Coalition Urges MACs to Pause LCD on Skin Grafts

By  Amy Lotven / August 9, 2024 at 5:48 PM

The Medicare Access to Skin Substitutes (MASS) Coalition of manufacturers, processors and distributors are urging Medicare Administrative Contractors (MACs) to scrap a proposed local coverage determination (LCD) that they say would limit patients’ access to evidence-based wound care.

Three MACs advanced a local coverage proposal last fall but withdrew it last September, days before the effective date, due to stakeholder concerns, according to the American Association of Tissue Banks, which noted at the time that a revived proposal would be forthcoming.

On April 25, all MACs issued the proposed LCD: “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (link). The MACs held public meetings and public comments through June 8, and a final decision could come any time.

The MASS Coalition is also urging patients and other stakeholders to lobby their lawmakers about the issue.

The coalition highlights a June 6comment from experts William Padula, assistant professor of pharmaceutical & health economics and a Fellow at USC’s Schaeffer Center for Health Policy & Economies, and David Armstong, professor of surgery and neurological Surgery and a Clinical Fellow at the Schaffer Center, who also urge the MACs to withdraw the proposal.

According to Padula and Armstrong, chronic wounds cost Medicare about $100 billion each year and the amputations that can result from such wounds have a five-year survival rate that is similar to cancer.

While research shows that applying skin substitutes can reduce rates of infection, amputations and mortality when compared to traditional methods, Padula and Armstrong stress that those findings are based on parameters that would not be available under the proposed LCD.

“Thus, this LCD would ignore the robust clinical evidence-base that we and other researchers have spent years building to promote advanced therapies for patients with chronic wounds to live longer, healthier lives,” they say.

The letter continues to warn of numerous consequences should the LCD be finalized, both on the health care economy and stakeholders. Providers will not be able to justify use of the skin substitutes since they’ll be unable to follow the parameters, patients will face higher risk of chronic wounds and infections and Medicare will spend more overall on the adverse outcomes, including infections and amputations, instead of saving money upfront through the investment in skin substitutes, the letter says.

On April 25, the same day the MACs unveiled the draft LCD, CMS released a statement acknowledging the move.

The MACs proposed the LCD, CMS says, “to make sure that Medicare covers, and people with Medicare have access to, skin substitute products that are supported by evidence that shows that they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population and that coverage aligns with professional guidelines for appropriately managing these wounds.”

The agency also encouraged interested parties to take part in meetings throughout May and to submit any comments by the June 8deadline. “Ensuring people with Medicare have access to clinically appropriate items and services is a priority for CMS. CMS will closely monitor this LCD process to ensure that there are adequate and meaningful opportunities for engagement,” the agency said.

-- Amy Lotven (alotven@iwpnews.com)