period access their health information through the use of an ONCcertified API that can be used by thirdparty applications or devices.
Measure 2: During the EHR reporting
period, for more than 35 percent of all
unique patients seen by the EP or discharged from the eligible hospital or
CAH during the EHR reporting period,
a secure message was sent using the
electronic messaging function of
CEHRT to the patient (or their authorized representatives), or in response
to a secure message sent by the patient.
Measure 3: Patient-generated health
data or data from a non-clinical setting
is incorporated into the certified EHR
technology for more than 15 percent
of all unique patients seen by the EP
or discharged by the eligible hospital
or CAH during the EHR reporting period.
Measure 1: For more than 50 percent of
transitions of care and referrals, the
EP, eligible hospital or CAH that transitions or refers their patient to another setting of care or provider of
care—(1) creates a summary of care
record using CEHRT; and (2) electronically exchanges the summary of
care record.
Measure 2: For more than 40 percent of
transitions or referrals received and
patient encounters in which the provider has never before encountered
the patient, the EP, eligible hospital or
CAH incorporates into the patient’s
record in their EHR an electronic summary of care document from a source
other than the provider’s EHR system.
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Burden estimate
per respondent
(hospitals)
10 minutes ........
10 minutes.
10 minutes ........
10 minutes.
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16785
TABLE 6—BURDEN ESTIMATES—Continued
Objectives—Eligible professionals
Objectives—Eligible hospitals/CAHs
.............................................................
.............................................................
.............................................................
.............................................................
The EP is in active engagement with a
PHA or 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.
The eligible hospital or CAH is in active
engagement with a PHA or 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.
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
.............................................................
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.............................................................
.............................................................
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Burden estimate
per respondent
(EPs)
Measures
Measure 3: For more than 80 percent of
transitions or referrals received and
patient encounters in which the provider has never before encountered
the patient, the EP, eligible hospital,
or CAH performs clinical information
reconciliation. The provider would
choose at least two of the following
three clinical information sets on
which to perform reconciliations:
Medication. Review of the patient’s
medication, including the name, dosage, frequency, and route of each
medication.
Medication allergy. Review of the patient’s known allergic medications.
Current Problem list. Review of the patient’s current and active diagnoses.
Providers must report data on an ongoing basis to established public health
registries.
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).
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).
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.
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.
Measure 5: Clinical Data Registry Reporting: The EP, eligible hospital, or
CAH is in active engagement to submit data to a clinical data registry.
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
EP Objective: report to 3 of the following
registries:
Immunization
Syndromic Surveillance
Case Reporting
Public Health
Clinical Data
EPs may choose to report to more than
one public health registry to meet the
number of measures required to meet
the objective.
EPs may choose to report to more than
one clinical data registry to meet the
number of measures required to meet
the objective.
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Burden estimate
per respondent
(hospitals)
1 minute ............
1 minute.
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TABLE 6—BURDEN ESTIMATES—Continued
Objectives—Eligible professionals
Objectives—Eligible hospitals/CAHs
.............................................................
.............................................................
.............................................................
Burden estimate
per respondent
(EPs)
Measures
Burden estimate
per respondent
(hospitals)
EH/CAH Objective: report to 4 of the following registries:
Immunization
Syndromic Surveillance
Case Reporting
Public Health
Clinical Data
Electronic Reportable Laboratory
Results.
Eligible hospitals and CAHs may choose
to report to more than one public
health registry to meet the number of
measures required to meet the objective.
Eligible hospitals and CAHs may choose
to report to more than one clinical
data registry to meet the number of
measures required to meet the objective.
..................................................................
..................................................................
6 hours 52 minutes.
6 hours 52 minutes.
Total—Criteria Burden ..............
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Criteria Burden Time to Attest and
Report Clinical Quality Measures.
..................................................................
..................................................................
6 hours 52 minutes.
6 hours 52 minutes.
In this proposed rule, we estimate that
it would take no longer than 6 hours
and 52 minutes for an EP to satisfy each
of the applicable objectives and
associated measures. The total burden
hours for an EP to attest to the criteria
previously specified would be 6 hours
52 minutes. We estimate that there
could be approximately 609,100 nonhospital-based Medicare and Medicaid
EPs in 2017.
We estimate the burden for the
approximately 13,635 MA EPs in the
MAO burden section. We estimate the
total burden associated with these
requirements for an EP would be 6
hours 52 minutes. The total estimated
annual cost burden for all EPs to attest
to EHR technology and meaningful use
objectives would be $385,834,395
(506,400 × 6 hours 52 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 core
meaningful use objectives and
associated measures, and would
electronically submit the clinical quality
measures. We estimate that it would
take no longer, than 6 hours and 52
minutes to attest that during the EHR
reporting period, they used the certified
EHR technology, specify the EHR
technology used and satisfied each of
the applicable objectives and associated
measures. We estimate that there are
about 4,900 eligible hospitals and CAHs
(3,397 acute care hospitals, 1,395 CAHs,
97 children’s hospitals, and 11 cancer
hospitals) that may attest to the
aforementioned criteria in FY 2017. We
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estimate the total burden associated
with these requirements for an eligible
hospital and CAH would be 6 hours 52
minutes. The total estimated annual cost
burden for all eligible hospitals and
CAHs to attest to EHR technology,
meaningful use core set and menu set
criteria, and electronically submit the
clinical quality measures would be
$2,135,204 (4,908 eligible hospitals and
CAHs × $63.46 (6 hours 52 minutes ×
$63.46 (mean hourly rate for lawyers
based on May 2013 BLS) data)).
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 in Stage 3, 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 together 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 estimate that, on average, it would
take an individual 45 minutes to collect
information necessary to determine if a
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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
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, we believe it would
cost the participating qualifying MA
organizations approximately $426,050
annually to make the attestations
([10,226 hours × $25.00] + [3,408 hours
× $50.00]).
C. ICR Regarding State Reporting
Requirements (§ 495.316 and § 495.352)
We are proposing to revise 42 CFR
495 regarding state reporting
requirements to CMS. With respect to
the annual reporting requirements in
§ 495.316 and the quarterly reporting
requirements in § 495.352, we do not
believe that the proposed amendments
to these reporting requirements would
increase the burden on states beyond
what was previously finalized under
OMB control number 0938–1158
following the Stage 2 final rule. The
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deadlines we propose or are considering
would be consistent with our past
practice, and the changes we propose or
consider to the data elements to be
reported on would be either reduced or
similar in burden. Similarly, we do not
expect the proposed amendments
regarding the 90-day EHR reporting
period for first time meaningful users
would impose a burden on states
because those amendments would
generally maintain the current policy.
However, we are proposing to revise
§ 495.316 to include a new quarterly
reporting requirement. Under the
proposed amendment, states would
report quarterly to CMS regarding the
EPs and Medicaid eligible hospitals that
have successfully demonstrated
meaningful use for each payment year.
We need this information to ensure that
those EPs who are meaningful EHR
users in the Medicaid EHR Incentive
Program are appropriately exempted
from the Medicare payment adjustment.
We cannot accurately exempt these
providers using the current data
received from states. We expect that it
would take a state 20 hours each year
to submit this report on a quarterly
basis. We believe that the state
employee reporting the information
could be equivalent to a GS 12, step 1
(2015 unadjusted for locality rate), with
an hourly rate of approximately $30.00/
hour. This amount is then reduced by
the 90 percent federal contribution for
administrative services for Medicaid
under the EHR Incentive Programs, this
equates to approximately $3.00/hour.
Therefore, for all state Medicaid
agencies to report four times per year at
20 hours per report the estimated cost
is $13,460 (4560 hours × $3.00/hour).
TABLE 7—ESTIMATED ANNUAL INFORMATION COLLECTION BURDEN
Reg section
§ 495.x—Objectives/
Measures (EPs) ........
§ 495.6—Objectives/
Measures (hospitals/
CAHs) .......................
§ 495.210—Gather information for attestation (MA EPs) ...........
§ 495.210—Attestation
on behalf of MA EPs
§ 495.316—Quarterly
Reporting ..................
Totals ....................
OMB Control
No.
Number of
respondents
Burden per
response
(hours)
Number of
responses
Hourly labor
cost of
reporting
($)
Total annual
burden
(hours)
Total cost
($)
0938–1158
609,100
609,100
6.86
4,178,426
92.25
385,834,395
0938–1158
4,900
4,900
6.86
33,614
63.46
2,135,204
0938–1158
13,635
13,635
0.75
10,226
25.00
255,650
0938–1158
13,635
13,635
0.25
3408.75
50.00
170,400
0938–1158
56
224
20
4480
3.00
13,440
........................
627,635
627,635
........................
4,225,674
........................
388,408,189
Notes:
All non-whole numbers in this table are rounded to 2 decimal places.
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 7.
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 final rule; or
2. Submit your comments to the
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Attention: CMS Desk Officer,
[CMS–3310–P], Fax: (202) 395–6974; or
Email: OIRA_submission@omb.eop.gov.
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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. This proposed rule
specifies applicable criteria for
demonstrating Stage 3 of meaningful
use.
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
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(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).
This proposed rule is anticipated to
have an annual effect on the economy
of $100 million or more, making it an
economically significant rule under the
Executive Order and a major rule under
the Congressional Review Act.
Accordingly, we have prepared a
Regulatory Impact Analysis (RIA) that
presents the estimated costs and
benefits of this proposed rule.
As noted in section I.A.2. of this
proposed rule, this proposed rule is one
of two coordinated rules related to the
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meaningful use of certified EHR
technology. The other is ONC’s 2015
Edition Health Information Technology
(Health IT) Certification Criteria, 2015
Edition Base Electronic Health Record
(EHR) Definition, and ONC Health IT
Certification Program Modifications
proposed elsewhere in this issue of the
Federal Register. This analysis focuses
on the impact associated with Stage 3
requirements for meaningful use, the
changes in quality measures that would
take effect beginning in 2017, and other
changes being proposed for the
Medicare and Medicaid EHR Incentive
Programs.
As we discussed in the Stage 2 final
rule (77 FR 54163 through 54291), a
number of factors would affect the
adoption of EHR systems and
demonstration of meaningful use. In this
proposed rule, we continue to believe
that a number of factors would affect the
adoption of EHR systems and
demonstration of meaningful use.
Readers should understand that these
forecasts are also subject to substantial
uncertainty since demonstration of
meaningful use will depend not only on
the standards and requirements for 2017
and for eligible hospitals and EPs, but
on future rulemakings issued by the
HHS.
We further stated in the 2012 Stage 2
final rule (77 FR 54135 through 54136),
the statute provides Medicare and
Medicaid incentive payments for the
meaningful use of certified EHR
technology. Additionally, the Medicaid
program also provides incentives for the
adoption, implementation, and upgrade
of certified EHR technology. Beginning
in 2015, payment adjustments are
incorporated into the Medicare EHR
Incentive Program for providers unable
to demonstrate meaningful use. The
absolute and relative strength of these is
unclear. For example, a provider with
relatively small Medicare billings will
be less disadvantaged by payment
adjustments than one with relatively
large Medicare billings. Another
uncertainty arises because there are
likely to be ‘‘bandwagon’’ effects as the
number of providers using EHRs rises,
thereby inducing more participation in
the incentives program, as well as
greater adoption by entities (for
example, clinical laboratories) that are
not eligible for incentives or subject to
payment adjustments, but do business
with EHR adopters. It is impossible to
predict exactly if and when such effects
may take hold.
An uncertainty arises because under
current law, physicians are scheduled
for a large payment reduction in April
2015 under the sustainable growth rate
(SGR) formula, which determines
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Medicare physician payment updates. A
large payment reduction could cause
major changes in physician behavior,
enrollee care, and other Medicare
provider payments, but the specific
nature of these changes is uncertain.
Under current law, the remaining EHR
incentives for Medicaid or the Medicaid
payment adjustments will exert only a
minor influence on physician behavior
relative to this large physician payment
reduction. However, the Congress has
legislatively avoided a large physician
payment reduction for each year since
2002.
All of these factors taken together
make it impossible in this proposed rule
to predict with precision the timing or
rates of adoption and meaningful use.
However, new data is currently
available regarding rates of adoption or
costs of implementation since the
publication of our Stage 1 and Stage 2
final rules. We have included the new
data in our estimates, although even
these forecasts are still fairly uncertain.
Overall, in this proposed rule, we
expect spending under the EHR
incentive program for transfer payments
to Medicare and Medicaid providers
between 2017 and 2020 to be $3.7
billion (this estimate includes net
payment adjustments for Medicare
providers who do not achieve
meaningful use in the amount of $0.8
billion). We have also estimated ‘‘per
entity’’ costs for EPs, eligible hospitals,
and CAHs for implementation/
maintenance and reporting requirement
costs, not all costs. We believe many
adopting entities may achieve dollar
savings at least equal to their total costs,
and that there may be additional
benefits to society. We also believe that
implementation costs are significant for
each participating entity because
providers who were like to qualify as
meaningful users of EHRs were likely to
purchase certified EHR technology.
However, we believe that providers who
have already purchased certified EHR
technology and participated in Stage 1
or Stage 2 of meaningful use will
experience significantly lower costs for
participation in the program. We
continue to believe that the short-term
costs to demonstrate meaningful use of
certified EHR technology may be
outweighed by the long-term benefits,
including practice efficiencies and
improvements in medical outcomes.
Although both cost and benefit
estimates are highly uncertain, the RIA
that we have prepared presents the
estimated costs and benefits of this
proposed rule.
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C. Anticipated Effects
The objective of the remainder of this
proposed RIA is to summarize the costs
and benefits of the HITECH Act
incentive program for the Medicare FFS,
Medicaid, and MA programs. We also
provide assumptions and a narrative
addressing the potential costs to the
health care industry for implementation
of this technology.
1. Overall Effects
a. EHR Technology Development and
Certification Costs
We note that the costs incurred by IT
developers for EHR technology
development and certification to the
2015 Edition certification criteria for
health IT are also in part attributable to
the requirements for the use of CEHRT
established in this proposed rule for
Stage 3 of the EHR Incentive Programs.
Therefore, to the extent that providers’
implementation and adoption costs are
attributable to this proposed rule, health
IT developers’ preparation and
development costs would also be
attributable as these categories of
activities may be directly or indirectly
incentivized by the requirements to
demonstrate meaningful use. However,
even if this Stage 3 proposed rule were
not finalized, other CMS programs (for
example PQRS and IQR) do require or
promote certification to ONC’s criteria—
or a professional organization or other
such entity could require or promote
certification to ONC’s critieria.13 As
noted previously, this analysis focuses
on the impact associated with Stage 3
requirements for meaningful use for
providers; while the development and
certification costs are addressed in the
the 2015 Edition proposed rule
published elsewhere in this issues of the
Federal Register.
b. 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
regulation will not have a significant
impact on a substantial number of small
entities. In the health care 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 nonprofit organizations are considered
small entities, regardless of size.
13 In this case, the provider implementation and
adoption costs discussed in this CMS RIA would
instead be attributable to ONC’s rulemaking.
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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
would be economically significant.
Accordingly, this RIA section, in
conjunction with the remainder of the
preamble, constitutes the required
Initial Regulatory Flexibility Analysis
(IRFA). We believe that the adoption
and meaningful use of EHRs will have
an impact on virtually every EP and
eligible hospital, as well as CAHs and
some EPs and hospitals affiliated with
MA organizations. While the program is
voluntary, in the first 5 years it carries
substantial positive incentives that
make it attractive to virtually all eligible
entities. Furthermore, entities that do
not demonstrate meaningful use of EHR
technology for an applicable reporting
period will be subject to significant
Medicare payment reductions beginning
in 2015. These Medicare payment
adjustments are expected to motivate
EPs, eligible hospitals, and CAHs to
adopt and meaningfully use certified
EHR technology.
For some EPs, CAHs, and eligible
hospitals the EHR technology currently
implemented could be upgraded to meet
the criteria for certified EHR technology
as defined for this program. These costs
may be minimal, involving no more
than a software upgrade. ‘‘Home-grown’’
EHR systems that might exist may also
require an upgrade to meet the
certification requirements. We believe
many currently used non-certified EHR
systems will require significant changes
to achieve certification and that EPs,
CAHs, and eligible hospitals will have
to make process changes to achieve
meaningful use.
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. 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
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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. The costs
for implementation and complying with
the criteria of meaningful use could lead
to higher operational expenses.
However, 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)
will demonstrate the actual costs
incurred by providers participating in
the EHR Incentive Programs.
(2) Conclusion
As discussed later in this analysis, we
believe that there are many positive
effects of adopting EHR on health care
providers. We believe that the net effect
on some individual providers may be
positive. 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
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16789
(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
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. This proposed rule would affect
the operations of a substantial number
of small rural hospitals because they
may be subject to adjusted Medicare
payments in 2015 if they fail to adopt
certified EHR technology by the
applicable reporting period. As stated
previously, we have determined that
this proposed rule would create a
significant impact on a substantial
number of small entities, and have
prepared a Regulatory Flexibility
Analysis as required by the RFA and, for
small rural hospitals, section 1102(b) of
the Act. Furthermore, any impacts that
would arise from the implementation of
certified EHR technology in a rural
eligible hospital would be positive, with
respect to the streamlining of care and
the ease of sharing information with
other EPs to avoid delays, duplication,
or errors. However, the Secretary retains
the discretionary statutory authority to
make case-by-case exceptions for
significant hardships, and has already
established certain categories where
case-by-case applications may be made
such as barriers to internet connectivity
that impact health information
exchange.
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 2014, that threshold is
approximately $141 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
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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.
The investments needed to meet the
meaningful use standards and obtain
incentive funding are voluntary, and
hence not ‘‘mandates’’ within the
meaning of the statute. However, the
potential reductions in Medicare
reimbursement beginning with FY 2015
would have a negative impact on
providers that fail to meaningfully use
certified EHR technology for the
applicable reporting period. We note
that we have no discretion as to the
amount of those potential payment
reductions. Private sector EPs that
voluntarily choose not to participate in
the program may anticipate potential
costs in the aggregate that may exceed
$141 million. However, because EPs
may choose for various reasons not to
participate in the program, we do not
have firm data for the percentage of
participation within the private sector.
This RIA, taken together with the
remainder of the preamble, constitutes
the analysis required by UMRA.
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 will not have a
substantial direct effect on state or local
governments, preempt state law, or
otherwise have a federalism
implication. Importantly, state Medicaid
agencies are receiving 100 percent
match from the federal government for
incentives paid and a 90-percent match
for expenses associated with
administering the program. As
previously stated, we believe that state
administrative costs are minimal. We
note that this proposed rule does add a
new business requirement for states,
because of the existing systems that
would need to be modified to track and
report on the new meaningful use
requirements for provider attestations.
We are providing 90-percent FFP to
states for modifying their existing EHR
Incentive Program systems. We believe
the federal share of the 90-percent
match will protect the states from
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burdensome financial outlays and as
noted previously, states offer the
Medicaid EHR incentive program at
their option.
2. Effects on EPs, Eligible Hospitals, and
CAHs
a. Background and Assumptions
The principal costs of this proposed
rule are the additional expenditures that
will be undertaken by eligible entities in
order to obtain the Medicare and
Medicaid incentive payments to adopt,
implement or upgrade and/or
demonstrate meaningful use of certified
EHR technology, and to avoid the
Medicare payment adjustments that will
ensue if they fail to do so. The estimates
for the provisions affecting Medicare
and Medicaid EPs, eligible hospitals,
and CAHs are somewhat uncertain for
several reasons: (1) The program is
voluntary although payment
adjustments will be imposed on
Medicare providers beginning in 2015 if
they are unable to demonstrate
meaningful use for the applicable
reporting period; (2) the criteria for the
demonstration of meaningful use of
certified EHR technology has been
finalized for Stage 1 and Stage 2 and is
being proposed for Stage 3, but may
change over time; and (3) the impact of
the financial incentives and payment
adjustments on the rate of adoption of
certified EHR technology by EPs,
eligible hospitals, and CAHs is difficult
to predict based on the information we
have currently collected. The net costs
and savings shown for this program
represent a possible scenario and actual
impacts could differ substantially.
Based on input from a number of
internal and external sources, we
estimated the numbers of EPs and
eligible hospitals, including CAHs
under Medicare, Medicaid, and MA and
used them throughout the analysis.
• About 675,500 Medicare FFS EPs in
2017 (some of whom will also be
Medicaid EPs).
• About 60,600 non-Medicare eligible
EPs (such as dentists, pediatricians, and
eligible non-physicians such as certified
nurse-midwives, nurse practitioners,
and physicians assistants) could be
eligible to receive the Medicaid
incentive payments in 2017.
• 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)
• All eligible hospitals, except for
children’s and cancer hospitals, may
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qualify and apply for both Medicare and
Medicaid incentive payments.
• About 16 MA organizations
b. Industry Costs and Adoption Rates
In the Stage 2 final rule (77 FR 54136
through 54146), we estimated the
impact on health care providers using
information from four studies. In the
absence of any more recent estimates
that we are aware of, in this proposed
rule, we continue to use the same
estimates cited in the Stage 2 final rule.
We continue to believe that these
estimates are reasonably reflective of
EHR costs. However, we note, we are
unable to delineate all costs due to the
great variability in characteristics among
the entities that are affected by the
proposed rule; the variability includes,
but is not limited to, the size of the
practice, extent of use of electronic
systems, type of system used, number of
staff using the EHR system and the cost
for maintaining and/or upgrading
systems. Based on these studies and
current average costs for available
certified EHR technology products, we
continue to estimate for EPs that the
average adopt/implement/upgrade cost
is $54,000 per physician FTE, while
annual maintenance costs average
$10,000 per physician FTE.
For all eligible hospitals, we continue
to estimate the range is from $1 million
to $100 million. Although reports vary
widely, we continue to anticipate that
the average will be $5 million to achieve
meaningful use, because providers who
will like to qualify as meaningful users
of EHRs will need to purchase certified
EHRs. We further acknowledge
‘‘certified EHRs’’ may differ in many
important respects from the EHRs
currently in use and may differ in the
functionalities they contain. We
continue to estimate $1 million for
maintenance, upgrades, and training
each year. Both of these estimates are
based on average figures provided in the
2008 CBO report. However, as noted
previously, we are unable to delineate
all costs due to the great variability in
characteristics among the entities that
are affected by the proposed rule; the
variability includes, but is not limited
to, the size of the hospital, extent of use
of electronic systems, type of system
used, number of staff using the EHR
system and the cost for maintaining
and/or upgrading systems.
Industry costs are important, in part,
because EHR adoption rates will be a
function of these industry costs and the
extent to which the costs of ‘‘certified
EHRs’’ are higher than the total value of
EHR incentive payments available to
EPs and eligible hospitals (as well as
adjustments, in the case of the Medicare
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EHR incentive program) and any
perceived benefits including societal
benefits. Because of the uncertainties
surrounding industry cost estimates, we
have made various assumptions about
adoption rates in the following analysis
in order to estimate the budgetary
impact on the Medicare and Medicaid
programs.
c. Costs of EHR Adoption for EPs
Since the publication of the Stage 1
final rule, there has been little data
published regarding the cost of EHR
adoption and implementation. A 2011
study (https://content.healthaffairs.org/
content/30/3/481.abstract) estimated
costs of implementation for a fivephysician practice to be $162,000, with
$85,500 in maintenance expenses in the
first year. In the absence of additional
data regarding the cost of adoption and
implementation costs for certified EHR
technology, we proposed to continue to
estimate for EPs that the average adopt/
implement/upgrade cost is $54,000 per
physician FTE, while annual
maintenance costs average $10,000 per
physician FTE, based on the cost
estimate of the Stage 1 final rule.
However, as noted previously, we are
unable to delineate all costs due to the
great variability that are affected by but
not limited to the size of the practice,
extent of use of electronic systems, type
of system used, number of staff using
the EHR system, and the cost for
maintaining and/or upgrading systems.
d. Costs of EHR Adoption for Eligible
Hospitals
According to the American Hospital
Association 2008 Survey, the range in
yearly information technology spending
among hospitals ranged from $36,000 to
over $32 million. EHR system costs
specifically were reported by other
experts to run as high as $20 million to
$100 million (77 FR 54139). We note
that recently we have seen about 96
percent of eligible hospitals have
received at least one incentive payment
under either the Medicare or Medicaid
programs. However, as noted
previously, we are unable to delineate
all costs due to the great variability that
are affected by but not limited to the
size of the eligible hospital, extent of
use of electronic systems, type of system
used, number of staff using the EHR
system, and the cost for maintaining
and/or upgrading systems.
3. Medicare Incentive Program Costs
The estimates for the HITECH Act
provisions are based on the economic
assumptions underlying the President’s
FY 2016 Budget. Under the statute,
Medicare incentive payments for
certified EHR technology are excluded
from the determination of MA
capitation benchmarks. We continue to
expect a negligible impact on benefit
payments to hospitals and EPs from
Medicare and Medicaid because of the
implementation of EHR technology.
As noted at the beginning of this
analysis, it is difficult to predict the
actual impacts of the HITECH Act with
great certainty. We believe the
assumptions and methods described
herein are reasonable for estimating the
financial impact of the provisions on the
Medicare and Medicaid programs, but
acknowledge the wide range of possible
outcomes.
a. Medicare Eligible Professionals (EPs)
We began making EHR Incentive
payments in 2011. Medicare payments
are to be paid for the successful
demonstration on meaningful use
through CY 2016. Due to the payment
lag, some payments may be issued in CY
2017. To avoid the Medicare payment
adjustment beginning in 2015, EPs need
to successfully demonstrate meaningful
use regardless of whether they earn an
incentive payment. We estimated the
percentage of the remaining EPs who
would be meaningful users each
calendar year. Table 8 shows the results
of these calculations.
TABLE 8—MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF CERTIFIED EHR TECHNOLOGY
Calendar year
2017
Medicare EPs who have claims with Medicare (thousands) ...........................
Non-Hospital-based Medicare EPs (thousands) .............................................
Percent of EPs who are Meaningful Users .....................................................
Meaningful Users (thousands) .........................................................................
Our estimates of the incentive
payment costs and payment adjustment
savings are presented in Table 9. They
reflect actual historical data and our
assumptions about the proportion of EPs
who will demonstrate meaningful use of
certified EHR technology. Estimated
2018
675.5
609.1
70
426.4
costs are expected to decrease in 2017
through 2020 due to a smaller number
of new EPs that would achieve
meaningful use and the cessation of the
incentive payment program. Payment
adjustment receipts represent the
estimated amount of money collected
2019
683.3
616.1
73
446.7
2020
691.1
623.1
75
467.3
698.8
630.1
78
488.3
due to the payment adjustments for
those not achieving meaningful use.
Estimated net costs for the Medicare EP
portion of the HITECH Act are also
shown in Table 9.
TABLE 9—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE EPS DEMONSTRATING MEANINGFUL USE OF
CERTIFIED EHR TECHNOLOGY
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[In Billions]
Incentive
payments
Fiscal Year
2017
2018
2019
2020
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
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—
—
—
Payment adjustment
receipts
¥$0.2
¥0.2
¥0.2
¥0.1
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payments
Net total
—
—
—
—
$0.3
¥0.2
¥0.2
¥0.1
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b. Medicare Eligible Hospitals and
CAHs
In brief, the estimates of hospital
adoption were developed by calculating
projected incentive payments and then
making assumptions about how rapidly
hospitals would adopt meaningful use.
Specifically, the first step in preparing
estimates of Medicare program costs for
eligible hospitals was to determine how
many eligible hospitals already received
payments under the EHR Incentive
program and for what years those
payments were received. In order to do
this, we used the most recent available
data that listed the recipients of
incentive payments, and the year and
payment amount. This information
pertained to eligible hospitals receiving
payments through September 2014.
We assume that all eligible hospitals
that receive a payment in the first year
will receive payments in future years.
We also assume the eligible hospitals
that have not yet received any incentive
payments will eventually achieve
meaningful use (either to receive
incentive payments or to avoid payment
adjustments). We assume that all
eligible hospitals would achieve
meaningful use by 2018. No new
incentive payments would be paid after
2016. However, some incentive
payments originating in 2016 would be
paid in 2017.
The average incentive payment for
each eligible hospital was $1.5 million
in the first year. In later years, the
amount of the incentive payments drops
according to the schedule allowed in
law. The average incentive payment for
CAHs received in the first year was
about $950,000. The average incentive
payment received in the second year
was about $332,500. The average
incentive payment received in the third
year was about $475,000. These average
amounts were used for these incentive
payments in the future. The third year
average was also used for the fourth
year. These assumptions about the
number of hospitals achieving
meaningful use in a particular year and
the average amount of an incentive
payment allows us to calculate the total
amount of incentive payments to be
made and the amount of payment
adjustments for those hospitals who
have not achieved meaningful use. The
payment incentives available to
hospitals under the Medicare and
Medicaid EHR Incentive Programs are
included in our regulations at 42 CFR
part 495. We further estimate that there
are 16 MA organizations that might be
eligible to participate in the incentive
program. Those plans have 32 eligible
hospitals. The costs for the MA program
have been included in the overall
Medicare estimates.
The estimated payments to eligible
hospitals were calculated based on the
hospitals’ qualifying status and
individual incentive amounts under the
statutory formula. Similarly, the
estimated payment adjustments for nonqualifying hospitals were based on the
market basket reductions and Medicare
revenues. The estimated savings in
Medicare eligible hospital benefit
expenditures resulting from the use of
hospital certified EHR systems were
discussed earlier in this section. We
assumed no future growth in the total
number of hospitals in the U.S. because
growth in acute care hospitals has been
minimal in recent years. The results are
shown in Table 10.
TABLE 10—ESTIMATED COSTS (+) AND SAVINGS (¥) FOR MEDICARE ELIGIBLE HOSPITALS DEMONSTRATING MEANINGFUL
USE OF CERTIFIED EHR TECHNOLOGY
[In billions]
Incentive
payments
Fiscal year
2017
2018
2019
2020
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
1 Savings
Payment
adjustment
receipts
Benefit
payments
(1)
(1)
0.0
0.0
$1.6
0.0
0.0
0.0
Net total
(1 )
(1 )
(1)
(1)
$1.6
(1 )
( 1)
( 1)
of less than $50 million. All numbers are projections.
4. Medicaid Incentive Program Costs
Under section, 4201 of the HITECH
Act, states and territories can
voluntarily participate in the Medicaid
EHR Incentive Program. However, as of
the writing of this proposed rule, all
states already participate. The payment
incentives available to EPs and eligible
hospitals under the Medicaid EHR
Incentive Program are included in our
regulations at 42 CFR part 495. The
federal costs for Medicaid incentive
payments to providers who can
demonstrate meaningful use of EHR
technology were estimated similarly to
the estimates for Medicare eligible
hospitals and EPs. Table 11 shows our
estimates for the net Medicaid costs for
eligible hospitals and EPs.
TABLE 11—ESTIMATED FEDERAL COSTS (+) AND SAVINGS (¥) UNDER MEDICAID
[In $billions]
Incentive payments
Fiscal year
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Hospitals
2017
2018
2019
2020
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
1 Savings
Eligible
professionals
0.4
0.1
0
0.0
0.8
0.5
0.3
0.2
of less than $50 million.
a. Medicaid EPs
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payments
Net total
(1)
(1)
(1)
(1)
1.2
0.6
0.3
0.2
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TABLE 12—ASSUMED NUMBER OF NONHOSPITAL BASED MEDICAID EPS WHO WOULD BE MEANINGFUL USERS OF
CERTIFIED EHR TECHNOLOGY
[Population figures in thousands]
Calendar year
2017
A ...................................
B ...................................
EPs who meet the Medicaid patient volume threshold ........
Medicaid only Eps .................................................................
Total Medicaid EPs (A + B) ..................................................
Percent of EPs receiving incentive payment during year .....
Number of EPs receiving incentive payment during year ....
Percent of EPs who have ever received incentive payment
Number of EPs who have ever received incentive payment
It should be noted that since the
Medicaid EHR Incentive Program
provides that a Medicaid EP can receive
an incentive payment in his or her 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 not only
meaningful users but eligible providers
implementing certified EHR technology
as well.
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b. Medicaid Hospitals
Medicaid incentive payments to most
eligible hospitals were estimated using
the same methodology as described
previously for Medicare eligible
hospitals and shown in Table 10. Many
eligible hospitals may qualify to receive
both the Medicare and Medicaid
incentive payment. We assume that all
eligible hospitals would achieve
meaningful use by 2016. However,
many of these eligible hospitals would
have already received the maximum
amount of incentive payments. Table 13
shows our assumptions about the
remaining incentive payments to be
paid.
101.3
60.6
161.8
44.7%
72.4
67.9%
109.9
average Medicaid incentive payment in
the first year was $1 million. The
estimated savings in Medicaid benefit
expenditures resulting from the use of
certified EHR technology are discussed
in section V.C.4. of this proposed rule.
Since we use Medicare data and little
data existed for children’s hospitals, we
estimated the Medicaid incentives
payable to children’s hospitals as an
add-on to the base estimate, using data
on the number of children’s hospitals
compared to non-children’s hospitals.
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
TABLE 13—ESTIMATED PERCENTAGE the Recent Literature Shows
OF HOSPITALS THAT COULD BE PAID Predominantly Positive Results’’ Health
FOR MEANINGFUL USE AND ESTI- Affairs.) found that 92 percent of articles
MATED PERCENTAGE PAYABLE IN published from July 2007 up to
February 2010 reached conclusions that
YEAR
showed the overall positive effects of
health information technology on key
Percent of
Percent of
hospitals who hospitals being aspects of care, including quality and
Fiscal year are meaningful
efficiency of health care. Among the
paid
users
positive results highlighted in these
2017 ..........
100.0
13.5 articles were decreases in patient
2018 ..........
100.0
5.2 mortality, reductions in staffing needs,
2019 ..........
100.0
1.5 correlation of clinical decision support
2020 ..........
100.0
0.0 to reduced transfusion and costs,
reduction in complications for patients
As stated previously, the estimated
in hospitals with more advanced health
eligible hospital incentive payments
IT, and a reduction in costs for hospitals
were calculated based on the eligible
with less advanced health IT. A
hospitals’ qualifying status and
subsequent 2013 study completed by
individual incentive amounts payable
the RAND Corporation for ONC
under the statutory formula. The
(Shekelle et al. 2013 ‘‘Health
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2018
102.3
61.7
164.0
30.9%
50.7
74.7%
122.5
2019
103.3
62.9
166.2
20.7%
34.5
78.0%
129.6
2020
104.4
64.0
168.4
14.3%
24.0
81.1%
136.6
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
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. As participation and
adoption increases, there will be more
opportunities to capture and report on
cost savings and benefits.
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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
rule are even harder to quantify because
they represent, in many cases, adding
functionality to existing systems and
reaping the network externalities
created by larger numbers of providers
participating in information exchange.
In the Stage 2 final rule at 77 FR
54144, 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): 16574; 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, health IT and safety 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.’’ However, data relating
specifically to the EHR Incentive
Programs is limited at this time.
7. Summary
In this proposed rule, the total cost to
the Medicare and Medicaid programs
between 2017 and 2020 is estimated to
be $3.7 billion in transfers. As discussed
in section V.C.4. of this proposed rule,
we do not estimate total costs to the
provider industry, but rather provide a
possible per EP and per eligible hospital
outlay for implementation and
maintenance.
TABLE 14—ESTIMATED EHR INCENTIVE PAYMENTS AND BENEFITS IMPACTS ON THE MEDICARE AND MEDICAID PROGRAMS
OF THE HITECH EHR INCENTIVE PROGRAM (FISCAL YEAR)
[In billions]
Medicare eligible
Medicaid eligible
Fiscal year
Total
Hospitals
2017 .....................................................................................
2018 .....................................................................................
2019 .....................................................................................
2020 .....................................................................................
Total ..............................................................................
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D. Alternatives Considered
As stated in the Stage 1 final rule (75
FR 44546), HHS has no discretion to
change the incentive payments or
payment adjustment reductions
specified in the statute for providers
that adopt or fail to adopt a certified
EHR and demonstrate meaningful use of
certified EHR technology. However, we
have discretion around how best to meet
the HITECH Act requirements for
meaningful use for FY 2017 and
subsequent years, which we have
exercised in this proposed rule.
Additionally, we have used our
discretion to appropriately propose the
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$1.6
0.0
0.0
0.0
1.6
$0.3
¥0.2
¥0.2
¥0.1
¥0.2
timing of registration, attestation and
payment requirements to allow EPs and
eligible organizations as much time as
possible in coordination with the
anticipated certification of EHR
technology to obtain and meaningfully
use certified EHRs. We recognize that
there may be additional costs that result
from various discretionary policy
choices by providers. However, those
costs cannot be estimated and are not
captured in this analysis.
E. Accounting Statement and Table
Whenever a rule is considered a
significant rule under Executive Order
12866, we are required to develop an
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Hospitals
$0.4
0.1
0.0
0.0
0.5
Professionals
$0.8
0.5
0.3
0.2
1.8
$3.1
0.4
0.1
0.1
3.7
accounting statement indicating the
classification of the expenditures
associated with the provisions of this
proposed rule. Monetary annualized
benefits and non-budgetary costs are
presented as discounted flows using 3
percent and 7 percent factors in the
following Table 15. We are not able to
explicitly define the universe of those
additional costs, nor specify what the
high or low range might be to
implement EHR technology in this
proposed rule. We note that federal
annualized monetized transfers
represent the net total of annual
incentive payments in the Medicare and
Medicaid EHR Incentive programs less
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the reductions in Medicare payments to
providers failing to demonstrate
meaningful use as a result of the related
Medicare payment adjustments.
Expected qualitative benefits include
improved quality of care, better health
outcomes, reduced errors and the like.
Private industry costs would include the
impact of EHR activities such as
temporary reduced staff productivity
related to learning how to use the EHR,
the need for additional staff to work
with HIT issues, and administrative
costs related to reporting.
TABLE 15—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES CYS 2017 THROUGH 2020
[In millions]
CATEGORY
BENEFITS
Qualitative ........................................................................................................
Expected qualitative benefits include improved quality of care,
better health outcomes, reduced errors and the like.
COSTS
Year dollar
........................
Annualized Monetized Costs to Private Industry Associated with Reporting
Requirements ...............................................................................................
Qualitative—Other private industry costs associated with the adoption of
EHR technology.
Estimates
(in millions)
Unit discount
rate
Period
covered
7%
3%
CY 2017
Primary
Estimate
2017
$478.1
$478.4
These costs would include the impact of EHR activities such as reduced staff productivity related to learning how to use the EHR
technology, the need for additional staff to work with HIT issues,
and administrative costs related to reporting.
TRANSFERS
Year dollar
Federal Annualized Monetized ........................................................................
From Whom To Whom? ..................................................................................
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F. Conclusion
The previous analysis, together with
the remainder of this preamble,
provides an RIA. We believe there are
many positive effects of adopting EHR
on health care providers. We believe
there are benefits that can be obtained
by eligible hospitals and EPs, including:
Reductions in medical recordkeeping
costs, reductions in repeat tests,
decreases in length of stay, and reduced
errors. Health IT can enable providers to
deliver health care more efficiently. For
example, 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. We also believe
that internal savings will likely come
through the reductions in the cost of
providing care. We believe that the net
effect on individual providers may be
positive over time in many cases.
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Estimates
(in millions)
Unit discount
rate
Period
covered
2017
$1,000.4
$954.8
7%
3%
CYs 2017–
2020
Federal Government to Medicare- and Medicaid-eligible
professionals and hospitals.
Accordingly, we believe that the object
of the Regulatory Flexibility Analysis to
minimize burden on small entities are
met by this proposed rule. We invite
public comments on the analysis and
request any additional data that would
help us determine more accurately the
impact on the EPs and eligible hospitals
affected by the proposed rule.
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 amend
42 CFR part 495 as set forth below:
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PART 495—STANDARDS FOR THE
ELECTRONIC HEALTH RECORD
TECHNOLOGY INCENTIVE PROGRAM
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).
2. Section 495.4 is amended as
follows:
■ A. Adding the definition for
‘‘Application-program interface (API)’’.
■ B. Revising the definition of ‘‘Certified
electronic health record technology’’.
■ C. Amending the definition of ‘‘EHR
reporting period’’ by—
■ i. Redesignating paragraphs (1)(i),
(1)(ii), (1)(iii) introductory text,
(1)(iii)(A), (1)(iii)(B), (1)(iii)(C),
(1)(iii)(D), and (1)(iv) as paragraphs
(1)(i)(A), (1)(i)(B), (1)(i)(C) introductory
text, (1)(i)(C)(1), (1)(i)(C)(2), (1)(i)(C)(3),
(1)(1)(C)(4), and (1)(i)(D), respectively.
■ ii. Adding new paragraph (1)(i)
introductory text.
■
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iii. Adding a new paragraph (1)(ii).
iv. Redesignating paragraphs (2)(i),
(2)(ii), (2)(iii) introductory text,
(2)(iii)(A), (2)(iii)(B), (2)(iii)(C), and
(2)(iii)(D), as paragraphs (2)(i)(A),
(2)(i)(B), (2)(i)(C) introductory text and
(2)(i)(C)(1), (2)(i)(C)(2), (2)(i)(C)(3), and
(2)(i)(C)(4), respectively.
■ v. Adding new paragraph (2)(i)
introductory text.
■ vi. Adding a new paragraph (2)(ii).
■ D. Amending the definition of ‘‘EHR
reporting period for a payment
adjustment year’’ by:
■ i. Redesignating paragraphs (1)(i)(A),
(1)(i)(B), (1)(ii), (1)(iii)(A), and (1)(iii)(B)
as paragraphs (1)(i)(A)(1), (1)(i)(A)(2),
(1)(i)(B), (1)(i)(C)(1) and (1)(i)(C)(2),
respectively.
■ ii. In newly redesignated paragraph
(1)(i)(A)(1), by removing the crossreference ‘‘paragraphs (1)(i)(B), (ii), and
(iii)’’ and adding in its place the crossreference ‘‘paragraphs (1)(i)(A)(2),
(1)(i)(B), and (1)(i)(C)’’.
■ iii. In newly redesignated paragraph
(1)(i)(A)(2), by removing the crossreference ‘‘paragraphs (1)(iii) or (iv)’’
and adding in its place the crossreference ‘‘paragraph (1)(i)(C)’’.
■ iv. Adding new paragraph (1)(i)
introductory text.
■ v. Adding a new paragraph (1)(ii).
■ vi. Redesignating paragraphs (2)(i)(A),
(2)(i)(B), (2)(ii), (2)(iii)(A), and (2)(iii)(B)
as paragraphs (2)(i)(A)(1), (2)(i)(A)(2),
(2)(i)(B), (2)(i)(C)(1) and (2)(i)(C)(2),
respectively.
■ vii. In newly redesignated paragraph
(2)(i)(A)(1), by removing the crossreference ‘‘paragraphs (2)(i)(B), (ii), and
(iii)’’ and adding in its place the crossreference ‘‘paragraphs (2)(i)(A)(2),
(2)(i)(B), and (2)(i)(C)’’.
■ viii. In newly redesignated paragraph
(2)(i)(A)(2), by removing the crossreference ‘‘paragraph (2)(iii)’’ and
adding in its place the cross-reference
‘‘paragraph (2)(i)(C)’’.
■ ix. Adding new paragraph (2)(i)
introductory text.
■ x. Adding new paragraph (2)(ii).
■ xi. Redesignating paragraphs (3)(i) and
(3)(ii) as paragraphs (3)(i)(A) and
(3)(i)(B).
■ xii. In newly redesignated paragraph
(3)(i)(A), by removing the crossreference ‘‘paragraph (3)(ii)’’ and adding
in its place the cross-reference
‘‘paragraph (3)(i)(B)’’.
■ xiii. Adding new paragraph (3)(i)
introductory text.
■ xiv. Adding new paragraph (3)(ii).
■ E. In the paragraph (1) of the
definition of ‘‘Meaningful EHR User’’ by
removing the reference ‘‘under § 495.6’’
and adding in its place the reference to
‘‘under § 495.6 or 495.7’’.
The additions read as follows:
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■
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§ 495.4
Definitions.
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Application-program interface (API)
means a set of programming protocols
established for multiple purposes. APIs
may be enabled by a provider or
provider organization to provide the
patient with access to their health
information through a third-party
application with more flexibility than
often found in many current ‘‘patient
portals.’’
Certified electronic health record
technology (CEHRT) means the
following:
(1) For any Federal fiscal year (FY) or
calendar year (CY) before 2018, EHR
technology (which could include
multiple technologies) certified under
the ONC Health IT Certification Program
that—
(i) Meets the—
(A) 2014 Edition Base EHR definition
(as defined at 45 CFR 170.102); or
(B) 2015 Edition Base EHR definition
(as defined at 45 CFR 170.102); or
(ii) Has been certified to the following
certification criteria:
(A)(1) CPOE at—
(i) 45 CFR 170.314(a)(1), (18), (19) or
(20); or
(ii) 45 CFR 170.315(a)(1), (2) or (3);
(2)(i) Record demographics at 45 CFR
170.314(a)(3); or
(ii) 45 CFR 170.315(a)(5).
(3)(i) Problem list at 45 CFR
170.314(a)(5); or
(ii) 45 CFR 170.315(a)(7).
(4)(i) Medication list at 45 CFR
170.314(a)(6); or (ii) 45 CFR
170.315(a)(8).
(5)(i) Medication allergy list 45 CFR
170.314(a)(7); or (ii) 45 CFR
170.315(a)(9);
(6)(i) Clinical decision support at 45
CFR 170.314(a)(8); or (ii) 45 CFR
170.315(a)(10).
(7) Health information exchange at
transitions of care at one of the
following:
(i) 45 CFR 170.314(b)(1) and (2).
(ii) 45 CFR 170.314(b)(1), (b)(2), and
(h)(1).
(iii) 45 CFR 170.314(b)(1), (b)(2), and
(b)(8).
(iv) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), and (h)(1).
(v) 45 CFR 170.314(b)(8) and (h)(1).
(vi) 45 CFR 170.314(b)(1), (b)(2), and
170.315(h)(2).
(vii) 45 CFR 170.314(b)(1), (b)(2),
(h)(1), and 170.315(h)(2).
(viii) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), and 170.315(h)(2).
(ix) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), (h)(1), and 170.315(h)(2).
(x) 45 CFR 170.314(b)(8), (h)(1), and
170.315(h)(2).
(xi) 45 CFR 170.314(b)(1), (b)(2), and
170.315(b)(1).
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(xii) 45 CFR 170.314(b)(1), (b)(2),
(h)(1), and 170.315(b)(1).
(xiii) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), and 170.315(b)(1).
(xiv) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), (h)(1), and 170.315(b)(1).
(xv) 45 CFR 170.314(b)(8), (h)(1), and
170.315(b)(1).
(xvi) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), (h)(1), 170.315(b)(1), and
170.315(h)(1).
(xvii) 45 CFR 170.314(b)(1), (b)(2),
(b)(8), (h)(1), 170.315(b)(1), and
170.315(h)(2).
(xviii) 45 CFR 170.314(h)(1) and
170.315(b)(1).
(xix) 45 CFR 170.315(b)(1) and (h)(1).
(xx) 45 CFR 170.315(b)(1) and (h)(2).
(xxi) 45 CFR 170.315(b)(1), (h)(1), and
(h)(2).
(B) Clinical quality measures at 45
CFR 170.314(c)(1) or 170.315(c)(1).
(C) The 2014 Edition or 2015 Edition
certification criteria that are necessary
to be a Meaningful EHR User (as defined
in this section), including the following:
(1) The applicable automated
numerator recording and automated
measure calculation certification criteria
that support attestation as a Meaningful
EHR User at 45 CFR 170.315(g)(1) and
(2) and 45 CFR 170.314(g)(1) and (2).
(2) Clinical quality measure
certification criteria that support the
calculation and reporting of clinical
quality measures at 45 CFR
170.314(c)(2) and (c)(3) or 45 CFR
170.315(c)(2) and (c)(3).
(2) For 2018 and subsequent years,
EHR technology (which could include
multiple technologies) certified under
the ONC Health IT Certification Program
that meets the 2015 Edition Base EHR
definition (as defined at 45 CFR
170.102) and has been certified to the
2015 Edition health IT certification
criteria that—
(i)(A) Include the capabilities to
record 45 CFR 170.315(a)(14); or
(B) Create and incorporate family
health history 45 CFR 170.315(a)(15).
(ii) Include the capabilities that
support patient health information
capture at 45 CFR 170.315(a)(19); and
(iii) Are necessary to be a Meaningful
EHR User (as defined in this section),
including the following:
(A) The applicable automated
numerator recording and automated
measure calculation certification criteria
that support attestation as a Meaningful
EHR User at 45 CFR 170.315(g)(1) and
(2).
(B) Clinical quality measure
certification criteria that support the
calculation and reporting of clinical
quality measures under the 2015 Edition
certification criteria 45 CFR
170.315(c)(2) and (c)(3).
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EHR reporting period. * * *
(1) * * *
(i) The following are applicable before
CY 2017.
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*
(ii) The following are applicable
beginning in CY 2017 under the
Medicaid EHR Incentive Program:
(A) For the payment year in which the
EP is first demonstrating he or she is a
meaningful EHR user, any continuous
90-day period within the calendar year.
(B) For the subsequent payment years
following the payment year in which
the EP first successfully demonstrates
he or she is a meaningful EHR user, the
calendar year.
(2) * * *
(i) The following are applicable before
CY 2017:
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*
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*
(ii) The following are applicable
beginning in CY 2017 under the
Medicaid EHR Incentive Program:
(A) For the payment year in which the
eligible hospital or CAH is first
demonstrating it is a meaningful EHR
user, any continuous 90-day period
within the calendar year.
(B) For the subsequent payment years
following the payment year in which
the eligible hospital or CAH first
successfully demonstrates it is a
meaningful EHR user, the calendar year.
EHR reporting period for a payment
adjustment year. * * *
(1) * * *
(i) The following are applicable before
CY 2017:
*
*
*
*
*
(ii) The following are applicable
beginning in CY 2017:
(A) Except as provided under
paragraph (1)(ii)(B) of this definition,
the calendar year that is 2 years before
the payment adjustment year.
(B) If an EP is demonstrating under
the Medicaid EHR Incentive Program
that he or she is a meaningful EHR user
for the first time in the calendar year
that is 2 years before the payment
adjustment year, then the continuous
90-day period that is the EHR reporting
period for the Medicaid incentive
payment within such (2 years prior)
calendar year.
(2) * * *
(i) The following are applicable before
CY 2017:
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*
*
*
*
(ii) The following are applicable
beginning in CY 2017:
(A) Except as provided in paragraph
(2)(ii)(B) of this definition, the calendar
year that is 2 years before the payment
adjustment year.
(B) If an eligible hospital is
demonstrating under the Medicaid EHR
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Incentive Program 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 the continuous 90-day period that
is the EHR reporting period for the
Medicaid incentive payment within
such (2 years prior) calendar year.
(3) * * *
(i) The following are applicable before
CY 2017:
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*
*
*
*
(ii) The following are applicable
beginning in CY 2017:
(A) Except as provided in paragraph
(3)(ii)(B) of this definition, the calendar
year that begins on the first day of the
second quarter of the Federal fiscal year
that is the payment adjustment year.
(B) If a CAH is demonstrating under
the Medicaid EHR Incentive Program
that it is a meaningful EHR user for the
first time in the calendar year that
begins on the first day of the second
quarter of the Federal fiscal year that is
the payment adjustment year, then any
continuous 90-day period within such
calendar year.
