From Pressure to Possibility: What 2025 Drug and Policy Shifts Mean for Wound Care Programs
- mdavis107
- Aug 6
- 7 min read
Updated: Aug 7
The Push for Price Fairness — and What It Means for Wound Care Teams
On July 31, the Trump administration urged 17 of the largest pharmaceutical companies to align U.S. drug prices with the lowest rates offered in other countries — known as the “most-favored-nation” price.¹
The request emphasized Medicaid access and fairness for American patients, calling on drugmakers to stop offering deeper discounts overseas while U.S. providers and payers absorb higher costs.
While the White House did not outline penalties or enforcement mechanisms, the message is clear: lowering U.S. drug prices is now a top federal priority — and hospitals should prepare for ripple effects across specialty medications, biologics, and outpatient formularies.²
Why it matters for wound care:
Advanced wound therapies, such as cellular and/or tissue-based products (CTPs), are often high-cost and subject to ongoing pricing scrutiny.
If pricing pressures drive changes to how products are distributed, reimbursed, or contracted, hospital wound centers may need to re-evaluate their product mix and utilization strategies.
340B at a Crossroads: Rebate Models, Medicaid Shifts, and What Comes Next
In August 2025, the Health Resources and Services Administration (HRSA) announced applications are now open for a voluntary 340B Rebate Model Pilot Program. This pilot marks a potential shift from upfront discounts to post-sale rebate processing, particularly for drugs subject to Medicare’s negotiated pricing under the Inflation Reduction Act.³
Under this model:
Covered entities would purchase outpatient drugs at full wholesale acquisition cost (WAC) up front, then submit claims to manufacturers for reimbursement through rebates.
The stated aim is to improve transparency and federal oversight, but health systems are raising alarms about the financial and administrative burdens this may create.⁴
A 2025 survey from 340B Health of over 300 participating hospitals found:
93% of participating hospitals said they would struggle to sustain uncompensated care under a rebate model.
Disproportionate share hospitals could face $72 million in added annual costs.
Critical access hospitals could see $1.7 million in new yearly burdens.⁵
At the same time, shifts in Medicaid eligibility requirements may reduce the number of patients who qualify for 340B-related benefits, further weakening the program’s reach and reliability.
Why it matters for wound care:
Many hospital-based wound care programs rely on 340B discounts to help offset the cost of advanced therapies — including cellular and/or tissue-based products (CTPs), biologics, and injectable agents.
If upfront savings give way to post-sale rebates:
Wound centers may face cash flow issues when ordering high-cost products.
There’s likely to be a heavier administrative lift on billing teams and pharmacy staff.
Smaller or rural facilities may rethink their service line offerings, especially for modalities with thin margins or inconsistent reimbursement.
Bypassing the Middleman: The Rise of Direct-to-Patient Drug Access
Amid growing pressure to lower U.S. drug prices, major pharmaceutical companies are unveiling direct‑to‑patient (DTP) or direct‑to‑consumer (DTC) distribution models that bypass pharmacy benefit managers (PBMs).⁶
Roche, in particular, is actively discussing a DTP model with HHS. CEO Thomas Schinecker framed the approach as a way to eliminate intermediaries which he said 'take more than 50% of the profitability' without contributing to innovation.⁷
Pfizer, Bristol‑Myers Squibb, Eli Lilly, and Novo Nordisk have followed suit: offering products (like Eliquis, Zepbound, or Wegovy) directly to uninsured or underinsured patients via telehealth-linked platforms (like LillyDirect or PfizerDirect) at discounted prices. For example, Eliquis will be sold for roughly a 43% cash discount, lowering its price from ~$606 to ~$346/month.⁸
The idea is simple: ship medications straight to the patient, reduce administrative friction, and offer lower prices where possible. But for hospitals — especially those running outpatient wound care programs — this shift may introduce new operational headaches.
Why it matters for wound care teams:
Pricing mismatches may arise between hospital formularies and online offerings.
Pharmacy and formulary contracts may be undermined by direct access models.
Patients may present with products not stocked in-house or sourced through unfamiliar channels — raising reimbursement and documentation concerns.
