CMS Delays Implementation of LCD(s) for Skin Substitutes after Hearing Concerns from AATB and other Stakeholders

September 15, 2023

The effective date of 3 “skin substitute” Local Coverage Determinations (LCDs) issued by CGS Administrators, LLC, First Coast Service Options, Inc., and Novitas Solutions, Inc. have been delayed by CMS for 2 weeks until October 1, 2023.

The AATB Tissue Policy Group sent letters dated September 8, 2023 to these 3 CMS Medicare Administrative Contractors (MACs), which expressed its concerns that the LCD will restrict access to critical allografts used in wound care. The letter urges the MACs to update the LCA to provide payment for appropriately regulated allografts in the Group 3 set of HCPCS codes considered “non-covered’, to provide at least 18 months for manufacturers to obtain proof of regulatory status, to revise the application limit to be consistent with patients’ clinical needs, and to postpone the proposed implementation date until at least January 1, 2024.

AATB also spoke on behalf of its accredited banks and members during a “listening session” on the matter hosted by CMS on September 13, 2023, and emphasized the points that were made in the letters. The Association encourages all affected tissue banks to contact their local Congressperson to inform them of how the LCDs, as written, will lead to problems with access to wound care allografts.

PDF: Re: L36690, A56696– Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers - 3 letters - September 8, 2023

View the PDF on the Government Advocacy Correspondence page

PDF: Comments provided by AATB during the CGS Listening Session held September 13, 2023

Download the PDF

Draft Email for Congressional Offices
Dear [Name],
I hope you’re well. My name is [Name], and I am [title] at [tissue bank]. I am reaching out regarding three recently published payment policies for “skin substitutes” that are scheduled to take effect on October 1st, 2023. [Tissue bank] has serious concerns that these policies will lead to adverse outcomes for patients, as do other stakeholders such as the American Association of Tissue Banks’ Tissue Policy Group (AATB TPG). The AATB TPG recently sent the three attached letters to the Medicare Administrative Contractors who published the new LCDs/LCAs.
Unfortunately, unless changes are made prior to the implementation date, the new policies will limit access to important skin substitutes that are used in wound care. Would you be willing to reach out to CMS to express your concerns with these policies?
I am happy to answer any questions you may have and appreciate your consideration of this request.