[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47563-47565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12122]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10454 and CMS-10858]


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 July 3, 2024.

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.

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    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: Extension of a currently 
approved collection; Title of information Collection: Disclosure of 
State Rating Requirements; Use: The final rule ``Patient Protection and 
Affordable Care Act; Health Insurance Market Rules; Rate Review'' 
implements sections 2701, 2702, and 2703 of the Public Health Service 
Act (PHS Act), as added and amended by the Affordable Care Act, and 
sections 1302(e) and 1312(c) of the Affordable Care Act. The rule 
directs that States submit to CMS certain information about State 
rating and risk pooling requirements for their individual, small group, 
and large group markets, as applicable. Specifically, States will 
inform CMS of age rating ratios that are narrower than 3:1 for adults; 
tobacco use rating ratios that are narrower than 1.5:1; a State-
established uniform age curve; geographic rating areas; whether 
premiums in the small and large group market are required to be based 
on average enrollee amounts (also known as composite premiums); and, in 
States that do not permit any rating variation based on age or tobacco 
use, uniform family tier structures and corresponding multipliers. In 
addition, States that elect to merge their individual and small group 
market risk pools into a combined pool will notify CMS of such 
election. This information will allow CMS to determine whether State-
specific rules apply or Federal default rules apply. It will also 
support the accuracy of the federal risk adjustment methodology. Form 
Number: CMS-10454 (OMB control number 0938-1258); Frequency: 
Occasionally; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 3; Total Annual Responses: 3; Total Annual 
Hours: 7.3. (For policy questions regarding this collection contact 
Russell Tipps at 301-869-3502.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: Rebate 
Reduction Requests under Sections 11101 and 11102 of the Inflation 
Reduction Act; Use: Under the authority in sections 11101 and 11102 of 
the Inflation Reduction Act of 2022 (Pub. L. 117-169), the Centers for 
Medicare & Medicaid Services (CMS) is implementing the Medicare Part B 
Drug Inflation Rebate Program and the Medicare Part D Drug Inflation 
Rebate Program codified in section 1847A(i) and section 1860D-14B of 
the Social Security Act (``the Act''), respectively.
    In accordance with section 1847A(i) of the Act, for calendar 
quarters beginning January 1, 2023, a manufacturer of a Part B 
rebatable drug will owe a rebate, to be deposited in the Federal 
Supplementary Medical Insurance Trust Fund, if the amount specified in 
section 1847A(i)(3)(A)(ii)(I) of the Act exceeds the inflation-adjusted 
payment amount, which is calculated as set forth in section 
1847A(i)(3)(C) of the Act. A ``Part B rebatable drug'' means a single-
source drug or biological product (as defined section 1847A(c)(6)(D) of 
the Act), including a biosimilar biological product (as defined section 
1847A(c)(6)(H) of the Act) but excluding a qualifying biosimilar 
biological product (as defined section 1847A(b)(8)(B)(iii) of the Act), 
for which payment is made under Medicare Part B, except such term shall 
not include such a drug or biological product if, as determined by the 
Secretary, the average total allowed charges for such drug or 
biological product under Part B for a year per individual that uses 
such a drug or biological product are less than the applicable 
threshold; or that is a vaccine described in subparagraph (A) or (B) of 
section 1861(s)(10) of the Act.
    In accordance with section 1860D-14B of the Act, for each 12-month 
applicable period, starting with the applicable period beginning 
October 1, 2022, a manufacturer of a Part D rebatable drug will owe a 
rebate, to be deposited in the Federal Supplementary Medical Insurance 
Trust Fund, if the annual manufacturer price exceeds the inflation-
adjusted payment amount. Section 1860D-14B(g)(1)(A) of the Act defines 
a ``Part D rebatable drug,'' in part, as a drug or biological described 
at section 1860D-14B(g)(1)(C) that is a ``covered Part D drug'' as that 
term is defined in section 1860D-2(e) of the Act. The definition of a 
Part D rebatable drug includes generic drugs that meet certain 
statutory criteria (effectively sole source generics). The definition 
of a Part D rebatable drug does not include a drug or biological if, as 
determined by the Secretary, the ``average annual total cost'' for such 
drug or biological under Part D for a year per individual that uses 
such a drug or biological is less than the applicable threshold.
    Sections 1847A(i)(3)(G)(ii) and 1860D-14B(b)(1)(C)(ii) of the Act 
require that CMS reduce or waive the inflation rebate amount owed (if 
any) for a Part B rebatable biosimilar biological product and generic 
Part D rebatable drug or biosimilar when CMS determines there is a 
severe supply chain disruption during a calendar quarter or applicable 
period, respectively, such as that caused by a natural disaster or 
other unique or unexpected event. CMS must also reduce or waive the 
inflation rebate amount owed (if any) for a generic Part D rebatable 
drug if CMS determines that without such reduction or waiver, the drug 
is likely to be in shortage in a subsequent applicable period, as 
required by section 1860D-14B(b)(1)(C)(iii) of the Act.
    CMS does not have information necessary to determine whether 
manufacturers of Part B and Part D rebatable drugs should have their 
rebate amount reduced due to either a severe supply chain disruption or 
a likely shortage as required by sections 1847A(i)(3)(G)(ii), 1860D-
14B(b)(1)(C)(ii), and 1860D-14B(b)(1)(C)(iii) of the Act. Some of the 
information and supporting documentation needed for CMS to make a 
determination regarding a severe supply chain disruption and the 
likelihood of a future shortage are held by manufacturers and are not 
available to CMS. As such, for CMS to determine whether there is a 
severe supply chain disruption or likelihood of future shortage, in 
accordance with sections 1847A(i)(3)(G)(ii), 1860D-14B(b)(1)(C)(ii), 
and 1860D-14B(b)(1)(C)(iii) of the Act, a manufacturer must submit to 
CMS a

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request for a rebate reduction along with supporting documentation. 
Form Number: CMS-10858 (OMB control number: 0938-new); Frequency: Once; 
Affected Public: Private Sector and Business or other for-profits; 
Number of Respondents: 10; Total Annual Responses: 10; Total Annual 
Hours: 310. (For policy questions regarding this collection contact 
Elisabeth Daniel at 667-290-8793.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-12122 Filed 5-31-24; 8:45 am]
BILLING CODE 4120-01-P