Does insurance cover stem cell therapy at unproven clinics?

Stem cell injections at unproven clinics are expensive and unproven so a lot of patients have asked me if insurance covers stem cell therapy at clinics?

Mostly the answer is “no”, but in rare cases there is some kind of coverage, mainly from employers that have inked some kind of deal with a stem cell clinic firm.

However, overall we just aren’t seeing insurance companies cover stem cell injections by clinics.

Does insurance cover stem cell therapy?

Does insurance cover stem cell therapy? Even at clinics? What about coverage from employers?
Does insurance cover stem cell therapy? Even at clinics? Generally, no. What about coverage from employers? Only extremely rarely.

It’s an important question because the average total stem cell injection price tag for an individual customer can easily end up being $10K-$20K or more. The expense adds up in part because the cost per injection (see poll data here) has to be multiplied by the number of injections (see data here) the customer gets over time. Some patients have received one or two dozen injections. Some clinic practitioners also self-treat as well with unproven stem cells.

If insurance won’t cover the expensive, unproven stem cell “treatments” at for-profit clinics, and I don’t blame them since in my view they are generally a big waste of money and are risky, then can the average person afford to pay so much themselves? Often they can’t.

Sadly many clinics are frequently now pushing patients to take out loans or go fundraise online to scrape together money.

Weirdly some clinics falsely claim that their offerings are covered by insurance when really they aren’t, a fact patients will quickly realize if they do a little research.

Do employers cover stem cell therapy?

From what I’ve seen, Regenexx seems to be the main provider of stem cell injections that has gotten some limited coverage okayed, mainly through certain employers. While Regenexx seems compliant with FDA regulations here in the U.S., in my opinion there aren’t rigorous data to prove it works. This new paper for knee arthritis with Regenexx is worth a closer look as it seems at least relatively stronger in design than past studies in this arena even if it wasn’t blinded/lacked placebo control and wasn’t a large study.

Overall, I haven’t seen other stem cell clinics get any kind of real insurance or corporate coverage, although perhaps there are a few buried amongst the ~1000 clinics out there these days. Medicare also does not cover stem cell injections.

Why doesn’t insurance cover stem cell injections? Why doesn’t Medicare? The reason is that the stem cell “therapies” from stem cell clinics are unproven and most often a waste of money.

Proven therapies like bone marrow transplant are covered

To be clear, proven bone marrow transplants/hematopoietic stem cell therapies such as for leukemia, which are established therapies covered by insurance, are a different story.

Note that still experimental uses of bone marrow combined with partial immune ablation for autoimmune disorders including MS have promise, but aren’t yet proven and mostly lack insurance coverage.

Hopefully in the future more FDA compliant stem cell therapies that are rigorously proven safe and effective from strong clinical trials will come onto the market and these are likely to be covered by insurers, reducing burdens on patients and their families.

16 thoughts on “Does insurance cover stem cell therapy at unproven clinics?”

  1. Thank you for all the useful information.
    Are you referring to the MSCs as stem cells?
    If so, there certainly doesn’t seem to be anything approved by the FDA.

    However, if HSCs are also included in the stem cells, then there is an FDA-approved product. And this seems to be covered by Medicare as well.

    https://www.healthline.com/health/medicare/medicare-stem-cell-therapy

    Will FDA-approved regenerative medicine products (not just stem cells, like MACI) be covered by Medicare / Medicaid / Private health insurance?

    Best regards,

  2. Thanks so much. You’ve helped me dodge a bullet tonight. My gut told me it was too good to be true. I’m wanting to avoid rotator cuff surgery.

