Notice2024-22547
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 2, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 191 (Wednesday, October 2, 2024)</title>
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[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80249-80250]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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: <a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing</a>
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
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</html>Indexed from Federal Register on October 2, 2024.
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