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■ 3. Section 495.6 is amended by
revising the section heading and adding
introductory text to read as follows:
§ 495.6 Meaningful use objectives and
measures for EPs, eligible hospitals, and
CAHs before 2018.
The following criteria are applicable
before 2018:
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■ 4. Section 495.7 is added to read as
follows:
§ 495.7 Stage 3 meaningful use objectives
and measures for EPs, eligible hospitals,
and CAHs for 2018 and subsequent years.
The following criteria are optional for
EPs, eligible hospitals, and CAHs in
2017 as outlined at § 495.8(a)(2)(i)(E)(3)
and (b)(2)(E)(3) and applicable for all
EPs, eligible hospitals, and CAHs for
2018 and subsequent years:
(a) Stage 3 criteria for EPs.
(1) General rule regarding Stage 3
criteria for meaningful use for EPs.
Except as specified in paragraphs (a)(2)
through (a)(3) of this section, EPs must
meet all objectives and associated
measures of the Stage 3 criteria
specified in paragraph (d) of this section
to meet the definition of a meaningful
EHR user.
(2) Selection of measures for specified
objectives in paragraph (d) of this
section. An EP may meet the criteria for
2 out of the 3 measures associated with
an objective, rather than meeting the
criteria for all 3 of the measures, if the
EP meets all of the following
requirements:
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(i) Must ensure that the objective in
paragraph (d) of this section includes an
option to meet 2 out of the 3 associated
measures.
(ii) Meets the threshold for 2 out of
the 3 measures for that objective.
(iii) Attests to all 3 of the measures for
that objective
(3) Exclusion for nonapplicable
objectives and measures.
(i) An EP may exclude a particular
objective that includes an option for
exclusion contained in paragraph (d) of
this section, if the EP meets all of the
following requirements:
(A) Meets the criteria in the
applicable objective that would permit
the exclusion.
(B) Attests to the exclusion.
(ii) An EP may exclude a measure
within an objective which allows for a
provider to meet the threshold for 2 of
the 3 measures, as outlined in paragraph
(a)(2) of this section, in the following
manner:
(A)(1) Meets the criteria in the
applicable measure or measures that
would permit the exlusion; and
(2) Attests to the exclusion or
exclusions.
(B)(1) Meets the threshold; and
(2) Attests to any remaining measure
or measures.
(4) Exception for Medicaid EPs who
adopt, implement or upgrade in their
first payment year. For Medicaid EPs
who adopt, implement or upgrade its
certified EHR technology in their first
payment year, the meaningful use
objectives and associated measures of
the Stage 3 criteria specified in
paragraph (d) of this section, apply
beginning with the second payment
year, and do not apply to the first
payment year.
(b) Stage 3 criteria for eligible
hospitals and CAHs.
(1) General rule regarding Stage 3
criteria for meaningful use for eligible
hospitals or CAHs. Except as specified
in paragraphs (b)(2) through (b)(3) of
this section, eligible hospitals and CAHs
must meet all objectives and associated
measures of the Stage 3 criteria
specified in paragraph (d) of this section
to meet the definition of a meaningful
EHR user.
(2) Selection of measures for specified
objectives in paragraph (d) of this
section. An eligible hospital or CAH
may meet the criteria for 2 out of the 3
measures associated with an objective,
rather than meeting the criteria for all 3
of the measures, if the eligible hospital
or CAH meets all of the following
requirements:
(i) Must ensure that the objective in
paragraph (d) of this section includes an
option to meet 2 out of the 3 associated
measures.
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(ii) Meets the threshold for 2 out of
the 3 measures for that objective.
(iii) Attests to all 3 of the measures for
that objective.
(3) Exclusion for nonapplicable
objectives and measures.
(i) An eligible hospital or CAH may
exclude a particular objective that
includes an option for exclusion
contained in paragraph (d) of this
section, if the eligible hospital or CAH
meets all of the following requirements:
(A) Meets the criteria in the
applicable objective that would permit
the exclusion.
(B) Attests to the exclusion.
(ii) An eligible hospital or CAH may
exclude a measure within an objective
which allows for a provider to meet the
threshold for 2 of the 3 measures, as
outlined in paragraph (b)(2) of this
section, in the following manner:
(A)(1) Meets the criteria in the
applicable measure or measures that
would permit the exclusion; and
(2) Attests to the exclusion or
exclusions.
(B)(1) Meets the threshold; and
(2) Attests to any remaining measure
or measures.
(4) Exception for Medicaid eligible
hospitals or CAHs that adopt,
implement or upgrade in their first
payment year. For Medicaid eligible
hospitals or CAHs who adopt,
implement or upgrade certified EHR
technology in their first payment year,
the meaningful use objectives and
associated measures of the Stage 3
criteria specified in paragraph (d) of this
section apply beginning with the second
payment year, and do not apply to the
first payment year.
(c) Objectives and associated
measures in paragraph (d) of this
section that rely on measures that count
unique patients or actions.
(1) If a measure (or associated
objective) in paragraph (d) of this
section references paragraph (c) 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 (c) of this section, then the
measure must be calculated by
reviewing all patient records, not just
those maintained using certified EHR
technology.
(d) Stage 3 objectives and measures
for EPs, eligible hospitals, and CAHs.
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(1) Protect patient health information.
(i) EP protect patient health
information.
(A) Objective. Protect electronic
protected health information (ePHI)
created or maintained by the certified
EHR technology (CEHRT) through the
implementation of appropriate
technical, administrative, and physical
safeguards.
(B) Measure. Conduct or review a
security risk analysis in accordance
with the requirements under 45 CFR
164.308(a)(1), including:
(1) Addressing the security (including
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),
(2) Implement security updates as
necessary, and
(3) Correct identified security
deficiencies as part of the EP’s risk
management process.
(ii) Eligible hospital/CAH protect
patient health information.
(A) Objective. Protect electronic
protected health information (ePHI)
created or maintained by the certified
EHR technology (CEHRT) through the
implementation of appropriate
technical, administrative, and physical
safeguards.
(B) Measure. Conduct or review a
security risk analysis in accordance
with the requirements under 45 CFR
164.308(a)(1), including—
(1) Addressing the security (including
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);
(2) Implement security updates as
necessary; and
(3) Correct identified security
deficiencies as part of the eligible
hospital’s or CAH’s risk management
process.
(2) Electronic prescribing.
(i) EP electronic prescribing.
(A) Objective. Generate and transmit
permissible prescriptions electronically
(eRx).
(B) Measure. Subject to paragraph (c)
of this section, more than 80 percent of
all permissible prescriptions written by
the EP are queried for a drug formulary
and transmitted electronically using
certified EHR technology (CEHRT).
(C) Exclusions in accordance with
paragraph (a)(3) of this section.
(1) Any EP who writes fewer than 100
permissible prescriptions during the
EHR reporting period; or
(2) Any EP who does not have a
pharmacy within its organization and
there are no pharmacies that accept
electronic prescriptions within 10 miles
of the EP’s practice location at the start
of his/her EHR reporting period.
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(ii) Eligible hospital/CAH electronic
prescribing.
(A) Objective. Generate and transmit
permissible discharge prescriptions
electronically (eRx).
(B) Measure. Subject to paragraph (c)
of this section, more than 25 percent of
hospital discharge medication orders for
permissible prescriptions (for new and
changed prescriptions) are queried for a
drug formulary and transmitted
electronically using certified EHR
technology (CEHRT).
(C) Exclusions in accordance with
paragraph (b)(3) of this section. Any
eligible hospital or CAH that does not
have an internal pharmacy that can
accept electronic prescriptions and
there are no pharmacies that accept
electronic prescriptions within 10 miles
at the start of the eligible hospital’s or
CAH’s EHR reporting period.
(3) Clinical decision support.
(i) EP clinical decision support.
(A) Objective. Implement clinical
decision support (CDS) interventions
focused on improving performance on
high-priority health conditions.
(B) Measures.
(1) Implement five clinical decision
support interventions related to four or
more clinical quality measures (CQMs)
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; and
(2) The EP has enabled and
implemented the functionality for drugdrug and drug-allergy interaction checks
for the entire EHR reporting period.
(C) Exclusion in accordance with
paragraph (a)(3) of this section for
paragraph (d)(3)(i)(B)(2) of this section.
An EP who writes fewer than 100
medication orders during the EHR
reporting period.
(ii) Eligible hospital/CAH clinical
decision support.
(A) Objective. Implement clinical
decision support (CDS) interventions
focused on improving performance on
high-priority health conditions.
(B) 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 (CQMs)
related to an eligible hospital or CAH’s
patient population, the clinical decision
support interventions must be related to
high-priority health conditions; and
(2) The eligible hospital or CAH has
enabled and implemented the
functionality for drug-drug and drug-
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allergy interaction checks for the entire
EHR reporting period.
(4) Computerized provider order entry
(CPOE).
(i) EP CPOE.
(A) Objective. Use computerized
provider order entry (CPOE) for
medication, laboratory, and diagnostic
imaging orders directly entered by any
licensed healthcare professional,
credentialed medical assistant, or a
medical staff member credentialed to
and performing the equivalent duties of
a credentialed medical assistant; who
can enter orders into the medical record
per state, local, and professional
guidelines.
(B) Measures. Subject to paragraph (c)
of this section—
(1) More than 80 percent of
medication orders created by the EP
during the EHR reporting period are
recorded using computerized provider
order entry;
(2) More than 60 percent of laboratory
orders created by the EP during the EHR
reporting period are recorded using
computerized provider order entry; and
(3) More than 60 percent of diagnostic
imaging orders created by the EP during
the EHR reporting period are recorded
using computerized provider order
entry.
(C) Exclusions in accordance with
paragraph (a)(3) of this section.
(1) For the measure specified in
paragraph (d)(4)(i)(B)(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 (d)(4)(i)(B)(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 (d)(4)(i)(B)(3) of this section,
any EP who writes fewer than 100
diagnostic imaging orders during the
EHR reporting period.
(ii) Eligible hospital and CAH CPOE.
(A) Objective. Use computerized
provider order entry (CPOE) for
medication, laboratory, and diagnostic
imaging orders directly entered by any
licensed healthcare professional,
credentialed medical assistant, or a
medical staff member credentialed to
and performing the equivalent duties of
a credentialed medical assistant; who
can enter orders into the medical record
per state, local, and professional
guidelines.
(B) Measures. Subject to paragraph (c)
of this section, more than—
(1) Eighty percent of medication
orders created by authorized providers
of the eligible hospital’s or CAH’s
inpatient or emergency department
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(POS 21 or 23) during the EHR reporting
period are recorded using computerized
provider order entry;
(2) Sixty 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; and
(3) Sixty percent of diagnostic
imaging 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.
(5) Patient electronic access to health
information.
(i) EP patient electronic access to
health information.
(A) Objective. The EP provides access
for patients to view online, download,
and transmit their health information, or
retrieve their health information
through an application-program
interface (API), within 24 hours of its
availability.
(B) Measures. EPs must meet the
following two measures:
(1) For more than 80 percent of all
unique patients seen by the EP)—
(i) The patient (or patient authorized
representatives) is provided access to
view online, download, and transmit
their health information within 24 hours
of its availability to the provider; or
(ii) The patient (or patient authorized
representatives) is provided access to an
ONC-certified application-program
interface (API) that can be used by thirdparty applications or devices to provide
patients (or patient authorized
representatives) access to their health
information, within 24 hours of its
availability to the provider.
(2) The EP must use clinically
relevant information from CEHRT to
identify patient-specific educational
resources and provide electronic access
to those materials to more than 35
percent of unique patients seen by the
EP during the EHR reporting period.
(C) Exclusions in accordance with
paragraph (a)(3) of this section.
(1) Any EP who has no office visits
during the reporting period may exclude
from the measures specified in
paragraphs (d)(7)(i)(B)(1) and (B)(2) of
this section.
(2) Any EP that conducts 50 percent
or more of his or her patient encounters
in a county that does not have 50
percent or more of its housing units
with 4Mbps broadband availability
according to the latest information
available from the FCC on the first day
of the EHR reporting period may
exclude from the measures specified in
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paragraphs (d)(7)(i)(B)(1) and (2) of this
section.
(ii) Eligible hospital and CAH patient
electronic access to health information.
(A) Objective. The eligible hospital or
CAH provides access for patients to
view online, download, and transmit
their health information, or retrieve
their health information through an
application-program interface (API),
within 24 hours of its availability.
(B) Measures. Eligible hospitals and
CAHs must meet the following two
measures:
(1) For more than 80 percent of all
unique patients discharged from the
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)—
(i) The patient (or patient authorized
representatives) is provided access to
view online, download, and transmit
their health information within 24 hours
of its availability to the provider; or
(ii) The patient (or patient authorized
representatives) is provided access to an
ONC-certified application-program
interface (API) that can be used by thirdparty applications or devices to provide
patients (or patient authorized
representatives) access to their health
information, within 24 hours of its
availability to the provider.
(2) The eligible hospital or CAH must
use clinically relevant information from
CEHRT to identify patient-specific
educational resources and provide
electronic access to those materials to
more than 35 percent of unique patients
discharged from the eligible hospital or
CAH inpatient or emergency department
(POS 21 or 23) during the EHR reporting
period.
(C) Exclusion in accordance with
paragraph (b)(3) 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 the measures specified in
paragraphs (d)(7)(ii)(B)(1) and (2) of this
section.
(6) Coordination of care through
patient engagement.
(i) EP coordination of care through
patient engagement.
(A) Objective. Use communications
functions of certified EHR technology to
engage with patients or their authorized
representatives about the patient’s care.
(B) Measures. In accordance with
paragraph (a)(2) of this section, an EP
must satisfy 2 out of the 3 following
measures in paragraphs (d)(5)(i)(B)(1),
(2), and (3) of this section except those
measures for which an EP qualifies for
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an exclusion under paragraph (a)(3) of
this section.
(1) During the EHR reporting period,
more than 25 percent of all unique
patients seen by the EP actively engage
with the electronic health record made
accessible by the provider. An EP may
meet measure specified in paragraph
(d)(5)(i)(B)(1) of this paragraph by
either—
(i) More than 25 percent of all unique
patients (or patient-authorized
representatives) seen by the EP during
the EHR reporting period view,
download or transmit to a third party
their health information; or
(ii) More than 25 percent of all unique
patients (or patient-authorized
representatives) seen by the EP during
the EHR reporting period access their
health information through the use of an
ONC-certified API that can be used by
third-party applications or devices.
(2) For more than 35 percent of all
unique patients seen by the EP during
the EHR reporting period, a secure
message was sent using the electronic
messaging function of CEHRT to the
patient (or their authorized
representatives), or in response to a
secure message sent by the patient.
(3) Patient generated health data or
data from a nonclinical setting is
incorporated into the certified EHR
technology for more than 15 percent of
all unique patients seen by the EP
during the EHR reporting period.
(C) Exclusions in accordance with
paragraph (a)(3) of this section.
(1) Any EP who has no office visits
during the reporting period may exclude
from the measures specified in
paragraphs (d)(5)(i)(B)(1), (B)(2) and
(B)(3) of this section.
(2) Any EP that conducts 50 percent
or more of his or her patient encounters
in a county that does not have 50
percent or more of its housing units
with 4Mbps broadband availability
according to the latest information
available from the FCC on the first day
of the EHR reporting period may
exclude from the measures specified in
paragraphs (d)(5)(i)(B)(1), (B)(2) and
(B)(3) of this section.
(ii) Eligible hospital and CAH
coordination of care through patient
engagement.
(A) Objective. Use communications
functions of certified EHR technology to
engage with patients or their authorized
representatives about the patient’s care.
(B) Measures. In accordance with
paragraph (b)(2) of this section, an
eligible hospital or CAH must satisfy 2
of the 3 following measures in
paragraph (d)(5)(ii)(B)(1), (2), and (3) of
this section, except those measures for
which an eligible hospital or CAH
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qualifies for an exclusion under
paragraph (b)(3) of this section.
(1) During the EHR reporting period,
more than 25 percent of all unique
patients discharged from the eligible
hospital or CAH inpatient or emergency
department (POS 21 or 23) actively
engage with the electronic health record
made accessible by the provider. An
eligible hospital or CAH may meet the
measure specified in paragraph
(d)(5)(ii)(B)(1) of this section by
having—
(i) More than 25 percent of all unique
patients (or patient-authorized
representatives) discharged from the
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period view,
download or transmit to a third party
their health information; or
(ii) More than 25 percent of all unique
patients (or patient-authorized
representatives) discharged from the
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period access
their health information through the use
of an ONC-certified API that can be used
by third-party applications or devices.
(2) For more than 35 percent of all
unique patients discharged from the
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period, a
secure message was sent using the
electronic messaging function of CEHRT
to the patient (or their authorized
representatives), or in response to a
secure message sent by the patient.
(3) Patient generated health data or
data from a non-clinical setting is
incorporated into the certified EHR
technology for more than 15 percent of
unique patients discharged from the
eligible hospital or CAH inpatient or
emergency department (POS 21 or 23)
during the EHR reporting period.
(C) Exclusions under paragraph (b)(3)
of this section.
(1) Any eligible hospital or CAH
operating in a location that does not
have 50 percent or more of its housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC on
the first day of the EHR reporting period
may exclude from the measures
specified in pargraphs (d)(5)(ii)(B)(1),
(B)(2), and (B)(3) of this section.
(7) Health information exchange.
(i) EP health information exchange.
(A) Objective. The EP provides a
summary of care record when
transitioning or referring their patient to
another setting of care, retrieves a
summary of care record upon the first
patient encounter with a new patient,
and incorporates summary of care
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information from other providers into
their EHR using the functions of
certified EHR technology.
(B) Measures. In accordance with
paragraph (a)(2) of this section, an EP
must attest to all 3 measures, but must
meet the threshold for 2 of the 3
measures in paragraph (d)(6)(i)(B)(1),
(2), and (3), in order to meet the
objective. Subject to paragraph (c) of
this section—
(1) Measure 1. For more than 50
percent of transitions of care and
referrals, the EP that transitions or refers
their patient to another setting of care or
provider of care—
(i) Creates a summary of care record
using CEHRT; and
(ii) Electronically exchanges the
summary of care record.
(2) Measure 2. For more than 40
percent of transitions or referrals
received and patient encounters in
which the provider has never before
encountered the patient, the EP
incorporates into the patient’s EHR an
electronic summary of care document
from a source other than the provider’s
EHR system.
(3) Measure 3. For more than 80
percent of transitions or referrals
received and patient encounters in
which the provider has never before
encountered the patient, the EP
performs clinical information
reconciliation. The EP must implement
clinical information reconciliation for
the following three clinical information
sets:
(i) Medication. Review of the patient’s
medication, including the name, dosage,
frequency, and route of each
medication.
(ii) Medication allergy. Review of the
patient’s known allergic medications.
(iii) Current problem list. Review of
the patient’s current and active
diagnoses.
(C) Exclusions in accordance with
paragraph (a)(3) of this section. An EP
must be excluded when any of the
following occur:
(1) An EP neither transfers a patient
to another setting nor refers a patient to
another provider during the EHR
reporting period must be excluded from
paragraph (d)(6)(i)(B)(1) of this section.
(2) Any EP for whom the total of
transitions or referrals recieved and
patient encounters in which the
provider has never before encountered
the patient, is fewer than 100 during the
EHR reporting period may be excluded
from paragraphs (d)(6)(i)(B)(2) and
(d)(6)(i)(B)(3) of this section.
(3) Any EP that conducts 50 percent
or more of his or her patient encounters
in a county that does not have 50
percent or more of its housing units
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with 4Mbps broadband availability
according to the latest information
available from the FCC on the first day
of the EHR reporting period may
exclude from the measures specified in
paragraphs (d)(6)(i)(B)(1), (B)(2) and
(B)(3) of this section.
(ii) Eligible hospitals and CAHs health
information exchange.
(A) Objective. The eligible hospital or
CAH provides a summary of care record
when transitioning or referring their
patient to another setting of care,
retrieves a summary of care record upon
the first patient encounter with a their
new patient, and incorporates summary
of care information from other providers
into EHR using the functions of certified
EHR technology.
(B) Measures. In accordance with
paragraph (b)(2) of this section, an
eligible hospital or CAH must attest to
all three measures, but must meet the
threshold for 2 of the 3 measures in
paragraph (d)(6)(ii)(B)(1), (2), and (3).
Subject to paragraph (c) of this section—
(1) Measure 1. For more than 50
percent of transitions of care and
referrals, the eligible hospital or CAH
that transitions or refers its patient to
another setting of care or provider of
care—
(i) Creates a summary of care record
using CEHRT; and
(ii) Electronically exchanges the
summary of care record.
(2) Measure 2. For more than 40
percent of transitions or referrals
received and patient encounters in
which the provider has never before
encountered the patient, the eligible
hospital or CAH incorporates into the
patient’s EHR an electronic summary of
care document from a source other than
the provider’s EHR system.
(3) Measure 3. For more than 80
percent of transitions or referrals
received and patient encounters in
which the provider has never before
encountered the patient, the eligible
hospital or CAH performs a clinical
information reconciliation. The provider
must implement clinical information
reconciliation for the following three
clinical information sets:
(i) Medication. Review of the patient’s
medication, including the name, dosage,
frequency, and route of each
medication.
(ii) Medication allergy. Review of the
patient’s known allergic medications.
(iii) Current problem list. Review of
the patient’s current and active
diagnoses.
(C) Exclusions in accordance with
paragraph (b)(3) of this section.
(1) Any eligible hospital or CAH for
whom the total of transitions or referrals
recieved and patient encounters in
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which the provider has never before
encountered the patient, is fewer than
100 during the EHR reporting period
may be excluded from paragraphs
(d)(6)(i)(B)(2) and (d)(6)(i)(B)(3) of this
section.
(2) Any eligible hospital or CAH
operating in a location that does not
have 50 percent or more of its housing
units with 4Mbps broadband
availability according to the latest
information available from the FCC on
the first day of the EHR reporting period
may exclude from the measures
specified in paragraphs (d)(6)(ii)(B)(1),
(2) and (3) of this section.
(8) Public Health and Clinical Data
Registry Reporting.
(i) EP Public Health and Clinical Data
Registry: Reporting objective.
(A) Objective. The EP 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.
(B) Measures. In order to meet the
objective under paragraph (d)(8)(i)(A) of
this section, an EP must choose from
measures 1 through 5 (paragraphs
(d)(8)(i)(B)(1) through (d)(8)(i)(B)(5) of
this section) and must successfully
attest to any combination of three
measures. These measures may be met
by any combination, including meeting
measure specified in paragraph
(d)(8)(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 (a)(3) of this section.
(1) Any EP meeting one or more of the
following criteria may be excluded from
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the immunization registry reporting
measure in paragraph (d)(8)(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 their 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 its EHR
reporting period.
(iii) Operates in a jurisdiction where
no immunization registry or
immunization information system has
declared readiness to receive
immunization data 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
(d)(8)(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 the EP’s
jurisdiction.
(ii) Operates in a jurisdiction for
which no public health agency is
capable of receiving electronic
syndromic surveillance 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 syndromic
surveillance data at the start of the EHR
reporting period.
(3) Any EP meeting one or more of the
following criteria may be excluded from
the case reporting measure at paragraph
(d)(8)(i)(B)(3) of this section if the EP:
(i) 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.
(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 EP meeting at least one of the
following criteria may be excluded from
the public health registry reporting
measure specified in paragraph
(d)(8)(i)(B)(4) of this section if the EP:
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(i) Does not diagnose or directly treat
any disease or condition associated with
a public health registry in the EP’s
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 beginning 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
(d)(8)(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 their
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 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 beginning of the EHR reporting
period.
(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 (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.
(B) Measures. In order to meet the
objective under paragraph (d)(8)(ii)(A)
of this section, an eligible hospital or
CAH must choose from measures 1
through 6 (as described in paragraphs
(d)(8)(ii)(B)(1) through (d)(8)(ii)(B)(6) of
this section) and must successfully
attest to any combination of four
measures. These measures may be met
by any combination, including meeting
the measure specified in paragraph
(d)(8)(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
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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
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 (b)(3) of this section.
(1) Any eligible hospital or CAH
meeting one or more of the following
criteria may be excluded from to the
immunization registry reporting
measure specified in paragraph
(d)(8)(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 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
(d)(8)(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 in the
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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 at the start of the EHR
reporting period.
(3) Any eligible hospital or CAH
meeting one or more of the following
criteria may be excluded from the case
reporting measure specified in
paragraph (d)(8)(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 their 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 their 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 (d)(8)(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 its
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 beginning 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 (d)(8)(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 for
which no clinical data registry is
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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)(8)(ii)(B)(6) of this section
if the eligible hospital or CAH:
(i) Does not perform or order
laboratory tests that are reportable in its
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 at the start
of the EHR reporting period.
■ 5. Section 495.8 is amended as
follows:
■ A. In paragraph (a) introductory text,
by removing the cross-reference ‘‘under
§ 495.6 of this subpart’’ and adding in
its place the cross-reference ‘‘under
§ 495.6 or § 495.7’’.
■ B. In paragraph (a)(1)(i)(B), by
removing the cross-reference ‘‘under
§ 495.6(d) and § 495.6(e) of this subpart’’
and adding in its place the crossreference ‘‘under § 495.6 or § 495.7’’.
■ C. In paragraph (a)(1)(iii), by removing
the cross-reference ‘‘in § 495.6 and
§ 495.8 of this subpart’’ and adding in
its place the cross-reference ‘‘in § 495.6
or § 495.7 and § 495.8’’.
■ D. In paragraph (a)(2)(i)(B), by
removing the cross-reference ‘‘under
§ 495.6’’ and adding in its place the
cross-reference ‘‘under § 495.6 or
§ 495.7’’.
■ E. Adding paragraph (a)(2)(i)(E).
■ F. In paragraph (a)(2)(iv), by removing
the cross-reference ‘‘in § 495.6 and
§ 495.8 of this subpart’’ and adding in
its place the cross-reference ‘‘in § 495.6
or § 495.7 and § 495.8’’.
■ G. In paragraph (b)(1)(i)(B), by
removing the cross-reference ‘‘under
§ 495.6(f) and § 495.6(g)’’ and adding in
its place the cross-reference ‘‘under
§ 495.6 or § 495.7’’.
■ H. Redesignating paragraph (b)(1)(iv)
and paragraph (b)(1)(iii).
■ I. In newly redesignated paragraph
(b)(1)(iii), by removing the cross-
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reference ‘‘in § 495.6 and § 495.8 of this
subpart’’ and adding in its place the
cross-reference ‘‘in § 495.6 or § 495.7
and § 495.8’’.
■ J. In paragraph (b)(2)(i)(B), by
removing the cross-reference ‘‘under
§ 495.6’’ and adding in its place the
cross-reference ‘‘under § 495.6 or
§ 495.7’’.
■ K. Adding paragraph (b)(2)(i)(E).
The additions read as follows:
§ 495.8 Demonstration of meaningful use
criteria.
(a) * * *
(2) * * *
(i) * * *
(E) For 2017 only, an EP may attest to
the following:
(1) Stage 1 objectives and measures
outlined at § 495.6 if the EP has never
before demonstrated meaningful use, or
if the EP previously demonstrated
meaningful use for the first time in 2015
or 2016.
(2) Stage 2 objectives and measures
outlined at § 495.6 if the EP previously
demonstrated meaningful use for any
year prior to 2017.
(3) Stage 3 objectives and measures
outlined at § 495.7 if the EP has never
before demonstrated meaningful use or
if the EP has demonstrated meaningful
use for any year prior to 2017.
*
*
*
*
*
(b) * * *
(2) * * *
(i) * * *
(E) For 2017 only, an eligible hospital
or CAH may attest to the following:
(1) Stage 1 objectives and measures
outlined at § 495.6 if the eligible
hospital or CAH has never before
demonstrated meaningful use, or if the
eligible hospital or CAH previously
demonstrated meaningful use for the
first time in 2015 or 2016.
(2) Stage 2 objectives and measures
outlined at § 495.6 if the eligible
hospital or CAH previously
demonstrated meaningful use for any
year prior to 2017.
(3) Stage 3 objectives and measures
outlined at § 495.7 if the eligible
hospital or CAH has never before
demonstrated meaningful use or if the
eligible hospital or CAH has
demonstrated meaningful use for any
year prior to 2017.
*
*
*
*
*
■ 6. Section 495.316 is amended by
revising paragraph (c) introductory text
and adding paragraphs (d)(2)(iii), (f), (g),
and (h) to read as follows:
§ 495.316 State monitoring and reporting
regarding activities required to receive an
incentive payment.
*
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*
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*
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16803
(c) Subject to § 495.332 and § 495.352,
the State is required to submit to CMS
annual reports, in the manner
prescribed by CMS, on the following:
*
*
*
*
*
(d) * * *
(2) * * *
(iii) Subject to § 495.332, the State
may propose a revised definition for
Stage 3 of meaningful use of certified
EHR technology, subject to CMS prior
approval, but only with respect to the
public health and clinical data registry
reporting objective described in
§ 495.7(d)(8).
*
*
*
*
*
(f) Each State must submit to CMS the
annual report described in paragraph (c)
of this section within 45 days of the end
of the second quarter of the Federal
fiscal year.
(g) The State must, on a quarterly
basis and in the manner prescribed by
CMS, submit a report(s) on the
following:
(1) The State and payment year to
which the quarterly report pertains.
(2) Subject to paragraph (h)(2) of this
section, provider-level attestation data
for each EP and eligible hospital that
attests to demonstrating meaningful use
for each payment year beginning with
2013.
(h)(1) Subject to paragraph (h)(2) of
this section, the quarterly report
described in paragraph (g) of this
section must include the following for
each EP and eligible hospital:
(i) The payment year number.
(ii) The provider’s National Provider
Identifier or CCN, as appropriate.
(iii) Attestation submission date.
(iv) The state qualification.
(v) The state qualification date, which
is the beginning date of the provider’s
EHR reporting period for which it
demonstrated meaningful use.
(vi) The State disqualification, if
applicable.
(vii) The State disqualification date,
which is the beginning date of the
provider’s EHR reporting period to
which the provider attested but for
which it did not demonstrate
meaningful use, if applicable.
(2) The quarterly report described in
paragraph (g) of this section is not
required to include information on EPs
who are eligible for the Medicaid EHR
incentive program on the basis of being
a nurse practitioner, certified nursemidwife or physician assistant.
■ 7. Section 495.352 is revised to read
as follows:
§ 495.352
Reporting requirements.
(a) Each State must submit to HHS on
a quarterly basis a progress report, in the
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Federal Register / Vol. 80, No. 60 / Monday, March 30, 2015 / Proposed Rules
manner prescribed by HHS,
documenting specific implementation
and oversight activities performed
during the quarter, including progress in
implementing the State’s approved
Medicaid HIT plan.
(b) The quarterly progress reports
must include, but need not be limited to
providing, updates on the following:
(1) State system implementation
dates.
(2) Provider outreach.
(3) Auditing.
(4) State-specific State Medicaid HIT
Plan tasks.
(5) State staffing levels and changes.
(6) The number and type of providers
that qualified for an incentive payment
on the basis of having adopted,
implemented or upgraded certified EHR
technology and the amounts of
incentive payments.
(7) The number and type of providers
that qualified for an incentive payment
on the basis of having demonstrated that
they are meaningful users of certified
EHR technology and the amounts of
incentive payments.
Dated: March 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: March 18, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2015–06685 Filed 3–20–15; 3:00 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
45 CFR Part 170
RIN 0991–AB93
2015 Edition Health Information
Technology (Health IT) Certification
Criteria, 2015 Edition Base Electronic
Health Record (EHR) Definition, and
ONC Health IT Certification Program
Modifications
Office of the National
Coordinator for Health Information
Technology (ONC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking
with comment period.
mstockstill on DSK4VPTVN1PROD with PROPOSALS2
AGENCY:
This notice of proposed
rulemaking introduces a new edition of
certification criteria (the 2015 Edition
health IT certification criteria or ‘‘2015
Edition’’), proposes a new 2015 Edition
Base EHR definition, and proposes to
SUMMARY:
VerDate Sep<11>2014
23:09 Mar 27, 2015
Jkt 235001
modify the ONC Health IT Certification
Program to make it open and accessible
to more types of health IT and health IT
that supports various care and practice
settings. The 2015 Edition would also
establish the capabilities and specify the
related standards and implementation
specifications that Certified Electronic
Health Record (EHR) Technology
(CEHRT) would need to include to, at a
minimum, support the achievement of
meaningful use by eligible professionals
(EPs), eligible hospitals, and critical
access hospitals (CAHs) under the
Medicare and Medicaid EHR Incentive
Programs (EHR Incentive Programs)
when such edition is required for use
under these programs.
DATES: To be assured consideration,
written or electronic comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
May 29, 2015.
ADDRESSES: You may submit comments,
identified by RIN 0991–AB93, by any of
the following methods (please do not
submit duplicate comments). Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
• Federal eRulemaking Portal: Follow
the instructions for submitting
comments. Attachments should be in
Microsoft Word, Microsoft Excel, or
Adobe PDF; however, we prefer
Microsoft Word. https://
www.regulations.gov.
• Regular, Express, or Overnight Mail:
Department of Health and Human
Services, Office of the National
Coordinator for Health Information
Technology, Attention: 2015 Edition
Health IT Certification Criteria Proposed
Rule, Hubert H. Humphrey Building,
Suite 729D, 200 Independence Ave SW.,
Washington, DC 20201. Please submit
one original and two copies.
• Hand Delivery or Courier: Office of
the National Coordinator for Health
Information Technology, Attention:
2015 Edition Health IT Certification
Criteria Proposed Rule, Hubert H.
Humphrey Building, Suite 729D, 200
Independence Ave SW., Washington,
DC 20201. Please submit one original
and two copies. (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 mail drop slots located in the main
lobby of the building.)
Enhancing the Public Comment
Experience: To facilitate public
comment on this proposed rule, a copy
will be made available in Microsoft
Word format. We believe this version
PO 00000
Frm 00074
Fmt 4701
Sfmt 4702
will make it easier for commenters to
access and copy portions of the
proposed rule for use in their individual
comments. Additionally, a separate
document will be made available for the
public to use to provide comments on
the proposed rule. This document is
meant to provide the public with a
simple and organized way to submit
comments on the certification criteria,
associated standards and
implementation specifications, and
respond to specific questions posed in
the preamble of the proposed rule.
While use of this document is entirely
voluntary, we encourage commenters to
consider using the document in lieu of
unstructured comments or to use it as
an addendum to narrative cover pages.
Roughly 30% of the public comments
submitted to our past two editions of
certification criteria proposed rules used
the provided template, which greatly
assisted in our ability to rapidly process
and more accurately categorize public
comments. Because of the technical
nature of this proposed rule, we believe
that use of the document may facilitate
our review and understanding of the
comments received. The Microsoft
Word version of the proposed rule and
the document that can be used for
providing comments can be found at
https://www.regulations.gov as part of
this proposed rule’s docket and on
ONC’s Web site (https://
www.healthit.gov).
Inspection of Public Comments: All
comments received before the close of
the comment period will be available for
public inspection, including any
personally identifiable or confidential
business information that is included in
a comment. Please do not include
anything in your comment submission
that you do not wish to share with the
general public. Such information
includes, but is not limited to: a
person’s social security number; date of
birth; driver’s license number; state
identification number or foreign country
equivalent; passport number; financial
account number; credit or debit card
number; any personal health
information; or any business
information that could be considered
proprietary. We will post all comments
that are received before the close of the
comment period at https://
www.regulations.gov.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov or the Department
of Health and Human Services, Office of
the National Coordinator for Health
Information Technology, Hubert H.
Humphrey Building, Suite 729D, 200
Independence Ave SW., Washington,
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[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Proposed Rules]
[Pages 16731-16804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06685]
[[Page 16731]]
Vol. 80
Monday,
No. 60
March 30, 2015
Part II
Department of Health and Human Services
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Centers for Medicare and Medicaid Services
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42 CFR Part 495
-----------------------------------------------------------------------
Office of the Secretary
-----------------------------------------------------------------------
45 CFR Part 170
Medicare and Medicaid Programs; Electronic Health Record Incentive
Program--Stage 3; 2015 Edition Health Information Technology (Health
IT) Certification Criteria, 2015 Edition Base Electronic Health Record
(EHR) Definition, and ONC Health IT Certification Program
Modifications; Proposed Rules
Federal Register / Vol. 80 , No. 60 / Monday, March 30, 2015 /
Proposed Rules
[[Page 16732]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 495
[CMS-3310-P]
RIN 0938-AS26
Medicare and Medicaid Programs; Electronic Health Record
Incentive Program--Stage 3
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This Stage 3 proposed rule would specify the meaningful use
criteria that eligible professionals (EPs), eligible hospitals, and
critical access hospitals (CAHs) must meet in order to qualify for
Medicare and Medicaid electronic health record (EHR) incentive payments
and avoid downward payment adjustments under Medicare for Stage 3 of
the EHR Incentive Programs. It would continue to encourage electronic
submission of clinical quality measure (CQM) data for all providers
where feasible in 2017, propose to require the electronic submission of
CQMs where feasible in 2018, and establish requirements to transition
the program to a single stage for meaningful use. Finally, this Stage 3
proposed rule would also change the EHR reporting period so that all
providers would report under a full calendar year timeline with a
limited exception under the Medicaid EHR Incentive Program for
providers demonstrating meaningful use for the first time. These
changes together support our broader efforts to increase simplicity and
flexibility in the program while driving interoperability and a focus
on patient outcomes in the meaningful use program.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 29, 2015.
ADDRESSES: In commenting, please refer to file code CMS-3310-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-3310-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-3310-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
Ed Howard (CMS), (410) 786-6368, Medicare Advantage
Deborah Krauss (CMS), (410) 786-5264, clinical quality measures
Alesia Hovatter (CMS), (410) 786-6861, clinical quality measures
Elise Sweeney Anthony (ONC), (202) 475-2485, certification definition
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
API Application-Program Interface
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
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
[[Page 16733]]
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
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 specify the policies that would be
applicable for Stage 3 of the Medicare and Medicaid EHR Incentive
Programs. Under Stage 3, we are proposing a set of requirements that
EPs, eligible hospitals, and CAHs must achieve in order to meet
meaningful use, qualify for incentive payments under the Medicare and
Medicaid EHR Incentive Programs, and avoid downward payment adjustments
under Medicare. These Stage 3 requirements focus on the advanced use of
certified EHR technology (CEHRT) to promote health information exchange
and improved outcomes for patients.
Stage 3 of meaningful use is expected to be the final stage and
would incorporate portions of the prior stages into its requirements.
In addition, following a proposed optional year in 2017, beginning in
2018 all providers would report on the same definition of meaningful
use at the Stage 3 level regardless of their prior participation,
moving all participants in the EHR Incentive Programs to a single stage
of meaningful use in 2018. The incorporation of the requirements into
one stage for all providers is intended to respond to stakeholder input
regarding the complexity of the program, the success of certain
measures which are part of the meaningful use program to date, and the
need to set a long-term, sustainable foundation based on a consolidated
set of key advanced use objectives for the Medicare and Medicaid EHR
Incentive Programs.
In addition, we propose changes to the EHR reporting period,
timelines, and structure of the Medicare and Medicaid EHR Incentive
Programs. We believe these changes would provide a flexible, clear
framework to reduce provider burden, streamline reporting, and ensure
future sustainability of the Medicare and Medicaid EHR Incentive
Programs. These changes together lay a foundation for our broader
efforts to support interoperability and quality initiatives focused on
improving patient outcomes.
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 EPs, eligible hospitals, and
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 critical access
hospitals (CAHs), respectively. Sections 1848(a)(7), 1853(l) and (m),
1886(b)(3)(B), and 1814(l) of the Act also establish downward payment
adjustments, beginning with calendar or fiscal year (FY) 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 titled, ``Medicare and Medicaid Programs; Electronic
Health Record Incentive Program; Final Rule'' (75 FR 44316 through
44317)).
2. Summary of Major Provisions
a. 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 their 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 Stage 1 of
meaningful use, we refer readers to the Stage 1 final rule (75 FR 44313
through 44588).)
In the September 4, 2012 Stage 2 final rule (77 FR 53967 through
54162), we focused on the next step after the foundation of data
capture in Stage 1, the exchange of that essential health data among
health care providers and patients to improve care coordination. To
this end, we maintained the same core-menu structure for several
finalized Stage 1 core and menu objectives. We finalized that EPs must
meet the measure for 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 included 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. We also finalized a set of clinical quality measures
(CQMs) for all providers participating in any stage of the program to
report to CMS beginning in 2014. (For a full discussion of the
meaningful use objectives and measures, and the CQMs we finalized under
Stage 2, we refer
[[Page 16734]]
readers to the Stage 2 final rule at 77 FR 53967 through 54162.)
In this Stage 3 proposed rule, we build on the groundwork
established in the Stage 1 and Stage 2 final rules, including
continuing our goal started under Stage 2 to increase interoperable
health data sharing among providers. In addition, this Stage 3 proposed
rule would also focus on the advanced use of EHR technology to promote
improved patient outcomes and health information exchange. We also
propose to continue improving program efficiency, effectiveness, and
flexibility by making changes to the Medicare and Medicaid EHR
Incentive Programs that simplify reporting requirements and reduce
program complexity. These changes proposed respond to comments received
in earlier rulemaking that expressed confusion and concerns regarding
increased reporting burden related to the number of program
requirements, the multiple stages of program participation, and the
timing of EHR reporting periods. In order to address these stakeholder
concerns, one significant change we propose for Stage 3 includes
establishing a single set of objectives and measures (tailored to EP or
eligible hospital/CAH) to meet the definition of meaningful use. This
new, streamlined definition of meaningful use proposed for Stage 3
would be optional for any provider who chooses to attest to these
objectives and measures for an EHR reporting period in 2017; and would
be required for all eligible providers--regardless of prior
participation in the EHR Incentive Program--for an EHR reporting period
in 2018 and subsequent years.
In addition to reducing program complexity, the Stage 3 proposed
rule would further support efforts to align the EHR Incentive Programs
with other CMS quality reporting programs that use certified EHR
technology, such as the Hospital Inpatient Quality Reporting (IQR) and
Physician Quality Reporting System (PQRS) programs, as well as continue
alignment across care settings for providers demonstrating meaningful
use. This alignment would both reduce provider burden associated with
reporting on multiple CMS programs and enhance CMS operational
efficiency. The Stage 3 proposed rule and ONC's 2015 Edition of 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 elsewhere in this edition of
the Federal Register would also continue to support the privacy and
security of patient health information within certified health IT.
b. Meaningful Use Requirements, Objectives and Measures for 2017 and
Subsequent Years
Under this Stage 3 proposed rule, with the exception of Medicaid
providers in their first year of demonstrating meaningful use as
detailed in section II.F.1. of this proposed rule, all providers (EPs,
eligible hospitals, and CAHs) would report on a calendar year EHR
reporting period beginning in calendar year 2017. This proposal builds
on efforts to align the EHR reporting period with reporting periods for
other quality reporting programs identified in the Stage 2 final rule
(77 FR 53971 through 53975 and 54049 through 54051) and the FY 2015
Hospital Inpatient Prospective Payment Systems (IPPS) final rule (79 FR
49854 through 50449). In addition, all providers, other than Medicaid
EPs and eligible hospitals demonstrating meaningful use for the first
time, would be required to attest based on a full year of data for a
single set of meaningful use objectives and measures to demonstrate
Stage 3 of meaningful use, which is proposed as optional for an EHR
reporting period in 2017 and mandatory for an EHR reporting period in
2018, and subsequent years for all providers participating in the
Medicare and Medicaid EHR Incentive Programs.
The methodology for the selection of the proposed Stage 3
objectives and measures for the Medicare and Medicaid EHR Incentive
Programs included the following:
Review attestation data for Stages 1 and 2 of meaningful
use.
Conduct listening sessions and interviews with providers,
EHR system developers, regional extension centers, and health care
provider associations.
Review recommendations from government agencies and
advisory committees focused on health care improvement, such as the
Health Information Technology (HIT) Policy Committee, the National
Quality Forum (NQF), and the Centers for Disease Control (CDC).
The information we gathered from these sources focused on analyzing
measure performance, implementing discrete EHR functionalities and
standards, and examining objectives and measures presenting the best
opportunity to improve patient outcomes and enhance provider support.
Based on this analysis, we are proposing a set of 8 objectives with
associated measures designed to do all of the following:
Align with national health care quality improvement
efforts.
Promote interoperability and health information exchange.
Focus on the 3-part aim of reducing cost, improving
access, and improving quality.
We intend to have this Stage 3 proposed rule be the last stage of
the meaningful use framework, which leverages the structure identified
in the Stage 1 and Stage 2 final rules, while simultaneously
establishing a single set of objectives and measures designed to
promote best practices and continued improvement in health outcomes in
a sustainable manner. Measures in the Stage 1 and Stage 2 final rules
that included paper-based workflows, chart abstraction, or other manual
actions would be removed or transitioned to an electronic format
utilizing EHR functionality for Stage 3. In addition, we are proposing
the removal of ``topped out'' measures, or measures that are no longer
useful in gauging performance, in order to reduce the reporting burden
on providers for measures already achieving widespread adoption.
c. Clinical Quality Measurement
EPs, eligible hospitals, and CAHs must report CQMs in order to
qualify for incentive payments under the Medicare and Medicaid EHR
Incentive Programs and avoid downward payment adjustments under
Medicare.
We are committed to continuing the electronic calculation and
reporting of key clinical data through the use of CQMs. We are also
focused on improving alignment of reporting requirements for CMS
programs using EHR technology, maintaining flexibility with reporting
requirements while streamlining reporting mechanisms for providers, and
increasing quality data integrity.
This proposed rule addresses quality reporting alignment on several
fronts. Our long-term vision seeks to have hospitals, clinicians, and
other health care providers report through a single, aligned mechanism
for multiple CMS programs. In the Stage 2 final rule, we outlined
preliminary alignment options for quality reporting programs with the
EHR Incentive Programs as the first step toward that vision (77 FR
54053).
In order to facilitate continuous quality improvement, we need a
method to allow changes to meaningful use CQMs and the associated
reporting requirements on an ongoing basis. For other CMS quality
reporting programs, changes occur through the annual Medicare payment
rules, such as the
[[Page 16735]]
Physician Fee Schedule (PFS) and the IPPS rules. Including CQMs in
these annual rules would allow us to capture changes and updates
annually. Therefore, we intend to further support alignment between the
Medicare and Medicaid EHR Incentive Programs and other CMS quality
reporting programs, such as PQRS and Hospital IQR, by including the
reporting requirements for CQMs for providers demonstrating meaningful
use in future rulemaking. We propose to continue encouraging CQM data
submission through electronic submission for Medicare participants in
2017, and to require electronic submission of CQMs where feasible
beginning in 2018 for Medicare providers demonstrating meaningful use.
(We further discuss Medicaid CQM submission in section II.F.3. of this
proposed rule.)
d. Payment Adjustments and Hardship Exceptions
The statute requires Medicare payment adjustment beginning in 2015.
For the Stage 3 proposed rule, we propose to maintain all payment
adjustment provisions for all EPs, eligible hospitals, and CAHs
finalized in the Stage 2 final rule (77 FR 54093 through 54113 and
54115 through 54119) except for a change to the relationship between
the EHR reporting period year and the payment adjustment year for CAHs.
We are proposing a change to the timing of the EHR reporting period and
related deadlines for attestations and hardship exceptions for CAHs in
relation to the payment adjustment year, in order to accommodate a
transition to EHR reporting for meaningful use on the calendar instead
of the fiscal year timeline. The payment adjustment provisions being
maintained in the Stage 3 proposed rule include the process we
finalized in Stage 2 by which a prior EHR reporting period determines a
payment adjustment. We also maintain the four categories of exceptions
based on all of the following:
The lack of availability of internet access or barriers to
obtain IT infrastructure.
A time-limited exception for newly practicing EPs or new
hospitals that would not otherwise be able to avoid payment
adjustments.
Unforeseen circumstances such as natural disasters that
would be handled on a case-by-case basis.
(EP only) exceptions due to a combination of clinical
features limiting a provider's interaction with patients or, if the EP
practices at multiple locations, lack of control over the availability
of CEHRT at practice locations constituting 50 percent or more of their
encounters.
e. Modifications to the Medicaid EHR Incentive Program
Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory
basis for the Medicaid EHR Incentive Program. For this Stage 3 proposed
rule, we propose that under the proposed changes to EHR reporting
periods that would begin in 2017, Medicaid EPs and eligible hospitals
demonstrating meaningful use for the first time in the Medicaid EHR
Incentive Program would be required to attest for an EHR reporting
period of any continuous 90-day period in the calendar year for
purposes of receiving an incentive, as well as avoiding the payment
adjustment under the Medicare Program.
We are proposing to continue to allow states to set up a CQM
submission process that Medicaid EPs and eligible hospitals may use to
report on CQMs for 2017 and subsequent years. We also propose
amendments to state reporting on providers who are participating in the
Medicaid EHR Incentive Program as well as state reporting on
implementation and oversight activities.
f. Summary of Costs and Benefits
Upon finalization, the provisions in this proposed rule are
anticipated to have an annual effect on the economy of $100 million or
more, making it an economically significant rule under the Executive
Order and a major rule under the Congressional Review Act. Accordingly,
we have prepared a Regulatory Impact Analysis that to the best of our
ability presents the costs and benefits of the final rule. The total
federal cost of the Medicare and Medicaid EHR Incentive Programs
between 2017 and 2020 is estimated to be $3.7 billion in transfers. In
this proposed rule we do not estimate total costs and benefits to the
provider industry, but rather provide a possible per EP and per
eligible hospital outlay for implementation and maintenance.
Nonetheless, we believe there are substantial benefits that can be
obtained by society (perhaps accruing to eligible hospitals and EPs),
including cost reductions related to improvements in patient safety and
patient outcomes and cost savings benefits through maximizing
efficiencies in clinical and business processes facilitated by
certified health IT.
Table 1--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the
HITECH EHR Incentive Program
[Fiscal year--in billions]
----------------------------------------------------------------------------------------------------------------
Medicare eligible Medicaid eligible
Fiscal year ------------------------------------------------------------------ Total
Hospitals Professionals Hospitals Professionals
----------------------------------------------------------------------------------------------------------------
2017............................. $1.6 $0.3 $0.4 $0.8 $3.1
2018............................. 0.0 -0.2 0.1 0.5 0.4
2019............................. 0.0 -0.2 0.0 0.3 0.1
2020............................. 0.0 -0.1 0.0 0.2 0.1
----------------------------------------------------------------------------------------------------------------
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 Incentive Program would consist of three
different stages of meaningful use requirements.
In the September 4, 2012 Federal Register (77 FR 53967 through
54162),
[[Page 16736]]
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; Final Rule (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.
For Stages 1 and 2, CMS and ONC worked closely to ensure that the
definition of meaningful use of CEHRT and the standards and
certification criteria for CEHRT were coordinated. Current ONC
regulations may be found at 45 CFR part 170. For this Stage 3 proposed
rule, CMS and ONC will again work together to align our regulations.
We urge those interested in this Stage 3 proposed rule to also
review the ONC 2015 Edition proposed rule, which is published elsewhere
in this Federal Register. Readers may also visit: https://www.cms.hhs.gov/EHRincentiveprograms and https://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. Meaningful Use Requirements, Objectives, and Measures for 2017 and
Subsequent Years
1. Definitions Across the Medicare Fee-for-Service, Medicare Advantage,
and Medicaid Programs
a. Uniform Definitions
As discussed in both the Stage 1 and 2 final 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. We
propose to maintain these definitions, unless stated otherwise in this
proposed rule. (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).
