CMS Requests Feedback on Upcoming Medicare Part D PBM Reforms
CMS seeks public input through an RFI on Pharmacy Benefit Manager (PBM) reforms under Medicare Part D, effective January 1, 2028. Stakeholders must consider how these changes will impact PBM compensation and the overall landscape of pharmacy services, as the Medicare Drug Price Negotiation Program advances alongside these reforms.
Key Signals
- CMS RFI on PBM compensation due July 20, 2026
- Public comments for Medicare Drug Price Negotiation close August 17, 2026
- Effective date for PBM reforms is January 1, 2028
On June 16, 2026, the Centers for Medicare & Medicaid Services (CMS) initiated a Request for Information (RFI) aimed at gathering industry feedback on implementing Section 6224 of the Consolidated Appropriations Act of 2026 (CAA 2026), a significant regulatory shift concerning Pharmacy Benefit Managers (PBMs) and their operations under Medicare Part D. This RFI is pivotal, as it precedes the formal enforcement of sweeping reforms that will take effect on January 1, 2028. As outlined in the CAA 2026, this provision focuses on enhancing transparency regarding PBM compensation mechanisms and establishing robust data collection protocols to mitigate potential abuse within the Medicare framework.
CMS's inquiry centers around defining the roles and boundaries of PBMs and their affiliates. By clarifying whom these regulations apply to, CMS aims to prevent loopholes that allow entities to evade compliance by altering their operational structures or labels. The agency's proactive approach suggests a strong commitment to ensuring that the intent of the law is upheld, protecting both consumers and pharmacies from unfair practices. CMS’s strategic questioning includes understanding the nature of payments within PBM operations, indicating a desire to scrutinize not just direct remuneration but also relationships with intermediaries and associated entities that might influence PBM functions.
Moreover, CMS's engagement with the public and industry stakeholders conveys an effort to foster a collaborative environment for implementing these reforms. Comments on the RFI are due by July 20, 2026, giving stakeholders a crucial opportunity to shape the final regulatory environment surrounding PBMs. Notably, this reform aligns with broader initiatives including the proposed rule for the Medicare Drug Price Negotiation Program, which also has public comment periods closing in August 2026. These simultaneous developments underscore the urgency and interconnectedness of healthcare regulatory reforms, which aim to improve affordability and access to medications for Medicare beneficiaries.
Procurement professionals keenly aware of the implications of these regulatory changes should evaluate how they could reshape contract terms and compliance obligations when dealing with PBM services. The changes prompted by Section 6224 and subsequent regulations will necessitate a re-evaluation of existing agreements and business strategies, particularly concerning pricing models and service fee structures. Companies involved in the provision of pharmacy benefits, reimbursement, or data reporting for Medicare encapsulate the primary audience for involvement in this open comment period, as their feedback can offer valuable insights into the practical impacts of these proposed requirements.
Agencies
- Centers for Medicare & Medicaid Services
- Senate Finance Committee Minority Staff
Sources
- Medicare Part D PBM Reform under the CAA 2026- CMS Seeks GuidanceThe National Law Review · Jun 25
- Federal Roundup: Key Regulatory Updates for PBMs and Medicare Advantage Organizations – June 2026 | Crowell & Moring LLPCrowell & Moring LLP · Jun 26
- CMS Seeks Guidance on Medicare Part D PBM Reform under the CAA 2026 | Mintz - Health Care Viewpoints - JDSupraJD Supra · Jun 26