[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Proposed Rules]
[Pages 29732-29738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11944]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 495
[CMS-0052-P]
RIN 0938-AS30
Office of the Secretary
45 CFR Part 170
RIN 0991-AB97
Medicare and Medicaid Programs; Modifications to the Medicare and
Medicaid Electronic Health Record Incentive Programs for 2014; and
Health Information Technology: Revisions to the Certified EHR
Technology Definition
AGENCY: Centers for Medicare & Medicaid Services (CMS), and Office of
the National Coordinator for Health Information Technology (ONC), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would change the meaningful use stage
timeline and the definition of certified electronic health record
technology (CEHRT). It would also change the requirements for the
reporting of clinical quality measures for 2014.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on July 21, 2014.
ADDRESSES: In commenting, please refer to file code CMS-0052-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-0052-P, P.O. Box 8013,
Baltimore, MD 21244-1850.
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-0052-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
[[Page 29733]]
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.
Elisabeth Myers, (410) 786-4751.
Steven Posnack, (202) 690-7151.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
A. Statutory Basis for the Medicare and Medicaid EHR Incentive Programs
The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L.
111-5) amended Titles XVIII and XIX of the Social Security Act (the
Act) to authorize incentive payments to eligible professionals (EPs),
eligible hospitals, critical access hospitals (CAHs), and Medicare
Advantage (MA) organizations to promote the adoption and meaningful use
of certified electronic health record (EHR) technology. Sections
1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the
statutory basis for the Medicare incentive payments made to meaningful
EHR users. These statutory provisions govern EPs, MA organizations (for
certain qualifying EPs and hospitals that meaningfully use certified
EHR technology (CEHRT), subsection (d) hospitals, and CAHs,
respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and
1814(l) of the Act also establish downward payment adjustments,
beginning with calendar or fiscal year 2015, for EPs, MA organizations,
subsection (d) hospitals, and CAHs that are not meaningful users of
CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F)
and 1903(t) of the Act provide the statutory basis for Medicaid
incentive payments.
B. Considerations in Defining Meaningful Use and CEHRT
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 of the Act. CEHRT used in a meaningful way is one piece of the
broader health information technology (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.
Certified EHR technology is defined for the Medicare and Medicaid
EHR Incentive Programs at 42 CFR 495.4, which references the Office of
the National Coordinator for Health Information Technology's (ONC)
definition of CEHRT under 45 CFR 170.102. For Stages 1 and 2 of
meaningful use, 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. The definition of
CEHRT under 45 CFR 170.102 requires, beginning with Federal fiscal year
(FY) and calendar year (CY) 2014, EHR technology certified to the 2014
Edition EHR certification criteria. Therefore, all EPs, eligible
hospitals, and CAHs must use 2014 Edition CEHRT to meet meaningful use
under the Medicare and Medicaid EHR Incentive Programs beginning with
FY 2014 and CY 2014.
On September 4, 2012, we published in the Federal Register (77 FR
53968 through 54162) a final rule titled ``Medicare and Medicaid
Programs; Electronic Health Record Incentive Program--Stage 2,'' that
established, among other final policies, the timeline for the stages of
meaningful use through 2021 and the EHR reporting periods in 2014, as
shown in Table 1 (77 FR 53973 through 53975).
Table 1--Stage of Meaningful Use Criteria by First Payment Year
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Stage of meaningful use
First payment year --------------------------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
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2011................................................. 1 1 1 * 2 2 3 3 TBD TBD TBD TBD
2012................................................. ....... 1 1 * 2 2 3 3 TBD TBD TBD TBD
2013................................................. ....... ....... 1 * 1 2 2 3 3 TBD TBD TBD
2014................................................. ....... ....... ....... * 1 1 2 2 3 3 TBD TBD
2015................................................. ....... ....... ....... ....... 1 1 2 2 3 3 TBD
2016................................................. ....... ....... ....... ....... ....... 1 1 2 2 3 3
2017................................................. ....... ....... ....... ....... ....... ....... 1 1 2 2 3
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* 3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at state option) for Medicaid EPs. All
providers in their first year in 2014 use any continuous 90-day EHR reporting period.
