[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81824-81828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32931]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3323-NC]


Request for Information: Certification Frequency and Requirements 
for the Reporting of Quality Measures Under CMS Programs

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Request for information.

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

SUMMARY: This request for information seeks public comment regarding 
several items related to the certification of health information 
technology (IT), including electronic health records (EHR) products 
used for reporting to certain CMS quality reporting programs such as, 
but not limited to, the Hospital Inpatient Quality Reporting (IQR) 
Program and the Physician Quality Reporting System (PQRS). In addition, 
we are requesting feedback on how often to require recertification, the 
number of clinical quality measures (CQMs) a certified Health IT Module 
should be required to certify to, and testing of certified Health IT 
Module(s).

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on February 1, 2016.

ADDRESSES: In commenting, refer to file code CMS-3323-NC. 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-3323-NC, 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.

[[Page 81825]]

    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-3323-NC, 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:
    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) 786-9994 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 FURTHER INFORMATION CONTACT:  Lisa Marie Gomez, 410-786-1175.

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

    The Health Information Technology for Economic and Clinical Health 
Act (Title IV of Division B of the American Recovery and Reinvestment 
Act of 2009 (ARRA) and Title XIII of Division A of the ARRA) authorizes 
incentive payments under Medicare and Medicaid for the adoption of and 
meaningful use of certified EHR technology (CEHRT) and downward payment 
adjustments under Medicare for failure to demonstrate meaningful use. 
Eligible professionals (EPs), eligible hospitals, and critical access 
hospitals (CAHs) that seek to qualify for incentive payments or avoid 
negative payment adjustments under the Medicare and Medicaid EHR 
Incentive Programs are required to use CEHRT. Some CMS quality 
reporting programs, such as the Hospital Inpatient Quality Reporting 
(IQR) Program and Physician Quality Reporting System (PQRS), either 
require or provide the option to use certified EHR technology, as 
defined under the EHR Incentive Program, for reporting quality data.
    The Office of the National Coordinator for Health Information 
Technology's (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 Final Rule'' (80 FR 62601) (2015 Edition final rule), 
establishes the capabilities and specifies the related standards and 
implementation specifications that CEHRT needs to include to support 
the achievement of meaningful use by EPs, eligible hospitals, and CAHs. 
ONC's Health IT Certification Program provides a process by which 
Health IT Module(s) can be certified so that they meet the standards, 
implementation specifications, and certification criteria that have 
been adopted by the Secretary. CEHRT is defined for the Medicare and 
Medicaid EHR Incentive Programs in 42 CFR 495.4. The definition 
establishes the requirements for EHR technology that must be used by 
providers to meet the MU objectives and measures or to qualify for an 
incentive payment under Medicaid for adopting, implementing, or 
upgrading CEHRT. For example, a Health IT Module is presented for 
certification to a criterion with a percentage-based measure and the 
Health IT Module can meet the ``automated numerator recording'' 
criterion or ``automated measure calculation'' criterion. The CQM data 
reported to us must originate from EHR technology that is certified in 
accordance with the ONC Health IT Certification Program's requirements 
(77 FR 54053).
    As stated in the Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program--Stage 3 and Modifications to Meaningful Use 
in 2015 through 2017 final rule (80 FR 62894), in 2017, all EPs, 
eligible hospitals, and CAHs have two options to report CQM data, 
either through attestation or use of established methods for electronic 
reporting where feasible. However, starting in 2018, EPs, eligible 
hospitals, and CAHs participating in the Medicare EHR Incentive Program 
must electronically report CQMs using CEHRT where feasible; and 
attestation to CQMs will no longer be an option except in certain 
circumstances where electronic reporting is not feasible.

II. Solicitation of Comments

    We are soliciting public input on the following areas of 
certification and testing of health IT, particularly relating to how 
often to require recertification, the number of CQMs a certified Health 
IT Module should be required to certify to, and the testing of 
certified Health IT Module(s) in order to reduce the burden and further 
streamline the process for providers and health IT developers while 
ensuring such products are certified and tested appropriately for 
effectiveness. The feedback will inform CMS and ONC of elements that 
may need to be considered for future rules relating to the reporting of 
quality measures under CMS programs. This request for information is 
part of the effort of CMS to streamline/reduce EP, eligible hospital, 
CAH, and health IT developer burden.

