One of the more interesting phenomena in the wild west of regenerative medicine is the fact that there are many alternative-health practitioners in this space. Why? There is a razor-thin argument that their practice acts allow the injection of “natural” substances. Utah has one of the more bizarre practice acts out there which when combined with lax enforcement has turned a naturopath into an interventional spine physician. S0 let’s review that as a way to explore this issue.
The Alt Med Regen Phenomenon
There is likely no other space in medicine that has as many nonphysicians performing surgical procedures as regenerative medicine. In fact, given the dangers involved in regenerative medicine, I suspect that it will be this space that ultimately defines the limits of nonphysician procedural practice. Why? Many nonphysicians are stretching their practice acts to their limits and beyond to perform these procedures. All of that portends malpractice risk for these providers, which has a way of acting as the final regulator of medical practice.
In some states, there are nonmedical practice acts for naturopaths, acupuncturists, and chiropractors that allow them to perform minor office procedures or to inject substances into the body. So as not to confuse the issue with an analysis of multiple types of practice acts from multiple states, we’ll focus today on naturopaths in Utah. Why Utah? It has the best example of both a confusing practice act and a practitioner who has stretched that practice act to its limit and way beyond.
A Naturopath as a Spinal Interventionalist?
A few years back, it came to my attention that there was a naturopath in Utah who was performing many X-ray-guided interventional spine procedures. I wasn’t the only one to notice. This was both bizarre and concerning to me. Why? Performing interventional spine procedures can involve placing needles, catheters, and other things millimeters away from important structures, like the spinal cord, spinal nerves, and critical feeder arteries. All of that takes years of knowledge to master and not only a medical degree but also a residency and then years more of training. All of that training is also required to handle the possible complications that might happen with these procedures.
The community of physicians performing regenerative spine procedures was very small at that time, so I asked around and I soon heard how he had been trained. He, of course, was not trained by naturopaths as there were no naturopaths at that time performing these procedures. Instead, he was trained by medical doctors in a stepping stone fashion. Basically, he was trained first in things his practice act clearly authorized and then pointed to his mastery of those things to get trained in things that were less likely to be authorized by his practice act.
This bigger topic of training naturopaths and other alternative-medicine providers actually came up when I sat on the board of a group long known for teaching regenerative medicine procedures. The group at that time was struggling to figure out what to do with the deluge of applications coming in from naturopaths who wanted to be trained. The board agreed that the complexity and risk of regenerative medicine procedures were beyond the scope of naturopathy training.
Naturopathy vs. Medical Training
I have written before that naturopaths are not trained in the same way as medical doctors. Even in their larger institutions, their training clinics deal with minor problems. Hence, they lack exposure to what to do when the proverbial poop hits the fan. Meaning, how to quickly recognize what’s wrong and then how to manage acutely ill patients with a risk of death or permanent harm.
A good resource for this discussion is one of KevinMD’s blogs written by a reformed naturopath. I’ll provide some excerpts from an insider:
“Naturopathic students are not trained in medical standards of care, let alone reality. Instructors would commonly discuss a patient’s “vital force” as if this could magically be detected.”
“Clinical training is mandated by the CNME to be no less than 850 hours of direct patient care. From my clinical training handbook at Bastyr, I discovered this benchmark is attainable only through accounting tricks. For example, time counted when students reviewed a case with peers or when we observed advanced students perform physical exams.”
“Naturopathic clinical sciences, like pediatrics, contained material that would never be taught in medical school. We read Dr. Bob Sears’s Vaccine Book and were lectured on flawed reasons why vaccines should be avoided or delayed. We learned to put sliced onions over a child’s ear for an infection and other folk remedies, like wearing wet socks at night to “boost the immune system.”
It’s worth reading the rest of the piece. So how do you get from here to injecting the spine under X-ray or ultrasound guidance? That’s a great question.
