Medicare Proposed Changes to Diabetic Foot Ulcer Treatment Could Be a Setback to Health Equity

Update from CMS, 9/28/23: "Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L35041/A54117) will not become effective on 10/01/2023. A new Proposed LCD will be published for comment and presented at an Open Meeting in the near future. In the meantime, current coverage has not changed and you are viewing the existing policy in effect."

As I was brainstorming the various topics that I wanted to address for this month’s Forum column, I came across the recent Centers for Medicare & Medicaid Services (CMS) local coverage determination (LCD), which at press time was set to become effective September 17, 2023.¹ I immediately reached out to my friend and mentor Daniel Kapp, MD, to collaborate on a joint piece addressing this change.

Here, CMS has issued payment policies that could restrict care for up to 40% of Medicare-eligible patients and could potentially have an even greater impact on underserved communities.¹ The CMS LCD update issued rules regarding applications of skin substitutes for diabetic foot ulcers (DFUs). These rules limit the number of these grafts to 4 applications in a 12-week period, which previously, Medicare allowed 10 applications in a 12-week period for DFUs.¹ These skin substitutes, made from everything from fish skin to sheep stomach, each have their own unique biochemical and physiological benefits to aid diabetic ulcer healing.

Preventing overutilization is reasonable, yet we feel overzealous CMS contractors issued inexplicable policies that miscategorized grafts, leading to an elimination of over half of previously covered grafts from coverage. According to studies, Black, Hispanic, and Native American communities are ravaged by diabetes with high rates of dialysis and leg amputations due to its complications.^2,3 This radical change, in our observation, puts these marginalized groups of patients at even higher risk if they do not have access to materials such as these grafts.

In a haste to restrict usage, CMS contractors ignored the Food and Drug Administration (FDA) guidelines, clinical science, and evidence-based medicine.⁴ The policy removes 130 skin substitutes from coverage but includes products which the FDA ordered off the market. Furthermore, CMS oddly included products still in clinical trial, and some products were cleared sans scientific data.⁴

This is a problem for several reasons. First, the 21st Century Cures Act requires the LCD to have a reasonable rationale for the decision and to provide data.⁵ No data supports approval of products that cannot be lawfully sold per the FDA, yet this determination includes such products. The contractors ignored data and meaningful input from stakeholders.⁶ Secondly, while patients have rights that allow them to file for an Administrative Law Hearing, meaning patients can appeal, but these appeals could potentially go on indefinitely. This delay leaves vulnerable patients in limbo with their limb in jeopardy, on a timeline that is not in their favor.

It is a surprise that contractors limited grafts to 4 applications in 12 weeks, because this forces providers into compromising positions by mandating a disregard of FDA product instructions to save CMS dollars. One analogy that resonates for us that this is equatable to underdosing chemotherapy or having a patient take daily blood pressure medications once a week to save money. Providers are forced into a dilemma: amputate lower legs for diabetic wounds if they do not successfully heal or charge patients an out-pocket expense for the grafts.

Health equity cannot be achieved if CMS contractors, in their zeal to save money, do so at the expense of limbs and lives, especially in our most vulnerable patient populations.

Dr. Johnson is a Clinical Assistant Professor in the Division of Foot and Ankle Orthopaedic Surgery at University of Michigan Medical School in Ann Arbor, MI. In addition, Dr. Johnson is the current Chairman of the Board of Directors for the American Society of Podiatric Surgeons (ASPS).

Dr. Kapp is a board-certified plastic surgeon and researcher in West Palm, FL.

Disclaimer: The views and opinions expressed are those of the author(s) and do not necessarily reflect the official policy or position of Podiatry Today or HMP Global, their employees and affiliates. Any content provided by our authors are of their opinion and are not intended to malign any religion, ethnic group, club, association, organization, company, individual, anyone or anything.

References
1.    Centers for Medicare & Medicaid Services. Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. Medicare Coverage Database. Accessed September 3, 2023.
2.    Brennan MB, Powell WR, Kaiksow F, et al. Association of race, ethnicity, and rurality with major leg amputation or death among Medicare beneficiaries hospitalized with diabetic foot ulcers. JAMA Netw Open. 2022;5(4):e228399.
3.    Haw JS, Shah M, Turbow S, Egeolu M, Umpierrez G. Diabetes complications in racial and ethnic minority populations in the USA. Curr Diab Rep. 2021;21(1):2
4.    Centers for Medicare & Medicaid Services (2023). Local Coverage Proposed LCDs by Contractor Report Results. Accessed September 3, 2023.
5.    U.S. Food and Drug Administration. (2020). 21st Century Cures Act.
6.     Carpenter S. Wound size matters: analysis of the new restrictive skin substitute LCD policy. Today’s Wound Clinic. Published September 2023.