Check out the entire series here.

Dr. Fife,

I thought you should see this advertisement for “research” with CTPs/skin subs. It’s not an isolated case. Many of them are doing this where the MACs have cracked down on Rebate programs, particularly in nursing homes…”

[Anonymous practitioner]

Since the ad is blurry, I will reproduce some of the wording below:


 Due to our IRB status with the Department of Health and Human Services our parent Institution/Organization [name redacted] will pay your clinic at a flat rate to participate in a case study.

 We do not believe in participating in rebate or discount programs.  . . .Our IRB backed research program allows providers to join a collaborative community to further knowledge and outcomes in the efficacy of pure amnion dual layer amniotic membranes.  . . .

 Sizing                    Research payment

1×1 cm2               $392

2 x 2 cm2             $1,568


I redacted the name of the company and the letter/number sequence that followed. Out of curiosity, I searched ClinicalTrials.gov to see if any research proposal was listed on that site for the company and did not find one. That does not mean the study is not legitimate, but industry sponsored trials are nearly always listed. I went on the HHS website to see if I could find any information about trials being done through them. I am not aware that HHS has an “IRB status” for manufacturers.

I am a big believer in the value of real world data, and have spent most of my career trying to advance it. I totally support the concept of using clinical data to understand the real world safety and effectiveness of products and also the need to compensate clinicians for the burden of collecting data. What worries me is the phrase, “our IRB status with the Department of Health and Human Services.” I worry that this is a thinly disguised rebate program, and it would be a shame if that approach backfires on legitimate research initiatives. It would also worry me if the reference to HHS means that they are targeting nursing homes since that raises a lot of issues with regard to informed consent in a vulnerable population. I will post any additional information I receive.