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Regulations to watch: Spring 2025

Learn what’s at stake for pharmacy benefits sponsors as federal oversight changes and state legislative sessions begin.

April 4, 2025 | 4-minute read

In this article

The pharmacy regulations you need to be aware of

At both the state and federal levels, Optum Rx closely monitors for rules and legislation with the potential to impact pharmacy benefits.

Federal update

Latest federal funding bill does not impact prescription drug benefits

On Mar. 15, 2025, President Trump signed into law a bill extending federal government funding through Sept. 30, 2025. The most recent extension did not contain provisions impactful to PBMs and prescription drug benefits.

However, Congress continues to consider such measures and could potentially advance a stand-alone bill. Another option is use of the budget procedure called reconciliation, which allows the Senate to pass legislation and avoid a filibuster with a 51-vote majority.  Among the provisions being considered by Congress are:

  • Commercial PBM reforms, including full rebate pass through to ERISA self-funded clients
  • “Delinking” policy to require that Part D Plan sponsors delink PBM compensation from drug prices
  • Ban on traditional/spread pricing and a mandated dispensing fee in Medicaid
  • Policy requiring Medicare rulemaking on standard terms and conditions in Part D Plans’ contracts for in-network pharmacies

Other commercial, Medicare and Medicaid provisions could be considered by Congress. It’s important to note that while any PBM and prescription drug benefit provision could be included in a stand-alone bill, only provisions that have budgetary impact can be passed through the reconciliation process. 

CMS issues 2026 Medicare Part C and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (CMS) issued the finalized Medicare Advantage (Part C) and Medicare Prescription Drug Benefit (Part D) rules for Contract year 2026. This “Final Rule” updated provisions of the Inflation Reduction Act that will become effective on Jan. 1, 2026. This included changes to annual out-of-pocket thresholds, changes to standard Part D benefit design and the start of the drug price negotiation program for 2026. CMS is not finalizing certain provisions from the proposed rule issued by the Biden administration in 2024, including Part D coverage of Anti-Obesity Medications (AOMs). CMS may address this proposal in future rulemaking.

State updates

States considering new laws in 2025

All 50 states are holding sessions during 2025 to consider passage of new laws. As of March 2025, state legislatures have introduced more than 1,250 bills on PBM and prescription drug benefit issues. By comparison, there were 635 bills introduced in 2024 and 658 bills introduced in 2023.

Many states have introduced individual bills that include multiple provisions impactful to PBMs or prescription drug benefits. Commonly, this type of omnibus legislation includes mandates related to pharmacy reimbursement, pharmacy networks, traditional/spread pricing, and rebates.

States that have introduced at least one omnibus bill include Arizona, California, Colorado, Connecticut, Hawaii, Illinois, Montana, Nebraska, New Jersey, New Mexico, North Carolina, Oklahoma, Oregon and Wisconsin. Alabama, Indiana, Missouri and Nevada are among the states that have introduced multiple omnibus bills.

Bills in progress

The legislative process of hearing bills in committee and passing bills through chambers of the legislature continues. The following are examples of bills that have passed through one chamber of a state’s legislature:

The Colorado House passed and advanced to the Senate HB 1094. The bill includes provisions that mandate pharmacy reimbursement at NADAC plus a reasonable and adequate dispensing fee.

The Indiana Senate passed SB 140, and the bill is now under consideration by the House. Among its provisions are a NADAC pharmacy reimbursement mandate plus dispensing fee of $10.64 and non-PBM-affiliated pharmacy reimbursement parity. This bill also bans mandatory mail or exclusive specialty, prohibits retroactive recoupments and reconciliation processes. A PBM licensed in the state would also be banned from having an ownership interest in a pharmacy. This pharmacy ownership provision could prevent PBMs from offering home delivery of prescriptions or specialty prescriptions from being mailed into the state. The Indiana Senate also approved HB 1604 which would require health insurers to allow coupons to be used against cost sharing requirements for prescription drugs. The legislation returns to the House for concurrence.

The Mississippi Senate passed HB 1123 which bans spread pricing and includes anti-steering provisions. The bill also modifies requirements around MAC list pricing, and prohibits retroactive reduction of claims payments. The House will now consider whether to concur with the Senate’s version of the bill. 

In Oklahoma, the Senate approved SB 789, which would modify pharmacy audit requirements, ban effective rate contracting, and require PBMs to reimburse pharmacies for each drug dispensed at no less than 106% of the National Average Drug Acquisition Cost (NADAC), plus a $15.00 dispensing fee. The legislation now advances to the House for consideration.

Iowa, Missouri and Oklahoma House of Representative chambers have passed prior authorization bills which will now be considered by each respective state’s Senate chamber.

  • Iowa HF 303 would establish maximum response times for prior authorization requests and mandate health plans develop a gold carding program without specifying a threshold or standard.
  • Missouri HB 618 would establish a gold carding program that requires a 90% threshold for approved claims and providers must be in network for one full year before being considered for the program.

Oklahoma HB 1808 would reform prior authorization practices for prescription drugs and requires prior authorization requests approved for drugs used to treat chronic conditions to be valid for three years, except for opioids, controlled substances, and weight loss drugs. In order to become law, a bill must pass through both chambers of a legislature and be signed into law by the state’s Governor.  

Optum Rx legislative and regulatory advocacy

Legislation regulating PBMs has the potential to have significant cost impacts on Optum Rx clients and their members. That is why we regularly meet with policymakers, legislators and regulators to educate them about the potential implications these laws can have.

Optum Rx, through its External Affairs team and the Pharmaceutical Care Management Association, is actively opposing legislation that will reduce choice and flexibility in how plan sponsors manage and design their prescription drug benefits.

If you wish to engage in outreach to policymakers about legislation in your state, please contact your Optum Rx representative. 

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