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.
I’ll continue to say it until I’m blue in the face. As a former employee of Extremity Scam LLC, they are the biggest culprit behind this.
If you worked for them, you know the rebate program and should become a whistleblower, as you know where the bodies are buried. Especially after his $2M campaign donation to the MAGA fund, and no one thinks that’s an issue?
Yes, we offered the biggest rebates to companies called Nuvida, 180 Health, Russell Health and wound pros during the time I was there. Some of these companies are connected and label themselves as distributors where they have a lot of podiatrist practices underneath them. While I have no proof of this, I’m convinced some of the podiatrists who sent orders in listed fake patient names. We would be invoicing/shipping 4×8 grafts to the same name for months when there is zero literature to back these grafts up. I would sometimes google the names of these patients that I invoiced out of curiosity and couldn’t find any record on them. I’m not saying this was the case for every order but especially the Vohra wound orders (just google them) that we sold as consignment inventory didn’t seem like they were being applied to the patients. Why does an 80 something year old man from Florida need 15-20 4×8 grafts invoiced/shipped to him over a period of 4 months? I have screenshots on my phone where I created 6 million dollar invoices and they received big discounts too. That scammer CEO from Legacy medical also tried returning a bunch of these grafts too. Extremity Scam ceo also likes to use his own distribution area to ship expensive wine through FedEx illegally to sales reps and customers. Lastly these grafts aren’t groundbreaking, when we were low on inventory, we would purchase the equivalent graft under a different brand manufacturer name. When the MAC prices would change every 6 months, they would rebrand the same product. The biggest irony is a lot of self-proclaimed liberals work at this company and they like to rub their politics in your face/are anti corporate yet they are working under a guy who paid Trump off. The most hypocritical, weird and fake environment I have ever worked in. Most of them were too naive to figure out all of this and it took the NYT writing about this to make them see. The owners took advantage of it being a startup environment and just promoted a bunch of yes men like me who had no idea what this was in the beginning. A lot of the management there is still clueless on how this business works and I think the owners prefer that. Lastly, the owner is moving into fad beauty products once this dries up.