80_FR_82075 80 FR 81824 - Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs

80 FR 81824 - Request for Information: Certification Frequency and Requirements for the Reporting of Quality Measures Under CMS Programs

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 251 (December 31, 2015)

Page Range81824-81828
FR Document2015-32931

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).

Federal Register, Volume 80 Issue 251 (Thursday, December 31, 2015)
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81824-81828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32931]


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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



                                              81824                     Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices

                                              for comprehensive guidance on all                       FOR FURTHER INFORMATION CONTACT:                      at http://www.pso.AHRQ.gov/
                                              phases of the submission, application,                  Eileen Hogan, Center for Quality                      index.html.
                                              and award implementation process.                       Improvement and Patient Safety, AHRQ,
                                                                                                                                                            Sharon B. Arnold,
                                                                                                      5600 Fishers Lane, Room 06N94B,
                                              Will D. Spoon,                                                                                                AHRQ Deputy Director.
                                                                                                      Rockville, MD 20857; Telephone (toll
                                              Program Analyst, Gulf Coast Ecosystem,                  free): (866) 403–3697; Telephone (local):             [FR Doc. 2015–32914 Filed 12–30–15; 8:45 am]
                                              Restoration Council.
                                                                                                      (301) 427–1111; TTY (toll free): (866)                BILLING CODE 4160–90–P
                                              [FR Doc. 2015–32924 Filed 12–30–15; 8:45 am]
                                                                                                      438–7231; TTY (local): (301) 427–1130;
                                              BILLING CODE P                                          Email: pso@AHRQ.hhs.gov.
                                                                                                                                                            DEPARTMENT OF HEALTH AND
                                                                                                      SUPPLEMENTARY INFORMATION:
                                                                                                                                                            HUMAN SERVICES
                                              DEPARTMENT OF HEALTH AND                                Background
                                              HUMAN SERVICES                                                                                                Centers for Medicare & Medicaid
                                                                                                         The Patient Safety Act authorizes the              Services
                                              Agency for Healthcare Research and                      listing of PSOs, which are entities or
                                              Quality                                                 component organizations whose                         [CMS–3323–NC]
                                                                                                      mission and primary activity are to
                                              Patient Safety Organizations:                           conduct activities to improve patient                 Request for Information: Certification
                                              Voluntary Relinquishment from the                       safety and the quality of health care                 Frequency and Requirements for the
                                              Texas Patient Safety Organization, Inc.                 delivery.                                             Reporting of Quality Measures Under
                                                                                                         HHS issued the Patient Safety Rule to              CMS Programs
                                              AGENCY: Agency for Healthcare Research                  implement the Patient Safety Act.
                                              and Quality (AHRQ), Department of                       AHRQ administers the provisions of the                AGENCY:  Centers for Medicare &
                                              Health and Human Services (HHS).                        Patient Safety Act and Patient Safety                 Medicaid Services (CMS), HHS.
                                              ACTION: Notice of Delisting.                            Rule relating to the listing and operation            ACTION: Request for information.
                                                                                                      of PSOs. The Patient Safety Rule
                                              SUMMARY:    The Patient Safety and                      authorizes AHRQ to list as a PSO an                   SUMMARY:    This request for information
                                              Quality Improvement Act of 2005, 42                     entity that attests that it meets the                 seeks public comment regarding several
                                              U.S.C. 299b–21 to b–26, (Patient Safety                 statutory and regulatory requirements                 items related to the certification of
                                              Act) and the related Patient Safety and                 for listing. A PSO can be ‘‘delisted’’ if             health information technology (IT),
                                              Quality Improvement Final Rule, 42                      it is found to no longer meet the                     including electronic health records
                                              CFR part 3 (Patient Safety Rule),                       requirements of the Patient Safety Act                (EHR) products used for reporting to
                                              published in the Federal Register on                    and Patient Safety Rule, when a PSO                   certain CMS quality reporting programs