EPs, eligible hospitals, and CAHs that attest to meaningful use for
2014 for their first year of Stage 2 or their second year of Stage 1
have a 3-month quarter EHR reporting period in CY 2014 (EPs) or FY 2014
(eligible hospitals and CAHs). For the Medicaid incentive payments for
meaningful use, EPs have an EHR reporting period of any continuous 90-
day period in CY 2014 as defined by the State Medicaid program, or, if
the State so chooses, any 3-month
[[Page 29734]]
CY quarter in 2014. EPs, eligible hospitals, and CAHs that demonstrate
meaningful use for the first time in 2014 have an EHR reporting period
of any continuous 90-day period in CY 2014 or FY 2014, respectively.
II. Provisions of the Proposed Regulations
A. Proposed Changes to Meaningful Use Stage Timeline and the Use of
CEHRT
1. Reporting in 2014
We are revisiting some of the requirements for the Medicare and
Medicaid EHR Incentive Programs for 2014. Many EHR vendors have
indicated, through letters to CMS, public forums and listening
sessions, survey data, and information related to the certification and
testing process, that the amount of time available after the
publication of the Stage 2 final rule in which to make the required
coding changes to enable their EHR products to be certified to the 2014
Edition of EHR certification criteria was much too short. We
understand, based on information gained from EHR technology developers
and ONC-Authorized Certification Bodies on timing, backlogs, and the
certification case load, many EHR products were certified later than
anticipated, which has impacted the corresponding time available to
providers--especially hospitals--to effectively deploy 2014 Edition
CEHRT and to make the necessary patient safety, staff training, and
workflow investments in order to be prepared to demonstrate meaningful
use in 2014. The availability of 2014 Edition CEHRT is further limited
by the large number of providers needing to upgrade to 2014 Edition
CEHRT. By the end of February 2014, over 350,000 providers had received
an EHR incentive payment for adopting, implementing, or upgrading, or
for successfully demonstrating meaningful use using 2011 Edition CEHRT.
All providers need 2014 Edition CEHRT to adopt, implement, or upgrade,
or to successfully demonstrate meaningful use for Stage 1 or Stage 2 in
2014. Through letters to CMS, public forums, listening sessions, and
public comment at CMS meetings, many provider associations have
expressed concern that, although 2014 Edition CEHRT may be available
for adoption, there is a backlog of many months for the updated version
to be installed and implemented so that providers can successfully
attest for 2014. We also understand that the delay in availability may
limit a provider's ability to fully implement 2014 Edition CEHRT across
the facility. For example, (1) a hospital may have different systems in
multiple settings, which all require an update and integration or (2) a
provider may have certain 2014 Edition CEHRT functionality that, once
implemented in a live setting, requires software patches or workflow
changes.
In an effort to grant more flexibility to providers who have
experienced 2014 Edition CEHRT product availability issues that impact
the ability to fully implement 2014 Edition CEHRT to attest to
meaningful use using 2014 Edition CEHRT, we are proposing the following
changes for the Medicare and Medicaid EHR Incentive Programs for 2014
for providers that are not able to fully implement 2014 Edition CEHRT
for a full EHR reporting period in 2014. We are proposing to allow
these EPs, eligible hospitals, and CAHs that could not fully implement
2014 Edition CEHRT for the 2014 reporting year due to delays in 2014
Edition CEHRT availability to continue to use 2011 Edition CEHRT or a
combination of 2011 Edition and 2014 Edition CEHRT for the EHR
reporting periods in CY 2014 and FY 2014, respectively. These proposed
alternatives are for providers that could not fully implement 2014
Edition CEHRT to meet meaningful use for the duration of an EHR
reporting period in 2014 due to delays in 2014 Edition CEHRT
availability.
