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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 Whitacre, the Chief Medical Officer at Bloom Healthcare, a company that has provided home based primary care for decades. Dr. Whitacre began looking at 2022 Medicare claims data for a group of Bloom patients who were in an Accountable Care Organization (A.C.O.) and saw worrying signs that the individuals treated with CTPs/skin substitutes in the home setting had an unexpected and worrisome number of hospitalizations and infections. It’s a sure bet that the ACOs are monitoring the spend in their patients. The article discusses concerns voiced by the National Association of Accountable Care Organizations, around potentially fraudulent use of skin substitutes.  

The recent Department of Justice post about the guilty plea by the Apex Medical couple had this chilling quote:

Gehrke then referred the patients to a company co-owned by King, whose company contracted with nurse practitioners, directing them to, “…suspend their own medical judgment and apply all grafts ordered by the sales representatives, even when medically unreasonable and unnecessary, which resulted in the application of grafts to infected wounds, wounds that had already healed, and wounds that were not responding to the grafts.”

In the debate over the use of high-cost amniotic products, I’ve been worried about wasted Medicare resources, bankruptcy triggering monetary paybacks as doctors are caught up in increasingly draconian Medicare audits, and the possibility that the deep discounts on expensive products could be viewed by the DOJ as illegal kickbacks. I thought that list was scary enough. Truthfully, I hadn’t thought about the possibility that patients might end up worse off than before – not necessarily because the CTP / skin substitute was harmful, but because the family thought someone experienced was monitoring their loved one… when in fact, the person seeing them may not have enough experience or training to identify a problem if one arises. I keep being told not to worry about a billion dollars being wasted here and there, and I keep being told how great it is that these neglected patients are finally getting wound care at home. But what if they aren’t?  As you ponder that question, do NOT miss the end of Ms. Pinder’s article…

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.