                                              November 21, 2008, 73 FR 70732–                         chooses to voluntarily relinquish its                 such as, but not limited to, the Hospital
                                              70814, provide for the formation of                     status as a PSO for any reason, or when               Inpatient Quality Reporting (IQR)
                                              Patient Safety Organizations (PSOs),                    a PSO’s listing expires. Section 3.108(d)             Program and the Physician Quality
                                              which collect, aggregate, and analyze                   of the Patient Safety Rule requires                   Reporting System (PQRS). In addition,
                                              confidential information regarding the                  AHRQ to provide public notice when it                 we are requesting feedback on how
                                              quality and safety of health care                       removes an organization from the list of              often to require recertification, the
                                              delivery. The Patient Safety Rule                       federally approved PSOs.                              number of clinical quality measures
                                              authorizes AHRQ, on behalf of the                          AHRQ has accepted a notification                   (CQMs) a certified Health IT Module
                                              Secretary of HHS, to list as a PSO an                   from the Texas Patient Safety                         should be required to certify to, and
                                              entity that attests that it meets the                   Organization, Inc., PSO number P0012,                 testing of certified Health IT Module(s).
                                              statutory and regulatory requirements                   to voluntarily relinquish its status as a             DATES: To be assured consideration,
                                              for listing. A PSO can be ‘‘delisted’’ by               PSO. Accordingly, the Texas Patient                   comments must be received at one of
                                              the Secretary if it is found to no longer               Safety Organization, Inc. was delisted                the addresses provided below, no later
                                              meet the requirements of the Patient                    effective at 12:00 Midnight ET (2400) on              than 5 p.m. on February 1, 2016.
                                              Safety Act and Patient Safety Rule,                     December 15, 2015. The Texas Patient                  ADDRESSES: In commenting, refer to file
                                              when a PSO chooses to voluntarily                       Safety Organization, Inc. submitted this              code CMS–3323–NC. Because of staff
                                              relinquish its status as a PSO for any                  request for voluntary relinquishment                  and resource limitations, we cannot
                                              reason, or when a PSO’s listing expires.                during expedited revocation                           accept comments by facsimile (FAX)
                                              AHRQ has accepted a notification of                     proceedings for cause.                                transmission.
                                              voluntary relinquishment from the                          The Texas Patient Safety                              You may submit comments in one of
                                              Texas Patient Safety Organization, Inc.                 Organization, Inc. has patient safety                 four ways (please choose only one of the
                                              of its status as a PSO, and has delisted                work product (PSWP) in its possession.                ways listed):
                                              the PSO accordingly. The Texas Patient                  The PSO has met the requirements of                      1. Electronically. You may submit
                                              Safety Organization, Inc. submitted this                section 3.108(c)(2)(i) of the Patient                 electronic comments on this regulation
                                              request for voluntary relinquishment                    Safety Rule regarding notification to                 to http://www.regulations.gov. Follow
                                              during expedited revocation                             providers that have reported to the PSO.              the ‘‘Submit a comment’’ instructions.
                                              proceedings for cause.                                  In addition, according to sections                       2. By regular mail. You may mail
                                              DATES: The directories for both listed                  3.108(c)(2)(ii) and 3.108(b)(3) of the                written comments to the following
                                              and delisted PSOs are ongoing and                       Patient Safety Rule regarding                         address ONLY: Centers for Medicare &
                                              reviewed weekly by AHRQ. The
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                                                                                                      disposition of PSWP, the PSO has 90                   Medicaid Services, Department of
                                              delisting was effective at 12:00 Midnight               days from the effective date of delisting             Health and Human Services, Attention:
                                              ET (2400) on December 15, 2015.                         and revocation to complete the                        CMS–3323–NC, P.O. Box 8013,
                                              ADDRESSES: Both directories can be                      disposition of PSWP that is currently in              Baltimore, MD 21244–8013.
                                              accessed electronically at the following                the PSO’s possession.                                    Please allow sufficient time for mailed
                                              HHS Web site: http://                                      More information on PSOs can be                    comments to be received before the
                                              www.pso.ahrq.gov/listed.                                obtained through AHRQ’s PSO Web site                  close of the comment period.