We are proposing this change for 2014 only. We will maintain the
existing policy that all providers must use 2014 Edition CEHRT for the
EHR reporting periods in CY 2015, FY 2015, and in subsequent years or
until new certification requirements are adopted in subsequent
rulemaking.
We strongly recommend eligible professionals, eligible hospitals,
and CAHs that have not yet purchased EHR technology to obtain 2014
Edition CEHRT as these providers will still need to use 2014 Edition
CEHRT for their EHR reporting period in 2015 as stated earlier.
In order to avoid inadvertently incentivizing the purchase of an
outdated product that cannot be used to demonstrate meaningful use in a
subsequent year, we are proposing that to qualify for an incentive
payment under Medicaid for 2014 for adopting, implementing, or
upgrading CEHRT, a provider must adopt, implement, or upgrade to 2014
Edition CEHRT only. A provider would not be able to qualify for a
Medicaid incentive payment for 2014 for adopting, implementing, or
upgrading to 2011 Edition CEHRT or a combination of 2011 and 2014
Edition CEHRT. We are proposing to revise the definition of ``Adopt,
Implement or Upgrade'' under 42 CFR 495.302 to reflect this proposal.
The edition of certified EHR technology which is available to a
provider dictates the stage and version of the meaningful use
objectives and measures to which the provider will be able to attest.
For example, 2011 Edition CEHRT alone does not have the necessary
functionality required to meet the Stage 2 objectives and measures. In
addition, the edition of CEHRT determines which clinical quality
measures a provider can calculate and report because the calculations
are part of the software programming within the CEHRT system.
The three options for the use of CEHRT editions and the available
Stage of meaningful use objectives and measures associated with each
option are as follows:
a. Using 2011 Edition CEHRT Only
We are proposing that all EPs, eligible hospitals, and CAHs that
use only 2011 Edition CEHRT for their EHR reporting period in 2014 must
meet the meaningful use objectives and associated measures for Stage 1
under 42 CFR 495.6 that were applicable for the 2013 payment year,
regardless of their current stage of meaningful use. We note that in
the Stage 2 final rule (77 FR 53975 through 53979), we finalized
certain changes to the Stage 1 objectives and associated measures, and
some of those changes were applicable beginning with 2013 while other
changes were applicable beginning with 2014. For ease of reference, we
will refer to the Stage 1 objectives and associated measures under 42
CFR 495.6 that were applicable for 2013 as the ``2013 Stage 1
objectives and measures,'' and we will refer to the Stage 1 objectives
and associated measures under 42 CFR 495.6 that are applicable for 2014
as the ``2014 Stage 1 objectives and measures.'' Providers who choose
this option must attest that they are unable to fully implement 2014
Edition CEHRT because of issues related to 2014 Edition CEHRT
availability delays when they attest to the meaningful use objectives
and measures.
b. Using a Combination of 2011 and 2014 Edition CEHRT
We are proposing that all EPs, eligible hospitals, and CAHs using a
combination of 2011 Edition CEHRT and 2014 Edition CEHRT for their EHR
reporting period in 2014 may choose to meet the 2013 Stage 1 objectives
and measures or the 2014 Stage 1 objectives and measures, or if they
are scheduled to begin Stage 2 in 2014 under the timeline shown in
Table 1, they may choose to meet the Stage 2 objectives and associated
measures under 42 CFR
[[Page 29735]]
495.6. Providers who choose this option must attest that they are
unable to fully implement 2014 Edition CEHRT because of issues related
to 2014 Edition CEHRT availability delays when they attest to the
meaningful use objectives and measures.
