Medical insurance companies routinely deny coverage by declaring a procedure or drug to be experimental, but what exactly do they mean? Is there an objective definition, and if so, is it reasonable or at least understandable? Does it serve the insured (i.e., the patient), or is it a moving target used as a tactic to serve the insurer?
Despite my innuendo, let’s be fair and set aside any preconceived answers and explore this anew together. For the sake of argument, let’s stipulate that insurance companies cannot be expected to pay indiscriminately for everything, and that an evenhanded policy of denying coverage for anything truly experimental might be reasonable. Let’s also make our discussion concrete and specific by focusing on the unfortunately handy example of proton beam therapy (PBT), often denied coverage for this very reason.
On the surface, we have merely to ask whether PBT is experimental. If so, by our assumptions above it would be reasonable for insurers not to cover it. But this begs the question: what exactly is meant by experimental? We’ll certainly need a specific answer before determining whether it applies to PBT or for that matter, any therapy, procedure, or drug.
There are two avenues for seeking an answer to this fundamental question of semantics. We can ask insurance companies to provide a definition of experimental, and we’ll do that later. First, let’s explore the objective definition used by everyone else—the one in the dictionary. I arbitrarily chose The Oxford Dictionary, which includes two possibly relevant definitions of experimental summarized here:
- based on untested ideas or techniques and not yet established or finalized: an experimental drug
- relating to scientific experiments: experimental results
Let’s examine the second one first. Does PBT “relate to scientific experiments,” thus producing “experimental results?” What exactly is an experiment? Again turning to Oxford, a scientific experiment is either a “procedure undertaken to make a discovery, test a hypothesis, or demonstrate a known fact.” Alternatively, it is a “course of action tentatively adopted without being sure of the eventual outcome.”
Testing a hypothesis?
… every proton patient and their doctor are most certainly expecting to demonstrate what they regard as a known fact: that PBT can kill cancer with minimal risk
Are PBT patients and physicians endeavoring to make a discovery or test a hypothesis? Surely that is not their main motive, if it’s one at all. But every proton patient and their doctor are most certainly expecting to demonstrate what they regard as a known fact: that PBT can kill cancer with minimal risk of side effects. In other words, it works. Well, isn’t that the same “fact” every cancer therapy claims and attempts to demonstrate with each patient? On that basis, all therapy would be experimental and none would pass the insurance companies’ litmus test, leaving insurers with nothing to insure.
As for the alternative definition, we must ask: Is PBT administered “without being sure of the eventual outcome?” Absolutely, and again, so is every therapy. We can never be sure of the eventual outcome, no matter how confident we may be. We weigh the risks of what are understood to be possible or likely outcomes, and continually refine our understanding of those by collecting and evaluating new data. But not even insurance carriers would suggest that all medical treatment is therefore experimental just because outcomes cannot be guaranteed. If that were the case, insurers would all be job hunting.
Whichever way we view it, Oxford’s second definition cannot be very useful to patients, doctors, or insurance companies, with one possible exception. Researchers and practitioners of proton therapy—or any other legitimate therapy—are continually seeking ways to improve the likelihood of positive outcomes. They tweak their mainstream protocol in small manageable increments, hoping to achieve a more effective, more convenient, less risky, less costly, overall better variation of their established approach.
For proton beam therapy, we are interested in whether fewer treatments of increased dosage (hypofractionation) would work as well or better than the current approach. We are interested in whether combining PBT with other therapies would produce even better results. When these and other variations and combinations are offered to patients, we usually call it a clinical trial. As defined by the World Health Organization, a clinical trial is “… any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
… they can say no to proton if they say it’s experimental when it’s not, but legally they must say yes if it actually is experimental as part of a research study.
Ironically, our current health legislation does not allow insurers to “deny coverage of routine costs to patients who choose to join an approved clinical trial,” as reported on Cancer.net. So insurers apparently can deny coverage for PBT if they call it experimental, but if a PBT variation is part of an approved trial that actually is experimental by its very nature, they cannot deny coverage. So let’s see … they can say no to proton if they say it’s experimental when it’s not, but legally they must say yes if it actually is experimental as part of a research study.
Untested? Not established?
Let’s continue by looking at Oxford’s definition#1. To be experimental by that definition, PBT must be “based on untested ideas or techniques” and “not yet established or finalized.” Untested? Many thousands of proton patients have been treated during more than a quarter century, so these techniques have undeniably been tested. Let’s not waste any more time on that notion.
But are proton therapy techniques established? If not, then what exactly are all those new proton facilities planning to do? What are they building? What are proton equipment manufacturers like IBA, Varian, Mevion and others selling them? The ever-increasing number of proton facilities worldwide and the millions of dollars they are spending to build state-of-the-art treatment centers is ample proof that the techniques of PBT are established.
… are proton therapy techniques established? If not, then what exactly are all those new proton facilities planning to do?
With regard to whether proton therapy is “finalized,” well of course not—at least in the broadest sense. As already stated, PBT is continually evolving, getting better and better. New ideas, new techniques, new technologies, clinical trials … nope, not done yet. But the mainstream protocol for delivering proton beam radiation? Yes, that’s pretty well established and we can reasonably say it’s finalized.
