80 FR 72725 - 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

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

Federal Register Volume 80, Issue 224 (November 20, 2015)

Page Range		72725-72727
FR Document		2015-29623

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.

Federal Register, Volume 80 Issue 224 (Friday, November 20, 2015)

[Federal Register Volume 80, Number 224 (Friday, November 20, 2015)]
[Notices]
[Pages 72725-72727]
From the Federal Register Online [www.thefederalregister.org]
[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

Federal Register / Vol. 80, No. 224 / Friday, November 20, 2015 / Notices 72727

offering of alternative non-opioid pain ++ Detailed descriptions of the and 1890A(e) of the Act and develop the
management, discussion of safe storage suggested topic area(s) and specific IRF PEC Survey into a quality measure
and proper disposal of opioids, purpose(s). that we may consider proposing for
screening for overdose risk, and review ++ Relevant peer-reviewed journal adoption in the IRF Quality Reporting
the history of substance use), discharge articles or full citations. Program (QRP). In accordance with
planning, family training, rehabilitation • When submitting publicly available section 102 of the Medicare Access and
services, medical and nursing care, instruments or survey questions, we CHIP Reauthorization Act of 2015
interdisciplinary team goal setting and encourage including to the extent (MACRA) (Pub. L. 114–110), the PRA
care planning. We are also soliciting available the following information: shall not apply to the collection of
information on publicly available ++ Name of the instrument. information for the development of
instruments for capturing patients’ and ++ Indication that the instrument is quality measures.
family members’ experiences with IRF publicly available. Also, as stated earlier in section I. of
care in a variety of formats (for example, ++ Copies of the full instrument in all this RFI, we will develop the CMS IRF
standardized, computer readable format) available languages. PEC Survey in accordance with
that can be collected by providers or ++ Topic areas included in the CAHPS® Survey Design Principles and
CAHPS® survey vendors. We are instrument. are developing this survey and plans to
interested in suggested topic areas and ++ Measures that can be derived from submit the resulting instrument to
publicly available instruments that can data collected using the instrument. AHRQ for recognition as a CAHPS®
measure the quality of care from the ++ Instrument reliability (internal survey. Upon receiving recognition as a
patients’ and/or family members’ consistency, test-retest, etc.) and CAHPS® survey and prior to
perspective in IRFs within acute-care validity (content, construct, criterion implementation, CMS will submit the
hospitals, critical access hospitals, and related). CAHPS recognized IRF PEC Survey
free-standing facilities; instruments that ++ Results of cognitive testing (one- through the OMB approval process. At
can be used to track changes over time; on-one testing with a small number of that time, the public will have the
and items that are developed for and/or respondents to ensure that they opportunity to review, comment, or
can be modified to address low case understand the questionnaire.) review and comment on the proposed
volume. Existing instruments are ++ Results of field testing. information collection request prior to
preferred if they have been tested, have ++ Current use of the instrument its submission to OMB for review and
been found to have a high degree of (who is using it, what it is being used approval.
reliability and validity, and for which for, what population it is being used
with, how instrument findings are IV. Response to Comments
there is evidence of wide use in one or
more patient care settings, including reported, and by whom the findings are Because of the large number of public
those in rural and frontier communities. used). comments we normally receive on
Instruments capable of risk adjustment, ++ Relevant peer-reviewed journal Federal Register documents, we are not
and/or instruments that minimize articles or full citations. able to acknowledge or respond to them
++ CAHPS® trademark status. individually. We will consider all
duplication of efforts and/or that utilize
++ NQF endorsement status. comments we receive by the date and
common quality measures, where
++ Survey administration time specified in the DATES section of
available, are preferred. Whenever
instructions. this preamble, and, when we proceed
possible, preference will be given to
++ Data analysis instructions. with a subsequent document, we will
quality measures identified by the ++ Guidelines for reporting survey
Secretary under section 1139A or 1139B respond to the comments in the
data.
of the Act, or endorsed under section preamble to that document.
If you wish to provide comments on
1890 of the Act. this information collection, please Dated: November 6, 2015.
The following information would be submit your comments as specified in Andrew M. Slavitt,
especially helpful in any comments the ADDRESSES section of this request for Acting Administrator, Centers for Medicare
responding to this request for information. & Medicaid Services.
information: Comments must be received on/by [FR Doc. 2015–29623 Filed 11–19–15; 8:45 am]
• A brief cover letter summarizing the January 19, 2016. BILLING CODE 4120–01–P
information requested for submitted
instruments and topic areas, III. Collection of Information
respectively, and how the submitted Requirements
DEPARTMENT OF HEALTH AND
materials could be used to help fulfil the This RFI does not impose any HUMAN SERVICES
intent of the survey. information collection requirements. We
• (Optional) Information about the believe it is a solicitation of comments Food and Drug Administration
person submitting the materials for the from the general public. As stated in the
purpose of follow-up questions about implementing regulations of the [Docket No. FDA–2012–N–0145]
the submission, which includes the Paperwork Reduction Act of 1995 (PRA)
at 5 CFR 1320.3(h)(4), it is exempt from Agency Information Collection
following:
the requirements of the PRA (44 U.S.C. Activities; Submission for Office of
++ Name. Management and Budget Review;
++ Title. 3501 et seq.).
The data collected via this RFI will be Comment Request; Improving Food
++ Organization. Safety and Defense Capacity of the
tkelley on DSK3SPTVN1PROD with NOTICES

used to develop the IRF PEC Survey.
++ Mailing address. While surveys are generally subject to State and Local Level: Review of State
++ Telephone number. the requirements of the PRA, we believe and Local Capacities
++ Email address. the IRF PEC Survey is exempt. Section AGENCY: Food and Drug Administration,
• When submitting topic areas, we I. of this RFI explains that we plan to HHS.
encourage including, to the extent collect this information in support of
ACTION: Notice.
available, the following information: the NQS and, under sections 1886(j)(7)

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Document Created: 2015-12-14 13:59:07
Document Modified: 2015-12-14 13:59:07

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for information.
Dates		To be assured consideration, comments must be
Contact		Judith Harvilchuck, Ph.D., 410-786- 3527.
FR Citation		80 FR 72725

80 FR 72725 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 224 (November 20, 2015)

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