As discussed in sections II.A.1.c.(1). and (2). of this proposed
rule, we are proposing a single set of criteria for meaningful use
(``Stage 3'') in order to eliminate the varying stages of the EHR
Incentive Programs. We propose that this Stage 3 definition of
meaningful use would be optional for providers in 2017 and mandatory
for all providers beginning in 2018. To support Stage 3, we propose
revising the uniform definitions under 42 CFR 495.4 for ``EHR reporting
period'' and ``EHR reporting period for a payment adjustment year,'' as
explained later in this section. The proposed revisions to these
uniform definitions include eliminating the current 90-day EHR
reporting period for EPs, eligible hospitals, and CAHs demonstrating
meaningful use for the first time, and instead creating a single EHR
reporting period aligned to the calendar year. The proposed removal of
the 90-day EHR reporting period would not apply to
[[Page 16737]]
Medicaid EPs and eligible hospitals demonstrating meaningful use for
the first time. We believe eliminating the 90-day EHR reporting period
for most providers would simplify reporting, by aligning providers on
the same EHR reporting timeline across all settings. In addition, a
single EHR reporting period on the calendar year would align the EHR
Incentive Program with other CMS quality reporting programs using
certified EHR technology such as the Hospital IQR Program and PQRS.
Finally, a single EHR reporting period based on the calendar year
allows for a single attestation period, thereby enabling the HHS
systems to better capture data, conduct enhanced stress testing and
issue resolution, and improve quality assurance of systems before each
deployment. We detail the proposed revisions to each of the uniform
definitions later in this section.
b. Meaningful EHR User
In the Stage 3 proposed rule, we propose to modify the definition
of ``Meaningful EHR User'' under 42 CFR 495.4 to include the Stage 3
objectives and measures defined at Sec. 495.7.
The definition of a ``Meaningful EHR User'' under the Act requires
the use of certified electronic health record technology (CEHRT) (see,
for example, section 1848(o)(2) of the Act). We note that the term
CEHRT is a defined term for the purpose of meeting the objectives of
the EHR Incentive Programs (defined at Sec. 495.4). The term
references ONC's certification criteria for a ``Base EHR,'' other ONC
certification criteria required in the EHR Incentive Programs and the
definition of a ``Meaningful EHR User.'' References to CEHRT within
this proposed rule are to certification criteria that are required for
purposes of the EHR Incentive Programs. We recognize that CEHRT is just
one form of health IT. For this reason, this proposed rule also
includes references to ``health IT'' where appropriate to capture the
broader category of technologies where applicable.
c. Definition of Meaningful Use
(1) Considerations in Defining Meaningful Use
In sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the
Congress identified the broad goal of expanding the use of EHRs through
the concept of meaningful use. Section 1903(t)(6)(C) of the Act also
requires that Medicaid providers adopt, implement, upgrade or
meaningfully use CEHRT if they are to receive incentives under Title
XIX. CEHRT used in a meaningful way is one piece of the broader HIT
infrastructure needed to reform the health care system and improve
health care quality, efficiency, and patient safety. This vision of
reforming the health care system and improving health care quality,
efficiency, and patient safety should inform the definition of
meaningful use.
As we explained in the Stage 1 and Stage 2 rules, we seek to
balance the sometimes competing considerations of health system
advancement (for example, improving health care quality, encouraging
widespread EHR adoption, promoting innovation) and minimizing burdens
on health care providers given the short timeframe available under the
HITECH Act.
Based on public and stakeholder input received during our Stage 1
rule, we laid out a phased approach to meaningful use. Such a phased
approach encompasses reasonable criteria for meaningful use based on
currently available technology capabilities and provider practice
experience, and builds up to a more robust definition of meaningful use
as technology and capabilities evolve. The HITECH Act acknowledges the
need for this balance by granting the Secretary the discretion to
require more stringent measures of meaningful use over time.
Ultimately, consistent with other provisions of law, meaningful use of
CEHRT should result in health care that is patient centered, evidence-
based, prevention-oriented, efficient, and equitable.
As stated in the Stage 2 final rule (77 FR 53973), we anticipated
the Stage 3 criteria for meaningful use would focus on promoting
improvements in quality, efficiency, and safety leading to improved
health outcomes. We also anticipated that Stage 3 would focus on
clinical decision support for national high priority conditions;
improving patient access to self-management tools; improving access to
comprehensive patient data through robust, secure, patient-centered
health information exchange; and improvements in population health.
For this Stage 3 proposed rule, we seek to streamline the criteria
for meaningful use. We intend to do this by--
Creating a single stage of meaningful use objectives and
measures (Stage 3), which would be optional for all providers in 2017
and mandatory for all providers in 2018;
Allowing providers flexible options for 2017;
Changing the EHR reporting period to a full calendar year
for all providers; and
Aligning with other CMS quality reporting programs using
certified health IT such as PQRS and Hospital IQR for clinical quality
measurement.
(a) Meaningful Use Stages
Under the phased approach to meaningful use, we updated 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 under Stages 1 and 2, including the recent
final rule extending Stage 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 is outlined in Table 2.
Table 2--Stage of Meaningful Use Criteria by First Payment Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage of meaningful use
First payment year -------------------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011...................................... 1 1 1 * 1 or 2 2 2 3 3 TBD TBD TBD
2012...................................... ........ 1 1 * 1 or 2 2 2 3 3 TBD TBD TBD
2013...................................... ........ ........ 1 * 1 2 2 3 3 TBD TBD TBD
2014...................................... ........ ........ ........ * 1 1 2 2 3 3 TBD TBD
2015...................................... ........ ........ ........ ........ 1 1 2 2 3 3 TBD
2016...................................... ........ ........ ........ ........ ........ 1 1 2 2 3 3
2017...................................... ........ ........ ........ ........ ........ ........ 1 1 2 2 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at Stage option) for Medicaid EPs. All
providers in the first year in 2014 use any continuous 90-day EHR reporting period.
[[Page 16738]]
In the Stage 2 final rule (77 FR 53974), we also stated that we
would indicate in future rulemaking our intent for the potential
development of stages or further criteria beyond Stage 3. In this
proposed rule, we intend for Stage 3 to be the final stage in
meaningful use and that no further stages would be developed. However,
we understand that multiple technological and clinical care standard
changes associated with EHR technology may result in the need to
consider changes to the objectives and measures of meaningful use under
the EHR Incentive Programs. Accordingly, we note that, as circumstances
warrant, we would consider addressing such changes in future
rulemaking.
As shown in Table 2, providers in any given year may be
participating in 1 of 3 different stages of the EHR Incentive Programs
in addition to other CMS quality reporting programs using certified
health IT such as PQRS and Hospital IQR. Through listening sessions,
correspondence, and public comment forums, providers expressed
frustration regarding the competing reporting requirements of multiple
CMS programs, and the overall challenge of planning and reporting on
the complex and numerous meaningful use requirements, including the
need to manage changing processes, workflows, and reporting systems. In
addition, group practices with EPs in different stages of meaningful
use have to simultaneously support multiple stages of the program in
order to demonstrate meaningful use for each EP. Meanwhile, if the
current 3-stage framework continues, HHS and state systems would be
required to support all 3 stages of the EHR Incentive Programs in
perpetuity with extensive implementation of complex processes to accept
submissions, analyze data, and coordinate systems.
Providers have expressed ongoing concern that the EHR Incentive
Programs are complicated, not focused on clinical reality and workflow,
and stifling to innovation in health IT development. Specifically,
providers have expressed concerns about the number of Stage 1 and 2
objectives and measures becoming obsolete or lacking any link to
improving outcomes. In addition, providers have expressed concern that
continued focus on Stage 1 measures impedes current and potential
future innovation in advanced utilization of health information
technology. Providers worry that Stage 3 of meaningful use would
exacerbate these existing concerns.
The certified EHR technology requirements within the EHR Incentive
Programs and included in ONC's Health IT Certification Program have
resulted in considerable increases in certified EHR technology adoption
among providers and are paving the way for more comprehensive, patient-
centered care across the care continuum. We recognize that while these
advancements have been beneficial there are concerns, as stated
previously, that require careful examination to ensure the
sustainability and efficacy of the program going forward--as HHS moves
to further encourage new uses of health IT and support the developing
health IT infrastructure beyond the strides already made. Therefore, we
seek to set a new foundation for this evolving program by proposing a
number of changes to meaningful use. First, we propose a definition of
meaningful use that would apply beginning in 2017. This definition of
meaningful use, although referred to as ``Stage 3'', would be the only
definition for the Medicare and Medicaid EHR Incentive Programs, and
would incorporate certain requirements and aspects of Stages 1 and 2.
Beginning with 2018, we propose to require all EPs, eligible hospitals,
and CAHs, regardless of their prior participation in the EHR Incentive
Program, to satisfy the requirements, objectives, and measures of Stage
3. However, for 2017, we propose that Stage 3 would be optional for
providers. This option would allow for a provider to move on to Stage 3
in 2017 or remain at Stage 2, or for some providers to remain at Stage
1, depending on their participation timeline. For example, under this
proposal, a provider in Stage 2 in 2016 could choose to remain in Stage
2 in 2017 or progress to Stage 3. In contrast to our rulemaking in 2014
to accommodate the use of multiple Editions to meet the definitions of
CEHRT during the EHR reporting periods in that year, this policy is
based on the provider selection of the objectives and measures for
their demonstration of meaningful use in 2017. Both the EHR technology
certified to the 2014 Edition and the EHR technology certified to the
2015 Edition will support attestations for Stage 1 or Stage 2 in 2017.
In addition, the development and certification process for EHR
technology products is not dependent on this selection by individual
providers. Therefore, we do not expect that this policy would affect
the availability of EHR technology certified to the 2015 Edition in
2017 or the ability of an individual provider to implement EHR
technology certified to the 2015 Edition during the year regardless of
which stage they choose for their EHR reporting period in 2017.
Therefore, we are proposing in section II.A.2.b. that all providers
would be required to use EHR technology certified to the 2015 Edition
for a full calendar year for the EHR reporting period in 2018. The
revised timeline based on these proposals is outlined in Table 3.
Table 3--Stage of Meaningful Use Criteria by First Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
Stage of meaningful use
------------------------------------------------------------------------------------------------------
First year as a meaningful EHR user 2021 and
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 future
years
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011............................................. 1 1 1 * 2 2 2 2 or 3 3 3 3 3
2012............................................. ....... 1 1 * 2 2 2 2 or 3 3 3 3 3
2013............................................. ....... ....... 1 1 2 2 2 or 3 3 3 3 3
2014............................................. ....... ....... ....... 1 1 2 2 or 3 3 3 3 3
2015............................................. ....... ....... ....... ....... 1 1 1, 2 or 3 3 3 3
3
2016............................................. ....... ....... ....... ....... ....... 1 1, 2 or 3 3 3 3
3
2017............................................. ....... ....... ....... ....... ....... ....... 1, 2 or 3 3 3 3
3
2018 and future years............................ ....... ....... ....... ....... ....... ....... ........ 3 3 3 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Please note, a provider scheduled to participate in Stage 2 in 2014, who instead elected to demonstrate stage 1 because of delays in availability of
EHR technology certified to the 2014 Edition, is still considered a stage 2 provider in 2014 despite the alternate demonstration of meaningful use. In
2015, all such providers are considered to be participating in their second year of Stage 2 of meaningful use.
[[Page 16739]]
Please note that the Medicare EHR Incentive Program and the
Medicaid EHR Incentive Program have different rules regarding the
number of payment years available, the last year for which incentive
payments may be received, and the last year to initiate the program and
receive an incentive payment. Medicaid EPs and eligible hospitals can
receive a Medicaid EHR incentive payment for ``adopting, implementing,
and upgrading'' (AIU) to Certified EHR Technology for their first
payment year, which is not reflected in Table 3. The applicable payment
years and the incentive payments available for each program are
discussed in the Stage 1 final rule (75 FR 44318 through 44320).
Although Table 3 outlines a provider's progression through the stages
of meaningful use, it does not necessarily reflect the relation to
incentive payments in the Medicare or Medicaid EHR Incentive Programs.
We note that some providers may not ever qualify to receive an
incentive payment depending on, among other factors, when and whether
they successfully demonstrate meaningful use in the EHR Incentive
Programs. We intend for the timeline in Table 3 to also apply to those
EPs, eligible hospitals, and CAHs that never receive an incentive
payment under the EHR Incentive Programs.
We are further proposing that Stage 3 would adopt a simplified
reporting structure on a focused set of objectives and associated
measures to replace all criteria under Stages 1 and 2. Specifically, we
are proposing criteria for meaningful use for EPs, eligible hospitals,
and CAHs (optional in 2017 and mandatory beginning in 2018), regardless
of a provider's prior participation in the Medicare and Medicaid EHR
Incentive Programs, as described in detail in section II.A.1.c. of this
proposed rule. We believe that a single set of objectives would reduce
provider burden and allow for greater focus on improving outcomes,
enhancing interoperability, and increasing patient engagement. In
addition, with all providers participating at the same level, the
impact of the scale of participation helps to support growth in health
information exchange and patient engagement infrastructure, as more
providers participate the ease of participation increases. Finally, the
associated measures proposed for Stage 3 in this proposed rule would
use advanced EHR functionality and IT-based processes. The
requirements, objectives, and measures are outlined further in sections
II.A.1.c.(2). of this proposed rule. In order to maintain clarity in
relation to the various rules and stages, provisions outlined in the
Stage 1 or Stage 2 final rules, and proposals under this Stage 3
proposed rule, we will maintain the ``Stage'' designation in order to
indicate the rule that contains the provision. The requirements,
objectives, and measures proposed as part of this proposed definition
of meaningful use would be referred to as ``Stage 3''.
We welcome public comment on these proposals.
(b) EHR Reporting Period
In the Stage 1 and Stage 2 final rules, we established that the EHR
reporting period for eligible hospitals and CAHs is based on the
federal fiscal year (October 1 through September 30). This fiscal year
EHR reporting period originally was designed to support coordination
between program implementation and CMS payment systems following the
development of the EHR Incentive Programs in 2010 to allow for
efficient payment of incentives for eligible hospitals and CAHs.
However, as the EHR Incentive Program evolved, we found the fiscal year
EHR reporting period resulted in varying reporting timelines between
provider types (for example, the EHR reporting period for EPs is based
on the calendar year) and a shortened timeline for system developers to
meet hospital and CAH technology requirements. Enhanced coordination
between CMS programs and other system implementation changes have
subsequently made it unnecessary to maintain a reporting timeframe for
eligible hospitals and CAHs based on the federal fiscal year.
Therefore, we are proposing changes to the EHR reporting period
beginning with the EHR reporting period in 2017 in order to do all of
the following:
Simplify reporting for providers, especially groups and
diverse systems.
Support further alignment of CMS quality reporting
programs using certified health IT such as Hospital IQR and PQRS.
Simplify HHS system requirements for data capture.
Provide for greater flexibility, stress testing, and
Quality Assurance (QA) of systems before deployment.
In the FY 2015 IPPS final rule (79 FR 49853 through 50449), we
aligned the reporting and submission timelines for CQMs for the
Medicare EHR Incentive Programs for eligible hospitals and CAHs with
the reporting and submission timelines for the Hospital IQR Program on
a calendar year basis. This was designed to allow for better alignment
between these programs in light of the directive in section
1886(n)(3)(B)(iii) of the Act to avoid redundant or duplicative
reporting. Calendar year reporting on quality data for hospitals allows
for greater efficiency in measure development, the electronic
specification of measures, and the update and deployment of measure
logic and value sets for electronic clinical quality measures. The FY
2014 IPPS final rule (78 FR 50904) clarified that eligible hospitals
and CAHs demonstrating meaningful use for the first time in FY 2014 and
reporting on CQMs electronically must report on a 3-month quarter in FY
2014, rather than on a continuous 90-day period. Such changes not only
better align program reporting but also allow for better data integrity
as previously discussed in the Stage 2 final rule (77 FR 53974 through
53975) and further discussed in section II.B.1.b. of this proposed
rule.
(i) Calendar Year Reporting
We are proposing to change the definitions of ``EHR reporting
period'' and ``EHR reporting period for a payment adjustment year''
under Sec. 495.4 for EPs, eligible hospitals, and CAHs such that the
EHR reporting period would be one full calendar year, with a limited
exception under the Medicaid EHR Incentive Program for providers
demonstrating meaningful use for the first time as discussed later in
this section and in section II.A.2.b. of this proposed rule. This would
allow for the full alignment of the EHR reporting timeline for the
meaningful use objectives and associated measures and the CQMs, and
align the timing of reporting by EPs, eligible hospitals, and CAHs. We
propose this change would apply beginning in CY 2017. For example, for
the incentive payments for the 2017 payment year, the EHR reporting
period for EPs, eligible hospitals, and CAHs would be the full 2017
calendar year. We note that the incentive payments under Medicare FFS
and Medicare Advantage (MA) (sections 1848(o), 1886(n), 1814(l)(3),
1853(l) and (m) of the Act) will end before 2017. However, under this
proposed change, EPs and eligible hospitals that seek to qualify for an
incentive payment under Medicaid would have a full calendar year EHR
reporting period if they are not demonstrating meaningful use for the
first time. For the payment adjustments under Medicare, we discuss the
timing of the EHR reporting period in relation to the payment
adjustment year in section II.D.2. of this proposed rule.
This proposal would mean that eligible hospitals and CAHs would
have
[[Page 16740]]
a reporting gap for the objectives and measures of meaningful use
consisting of the 3-month quarter from October 1, 2016 through December
31, 2016. Depending on future rulemaking, eligible hospitals and CAHs
may still be required to report on CQMs over this time. The next EHR
reporting period for eligible hospitals and CAHs to collect data on the
objectives and measures of meaningful use would then begin on January
1, 2017 and end on December 31, 2017. Eligible hospitals and CAHs would
then report on a full calendar year basis from that point forward.
(ii) Eliminate 90-Day EHR Reporting Period
We are further proposing to eliminate the 90-day EHR reporting
period for new meaningful EHR users beginning in 2017, with a limited
exception for Medicaid EPs and eligible hospitals demonstrating
meaningful use for the first time. This would allow for a single EHR
reporting period of a full calendar year for all providers across all
settings. Specifically, we propose to eliminate the EHR reporting
period of any continuous 90 days for EPs, eligible hospitals, and CAHs
that are demonstrating meaningful use for the first time. Those
providers instead would have an EHR reporting period of a full calendar
year, as described previously. However, as discussed in section
II.A.2.b. of this proposed rule, we propose to maintain the 90-day EHR
reporting period for a provider's first payment year based on
meaningful use for EPs and eligible hospitals participating in the
Medicaid EHR Incentive Program. We propose corresponding revisions to
the definitions of ``EHR reporting period'' and ``EHR reporting period
for a payment adjustment year'' under Sec. 495.4. We propose these
changes would apply beginning in CY 2017.
As stated previously, all providers would attest based on a single
EHR reporting period consisting of one full calendar year for the
applicable objectives and measures of meaningful use in 2017 and
subsequent years. These providers would submit their data in the 2
months following the close of the EHR reporting period. For further
information on the submission methods, see section II.D.9.b. of this
proposed rule.
We welcome public comment on these proposals.
(iii) State Flexibility for Stage 3 of Meaningful Use
Consistent with our approach under both Stage 1 and 2, we propose
to continue to offer states flexibility under the Medicaid EHR
Incentive Program in Stage 3 by adding a new provision at Sec.
495.316(d)(2)(iii) subject to the same conditions and standards as the
Stage 2 flexibility policy. Under Stage 3, state flexibility would
apply only with respect to the public health and clinical data registry
reporting objective outlined under section II.A.1.c.(1).(b).(i). of
this proposed rule.
For Stage 3 of meaningful use, we would continue to allow states to
specify the means of transmission of the data and otherwise change the
public health agency reporting objective as long as it does not require
functionality greater than what is required for Stage 3 and included in
the 2015 Edition proposed rule elsewhere in this issue of the Federal
Register.
We welcome comment on this proposal.
(2) Criteria for Meaningful Use Stage 3
In the Stage 1 and Stage 2 final rules, meaningful use included the
concept of a core and a menu set of objectives. Each objective had
associated measures that a provider needed to meet as part of
demonstrating meaningful use of CEHRT. In Stage 2 of meaningful use, we
also combined some of the objectives of Stage 1 and incorporated them
into objectives for Stage 2. For example, we combined the objectives of
maintaining an up-to-date problem list, active medication list, and
active medication allergy list with the objective of providing a
summary of care record for each transition of care or referral through
required fields in the summary of care document (77 FR 53990 through
53991 and 77 FR 54013 through 54016). We did this to allow for the more
advanced use of EHR technology functions to support clinical processes,
and to eliminate the need for providers to individually report on
measures that were often already incorporated in workflows and for
which many providers were already meeting the threshold (known as
``topping out''). In the Stage 2 final rule (77 FR 53973), we signaled
that the Stage 2 core and menu objectives would all be included in the
Stage 3 proposal for meaningful use.
Since the publication of the Stage 2 final rule, we have reviewed
meaningful use performance from both a qualitative and quantitative
perspective including analyzing performance rates, reviewing CEHRT
functionalities and standards, and considering information gained by
engaging with providers through listening sessions, correspondence, and
open forums like the HIT Policy Committee. The data support a number of
key points for consideration:
Providers are performing higher than the thresholds for
some of the meaningful use measures using some EHR functionalities
that--prior to the Stage 1 and Stage 2 final rules--were not common
place (such as the maintenance of problem lists).
Providers in different specialties and settings
implemented CEHRT and met objectives in different ways.
Providers express support for reducing the reporting
burden on measures that have ``topped out.''
Providers expressed support for advanced functionality
that would offer value to providers and patients.
Providers expressed support for flexibility regarding how
objectives are implemented in their practice settings.
Providers in health systems and large group practices
expressed frustration about the reporting burden of having to compile
multiple reports spanning multiple stages and objectives.
Since the EHR Incentive Programs began in 2011, stakeholder
associations and providers have requested that we consider changes to
the number of objectives and measures that providers must meet to
demonstrate meaningful use of certified EHR technology under the EHR
Incentive Programs. These recommendations also extended to
considerations for the structure of Stage 3 of meaningful use. Many of
these recommendations include allowing a provider to fail any two
objectives (in effect making all objectives ``menu'' objectives) and
still meet meaningful use, or to allow providers to receive an
incentive payment or avoid a downward payment adjustment based on
varied percentages of performance, and removing all measure thresholds.
We have reviewed these recommendations and have declined to follow this
course for a number of reasons.
First, the statute specifically 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, for example, section
1848(o)(2)(A)(iii) of the Act). This is one reason why we established
stages of meaningful use to move providers along a progression from
adoption to advanced use of certified EHR technology. Therefore, we
intend to continue to use measure thresholds that may increase over
time, and to incorporate advanced use functions of certified EHR
technology into meaningful use objectives and measures.
Second, there are certain objectives and measures which capture
policies specifically required by the statute as core goals of
meaningful use of certified EHR technology, such as electronic
[[Page 16741]]
prescribing for EPs, health information exchange, and clinical quality
measurement (see sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act).
Specific to the health information exchange, the statute requires
certified EHR technology connected in a manner that provides for the
electronic exchange of health information to improve the quality of
health care, such as promoting care coordination.
Further, the statute requires that the certified EHR technology
which providers must use shall be a ``qualified EHR'' as defined in
section 3000(13) of the Public Health Service Act as an electronic
record of health-related information on an individual that includes
patient demographic and clinical health information, such as medical
history and problem lists; and has the capacity to--
Provide clinical decision support;
Support physician order entry;
Capture and query information relevant to health care
quality; and
Exchange electronic health information with, and integrate
such information from, other sources (see section 1848(o)(4) of the
Act).
The objectives that address these requirements are integral to the
foundational goals of the program, which would be undermined if
providers were allowed to fail to meet these objectives and still be
considered meaningful EHR users. For these reasons, we intend to
continue to require providers to meet the objectives and measures of
meaningful use as required for the program, rather than allowing
providers to fail any two objectives of their choice or making all
objectives menu objectives.
Finally, while we understand providers are seeking to reduce the
overall burden of reporting, we do not believe these recommendations
accomplish that goal. Adding all objectives and measures to the menu
set and allowing for varying degrees of participation may add
complexity for the individual provider seeking to determine how they
can meet the requirements and demonstrate meaningful use of certified
EHR technology. We instead are proposing (as discussed in sections
II.A.1. and II.B. of this proposed rule) to reduce provider burden and
simplify the program by aligning reporting periods and CQM reporting.
In addition, the statute provides that in selecting measures for the
EHR Incentive Program, the Secretary shall seek to avoid redundant or
duplicative reporting otherwise required, including reporting under the
PQRS and Hospital IQR Program (see sections 1848(o)(2)(B)(iii) and
1886(n)(3)(B)(iii) of the Act). Although the statute refers to
redundant or duplicative reporting in the context of other CMS quality
reporting programs, we believe it is also useful and appropriate to
consider whether there are redundant or duplicative aspects of the
objectives and measures of Stages 1 and 2 of meaningful use as we
develop policies for Stage 3.
To that end, we have analyzed the objectives and measures of
meaningful use in Stage 1 and Stage 2 of the program to determine where
measures are redundant, duplicative, or have ``topped out.'' ``Topped
out'' is the term used to describe measures that have achieved
widespread adoption at a high rate of performance and no longer
represent a basis upon which provider performance may be
differentiated. We considered redundant objectives and measures to
include those where a viable health IT-based solution may replace
paper-based actions, such as the Stage 2 Clinical Summary objective (77
FR 54001 and 54002). We considered duplicative objectives and measures
to include those where some aspect is also captured in the course of
meeting another objective or measure, such as recording vital signs
which is also required as part of the summary of care document under
the Stage 2 Summary of Care objective (77 FR 54013 through 54021).
Finally, measures which have ``topped out'' 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 as
directed in the statute (see section 1848(o)(2)(A)(iii) of the Act).
For further discussion of ``topped out'' measures, we direct readers to
section II.A.2.a. of this proposed rule.
Therefore, our proposals for Stage 3 would continue the precedent
of focusing on the advanced use of certified EHR technology. They would
reduce the reporting burden; eliminate measures that are now redundant,
duplicative, and ``topped out''; create a single set of objectives for
all providers with limited variation between EPs, eligible hospitals,
and CAHs as necessary; and provide flexibility within the objectives to
allow providers to focus on implementations that support their
practice.
(a) Topped Out Objectives and Measures
In other contexts and CMS programs, CQMs are regularly evaluated to
determine whether they have ``topped out,'' which means generally that
measure performance among providers is so high and unvarying that
meaningful distinctions and improvements in performance can no longer
be made. Examples of this type of evaluation are found in the Hospital
Inpatient Quality Reporting (IQR) program, the Hospital-Value Based
Purchasing (HVBP) program, the End-Stage Renal Disease (ESRD) Quality
Initiative, and within the National Quality Forum (NQF) endorsement and
maintenance process for CQMs. We believe that quality measures, once
``topped-out,'' represent care standards that have been widely adopted.
We believe such measures should be considered for removal from program
reporting because their associated reporting burden may outweigh the
value of the quality information they provide and because, in some
cases, the inclusion of these measures may impact the ability to
differentiate among provider performance as a whole for programs which
use baseline and benchmarking based on measure performance scores.
Therefore, measures are regularly subject to an evaluation process to
identify their continued efficacy. This evaluation process is used to
determine whether a measure is ``topped out'' and, if so, whether that
measure should be removed from program reporting requirements. We note
that both the identification and the determination of a measure are
part of the process as a measure may be identified as topped out, but
still be determined useful as a measure for a specific program because
of other factors that merit continued use of the measure.
While the EHR Incentive Program does not use a benchmarking system
to rate the overall and relative performance of providers as part of
the definitions of meaningful use; we are proposing to adopt an
approach to evaluate whether objectives and measures have become
``topped out'' and, if so, whether a particular objective or measure
should be considered for removal from reporting requirements. We
propose to apply the following two criteria, which are similar to the
criteria used in the Hospital IQR and HVBP Programs (79 FR 50203): 1--
Statistically indistinguishable performance at the 75th and 99th
percentile, and 2--performance distribution curves at the 25th, 50th,
and 75th percentiles as compared to the required measure threshold.
An example of a current Stage 1 objective which would be considered
``topped out'' under this approach is the objective to record
demographics (75 FR 44340 through 44343). For the record demographics
objective, we reviewed performance data submitted by providers through
attestation and
[[Page 16742]]
determined that across all years of participation, the 75th percentile
is performing at 99.8 percent with the 99th percentile performing at
100 percent. In addition, the 25th, 50th, and 75th percentiles are all
performing with minimal variance and significantly higher than the
measure threshold of 50 percent, with performance rates at 97 percent,
99 percent, and 100 percent respectively for eligible hospitals and 92
percent, 98 percent and 100 percent respectively for EPs in Stage 1.\1\
For more information on the performance data, please see the EHR
Incentive Programs Objective and Measure Performance Report by
Percentile available at https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html. We further note
that this particular objective may also be considered duplicative as
further discussed in section II.A.2.c. of this proposed rule, as the
functionality which supports the objective within the EHR is also used
in other objectives such as the objective to provide patient-specific
education resources (77 FR 54011 through 54012) and the Stage 2 summary
of care objective (77 FR 54013 through 54021). Therefore, this is an
example of an objective that we determined is topped out and may no
longer provide value as an independent objective in the program.
---------------------------------------------------------------------------
\1\ Data may be found on the CMS Web site data and program
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------
We welcome public comments on our proposed approach for topped out
objectives and measures.
(b) Electronic Versus Paper-Based Objectives and Measures
In Stages 1 and 2, we require or allow providers the option to
include paper-based formats for certain objectives and measures. For
these objectives and measures, providers would print, fax, mail, or
otherwise produce a paper document and manually count these actions to
include in the measure calculation. Examples of these include: The
provision of a non-electronic summary of care document for a transition
or referral to meet the measure at Sec. 495.6(j)(14)(i) for EPs and
for eligible hospitals and CAHs atSec. 495.6(l)(11)(i): ``The
[provider] who transitions or refers their patient to another setting
of care or provider of care provides a summary of care record for more
than 50 percent of transitions of care and referrals;'' and the
provision of paper-based patient education materials measure for at
Sec. 495.6(j)(12)(i) for EPs and Sec. 495.6(l)(9)(i) requiring:
``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 [or discharged from
the eligible hospital or CAH] during the EHR reporting period.'' Each
of these measures may be met using a non-electronic format or action,
and we propose to discontinue this policy for Stage 3. We recognize the
strides that providers have made in the use of CEHRT and as we move
forward in MU, it is appropriate to remove the earlier iterations of
objectives and measures that were designed to support beginning EHR use
and instead focus on objectives that are based solely on electronic use
of data. This does not imply that we do not support the continued use
of paper-based materials in a practice setting. Some patients may
prefer to receive a paper version of their clinical summary or may want
to receive education items or reminders on paper or some other method
that is not electronic. We strongly recommend that providers continue
to provide patients with visit summaries, patient health information,
and preventative care recommendations in the format that is most
relevant for each individual patient and easiest for that patient to
access. In some cases, this may include the continued use of non-IT-
based resources. We are simply proposing that paper-based formats would
not be required or allowed for the purposes of the objectives and
measures for Stage 3 of meaningful use. We welcome public comments on
this proposal.
(c) Advanced EHR Functions
As discussed in section II.A.1.c.(2).(a). of this proposed rule, we
are proposing to simplify requirements for meaningful use through an
analysis of existing objectives and measures for Stages 1 and 2 to
determine if they are redundant, duplicative, or ``topped out''. We
note that some of the objectives and measures which meet these criteria
involve EHR functions that are required by the statutory definition of
``certified EHR technology'' (see section 1848(o)(4) of the Act, which
references the definition of ``qualified EHR'' in section 3000(13) of
the Public Health Service Act) which a provider must use to demonstrate
meaningful use. The objectives and measures proposed for Stage 3 would
include uses of these functions in a more advanced form. For example,
patient demographic information is included in an electronic summary of
care document called a consolidated clinical document architecture
(CCDA) provided during a transition of care in the Stage 2 Summary of
Care objective and measures (77 FR 54013 through 54021), which
represents a more advanced use of the EHR function than in the Stage 1
and 2 objective to record patient demographic information (77 FR 53991
through 53993).
We adopted a multi-part approach to identify the objectives and
measures which would be proposed for providers to demonstrate
meaningful use for Stage 3. This methodology included the analysis
mentioned previously of existing Stage 1 and 2 objectives and measures,
and provider performance; a review and consideration of the HIT Policy
Committee recommendations (which are publically available for review
at: https://www.healthit.gov/facas/health-it-policy-committee/health-it-policy-committee-recommendations-national-coordinator-health-it); and
an evaluation of how the potential objectives and measures align with
the foundational goals of the program defined in the HITECH Act.
In the Stage 2 proposed and final rules, we often identified the
HIT Policy Committee recommendations as part of our discussion of the
specific objectives and measures, for example in the Stage 2 CPOE
objective at 77 FR 43985. In this proposed rule for Stage 3 of
meaningful use, although we have considered the HIT Policy Committee's
recommendations in developing our proposed policies, we are not
referencing the recommendations in each individual proposed objective
and measure as there are multiple factors that contribute to the
selection of each proposed objective and measure. In addition, many of
the HIT Policy Committee recommendations address functions and
standards that are part of the advanced use of certified EHR technology
captured by one or more objectives proposed for Stage 3 of meaningful
use. For example, the HIT Policy Committee has recommended an expansion
of demographic data captured as structured data as well as a change to
the related standards for use. However, this function and standard is
required for certification of EHR technology for meaningful use and it
is a required field for an electronic summary of care document for
health information exchange. It is also to be included in the
information accessible to a patient within their electronic patient
record. Therefore, to provide clarity for readers, we provide a
notation within Table 4 to identify alignment between the proposed
Stage 3 objectives and measures and the recommendations of the HIT
Policy Committee for Stage 3 of meaningful
[[Page 16743]]
use. We direct readers to the HIT Policy Committee recommendations
available on HealthIT.gov for further information (https://www.healthit.gov/facas/health-it-policy-committee/health-it-policy-committee-recommendations-national-coordinator-health-it).
As mentioned previously, the statute includes certain foundational
goals and requirements for meaningful use of certified EHR technology
and the functions of that technology. Therefore, after review of the
existing Stage 1 and Stage 2 objectives and measures of meaningful use,
the recommendations of the HIT Policy Committee, and the foundational
goals and requirements under the HITECH Act; we have identified eight
key policy areas which represent the advanced use of EHR technology and
align with the program's foundational goals and overall national health
care improvement goals, such as those found in the CMS National Quality
Strategy.\2\ These eight policy areas provide the basis for the
proposed objectives and measures for Stage 3 of meaningful use. They
are included in Table 4 as follows:
---------------------------------------------------------------------------
\2\ The National Quality Strategy: ``HHS National Strategy for
Quality Improvement in Health Care'' https://www.ahrq.gov/workingforquality/about.htm.
Table 4--Objectives and Measures for Meaningful Use in 2017 and
Subsequent Years
------------------------------------------------------------------------
Delivery system reform goal
Program goal/objective alignment
------------------------------------------------------------------------
Protect Patient Health Information..... Foundational to Meaningful Use
and Certified EHR Technology
*.
Recommended by HIT Policy
Committee.
Electronic Prescribing (eRx)........... Foundational to Meaningful Use.
National Quality Strategy
Alignment.
Clinical Decision Support (CDS)........ Foundational to Certified EHR
Technology.
Recommended by HIT Policy
Committee.
National Quality Strategy
Alignment.
Computerized Provider Order Entry Foundational to Certified EHR
(CPOE). Technology.
National Quality Strategy
Alignment.
Patient Electronic Access to Health Recommended by HIT Policy
Information. Committee.
National Quality Strategy
Alignment.
Coordination of Care through Patient Recommended by HIT Policy
Engagement. Committee.
National Quality Strategy
Alignment.
Health Information Exchange (HIE)...... Foundational to Meaningful Use
and Certified EHR Technology.
Recommended by HIT Policy
Committee.
National Quality Strategy
Alignment.
Public Health and Clinical Data Recommended by HIT Policy
Registry Reporting. Committee.
National Quality Strategy
Alignment.
------------------------------------------------------------------------
* See, for example, sections 1848(o)(2) and (4) of the Act.
These objectives build on the measures and EHR functionalities from the
Stage 1 final rule and the Stage 2 final rule to advance the core
functions of EHRs in a clinically relevant way that benefits providers
and patients.
Under this proposal, which would apply to Stage 3 of meaningful use
in 2017 and subsequent years, providers must successfully attest to
these eight objectives and the associated measures (or meet the
exclusion criteria for the applicable measure). As mentioned
previously, 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). While we are proposing to simplify the program by removing
topped-out, redundant, and duplicative measures and aligning reporting
periods for providers; we are maintaining the push to improve the use
of EHRs over time through these eight objectives and the associated
measures proposed for Stage 3 of meaningful use. These proposed
objectives and measures include advanced EHR functions, use a wide
range of structured standards in CEHRT, employ increased thresholds
over similar Stage 1 and 2 measures, support more complex clinical and
care coordination processes, and require enhanced care coordination
through patient engagement through a flexibility structure of active
engagement measures.
These proposed objectives and their associated measures are further
discussed in section II.A.1.(c).(2). of this proposed rule. CMS and ONC
will continue to monitor and review performance on the objectives and
measures finalized for Stage 3 to continue to evaluate them for rigor
and efficacy and, if necessary, propose changes in future rulemaking.
(d) Flexibility Within Meaningful Use Objectives and Measures
We are proposing to incorporate flexibility within certain
objectives proposed for Stage 3 for providers to choose the measures
most relevant to their unique practice setting. This means that as part
of successfully demonstrating meaningful use, providers would be
required to attest to the results for the numerators and denominators
of all measures associated with an objective; however, a provider would
only need to meet the thresholds for two of the three associated
measures. The proposed Stage 3 objectives including flexible measure
options are as follows:
Coordination of Care through Patient Engagement--Providers
must meet the thresholds of two of three measures and must attest to
the numerators and denominators of all three measures.
Health Information Exchange--Providers must meet the
thresholds of two of three measures and must attest to the numerators
and denominators of all three measures.
Public Health Reporting--EPs must report on three measures
and eligible hospitals and CAHs must report on four measures.
We propose that if a provider meets the exclusion criteria for a
particular measure within an objective which allows providers to meet
the thresholds for two of three measures (namely, the Coordination of
Care through Patient Engagement objective and the Health Information
Exchange objective), the provider may exclude the measure and must meet
the thresholds of the remaining two measures to meet the
[[Page 16744]]
objective. If a provider meets the exclusion criteria for two measures
for such an objective, the provider may exclude those measures and must
meet the threshold of the remaining measure to meet the objective. If a
provider meets the exclusion criteria for all three measures for such
an objective, the provider may exclude those measures and would be
considered to have met the objective.
We discuss the proposed policy for exclusions for the public health
reporting objective as well as the exclusion criteria in further detail
within the individual objectives and measures in section
II.A.1.(c).(2). of this proposed rule.
(e) EPs Practicing in Multiple Practices/Locations
For Stage 3, we propose to maintain the policy from the Stage 2
final rule (77 FR 53981) which states that to be a meaningful user, an
EP must have 50 percent or more of his or her outpatient encounters
during the EHR reporting period at a practice/location or practices/
locations equipped with CEHRT. An EP who does not conduct at least 50
percent of their patient encounters in any one practice/location would
have to meet the 50 percent threshold through a combination of
practices/locations equipped with CEHRT. For example, if the EP
practices at a federally qualified health center (FQHC) and within his
or her individual practice at two different locations, we would include
in our review all three of these locations, and CEHRT would have to be
available at one location or a combination of locations where the EP
has 50 percent or more of his or her patient encounters. If CEHRT is
only available at one location, then only encounters at this location
would be included in meaningful use assuming this one location
represents 50 percent or more of the EP's patient encounters. If CEHRT
is available at multiple locations that collectively represent 50
percent or more of the EP's patient encounters, then all encounters
from those locations would be included in meaningful use. In the Stage
2 final rule at (77 FR 53981), we defined patient encounter as any
encounter where a medical treatment is provided or evaluation and
management services are provided. This includes both individually
billed events and events that are globally billed, but are separate
encounters under our definition.
In addition, in the Stage 2 final rule at (77 FR 53981) we defined
a practice/location as equipped with CEHRT if the record of the patient
encounter that occurs at that practice/location is created and
maintained in CEHRT. This can be accomplished in the following three
ways: CEHRT could be permanently installed at the practice/location,
the EP could bring CEHRT to the practice/location on a portable
computing device, or the EP could access CEHRT remotely using computing
devices at the practice/location. We propose to maintain these
definitions for Stage 3.
(f) Denominators
The objectives for Stage 3 of meaningful use include percentage-
based measures wherever possible. In the Stage 2 final rule, we
included a discussion of the denominators used for the program that
included the use of one of four denominators for each of the measures
associated with the meaningful use objectives outlined in the Stage 2
final rule at 77 FR 53982 for EPs and 77 FR 53983 for eligible
hospitals and CAHs. We focused on denominators because the action that
moves something from the denominator to the numerator requires the use
of CEHRT by the provider. For Stage 3 we refer readers to each of the
proposed objectives and measures for Stage 3 for the specific
calculation of each denominator for each measure. Here, we simply
outline the general proposals for determining the scope of the measure
denominators.
For EPs, the references used to define the scope of the potential
denominators for measures include the following:
Unique patients seen by the EP during the EHR reporting
period. The scope for this calculation may be limited to only those
patients whose records are maintained in the EHR for the denominator of
the measures for objectives other than those referencing ``unique
patients'' as previously established in the Stage 2 final rule at (77
FR 53981). We propose to maintain the policy that EPs who practice at
multiple locations or switch CEHRT during the EHR reporting period may
determine for themselves the method for counting unique patients in the
denominators to count unique patient across all locations equipped with
different CEHRT, or to count at each location equipped with CEHRT. In
cases where a provider switches CEHRT products at a single location
during the EHR reporting period, they also have the flexibility to
count a patient as unique on each side of the switch and not across it.
EPs in these scenarios must choose one of these methods for counting
unique patients and apply it consistently throughout the entire EHR
reporting period.
A patient is seen by the EP when the EP has a real time physical
encounter with the patient in which they render any service to the
patient. We also consider a patient seen through telehealth as a
patient ``seen by the EP'' (telehealth may include the commonly known
telemedicine as well as telepsychiatry, telenursing, and other diverse
forms of technology-assisted health care). However, in cases where the
EP and the patient do not have a real time physical or telehealth
encounter, but the EP renders a consultative service for the patient,
such as reading an EKG, virtual visits, or asynchronous telehealth, the
EP may choose whether to include the patient in the denominator as
``seen by the EP.'' This is necessary so that these providers can avoid
reporting a zero in the denominator and be able to satisfy meaningful
use. However, we stress that once providers choose, they must maintain
that denominator choice for the entire EHR reporting period and for all
relevant meaningful use measures.
Office visits. The denominators of the measures that
reference ``office visits'' may be limited to only those patients whose
records are maintained using CEHRT. An office visit is defined as any
billable visit that includes the following:
++ Concurrent care or transfer of care visits,
++ Consultant visits, or
++ Prolonged physician service without direct, face-to-face patient
contact (for example, telehealth).
All medication, laboratory, and diagnostic imaging orders
created during the reporting period
Transitions of care and referrals including at least--
++ When the EP is the recipient of the transition or referral, the
first encounter with a new patient and encounters with existing
patients where a summary of care record (of any type) is provided to
the receiving EP; and
++ When the EP is the initiator of the transition or referral,
transitions and referrals ordered by the EP.
Transitions of care are the movement of a patient from one setting
of care to another. Referrals are cases where one provider refers a
patient to another, but the referring provider maintains their care of
the patient as well. For the purposes of distinguishing settings of
care in determining the movement of a patient, we propose that a
transition or referral may take place when a patient is transitioned or
referred between providers with different billing identities, such as a
different National Provider Identifier (NPI) or hospital CMS
Certification Number (CCN). We
[[Page 16745]]
also propose that in the cases where a provider has a patient who seeks
out and receives care from another provider without a prior referral,
the first provider may include that transition as a referral if the
patient subsequently identifies the other provider of care.
For further explanation of the terms ``unique patient,'' ``seen by
the EP,'' ``office visit,'' ``transitions of care,'' and ``referrals,''
we refer readers to the discussion at 77 FR 53982 through 53983. For
eligible hospitals and CAHs, the references used to define the scope of
the potential denominators for measures include the following:
Unique patients admitted to the eligible hospital's or
CAH's inpatient or emergency department during the EHR reporting
period.
All medication, laboratory, and diagnostic imaging orders
created during the reporting period.
Transitions of care and referrals including at least--
++ When the hospital is the recipient of the transition or
referral: all admissions to the inpatient and emergency departments;
and
++ When the hospital is the initiator of the transition or
referral: all discharges from the inpatient department; and after
admissions to the emergency department when follow-up care is ordered
by an authorized provider.
We propose that the explanation of the terms ``unique patients,''
``transitions of care,'' and ``referrals'' stated previously for EPs
would also apply for eligible hospitals and CAHs, and we refer readers
to the discussion of those terms in the hospital context in the Stage 2
final rule (77 FR 53983 and 53984). We propose for Stage 3 to maintain
the policy that admissions may be calculated using one of two methods
(the observation services method and the all emergency department
method), as described for Stage 2 at 77 FR 53984. The method an
eligible hospital or CAH chooses must be used uniformly across all
measures for all objectives.
We reiterate that all discharges from an inpatient setting are
considered a transition of care. We further propose for transitions
from an emergency department, that eligible hospitals and CAHs must
count any discharge where follow up care is ordered by an authorized
provider regardless of the completeness of information available on the
receiving provider. The eligible hospital or CAH should determine an
internal policy applicable for the identification and capture of a
patient's primary care provider or other relevant care team members for
the purposes of ordering potential follow-up care. This will allow
eligible hospitals and CAHs to better differentiate between discharges
where care is ordered and discharges to home where no follow up care is
ordered.
(g) Patient-Authorized Representatives
In the Stage 3 Coordination of Care through Patient Engagement
objective and the Patient Electronic Access objective outlined in
section II.A.1.c.(2).(i). of this proposed rule, we propose the
inclusion of patient-authorized representatives in the numerators as
equivalent to the inclusion of the patient. We recognize that patients
often consult with and rely on trusted family members and other
caregivers to help coordinate care, understand health information, and
make health care decisions. Accordingly, as part of these objectives,
we encourage providers to provide access to health information to
patient-authorized representatives in accordance with all applicable
laws. We expect that patient-authorized representatives accessing such
information under these objectives could include a wide variety of
sources, including caregivers and various family members. However, we
expect that patient-authorized representatives with access to such
health information will always act on the patient's behalf and in the
patient's best interests, and will remain free from any potential or
actual conflict of interest with the patient. We further expect that
the patient-authorized representatives would have the patient's best
interests at heart and will act in a manner protective of the patient.
(h) Discussion of the Relationship of Meaningful Use to CEHRT
We propose to continue our policy of linking each meaningful use
objective to the CEHRT definition and to ONC-established certification
criteria. As with Stage 1 and Stage 2, EPs, eligible hospitals, and
CAHs must use technology certified to the certification criteria in the
ONC Health IT Certification Program to meet the objectives and
associated measures for Stage 3 of meaningful use. In some instances,
meaningful use objectives and measures may not be directly enabled by
certification criteria of the Health IT Certification Program. For
example, in e-Rx and public health reporting, the CEHRT definition
requires criteria established by the Health IT Certification Program to
be applied to the message being sent or received and for purposes of
message transmission. However, to actually engage in e-Rx or public
health reporting, there are many steps that must be taken to meet the
requirements of the measure, such as contacting both parties and
troubleshooting issues that may arise through the normal course of
business. In these cases, the EP, eligible hospital, and CAH remain
responsible for meeting the objectives and measures of meaningful use,
but the way they do so is not entirely constrained by the CEHRT
definition.
(i) Discussion of the Relationship Between a Stage 3 Meaningful Use
Objective and Its Associated Measure
We propose to continue our Stage 1 and 2 policy that regardless of
any actual or perceived gaps between the measure of an objective and
full compliance with the objective, meeting the criteria of the measure
means that the provider has met the objective for meaningful use in
Stage 3.
Objective 1: Protect Patient Health Information
The Health Insurance Portability and Accountability Act (HIPAA) was
enacted in part to provide federal protections for individually
identifiable health information (IIHI). The Secretary of HHS adopted
what are commonly known as the HIPAA Privacy, Security and Breach
Notification Rules (HIPAA Rules) to implement certain aspects of the
HIPAA statute and the HITECH statute pertaining to a patient's IIHI.
The Privacy Rule provides protections for most individually
identifiable health information, in any form or media, whether
electronic, paper, or oral, held by covered entities and business
associates. The Security Rule specifies a series of administrative,
physical, and technical standards that provide protections for most
electronic individually identifiable health information, held by
covered entities and business associates. Covered entities consist of
most health care providers, health plans, and health care
clearinghouses. Business associates consist of persons or organizations
that perform certain functions or activities on behalf of, or provide
certain services to, covered entities or other business associates that
involve the use or disclosure of individually identifiable health
information. Individually identifiable health information is
information that relates to an individual's physical or mental health
or condition, the provision of health care to an individual, or the
payment for the provision of health care to an individual. Individually
identifiable health information is information that identifies an
individual directly or with
[[Page 16746]]
respect to which there is a reasonable basis to believe it can be used
to identify an individual. The individually identifiable health
information protected by the HIPAA Rules is known as ``protected health
information'' and that information in electronic form is known as
``electronic protected health information'' (ePHI). The Privacy Rule
can be found at 45 CFR Part160 and subparts A and E of part 164 and the
Security Rule can be found at 45 CFR Part160 and Subparts A and C of
Part 164. Section 164.308(a)(1) of the Security Rule requires covered
entities and business associates, among other things, to conduct a
security risk analysis to assess the potential risks to the ePHI they
create, receive, maintain, or transmit.
Consistent with HIPAA and its implementing regulations, and as we
stated under both the Stage 1 and Stage 2 final rules (75 FR 44368
through 44369 and 77 FR 54002 through 54003), protecting ePHI remains
essential to all aspects of meaningful use under the EHR Incentive
Programs. We remain cognizant that unintended or unlawful disclosures
of ePHI could diminish consumer confidence in EHRs and the overall
exchange of ePHI. Therefore, in both the Stage 1 and 2 final rules, we
created a meaningful use core objective aimed at protecting patients'
health care information. Most recently, we finalized at (77 FR 54002
and 54003), a Stage 2 meaningful use core objective requiring providers
to ``protect ePHI created or maintained by the certified EHR technology
through the implementation of appropriate technical capabilities.'' The
measure for this objective requires providers to 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), implementing
security updates as necessary, and correcting identified security
deficiencies as part of the provider's risk management process. For
further detail on this objective, we refer readers to the Stage 2
proposed and final rules (77 FR 13716 through 13717 and 77 FR 54002).
In this Stage 3 proposed rule, we continue to emphasize the
importance of protecting ePHI under the EHR Incentive Programs. With
more and more users using electronic health records, we believe that
adequate protection of ePHI remains instrumental to the continued
success of the EHR Incentive Program.