The Utah Naturopathic Practice Act
I’ve chosen to look at Utah’s practice act because it’s not only confusing, but it’s in Utah that we have a naturopath who is practicing interventional spine and surgical procedures involving regenerative medicine. So, on the one hand, we have a practice act designed to allow naturopaths to do things like muscle trigger-point injections of natural substances, like Traumeel, and on the other, we have a naturopath performing things like intradiscal injections using X-ray guidance. So let’s dig in.
This is part of the Utah Naturopathic Practice Act that’s the most important for the analysis:
(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.
(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
So a naturopath can perform minor office procedures. This usually means removing a splinter, taking out stitches, or lancing a boil. However, this is also where it gets very confusing. If the substance is approved by the FDA, then you can inject local anesthetics and “natural substances.” However, for example, in the first part (a), it says you can inject tendons, but in section (b), it says that a minor office procedure can’t involve tendons. However, in neither case are you permitted to inject (or perform a procedure on) nerves, veins, or arteries. In addition, in multiple places in the document, it discusses that spinal anesthesia is off limits.
The Legislative Intent
Note that the word “minor” has clearly been inserted in front of the phrase “office procedures.” Also, note that the word “office” has been inserted in front of the word “procedures.” Both of these are modifiers that only point in one direction.
Those modifiers look something like this in a Venn diagram:
All procedures would include such invasive surgeries as open-heart surgery or knee replacement. Office-based procedures would include things like a mini-needle arthroscopy, mini-liposuction, or bone marrow aspirate. A minor office procedure would be the kind of thing that a physician assistant would do in a family-medicine office or urgent care, like removing stitches or lancing a boil.
When bills involving nonphysicians expanding their practice acts are proceeding toward becoming law or regulation, the legislature often hears from many voices. In this case, this would have included the Utah medical and nursing boards. Almost always, the medical board argues that to protect patients, any use of surgical procedures needs to be very limited. Hence, the words “minor” and “office” used here in the Utah Naturopathic Practice Act. This is a report on this recent 2014 amendment to the Utah Naturopathic Practice Act that added “minor office procedures.”
One of the things that can happen to bills is that they are frequently updated and edited as they pass in and out of various committees. This back-and-forth allows all interested parties to become satisfied. When laws or regulations are later confusing because amendments point in opposite directions, the court system looks at the intent of the legislators. For example, what did they mean by the terms “minor” and “office” here?
If the Utah legislators wanted naturopaths to be able to perform all or anything other than a restricted level of medical procedures, they would have left out the terms “minor” and “office.” Instead, they clearly restricted the scope of practice here. Now let’s vet common regenerative medicine procedures against that restriction.
Vetting the Utah Practice Act Against Common Regenerative Medicine Procedures
There are a number of autologous procedures used in regenerative medicine. Now let’s vet three of those against this act:
Bone Marrow Aspiration (BMA)
Here a doctor places a thick needle into the bone and draws out not only bone marrow aspirate but also peripheral blood, as this space communicates with the peripheral circulation. So is a BMA a minor office procedure? No, absolutely not. For example, the average physician assistant or nurse practitioner working with a family physician would not include BMA as a skill. In fact, only midlevels working in oncology hospitals would have been trained in this specialized skill. Nor would the average family doctor know how to perform this procedure.
Our Utah naturopath performs liposuction. Actually, what he calls a “lipo-aspiration.” However, another name for this is a mini-liposuction. The goal of this procedure is to numb the area and then to forcefully liquify structural tissue so that it can be sucked out through a cannula.
What are the risks of liposuction? Hitting an artery, vein, or nerve and destroying it. Hence, excessive bleeding, nerve damage, and infection. Is this a minor office procedure? No, as again, the average family doctor wouldn’t consider performing liposuction in an office setting. Nor would that family doctor be trained in this procedure.
Reinjection of Processed Autologous Tissues, Like Bone Marrow Concentrate or a Fat Graft
The practice act says that you can inject FDA-approved anesthetics or natural substances into “skin, tendons, ligaments, muscles, and joints.” However, bone marrow concentrate and fat grafts are not “FDA Approved,” but instead are not regulated by the FDA because of the same surgical procedure exemption found at 21 CFR 1271.15(b). Hence, they are regulated by the individual state medical practice acts and not on a federal level. No place in the Utah Naturopathic Act is this type of procedure contemplated.
