[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72725-72727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3328-NC]


Medicare Program; Request for Information To Aid in the Design 
and Development of a Survey Regarding Patient and Family Member 
Experiences With Care Received in Inpatient Rehabilitation Facilities

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

ACTION: Request for information.

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SUMMARY: This request for information will aid in the design and 
development of a survey regarding patient and family member experiences 
with the care received in inpatient rehabilitation facilities (IRFs).
    Comment Date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on January 19, 2016.

ADDRESSES: In commenting, refer to file code CMS-3328-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-3328-NC, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    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-3328-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) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.

FOR FURTHER INFORMATION CONTACT: Judith Harvilchuck, Ph.D., 410-786-
3527.

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

[[Page 72726]]

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

    In accordance with section 399HH of the Public Health Service Act 
(PHSA), as added by section 3011 of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148, enacted on Mar. 23, 2010), the 
Department of Health and Human Services (HHS) developed the National 
Quality Strategy (NQS), which is led by the Agency for Healthcare 
Research and Quality (AHRQ), to create national aims and priorities to 
guide local, state, and national efforts to improve the quality of 
health care (http://www.ahrq.gov/workingforquality/). The NQS 
established three aims supported by six priorities.
    The three aims are as follows:
     Better Care: Improve the overall quality, by making health 
care more patient-centered, reliable, accessible, and safe.
     Healthy People/Healthy Communities: Improve the health of 
the U.S. population by supporting proven interventions to address 
behavioral, social, and environmental determinants of health in 
addition to delivering higher-quality care.
     Affordable Care: Reduce the cost of quality health care 
for individuals, families, employers, and government.
    The six priorities are: (1) Making care safer by reducing harm 
caused by the delivery of care; (2) ensuring that each person and 
family are engaged as partners in their care; (3) promoting effective 
communication and coordination of care; (4) promoting the most 
effective prevention and treatment practices for the leading causes of 
mortality, starting with cardiovascular disease; (5) working with 
communities to promote wide use of best practices to enable healthy 
living; and (6) making quality care more affordable for individuals, 
families, employers, and governments by developing new health care 
delivery models.
    To support the collection of data that can be used to pursue these 
aims and progress on these priorities in the IRF setting, we are 
developing a survey hereinafter referred to as the ``IRF Patient and 
Family Member Experience of Care (PEC) Survey,'' which supports the NQS 
goal of Better Care and the priorities of:
     Ensuring that each person and family are engaged as 
partners in their care (priority #2); and
     Promoting effective communication and coordination of care 
(priority #3).
    Under authority of sections 1886(j)(7) and 1890A(e) of the Social 
Security Act (the Act), we plan to collect this information in support 
of the NQS aims. When this survey is fully developed, we will consider 
proposing it for adoption as a quality measure under the IRF Quality 
Reporting Program (QRP) (for details on CMS' measure development 
process, please see the Blueprint at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MeasuresManagementSystemBlueprint.html). We intend to develop the IRF 
PEC Survey in accordance with Consumer Assessment of Healthcare 
Providers and Systems (CAHPS[supreg]) Survey Design Principles and 
