[Federal Register Volume 88, Number 73 (Monday, April 17, 2023)]
[Notices]
[Pages 23429-23431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10110, CMS-10537, CMS-10344 and CMS-10527]


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 May 17, 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 a currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals; Use: Section 401 of

[[Page 23430]]

Division CC of Title IV of the Consolidated Appropriations Act (CAA), 
2021 amended section 1847A of the Social Security Act (the Act) to add 
new section 1847A(f)(2) of the Act, which requires manufacturers 
without a Medicaid drug rebate agreement to report average sales price 
(ASP) information to CMS for calendar quarters beginning on January 1, 
2022, for drugs or biologicals payable under Medicare Part B and 
described in sections 1842(o)(1)(C), (E), or (G) or 1881(b)(14)(B) of 
the Act, including items, services, supplies, and products that are 
payable under Part B as a drug or biological. The reported ASP data are 
used to establish the Medicare payment amounts. Form Number: CMS-10110 
(OMB control number: 0938-0921); Frequency: Quarterly; Affected Public: 
Private sector, Business or other for-profit; Number of Respondents: 
500; Total Annual Responses: 2,000; Total Annual Hours: 26,000. (For 
policy questions regarding this collection contact Felicia Brown at 
410-786-9287)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: CAHPS Hospice 
Survey; Use: CMS is required to collect and publicly report information 
on the quality of services provided by hospices under provisions in the 
Social Security Act. Specifically, sections 1814(i)(5)(A) through (C) 
of the Act, as added by section 3132(a) of the Patient Protection and 
Affordable Care Act (PPACA) (Pub. L. 111-148), required hospices to 
begin submitting quality data, based on measures specified by the 
Secretary of the Department of Health and Human Services (the 
Secretary) for FY 2014 and subsequent FYs.
    The goal of the survey is to measure the experiences of patients 
and their caregivers with hospice care. The survey was developed to:
     Provide a source of information from which selected 
measures could be publicly reported to beneficiaries and their family 
members as a decision aid for selection of a hospice program;
     Aid hospices with their internal quality improvement 
efforts and external benchmarking with other facilities;
     Provide CMS with information for monitoring the care 
provided.
    Form Number: CMS-10537 (OMB control number: 0938-1257); Frequency: 
Once; Affected Public: Individuals and Households; Number of 
Respondents: 1,140,695; Total Annual Responses: 1,140,695; Total Annual 
Hours: 198,481. (For policy questions regarding this collection contact 
Lauren Fuentes at 410-786 2290 or 443-618-2123.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Elimination of 
Cost-Sharing for full benefit dual-eligible Individuals Receiving Home 
and Community-Based Services; Use: Section 1860 D-14 of the Social 
Security Act sets forth requirements for premium and cost-sharing 
subsidies for low-income beneficiaries enrolled in Medicare Part D. 
Based on this statute, 42 CFR 423.771, provides guidance concerning 
limitations for payments made by and on behalf of low-income Medicare 
beneficiaries who enroll in Part D plans. 42 CFR 423.771 (b) 
establishes requirements for determining a beneficiary's eligibility 
for full subsidy under the Part D program. Regulations set forth in 
423.780 and 423.782 outline premium and cost sharing subsidies to which 
full subsidy eligible are entitled under the Part D program
    Each month CMS deems individuals automatically eligible for the 
full subsidy, based on data from State Medicaid Agencies and the Social 
Security Administration (SSA). The SSA sends a monthly file of 
Supplementary Security Income-eligible beneficiaries to CMS. Similarly, 
the State Medicaid agencies submit Medicare Modernization Act files to 
CMS that identify full subsidy beneficiaries. CMS deems the 
beneficiaries as having full subsidy and auto-assigns these 
beneficiaries to bench mark Part D plans. Part D plans receive premium 
amounts based on the monthly assessments. Form Number: CMS-10344 (OMB 
control number 0938-1127); Frequency: Monthly; Affected Public: Private 
Sector (business or other for-profits, not-for-profit institutions); 
Number of Respondents: 51; Number of Responses: 612; Total Annual 
Hours: 621. (For policy questions regarding this collection contact 
Roland Herrera at 410-786-0668).
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Annual 
Eligibility Redetermination, Product Discontinuation and Renewal 
Notices; Use: Section 1411(f)(1)(B) of the Affordable Care Act directs 
the Secretary of Health and Human Services (the Secretary) to establish 
procedures to redetermine the eligibility of individuals for premium 
tax credits on a periodic basis in appropriate circumstances. Section 
1321(a) of the Affordable Care Act provides authority for the Secretary 
to establish standards and regulations to implement the statutory 
requirements related to Exchanges, qualified health plans (QHPs) and 
other components of title I of the Affordable Care Act. Under section 
2703 of the Public Health Service Act (PHS Act), as added by the 
Affordable Care Act, and former section 2712 and section 2741 of the 
PHS Act, enacted by the Health Insurance Portability and Accountability 
Act of 1996, health insurance issuers in the group and individual 
markets must guarantee the renewability of coverage unless an exception 
applies.
    The 2014 final rule ``Patient Protection and Affordable Care Act; 
Annual Eligibility Redeterminations for Exchange Participation and 
Insurance Affordability Programs; Health Insurance Issuer Standards 
Under the Affordable Care Act, Including Standards Related to 
Exchanges'' (79 FR 52994, September 5, 2014), provides that an Exchange 
may choose to conduct the annual redetermination process for a plan 
year (1) in accordance with the existing procedures described in 45 CFR 
155.335; (2) in accordance with procedures described in guidance issued 
by the Secretary for the applicable benefit year; or (3) using an 
alternative procedure proposed by the Exchange and approved by the 
Secretary. The 2014 final rule established a renewal and reenrollment 
hierarchy at 45 CFR 155.335(j) to minimize potential enrollment 
disruptions. The 2016 final rule ``Patient Protection and Affordable 
Care Act; HHS Notice of Benefit and Payment Parameters for 2017'' (81 
FR 12204, March 8, 2016) amended the enrollment hierarchy to further 
minimize potential disruptions of enrollee eligibility for cost-sharing 
reductions. The final rule ``Patient Protection and Affordable Care 
Act, HHS Notice of Benefit and Payment Parameters for 2024'' adopted 
changes to 45 CFR 155.335(j) to allow the Exchange, beginning in the 
2024 plan year, to direct re-enrollment for enrollees who are eligible 
for cost-sharing reductions in accordance with Sec.  155.305(g) from a 
bronze QHP to a silver QHP with a lower or equivalent premium after 
advance payments of the premium tax credit within the same product and 
QHP issuer, regardless of whether their current plan is available or 
not, if certain conditions are met (referred to here as the ``bronze to 
silver crosswalk policy'').
    The guidance document ``Guidance on Annual Eligibility 
Redetermination and Re-enrollment for Exchange Coverage for 2019 and 
Later Years'' contains the procedures that the Secretary specified for 
the coverage year, as noted in (2) above, and specified that these 
procedures will be

