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DENIAL LITIGATION HEATS UP

"It is undisputed among legitimate medical experts that proton radiation therapy is not experimental and causes much less collateral damage than traditional radiation. To deny a patient this treatment, if it is available, is immoral and barbaric." This unequivocal statement from U. S. District Judge Robert Scola in Florida went viral in the legal and proton therapy communities.

With these and other comments, judge Scola recused himself from a suit against United Healthcare for wrongful denial of proton therapy. The judge himself has been diagnosed with prostate cancer and points out that the experts he consulted throughout the country determined that proton therapy was the "wiser course of action" if he opted for radiation.

After several highly visible and sizable judgments against insurance companies, I have found an increase in law firms advertising that they will handle either individual or class action suits for wrongful denial of proton therapy. In the case above, United Healthcare denied coverage for prostate cancer prior to January, 2019, even though on that date they reversed their policy and said they would now cover it. Needless to say the above suit made this an important contention. “This class action lawsuit seeks to require United Healthcare to reprocess claims that were denied based on the pre-January 1, 2019 medical policy for insureds nationwid

If proton therapy is acceptable this year, shouldn’t it have been so last year? DId anything magical change on January 1, 2019, except their mid? Why would United Healthcare keep fighting that case?

Insurance companies always say they base their policy on the latest scientific evidence, but in fact, they are woefully deficient in that area. They use old, out-dated studies or, perhaps, none at all. The quality of their evidence is certainly a weakness that can be exploited during legal challenges. For example, in last year’s twenty-five million dollar settlement against Aetna, the plaintiffs pointed out this glaring inconsistency. Proton therapy, Aetna conceded, is beneficial for children, which they classify as anyone under 19 years of age. And, it is covered by Medicare for those over 65 years of age. But from 19-65 they call it investigational and experimental.

This policy made Aetna look rather silly in court. Yet, here we are with United Healthcare in Florida, and they are saying proton therapy falls into the category of experimental, investigational or unproven services for patients over 19 years old. In another suit for denying proton therapy for cervical cancer, the plaintiffs charged that United Heathcare’s policy relied on "outdated medical evidence, ignores contemporary medical evidence, and relies more heavily on actuarial calculation of risk pools" because it covers the therapy for patients younger than 19 and older than 65.

The attempt to brand proton therapy as experimental and unproven is particularly unfounded, but common. Florida Blue Cross Blue Shield denied coverage for oligodendroglioma (brain tumor), for which there is almost universal agreement that proton therapy is particularly well suited. According to the suit, Florida Blue "never examined (the plaintiff) in person, and robotically applied antiquated written 'guidelines' as if (the plaintiff) was a mere sub-number of a Plan number rather than a living, breathing, real life person." The inhumanity of insurance companies doesn’t play well in front of juries.

Two thirds of proton therapy claims are initially denied. Eventually many of them are approved, but it takes time and expense. Gianelli and Morris (San Francisco) is a legal firm that emphasizes the wrongful stance that particular well-accepted medical modalities are experimental or investigational. The following information (in itallics) is taken from their website. It pertains to any treatment, not just proton therapy.

Whether a particular treatment is investigational or experimental will depend on how it is defined in the health plan contract. One example of such an exclusion is Anthem Blue Cross’s policy provision excluding experimental and investigational treatments. Anthem Blue Cross defines those terms as:

“Experimental or Investigational — any treatment, therapy, procedure, Drug or Drug usage for non-FDA approved indications, facility or facility usage, equipment or equipment usage, device or device usage, or supplies which are not recognized in accordance with generally accepted professional medical standards as being safe and effective for use in the treatment of an illness, injury, or condition at issue.”

Under this language, treatments that are FDA approved and generally accepted in the medical profession as safe and effective should not be denied as investigational or experimental. 