    1. Vicki, many years ago a trainer at my gym gave me this 1 exercise for my shoulder/RC. I could lift a 1gal bottle out of the fridge. To this day, I do have an occasional twinge, but the strength is there. It is such a simple exercise. I don’t know why physical therapists don’t tell their patients. Are you ready? Do you have an exercise ball? Do you have a wall? You are almost there. Now place your hands on the ball, on the wall about chest high. Take a couple of steps back to get comfortable. So now your body is at a slight angle with pressure on the ball from your extended arms. now try walking the ball up the wall and down the wall. Go as high and as low as you can. It is not a race or endurance contest. If you can only walk the ball up a couple hands and lower it a couple of hands, thats a great start. If you can only do it once today, try twice the next time. As you get more comfortable you will be able to go higher and lower with more repetitions. Oh shoot I see you posted this in 2019. I hope you are feeling better.

  3. Feisty Susan! Someone asked me about the same type of deal and here is the scoop from my family that bought purported “stem cell therapy” only to discover that we were all 3 injected with a product that is deceptively marketed that was Never Intended to be used therapeutically in humans, per the Compliance Director of the company! The product is labeled “for research use only” and the physicians and the companies that purchase these “”tissues” straight off the press (literally) require a purchase order agreement to be signed that they will be used “for research use only,” all while being marketed as a cure all. Here is the flyer they received:

    IMG_1395.jpeg

    Questions they asked :
    Rec’d this in mail.  Need to compose list of questions to pass on for someone to ask to expose fraud.  Would you make out this list of questions – it could help others in attendance.
    End of a webpage looking site without any mention of who the physicians are along with a complete disclaimer at the end of the page:
    Image-1.jpg

    Reply based on our own direct experience:

    They state it cures all kinds of things in the advertisement and online. It is not even a real website it’s just an advertisement made to look like a website and then at the bottom they have to put the disclaimer because, legally, they can’t make those claims because that is illegal for them to do so. Remember, this is perceptive based marketing only.
    People tend to understand that when they go buy a car, however they do not expect these marketing companies to be masquerading as medical doctors/ companies.
    It’s really simple though, if their product is a 361 FDA Registered Amniotic and cord blood product( ask) , then, Ask then why does the FDA say that 361 FDA registered products cannot contain any living stem cells?
    And why are they making claims about their product containing living stem cells when by law the FDA says that 361 Registered Products cannot/ do not contain them?

    1) What is the name of your product, please?
    2) is it an Amniotic and Cord Blood Product?
    3) Is it FDA Approved? ( it will Not be )
    4) Is it FDA Registered?
    5) per the FDA ( CBER, PHSA, Code of Federal Regulations, basically)
    FDA Registered amniotic & Cord Blood Products do not and cannot contain any living stem cells, FYI.
    6) How is the product sterilized? ( this is good because there is no known method of sterilization per the FDA/ CDC MMWR 2018.)
    7) Does it cause Graft vs Host Disease since it is not donor matched? ( ANY cell transplantation requires donor matching so as not to cause illness whereby the host’s body rejects it as in GVHD. This is basic biology/ med school 101 info. They will tell you that it is immune-privileged, but it is not and causes GVHD in up to 80% of those injected. Plus, the 8 other communicable diseases the Florida Department of Health says to be tested.
    8) Is this product intended to be used in humans therapeutically or is it labeled for research use only?
    9) May we please see a copy of your purchase order agreement?

    Give it a try!

    Thank you for posting, Paul!

  4. my husband got a flyer in the mail and signed us up for one of those free dinner and a presentation deals about stem cell therapy for pain control. He feels bad that I deal with so much pain, that after doing a little bit of research online I just I doubt very much that this is a legitimate therapy these people will be talking about. my mama taught me if it sounds too good to be true it probably is. These people are treating us to a free dinner oh, and what do they expect in exchange? My bet is they want us to drop some big bucks. It’s not going to happen. I keep a very tight rein on the purse strings and those strings are very short. I don’t even want to go because if I do tomorrow will be a painful day. He said he’s going without me. I know they won’t like that because when a couple is separated when attending these deliveries their hopes of getting your money are slim to none. Maybe I’ll just muster and go anyway and give them a hard time. I feel a little feisty this afternoon!

    1. My best to you, Susan. Here are some observations about these sales seminars. I went to one seminar myself to see what it was lke.