[[Page 23431]]

used by all Exchanges using the Federal eligibility and enrollment 
platform, unless otherwise specified in future guidance or rulemaking.
    The 2014 final rule also amended the requirements for product 
renewal and re-enrollment (or non-renewal) notices to be sent by QHP 
issuers in the Exchanges and specifies content for these notices. The 
guidance document ``Updated Federal Standard Renewal and Product 
Discontinuation Notices, and Enforcement Safe Harbor for Product 
Discontinuation Notices in Connection with the Open Enrollment Period 
for Coverage in the Individual Market in the 2020 Benefit Year'' 
provides standard notices for product discontinuation and renewal to be 
sent by issuers of individual market QHPs and issuers in the individual 
market.
    The Federal standard notices to be sent by issuers of individual 
market QHPs and issuers in the individual market have been revised to 
improve consumer understanding and update out-of-date information, and 
to include language to reference the potential for a bronze to silver 
crosswalk under 45 CFR 155.335(j)(4). The revised notices in this 
information collection will be required for notices provided in 
connection with coverage beginning in the 2024 plan year.
    Issuers in the small group market may use the draft Federal 
standard small group notices released in the June 26, 2014 bulletin 
``Draft Standard Notices When Discontinuing or Renewing a Product in 
the Small Group or Individual Market'', or any forms of the notice 
otherwise permitted by applicable laws and regulations. States that are 
enforcing the guaranteed renewability provisions of the Affordable Care 
Act may develop their own standard notices for product discontinuances, 
renewals, or both, provided the state-developed notices are at least as 
protective as the Federal standard notices. Form Number: CMS-10527 (OMB 
Control Number 0938-1254); Frequency: Annually; Affected Public: 
Private Sector, State Governments; Number of Respondents: 1,340; Total 
Annual Responses: 5,881; Total Annual Hours: 72,147. (For policy 
questions regarding this collection contact Russell Tipps at 301-492-
4371.)

    Dated: April 12, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-08069 Filed 4-14-23; 8:45 am]
BILLING CODE 4120-01-P