Consider this in terms of proton therapy. It was approved by the FDA decades ago, and also Medicare. Tens of thousands of people have been treated using this technology. Standards are rigorous. One of the reasons proton therapy is more expensive is not just the cost of the installation of the equipment, but also the size of the staff required. Keeping the synchroton in calibration and calculating the dosage and treatment plan, taking scans and using lasers and tattoos for alignment. Such procedures have been developed to a high level of expertise that goes far beyond “generally accepted professional medical standards as being safe and effective.” Here are two cases ths law firm cites that have adjudicated these issues.

Boldon v. Humana Ins. Co., 466 F.Supp.2d 1199, 1212 (D. Ariz. 2006) (health plan’s classification of cancer treatment as “investigational” was an abuse of discretion based in part on evidence of treatment’s widespread use in cancer treatment centers across the United States). Potter v. Blue Cross Blue Shield of Michigan, No. 10-cv-14981, 2013 WL 4413310 (Mar. 30, 2013 E.D. Mich.) (medical literature established “long term” efficacy of treatment).

United HealthCare Insurance Company uses an exclusion in its medical policies for treatments it considers “Experimental or Investigational or Unproven.” The investigational definition merely requires that the treatment have approval from an appropriate regulatory body such as the FDA. The Unproven definition, however, excludes treatments:

“. . . that are determined not to be effective for treatment of the medical condition and/or not to have a beneficial effect on net health outcomes due to insufficient and inadequate clinical evidence from well-conducted randomized controlled trials or cohort studies in the prevailing published peer-reviewed medical literature.”

Well, this is familiar territory. The claim that there are not enough randomized studies to support proton therapy is one of issues facing any new technology.Such studies take time to accumulate. Nevertheless, there are hundreds of studies showing its effectiveness No reasonable person could conclude that the evidence is "insufficient and inadequate." In the Aetna trial in Oklahoma that led to such a large judgment, the jury found Dr. Andrew Chang to be a very convincing witness as to the efficacy of proton therapy. In fact, one of the jurors later was quoted as saying should she ever be diagnosed with cancer, she would seek out Dr. Chang. Aetna, on the other hand, despite its claim of using the best science to determine its policy, quoted out-dated studies which used double scanning technology, rather than the more accurate and up-to-date pencil beam scanning.

X-ray radiologists defending their turf are the ones that make the greatest demands for scientific studies proving the superiority of proton therapy, yet their own technology was adopted and became widely accepted without similar proof. This is more than a double standard, because insurance companies use the critical literature they produce to deny proton therapy and authorize x-rays. As a result of a report issued by ASTRO (a national organization of radiologists) several insurance companies that were accepting proton therapy decided not to cover it.

In Oklahoma a few years ago a law was passed prohibiting insurance companies from holding proton therapy to a higher standard than other forms of treatment. A number of other states have passed or are considering similar laws. One such law, in Tennessee, was vetoed by the governor who was in the pocket of the insurance industry. Now they have a new governor and hope for the bill has improved.

Nor is it always about the cost. I read of a case in which treatment with proton therapy at the Mayo Clinic was denied, even though they charge the same for protons as for photons (x-rays). It’s almost as if the insurance companies don’t want to budge even an inch, in case the hole in the dike of their resistance leads to a flood. However, without a cost difference, they have no defense other than saying it is experimental, which can be easily countered. I find a lot of hope that the insurance industry is going to lose many of these suits. A few class action suits should certainly get their attention. Look at United Healthcare’s turn around with regard to accepting proton therapy for prostate cancer.

Such resistance was common for other modalities, as well. Here Gianelli and Morris give an example.

Companies like Anthem Blue Cross, Kaiser, Aetna, Cigna, Health Net and United HealthCare Insurance Company often deny medical claims using these types of denial reasons. For instance, Anthem Blue Cross, Aetna and United HealthCare Insurance Company have refused to cover lumbar artificial disc surgery despite the fact that the surgery has been FDA approved since 2004 and is frequently performed by renowned surgeons at leading medical centers.

