Health Law Diagnosed: The Summer / Fall 2025 PBM Policy and Legislative Update

In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate David Gilboa for an overview of the Summer / Fall 2025 PBM Policy and Legislative Update, unpacking the latest developments in PBM policy from April through October 2025.

Together, Bridgette and David highlight stalled federal reform efforts, including the stripped-down One Big Beautiful Bill Act and the newly introduced PBM Reform Act of 2025. They also turn to the state level, where states like Iowa and Arkansas are ramping up regulatory activity. Bridgette and David note ongoing litigation around insulin and opioids, renewed scrutiny of copay accumulator and maximizer programs, and the Trump administration’s push for global drug pricing benchmarks.

For a deeper dive on these topics and more, be sure to check out the Summer / Fall 2025 PBM Policy and Legislative Update.

Have questions or want to connect with the team? Reach out to us at [email protected].

Health Law Diagnosed: The Summer / Fall 2025 PBM Policy and Legislative Update Transcript

Bridgette Keller: Hi there. Welcome back to Health Law Diagnosed, a Mintz podcast dedicated to health policy, and social issues in the health care industry. I’m Bridgette Keller, your podcast host. Today we’re diving into the combined Summer / Fall 2025 PBM Policy and Legislative Update. Joining me is my colleague and fellow policy expert, David Gilboa. David, welcome back.

David Gilboa: Thanks Bridgette. I’m happy to preview our PBM Policy and Legislative Update for the readers and listeners.

BK: This issue is a combined publication that highlights activity in the space from April 2025 through the end of September 2025, with a few October updates that occurred since we went to publication. In part, this combined issue is due to the fact that activity slowed down a bit over the summer.

Federal PBM Reform: Progress and Roadblocks

BK: What’s been happening at the federal level, David?

DG: Despite the rhetoric in Washington about bipartisan support to regulate PBMs, Congress has not passed any meaningful PBM reform, and this continues to be the case. The One Big Beautiful Bill Act, a reconciliation bill, included several PBM reform measures specific to Medicare and Medicaid when it was initially proposed and passed by the House in May. However, these provisions were ultimately stripped from the version that was passed by the Senate and later enacted.

BK: One surprising thing about the PBM reform measures was that the proposals were not the broad, sweeping PBM reform package that Congress had been working toward. Not only were the provisions specific to Medicare and Medicaid only, but PBMs are generally complying with many of the proposed requirements, so these proposals were unlikely to significantly impact the drug supply chain or PBM practices. Anything else happening at the federal level, David?

DG: Representatives in the House introduced the PBM Reform Act of 2025, a standalone, bipartisan bill that would, among other things, ban spread pricing in Medicaid, require PBMs to pass 100% of manufacturer rebates to plan sponsors, and delink PBM compensation from drug prices in Medicare Part D. It also would require detailed reporting and would grant federal agencies broad authority to audit and monitor PBM practices.

BK: Sounds really similar to the initial proposals in the One Big Beautiful Bill Act.

DG: Dr. Oz also signaled that CMS will initiate rulemaking requiring health insurers and PBMs to disclose net prices of drugs. And the FTC’s in-house case regarding insulin pricing is moving forward, with evidentiary hearings scheduled to start in April 2026, pending the Commission’s decision on the PBMs’ motion to dismiss. The FTC also held listening sessions this summer to discuss ways to make prescription drugs more affordable.

BK: So even through the slower summer months, there was still a lot going on.

State-Level Legislation and Litigation

BK: Now let’s talk about the states.

DG: The states are always active. Sixteen states enacted 26 bills that will regulate PBM contracts with pharmacies and providers, pharmacy pricing and reimbursement requirements, pharmacy network requirements, and PBM licensure and registration requirements. An additional eight states proposed 19 bills for consideration.

BK: Any of particular interest?

DG: Yes, a lot is happening in Iowa. Iowa’s S.F. 383, passed in June 2025, imposes sweeping PBM reforms, including full rebate pass-through, NADAC-based reimbursement plus a fixed dispensing fee, and bans on patient, steering, and spread pricing. The law is currently being litigated in Iowa Association of Business and Industry v. Ommen, where a federal court issued a preliminary injunction blocking enforcement of certain provisions for the named plaintiffs, with appeals pending. Despite the litigation, the Iowa Insurance Division issued a bulletin clarifying that the law remains fully enforceable for nonplaintiffs and signaling active enforcement under the Insurance Trade Practices Act. Listeners and readers should check back for more detailed information.

BK: We’ll definitely be tracking that one, David. I also noted that a federal judge temporarily blocked Arkansas from enforcing Act 624. This is the legislation that bars PBMs from owning or operating pharmacies in the state. The court blocked it on the grounds that the law likely violates the Commerce Clause by discriminating against out-of-state entities and it’s preempted by Tricare. This case continues on appeal in the US District Court for the Eastern District of Arkansas and is being closely watched as a potentially precedent-setting test of a state’s authority over PBMs.

DG: We are watching the appeal closely. There were also a variety of procedural updates in the state cases against PBMs in Michigan, Ohio, and Hawaii.

Industry Litigation and Pricing Models

BK: I noticed in the other industry news section of the Update, we’ve had movement in the insulin cases, including the multi-district litigation, as well as some new litigation from cities in the state of Connecticut. The opioid cases also continued to move forward. So listeners and readers should check there for updates. Anything else you saw in the industry news, David?

DG: Copay accumulator and maximizer programs are back in the federal spotlight, with the introduction of the HELP Copays Act that was introduced in March 2025.

BK: There was also federal activity stemming from the Trump administration’s Executive Order on most-favored-nation pricing for the American patient. That set off a stream of activity with the Executive Order and President Trump’s letters to manufacturers — then you had the manufacturers’ responses, where many of them were announcing changes to pricing or entering into direct-to-consumer platforms. We’ve been following that on our blog as well as in the Update. Where did that end, David?

DG: On September 25, 2025, the Trump administration posted a notice on the federal website referring to a proposed rule for global benchmarking for an efficiency drug pricing model, the GLOBE Model, that would be issued by HHS and CMS. While the rule has yet to be posted, this likely signifies that the Trump administration is looking to regulate drug pricing in accordance with President Trump’s May 12 Executive Order.

BK: We’ll see what happens when the government shutdown ends — maybe this rule will come out for publishing.

Key Takeaways and Wrap-up

BK: So, David: key takeaways from the summer / fall Update?

DG: The main takeaway is that the PBM industry continues to face pressure from all sides. Federal legislation, state reforms, litigation, and market disruption.

BK: Well said. For our listeners and readers, whether you’re a health plan, a PBM, an employer group, or another industry stakeholder, it’s vital that you continue to stay engaged and be proactive.

DG: And we’ll be here to keep you informed every step of the way.

BK: Thanks so much for joining me today, David. Listeners and readers, thank you for joining us for this episode of Health Law Diagnosed. If you have any questions about the Summer / Fall 2025 PBM Policy and Legislative Update, please feel free to reach out to us directly or email us at [email protected]. I’m Bridgette Keller, and this was Health Law Diagnosed.

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