Federal Register #CMS10110

CMS Requests Comment on ASP Data Collection for Medicare Part B Drugs and Biologicals

The Centers for Medicare & Medicaid Services (CMS), part of the Department of Health and Human Services, is seeking public comment on a proposed information collection related to Medicare Part B drugs and biologicals. - Government Buyer: - Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services - Purpose: - Request for public comment on the collection of Average Sales Price (ASP) data from manufacturers for Medicare Part B drugs and biologicals - Includes revisions to the Bona Fide Service Fee Certification form and updates to burden estimates - Requirements: - Manufacturers must submit ASP data as required by Section 1847A of the Social Security Act and 42 CFR 414.800-806 - Feedback is requested on the necessity, utility, and clarity of the collection, and suggestions for minimizing burden through automation - OEMs and Vendors: - No specific OEMs or vendors are named; applies broadly to manufacturers of Medicare Part B drugs and biologicals - Products/Services: - No procurement of products or services; this is a notice for information and comment - Unique Aspects: - Focus on regulatory compliance and public input rather than acquisition of goods or services

Description

The Centers for Medicare & Medicaid Services (CMS) is seeking public comments on its intention to collect information from the public under the Paperwork Reduction Act of 1995. This notice invites feedback on the burden estimate, necessity, utility, and clarity of the proposed information collection, as well as suggestions for minimizing the burden through automated techniques. The collection involves data submissions related to Medicare Part B drugs and biologicals, with revisions proposed to the Bona Fide Service Fee Certification form and burden estimates. Comments are due by May 7, 2026.

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