c. Using 2014 Edition CEHRT for 2014 Stage 1 Objectives and Measures in
2014 for Providers Scheduled To Begin Stage 2
A provider's ability to fully implement all of the functionality of
2014 Edition CEHRT may be limited by the availability and timing of
product installation, deployment of new processes and workflows, and
employee training. This effect is compounded for providers in Stage 2
as some providers may not be able to fully implement all of the
functions included in 2014 Edition CEHRT that are necessary to meet the
Stage 2 objectives and measures in time to complete their EHR reporting
period in 2014. Therefore, under our proposal, providers who are
scheduled to begin Stage 2 for the 2014 EHR reporting period but are
unable to fully implement all the functions of their 2014 Edition CEHRT
required for Stage 2 objectives and measures due to delays in 2014
Edition CEHRT availability would have the option of using 2014 Edition
CEHRT to attest to the 2014 Stage 1 objectives and measures for the
2014 EHR reporting period. Providers who are scheduled to begin Stage 2
in 2014 who choose this option must attest that they are unable to
fully implement 2014 Edition CEHRT because of issues related to 2014
Edition CEHRT availability delays when they attest to the meaningful
use objectives and measures.
The EHR reporting periods in 2014 already have been established,
and we are not proposing any changes. Under the current timeline shown
in Table 1, providers that first demonstrated meaningful use Stage 1 in
2011 or 2012 are required to begin Stage 2 in 2014. We are proposing
that the flexibility regarding use of the various editions of CEHRT as
outlined earlier would apply only to the EHR reporting periods in 2014
for the EHR Incentive Program. Providers that were scheduled to begin
Stage 2 in 2014 that instead meet the Stage 1 criteria in 2014 will be
required to begin Stage 2 in 2015 as noted in Table 3. In 2015, all
providers, except those in their first year of demonstrating meaningful
use, are required to have a full year EHR reporting period. In
addition, in 2015, all providers are required to have 2014 Edition
CEHRT in order to successfully demonstrate meaningful use.
Table 2--Proposed CEHRT Systems Available for Use in 2014
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You would be able to attest for Meaningful Use:
If you were scheduled to ------------------------------------------------------------------------------
demonstrate: Using 2011 Edition CEHRT Using 2011 & 2014 Using 2014 Edition CEHRT
to do: Edition CEHRT to do: to do:
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Stage 1 in 2014.................. 2013 Stage 1 objectives 2013 Stage 1 objectives 2014 Stage 1 objectives
and measures *. and measures *. and measures
-OR-
2014 Stage 1 objectives
and measures *.
Stage 2 in 2014.................. 2013 Stage 1 objectives 2013 Stage 1 objectives 2014 Stage 1 objectives
and measures *. and measures *. and measures *
-OR- -OR-
2014 Stage 1 objectives Stage 2 objectives and
and measures *. measures *
-OR-
Stage 2 objectives and
measures *.
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* Only providers that could not fully implement 2014 Edition CEHRT for the reporting period in 2014 due to
delays in 2014 Edition CEHRT availability.
The following are example scenarios under our proposal.
Example A: An EP initiated participation in the Medicare EHR
Incentive Program in 2011. The EP successfully demonstrated meaningful
use and received incentive payments for 2011, 2012, and 2013. Based on
the timeline in the Stage 2 final rule, the EP is required to use 2014
Edition CEHRT and demonstrate Stage 2 of meaningful use in 2014. Under
our proposal, this EP who is scheduled to begin Stage 2 in 2014 would
have the following options:
Attest to the Stage 2 objectives and measures of
meaningful use using 2014 Edition CEHRT in 2014 as scheduled.
Attest to the Stage 2 objectives and measures of
meaningful use using a combination of 2011 and 2014 Edition CEHRT in
2014 if they are unable to fully implement 2014 Edition CEHRT due to
delays in 2014 Edition CEHRT availability.
Attest to the 2014 Stage 1 objectives and measures using
2014 Edition CEHRT or a combination of 2011 and 2014 Edition CEHRT in
2014 if they are unable to fully implement 2014 Edition CEHRT due to
delays in 2014 Edition CEHRT availability.
