The Trump administration has announced a delay in the implementation of a Biden-era rule aimed at restricting coverage of unproven and costly skin substitutes until 2026. This decision has been met with criticism as it allows companies to continue setting high prices for these products, with Medicare spending on the coverings soaring to over $10 billion in 2024. Critics argue that this is one of the largest examples of waste in the history of Medicare.
President Trump has been vocal in his opposition to the policy, claiming it would harm patients who use the products on diabetic sores. Extremity Care, a leading seller of skin substitutes which donated $2 million to a super PAC for Trump’s election campaign, also criticized the plan, citing disruptions in supply chains and increased costs for doctors and patients. The Biden-era rule would have restricted Medicare coverage to a small subset of products proven effective in clinical trials.
Medicare has stated that it will be reviewing the policy during the transition to a new administration, emphasizing the importance of maintaining patient access to skin substitute products with high-quality evidence of effectiveness. The delay has been welcomed by the MASS Coalition, a group supporting the skin substitute industry, as it will provide time for the Trump administration to evaluate the policy change and work on a coverage policy and payment reform that ensures access to these products.
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