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[Federal Register Volume 78, Number 2 (Thursday, January 3, 2013)]
[Notices]
[Pages 308-310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31582]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3278-NC]

Medicare Program; Request for Information on Hospital and Vendor 
Readiness for Electronic Health Records Hospital Inpatient Quality Data 
Reporting

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

ACTION: Request for information.

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SUMMARY: This document is a request for information from hospitals, 
electronic health record (EHR) vendors, and other interested parties 
regarding hospital readiness beginning calendar year 2014 discharges to 
electronically report certain patient-level data under the Hospital 
Inpatient Quality Reporting (IQR) Program using the Quality Reporting 
Document Architecture (QRDA) Category I.

DATES: The information solicited in this document must be received at 
the address provided below, no later than 5 p.m. eastern standard time 
(e.s.t.) on January 22, 2013.

ADDRESSES: In commenting, refer to file code CMS-3278-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-3278-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.
    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-3278-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.

[[Page 309]]

    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Maria Harr, (410) 786-6710.

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

    We are interested in increasing efficiency and reducing the burden 
associated with hospital collection and submission of patient-level 
data on clinical quality measures (CQMs) and are exploring ways that 
hospitals might be able to report data on a subset of Hospital 
Inpatient Quality Reporting (IQR) Program measures specified under 
section 1886(b)(3)(B)(viii) of the Social Security Act (the Act) using 
the same certified electronic health record technology (CEHRT) that is 
used for reporting under the Electronic Health Record (EHR) Incentive 
Program as authorized by section 4102 of the American Recovery and 
Reinvestment Act of 2009 (ARRA). The goals of aligning quality 
measurement and reporting among our quality reporting programs are all 
of the following:
     Streamline our quality reporting programs through 
automatic collection and reporting of data on CQMs using CEHRT.
     Reduce burden to hospitals by allowing them to use EHRs to 
submit data on CQMs that are adopted for both the Hospital IQR Program 
and the EHR Incentive Program.
     Develop a single set of electronic specifications for CQMs 
adopted under multiple quality reporting programs.
     Support quality care improvement.
     Adopt data standards to facilitate hospitals' capturing, 
transmitting, and formatting data elements consistently and clearly.
    The Health Information Technology for Economic and Clinical Health 
(HITECH) Act, part of the American Recovery and Reinvestment Act of 
2009 (ARRA, Pub. L. 111-5), authorized Medicare and Medicaid incentive 
payments to eligible professionals and eligible hospitals when they 
adopt and meaningfully use CEHRT, as well as payment adjustments under 
Medicare beginning in 2015 for failure to demonstrate meaningful use. 
We have promulgated regulations establishing the criteria for Stage 1 
and Stage 2 of meaningful use. More than 120,000 eligible health care 
professionals and more than 3,300 hospitals have qualified to 
participate in the program and receive an incentive payment since it 
began in January 2011.
    The EHR Incentive Program Stage 2 final rule (77 FR 53968) outlines 
our commitment to aligning quality measurement and reporting programs, 
including the Hospital IQR program, the Physician Quality Reporting 
System (PQRS), the Children's Health Insurance Program (CHIP), and the 
Pioneer Accountable Care Organization (ACO) Model. The automatic 
collection and reporting of data elements for many measures through 
CEHRT is expected to greatly simplify reporting for various quality 
reporting programs. We envisage that hospitals will be able to switch 
primarily to EHR-based reporting of clinical quality data for many 
measures that are currently manually chart-abstracted and submitted to 
CMS for the Hospital IQR Program.
    The Hospital IQR Program (http://www.qualitynet.org/dcs/ 
ContentServer?cid=113811 5987129&pagename=Qnet Public%2FPage%2FQnetTier 
2&c=Page), which is authorized by section 1886(b)(3)(B)(viii) of the 
Act, is intended to equip patients with hospital quality of care 
information to make informed decisions about healthcare options and is 
also intended to encourage hospitals and clinicians to improve the 
quality of inpatient care provided to all patients. Hospital IQR 
Program data is available to consumers on the Hospital Compare Web site 
(http://www.hospitalcompare.hhs.gov/).
    Under the Hospital IQR Program, subsection (d) hospitals report 
data on selected quality measures to CMS. In selecting measures for the 
program, we strive to be consistent with the priorities identified in 
the National Quality Strategy. Subsection (d) hospitals report quality 
measures of process, structure, outcomes, patient perspectives on care, 
and efficiency that relate to services furnished in an inpatient acute 
care hospital setting in order to receive the full annual payment 
update (APU). Sections 1886(b)(3)(B)(viii)(I) of the Act states that 
the applicable percentage increase, for FY 2007 and each subsequent 
fiscal year, shall be reduced by 2.0 percentage points (or, beginning 
with FY 2015, by one-quarter of such applicable percentage increase 
(determined without regard to sections 1886(b)(3)(B)(ix), (xi), or 
(xii) of the Act)) for any subsection (d) hospital that does not submit 
quality data in a form and manner, and at a time, specified by the 
Secretary.