And with Medicaid eligibility tightening, fewer patients may qualify for support programs tied to provider-purchased medications.
The result? Hospitals face a growing risk of care gaps, billing delays, and formulary confusion — all while trying to maintain consistency in treatment protocols.
At Shared Health Services, we help partners stay ahead of these shifts by aligning compliance safeguards and documentation workflows — ensuring wound care programs don’t get caught off guard when the market changes.
NIH Funding: A Quiet Win for Wound Research
Amid the noise of drug pricing reform and 340B uncertainty, one piece of good news emerged from Washington: the Senate Appropriations Committee voted to increase the National Institutes of Health (NIH) budget by $400 million — a move that reflects continued congressional commitment to medical research, especially after earlier proposals aimed to slash NIH funding by nearly 40%.⁹
While this decision may not make headlines, it’s an important signal of continued bipartisan support for medical research — including wound healing science.
Why this matters:
NIH funds critical research into chronic wounds, vascular conditions, pressure injuries, and diabetic ulcers.
Ongoing support enables continued progress in growth factor development, tissue engineering, and clinical data modeling — all of which drive innovation in wound care.
Stable funding ensures hospitals and academic centers can pursue evidence-based approaches that improve outcomes and expand access to care.
For wound care teams, the NIH boost isn’t just symbolic — it helps safeguard the long-term pipeline of innovation that patients and providers rely on.
What Wound Care Leaders Should Be Watching Now
With so many changes in motion — from pricing pressures to policy pilots — now is the time for wound care programs to act, not wait.
1. Monitor Advanced Therapy Access and Pricing
Stay closely connected with your product reps and supply chain teams — especially if you’re using high-cost CTPs or brand-name biologics without generics. Know your break-even points, and document clinical use defensibly.
2. Assess Your 340B Exposure
If your hospital relies on 340B savings to support wound care operations, model the financial impact of a rebate-based structure. Work with finance, pharmacy, and leadership to identify risks and mitigation plans.
3. Shore Up Documentation and Reimbursement
With increased federal scrutiny and payer reform, now is the time to double down on accurate coding, outcomes tracking, and compliant billing practices. These are the cornerstones of a sustainable program — no matter what the policy landscape looks like.
4. Make Your Voice Heard
HRSA is accepting public comments on its 340B Rebate Model Pilot Program through September 2, 2025. While only drug manufacturers are eligible to apply to participate, (applications are due by September 15), the program will directly affect hospitals that purchase impacted drugs. HRSA will review and approve these manufacturer-submitted plans in October, with the pilot set to begin on January 1, 2026.³
Covered entities won’t be submitting applications — but they have a real stake in the outcome. This is the time to engage with HRSA, 340B Health, or regional hospital associations to ensure hospital perspectives are represented as HRSA finalizes the program design.
Consistent Oversight Matters
These are not small rule changes — they reshape how hospitals access and manage drug pricing. Active participation in public comment periods gives safety-net and rural providers a seat at the table as the 340B program evolves.
A Rural Reset: $50 Billion on the Horizon for Underserved Hospitals
As hospitals navigate complex policy shifts like the 340B rebate model, new funding opportunities are also emerging — offering a chance to regain ground. According to CMS Administrator Dr. Mehmet Oz, applications for the Rural Health Transformation Program — part of the “One Big Beautiful Bill” Act enacted in July 2025 — are expected to open in early September. This initiative allocates $50 billion over five years (2026–2030) to strengthen rural healthcare through:
Workforce Development
System Right-Sizing
Expanded Telehealth
and Technology Access¹⁰
Half of the funding ($25 billion) will be distributed equally among states with approved applications, while the remaining $25 billion is allocated at CMS’s discretion—based on factors like rural population size, facility density, and local hospital needs.¹¹
Why this matters for wound care:
Rural hospitals often serve high-need, low-resource populations with rising rates of chronic wounds.
Funds may be available to support clinical staffing, technology upgrades, or telehealth consults that extend wound care access.
If distributed equitably, the program could help level the playing field for smaller hospitals competing with larger systems.
As the details roll out, wound care leaders should stay proactive to ensure their facility’s strategic goals are reflected in hospital and state rural health proposals. Between pricing reform, 340B uncertainty, and a major federal investment in rural health, the second half of 2025 will shape how wound care programs survive — and thrive — for years to come.