Attest to the 2013 Stage 1 objectives and measures using
2011 Edition CEHRT or a combination of 2011 and 2014 Edition CEHRT in
2014 if they are unable to fully implement 2014 Edition CEHRT due to
delays in 2014 Edition CEHRT availability. Clinical quality measures
must be submitted through attestation if attesting to the 2013 Stage 1
objectives and measures as discussed below in section B of this
proposal.
Example B: An EP initiated participation in the Medicare EHR
Incentive Program in 2013. The EP successfully demonstrated meaningful
use and received an incentive payment for 2013. Based on the timeline
in the Stage 2 final rule, the EP is required to use 2014 Edition CEHRT
and demonstrate Stage 1 of meaningful use in 2014. Under our proposal,
this EP would have one of the following options:
Attest using 2014 Edition CEHRT to the 2014 Stage 1
objectives and measures of meaningful use in 2014 as scheduled.
Attest using a combination of 2011 and 2014 Edition CEHRT
and meet the 2014 Stage 1 objectives and measures of meaningful use in
2014 if they are unable to fully implement 2014 Edition CEHRT due to
delays in 2014 Edition CEHRT availability.
Attest using 2011 Edition CEHRT or a combination of 2011
and 2014 Edition CEHRT and meet the 2013 Stage 1
[[Page 29736]]
objectives and measures of meaningful use in 2014 if they are unable to
fully implement 2014 Edition CEHRT due to delays in 2014 Edition CEHRT
availability. Clinical quality measures must be submitted through
attestation if attesting to the 2013 Stage 1 objectives and measures as
discussed in section II.B. of this proposed rule.
2. Extension of Stage 2
Under the current timeline shown in Table 1, an EP, eligible
hospital or CAH that first became a meaningful user in 2011 or 2012
would be required to begin Stage 3 on January 1, 2016 (the first day of
CY 2016 for EPs) or October 1, 2015 (the first day of FY 2016 for
eligible hospitals or CAHs), respectively. However, because we intend
to analyze the meaningful use Stage 2 data to inform our development of
the criteria for Stage 3 of meaningful use, we are proposing a 1-year
extension of Stage 2 for those providers as is reflected in Table 3. We
are proposing that Stage 3 would begin in CY 2017 for EPs and FY 2017
for eligible hospitals and CAHs that first became meaningful users in
2011 or 2012. The goal of this proposed change is two-fold: First, to
allow CMS and ONC to focus efforts on the successful implementation of
the enhanced patient engagement, interoperability, and health
information exchange requirements in Stage 2; and second, to utilize
data from Stage 2 participation to inform policy decisions for Stage 3.
This proposed change would allow EPs, eligible hospitals, and CAHs
that first became meaningful users in 2011 or 2012 to begin Stage 3 on
January 1, 2017 (EPs) and October 1, 2016 (eligible hospitals and
CAHs). We will maintain the existing timeline for providers that first
became meaningful users in 2013 and for those that begin in 2014 and
subsequent years or until new certification requirements are adopted in
subsequent rulemaking, as shown in Table 3.
Table 3--Proposed Stage of Meaningful Use Criteria by First Payment Year
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Stage of meaningful use
First payment year ------------------------------------------------------------------------------
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
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2011............................. 1 1 1 * 1 or 2 2 3 3 TBD TBD TBD
2
2012............................. ..... 1 1 * 1 or 2 2 3 3 TBD TBD TBD
2
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
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* 3-month quarter EHR reporting period for Medicare and continuous 90-day EHR reporting period (or 3 months at
State option) for Medicaid EPs. All providers in their first year in 2014 use any continuous 90-day EHR
reporting period.
We invite public comment on our proposals.