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                                                                        Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices                                            81825

                                                 3. By express or overnight mail. You                 Baltimore, Maryland 21244, Monday                     calculation’’ criterion. The CQM data
                                              may send written comments to the                        through Friday of each week from 8:30                 reported to us must originate from EHR
                                              following address ONLY: Centers for                     a.m. to 4 p.m. To schedule an                         technology that is certified in
                                              Medicare & Medicaid Services,                           appointment to view public comments,                  accordance with the ONC Health IT
                                              Department of Health and Human                          phone 1–800–743–3951.                                 Certification Program’s requirements (77
                                              Services, Attention: CMS–3323–NC,                                                                             FR 54053).
                                                                                                      I. Background                                            As stated in the Medicare and
                                              Mail Stop C4–26–05, 7500 Security
                                              Boulevard, Baltimore, MD 21244–1850.                       The Health Information Technology                  Medicaid Programs; Electronic Health
                                                 4. By hand or courier. Alternatively,                for Economic and Clinical Health Act                  Record Incentive Program—Stage 3 and
                                              you may deliver (by hand or courier)                    (Title IV of Division B of the American               Modifications to Meaningful Use in
                                              your written comments ONLY to the                       Recovery and Reinvestment Act of 2009                 2015 through 2017 final rule (80 FR
                                              following addresses:                                    (ARRA) and Title XIII of Division A of                62894), in 2017, all EPs, eligible
                                                 a. For delivery in Washington, DC—                   the ARRA) authorizes incentive                        hospitals, and CAHs have two options
                                              Centers for Medicare & Medicaid                         payments under Medicare and Medicaid                  to report CQM data, either through
                                              Services, Department of Health and                      for the adoption of and meaningful use                attestation or use of established methods
                                              Human Services, Room 445–G, Hubert                      of certified EHR technology (CEHRT)                   for electronic reporting where feasible.
                                              H. Humphrey Building, 200                               and downward payment adjustments                      However, starting in 2018, EPs, eligible
                                              Independence Avenue SW.,                                under Medicare for failure to                         hospitals, and CAHs participating in the
                                              Washington, DC 20201.                                   demonstrate meaningful use. Eligible                  Medicare EHR Incentive Program must
                                                 (Because access to the interior of the               professionals (EPs), eligible hospitals,              electronically report CQMs using
                                              Hubert H. Humphrey Building is not                      and critical access hospitals (CAHs) that             CEHRT where feasible; and attestation
                                              readily available to persons without                    seek to qualify for incentive payments                to CQMs will no longer be an option
                                              Federal government identification,                      or avoid negative payment adjustments                 except in certain circumstances where
                                              commenters are encouraged to leave                      under the Medicare and Medicaid EHR                   electronic reporting is not feasible.
                                              their comments in the CMS drop slots                    Incentive Programs are required to use
                                                                                                      CEHRT. Some CMS quality reporting                     II. Solicitation of Comments
                                              located in the main lobby of the
                                              building. A stamp-in clock is available                 programs, such as the Hospital Inpatient                 We are soliciting public input on the
                                                                                                      Quality Reporting (IQR) Program and                   following areas of certification and
                                              for persons wishing to retain a proof of
                                                                                                      Physician Quality Reporting System                    testing of health IT, particularly relating
                                              filing by stamping in and retaining an
                                                                                                      (PQRS), either require or provide the                 to how often to require recertification,
                                              extra copy of the comments being filed.)
                                                                                                      option to use certified EHR technology,               the number of CQMs a certified Health
                                                 b. For delivery in Baltimore, MD—
                                                                                                      as defined under the EHR Incentive                    IT Module should be required to certify
                                              Centers for Medicare & Medicaid
                                                                                                      Program, for reporting quality data.                  to, and the testing of certified Health IT
                                              Services, Department of Health and
                                                                                                         The Office of the National                         Module(s) in order to reduce the burden
                                              Human Services, 7500 Security