      These seminars come in different forms, but generally they pressure you to purchase a stem cell injection. For instance, they’ll often offer a $1000 discount if you sign up right at the dinner.

      The speaker may be a doctor or they maybe a professional sales person who is paid on commission. There may be one or two plants in the audience, meaning people who are there to portray enthusiastic patients.

      Often what is claimed at these dinners/seminars is not accurate. They exaggerate potential benefit and downplay risks, when frankly most of the time they don’t have good data on either.

      One good question to ask is what exactly is being injected?
      Also, is it living cells? Definitely stem cells? How do they know (i.e. how do they test them)? How many cells do they inject and why?

  5. My sister wants to try getting stem cell treatment. I didn’t know your insurance and Medicare won’t cover the cost. I’ll have to show this to my sister, so we can find a clinic that has flexible payment options.

    1. Dear Sarah,

      Do be aware that insurance also may not cover your blood and stool tests if the purported “ stem cell therapy” that you might receive should cause infection and disease, even if the Department of Health recommends that each patient that was injected get tested for a range of communicable disease for which there are no known methods of sterilization for certain types of tissue including the amniotic and cord blood tissues that are only 361 Registered FDA Human Cellular Tissue Products ( HCT/Ps) that are being currently marketed unlawfully according to the CDC MMWR September 2018 report.
      In Florida, Google Dr. Joeseph Purita and the Florida Department of Health letter that he publicly posted that the Florida Department of Health sent to physicians to warn their patients to get tested if they were injected with a particular amniotic cord blood product. Do you think the physicians that told us that we were getting actual living stem cells from a live healthy screened donor even bothered to send it to us? No, of course not. It is not their business model. We did contact the Department of Health to get the letter that was sent out.
      Dr. Chris Centeno wrote an article called the “ Amniotic and Cord Blood Bait and Switch” that exposes the scam and how it is done.
      Dr. Knoepfler also has written and published many helpful articles to help expose these products that call themselves “ stem cell therapy, “ but have been proven, even in University tests, not to have any living stem cells in them like the physicians tell you to get you to buy their product.
      Three of our family members were lied to about what we were getting and have had numerous health issues and are now faced with the fact that we were all injected with unscreened, untested and possibly contaminated material that was unlawfully sold to us by unscrupulous salesmen with medical designations from MD to DC.
      A Veterans Service Officer once told me that out of 100% of all the Veterans that could be service connected, only about 5% actually are compensated for their service connected issues and when I see the media confusing the term “ stem cell therapy” by calling everything from PRP, Bone Marrow Aspirate and Adipose to , now, include amniotic cord blood products ( not the patients own cells taken and re-injected back into their own body), but allograft tissues from other donors that are actually classified as a drug, being sold to people as if they are a FDA Approved Drug, when all these amniotic cord blood companies did was go online and fill out a quick form to “Register” their Unapproved 361 Registered Only Product.
      As Dr. Purita says on his blog: “ this is a black and white issue here, there is no “ gray area here.” If a product claims that it contains living stem cells, then it must be an FDA Approved Drug or in the process of an IND, otherwise, there are either physicians selling Unapproved Drugs or there are physicians misleading people about what they are actually getting.
      If we only knew that what we were getting was not really stem cells, if we had been told the truth about what these amniotic cord blood products are and after one of our family members suffering a gut rupture requiring an emergency surgery, an amputation and a pacemaker and the rest of us with our other things, we would Never have put this garbage into our bodies, let alone paid for it! No one being told the truth ever would.
      Save yourself and your sister a lot of money and possibly your health and life and look deeply into what you are being offered because the quality of your life might depend on it. Seems like various tissues sourced from various places are called “ stem cell therapy,” but 361 Registered products actually do not contain living stem cells and have conveniently thrown themselves into the mix without many noticing.
      People are having difficulty discerning what is actually stem cell therapy and the 361 FDA Registered only amniotic cord blood product companies are enjoying a huge profit at the demise of many by capitalizing on the misinformation of this deceptive injection.