B. Clinical Quality Measure Submission in 2014
In 2014, as part of the definition of ``meaningful EHR user'' under
42 CFR 495.4, all providers are required to select and report on
clinical quality measures (CQMs) from the relevant sets adopted in the
Stage 2 final rule (77 FR 54069 through 54075, and 77 FR 54081 through
54089 and further specified as noted in the December 7, 2012 interim
final rule with comment period (77 FR 72985) and published on the CMS
eCQM Library [http://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html], regardless of their stage of
meaningful use or year of participation in the EHR Incentive Program.
We are proposing the following changes for reporting on clinical
quality measures in 2014 for EPs, eligible hospitals, and CAHs for the
Medicare and Medicaid EHR Incentive Programs. The method of CQM
submission under this proposal would depend on the edition of CEHRT a
provider uses to record, calculate, and report its clinical quality
measures for the selected EHR reporting period in 2014.
Due to limitations in the Registration and Attestation System for
the EHR Incentive Program and other CMS data systems, the reporting
options and methods for CQMs for 2014 would depend upon the edition of
CEHRT that a provider uses for its EHR reporting period in 2014. If a
provider elects to use only 2011 Edition CEHRT for its EHR reporting
period in 2014, the provider would be required to report CQMs by
attestation as follows:
EPs would report from the set of 44 measures and according
to the reporting criteria finalized in the Stage 1 final rule (75 FR
44386 through 44411)--
++ Three core/alternate core;
++ Three additional measures; and
++ The reporting period would be any continuous 90 days within CY 2014
for EPs that are demonstrating meaningful use for the first time or a
3-month CY quarter for EPs that have previously demonstrated meaningful
use.
Eligible hospitals and CAHs would report all 15 measures
finalized in the Stage 1 final rule (75 FR 44411 through 44422).
The reporting period would be any continuous 90 days
within FY 2014 for hospitals that are demonstrating meaningful use for
the first time or a 3-month FY quarter for hospitals that have
previously demonstrated meaningful use.
If a provider elects to use a combination of 2011 Edition and 2014
Edition CEHRT and chooses to attest to the 2013 Stage 1 objectives and
measures for its EHR reporting period in 2014, the provider would be
required to report CQMs by attestation using the same measure sets and
reporting criteria outlined earlier for providers who elect to use only
2011 Edition CEHRT for their EHR reporting periods in 2014. Because of
the differences in how CQMs are calculated and tested between the 2011
and the 2014 Editions of CEHRT, we are further proposing that a
provider may attest to data for the CQMs derived exclusively from the
2011 Edition CEHRT for the portion of the reporting period in which
2011 Edition CEHRT was in place.
If a provider elects to use a combination of 2011 Edition and 2014
Edition CEHRT and chooses to attest to the 2014 Stage 1 objectives and
measures or the Stage 2 objectives and measures, the provider would be
required to submit CQMs in accordance with the requirements and
policies established for clinical quality measure reporting for 2014 in
the Stage 2 final rule and subsequent rulemakings. For further
explanation, we refer readers to
[[Page 29737]]
the following: For EPs--77 FR 54049 through 54089, 77 FR 72985 through
72991, 78 FR 74753 through 74757; and for eligible hospitals and CAHs--
77 FR 54049 through 54089, 77 FR 72985 through 72991, 78 FR 50903
through 50906. We are also proposing that a provider must submit CQMs
in accordance with the requirements and policies established for 2014
in those rulemakings if the provider elects to use only 2014 Edition
CEHRT for the entire duration of its EHR reporting period in 2014,
regardless of the stage of meaningful use that the provider chooses to
meet.
For the Medicaid EHR Incentive Program, the method of reporting
CQMs for EPs and eligible hospitals will continue to be at the state's
discretion subject to our prior approval, as established in the Stage 2
final rule (77 FR 54075 through 54078, and 54087 through 54089).
We invite public comment on our proposal.
