In late 2025, the Trump Administration (the “Administration”) unveiled a new initiative aimed at lowering the cost of in vitro fertilization (IVF) medications. To date, the Administration has reached agreements with three pharmaceutical manufacturers to offer select IVF medications at reduced prices. These discounted medications will be made available to patients purchasing directly through the government’s new TrumpRx platform. Although details remain preliminary, this initiative could have significant implications for fertility clinics and pharmacies that provide specialized fertility care. For pharmacies in particular, the model could alter patient flow, margin structure, pricing policies, inventory strategies, and compliance risk profiles in ways that warrant proactive planning.
Direct-to-Consumer Model
The TrumpRx platform will offer discounted IVF medications through a direct-to-consumer (DTC) model. Patients will be able to visit the TrumpRx website, select their medications, and be redirected to the manufacturer’s DTC portal to complete the purchase, bypassing insurance in exchange for the discounted cash price. Several large pharmacy networks, such as CVS Health and Cigna, have already reached agreements to serve as TrumpRx “partner pharmacies” providing specialized fertility care. It remains unclear, however, whether pharmacies will need to partner with TrumpRx to access or dispense the newly discounted IVF medications and whether fulfillment will be limited to designated partner pharmacies such as CVS Specialty and Evernorth pharmacies, Freedom Fertility, or VFP Pharmacy Group.
For fertility clinics and independent pharmacies, this structure presents several potential challenges:
- Increased competition from manufacturers offering the same medications at TrumpRx’s lower cash prices.
- Pressure to match discounted cash prices.
- Reduced access to discounted products for non-partner pharmacies in the event manufacturers’ DTC portals limit fulfillment of discounted products to TrumpRx’s designated partner pharmacies.
- Potential loss of patient volume to designated partner pharmacies.
Operational Considerations
Pharmacies should evaluate whether existing workflows and service models remain viable under the TrumpRx framework. Key considerations include:
- Redesigning intake and counseling workflows for patients comparing cash and insurance pricing.
- Developing standardized scripts and documentation for pricing discussions and patient choice.
- Maintaining non-resident pharmacy licensing, specialty accreditation, and robust cold-chain capabilities.
- Reviewing return, replacement, and recall policies for temperature-sensitive products.
- Ensuring compliance with Drug Supply Chain Security Act (DSCSA) transaction requirements for drop-ship or direct manufacturer fulfillment.
In addition, some clinics may steer patients to TrumpRx partner pharmacies as part of treatment protocols. Independent pharmacies should engage clinic partners to clarify referral patterns, explore service offerings, and preserve continuity of care for patients requiring individualized services.
Pricing and U&C Implications
Pharmacies should assess whether and how to respond to patient requests to match TrumpRx cash pricing. Beyond immediate margin compression, such price matching may affect reimbursement if it is viewed as the pharmacy’s “usual and customary” (U&C) price. Key considerations include:
- Consistent documentation of discounted transactions in accordance with contractual definitions.
- Evaluating whether IVF-specific discounts affect reimbursement across other drug categories if U&C logic is applied globally in PBM claims processing.
- If a pharmacy implements IVF-specific discounts, it should adopt written policies that define eligibility and duration, train staff to avoid ad hoc concessions, and periodically test claims to identify any unintended impact on U&C and plan reimbursements.
Inventory and Supply Chain Considerations
If patient volume shifts to partner pharmacies, non-partner pharmacies may experience slower inventory turns and increased risk of expiration for high-cost IVF products. Pharmacies should consider:
- Recalibrating order quantities and using just-in-time purchasing where feasible.
- Reviewing wholesaler return policies for short-dated items.
- Enhancing cold-chain procedures, backup power systems, continuous temperature monitoring, and validated packaging to mitigate shipping delays and withstand regulatory or PBM audit reviews.
- To remain competitive, pharmacies may need to focus on other service elements, including rapid fulfillment aligned to cycle start dates, weekend and after-hours support, language access, and coordination with clinic calendars.
PBM Audit Risks
Pharmacies dispensing discounted IVF medications may also face increased PBM audit scrutiny. Inadequate recordkeeping and even minor failures to comply with PBM requirements can expose pharmacies to recoupments, clawbacks, or network termination.
PBMs frequently treat a pharmacy’s U&C cash price as a ceiling for plan reimbursement, and many contracts define U&C broadly to include prices offered to the public. Matching TrumpRx cash pricing or offering similar discounts may reset U&C and depress reimbursement for insured claims, including those unrelated to IVF. Pharmacies should review U&C definitions, price-match practices, and signage to avoid inadvertently establishing a new U&C and consider limited, documented patient-specific financial hardship adjustments consistent with contract terms.
Even where IVF purchases are cash-pay and outside federal program coverage, pharmacies should evaluate state anti-inducement rules, commercial plan restrictions on routine copay waivers, and contract limits on coupons or manufacturer assistance. Strong documentation (such as prescriber notes supporting day-supply choices, product selection rationale where multiple National Drug Codes (NDCs) exist, and proof of patient counseling) can mitigate audit exposure.
Finally, pharmacies should expect closer review of claim-level accuracy, including Dispense as Written (DAW) codes when a specific brand is medically necessary, dispense quantities that align with cycle timing, and shipping documentation for mail-order deliveries. Establishing a contemporaneous audit file with invoices, DSCSA transaction data, temperature logs, delivery confirmation, and relevant patient communications can reduce recoupment risk.
How Frier Levitt Can Help
Frier Levitt is closely monitoring the TrumpRx initiative and its potential impact on fertility clinics and independent pharmacies. Our attorneys regularly counsel pharmacies and health care providers in navigating new pricing structures, manufacturer discount programs, and PBM audit and compliance risks.