  6. Could you shed some light on workers compensation insurance that covers stem cell treatments in some states?

  7. The purported, “stem cell therapy products” used on our 3 family members had to be paid for BEFORE they were ordered and insurance was not accepted. The product, Liveyon (now a FDA Class1 ReCalled product) was then shipped overnight and supposedly on dry ice to the clinic where our appointments were scheduled to receive the injections and IV’s of Liveyon. After a hefty investment upfront, 3 family members injected and no results that were claimed actually happening, we learned the difference between 361 FDA REGISTERED products that are referred to as “stem cell therapy,” but actually do NOT contain any living stem cells-only 351 FDA APPROVED Drugs contain actual living stem cells and are currently only APPROVED for blood to blood use, not in blood to orthopedic use. Please do not confuse the term “stem cell therapy products” with actual bone marrow aspirate or PRP.
    We were offered these “stem cell therapy products” at what the DC and MD claimed was their cost. Wanting to find out exactly HOW MUCH their “at cost” profit was, we made a call to a company looking for investors for the Liveyon product. The company was called REGENPATH and the salesman who said that his name was John, said that profits were as much as $5000-$7500 per injection and proceeded to give us the price paid by the clinic per vial, depending on the size, and we learned that our “at cost” price for the clinic was somewhere between $999.00-$1800. So, the profit made from our family’s “at cost” price was sizeable to say the least. “John,” also went on to say that “this is more of a perception based product, than a reality based situation.” Please do your research on what is being offered as “361 FDA Registered stem cell therapy products” like the now FDA Recalled, Liveyon. We created a website to share our experience and insights and hopefully help called avoidthestemcellscam.com

    1. I’m not knocking chiropractic medicine, http://www.avoidthestemcellscam.com. In fact I have been helped by a very good Chiropractor in my area in times past. I would not trust in her skill set though to inject me with much of anything into my joints. That is not part of chiropractic training as far as I know. I would trust only the Doctors, & Nurses in the regenerative medicine clinic that I frequent to treat me in this manner. (D.O’s, M.D.’s R.N’s …those sorts of folks).
      I’m curious, however. Why would you and your family elect to have a type of therapy utilizing a product that comes from outside your own body? In other words why engage in a type of “allogeneic” as opposed to an autologous procedure for your various and assorted orthopedic ills? I’ll try to read your website more thoroughly. Perhaps it has answers to my following questions. Was it the cost that compelled you to go “allogeneic” rather than autologous? Was it less expensive? Were you the victim of a very good sales job on the part of the medical providers? Please understand. I am not blaming you. Not in the least.
      PRP is autologous, which as far as I am concerned is a much safer route to take over “allogeneic”. Also, PRP, though not cheap, is better priced than stem cell therapies even though my insurance company will not pay for it. They have, however paid for the physical therapy that the clinic I have frequented since 2014 has performed on me as well as for certain ultrasonic diagnostic procedures, cortisone and synovisc injections.
      It seems to me the FDA has the authority to investigate or “go after” companies or corporations that are shipping medically related products through interstate commerce. Liveyon or REGENPATH seem to have engaged in practices of this sort.