C. Revision to the CEHRT Definition for Additional Flexibility in 2014
To support the CMS proposals to provide additional flexibility in
the Medicare and Medicaid EHR Incentive Programs during 2014, ONC is
proposing to make a minor, but necessary, corresponding revision to the
CEHRT definition at 45 CFR 170.102.
ONC is proposing to revise the CEHRT definition to change certain
Federal fiscal year (FY)/calendar year (CY) cutoffs in paragraphs (1)
and (2) of the CEHRT definition under 45 CFR 170.102. These FY/CY
cutoffs were finalized in ONC's 2014 Edition final rule (77 FR 54257
through 54260). The policy in paragraph (1) of the definition applies
to any fiscal year/calendar year up to and including 2013. The policy
in paragraph (2) of the definition applies to FY 2014/CY 2014 and all
subsequent years.
Paragraph (1) sets forth policy that permitted the use of 2011
Edition certified Complete EHRs and EHR Modules, a combination of 2011
and 2014 Edition certified Complete EHRs and EHR Modules, and 2014
Edition certified Complete EHRs and EHR Modules to be used to meet the
CEHRT definition through the end of FY 2013/CY 2013. However, paragraph
(2) establishes policy that, starting with FY 2014/CY 2014, only the
use of 2014 Edition certified Complete EHRs and EHR Modules could be
used to meet the CEHRT definition.
The following specific proposed revisions to the CEHRT definition
are necessary to support the added flexibility we proposed for 2014.
The effect of these proposed revisions would be to allow EPs, eligible
hospitals, and CAHs to use either 2011 Edition or a combination of 2011
and 2014 Edition certified Complete EHRs and EHR Modules to meet the
CEHRT definition and to demonstrate meaningful use Stage 1 for 2014.
Specifically, ONC is proposing to modify the CEHRT definition at 45
CFR 170.102 to replace the following
``2013'' with ``2014'' in the first sentence of paragraph
(1).
``FY and CY 2014'' with ``FY and CY 2015'' in paragraph
(1)(i) and (1)(iii).
``2014'' with ``2015'' in the first sentence of paragraph
(2).
Overall, this proposed revision would make the first day of FY 2015
(for eligible hospitals and CAHs) and CY 2015 (for eligible
professionals) the new required start date for exclusive use of 2014
Edition certified Complete EHRs and EHR Modules to meet the CEHRT
definition.
We invite public comment on our proposals.
III. Collection of Information Requirements
This document does not impose any new information collection
requirements, that is, reporting, recordkeeping or third-party
disclosure requirements, as defined under the Paperwork Reduction Act
of 1995 (5 CFR 1320). However, it does make reference to the currently
approved information collection request associated with the Electronic
Health Record Incentive Program. The information collection
requirements for the program are currently approved under OMB control
number 0938-1158 with an expiration date of April 30, 2015.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Statement
We have examined the impact 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 rule does not reach the economic threshold and thus is not
considered a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
less than $7.0 million to $35.5 million in any 1 year. Individuals and
States are not included in the definition of a small entity. We are not
preparing an analysis for the RFA because we have determined, and the
Secretary certifies, that this proposed rule would not have a
significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may 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 for Medicare payment regulations and has fewer than
100 beds. We are not preparing an analysis for section 1102(b) of the
Act because we have determined, and the Secretary certifies, that this
proposed rule would not have a significant impact on the operations of
a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2014, that
threshold is approximately
[[Page 29738]]
$141 million. This rule will have no consequential effect on State,
local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this rule does not impose any costs on State or
local governments, the requirements of Executive Order 13132 are not
applicable.
CMS is proposing, for 2014 only, that EPs, eligible hospitals, and
CAHs would be able to use either 2011 Edition, 2014 Edition or a
combination of 2011 and 2014 Edition certified Complete EHRs and EHR
Modules to meet the CEHRT definition and to demonstrate meaningful use
during 2014.
