Becoming an MD or DO physician is hard. Four years of college where you bust your butt to make good enough grades to get into medical school. Four years of medical school where you work hard to get your choice of residency. Then another four years (or more) of residency and fellowship training. By the time you’re out, your twenties are behind you, and your college friends are a decade into their post-educational lives while yours has just begun. Is it worth it? Well, traditionally this path allows you to safely care for patients using a broad array of tools from medications to procedures to surgery. However, that’s all changing. We now have alternative-health practitioners with a fraction of that level of training performing live stem cell injections and dead amniotic and cord-blood procedures. How is this happening? Is this even legal?
My First Exposure to Scope-of-Practice Creep
About four or five years ago I was told about a naturopath in Utah who was performing high-level and high-risk spinal-injection procedures under fluoroscopic guidance. At first, I dismissed the concept as a hoax, but I went on the naturopath’s website and was floored. Here was a naturopath with one-third the training of a newly minted MD or DO physician just out of residency, performing procedures where being off by a few millimeters can cause serious harm and an immediate need for advanced resuscitation skills. How did this happen?
When I looked into how a naturopath with little training could get specialist physicians to train him in these areas, I soon found out that he had used a “stepping stone” approach with many instructors, some of whom I knew. Basically, he started with lower-level skills that he claimed his practice act would allow. Then he went to slightly more difficult and then more difficult, pointing back to the prior training as proof that he was qualified. Before anyone had a chance to consider whether all of this was a good idea, he had assembled enough training to begin performing high-risk spinal injections.
Orthobiologics Has Been like Gasoline to the Bonfire of Alternative-Medicine-Practice Creep
This past month, I have seen evidence of chiropractors, naturopaths, and acupuncturists all performing stem cell, PRP, and dead-birth-tissue injection procedures that are technically not within their scope of practice, basically illegally practicing medicine without a license. How did we get here? We got here because the nature of regenerative medicine and its current focus on the use of the body’s own natural healing powers has created a regulatory gray area for these practitioners.
After looking at many of the state practice acts for alternative-health practitioners and physicians, it’s clear that there are a few loopholes that are being used to justify this expansion of scope of practice.
However, these are a few common restrictions that these alternative practitioners have to work within:
- The can’t use, prescribe, or inject prescription drugs.
- They usually can’t inject something as simple as intravenous, but other areas are gray. For example, Utah’s acupuncture law allows for the injection of supplements or homeopathic medications into acupuncture points, but nothing else.
So how is it possible that any of this is happening? The expansion of medical-delegation laws created to allow paraprofessionals (like aestheticians in dermatology) has opened the door to alternative-health practitioners to claim that they are being supervised by a physician
Let’s take each of these in turn.
Almost all practice acts prohibit alternative practitioners from prescribing or using prescription drugs. This makes sense as these providers don’t have the training to understand and deal with the side effects or pharmacology. However, regenerative medicine has changed what is injected, which is where this problem starts.
Autologous orthobiologics, like platelet rich plasma and stem cells, change things a bit for alternative practitioners. They aren’t technically a prescription drug. However, obtaining these preparations requires an intravenous blood draw, bone marrow aspiration, or liposuction. These procedures are generally beyond the scope of the practice acts that define what these providers are permitted to perform. More on that below.
What’s interesting is that most of these providers, because of the issues discussed above, have moved toward injecting birth tissues, like amniotic and cord blood. Why? This gets rid of the procedures needed to harvest the patient’s own cells.
Amniotic and cord-blood tissues are regulated to be nonliving products covered under the FDA 361 tissue-registration system. The problem here is that injecting this category of 361 registered tissues isn’t covered by any of these practice acts that I have reviewed. Let’s take the Utah acupuncture act, one of the more aggressive in the nation.
(1) “Administration”, as used in Subsection 58-72-102(4)(b)(ii), means the direct application of an herb, homeopathic, or supplement by ingestion, topical, inhalation, or acupoint injection therapy (AIT), to the body of a patient. Administration does not include: venous injections, immunizations, legend drugs and controlled substances.
