Federal Register #CMS4218NC

RFI: Technical Input on PBM Compensation, Data Collection, and Regulatory Definitions

This opportunity is a Request for Information (RFI) from the Centers for Medicare & Medicaid Services (CMS), part of the Department of Health and Human Services (HHS), focused on pharmacy benefit managers (PBMs) and their affiliates. - Government Buyer: - Department of Health and Human Services (HHS) - Centers for Medicare & Medicaid Services (CMS) - Purpose: - Gather technical input on PBM services, compensation practices, affiliate relationships, and data reporting requirements - Inform implementation of new legislative requirements under the Consolidated Appropriations Act, 2026, effective beginning calendar year 2028 - Key Focus Areas: - Restrictions on PBM and affiliate remuneration for services related to covered Part D drugs - Annual data collection and reporting standards for PBMs - Definitions of PBMs, affiliates, bona fide service fees, and fair market value - Pharmacy payment arrangements and compensation structures - Notable Requirements: - Stakeholder feedback is sought on technical definitions, business practices, compensation arrangements, affiliate relationships, and fair market value determination - No specific products, part numbers, or OEMs are named; the RFI is for policy and regulatory input only - Also includes proposed amendments to child support enforcement regulations to reduce bureaucracy and obsolete rules (secondary to the main PBM focus) - No procurement of goods or services is occurring at this stage; the RFI is for information gathering to shape future rulemaking and policy guidance

Description

This Request for Information (RFI) seeks technical input on the services and business practices of pharmacy benefit managers (PBMs) and their affiliates to inform the implementation of recent legislation. The focus is on two legislative requirements effective beginning calendar year 2028: restrictions on remuneration PBMs and their affiliates may receive for services related to covered Part D drugs, and data reporting requirements. The RFI invites comments and information to assist in rulemaking and policy development related to these topics.

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