[Federal Register Volume 89, Number 19 (Monday, January 29, 2024)]
[Notices]
[Pages 5548-5549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10858, CMS-10215 and CMS-10394]


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 (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 March 29, 2024.

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, 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 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-10858 Rebate Reduction Requests under Sections 11101 and 11102 of 
the Inflation Reduction Act
CMS-10215 Identifying Medicaid Payment for Physician Administered Drugs
CMS-10394 Application To Be a Qualified Entity to Receive Medicare Data 
for Performance Measurement/Reapplication/Annual Report Worksheet

    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: 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

[[Page 5549]]

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 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: 20; 
Total Annual Hours: 620. (For policy questions regarding this 
collection contact Elisabeth Daniel at 667-290-8793.)
    2. Type of Information Collection Request: Extension of currently 
approved collection; Title of Information Collection: Identifying 
Medicaid Payment for Physician Administered Drugs; Use: States are 
required to provide for the collection and submission of utilization 
data for certain physician-administered drugs in order to receive 
Federal financial participation for these drugs. Physicians, serving as 
respondents to States, submit National Drug Code numbers and 
utilization information for ``J'' code physician-administered drugs so 
that the States will have sufficient information to collect drug rebate 
dollars. Form Number: CMS-10215 (OMB control number: 0938-1026); 
Frequency: Weekly; Affected Public: Business or other for-profits and 
not-for-profit institutions); Number of Respondents: 26,000; Total 
Annual Responses: 39,053,932; Total Annual Hours: 162,074. (For policy 
questions regarding this collection contact Michael Forman at 410-786-
2666.)
    2. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Application to be a Qualified Entity to Receive Medicare Data for 
Performance Measurement/Reapplication/Annual Report Worksheet; Use: The 
Patient Protection and Affordable Care Act (ACA) was enacted on March 
23, 2010 (Pub. L. 111-148). ACA amends section 1874 of the Social 
Security Act by adding a new subsection (e) to make standardized 
extracts of Medicare claims data under Parts A, B, and D available to 
QEs to evaluate the performance of providers of services and suppliers. 
This is the Application, Reapplication, and ARW which provides CMS with 
the information it needs to determine whether an organization earns 
approval and continues as a QE.
    CMS established the Qualified Entity Certification Program (QECP) 
to evaluate an organization's eligibility across three areas: (1) 
organizational and governance capabilities, (2) addition of claims data 
from other sources (as required in the statute), and (3) data privacy 
and security. QE certification lasts for 3 years. Organizations that 
are interested in remaining in the QE program must submit a 
Reapplication that is reviewed and approved by QECP. In addition, each 
year QEs must submit an annual report to QECP that provides information 
required by statute. Form Number: CMS-10394 (OMB control number: 0938-
1144); Frequency: Yearly; Affected Public: Business or other for-
profits; Number of Respondents: 40; Total Annual Responses: 210; Total 
Annual Hours: 17,400. (For policy questions regarding this collection 
contact Kari Gaare at [email protected]).

    Dated: January 24, 2024.
William N. Parham, III
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-01723 Filed 1-26-24; 8:45 am]
BILLING CODE 4120-01-P