As you can see, there’s no statement here about injecting amniotic or cord-blood or any 361 FDA-registered tissue.
As another example, let’s look at the Florida acupuncture act. I can find no evidence that there is an injection of any substance allowed. Having said that, I have found a website of an acupuncturist in Florida who, through the research I have done, claims to be performing stem cell injections.
Not only is it not clear that these alternative practitioners can inject amniotic tissue or cord blood, in many instances, it’s also not clear that they can perform the procedures needed to treat patients. As an example, let’s look at our Utah naturopath performing liposuction to draw cells and reinjecting them into the low-back disc. The Utah Naturopathic practice act is one of the country’s most aggressive in allowing naturopaths to do many things they are not permitted to do in other states. However, it includes these statements:
“(b) “Minor office procedures” does not include:
(i) general or spinal anesthesia;
(ii) office procedures more complicated or extensive than those set forth in Subsection (7)(a);
(iii) procedures involving the eye; and
(iv) any office procedure involving tendons, nerves, veins, or arteries.”
The minor procedures that are permitted include:
“(a) “Minor office procedures” means:
(i) the use of operative, electrical, or other methods for repair and care of superficial lacerations,
abrasions, and benign lesions;
(ii) removal of foreign bodies located in the superficial tissues, excluding the eye or ear;
(iii) the use of antiseptics and local anesthetics in connection with minor office surgical
(iv) if approved by the United States Food and Drug Administration, percutaneous injection into
skin, tendons, ligaments, muscles, and joints with:
(A) local anesthetics and nonscheduled prescription medications; and
(B) natural substances”
Hence, for our naturopath in Utah, a major surgical procedure like liposuction would not be permitted. In addition, given that injecting anything inside the disc means that you are by proxy injecting something around spinal nerves (because the substance will leak out around the nerves), that’s also not allowed. Hence, our naturopath in Utah appears to be practicing medicine without a medical license.
One of the ways that alternative-health practitioners are getting around their own practice acts that would prohibit stem cell and PRP or amniotic/cord blood injections is that they often claim to have a medical supervisor. I ran into this recently in Colorado, when a patient who failed an amniotic “stem cell” injection stated that his chiropractor had injected his shoulder and ankle and that a nurse had injected his low back.
Most medical-practice acts have some sort of delegation clause where a physician can delegate certain duties to a lower-level provider as long as some sort of supervision is exercised. When I called a local chiro friend to ask if this chiropractor could use a supervising physician to perform these procedures, what I heard was that our own medical-delegation act had recently been massively expanded to accommodate dermatologists who wanted to allow aestheticians to perform some minor procedures and use LASERs. Hence, as I researched our own act, it was unclear whether a chiropractor with a medical supervisor could perform this procedure.
On the other hand, when I did the research on the acupuncturist above, it looked like this clinic also claimed a medical supervisor whose practice was an hour and a half away. The Florida Medical Practice Act is not clear at all that such supervision for an acupuncturist to perform injections is permitted. In fact, it provides for sanctions on physicians who inappropriately delegate medical care:
“(w) Delegating professional responsibilities to a person when the licensee delegating such responsibilities knows or has reason to know that such person is not qualified by training, experience, or licensure to perform them.”
In summary, having a physician supervisor as an alternative-healthcare provider to try to get around the limitations of your own medical-practice act is risky business. However, this is happening.
The upshot? Lions and tigers and bears, oh my! Today it’s acupuncturists and naturopaths and chiropractors…oh my! First, it’s unsure why any patient in the U.S. would want an alternative-health practitioner injecting stem cells or even dead amniotic and cord-blood tissue. Second, these moves by alternative-healthcare practitioners to expand their medical-practice acts is dangerous in my opinion. These providers have a fraction of the training needed to perform these procedures safely. As I always say, it’s crazy out there, so buyer beware!