A. Frequency of Certification

    We conduct an annual analysis of CQM specifications in order to 
ensure measure efficacy, accuracy, and clinical relevance. Any updates 
to the calculation of a CQM through this process are released with the 
annual updates to the electronic specifications for EHR submission 
published by CMS (https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html). Because we require 
the most recent version of the CQM specifications to be used for 
electronic reporting methods (79 FR 67906 and 80 FR 49760), we 
understand that health IT developers must make CQM updates annually and 
providers must regularly implement those updates to stay current with 
the most recent CQM version. To

[[Page 81826]]

ensure accuracy of the implementation of these updates, we have 
considered requiring recertification of already certified EHR products 
with these annual updates. We understand that standards for 
electronically representing CQMs continue to evolve, and believe there 
may be value in retesting certified Health IT Modules (including CEHRT) 
periodically to ensure that CQMs are being accurately calculated and 
represented, and that they can be reported as required. However, we 
have not required this recertification to date. With the continuing 
evolution of technology and clinical standards, as well as the need for 
a predictable cycle from measure development to provider data 
submission, we indicated, in the Fiscal Year (FY) 2016 Hospital 
Inpatient Prospective Payment Systems (IPPS) and Long-term Care 
Hospital (LTCH) Prospective Payment System (PPS) final rule (80 FR 
49760) (hereinafter referred to as the FY 2016 IPPS/LTCH PPS final 
rule), that we would be issuing a request for information on the 
establishment of an ongoing cycle for the introduction and 
certification of new measures, the testing of updated measures, and the 
testing and certification of submission capabilities.
    While we believe that health IT developers should test and certify 
their products to the most recent version of the electronic 
specifications for the CQMs when feasible, we understand the burdens 
associated with this requirement and therefore, have not historically 
required re-certification of previously certified products when updates 
are made to CQM electronic specifications or to the standards required 
for reporting. During the FY 2016 IPPS/LTCH PPS rulemaking process, we 
received comments and requests from stakeholders to change this policy. 
We acknowledge that the certification process can be burdensome to 
health IT developers and believe that annual certification could 
compress the timeline for CQM and standard updates. We also acknowledge 
that stakeholders and providers reporting electronic CQMs have an 
interest in ensuring that their Health IT Module is tested and 
certified to the most recent version of electronic CQM specifications. 
We are soliciting feedback regarding testing and recertification, 
particularly relating to: The requirement for CEHRT products to be 
recertified when a new version of the CEHRT is available in order to 
ensure the accuracy of implementation; and the requirement for Health 
IT Modules to undergo annual CQM testing through CMS approved testing 
tools and the ONC Health IT Certification Program. We are also seeking 
comment on the following.
     What is the burden (both time and money) of additional 
testing and recertification?
     What are the benefits of requiring additional testing and 
recertification?
     How will it affect the timeline for CQM and standard 
updates?
     What are the benefits and challenges of establishing a 
predictable cycle from measure development to provider data submission?