To support the CMS proposals to provide added flexibility in the
Medicare and Medicaid EHR Incentive Programs during 2014, ONC is
proposing to make a minor, but necessary, corresponding revision to the
CEHRT definition specified at 45 CFR 170.102, to change certain FY/CY
cutoffs in paragraphs (1) and (2) of the CEHRT definition. These FY/CY
cutoffs were finalized in ONC's 2014 Edition final rule (77 FR 54257
through 54260).
With respect to our proposal to allow the flexibility to use 2011
Edition Certified EHR Technology, a combination of 2011 Edition and
2014 Edition Certified EHR Technology, or solely 2014 Edition Certified
EHR Technology in 2014, we do not believe that this proposal will have
a significant impact as it merely gives providers the flexibility to
choose to retain and use their 2011 Edition CEHRT, a combination of
2011 and 2014 Edition CEHRT, or 2014 Edition CEHRT in 2014. We are
making this proposal in response to concerns that the availability of
2014 Edition CEHRT is quite limited. We refer readers to the impact
analyses included in the final rule titled ``Medicare and Medicaid
Programs; Electronic Health Record Incentive Program--Stage 2'' (77 FR
53698 through 54162). Similarly, the ONC proposal to revise the CEHRT
definition merely provides additional flexibility in support of the CMS
proposals and ONC does not believe that it will have a significant
impact (see ``Health Information Technology: Standards, Implementation
Specifications, and Certification Criteria for Electronic Health Record
Technology, 2014 Edition; Revisions to the Permanent Certification
Program for Health Information Technology'' (77 FR 54163 through
54292)).
In accordance with the provisions of Executive Order 12866, this
rule was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 495
Administrative practice and procedure, Health facilities, Health
maintenance, organizations (HMO), Medicare, Penalties, Privacy,
Reporting and recordkeeping requirements.
45 CFR Part 170
Computer technology, Electronic health record, Electronic
information system, Electronic transactions, Health, Health care,
Health information technology, Health insurance, Health records,
Hospitals, Incorporation by reference, Laboratories, Medicaid,
Medicare, Privacy, Reporting and recordkeeping requirements, Public
health, Security.
For the reasons stated in the preamble of this proposed rule, the
Centers for Medicare & Medicaid Services is proposing to amend 42 CFR
Part 495 and the Department is proposing to amend 45 CFR Part 170 as
set forth below:
Title 42--Public Health
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 495.302 is amended by adding paragraph (4) to the definition
of ``Adopt, implement or upgrade'' to read as follows:
Sec. 495.302 Definitions.
* * * * *
Adopt, implement or upgrade means--
* * * * *
(4) For payment year 2014, the references to ``certified EHR
technology'' in paragraphs (1) through (3) of this definition are
deemed to be references to paragraph (2) of the definition of
``Certified EHR Technology'' under 45 CFR 170.102 (that is, the
definition of ``Certified EHR Technology'' for FY and CY 2015 and
subsequent years).
* * * * *
Title 45--Public Health
PART 170--HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION
SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION
PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY
0
3. The authority citation for part 170 continues to read as follows:
Authority: 42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C.
552.
Sec. 170.102 [Amended]
0
4. In Sec. 170.102, the definition of ``Certified EHR Technology'' is
amended as follows:
0
A. In paragraph (1) introductory text, by removing the year ``2013''
and adding in its place the year ``2014''.
0
B. In paragraph (1)(i), by removing ``; or '' and adding in its place
``;''.
0
C. In paragraph (1)(iii), by removing the phrase ``FY and CY 2014'' and
adding in its place the phrase ``FY and CY 2015'' and by removing the
cross-reference ``paragraph (2);'' and adding in its place the cross-
reference ``paragraph (2) of this definition''.
0
D. In paragraph (2), by removing the phrase ``FY and CY 2014'' and
adding in its place the phrase ``FY and CY 2015''.
Dated: May 12, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Approved: May 13, 2014.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2014-11944 Filed 5-20-14; 4:15 pm]
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