Notice2021-24393
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 9, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Full Text
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<title>Federal Register, Volume 86 Issue 214 (Tuesday, November 9, 2021)</title>
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[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62173-62174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-24393]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10792, CMS-10793, and CMS-367a-e]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect information from the public. Under the Paperwork Reduction
Act of 1995 (the PRA), federal agencies are required to publish notice
in the Federal Register concerning each proposed collection of
information (including each proposed extension or reinstatement of an
existing collection of information) and to allow 60 days for public
comment on the proposed action. Interested persons are invited to send
comments regarding our burden estimates or any other aspect of this
collection of information, including the necessity and utility of the
proposed information collection for the proper performance of the
agency's functions, the accuracy of the estimated burden, ways to
enhance the quality, utility, and clarity of the information to be
collected, and the use of automated collection techniques or other
forms of information technology to minimize the information collection
burden.
DATES: Comments must be received by January 10, 2022.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number: ___ , Room C4-26-05, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html</a>.
FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10792 Patient-Reported Indicator Survey (PaRIS)
CMS-10793 Medicare Advantage and Prescription Drug Plan Consumer
Assessment of Healthcare Providers and Systems (CAHPS) Survey Field
Test
CMS-367a-e Medicaid Drug Rebate Program Labeler Reporting Format
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain
approval from the Office of Management and Budget (OMB) for each
collection of information they conduct or sponsor. The term
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies
to publish a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
or reinstatement of an existing collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, CMS is publishing this notice.
Information Collection
1. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Patient-Reported Indicator Survey (PaRIS); Use: The Centers for
Medicare and Medicaid Services (CMS) invites comments on a proposed new
Information Collection Request (ICR) to conduct the International
Survey of People Living with Chronic Conditions (hereafter referred to
as the PaRIS Survey). This survey has been developed by a collaborative
workgroup under the auspices of the Organization for Economic
Cooperation and Development (OECD), an international organization that
works with governments, policy makers, and citizens to shape policies
that foster prosperity, equality, opportunity, and well-being for all.
The OECD launched the PaRIS initiative in 2017 to address gaps in
health outcomes measures, particularly regarding user experiences with
health care services. OECD member countries,
[[Page 62174]]
including the U.S., are working together to develop, standardize, and
implement indicators that measure outcomes and experiences of health
care that matter most to people. The PaRIS Survey will provide a common
set of measures that support policy makers across participating
countries to improve health care delivery. On behalf of the Department
of Health and Human Services (DHHS) Assistant Secretary for Planning
and Evaluation (ASPE), the Office of Enterprise Data and Analytics
(OEDA) in CMS has been designated as the lead participant for the U.S.
The PaRIS Survey will help to close critical policy gaps by
focusing on: (1) Patient Reported Experience Measures (PREMS) which
measure how patients experience health care, and (2) Patient Reported
Outcome Measures (PROMS) which measure how patients assess the results
of the care they receive. The PaRIS survey includes both PREMS and
PROMS items and aims to collect vital information about primary health
care, by asking about topics such as the respondent's health, health
behaviors, patient activation and confidence in managing their health
care, experiences with health care and health providers including
access to health care, quality of life, physical functioning, and
psychological well-being.
OECD and its member countries will use data collected by the PaRIS
Survey to shed light on key questions about how well care in each
country is organized around the needs of patients. Results from the
survey will show how key outcomes and experiences vary across and
within countries. This will allow countries to benchmark and learn from
each other's approaches. The survey will also help policy makers in
OECD member countries understand how health systems are addressing the
needs of persons with chronic health conditions. Findings will foster a
dialogue with service providers about how to further improve the
performance and people-centeredness of primary health care services.
