By Sheila M. Arquette, RPh
President & CEO, National Association of Specialty Pharmacy
Ensuring patients have access to the medications they need from the specialty pharmacy of their choosing and championing protections essential to the long-term sustainability of the specialty pharmacy business model have always been top priorities for NASP.
The Inflation Reduction Act’s (IRA) drug negotiation provisions, the new Medicare Transaction Facilitator (MTF) infrastructure, “maximum fair price” (MFP) constructs, MFN-style reference pricing, and the introduction of TrumpRx and other direct-to-consumer (DTC) channels together represent a major structural realignment for specialty pharmacy. These policies promise lower patient and payer costs, but they also compress traditional buy-and-bill reimbursement processes and dispensing margins and risk undermining specialty pharmacy financial viability and the very personalized, high touch specialty pharmacy services that patients rely on.
IRA Pricing and MFPs: Margin Compression and Operational Burden
Under the IRA’s Medicare Drug Price Negotiation Program, CMS now negotiates “maximum fair prices” for selected high-spend Part D and Part B drugs, with the first group of MFPs taking effect in January 2026 and expanding in subsequent years.1,2 Early analyses from CBO and MedPAC indicate that negotiated price ceilings will exert downward pressure on both list and net prices across therapeutic classes.3,4
For specialty pharmacies, this changes both the revenue model and the cash-flow profile. MFPs are, by design, substantially below current net prices which will likely compress gross margins unless acquisition costs fall in lockstep. This margin is the economic foundation supporting specialty pharmacist clinical services and specialty patient management and care coordination. At the same time, the MTF will sit in the middle of claims flows to exchange pharmacy claims data with manufacturers and route retrospective MFP refund payments back to dispensing entities.5,6
CMS has been explicit that no additional fees may be assessed on pharmacies to effectuate the MTF and that the MTF must generate standardized remittance data (835s) to support reconciliation Still, the operational burden is real: specialty pharmacies need upgraded IT, robust data mapping, and staff resources to manage MFP eligibility, refunds, and audit trails 5,6. Specialty pharmacies currently receiving reimbursement below acquisition cost for some drugs, may find it extremely difficult to absorb the investments required to address the added administrative complexity without corresponding service fee reimbursement or better spread economics.
MFN and International Reference Pricing Pressures
The Trump administration’s “most favored nation” (MFN) style pricing frameworks link federal program pricing prices to the lowest prices available in other high-income, comparator countries7.
From a specialty pharmacy perspective, lower prices can be a double-edged sword. They may reduce working capital needs and patient cost-sharing but are not necessarily offset by proportional reductions in acquisition costs. As margins narrow even further this reduces the funds available to support non-dispensing services.
TrumpRx and DTC Disruption
TrumpRx, introduces a federally backed DTC channel for purchasing select prescription drugs at discounted prices enabled through direct manufacturer contracting and, in some cases, MFN-linked pricing commitments.8,9
For specialty pharmacies, the implications include:
1. Disintermediation: If manufacturers and TrumpRx-contracted pharmacies control fulfillment, non-participating specialty pharmacies lose access to their patients and the prescription volume that supports non-dispensing services.
2. Data fragmentation: DTC channels that circumvent plan adjudication systems, reduce visibility into adherence, persistence, and refill patterns. Health policy experts have warned that such models weaken the data infrastructure required for comprehensive coordinated care.10
3. Safety gaps and fragmentation of care: Specialty drugs require extensive monitoring, dose titration, side effect management and interdisciplinary communication. When patients obtain medications through DTC channels decoupled from clinical management, risks of toxicity, nonadherence, and treatment failure increase.
4. Broader DTC Expansion and Risks to Specialty Care
The rapid proliferation of manufacturer-owned pharmacies, cash-pay online platforms, and telehealth-enabled prescribing is reshaping drug access.11 While these models offer decreased costs for some patients, they may be poorly aligned with the needs associated with complex biologics, oncology therapies, autoimmune agents, gene-based treatments, and orphan-drug regimens. Specialty products are not interchangeable generics.
When access shifts to channels that are optimized for low-touch dispensing rather than high-touch comprehensive management, the system risks treating specialty drugs like commodities. This can undermine outcomes and, paradoxically, increase total cost of care through avoidable hospitalizations, therapy discontinuation, or suboptimal dosing.
Protecting specialty pharmacy viability and patient care
To ensure these reforms lower costs while maintaining access to high-quality specialty pharmacy care services and preserving patient choice, several guardrails are essential:
- Service-based reimbursement: For high-touch products, CMS and plans should reimburse separately for care management, monitoring, and patient education rather than expecting those services to be cross-subsidized from shrinking drug margins.
- MTF as a platform for value, not just refunds. The data flowing through the MTF could support quality measures, adherence tracking, and outcomes-based contracts. Policy makers should design the system so specialty pharmacies can access actionable information and be rewarded for improving outcomes, not treated purely as pass-through dispensers.
- Integration of TrumpRx with specialty care. TrumpRx and similar DTC programs should not operate as stand-alone programs. Requirements for clinical coordination, data-sharing, and that specialty pharmacy patients receive care through nationally accredited specialty pharmacies are critical.
- Network design that protects patient choice and expertise. Plan sponsors and manufacturers should avoid network designs that eliminate access to nationally accredited specialty pharmacies simply to chase the lowest unit price. For complex conditions, oncology, autoimmune disease, transplant, rare disease, where medication errors or poor adherence carry substantial clinical and economic risk, the value of expert specialty pharmacy care is not just beneficial; it is essential.
NASP shares the Administration’s goal of making life-changing specialty medications and biologics affordable for all Americans. However, achieving this goal requires more than drug price reduction alone, it demands a patient-centered approach that preserves the specialized clinical support, medication management, and care coordination that transform expensive therapies into effective treatments.
ABOUT NASP
The National Association of Specialty Pharmacy (NASP) is a 501(c)(6) non-profit trade organization and is the only national association representing all stakeholders in the specialty pharmacy industry. The mission of NASP is to empower specialty pharmacy stakeholders to advance the standard of patient care. To learn more visit www.naspnet.org .
References
1. Centers for Medicare & Medicaid Services. Medicare Drug Price Negotiation Program Guidance. 2023–2024.
2. Inflation Reduction Act of 2022, Pub. L. 117-169.
3. Congressional Budget Office. Budgetary Effects of the IRA Drug Price Negotiation Program. 2023.
4. Medicare Payment Advisory Commission. Report to the Congress: Medicare and the Health Care Delivery System. 2023–2024.
5. Centers for Medicare & Medicaid Services. Medicare Transaction Facilitator Overview and Technical Guidance. 2024.
6. Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation. Manufacturer Refund and MFP Operational Requirements. 2024.
7. ASPE. International Prescription Drug Price Comparisons. 2020–2023.
8. Politico / STAT News. Coverage of the TrumpRx Direct-to-Consumer Drug Program and MFN-linked pricing agreements. 2024–2025.
9. U.S. Department of Health & Human Services announcements on DTC drug access initiatives, 2024–2025.
10. KFF. Direct-to-Consumer Drug Models and Implications for Insurance, Data, and Access. 2024.
11. IQVIA Institute for Human Data Science. The Use of Medicines in the United States. 2023–2024.
