Agency Information Collection Activities: Proposed Collection; Comment Request
| Published date | 20 February 2024 |
| Record Number | 2024-03348 |
| Citation | 89 FR 12844 |
| Court | Centers For Medicare & Medicaid Services,Health And Human Services Department |
| Section | Notices |
Federal Register, Volume 89 Issue 34 (Tuesday, February 20, 2024)
[Federal Register Volume 89, Number 34 (Tuesday, February 20, 2024)]
[Notices]
[Pages 12844-12845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03348]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10110]
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 April 22, 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-10110 Manufacturer Submission of Average Sales Price (ASP) Data for
Medicare Part B Drugs and Biologicals
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
[[Page 12845]]
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: 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 [email protected]).
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-03348 Filed 2-16-24; 8:45 am]
BILLING CODE 4120-01-P
