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MACs Propose Non-Coverage of Fluorescence Wound Imaging

by | Oct 14, 2026 | Fight the Good Fight | 0 comments

MACs Propose Non-Coverage of Fluorescence Wound Imaging

A Walk Down History Lane… and Why We Need Real-World Data

As most of you know by now, the CMS Medicare Administrative Contractors (MACs) just released drafts of non-coverage policies for Near-Infrared Spectroscopy (NIRS) in Wound and Flap Management and Real-Time Fluorescence Wound Imaging for Bacterial Presence. Just to be clear, non-contact NIRS was non-covered by Palmetto’s in 2023 (L39385).  The 2026 DL39385 re-presents that LCD after a reconsideration request but the other MACs (e.g., WPS DL40479, Noridian DL40458) are newly proposing NIRS non-coverage. However, fluorescence imaging is a new non-coverage proposal from all 7 Part B MACs.

If these policies are finalized, it will affect a lot of clinicians and patients. It may seem surprising that Medicare and/or the MACs would simply decide to stop paying for bacterial imaging. However, I think the origin of this is 20 years old. I know I am starting to sound like my grandmother – but here’s a history lesson:

On March 29, 2005, a Medicare Coverage Advisory Committee (MCAC, now called the MEDCAC) meeting on the “Usual Care of Chronic Wounds” changed the course of my life. Five years earlier, I had co-founded an electronic health record (EHR) company (Intellicure) committed to collecting structured data on wound care. I was focused on getting practitioners paid properly (by calculating the charges correctly) and making sure that patients got the care they needed (for example, the relatively new surgical dressing policy required specific wound details for dressings to be covered). I wanted to use structured data to optimize the care of individual patients and the payment for individual clinical visits. However, what was said at the 2005 MCAC meeting made me realize that if we wanted to keep even BASIC wound care treatments covered by Medicare,  we needed to analyze longitudinal, real world data from all the visits on all the patients and perform real world comparative effectiveness research (CER).

These committees (MCAC then, MEDCAC now) are advisory forums designed to help CMS make decisions on whether specific medical services are “reasonable and necessary” under Medicare law (meaning whether Medicare will pay for it). You can find the transcript here. I listed the specific questions reviewed by the committee below, but if I could summarize the purpose of the meeting in one sentence, CMS was asking, “Do any of your wound treatments work, and how would we know if they did?” And CMS was asking this about the most basic “usual” care like debridement, compression, and off-loading! Even 20 years ago those treatments had published evidence — but that’s not what CMS was asking. CMS was asking if we had evidence that basic treatments provided benefit in real world practice. Perhaps not surprisingly, the panel agreed that the treatments produce clinically significant benefit and are “likely to apply to Medicare-aged patients” – but when asked whether usual care could be generalized to providers in community practice, the answer was NOT SUFFICIENT EVIDENCE. In other words, there was no proof that basic wound care, as actually delivered in the real world, worked. The panel’s recommendation was to build large comparative databases to determine which treatment combinations are effective.

Here are verbatim quotes from the meeting:

“…we have become concerned that the evidence base for a particular technology is not as strong as it needs to be and therefore, we are beginning a series of discussions around the appropriate methods of treating chronic wounds…”

“…one of the difficulties we encountered was…the lack of standardization in the documentation process…[this will] affect how we are able to compare the effectiveness of technology in a large sample population…”

“…we need to know what [was] done with a great deal of detail…the treatments and the outcomes…to look at…patients that have comparable co-morbidities, ages, gender, location of wounds,… And…go beyond the restrictions in a randomized trial…to examining all patients…[to] look what’s done in the actual practice of care to determine what combinations are associated with best outcomes.” [Steve Phurrough MD, MPA, Director Coverage and Analysis Group, CMS Liaison to the MCAC, and various committee members]

That’s how, in 2005, I became focused on aggregating and analyzing the data that could be obtained from standardized documentation of routine clinical care in order to determine what treatments were effective in the real world. Four years later, Marissa Carter and I published the first of many papers on real world data (RWD), starting by describing the difference between wound care patients and clinical trial subjects (Adv Skin Wound Care. 2009;22(7):316-24).

It’s been a hard slog for two decades – but not because it was hard to get the data. We had good data by 2007. To my surprise, I found out that manufacturers weren’t particularly interested in whether their products worked in the real world. And maybe I can’t blame them since it’s taken decades for the FDA to even consider real world evidence (RWE). Most manufacturers thought that once they got their device or treatment approved or cleared the need for data was over. Clearly, it isn’t.

The MACs are proposing to stop covering two assessment/imaging tools – stating that they don’t have sufficient evidence that they are “reasonable and necessary” – meaning, they don’t have evidence that they are beneficial in the real world. It is upsetting – but not surprising.  CMS’s advisory committee told us twenty years ago that if we couldn’t produce data on real world effectiveness in wound care, Medicare wasn’t going to cover it. It’s taken 20 years, but now we’ve got large comparative databases.  There’s no question the data are needed. The only question is whether it’s going to be used in time.

–Caroline

The Questions Asked by the MEDCAC About Wound Care in 2005:

QUESTION 1: Usual care for chronic wounds commonly includes debridement, cleansing, dressing, compression, antibiotics and off-loading.

a. Is there sufficient evidence to assess the health benefit of these modalities?
b. Are there other modalities that provide a health benefit?

QUESTION 2: The following outcomes are commonly used to assess healing of chronic wounds:

  • Time to complete healing (Yes);
  • Partial healing rate, depending on scale-change over time (Yes);
  • Recurrence rate (No);
  • Elimination of infection (No);
  • Amputation rate (Yes);
  • Validated quality of life measures (Yes);
  • Percent healed (Yes).

QUESTION 3. Based on evidence reviewed, how likely is it that the treatments discussed in Question 1 will positively affect the outcomes discussed in Question 2?

QUESTION 4. Based on the evidence reviewed, do the treatments reviewed in Question 1, singly or in combination, produce clinically significant net health benefits in the treatment of chronic wounds? (Yes)

QUESTION 5. Based on the evidence reviewed, how likely is it that usual care used to treat chronic wounds can be generalized to:

a. The Medicare population (aged 65+). (Yes, likely)
b. Providers (Facilities/physicians) in community practice. (Not sufficient evidence.)

QUESTION 6. What are the knowledge gaps in current evidence pertaining to the usual care of chronic wounds? (Training of staff, education level of staff, patient education, wound product knowledge.)

QUESTION 7. What trial designs will support the development of sufficient evidence to determine the appropriate treatment of chronic wounds?
What units of analysis and covariates can be considered? (Large comparative databases to determine what treatment combinations are effective.)

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.

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