However, public comments on the Stage 2 final rule and subsequent
comments received through public forums, suggest some confusion remains
among providers between the requirements of this meaningful use
objective and the requirements established under 45 CFR 164.308(a)(1),
45 CFR 164.312(a)(2)(iv) and 45 CFR 164.306(d)(3) of the HIPAA Security
Rule. Although we stressed that the objective and measure finalized
relating to ePHI are specific to the EHR Incentive Programs, and
further added that compliance with the requirements in the HIPAA
Security Rule falls outside the scope of this rulemaking, we
nonetheless continued to receive inquiries about the relationship
between our objective and the HIPAA Rules. Therefore, for Stage 3, in
order to alleviate provider confusion and simplify the EHR Incentive
Program, we are proposing to maintain the previously finalized Stage 2
objective on protecting ePHI. However, we propose further explanation
of the security risk analysis timing and review requirements for
purposes of meeting this objective and associated measure for Stage 3.
Proposed Objective: Protect electronic protected health information
(ePHI) created or maintained by the certified EHR technology (CEHRT)
through the implementation of appropriate technical, administrative,
and physical safeguards.
For the proposed Stage 3 objective, we have added language to the
security requirements for the implementation of appropriate technical,
administrative, and physical safeguards. We propose to include
administrative and physical safeguards because an entity would require
technical, administrative, and physical safeguards to enable it to
implement risk management security measures to reduce the risks and
vulnerabilities identified. Technical safeguards alone are not enough
to ensure the confidentiality, integrity, and availability of ePHI.
Administrative safeguards (for example, risk analysis, risk management,
training, and contingency plans) and physical safeguards (for example,
facility access controls, workstation security) are also required to
protect against threats and impermissible uses or disclosures to ePHI
created or maintained by CEHRT.
Proposed Measure: Conduct or review a security risk analysis in
accordance with the requirements under 45 CFR 164.308(a)(1), including
addressing the security (including 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), implement security updates as necessary, and correct
identified security deficiencies as part of the provider's risk
management process.
Under this proposed measure, a risk analysis must assess the risks
and vulnerabilities to ePHI created or maintained by the CEHRT and must
be conducted or reviewed for each EHR reporting period, which, as
proposed in this rule, would be a full calendar year, and any security
updates and deficiencies identified should be included in the
provider's risk management process and implemented or corrected as
dictated by that process.
To address inquiries about the relationship between this measure
and the HIPAA Security Rule, we explain that the requirement of this
proposed measure is narrower than what is required to satisfy the
security risk analysis requirement under 45 CFR 164.308(a)(1). The
requirement of this proposed measure is limited to annually conducting
or reviewing a security risk analysis to assess whether the technical,
administrative, and physical safeguards and risk management strategies
are sufficient to reduce the potential risks and vulnerabilities to the
confidentiality, availability, and integrity of ePHI created by or
maintained in CEHRT. In contrast, the security risk analysis
requirement under 45 CFR 164.308(a)(1) must assess the potential risks
and vulnerabilities to the confidentiality, availability, and integrity
of all ePHI that an organization creates, receives, maintains, or
transmits. This includes ePHI in all forms of electronic media, such as
hard drives, floppy disks, CDs, DVDs, smart cards or other storage
devices, personal digital assistants, transmission media, or portable
electronic media.
We propose that the timing or review of the security risk analysis
to satisfy this proposed measure must be as follows:
EPs, eligible hospitals, and CAHs must conduct the
security risk analysis upon installation of CEHRT or upon upgrade to a
new Edition of certified EHR Technology. The initial security risk
analysis and testing may occur prior to the beginning of the first EHR
reporting period using that certified EHR technology.
In subsequent years, a provider must review the security
risk analysis of the CEHRT and the administrative, physical, and
technical safeguards implemented, and make updates to its analysis as
necessary, but at least once per EHR reporting period.
We note that providers have several resources available for
strategies and
[[Page 16747]]
methods for securing ePHI. Completing a security risk analysis requires
a time investment, and may necessitate the involvement of security,
health IT, or system IT staff or support teams at your facility. The
Office for Civil Rights (OCR) provides broad scale guidance on security
risk analysis requirements at: https://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/rafinalguidancepdf.pdf.
In addition, other tools and resources are available to assist
providers in the process. For example, the Office of the National
Coordinator for Health IT (ONC) provides guidance and a Security Risk
Assessment (SRA) tool created in conjunction with OCR on its Web site
at: https://www.healthit.gov/providers-professionals/security-risk-assessment-tool. The SRA Tool is a self-contained application available
at no cost to the provider. There are a total of 156 questions and
resources are included with each question to--
Assist in understanding the context of the question
Consider the potential impacts to ePHI if the requirement
is not met
See the actual safeguard language of the HIPAA Security
Rule
In addition, the SRA Tool assists a provider by suggesting when
corrective action may be required for a particular item. This tool is
not required by the HIPAA Security Rule, but is one means by which
providers and professionals in small and medium sized practices may
perform a security risk analysis.
We further note that the 2015 Edition proposed rule published
elsewhere in this issue of the Federal Register includes an auditable
events and tamper-resistance criterion which is known as an ``audit
log'' which can be a valuable resource in ensuring the protection of
ePHI. While we recognize there may be legitimate instances where the
function must be disabled for a short time, we strongly recommend
providers ensure this function is enabled at all times when the CEHRT
is in use. The audit log function serves to ensure consistent
protection of ePHI as well as providing support in mitigating risk in
other areas such as patient safety, adverse events, and in the event of
any potential breach.
We emphasize that our discussion of this measure as it relates to
45 CFR 164.308(a)(1) is only relevant for purposes of the meaningful
use requirements and is not intended to supersede or satisfy the
broader, separate requirements under the HIPAA Security Rule and other
rulemaking. Compliance with the requirements in the HIPAA Security Rule
fall outside of the scope of this rulemaking. Compliance with 42 CFR
part 2 and state mental health privacy and confidentiality laws also
fall outside the scope of this rulemaking. EPs, eligible hospitals, or
CAHs affected by 42 CFR part 2 should consult with the Substance Abuse
and Mental Health Services Administration (SAMHSA) or State
authorities.
We welcome public comments on this proposal.
Objective 2: Electronic Prescribing
For Stage 3, we propose to maintain the objective and measure
finalized in the Stage 2 final rule for electronic prescribing for EPs,
with minor changes. In the Stage 2 final rule, we included for eligible
hospitals and CAHs a menu set objective for the electronic prescription
of discharge medications. We are proposing to include the Stage 2 menu
objective, with a modification to increase the threshold, as a required
objective for Stage 3 of meaningful use for eligible hospitals and
CAHs.
For a full discussion of electronic prescribing as a meaningful use
objective in the Stage 2 final rule, we direct readers to (77 FR 53989
through 53990 for EPs and 77 FR 54035 through 54036 for eligible
hospitals and CAHs).
Proposed Objective: EPs must generate and transmit permissible
prescriptions electronically, and eligible hospitals and CAHs must
generate and transmit permissible discharge prescriptions
electronically (eRx).
As discussed in the Stage 2 final rule (77 FR 53989), transmitting
the prescription electronically promotes efficiency and patient 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 that works in conjunction with
clinical decision support interventions enabled at the generation of
the prescription. While the EP performance rate across all years and
stages of participation indicate wide spread adoption, with the median
rate at 89 percent for Stage 1 and 92 percent for Stage 2 \3\, we
believe continued support of this objective is warranted to support the
continued development of the ePrescribing marketplace. The continued
expansion of the number and variety of products helps to reduce entry
barriers and proliferate important standards for ePrescribing for a
wide range of providers beyond those eligible for the EHR Incentive
Programs. This represents a benefit to patients and to population
health through a potential overall reduction in the occurrence of
prescription drug related adverse events. For eligible hospitals and
CAHs, the performance rate among Stage 2 providers selecting the
measure is higher than the 10 percent threshold and has increased since
the previous report (median rate is 76 \4\ percent). This opportunity
to expand on early success, combined with the continued expansion of
the pharmacy market acceptance of electronic prescriptions leads CMS to
believe providers can meet an even higher threshold and should be
encouraged to do so.
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\3\ Data may be found on the CMS Web site data and program
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
\4\ Data may be found on the CMS Web site data and program
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
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We propose to continue to define ``prescription'' as the
authorization by a provider to dispense a drug that would not be
dispensed without such authorization. This includes authorization for
refills of previously authorized drugs. We propose to continue to
generally define a ``permissible prescription'' as all drugs meeting
the definition of prescription not listed as a controlled substance in
Schedules II-V (DEA Web site at https://www.deadiversion.usdoj.gov/schedules/ (77 FR 53989) with a slight modification to allow
for inclusion of scheduled drugs where such drugs are permissible to be
electronically prescribed. We note that the electronic prescribing of
controlled substances (EPCS) is now legal in many states. This
functionality provides prescribers with a way to manage treatments for
patients with pain electronically and also deters creation of
fraudulent prescriptions, which is a major concern in combating opioid
misuse and abuse. While the technology may, in many instances, be in
place to support EPCS, workflow challenges and additional modifications
may need to occur to meet the requirements of Drug Enforcement Agency
regulations (75 FR 16236). However, as Stage 3 would not begin until
January of 2017 and would not be required until January of 2018, it is
possible that significant progress in the availability of products
enabling the electronic prescribing of controlled substances may occur.
Therefore, we are proposing that providers who practice in a state
where controlled substances may be electronically prescribed who wish
to include these prescriptions in the numerator and denominator may do
so under the definition of ``permissible prescriptions'' for their
practice. If a provider chooses to include such
[[Page 16748]]
prescriptions, they must do so uniformly across all patients and across
all allowable schedules for the duration of the EHR reporting period.
For Stage 2, we requested comment on whether over-the-counter (OTC)
medicines should be included in the definition of a prescription for
this objective and determined that they should be excluded. For further
information on that discussion, we direct readers to (77 FR 53989 and
53990). We maintain that OTC medicines will not be routinely
electronically prescribed and propose to continue to exclude them from
the definition of a prescription. However, we encourage public comment
on this assumption and whether OTC medicines should be included in this
objective for Stage 3.
In the Stage 2 final rule at (77 FR 53989), we discussed several
different workflow scenarios that are possible when an EP prescribes a
drug for a patient and that these differences in transmissions create
differences in the need for standards. We propose to maintain this
policy for Stage 3 for EPs and extend it to eligible hospitals and CAHs
so that only a scenario in which a provider--
Prescribes the drug;
Transmits it to a pharmacy independent of the provider's
organization; and
The patient obtains the drug from that pharmacy requires
the use of standards to ensure that the transmission meets the goals of
electronic prescribing. In that situation, standards can ensure the
whole process functions reliably. In all cases under this objective,
the provider needs to use CEHRT as the sole means of creating the
prescription, and when transmitting to an external pharmacy that is
independent of the provider's organization, such transmission must be
pursuant to ONC Health IT Certification Program criteria.
Proposed EP Measure: More than 80 percent of all permissible
prescriptions written by the EP are queried for a drug formulary and
transmitted electronically using CEHRT.
In Stage 1 of meaningful use, we adopted a measure of more than 40
percent of all permissible prescriptions written by the EP are
transmitted electronically using CEHRT. In the Stage 1 final rule (75
FR 44338), we acknowledged that there were reasons why a patient may
prefer a paper prescription such as the desire to shop for the best
price (especially for patients in the Part D ``donut hole''), the
indecision about whether to have the prescription filled locally or by
mail order, and the desire to use a manufacturer coupon (except in the
Part D program) to obtain a discount.
In Stage 2, we adopted a measure of more than 50 percent of all
permissible prescriptions written by the EP are queried for a drug
formulary and transmitted electronically using CEHRT. Our analysis of
attestation data from Stages 1 and 2 shows that the median performance
on this measure for Stage 1 EPs is 89 percent and for Stage 2 EPs is 92
percent, which demonstrates that the 50 percent threshold does not
exceed the ceiling created by patient preferences \5\. We believe that
with continued experience with this objective and the continued
expansion of the pharmacy market acceptance of electronic
prescriptions, providers can meet an even higher threshold and should
be encouraged to do so in line with the statutory directive to seek to
improve the use of EHRs and health care quality over time by requiring
more stringent measures of meaningful use (see section
1848(o)(2)(A)(iii) of the Act). Therefore, we are proposing a threshold
of 80 percent for this measure for Stage 3.
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\5\ Data can be found on the CMS Web site data and program
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
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We propose to maintain for Stage 3 the exclusion from Stage 2 for
EPs who write fewer than 100 permissible prescriptions during the EHR
reporting period. We also propose to maintain for Stage 3 the exclusion
from Stage 2 if no pharmacies within a 10-mile radius of an EP's
practice location at the start of his or her EHR reporting period
accept electronic prescriptions (77 FR 53990). This is 10 miles in any
straight line from the practice location independent of the travel
route from the practice location to the pharmacy. For EPs practicing at
multiple locations, they are eligible for the exclusion if any of their
practice locations equipped with CEHRT meet this criterion. 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.
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 80 percent in
order for an EP to meet this measure.
Exclusions: Any EP who: (1) Writes fewer than 100 permissible
prescriptions during the EHR reporting period; or (2) does not have a
pharmacy within their 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.
Proposed Eligible Hospital/CAH Measure: More than 25 percent of
hospital discharge medication orders for permissible prescriptions (for
new and changed prescriptions) are queried for a drug formulary and
transmitted electronically using CEHRT.
In the Stage 2 final rule, we included in this measure new,
changed, and refill prescriptions ordered during the course of
treatment of the patient while in the hospital (77 FR 54036). We are
proposing to limit this measure for Stage 3 to only new and changed
prescriptions. We believe this limitation is appropriate because
prescriptions that originate prior to the hospital stay, and that
remain unchanged, would be within the purview of the original
prescriber, and not hospital staff or attending physicians. We propose
to include this limitation as we believe that in most cases a hospital
would not issue refills for medications that were not authorized or
altered during a patient's hospital stay. With this new proposal, we
invite public comment on whether a hospital would issue refills upon
discharge for medications the patient was taking when they arrived at
the hospital and, if so, whether distinguishing those refill
prescriptions from new or altered prescriptions is unnecessarily
burdensome for the hospital.
Our review of the Stage 2 attestation data for eligible hospitals
and CAHs indicates performance levels of 53 percent at the median and
31 percent for the lowest quartile (www.cms.gov/ehrincentiveprograms
Data and Reports). Thus, we are proposing to increase the threshold for
the measure from 10 percent to 25 percent for Stage 3 of meaningful use
for eligible hospitals and CAHs.
We propose to maintain the Stage 2 exclusion for any eligible
hospital or CAH that does not have an internal pharmacy that can accept
electronic
[[Page 16749]]
prescriptions and is not located within 10 miles of any pharmacy that
accepts electronic prescriptions at the start of their EHR reporting
period (77 FR 54036).
We recognize that not every patient will have a formulary that is
relevant for him or her. If a relevant formulary is available, then the
information can be provided. If there is no formulary for a given
patient, the comparison could return a result of formulary unavailable
for that patient and medication combination, and the provider may count
the prescription in the numerator if they generate and transmit the
prescription electronically as required by the measure.
To calculate the percentage, CMS and ONC have worked together to
define the following for this objective:
Denominator: The number of new or changed prescriptions written for
drugs requiring a prescription in order to be dispensed other than
controlled substances for patients discharged during the EHR reporting
period.
Numerator: The number of prescriptions in the denominator
generated, queried for a drug formulary and transmitted electronically.
Threshold: The resulting percentage must be more than 25 percent in
order for an eligible hospital or CAH to meet this measure.
Exclusion: Any eligible hospital or CAH that does not have an
internal pharmacy that can accept electronic prescriptions and there
are no pharmacies that accept electronic prescriptions within 10 miles
at the start of their EHR reporting period.
We invite public comment on these proposals.
Objective 3: Clinical Decision Support
Proposed Objective: Implement clinical decision support (CDS)
interventions focused on improving performance on high-priority health
conditions.
Clinical decision support at the relevant point of care is an area
of health IT in which significant evidence exists for substantial
positive impact on the quality, safety, and efficiency of care
delivery. For Stage 2, we finalized an objective for the use of CDS to
improve performance on high-priority health conditions, and two
associated measures (77 FR 53995 through 53998). The first measure
requires a provider to implement five CDS interventions related to four
or more CQMs at a relevant point in patient care for the entire EHR
reporting period. Absent four CQMs related to the provider's scope of
practice or patient population, the CDS interventions must be related
to high-priority health conditions. At least one of the CDS
interventions should be related to improving healthcare efficiency. To
meet the Stage 2 Clinical Decision Support objective, 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. Although we leave it to the
provider's clinical discretion to determine the relevant point in
patient care when such interventions will be most effective, the
interventions must be presented through Certified EHR Technology to a
licensed healthcare professional who can exercise clinical judgment
about the decision support intervention before an action is taken on
behalf of the patient. For the second measure, we consolidated the
Stage 1 ``drug-drug/drug-allergy interaction checks'' objective into
the Stage 2 CDS objective in the Stage 2 final rule (77 FR 53995
through 53998). The second measure requires a provider to enable and
implement the functionality for drug-drug and drug-allergy interaction
checks for the entire EHR reporting period. We also finalized an
exclusion for the second measure for any EP who writes fewer than 100
medication orders during the EHR reporting period.
For Stage 3 of meaningful use, we propose to maintain the Stage 2
objective with slight modifications and further explanation of the
relevant point of care, the types of CDS allowed, and the selection of
a CDS applicable to a provider's scope of practice and patient
population.
First, we offer further explanation of the concept of the relevant
point of care and note that providers should implement the CDS
intervention at a relevant point in clinical workflows when the
intervention can influence clinical decision making before diagnostic
or treatment action is taken in response to the intervention. Second,
many providers may associate CDS with pop-up alerts; however, these
alerts are not the only method of providing CDS. CDS should not be
viewed as simply an interruptive alert, notification, or explicit care
suggestion. Well-designed CDS encompasses a variety of workflow-
optimized information tools, which can be presented to providers,
clinical and support staff, patients, and other caregivers at various
points in time. These may include but are not limited to: Computerized
alerts and reminders for providers and patients; information displays
or links; context-aware knowledge retrieval specifications which
provide a standard mechanism to incorporate information from online
resources (commonly referred to as InfoButtons); clinical guidelines;
condition-specific order sets; focused patient data reports and
summaries; documentation templates; diagnostic support; and
contextually relevant reference information. These functionalities may
be deployed on a variety of platforms (that is, mobile, cloud-based,
installed).\6\ We encourage innovative efforts to use CDS to improve
care quality, efficiency, and outcomes. HIT functionality that builds
upon the foundation of an EHR to provide persons involved in care
processes with general and person-specific information, intelligently
filtered and organized, at appropriate times, to enhance health and
health care. CDS is not intended to replace clinician judgment, but
rather, is a tool to assist care team members in making timely,
informed, and higher quality decisions.
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\6\ FDASIA Health IT report available on the FDA Web site at:
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM391521.pdf.
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We propose to retain both measures of the Stage 2 objective for
Stage 3 and we are proposing that these additional options mentioned
previously on the actions, functions, and interventions may constitute
CDS for purposes of meaningful use would meet the measure requirements
outlined in the proposed measures.
Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy
both measures in order to meet the objective:
Measure 1: Implement five clinical decision support interventions
related to four or more CQMs at a relevant point in patient care for
the entire EHR reporting period. Absent four CQMs 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.
Exclusion: For the second measure, any EP who writes fewer than 100
medication orders during the EHR reporting period.
We recommend that providers explore a wide range of potential CDS
interventions and determine the best mix for their practice and patient
population. There are a wide range of CQMs which providers may
implement in conjunction with the CDS. We refer readers to the CMS eCQM
Library (www.cms.gov/ehrincentiveprograms/ecqmlibrary) for a list of
the CQMs
[[Page 16750]]
currently in use and under development for CMS programs and the
associated National Quality Strategy domain categories.
In alignment with the HHS National Quality Strategy goals,\7\
providers are encouraged to implement CDS related to quality
measurement and improvement goals on the following areas:
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\7\ HHS National Quality Strategy: https://www.ahrq.gov/workingforquality/.
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Preventive care.
Chronic condition management.
Heart disease and hypertension.
Appropriateness of diagnostic orders or procedures such as
labs, diagnostic imaging, genetic testing, pharmacogenetic and
pharmacogenomic test result support or other diagnostic testing.
Advanced medication-related decision support, to include
pharmacogenetic and pharmacogenomic test result support.
An example of a potential CDS a provider may include which
highlights the proposed expansion of the variety of workflow-optimized
tools available for providers, and the link between a CDS and a high
priority health condition, may be found in the use of treatment
protocols and algorithms within the Million Hearts initiative. The
Million Hearts initiative emphasizes the use of treatment protocols
which can be embedded throughout the clinical workflow for hypertension
control to standardize a team's or system's approach to achieving
outcomes of interest. These treatment protocols or algorithms can
expand the number of care team members that can assist in achieving
desired outcomes; lend clarity, efficiency, and cost-effectiveness to
selection of medications; and specify intervals and processes for
patient follow up for care related to hypertension. For further
information on this example, we direct readers to the Million Hearts
initiative protocols https://millionhearts.hhs.gov/resources/protocols.html. In this example, these CDS interventions are applied to
utilize standardized treatment approaches or protocols specific to
hypertension control; however, we emphasize that similar strategies and
approaches to the implementation of a variety of CDS can be widely
applied. Another relevant example is clinical decision support in
certified EHR technology that is used for consultation regarding
appropriate use criteria for applicable imaging services as outlined in
section 218 of the ``Protecting Access to Medicare Act of 2014'' which
includes provisions focused on promoting evidence based care. We
welcome public comments on the proposals.
As in the Stage 2 final rule (77 FR 53997), we do not propose to
require the provider to report a change in performance on individual
CQMs either independently or in relation to the paired CDS. Rather, we
recommend each provider set internal goals for improved performance
using the CQM, or related set of CQMs, as indicators for their own
reference when selecting and implementing a CDS intervention. We note
that for CDS and CQM pairings, we recommend providers focus on the use
of CQMs which measure patient outcomes (also known as outcome
measures), as preferred over CQMs which measure clinical process
without consideration of a particular outcome (also known as process
measures). Outcome measure CQMs are designed to provide a patient-
centered and outcome-focused indicator for quality improvement goal-
setting and planning. Where possible, we recommend providers implement
CDS interventions which relate to care quality improvement goals and a
related outcome measure CQM. However, for specialty hospitals and
certain EPs, if there are no CQMs which are outcome measures related to
their scope of practice, the provider should implement a CDS
intervention related to a CQM process measure; or if none of the
available CQMs apply, the provider should apply an intervention that he
or she believes will be effective in improving the quality, safety, or
efficiency of patient care.
CMS and ONC are committed to harmonizing the quality improvement
ecosystem, refining and developing outcome measures, and aligning
standards for CDS and quality measurement. Work is underway in the ONC
Standards and Interoperability Framework to align and develop a shared
quality improvement data model and technical expression standards for
both CDS and quality measurement. Upon successful completion, such
standards may be considered for inclusion in future quality measurement
and certification rulemaking.
Given the wide range of CDS interventions currently available and
the continuing development of new technologies, we do not believe that
any EP, eligible hospital, or CAH would be unable to identify and
implement five CDS interventions as previously described. Therefore, we
do not propose any exclusion for the first measure of this objective.
Objective 4: Computerized Provider Order Entry
In the Stage 2 final rule, we expanded the use of computerized
provider order entry (CPOE) from the Stage 1 objective requiring only
medication orders to be entered using CPOE to include laboratory orders
and radiology orders. For a full discussion of this expansion, we
direct readers to (77 FR 53985 through 53989). We maintain CPOE
continues to represent an opportunity for providers to leverage
technology to capture these orders to reduce error and maximize
efficiencies within their practice, therefore we are proposing to
maintain the use of CPOE for these orders as an objective of meaningful
use for Stage 3.
Proposed Objective: Use computerized provider order entry (CPOE)
for medication, laboratory, and diagnostic imaging orders directly
entered by any licensed healthcare professional, credentialed medical
assistant, or a medical staff member credentialed to and performing the
equivalent duties of a credentialed medical assistant; who can enter
orders into the medical record per state, local, and professional
guidelines.
We propose to continue to define CPOE as the provider's use of
computer assistance to directly enter clinical 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.
We propose to continue our policy from the Stage 2 final rule that
the orders to be included in this objective are medication, laboratory,
and radiology orders as such orders are commonly included in CPOE
implementation and offer opportunity to maximize efficiencies for
providers. However, for Stage 3, we are proposing to expand the
objective to include diagnostic imaging, which is a broader category
including other imaging tests such as ultrasound, magnetic resonance,
and computed tomography in addition to traditional radiology. This
change addresses the needs of specialists and allows for a wider
variety of clinical orders relevant to particular specialists to be
included for purposes of measurement.
In Stage 3, we propose to continue the policy from the Stage 2
final rule at 77 FR 53986 that orders entered by any licensed
healthcare professional or credentialed medical assistant would
[[Page 16751]]
count toward this objective. A credentialed medical assistant may enter
orders if they are credentialed to perform the duties of a medical
assistant by a credentialing body other than the employer. If a staff
member of the eligible provider is appropriately credentialed and
performs assistive services similar to a medical assistant, but carries
a more specific title due to either specialization of their duties or
to the specialty of the medical professional they assist, orders
entered by that staff member would be included in this objective. We
further note that medical staff whose organizational or job title, or
the title of their credential, is other than medical assistant may
enter orders if these staff are credentialed to perform the equivalent
duties of a credentialed medical assistant by a credentialing body
other than their employer and perform such duties as part of their
organizational or job title. We defer to the provider's discretion to
determine the appropriateness of the credentialing of staff to ensure
that any staff entering orders have the clinical training and knowledge
required to enter orders for CPOE. This determination must be made by
the EP or representative of the eligible hospital or CAH based on--
Organizational workflows;
Appropriate credentialing of the staff member by an
organization other than the employing organization;
Analysis of duties performed by the staff member in
question; and
Compliance with all applicable federal, state, and local
laws and professional guidelines.
However, as stated in the Stage 2 final rule at 77 FR 53986, it is
apparent that the prevalent time when CDS interventions are presented
is when the order is entered into CEHRT, and that not all EHRs also
present CDS when the order is authorized (assuming such a multiple step
ordering process is in place). This means that the person entering the
order would be required to enter the order correctly, evaluate a CDS
intervention either using their own judgment or through accurate relay
of the information to the ordering provider, and then either make a
change to the order based on the information provided by the CDS
intervention or bypass the intervention. The execution of this role
represents a significant impact on patient safety; therefore, we
continue to maintain for Stage 3 that a layperson is not qualified to
perform these tasks. We believe that the order must be entered by a
qualified individual. We further propose that if the individual
entering the orders is not the licensed healthcare professional, the
order must be entered with the direct supervision or active engagement
of a licensed healthcare professional.
We propose to maintain for Stage 3 our existing policy for Stages 1
and 2 that the CPOE function should be used the first time the order
becomes part of the patient's medical record and before any action can
be taken on the order. The numerator of this objective also includes
orders entered using CPOE initially when the patient record became part
of the certified EHR. This does not include paper orders entered
initially into the patient record and then transferred to CEHRT by
other individuals at a later time, nor does it include orders entered
into technology not compliant with the CEHRT definition and transferred
into the CEHRT at a later time. In addition, based on the discussion in
the Stage 2 final rule (77 FR 53986), we propose to maintain for Stage
3 that ``protocol'' or ``standing'' orders may be excluded from this
objective. The defining characteristic of these orders is that they are
not created due to a specific clinical determination by the ordering
provider for a given patient, but rather are predetermined for patients
with a given set of characteristics (for example, administer medication
X and order lab Y for all patients undergoing a certain specific
procedure or refills for given medication). We agree that this category
of orders warrant different considerations than orders that are due to
a specific clinical determination by the ordering provider for a
specific patient. Therefore, we allow providers to exclude orders that
are predetermined for a given set of patient characteristics or for a
given procedure from the calculation of CPOE numerators and
denominators. However, the exclusion of this type of order may not be a
blanket policy for patients presenting with a specific diagnosis or
symptom which requires the evaluation and determination of the provider
for the order.
We propose to maintain the Stage 2 description of ``laboratory
services'' as any service provided by a laboratory that could not be
provided by a non-laboratory for the CPOE objective for Stage 3 (77 FR
53984). We also propose to maintain for Stage 3 the Stage 2 description
of ``radiologic services'' as any imaging service that uses electronic
product radiation (77 FR 53986). Even though we are proposing to expand
the CPOE objective from radiology orders to all diagnostic imaging
orders, this description would still apply for radiology services
within the expanded objective.
We invite public comment on these proposals.
Proposed Measures: An EP, eligible hospital or CAH must meet all
three measures.
Proposed Measure 1: More than 80 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 computerized provider order entry;
Proposed Measure 2: More than 60 percent of laboratory 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 computerized provider order entry;
and
Proposed Measure 3: More than 60 percent of diagnostic imaging
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 computerized
provider order entry.
We propose to continue a separate percentage threshold for all
three types of orders: medication, laboratory, and diagnostic imaging.
We continue to believe that an aggregate denominator cannot best
capture differentiated performance on the individual order types within
the objective, and therefore maintain a separate denominator for each
order type. We propose to retain exclusionary criteria from Stage 2 for
those EPs who so infrequently issue an order type specified by the
measures (write fewer than 100 of the type of order), that it is not
practical to implement CPOE for that order type.
Based on our review of attestation data from Stages 1 and 2
demonstrating provider performance on the CPOE measures, we propose to
increase the threshold for medication orders to 80 percent and to
increase the threshold for diagnostic imaging orders and laboratory
orders to 60 percent. Median performance for Stage 1 on medication
orders is 95 percent for EPs and 93 percent foreligible hospitals and
CAHs. Stage 2 median performance on laboratory and radiology orders is
80 percent and 83 percent for eligible hospitals and CAHs and 100
percent for EPs for both measures.\8\ We believe it is reasonable to
expect the actual use of CPOE for medication orders to increase from 60
percent in Stage 2 to 80 percent in Stage 3 and the actual use of CPOE
for diagnostic imaging and laboratory
[[Page 16752]]
orders to increase from 30 percent in Stage 2 to 60 percent in Stage 3.
We note that despite the expansion of the category for radiology orders
to diagnostic imaging orders, we do not anticipate a negative impact on
the ability of providers to meet the higher threshold as the adoption
of the expanded functionality does not require additional workflow
implementation and allows for inclusion of a wider range of orders
already being captured by many providers. Therefore, for medication
orders we propose the threshold at 80 percent and for diagnostic
imaging and laboratory orders we propose the threshold at 60 percent
for Stage 3.
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\8\ Data can be found on the CMS Web site data and program
reports page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
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In the Stage 2 final rule, we addressed the concern posed when
calculating a denominator of all orders entered into the CEHRT while
limiting the numerator to only those entered into CEHRT using CPOE (77
FR 53987 through 53988). Potentially, this would exclude those orders
that are never entered into the CEHRT in any manner. The provider would
be responsible for including those orders in their denominator.
However, we believe that providers using CEHRT use it as the patient's
medical record; therefore, an order not entered into CEHRT would be an
order that is not entered into a patient's medical record. For this
reason, we expect that orders given for patients that are never entered
into the CEHRT to be few in number or non-existent. While our
experience with both Stage 1 and Stage 2 of meaningful use has shown
that a denominator of all orders created by the EP or in the hospital
would not be unduly burdensome for providers and would create a better
measurement for CPOE usage, particularly for EPs who infrequently order
medications, this does not guarantee such a denominator would be
feasible for all providers. We invite comments on whether to continue
to allow, but not require, providers to limit the measure of this
objective to those patients whose records are maintained using CEHRT.
Proposed Measure 1: To calculate the percentage, CMS and ONC have
worked together to define the following for this measure:
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 80 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.
Proposed Measure 2: To calculate the percentage, CMS and ONC have
worked together to define the following for this measure:
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 60 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.
Proposed Measure 3: To calculate the percentage, CMS and ONC have
worked together to define the following for this measure:
Denominator: Number of diagnostic imaging 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 diagnostic imaging
orders during the EHR reporting period.
We seek comment on if there are circumstances which might warrant
an additional exclusion for an EP such as a situation representing a
barrier to successfully implementing the technology required to meet
the objective. We also seek comment on if there are circumstances where
an eligible hospital or CAH which focuses on a particular patient
population or specialty may have an EHR reporting period where the
calculation results in a zero denominator for one of the measures, how
often such circumstances might occur, and whether an exclusion would be
appropriate.
An EP through a combination of meeting the thresholds and
exclusions must satisfy all three measures for this objective. An
eligible hospital or CAH must meet the thresholds for all three
measures.
We welcome public comment on these proposals.
Objective 5: Patient Electronic Access to Health Information
The Stage 1 and Stage 2 final rules included a number of objectives
focused on increasing patient access to health information and
supporting provider and patient communication. These objectives include
patient reminders (77 FR 54005 through 54007), patient-specific
education resources (77 FR 54011 through 54012), clinical summaries of
office visits (77 FR 53998 through 54002), secure messaging (77 FR
54031 through 54033), and the ability for patients to view, download,
and transmit their health information to a third party (77 FR 54007
through 54011). For Stage 3, we generally identified two related policy
goals within the overall larger goal of improved patient access to
health information and patient-centered communication. The first is to
ensure patients have timely access to their full health record and
related important health information; and the second is to engage in
patient-centered communication for care planning and care coordination.
While these two goals are intricately linked, we see them as two
distinct priorities requiring different foci and measures of success.
For the first goal, we are proposing to incorporate the Stage 2
objectives related to providing patients with access to health
information, including the objective for providing access for patients
(or their authorized representatives) to view online, download, and
transmit their health information and the objective for patient-
specific education resources, into a new Stage 3 objective entitled,
``Patient Electronic Access'' (Objective 5), focused on using certified
EHR technology to support increasing patient access to important health
information. For the second goal, we are proposing an objective
entitled Coordination of Care through Patient Engagement (Objective 6)
incorporating the policy goals of the Stage 2 objectives related to
secure messaging, patient reminders, and the ability for patients (or
their authorized representatives) to view online, download, and
transmit their health information using the functionality of the
certified EHR technology.
In this Stage 3 Patient Electronic Access Objective, we are
proposing to incorporate certain measures and objectives from Stage 2
into a single objective focused on providing patients with timely
access to information related to their care. This proposed objective is
a consolidation of the first measure of the Stage 2 Core Objective
[[Page 16753]]
for EPs of ``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'' and the Stage 2 Core Objective
for EPs to ``Use clinically relevant information from CEHRT to identify
patient-specific education resources and provide those resources to the
patient.'' For eligible hospitals and CAHs, this proposed objective
consolidates the first measure of the Stage 2 Core Objective for
eligible hospitals/CAHs of ``Provide patients the ability to view
online, download, and transmit information about a hospital admission''
and the Stage 2 Core Objective ``Use clinically relevant information
from CEHRT to identify patient-specific education resources and provide
those resources to the patient.'' For further discussion around the
development of the Stage 2 objectives, we direct readers to the Stage 2
final rule at (77 FR 53973).
In Stage 2, there are objectives that allow providers to
communicate and provide information to patients through paper-based
means, such as clinical summaries of office visits and patient-specific
education resources. Although these methods of communication and
information exchange are embraced by many providers and patients and we
continue to support their use, we will no longer require or allow
providers to capture and calculate these actions or attest to these
measures for meaningful use Stage 3. While we believe that providing
patients access to health information in many formats is beneficial to
patient-centered communication, care delivery, and quality improvement,
meaningful use Stage 3 focuses exclusively on electronic, certified EHR
technology supported communication.
We are also proposing to expand the options through which providers
may engage with patients under the EHR Incentive Programs.
Specifically, we are proposing an additional functionality, known as
application-program interfaces (APIs), which would allow providers to
enable new functionalities to support data access and patient exchange.
An API is a set of programming protocols established for multiple
purposes. APIs may be enabled by a provider or provider organization to
provide the patient with access to their health information through a
third-party application with more flexibility than often found in many
current ``patient portals.'' From the provider perspective, using this
option would mean the provider would not be required to separately
purchase or implement a ``patient portal,'' nor would they need to
implement or purchase a separate mechanism to provide the secure
download and transmit functions for their patients because the API
would provide the patient the ability to download or transmit their
health information to a third party. If the provider elects to
implement an API, the provider would only need to fully enable the API
functionality, provide patients with detailed instructions on how to
authenticate, and provide supplemental information on available
applications which leverage the API. For further discussion on the
technical requirements for APIs, we direct readers to the 2015 Edition
proposed rule published elsewhere in this issue of the Federal
Register. The certification criteria proposed by ONC would establish
API criteria which would allow patients, through a third-party
application, to pull certain components of their unique health data
directly from the provider's CEHRT, and potentially could--on demand--
pull such information from multiple providers caring for a patient.
Therefore, we are proposing for the Patient Electronic Access objective
to allow providers to enable API functionality in accordance with the
proposed ONC requirements in the 2015 Edition proposed rule published
elsewhere in this issue of the Federal Register.
From the patient perspective, an API enabled by a provider will
empower the patient to receive information from their provider in the
manner that is most valuable to that particular patient. Patients would
be able to collect their health information from multiple providers and
potentially incorporate all of their health information into a single
portal, application, program, or other software. We also believe that
provider-enabled APIs allow patients to control the manner in which
they receive their health information while still ensuring the
interoperability of data across platforms. In addition, we recognize
that a large number of patients consult with and rely on trusted family
members and other caregivers to help coordinate care, understand health
information, and make decisions. Therefore, we encourage providers to
provide access to health information to appropriately authorized
patient representatives.
As some low-cost and free API functions already exist in the health
IT industry, we expect third-party application developers to continue
to create low-cost solutions that leverage APIs as part of their
business models. Therefore, we encourage health IT system developers to
leverage these existing API platforms and applications to allow
providers no-cost, or low-cost solutions to implement and enable an API
as part of their CEHRT systems. In addition, we do not believe it would
be appropriate for EPs and hospitals to charge patients a fee for
accessing their information using an API.
The goal of this objective is to allow patients easy access to
their health information as soon as possible, so that they can make
informed decisions regarding their care and share their most recent
clinical information with other health care providers and personal
caregivers as they see fit. We believe this is also integral to the
hospital Partnership for Patients initiative and reducing hospital
readmissions. This objective aligns with the Fair Information Practice
Principles (FIPPS),\9\ in affording baseline privacy protections to
individuals.\10\
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\9\ 1 In 1973, the Department of Health, Education, and Welfare
(HEW) released its report, Records, Computers, and the Rights of
Citizens, which outlined a Code of Fair Information Practices that
would create ''safeguard requirements'' for certain ''automated
personal data systems'' maintained by the Federal Government. This
Code of Fair Information Practices is now commonly referred to as
fair information practice principles (FIPPs) and established the
framework on which much privacy policy would be built. There are
many versions of the FIPPs; the principles described here are
discussed in more detail in The Nationwide Privacy and Security
Framework for Electronic Exchange of Individually Identifiable
Health Information, December 15, 2008. https://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
\10\ The FIPPs, developed in the United States nearly 40 years
ago, are well-established and have been incorporated into both the
privacy laws of many states with regard to government-held records 2
and numerous international frameworks, including the development of
the OECD's privacy guidelines, the European Union Data Protection
Directive, and the Asia-Pacific Economic Cooperation (APEC) Privacy
Framework. https://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_privacy_security_framework/1173.
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We seek comment on what additional requirements might be needed to
ensure that if the eligible hospital, CAH or EP selects the API
option--(1) the functionality supports a patient's right to have his or
her protected health information sent directly to a third party
designated by the patient; and (2) patients have at least the same
access to and use of their health information that they have under the
view, download, and transmit option.
Proposed Objective: The EP, eligible hospital, or CAH provides
access for patients to view online, download, and transmit their health
information, or retrieve their health information through an API,
within 24 hours of its availability.
We continue to believe that patient access to their electronic
health
[[Page 16754]]
information is a high priority for the EHR Incentive Programs.
Furthermore, providing educational resources about a patient's health
including recommendations for preventative care and screenings,
identifying risk factors, and other important health resources can help
to increase patient health literacy, empower patients to make more
informed decisions, and support the efforts of providers in managing a
patient care plan. We also believe that patient access to health
information should be provided in the manner requested by the patient
when possible.
We note that for this objective, the provider is only required to
provide access to the information through these means; the patient is
not required to take action in order for the provider to meet this
objective. In the Patient Electronic Access to Health Information
objective, we note that ``provides access'' means that the patient has
all the tools they need to gain access to their health information
including any necessary instructions, user identification information,
or the steps required to access their information if they have
previously elected to ``opt-out'' of electronic access. If this
information is provided to the patient in a clear and actionable
manner, the provider may count the patient for this objective.
Additionally, this objective should not require the provider to make
extraordinary efforts to assist patients in use or access of the
information, but the provider must inform patients of these options,
and provide sufficient guidance so that all patients could leverage
this access. The providers may withhold from online disclosure any
information either prohibited by federal, state, or local laws or if
such information provided through online means may result in
significant harm. We also note, as we have previously, that this is a
meaningful use requirement, which does not affect an individual's right
under HIPAA to access his or her health information. Providers must
continue to comply with all applicable requirements under the HIPAA
Privacy Rule, including the access provisions of 45 CFR 164.524.
Proposed Measures: EPs, eligible hospitals, and CAHs must satisfy
both measures in order to meet the objective:
Proposed Measure 1: For more than 80 percent of all unique patients
seen by the EP or discharged from the eligible hospital or CAH
inpatient or emergency department (POS 21 or 23):
(1) The patient (or patient-authorized representative) is provided
access to view online, download, and transmit their health information
within 24 hours of its availability to the provider; or
(2) The patient (or patient-authorized representative) is provided
access to an ONC-certified API that can be used by third-party
applications or devices to provide patients (or patient-authorized
representatives) access to their health information, within 24 hours of
its availability to the provider.
Proposed Measure 2: The EP, eligible hospital or CAH must use
clinically relevant information from CEHRT to identify patient-specific
educational resources and provide electronic access to those materials
to more than 35 percent of unique patients seen by the EP or discharged
from the eligible hospital or CAH inpatient or emergency department
(POS 21 or 23) during the EHR reporting period.
We propose that for measure 1, the patient must be able to access
this information on demand, such as through a patient portal, personal
health record (PHR), or API and have everything necessary to access the
information even if they opt out. All three functionalities (view,
download, and transmit) or an API must be present and accessible to
meet the measure. The functionality must support a patient's right to
have his or her protected health information sent directly to a third
party designated by the patient consistent with the provision of access
requirements at 45 CFR 164.524(c) of the HIPAA Privacy Rule.
However, if the provider can demonstrate that at least one
application that leverages the API is available (preferably at no cost
to the patient) and that more than 80 percent of all unique patients
have been provided instructions on how to access the information; the
provider need not create, purchase, or implement redundant software to
enable view, download, and transmit capability independently of the
API.
We propose to increase the threshold for measure 1 from the Stage 1
and Stage 2 threshold of 50 percent to a threshold of 80 percent for
Stage 3. We believe that all patients should be provided access to
their electronic health record; however, we are setting the threshold
at 80 percent based on the highest threshold defined for measures based
on unique patients seen by the provider during the EHR reporting period
in the Stage 2 final rule (for example see 77 FR 53993). Based on the
continued progress toward automation and standardization of data
capture supported by CEHRT which facilitates a faster response time, we
further propose to decrease patient wait time for the availability of
information to within 24 hours of the office visit or of the
information becoming available to the provider for potential inclusion
in the case of lab or other test results which require sufficient time
for processing and returning results.
For measure 2, we propose to increase the threshold that was
finalized in Stage 2 from 10 percent to 35 percent. We believe that the
35 percent threshold both ensures that providers are using CEHRT to
identify patient-specific education resources and is low enough to not
infringe on the provider's freedom to choose education resources and to
which patients these resources will be provided.
We continue to propose that both measures for this objective must
be met using CEHRT. For the purposes of meeting this objective, this
would mean the capabilities provided by a patient portal, PHR, or any
other means of online access that would permit a patient or authorized
representatives to view, download, and transmit their personal health
information and/or any API enabled, must be certified in accordance
with the certification requirements adopted by ONC.
We are proposing a continuation of the exclusion in Stage 2 for
both EPs and eligible hospitals/CAHs in that any EP, eligible hospital,
or CAH would be excluded from the first measure if it is located in a
county that does not have 50 percent or more of their housing units
with 4Mbps broadband availability according to the latest information
available from the FCC at the start of the EHR reporting period. We
continue to recognize that in areas of the country where a significant
section of the patient population does not have access to broadband
internet, this measure may be significantly harder or impossible to
achieve. Finally, we propose an additional exclusion for EPs for Stage
3, that any EP who has no office visits during the EHR reporting period
may be excluded from the measures. We encourage comments on these
exclusions and will evaluate them again in light of the public comments
received.
Proposed Measure 1: To calculate the percentage, CMS and ONC have
worked together to define the following for this measure:
Denominator: The number of unique patients seen by the EP or the
number of unique patients discharged from an eligible hospital or CAH
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Numerator: The number of patients in the denominator who are
provided access to information within 24 hours of its availability to
the EP or eligible hospital/CAH.
[[Page 16755]]
Threshold: The resulting percentage must be more than 80 percent in
order for a provider to meet this measure.
Exclusions: An EP may exclude from the measure if they have no
office visits during the EHR reporting period.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude the measure.
Any eligible hospital or CAH will be excluded from the measure if
it is located in a county that does not have 50 percent or more of
their housing units with 4Mbps broadband availability according to the
latest information available from the FCC at the start of the EHR
reporting period.
Proposed Measure 2: To calculate the percentage, CMS and ONC have
worked together to define the following for this measure:
Denominator: The number of unique patients seen by the EP or the
number of unique patients discharged from an eligible hospital or CAH
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Numerator: The number of patients in the denominator who were
provided electronic access to patient-specific educational resources
using clinically relevant information identified from CEHRT.
Threshold: The resulting percentage must be more than 35 percent in
order for a provider to meet this measure.
Exclusions: An EP may exclude from the measure if they have no
office visits during the EHR reporting period.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude the measure.
Any eligible hospital or CAH will be excluded from the measure if
it is located in a county that does not have 50 percent or more of
their housing units with 4Mbps broadband availability according to the
latest information available from the FCC at the start of the EHR
reporting period.
Alternate Proposals:
We note that for measure one we are seeking comment on the
following set of alternate proposals for providers to meet the measure
using the functions of CEHRT outlined previously in this section. These
alternate proposals involve the requirements to use a view, download,
and transmit function or an API to provide patients access to their
health information. We believe the current view, download, and transmit
functions are widely in use and represent the current standard for
patient access to their health record. However, we believe that the use
of APIs could potentially replace this function and move toward a more
accessible means for patients to access their information. Therefore,
we are seeking comment on alternatives which would present a different
mix of CEHRT functionality for providers to use for patients seeking to
access their records. The proposed first measure discussed previously
would allow providers the option either to give patients access to the
view, download, and transmit functionality, or to give patients access
to an API. Specifically, we are seeking comment on whether the API
option should be required rather than optional for providers, and if
so, should providers also be required to offer the view, download, and
transmit function.
Proposed Measure 1: For more than 80 percent of all unique patients
seen by the EP or discharged from the eligible hospital or CAH
inpatient or emergency department (POS 21 or 23):
(1) The patient (or patient-authorized representative) is provided
access to view online, download, and transmit their health information
within 24 hours of its availability to the provider; or
(2) The patient (or the patient-authorized representative) is
provided access to an ONC-certified API that can be used by third-party
applications or devices to provide patients (or patient authorized
representatives) access to their health information, within 24 hours of
its availability to the provider.
Alternate A: For more than 80 percent of all unique patients seen
by the EP or discharged from the eligible hospital or CAH inpatient or
emergency department (POS 21 or 23):
(1) The patient (or the patient-authorized representative) is
provided access to view online, download, and transmit his or her
health information within 24 hours of its availability to the provider;
and
(2) The patient (or patient-authorized representatives) is provided
access to an ONC-certified API that can be used by third-party
applications or devices to provide patients (or patient authorized
representatives) access to their health information within 24 hours of
its availability to the provider.
Alternate B: For more than 80 percent of all unique patients seen
by the EP or discharged from the eligible hospital or CAH inpatient or
emergency department (POS 21 or 23):
(1) The patient (or patient-authorized representative) is provided
access to view online, download, and transmit their health information
within 24 hours of its availability to the provider; and the patient
(or patient-authorized representative) is provided access to an ONC-
certified API that can be used by third-party applications or devices
to provide patients (or patient authorized representatives) access to
their health information within 24 hours of its availability to the
provider; or,
(2) The patient (or patient-authorized representatives) is provided
access to an ONC-certified API that can be used by third-party
applications or devices to provide patients (or patient authorized
representatives) access to their health information within 24 hours of
its availability to the provider.
Alternate C: For more than 80 percent of all unique patients seen
by the EP or discharged from the eligible hospital or CAH inpatient or
emergency department (POS 21 or 23), the patient (or patient-authorized
representative) is provided access to an ONC-certified API that can be
used by third-party applications or devices to provide patients (or
patient-authorized representatives) access to their health information,
within 24 hours of its availability to the provider.
These three alternate proposals would represent different use cases
for the CEHRT function to support view, download, and transmit and/or
API functionality. We note that under these proposed alternates the
following mix of functions would be applicable: Alternate A would
require both functions to be available instead of allowing the provider
to choose between the two; Alternate B would require the provider to
choose to have either both functions, or just an API function; and
Alternate C would require the provider to only have the API function.
For Alternate C, the use of a separate view, download, and transmit
function would be entirely at the provider's discretion and not
included as part of the definition of meaningful use.
We welcome public comment on these proposals.
Objective 6: Coordination of Care Through Patient Engagement
As mentioned previously, the Stage 1 and Stage 2 final rules
included a number of objectives focused on patient access to health
information and communication among providers, care teams, and
patients. These patient engagement objectives focused on changing
behaviors among providers and patients to promote patient
[[Page 16756]]
involvement in health care. Specifically, the objectives included
supporting provider and patient communication about their health,
improving overall patient health literacy, and supporting patient-
driven coordination with providers and other members of the patient's
care team. The Stage 1 and Stage 2 objectives included patient
reminders (77 FR 54005 through 54007), patient-specific education
resources (77 FR 54011 through 54012), clinical summaries of office
visits (77 FR 53998 through 54002), secure messaging (77 FR 54031
through 54033), and the ability for patients to view, download, and
transmit their health information to a third party (77 FR 54007 through
54011). For Stage 3, as mentioned previously, we are proposing to
incorporate the Stage 2 objectives related to providing patients with
access to health information into a new Stage 3 objective entitled,
``Patient Electronic Access'' (Objective 5). For the proposed objective
entitled Coordination of Care through Patient Engagement (Objective 6),
we are proposing to incorporate the policy goals of the Stage 2
objectives related to secure messaging, patient reminders, and the
measure of patient engagement requiring patients (or their authorized
representatives) to view, download, and transmit their health
information using the functionality of the certified EHR technology.
As mentioned previously, while we believe there may be many methods
of communication and information sharing among providers, or other care
team members, and patients (including paper-based or telephone
communications), meaningful use Stage 3 focuses exclusively on
electronic, certified EHR technology supported communication in the
requirements outlined in this proposed objective for Coordination of
Care through Patient Engagement.