To facilitate U.S. participation in this important initiative, CMS
will leverage the existing sample for the Medicare Current Beneficiary
Survey (MCBS). The MCBS is a continuous, multi-purpose survey of a
representative national sample of the Medicare population, including
the population of beneficiaries aged 65 and over and beneficiaries aged
64 and below with certain disabling conditions, residing in the U.S.;
it is conducted under OMB clearance number 0938-0568. Given the age and
health characteristics of Medicare beneficiaries, the MCBS sample will
provide a comparable population to survey respondents selected in other
participating OECD countries. Interviewers will telephone MCBS
respondents and administer the PaRIS Survey by phone as a one-time
standalone survey during January through April 2023. Non-response
follow-up will be conducted by telephone and in-person as needed. It is
estimated that 7,559 Medicare beneficiaries will participate in this
40-minute survey. CMS plans to release a disclosure protected public
use file with accompanying methodological documentation. This public
use file will also be made available to OECD for analysis and released
with data from other participating countries. Form Number: CMS-10792
(OMB: 0938-New); Frequency: One-time collection; Affected Public:
Individuals residing in households; Number of Respondents: 7,559; Total
Hours: 5,065 (For policy questions regarding this collection contact
William Long at 410-786-7927.)
2. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Medicare Advantage and Prescription Drug Plan Consumer Assessment of
Healthcare Providers and Systems (CAHPS) Survey Field Test; Use: CMS is
required to collect and report information on the quality of health
care services and prescription drug coverage available to persons
enrolled in a Medicare health or prescription drug plan under
provisions in the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA). Specifically, the MMA under Sec.
1860D-4 (Information to Facilitate Enrollment) requires CMS to conduct
consumer satisfaction surveys regarding Medicare PDPs and MA plans and
report this information to Medicare beneficiaries prior to the Medicare
annual enrollment period. The Medicare CAHPS survey meets the
requirement of collecting and publicly reporting consumer satisfaction
information.
Currently, the MA & PDP CAHPS Surveys (0938-0732) are administered
using a mixed mode data collection protocol (mail+phone) that includes
two survey mailings and phone follow-up with non-respondents. This
request is to conduct a field test with the main goal of testing the
effects of new survey content and a web-based mode on patterns of
response and survey scores. The test will also allow for assessment of
the measurement properties of new survey items. The results of the
field test will inform CMS's decision-making about updates to MA & PDP
CAHPS survey content and survey administration procedures. Form Number:
CMS-10793 (OMB control number: 0938-New); Frequency: Yearly; Affected
Public: Individuals and Households; Number of Respondents: 5,000; Total
Annual Responses: 5,000; Total Annual Hours: 1,290. (For policy
questions regarding this collection contact Lauren K. Fuentes at 410-
786-2290.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicaid Drug
Rebate Program Labeler Reporting Format; Use: Labelers transmit drug
product and pricing data to CMS within 30 days after the end of each
calendar month and quarter. CMS calculates the unit rebate amount (URA)
and the unit rebate offset amount (UROA) for each new drug application
(NDC) and distributes to all State Medicaid agencies. States use the
URA to invoice the labeler for rebates and the UROA to report onto CMS-
64. The monthly data is used to calculate Federal Upper Limit (FUL)
prices for applicable drugs and for states that opt to use this data to
establish their pharmacy reimbursement methodology. In this November
2021 iteration, CMS-367d (Manufacturer Contact Form) is being revised
to include a signature/date line for the submitter to confirm that the
information provide is accurate, and we have additionally updated the
entire 367d to a fillable format, per multiple labeler requests. CMS-
367e (Quarterly VBP-MBP Data) is a new form that is intended for
manufacturers to use (as needed) on a quarterly basis, to transmit
pricing data (best prices associated with value-based purchasing (VBP)
arrangements) for each of their covered outpatient drugs (CODs) to CMS
either via direct file upload to the MDP System or manual on-line
entry. The CMS-367e form is optional. We are not proposing any changes
to the CMS-367a (Quarterly Pricing), CMS-367b (Monthly Pricing), or
CMS-367c (Product Data) forms. Form Number: CMS-367a, b, c, d, and e
(OMB control number: 0938-0578); Frequency: Monthly, quarterly, and on
occasion; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 780; Total Annual Responses: 15,020;
Total Annual Hours: 564,394. (For policy questions regarding this
collection contact Andrea Wellington at 410-786-3490.)
Dated: November 3, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2021-24393 Filed 11-8-21; 8:45 am]
BILLING CODE 4120-01-P
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