[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80249-80250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10844 and CMS-10157]


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 November 1, 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.
    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: Small Biotech 
Exception and Biosimilar Delay Information Collection Request (ICR) for 
Initial Price Applicability Year 2027; Use: Under the authority in 
sections 11001 and 11002 of the Inflation Reduction Act of 2022 (Pub. 
L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is 
implementing the Medicare Drug Price Negotiation Program, codified in 
sections 1191 through 1198 of the Social Security Act (the Act). The 
Information Collection Request Forms for the Small Biotech Exception 
and Biosimilar Delay Information Collection Request for Initial Price 
Applicability Year 2027 must be submitted to CMS before CMS establishes 
the selected drug list for initial price applicability year 2027.
    Small Biotech Exception: In accordance with section 1192(d)(2) of 
the Act, the term ``negotiation-eligible drug'' excludes, with respect 
to the initial price applicability years 2026, 2027, and 2028, a 
qualifying single source drug that meets the requirements for the 
exception for small biotech drugs (the ``Small Biotech Exception,'' or 
``SBE'').

[[Page 80250]]

    This information is required in order for CMS to accurately 
identify whether a given drug meets the criteria for the Small Biotech 
Exception in accordance with section 1192(d)(2) of the Act. To ensure 
that only covered Part D drugs that meet the requirements for the SBE 
are excluded from the term ``negotiation-eligible drug,'' a 
manufacturer that seeks the SBE for its covered Part D drug 
(``Submitting Manufacturer'') must submit information to CMS about the 
company and its products in order for the drug to be considered for the 
exception. If the Submitting Manufacturer seeks the SBE for a covered 
Part D drug it acquired after December 31, 2021, the Submitting 
Manufacturer must also submit information related to the separate 
entity that had the Medicare Coverage Gap Discount Program agreement 
for the drug on December 31, 2021. If the Submitting Manufacturer was 
acquired by another entity after December 31, 2021, the Submitting 
Manufacturer must provide information regarding that acquiring entity 
for CMS to assess whether the acquisition triggers the limitation at 
section 1192(d)(2)(B)(ii) of the Act.
    Biosimilar Delay: In accordance with section 1192(f)(1)(B) of the 
Act, the manufacturer of a biosimilar biological product (``Biosimilar 
Manufacturer'' of a ``Biosimilar'') may submit a request, prior to the 
selected drug publication date, for CMS' consideration to delay the 
inclusion of a negotiation-eligible drug that includes the reference 
product for the Biosimilar (such a negotiation-eligible drug is herein 
referred to as a ``Reference Drug'') on the selected drug list for a 
given initial price applicability year (the ``Biosimilar Delay''). This 
information is required in order for CMS to accurately determine if a 
drug meets the criteria for the Biosimilar Delay for initial price 
applicability year 2027 in accordance with section 1192(f) of the Act. 
To ensure that the delay of selection and negotiation of biologics is 
only applied if there is a high likelihood of biosimilar market entry 
that meets the requirements for the Biosimilar Delay, a Biosimilar 
Manufacturer that seeks the Biosimilar Delay must submit information to 
CMS related to the Biosimilar. This information includes identifying 
information for the Biosimilar and the Reference Drug; the licensure 
status of the Biosimilar; attestations that the Biosimilar Manufacturer 
is not the same or treated as the same entity as the Reference 
Manufacturer, that the Biosimilar Manufacturer and the Reference 
Manufacturer (who is the manufacturer of the Reference Drug) have not 
entered into an agreement that requires or incentivizes the Biosimilar 
Manufacturer to submit the Biosimilar Delay, or directly or indirectly 
restricts the quantity of the Biosimilar that may be sold in the United 
States over a specified period of time; and documentation specified 
under section 1192(f)(3) of the Act to demonstrate there is a high 
likelihood of Biosimilar market entry within two years of the 
statutorily-defined selected drug publication date for initial price 
applicability year 2027. Form Number: CMS-10844 (OMB control number: 
0938-1443); Frequency: Once; Affected Public: Private sector, Business 
or other for-profit; Number of Respondents: 25; Total Annual Responses: 
25; Total Annual Hours: 415; (For policy questions regarding this 
collection contact Elisabeth Daniel at 667-290-8793.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: The HIPAA 
Eligibility Transaction System (HETS); Use: CMS created the HIPAA 
(Health Insurance Portability and Accountability Act of 1996) 
Eligibility Transaction System (HETS) to provide HIPAA Accredited 
Standards Committee X12 270/271 health care eligibility inquiries (270) 
and responses (271) on a real-time basis. HETS allows health care 
providers or their designees to check Medicare beneficiary eligibility 
data in real-time. They use HETS to prepare accurate Medicare claims, 
determine beneficiary liability, or check eligibility for specific 
services. HETS allows users to submit HIPAA compliant 270 eligibility 
request over a secure connection and receive 271 responses in real-
time. In creating the HETS system, federal law requires that CMS take 
precautions to minimize the security risk to federal information 
systems. Accordingly, CMS requires that trading partners who wish to 
connect to the HETS 270/271 system via the CMS Extranet and/or internet 
to agree to the HETS Rules of Behavior and the HETS Authorized 
Representative Roles and Responsibilities terms as a condition of 
receiving Medicare eligibility information. Applicants complete the 
entire Trading Partner Agreement form to indicate agreement with CMS 
trading partner terms and provide sufficient information to establish 
connectivity to the service and assure that those entities that access 
the Medicare eligibility information are aware of applicable provisions 
and penalties for the misuse of information.
    CMS uses the Trading Partner Agreement Form to capture certain 
information whereby a person certifies that they are fully aware of all 
penalties related to the use of PHI and their access to this data from 
the HETS application. The information is an attestation by the 
authorized representative of an entity that wishes to access the 
Medicare eligibility information to conduct real-time eligibility 
transactions. The authorized representative is a person responsible for 
business decisions on behalf of the Organization who is submitting the 
access request. The data captured includes the authorized 
representative's name, title contact number and the name of the 
submitting entity. Other data captured is the submitter's National 
Provider Identifier, business name, billing address, physical address, 
and telephone number.
    The Trading Partner Agreement Form is also used by CMS to capture 
certain information whereby a person identifies the particular 
connectivity protocol that they will use to connect to CMS and specific 
organization information which is reviewed and authorized prior to the 
access being granted. Form Number: CMS-10157 (OMB control number: 0938-
0960); Frequency: Yearly; Affected Public: Private Sector, State, 
Local, or Tribal Governments, Federal Government, Business or other 
for-profits, Not-for-profits institutions; Number of Respondents: 
1,000; Total Annual Responses: 1,000; Total Annual Hours: 250. (For 
policy questions regarding this collection contact William Money at 
410-786-1956).

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-22547 Filed 10-1-24; 8:45 am]
BILLING CODE 4120-01-P