CMS Must Stop Restricting Access to Lifesaving Wound Care Treatments

COMMENTARY

A devastating change is coming for millions of Americans with chronic wounds. The Centers for Medicare and Medicaid Services is poised to eliminate Medicare coverage for more than 200 innovative wound care products in April.

If this Biden-era policy is implemented, diabetics, military veterans and seniors suffering from chronic wounds will lose access to life-changing treatments, forcing many toward amputation and prolonged hospital stays.

As CEO of a leading medtech company focused on placental-derived wound care products, I am fighting to prevent this policy from taking effect.

The local coverage determination proposed by Medicare Administrative Contractors is a regulatory overreach that circumvents the national coverage determination process. While marketed as a policy to ensure “clinically proven” products are covered, its true aim is simple: cost-cutting at the expense of patients.

This is a textbook example of how bureaucratic mismanagement stifles medical innovation and patient access.

Chronic wound patients — especially those with diabetic foot ulcers or venous leg ulcers — are at high risk for infection, hospitalization and amputation. Amputation rates in diabetics can be reduced by as much as 85% with proper wound care. This is why providers have increased their use of clinically advanced products, recognizing that these treatments save limbs and lives. 

Despite this, Medicare’s flawed coverage determination process makes it nearly impossible for new, advanced wound care products to reach patients in a timely manner. Under current policies, these products must wait until the beginning of each year to undergo a formal reconsideration process with each of the seven Medicare Administrative Contractors to gain coverage.

The current process stifles innovation, deters investment and, most critically, delays or denies patients access to effective treatments. Without immediate reform, patients will continue to suffer and lifesaving technologies will struggle to gain traction. 

To prevent unjust coverage restrictions, innovation bottlenecks and harmful audits, CMS must implement a phased, evidence-based reform plan to stabilize patient access and overhaul an outdated regulatory system. 

First, CMS must halt this ill-advised LCD before it disrupts patient access nationwide. Medicare cannot afford to gamble with the health of millions of Americans by arbitrarily cutting off effective treatments. 

Second, to prevent chaos, CMS should pause new LCD applications while developing a clear, transparent reimbursement framework. This ensures stability without further price escalation. Breakthrough therapies and urgent public health solutions should still be reviewed during this transition.

Next, a centralized, evidence-based system should replace the fragmented MAC process. Coverage determinations should be based on rigorous clinical data, including randomized controlled trials with statistically significant outcomes, comparative effectiveness studies against standard-of-care treatments, and real-world data validating long-term patient benefits.

By 2027, all products should transition to average sales price-based payment to create consistency across Medicare settings. 

Finally, CMS must overhaul its auditing process to prevent unlawful recoupments and provide clear guidelines for approving new therapies. Simultaneously, CMS and the Food and Drug Administration must collaborate to create a streamlined approval and reimbursement process for advanced wound care products. A new regulatory pathway should allow innovative skin substitutes, including placental tissue products, to obtain specific indications for use. Products that receive FDA approval through this pathway should automatically qualify for Medicare coverage, eliminating bureaucratic delays that keep lifesaving treatments from patients.

Reforming Medicare’s flawed system would ensure that breakthrough therapies reach patients faster, reducing amputation rates and improving overall health outcomes. This is not a political issue — it’s a patient issue.

The Trump administration previously championed aggressive, innovative medical interventions through initiatives like the Right to Try Act, while policymakers across the aisle, including Health and Human Services Secretary Robert F. Kennedy Jr., have emphasized the importance of protecting medical innovation. 

By implementing this evidence-based framework, CMS and policymakers could improve patient care, reduce long-term costs and foster trust in government decision-making.

Jason Matuszewski is the CEO of medtech company BioStem, a leader within the chronic wound care industry. He can be found here.