Proposed Objective: Use communications functions of certified EHR
technology to engage with patients or their authorized representatives
about the patient's care.
Specifically, this proposed rule focuses on encouraging the use of
EHR functionality for secure dialogue and efficient communication
between providers, care team members, and patients about their care and
health status, as well as important health information such as
preventative and coordinated care planning. In addition, certified EHR
technology functions designed to support patient engagement can be a
platform to securely capture and record patient-generated health data
and information provided in non-clinical care settings.
We are also proposing to expand the options through which providers
may engage with patients under the EHR Incentive Programs including the
use of APIs as mentioned previously. An API can enable a patient--
through a third-party application--to access and retrieve their health
information from a care provider in a way that is most valuable to that
particular patient.
Therefore, we are proposing a meaningful use objective for Stage 3
to support this provider and patient engagement continuum based on the
foundation already created within the EHR Incentive Programs but using
new methods and expanded options to advance meaningful patient
engagement and patient-centered care. We also propose that for purposes
of this objective, patient engagement may include patient-centered
communication between and among providers facilitated by authorized
representatives of the patient and of the EP, eligible hospital, or
CAH. As care delivery evolves, the participation of a diverse group of
care team members enables more robust care for the patient. Engagement
between the patient and, for example, nutritionists, social workers,
physical therapists, or other members of the provider's care team is
crucial to effective patient engagement and are therefore included in
this objective.
For Stage 3 of meaningful use, we propose the following measures
for the Patient Engagement Objective:
Proposed Measures: We are proposing that providers must attest to
the numerator and denominator for all three measures, but would only be
required to successfully meet the threshold for two of the three
proposed measures to meet the Coordination of Care through Patient
Engagement Objective. These three measures support the communication
continuum between providers, patients, and the patient's authorized
representatives through the use of view, download, and transmit
functionality. They also support using API functionality through
patient engagement with their health data, but also potentially through
secure messaging functions and standards, and the capture and inclusion
of data collected from non-clinical settings, including patient-
generated health data.
Proposed Measure 1: During the EHR reporting period, more than 25
percent of all unique patients seen by the EP or discharged from the
eligible hospital or CAH inpatient or emergency department (POS 21 or
23) actively engage with the electronic health record made accessible
by the provider. An EP, eligible hospital or CAH may meet the measure
by either:
(1) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP or discharged from the
eligible hospital or CAH inpatient or emergency department (POS 21 or
23) during the EHR reporting period view, download or transmit to a
third party their health information; or
(2) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP or discharged from the
eligible hospital or CAH inpatient or emergency department (POS 21 or
23) during the EHR reporting period access their health information
through the use of an ONC-certified API that can be used by third-party
applications or devices.
Proposed Measure 2: For more than 35 percent of all unique patients
seen by the EP or discharged from the eligible hospital or CAH
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period, a secure message was sent using the electronic
messaging function of CEHRT to the patient (or the patient's authorized
representatives), or in response to a secure message sent by the
patient (or the patient's authorized representative).
Proposed Measure 3: Patient-generated health data or data from a
non-clinical setting is incorporated into the certified EHR technology
for more than 15 percent of all unique patients seen by the EP or
discharged by the eligible hospital or CAH inpatient or emergency
department (POS 21 or 23) during the EHR reporting period.
For measure 1, we are proposing to increase the threshold for the
measure from 5 percent to 25 percent based on provider performance on
the related Stage 2 measure requiring more than 5 percent of patients
to view, download, or transmit to a third party the health information
made available to them by the provider. Stage 2 median performance for
an EP on this measure is 32 percent and 11 percent for eligible
hospitals.\11\ Therefore, we are proposing more than 25 percent of all
unique patients (or the patient's authorized representatives) seen by
the EP, eligible hospital or CAH during the EHR reporting period must
view, download, or transmit to a third party their health information
or access their health information through the use of an ONC-certified
API that can be used by third-party applications or devices. For the
API option, we propose that providers must attest that they have
enabled an API and that at least one application
[[Page 16757]]
which leverages the API is available to patients (or the patient-
authorized representatives) to retrieve health information from the
provider's certified EHR.
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\11\ Data can be found on CMS Web site Data and Program Reports
page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAndReports.html.
---------------------------------------------------------------------------
CMS recognizes that there may be inherent challenges in measuring
patient access to CEHRT through third-party applications that utilize
an ONC-certified API, and we solicit comment on the nature of those
challenges and what solutions can be put in place to overcome them. For
example, are there specific requirements around the use of APIs or are
there specific certification requirements for APIs that could make the
measurement of this objective easier. We also solicit comment on
suggested alternate proposals for measuring patient access to CEHRT
through third-party applications that utilize an API, including the
pros and cons of measuring a minimum number of patients (one or more)
who must access their health information through the use of an API in
order to meet the measure of this objective.
For measure 2, the EP, eligible hospital, CAH, or the provider's
authorized representative must communicate with the patient (or the
patient's authorized representatives), through secure electronic
messaging for more than 35 percent of the unique patients seen by the
provider during the EHR reporting period. ``Communicate'' means when a
provider sends a message to a patient (or the patient's authorized
representatives) or when a patient (or the patient's authorized
representatives) sends a message to the provider. In patient-to-
provider communication, the provider must respond to the patient (or
the patient's authorized representatives) for purposes of this measure.
We propose to increase the threshold for this measure over the
threshold for the Stage 2 measure because for Stage 3 provider
initiated messages would count toward the measure numerator.
For measure 2, we propose to include in the measure numerator
situations where providers communicate with other care team members
using the secure messaging function of certified EHR technology, and
the patient is engaged in the message and has the ability to be an
active participant in the conversation between care providers. However,
we seek comment on how this action could be counted in the numerator,
and the extent to which that interaction could or should be counted for
eligible providers engaged in the communication. For example, should
only the initiating provider be allowed to include the communication as
an action in the numerator? Or, should any provider who contributes to
such a message during the EHR reporting period be allowed to count the
communication? In addition, we seek comment on what should be
considered a contribution to the patient-centered communication; for
example, a contribution must be active participation or response, a
contribution may be viewing the communication, or a contribution may be
simple inclusion in the communication.
We specify that the secure messages sent should contain relevant
health information specific to the patient in order to meet the measure
of this objective. We believe the provider is the best judge of what
health information should be considered relevant in this context. For
the purposes of this measure, we are proposing that secure messaging
content may include, but is not limited to, questions about test
results, problems, and medications; suggestions for follow-up care or
preventative screenings; confirmations of diagnosis and care plan
goals; and information regarding patient progress. However, we note
that messages with content exclusively relating to billing questions,
appointment scheduling, or other administrative subjects should not be
included in the numerator. For care team secure messaging with the
patient included in the conversation, we also believe the provider may
exercise discretion if further communications resulting from the
initial action should be excluded from patient disclosure to prevent
harm. We note that if such a message is excluded, all subsequent
actions related to that message would not count toward the numerator.
For measure 3, EPs, eligible hospitals, and CAHs (or their
authorized representatives) must incorporate health data obtained from
a non-clinical setting in a patient's electronic health record for more
than 15 percent of unique patients seen during the EHR reporting
period. We note that the use of the term ``clinical'' means different
things in relation to place of service for billing for Medicare and
Medicaid services. However, for purposes of this measure only, we are
proposing that a non-clinical setting shall be defined as a setting
with any provider who is not an EP, eligible hospital or CAH as defined
for the Medicare and Medicaid EHR Incentive Programs. Therefore, for
this measure, a non-clinical setting is any provider or setting of care
which is not an EP, eligible hospital, or CAH in either the Medicare or
Medicaid EHR Incentive Programs and where the care provider does not
have shared access to the EP, eligible hospital, or CAHs certified EHR.
This may include, but is not limited to, health and care-related data
from care providers such as nutritionists, physical therapists,
occupational therapists, psychologists, and home health care providers
as well as data obtained from patients themselves. We specifically
mention this last item and refer to this sub-category as patient-
generated health data, which may result from patient self-monitoring of
their health (such as recording vital signs, activity and exercise,
medication intake, and nutrition), either on their own, or at the
direction of a member of the care team. We are proposing this measure
in response to requests from providers to support the capture and
incorporation of patient-generated health data, and the capture and
incorporation of data from a non-clinical setting into an EHR.
Providers have expressed a desire to have this information captured in
a useful and structured way and made available in the EHR. The capture
and incorporation of this information is an integral part of ensuring
that providers and patients have adequate information to partner in
making clinical care decisions, especially for patients with chronic
disease and complex health conditions for whom self-monitoring is an
important part of an ongoing care plan.
We are seeking comment on how the information for measure 3 could
be captured, standardized, and incorporated into an EHR. For the
purposes of this measure, the types of data that would satisfy the
measure is broad. It may include, but is not limited to social service
data, data generated by a patient or a patient's authorized
representatives, advance directives, medical device data, home health
monitoring data, and fitness monitor data. In addition, the sources of
data vary and may include mobile applications for tracking health and
nutrition, home health devices with tracking capabilities such as
scales and blood pressure monitors, wearable devices such as activity
trackers or heart monitors, patient reported outcome data, and other
methods of input for patient and non-clinical setting generated health
data. We emphasize that these represent several examples of the data
types that could be covered under this measure. We also note that while
the scope of data covered by this measure is broad, it may not include
data related to billing, payment, or other insurance information. As
part of determining the proper scope of this measure, we are seeking
comment on the following questions:
Should the data require verification by an authorized
provider?
[[Page 16758]]
Should the incorporation of the data be automated?
Should there be structured data elements available for
this data as fields in an EHR?
Should the data be incorporated in the CEHRT with or
without provider verification?
Should the provenance of the data be recorded in all cases
and for all types of data?
We also seek comment on whether this proposed measure should have a
denominator limited to patients with whom the provider has multiple
encounters, such as unique patients seen by the provider two or more
times during the EHR reporting period. We also seek comment on whether
this measure should be divided into two distinct measures. The first
measure would include only the specific sub-category of patient-
generated health data, or data generated predominantly through patient
self-monitoring rather than by a provider. The second measure would
include all other data from a non-clinical setting. This would result
in the objective including four measures with providers having an
option of which two measures to focus on for the EHR reporting period.
We also seek comment on whether the third measure should be
proposed for eligible hospitals and CAHs, or remain an option only for
eligible professionals. For those commenters who believe it should not
be applicable for eligible hospitals and CAHs, we seek further comment
on whether eligible hospitals and CAHs should then choose one of the
remaining two measures or be required to attest to both.
Providers must attest to the numerator and denominator for all
three measures, and must meet the threshold for two of the three
measures to meet the objective for Stage 3 of meaningful use:
Proposed Measure 1: We have identified the following for measure 1
of this objective:
Option 1: View, Download, or Transmit to a Third Party
Denominator: Number of unique patients seen by the EP, or the
number of unique patients discharged from an eligible hospital or CAH
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Numerator: The number of unique patients (or their authorized
representatives) in the denominator who have viewed online, downloaded,
or transmitted to a third party the patient's health information.
Threshold: The resulting percentage must be more than 25 percent in
order for an EP, eligible hospital, or CAH to meet this measure.
Option 2: API
Denominator: The number of unique patients seen by the EP or the
number of unique patients discharged from an eligible hospital or CAH
inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Numerator: The number of unique patients (or their authorized
representatives) in the denominator who have accessed their health
information through the use of an an ONC-certified API.
Threshold: The resulting percentage must be more than 25 percent in
order for an EP, eligible hospital, or CAH to meet this measure.
Exclusions: Applicable for either option discussed previously, the
following providers may exclude from the measure:
Any EP who has no office visits during the EHR reporting period may
exclude from the measure.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude from the measure.
Any eligible hospital or CAH operating in a location that does not
have 50 percent or more of its housing units with 4Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude from the
measure.
Measure 2: Denominator: Number of unique patients seen by the EP or
the number of unique patients discharged from an eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Numerator: The number of patients in the denominator for whom a
secure electronic message is sent to the patient, the patient's
authorized representatives, or in response to a secure message sent by
the patient.
Threshold: The resulting percentage must be more than 35 percent in
order for an EP, eligible hospital, or CAH to meet this measure.
Exclusion: Any EP who has no office visits during the EHR reporting
period may exclude from the measure.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude from the measure.
Any eligible hospital or CAH operating in a location that does not
have 50 percent or more of its housing units with 4Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude from the
measure.
Measure 3: Denominator: Number of unique patients seen by the EP or
the number of unique patients discharged from an eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
Numerator: The number of patients in the denominator for whom data
from non-clinical settings, which may include patient-generated health
data, is captured through the certified EHR technology into the patient
record.
Threshold: The resulting percentage must be more than 15 percent in
order for an EP, eligible hospital, or CAH to meet this measure.
Exclusion: Any EP who has no office visits during the EHR reporting
period may exclude from the measure.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude from the measure.
Any eligible hospital or CAH operating in a location that does not
have 50 percent or more of its housing units with 4Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude from the
measure.
We seek comment on this proposed objective and the related proposed
measures.
Objective 7: Health Information Exchange
Improved communication between providers caring for the same
patient can help providers make more informed care decisions and
coordinate the care they provide. Electronic health records and the
electronic exchange of health information, either directly or through
health information exchanges, can reduce the burden of such
communication. The purpose of this objective is to ensure a summary of
care record is transmitted or captured electronically and incorporated
into the EHR for patients seeking care among
[[Page 16759]]
different providers in the care continuum, and to encourage
reconciliation of health information for the patient. This objective
promotes interoperable systems and supports the use of CEHRT to share
information among care teams.
Proposed Objective: The EP, eligible hospital, or CAH provides a
summary of care record when transitioning or referring their patient to
another setting of care, retrieves a summary of care record upon the
first patient encounter with a new patient, and incorporates summary of
care information from other providers into their EHR using the
functions of certified EHR technology.
In the Stage 2 final rule at 77 FR 53983, we described transitions
of care as the movement of a patient from one setting of care
(hospital, ambulatory primary care practice, ambulatory specialty care
practice, long-term care, home health, rehabilitation facility) to
another. Referrals are cases where one provider refers a patient to
another provider, but the referring provider also continues to provide
care to the patient. In this rule, we also recognize there may be
circumstances when a patient refers himself or herself to a setting of
care without a provider's prior knowledge or intervention. These
referrals may be included as a subset of the existing referral
framework and they are an important part of the care coordination loop
for which summary of care record exchange is integral. Therefore, a
provider should include these instances in their denominator for the
measures if the patient subsequently identifies the provider from whom
they received care. In addition, the provider may count such a referral
in the numerator for each measure if they undertake the action required
to meet the measure upon disclosure and identification of the provider
from whom the patient received care.
In the Stage 2 final rule, we indicated that a transition or
referral within a single setting of care does not qualify as a
transition of care (77 FR 53983). We received public comments and
questions requesting clearer characterization of when a setting of care
can be considered distinct from another setting of care. For example,
questions arose whether EPs who work within the same provider practice
are considered the same or two distinct settings of care. Similarly,
questions arose whether an EP who practices in an outpatient setting
that is affiliated with an inpatient facility is considered a separate
entity. Therefore, for the purposes of distinguishing settings of care
in determining the movement of a patient, we explain that for a
transition or referral, it must take place between providers which
have, at the minimum, different billing identities within the EHR
Incentive Programs, such as a different National Provider Identifiers
(NPI) or hospital CMS Certification Numbers (CCN) to count toward this
objective.
Please note that a ``referral'' as defined here and elsewhere in
this proposed rule only applies to the EHR Incentive Programs and is
not applicable to other federal regulations.
We stated in the Stage 2 proposed rule at 77 FR 13723 that if the
receiving provider has access to the medical record maintained by the
provider initiating the transition or referral, then the summary of
care record would not need to be provided and that patient may be
excluded from the denominators of the measures for the objective. We
further note that this access may vary from read-only access of a
specific record, to full access with authoring capabilities, depending
on provider agreements and system implementation among practice
settings. In many cases, a clinical care summary for transfers within
organizations sharing access to an EHR may not be necessary, such as a
hospital sharing their CEHRT with affiliated providers in ambulatory
settings who have full access to the patient information. However,
public comments received and questions submitted by the public on the
Stage 2 Summary of Care Objective reveal that there may be benefits to
the provision of a summary of care document following a transition or
referral of a patient, even when access to medical records is already
available. For example, a summary of care document would notify the
receiving provider of relevant information about the latest patient
encounter as well as highlight the most up-to-date information. In
addition, the ``push'' of a summary of care document may function as an
alert to the recipient provider of the transition that a patient has
received care elsewhere and would encourage the provider to review a
patient's medical record for follow-up care or reconciliation of
clinical information.
Therefore, we are revising this objective for Stage 3 to allow the
inclusion of transitions of care and referrals in which the recipient
provider may already have access to the medical record maintained in
the referring provider's CEHRT, as long as the providers have different
billing identities within the EHR Incentive Program. We note that for a
transition or referral to be included in the numerator, if the
receiving provider already has access to the CEHRT of the initiating
provider of the transition or referral, simply accessing the patient's
health information does not count toward meeting this objective.
However, if the initiating provider also sends a summary of care
document, this transition can be included in the denominator and the
numerator, as long as this transition is counted consistently across
the organization.
Proposed Measures: We are proposing that providers must attest to
the numerator and denominator for all three measures, but would only be
required to successfully meet the threshold for two of the three
proposed measures to meet the Health Information Exchange Objective.
Proposed Measure 1: For more than 50 percent of transitions of care
and referrals, the EP, eligible hospital or CAH that transitions or
refers their patient to another setting of care or provider of care:
(1) creates a summary of care record using CEHRT; and (2)
electronically exchanges the summary of care record.
Proposed Measure 2: For more than 40 percent of transitions or
referrals received and patient encounters in which the provider has
never before encountered the patient, the EP, eligible hospital or CAH
incorporates into the patient's EHR an electronic summary of care
document from a source other than the provider's EHR system.
Proposed Measure 3: For more than 80 percent of transitions or
referrals received and patient encounters in which the provider has
never before encountered the patient, the EP, eligible hospital, or CAH
performs a clinical information reconciliation. The provider must
implement clinical information reconciliation for the following three
clinical information sets:
Medication. Review of the patient's medication, including
the name, dosage, frequency, and route of each medication.
Medication allergy. Review of the patient's known allergic
medications.
Current Problem list. Review of the patient's current and
active diagnoses.
For the first measure, we are maintaining the requirements
established in the Stage 2 final rule to capture structured data within
the certified EHR and to generate a summary of care document using
CEHRT for purposes of this measure (77 FR 54014). For purposes of this
measure, we are requiring that the summary of care document created by
CEHRT be sent electronically to the receiving provider.
In the Stage 2 final rule at 77 FR 54016, we specified all summary
of care documents must include the following
[[Page 16760]]
information in order to meet the objective, if the provider knows it:
Patient name.
Referring or transitioning provider's name and office
contact information (EP only).
Procedures.
Encounter diagnosis.
Immunizations.
Laboratory test results.
Vital signs (height, weight, blood pressure, BMI).
Smoking status.
Functional status, including activities of daily living,
cognitive and disability status.
Demographic information (preferred language, sex, race,
ethnicity, date of birth).
Care plan field, including goals and instructions.
Care team including the primary care provider of record
and any additional known care team members beyond the referring or
transitioning provider and the receiving provider.
Discharge instructions (Hospital Only).
Reason for referral (EP only).
For the 2015 Edition proposed rule, ONC has proposed a set of
criteria called the Common Clinical Data Set which include the required
elements for the summary of care document, the standards required for
structured data capture of each, and further definition of related
terminology and use. Therefore, for Stage 3 of meaningful use we are
proposing that summary of care documents used to meet the Stage 3
Health Information Exchange objective must include the requirements and
specifications included in the Common Clinical Data Set (CCDS)
specified by ONC for certification to the 2015 Edition proposed rule
published elsewhere in this issue of the Federal Register.
We note that ONC's 2015 Edition proposed rule may include
additional fields beyond those initially required for Stage 2 of
meaningful use as new standards have been developed to accurately
capture vital information on patient health. For example, the 2015
Edition proposed rule includes a criterion and standard for capturing
the unique device identifier (UDI) for implantable medical devices. The
inclusion of the UDI in the CCDS reflects the understanding that UDIs
are an important part of patient information that should be exchanged
and available to providers who care for patients with implanted medical
devices. Hundreds of thousands of Medicare beneficiaries receive some
type of implantable medical device each year. Some implants require
ongoing monitoring and medication for the device to perform
effectively, such as a mechanical heart valve. Other implanted devices
are affected by imaging procedures and are not MRI safe such as some
pace makers. Even the variation between specific makes and models of
similar devices may impact the clinical processes required to mitigate
against patient safety risk. Without readily available data, the
patient is put at risk if the provider does not have adequate knowledge
of the existence and specific details of medical implants. Therefore,
the documentation of UDIs in a patient medical record and the inclusion
of that data field within the CCDS requirements for the summary of care
documents is a key step toward improving the quality of care and
ensuring patient safety. This example highlights the importance of
capturing health data in a structured format using specified,
transferable standards.
In circumstances where there is no information available to
populate one or more of the fields included in the CCDS, either because
the EP, eligible hospital, or CAH can be excluded from recording such
information (for example, vital signs) or because there is no
information to record (for example, laboratory tests), the EP, eligible
hospital, or CAH may leave the field blank and still meet the
requirements for the measure.
However, all summary of care documents used to meet this objective
must be populated with the following information using the CCDS
certification standards for those fields:
Current problem list (Providers may also include
historical problems at their discretion).
A current medication list.
A current medication allergy list.
We define allergy as an exaggerated immune response or reaction to
substances that are generally not harmful. Information on problems,
medications, and medication allergies could be obtained from previous
records, transfer of information from other providers (directly or
indirectly), diagnoses made by the EP or hospital, new medications
ordered by the EP or in the hospital, or through querying the patient.
We propose to maintain that all summary of care documents contain
the most recent and up-to-date information on all elements. In the
event that there are no current diagnoses for a patient, the patient is
not currently taking any medications, or the patient has no known
medication allergies; the EP, eligible hospital, or CAH must record or
document within the required fields that there are no problems, no
medications, or no medication allergies recorded for the patient to
satisfy the measure of this objective. The EP or hospital must verify
that the fields for problem list, medication list, and medication
allergy list are not blank and include the most recent information
known by the EP or hospital as of the time of generating the summary of
care document.
For summary of care documents at transitions of care, we encourage
providers to send a list of items that he or she believes to be
pertinent and relevant to the patient's care, rather than a list of all
problems, whether active or resolved, that have ever populated the
problem list. While a current problem list must always be included, the
provider can use his or her judgment in deciding which items
historically present on the problem list, medical history list (if it
exists in CEHRT), or surgical history list are relevant given the
clinical circumstances.
Similarly, for Stage 3 we have received comments from stakeholders
and through public forums and correspondence on the potential of
allowing only clinically relevant laboratory test results and clinical
notes (rather than all laboratory tests results and clinical notes) in
the summary of care document for purposes of meeting the objective. We
believe that while there may be a benefit and efficiency to be gained
in the potential to limit laboratory test results or clinical notes to
those most relevant for a patient's care; a single definition of
clinical relevance may not be appropriate for all providers, all
settings, or all individual patient diagnosis. Furthermore, we note
that should a reasonable limitation around a concept of ``clinical
relevance'' be added; a provider must still have the CEHRT
functionality to include and send all labs or clinical notes.
Therefore, we defer to provider discretion on the circumstances and
cases wherein a limitation around clinical relevance may be beneficial
and note that such a limitation would be incumbent on the provider to
define and develop in partnership with their health IT developer as
best fits their organizational needs and patient population. We specify
that while the provider has the discretion to define the relevant
clinical notes or relevant laboratory results to send as part of the
summary of care record, providers must be able to provide all clinical
notes or laboratory results through an electronic transmission of a
summary of care document if that level of detail is subsequently
requested by a provider receiving a transition of care or referral or
the patient is transitioning to another setting of care. We note that
this proposal would apply for lab results,
[[Page 16761]]
clinical notes, problem lists, and the care plan within the summary of
care document.
For the second measure, we are proposing to address the other end
of the transition of care continuum. In the Stage 2 rule, we limited
the action required by providers to sending an electronic transmission
of a summary of care document. We did not have a related requirement
for the recipient of that transmission. We did not adopt a
certification requirement for the receiving end of a transition or
referral or for the measure related to sending the summary, as that is
a factor outside the sending provider's immediate control. However, in
Stage 3 of meaningful use, we are proposing a measure for the provider
as the recipient of a transition or referral requiring them to actively
seek to incorporate an electronic summary of care document into the
patient record when a patient is referred to them or otherwise
transferred into their care. This proposal is designed to complete the
electronic transmission loop and support providers in using CEHRT to
support the multiple roles a provider plays in meaningful health
information exchange.
For the purposes of defining the cases in the denominator, we are
proposing that what constitutes ``unavailable'' and therefore, may be
excluded from the denominator, will be that a provider--
Requested an electronic summary of care record to be sent
and did not receive an electronic summary of care document; and
Queried at least one external source via HIE functionality
and did not locate a summary of care for the patient, or the provider
does not have access to HIE functionality to support such a query.
We seek comment on whether electronic alerts received by EPs from
hospitals when a patient is admitted, seen in the emergency room or
discharged from the hospital--so called ``utilization alerts''--should
be included in measure two, or as a separate measure. Use of this form
of health information exchange is increasingly rapidly, driven by
hospital and EP efforts to improve care transitions and reduce
readmissions. We also seek comment on which information from a
utilization alert would typically be incorporated into a patient's
record and how this is done today.
For both the first and second measures, we are proposing that a
provider may use a wide range of health IT system for health
information exchange to receive or send an electronic summary of care
document, but must use their certified EHR technology to create the
summary of care document sent or to incorporate the summary of care
document received into the patient record. We are also proposing that
the receipt of the summary of care document (CCDA) may be passive
(provider is sent the CCDA and incorporates it) or active (provider
requests a direct transfer of the CCDA or provider queries an HIE for
the CCDA). In the Stage 2 proposed rule, we noted the benefits of
requiring standards for the transport mechanism for health information
exchange consistently nationwide (77 FR 13723). We requested public
comment in that proposed rule on the Nationwide Health Information
Network specifications and a governance mechanism for health
information exchange to be established by ONC. In the final rule, a
governance mechanism option was included in the second measure for the
Stage 2 summary of care objective at 77 FR 54020. In this Stage 3
proposed rule, we again seek comment on a health information exchange
governance mechanism. Specifically we seek comment on whether providers
who create a summary of care record using CEHRT for purposes of Measure
1 should be permitted to send the created summary of care record
either--(1) through any electronic means; or (2) in a manner that is
consistent with the governance mechanism ONC establishes for the
nationwide health information network. We additionally seek comment on
whether providers who are receiving a summary of care record using
CEHRT for the purposes of Measure 2 should have a similar requirement
for the transport of summary of care documents requested from a
transitioning provider. Finally, we seek comment on how a governance
mechanism established by ONC at a later date could be incorporated into
the EHR Incentive Programs for purposes of encouraging interoperable
exchange that benefits patients and providers, including how the
governance mechanism should be captured in the numerator, denominator,
and thresholds for both the first (send) and second (receive) measures
of this Health Information exchange objective.
For the third measure, we are proposing a measure of clinical
information reconciliation which incorporates the Stage 2 objective for
medication reconciliation and expands the options to allow for the
reconciliation of other clinical information such as medication
allergies, and problems which will allow providers additional
flexibility in meeting the measure in a way that is relevant to their
scope of practice. In the Stage 2 final rule, we outlined the benefits
of medication reconciliation, which enables providers to validate that
the patient's list of active medications is accurate (77 FR 54011
through 54012). This activity improves patient safety, improves care
quality, and improves the validity of information that the provider
shares with others through health information exchange. We believe that
reconciliation of medication allergies and problems affords similar
benefits.
For this proposed measure, we specify that the EP, eligible
hospital, or CAH that receives the patient into their care should
conduct the clinical information reconciliation. It is for the
receiving provider that up-to-date information will be most crucial to
make informed clinical judgments for patient care. We reiterate that
this measure does not dictate what subset of information must be
included in reconciliation. Information included in the process is
determined by the provider's clinical judgment of what is most relevant
to patient care.
For this measure, we propose to define clinical information
reconciliation as the process of creating the most accurate patient-
specific information in one or more of the specified categories by
using the clinical information reconciliation capability of their
certified EHR technology which will compare the ``local'' information
to external/incoming information that is being incorporated into the
certified EHR technology from any external source. We refer providers
to the standards and certification criteria for clinical information
reconciliation proposed in ONC's 2015 Edition proposed rule published
elsewhere in this issue of the Federal Register.
As with medication reconciliation, we believe that an electronic
exchange of information following the transition of care of a patient
is the most efficient method of performing clinical information
reconciliation.
We recognize that workflows to reconcile clinical information vary
widely across providers and settings of care, and we request comment on
the challenges that this objective might present for providers, and how
such challenges might be mitigated, while preserving the policy intent
of the measure. In particular, we solicit comment on the following:
Automation and Manual Reconciliation. The Stage 2 measure
does not specify whether reconciliation must be automated or manual.
Some providers have expressed concern over the automatic inclusion of
data in the patient record from referring providers, while others have
indicated that
[[Page 16762]]
requiring manual reconciliation imposes significant workflow burden. We
also seek comment on whether the use and display of meta-tagged data
could address concerns related to the origin of data and thereby permit
more automated reconciliation of these data elements.
Review of Reconciled Information. Depending on clinical
setting, this measure could be accomplished through manual
reconciliation or through automated functionality. In either scenario,
should the reconciliation or review of automated functionality be
performed only by the same staff allowed under the Stage 3 requirements
for the Computerized Provider Order Entry objective?
What impact would the requirement of clinical information
reconciliation have on workflow for specialists? Are there particular
specialties where this measure would be difficult to meet?
What additional exclusions, if any, should be considered
for this measure?
We also encourage comment on the proposal to require reconciliation
of all three clinical information reconciliation data sets, or if we
should potentially require providers to choose 2 of 3 information
reconciliation data sets relevant to their specialty or patient
population. We expect that most providers would find that conducting
clinical information reconciliation for medications, medication
allergies, and problem lists is relevant for every patient encountered.
We solicit examples describing challenges and burdens that providers
who deliver specialist care or employ unique clinical workflow
practices may experience in completing clinical information
reconciliation for all three data sets and whether an exclusion should
be considered for providers for whom such reconciliation may not be
relevant to their scope of practice or patient population.
Additionally, we solicit comments around the necessity to conduct
different types of clinical information reconciliation of data for each
individual patient. For example, it is possible that the data for
certain patients should always be reviewed for medication allergy
reconciliation, when it may not be as relevant to other patient
populations.
We propose that to meet this objective, a provider must attest to
the numerator and denominator for all three measures but would only be
required to successfully meet the threshold for two of the three
proposed measures. We invite public comment on this proposal.
Measure 1: To calculate the percentage of the first measure, CMS
and ONC have worked together to define the following for this measure:
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 exchanged electronically.
Threshold: The percentage must be more than 50 percent in order for
an EP, eligible hospital, or CAH to meet this measure.
Exclusion: An EP neither transfers a patient to another setting nor
refers a patient to another provider during the EHR reporting period.
* Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude the measures.
Any eligible hospital or CAH will be excluded from the measure if
it is located in a county that does not have 50 percent or more of
their housing units with 4Mbps broadband availability according to the
latest information available from the FCC at the start of the EHR
reporting period.
Measure 2: To calculate the percentage of the second measure, CMS
and ONC have worked together to define the following for this measure:
Denominator: Number of patient encounters during the EHR reporting
period for which an EP, eligible hospital, or CAH was the receiving
party of a transition or referral or has never before encountered the
patient and for which an electronic summary of care record is
available.
Numerator: Number of patient encounters in the denominator where an
electronic summary of care record received is incorporated by the
provider into the certified EHR technology.
Threshold: The percentage must be more than 40 percent in order for
an EP, eligible hospital, or CAH to meet this measure.
Exclusion: Any EP, eligible hospital or CAH for whom the total of
transitions or referrals received and patient encounters in which the
provider has never before encountered the patient, is fewer than 100
during the EHR reporting period is excluded from this measure.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude the measures.
Any eligible hospital or CAH will be excluded from the measure if
it is located in a county that does not have 50 percent or more of
their housing units with 4Mbps broadband availability according to the
latest information available from the FCC at the start of the EHR
reporting period.
Measure 3: To calculate the percentage, CMS and ONC have worked
together to define the following for this measure:
Denominator: Number of transitions of care or 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 recipient of
the transition or referral or has never before encountered the patient.
Numerator: The number of transitions of care or referrals in the
denominator where the following three clinical information
reconciliations were performed: medication list, medication allergy
list, and current problem list.
Threshold: The resulting percentage must be more than 80 percent in
order for an EP, eligible hospital, or CAH to meet this measure.
Exclusion: Any EP, eligible hospital or CAH for whom the total of
transitions or referrals received and patient encounters in which the
provider has never before encountered the patient, is fewer than 100
during the EHR reporting period is excluded from this measure.
Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude the measure.
Any eligible hospital or CAH will be excluded from the measure if
it is located in a county that does not have 50 percent or more of
their housing units with 4Mbps broadband availability according to the
latest information available from the FCC at the start of the EHR
reporting period.
We welcome comment on these proposals.
Objective 8: Public Health and Clinical Data Registry Reporting
[[Page 16763]]
This objective builds on the requirements set forth in the Stage 2
final rule (77 FR 54021 through 54026). In addition, this objective
includes improvements to the Stage 2 measures, supports innovation that
has occurred since the Stage 2 rule was released, and adds flexibility
in the options that an eligible provider has to successfully report.
Further, this objective places increased focus on the importance of
the ongoing lines of communication that should exist between providers
and public health agencies (PHAs) or as further discussed later in this
section, between providers and clinical data registries (CDRs).
Providers' use of certified EHR technology can increase the flow of
secure health information and reduce the burden that otherwise could
attach to these important communications. The purpose of this Stage 3
objective is to further advance communication between providers and
PHAs or CDRs, as well as strengthen the capture and transmission of
such health information within the care continuum.
In this Stage 3 proposed rule, we are proposing 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. We propose to include a new measure for case
reporting to reflect the diverse ways that providers can electronically
exchange data with PHAs and CDRs. In addition, we are using new terms
such as public health registries and clinical data registries to
incorporate the Stage 2 designations for cancer registries and
specialized registries under these categories which are used in the
health care industry to designate a broader range of registry types. We
further explain the use of these terms within the specifications
outlined for each applicable measure.
Proposed Objective: The EP, eligible hospital, or CAH is in active
engagement with a PHA or 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.
For Stage 3, we are proposing to remove the prior ``ongoing
submission'' requirement and replace it with an ``active engagement''
requirement. Depending on the measure, the ongoing submission
requirement from the Stage 1 and Stage 2 final rules required the
successful ongoing submission of applicable data from certified EHR
technology to a PHA or CDR for the entire EHR reporting period. As part
of the Stage 2 final rule, we provided examples demonstrating how
ongoing submission could satisfy the measure (77 FR 54021). However,
stakeholders noted that the ongoing submission requirement does not
accurately capture the nature of communication between providers and a
PHA or CDR, and does not consider the many steps necessary to arrange
for registry submission to a PHA or CDR. Given this feedback, we
believe that ``active engagement'' as defined later in this section is
more aligned with the process providers undertake to report to a CDR 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 also propose to provide support to providers seeking to meet the
requirements of this objective by creating a centralized repository of
national, state, and local PHA and CDR readiness. In the Stage 2 final
rule (77 FR 54021), we noted the benefits of developing a centralized
repository where a PHA could post readiness updates regarding their
ability to accept electronic data using specifications prescribed by
ONC for the public health objectives. We also published, pursuant to
the Paperwork Reduction Act of 1995, a notice in the Federal Register
on February 7, 2014 soliciting public comment on the proposed
information collection required to develop the centralized repository
on public health readiness (79 FR 7461). We considered the comments and
we now propose moving forward with the development of the centralized
repository. The centralized repository is integral to meaningful use
and is expected to be available by the start of CY 2017. We expect that
the centralized repository will include readiness updates for PHAs and
CDRs at the state, local, and national level. We welcome your comments
on the use and structure of the centralized repository.
Proposed Measures: We are proposing a total of six possible
measures for this objective. EPs would be required to choose from
measures 1 through 5, and would be required to successfully attest to
any combination of three measures. Eligible hospitals and CAHs would be
required to choose from measures one through six, and would be required
to successfully attest to any combination of four measures. The
measures are as shown in Table 5. As noted, measures four and five 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 16764]]
Table 5--Measures for Objective 8: Public Health And Clinical Data
Registry Reporting Objective
------------------------------------------------------------------------
Maximum times
Maximum times measure can
measure can count towards
Measure count towards objective for
objective for eligible
EP hospital or
CAH
------------------------------------------------------------------------
Measure 1--Immunization Registry 1 1
Reporting..............................
Measure 2--Syndromic Surveillance 1 1
Reporting..............................
Measure 3--Case Reporting............... 1 1
Measure 4--Public Health Registry 3 4
Reporting*.............................
Measure 5--Clinical Data Registry 3 4
Reporting**............................
Measure 6--Electronic Reportable N/A 1
Laboratory Results.....................
------------------------------------------------------------------------
* EPs, eligible hospitals, and CAHs may choose to report to more than
one public health registry 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 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 three measures. Instead, in order to meet this
objective, an EP would need to meet three 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
three, the EP can meet the objective by meeting all of the remaining
measures available to them and claiming the applicable exclusions.
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 four measures. Instead, in
order to meet this objective an eligible hospital or CAH would need to
meet four 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 four, the eligible hospital or CAH can meet the
objective by meeting all of the remaining measures available to them
and claiming the applicable exclusions. 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 will aid the
provider's ability to care for their patients.
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 Stage 3 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 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
published by ONC elsewhere in this issue of the Federal Register, 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 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 for Measure 1: 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: (1) 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; (2) 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; or (3) operates in a
jurisdiction where no immunization registry or immunization information
system has declared readiness to receive immunization data 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
Stage 3 because electronic syndromic surveillance is valuable for early
detection of outbreaks, as well as monitoring disease and condition
trends. We are
[[Page 16765]]
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 later in this
section.
Exclusion for EPs for Measure 2: Any EP meeting one or more of the
following criteria may be excluded from the syndromic surveillance
reporting measure if the EP: (1) Does not treat or diagnose or directly
treat any disease or condition associated with a syndromic surveillance
system in their jurisdiction; (2) 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 (3)
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 for Measure 2: 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: (1) Does not have an emergency or urgent care
department; (2) 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
(3) 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. However, electronic case reporting
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 will 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, published elsewhere in this issue of the Federal
Register.
Exclusion for Measure 3: 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: (1) 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; (2) 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 (3) 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 reponses to the February 2014
Public Health Reporting RFI; 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 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 will 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 final rule ``2014 Edition, Release 2 EHR
Certification Criteria and the ONC HIT Certification Program;
Regulatory Flexibilities, Improvements, and Enhanced Health Information
Exchange'' (79 FR 54468) and we 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
[[Page 16766]]
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 registry 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. We note that cancer case reporting is not an option for
eligible hospitals and CAHs under this measure because hospitals have
traditionally diagnosed or treated cancers and have the infrastructure
needed to report cancer cases.
Exclusions for Measure 4: 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:
(1) Does not diagnose or directly treat any disease or condition
associated with a public health registry in their jurisdiction during
the EHR reporting period; (2) 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 (3) 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.\12\ 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.
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\12\ https://download.ama-assn.org/resources/doc/cqi/x-pub/nqrn-what-is-clinical-data-registry.pdf.
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As noted previously, we reiterate that any EP, eligible hospital,
or CAH may report to more than one clinical data registry to meet the
total number of required measures for this objective. ONC will 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.
Exclusions for Measure 5: 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: (1) Does not diagnose or directly treat any disease or
condition associated with a clinical data registry in their
jurisdiction during the EHR reporting period; (2) 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 (3) 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 Stage 3 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 for Measure 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 if the eligible hospital
or CAH: (1) Does not perform or order laboratory tests that are
reportable in their jurisdiction during the EHR reporting period; (2)
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 (3) operates in
a jurisdiction where no public health agency has declared readiness to
receive electronic reportable laboratory results from an eligible
hospital or CAH at the start of the EHR reporting period.
The Use of CEHRT for the Public Health and Clinical Data Registry
Reporting Objective
As proposed previously, the Public Health and Clinical Data
Registry Reporting objective requires active engagement with a public
health agency to submit electronic public health data from certified
EHR technology. ONC defined the standards and certification criteria to
meet the definition of CEHRT in its 2011, 2014, and 2014 Release 2
Edition EHR certification criteria rules (see section II.B. of the
``2014 Edition, Release 2 EHR Certification Criteria and the ONC HIT
Certification Program; Regulatory Flexibilities, Improvements, and
Enhanced Health Information Exchange'' for a full description of ONC's
regulatory history; (79 FR 54434)). For example, ONC adopted standards
for immunization reporting (see Sec. 170.314(f)(1) and (f)(2)),
inpatient syndromic surveillance (see Sec. 170.314(f)(3) and (f)(7)),
ELR (see Sec. 170.314(f)(4)), and cancer case reporting (see Sec.
170.314(f)(5) and (f)(6)) in its 2014 Edition final rule.
We support ONC's intent to promote standardized and interoperable
exchange of public health data across the country. Therefore, to meet
all of the measures within this public health objective EPs, eligible
hospitals, and CAHs must use CEHRT as we propose to define it under
Sec. 495.4 in this proposed rule and use the standards included in the
2015 Edition proposed rule published elsewhere in this edition of the
Federal Register. We anticipate that as new public health registries
and clinical data registries are created, ONC and CMS will work with
the public health community and clinical specialty societies to develop
ONC-certified
[[Page 16767]]
electronic reporting standards for those registries so that providers
have the option to count participation in those registries under the
measures of this objective. ONC will look to adopt such standards, as
appropriate, in future rules published by ONC.
We welcome public comment on these proposals.
II. Provisions of the Proposed Regulations
A. Meaningful Use Requirements, Objectives and Measures
2. Certified EHR Technology (CEHRT) Requirements
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 under 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 under 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).
On September 4, 2014, CMS and ONC published a final rule in the
Federal Register (79 FR 52910 through 52933) that, among other things,
modified the meaningful use requirements for 2014 and the CEHRT
definition.
First, we granted flexibility to providers who experienced product
availability issues that affected their ability to fully implement EHR
technology certified to the 2014 Edition of certification criteria (79
FR 52913 through 52926). We allowed those EPs, eligible hospitals, and
CAHs to continue using either EHR technology certified to the 2011
Edition, or a combination of EHR technology certified to the 2011
Edition and 2014 Edition, for the EHR reporting periods in CY 2014 and
FY 2014. EPs, eligible hospitals, and CAHs could take one of these
approaches if they were unable to fully implement EHR technology
certified to the 2014 Edition for an EHR reporting period in 2014 due
to delays in the availability of EHR technology certified to the 2014
Edition.
Second, we established that in order to receive an incentive
payment for 2014 under Medicaid for adopting, implementing, or
upgrading CEHRT, a provider must adopt, implement, or upgrade to EHR
technology certified to the 2014 Edition and meet the CEHRT definition
(79 FR 52925 through 52926).
Finally, ONC revised the CEHRT definition under 45 CFR 170.102 to
align with our policy allowing for the use of EHR technology certified
to the 2011 Edition, or a combination of EHR technology certified to
the 2011 Edition and 2014 Edition, in 2014 (79 FR 52930).
For further detail on the changes to the requirements for 2014 and
CEHRT definition, we refer readers to the 2014 CEHRT Flexibility final
rule (79 FR 52910 through 52933).
a. CEHRT Definition for the EHR Incentive Programs
As we have stated previously in rulemaking, the statute and
regulations require EPs, eligible hospitals, and CAHs to use
``Certified EHR Technology'' if they are to be considered meaningful
EHR users and eligible for incentive payments under Medicare or
Medicaid, and to avoid payment adjustments under Medicare (for example,
see section 1848(o)(2)(A)(i) of the Act, and 42 CFR 495.4). However, in
contrast to prior rulemaking cycles where ONC has established a
meaningful-use-specific CEHRT definition for the EHR Incentive Programs
that CMS has adopted by cross-reference under 42 CFR 495.4, we propose
to take a different approach under which we would define the term
``Certified EHR Technology,'' and that definition would be specific to
the EHR Incentive Programs.
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 EHR Incentive Programs is clearly
referenced in CMS regulations. For example, ONC's definition of CEHRT
under 45 CFR 170.102 includes the compliance dates for EPs, eligible
hospitals, and CAHs to use EHR technology certified to a particular
edition of certification criteria to meet the CEHRT definition and for
purposes of the EHR Incentive Programs, such as the requirement to use
EHR technology certified to the 2014 Edition beginning in 2015. Under
the proposed new approach, we would establish through rulemaking for
the EHR Incentive Programs (either with stand-alone rulemaking or
through other vehicles such as the annual Medicare payment rules) the
compliance dates by which providers must use EHR technology certified
to a particular edition of certification criteria to meet the CEHRT
definition, which would be reflected in our regulations under 42 CFR
part 495 rather than ONC's regulations under 45 CFR part 170.
b. Defining CEHRT for 2015 Through 2017 and for 2018 and Subsequent
Years
In adopting a CEHRT definition specific for the EHR Incentive
Programs, we propose to include, as currently for the ONC CEHRT
definition under 45 CFR 170.102, the relevant Base EHR definitions
adopted by ONC in 45 CFR 170.102 and other ONC certification criteria
relevant to the EHR Incentive Programs. We refer readers to ONC's 2015
Edition proposed rule published elsewhere in this issue of the Federal
Register for the proposed 2015 Edition Base EHR definition and
discussion of the 2014 Edition Base EHR definition. We are including
the Base EHR definition(s) because as ONC explained in the 2014 Edition
final rule ``2014 Edition, Release 2 EHR Certification Criteria and the
ONC HIT Certification Program; Regulatory Flexibilities, Improvements,
and Enhanced Health Information Exchange'' (77 FR 54443 through 54444)
the ``Base EHR'' essentially serves as a substitute for the term
``Qualified EHR'' in the definition of CEHRT. The term ``Qualified
EHR'' is defined in section 3000(13) of the PHSA, to include certain
capabilities listed in that section, and is included in the statutory
definition of ``certified EHR technology'' for the EHR Incentive
Programs (for example, see section 1848(o)(4) of the Act). The Base EHR
definition(s) also include additional capabilities as proposed by ONC
that we agree all providers should have that are participating in the
EHR Incentive Programs to support their attempts to meet meaningful use
objectives and measures as well as interoperable health information
exchange.
We propose to define the editions of certification criteria that
may be used for years 2015 through 2017 to meet the CEHRT definition.
At a minimum, EPs, eligible hospitals, and CAHs would be required to
use EHR technology certified to the 2014 Edition certification criteria
for their respective EHR reporting periods in 2015 through 2017. A
provider may also upgrade to the 2015 Edition prior to 2018 to meet the
required certified EHR technology definition for the EHR reporting
periods in 2015, 2016, or 2017, or they may use a combination of 2014
and 2015 Editions prior to 2018 if they have modules from both Editions
which meet the requirements for the objectives and measures or if they
fully upgrade during an EHR reporting period.
[[Page 16768]]
Based on experience with delays in the availability of EHR
technology certified to the 2014 Edition for providers to implement and
use to meet meaningful use for an EHR reporting period in 2014, we
propose to include as part of the CEHRT definition a longer period of
time for providers to use technology certified to the 2014 Edition in
an effort to give providers more time in updating their technology to
the 2015 Edition before the EHR reporting period in 2018. We also
propose to make the use of a combination of technology certified to the
2014 Edition and 2015 Edition to meet the CEHRT definition more
flexible in 2015 through 2017 by taking into account ONC's proposed new
privacy and security certification approach for health IT (see ONC's
2015 Edition proposed rule published elsewhere in this issue of the
Federal Register). Specifically, as a provider updates to technology
certified to the 2015 Edition, the provider would not necessarily need
to continue to meet the privacy and security capability requirements of
the 2014 Edition Base EHR definition because the technology they adopt
certified to the 2015 Edition would include necessary privacy and
security capabilities. Additionally, because ONC is proposing, for the
2015 Edition, to no longer require certification of Health IT Modules
to capabilities that support meaningful use objectives with percentage-
based measures, we propose to include these capabilities (45 CFR
170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2)), as applicable, in
the CEHRT definition for 2015 through 2017 so that providers have
technology that can appropriately record and calculate meaningful use
measures. We note that there are many combinations of 2014 and 2015
Edition certified technologies that could be used to successfully meet
the transitions of care requirements included in the 2014 and 2015
Edition Base EHR definitions for the purposes of meeting meaningful use
objectives and measures. We believe we have identified all combinations
in the proposed regulation text under Sec. 495.4 that could be used to
meet the CEHRT definition through 2017 and be used for the purposes of
meeting meaningful use objectives and measures. We welcome comments on
the accuracy of the identified available options.
We propose that starting with 2018, all EPs, eligible hospitals,
and CAHs would be required to use technology certified to the 2015
Edition to meet the CEHRT definition and demonstrate meaningful use for
an EHR reporting period in 2018 and subsequent years. The CEHRT
definition would include, for the reasons discussed previously, meeting
the 2015 Edition Base EHR definition and having other important
capabilities, that include the capabilities to--
Record or create and incorporate family health history;
Capture patient health information such as advance
directives;
Record numerators and denominators for meaningful use
objectives with percentage-based measures and calculate the
percentages;
Calculate and report clinical quality measures; and
Any other capabilities needed to be a Meaningful EHR User.
For information on 2015 Edition certification criteria that include
these capabilities and are associated with proposed Meaningful Use
objectives for Stage 3, please see the 2015 Edition proposed rule
published elsewhere in this issue of the Federal Register. We expect
that the certification criteria with capabilities that support CQM
calculation and reporting would be jointly proposed with CQM reporting
requirements in a separate rulemaking.
c. Proposed Definition for CEHRT
For the reasons stated previously, we propose to adopt a definition
of Certified EHR Technology under 42 CFR 495.4 for the Medicare and
Medicaid EHR Incentive Programs that would apply for the EHR reporting
periods in 2015 up to and including 2017 and for the EHR reporting
periods in 2018 and subsequent years. We refer readers to ONC's 2015
Edition proposed rule published elsewhere in this issue of the Federal
Register for further explanation of the concepts and terms used in our
proposed definition of Certified EHR Technology, including the 2014
Edition Base EHR definition, 2015 Edition Base EHR definition,
certification criteria, and the regulation text under 45 CFR part 170.
B. Reporting on Clinical Quality Measures Using Certified EHR
Technology by EPs, Eligible Hospitals, and Critical Access Hospitals
1. Clinical Quality Measure (CQM) Requirements for Meaningful Use in
2017 and Subsequent Years
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 regard to the selection of CQMs, we expect to continue to
include CQMs that align with the National Quality Strategy; as well as,
the our Quality Strategy. We also expect to consider programmatic goals
and outcome measures that would advance patient and population health.
a. Clinical Quality Measure Reporting Requirements for EPs
Section 1848(o)(2)(B)(iii) of the Act requires that in selecting
measures for EPs for the Medicare EHR Incentive Program, and in
establishing the form and manner of reporting, the Secretary shall seek
to avoid redundant or duplicative reporting, including reporting under
subsection (k)(2)(C) for the Physician Quality Reporting System (PQRS).
