Colleagues send me stuff all the time to review. Some of my favorite myth-buster activities come from reviewing aggressive sales emails sent to doctors to try to get them to purchase fake stem cell products. One such email just came across my desk that I’ll review today. The goal is to educate consumers and doctors so they don’t get scammed or in trouble. Let’s dig in.
Believe it or not, for decades, doctors have used amniotic membrane in surgery to help patch holes. Before the FDA declared all donor tissues regulated, a neurosurgeon trying to patch the dura (covering of the brain or spinal cord) or an ophthalmologist treating a corneal injury would send someone down to the OB Ward to grab a bit of amniotic membrane. This is the tissue that makes up the birth sac.
Once donor tissue products became regulated in the 70s, this was a tiny nitch market in medicine that the FDA loosely regulated. Meaning if you wanted to sell these tissues to a doctor or hospital, all you needed to do was to register yourself with the FDA without any approval or clearance by the agency. If there was an issue like an infection caused by the product, the FDA knew where to find you.
About 8 years ago, I noticed a handful of these companies begin to advertise amniotic products as containing many live and functional stem cells. In fact, one Florida sales rep made this claim to me so I had him send me a sample. I had our advanced stem cell research lab here in Colorado test it and it was all dead. No stem cells and no living cells. That was really interesting, so we bought some more amniotic and then umbilical cord products where the reps were claiming live stem cells and they too, all turned out to be dead tissue. After we presented that data at a conference, UC Davis got in on the testing and also published a paper showing that these products contained no living stem cells (4,5).
One of the products that both our team and UC Davis tested was Pallingen Flow. This is an amniotic fluid product. The amniotic fluid is what escapes from the woman’s womb when the “water breaks”. It’s also what surrounds the fetus in the birth sack. One issue with amniotic fluid is that it’s also where the baby poops and pees. This is a quote from a medical textbook on the topic (6):
“By the second trimester…At this time, a fetus contributes to amniotic fluid volume and composition almost exclusively through urination.”
Pallingen Flow, like all amniotic fluid products that were tested, was also dead with no living stem cells. This was so bizarre to me that I created a video on our findings:
This is why I was shocked by a recent email sent by a sales rep for the company to one of my colleagues.
I’ve highlighted below the problematic statements that we’ll vet:
From: Paulette Weber <>
Subject: Marketing information that you may be interested in
I liked one of the Regenexx ads on Facebook. Today I received the message below through Facebook messenger. I thought you would want to know. Very dirty and sneaky marketing technique on their part!
Hi …, I saw your interest on the Regenexx ad.
Just to let you know,
Stem cells are covered by Insurance through a different company.
Regenexx does not have FDA clearance and insurance approval like we do.
Our company has invested time and money over the last five years to be the only stem cell product on the market that IS covered by Medicare and most major Insurance now. Tricare also covers us, but is covered at 100%!!
It is approved for ALL joints.
Please talk to your Dr about us, and share that link below with them.
Our product is one your primary care Dr can use on you to regenerate your own cartilage with a simple 15 minute injection.
So let’s vet these claims in this email:
Stem Cell Product? Regenerate Cartilage?
After a little research, it turns out that what’s being sold here is Pallingen Flow. The sales rep claims that they are selling a stem cell product, but on the Regenerative Medical Supply website we see the term “Stem Cell Activation Therapy”. Then when we click on that link we see:
“These are not Stem Cells but rather natural occurring growth factors and many other healing chemicals that activate your body’s own healing cells that can regenerate new tissue and help rebuild your joints.”
So while the sales rep claims to be selling a product containing stem cells, the website listed in the email makes it clear that there are no stem cells. That’s also what our lab and UC Davis found. Why then claim that this is a “stem cell” product in an email to a doctor?
Are there any clinical studies showing that Pallingen Flow can regenerate new tissue and help rebuild cartilage? A search of the US National Library of Medicine showed no results when I searched the term “Palingen Flow”. I eventually did find one low-level study of 44 patients who received Palingen Flow injections for plantar fasciitis and Achilles tendinosis who also received an energy therapy (ZimmerWave). That’s it for any research on this product. Hence there is ZERO evidence that Palingen Flow can “regenerate your cartilage”.
