Market Responds to Final MAC LCDs
This blog was originally posted on SmartTrak's website on December 31, 2024: https://blog.smarttrak.com/market-responds-to-final-mac-lcds. Reposted with permission.
SmartTRAK looks at the market’s response to the recently finalized LCDs and the potential impact on the US Market for Skin Substitutes.
On December 10, 2024, the Medicare Administrative Contractors (MACs) held a town hall session to discuss the Local Coverage Decisions (LCDs), “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers,” which were issued on November 14. The proposed LCDs were announced on April 25 of this year, a comment period followed, and then things went black as the MACs contemplated whether any changes should be made to the LCDs. Two key improvements in the final version included an increase in the number of skin substitute applications from four to eight and an increase in care time from 12 to 16 weeks. In this article, SmartTRAK will discuss the ongoing activities since these LCDs were announced, including the requirement for published peer-reviewed clinical evidence, market activities to shore up position and activities to rescind the LCDs. The article will close with SmartTRAK’s forward analysis of the impact of these LCDs on the market should they be implemented as planned.
Clinical Evidence
When SmartTRAK began covering the Skin Substitute segment almost fifteen years ago, the gold standard for Medicare coverage was a published randomized clinical trial demonstrating evidence of improved wound closure. Since that time, Medicare has drifted away from that requirement allowing the physician to make the determination of the product to be used. The newly issued LCDs return to that gold standard, only covering products with published clinical data. During the comment period, four products were added in which clinical data was missed on the initial review, and one was deleted. The covered products are currently limited to eighteen, but actually only sixteen, as two of the products are no longer available on the market. This is a drastic decline as today, there are over 200 products available to practitioners. Stakeholders expressed concern during the town hall meeting whether the sixteen products could adequately serve the needs of the patients. See Table 1 for the LCD-covered product list.
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