by Caroline Fife, M.D. | Apr 24, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Guest Blog by Michael Crouch Dr. Fife – Like you, I follow the blog of well-known healthcare attorney, Knicole Emanuel, and her recent post “The End of Chevron Deference: How Loper Bright Could Help Defendants Challenge Materiality in False Claims Act Cases |...
by Caroline Fife, M.D. | Apr 3, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
In response to the dramatic change in CTP (“skin substitute”) payment methodology, an organization representing many skin substitute manufacturers and distributors sued the Department of Health and Human Services (HHS). Dr. Ryan Mathis, Director of Global Medical...
by Caroline Fife, M.D. | Feb 10, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Medicare audits on CTPs/skin substitutes are ubiquitous and the audits all seem to follow the pattern that Michael Crouch described in his articles The Incredible Journey: Lessons Learned from a “Skin Substitute Graft” Audit – Part One and Here Comes the...
by Caroline Fife, M.D. | Feb 9, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
On Jan. 8, 2026, HMP posted the first part of my interview on the Viewpoints section of “Wounds” (HMP Global Learning Network). This segment is about “The Impact of CTP Changes on Provider Types.” You can access content here: The Impact of CTP Changes on Provider...
by Caroline Fife, M.D. | Feb 4, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
Dear Manufacturer of Cellular Tissue Product (CTP) Skin Substitutes, In the past few weeks, the CTP/skin sub market has completely changed and the roadmap for the clinical use of your products is completely different. I thought I’d say the quiet part out loud about...
by Caroline Fife, M.D. | Jan 9, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes, Uncategorized
I understand why CMS did it. There has been wild abuse of the Cellular Tissue Product (CTP) / skin substitute wastage code. The payment model incentivized practitioners to use large pieces even on small wounds, because they could get paid for the amount they wasted....
by Caroline Fife, M.D. | Jan 6, 2026 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
CMS has updated its FAQs on the JW and JZ modifiers. These FAQs clearly state that Medicare fee for service (FFS) does not pay for discarded amounts of “incident to supplies” (which is how all non-BLA CTPs/skin subs are now classified) and will only pay for the amount...
by Caroline Fife, M.D. | Dec 29, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
It was downright hot in Texas for Christmas (~80° F) but for New Year’s Eve, the storms battering the northeast are making their presence known as far south as Houston and the temperature has dropped 40 degrees in a few hours. The “skin substitute” market has been as...
by Caroline Fife, M.D. | Dec 25, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
The CMS newsroom just released this press release yesterday, announcing that Final Local Coverage Determinations (LCDs) for Certain Skin Substitutes Have Been Withdrawn. Effective immediately, CMS’ A/B Medicare Administrative Contractors (MACs) are withdrawing the...
by Caroline Fife, M.D. | Dec 23, 2025 | Cellular / Tissue-Based Products, CTP / Skin Substitutes
The Medicare final rule on the payment policy for CTPs/skin substitutes discussed the possibility of creating different pricing structures based on the product’s FDA pathway – particularly for “BLA” products. I didn’t know there were any BLA products approved for...