                                                                                                      Coordinator for Health Information                    and further streamline the process for
                                              Boulevard, Baltimore, MD 21244–1850.
                                                                                                      Technology’s (ONC’s) ‘‘2015 Edition                   providers and health IT developers
                                                 If you intend to deliver your
                                                                                                      Health Information Technology (Health                 while ensuring such products are
                                              comments to the Baltimore address, call
                                                                                                      IT) Certification Criteria, 2015 Edition              certified and tested appropriately for
                                              telephone number (410) 786–9994 in
                                                                                                      Base Electronic Health Record (EHR)                   effectiveness. The feedback will inform
                                              advance to schedule your arrival with
                                                                                                      Definition, and ONC Health IT                         CMS and ONC of elements that may
                                              one of our staff members.
                                                                                                      Certification Program Modifications                   need to be considered for future rules
                                                 Comments erroneously mailed to the
                                                                                                      Final Rule’’ (80 FR 62601) (2015 Edition              relating to the reporting of quality
                                              addresses indicated as appropriate for
                                                                                                      final rule), establishes the capabilities             measures under CMS programs. This
                                              hand or courier delivery may be delayed
                                                                                                      and specifies the related standards and               request for information is part of the
                                              and received after the comment period.                  implementation specifications that                    effort of CMS to streamline/reduce EP,
                                              FOR FURTHER INFORMATION CONTACT: Lisa                   CEHRT needs to include to support the                 eligible hospital, CAH, and health IT
                                              Marie Gomez, 410–786–1175.                              achievement of meaningful use by EPs,                 developer burden.
                                              SUPPLEMENTARY INFORMATION:                              eligible hospitals, and CAHs. ONC’s
                                                 Inspection of Public Comments: All                   Health IT Certification Program                       A. Frequency of Certification
                                              comments received before the close of                   provides a process by which Health IT                   We conduct an annual analysis of
                                              the comment period are available for                    Module(s) can be certified so that they               CQM specifications in order to ensure
                                              viewing by the public, including any                    meet the standards, implementation                    measure efficacy, accuracy, and clinical
                                              personally identifiable or confidential                 specifications, and certification criteria            relevance. Any updates to the
                                              business information that is included in                that have been adopted by the Secretary.              calculation of a CQM through this
                                              a comment. We post all comments                         CEHRT is defined for the Medicare and                 process are released with the annual
                                              received before the close of the                        Medicaid EHR Incentive Programs in 42                 updates to the electronic specifications
                                              comment period on the following Web                     CFR 495.4. The definition establishes                 for EHR submission published by CMS
                                              site as soon as possible after they have                the requirements for EHR technology                   (https://www.cms.gov/Regulations-and-
                                              been received: http://                                  that must be used by providers to meet                Guidance/Legislation/
                                              www.regulations.gov. Follow the search                  the MU objectives and measures or to                  EHRIncentivePrograms/eCQM_
                                              instructions on that Web site to view                   qualify for an incentive payment under                Library.html). Because we require the
                                              public comments.                                        Medicaid for adopting, implementing,                  most recent version of the CQM
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                                                 Comments received timely will also                   or upgrading CEHRT. For example, a                    specifications to be used for electronic
                                              be available for public inspection as                   Health IT Module is presented for                     reporting methods (79 FR 67906 and 80
                                              they are received, generally beginning                  certification to a criterion with a                   FR 49760), we understand that health IT
                                              approximately 3 weeks after publication                 percentage-based measure and the                      developers must make CQM updates
                                              of a document, at the headquarters of                   Health IT Module can meet the                         annually and providers must regularly
                                              the Centers for Medicare & Medicaid                     ‘‘automated numerator recording’’                     implement those updates to stay current
                                              Services, 7500 Security Boulevard,                      criterion or ‘‘automated measure                      with the most recent CQM version. To