submit the resulting instrument to AHRQ for recognition as a 
CAHPS[supreg] survey. CAHPS[supreg] Survey Design Principles and 
implementation instructions can be found at https://www.cahps.ahrq.gov/about-cahps/principles/index.html.
    We have previously implemented a number of nationwide patient 
experience CAHPS[supreg] surveys in both inpatient and outpatient 
settings and for different services. Specifically, we implemented 
CAHPS[supreg] surveys for Medicare health and drug plans, inpatient 
hospitals, home health agencies, in-center dialysis facilities, 
hospices, and Accountable Care Organizations, and recently developed a 
CAHPS[supreg] survey for outpatient and ambulatory surgery centers; and 
we have begun development of a Long Term Care Hospital Patient 
Experience of Care Survey. The planned IRF PEC Survey differs from 
other CMS PEC surveys because the target population for the IRF PEC 
Survey consists of patients who have significant rehabilitation needs, 
some of which are complex. Although the vast majority of IRFs exist as 
part of acute care hospitals, IRF patients are specifically excluded 
from the survey population of the Hospital CAHPS[supreg] surveys for 
purposes of CMS' Hospital Inpatient Quality Reporting Program.
    IRFs are hospitals or units of acute care (or critical access) 
hospitals that provide intensive rehabilitation services to patients 
typically following an injury, illness, or surgery.\1\ Patient who are 
admitted require intensive rehabilitation therapy services, as 
documented by physician assessment, which are uniquely provided in 
IRFs. Although the intensity of these services can be reflected in 
various ways, the generally-accepted standard by which it is typically 
demonstrated in IRFs is by the provision of intensive therapies at 
least 3 hours a day for 5 days a week.\2\ This resource-intensive 
inpatient hospital environment is for patients who, due to the 
complexity of their nursing, medical management, and rehabilitation 
needs, require an inpatient stay and an interdisciplinary team approach 
to the delivery of rehabilitation care.
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    \1\ http://www.medpac.gov/documents/reports/mar14_ch10.pdf?sfvrsn=0.
    \2\ https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/Inpatient_Rehab_Fact_Sheet_ICN905643.pdf.
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    We believe that the following aspects of IRF care that would have 
to be taken into consideration in developing the survey, but we invite 
comment on these considerations as well as any potential omissions from 
this list:
     Complexity of rehabilitation needs and long-term options.
     Interdisciplinary team approach to care delivery.
     Coordination and collaboration on patient and medical 
goals of care when many patients have goals of returning to their home- 
or community-based setting.
     Patient and family education on the types and limitations 
of rehabilitative services and long-term levels of care and supports 
following IRF discharge.
     Addressing psycho-social needs related to the oftentimes 
unexpected setback that resulted in the IRF stay.
    Given the unique environment and patient population of the IRF 
setting, we are exploring the level of adequacy of existing patient 
experience of care instruments designed for other settings for 
capturing IRF care experiences. Therefore, we are in the process of 
reviewing potential topic areas (as discussed in section II. of this 
RFI), as well as publicly available instruments and measures, for the 
purpose of developing an IRF PEC Survey that will enable objective 
comparisons of IRF experiences across the country. A rigorous, well-
designed IRF PEC Survey will allow us to understand patient experiences 
throughout their IRF care, as reported by the patients themselves, if 
possible, or by family members. Should we ultimately adopt the IRF PEC 
Survey as a quality measure in the IRF QRP, the public reporting of 
data from the measure could help consumers make more informed decisions 
about different IRF providers, as well as drive improvements in the 
quality of IRF care.