SHS Perspective: Navigating Change, Strengthening What Matters
At Shared Health Services, we work alongside hospitals and physician practices to anticipate change — and turn it into opportunity. From policy reform to reimbursement pressures, our focus is simple: equip your wound care program to remain stable, strategic, and compliant in a shifting landscape.
That includes helping our rural partners think proactively about emerging funding opportunities like the Rural Health Transformation Program — ensuring wound care is included in hospital-wide proposals for staffing, technology, and access.
Our role is to support your team with:
Guidance on CTP use, documentation, and defensible coding
Support for navigating 340B workflows and rebate transitions
Training on compliant billing, eligibility screening, and payer alignment
Forward-looking insight into regulatory and legislative trends
The world of wound care policy is moving fast — but you don’t have to face it alone. We’re here to help you stay ready, steady, and focused on delivering excellent care.
Curious how these shifts could affect your wound care program? Schedule a conversation with our team of wound care experts today — and let’s talk strategy.
References:
Mason J, Bose N, Wingrove P. Trump pressures 17 pharma CEOs to cut US drug prices. Reuters. Published July 31, 2025. Accessed August 6, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/trump-pressures-17-pharma-ceos-cut-us-drug-prices-2025-07-31/
The White House. Fact sheet: President Donald J. Trump announces actions to get Americans the best prices in the world for prescription drugs. Published July 31, 2025. Accessed August 6, 2025. https://www.whitehouse.gov/fact-sheets/2025/07/fact-sheet-president-donald-j-trump-announces-actions-to-get-americans-the-best-prices-in-the-world-for-prescription-drugs/
Health Resources and Services Administration (HRSA). HRSA announces application process for the 340B rebate model pilot program and request for public comment. Published July 31, 2025. Accessed August 6, 2025. https://www.hrsa.gov/about/news/press-releases/rebate-model-pilot-program
340B Health. 340B Health responds to HRSA 340B rebate pilot program. 340B Health. Published July 31, 2025. Accessed August 6, 2025. https://www.340bhealth.org/newsroom/340b-health-responds-to-hrsa-340b-rebate-pilot-program/
340B Health. New report: Drugmakers’ 340B rebate schemes threaten massive financial harm to safety-net hospitals. 340B Health. Published July 18, 2025. Accessed August 6, 2025. https://www.340bhealth.org/newsroom/new-report-drugmakers-340b-rebate-schemes-threaten-massive-financial-harm-to-safety-net-hospitals/
Satija B, Fick M. Roche considering selling drugs directly to US patients, CEO says. Reuters. Published July 24, 2025. Accessed August 6, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/roche-considering-selling-drugs-directly-us-patients-ceo-says-2025-07-24/
Becker Z. Roche CEO weighs direct-to-consumer drug sales to ease US drug pricing woes, cut out middlemen. Fierce Pharma. Published July 24, 2025. Accessed August 6, 2025. https://www.fiercepharma.com/pharma/roche-weighing-direct-consumer-drug-sales-ease-us-drug-pricing-woes-cut-out-pbms-ceo-says
Roy M, Erman M. Bristol Myers, Pfizer to sell blood thinner Eliquis directly to US patients. Reuters. Published July 17, 2025. Accessed August 6, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/bristol-myers-pfizer-sell-blood-thinner-eliquis-directly-us-patients-2025-07-17/
American Hospital Association. Senate committee advances appropriations bill. AHA News. Published August 1, 2025. Accessed August 6, 2025. https://www.aha.org/news/headline/2025-08-01-senate-committee-advances-appropriations-bill
Ashley M. CMS targets September for $50B rural healthcare fund applications. Becker’s Hospital Review. Published August 5, 2025. Accessed August 6, 2025. https://www.beckershospitalreview.com/finance/cms-targets-september-for-50b-rural-healthcare-fund-applications/
National Rural Health Association. Rural Health Transformation Program Summary. Accessed August 6, 2025. https://www.ruralhealth.us/nationalruralhealth/media/documents/advocacy/2025/rural-health-transformation-program-summary.pdf
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