[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43355-43356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10488, CMS-10708 and CMS-10846]


Agency Information Collection Activities: Submission for OMB 
Review; 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 (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 a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate 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 on the collection(s) of information must be received by 
the OMB desk officer by August 7, 2023.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(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 (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to publish a 30-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 that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Revision of currently 
approved collection; Title of Information Collection: Consumer 
Experience Survey Data Collection; Use: Section 1311(c)(4) of the 
Affordable Care Act requires the Department of Health and Human 
Services (HHS) to develop an enrollee satisfaction survey system that 
assesses consumer experience with qualified health plans (QHPs) offered 
through an Exchange. It also requires public display of enrollee 
satisfaction information by the Exchange to allow individuals to easily 
compare enrollee satisfaction levels between comparable plans. HHS 
established the QHP Enrollee Experience Survey (QHP Enrollee Survey) to 
assess consumer experience with the QHPs offered through the 
Marketplaces. The survey includes topics to assess consumer experience 
with the health care system such as communication skills of providers 
and ease of access to health care services.
    CMS developed the survey using the Consumer Assessment of Health 
Providers and Systems (CAHPS[supreg]) principles (https://www.ahrq.gov/cahps/about-cahps/principles/index.html) and established an application 
and approval process for survey vendors who want to participate in 
collecting QHP enrollee experience data. The QHP Enrollee Survey, which 
is based on the CAHPS[supreg] Health Plan Survey, will be used to (1) 
help consumers choose among competing health plans, (2) provide 
actionable information that the QHPs can use to improve performance, 
(3) provide information that regulatory and accreditation organizations 
can use to regulate and accredit plans, and (4) provide a longitudinal 
database for consumer research. CMS completed two rounds of 
developmental testing including 2014 psychometric testing and 2015 beta 
testing of the QHP Enrollee Survey.
    The psychometric testing helped determine psychometric properties 
and

[[Page 43356]]

provided an initial measure of performance for Marketplaces and QHPs to 
use for quality improvement. Based on psychometric test results, CMS 
further refined the questionnaire and sampling design to conduct the 
2015 beta test of the QHP Enrollee Survey. CMS previously obtained 
clearance for the 2016-2023 administrations of the QHP Enrollee Survey. 
At this time, CMS is requesting to renew approval for the information 
collection related to the QHP Enrollee Experience Survey in 2024-2026. 
These activities are necessary to ensure that CMS fulfills legislative 
mandates established by section 1311(c)(4) of the Affordable Care Act 
to develop an ``enrollee satisfaction survey system'' and provide such 
information on Marketplace websites. CMS is also seeking approval to 
remove the flu vaccine question and revise the race and ethnicity 
questions to align with the 2011 HHS Data Collection Standard for the 
QHP Enrollee Survey 2024 administration. Form Number: CMS-10488 (OMB 
control number: 0938-1221); Frequency: Annually; Affected Public 
Sector: (Individuals and households), private sector (business or other 
for-profits and not-for-profit institutions); Number of Respondents: 
97,505; Total Annual Responses: 97,505; Total Annual Hours: 16,290. 
(For policy questions regarding this collection contact Nidhi Singh 
Shah at 301-492-5110.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Proposed 
Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior 
Authorization Process and Requirements for a Potential National Model; 
Use: Section 515(b) of MACRA (Pub. L. 114-10) added paragraph (16) to 
section 1834(l) of the Act, which requires that, beginning January 1, 
2017, the Secretary expand the RSNAT Prior Authorization Model 
nationally to all states if model expansion meets certain statutory 
requirements for Innovation Center programs. These requirements are 
described in paragraphs (1) through (3) of section 1115A(c) of the Act: 
the Secretary determines that such expansion is expected to--reduce 
spending under applicable title without reducing the quality of care; 
or--(A) improve the quality of patient care without increasing 
spending; and (1) the Chief Actuary of the Centers for Medicare & 
Medicaid Services certifies that such expansion would reduce (or would 
not result in any increase in) net program spending under applicable 
titles; and (2) the Secretary determines that such expansion would not 
deny or limit the coverage or provision of benefits under the 
applicable title for applicable individuals.
    Pursuant to the authority in section 515(b) of MACRA (Pub. L. 114-
10), CMS is seeking to renew the necessary approval under the existing 
OMB approval for the collection of information to continue operating 
the RSNAT Prior Authorization Model. Form Number: CMS-10708 (OMB 
control number: 0938-1380); Frequency: Occasionally; Affected Public: 
Private sector (business or other for-profits, not-for-profit 
institutions); Number of Respondents: 1,580; Number of Responses: 
83,374; Total Annual Hours: 46,427. (For questions regarding this 
collection contact Angela Gaston at 410-786-7409.)
    3. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Medicare Part D Manufacturer Discount Program Agreement; Use: Congress 
enacted the Inflation Reduction Act of 2022, Public Law 117-169 (IRA). 
Section 11201 of the IRA eliminates the coverage gap phase of the Part 
D benefit. It also sunsets the coverage gap discount program (CGDP) 
after December 31, 2024, and amends the Social Security Act (the Act) 
to add section 1860D-14C, requiring the Secretary to establish a new 
Medicare Part D manufacturer discount program (MDP) beginning January 
1, 2025. Under the MDP, participating manufacturers are required to 
provide discounts on their ``applicable drugs'' (brand drugs, 
biologics, and biosimilars) both in the initial coverage phase and in 
the catastrophic coverage phase of the Part D benefit.
    Information in this collection is needed to set up agreements 
between manufacturers and CMS. Under section 1860D-14C(a) of the Act, 
such agreements are required for manufacturers in order to participate 
in the MDP and, under section 1860D43(a) of the Act, for their 
applicable drugs to be covered under Part D beginning in 2025. The 
information collected from manufacturers in the Health Plan Management 
System (HPMS) (Appendix A) is needed to create and execute MDP 
agreements and to determine which manufacturers qualify as a specified 
manufacturer or specified small manufacturer for phased-in discounts 
under section 1860D-14C(g)(4) of the Act. Banking information collected 
by the TPA from manufacturers and plan sponsors (Appendix B) is needed 
to prepare invoices and process financial transactions (deposits and 
payments) through the ACH. Form Number: CMS-10846 (OMB control number: 
0938-New); Frequency: Once; Affected Public: Private Sector: Business 
or other for-profit and not-for-profit institutions; Number of 
Respondents: 659; Total Annual Responses: 659; Total Annual Hours: 
4,613. (For policy questions regarding this collection contact Beckie 
Peyton at 410-786-1572.)

    Dated: June 30, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-14306 Filed 7-6-23; 8:45 am]
BILLING CODE 4120-01-P