II. Solicitation of Information

    We are soliciting the submission of suggested topic areas such as 
communication with providers, rehabilitation, functional status, pain 
management/control or non-pain symptom management (including

[[Page 72727]]

offering of alternative non-opioid pain management, discussion of safe 
storage and proper disposal of opioids, screening for overdose risk, 
and review the history of substance use), discharge planning, family 
training, rehabilitation services, medical and nursing care, 
interdisciplinary team goal setting and care planning. We are also 
soliciting information on publicly available instruments for capturing 
patients' and family members' experiences with IRF care in a variety of 
formats (for example, standardized, computer readable format) that can 
be collected by providers or CAHPS[supreg] survey vendors. We are 
interested in suggested topic areas and publicly available instruments 
that can measure the quality of care from the patients' and/or family 
members' perspective in IRFs within acute-care hospitals, critical 
access hospitals, and free-standing facilities; instruments that can be 
used to track changes over time; and items that are developed for and/
or can be modified to address low case volume. Existing instruments are 
preferred if they have been tested, have been found to have a high 
degree of reliability and validity, and for which there is evidence of 
wide use in one or more patient care settings, including those in rural 
and frontier communities. Instruments capable of risk adjustment, and/
or instruments that minimize duplication of efforts and/or that utilize 
common quality measures, where available, are preferred. Whenever 
possible, preference will be given to quality measures identified by 
the Secretary under section 1139A or 1139B of the Act, or endorsed 
under section 1890 of the Act.
    The following information would be especially helpful in any 
comments responding to this request for information:
     A brief cover letter summarizing the information requested 
for submitted instruments and topic areas, respectively, and how the 
submitted materials could be used to help fulfil the intent of the 
survey.
     (Optional) Information about the person submitting the 
materials for the purpose of follow-up questions about the submission, 
which includes the following:
    ++ Name.
    ++ Title.
    ++ Organization.
    ++ Mailing address.
    ++ Telephone number.
    ++ Email address.
     When submitting topic areas, we encourage including, to 
the extent available, the following information:
    ++ Detailed descriptions of the suggested topic area(s) and 
specific purpose(s).
    ++ Relevant peer-reviewed journal articles or full citations.
     When submitting publicly available instruments or survey 
questions, we encourage including to the extent available the following 
information:
    ++ Name of the instrument.
    ++ Indication that the instrument is publicly available.
    ++ Copies of the full instrument in all available languages.
    ++ Topic areas included in the instrument.
    ++ Measures that can be derived from data collected using the 
instrument.
    ++ Instrument reliability (internal consistency, test-retest, etc.) 
and validity (content, construct, criterion related).
    ++ Results of cognitive testing (one-on-one testing with a small 
number of respondents to ensure that they understand the 
questionnaire.)
    ++ Results of field testing.
    ++ Current use of the instrument (who is using it, what it is being 
used for, what population it is being used with, how instrument 
findings are reported, and by whom the findings are used).
    ++ Relevant peer-reviewed journal articles or full citations.
    ++ CAHPS[supreg] trademark status.
    ++ NQF endorsement status.
    ++ Survey administration instructions.
    ++ Data analysis instructions.
    ++ Guidelines for reporting survey data.
    If you wish to provide comments on this information collection, 
please submit your comments as specified in the ADDRESSES section of 
this request for information.
    Comments must be received on/by January 19, 2016.

III. Collection of Information Requirements

    This RFI does not impose any information collection requirements. 
We believe it is a solicitation of comments from the general public. As 
stated in the implementing regulations of the Paperwork Reduction Act 
of 1995 (PRA) at 5 CFR 1320.3(h)(4), it is exempt from the requirements 
of the PRA (44 U.S.C. 3501 et seq.).
    The data collected via this RFI will be used to develop the IRF PEC 
Survey. While surveys are generally subject to the requirements of the 
PRA, we believe the IRF PEC Survey is exempt. Section I. of this RFI 
explains that we plan to collect this information in support of the NQS 
and, under sections 1886(j)(7) and 1890A(e) of the Act and develop the 
IRF PEC Survey into a quality measure that we may consider proposing 
for adoption in the IRF Quality Reporting Program (QRP). In accordance 
with section 102 of the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA) (Pub. L. 114-110), the PRA shall not apply to the 
collection of information for the development of quality measures.
    Also, as stated earlier in section I. of this RFI, we will develop 
the CMS IRF PEC Survey in accordance with CAHPS[supreg] Survey Design 
Principles and are developing this survey and plans to submit the 
resulting instrument to AHRQ for recognition as a CAHPS[supreg] survey. 
Upon receiving recognition as a CAHPS[supreg] survey and prior to 
implementation, CMS will submit the CAHPS recognized IRF PEC Survey 
through the OMB approval process. At that time, the public will have 
the opportunity to review, comment, or review and comment on the 
proposed information collection request prior to its submission to OMB 
for review and approval.

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: November 6, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-29623 Filed 11-19-15; 8:45 am]
BILLING CODE 4120-01-P