by Caroline Fife, M.D. | Feb 12, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Projected earnings for this company’s sales are in the millions of dollars. This is possible because at least some of the amniotic products sold cost more than $4,000/cm2. Claims on individual patient wounds can exceed $1M (as ACO medical directors have complained)....
by Caroline Fife, M.D. | Feb 5, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Skin substitutes and possible danger: Is patient harm happening in wound care? Jeanne Pinder from Clear Health Costs has posted a powerful follow up article on the use of Cellular Tissue Products (CTPs) / skin substitutes. Ms. Pinder interviewed Dr. Danielle...
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 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. | 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. | Jan 13, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitute Arrests
The CGS J15 Contractor Medical Directors have given me permission to share the slide deck that was presented on December 20th, which was a training session on the upcoming “skin sub” LCD. This PDF of the slide deck reviews the LCD requirements for the treatment of...
by Caroline Fife, M.D. | Jan 10, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitute Arrests
According to data obtained from SmartTrak Medical Device and Wound Market Intelligence, in the third quarter of 2024 (Q324), the US Skin Substitute / Cellular Tissue Product (CTP) market reached $1.75 BILLION. That figure is up 64.0% compared to the third quarter of...