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                                              81826                     Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices

                                              ensure accuracy of the implementation                   We are also seeking comment on the                       • Option 2: Incrementally increase
                                              of these updates, we have considered                    following.                                            the number of CQMs required to be
                                              requiring recertification of already                      • What is the burden (both time and                 certified each year until Health IT
                                              certified EHR products with these                       money) of additional testing and                      Modules are certified for all CQMs
                                              annual updates. We understand that                      recertification?                                      available for reporting by EPs, eligible
                                              standards for electronically representing                 • What are the benefits of requiring                hospitals, and CAHs to meet their CQM
                                              CQMs continue to evolve, and believe                    additional testing and recertification?               reporting requirements. For Option 2,
                                              there may be value in retesting certified                 • How will it affect the timeline for               we invite input on the advantages and
                                              Health IT Modules (including CEHRT)                     CQM and standard updates?                             disadvantages of an incremental
                                              periodically to ensure that CQMs are                      • What are the benefits and                         increase in the number of CQMs
                                              being accurately calculated and                         challenges of establishing a predictable              required to be certified each year.
                                              represented, and that they can be                       cycle from measure development to                        • Option 3: Require EP health IT
                                              reported as required. However, we have                  provider data submission?                             developers to certify health IT products
                                              not required this recertification to date.              B. Changes to Minimum CQM                             to more than the current minimum
                                              With the continuing evolution of                        Certification Requirements                            number of CQMs required for reporting,
                                              technology and clinical standards, as                      The Medicare and Medicaid                          but not to all available CQMs.
                                              well as the need for a predictable cycle                                                                         For Option 3, we invite stakeholders’
                                                                                                      Programs; Electronic Health Record
                                              from measure development to provider                                                                          input regarding the following
                                                                                                      Incentive Program—Stage 3 and
                                              data submission, we indicated, in the                   Modifications to Meaningful Use in                    approaches that are specific examples of
                                              Fiscal Year (FY) 2016 Hospital Inpatient                2015 through 2017 final rule (80 FR                   implementation of the policy goal:
                                              Prospective Payment Systems (IPPS)                                                                               • Option A: An approach that would
                                                                                                      62761) specifies the meaningful use
                                              and Long-term Care Hospital (LTCH)                                                                            set a minimum number of measures
                                                                                                      criteria that EPs, eligible hospitals, and
                                              Prospective Payment System (PPS) final                  CAHs must meet in order to qualify for                health IT developers must certify to for
                                              rule (80 FR 49760) (hereinafter referred                Medicare and Medicaid EHR incentive                   EP settings or eligible hospital/CAH
                                              to as the FY 2016 IPPS/LTCH PPS final                   payments and avoid downward                           settings that is greater than the
                                              rule), that we would be issuing a request               payment adjustments under Medicare.                   minimum number required for provider
                                              for information on the establishment of                 We believe EHRs should be certified to                reporting. For example, EP health IT
                                              an ongoing cycle for the introduction                   more than the minimum number of                       developers could be required to certify
                                              and certification of new measures, the                  CQMs as required by the ONC 2014                      to a minimum of 15 measures, and
                                              testing of updated measures, and the                    Edition Base EHR definition of a                      eligible hospital/CAH health IT
                                              testing and certification of submission                 minimum of 9 CQMs for EPs or 16 for                   developers could be required to certify
                                              capabilities.                                           eligible hospitals and CAHs (80 FR                    to a minimum number of 25 measures.
                                                 While we believe that health IT                      16771, see also 45 CFR 170.102). With                 We note that these numbers are
                                              developers should test and certify their                health IT developers having EHRs                      provided as examples only, and we
                                              products to the most recent version of                  certified to the minimum number of                    solicit comment on the appropriate
                                              the electronic specifications for the                   CQMs, EPs, eligible hospitals, and CAHs               number health IT developers could be
                                              CQMs when feasible, we understand the                   may have limited CQMs available to                    required to certify to. Under this
                                              burdens associated with this                            them and may not be able to report on                 approach, health IT developers could
                                              requirement and therefore, have not                     CQMs that are applicable to their                     choose from any measures in the list of
                                              historically required re-certification of               patient population or scope of practice.              available CQMs.
                                              previously certified products when                      As stated in the preamble of the final                   • Option B: An EP-specific approach
                                              updates are made to CQM electronic                      rule (80 FR 62895), we believe EPs,                   that would require an EP health IT
                                              specifications or to the standards                      eligible hospitals, and CAHs should                   developer to certify to all the measures
                                              required for reporting. During the FY                   have a choice of which CQMs to report                 in a core/required set and all the
                                              2016 IPPS/LTCH PPS rulemaking                           so that they can report on those CQMs                 measures in at least one specialty
                                              process, we received comments and                       most applicable to their patient                      measure set relevant to the scope of
                                              requests from stakeholders to change                    population or scope of practice.                      practice for which the product is
                                              this policy. We acknowledge that the                    Accordingly, we are soliciting comment                intended. We are looking for feedback
                                              certification process can be burdensome                 on the following policy options that                  on the general concept of requiring
                                              to health IT developers and believe that                could provide greater choice for EPs,                 health IT developers to ensure that they
                                              annual certification could compress the                 eligible hospitals, and CAHs.                         are certified to the types of measures
                                              timeline for CQM and standard updates.                  Specifically, we are soliciting comment               that are most relevant to their client
                                              We also acknowledge that stakeholders                   on: The feasibility of health IT                      base. For example, if a product serves
                                              and providers reporting electronic                      developers complying with the                         multiple specialties, then it needs to be
                                              CQMs have an interest in ensuring that                  requirements of each option in the first              certified to the measures that are most
                                              their Health IT Module is tested and                    year in which the requirements would                  likely needed by all of the specialties it
                                              certified to the most recent version of                 become effective; the impact of each                  serves. On the other hand, if the product
                                              electronic CQM specifications. We are                   option on EPs, eligible hospitals/CAHs,               is a niche product, such as a dental
                                              soliciting feedback regarding testing and               and health IT developers; and what we                 product, then it only needs to be
                                              recertification, particularly relating to:              would need to consider when assessing                 certified to the measures that are
                                              The requirement for CEHRT products to                   each of these options.                                relevant for that particular section of the
                                                                                                         • Option 1: Require EP health IT                   market. As another example, we have
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                                              be recertified when a new version of the
                                              CEHRT is available in order to ensure                   developers to certify Health IT Modules               provided a pediatric recommended core
                                              the accuracy of implementation; and the                 to all CQMs in the EP selection list; and             set 1 and an adult recommended core
                                              requirement for Health IT Modules to                    require eligible hospital/CAH health IT                 1 http://www.cms.gov/Regulations-and-Guidance/
                                              undergo annual CQM testing through                      developers to certify to all CQMs in the              Legislation/EHRIncentivePrograms/Downloads/
                                              CMS approved testing tools and the                      selection list for eligible hospitals and             2014_CQM_PrediatricRecommended_
                                              ONC Health IT Certification Program.                    CAHs.                                                 CoreSetTable.pdf.



