Pharmaceutical middlemen propose business practice modifications, hope to avoid new regulations

Pharmacy benefit managers (PBMs) are currently developing a proposal to voluntarily modify certain business practices in an effort to avoid new regulations from the Trump administration, according to sources familiar with the ongoing discussions.

The Pharmaceutical Care Management Association (PCMA), the primary lobbying organisation representing these pharmacy middlemen, has drafted recommendations intended for submission to the Centers for Medicare and Medicaid Services, as revealed in documents reviewed by Bloomberg News.

These PBMs have come under increasing scrutiny as the Trump administration calls for stricter regulations on how the industry negotiates discounts on prescription medications with pharmaceutical manufacturers on behalf of health plans and employers.

The proposed voluntary changes come amidst a broader push for PBM reform across the United States. In July 2025, Representative Earl L. Carter introduced the bipartisan PBM Reform Act, aimed at addressing what critics describe as anticompetitive and opaque practices within the industry. The legislation seeks to restore transparency and fairness in the prescription drug supply chain.

Several states have already taken action against certain PBM practices. California lawmakers, for instance, have been pursuing legislation that would prohibit spread pricing – where PBMs charge insurers higher rates for drugs than what they pay to pharmacies. The California bill would also bar PBMs from requiring patients to use only specified affiliated pharmacies.

Industry stakeholders remain divided on the issue. Insurance companies and employers argue that PBMs make administering pharmacy benefits more efficient and help control costs by challenging unreasonable prices from drugmakers. Pharmaceutical manufacturers, however, have advocated for increased restrictions on PBMs.

CVS Health, a major player in the PBM space, declined to confirm the report about voluntary changes but stated it stands "ready and willing to work with the Administration and Congress to support efforts that make prescription drug coverage more affordable and easier to use".

The Trump administration previously signed an executive order designed to lower prescription drug costs in the US, with provisions specifically targeting PBM control and encouraging competition and innovation in the pharmaceutical market.

As these discussions continue, multiple pharmaceutical manufacturers including Eli Lilly & Co., Pfizer Inc., Novo Nordisk A/S, and Bristol Myers Squibb have launched their own direct sales initiatives, whilst others such as AstraZeneca Plc, Roche, Merck KGaA, and GSK Plc have expressed interest in similar approaches.

The outcome of these voluntary proposals from PBMs could significantly impact the future regulatory landscape for prescription drug pricing and distribution in the United States.

Source:

Drug Middlemen Aim to Avoid New Rules With Voluntary Changes [Accessed September 25, 2025] https://www.bloomberg.com/news/articles/2025-09-24/drug-middlemen-seek-to-head-off-new-rules-with-voluntary-changes