[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Stage of meaningful use
                  First payment year                  --------------------------------------------------------------------------------------------------
                                                         2011     2012     2013     2014     2015     2016     2017     2018     2019     2020     2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011.................................................        1        1        1      * 2        2        3        3      TBD      TBD      TBD      TBD
2012.................................................  .......        1        1      * 2        2        3        3      TBD      TBD      TBD      TBD
2013.................................................  .......  .......        1      * 1        2        2        3        3      TBD      TBD      TBD
2014.................................................  .......  .......  .......      * 1        1        2        2        3        3      TBD      TBD
2015.................................................  .......  .......  .......  .......        1        1        2        2        3        3      TBD
2016.................................................  .......  .......  .......  .......  .......        1        1        2        2        3        3
2017.................................................  .......  .......  .......  .......  .......  .......        1        1        2        2        3
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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
----------------------------------------------------------------------------------------------------------------
                                                  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:
----------------------------------------------------------------------------------------------------------------
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 *.
----------------------------------------------------------------------------------------------------------------
* 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
----------------------------------------------------------------------------------------------------------------
                                                              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      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
----------------------------------------------------------------------------------------------------------------
* 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]
BILLING CODE 4120-01-P