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                                                                        Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices                                           81827

                                              set 2 of measures. Note that none of the                one method of grouping measures could                 export, capture, calculate, and report
                                              measures in the core sets are currently                 be by those that are invasive (for                    CQM data according to certain
                                              required for health IT developer                        example, surgical), non-invasive, and                 standards) through the Cypress Testing
                                              certification, but only recommended.                    cognitive. Another method could be by                 and Certification Tool by enabling
                                              We solicit comment on whether we                        setting of care/venue.                                repeatable and rigorous testing of a
                                              should require health IT developers to                    As stated in the Medicare and                       product’s capability to accurately
                                              certify to all the measures in a core set               Medicaid Programs; Electronic Health                  calculate CQMs.4 There are potential
                                              depending on whether the product is                     Record Incentive Program—Stage 3 and                  areas of improvement to increase the
                                              intended to serve pediatric or adult                    Modifications to Meaningful Use in                    robustness of that testing. Therefore, we
                                              settings. We are considering a structure                2015 through 2017 final rule (80 FR                   are requesting information on the
                                              for providing specialty measure sets                    62895), any specific proposals for the                following:
                                              similar to those recommended under the                  number of measures vendors would be                      • What changes to testing are
                                              PQRS 3 which have been developed by                     required to certified to would be                     recommended (or are not
                                              CMS together with specialty societies.                  outlined in separate notice and                       recommended) to increase testing
                                              These specialty measure sets have been                  comment rulemaking such as the                        robustness?
                                              developed to ensure that measures                       Physician Fee Schedule or Inpatient                      • How could CMS and ONC
                                              represented within Specialty Measure                    Prospective Payment Systems rules.                    determine how many test cases are
                                              Sets accurately illustrate measures that                C. CQM Testing and Certification                      needed for adequate test coverage?
                                              are relevant within a particular clinical                                                                        • Are there recommendations for the
                                              area. While soliciting general comment                     ONC offers health IT certification for             format of test cases that could be
                                              on this proposed alternate approach, we                 CQMs to record and export, import and                 entered both manually and
                                              recognize that there may not be a                       calculate, and electronically report                  electronically?
                                              specialty measure set for every specialty               CQMs through its ONC Health IT                           • What kind of errors should
                                              type eligible to participate in the EHR                 Certification Program. This year, ONC                 constitute warnings rather than test
                                              Incentive Programs. We are working on                   has adopted a new edition of                          failures?
                                              increasing the number of specialties for                certification criteria in the 2015 Edition               • Are there recommendations for or
                                              which there is a Specialty Measure Set                  final rule (80 FR 62601). One objective               against single measure testing?
                                              in PQRS, but solicit comment on what                    of testing for the 2015 Edition CQM                      • How could the test procedures and
                                              additional specialties would benefit                    criteria (80 FR 62651) is to increase                 certification companion guides
                                              from a Specialty Measure Set and                        testing robustness (for example,                      published by ONC be improved to help
                                              whether there are efforts underway to                   increasing number of test records,                    you be more successful in preparing for
                                              establish a list we could consider for our              robustly testing pathways by which a                  and passing certification testing?
                                              programs. We also acknowledge that                      patient can enter the numerator or                       CMS and ONC believe that increased
                                              there may not be e-specified CQMs                       denominator of a measure), thereby                    testing robustness adds value to the
                                              available for every Specialty Measure                   ensuring that all certified products have             process of certification, but
                                              Set and solicit comments on whether                     capabilities commensurate to the                      acknowledge that it would increase
                                              this approach would achieve the desired                 increased requirements enumerated in                  health IT developer burden in certifying
                                              goal for all specialty types to have                    the 2015 Edition final rule.                          their products. Therefore, we welcome
                                              certified measures relevant to their                       In the 2011 and 2014 Editions of                   comments on the following:
                                              scope of practice available in their                    certification criteria, the certification                • How can the CQM certification
                                              certified Health IT Module.                             program sought to test basic capabilities             process be made more efficient and how
                                                 • Option C: Another approach with 3                  and minimum requirements. Our                         can the certification tools and resources
                                              options from which a health IT                          expectation is that as time progresses                be augmented or made more useable?
                                              developer must choose one:                              and technology improves, EHR systems                     • What, if any, adverse implications
                                                 ++ Multispecialty health IT                          will have to demonstrate they are able                could the increased certification
                                              developer—certifies all CQMs.                           to perform to increasing levels of                    standards have on providers?
                                                 ++ Primary care health IT developer—                 complexity, including requirements to                    • What levels of testing will ensure
                                              certifies a set of primary care CQMs.                   identify errors, consume larger numbers               that providers and other product
                                                 ++ Specialty provider health IT                      of test cases, and demonstrate stricter               purchasers will have enough
                                              developer—certifies a minimum number                    adherence to standards. This is to                    information on the usability and
                                              of CQMs on an ‘‘a la carte’’ basis.                     ensure that investments into certified                effectiveness of the tool without unduly
                                                 For this approach, we solicit comment                products yield the functionality                      burdening health IT developers?
                                              on the number of measures that would                    expected to improve health care.                         • Would flexibility on the vocabulary
                                              be reasonable to require for certification              Certification criteria also includes                  codes allowed for test files reduce
                                              under the ‘‘primary care health IT                      optional and required elements that                   burden on health IT developers?
                                              developer’’ option as well as the                       allow end users and quality                              • What are other ways in which the
                                              ‘‘specialty provider health IT                          improvement leaders to view, filter, and              Cypress testing tool could be improved?
                                              developer’’ option. We invite general                   export quality measure data. These data                  • When 45 CFR 170.315(c)(1) requires
                                              comment on this overall approach.                       enable point-of-care, iterative quality               users to export quality measure data on
                                                 We are soliciting public input on                    improvement efforts to identify patients              demand, how would you want that to be
                                              other ways of grouping or classifying                   whose care and conditions are not                     accessed by users and what
                                              measures to ensure applicability and                    compliant with evidence-based                         characteristics are minimally required to
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                                              selection for providers. For example,                   guidelines, take action to improve their              make this feature useful to end users?
                                                                                                      engagement with care processes, and                      • ONC finalized a 2015 Edition
                                                2 http://www.cms.gov/Regulations-and-Guidance/
                                                                                                      achieve better outcomes.                              certification criterion for filtering of
                                              Legislation/EHRIncentivePrograms/Downloads/                CMS and ONC’s Health IT
                                              2014_CQM_AdultRecommend_CoreSetTable.pdf.
                                                                                                                                                            CQMs (45 CFR 170.315(c)(4)) to the
                                                3 http://www.cms.gov/Medicare/Quality-                Certification Program test CQM                        following filters:
                                              Initiatives-Patient-Assessment-Instruments/PQRS/        functionality (for example, by testing a
                                              MeasuresCodes.html.                                     health IT system’s ability to import,                   4 http://projectcypress.org/.




