What Is R3 Stem Cell?
R3 is a marketing company out of Arizona founded by a defrocked orthopedic surgeon by the name of David Greene. Dr. Greene had his medical license taken away in 2007 because he represented an imminent threat to public health and safety. After that, he appears to have begun a marketing company focused on healthcare. That finally led to a stem cell business called R3.
R3 has been selling amniotic and umbilical cord “stem cell” therapies for years. The problem? There is no such thing, meaning that the commercially available birth tissues that R3 and many other companies sell have no living stem cells.
In addition, according to an FDA Tissue Establishment Registration look-up, R3 isn’t an FDA registered distributor nor manufacturer of these products. In fact, the company received a letter from the FDA in May of 2019. That letter pointed out how it was illegal for R3 to offer “stem cell therapy” for a host of incurable diseases. From that letter:
“We note that your products are intended to treat a variety of serious or life-threatening diseases or conditions. Such unapproved uses raise potential significant safety concerns. Additionally, because the products are administered by various higher risk routes of administration, including IV, their use, if contaminated could cause a range of adverse events. “
R3 responded with a press release in which it stated:
“However, in response to the FDA Letter and to reaffirm its commitment to public health and safety, R3 is undertaking a comprehensive review of its business.
“We respect and appreciate the role of the U.S. FDA in regulating and providing guidance regarding human cells, tissues, and cellular and tissue-based products (HCT/P’s) and share FDA’s goal of promoting public health and safety,” said Dr. David Greene, CEO of R3.”
So did R3 clean up its act? You decide.
Some Recent Email Blasts from R3 Stem Cell
I get sent stuff all the time by colleagues, so a recent R3 email blast to medical providers was sent my way. Its focus was on “amniotic and umbilical cord stem cell therapy” to restore cartilage in patients with knee arthritis. That email referenced a presentation that I watched. This is from that presentation:
You’ll notice that in this slide there is a reference to a case study published in the medical journal Pain Physician in 2008 (blue dashed oval). That one looked familiar to me. Why? That’s the paper I published more than a decade ago after using cultured bone marrow stem cells from the same patient to help heal a hole in someone’s cartilage. Does that therapy have anything to do with what David Greene and R3 stem cell are selling? Nope, not at all. Remember, the birth tissue products being sold by R3, and that are the subject of this presentation have no stem cells.
Further on in this presentation, we see:
The problem? Again, there is no credible data supporting the concept that what R3 sells has any living stem cells. In fact, we have three research investigations that show that this assertion is fiction (1-3).
Billing Fraud 101
While it would be bad enough for R3 to be selling fake stem cell therapies, it gets worse. How about this email:
“As we make it through the pandemic, more patients than ever are asking about insurance reimbursement for regenerative interventional orthopedic procedures.
Instead of losing those patients, wouldn’t you like to capture them and receive thousands in reimbursement on each injection?
In addition, the Regenerative Interventional Orthopedic Procedure Insurance Program will not change no matter what FDA changes are implemented next year.
At the Comprehensive R3 Stem Cell Training Course, we will teach you how to bill insurance for excellent reimbursement from Medicare, Tricare, BCBS and other commercial payers!”
Given that no insurers or government programs like Medicare and Tricare cover stem cell therapies derived from amniotic or umbilical cord for use to treat orthopedic conditions, how could this be possible? R3, like other companies, is inappropriately using an obscure product reimbursement code that’s meant to be used in a narrow number of skin wound applications and tricking carriers into paying this claim for problems like knee arthritis. How do I know this? I’ve spoken to a medical coder plus a medical director for United Healthcare, one of the companies that was supposedly paying for these therapies. I was told that if the company is paying these claims, that’s an error on their part. In addition, there are dozens of insurance companies that state that there is no coverage for these products to treat orthopedic or pain applications:
- United Heath Care – NO COVERAGE for all orthopedic conditions
- Anthem – NO COVERAGE for all orthopedic conditions
- Capital Blue Cross – NO COVERAGE for all orthopedic conditions
- HCSC (Illinois, Texas, Montana, New Mexico, and Oklahoma’s BCBS) – NO COVERAGE for all orthopedic conditions
- BCBSMA – NO COVERAGE for all orthopedic conditions
- Wellmark (Iowa and South Dakota BCBS)– NO COVERAGE for all orthopedic conditions
- BCBSRI – NO COVERAGE for all orthopedic conditions
- BCBS Kansas – NO COVERAGE for all orthopedic conditions
- Horizon BCBS – NO COVERAGE for all orthopedic conditions
- Federal Employee BCBS – NO COVERAGE for all orthopedic conditions
- Highmark – NO COVERAGE for all orthopedic conditions
- Cigna – NO COVERAGE for all orthopedic conditions
- Aetna – NO COVERAGE for all orthopedic conditions
- Humana – NO COVERAGE for all orthopedic conditions
- BCBS of Minnesota – NO COVERAGE for all orthopedic conditions
- Premera – NO COVERAGE for all orthopedic conditions
- BCBS of Tennessee – NO COVERAGE for all orthopedic conditions
- Capital Blue – NO COVERAGE for all orthopedic conditions
- BCBS of Florida – NO COVERAGE for all orthopedic conditions
- Blue of California – NO COVERAGE for all orthopedic conditions
The Medicare guidelines say the same thing. Hence, any attempt to get these products covered to treat orthopedic conditions or pain is problematic. The video below explains how this billing scam works:
As a Patient, Why Should I Care if a Doctor Gets Paid by Medicare Inappropriately?
