by Caroline Fife, M.D. | Jul 1, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitute Arrests, CTP / Skin Substitutes
In yesterday’s press release, the specific mention of the abuse of “skin grafts” (sic) is from minutes 4:50 to 5:31 Excerpt from remarks by Matthew Galeotti, Head of the Department of Justice (DOJ) Criminal Division, June 30, 2025: “Many of the defendants charged as...
by Caroline Fife, M.D. | Jun 27, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitute Arrests, CTP / Skin Substitutes
The Houston Chronicle has reported that a Houston podiatrist and his business partner have been charged with $45 million in healthcare fraud in relation to the billing of bioengineered skin substitutes Dr. David Jenson and Nestor Refael Romero Magallanes are...
by Caroline Fife, M.D. | Apr 28, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes, The Patient's Voice
I just got this letter by email from a physician emphasizing (in addition to the ethical issues) the need for clinical studies of Cellular Tissue Products / Skin Substitutes on pressure ulcers. Thoughts anyone? –Caroline Dear Dr. Fife, I am writing to express a...
by Caroline Fife, M.D. | Mar 28, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Welcome to the Circus: The State of Healthcare in America | medicaidlaw-nc Attorney Knicole Emanuel has another blog post (yes, I am a big fan of her blog) about Medicare audits. She describes “compliance” as a “Kafkaesque masterpiece of government regulation.” The...
by Caroline Fife, M.D. | Jan 31, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitute Arrests
A lot is being said about the way that the new LCD(s) around Cellular Tissue Products (CTPs) / skin substitutes might impact access to care. A big issue is around product choice and ensuring that there is a large enough suite of covered products from which physicians...
by Caroline Fife, M.D. | Dec 12, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Health and Human Services (HHS) announced Active Work Plan items (e.g., OIG audits, evaluations, and inspections) that are underway or planned over the next 2 years. Investigations regarding various aspects of “skin substitute” use are on the list along with the...
by Caroline Fife, M.D. | Dec 2, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Recently someone passed on what a clinician had told them about the Cellular Tissue Products / Skin Substitutes that they were using. The clinician said they were not worried about being paid for a particular product because it had an established ASP (Average Sales...
by Caroline Fife, M.D. | Nov 25, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes, Health Information Technology and Wound Care
You should read the entire LCD, because there is a lot to unpack. I will tackle various topics over the next several weeks, but here’s the list of covered and not-covered CTPs/skin subs for diabetic foot ulcers (DFUs) and Venous Leg Ulcers (VLUs). When will the...
by Caroline Fife, M.D. | Nov 14, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Read them here (more to come): LCD Cellular Tissue Products View on CMS...
by Caroline Fife, M.D. | Oct 24, 2024 | Fight the Good Fight, Quiz / Survey
The results are in! Assuming the proposed Local Coverage Determinations (LCDs) are implemented as currently written, in which of the following would NOT be covered by Medicare in a DFU or VLU? A) A CTP applied over necrotic material B) A CTP applied over fat, muscle,...
