Attorney Knicole Emanuel’s most recent blog post is about Medicare audits focused on the use of “skin substitutes” by Recovery Audit Contractors (RACs) and Unified Program Integrity Contractors (UPICs). The proposed skin substitute LCD(s) may be on hold, but that has not stopped Medicare from auditing physicians on their use — using criteria that sound very much like the language of the still-on-hold-LCDs.
More than one practitioner has told me that they have paid back 100% of their revenue from skin sub applications after an audit. Two things can be true at the same time – many practitioners have terrible documentation, and good practitioners have lost money in Medicare audits of “skin substitutes.” It is true that the documentation required is highly detailed and the list is long. It is also true that the documentation elements are things that a good wound care practitioner should be doing (and documenting that they did).
It is important to know that practitioners cannot establish the medical necessity of a CTP/skin substitute simply by creating an incredibly long and detailed procedure note. The entire chart needs to tell the clinical story of what care has been provided and failed, and must substantiate that the standard of care has been met. It is also true that despite good documentation, some auditors have over-reached in their denials. However, as Ms. Emanuel explains, if the necessary information is in the chart, it is possible to overturn unfair audit decisions during the appeals process. If the documentation is not there, then a clinician can expect to pay money back, sometimes with monetary penalties.
In her blog, Ms. Emanuel discusses two cases and what happened during the appeal process. Here is her list of reasons why auditors have flagged treatments as “not medically necessary.”
Why Auditors Flag Skin Grafts as “Not Medically Necessary”
Auditors frequently argue skin grafts or tissue products lack medical necessity based on Medicare’s definitions in CMS IOM 100 08, Chapter 13, §13.5.1 and applicable Local Coverage Determinations (LCDs)
Common denial rationales include:
- Failure to document at least four weeks of prior conservative care (such as dressings, offloading, antibiotics, physical therapy or splints) that failed before applying a skin substitutes
- Exceeding allowable applications or duration, when LCDs limit use—for example, skin substitute applications are limited to a certain number within a 12 week period;
- Use of products deemed investigational, off label, or used in a non homologous manner under FDA and CMS guidelines.
- Allegations of excessive units or reapplications without documented improvement, or use of expensive products without justification
- Anti kickback concerns, including rebate agreements or manufacturer marketing influence that could bias product choice.
Be sure to read Ms. Emanuel’s blog and check out the additional resources below.
Additional Resources:
- UPIC Auditors Demand Skin Substitute Invoices & Rebate Agreements – Guest Blog by Martha Kelso – Caroline Fife M.D.
- More Details About Audit Requirements: Guest Blog from Michael Crouch – Caroline Fife M.D.
- The Daunting Documentation Demands of the LCD: Why Templates & Lists Will Not Suffice – Caroline Fife M.D.
- >Be a Wound Care Millionaire with 25 Patients or Less – and Maybe Lose it All in a RAC Audit? – Caroline Fife M.D.
- RAC Overpayment Allegations Versus FCA Accusations – Caroline Fife M.D.
- You Only THINK You Aren’t Being Audited by Medicare… Check Again – Caroline Fife M.D.
- Addressing Both the What and the Why of Clinical Documentation
- Useful Materials for Responding to a Medicare Audit: Part 1

Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.