Because you’re the one who is usually on the hook for the bill if your insurance company claws back this payment from the doctor. It’s basically pay now or get a surprise bill at some point.
A Free Stem Cell Procedure for Every Provider Taking a Course?
Ok, we have consumer fraud in offering stem cell therapies that don’t contain actual live and functional stem cells. Then we have billing fraud for Medicare claims, which is a federal offense that can buy 10-years in federal prison for each bill submitted. However, it gets even worse. Check out this R3 course.
First, this caught my eye:
“EACH PROVIDER WILL RECEIVE A FREE STEM CELL PROCEDURE!”
Huh? Given that we now know that the amniotic or umbilical cord products contain no live and functional mesenchymal stem cells, not sure how that one is supposed to work. In addition, is this common at courses for doctors? Nope. In fact, IMHO it’s pushing ethical boundaries big time. Why? Candidacy for one. That means that any medical procedure has patients who are candidates for that procedure and patients who are not. So if we get 100 doctors in a room, how many will be a candidate for this type of therapy?
Then we have this:
“This courses are designed for all providers (MD, DO, NP, RN, ND, NA, PA, DC, etc) desiring an education in the practical techniques for offering regenerative therapies.”
Forgetting about the syntax issue, many of these provider types aren’t even permitted to perform these procedures in many states. For example, an RN (nurse) and ND (naturopath) wouldn’t be permitted to perform these procedures in most states.
Here’s another example, one of the courses is in Tennessee and the above shows us that a naturopath (ND) can take the course. The problem, that state bans Naturopaths:
“Tennessee has banned the practice of naturopathy, which means no schools offer degree programs in the field. As defined by Tennessee law, it’s illegal to practice naturopathy, which uses natural methods to prevent, cure or treat diseases or ailments.”
So what happens if a naturopath shows up at the Tennessee course wanting to be trained? That could be a real problem as we read this about the course:
“All of the training courses are HANDS ON with real patients and real biologics. NO cadavers or animal meat.”
That means that instead of injecting cadavers, these course participants will practice on real patients. Hence, based on what’s in this marketing e-mail for this R3 stem cell course, a naturopath in Tennessee could be injecting patients and could be charged by local authorities with practicing medicine without a license.
A Liposuction Course Taught by a Naturopath?
Just when I thought that this was the rock bottom of this crazy story, I found this in rereading one of the emails:
“We have added Adipose Stem Cell Training…”
The email then directed me to watch a video by Dr. Sabrina Holt on adipose training:
When I looked into Dr. Holt, turns out that she isn’t an MD/DO physician, but a naturopath. I’ve gone over these issues before, as Naturopaths don’t have enough training to perform surgical procedures, which is why in almost all states that allow naturopaths to practice, they are limited to very minor procedures.
In the video, we see Sabrina performing abdominal liposuction and she is introduced to us as the adipose trainer for R3. So if Sabrina shows up in San Diego (one site of this course) or Tennessee (the other site), how will those local naturopathic acts look upon her performing a surgical procedure like liposuction?
“May administer subcutaneous and intramuscular injections and intravenous injections after undergoing additional training. May not suture or perform biopsies. May not administer general or spinal anesthesia or perform any surgical procedure.”
Since Liposuction is a surgical procedure that often requires you to suture, in my opinion, it would be well beyond the scope of naturopaths in California. In Tennessee, naturopaths are not permitted to practice.
We have an orthopedic surgeon who lost his license based on bad results and complications such that the state of Arizona declared him a danger to public health. He then reinvents himself as a stem cell expert (BTW he has no scientific publications on this topic) and begins selling “stem cell” products that have no living and functional stem cells. He then gets a nastygram from the FDA for promising to cure all sorts of incurable medical conditions with those fake stem cell treatments. He then tells doctors that they can bill Medicare for using these products to treat things like knee arthritis when that’s clearly not true based on Medicare guidelines and knowingly submitting false claims to Medicare is a serious federal offense. He then holds courses on how to perform these procedures, teaching anyone who will show up and promising that they will get to perform procedures on live patients, even though some will have no license that permits them to perform those procedures. Am I missing something?
The upshot? This is one of the crazier things I’ve seen. A lost medical license, fake stem cell products, billing fraud, and courses using live humans to teach any medical provider who will show up? As I always say, you can’t make this stuff up!
(1) Berger D, Lyons N, Steinmetz, N. In Vitro Evaluation of Injectable, Placental Tissue-Derived Products for Interventional Orthopedics. Interventional Orthopedics Foundation Annual Meeting. Denver, 2015. https://interventionalorthopedics.org/wp-content/uploads/2017/08/AmnioProducts-Poster.pdf
(2) Becktell L, Matuska A, Hon S, Delco M, Cole B, Fortier L. Proteomic analysis and cell viability of nine amnion-derived biologics. Orthopedic Research Society Annual Meeting, New Orleans, 2018. https://app.box.com/s/vcx7uw17gupg9ki06i57lno1tbjmzwaf
(3) Panero, A, Hirahara, A., Andersen, W, Rothenberg J, Fierro, F. Are Amniotic Fluid Products Stem Cell Therapies? A Study of Amniotic Fluid Preparations for Mesenchymal Stem Cells With Bone Marrow Comparison. The American Journal of Sports Medicine, 2019 47(5), 1230–1235. https://doi.org/10.1177/0363546519829034