Trump Administration Delays Biden-Era Skin Substitute Regulation Until 2026
On Friday, the Trump administration made headlines by announcing a significant delay in implementing a rule introduced during the Biden administration, aimed at regulating the coverage of costly and unproven medical products known as skin substitutes.
Impact of Delay on Medicare and Costs
The new policy, which will now be postponed until 2026, permits manufacturers to maintain high pricing structures for these products. Reports indicate that the manufacturers sell these bandages at discounted rates to medical practitioners, who in turn bill Medicare at the full price, retaining the difference for themselves. This practice has contributed to soaring Medicare spending on these items, which exceeded $10 billion in 2024, a dramatic increase from $1.6 billion in 2022, according to analysis from Early Read, a health care actuarial firm.
Concerns Regarding Healthcare Waste
Experts have raised alarms, labeling the expenses related to skin substitutes as one of the largest wasteful expenditures in Medicare’s history. More than 120 various skin substitutes are currently available on the market, with a shocking average price of $5,089 per square inch, and some variants exceeding $23,000.
The Controversial Rule and Its Suspension
Under the previously designed Biden administration rule, Medicare coverage would have been restricted to a select group of skin substitutes proven effective in randomized clinical trials. This rule specifically targeted products used for treating foot and leg ulcers, which are prevalent among patients with diabetes and poor circulation.
Political Reactions and Industry Response
Acknowledging the opposition from various stakeholders, Medicare commented that it is currently evaluating the policy amidst the transition to a new administration. The agency expressed its view on the necessity of maintaining patient access to skin substitutes backed by substantial evidence of effectiveness.
Political dynamics have also come into play, with a notable contribution of $2 million to President Trump’s election campaign from Extremity Care, a prominent supplier of skin substitutes. Trump has publicly criticized the original policy, claiming it could exacerbate health issues for diabetic patients reliant on these products. He voiced his concerns on social media, asserting, “’Crooked Joe’ rammed through a policy that would create more suffering and death for diabetic patients on Medicare.”
The MASS Coalition, supporting the skin substitute industry, expressed satisfaction with the delay, indicating that it provides the administration with more time to assess the policy changes. A spokesperson for the coalition, Preeya Noronha Pinto, stated that they are eager to engage with Medicare in crafting a coverage policy and reforming payment systems that would continue to allow access to these products.
Conclusion
The potential implications of this delay extend beyond mere financial considerations. As the Trump administration prepares for a reevaluation of Medicare policies, the ongoing discourse highlights the intricacies of healthcare regulation, patient access, and the need for stringent oversight in Medicare expenditures.
