If for perhaps no other reason, one must admire the Biden administration for its consistency; over the course of four years, they have sought every opportunity to discourage and frustrate innovation.
The drug price negotiation program, a demonstration to cut reimbursement for accelerated approval drugs, and repealing an expedited coverage pathway for medical devices are just a few examples of how the Biden administration has inserted itself as a roadblock between patients and innovative treatments. In the latest, and hopefully last, example, the administration is on the cusp of adopting a new coverage policy for skin substitute grafts, placing many novel products beyond the reach of patients.
A significant portion of Medicare patients with chronic wounds like pressure ulcers, diabetic foot ulcers, and venous leg ulcers use skin substitutes as part of their treatment.
These substitutes temporarily or permanently replace the skin’s structure and function, promoting tissue regeneration in wounds that struggle to heal on their own. They reduce the risk of infection, protect the wound, and accelerate healing by encouraging the body’s cells to regenerate damaged tissue. For Medicare beneficiaries with chronic wounds, these skin substitutes reduce the likelihood of hospitalization or even amputation.
Patients with chronic wounds often have underlying health issues, such as diabetes or vascular insufficiency, which prevent natural healing. Furthermore, increases in the use of Xylazine can cause patients to suffer from wounds that are difficult to treat.
Medicare’s latest approach abandons Americans struggling with open wounds. President Trump has weighed in on the issue, writing on Truth Social that the new policy “will not cover more than 50,000 Americans.” Mr. Trump characterized the Biden administration’s response to these Americans as, “Tough it out.” Mr. Trump’s comments underscore that this policy shift benefits a select few companies while restricting access to hundreds of wound care products that millions of Medicare beneficiaries rely on for chronic wound treatment.
For patients, this policy change isn’t just administrative red tape; it affects access to products that doctors depend on for complex wound care. Team Biden’s policy eliminates more than 200 products from coverage. The narrow selection of remaining products represent older technologies that may not work as successfully as newer, more advanced products.
While bad for patients and bad for doctors, this policy change is a win for a small group of companies that meet Medicare’s inconsistently applied evidence standards. It is a major loss for millions of Medicare beneficiaries who now have fewer options for wound healing.
In wound care, the need for individualized and adaptive solutions is paramount. Innovation is essential to improving patient outcomes. By narrowing the market, Medicare is stifling progress being made right now in the field of chronic wound care. Team Biden is instead choosing to favor a few established players over new, promising technologies that could better address the needs of Medicare beneficiaries.
The exclusion of hundreds of products representing the latest medical advancements also sends the wrong message to the people and companies investing in research and development. Those companies now find themselves locked out of the Medicare market, a critical revenue source, which will discourage future investments in new technologies.
Fortunately, the Trump administration has the ability to change the trajectory of this mistake; the new policy does not take effect until February. The incoming team should intervene to postpone the effective date of this coverage policy until it can be reviewed and its flaws can be corrected.
Chronic wound patients need and deserve a system that supports variety, adaptability, and ongoing innovation, not one that restricts access and discourages investment in life-changing technologies.
The Trump administration is inheriting a tremendous mess that will not be easy to clean up. The new team inherits a deficit run rate of almost $2 trillion annually. The annual budget of the Department of Health and Human Services is $1.9 trillion, roughly $700 billion more than in 2019, the year before the pandemic hit. Now that the pandemic has receded, that $700 billion in additional spending is claimed by a whole army of lobbyists and special interests who will fight to keep it flowing.
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