CGS Local Coverage Determination Places New Limits on Use of Skin Substitutes
CGS Part B Medicare Administrative Contractors finalized skin substitute policies for the treatment of diabetic foot ulcers and venous leg ulcers that become effective September 17, 2023.
The new CGS Local Coverage Determination (LCD) states “greater than four applications of a skin substitute graft or cellular and/or tissue-based products (CTP) within the episode of skin replacement surgery (defined as 12 weeks from the first application of a skin substitute graft or CTP)” are “not medically reasonable and necessary.”
Furthermore, the policy lists 58 products that meet the necessary FDA regulatory requirements for indications covered in the policy and 130 products that are considered non-covered.
The CGS Part B jurisdiction includes KY and OH. The Local Coverage Determination (LCD) from CGS mirrors policies adopted by two other Medicare Administrative Contractors, Novitas and First Coast Service Options.
CGS Informational Sessions
Join the CGS Chief Medical Officer, Meredith Loveless, MD for an overview of the LCD on Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The call will feature an overview of billing and coding procedures.
Thursday, September 21
4:00 p.m. - 5:00 p.m.
Friday, September 22
10:00 a.m. - 11:00 p.m.
Once you register to attend this event you will see the items that will be discussed during this hour event. We ask that you take a few minutes review and submit your questions prior to the event.
Pre-submitted questions can be submitted to J15_PARTB_EDUCATION@cgsadmin.com
The American Podiatric Medical Association (APMA) submitted a letter, endorsed by OHFAMA, in November 2022 outlining concerns with aspects of the proposed LCD.
In the letter, APMA underscored the medical, social, psychological, and financial burdens that chronic wounds present for patients and healthcare systems, and took exception to limitations on the number of applications of CTPs, required use of RT or LT Modifier, and the incomplete set of included ICD-10 codes.
Then-APMA President Laura Pickard, DPM, strongly objected to CGS’ position that more than four applications of a skin substitute graft or CTP within the episode of skin replacement surgery are “not medically reasonable and necessary.”
“This is a dangerous proposal that is not rooted in science, not supported by peer-reviewed literature, and would certainly lead to poor outcomes for our patients and CGS beneficiaries, in addition to increased costs for CGS,” said Pickard. “In many cases, this limitation would not allow our providers to follow the guidance of peer-reviewed literature, address these pathologies with evidence-based treatments, fulfill their oaths, and provide advanced care options.”
APMA presented several peer-reviewed scientific papers to support our argument and requested CGS maintain the current CGS limit of 10 applications.
“The robust body of evidence supports the need for more than four applications of a specific skin substitute graft product within many episodes of skin replacement surgery for wound care and refutes the proposal that more than four applications of a specific skin substitute graft product within the episode of skin replacement surgery for wound care is never medically reasonable or necessary,” said Pickard.
Despite the compelling evidence provided by APMA and OHFAMA, CGS incorporated the limitations on the number of applications of CTPs and the required use of RT or LT Modifier in its final LCD.