      1. Douglas,
        You pose outstanding questions and obviously approach your life with a well developed sense of acuity that many may still be learning. There is always more to learn and that is why we created a simple website to fill in the gaps in understanding between many people with diverse backgrounds and reasons to be engaged right now with the term “stem cell therapy.”
        From our perspective and experience, it seems that the term “stem cell therapy” has been loosely adapted to include not only the types used from one’s own body, such as bone marrow aspirate, adipose and platelet-rich-plasma, along with 351 FDA Approved Drugs, but also now include amniotic and cord blood products that are actually only Human Cellular Tissue Products (HCTP’s) that require only a FDA 361 Registration and by that Registration’s definition, do not contain any living stem cells. The fact that these HCTP’s are even allowed to represent themselves as even being the same as actual living stem cells is outrageous! The fact that HCTP’s can be called “stem cell therapy” and not contain any living stem cells should be corrected so that the public will be better able to discern the difference between HCTP’s and their 361 FDA Registration vs 351 FDA APPROVED Drugs that actually do contain living stem cells. Perhaps stem cells derived from one’s own body could also be given a distinctive designation so that those procedures are not confused with 351 Approved stem cell drugs or 361 FDA Registered HCTP’s. Grouping all of these very uniquely “sourced” therapies together as if they are all living stem cells is misleading.
        To answer your question about why we chose to use a purported “stem cell therapy product” instead of our own bone marrow is because we were deliberately mislead by the DC and MD that lied to us about what we would actually be getting. They said that we were going to be receiving “LIVING STEM CELLS” from healthy live birth tissue that was loaded with trillions more “living stem cells” than our own bone marrow or our own PRP would ever contain given our age and orthopedic conditions. Also, they said that the bone marrow aspirate was painful and had it’s own complications. They recited their own “miraculous recoveries” and claimed much clinical research. They also cited some issue about Big-Pharma being upset and trying to suppress this product because Liveyon would cut into their profits and explained that a lot of people still have not learned about it, yet.
        The cost was more expensive than PRP and more than most bone marrow aspirate injections as far as online research price quotes. For example, our family member that received 2 IV’s, was quoted a full price at 20K for both IV’s, but the DC, who was the direct salesman in our case, offered an “at clinic cost discount” of 4K, so the cost was $16K for two IV’s. The MD performed the actual injections.
        They literally “roll out the red carpet,” as they invited us to their beach front home to meet the family and to seal the deal, literally. They cited stories to match our own orthopedic issues that they also claimed to have and were miraculously healed by their product. They also planted into their sales pitch the need to purchase several rounds of their product. You might be interested in the “Cult of Branding,” by a man who shares your name who asks good questions to find out what is appealing to people and makes them “bite.” The reason that I bring this up is two-fold: the founder and CEO of Liveyon has been barred from the securities industry as well as indited on health care fraud, so it seems there are individuals who purposely look for loopholes in industries as way of life for a profit and People as a whole may want to understand these crafty sales gambits to protect themselves, as I know firsthand, when there is a crippling and painful situation with slim to none known options, there is vulnerability.
        Our family has had one of the best chiropractors, ever, in my opinion, for many years and I visit the office regularly for Klaser laser treatments. We also have friends who are chiropractors as a lot of them seem to have a rather “holistic” approach to living that is appealing to many. Having many positive interactions with multiple chiropractors in my life, also probably contributed to trusting another about what they said. Chiropractors are in a unique position to assist people in many ways. Since they are not bound to the same requirements as MD’s, this also can lead to the misuse of their licensed “Doctor of Chiropractic” skills, just like many MD’s.
        We are all accountable for ourselves and our choices and by trusting in the medical system, we got duped. Really duped, as we do not know or understand what the long term consequences of having dead, gamma-irradiated birth tissue that could have been contaminated even more, put into us. Obviously, if we had been told the truth about the purported “stem-cell therapy,” we never would have bought into it. We are choosing to help others understand what is going on so that they may have the opportunity to make an informed choice based on what actually comprises some alleged “stem-cell therapy” products. See avoidthestemcellscam.com for more information.

        Editor’s note: this comment was edited in some small ways to be compliant with The Niche’s comment policy. This comment reflects a patient’s personal account and opinions of their experiences. Patient voices and experiences are very important, but The Niche has no direct knowledge of the accuracy of the statements or allegations.

        1. You’ve been through a lot. It’s easy to get duped even with online sources available. And to further the tragedy, you got taken in by folks who normally we as a society tend to trust in.
          I think it’s a good thing what you are doing in warning others about what happened to you. I’m so sorry for you and your families’ troubles. I do wish you the best…
          Douglas

  8. We too have gotten “coverage” for our PRP and cellular procedures on a case by case basis. You should keep in mind that insurance companies continue to pay for very expensive procedures such as spinal fusion with limited evidence of efficacy and other procedures such as partial meniscectomy that had had been shown to be NO BETTER than SHAM surgery !

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