[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62173-62174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 
http://www.regulations.gov. 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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

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