Here we are, decades beyond the first use of proton beam therapy in a clinical setting in the US, and insurance companies still call it experimental. For me, this is annoying. For those who want proton therapy but are denied insurance coverage because of its “experimental” status, this is much worse than merely annoying. When a cancer patient who recognizes proton therapy as their best option for controlling their cancer while minimizing the risk of side effects is told they cannot have it, the denial can be devastating.
Inspired by yet another insurance rejection in the news, I am compelled to revisit the topic a second time. “A federal judge granted Blue Cross Blue Shield Association’s motion to dismiss a lawsuit” filed in Texas by a patient with a tumor in her lower left abdomen, according to Becker’s Hospital Review. “BCBSA had deemed the treatment experimental.” The Texas judge said, “claims in the lawsuit were preempted by federal law.”
Well, maybe so. What I question is not which court has jurisdiction over this or similar disputes. I want to know how BCBS and other insurers can still get away with deeming proton therapy experimental, and why the courts back them up.
I read the article, shook my head and thought, “Really? Still experimental? What’s it going to take?” My precise question is: What exactly must happen for proton therapy to lose its designation as “experimental?” How can we proton advocates satisfy this objection once and for all? Unless we do, insurance companies will continue using this ridiculous excuse to deny reimbursement.
My precise question is: What exactly must happen for proton therapy to lose its designation as experimental?”
But of course, they are not going to tell us how, and they themselves may not know or care. Why should they bother expending any energy on the question? Why even acknowledge that it is a question? “Experimental” is working beautifully for them. It is our problem, not theirs. For them, if it ain’t broke …
But for us, it is broke. How can we fix it?
Because I said so
As a young child I would frequently ask my mother for many things—an extra cookie, an extended bedtime, permission to go to a friend’s house, etc. She alone had the power to grant or deny such requests. Of course, with each denial I would respond with the classic mantra, “But why, Mom?” to which she would sometimes respond, “Because I said so.” Case closed. I was left with no way to argue the point.
This is one hundred percent analogous to the exchange between a patient and their insurance carrier. In both cases denial is, at its essence, arbitrary. Without explaining why proton is considered experimental (or why she said so), “because it is experimental” is no different than “because I said so.” This was infuriating as a child and is worse than disheartening for an adult seeking their preferred cancer therapy.
Without explaining why proton is considered experimental … “because it is experimental” is no different than “because I said so.”
My seven-year-old self had little choice but to accept Mom’s summary judgement as final. A seventy-year-old fighting cancer need not be as quick to concede. We can appeal and ask the insurance representative to begin a discussion by clarifying why proton is experimental, but the answer will be predictably vague and useless. If it were otherwise, they will have handed us exactly what we need to build our case.
Our only option
We must acknowledge and accept that it delusional to expect insurers to provide us with a winning strategy to successfully challenge them. As long as they can get away with labeling proton therapy as experimental, they can and will refuse reimbursement and the courts will usually concur. And having no clear definition of why proton is experimental, how can we argue that it is not? We are left without a well-defined path for rebuttal.
We must disprove every imaginable excuse for labeling proton therapy as experimental.
What are we to do? What can we do? We must disprove every imaginable excuse for labeling proton therapy as experimental. We must give the courts every justification they need to reverse a denial of coverage. By providing evidence to dispute any and every so-called rationale that proton therapy is experimental, siding with the patient can become the court’s path of least resistance. I realize this is somewhat wishful thinking, but what the heck … let’s wish. There is nothing to lose.
So let’s do it. Let’s knock down every plausible justification, one by one. I can think of five, but if I missed one, let me know.
FDA Approval?
This is a simple yes-or-no litmus test of sorts. Until a medical product or drug has full FDA approval (excluding clinical trials), we can graciously concede that it might reasonably be considered experimental. At least in this country, the FDA is the authority for approving which products and drugs are legally permitted.
Fortunately, our answer is easy. Proton therapy became legal in 1988 when the Loma Linda Proton Beam Therapy System—a synchrotron-based system—won FDA approval. More recently, the Proteus One cyclotron-based system from IBA was approved, and there are others. Proton is FDA-legit.
There are also innovative clinical trials for new approaches to proton therapy delivery, but there is no denying that proton therapy—whether via synchrotrons or cyclotrons—is FDA approved. So at least by this standard, proton cannot be regarded as experimental.
Proton is FDA approved, so proton is safe and effective. Does that sound like an experiment?
From their own website: “FDA makes sure medical treatments are safe and effective for people to use.” Proton is FDA approved, so proton is safe and effective. Does that sound like an experiment?
Limited availability?
If a therapy were provided only in a single facility, one might regard it as a pioneer, and maybe also a test site. Even McDonald’s began with a single location, pioneering a new era in fast food while experimenting with precisely how to make it work most effectively and efficiently. Likewise, a new therapy typically begins with one location conducting the first clinical trial, and the first of anything is perhaps experimental by definition. Someone must pave the road for those who follow.
Well now, let’s think back. There was certainly a time (1990) when proton therapy in a clinical setting was only available in one place. In the U.S. it was in California at the Loma Linda Proton Therapy Center—universally recognized as a proton pioneer. But now there are well over thirty US facilities offering proton, and the list is growing.
If proton therapy is still experimental, it has become an unbelievably gigantic experiment that everyone wants to get in on. There are dozens of existing and planned proton centers throughout the US, as well as several large international manufacturers of proton equipment competing to supply new facilities and upgrade existing ones. Worldwide, proton capability is becoming a must-have option for leading cancer centers.
If proton therapy is still experimental, it has become an unbelievably gigantic experiment that everyone wants to get in on.
