Carter introduces bipartisan bill to lower costs, preserve access to wound care

WASHINGTON, D.C. - Reps. Earl L. "Buddy" Carter (R-GA), Marc Veasey (D-TX), Greg Steube (R-FL), and Rich McCormick (R-GA) introduced the Skin Substitute Access and Payment Reform Act, a bill modernizing Medicare's payment system for skin substitute products, defined as biological materials used to cover and promote the healing of skin wounds.

"Recently, there has been an inappropriate and concerning rise in skin substitute prices and costs. This escalation wastes Medicare resources and hinders access to care for thousands of Americans who rely on these products to successfully heal their diabetic wounds, avoid amputations, and other downstream costs. My bill puts an end to runaway prices and inappropriate prescribing by implementing new program integrity reforms and ensuring that patients in need receive affordable, accessible, and high-quality care," said Rep. Carter.

"Every Texan deserves access to innovative, effective treatments that can save their limbs and their lives. Too many of our seniors, veterans, and neighbors living with diabetes and other chronic conditions face preventable amputations simply because care is too expensive or out of reach. This bill helps to protect patients' access to advanced wound care therapies while also ensuring taxpayer dollars are spent responsibly. By modernizing the system, we can help Texans heal faster and live healthier," said Rep. Veasey.

"Patients deserve financial security and peace of mind when it comes to their medical bills," said Rep. Steube. "It is unacceptable that Medicare recipients suffering from chronic wounds must also endure unpredictable pricing for the treatment they need. By updating billing and payment processes and opening up the market for new treatments, this bill puts the interests of patients first. I am grateful to partner with Congressman Carter and Senator Cassidy on this legislation that will have a direct and positive impact on the residents of Southwest Florida."

"This bill ensures that healthcare providers can make the best decisions for their patients," said Rep. McCormick. "By maintaining Medicare coverage for skin substitute products, we're empowering physicians to provide the best course of treatment for those who need this critical care. I'm proud to co-lead this effort with Congressman Buddy Carter to put patients and providers first."

"I commend Representatives Carter, Veasey, Steube, and McCormick for introducing the Skin Substitute Access and Payment Reform Act (H.R. 5768). This bipartisan legislation represents an important step toward ensuring that Medicare beneficiaries with hard-to-heal wounds retain access to clinically proven advanced skin substitute therapies. By modernizing the Medicare payment methodology while preserving program integrity, H.R. 5768 strikes the right balance between fiscal responsibility, patient access, and clinical innovation. This reform will help stabilize care delivery across hospital outpatient, private physician-office and mobile wound care settings while maintaining incentives for continued scientific advancement in regenerative wound therapies. I strongly support this legislation and applaud Congress for recognizing that protecting access to effective skin substitute products is both cost-effective and life-saving," said Dr. William H. Tettelbach.

The Skin Substitute Access and Payment Reform Act of 2025 would:

• Effective January 1, 2026: set payment limits for all skin substitute products based on historic volume-weighted average prices to end the "race to the top" price escalation and ensure fair and consistent reimbursement.
• Recognize the similar clinical effectiveness of various skin substitute products by providing a one-year delay of the national local coverage determination noncoverage proposal to allow companies time to complete standardized clinical trials.
• Establish program integrity provisions to crack down on fraudulent and abusive provider prescribing:
  • Effective January 1, 2026, identify the 3% of "outlier" providers that are generating most of the costs of skin substitutes and begin immediate prepayment review and prior authorization until they achieve approval rates of over 90%.
  • Identify providers for potential Medicare exclusion if they cannot achieve a claim approval rate above 25% in a 6-month period.

Read the full bill text here.

Background

Each year, more than 10.5 million Medicare beneficiaries seek treatment for advanced chronic wounds. Among these patients, older adults living with diabetes are particularly vulnerable to foot ulcers, such as diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), which can lead to devasting complications, including amputations. A lower limb is amputated every 20 seconds - and 85% of these amputations are preceded by a foot ulcer. The 5-year mortality rate following a major amputation exceeds 50%, higher than that of breast cancer and all other cancers and second to only lung cancer. Fortunately, regenerative human cell and tissue products (typically derived from placental material from live births) - as well as animal-derived and synthetic skin substitutes - have shown to function similarly to a patient's own skin and significantly accelerate wound healing.

Despite their strong clinical foundation, Medicare expenditures for skin substitutes administered in the home and physician office have increased dramatically - from approximately $500 million in 2020 to $6.5 billion in 2024. While some of this growth reflects increased utilization in non-hospital care settings, a major driver of this spending escalation is a flawed reimbursement system that incentivizes the use of higher-priced products. This dynamic is further exacerbated by clearly abusive practices by a small number of providers. Indeed, the top 100 billing providers generated nearly two-thirds of the cost in 2023 ($3.8B) on only 5-6 percent of patients, and similarly 2024 shows that same small outlier group generated nearly half the costs in the sector.

Congress must act to put an end to fraud, waste and abuse in this sector while simultaneously ensuring patient access to necessary skin substitute products.

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