The Other Side of This Argument
I have been notified through correspondence that Utah naturopaths are relying on a part of their practice act to perform these autologous procedures. Here is the argument as it was relayed to me:
- They begin with the idea that a naturopath can diagnose.
- They then move on to the fact that under 58-71-102(a) it says that a naturopath can “examine in any manner another person, parts of a person’s body, substances, fluids, or materials excreted, taken, or removed from a person’s body.”
- They then conclude that this would include removing those tissues through a bone marrow aspiration or fat aspiration, as well as through spinal taps and even liver biopsies.
Note that the word “examine” is used here. Also, note what is not written. We don’t see the words remove, harvest, draw, take, or withdraw. Meaning, the phrase “in any manner” is modified by a word that means to observe. So a naturopath can look at a person’s body, substances, fluids, or excreted substances “in any manner”.
Now notice that the phrase after that is “taken or removed”. These words are both past tense. Meaning, what isn’t contained here is a description of the naturopath being able to remove these items from the body.
Let’s explore all of this a bit further. If we rewrote this section to make it clear that a naturopath could remove any part of the body to observe it, the wording would look something like this: a naturopath can “remove for the purposes of examination in any manner any parts of a person’s body, substances, fluids, or materials excreted”. However, if this were clarified like this, it could mean that a naturopath could surgically remove someone’s arm to examine that body part. Hence, rewriting this section to make it consistent with the above theory gives naturopath’s full surgical privileges that now conflict with the rest of the statute (i.e. minor office procedures).
In addition, the operative term above is “diagnose.” The purpose of taking these tissues from the patient is not to diagnose anything but, in fact, to reinject them after minimal manipulation as a treatment. So that word severely limits what can be done with these tissues that are removed.
In addition, let’s look at the position of Utah naturopaths that this creative interpretation of 58-71-102(a) permits a spinal tap. How do you get from a minor office procedure to a spinal tap? Especially given that the act clearly sets spinal anesthesia as off-limits? Spinal anesthesia is most commonly the less invasive epidural version of numbing the spinal nerves, while a “spinal tap” is a more invasive “intra-dural” procedure. So if a less invasive procedure is beyond what was contemplated in the act, how is a more invasive procedure allowed?
In summary, it would seem that applying the wording and intent of the act and its restriction on naturopaths to perform only minor office procedures, that complex regenerative medicine procedures were not contemplated. Nor are they authorized through the use of FDA-approved natural substances, given that these procedures are not regulated by the FDA, but instead by state medical boards. In addition, the intent of performing these procedures is not to diagnose but to treat.
In two places in the act, (7(b)(I) and 9(b)(ii)), spinal anesthesia is beyond the scope of a naturopath. However, our Utah naturopath is performing intervertebral disc injections. Given that physician training programs in interventional spine clearly consider these procedures more invasive than spinal anesthesia (epidural injections), this is not consistent with the intent of the act.
As an example, the gold standard for interventional spine education has long been the Spine Intervention Society (SIS). However, note that the group teaches spinal anesthesia in terms of a lumbar epidural injection in its basic lumbar course. However, it reserves intervertebral disc injection for its advanced course. This means that some of the world experts in interventional spine procedures who authored the SIS curriculum consider disc injections riskier than spinal anesthesia.
So we have world experts stating that disc injections are more invasive than the spinal anesthesia that the practice act sees as off limits. That makes sense, as medicine has always ordered its procedures from less to more invasive. Hence, a disc injection is clearly over the line established by the Utah regulations.
Not a Diagnostic X-ray
Utah law includes “taking and using diagnostic x-rays, electrocardiograms, ultrasound, and physiological functions tests” as included in the “practice of naturopathic medicine,” under (12)(a). However, an apt comparison here is the chiropractic practice acts across the country that also authorize the use of diagnostic X-rays. However, none of those practice acts nor the Utah Naturopathic Act contemplate using X-ray to guide needles into the spine. In fact, that’s not a diagnostic X-ray but a whole different animal.