The pioneering days of proton therapy are behind us, and it would be hard to argue otherwise. Proton therapy is now routinely offered as “standard of care” in dozens of proton centers worldwide. There is no way to justify labeling it as experimental based on lack of routine availability. Proton therapy has arrived in a big way and is clearly here to stay.
Too new?
There is often an experimental aspect to just about anything brand new. This year’s newest Ford pickup truck has no track record, so we cannot be totally sure how it will perform. Although it is built on decades of experience, it is still a bit of an experiment. Because something new has no history, there is necessarily an element of uncertainty about it. It might even be regarded as experimental.
We cannot know the long-term prospects for any new, innovative idea, product, or service. A new style of music might become the next big thing or quickly fizzle out. A new form of currency (Bitcoin?) might transform financial markets or become a passing fad. A new type of vehicle could render traditional automobiles obsolete or go nowhere at all. A new book could become a classic or a handy source of kindling. Some new things succeed, some do not. Some thrive and survive, while others fail to meet expectations and disappear.
But what exactly constitutes being new? By definition, it is a matter of timing. We must determine when it—whatever “it” is—can no longer be considered new. A week? A month? A year? A decade? There must be a time limit for “new” because otherwise “new” ceases to have any meaning at all. When Progresso labels a soup as new, it grabs my attention. But if they never dropped the term from their latest variety, eventually all their cans would say “new,” which would render the term meaningless.
If insurers want to call proton experimental because it is too new, fine. Tell us when it will no longer be …
So when is a cancer therapy no longer new? Surgery was once new, and now it is not. Conventional radiation … same. While there is no legal time limit, there must certainly come a time when proton therapy is no longer regarded as new. If insurers want to call proton experimental because it is too new, fine. Tell us when it will no longer be regarded as such. The courts can ask that question, and I am guessing that thirty years is a reasonable limit. Calling proton new after decades of use is absurd.
Uncertain Outcomes?
Similar but not identical to the “too new” excuse, could proton be thought of as experimental because we cannot be 100% sure of the outcome? We can never say with complete certainty that it will control the cancer with no side effects or secondary cancers forever, or at all. The odds are excellent, but the results are not guaranteed.
Well, this is the nature of medicine. If insurance companies cite uncertain, unguaranteed outcomes as reason for proton’s experimental status, then they must not stop there. To be consistent, they must also classify surgery, conventional radiation, and every existing cancer therapy as experimental. None represents the silver bullet we all wish for. None has a guaranteed outcome.
Should insurance companies cease reimbursement for all cancer therapy? Are the courts willing to require patients to self-pay for all cancer-fighting tools in our present-day arsenal until the silver bullet is found? If a treatment cannot guarantee to provide perfect results forever, does that mean it is little more than an experiment unworthy of insurance coverage?
Too limited?
Is proton therapy a niche procedure, potentially helpful to relatively few patients? Is it on the fringe of mainstream cancer therapy, only applicable to a tiny fraction of the arena in which it plays? If it is seen as narrow in scope and rarely useful, then someone might legitimately wonder what this seemingly outlier therapy is all about. They might view it as a small experiment with limited application and few patients. Does proton fit this description?
Nope. Not niche. Many applications. Tons of patients. A quick inventory of cancers treatable with proton therapy includes not only prostate cancer, but also breast cancer, pancreatic cancer, brain tumors, lungs, sarcomas, throat, eye, head, neck, liver, and more. No, proton therapy is not fringe. It is mainstream. It is used to treat a long list of cancers.
And how many patients are enough? Let’s tally the count at just five of the leading proton centers in the US. Loma Linda, 17,500 proton patients. UF Health Proton, 8,700. Mass General, 10,000. MD Anderson, 9,300. Penn Medicine, 6,000. Let’s see … that’s over fifty thousand patients treated so far at just a handful of centers.
Which insurance company wants to claim that tens of thousands of people are serving as guinea pigs in a massive proton experiment?
Which insurance company wants to claim that tens of thousands of people are serving as guinea pigs in a massive proton experiment? Come on, now. Don’t be shy. Raise your hand.
Too many excuses
I suspect that some of you might be tempted to say it’s all about the money, and maybe it is. But even if true, this cliché distracts us from the fact that for a patient in need of proton therapy, it’s all about their life. They need a concrete strategy to reverse denials of reimbursement from insurers, so I have offered one here. I am not a lawyer, so please think of this as a layman’s blueprint to argue that proton is not experimental.
I also know that even after contemplating the above five faulty rationales for declaring proton therapy to be experimental, you might reasonably ask, “Ron, why not just check the definition? Wouldn’t that be easier? First check the dictionary, and then find out how the insurance companies themselves define it.” Well yes, I could do that, and I took the linguistic approach about five years ago in my article, Examining the Anti-Proton Experimental Exclusion Policy. Yet, here we are again, still stuck with the label.
Classifying proton therapy as experimental is just one of the unsupportable excuses used to deny insurance reimbursement. The other two in the top three are “it’s no better than other, cheaper therapies,” and “it’s not considered medically necessary.” Maybe we should adopt similar strategies to fight those misguided assertions, compiling our own lists of rebuttals for every conceivable rationale, taking our lists into court when necessary.
When doctors and patients agree that proton therapy is their best hope, insurance companies—who universally claim to have the patient’s best interest in mind—should ditch the excuses and get on board.
Because I said so is not a good enough reason to stand in a patient’s way.
I listed 5 rebuttals to “experimental.” Did I miss one? Email me!
Want more on this subject? Read my earlier articles:
Examining the Anti-Proton Experimental Exclusion Policy
See Ron's 2023 book!available now on Amazon Already read it?Review it now on Amazon