Consistent with that requirement, in the Stage 2 final rule, we
finalized a policy to align certain aspects of reporting CQMs for the
Medicare EHR Incentive Program for EPs with reporting under the PQRS.
Specifically, we stated that Medicare EPs who participate in both the
PQRS and the Medicare EHR Incentive Program will satisfy the CQM
reporting component of meaningful use if they submit and satisfactorily
report PQRS CQMs under the PQRS's EHR reporting option using CEHRT (77
FR 54058).
Section 1848(m)(7) of the Act requires the Secretary to develop a
plan to integrate reporting on quality measures under the PQRS with
reporting requirements under the Medicare EHR Incentive Program
relating to the meaningful use of electronic health records. Therefore,
it is our goal to align the reporting requirements for the CQM
component of meaningful use under the Medicare EHR Incentive Program
and for PQRS wherever possible. Historically, most requirements for the
Medicare and Medicaid EHR Incentive Programs have been established
through stand-alone rulemaking, such as the rules for Stage 1 (75 FR
44314 through 44588) and Stage 2 (77 FR 53968 through 54162), which
span multiple program years. This limited our ability to align the EHR
Incentive Program with the requirements established in the annual
Medicare payment rules for other CMS quality programs affecting
physicians and other EPs.
To further our goals of alignment and avoiding redundant or
duplicative reporting across the various CMS quality reporting
programs, we intend to address CQM reporting requirements for the
Medicare and Medicaid EHR Incentive Program for EPs for 2017 and
subsequent years in the Medicare Physician Fee Schedule (PFS)
rulemaking, which also establishes the requirements for PQRS and other
[[Page 16769]]
quality programs affecting EPs. We note that the form and manner of
reporting of CQMs for Medicare EPs would also be included in the PFS,
while for Medicaid we would continue to allow the states to determine
form and method requirements subject to CMS approval. We propose to
continue the policy of establishing certain CQM requirements that apply
for both the Medicare and Medicaid EHR Incentive Programs including a
common set of CQMs and the reporting periods for CQMs in the EHR
Incentive Programs. However, we believe that receiving and reviewing
public comments for various CMS quality programs at one time (for
example, EHR Incentive Program, PQRS, Physician Compare); and
finalizing the requirements for these programs simultaneously, would
allow us to better align these programs for EPs to support streamlined
reporting and program efficacy. We propose to continue to support
active communication with providers to facilitate the sharing of
information related to CQM selection and reporting, the announcement of
opportunities for public comment on CQM selection and reporting, and
upcoming or relevant CQM program milestones in partnership with state
Medicaid programs and the Medicare quality reporting programs. We
propose to continue to post the defined CQM sets and the published
electronic specifications for CQM that are in use for all aligned
programs on the CMS Web site as currently posted on the eCQM Library
page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html.
b. CQM Reporting Requirements for Eligible Hospitals and Critical
Access Hospitals
Section 1886(n)(3)(B)(iii) of the Act requires that, in selecting
measures for eligible hospitals for the Medicare EHR Incentive Program,
and establishing the form and manner for reporting measures, the
Secretary shall seek to avoid redundant or duplicative reporting with
reporting otherwise required, including reporting under section
1886(b)(3)(B)(viii) of the Act, the Hospital IQR Program.
Similar to our intentions for EPs discussed previously, and to
further our alignment goal among CMS quality reporting programs for
eligible hospitals and CAHs, and avoid redundant or duplicative
reporting among hospital programs, we intend to address CQM reporting
requirements for the Medicare and Medicaid EHR Incentive Program for
eligible hospitals and CAHs for 2016, 2017, and future years, in the
Inpatient Prospective Payment System (IPPS) rulemaking. IPPS rulemaking
also establishes the requirements for the Hospital IQR Program and
other quality programs affecting hospitals. We intend to include all
Medicare EHR Incentive Program requirements related to CQM reporting in
the IPPS rulemaking including, but not limited to, new program
requirements, reporting requirements, reporting and submission periods,
reporting methods, and information regarding the CQMs. As with EPs, for
the Medicaid EHR Incentive Program we would continue to allow the
states to determine form and method requirements subject to CMS
approval. However, as previously noted, this proposal would continue
the policy of establishing certain CQM requirements that apply for both
the Medicare and Medicaid EHR Incentive Programs including a common set
of CQMs and the reporting periods for CQMs in the EHR Incentive
Programs. We believe that receiving and reviewing public comments for
various CMS quality programs at one time and finalizing the
requirements for these programs simultaneously would allow us to better
align these programs for eligible hospitals and CAHs, allow more
flexibility into the Medicare and Medicaid EHR Incentive Programs, and
add overall value and consistency by providing us the opportunity to
address public comments that affect multiple programs at one time. We
propose to continue to support active communication with providers to
facilitate the sharing of information related to CQM selection and
reporting, the announcement of opportunities for public comment on CQM
selection and reporting, and upcoming or relevant CQM program
milestones in partnership with state Medicaid programs and the Medicare
quality reporting programs. We propose to continue to post the defined
CQM sets and the published electronic specifications for CQM that are
in use for all aligned programs on the CMS Web site as currently posted
on the eCQM Library page: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html.
2. CQM Reporting Period
In the Stage 2 final rule, we finalized a reporting period for CQMs
for EPs, eligible hospitals, and CAHs (see 77 FR 54049 through 54051).
In the FY 2015 IPPS final rule, we began to shift CQM reporting to a
calendar year basis for eligible hospitals and CAHs for the Medicare
EHR Incentive Program (79 FR 50319 through 50321). We established that
for eligible hospitals and CAHs that submit CQMs electronically in
2015, the reporting period is one calendar quarter from Q1, Q2, or Q3
of CY 2015 (79 FR 50321).
As discussed in sections II.A.1.c.(1).(b).(i). and II.F. of this
proposed rule, we are proposing to require an EHR reporting period of 1
full calendar year for meaningful use for providers participating in
the Medicare EHR Incentive Program, with a limited exception for
Medicaid providers demonstrating meaningful use for the first time. We
are proposing to require the same length for the CQM reporting period
for EPs, eligible hospitals, and CAHs beginning in 2017. As noted, we
are proposing a limited exception for Medicaid providers demonstrating
meaningful use for the first time who would have a CQM reporting period
of any continuous 90 days that is the same 90-day period as their EHR
Reporting Period.
We believe full year reporting would allow for the collection of
more comparable data across CMS quality programs and increase alignment
across those programs. The more robust data set provided by a full year
reporting period offers more opportunity for alignment than the data
set provided by a shorter reporting period, especially compared across
years. We further believe this full calendar year reporting period for
CQMs would reduce the complexity of reporting requirements for the
Medicare EHR Incentive Program by streamlining the reporting timeline
for providers for CQMs and meaningful use objectives and measures. We
welcome comment on the following proposals.
a. CQM Reporting Period for EPs
With the previously stated considerations in mind, and in an effort
to align with other CMS quality reporting programs such as the PQRS, we
propose to require for CQM reporting under the EHR Incentive Program a
reporting period of one full calendar year for all EPs participating in
the Medicare and Medicaid EHR Incentive Program, with a limited
exception for Medicaid providers demonstrating meaningful use for the
first time who would have a CQM reporting period of any continuous 90
days that is the same 90-day period as their EHR Reporting Period.
These reporting periods would apply beginning in CY 2017 for all EPs
participating in the EHR Incentive Program.
[[Page 16770]]
b. CQM Reporting Period for Eligible Hospital/CAH
For eligible hospitals and CAHs in 2017 and subsequent years, we
are proposing to require a reporting period of 1 full calendar year
which consists of 4 quarterly data reporting periods for providers
participating in the Medicare and Medicaid EHR Incentive Program, with
a limited exception for Medicaid providers demonstrating meaningful use
for the first time who would have a CQM reporting period of any
continuous 90 days that is the same 90-day period as their EHR
Reporting Period. More details of the form and manner will be provided
in the IPPS rulemaking cycle.
c. Reporting Flexibility EPs, Eligible Hospitals, CAHs 2017
In order to align with the flexibility option of participation in
Meaningful Use in 2017 (see section II.C.1.b. of this proposed rule),
we are proposing that EPs, eligible hospitals, and CAHs would be able
to have more flexibility to report CQMs in one of two ways in 2017--via
electronic reporting or attestation. First EPs, eligible hospitals, and
CAHs may choose to report eCQMs electronically using the CQMs finalized
for use in 2017 using the most recent version of the eCQMs (electronic
specifications), which would be the electronic specifications of the
CQMs published by CMS in 2016. Alternately, a provider may choose to
continue to attest also using the most recent (2016 version) eCQM
electronic specifications. We note that the intent to allow attestation
in 2017 is to provide flexibility for providers transitioning between
versions of CEHRT in 2017 and believe that requiring the most recent
version of the annual updates should not be a significant burden given
that developers do not need to recertify a product each time CQM
specifications are updated. However, we seek comment on if CMS should
consider allowing providers to report using another earlier version of
the specifications.
We note that, unlike the flexible options established in rulemaking
in 2014 (79 FR 52927 through 52930), providers may select the CQMs they
choose to report separately from the Stage objectives and measures of
meaningful use for their EHR reporting period in 2017.
We invite public comment on our proposals.
3. Reporting Methods for CQMs
In the Stage 2 final rule, we finalized the reporting methods for
CQMs for EPs (77 FR 54075 through 54078), eligible hospitals, and CAHs
(77 FR 54087 through 54089) for the Medicare EHR Incentive Program,
which included reporting electronically, where feasible, or by
attestation. To further align the Medicare and Medicaid EHR Incentive
Programs with programs such as PQRS and the Hospital IQR program,
starting in 2017, we propose to continue to encourage electronic
submission of CQM data for all EPs, eligible hospitals, and CAHs where
feasible; however, as outlined in section II.C.1.b. of this proposed
rule, we would allow attestation for CQMs in 2017. For 2018 and
subsequent years, we are proposing that providers participating in the
Medicare program must electronically report where feasible and that
attestation to CQMs would no longer be an option except in certain
circumstances where electronic reporting is not feasible. This would
include providers facing circumstances which render them unable to
electronically report (such as a data submission system failure,
natural disaster, or certification issue outside the control of the
provider) who may attest to CQMs if they also attest that
electronically reporting was not feasible for their demonstration of
meaningful use for a given year. We believe that the collection and
electronic reporting of data through health information technology
would greatly simplify and streamline reporting for many CMS quality
reporting programs and reduce the burden of quality measure reporting
for providers who participate in these programs. We also believe this
would further encourage the adoption and use of certified EHR
technology by allowing EPs, eligible hospitals, and CAHs to report data
for multiple programs through a single electronic submission. Through
electronic reporting, EPs, eligible hospitals, and CAHs would be able
to leverage EHRs to capture, calculate, and electronically submit
quality data to CMS for the Medicare EHR Incentive Program. We note
that we intend to address the form and manner of electronic reporting
in future Medicare payment rules.
For the Medicaid EHR Incentive Program, as in the Stage 2
rulemaking (77 FR 54089), we propose that states would continue in
Stage 3 to be responsible for determining whether and how electronic
reporting of CQMs would occur, or whether they wish to continue to
allow reporting through attestation. If a state does require such
electronic reporting, the state is responsible for sharing the details
of the process with its provider community. We anticipate that whatever
means states have deployed for capturing CQMs electronically for Stages
1 and 2 would be similar for reporting in Stage 3. However, we note
that subject to our prior approval, this is within the states' purview.
We propose for Stage 3 that the states would establish the method and
requirements, subject to our prior approval, for the electronic capture
and reporting of CQMs from CEHRT.
Proposed eCQM Reporting Timelines for Medicare & Medicaid EHR Incentive Program
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Year............................ 2017 only......... 2017 only......... 2018 and 2018 and
subsequent years. subsequent years.
Reporting Method Available...... Attestation....... Electronic Attestation....... Electronic
Reporting. Reporting.
Provider Type who May Use Method All Medicare All Medicare Medicare Providers All Medicare
providers. Providers. with Providers.
circumstances
rendering them
unable to eReport.
Medicaid providers Medicaid providers Medicaid providers Medicaid providers
must refer to must refer to must refer to must refer to
state state state state
requirements for requirements for requirements for requirements for
reporting. reporting. reporting. reporting.
CQM Reporting Period............ 1 CY for Medicare. 1 CY for Medicare. 1 CY for Medicare. 1 CY for Medicare.
1 CY for returning 1 CY for returning 1 CY for returning 1 CY for returning
Medicaid. Medicaid. Medicaid. Medicaid.
90 days for first 90 days for first 90 days for first 90 days for first
time meaningful time meaningful time meaningful time meaningful
user Medicaid. user Medicaid. user Medicaid. user Medicaid.
[[Page 16771]]
eCQM Version Required (CQM 2016 Annual Update 2016 Annual Update 2016 Annual Update 2017 Annual
electronic specifications or more recent Update.
update). version.
CEHRT Edition Required.......... 2014 Edition...... 2014 Edition...... 2015 Edition...... 2015 Edition.
Or................ Or................
2015 Edition...... 2015 Edition......
----------------------------------------------------------------------------------------------------------------
We invite public comments on our proposals.
a. Quality Reporting Data Architecture Category III (QRDA-III) Option
for Eligible Hospitals and CAHs
In the Stage 2 final rule (77 FR 54088), we finalized two options
for eligible hospitals and CAHs to electronically submit CQMs beginning
in FY 2014 under the Medicare EHR Incentive Program. Option 1 was to
submit aggregate level CQM data using QRDA-III electronically. Option 2
was to submit data electronically using a method similar to the 2012
and 2013 Medicare EHR Incentive Program electronic reporting pilot for
eligible hospitals and CAHs, which used QRDA-I (patient-level data).
We noted in the FY 2014 and 2015 IPPS/LTCH PPS final rules (78 FR
50904 through 50905 and 79 FR 50321 through 50322) that we had
determined that the electronic submission of aggregate-level data using
QRDA-III would not be feasible in 2014 or 2015 for eligible hospitals
and CAHs under the Medicare EHR Incentive Program. We stated that we
would reassess this policy for future reporting periods.
In this proposed rule, we are proposing to remove the QRDA-III
option for eligible hospitals and CAHs, as we have found this is not an
option for electronic reporting as we move forward with the EHR
Incentive Program, we believe the calculations, per the QRDA-III, are
not advantageous to quality improvement. As the EHR Incentive Program
further aligns with the Hospital IQR program, we intend to continue
utilizing the electronic reporting standard of QRDA-I patient level
data that we finalized in the FY 2015 IPPS rule (79 FR 50322), which
will allow the same level of CQM reporting, and use and analysis of
these data for quality improvement initiatives.
As we understand the need to support state flexibility, we are also
proposing that states would continue to have the option, subject to our
prior approval, to allow or require QRDA-III for CQM reporting.
4. CQM Specification and Changes to the Annual Update
In the Stage 2 final rule, we stated that we do not intend to use
notice and comment rulemaking as a means to update or modify electronic
CQM (eCQM) specifications (77 FR 54055). In general, it is the role of
the measure steward to make changes to a CQM in terms of the initial
patient population, numerator, denominator, potential exclusions,
logic, and value sets. We recognize that it may be necessary to update
CQM specifications after they have been published to ensure their
continued clinical relevance, accuracy, and validity. CQM specification
updates may include administrative changes, such as adding the NQF
endorsement number to a CQM, correcting faulty logic, adding or
deleting codes as well as providing additional implementation guidance
for a CQM.
These changes are described through the annual updates to the
electronic specifications for EHR submission published by CMS. CQMs are
currently tracked on a version basis as updates are made and we require
EPs, eligible hospitals, and CAHs to submit the versions of the CQMs as
identified on our Web site. The Web site contains all versions of the
CQMs since reporting via attestation does not require the most recent
version of the CQMs, but electronic reporting of the CQMs does require
the most recent version to be reported. Because we require the most
recent version of the CQM specifications to be used for electronic
reporting methods, we understand that EHR vendors must make CQM updates
on an annual basis. We also understand that providers must regularly
implement those updates to stay current with the most recent CQM
version.
We continue to evaluate the CQM update timeline and look for ways
to provide CQM updates timely, so that vendors can develop, test, and
deploy these updates and providers can implement those updates as
necessary. We have the flexibility to update CQMs so they remain
clinically relevant, accurate, and valid. While we are not proposing
any change to our policy on updating CQM specifications in this
proposed rule, we seek comment on our annual update timeline and
suggestions for how to improve the CQM update process.
5. EHR Technology Certification Requirements for Reporting of CQMs
In the 2014 Edition EHR Certification Criteria Final Rule, ONC
finalized certain certification criteria to support the MU objectives
and CQMs set forth by CMS. In that rule, ONC also specified that in
order for an EP, eligible hospital, or CAH to have EHR technology that
meets the Base EHR definition, the EHR technology must be certified to
a minimum of nine CQMs for EPs or 16 CQMs for eligible hospitals and
CAHs (77 FR 54264 through 54265; see also 45 CFR 170.102). This is the
same number required for quality reporting to the Medicare and Medicaid
EHR Incentive Programs, the PQRS EHR reporting and, beginning in 2015,
the electronic reporting option under the Hospital IQR Program. In
certain cases, an EP, eligible hospital or CAH may purchase an EHR
product that is certified to the minimum number of CQMs and discover
that, for at least one of those CQMs, they do not have data on which to
report. In these cases, the EP (77 FR 54058 through 54059), eligible
hospital or CAH (77 FR 54051) would report a zero denominator for one
or more CQMs.
We believe EHRs should be certified to more than the minimum number
of CQMs required by one or more CMS quality reporting programs so that
EPs, eligible hospitals, and CAHs have a choice of which CQMs to
report, and could therefore choose to report on CQMs most applicable to
their patient population or scope of practice.
We realize that requiring EHRs to be certified to more than the
minimum number of CQMs required by the Medicare and Medicaid EHR
Incentive Programs may increase the burden on EHR vendors. However, in
the interest of EPs, eligible hospitals, and CAHs being able to choose
to report eCQMs that represent their patient populations, we would like
to see EP vendors certify to all eCQMs that are in the EP selection
list, or eligible hospital/CAH vendors certify to all eCQMs in the
selection list for those stakeholders.
We are also considering a phased approach such that the number of
CQMs required for the vendors to have
[[Page 16772]]
certified would increase each year until EHR products are required to
certify all CQMs required for reporting by EPs, eligible hospitals, and
CAHs. For example, in year one of this phased plan, we might require
that EHRs be certified to at least 18 of 64 available CQMs for EPs and
22 of 29 available CQMs for eligible hospitals and CAHs; in year two,
we might require at least 36 CQMs for EPs and all 29 CQMs for eligible
hospitals and CAHs; in subsequent years of the plan, we would increase
the number of required CQMs for EPs until the EHR is certified to all
applicable CQMs for EPs, eligible hospitals, and CAHs.
We have also considered alternate plans that would require EHRs to
be certified to more than the minimum number of CQMs required for
reporting, but would not require the EHR to be certified to all
available CQMs. For example, we might require that EHRs be certified to
a certain core set of CQMs plus an additional 9 CQMs for EPs, and a
certain core set of CQMs plus an additional 16 CQMs for eligible
hospitals and CAHs, which the EHR vendor could choose from the list of
available CQMs.
We note that the specifics of this plan would be outlined in
separate notice-and-comment rulemaking such as the PFS or IPPS rules.
We specifically seek comment on this issue of a plan to increase the
number of CQMs to which an EHR is certified.
6. Electronic Reporting of CQMs
As previously stated in the Medicare and Medicaid EHR Incentive
Programs Stage 2 final rule (77 FR 54051 through 54053), CQM data
submitted by EPs, eligible hospitals, and CAHs are required to be
captured, calculated and reported using certified EHR technology. We
received numerous questions from stakeholders expressing confusion over
what it means to capture data in certified EHR technology.
Specifically, stakeholders question whether they may manually abstract
data into the EHR from a patient's chart. We do not consider the manual
abstraction of data from the EHR to be capturing the data using
certified EHR technology. We believe that electronic information
interfaced or electronically transmitted from non-certified EHR
technology, such as lab information systems, automated blood pressure
cuffs, and electronic scales, into the certified EHR, would satisfy the
``capture'' requirement, as long as that data is visible to providers
in the EHR.
C. Demonstration of Meaningful Use and Other Issues
1. Demonstration of Meaningful Use
a. 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.
b. Methods for Demonstration of the Stage 3 Criteria of Meaningful Use
for 2017 and Subsequent Years
We are proposing to continue the use of attestation as the method
for demonstrating that an EP, eligible hospital, or CAH has met the
Stage 3 objectives and measures of meaningful use. We are proposing to
continue the existing optional batch file process for attestation in
lieu of individual Medicare EP attestation through our registration and
attestion system. This batch reporting process ensures that meaningful
use of certified EHR technology continues to be measured at the
individual level, while promoting efficiencies for group practices that
must submit attestations on large groups of individuals (77 FR 54089).
We would continue to leave open the possibility for CMS and the
states to test options for demonstrating meaningful use that utilize
existing and emerging HIT products and infrastructure capabilities.
These options could involve the use of registries or the direct
electronic reporting of measures associated with the objectives of
meaningful use. We would not require any EP, eligible hospital, or CAH
to participate in this testing in order to receive an incentive payment
or avoid the payment adjustment.
For 2017 only, we are proposing changes to the attestation process
for the meaningful use objectives and measures, which would allow
flexibility for providers during this transitional year. These
proposals are supported by a similar flexibility proposed in the
requirements for the Edition of CEHRT a provider may use in 2017 as
further discussed in section II.A.I.C.(1).(b).(3). of this proposed
rule. In addition, we discuss the attestation changes proposed for CQM
reporting in detail under section II.B.2.a. of this proposed rule.
(1) Meaningful Use Objective and Measures in 2017
In order to allow all providers to successfully transition to Stage
3 of meaningful use for a full year-long EHR reporting period in 2018,
we are proposing to allow flexibility for the EHR Incentive Programs in
2017. This transition period would allow providers to establish and
test their processes and workflows for Stage 3 of meaningful use prior
to 2018. Specifically, for 2017, we are proposing that providers may
either repeat a year at their current stage or move up stage levels.
However, for 2017, a provider may not move backward in their
progression. Under this proposal, providers who participated in Stage 1
in 2016 may choose to attest to the Stage 1 objective and measures, or
they may move on to Stage 2 or Stage 3 objectives and measures for an
EHR reporting period in 2017. Providers who participated in Stage 2 in
2016 may choose to attest to the Stage 2 objectives and measures or
move on to Stage 3 objectives and measures for an EHR reporting period
in 2017. However, under no circumstances, may providers return to Stage
1. In 2018, all providers, regardless of their prior participation or
the stage level chosen in 2017, would be required to attest to Stage 3
objectives and measures for an EHR reporting period in 2018.
(2) CEHRT and Stage Flexibility in 2017
Based on the delays providers experienced with fully implementing
the EHR technology certified to the 2014 Edition (as further described
in the 2014 CEHRT Flexibility final rule (79 FR 52910 through 52933) we
believe it is necessary to preemptively prepare for the upgrade to EHR
technology certified to the 2015 Edition and the transition to Stage 3.
Preparation for the upgrade would ensure that providers and developers
have adequate time to certify, install, fully implement the software,
and establish the processes and workflows for the objectives and
measures for providers moving to the next stage of the EHR Incentive
Programs. Accordingly, we propose allowing providers flexible CEHRT
options for 2017. These options may impact the selection of objectives
and measures to which a provider can attest. Specifically, under the
CEHRT options for 2017, we propose that providers would have the option
to continue to use EHR technology certified to the 2014 Edition, in
whole or in part, for an EHR reporting period in 2017. We note that
providers who use only the EHR technology certified to the 2014 Edition
for an EHR reporting period in 2017 may not choose to attest to the
Stage 3 objectives and measures as those objectives and measures
require the support of EHR technology certified to the 2015 Edition.
[[Page 16773]]
Providers using only EHR technology certified in whole or in
relevant part to the 2014 Edition certification criteria may attest to
the objectives and measures of meaningful use in the following manner:
If a provider first demonstrated meaningful use in 2015 or
2016, they may attest to Stage 1 objectives and measures or Stage 2
objectives and measures.
If a provider first demonstrated meaningful use in any
year prior to 2015, they may attest to the Stage 2 objectives and
measures.
Providers using EHR technology certified in whole or in relevant
part to the 2015 Edition certification criteria may elect to attest to
the objectives and measures of meaningful use in the following manner:
If a provider first demonstrated meaningful use in 2015 or
2016, they may attest to Stage 1 objectives and measures, Stage 2
objectives and measures, or Stage 3 objectives and measures if they
have all the 2015 Edition functionality required to meet all Stage 3
objectives.
If a provider first demonstrated meaningful use in any
year prior to 2015, they may attest to Stage 2 objectives and measures,
or Stage 3 objectives and measures if they have all the 2015 Edition
functionality required to meet all Stage 3 objectives.
We note that all providers would be required to fully upgrade to
EHR technology certified to the 2015 Edition for the EHR reporting
period in 2018. We also reiterate that providers may elect to attest to
Stage 3 of the program using EHR technology certified to the 2015
Edition beginning in 2017. We further stress that the use of 2011
CEHRT, although an option under the 2014 CEHRT Flexibility final rule
(79 FR 52913 through 52914), is not an option under this proposal.
However, as part of this proposal, we would like to seek comment on
alternate flexibility options. Specifically, we are seeking comment on
whether the flexible option to attest to Stages 1 or 2 should be
limited to only those providers who could not fully implement EHR
technology certified to the 2015 Edition in 2017. We are also seeking
comment on whether those providers with fully implemented EHR
technology certified to the 2015 Edition in 2017 should be required to
attest to Stage 3 only in 2017. Finally, we seek comment on whether
providers should not have the option to attest to Stage 3 in 2017
regardless of an upgrade to EHR technology certified to the 2015
Edition in 2017, and should instead be required to wait to demonstrate
Stage 3 until 2018 using EHR technology certified to the 2015 Edition.
We welcome comments on these proposals.
(3) CQM Flexibility in 2017
In the 2014 CEHRT Flexibility final rule, we did not allow
providers to separate their CQM reporting selection from the year of
meaningful use objectives they reported on. We did not allow this
reporting for a number of reasons including how we defined CQMs, as
well as the number of CQMs reporting changes occurring between Stage 1
in 2011 through 2013, and Stage 1 and 2 in 2014. For further
discussion, we direct readers to 79 FR 52927 through 52930.
To report CQMs for 2017, we propose to allow greater flexibility by
proposing to split the use of CEHRT for CQM reporting from the use of
CEHRT for the objectives and measures. This means that providers would
be able to separately report CQMs using EHR technology certified to the
2015 Edition even if they use EHR technology certified to the 2014
Edition for the meaningful use objectives and measures for an EHR
reporting period in 2017. Providers may also use EHR technology
certified to the 2015 Edition for their meaningful use objectives and
measures in 2017 and use EHR technology certified to the 2014 Edition
for their CQM reporting for an EHR reporting period in 2017.
For an EHR reporting period in 2017, EPs, eligible hospitals, and
CAHs may choose to report eCQMs electronically using the CQMs finalized
for use in 2017 using the most recent version of the eCQMs (electronic
specifications), which would be the electronic specifications of the
CQMs published by CMS in 2016. Alternately, a provider may choose to
continue to attest to the CQMs established for use in 2017 also using
the most recent (2016 version) eCQM electronic specifications. These
options are available for provider using either EHR technology
certified to the 2014 Edition or EHR technology certified to the 2015
Edition. These flexible options for an EHR reporting period in 2017 are
further discussed in sections II.B.2.a. of this proposed rule. An EP,
eligible hospital, or CAH must use certified EHR technology,
successfully attest to the meaningful use objectives and measures, and
successfully submit CQMs to be a meaningful EHR user. We note that
states may determine the form and method of CQM submission for
participants in the Medicaid program subject to our approval as outline
in sections II.B.3 and II.F.3. of this proposed rule. However, the
selection of CQMs and the minimum reporting period are the same for
providers in both Medicare and Medicaid as outlined in section II.B.3.
of this proposed rule.
Similar to our rationale under the 2014 CEHRT Flexibility final
rule (79 FR 52910 through 52933), we believe the proposals outlined for
attestation in 2017 would allow providers the flexibility to choose the
option which applies to their particular circumstances and use of
CEHRT. Upon attestation, providers may select one of the proposed
options available for their participation year and EHR Edition. The EHR
Incentive Program Registration and Attestation System would then prompt
the provider to attest to meeting the objectives, measures, and CQMs
applicable under that option. We further propose that auditors would be
provided guidance related to reviewing attestations associated with the
options for using CEHRT in 2017, as was done for 2014.
We welcome comment on this proposal.
c. EHR Reporting Period in 2017 and Subsequent Years
We are proposing, with limited exceptions outlined in section
II.F.1. of this proposed rule, that the EHR reporting period in 2017
would be a full calendar year for all providers. We encourage providers
to begin Stage 3 in 2017. However, under the current timeline shown in
Table 3, we recognize that providers first demonstrating meaningful use
under Stage 1 in 2016 or 2017 or under Stage 2 in 2016 or 2017 must
begin Stage 3 in 2018. We further recognize providers scheduled to
begin Stage 3 in 2017 that instead choose to meet the Stage 2 criteria
in 2017 must begin Stage 3 in 2018. However, in 2018, all providers,
except as outlined in section II.F.1. of this proposed rule, must
report based on a full calendar year EHR reporting period for the Stage
3 objectives and measures. In addition, in 2018, all providers must use
EHR technology certified to the 2015 Edition for the full EHR reporting
period in order to successfully demonstrate meaningful use.
For CQM reporting in 2018 and subsequent years, as outlined in
section II.B.3 of this proposed rule, we are proposing that providers
participating in the Medicare program must electronically report, where
feasible, and that attestation to CQMs would no longer be an option
except in circumstances where electronic reporting is not feasible.
This would include providers facing circumstances which render them
unable to
[[Page 16774]]
electronically report (such as a data submission system failure,
natural disaster, or certification issue outside the control of the
provider) who may attest to CQMs if they also attest that
electronically reporting was not feasible for their demonstration of
meaningful use for a given year.
We welcome public comment on this proposal.
2. Data Collection for Online Posting, Program Coordination, and
Accurate Payments
We propose to continue posting Stage 1 and Stage 2 aggregate and
individual performance and participation data resulting from the EHR
Incentive programs online regularly for public use. We further note our
intent to potentially publish the performance and participation data on
Stage 3 objectives and measures of meaningful use in alignment with
quality programs which utilize publicly available performance data such
as physician compare.
In addition to the data already being collected under our
regulations, as outlined in section III. of this proposed rule, we
propose to collect the following information from providers to ensure
providers keep their information up-to-date through the system of
record for their National Provider Identifier (NPI) in the National
Plan & Provider Enumeration System:
Primary Practice Address (address, city, state zip,
country code, etc.).
Primary Business/Billing Address (address, city, state,
zip, country code, etc.).
Primary License information (for example, provide medical
license in at least one state (or territory)).
Contact Information (phone number, fax number, and contact
email address).
Health Information Exchange Information:
++ Such as DIRECT address required (if available).
++ If DIRECT address is not available, Electronic Service
Information is required.
++ If DIRECT address is available, Electronic Service Information
is optional in addition to DIRECT address.
We do not propose any changes to the registration for the Medicare
and Medicaid EHR Incentive Programs.
3. Interaction With Other Programs
There are no proposed changes to the ability of providers to
participate in the Medicare and Medicaid EHR Incentive Programs and
other CMS programs. We continue to work on aligning the data collection
and reporting of the various CMS programs, especially in the area of
clinical quality measurement. See sections II.B.1. through II.B.6. of
this proposed rule for the proposed alignment initiatives for CQMs.
D. 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 for
EPs
Section 1848(a)(7) of the Act provides for payment adjustments,
effective for CY 2015 and subsequent years, for EPs as defined in 42
CFR 495.100, who are not meaningful EHR users during the relevant EHR
reporting period for the year. Section 1848(a)(7) 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 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 final rules for Stages 1
and 2 (75 FR 44442 through 44448 and 77 FR 54093 through 54102) for
more information.
2. EHR Reporting Period for Determining Whether an EP Is Subject to the
Payment Adjustment for CY 2018 and Subsequent Calendar Years
Section 1848(a)(7)(E)(ii) of the Act provides the Secretary with
broad authority to choose the EHR reporting period that will apply for
purposes of determining the payment adjustments 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 the 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. Stated generally, 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 the
regulations and the discussion in the Stage 2 final rule (77 FR 54095
through 54096). We
[[Page 16775]]
established that these policies apply for the CY 2015 payment
adjustment year and subsequent payment adjustment years.
However, in this Stage 3 proposed rule, we propose to eliminate the
exception discussed previously for a 90-day EHR reporting period for
new meaningful EHR users beginning with the EHR reporting period in
2017, with a limited exception for Medicaid EPs demonstrating
meaningful use for the first time. We propose that for EPs 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 example, for all EPs demonstrating meaningful use,
the full CY 2017 would be the EHR reporting period for the CY 2019
payment adjustment year. To avoid a payment adjustment in CY 2019, EPs
must demonstrate meaningful use of certified EHR technology for an EHR
reporting period of the entire CY 2017. This policy would continue to
apply in subsequent years.
As discussed in sections II.A.1.a. and II.F.1. of this proposed
rule, we are proposing to maintain a 90-day EHR reporting period for
the first payment year based on meaningful use for Medicaid EPs
demonstrating meaningful use for the first time. We recognize that
these EPs may be subject to payment adjustments under Medicare if they
fail to demonstrate meaningful use, and thus we propose that the same
90-day EHR reporting period used for the Medicaid incentive payment
would also apply for purposes of the Medicare payment adjustment for
the payment adjustment year two years after the calendar year in which
the provider demonstrates meaningful use. We note under our current
policy, if an EP has never successfully demonstrated meaningful use,
the EHR reporting period for a payment adjustment year is 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. We do not propose to maintain this policy,
and thus for Medicaid EPs who are new meaningful EHR users, the 90-day
EHR reporting period for a payment adjustment year must occur within
the calendar year that is 2 years before the payment adjustment year.
These proposals for Medicaid EPs would apply beginning with the EHR
reporting period in CY 2017.
We provide the following example:
Example A: If an EP has never successfully demonstrated meaningful
use prior to CY 2017 and demonstrates under the Medicaid EHR Incentive
Program that he or she is a meaningful EHR user for the first time in
CY 2017, the EHR reporting period for the Medicaid incentive payment
would be any continuous 90-day period within CY 2017. The same 90-day
period would also serve as the EHR reporting period for the CY 2019
payment adjustment year under Medicare. This 90-day period would not
serve as the EHR reporting period for the CY 2018 payment adjustment
year under Medicare even if the EP registers for and attests to
meaningful use by October 1, 2017. The EP would have to demonstrate
meaningful use for an EHR reporting period of the full CY 2018 to earn
an incentive payment under Medicaid for the CY 2018 payment year and
avoid the payment adjustment under Medicare for the CY 2020 payment
adjustment year.
We propose these changes to further our goal to align reporting
requirements under the EHR Incentive Program and the reporting
requirements for various CMS quality reporting programs, to respond to
stakeholders who cited difficulty with following varying reporting
requirements, and to simplify HHS system requirements for data capture.
We further note that newly practicing EPs have the ability to apply for
a hardship exception from the Secretary under Sec. 495.102(d)(4)(ii),
which provides for an exception from the payment adjustments for the 2
years after they begin practicing. We propose amendments to the
definition of ``EHR reporting period for a payment adjustment year''
under Sec. 495.4 to reflect these proposals. We welcome public
comments on this proposal.
3. Exception to the Application of the Payment Adjustment to EPs in CY
2017 and Subsequent Years
As previously discussed, sections 1848(a)(7)(B) of the Act provides
that the Secretary may, on a case-by-case basis, exempt an EP from the
application of the payment adjustment in CY 2015 and subsequent
calendar years if the Secretary determines that compliance with the
requirements for being a meaningful EHR user will result in a
significant hardship, such as an EP who practices in a rural area
without sufficient internet access. As provided by the statute, the
exception is subject to annual renewal, but in no case may an EP be
granted an exception for more than 5 years. The statute does not
require the Secretary to grant exceptions. However, as we stated in the
Stage 2 final rule at 77 FR 54097, we believe that certain
circumstances evidence the existence of a hardship, thereby justifying
the need for an exception by the Secretary. Therefore, in the Stage 2
final rule, we finalized various types of hardship exceptions that EPs
could apply for, which included insufficient internet access, newly
practicing EPs, extreme circumstances outside of an EP's control, lack
of control over the availability of CEHRT for EPs practicing in
multiple locations, lack of face-to-face patient interactions and lack
of need for follow-up care, and certain primary specialties. For
further discussion of the hardship exceptions, we refer readers to the
Stage 2 final rule at 77 FR 54097 through 54101 and 42 CFR
495.102(d)(4).
In this Stage 3 proposed rule, we propose no changes to the types
of exceptions previously finalized for EPs, nor do we propose any new
types of exceptions for 2017 and subsequent years. Accordingly, we
propose that the exceptions continue as previously finalized.
4. Statutory Basis for Payment Adjustments and Hardship Exceptions for
Eligible Hospitals
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 will
be ``33\1/3\ percent for FY 2015, 66\2/3\ percent for FY 2016, and 100
percent for FY 2017 and each subsequent FY.'' In other words, for
eligible hospitals that are not meaningful EHR users, the Secretary
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,
[[Page 16776]]
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 fiscal year involved and the Secretary
shall not take into account such reduction in computing the applicable
percentage increase for a subsequent fiscal year.
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 will result in a significant hardship, such as in the case of
a hospital in a rural area without sufficient internet access. This
section also provides that such determinations are subject to annual
renewal, and that in no case may a hospital be granted an exception for
more than 5 years.
5. Applicable Market Basket Update Adjustment for Eligible Hospitals
That Are Not Meaningful EHR Users for FY 2019 and Subsequent Fiscal
Years
Section 412.64(d) of the 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.
6. EHR Reporting Period for Determining Whether a Hospital Is Subject
to the Market Basket Update Adjustment for FY 2018 and Subsequent
Fiscal Years
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 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 the 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. However, in this Stage 3 proposed rule, beginning in
2017, we propose to change the EHR reporting period for a payment
adjustment year for eligible hospitals from a fiscal year basis to a
calendar year basis. Specifically, we propose to revise the definition
of ``EHR reporting period for a payment adjustment year'' under Sec.
495.4 such that the EHR reporting period for a payment adjustment year
for an eligible hospital would be the full calendar year that is 2
years before the payment adjustment year. For example, the entire CY
2017 would be the EHR reporting period used to determine whether the
payment adjustment would apply for an eligible hospital for FY 2019.
This change would apply beginning with the CY 2017 EHR reporting period
for purposes of the FY 2019 payment adjustment year, and continue to
apply in subsequent years. We note that eligible hospitals would have
ample time to adjust to the new calendar year reporting timeframe given
that under our current policy, the EHR reporting period occurs prior to
the payment adjustment year. We further believe that aligning all
providers, including eligible hospitals, to a calendar year EHR
reporting timeframe for purposes of the payment adjustment, would
simplify reporting for all providers, especially for larger providers
with diverse systems and groups. In addition, placing all providers,
including eligible hospitals, onto a calendar year timeframe would
further simplify HHS system requirements for data capture and would
move the EHR Incentive Program another step closer to alignment with
various CMS quality reporting programs. We welcome comments on this
proposal.
Further, in the Stage 2 final rule, 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. Stated generally, 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
and 54105).
However, in this Stage 3 proposed rule, we propose to eliminate
this exception for eligible hospitals that are new meaningful EHR users
beginning with the EHR reporting period in 2017, with a limited
exception for Medicaid eligible hospitals demonstrating meaningful use
for the first time. As explained previously, we propose that for
eligible hospitals that have successfully demonstrated meaningful use
in a prior year as well as those that 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 example, for
all eligible hospitals, the full CY 2017 would be the EHR reporting
period for the FY 2019 payment adjustment year. This policy would
continue to apply in subsequent years.
Though, as discussed in sections II.A.1.a. and II.F.1. of this
proposed rule, for Medicaid eligible hospitals demonstrating meaningful
use for the first time, we are proposing to maintain a 90-day EHR
reporting period for the first payment year based on meaningful use. We
recognize that these eligible hospitals may be subject to payment
adjustments under Medicare if they fail to demonstrate meaningful use,
and thus we propose that the same 90-day EHR reporting period used for
the Medicaid incentive payment would also apply for purposes of the
Medicare payment adjustment for the payment adjustment year 2 years
after the calendar year in which the provider demonstrates meaningful
use. We note under our current policy, if an eligible hospital has
never successfully demonstrated meaningful use, the EHR reporting
period for a payment adjustment year is any continuous 90-day period
that both begins in the federal fiscal year 1 year before the payment
adjustment year and ends at least 3 months before the end of such prior
year. We do not propose to maintain this policy, and thus for Medicaid
eligible hospitals that are new meaningful EHR users, the 90-day EHR
reporting period for a payment adjustment year must occur within the
calendar year that is 2 years before the payment adjustment year. These
proposals for Medicaid eligible hospitals would apply beginning with
the EHR reporting period in CY 2017.
We provide the following example:
Example A: If an eligible hospital has never successfully
demonstrated meaningful use prior to CY 2017 and demonstrates under the
Medicaid EHR
[[Page 16777]]
Incentive Program that it is a meaningful EHR user for the first time
in CY 2017, the EHR reporting period for the Medicaid incentive payment
would be any continuous 90-day period within CY 2017. The same 90-day
period would also serve as the EHR reporting period for the FY 2019
payment adjustment year under Medicare. This 90-day period would not
serve as the EHR reporting period for the FY 2018 payment adjustment
year under Medicare even if the eligible hospital registers for and
attests to meaningful use by July 1, 2017. The eligible hospital would
have to demonstrate meaningful use for an EHR reporting period of the
full CY 2018 to earn an incentive payment under Medicaid for the 2018
payment year and avoid the payment adjustment under Medicare for the FY
2020 payment adjustment year.
Like our proposal to move eligible hospitals to a calendar year
timeframe, we believe that removing the continuous 90-day EHR reporting
period for most eligible hospitals would simplify reporting for
providers, especially those hospitals with diverse groups and systems.
In addition, eliminating the 90-day EHR reporting period would move the
EHR Incentive Program one step closer to alignment within the program
and with CMS quality reporting programs and would simplify HHS system
requirements for data capture. Therefore, moving eligible hospitals to
a calendar year EHR reporting period for the payment adjustment years,
as well as requiring all providers (EPs and hospitals) to report based
on the same full year calendar timeframe would accomplish these goals
and be responsive to prior public comments asking us to simplify the
EHR Incentive Program.
We propose amendments to the definition of ``EHR reporting period
for a payment adjustment year'' under Sec. 495.4 to reflect these
proposals.
We note that hospitals that are eligible under both the Medicaid
and Medicare incentive programs, and that are attesting for the
Medicaid program, do not need to separately attest in the Medicare
program in 2017 and subsequent years, because the statute does not
allow for Medicare EHR incentive payments to eligible hospitals after
FY 2016. If a hospital eligible under both programs is demonstrating
meaningful use for the first time, and using a continuous 90-day EHR
reporting period under the Medicaid program, it could attest for the
Medicaid program only, and still avoid the Medicare payment adjustment
that is 2 years after the calendar year in which the EHR reporting
period occurs. However, if a hospital eligible under both programs
chooses also to attest for the Medicare program, it would be required
to complete an EHR reporting period of 1 full calendar year to avoid
the Medicare payment adjustment that is 2 years after that calendar
year.
We welcome public comments on these proposals.
7. Exception to the Application of the Market Basket Update Adjustment
to Hospitals in FY 2019 and Subsequent Fiscal Years
As stated previously, section 1886(b)(3)(B)(ix)(II) of the Act, as
amended by section 4102(b)(1) of the HITECH Act, provides that the
Secretary, may, on a case-by-case basis, exempt a hospital from the
application of the applicable percentage increase payment adjustment
for a fiscal year if the Secretary determines that compliance with the
requirements for being a meaningful EHR user will result in a
significant hardship, such as an eligible hospital located in a rural
area without sufficient internet access. Section 1886(b)(3)(B)(ix)(III)
also provides that the exception is subject to annual renewal, but in
no case may a hospital be granted an exception for more than 5 years.
The Secretary's hardship exception authority is discretionary.
As we explained in the Stage 2 final rule at 77 FR 54105 through
54106, we believe that certain circumstances may constitute a hardship
that would warrant the Secretary's use of the exception authority.
Therefore, in the Stage 2 final rule, we finalized various types of
hardship exceptions for which eligible hospitals may apply, which
included lack of insufficient internet access, extreme circumstances
outside of a hospital's control, and the establishment of new
hospitals. For further discussion of the hardship exceptions, we refer
readers to the Stage 2 final rule at 77 FR 54105 through 54108 as well
as 42 CFR 412.64(d)(4).
In this Stage 3 proposed rule, we propose no changes to the types
of exceptions previously finalized for eligible hospitals, nor do we
propose any new exceptions for eligible hospitals. Accordingly, for
Stage 3, we propose to continue the hardship exceptions for 2017 and
subsequent years as previously finalized.
8. Statutory Basis for Payment Adjustments to CAHs
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 will 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 case 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.
9. Reduction of Reasonable Cost Reimbursement in FY 2015 and Subsequent
Years for CAHs That Are Not Meaningful EHR Users
a. Applicable Reduction of Reasonable Cost Payment Reduction in FY 2015
and Subsequent Years for CAHs That Are Not Meaningful EHR Users
In the Stage 1 final rule (75 FR 44564), we finalized the
regulations regarding the CAH adjustment at Sec. 495.106(e) and Sec.
413.70(a)(6).
b. EHR Reporting Period for Determining Whether a CAH Is Subject to the
Applicable Reduction of Reasonable Cost Payment in FY 2015 and
Subsequent Years
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
[[Page 16778]]
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 fiscal year as described in Sec. 413.70(a)(6)(i). We further
finalized that CAHs submit their attestations on meaningful use by
November 30 of the following fiscal year. 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, will then affect interim payments to the
CAH made after December 1 of the applicable fiscal year. If the cost
reporting period ends prior to December 1 of the applicable fiscal
year, then any applicable payment adjustment will be made through the
cost report settlement process.
Under this Stage 3 proposed rule, we are proposing a change to the
EHR reporting period that would apply for the payment adjustments for
CAHs, beginning with the FY 2017 payment adjustment year. First,
similar to what we proposed for eligible hospitals previously, we
propose 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 propose 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 CY 2017. This proposed change would mean
that the EHR reporting period would no longer precisely align with the
payment adjustment year. We propose amendments to the definition of
``EHR reporting period for a payment adjustment year'' under Sec.
495.4 to reflect these proposals.
In the Stage 2 final rule, we note the process for the
implementation of a payment adjustment to CAH cost reports in relation
to the EHR reporting period attestation deadline (77 FR 54109 and
54110). Under our Stage 3 proposal, we would need to move the CAH
attestation deadline in order to accommodate the change to a calendar
year-based EHR reporting period. Therefore, we propose to move the CAH
attestation deadline to the last day in February following the end of
the EHR reporting period as we currently allow for EPs. Any accounting
shifts that occur as a result from the change to a calendar year-based
EHR reporting period can be accommodated through the cost reporting and
settlement process. The CAH must attest no later than 2 months
(February 28 or February 29 if applicable) following the close of the
EHR reporting period at the end of each calendar year to avoid the
payment adjustment. Such an attestation or lack thereof, will then
affect interim payments to the CAH made after March 1 of the applicable
federal fiscal year. If the cost reporting period ends prior to March 1
of the applicable fiscal year, then any applicable payment adjustment
will be made through the cost report settlement process.
We are proposing this change to the EHR reporting period for the
payment adjustment year to further align most providers to a calendar
year-based EHR reporting period. We believe that the change to calendar
year reporting for CAHs is feasible given that the cost reporting and
cost settlement processes is unique to CAHs under the Medicare EHR
Incentive Program. Unlike eligible hospitals or EPs, who use a claims
processing system to determine the payment adjustment under the
Medicare EHR Program, CAHs are required to file an annual Medicare cost
report that is typically for a consecutive 12-month period. The cost
report reflects the inpatient statistical and financial data that forms
the basis of the CAH's Medicare reimbursement. Interim Medicare payment
may be made to the CAH during the cost reporting period based on the
previous year's data. Cost reports are filed with the CAH's Medicare
contractor after the close of the cost reporting period, and the data
on the cost report are subject to the reconciliation and settlement
process prior to a final Medicare payment being made. The proposed
change to a calendar year EHR reporting period for CAHs would not
significantly impact the ability to implement the payment adjustments
in the cost report reconciliation process for either CAHs or CMS. It
would only shift the potential date where the reconciliation of any
payment adjustment in the cost reporting process may occur. These
payments would still be subject to the reconciliation and settlement
process prior to a final Medicare payment being made.
For example, currently CAHs must file their attestations on
meaningful use by November 30 of the federal fiscal year following the
close of the federal fiscal year in which the EHR reporting period
occurs. Under our current system, if a CAH is attesting that it was a
meaningful EHR user for FY 2015, the attestation must be submitted not
later than November 30, 2015. A payment adjustment applied if the CAH
does not successfully attest would affect interim payment to the CAH
made after December 1 of 2015. If the cost reporting period ends prior
to December 1, 2015, then any applicable payment adjustment will be
made under the cost reporting settlement process.
In an example of a similar scenario under the new proposal, a CAH
that does not successfully demonstrate meaningful use based on a
calendar year EHR reporting period in 2017 (January 1, 2017 through
December 31, 2017) would be subject to a payment adjustment applied to
its reasonable costs incurred in the cost reporting period beginning in
FY 2017 (October 1, 2017 through September 30, 2018). To avoid the
payment adjustment in this example, the CAH must attest no later than
February 28, 2018 to demonstrate meaningful use for an EHR reporting
period in 2017. If the CAH does not attest by February 28, 2018, a
payment adjustment would then affect interim payments to the CAH made
after March 1, 2018. If the cost reporting period ends prior to March
1, 2018, then any applicable payment adjustment would be made through
the cost report settlement process. We note that this is reflective of
a similar policy in the Stage 2 final rule addressing the process for
CAH payment adjustments with an attestation deadline of November 30 in
a given year and direct readers to 77 FR 54110 for further information
on this policy.
Second, as noted previously, and outlined in the definition of
``EHR reporting period for a payment adjustment year'' under Sec.
495.4, we established an exception for first-time CAH meaningful EHR
users. Under our current policy, if a CAH is demonstrating it is a
meaningful EHR user for the first time in the payment adjustment year,
the applicable EHR reporting period is any continuous 90-day period
within the federal fiscal year that is the payment adjustment year.
For this Stage 3 proposed rule, we propose to eliminate this
exception for CAHs that are new meaningful EHR users beginning with the
EHR reporting period in 2017, with a limited exception for CAHs
demonstrating meaningful use for the first time under the Medicaid EHR
Incentive Program. As discussed in II.A.1.a. and II.F.1. of this
proposed rule, for CAHs that demonstrate meaningful use for the first
time under Medicaid, we are proposing to maintain a 90-day EHR
reporting period for the first payment year based on meaningful use. We
recognize that these CAHs may be
[[Page 16779]]
subject to payment adjustments under Medicare if they fail to
demonstrate meaningful use, and thus we propose that the same 90-day
EHR reporting period used for the Medicaid incentive payment would also
apply for purposes of the Medicare payment adjustment.