B. Changes to Minimum CQM Certification Requirements

    The Medicare and Medicaid Programs; Electronic Health Record 
Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 
through 2017 final rule (80 FR 62761) specifies the meaningful use 
criteria that EPs, eligible hospitals, and CAHs must meet in order to 
qualify for Medicare and Medicaid EHR incentive payments and avoid 
downward payment adjustments under Medicare. We believe EHRs should be 
certified to more than the minimum number of CQMs as required by the 
ONC 2014 Edition Base EHR definition of a minimum of 9 CQMs for EPs or 
16 for eligible hospitals and CAHs (80 FR 16771, see also 45 CFR 
170.102). With health IT developers having EHRs certified to the 
minimum number of CQMs, EPs, eligible hospitals, and CAHs may have 
limited CQMs available to them and may not be able to report on CQMs 
that are applicable to their patient population or scope of practice. 
As stated in the preamble of the final rule (80 FR 62895), we believe 
EPs, eligible hospitals, and CAHs should have a choice of which CQMs to 
report so that they can report on those CQMs most applicable to their 
patient population or scope of practice. Accordingly, we are soliciting 
comment on the following policy options that could provide greater 
choice for EPs, eligible hospitals, and CAHs. Specifically, we are 
soliciting comment on: The feasibility of health IT developers 
complying with the requirements of each option in the first year in 
which the requirements would become effective; the impact of each 
option on EPs, eligible hospitals/CAHs, and health IT developers; and 
what we would need to consider when assessing each of these options.
     Option 1: Require EP health IT developers to certify 
Health IT Modules to all CQMs in the EP selection list; and require 
eligible hospital/CAH health IT developers to certify to all CQMs in 
the selection list for eligible hospitals and CAHs.
     Option 2: Incrementally increase the number of CQMs 
required to be certified each year until Health IT Modules are 
certified for all CQMs available for reporting by EPs, eligible 
hospitals, and CAHs to meet their CQM reporting requirements. For 
Option 2, we invite input on the advantages and disadvantages of an 
incremental increase in the number of CQMs required to be certified 
each year.
     Option 3: Require EP health IT developers to certify 
health IT products to more than the current minimum number of CQMs 
required for reporting, but not to all available CQMs.
    For Option 3, we invite stakeholders' input regarding the following 
approaches that are specific examples of implementation of the policy 
goal:
     Option A: An approach that would set a minimum number of 
measures health IT developers must certify to for EP settings or 
eligible hospital/CAH settings that is greater than the minimum number 
required for provider reporting. For example, EP health IT developers 
could be required to certify to a minimum of 15 measures, and eligible 
hospital/CAH health IT developers could be required to certify to a 
minimum number of 25 measures. We note that these numbers are provided 
as examples only, and we solicit comment on the appropriate number 
health IT developers could be required to certify to. Under this 
approach, health IT developers could choose from any measures in the 
list of available CQMs.
     Option B: An EP-specific approach that would require an EP 
health IT developer to certify to all the measures in a core/required 
set and all the measures in at least one specialty measure set relevant 
to the scope of practice for which the product is intended. We are 
looking for feedback on the general concept of requiring health IT 
developers to ensure that they are certified to the types of measures 
that are most relevant to their client base. For example, if a product 
serves multiple specialties, then it needs to be certified to the 
measures that are most likely needed by all of the specialties it 
serves. On the other hand, if the product is a niche product, such as a 
dental product, then it only needs to be certified to the measures that 
are relevant for that particular section of the market. As another 
example, we have provided a pediatric recommended core set \1\ and an 
adult recommended core

[[Page 81827]]

set \2\ of measures. Note that none of the measures in the core sets 
are currently required for health IT developer certification, but only 
recommended. We solicit comment on whether we should require health IT 
developers to certify to all the measures in a core set depending on 
whether the product is intended to serve pediatric or adult settings. 
We are considering a structure for providing specialty measure sets 
similar to those recommended under the PQRS \3\ which have been 
developed by CMS together with specialty societies. These specialty 
measure sets have been developed to ensure that measures represented 
within Specialty Measure Sets accurately illustrate measures that are 
relevant within a particular clinical area. While soliciting general 
comment on this proposed alternate approach, we recognize that there 
may not be a specialty measure set for every specialty type eligible to 
participate in the EHR Incentive Programs. We are working on increasing 
the number of specialties for which there is a Specialty Measure Set in 
PQRS, but solicit comment on what additional specialties would benefit 
from a Specialty Measure Set and whether there are efforts underway to 
establish a list we could consider for our programs. We also 
acknowledge that there may not be e-specified CQMs available for every 
Specialty Measure Set and solicit comments on whether this approach 
would achieve the desired goal for all specialty types to have 
certified measures relevant to their scope of practice available in 
their certified Health IT Module.
---------------------------------------------------------------------------

    \1\ http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/2014_CQM_PrediatricRecommended_CoreSetTable.pdf.
    \2\ http://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/2014_CQM_AdultRecommend_CoreSetTable.pdf.
    \3\ http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/MeasuresCodes.html.
---------------------------------------------------------------------------

     Option C: Another approach with 3 options from which a 
health IT developer must choose one:
    ++ Multispecialty health IT developer--certifies all CQMs.
    ++ Primary care health IT developer--certifies a set of primary 
care CQMs.
    ++ Specialty provider health IT developer--certifies a minimum 
number of CQMs on an ``a la carte'' basis.
    For this approach, we solicit comment on the number of measures 
that would be reasonable to require for certification under the 
``primary care health IT developer'' option as well as the ``specialty 
provider health IT developer'' option. We invite general comment on 
this overall approach.
    We are soliciting public input on other ways of grouping or 
classifying measures to ensure applicability and selection for 
providers. For example, one method of grouping measures could be by 
those that are invasive (for example, surgical), non-invasive, and 
cognitive. Another method could be by setting of care/venue.
    As stated in the Medicare and Medicaid Programs; Electronic Health 
Record Incentive Program--Stage 3 and Modifications to Meaningful Use 
in 2015 through 2017 final rule (80 FR 62895), any specific proposals 
for the number of measures vendors would be required to certified to 
would be outlined in separate notice and comment rulemaking such as the 
Physician Fee Schedule or Inpatient Prospective Payment Systems rules.