Covered by Insurance if You Want an Orange Jumpsuit Award
Is Pallingen Flow covered by medicare or any other insurance carrier to treat arthritis? NO. There are meeting minutes from a Medicare meeting 2016 when the company submitted to get a product code (1). Specifically, Pallingen Flow was submitted to get a code for wound healing. The words “arthritis” or “tendon” do not appear in this document. Medicare approved the code to treat non-healing wounds, with the concept being that like many amniotic derived products, Palingen Flow would be used to treat skin wounds. Hence, Pallingen Flow is NOT APPROVED for the treatment of arthritis or tendon problems.
How about private insurance? This document from United Healthcare mentions Pallingen Flow among many other amniotic products, but states that coverage is only available for non-healing wounds (2). How about Blue Cross? Same issue. In fact, they add this statement (3):
“Injection of micronized or particulated human amniotic membrane is considered INVESTIGATIONAL for all indications, including but not limited to treatment of osteoarthritis and plantar fasciitis.
Injection of human amniotic fluid is considered INVESTIGATIONAL for all indications.”
What happens when a doctor submits a claim for an amniotic fluid injection to treat arthritis and claims to Medicare that he’s really treating a non-healing diabetic skin wound? That’s called healthcare fraud and is punishable by fines and/or federal prison time.
The sales rep stated that Pallingen Flow had FDA clearance. Is this true? Nope. Look no further than the website referenced in the email which says:
“As an HCT/P regulated solely under Section 361 of the PHS Act, RegenMed Supply ™ products are exempt from FDA pre-market review, clearance, and approval from FDA.”
So the website says there is no FDA clearance. Pallingen Flow has a simple 45-minute FDA registration without any clearance or approval from FDA. In fact, by this sales rep claiming that this is a stem cell product, she is moving the classification of this amniotic product from a donor tissue that you can register to a 351 drug that does require FDA approval. Multiple FDA warning letters to multiple companies have made that abundantly clear.
To learn more about the FDA and amniotic products, watch my video below:
Based on what I have been able to look up and in my opinion, none of the claims made by the sales rep are true. That doesn’t come as any surprise to me. However, I’m sure some doctors will purchase this stuff believing it is a stem cell product and these doctors may get paid by Medicare. However, by submitting a false claim to get it paid (stating or implying that they use using it for skin wound care), they are at risk for serious issues with Medicare.
Actual Insurance Coverage for Regen Med
Regenexx has been direct contracting with self-funded health plans for years. Rather than the “fake and bake” approach of telling insurers that we’re treating wounds and instead of treating arthritis, all of our plans know exactly what we treat and how we treat it. We now have about 8 million covered lives who all have full health insurance coverage for what we do.
The upshot? These types of marketing emails are frightening. The scariest thing is not the fact that some rep typed this up in a few minutes, but that debunking it takes hours of research. That means that the vast majority of physicians and patients will just believe what’s written. For doctors, that may mean a very sticky and uncomfortable conflict with the Feds.
(1) Centers for Medicare & Medicaid Services-(CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda for Drugs/Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents Thursday, May 19, 2016 9:00 am – 5:00 pm. https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/Drug-Agenda-2016-05-19.pdf Accessed 7/1/20.
(2) United healthcare. Skin and Soft Tissue Substitutes. Effective Date January 1, 2020. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/skin-soft-tissue-substitutes.pdf Accessed 7/1/20.
(3) Blue Cross Blue Sheild of Massachusetts. Medical Policy Amniotic Membrane and Amniotic Fluid. https://www.bluecrossma.com/common/en_US/medical_policies/643%20Amniotic%20Membrane%20and%20Amniotic%20Fluid%20prn.pdf Accessed 7/1/20.
(4) 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
(5) 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
(6) Fitzsimmons ED, Bajaj T. Embryology, Amniotic Fluid. [Updated 2019 May 6]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK541089/