We propose amendments to the definition of ``EHR reporting period
for a payment adjustment year'' under Sec. 495.4 to reflect these
proposals. Example A: If a CAH has never successfully demonstrated
meaningful use prior to CY 2017 and demonstrates under the Medicaid EHR
Incentive Program that it is a meaningful EHR user for the first time
in CY 2017, the EHR reporting period for the Medicaid incentive payment
would be any continuous 90-day period within CY 2017. The same 90-day
period would also serve as the EHR reporting period for the FFY 2017
payment adjustment year under Medicare.
Like our proposal to move CAHs to a calendar year timeframe, we
believe that removing the continuous 90-day EHR reporting period for
most CAHs would simplify reporting for providers, especially those CAHs
with diverse groups and systems. In addition, eliminating the 90-day
EHR reporting period would move the EHR Incentive Program one step
closer to alignment within the program and with CMS quality reporting
programs, and would simplify HHS system requirements for data capture.
Therefore, moving CAHs to a calendar year EHR reporting period for the
payment adjustment year, as well as requiring most providers (EPs,
CAHs, and eligible hospitals) to report based on the same full year
calendar timeframe would accomplish these goals and be responsive to
prior public comments asking us to simplify the EHR Incentive Program.
We welcome public comments on these proposals.
10. Administrative Review Process of Certain Electronic Health Record
Incentive Program Determinations
In the Stage 2 final rule (77 FR 54112 through 54113), we discussed
an administrative appeals process for both Stages 1 and 2 of meaningful
use. We believe this appeals process is primarily procedural and does
not need to be specified in regulation. We have developed guidance on
the appeals process, which is available on our Web site at www.cms.gov/
EHRIncentivePrograms. We propose no changes in this proposed rule and
intend to continue to specify the appeals process in guidance available
on our Web site.
E. Medicare Advantage Organization Incentive Payments
We are not proposing any changes to the existing policies and
regulations for Medicare Advantage (MA) organizations. Our existing
policies and regulations include provisions concerning the EHR
incentive payments to qualifying MA organizations and the payment
adjustments for 2015 and subsequent MA payment adjustment years. (For
more information on MA organization incentive payments, we refer
readers to the final rules for Stages 1 and 2 (75 FR 44468 through
44482 and 77 FR 54113 through 54119).)
F. The Medicaid EHR Incentive Program
The proposals discussed in sections II.F.1. through II.F.3. of this
proposed rule would be applicable upon the effective date of the final
rule, not when Stage 3 of meaningful use of certified EHR technology
begins, unless otherwise indicated.
1. EHR Reporting Period for First Year of Meaningful Use
We are proposing amendments to the definitions of ``EHR reporting
period'' and ``EHR reporting period for a payment adjustment year'' in
Sec. 495.4 to shift the EHR reporting periods for eligible hospitals
and CAHs to periods that are based on the calendar year, not the
federal fiscal year, and to establish a full calendar year as the EHR
reporting period or EHR reporting period for a payment adjustment year
for almost all providers beginning in 2017. However, we are also
proposing a limited exception under which Medicaid EPs and eligible
hospitals demonstrating meaningful use for the first time could use any
continuous 90-day EHR reporting period within the calendar year. This
EHR reporting period for Medicaid providers demonstrating meaningful
use for the first time would apply both for purposes of receiving an
incentive payment in the Medicaid program and for purposes of avoiding
the payment adjustment under the Medicare program for the payment
adjustment year that is two years after the calendar year in which the
provider first demonstrates meaningful use for an EHR reporting period.
Under this proposal, Medicaid EPs and eligible hospitals would have an
EHR reporting period of any continuous 90-day period in the calendar
year that is the payment year, for their first payment year based on
meaningful use, beginning in 2017. We note that hospitals that are
eligible under both the Medicaid and Medicare incentive programs, and
that are attesting for the Medicaid program, do not need to separately
attest in the Medicare program in 2017 and subsequent years, because
the statute does not allow for Medicare EHR incentive payments to
eligible hospitals after FY 2016. If a hospital eligible under both
programs is demonstrating meaningful use for the first time, and using
a continuous 90-day EHR reporting period under the Medicaid program, it
could attest for the Medicaid program only, and still avoid the
Medicare payment adjustment that is 2 years after the calendar year in
which the EHR reporting period occurs. However, if a hospital eligible
under both programs chooses also to attest for the Medicare program, it
would be required to complete an EHR reporting period of 1 full
calendar year to avoid the Medicare payment adjustment that is 2 years
after that calendar year. We note that, consistent with the other
proposed amendments to Sec. 495.4 discussed previously, this proposal
would change the EHR reporting period for eligible hospitals from one
that is based on the federal fiscal year to one that is based on the
calendar year, beginning in 2017. For further discussion of the
relationship between the 90-day EHR reporting period under the Medicaid
EHR Incentive Program and the payment adjustments under Medicare, we
refer readers to section II.D. of this proposed rule.
This policy would allow Medicaid providers flexibility in their
first year of demonstrating meaningful use. It also would reduce the
burden on states to implement significant policy and system changes in
preparation for Stage 3, as the 90-day period for the first year of
meaningful use is consistent with our previous policies and meaningful
use timelines.
2. Reporting Requirements
a. State Reporting on Program Activities
As discussed in section II.A.1.c.(1).(b).(iii). of this proposed
rule, we are adding a new provision at Sec. 495.316(d)(2)(iii) to
provide states with flexibility regarding the Stage 3 public health and
clinical data registry reporting objective.
We also propose to amend Sec. 495.316(c), as well as add a new
paragraph Sec. 495.316(f), to formalize the process of how states
report to us annually on the providers that have attested to adopt,
implement, or upgrade (AIU), or that have attested to meaningful use.
Under this proposal, states would follow a structured submission
process, in the manner prescribed by CMS, which would include a new
annual reporting
[[Page 16780]]
deadline. We propose to require states to submit annual reports to CMS
within 45 days of the end of the second quarter of each federal fiscal
year.
We propose to regularize the timing of the annual reporting process
described in Sec. 495.316 to ensure more timely annual reports and
allow for clearer communication to states on when the reports should be
submitted to CMS. In addition, CMS and states would be able to more
effectively track the progress of states' incentive program
implementation and oversight as well as provider progress in achieving
meaningful use. Predictable deadlines for annual reporting would permit
CMS and the states to more quickly compare and assess overall program
impact each year.
We are also considering changes to the data that the annual
reporting requirements outlined in Sec. 495.316(d) require states to
include in their annual reports. Specifically, we are considering
whether to remove the requirement that states report information about
practice location for providers that qualify for incentive payments on
the basis of having adopted, implemented, or upgraded certified EHR
technology or on the basis of demonstrating they are meaningful users
of certified EHR technology. While we believe that this data is useful
to both CMS and the states for program implementation purposes, we
believe the benefits of including it in state reports might be
outweighed by the burdens to states of reporting it. Therefore, we are
seeking more information on state burdens and costs associated with
complying with this requirement. We solicit comments both on the
burdens associated with the requirement to report practice location
information for providers that receive incentive payments through the
Medicaid EHR Incentive Program, and on the benefits of including this
information in state reports.
We propose to amend Sec. 495.352 to formalize the process of how
states submit quarterly progress reports on implementation and
oversight activities and to specify the elements that should be
included in the quarterly reports. Under this proposal, states would
follow a structured submission process, in the manner prescribed by
CMS. We propose that states would report on the following activities:
State system implementation dates; provider outreach; auditing; state-
specific SMHP tasks; state staffing levels and changes; the number and
type of providers that qualified for an incentive payment on the basis
of demonstrating that they are meaningful EHR users of certified EHR
technology and the amounts of incentive payments; and the number and
type of providers that qualified for an incentive payment on the basis
of having adopted, implemented, or upgraded certified EHR technology
and the amounts of incentive payments.
We propose these changes to the quarterly reporting process
described in Sec. 495.352 so that CMS and states can better track
state implementation and oversight activity progress in a way that
would permit CMS and the states to compare overall programmatic and
provider progress. We also expect that streamlined and enhanced
quarterly progress reporting would lead to an improvement in overall
data quality that would help inform future meaningful use activity
across states.
We would like to include a deadline for states' quarterly reporting
under the proposed amendments to Sec. 495.352, and are considering
requiring states to submit quarterly progress reports to CMS within 30
days after the end of each federal fiscal year quarter. We believe that
a set deadline would improve timeliness and communication, but we do
not want to set a deadline that is overly burdensome for a report that
must be submitted quarterly. We seek public comment on the deadline we
are considering.
b. State Reporting on Meaningful EHR Users
Starting in FY 2015 for eligible hospitals and CY 2015 for EPs,
providers that fail to demonstrate meaningful use for an applicable EHR
reporting period will be subject to downward payment adjustments under
Medicare. As discussed in the Stage 2 final rule (77 FR 54094), EPs who
are meaningful EHR users under the Medicaid EHR Incentive Program for
an applicable EHR reporting period will be considered meaningful EHR
users for that period for purposes of avoiding the Medicare payment
adjustments. Currently, hospitals eligible for both Medicaid and
Medicare incentive payments attest in both the Medicare and Medicaid
systems to earn an incentive payment in both programs. The statute does
not authorize Medicare EHR incentive payments to eligible hospitals
after FY 2016. To avoid duplicative reporting, hospitals eligible under
both programs will not be required to attest in both programs beginning
in 2017. Therefore, we must have accurate and timely data from states
regarding both EPs and eligible hospitals that have successfully
demonstrated meaningful use for each payment year to ensure that
meaningful EHR users in the Medicaid EHR Incentive Program are
appropriately exempted from the Medicare payment adjustment for the
applicable payment adjustment year. This additional reporting is
necessary because the electronic data currently contained in the
National Level Repository are insufficient to determine which Medicaid
providers should be exempted from the Medicare payment adjustments in
an accurate and timely manner. Accordingly, we propose to add new
paragraphs (g) and (h) to Sec. 495.316 to require that states submit
reports on a quarterly basis that identify certain providers that
attested to meaningful use through the Medicaid EHR Incentive Program
for each payment year. Under this proposal, states would submit
quarterly reports for Medicaid EPs and eligible hospitals that
successfully attest to meaningful use for each payment year.
We propose that states would report quarterly, in the manner
prescribed by CMS, information on each provider that successfully
attests to meaningful use, regardless of whether the provider has been
paid yet. The report would be required to specify the Medicaid state
and payment year. For each EP or eligible hospital listed in the
report, the state would also specify the Payment Year Number, the NPI
for EPs and the CCN for eligible hospitals, the Attestation Submission
Date, the State Qualification (as either meaningful use or blank), and
the State Qualification Date (the beginning date of the reporting
period in which successful meaningful use attestation was achieved by
the EP or eligible hospital). The EP or eligible hospital's ``payment
year number'' refers to the number of years that the provider has been
paid in the EHR Incentive Program; so, for example, this would be ``2''
for the 2014 payment year if the provider received payments for 2013
and 2014. States would have this data, even for providers that have
previously received an incentive payment through the Medicare EHR
Incentive Program. If the state is reporting a disqualification, then
the state would leave the State Qualification field blank. If
applicable, in the cases of EPs or eligible hospitals previously
identified as meaningful EHR users, the state would be required to
specify the State Disqualification and State Disqualification Date
(that is, the beginning date of the EHR reporting period during which
an EP or eligible hospital was found not to meet the definition of a
meaningful EHR user).
Under this proposal, states would submit this information beginning
with payment year 2013 data. The reports would cover back to the 2013
payment year because that would be the EHR
[[Page 16781]]
reporting period for the 2015 Medicare payment adjustment year under
Sec. 495.4. Providers that successfully attested to meaningful use for
2013 would be exempt from the Medicare payment adjustment in 2015.
Under this proposal, states would not be required to include
information about certain providers in their reports. We recognize that
several provider types that are eligible for the Medicaid EHR Incentive
Program are not subject to the Medicare payment adjustments.
Accordingly, states would not be required to report on those EPs who
are eligible for the Medicaid EHR Incentive Program on the basis of
being a nurse practitioner, certified nurse-midwife, or physician
assistant.
3. Clinical Quality Measurement for the Medicaid Program
States are, and will continue in Stage 3 to be, responsible for
determining whether and how electronic reporting of CQMs would occur,
or whether they wish to allow reporting through attestation. This is
consistent with our policy in the Stage 2 final rule (77 FR 54075). If
a state does require electronic reporting, the state is responsible for
sharing the details on the process with its provider community. We
anticipate that whatever means states have deployed for capturing
Stages 1 and 2 clinical quality measures electronically would be
similar for reporting in 2017 and subsequent years. However, we note
that subject to our prior approval, this is within the states' purview.
States that wish to establish the method and requirements for
electronically reporting would continue to be required to do so through
the SMHP submission, subject to our prior approval.
To further our goals of alignment and avoiding duplicative
reporting across quality reporting programs, we would recommend that
states include a narrative in their SMHP for CY 2017 describing how
their proposed meaningful use CQM data submission strategy aligns with
their State Medicaid Quality Strategy and report which certified EHR
technology requirements they mandate for eCQM reporting.
For more information on requirements around the State Medicaid
Quality Strategy, see https://medicaid.gov/Federal-Policy-Guidance/Downloads/SHO-13-007.pdf.
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 collection
of information 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 V.C. of this proposed rule. The actual burden would remain
constant for all of Stage 3 as EPs, eligible hospitals, and CAHs would
only need to attest that they have successfully demonstrated meaningful
use in 2017 and annually thereafter. The only variable from year-to-
year in Stage 3 would be the number of respondents, as noted in the
impact analysis assumptions. For the purposes of this analysis, we are
focusing only on 2017, the first year in which a provider may
participate in Stage 3 of the Medicare EHR Incentive Program. We do not
believe the burden for EPs, eligible hospitals, and CAHs participating
in Stages 1 and 2 prior to 2017 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
have the option to electronically report their clinical quality
measures through the respective electronic reporting pilots. For
eligible hospitals and CAHs, the burden is discussed in the CY 2012
Hospital Outpatient Prospective Payment System final rule with comment
period (76 FR 73450 through 73451).
As discussed in section I.A.1.a. of this proposed rule, Stage 3 is
intended to build on Stages 1 and 2 with a focus on advanced use of
certified EHR technology to promote improved patient outcomes while
assuring that the framework is flexible and does not hinder innovation.
In this proposed rule, the definition of meaningful use with associated
reporting requirements would replace all prior definitions and
requirements beginning in 2018. At that point, all eligible providers
would be required to report only Stage 3 requirements on an annual
basis. For 2017, providers may simply repeat their current status at
Stage 1 or Stage 2, or move on to Stage 3. The same reporting time
would apply to all providers. Consequently, the proposed ICRs reflect
the provider burden associated with complying with and reporting of
Stage 3 requirements beginning in 2017 and each subsequent year.
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. 495.6,
Sec. 495.7 and Sec. 495.8)
In Sec. 495.7 we propose that to successfully demonstrate
meaningful use of certified EHR technology for Stage 3, 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--
The provider used certified EHR technology and specified
the technology was used; and
The provider satisfied each of the applicable objectives
and associated measures in Sec. 495.7.
In Sec. 495.8, 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 that require the provider to
attest that they have done so.
We propose that there would be 5 objectives and 10 measures that
would require an EP to enter numerators and denominators during
attestation. Eligible hospitals and CAHs would have to attest they have
met 5 objectives and 10 measures that would require numerators and
denominators. For objectives and associated measures requiring a
numerator and denominator in this proposed rule, we limit our estimates
to actions taken in the presence of certified EHR technology. We do not
anticipate a provider would
[[Page 16782]]
maintain two 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. The security risk assessment and its associated measure
would not require a numerator and denominator and we would expect it
would take an individual provider or designee approximately 6 hours to
complete. The clinical decision support and active engagement with a
public health agency measures would take an eligible professional,
eligible hospital or critical access hospital 1 minute each to report
each CDS intervention or registry.
We propose that EPs would be required to report on a total of 8
objectives and 16 associated measures. For the purpose of this proposed
collection of information, we assumed that all eligible providers would
comply with the requirements of meaningful use Stage 3. We propose that
eligible hospitals and CAHs would be required to report on a total of 8
objectives and 17 associated measures. We estimated the total annual
cost burden for all eligible hospitals and CAHs to attest to EHR
technology, meaningful use objectives and associated measures, and
electronically submit the clinical quality measures would be $2,135,204
(4,900 eligible hospitals and CAHs x 6 hours 52 minutes x $63.46 (mean
hourly rate for lawyers based on May 2013 BLS) data)). We estimate the
total annual cost burden for all EPs to attest to EHR technology,
meaningful use objectives and associated measures, and electronically
submit the clinical quality measures would be $385,834,395 (609,100 EPs
x 6 hours 52 minutes x $92.25 (mean hourly rate for physicians based on
May 2013 BLS) data).
In this proposed rule, there are 5 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 five
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 two 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 each CQM for
providers attesting in their first year of the program.
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 three objectives
that would require a ``yes'' or ``no'' response during attestation. As
discussed previously, the associated measures are that EPs are required
to conduct a security risk analysis, report to three registries to
fulfil the public health objective, and must implement at least five
clinical decision support interventions. For eligible hospitals and
CAHs, there are three objectives that would require a ``yes'' or ``no''
response during attestation. The associated measures for eligible
hospitals and CAHs require the provider to conduct a security risk
analysis, report to four registries to fulfill the public health
objective and must implement at least five clinical decision support
interventions. We estimate each of these measures would take 1 minute
to report.
Providers would also be required to attest that they are protecting
electronic health information. 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 6 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 52 minutes to complete, and would
take an eligible hospital or CAH 6 hours 52 minutes to complete.
In this proposed rule EPs, eligible hospitals, and CAHs have
virtually identical burdens. Eligible hospitals and CAHs are required
to report to one additional registry than EPs are required to report.
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 6--Burden Estimates
----------------------------------------------------------------------------------------------------------------
Burden estimate Burden estimate
Objectives--Eligible Objectives--Eligible Measures per respondent per respondent
professionals hospitals/CAHs (EPs) (hospitals)
----------------------------------------------------------------------------------------------------------------
Protect electronic protected Protect electronic Conduct or review 6 hours.......... 6 hours.
health information (ePHI) protected health a security risk
created or maintained by the information (ePHI) analysis in
CEHRT through the created or maintained accordance with
implementation of appropriate by the CEHRT through the requirements
technical, administrative and the implementation of under 45 CFR
physical safeguards. appropriate 164.308(a)(1),
technical, including
administrative and addressing the
physical safeguards. 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),
implement
security updates
as necessary,
and correct
identified
security
deficiencies as
part of the
provider's risk
management
process.
Generate and transmit Generate and transmit 1. EP Measure: 10 minutes....... 10 minutes.
permissible prescriptions permissible discharge More than 80% of
electronically (eRx.). prescriptions all permissible
electronically (eRx). prescriptions
written by the
EP are queried
for a drug
formulary and
transmitted
electronically
using CEHRT.
[[Page 16783]]
...................... 2. Eligible
Hospital
Measure: More
than 25% of
hospital
discharge
medication
orders for
permissible
prescriptions
(for new and
changed
prescriptions)
are queried for
a drug formulary
and transmitted
electronically
using CEHRT.
Implement clinical decision Implement clinical Measure 1: The 1 minute......... 1 minute.
support (CDS) interventions decision support EP, eligible
focused on improving (CDS) interventions hospital and CAH
performance on high-priority focused on improving must implement
health conditions. performance on high- five clinical
priority health decision support
conditions. interventions
related to four
or more CQMs at
a relevant point
in patient care
for the entire
EHR reporting
period. Absent
four CQMs
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.
Use computerized provider order Use computerized Measure 1: More 10 minutes....... 10 minutes.
entry (CPOE) for medication, provider order entry than 80 percent
laboratory, and diagnostic (CPOE) for of medication
imaging orders directly medication, orders created
entered by any licensed laboratory, and by the EP or
healthcare professional, diagnostic imaging authorized
credentialed medical orders directly providers of the
assistant, or a medical staff entered by any eligible
member credentialed to and licensed healthcare hospital's or
performing the equivalent professional, CAH's inpatient
duties of a credentialed credentialed medical or emergency
medical assistant; who can assistant, or a department (POS
enter orders into the medical medical staff member 21 or 23) during
record per state, local, and credentialed to and the EHR
professional guidelines. performing the reporting period
equivalent duties of are recorded
a credentialed using
medical assistant; computerized
who can enter orders provider order
into the medical entry..
record per state,
local, and
professional
guidelines.
...................... Measure 2: More
than 60 percent
of laboratory
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
computerized
provider order
entry
...................... Measure 3: More
than 60 percent
of diagnostic
imaging 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
computerized
provider order
entry.
The EP provides access for The eligible hospital Measure 1: For 10 minutes....... 10 minutes.
patients to view online, or CAH provides more than 80
download, and transmit their access for patients percent of all
health information, or to view online, unique patients
retrieve their health download, and seen by the EP
information through an API, transmit their health or discharged
within 24 hours of its information, or from the
availability. retrieve their health eligible
information through hospital or CAH
an API, within 24 inpatient or
hours of its emergency
availability. department (POS
21 or 23):
...................... (1) The patient
(or the patient
authorized
representative)
is provided
access to view
online,
download, and
transmit his or
her health
information
within 24 hours
of its
availability to
the provider; or
...................... (2) The patient
(or the patient
authorized
representative)
is provided
access to an ONC-
certified API
that can be used
by third-party
applications or
devices to
provide patients
(or patient
authorized
representatives)
access to their
health
information,
within 24 hours
of its
availability to
the provider
[[Page 16784]]
...................... Measure 2: The
EP, eligible
hospital or CAH
must use
clinically
relevant
information from
CEHRT to
identify patient-
specific
educational
resources and
provide
electronic
access to those
materials to
more than 35
percent of
unique patients
seen by the EP
or discharged
from the
eligible
hospital or CAH
inpatient or
emergency
department (POS
21 or 23) during
the EHR
reporting
period.
Use communications functions of Use communications Measure 1: During 10 minutes....... 10 minutes.
certified EHR technology to functions of the EHR
engage with patients or their certified EHR reporting
authorized representatives technology to engage period, more
about the patient's care. with patients or than 25 percent
their authorized of all unique
representatives about patients seen by
the patient's care the EP or
discharged from
the eligible
hospital or CAH
inpatient or
emergency
department (POS
21 or 23)
actively engage
with the
electronic
health record
made accessible
by the provider.
An EP may meet
the measure by
either--.
...................... (1) More than 25
percent of all
unique patients
(or patient-
authorized
representatives)
seen by the EP
or discharged
from the
eligible
hospital or CAH
during the EHR
reporting period
view, download
or transmit to a
third party
their health
information; or
...................... (2) More than 25
percent of all
unique patients
(or patient-
authorized
representatives)
seen by the EP
or discharged
from the
eligible
hospital or CAH
inpatient or
emergency
department (POS
21 or 23) during
the EHR
reporting period
access their
health
information
through the use
of an ONC-
certified API
that can be used
by third-party
applications or
devices.
...................... Measure 2: During
the EHR
reporting
period, for more
than 35 percent
of all unique
patients seen by
the EP or
discharged from
the eligible
hospital or CAH
during the EHR
reporting
period, a secure
message was sent
using the
electronic
messaging
function of
CEHRT to the
patient (or
their authorized
representatives)
, or in response
to a secure
message sent by
the patient.
...................... Measure 3:
Patient-
generated health
data or data
from a non-
clinical setting
is incorporated
into the
certified EHR
technology for
more than 15
percent of all
unique patients
seen by the EP
or discharged by
the eligible
hospital or CAH
during the EHR
reporting
period.
The EP provides a summary of The eligible hospital Measure 1: For 10 minutes....... 10 minutes.
care record when transitioning or CAH provides a more than 50
or referring their patient to summary of care percent of
another setting of care, record when transitions of
retrieves a summary of care transitioning or care and
record upon the first patient referring their referrals, the
encounter with a new patient, patient to another EP, eligible
and incorporates summary of setting of care, hospital or CAH
care information from other retrieves a summary that transitions
providers into their EHR using of care record upon or refers their
the functions of certified EHR the first patient patient to
technology. encounter with a new another setting
patient, and of care or
incorporates summary provider of
of care information care--(1)
from other providers creates a
into their EHR using summary of care
the functions of record using
certified EHR CEHRT; and (2)
technology. electronically
exchanges the
summary of care
record.
...................... Measure 2: For
more than 40
percent of
transitions or
referrals
received and
patient
encounters in
which the
provider has
never before
encountered the
patient, the EP,
eligible
hospital or CAH
incorporates
into the
patient's record
in their EHR an
electronic
summary of care
document from a
source other
than the
provider's EHR
system.
[[Page 16785]]
...................... Measure 3: For
more than 80
percent of
transitions or
referrals
received and
patient
encounters in
which the
provider has
never before
encountered the
patient, the EP,
eligible
hospital, or CAH
performs
clinical
information
reconciliation.
The provider
would choose at
least two of the
following three
clinical
information sets
on which to
perform
reconciliations:
...................... Medication.
Review of the
patient's
medication,
including the
name, dosage,
frequency, and
route of each
medication.
...................... Medication
allergy. Review
of the patient's
known allergic
medications.
...................... Current Problem
list. Review of
the patient's
current and
active
diagnoses.
The EP is in active engagement The eligible hospital Providers must 1 minute......... 1 minute.
with a PHA or CDR to submit or CAH is in active report data on
electronic public health data engagement with a PHA an ongoing basis
in a meaningful way using or CDR to submit to established
certified EHR technology, electronic public public health
except where prohibited, and health data in a registries.
in accordance with applicable meaningful way using
law and practice. certified EHR
technology, except
where prohibited, and
in accordance with
applicable law and
practice.
...................... 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).
...................... 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).
...................... 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.
...................... 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.
...................... Measure 5:
Clinical Data
Registry
Reporting: The
EP, eligible
hospital, or CAH
is in active
engagement to
submit data to a
clinical data
registry.
...................... 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
...................... EP Objective:
report to 3 of
the following
registries:
Immunization.....
Syndromic
Surveillance.
Case Reporting...
Public Health....
Clinical Data....
...................... EPs may choose to
report to more
than one public
health registry
to meet the
number of
measures
required to meet
the objective.
...................... EPs may choose to
report to more
than one
clinical data
registry to meet
the number of
measures
required to meet
the objective.
[[Page 16786]]
...................... EH/CAH Objective:
report to 4 of
the following
registries:
Immunization.....
Syndromic
Surveillance.
Case Reporting...
Public Health....
Clinical Data....
Electronic
Reportable
Laboratory
Results..
...................... Eligible
hospitals and
CAHs may choose
to report to
more than one
public health
registry to meet
the number of
measures
required to meet
the objective.
...................... Eligible
hospitals and
CAHs may choose
to report to
more than one
clinical data
registry to meet
the number of
measures
required to meet
the objective.
--------------------------------------------------------------------------------
Criteria Burden Time to ...................... ................. 6 hours 52 6 hours 52
Attest and Report Clinical minutes. minutes.
Quality Measures.
-------------------------------------
Total--Criteria Burden. ...................... ................. 6 hours 52 6 hours 52
minutes. minutes.
----------------------------------------------------------------------------------------------------------------
In this proposed rule, we estimate that it would take no longer
than 6 hours and 52 minutes for an EP to satisfy each of the applicable
objectives and associated measures. The total burden hours for an EP to
attest to the criteria previously specified would be 6 hours 52
minutes. We estimate that there could be approximately 609,100 non-
hospital-based Medicare and Medicaid EPs in 2017.
We estimate the burden for the approximately 13,635 MA EPs in the
MAO burden section. We estimate the total burden associated with these
requirements for an EP would be 6 hours 52 minutes. The total estimated
annual cost burden for all EPs to attest to EHR technology and
meaningful use objectives would be $385,834,395 (506,400 x 6 hours 52
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 core meaningful use objectives and associated measures, and
would electronically submit the clinical quality measures. We estimate
that it would take no longer, than 6 hours and 52 minutes to attest
that during the EHR reporting period, they used the certified EHR
technology, specify the EHR technology used and satisfied each of the
applicable objectives and associated measures. We estimate that there
are about 4,900 eligible hospitals and CAHs (3,397 acute care
hospitals, 1,395 CAHs, 97 children's hospitals, and 11 cancer
hospitals) that may attest to the aforementioned criteria in FY 2017.
We estimate the total burden associated with these requirements for an
eligible hospital and CAH would be 6 hours 52 minutes. The total
estimated annual cost burden for all eligible hospitals and CAHs to
attest to EHR technology, meaningful use core set and menu set
criteria, and electronically submit the clinical quality measures would
be $2,135,204 (4,908 eligible hospitals and CAHs x $63.46 (6 hours 52
minutes x $63.46 (mean hourly rate for lawyers based on May 2013 BLS)
data)).
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 in Stage 3, 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 together 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 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
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, we believe it would cost the
participating qualifying MA organizations approximately $426,050
annually to make the attestations ([10,226 hours x $25.00] + [3,408
hours x $50.00]).
C. ICR Regarding State Reporting Requirements (Sec. 495.316 and Sec.
495.352)
We are proposing to revise 42 CFR 495 regarding state reporting
requirements to CMS. With respect to the annual reporting requirements
in Sec. 495.316 and the quarterly reporting requirements in Sec.
495.352, we do not believe that the proposed amendments to these
reporting requirements would increase the burden on states beyond what
was previously finalized under OMB control number 0938-1158 following
the Stage 2 final rule. The
[[Page 16787]]
deadlines we propose or are considering would be consistent with our
past practice, and the changes we propose or consider to the data
elements to be reported on would be either reduced or similar in
burden. Similarly, we do not expect the proposed amendments regarding
the 90-day EHR reporting period for first time meaningful users would
impose a burden on states because those amendments would generally
maintain the current policy.
However, we are proposing to revise Sec. 495.316 to include a new
quarterly reporting requirement. Under the proposed amendment, states
would report quarterly to CMS regarding the EPs and Medicaid eligible
hospitals that have successfully demonstrated meaningful use for each
payment year. We need this information to ensure that those EPs who are
meaningful EHR users in the Medicaid EHR Incentive Program are
appropriately exempted from the Medicare payment adjustment. We cannot
accurately exempt these providers using the current data received from
states. We expect that it would take a state 20 hours each year to
submit this report on a quarterly basis. We believe that the state
employee reporting the information could be equivalent to a GS 12, step
1 (2015 unadjusted for locality rate), with an hourly rate of
approximately $30.00/hour. This amount is then reduced by the 90
percent federal contribution for administrative services for Medicaid
under the EHR Incentive Programs, this equates to approximately $3.00/
hour. Therefore, for all state Medicaid agencies to report four times
per year at 20 hours per report the estimated cost is $13,460 (4560
hours x $3.00/hour).
Table 7--Estimated Annual Information Collection Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per Hourly labor
Reg section OMB Control Number of Number of response Total annual cost of Total cost ($)
No. respondents responses (hours) burden (hours) reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 495.x--Objectives/Measures (EPs). 0938-1158 609,100 609,100 6.86 4,178,426 92.25 385,834,395
Sec. 495.6--Objectives/Measures 0938-1158 4,900 4,900 6.86 33,614 63.46 2,135,204
(hospitals/CAHs).......................
Sec. 495.210--Gather information for 0938-1158 13,635 13,635 0.75 10,226 25.00 255,650
attestation (MA EPs)...................
Sec. 495.210--Attestation on behalf of 0938-1158 13,635 13,635 0.25 3408.75 50.00 170,400
MA EPs.................................
Sec. 495.316--Quarterly Reporting..... 0938-1158 56 224 20 4480 3.00 13,440
-----------------------------------------------------------------------------------------------
Totals.............................. .............. 627,635 627,635 .............. 4,225,674 .............. 388,408,189
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
All non-whole numbers in this table are rounded to 2 decimal places.
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 7.
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 final rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
[CMS-3310-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. This proposed rule specifies
applicable criteria for demonstrating Stage 3 of meaningful use.
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).
This proposed rule is anticipated to have an annual effect on the
economy of $100 million or more, making it an economically significant
rule under the Executive Order and a major rule under the Congressional
Review Act. Accordingly, we have prepared a Regulatory Impact Analysis
(RIA) that presents the estimated costs and benefits of this proposed
rule.
As noted in section I.A.2. of this proposed rule, this proposed
rule is one of two coordinated rules related to the
[[Page 16788]]
meaningful use of certified EHR technology. The other is ONC's 2015
Edition Health Information Technology (Health IT) Certification
Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition,
and ONC Health IT Certification Program Modifications proposed
elsewhere in this issue of the Federal Register. This analysis focuses
on the impact associated with Stage 3 requirements for meaningful use,
the changes in quality measures that would take effect beginning in
2017, and other changes being proposed for the Medicare and Medicaid
EHR Incentive Programs.
As we discussed in the Stage 2 final rule (77 FR 54163 through
54291), a number of factors would affect the adoption of EHR systems
and demonstration of meaningful use. In this proposed rule, we continue
to believe that a number of factors would affect the adoption of EHR
systems and demonstration of meaningful use. Readers should understand
that these forecasts are also subject to substantial uncertainty since
demonstration of meaningful use will depend not only on the standards
and requirements for 2017 and for eligible hospitals and EPs, but on
future rulemakings issued by the HHS.
We further stated in the 2012 Stage 2 final rule (77 FR 54135
through 54136), the statute provides Medicare and Medicaid incentive
payments for the meaningful use of certified EHR technology.
Additionally, the Medicaid program also provides incentives for the
adoption, implementation, and upgrade of certified EHR technology.
Beginning in 2015, payment adjustments are incorporated into the
Medicare EHR Incentive Program for providers unable to demonstrate
meaningful use. The absolute and relative strength of these is unclear.
For example, a provider with relatively small Medicare billings will be
less disadvantaged by payment adjustments than one with relatively
large Medicare billings. Another uncertainty arises because there are
likely to be ``bandwagon'' effects as the number of providers using
EHRs rises, thereby inducing more participation in the incentives
program, as well as greater adoption by entities (for example, clinical
laboratories) that are not eligible for incentives or subject to
payment adjustments, but do business with EHR adopters. It is
impossible to predict exactly if and when such effects may take hold.
An uncertainty arises because under current law, physicians are
scheduled for a large payment reduction in April 2015 under the
sustainable growth rate (SGR) formula, which determines Medicare
physician payment updates. A large payment reduction could cause major
changes in physician behavior, enrollee care, and other Medicare
provider payments, but the specific nature of these changes is
uncertain. Under current law, the remaining EHR incentives for Medicaid
or the Medicaid payment adjustments will exert only a minor influence
on physician behavior relative to this large physician payment
reduction. However, the Congress has legislatively avoided a large
physician payment reduction for each year since 2002.
All of these factors taken together make it impossible in this
proposed rule to predict with precision the timing or rates of adoption
and meaningful use. However, new data is currently available regarding
rates of adoption or costs of implementation since the publication of
our Stage 1 and Stage 2 final rules. We have included the new data in
our estimates, although even these forecasts are still fairly
uncertain.
Overall, in this proposed rule, we expect spending under the EHR
incentive program for transfer payments to Medicare and Medicaid
providers between 2017 and 2020 to be $3.7 billion (this estimate
includes net payment adjustments for Medicare providers who do not
achieve meaningful use in the amount of $0.8 billion). We have also
estimated ``per entity'' costs for EPs, eligible hospitals, and CAHs
for implementation/maintenance and reporting requirement costs, not all
costs. We believe many adopting entities may achieve dollar savings at
least equal to their total costs, and that there may be additional
benefits to society. We also believe that implementation costs are
significant for each participating entity because providers who were
like to qualify as meaningful users of EHRs were likely to purchase
certified EHR technology. However, we believe that providers who have
already purchased certified EHR technology and participated in Stage 1
or Stage 2 of meaningful use will experience significantly lower costs
for participation in the program. We continue to believe that the
short-term costs to demonstrate meaningful use of certified EHR
technology may be outweighed by the long-term benefits, including
practice efficiencies and improvements in medical outcomes. Although
both cost and benefit estimates are highly uncertain, the RIA that we
have prepared presents the estimated costs and benefits of this
proposed rule.
C. Anticipated Effects
The objective of the remainder of this proposed RIA is to summarize
the costs and benefits of the HITECH Act incentive program for the
Medicare FFS, Medicaid, and MA programs. We also provide assumptions
and a narrative addressing the potential costs to the health care
industry for implementation of this technology.
1. Overall Effects
a. EHR Technology Development and Certification Costs
We note that the costs incurred by IT developers for EHR technology
development and certification to the 2015 Edition certification
criteria for health IT are also in part attributable to the
requirements for the use of CEHRT established in this proposed rule for
Stage 3 of the EHR Incentive Programs. Therefore, to the extent that
providers' implementation and adoption costs are attributable to this
proposed rule, health IT developers' preparation and development costs
would also be attributable as these categories of activities may be
directly or indirectly incentivized by the requirements to demonstrate
meaningful use. However, even if this Stage 3 proposed rule were not
finalized, other CMS programs (for example PQRS and IQR) do require or
promote certification to ONC's criteria--or a professional organization
or other such entity could require or promote certification to ONC's
critieria.\13\ As noted previously, this analysis focuses on the impact
associated with Stage 3 requirements for meaningful use for providers;
while the development and certification costs are addressed in the the
2015 Edition proposed rule published elsewhere in this issues of the
Federal Register.
---------------------------------------------------------------------------
\13\ In this case, the provider implementation and adoption
costs discussed in this CMS RIA would instead be attributable to
ONC's rulemaking.
---------------------------------------------------------------------------
b. 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 regulation will not have a significant impact on a
substantial number of small entities. In the health care 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.
[[Page 16789]]
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 would be economically
significant. Accordingly, this RIA section, in conjunction with the
remainder of the preamble, constitutes the required Initial Regulatory
Flexibility Analysis (IRFA). We believe that the adoption and
meaningful use of EHRs will have an impact on virtually every EP and
eligible hospital, as well as CAHs and some EPs and hospitals
affiliated with MA organizations. While the program is voluntary, in
the first 5 years it carries substantial positive incentives that make
it attractive to virtually all eligible entities. Furthermore, entities
that do not demonstrate meaningful use of EHR technology for an
applicable reporting period will be subject to significant Medicare
payment reductions beginning in 2015. These Medicare payment
adjustments are expected to motivate EPs, eligible hospitals, and CAHs
to adopt and meaningfully use certified EHR technology.
For some EPs, CAHs, and eligible hospitals the EHR technology
currently implemented could be upgraded to meet the criteria for
certified EHR technology as defined for this program. These costs may
be minimal, involving no more than a software upgrade. ``Home-grown''
EHR systems that might exist may also require an upgrade to meet the
certification requirements. We believe many currently used non-
certified EHR systems will require significant changes to achieve
certification and that EPs, CAHs, and eligible hospitals will have to
make process changes to achieve meaningful use.
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. 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. The costs for implementation and
complying with the criteria of meaningful use could lead to higher
operational expenses. However, 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)
will demonstrate the actual costs incurred by providers participating
in the EHR Incentive Programs.
(2) Conclusion
As discussed later in this analysis, we believe that there are many
positive effects of adopting EHR on health care providers. We believe
that the net effect on some individual providers may be positive.
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 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. This proposed rule would
affect the operations of a substantial number of small rural hospitals
because they may be subject to adjusted Medicare payments in 2015 if
they fail to adopt certified EHR technology by the applicable reporting
period. As stated previously, we have determined that this proposed
rule would create a significant impact on a substantial number of small
entities, and have prepared a Regulatory Flexibility Analysis as
required by the RFA and, for small rural hospitals, section 1102(b) of
the Act. Furthermore, any impacts that would arise from the
implementation of certified EHR technology in a rural eligible hospital
would be positive, with respect to the streamlining of care and the
ease of sharing information with other EPs to avoid delays,
duplication, or errors. However, the Secretary retains the
discretionary statutory authority to make case-by-case exceptions for
significant hardships, and has already established certain categories
where case-by-case applications may be made such as barriers to
internet connectivity that impact health information exchange.
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 2014,
that threshold is approximately $141 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
[[Page 16790]]
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.
The investments needed to meet the meaningful use standards and
obtain incentive funding are voluntary, and hence not ``mandates''
within the meaning of the statute. However, the potential reductions in
Medicare reimbursement beginning with FY 2015 would have a negative
impact on providers that fail to meaningfully use certified EHR
technology for the applicable reporting period. We note that we have no
discretion as to the amount of those potential payment reductions.
Private sector EPs that voluntarily choose not to participate in the
program may anticipate potential costs in the aggregate that may exceed
$141 million. However, because EPs may choose for various reasons not
to participate in the program, we do not have firm data for the
percentage of participation within the private sector. This RIA, taken
together with the remainder of the preamble, constitutes the analysis
required by UMRA.
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 will not have a substantial direct effect on state or
local governments, preempt state law, or otherwise have a federalism
implication. Importantly, state Medicaid agencies are receiving 100
percent match from the federal government for incentives paid and a 90-
percent match for expenses associated with administering the program.
As previously stated, we believe that state administrative costs are
minimal. We note that this proposed rule does add a new business
requirement for states, because of the existing systems that would need
to be modified to track and report on the new meaningful use
requirements for provider attestations. We are providing 90-percent FFP
to states for modifying their existing EHR Incentive Program systems.
We believe the federal share of the 90-percent match will protect the
states from burdensome financial outlays and as noted previously,
states offer the Medicaid EHR incentive program at their option.
2. Effects on EPs, Eligible Hospitals, and CAHs
a. Background and Assumptions
The principal costs of this proposed rule are the additional
expenditures that will be undertaken by eligible entities in order to
obtain the Medicare and Medicaid incentive payments to adopt, implement
or upgrade and/or demonstrate meaningful use of certified EHR
technology, and to avoid the Medicare payment adjustments that will
ensue if they fail to do so. The estimates for the provisions affecting
Medicare and Medicaid EPs, eligible hospitals, and CAHs are somewhat
uncertain for several reasons: (1) The program is voluntary although
payment adjustments will be imposed on Medicare providers beginning in
2015 if they are unable to demonstrate meaningful use for the
applicable reporting period; (2) the criteria for the demonstration of
meaningful use of certified EHR technology has been finalized for Stage
1 and Stage 2 and is being proposed for Stage 3, but may change over
time; and (3) the impact of the financial incentives and payment
adjustments on the rate of adoption of certified EHR technology by EPs,
eligible hospitals, and CAHs is difficult to predict based on the
information we have currently collected. The net costs and savings
shown for this program represent a possible scenario and actual impacts
could differ substantially.
Based on input from a number of internal and external sources, we
estimated the numbers of EPs and eligible hospitals, including CAHs
under Medicare, Medicaid, and MA and used them throughout the analysis.
About 675,500 Medicare FFS EPs in 2017 (some of whom will
also be Medicaid EPs).
About 60,600 non-Medicare eligible EPs (such as dentists,
pediatricians, and eligible non-physicians such as certified nurse-
midwives, nurse practitioners, and physicians assistants) could be
eligible to receive the Medicaid incentive payments in 2017.
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)
All eligible hospitals, except for children's and cancer
hospitals, may qualify and apply for both Medicare and Medicaid
incentive payments.
About 16 MA organizations
b. Industry Costs and Adoption Rates
In the Stage 2 final rule (77 FR 54136 through 54146), we estimated
the impact on health care providers using information from four
studies. In the absence of any more recent estimates that we are aware
of, in this proposed rule, we continue to use the same estimates cited
in the Stage 2 final rule. We continue to believe that these estimates
are reasonably reflective of EHR costs. However, we note, we are unable
to delineate all costs due to the great variability in characteristics
among the entities that are affected by the proposed rule; the
variability includes, but is not limited to, the size of the practice,
extent of use of electronic systems, type of system used, number of
staff using the EHR system and the cost for maintaining and/or
upgrading systems. Based on these studies and current average costs for
available certified EHR technology products, we continue to estimate
for EPs that the average adopt/implement/upgrade cost is $54,000 per
physician FTE, while annual maintenance costs average $10,000 per
physician FTE.
For all eligible hospitals, we continue to estimate the range is
from $1 million to $100 million. Although reports vary widely, we
continue to anticipate that the average will be $5 million to achieve
meaningful use, because providers who will like to qualify as
meaningful users of EHRs will need to purchase certified EHRs. We
further acknowledge ``certified EHRs'' may differ in many important
respects from the EHRs currently in use and may differ in the
functionalities they contain. We continue to estimate $1 million for
maintenance, upgrades, and training each year. Both of these estimates
are based on average figures provided in the 2008 CBO report. However,
as noted previously, we are unable to delineate all costs due to the
great variability in characteristics among the entities that are
affected by the proposed rule; the variability includes, but is not
limited to, the size of the hospital, extent of use of electronic
systems, type of system used, number of staff using the EHR system and
the cost for maintaining and/or upgrading systems.
Industry costs are important, in part, because EHR adoption rates
will be a function of these industry costs and the extent to which the
costs of ``certified EHRs'' are higher than the total value of EHR
incentive payments available to EPs and eligible hospitals (as well as
adjustments, in the case of the Medicare
[[Page 16791]]
EHR incentive program) and any perceived benefits including societal
benefits. Because of the uncertainties surrounding industry cost
estimates, we have made various assumptions about adoption rates in the
following analysis in order to estimate the budgetary impact on the
Medicare and Medicaid programs.
c. Costs of EHR Adoption for EPs
Since the publication of the Stage 1 final rule, there has been
little data published regarding the cost of EHR adoption and
implementation. A 2011 study (https://content.healthaffairs.org/content/30/3/481.abstract) estimated costs of implementation for a five-
physician practice to be $162,000, with $85,500 in maintenance expenses
in the first year. In the absence of additional data regarding the cost
of adoption and implementation costs for certified EHR technology, we
proposed to continue to estimate for EPs that the average adopt/
implement/upgrade cost is $54,000 per physician FTE, while annual
maintenance costs average $10,000 per physician FTE, based on the cost
estimate of the Stage 1 final rule. However, as noted previously, we
are unable to delineate all costs due to the great variability that are
affected by but not limited to the size of the practice, extent of use
of electronic systems, type of system used, number of staff using the
EHR system, and the cost for maintaining and/or upgrading systems.
d. Costs of EHR Adoption for Eligible Hospitals
According to the American Hospital Association 2008 Survey, the
range in yearly information technology spending among hospitals ranged
from $36,000 to over $32 million. EHR system costs specifically were
reported by other experts to run as high as $20 million to $100 million
(77 FR 54139). We note that recently we have seen about 96 percent of
eligible hospitals have received at least one incentive payment under
either the Medicare or Medicaid programs. However, as noted previously,
we are unable to delineate all costs due to the great variability that
are affected by but not limited to the size of the eligible hospital,
extent of use of electronic systems, type of system used, number of
staff using the EHR system, and the cost for maintaining and/or
upgrading systems.
3. Medicare Incentive Program Costs
The estimates for the HITECH Act provisions are based on the
economic assumptions underlying the President's FY 2016 Budget. Under
the statute, Medicare incentive payments for certified EHR technology
are excluded from the determination of MA capitation benchmarks. We
continue to expect a negligible impact on benefit payments to hospitals
and EPs from Medicare and Medicaid because of the implementation of EHR
technology.
As noted at the beginning of this analysis, it is difficult to
predict the actual impacts of the HITECH Act with great certainty. We
believe the assumptions and methods described herein are reasonable for
estimating the financial impact of the provisions on the Medicare and
Medicaid programs, but acknowledge the wide range of possible outcomes.
a. Medicare Eligible Professionals (EPs)
We began making EHR Incentive payments in 2011. Medicare payments
are to be paid for the successful demonstration on meaningful use
through CY 2016. Due to the payment lag, some payments may be issued in
CY 2017. To avoid the Medicare payment adjustment beginning in 2015,
EPs need to successfully demonstrate meaningful use regardless of
whether they earn an incentive payment. We estimated the percentage of
the remaining EPs who would be meaningful users each calendar year.
Table 8 shows the results of these calculations.
Table 8--Medicare EPS Demonstrating Meaningful Use of Certified EHR Technology
----------------------------------------------------------------------------------------------------------------
Calendar year
---------------------------------------------------------------
2017 2018 2019 2020
----------------------------------------------------------------------------------------------------------------
Medicare EPs who have claims with Medicare 675.5 683.3 691.1 698.8
(thousands)....................................
Non-Hospital-based Medicare EPs (thousands)..... 609.1 616.1 623.1 630.1
Percent of EPs who are Meaningful Users......... 70 73 75 78
Meaningful Users (thousands).................... 426.4 446.7 467.3 488.3
----------------------------------------------------------------------------------------------------------------
Our estimates of the incentive payment costs and payment adjustment
savings are presented in Table 9. They reflect actual historical data
and our assumptions about the proportion of EPs who will demonstrate
meaningful use of certified EHR technology. Estimated costs are
expected to decrease in 2017 through 2020 due to a smaller number of
new EPs that would achieve meaningful use and the cessation of the
incentive payment program. Payment adjustment receipts represent the
estimated amount of money collected due to the payment adjustments for
those not achieving meaningful use. Estimated net costs for the
Medicare EP portion of the HITECH Act are also shown in Table 9.
Table 9--Estimated Costs (+) and Savings (-) for Medicare EPS Demonstrating Meaningful Use of Certified EHR
Technology
[In Billions]
----------------------------------------------------------------------------------------------------------------
Payment
Fiscal Year Incentive adjustment Benefit Net total
payments receipts payments
----------------------------------------------------------------------------------------------------------------
2017............................................ $0.6 -$0.2 -- $0.3
2018............................................ -- -0.2 -- -0.2
2019............................................ -- -0.2 -- -0.2
2020............................................ -- -0.1 -- -0.1
----------------------------------------------------------------------------------------------------------------
[[Page 16792]]
b. Medicare Eligible Hospitals and CAHs
In brief, the estimates of hospital adoption were developed by
calculating projected incentive payments and then making assumptions
about how rapidly hospitals would adopt meaningful use.
Specifically, the first step in preparing estimates of Medicare
program costs for eligible hospitals was to determine how many eligible
hospitals already received payments under the EHR Incentive program and
for what years those payments were received. In order to do this, we
used the most recent available data that listed the recipients of
incentive payments, and the year and payment amount. This information
pertained to eligible hospitals receiving payments through September
2014.
We assume that all eligible hospitals that receive a payment in the
first year will receive payments in future years. We also assume the
eligible hospitals that have not yet received any incentive payments
will eventually achieve meaningful use (either to receive incentive
payments or to avoid payment adjustments). We assume that all eligible
hospitals would achieve meaningful use by 2018. No new incentive
payments would be paid after 2016. However, some incentive payments
originating in 2016 would be paid in 2017.
The average incentive payment for each eligible hospital was $1.5
million in the first year. In later years, the amount of the incentive
payments drops according to the schedule allowed in law. The average
incentive payment for CAHs received in the first year was about
$950,000. The average incentive payment received in the second year was
about $332,500. The average incentive payment received in the third
year was about $475,000. These average amounts were used for these
incentive payments in the future. The third year average was also used
for the fourth year. These assumptions about the number of hospitals
achieving meaningful use in a particular year and the average amount of
an incentive payment allows us to calculate the total amount of
incentive payments to be made and the amount of payment adjustments for
those hospitals who have not achieved meaningful use. The payment
incentives available to hospitals under the Medicare and Medicaid EHR
Incentive Programs are included in our regulations at 42 CFR part 495.
We further estimate that there are 16 MA organizations that might be
eligible to participate in the incentive program. Those plans have 32
eligible hospitals. The costs for the MA program have been included in
the overall Medicare estimates.