Fluoroscopic guidance is the use of live X-ray beams to guide needles and catheters inside the body. This includes everything from the spinal procedures we’re talking about here to heart catheterization. Nowhere in the Utah practice act is fluoroscopic guidance contemplated. Why? These two things have a completely different risk matrix.
What’s the risk of observing something with an X-ray? Very minimal. It’s also not an accurate comparison to consider a diagnostic spine X-ray the same thing as using an X-ray beam to guide a needle deep into the body. Why? The risk matrix of the latter is drastically different from the former. For example, it’s hard to kill or harm someone with an X-ray performed for diagnostic purposes, but it’s possible to misapply a spinal injection so that it kills or harms a patient.
How Did We Get Here?
In speaking with the movers and shakers in Utah politics many years ago, they all relayed the same story as others around the country who have been involved in many practice act expansions. The argument is always the same. We don’t have enough physicians in rural areas, so adding things like minor office procedures to naturopathic practice allows this need to be met.
First, nothing about how this practice act expansion is being applied in regenerative medicine fits with the intent of allowing naturopaths to perform minor office procedures in rural areas. Meaning, performing expensive cash-based regenerative medicine procedures in wealthy suburbs or ski towns isn’t the same as serving the poor parts of rural Utah. That’s just apples and oranges.
In addition, as I have shown, stretching of the practice act creates a distinct risk mismatch between the minimal risks of the practice act expansion authorized by the legislature and what’s actually happening. Who would police this slippery slope? It could only be either the Utah naturopathic or medical boards.
In the case of the naturopathic board, there is a serious built-in conflict of interest as that board wants to see its practice act expanded. In addition, this naturopath is on the Utah naturopathic board. Hence, it’s more likely than not that his colleagues consider what he is doing as within their scope of practice.
On the other hand, medical boards and societies all over the country weigh in every year to block the practice act expansions of various provider types in order to protect patients. They also prosecute cases against nonphysicians stepping over the bounds of their practice acts. In Utah, the former clearly happened when the bill was being written. This was either by the naturopaths recognizing that they couldn’t get more through the legislature or through an agreement with the medical board. However, the latter hasn’t happened. For example, I know of medical board complaints that have been filed against a naturopath performing invasive spinal procedures, but that board has chosen not to act. They instead are tragically waiting for a catastrophe to happen to test the waters.
Hold That Line
When I was a kid, my mother would bake a raisin cookie sheet only a few times a year. This was a Depression-era special that was like a raisin pie but spread out thin across a cookie baking tin. We kids wouldn’t be allowed to indulge until after dinner, but someone always had a piece during the day, and then we played a game we called “hold that line.” This meant that each of us would slice off just a little bit, moving the line of the raisin cookie sheet an imperceptible amount. The problem was that my mother was watching, and once all seven kids had sliced off a little bit, you could easily tell that her prized confection was being eaten before dinner.
How does this type of authorized and then unauthorized practice act expansion happen? It’s an example of hold that line. First, it’s adding simple prolotherapy joint injections that fit within the scope of practice. Then the next step is prolotherapy spinal injections that are only into the ligaments and tendons of the spine but are likely just beyond the risk matrix contemplated by the act. This is because there is some risk of injecting anesthetics into the spine and getting a dangerous “high spinal” situation that needs to be emergently managed to turn a “really bad day” into “no big deal.” All of that then morphs and stretches to injecting discs because that’s only just one step further.
The upshot? As you can see, Utah is a great example of a naturopathic practice act that has been stretched to its limits and beyond through very creative interpretation. However, it’s not at all unique. The same thing is happening in many other states where naturopaths, acupuncturists, and advanced-practice chiropractors are permitted to perform simple injections. In these cases, only physicians can “hold that line” to protect patients. If you want to learn more, here’s a blog that explores all of the naturopathic practice acts in all 20 states that have an actual written law.