Federal Register #2026-17128

CMS Seeks Public Comment on Revisions to ESRD and Medicare Drug Price Information Collections

This opportunity involves the Centers for Medicare & Medicaid Services (CMS), under the Department of Health and Human Services, seeking public comment on proposed revisions to two key information collection activities: - Government Buyer: - Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services - Products/Services Requested: - End Stage Renal Disease Medical Evidence Report (CMS-2728) - Used to determine Medicare eligibility for ESRD patients and monitor quality of care - Data sources include United States Renal Data System (USRDS), United Network for Organ Sharing (UNOS), and ESRD Program Management and Medical System (PMMIS) - Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biologicals (CMS-10110) - Supports Medicare Drug Price Negotiation Program and ensures compliance with pricing regulations - Requires quarterly data submissions from manufacturers - Unique/Notable Requirements: - No specific OEMs or vendors are named - The notice invites public feedback on burden estimates, necessity, utility, and suggestions for improving data quality and clarity - Reporting requirements are annual (for ESRD) and quarterly (for ASP data) - Focus on regulatory compliance and data-driven program management - Key Data Systems Referenced: - USRDS, UNOS, PMMIS - No physical products or hardware are being procured; this is an information collection and reporting requirement.

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. The collections include revisions to currently approved collections such as the End Stage Renal Disease Medical Evidence Report and Manufacturer Submission of Average Sales Price Data for Medicare Part B Drugs and Biologicals. The information collected will be used to monitor and assess quality of care, support Medicare eligibility determinations, and administer the Medicare Drug Price Negotiation Program. Comments are invited on burden estimates, necessity, utility, and ways to enhance the quality and clarity of the information collected.

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