Notice2024-10541
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Primary source
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Published
May 14, 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 94 (Tuesday, May 14, 2024)</title>
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[Federal Register Volume 89, Number 94 (Tuesday, May 14, 2024)]
[Notices]
[Page 41968]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-10541]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10110]
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 June 13, 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 currently
approved collection; Title of Information Collection: Manufacturer
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs
and Biologicals; Use: Section 1847A of the Act requires that the
Medicare Part B payment amounts for covered drugs and biologicals not
paid on a cost or prospective payment basis be based upon
manufacturers' average sales price data submitted quarterly to the
Centers for Medicare & Medicaid Services (CMS). The reporting
requirements are specified in 42 CFR part 414 Subpart J.
CMS, specifically, the Division of Data Analysis and Market-based
Pricing (DDAMBP) will utilize the ASP data (ASP and number of units
sold as specific in section 1847A of the Act) to determine the Medicare
Part B drug payment amounts for CY 2005 and beyond. The manufacturers
submit their ASP data for all of their National Drug Codes (NDC) for
Part B drugs. DDAMBP compiles the data, analyzes the data and runs the
data through software to calculate the volume-weighted ASP for all of
the NDCs that are grouped within a given HCPCS code. The formula to
calculate the volume-weighted ASP is the Sum (ASP * units) for all
NDCs/Sum (units * bill units per pkg) for all NDCs. DDAMBP provides ASP
payment amounts for several components within CMS that utilize 1847(A)
payment methodologies to implement various payment policies including,
but not limited to, ESRD, OPPS, OTP and payment models. CMS will also
use reported ASP and units to calculate inflation adjusted coinsurance
and rebates. The Department of Health and Human Services' Office of the
Inspector General also uses the ASP data in conducting studies. Form
Number: CMS-10110 (OMB Control Number: 0938-0921); Frequency:
Quarterly; Affected Public: Private and Business or other for-profits;
Number of Respondents: 500; Number of Responses: 2,00; Total Annual
Hours: 26,000. (For policy questions regarding this collection contact
Felicia Brown at (410) 786-9287 or <a href="/cdn-cgi/l/email-protection#3375565f5a505a521d51415c445d73505e401d5b5b401d545c45"><span class="__cf_email__" data-cfemail="0f496a63666c666e216d7d6078614f6c627c2167677c21686079">[email protected]</span></a>).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-10541 Filed 5-13-24; 8:45 am]
BILLING CODE 4120-01-P
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