Impacted: All clients across all lines of business

What you need to know

Last week, the Trump administration announced the launch of TrumpRx, a federal platform intended to connect patients to lower cost, cash-pay prescription drug options. The site currently lists 43 drugs across multiple therapeutic categories, 22 of which have generic options available today.

On Jan. 27, 2026, the U.S. Department of Health and Human Services (HHS):

• Issued guidance clarifying when pharmaceutical manufacturers may sell prescription drugs directly to patients — including Medicare and Medicaid enrollees — without violating the federal Anti-Kickback Statute, provided specific safeguards are met.
• HHS also indicated it is seeking additional stakeholder input through a request for information as it evaluates whether further policy clarification or guardrails are needed. 

Together, these developments reflect growing federal support for direct-to-consumer (DTC) prescription drug purchasing models that operate outside traditional pharmacy benefits and may affect plan design, member experience and cost management-to-consumer (MTC). 

Prime is proactively monitoring and analyzing the evolving DTC and cash-pay drug landscape — including TrumpRx — and collaborating with industry partners to keep clients informed and advocate for effective health plan solutions.

Overview

TrumpRx, first announced in September 2025, is a government-run web portal intended to direct patients to participating pharmaceutical manufacturers’ DTC prescription drug programs. TrumpRx is not a licensed pharmacy. The platform does not dispense medications or process insurance claims; instead, it connects consumers to manufacturer websites or in some cases provides coupons to be used at local pharmacies where medications may be purchased on a cash-pay basis.

Each drug on TrumpRx includes a short disclaimer, "This is an out-of-pocket price. If you have insurance, check your co-pay first, it may be even lower.” For drugs with available coupons, there is a longer disclaimer acknowledging that these drugs are not covered by insurance. The disclaimer also advises patients to check with their insurer to see if these purchases can count toward their deductible or out-of-pocket maximum. 

As of today, TrumpRx is live and includes 43 drugs used to treat a range of conditions, each offered at varying discount levels. Of the 43 drugs currently available, 22 have more affordable generic alternatives.

HHS guidance

In addition, on Jan. 27, 2026, HHS — through its Office of Inspector General (OIG) — released a Special Advisory Bulletin outlining circumstances in which manufacturer DTC prescription drug sales may be considered “low risk” under the federal Anti-Kickback Statute. The guidance explains that arrangements are generally viewed as lower risk when they involve:

• Cash-pay transactions only (not billed to Medicare, Medicaid or other federal programs) 
• Not used to market other federally reimbursable products
• Not tied to future purchases, referrals or other inducements

HHS also requested public input as it evaluates whether additional guidance or guardrails are necessary as DTC drug programs expand. 

Prime's position

Prime is actively monitoring the TrumpRx launch and broader developments around manufacturer DTC and cash‑pay drug programs. 

Considerations for health plans:

• Purchases made through DTC or cash-pay programs may lower out-of-pocket costs for some members, but they occur outside the pharmacy benefit. These purchases typically do not count toward deductibles or out-of-pocket maximums, and do not receive a plan’s clinical or safety oversight.
• As off-benefit use increases, health plans may see more questions from members about cost, coverage and documentation for reimbursement. There may also be reduced visibility into which medications members use, making adherence and safety monitoring more difficult.
• Staying within the pharmacy benefit usually results in prescriptions being reviewed for safety and tends to deliver lower out-of-pocket costs — particularly for GLP-1 drugs — based on Prime’s data. 

What Prime is doing

• We are actively collaborating with trade associations like the Pharmaceutical Care Management Association (PCMA) to monitor developments and advocacy opportunities. 
• Conducting an in-depth analysis comparing TrumpRx cash prices to standard commercial benefit pricing, and evaluating utilization of applicable benefit tools, which automatically finds the lowest price for members at the point of sale. Because pricing varies by client, results will differ, and additional insights will be shared on a client-by-client basis as the analysis concludes.
• Continuing to monitor the functionality, performance and manufacturer participation in TrumpRx, along with tracking new federal guidance and HHS actions.

We will continue to provide timely updates as more information emerges, all with the goal of supporting our clients and their members through this evolving landscape.

Questions

Reach out to your Prime account team representative.