Patients Before Middlemen Act
The Patients Before Middlemen Act is a Senate bill that would broaden Medicare prescription drug protections by reforming access, negotiation, and oversight in Parts D and MA-PD. The key ideas are to (1) guarantee participation of any willing community pharmacy in prescription drug plan (PDP) networks and enforce standards for reasonable contract terms starting in 2028, (2) create a new category of “essential retail pharmacies” and require regular reporting about their costs, participation, and impact, (3) establish stricter accountability for pharmacy benefit managers (PBMs) with new provider agreements, transparency, and data reporting, and (4) require ongoing enforcement oversight and penalties for noncompliance. The bill also introduces new enforcement mechanisms, a dedicated PBM accountability provision, and biennial reporting to track implementation and impact. In practical terms, the bill aims to (a) expand access by removing certain network barriers for pharmacies, (b) increase transparency and data collection around drug pricing, rebates, and network performance, and (c) hold PBMs and plan sponsors to stricter standards with consequences for violations. It would impose specific timelines for standard-setting, require disclosure of affiliate relationships and incentive payments, and push for more detailed price and utilization data to CMS and plan sponsors. The overall effect would be to increase beneficiary choice and visibility into how middlemen (PBMs) influence drug access and costs.
Key Points
- 1Participation and contract standards for networks
- 2- PDP sponsors must allow any willing pharmacy that meets standard contract terms to participate in the plan’s network.
- 3- Starting in plan years beginning 2028, contract terms must be “reasonable and relevant” per standards to be set by the Secretary (standards to be issued by April 2027; information gathering in 2026 to inform those standards).
- 4Essential retail pharmacies
- 5- Creates a designation of “essential retail pharmacies” based on location (rural/ underserved areas and specific distance thresholds in suburban/urban areas).
- 6- The Secretary must publish a biannual (through 2034) report on trends related to essential retail pharmacies and require PDP sponsors and MA organizations to report on affiliates, incentive payments, and other fees.
- 7- Requires a published list of essential retail pharmacies and submission of affiliate relationships and incentive/fee data by sponsors.
- 8Enforcement and penalties
- 9- Adds an enforcement subparagraph to 1860D-4(b)(1) to allow the Secretary to handle alleged violations of the new contract standards, with a process for allegations, investigations, and civil penalties or other sanctions.
- 10- Provides anti-retaliation and anti-coercion protections for pharmacies submitting allegations.
- 11PBM accountability for violations
- 12- PBMs (and their affiliates) must have written agreements with PDP sponsors to reimburse the sponsor for amounts paid due to violations related to delegated PBM responsibilities.
- 13- Requires new transparency around remuneration, including what constitutes bona fide service fees, handling of rebates/discounts, and ensuring pass-through to sponsors.
- 14- Mandates evaluation of remuneration arrangements for fair market value and potential disgorgement of improper remuneration to the sponsor.
- 15- Requires detailed reporting on pricing guarantees, cost performance measures, and drug-specific data, including discounts, rebates, and NADAC-based comparisons, with special provisions for affiliates and 340B interactions.
- 16MA-PD plan parity
- 17- The PBM accountability provisions apply to MA-PD plans as well, with amendments to MA-PD statute to align enforcement.
- 18Biennial enforcement and oversight reporting
- 19- Requires a biennial CMS/Secretary report on enforcement and oversight actions related to the new pharmacy access requirements, with protections to avoid disclosing sensitive individual or trade secret information.
- 20Data and transparency requirements for PBMs
- 21- PBMs must provide extensive annual reports to PDP sponsors and the Secretary, covering drug lists, dispensing channels, volumes, costs, rebates, DIR, NADAC, and other price-concession data.
- 22- If an affiliate operates a retail, mail-order, or specialty pharmacy, detailed data about affiliate vs. non-affiliate dispensing and the overall cost impact must be reported.