II. Solicitation for Information

    We are soliciting information from hospitals, EHR vendors, and 
other interested parties on a variety of subject matters.
    The following questions are intended for all hospitals, EHR 
vendors, and other interested parties:
     How do hospitals and vendors perceive the alignment of 
EHR-based reporting and hospital quality reporting programs? What are 
the foreseen benefits and challenges?
     Do hospitals and vendors envision being able to meet the 
criteria for reporting clinical quality measures electronically for the 
EHR Incentive Program as set forth in the EHR Incentive Program--Stage 
2 final rule (77 FR 53968) and any related guidance issued? If not, 
what are the issues in meeting the requirements and what additional 
information is needed?
    We are specifically soliciting comments from hospitals and other 
interested parties on the following topics:
     Is the hospital planning to adopt EHR technology that has 
been certified to the 2014 Edition EHR certification criteria during or 
before calendar year (CY) 2014?
     Is the hospital aware of the payment adjustments 
authorized under the HITECH Act beginning in FY 2015 for failing to 
demonstrate meaningful use under the Medicare EHR Incentive Program?
     Is the hospital planning to electronically report CQM 
data--specifically venous thromboembolism (VTE) and stroke (STK) and 
emergency department (ED) measures--under the Medicare EHR Incentive 
Program in FY 2014?
     Is the hospital already participating in or planning to 
participate in the 2013 Medicare EHR Incentive Program Electronic 
Reporting Pilot for Eligible Hospitals and Critical Access Hospitals

[[Page 310]]

(CAHs) (``Pilot'')? The pilot provides eligible hospitals and CAHs with 
an opportunity to meet the CQM reporting requirements of the Medicare 
EHR Incentive Program through electronic submission of CQM data. The 
pilot is a voluntary electronic reporting method used to satisfy the 
CQM reporting requirements for the Medicare EHR Incentive Program. If 
not, what barriers prevent the hospital from participating?
     Does the hospital plan to report data leveraging any state 
health information exchange (HIE) initiative?
     Does the hospital plan to report data leveraging the 
Nationwide Health Information Network (NwHIN) Exchange, which is now 
the eHealth Exchange?
     Will the hospital use a third party to report quality data 
required under the EHR Incentive Program?
     Are there operational challenges to electronically 
reporting quality data? If so, does the hospital have mitigation plans 
to overcome these challenges?
     Has the hospital chief information officer (CIO) and/or 
chief operating officer (COO) prioritized electronically reporting 
quality data over the next 3 years (2013 through 2015)?
     Are there any evaluation or data validation methodologies 
that have been used by the hospital to assess the accuracy and 
reliability of clinical process of care quality data using QRDA 
category I standards?
     What barriers and opportunities would be created by 
including sampling criteria for electronically reported measures under 
the EHR Incentive Program?
    We are specifically soliciting comments from EHR vendors and other 
interested parties in the following areas:
     Is the EHR vendor's technology currently certified under 
the Office of the National Coordinator for Health Information 
Technology (ONC) Health Information Technology (HIT) Certification 
Program to the 2001 Edition EHR Certification Criteria? Does the vendor 
intend to have its EHR technology certified to the 2014 Edition EHR 
Certification Criteria? If so, when?
     What are the top three operational challenges facing EHR 
vendors over the next 3 years (2013 through 2015)? Of those identified, 
does the EHR vendor have mitigation plans to overcome these challenges?
     Are there any evaluation or data validation methodologies 
that have been used to assess the accuracy and reliability of clinical 
process of care quality data using QRDA category I standards?
     Have vendors included random sampling functionalities in 
currently certified systems? If yes, what guidance for random sampling 
has been employed, if any? If no, what barriers are presented by adding 
this functionality to your currently certified systems?

III. 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 request for 
information, and, when we proceed with a subsequent document, we will 
respond to the comments in that document.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: December 21, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2012-31582 Filed 12-28-12; 11:15 am]
BILLING CODE 4120-01-P
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