Frankly, at issue is not proton therapy. It’s a battle between profit and health care. The name United Healthcare seems to be an oxymoron. It should be United Profit. It is, of course, the unencumbered capitalistic approachin the United States that results in the cost of our healthcare being twice as much and delivering half the results as the universal care offered in every other industrialized country. Don’t get me started on that.

Here are two cases in which Gianelli and Morris prevailed against insurance companies.

Gianelli & Morris successfully handled a class action lawsuit against Blue Shield of California over that company’s refusal to cover lumbar artificial disc surgery on the basis it was investigational. In Escalante v. Blue Shield of California, Gianelli & Morris won class certification of a class of individuals whose had these claims denied. Escalante v. California Physicians Service dba Blue Shield of California, 309 F.R.D. 612 (C.D. Cal., 2015). That case was later resolved successfully with Blue Shield retracting its “investigational” denial basis and agreeing to cover the surgery.
Gianelli & Morris also won class certification in a case against UntiedHealth Care based upon its refusal to cover artificial disc surgery as “investigational.” Hill v. UnitedHealthcare Insurance Company, United States District Court for the Central District of California, Case No. SA CV 15-0526-DOC.

So you see, it is possible to win against the insurance companies. Yet, only small fraction of those who are denied go on to challenge the decision. When faced with the urgency of cancer patients accept the insurance company's insistance for x-rays as the final word. Knowing this, the insurance companies have made denial their default position, even if their case is being weak and unsupportable. My hope is that denial will cost them dearly, such as the $25MM judgment against Aetna. Perhaps in the end, the cost of litigation and settlements will be higher than just covering proton therapy, and so they will change.

In a number of cases, after being denied, the patient has paid for proton therapy from their own funds, often accumulated from Go Fund Me campaigns and friends and family. In one case, they had four days to come up with $200,000. Then, after the fact, they sue the insurance company for reimbursement. If such a strategy is possible, it avoids the deadly result of their "deny and delay" strategyl. I personally know someone who waited more than six months and then, even though he was approved to receive proton therapy, the cancer had grown out of control and he died withi three months. There is no doubt in my mind that he was a needless casualty to the intransigence of insurance compaies.

My book on proton therapy (Proton Therapy: Revolutionary Treatment for 80% of ALL Cancers) is dedicated to my wife Ruth who died of breast cancer in 2007 after a six-year battle. (Having made it past five years, she was classified as a “survivor.” Not hardly.) Had I known about proton therapy then, instead of the tens of thousands of dollars we spent on alternative treatments (including going to Germany), I would gladly have paid whatever the cost for protons. I think my Ruthie could still have been alive today. Yes, I have remarried and have a wonderful life, but Ruth deserved to live beyond age 62. I became very politicized over our health care system. People are not living longer, they are dying longer.

And so, we continue the good fight. Let me end by quoting an early motto by the Association for Proton Therapy Access. To insurance companies, they say “Fight Cancer, Not Us.” I don’t like to use war metaphors. Winning implies that someone else loses. Why can’t we all work together and have a win-win result in overcoming cancer. Amen.

Just this week I gave a copy of my book to someone whose wife has breast cancer and plans to start radiation in a couple of weeks. Her doctor mentioned proton therapy, but described its strength as if it were a weakness. X-rays, he pointed out, treat the whole breast, assuring that they get the cancer. Protons, on the other hand, only treat little spots here and there, and are likely to miss some of it. Whew. I never heard that argument before. Only treating the cancer and sparing the healthy tissue is proton therapy’s main claim to fame. That someone could make it sound undesirable is an example of the misinformation we get from our doctors. This person does not have the strength or inclination to suddenly go against her doctor and to travel to some distant city to get proton therapy.

I hope very soon to post some blogs that take head on some of the misinformation and fake criticism that is out there about proton therapy. As usual, I won't mince any words. Remember, these are just my opinions. I think they are well based, but be sure to do your research and decide for yourself. When in doubt, get a second opinion from a qualified source.