The Pathway to Acceptance

©2025 HMP Global. All Rights Reserved. 

Any views and opinions expressed are those of the author(s) and/or participants and do not necessarily reflect the views, policy, or position of Wounds or HMP Global, their employees, and affiliates.

Dear Readers:

There are many items (devices, primarily, as well as some biologics and very few pharmaceuticals) that we use almost every day to take care of our patients. The pathway of getting those items into our hands is very arduous. And for the various categories—devices, biologics, and pharmaceuticals—the journey to acceptance and availability is very different. For those of you not intimately involved in this process, it is probably worth thinking about it at times.

That being said, acceptance happens at different levels—clinical acceptance by the specialty, economic acceptance by the payors, and acceptance by our patients. The clinical acceptance requires clinical trials and several years of safety and outcomes data. The economic acceptance requires demonstrating clinical need and superiority, with a very prolonged and capricious presentation to governmental and non-governmental agencies, including commercial insurance.

Availability does not occur in the United States until the product is cleared or determined exempt by the US Food and Drug Administration and covered by insurance. Which at the federal level is only available to individuals in their seventh decade of life, and is regulated by 7 different regional groups. At the state and private level, it is a maze. Another nuance is that if accepted by providers, it also has to be recognized and supported by other parts of the health care team; in 2000, when I started academic clinical practice in New York, negative pressure wound therapy (NPWT) was not supported by the largest home care nursing agency.

This leads me to the journey of topical oxygen therapy (TOT). As of the end of 2024, TOT was not supported by New York’s largest home care agency, making acceptance questionable. Yet this is a therapeutic modality that has more than 70 publications to support its use and multiple prospective randomized trials. It comes in both episodic and continuous forms which lend themselves a variety of therapeutic algorithms. The therapy is easy to use and safe, and is considered FDA Class I (low-risk devices). However, clinical and payor acceptance remains sporadic.  

Worse, there recently was a (yes, this is an absurdly long name) Durable Medical Equipment Medicare Administrative Contractor (DMEMAC) Contractor Advisory Committee (CAC) meeting around coverage for TOT. This federal regulatory meeting—while in no way political nor binding—was heavily biased against the therapy and asked questions that were flawed and close-ended, and which could only be answered in a negative way. So here is an example of a clinical therapy that has shown efficacy, for which companies that make different products have worked together to gain approval, and they still have not been able to overcome primary payor apathy or lack of insight. As such, the regulatory bodies at times may not understand the topic they are tasked with regulating. 

Therapies that may have similar problems in the future could be cold plasma and concurrent optical and magnetic stimulation therapy. Previous products that have needed to navigate these waters are most notably NPWT and topical extracorporeal shock wave therapy. The differences are notable in their general applicability, overall ease of use, and effectiveness. As we move forward down this convoluted pathway that we must navigate, one must heed that the process should be made more straightforward and more manageable. While saying this, one must realize that in general, only therapies that provide added benefit should be pursued.

I certainly do not have the correct answers to the current morass that is the regulatory and payor mix. I may have some thoughts, but their reality is unlikely, and the tone may seem to some to be political in nature. It should be noted that there are many administrators, non-clinicians, statisticians, and other regulators who are trying their best. However, wound care devices are not pharma, and using the same criteria as pharma to assess and determine the efficacy of devices is unreasonable. Sometimes the process can be downright alarming when it comes to the lack of fairness and productivity. 

In closing, when you are using a wound care device that works, take a moment to marvel not only at the engineering that goes into it, but the clinical research, administrative time, legal briefs, and lobbying that have gone toward getting that device in your hands to help your patients.  

John C. Lantis II, MD
Editor-in-Chief, Wounds
woundseditor@hmpglobal.com