The estimated payments to eligible hospitals were calculated based
on the hospitals' qualifying status and individual incentive amounts
under the statutory formula. Similarly, the estimated payment
adjustments for non-qualifying hospitals were based on the market
basket reductions and Medicare revenues. The estimated savings in
Medicare eligible hospital benefit expenditures resulting from the use
of hospital certified EHR systems were discussed earlier in this
section. We assumed no future growth in the total number of hospitals
in the U.S. because growth in acute care hospitals has been minimal in
recent years. The results are shown in Table 10.
Table 10--Estimated Costs (+) and Savings (-) for Medicare Eligible Hospitals Demonstrating Meaningful Use of
Certified EHR Technology
[In billions]
----------------------------------------------------------------------------------------------------------------
Payment
Fiscal year Incentive adjustment Benefit Net total
payments receipts payments
----------------------------------------------------------------------------------------------------------------
2017............................................ $1.6 (\1\) (\1\) $1.6
2018............................................ 0.0 (\1\) (\1\) (\1\)
2019............................................ 0.0 0.0 (\1\) (\1\)
2020............................................ 0.0 0.0 (\1\) (\1\)
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million. All numbers are projections.
4. Medicaid Incentive Program Costs
Under section, 4201 of the HITECH Act, states and territories can
voluntarily participate in the Medicaid EHR Incentive Program. However,
as of the writing of this proposed rule, all states already
participate. The payment incentives available to EPs and eligible
hospitals under the Medicaid EHR Incentive Program are included in our
regulations at 42 CFR part 495. The federal costs for Medicaid
incentive payments to providers who can demonstrate meaningful use of
EHR technology were estimated similarly to the estimates for Medicare
eligible hospitals and EPs. Table 11 shows our estimates for the net
Medicaid costs for eligible hospitals and EPs.
Table 11--Estimated Federal Costs (+) and Savings (-) Under Medicaid
[In $billions]
----------------------------------------------------------------------------------------------------------------
Incentive payments
-------------------------------- Benefit
Fiscal year Eligible payments Net total
Hospitals professionals
----------------------------------------------------------------------------------------------------------------
2017............................................ 0.4 0.8 (\1\) 1.2
2018............................................ 0.1 0.5 (\1\) 0.6
2019............................................ 0 0.3 (\1\) 0.3
2020............................................ 0.0 0.2 (\1\) 0.2
----------------------------------------------------------------------------------------------------------------
\1\ Savings of less than $50 million.
a. Medicaid EPs
[[Page 16793]]
Table 12--Assumed Number of Nonhospital Based Medicaid EPS Who Would Be Meaningful Users of Certified EHR
Technology
[Population figures in thousands]
----------------------------------------------------------------------------------------------------------------
Calendar year
---------------------------------------------------
2017 2018 2019 2020
----------------------------------------------------------------------------------------------------------------
A................................... EPs who meet the 101.3 102.3 103.3 104.4
Medicaid patient
volume threshold.
B................................... Medicaid only Eps..... 60.6 61.7 62.9 64.0
Total Medicaid EPs (A 161.8 164.0 166.2 168.4
+ B).
Percent of EPs 44.7% 30.9% 20.7% 14.3%
receiving incentive
payment during year.
Number of EPs 72.4 50.7 34.5 24.0
receiving incentive
payment during year.
Percent of EPs who 67.9% 74.7% 78.0% 81.1%
have ever received
incentive payment.
Number of EPs who have 109.9 122.5 129.6 136.6
ever received
incentive payment.
----------------------------------------------------------------------------------------------------------------
It should be noted that since the Medicaid EHR Incentive Program
provides that a Medicaid EP can receive an incentive payment in his or
her 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 not only meaningful users
but eligible providers implementing certified EHR technology as well.
b. Medicaid Hospitals
Medicaid incentive payments to most eligible hospitals were
estimated using the same methodology as described previously for
Medicare eligible hospitals and shown in Table 10. Many eligible
hospitals may qualify to receive both the Medicare and Medicaid
incentive payment. We assume that all eligible hospitals would achieve
meaningful use by 2016. However, many of these eligible hospitals would
have already received the maximum amount of incentive payments. Table
13 shows our assumptions about the remaining incentive payments to be
paid.
Table 13--Estimated Percentage of Hospitals That Could Be Paid for
Meaningful Use and Estimated Percentage Payable in Year
------------------------------------------------------------------------
Percent of
hospitals who Percent of
Fiscal year are meaningful hospitals
users being paid
------------------------------------------------------------------------
2017.................................... 100.0 13.5
2018.................................... 100.0 5.2
2019.................................... 100.0 1.5
2020.................................... 100.0 0.0
------------------------------------------------------------------------
As stated previously, the estimated eligible hospital incentive
payments were calculated based on the eligible hospitals' qualifying
status and individual incentive amounts payable under the statutory
formula. The average Medicaid incentive payment in the first year was
$1 million. The estimated savings in Medicaid benefit expenditures
resulting from the use of certified EHR technology are discussed in
section V.C.4. of this proposed rule. Since we use Medicare data and
little data existed for children's hospitals, we estimated the Medicaid
incentives payable to children's hospitals as an add-on to the base
estimate, using data on the number of children's hospitals compared to
non-children's hospitals.
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 et 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 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. As participation and
adoption increases, there will be more opportunities to capture and
report on cost savings and benefits.
[[Page 16794]]
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 rule are even harder to quantify because they
represent, in many cases, adding functionality to existing systems and
reaping the network externalities created by larger numbers of
providers participating in information exchange.
In the Stage 2 final rule at 77 FR 54144, 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, health IT and safety 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.'' However, data relating specifically to
the EHR Incentive Programs is limited at this time.
7. Summary
In this proposed rule, the total cost to the Medicare and Medicaid
programs between 2017 and 2020 is estimated to be $3.7 billion in
transfers. As discussed in section V.C.4. of this proposed rule, we do
not estimate total costs to the provider industry, but rather provide a
possible per EP and per eligible hospital outlay for implementation and
maintenance.
Table 14--Estimated EHR Incentive Payments and Benefits Impacts on the Medicare and Medicaid Programs of the
Hitech EHR Incentive Program (Fiscal Year)
[In billions]
----------------------------------------------------------------------------------------------------------------
Medicare eligible Medicaid eligible
Fiscal year ---------------------------------------------------------------- Total
Hospitals Professionals Hospitals Professionals
----------------------------------------------------------------------------------------------------------------
2017............................ $1.6 $0.3 $0.4 $0.8 $3.1
2018............................ 0.0 -0.2 0.1 0.5 0.4
2019............................ 0.0 -0.2 0.0 0.3 0.1
2020............................ 0.0 -0.1 0.0 0.2 0.1
Total....................... 1.6 -0.2 0.5 1.8 3.7
----------------------------------------------------------------------------------------------------------------
D. Alternatives Considered
As stated in the Stage 1 final rule (75 FR 44546), HHS has no
discretion to change the incentive payments or payment adjustment
reductions specified in the statute for providers that adopt or fail to
adopt a certified EHR and demonstrate meaningful use of certified EHR
technology. However, we have discretion around how best to meet the
HITECH Act requirements for meaningful use for FY 2017 and subsequent
years, which we have exercised in this proposed rule. Additionally, we
have used our discretion to appropriately propose the timing of
registration, attestation and payment requirements to allow EPs and
eligible organizations as much time as possible in coordination with
the anticipated certification of EHR technology to obtain and
meaningfully use certified EHRs. We recognize that there may be
additional costs that result from various discretionary policy choices
by providers. However, those costs cannot be estimated and are not
captured in this analysis.
E. Accounting Statement and Table
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. Monetary annualized benefits and non-
budgetary costs are presented as discounted flows using 3 percent and 7
percent factors in the following Table 15. We are not able to
explicitly define the universe of those additional costs, nor specify
what the high or low range might be to implement EHR technology in this
proposed rule. We note that federal annualized monetized transfers
represent the net total of annual incentive payments in the Medicare
and Medicaid EHR Incentive programs less
[[Page 16795]]
the reductions in Medicare payments to providers failing to demonstrate
meaningful use as a result of the related Medicare payment adjustments.
Expected qualitative benefits include improved quality of care,
better health outcomes, reduced errors and the like. Private industry
costs would include the impact of EHR activities such as temporary
reduced staff productivity related to learning how to use the EHR, the
need for additional staff to work with HIT issues, and administrative
costs related to reporting.
Table 15--Accounting Statement: Classification of Estimated Expenditures CYs 2017 Through 2020
[In millions]
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
CATEGORY
----------------------------------------------------------------------------------------------------------------
BENEFITS
----------------------------------------------------------------------------------------------------------------
Qualitative..................................... Expected qualitative benefits include improved quality of
care, better health outcomes, reduced errors and the like.
---------------------------------------------------------------
COSTS
---------------------------------------------------------------
Year dollar Estimates Unit discount Period covered
(in millions) rate
---------------------------------------------------------------
.............. Primary ..............
Estimate
---------------------------------------------------------------
Annualized Monetized Costs to Private Industry 2017 $478.1 7% CY 2017
Associated with Reporting Requirements......... $478.4 3%
----------------------------------------------------------------------------------------------------------------
Qualitative--Other private industry costs
associated with the adoption of EHR technology. These costs would include the impact of EHR activities such as
reduced staff productivity related to learning how to use the
EHR technology, the need for additional staff to work with HIT
issues, and administrative costs related to reporting.
----------------------------------------------------------------------------------------------------------------
TRANSFERS
---------------------------------------------------------------
Year dollar Estimates Unit discount Period covered
(in millions) rate
---------------------------------------------------------------
Federal Annualized Monetized.................... 2017 $1,000.4 7% CYs 2017-2020
$954.8 3%
----------------------------------------------------------------------------------------------------------------
From Whom To Whom?.............................. Federal Government to Medicare[dash] and
Medicaid[dash]eligible professionals and hospitals.
----------------------------------------------------------------------------------------------------------------
F. Conclusion
The previous analysis, together with the remainder of this
preamble, provides an RIA. We believe there are many positive effects
of adopting EHR on health care providers. We believe there are benefits
that can be obtained by eligible hospitals and EPs, including:
Reductions in medical recordkeeping costs, reductions in repeat tests,
decreases in length of stay, and reduced errors. Health IT can enable
providers to deliver health care more efficiently. For example, 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. We also believe that internal savings will
likely come through the reductions in the cost of providing care. We
believe that the net effect on individual providers may be positive
over time in many cases. Accordingly, we believe that the object of the
Regulatory Flexibility Analysis to minimize burden on small entities
are met by this proposed rule. We invite public comments on the
analysis and request any additional data that would help us determine
more accurately the impact on the EPs and eligible hospitals affected
by the proposed rule.
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 amend 42 CFR part 495 as set forth
below:
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. Adding the definition for ``Application-program interface (API)''.
0
B. Revising the definition of ``Certified electronic health record
technology''.
0
C. Amending the definition of ``EHR reporting period'' by--
0
i. Redesignating paragraphs (1)(i), (1)(ii), (1)(iii) introductory
text, (1)(iii)(A), (1)(iii)(B), (1)(iii)(C), (1)(iii)(D), and (1)(iv)
as paragraphs (1)(i)(A), (1)(i)(B), (1)(i)(C) introductory text,
(1)(i)(C)(1), (1)(i)(C)(2), (1)(i)(C)(3), (1)(1)(C)(4), and (1)(i)(D),
respectively.
0
ii. Adding new paragraph (1)(i) introductory text.
[[Page 16796]]
0
iii. Adding a new paragraph (1)(ii).
0
iv. Redesignating paragraphs (2)(i), (2)(ii), (2)(iii) introductory
text, (2)(iii)(A), (2)(iii)(B), (2)(iii)(C), and (2)(iii)(D), as
paragraphs (2)(i)(A), (2)(i)(B), (2)(i)(C) introductory text and
(2)(i)(C)(1), (2)(i)(C)(2), (2)(i)(C)(3), and (2)(i)(C)(4),
respectively.
0
v. Adding new paragraph (2)(i) introductory text.
0
vi. Adding a new paragraph (2)(ii).
0
D. Amending the definition of ``EHR reporting period for a payment
adjustment year'' by:
0
i. Redesignating paragraphs (1)(i)(A), (1)(i)(B), (1)(ii), (1)(iii)(A),
and (1)(iii)(B) as paragraphs (1)(i)(A)(1), (1)(i)(A)(2), (1)(i)(B),
(1)(i)(C)(1) and (1)(i)(C)(2), respectively.
0
ii. In newly redesignated paragraph (1)(i)(A)(1), by removing the
cross-reference ``paragraphs (1)(i)(B), (ii), and (iii)'' and adding in
its place the cross-reference ``paragraphs (1)(i)(A)(2), (1)(i)(B), and
(1)(i)(C)''.
0
iii. In newly redesignated paragraph (1)(i)(A)(2), by removing the
cross-reference ``paragraphs (1)(iii) or (iv)'' and adding in its place
the cross-reference ``paragraph (1)(i)(C)''.
0
iv. Adding new paragraph (1)(i) introductory text.
0
v. Adding a new paragraph (1)(ii).
0
vi. Redesignating paragraphs (2)(i)(A), (2)(i)(B), (2)(ii),
(2)(iii)(A), and (2)(iii)(B) as paragraphs (2)(i)(A)(1), (2)(i)(A)(2),
(2)(i)(B), (2)(i)(C)(1) and (2)(i)(C)(2), respectively.
0
vii. In newly redesignated paragraph (2)(i)(A)(1), by removing the
cross-reference ``paragraphs (2)(i)(B), (ii), and (iii)'' and adding in
its place the cross-reference ``paragraphs (2)(i)(A)(2), (2)(i)(B), and
(2)(i)(C)''.
0
viii. In newly redesignated paragraph (2)(i)(A)(2), by removing the
cross-reference ``paragraph (2)(iii)'' and adding in its place the
cross-reference ``paragraph (2)(i)(C)''.
0
ix. Adding new paragraph (2)(i) introductory text.
0
x. Adding new paragraph (2)(ii).
0
xi. Redesignating paragraphs (3)(i) and (3)(ii) as paragraphs (3)(i)(A)
and (3)(i)(B).
0
xii. In newly redesignated paragraph (3)(i)(A), by removing the cross-
reference ``paragraph (3)(ii)'' and adding in its place the cross-
reference ``paragraph (3)(i)(B)''.
0
xiii. Adding new paragraph (3)(i) introductory text.
0
xiv. Adding new paragraph (3)(ii).
0
E. In the paragraph (1) of the definition of ``Meaningful EHR User'' by
removing the reference ``under Sec. 495.6'' and adding in its place
the reference to ``under Sec. 495.6 or 495.7''.
The additions read as follows:
Sec. 495.4 Definitions.
* * * * *
Application-program interface (API) means a set of programming
protocols established for multiple purposes. APIs may be enabled by a
provider or provider organization to provide the patient with access to
their health information through a third-party application with more
flexibility than often found in many current ``patient portals.''
Certified electronic health record technology (CEHRT) means the
following:
(1) For any Federal fiscal year (FY) or calendar year (CY) before
2018, EHR technology (which could include multiple technologies)
certified under the ONC Health IT Certification Program that--
(i) Meets the--
(A) 2014 Edition Base EHR definition (as defined at 45 CFR
170.102); or
(B) 2015 Edition Base EHR definition (as defined at 45 CFR
170.102); or
(ii) Has been certified to the following certification criteria:
(A)(1) CPOE at--
(i) 45 CFR 170.314(a)(1), (18), (19) or (20); or
(ii) 45 CFR 170.315(a)(1), (2) or (3);
(2)(i) Record demographics at 45 CFR 170.314(a)(3); or
(ii) 45 CFR 170.315(a)(5).
(3)(i) Problem list at 45 CFR 170.314(a)(5); or
(ii) 45 CFR 170.315(a)(7).
(4)(i) Medication list at 45 CFR 170.314(a)(6); or (ii) 45 CFR
170.315(a)(8).
(5)(i) Medication allergy list 45 CFR 170.314(a)(7); or (ii) 45 CFR
170.315(a)(9);
(6)(i) Clinical decision support at 45 CFR 170.314(a)(8); or (ii)
45 CFR 170.315(a)(10).
(7) Health information exchange at transitions of care at one of
the following:
(i) 45 CFR 170.314(b)(1) and (2).
(ii) 45 CFR 170.314(b)(1), (b)(2), and (h)(1).
(iii) 45 CFR 170.314(b)(1), (b)(2), and (b)(8).
(iv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and (h)(1).
(v) 45 CFR 170.314(b)(8) and (h)(1).
(vi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(h)(2).
(vii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(h)(2).
(viii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(h)(2).
(ix) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and
170.315(h)(2).
(x) 45 CFR 170.314(b)(8), (h)(1), and 170.315(h)(2).
(xi) 45 CFR 170.314(b)(1), (b)(2), and 170.315(b)(1).
(xii) 45 CFR 170.314(b)(1), (b)(2), (h)(1), and 170.315(b)(1).
(xiii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), and 170.315(b)(1).
(xiv) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), and
170.315(b)(1).
(xv) 45 CFR 170.314(b)(8), (h)(1), and 170.315(b)(1).
(xvi) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1),
and 170.315(h)(1).
(xvii) 45 CFR 170.314(b)(1), (b)(2), (b)(8), (h)(1), 170.315(b)(1),
and 170.315(h)(2).
(xviii) 45 CFR 170.314(h)(1) and 170.315(b)(1).
(xix) 45 CFR 170.315(b)(1) and (h)(1).
(xx) 45 CFR 170.315(b)(1) and (h)(2).
(xxi) 45 CFR 170.315(b)(1), (h)(1), and (h)(2).
(B) Clinical quality measures at 45 CFR 170.314(c)(1) or
170.315(c)(1).
(C) The 2014 Edition or 2015 Edition certification criteria that
are necessary to be a Meaningful EHR User (as defined in this section),
including the following:
(1) The applicable automated numerator recording and automated
measure calculation certification criteria that support attestation as
a Meaningful EHR User at 45 CFR 170.315(g)(1) and (2) and 45 CFR
170.314(g)(1) and (2).
(2) Clinical quality measure certification criteria that support
the calculation and reporting of clinical quality measures at 45 CFR
170.314(c)(2) and (c)(3) or 45 CFR 170.315(c)(2) and (c)(3).
(2) For 2018 and subsequent years, EHR technology (which could
include multiple technologies) certified under the ONC Health IT
Certification Program that meets the 2015 Edition Base EHR definition
(as defined at 45 CFR 170.102) and has been certified to the 2015
Edition health IT certification criteria that--
(i)(A) Include the capabilities to record 45 CFR 170.315(a)(14); or
(B) Create and incorporate family health history 45 CFR
170.315(a)(15).
(ii) Include the capabilities that support patient health
information capture at 45 CFR 170.315(a)(19); and
(iii) Are necessary to be a Meaningful EHR User (as defined in this
section), including the following:
(A) The applicable automated numerator recording and automated
measure calculation certification criteria that support attestation as
a Meaningful EHR User at 45 CFR 170.315(g)(1) and (2).
(B) Clinical quality measure certification criteria that support
the calculation and reporting of clinical quality measures under the
2015 Edition certification criteria 45 CFR 170.315(c)(2) and (c)(3).
* * * * *
[[Page 16797]]
EHR reporting period. * * *
(1) * * *
(i) The following are applicable before CY 2017.
* * * * *
(ii) The following are applicable beginning in CY 2017 under the
Medicaid EHR Incentive Program:
(A) For the payment year in which the EP is first demonstrating he
or she is a meaningful EHR user, any continuous 90-day period within
the calendar year.
(B) For the subsequent payment years following the payment year in
which the EP first successfully demonstrates he or she is a meaningful
EHR user, the calendar year.
(2) * * *
(i) The following are applicable before CY 2017:
* * * * *
(ii) The following are applicable beginning in CY 2017 under the
Medicaid EHR Incentive Program:
(A) For the payment year in which the eligible hospital or CAH is
first demonstrating it is a meaningful EHR user, any continuous 90-day
period within the calendar year.
(B) For the subsequent payment years following the payment year in
which the eligible hospital or CAH first successfully demonstrates it
is a meaningful EHR user, the calendar year.
EHR reporting period for a payment adjustment year. * * *
(1) * * *
(i) The following are applicable before CY 2017:
* * * * *
(ii) The following are applicable beginning in CY 2017:
(A) Except as provided under paragraph (1)(ii)(B) of this
definition, the calendar year that is 2 years before the payment
adjustment year.
(B) If an EP is demonstrating under the Medicaid EHR Incentive
Program that he or she is a meaningful EHR user for the first time in
the calendar year that is 2 years before the payment adjustment year,
then the continuous 90-day period that is the EHR reporting period for
the Medicaid incentive payment within such (2 years prior) calendar
year.
(2) * * *
(i) The following are applicable before CY 2017:
* * * * *
(ii) The following are applicable beginning in CY 2017:
(A) Except as provided in paragraph (2)(ii)(B) of this definition,
the calendar year that is 2 years before the payment adjustment year.
(B) If an eligible hospital is demonstrating under the Medicaid EHR
Incentive Program 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 the continuous 90-day period that is the EHR reporting
period for the Medicaid incentive payment within such (2 years prior)
calendar year.
(3) * * *
(i) The following are applicable before CY 2017:
* * * * *
(ii) The following are applicable beginning in CY 2017:
(A) Except as provided in paragraph (3)(ii)(B) of this definition,
the calendar year that begins on the first day of the second quarter of
the Federal fiscal year that is the payment adjustment year.
(B) If a CAH is demonstrating under the Medicaid EHR Incentive
Program that it is a meaningful EHR user for the first time in the
calendar year that begins on the first day of the second quarter of the
Federal fiscal year that is the payment adjustment year, then any
continuous 90-day period within such calendar year.
* * * * *
0
3. Section 495.6 is amended by revising the section heading and adding
introductory text to read as follows:
Sec. 495.6 Meaningful use objectives and measures for EPs, eligible
hospitals, and CAHs before 2018.
The following criteria are applicable before 2018:
* * * * *
0
4. Section 495.7 is added to read as follows:
Sec. 495.7 Stage 3 meaningful use objectives and measures for EPs,
eligible hospitals, and CAHs for 2018 and subsequent years.
The following criteria are optional for EPs, eligible hospitals,
and CAHs in 2017 as outlined at Sec. 495.8(a)(2)(i)(E)(3) and
(b)(2)(E)(3) and applicable for all EPs, eligible hospitals, and CAHs
for 2018 and subsequent years:
(a) Stage 3 criteria for EPs.
(1) General rule regarding Stage 3 criteria for meaningful use for
EPs. Except as specified in paragraphs (a)(2) through (a)(3) of this
section, EPs must meet all objectives and associated measures of the
Stage 3 criteria specified in paragraph (d) of this section to meet the
definition of a meaningful EHR user.
(2) Selection of measures for specified objectives in paragraph (d)
of this section. An EP may meet the criteria for 2 out of the 3
measures associated with an objective, rather than meeting the criteria
for all 3 of the measures, if the EP meets all of the following
requirements:
(i) Must ensure that the objective in paragraph (d) of this section
includes an option to meet 2 out of the 3 associated measures.
(ii) Meets the threshold for 2 out of the 3 measures for that
objective.
(iii) Attests to all 3 of the measures for that objective
(3) Exclusion for nonapplicable objectives and measures.
(i) An EP may exclude a particular objective that includes an
option for exclusion contained in paragraph (d) of this section, if the
EP meets all of the following requirements:
(A) Meets the criteria in the applicable objective that would
permit the exclusion.
(B) Attests to the exclusion.
(ii) An EP may exclude a measure within an objective which allows
for a provider to meet the threshold for 2 of the 3 measures, as
outlined in paragraph (a)(2) of this section, in the following manner:
(A)(1) Meets the criteria in the applicable measure or measures
that would permit the exlusion; and
(2) Attests to the exclusion or exclusions.
(B)(1) Meets the threshold; and
(2) Attests to any remaining measure or measures.
(4) Exception for Medicaid EPs who adopt, implement or upgrade in
their first payment year. For Medicaid EPs who adopt, implement or
upgrade its certified EHR technology in their first payment year, the
meaningful use objectives and associated measures of the Stage 3
criteria specified in paragraph (d) of this section, apply beginning
with the second payment year, and do not apply to the first payment
year.
(b) Stage 3 criteria for eligible hospitals and CAHs.
(1) General rule regarding Stage 3 criteria for meaningful use for
eligible hospitals or CAHs. Except as specified in paragraphs (b)(2)
through (b)(3) of this section, eligible hospitals and CAHs must meet
all objectives and associated measures of the Stage 3 criteria
specified in paragraph (d) of this section to meet the definition of a
meaningful EHR user.
(2) Selection of measures for specified objectives in paragraph (d)
of this section. An eligible hospital or CAH may meet the criteria for
2 out of the 3 measures associated with an objective, rather than
meeting the criteria for all 3 of the measures, if the eligible
hospital or CAH meets all of the following requirements:
(i) Must ensure that the objective in paragraph (d) of this section
includes an option to meet 2 out of the 3 associated measures.
[[Page 16798]]
(ii) Meets the threshold for 2 out of the 3 measures for that
objective.
(iii) Attests to all 3 of the measures for that objective.
(3) Exclusion for nonapplicable objectives and measures.
(i) An eligible hospital or CAH may exclude a particular objective
that includes an option for exclusion contained in paragraph (d) of
this section, if the eligible hospital or CAH meets all of the
following requirements:
(A) Meets the criteria in the applicable objective that would
permit the exclusion.
(B) Attests to the exclusion.
(ii) An eligible hospital or CAH may exclude a measure within an
objective which allows for a provider to meet the threshold for 2 of
the 3 measures, as outlined in paragraph (b)(2) of this section, in the
following manner:
(A)(1) Meets the criteria in the applicable measure or measures
that would permit the exclusion; and
(2) Attests to the exclusion or exclusions.
(B)(1) Meets the threshold; and
(2) Attests to any remaining measure or measures.
(4) Exception for Medicaid eligible hospitals or CAHs that adopt,
implement or upgrade in their first payment year. For Medicaid eligible
hospitals or CAHs who adopt, implement or upgrade certified EHR
technology in their first payment year, the meaningful use objectives
and associated measures of the Stage 3 criteria specified in paragraph
(d) of this section apply beginning with the second payment year, and
do not apply to the first payment year.
(c) Objectives and associated measures in paragraph (d) of this
section that rely on measures that count unique patients or actions.
(1) If a measure (or associated objective) in paragraph (d) of this
section references paragraph (c) 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 (c) of this section, then the measure must be calculated by
reviewing all patient records, not just those maintained using
certified EHR technology.
(d) Stage 3 objectives and measures for EPs, eligible hospitals,
and CAHs.
(1) Protect patient health information.
(i) EP protect patient health information.
(A) Objective. Protect electronic protected health information
(ePHI) created or maintained by the certified EHR technology (CEHRT)
through the implementation of appropriate technical, administrative,
and physical safeguards.
(B) Measure. Conduct or review a security risk analysis in
accordance with the requirements under 45 CFR 164.308(a)(1), including:
(1) Addressing the security (including 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),
(2) Implement security updates as necessary, and
(3) Correct identified security deficiencies as part of the EP's
risk management process.
(ii) Eligible hospital/CAH protect patient health information.
(A) Objective. Protect electronic protected health information
(ePHI) created or maintained by the certified EHR technology (CEHRT)
through the implementation of appropriate technical, administrative,
and physical safeguards.
(B) Measure. Conduct or review a security risk analysis in
accordance with the requirements under 45 CFR 164.308(a)(1),
including--
(1) Addressing the security (including 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);
(2) Implement security updates as necessary; and
(3) Correct identified security deficiencies as part of the
eligible hospital's or CAH's risk management process.
(2) Electronic prescribing.
(i) EP electronic prescribing.
(A) Objective. Generate and transmit permissible prescriptions
electronically (eRx).
(B) Measure. Subject to paragraph (c) of this section, more than 80
percent of all permissible prescriptions written by the EP are queried
for a drug formulary and transmitted electronically using certified EHR
technology (CEHRT).
(C) Exclusions in accordance with paragraph (a)(3) of this section.
(1) Any EP who writes fewer than 100 permissible prescriptions
during the EHR reporting period; or
(2) Any EP who does not have a pharmacy within its organization and
there are no pharmacies that accept electronic prescriptions within 10
miles of the EP's practice location at the start of his/her EHR
reporting period.
(ii) Eligible hospital/CAH electronic prescribing.
(A) Objective. Generate and transmit permissible discharge
prescriptions electronically (eRx).
(B) Measure. Subject to paragraph (c) of this section, more than 25
percent of hospital discharge medication orders for permissible
prescriptions (for new and changed prescriptions) are queried for a
drug formulary and transmitted electronically using certified EHR
technology (CEHRT).
(C) Exclusions in accordance with paragraph (b)(3) of this section.
Any eligible hospital or CAH that does not have an internal pharmacy
that can accept electronic prescriptions and there are no pharmacies
that accept electronic prescriptions within 10 miles at the start of
the eligible hospital's or CAH's EHR reporting period.
(3) Clinical decision support.
(i) EP clinical decision support.
(A) Objective. Implement clinical decision support (CDS)
interventions focused on improving performance on high-priority health
conditions.
(B) Measures.
(1) Implement five clinical decision support interventions related
to four or more clinical quality measures (CQMs) 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; and
(2) The EP has enabled and implemented the functionality for drug-
drug and drug-allergy interaction checks for the entire EHR reporting
period.
(C) Exclusion in accordance with paragraph (a)(3) of this section
for paragraph (d)(3)(i)(B)(2) of this section. An EP who writes fewer
than 100 medication orders during the EHR reporting period.
(ii) Eligible hospital/CAH clinical decision support.
(A) Objective. Implement clinical decision support (CDS)
interventions focused on improving performance on high-priority health
conditions.
(B) 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 (CQMs) related to an eligible hospital or CAH's
patient population, the clinical decision support interventions must be
related to high-priority health conditions; and
(2) The eligible hospital or CAH has enabled and implemented the
functionality for drug-drug and drug-
[[Page 16799]]
allergy interaction checks for the entire EHR reporting period.
(4) Computerized provider order entry (CPOE).
(i) EP CPOE.
(A) Objective. Use computerized provider order entry (CPOE) for
medication, laboratory, and diagnostic imaging orders directly entered
by any licensed healthcare professional, credentialed medical
assistant, or a medical staff member credentialed to and performing the
equivalent duties of a credentialed medical assistant; who can enter
orders into the medical record per state, local, and professional
guidelines.
(B) Measures. Subject to paragraph (c) of this section--
(1) More than 80 percent of medication orders created by the EP
during the EHR reporting period are recorded using computerized
provider order entry;
(2) More than 60 percent of laboratory orders created by the EP
during the EHR reporting period are recorded using computerized
provider order entry; and
(3) More than 60 percent of diagnostic imaging orders created by
the EP during the EHR reporting period are recorded using computerized
provider order entry.
(C) Exclusions in accordance with paragraph (a)(3) of this section.
(1) For the measure specified in paragraph (d)(4)(i)(B)(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 (d)(4)(i)(B)(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 (d)(4)(i)(B)(3) of this
section, any EP who writes fewer than 100 diagnostic imaging orders
during the EHR reporting period.
(ii) Eligible hospital and CAH CPOE.
(A) Objective. Use computerized provider order entry (CPOE) for
medication, laboratory, and diagnostic imaging orders directly entered
by any licensed healthcare professional, credentialed medical
assistant, or a medical staff member credentialed to and performing the
equivalent duties of a credentialed medical assistant; who can enter
orders into the medical record per state, local, and professional
guidelines.
(B) Measures. Subject to paragraph (c) of this section, more than--
(1) Eighty 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) Sixty 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; and
(3) Sixty percent of diagnostic imaging 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.
(5) Patient electronic access to health information.
(i) EP patient electronic access to health information.
(A) Objective. The EP provides access for patients to view online,
download, and transmit their health information, or retrieve their
health information through an application-program interface (API),
within 24 hours of its availability.
(B) Measures. EPs must meet the following two measures:
(1) For more than 80 percent of all unique patients seen by the
EP)--
(i) The patient (or patient authorized representatives) is provided
access to view online, download, and transmit their health information
within 24 hours of its availability to the provider; or
(ii) The patient (or patient authorized representatives) is
provided access to an ONC-certified application-program interface (API)
that can be used by third-party applications or devices to provide
patients (or patient authorized representatives) access to their health
information, within 24 hours of its availability to the provider.
(2) The EP must use clinically relevant information from CEHRT to
identify patient-specific educational resources and provide electronic
access to those materials to more than 35 percent of unique patients
seen by the EP during the EHR reporting period.
(C) Exclusions in accordance with paragraph (a)(3) of this section.
(1) Any EP who has no office visits during the reporting period may
exclude from the measures specified in paragraphs (d)(7)(i)(B)(1) and
(B)(2) of this section.
(2) Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude from the measures specified in paragraphs
(d)(7)(i)(B)(1) and (2) of this section.
(ii) Eligible hospital and CAH patient electronic access to health
information.
(A) Objective. The eligible hospital or CAH provides access for
patients to view online, download, and transmit their health
information, or retrieve their health information through an
application-program interface (API), within 24 hours of its
availability.
(B) Measures. Eligible hospitals and CAHs must meet the following
two measures:
(1) For more than 80 percent of all unique patients discharged from
the eligible hospital or CAH inpatient or emergency department (POS 21
or 23)--
(i) The patient (or patient authorized representatives) is provided
access to view online, download, and transmit their health information
within 24 hours of its availability to the provider; or
(ii) The patient (or patient authorized representatives) is
provided access to an ONC-certified application-program interface (API)
that can be used by third-party applications or devices to provide
patients (or patient authorized representatives) access to their health
information, within 24 hours of its availability to the provider.
(2) The eligible hospital or CAH must use clinically relevant
information from CEHRT to identify patient-specific educational
resources and provide electronic access to those materials to more than
35 percent of unique patients discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
(C) Exclusion in accordance with paragraph (b)(3) 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 the
measures specified in paragraphs (d)(7)(ii)(B)(1) and (2) of this
section.
(6) Coordination of care through patient engagement.
(i) EP coordination of care through patient engagement.
(A) Objective. Use communications functions of certified EHR
technology to engage with patients or their authorized representatives
about the patient's care.
(B) Measures. In accordance with paragraph (a)(2) of this section,
an EP must satisfy 2 out of the 3 following measures in paragraphs
(d)(5)(i)(B)(1), (2), and (3) of this section except those measures for
which an EP qualifies for
[[Page 16800]]
an exclusion under paragraph (a)(3) of this section.
(1) During the EHR reporting period, more than 25 percent of all
unique patients seen by the EP actively engage with the electronic
health record made accessible by the provider. An EP may meet measure
specified in paragraph (d)(5)(i)(B)(1) of this paragraph by either--
(i) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP during the EHR reporting
period view, download or transmit to a third party their health
information; or
(ii) More than 25 percent of all unique patients (or patient-
authorized representatives) seen by the EP during the EHR reporting
period access their health information through the use of an ONC-
certified API that can be used by third-party applications or devices.
(2) For more than 35 percent of all unique patients seen by the EP
during the EHR reporting period, a secure message was sent using the
electronic messaging function of CEHRT to the patient (or their
authorized representatives), or in response to a secure message sent by
the patient.
(3) Patient generated health data or data from a nonclinical
setting is incorporated into the certified EHR technology for more than
15 percent of all unique patients seen by the EP during the EHR
reporting period.
(C) Exclusions in accordance with paragraph (a)(3) of this section.
(1) Any EP who has no office visits during the reporting period may
exclude from the measures specified in paragraphs (d)(5)(i)(B)(1),
(B)(2) and (B)(3) of this section.
(2) Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units with 4Mbps broadband availability according to the latest
information available from the FCC on the first day of the EHR
reporting period may exclude from the measures specified in paragraphs
(d)(5)(i)(B)(1), (B)(2) and (B)(3) of this section.
(ii) Eligible hospital and CAH coordination of care through patient
engagement.
(A) Objective. Use communications functions of certified EHR
technology to engage with patients or their authorized representatives
about the patient's care.
(B) Measures. In accordance with paragraph (b)(2) of this section,
an eligible hospital or CAH must satisfy 2 of the 3 following measures
in paragraph (d)(5)(ii)(B)(1), (2), and (3) of this section, except
those measures for which an eligible hospital or CAH qualifies for an
exclusion under paragraph (b)(3) of this section.
(1) During the EHR reporting period, more than 25 percent of all
unique patients discharged from the eligible hospital or CAH inpatient
or emergency department (POS 21 or 23) actively engage with the
electronic health record made accessible by the provider. An eligible
hospital or CAH may meet the measure specified in paragraph
(d)(5)(ii)(B)(1) of this section by having--
(i) More than 25 percent of all unique patients (or patient-
authorized representatives) discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period view, download or transmit to a third party their
health information; or
(ii) More than 25 percent of all unique patients (or patient-
authorized representatives) discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period access their health information through the use of an
ONC-certified API that can be used by third-party applications or
devices.
(2) For more than 35 percent of all unique patients discharged from
the eligible hospital or CAH inpatient or emergency department (POS 21
or 23) during the EHR reporting period, a secure message was sent using
the electronic messaging function of CEHRT to the patient (or their
authorized representatives), or in response to a secure message sent by
the patient.
(3) Patient generated health data or data from a non-clinical
setting is incorporated into the certified EHR technology for more than
15 percent of unique patients discharged from the eligible hospital or
CAH inpatient or emergency department (POS 21 or 23) during the EHR
reporting period.
(C) Exclusions under paragraph (b)(3) of this section.
(1) Any eligible hospital or CAH operating in a location that does
not have 50 percent or more of its housing units with 4Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude from the
measures specified in pargraphs (d)(5)(ii)(B)(1), (B)(2), and (B)(3) of
this section.
(7) Health information exchange.
(i) EP health information exchange.
(A) Objective. The EP provides a summary of care record when
transitioning or referring their patient to another setting of care,
retrieves a summary of care record upon the first patient encounter
with a new patient, and incorporates summary of care information from
other providers into their EHR using the functions of certified EHR
technology.
(B) Measures. In accordance with paragraph (a)(2) of this section,
an EP must attest to all 3 measures, but must meet the threshold for 2
of the 3 measures in paragraph (d)(6)(i)(B)(1), (2), and (3), in order
to meet the objective. Subject to paragraph (c) of this section--
(1) Measure 1. For more than 50 percent of transitions of care and
referrals, the EP that transitions or refers their patient to another
setting of care or provider of care--
(i) Creates a summary of care record using CEHRT; and
(ii) Electronically exchanges the summary of care record.
(2) Measure 2. For more than 40 percent of transitions or referrals
received and patient encounters in which the provider has never before
encountered the patient, the EP incorporates into the patient's EHR an
electronic summary of care document from a source other than the
provider's EHR system.
(3) Measure 3. For more than 80 percent of transitions or referrals
received and patient encounters in which the provider has never before
encountered the patient, the EP performs clinical information
reconciliation. The EP must implement clinical information
reconciliation for the following three clinical information sets:
(i) Medication. Review of the patient's medication, including the
name, dosage, frequency, and route of each medication.
(ii) Medication allergy. Review of the patient's known allergic
medications.
(iii) Current problem list. Review of the patient's current and
active diagnoses.
(C) Exclusions in accordance with paragraph (a)(3) of this section.
An EP must be excluded when any of the following occur:
(1) An EP neither transfers a patient to another setting nor refers
a patient to another provider during the EHR reporting period must be
excluded from paragraph (d)(6)(i)(B)(1) of this section.
(2) Any EP for whom the total of transitions or referrals recieved
and patient encounters in which the provider has never before
encountered the patient, is fewer than 100 during the EHR reporting
period may be excluded from paragraphs (d)(6)(i)(B)(2) and
(d)(6)(i)(B)(3) of this section.
(3) Any EP that conducts 50 percent or more of his or her patient
encounters in a county that does not have 50 percent or more of its
housing units
[[Page 16801]]
with 4Mbps broadband availability according to the latest information
available from the FCC on the first day of the EHR reporting period may
exclude from the measures specified in paragraphs (d)(6)(i)(B)(1),
(B)(2) and (B)(3) of this section.
(ii) Eligible hospitals and CAHs health information exchange.
(A) Objective. The eligible hospital or CAH provides a summary of
care record when transitioning or referring their patient to another
setting of care, retrieves a summary of care record upon the first
patient encounter with a their new patient, and incorporates summary of
care information from other providers into EHR using the functions of
certified EHR technology.
(B) Measures. In accordance with paragraph (b)(2) of this section,
an eligible hospital or CAH must attest to all three measures, but must
meet the threshold for 2 of the 3 measures in paragraph
(d)(6)(ii)(B)(1), (2), and (3). Subject to paragraph (c) of this
section--
(1) Measure 1. For more than 50 percent of transitions of care and
referrals, the eligible hospital or CAH that transitions or refers its
patient to another setting of care or provider of care--
(i) Creates a summary of care record using CEHRT; and
(ii) Electronically exchanges the summary of care record.
(2) Measure 2. For more than 40 percent of transitions or referrals
received and patient encounters in which the provider has never before
encountered the patient, the eligible hospital or CAH incorporates into
the patient's EHR an electronic summary of care document from a source
other than the provider's EHR system.
(3) Measure 3. For more than 80 percent of transitions or referrals
received and patient encounters in which the provider has never before
encountered the patient, the eligible hospital or CAH performs a
clinical information reconciliation. The provider must implement
clinical information reconciliation for the following three clinical
information sets:
(i) Medication. Review of the patient's medication, including the
name, dosage, frequency, and route of each medication.
(ii) Medication allergy. Review of the patient's known allergic
medications.
(iii) Current problem list. Review of the patient's current and
active diagnoses.
(C) Exclusions in accordance with paragraph (b)(3) of this section.
(1) Any eligible hospital or CAH for whom the total of transitions
or referrals recieved and patient encounters in which the provider has
never before encountered the patient, is fewer than 100 during the EHR
reporting period may be excluded from paragraphs (d)(6)(i)(B)(2) and
(d)(6)(i)(B)(3) of this section.
(2) Any eligible hospital or CAH operating in a location that does
not have 50 percent or more of its housing units with 4Mbps broadband
availability according to the latest information available from the FCC
on the first day of the EHR reporting period may exclude from the
measures specified in paragraphs (d)(6)(ii)(B)(1), (2) and (3) of this
section.
(8) Public Health and Clinical Data Registry Reporting.
(i) EP Public Health and Clinical Data Registry: Reporting
objective.
(A) Objective. The EP 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.
(B) Measures. In order to meet the objective under paragraph
(d)(8)(i)(A) of this section, an EP must choose from measures 1 through
5 (paragraphs (d)(8)(i)(B)(1) through (d)(8)(i)(B)(5) of this section)
and must successfully attest to any combination of three measures.
These measures may be met by any combination, including meeting measure
specified in paragraph (d)(8)(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 (a)(3) 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
(d)(8)(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 their 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 its EHR
reporting period.
(iii) Operates in a jurisdiction where no immunization registry or
immunization information system has declared readiness to receive
immunization data 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 (d)(8)(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 the EP's
jurisdiction.
(ii) Operates in a jurisdiction for which no public health agency
is capable of receiving electronic syndromic surveillance 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 syndromic surveillance data at the start
of the EHR reporting period.
(3) Any EP meeting one or more of the following criteria may be
excluded from the case reporting measure at paragraph (d)(8)(i)(B)(3)
of this section if the EP:
(i) 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.
(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 EP meeting at least one of the following criteria may be
excluded from the public health registry reporting measure specified in
paragraph (d)(8)(i)(B)(4) of this section if the EP:
[[Page 16802]]
(i) Does not diagnose or directly treat any disease or condition
associated with a public health registry in the EP's 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 beginning 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 (d)(8)(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 their 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 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 beginning of the EHR reporting
period.
(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 (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.
(B) Measures. In order to meet the objective under paragraph
(d)(8)(ii)(A) of this section, an eligible hospital or CAH must choose
from measures 1 through 6 (as described in paragraphs (d)(8)(ii)(B)(1)
through (d)(8)(ii)(B)(6) of this section) and must successfully attest
to any combination of four measures. These measures may be met by any
combination, including meeting the measure specified in paragraph
(d)(8)(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 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 (b)(3) of this section.
(1) Any eligible hospital or CAH meeting one or more of the
following criteria may be excluded from to the immunization registry
reporting measure specified in paragraph (d)(8)(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 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 (d)(8)(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 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 at the start
of the EHR reporting period.
(3) Any eligible hospital or CAH meeting one or more of the
following criteria may be excluded from the case reporting measure
specified in paragraph (d)(8)(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 their 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 their
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 (d)(8)(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 its 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 beginning
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 (d)(8)(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 for which no clinical data registry
is
[[Page 16803]]
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)(8)(ii)(B)(6) of this section if the eligible hospital or CAH:
(i) Does not perform or order laboratory tests that are reportable
in its 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
at the start of the EHR reporting period.
0
5. Section 495.8 is amended as follows:
0
A. In paragraph (a) introductory text, by removing the cross-reference
``under Sec. 495.6 of this subpart'' and adding in its place the
cross-reference ``under Sec. 495.6 or Sec. 495.7''.
0
B. In paragraph (a)(1)(i)(B), by removing the cross-reference ``under
Sec. 495.6(d) and Sec. 495.6(e) of this subpart'' and adding in its
place the cross-reference ``under Sec. 495.6 or Sec. 495.7''.
0
C. In paragraph (a)(1)(iii), by removing the cross-reference ``in Sec.
495.6 and Sec. 495.8 of this subpart'' and adding in its place the
cross-reference ``in Sec. 495.6 or Sec. 495.7 and Sec. 495.8''.
0
D. In paragraph (a)(2)(i)(B), by removing the cross-reference ``under
Sec. 495.6'' and adding in its place the cross-reference ``under Sec.
495.6 or Sec. 495.7''.
0
E. Adding paragraph (a)(2)(i)(E).
0
F. In paragraph (a)(2)(iv), by removing the cross-reference ``in Sec.
495.6 and Sec. 495.8 of this subpart'' and adding in its place the
cross-reference ``in Sec. 495.6 or Sec. 495.7 and Sec. 495.8''.
0
G. In paragraph (b)(1)(i)(B), by removing the cross-reference ``under
Sec. 495.6(f) and Sec. 495.6(g)'' and adding in its place the cross-
reference ``under Sec. 495.6 or Sec. 495.7''.
0
H. Redesignating paragraph (b)(1)(iv) and paragraph (b)(1)(iii).
0
I. In newly redesignated paragraph (b)(1)(iii), by removing the cross-
reference ``in Sec. 495.6 and Sec. 495.8 of this subpart'' and adding
in its place the cross-reference ``in Sec. 495.6 or Sec. 495.7 and
Sec. 495.8''.
0
J. In paragraph (b)(2)(i)(B), by removing the cross-reference ``under
Sec. 495.6'' and adding in its place the cross-reference ``under Sec.
495.6 or Sec. 495.7''.
0
K. Adding paragraph (b)(2)(i)(E).
The additions read as follows:
Sec. 495.8 Demonstration of meaningful use criteria.
(a) * * *
(2) * * *
(i) * * *
(E) For 2017 only, an EP may attest to the following:
(1) Stage 1 objectives and measures outlined at Sec. 495.6 if the
EP has never before demonstrated meaningful use, or if the EP
previously demonstrated meaningful use for the first time in 2015 or
2016.
(2) Stage 2 objectives and measures outlined at Sec. 495.6 if the
EP previously demonstrated meaningful use for any year prior to 2017.
(3) Stage 3 objectives and measures outlined at Sec. 495.7 if the
EP has never before demonstrated meaningful use or if the EP has
demonstrated meaningful use for any year prior to 2017.
* * * * *
(b) * * *
(2) * * *
(i) * * *
(E) For 2017 only, an eligible hospital or CAH may attest to the
following:
(1) Stage 1 objectives and measures outlined at Sec. 495.6 if the
eligible hospital or CAH has never before demonstrated meaningful use,
or if the eligible hospital or CAH previously demonstrated meaningful
use for the first time in 2015 or 2016.
(2) Stage 2 objectives and measures outlined at Sec. 495.6 if the
eligible hospital or CAH previously demonstrated meaningful use for any
year prior to 2017.
(3) Stage 3 objectives and measures outlined at Sec. 495.7 if the
eligible hospital or CAH has never before demonstrated meaningful use
or if the eligible hospital or CAH has demonstrated meaningful use for
any year prior to 2017.
* * * * *
0
6. Section 495.316 is amended by revising paragraph (c) introductory
text and adding paragraphs (d)(2)(iii), (f), (g), and (h) to read as
follows:
Sec. 495.316 State monitoring and reporting regarding activities
required to receive an incentive payment.
* * * * *
(c) Subject to Sec. 495.332 and Sec. 495.352, the State is
required to submit to CMS annual reports, in the manner prescribed by
CMS, on the following:
* * * * *
(d) * * *
(2) * * *
(iii) Subject to Sec. 495.332, the State may propose a revised
definition for Stage 3 of meaningful use of certified EHR technology,
subject to CMS prior approval, but only with respect to the public
health and clinical data registry reporting objective described in
Sec. 495.7(d)(8).
* * * * *
(f) Each State must submit to CMS the annual report described in
paragraph (c) of this section within 45 days of the end of the second
quarter of the Federal fiscal year.
(g) The State must, on a quarterly basis and in the manner
prescribed by CMS, submit a report(s) on the following:
(1) The State and payment year to which the quarterly report
pertains.
(2) Subject to paragraph (h)(2) of this section, provider-level
attestation data for each EP and eligible hospital that attests to
demonstrating meaningful use for each payment year beginning with 2013.
(h)(1) Subject to paragraph (h)(2) of this section, the quarterly
report described in paragraph (g) of this section must include the
following for each EP and eligible hospital:
(i) The payment year number.
(ii) The provider's National Provider Identifier or CCN, as
appropriate.
(iii) Attestation submission date.
(iv) The state qualification.
(v) The state qualification date, which is the beginning date of
the provider's EHR reporting period for which it demonstrated
meaningful use.
(vi) The State disqualification, if applicable.
(vii) The State disqualification date, which is the beginning date
of the provider's EHR reporting period to which the provider attested
but for which it did not demonstrate meaningful use, if applicable.
(2) The quarterly report described in paragraph (g) of this section
is not required to include information on EPs who are eligible for the
Medicaid EHR incentive program on the basis of being a nurse
practitioner, certified nurse-midwife or physician assistant.
0
7. Section 495.352 is revised to read as follows:
Sec. 495.352 Reporting requirements.
(a) Each State must submit to HHS on a quarterly basis a progress
report, in the
[[Page 16804]]
manner prescribed by HHS, documenting specific implementation and
oversight activities performed during the quarter, including progress
in implementing the State's approved Medicaid HIT plan.
(b) The quarterly progress reports must include, but need not be
limited to providing, updates on the following:
(1) State system implementation dates.
(2) Provider outreach.
(3) Auditing.
(4) State-specific State Medicaid HIT Plan tasks.
(5) State staffing levels and changes.
(6) The number and type of providers that qualified for an
incentive payment on the basis of having adopted, implemented or
upgraded certified EHR technology and the amounts of incentive
payments.
(7) The number and type of providers that qualified for an
incentive payment on the basis of having demonstrated that they are
meaningful users of certified EHR technology and the amounts of
incentive payments.
Dated: March 10, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: March 18, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-06685 Filed 3-20-15; 3:00 pm]
BILLING CODE 4120-01-P