Objectively speaking—by the Oxford Dictionary definition—proton beam therapy is not experimental. But as we’ve seen and as some patients have experienced firsthand, that doesn’t really matter. Insurance companies can still say it is, and that’s exactly what they do. Then they use that label as an excuse to deny coverage.
What is their definition? The glossary of terms on the Medicare.gov website does not include experimental or its first cousin, investigational. So we’ll find no help there. However, I did find definitions from several private companies (United Health Care, Blue Cross Blue Shield, Molina, etc.). Some descriptions are more detailed than others, but the common thread is reference to a procedure’s acceptance by the “medical community.”
The Medicare Advantage plan my former employer offers retirees includes this fairly typical statement: “Experimental procedures and items are those items and procedures determined by our plan and Original Medicare to not be generally accepted by the medical community.”
They can use their conveniently vague definition to dismissively claim PBT is experimental, and we are left running around chasing rabbits as we try to prove it’s not.
Now, we could go down the rabbit hole of trying to figure out exactly where to find the “medical community” so we can ask it some questions. We could parse the words and look for clarity about what is meant by “generally accepted.” And we would surely like to know how “our plan” makes the determination referenced in the statement above. But why bother? They can use their conveniently vague definition to dismissively claim PBT is experimental, and we are left running around chasing rabbits as we try to prove it’s not.
There is no law against redefining or misapplying words to suit an agenda. Politicians do it all the time. We can debate and discuss why insurance companies do this—calling PBT experimental when objectively it is not—but again, it doesn’t matter. Insurers are intentionally misusing language to mislead the public. Magicians would call this technique misdirection. Instead of talking about the merits of proton therapy, we are discussing whether it can properly be called experimental.
If we point to an objective definition and “prove” that proton therapy is not experimental, insurance companies would likely respond with something like, “well, that’s not what we mean by experimental.” Of course. Clearly what they mean is “arbitrarily not covered for reimbursement.” Why don’t they end the confusion: instead of making up their own definition of a word we already understand to mean something else, take a more honest route and create an entirely new word. Why not just say that PBT is inconsurant or some such thing? Their word, their definition … not debatable.
We should not pretend insurance companies exist to promote or protect our best interests, regardless of the smoke and mirrors they use to convince us otherwise via clever marketing. Like any business, they necessarily and rightfully seek a healthy bottom line by increasing revenue and decreasing costs. Their objective as a business is to pay out as little as possible in the short-term and to a lesser degree, throughout the years. Our objective as a patient is to receive the best treatment available for our condition in order to have as many years of quality life as possible.
… let’s at least remain clear that we do not want our health insurance company to provide medical advice that somehow trumps that of our doctors.
These are often conflicting agendas, and both cannot always be satisfied. In that case, we patients generally lose because we have no real leverage. We can’t easily move to another insurer who has a friendlier definition of experimental or a better proton policy. The result is that many patients who could benefit from the unique characteristics of PBT must instead settle for their second choice.
This experimental exclusion often compromises the recommendations of our trusted medical team, and is understandably frustrating to them as well as to their patients. After all, they are the medical experts we’ve asked to guide us. If we have become confused about what is experimental, let’s at least remain clear that we do not want our health insurance company to provide medical advice that somehow trumps that of our doctors.
I highly recommend reading the outstanding article by Steven J. Frank, MD, who eloquently tackles a closely related and widely debated misuse of language by insurers. His frustration with their misapplication of “medical necessity” has similarities to our exasperation with their misuse of “experimental.” After a thorough and engaging discussion, he offers this partial solution: “… we need a consistent definition of medical necessity and uniform coverage that ensures patient access to proton therapy when that therapy is recommended by multidisciplinary medical teams.”
I couldn’t agree more. We also need a consistent definition of experimental—especially if that label is to be used to deny coverage for proton therapy when patients and their trusted urologists, oncologists, physicists, and other medical experts agree it is the preferred therapy for them.
So where does that leave us? It’s actually pretty simple. If the policy of an insurance company is to evenhandedly deny coverage for experimental therapies, then there are only three possible conclusions, one of which must apply:
- If proton beam therapy is experimental, then so is every therapy and none should be covered.
- If mainstream PBT is not experimental, then it should be covered in the same manner as any other therapy.
- If insurers can say PBT is experimental whether it is or not, then they can arbitrarily deny coverage whenever they choose.
An alternative challenge
If insurance companies will not or cannot agree on a consistent definition of experimental to share with the rest of the world, then I have a suggestion. Tell us instead how they determine when a drug or therapy is not experimental and therefore worthy of coverage. If they’ll at least do that, we can work it backwards from there.
I will close with another quote from Dr. Frank, who wrote, “If we wish to defeat cancer once and for all, all parties—both doctors and insurers—must finally unite in support of best practices such as proton therapy.”
There is no better way to say it.
Is proton experimental, or are insurance companies playing semantic games? with your views!