Navigating 3 New Pharmacy Regulations in 2026

In this article

A new year promises a full array of legislative and statutory actions with the potential to significantly alter the cost and effectiveness of the pharmacy benefit. Here are 3 themes you should watch in the year ahead:

MFN prescription drug pricing and pharmaceutical tariffs
Vaccine policy shifts
Federal and state-level legislative action

1. Most-Favored-Nation drug pricing and pharmaceutical tariffs

Throughout 2025, the Trump administration announced shifts in federal policy intended to bring pricing down for prescription medications.

In May, an executive order outlined actions to achieve Most Favored Nation prescription drug pricing to link American drug prices with those paid by other countries.
In November, the White House announced agreements reached with pharmaceutical manufacturers Eli Lilly and Company and Novo Nordisk, makers of the popular GLP-1 medications, to provide discounted versions of their drugs via Medicare and Medicaid as well as a new direct-to-consumer entity, TrumpRx.

In the wake of those announcements, many details remained to be finalized in 2026, including specifics on:

Pricing
Dosages
Eligibility
Clinical criteria
Potential statutory changes necessary to cover weight-loss drugs under Medicare

Likewise, the issue of potential tariffs of imported pharmaceuticals will resurface in 2026. The Supreme Court heard arguments on the legality of tariffs in November and is expected to render a decision soon.

2. Legislative and vaccine policy shifts

After HHS Secretary Robert Kennedy removed all 17 members of the Advisory Committee on Immunization Practices (ACIP), there will no longer be a blanket recommendation for COVID-19 vaccines for adults over 65.

In November, ACIP voted to change the recommendation for when children should get their first dose of the hepatitis B vaccine. 

In response to the shifting federal vaccine recommendations, states have formed coalitions to issue independent vaccine recommendations.

The West Coast Health Alliance contains:

Washington
Oregon
California
Hawaii

The Northeast Public Health Collaborative is comprised of:

Connecticut
Massachusetts
Maine
Rhode Island
New York
Pennsylvania
New Jersey

While these changes in ACIP recommendations and subsequent (and pending) changes in Centers for Disease Control and Prevention (CDC) recommendations do bear watching in the long term, they do not necessarily impact coverage in 2026.

3. Federal and state-level legislative action

Expect much of the proposed legislation advanced in the previous year to return in the current one. At the federal level, Congress considered a year-end healthcare package including several provisions with potentially impactful pharmacy benefits, including:

Transparency and reporting requirements
Mandated rebate pass-through
Spread pricing prohibitions

A similar flurry of activity will exist within state legislatures this year.

In 2025, plan sponsors and members in Arkansas learned just how much state-level regulations can adversely affect pharmacy benefits after a newly enacted law led to pharmacy closures in the state. Equally consequential laws are likely to resurface around the nation as legislative sessions begin.

How to keep informed of legislation

Legislation regulating pharmacy benefit managers (PBMs) has the potential to have significant cost impacts on Optum Rx clients and reduce choice and flexibility in how they manage and design prescription drug benefits for their members. That is why we regularly meet with policymakers, legislators and regulators to educate them about the potential implications these laws can have.

To help keep you informed of this increasingly complex and active regulatory environment, members of the Optum Rx Regulatory affairs team will host 6 webinars in the coming year. These bimonthly, interactive sessions will dive deep into the specifics of all the proposed and enacted legislation and rulemaking you need to be aware of.