Photo Credit: Iván Jesús Cruz Civieta

Skin substitutes made from donated amniotic tissue significantly enhance healing rates, reduce emergency admissions, and decrease the need for amputations.

Skin substitutes made from donated amniotic tissue are used in dermatology to transform chronic wounds into an acute state, improving the healing environment. These substitutes significantly enhance healing rates, reduce emergency admissions, and decrease the need for amputations when used alongside quality care practices like debridement and offloading.

Proposed Medicare changes that could limit access to these products would negatively impact patient care by reducing treatment options and potentially increasing infection risks and hospitalizations, underscoring the need for comprehensive coverage and interdisciplinary management.

Physician’s Weekly (PW) spoke with David Armstrong, MD, PhD, professor of surgery and neurological surgery at the Keck School of Medicine of the University of Southern California, to better understand the benefits of skin substitutes and how treatment could change under the proposed Medicare changes.

Can you explain how skin substitutes, particularly those made from donated amniotic tissue, can treat chronic wounds?

Dermatologists, like any folks with significant specialties in wound healing, may want to use products like this because they do not necessarily serve like a skin graft but work in many ways, like an immune modulator. In doing that, they help transform the histology of the wound from one that is more of a chronic profile to one that is more of an acute profile.

It can make the wound environment much less hostile and help prepare the wound for closure.

What are the typical outcomes you’ve observed when using skin substitutes?

The data now point in one direction across the United States and worldwide: using skin substitutes is associated with a higher rate of healing, a lower rate of emergency department admission, a lower rate of foot-level limb sparing, and a lower rate of amputations and high-level amputations.

From all those perspectives, we see a net positive when used appropriately and with other good quality care, like good quality debridement, good quality offloading, pressure protection, and an interdisciplinary management team because it takes a team here. No clinician is an island here; putting those folks together can affect positive change.

How would proposed Medicare changes affect your ability to treat these patients?

Limiting our use of these products limits clinicians’ options in looking after these patients. When that happens, it can put our patients at greater risk when we don’t have everything we want to use to treat them. This tool is a significant one in our arsenal with real, consistent data to suggest that it helps our patients. When you limit that, common sense dictates that it is a net negative for our patients.

What are the potential risks associated with not having access to these substitutes?

The risks could include a lack of access to these and a longer time to healing. Time is tissue, and the longer these wounds are open, the greater they are at risk of getting infected and then hospitalization.

Once one of these patients is hospitalized, especially people with diabetes, about 20% of those hospitalizations will end up in some form of lower extremity amputation. And that’s why there’s an amputation every 20 seconds worldwide. And this is something that we as a family can do something about. We can marry technology with our team and a little tenacity to make a difference.

What would the potential impact be on patient care if Medicare restricted coverage for a wide range of skin substitutes?

The impact would be a net negative here. I can’t see any space where this is a positive limiting the use of these products.

When these products are used with a good quality team and clinicians focusing on the patient first, limiting our access to this effectively limits and can tie our hands clinically; we don’t want that. We have too many things up against us when we’re looking at these patients with these wounds. These folks with chronic wounds are often neglected in many ways. They’re modern day lepers, and people often ignore them. This is yet another way of doing that administratively, and we need to do the exact opposite. Only when we do that can we make a big difference. A few years ago, I was recruited to LA with the idea of eliminating preventable amputations in people with diabetes. I think we can do it, but we can’t do it unless we team up from the bottom up and from the top down. That starts with us, doctors, with our patients, and goes all the way to us with policymakers.

Both are important, and there’s no evil cabal trying to stop this. I think informing our patients and policymakers who can be partners with us in looking after these patients and real advocates who can affect positive change. I’ve seen it happen in my career, and I think the future is bright in this area—if we adhere to all these precepts.