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                                              81828                     Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices

                                                ++ Taxpayer Identification Number                     SUMMARY:   The Centers for Medicare &                   3. Call the Reports Clearance Office at
                                              (TIN).                                                  Medicaid Services (CMS) is announcing                 (410) 786–1326.
                                                ++ National Provider Identifier (NPI).                an opportunity for the public to                      FOR FURTHER INFORMATION CONTACT:
                                                ++ Provider type.                                     comment on CMS’ intention to collect                  Reports Clearance Office at (410) 786–
                                                ++ Practice site address.                             information from the public. Under the                1326.
                                                ++ Patient insurance.                                 Paperwork Reduction Act of 1995 (the
                                                ++ Patient age.                                                                                             SUPPLEMENTARY INFORMATION:
                                                                                                      PRA), federal agencies are required to
                                                ++ Patient sex.
                                                ++ Patient race and ethnicity.                        publish notice in the Federal Register                Contents
                                                ++ Patient problem list data.                         concerning each proposed collection of                  This notice sets out a summary of the
                                                How useful are the ‘‘filtering’’ criteria             information (including each proposed                  use and burden associated with the
                                              to end users of systems for the purpose                 extension or reinstatement of an existing             following information collections. More
                                              of safety and quality improvement? To                   collection of information) and to allow               detailed information can be found in
                                              quality improvement staff and                           60 days for public comment on the                     each collection’s supporting statement
                                              organizations?                                          proposed action. Interested persons are               and associated materials (see
                                                • Are there additional filters/data                   invited to send comments regarding our                ADDRESSES).
                                              would be helpful to stratify CQM-Filters                burden estimates or any other aspect of
                                              (45 CFR 170.315(c)(4)) data by?                         this collection of information, including             CMS–R–284 Medicaid Statistical
                                                • What, if anything additional,                       any of the following subjects: (1) The                Information System (MSIS) and
                                              regarding this testing/certification                    necessity and utility of the proposed                 Transformed—Medicaid Statistical
                                              should be published via the Certified                   information collection for the proper                 Information System (T–MSIS)
                                              Health IT Product List?                                 performance of the agency’s functions;                  Under the PRA (44 U.S.C. 3501–
                                                                                                      (2) the accuracy of the estimated                     3520), federal agencies must obtain
                                              III. Collection of Information                          burden; (3) ways to enhance the quality,
                                              Requirements                                                                                                  approval from the Office of Management
                                                                                                      utility, and clarity of the information to            and Budget (OMB) for each collection of
                                                 This document does not impose                        be collected; and (4) the use of                      information they conduct or sponsor.
                                              information collection requirements,                    automated collection techniques or                    The term ‘‘collection of information’’ is
                                              that is, reporting, recordkeeping or                    other forms of information technology to              defined in 44 U.S.C. 3502(3) and 5 CFR
                                              third-party disclosure requirements.                    minimize the information collection                   1320.3(c) and includes agency requests
                                              Consequently, there is no need for                      burden.                                               or requirements that members of the
                                              review by the Office of Management and                                                                        public submit reports, keep records, or
                                                                                                      DATES:  Comments must be received by
                                              Budget under the authority of the                                                                             provide information to a third party.
                                                                                                      February 29, 2016.
                                              Paperwork Reduction Act of 1995 (44                                                                           Section 3506(c)(2)(A) of the PRA
                                              U.S.C. 3501 et seq.).                                   ADDRESSES: When commenting, please
                                                                                                      reference the document identifier or                  requires federal agencies to publish a
                                              IV. Response to Comments                                OMB control number. To be assured                     60-day notice in the Federal Register
                                                                                                      consideration, comments and                           concerning each proposed collection of
                                                Because of the large number of public
                                                                                                      recommendations must be submitted in                  information, including each proposed
