# Agency Information Collection Activities: Submission for OMB Review; Comment Request
**AGENCY:**
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
**ACTION:**
Notice.
**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®) 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® 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 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.