C. CQM Testing and Certification

    ONC offers health IT certification for CQMs to record and export, 
import and calculate, and electronically report CQMs through its ONC 
Health IT Certification Program. This year, ONC has adopted a new 
edition of certification criteria in the 2015 Edition final rule (80 FR 
62601). One objective of testing for the 2015 Edition CQM criteria (80 
FR 62651) is to increase testing robustness (for example, increasing 
number of test records, robustly testing pathways by which a patient 
can enter the numerator or denominator of a measure), thereby ensuring 
that all certified products have capabilities commensurate to the 
increased requirements enumerated in the 2015 Edition final rule.
    In the 2011 and 2014 Editions of certification criteria, the 
certification program sought to test basic capabilities and minimum 
requirements. Our expectation is that as time progresses and technology 
improves, EHR systems will have to demonstrate they are able to perform 
to increasing levels of complexity, including requirements to identify 
errors, consume larger numbers of test cases, and demonstrate stricter 
adherence to standards. This is to ensure that investments into 
certified products yield the functionality expected to improve health 
care. Certification criteria also includes optional and required 
elements that allow end users and quality improvement leaders to view, 
filter, and export quality measure data. These data enable point-of-
care, iterative quality improvement efforts to identify patients whose 
care and conditions are not compliant with evidence-based guidelines, 
take action to improve their engagement with care processes, and 
achieve better outcomes.
    CMS and ONC's Health IT Certification Program test CQM 
functionality (for example, by testing a health IT system's ability to 
import, export, capture, calculate, and report CQM data according to 
certain standards) through the Cypress Testing and Certification Tool 
by enabling repeatable and rigorous testing of a product's capability 
to accurately calculate CQMs.\4\ There are potential areas of 
improvement to increase the robustness of that testing. Therefore, we 
are requesting information on the following:
---------------------------------------------------------------------------

    \4\ http://projectcypress.org/.
---------------------------------------------------------------------------

     What changes to testing are recommended (or are not 
recommended) to increase testing robustness?
     How could CMS and ONC determine how many test cases are 
needed for adequate test coverage?
     Are there recommendations for the format of test cases 
that could be entered both manually and electronically?
     What kind of errors should constitute warnings rather than 
test failures?
     Are there recommendations for or against single measure 
testing?
     How could the test procedures and certification companion 
guides published by ONC be improved to help you be more successful in 
preparing for and passing certification testing?
    CMS and ONC believe that increased testing robustness adds value to 
the process of certification, but acknowledge that it would increase 
health IT developer burden in certifying their products. Therefore, we 
welcome comments on the following:
     How can the CQM certification process be made more 
efficient and how can the certification tools and resources be 
augmented or made more useable?
     What, if any, adverse implications could the increased 
certification standards have on providers?
     What levels of testing will ensure that providers and 
other product purchasers will have enough information on the usability 
and effectiveness of the tool without unduly burdening health IT 
developers?
     Would flexibility on the vocabulary codes allowed for test 
files reduce burden on health IT developers?
     What are other ways in which the Cypress testing tool 
could be improved?
     When 45 CFR 170.315(c)(1) requires users to export quality 
measure data on demand, how would you want that to be accessed by users 
and what characteristics are minimally required to make this feature 
useful to end users?
     ONC finalized a 2015 Edition certification criterion for 
filtering of CQMs (45 CFR 170.315(c)(4)) to the following filters:

[[Page 81828]]

    ++ Taxpayer Identification Number (TIN).
    ++ National Provider Identifier (NPI).
    ++ Provider type.
    ++ Practice site address.
    ++ Patient insurance.
    ++ Patient age.
    ++ Patient sex.
    ++ Patient race and ethnicity.
    ++ Patient problem list data.
    How useful are the ``filtering'' criteria to end users of systems 
for the purpose of safety and quality improvement? To quality 
improvement staff and organizations?
     Are there additional filters/data would be helpful to 
stratify CQM-Filters (45 CFR 170.315(c)(4)) data by?
     What, if anything additional, regarding this testing/
certification should be published via the Certified Health IT Product 
List?

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

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.

    Dated: December 3, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-32931 Filed 12-30-15; 8:45 am]
BILLING CODE 4120-01-P