by Caroline Fife, M.D. | Feb 3, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitute Arrests, CTP / Skin Substitutes
Office of Public Affairs | Arizona Couple Pleads Guilty to $1.2B Health Care Fraud | United States Department of Justice The Department of Justice (DOJ) office of public affairs has announced that on October 24, 2024, Alexandra Gehrke pleaded guilty to conspiracy to...
by Caroline Fife, M.D. | Jan 29, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
The delay of the LCD(s) is good news for many manufacturers since it will continue to enable unlimited use of amniotic products, some of which are priced around $5,000 per sq cm. (That’s more than a 3,000% increase in cost with no data to indicate any improvement in...
by Caroline Fife, M.D. | Jan 27, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Check out this article by investigative reporter Jeanne Pinder, CEO of Clear Health Costs, who set out to understand the cost of “skin substitutes.” Caroline Fife, M.D.Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through...
by Caroline Fife, M.D. | Jan 25, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
CMS has indeed delayed the implementation date for the Skin Substitute Grafts/ Cellular and Tissue-Based Products (CTP) for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers LCDs from 2/12/25 to 4/13/25. The policies on the CMS website are now...
by Caroline Fife, M.D. | Jan 22, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
There are rumors swirling that President Trump’s Executive Order (EO) which freezes pending federal regulations and guidance documents will stop the implementation of the LCD(s). I have no inside information about this, but the issue is far from certain. The EO...
by Caroline Fife, M.D. | Dec 20, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
On December 10th, the Medicare Administrative Contactors (MACs) held a virtual Town Hall meeting to discuss Local Coverage Determination (LCD) for Skin Substitutes / Cellular Tissue Products that goes into effect on February 12, 2025. The MAC medical directors spent...
by Caroline Fife, M.D. | Dec 18, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
The Department of Justice (DOJ) released its annual report on fraud and abuse for the 2023 fiscal year. The lengthy report includes one account related to CTPs/skin subs which I mentioned in a previous blog when it happened. A Beverly Hills, California, plastic...
by Caroline Fife, M.D. | Dec 16, 2024 | Cellular / Tissue-Based Products, CTP / Skin Substitutes, The Patient's Voice
This email inquiry is from a real patient who is a retired nurse. I can answer some of her questions but not all of them, particularly the ones around when a patient might be required to sign an ABN for skin subs. I will post any helpful answers that you send...
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...