                                              comments we normally receive on
                                                                                                      any one of the following ways:                        extension or reinstatement of an existing
                                              Federal Register documents, we are not
                                                                                                        1. Electronically. You may send your                collection of information, before
                                              able to acknowledge or respond to them
                                                                                                      comments electronically to http://                    submitting the collection to OMB for
                                              individually. We will consider all
                                                                                                      www.regulations.gov. Follow the                       approval. To comply with this
                                              comments we receive by the date and
                                                                                                      instructions for ‘‘Comment or                         requirement, CMS is publishing this
                                              time specified in the DATES section of
                                                                                                      Submission’’ or ‘‘More Search Options’’               notice.
                                              this preamble, and, when we proceed
                                                                                                      to find the information collection                      1. Type of Information Collection
                                              with a subsequent document, we will
                                                                                                      document(s) that are accepting                        Request: Revision of a currently
                                              respond to the comments in the
                                                                                                      comments.                                             approved collection. Title of
                                              preamble to that document.
                                                                                                        2. By regular mail. You may mail                    Information Collection: Medicaid
                                                Dated: December 3, 2015.                                                                                    Statistical Information System (MSIS)
                                                                                                      written comments to the following
                                              Andrew M. Slavitt,                                                                                            and Transformed—Medicaid Statistical
                                                                                                      address:
                                              Acting Administrator, Centers for Medicare                                                                    Information System (T–MSIS); Use: The
                                              & Medicaid Services.                                    CMS, Office of Strategic Operations and               data reported in MSIS/T–MSIS are used
                                              [FR Doc. 2015–32931 Filed 12–30–15; 8:45 am]              Regulatory Affairs, Division of                     by federal, state, and local officials, as
                                              BILLING CODE 4120–01–P                                    Regulations Development, Attention:                 well as by private researchers and
                                                                                                        Document Identifier/OMB Control                     corporations to monitor past and
                                                                                                        Number __ Room C4–26–05, 7500                       projected future trends in the Medicaid
                                              DEPARTMENT OF HEALTH AND                                  Security Boulevard, Baltimore,                      program. These data provide the only
                                              HUMAN SERVICES                                            Maryland 21244–1850.                                national level information available on
                                                                                                        To obtain copies of a supporting                    enrollees, beneficiaries, and
                                              Centers for Medicare & Medicaid                         statement and any related forms for the               expenditures. They also provide the
                                              Services                                                proposed collection(s) summarized in                  only national level information
                                              [Document Identifier: CMS–R–284]                        this notice, you may make your request                available on Medicaid utilization. This
                                                                                                      using one of following:                               information is the basis for analyses and
tkelley on DSK3SPTVN1PROD with NOTICES




                                              Agency Information Collection                             1. Access CMS’ Web site address at                  for cost savings estimates for the
                                              Activities: Proposed Collection;                        http://www.cms.hhs.gov/                               Department’s cost sharing legislative
                                              Comment Request                                         PaperworkReductionActof1995.                          initiatives to Congress. The collected
                                              AGENCY: Centers for Medicare &                            2. Email your request, including your               data are also crucial to our actuarial
                                              Medicaid Services.                                      address, phone number, OMB number,                    forecasts. Form Number: CMS–R–284
                                                                                                      and CMS document identifier, to                       (OMB control number: 0938–0345);
                                              ACTION: Notice.
                                                                                                      Paperwork@cms.hhs.gov.                                Frequency: Quarterly and monthly;


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Document Created: 2015-12-31 02:14:52
Document Modified: 2015-12-31 02:14:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for information.
DatesTo be assured consideration, comments must be received at one of
ContactLisa Marie Gomez, 410-786-1175.
FR Citation80 FR 81824 

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