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More about the Oklahoma / Aetna judgment

April 2, 2019

At the 2019 national conference of the National Association of Proton Therapy (NAPT) in Coral Gables, Florida, in March, one of the sessions was about the large settlement ($25.5 million) against Aetna in a case from Oklahoma, to which I have given quite a bit of space in my blogs. Here is the latest update and legal suggestions.

Two of the attorneys and Dr. Andrew L.Chang were on the panel. The actual case is: Ron Cunningham vs. Aetna Life Insurance Company -- CJ-2015 Oklahoma County State of Oklahoma. The plaintiff charged Aetna with breach of contract for failing to consider the claim for proton therapy coverage in good faith and with fair dealing. It took 3 ½ years to get to trial, which lasted 14 days.

Orrana Cunningham had a complicated Nasopharyngeal Cancer. MD Anderson recommended proton therapy as the ONLY life-saving treatment. Aetna denied the claim through all levels of appeal on the ground that proton therapy was investigational. Ms. Cunningham used other resources to obtain proton therapy. Scans showed the treatment was shrinking the tumors, but but she died shortly thereafter, I believe from encephalitis unrelated to the treatment. (That fact went by pretty fast and I’m not sure I got it right.)

The tumor was located at the base of the skull within 1-3 millimeters of her brain stem. That’s about the thickness of a dime. Adjacent multiple critical structures included her brain left temporal lobe, brain stem, and optic nerves. The dosage needed to kill the cancer was higher than the dose that could be sustained by surrounding tissue.

To kill the tumor: 70 Gy (Gy stands for Gray, a measurement of radiation strength)
Brain stem tolerance: 54-60 Gy
Optic nerve tolerance: 54 Gy
Brain tissue: 65 Gy

Cunningham’s legal team pointed out that without the precision of proton therapy, x-rays would likely produce cognitive problems and cause blindness. They showed two targets with circles. The one for protons showed a hole in the center, indicating its accuracy. The one for x-rays showed little holes all over the target. The latter is what Aetna was willing to cover.

The contract (insurance policy) was very vague. It essentially said a condition is not covered except to the extent that it is covered. Strangely, “accelerated particles,” which includes proton therapy, was actually listed as one of the treatments covered in the policy. Yet they denied the claim saying proton therapy for this type of cancer was investigational, which is defined as “not enough outcomes data available from controlled clinical trials published in peer reviewed literature to substantiate its safety and effectiveness for the illness or injury involved.” Not enough? How many are enough? M. D. Anderson supplied 84 pages of material in support of the claim, including details of many studies that supported the need for proton therapy. Why was that not enough? Did anyone even take those 84 pages into consideration? It looks as if they didn't.

The Cunningham team brought in as an expert witness Dr. Andrew L. Chang from California Proton Center in San Diego. Dr. Chang was on the stand for six hours. He described how protons worked, why they are superior, and why they were the only choice. Further, he challenged that it was investigational, pointing out that no medical source doubted the effectiveness, only insurance companies. Cunningham’s attorneys presented evidence that proton therapy is widely accepted by Aetna for pediatric cancers for people under 21 years of age. It is also covered by Medicare for people over 65 years of age. For those age groups it is not investigational. So why is considered investigational for people age 21 to 65? Aetna’s policy was inconsistent and not defensible.

Aetna’s position seemed to be driven by the Clinical Policy Bulletins (CPBs), which state their particular stance for coverage or lack thereof. These were one area of weakness which the legal team attacked. The jury had to decide if Aetna’s denial was unreasonable. The defense revealed the inner workings of the denial, which convinced the jury that Aetna was indeed being unreasonable. Through the various levels of claims and appeals, six Aetna personnel rejected the claim. All six testified that they had never read the contract (insurance policy).

Three nurses and three doctors made the decision. None of the nurses had any knowledge or expertise in proton therapy. They went solely by the CPBs. None of the doctors had any radiology expertise or experience. They had never treated a single patient with radiation, of any kind. One was a family practitioner, for example, and another a surgeon.

Any exclusions in an insurance policy must by law be displayed conspicuously. When testifying, the medical director was given a copy of the policy and asked to find the exclusion upon which he based his denial. After some time in looking, he was unable to find it until an Aetna lawyer came to the stand and pointed out where to find it.

In saying that x-rays were sufficient, Aetna showed a poor-quality scan of the cancer in black and white. The Cunningham team showed a full color version illustrating by color the strength of the radiation and why that was pertinent. The Aetna document was not a serious attempt to show or prove anything realistic regarding radiation. They were just throwing in a few documents to make a pretense of giving the claim adequate consideration.

If they ever read the 84 pages of presented material, they never mentioned them. Instead they used a study from 2013 which said essentially that proton therapy for . . . cancer of this type is not called for. Looking back to that study to find what was missing in those ellipses (the three dots) it was discovered that the word “routine” had been eliminated. In the Cunningham case, with the cancer smack up against the brain stem, it was anything but routine. Aetna treid to make it look like all types of this cancer weeere not covered.

Aetna said that they keep up to date with technology and update their CPBs accordingly, yet their examples were out dated and not relevant.

For the second appellate review, the doctor considering the claim is supposed to be a match for the patient’s doctor, in this case, a radiologist with knowledge of proton therapy. Such was not the case. The doctor knew nothing about protons. When in a direct conversation with the M. D. Anderson doctor in the supposed peer-to-peer discussion, it became clear that the Aetna doctor was not familiar with proton therapy and seemed to be just reading from the CPB.

It appears that the CPB was the determining factor in the decision to deny the claim, yet the policy holder had never been given a copy. The Aetna head of the CPB department testified. He was a lawyer and a doctor and pretty sharp. He clarified that CPBs are used as a guideline but not sufficient in and of themselves to deny a claim request.

The jury decision was not unanimous (which is not required) because a few jurors wanted the judgment to be even higher.

There is a major barrier to suing insurance companies for bad faith, namely a law called the Employee Retirement Income Security Act of 1974 (ERISA). The case Aetna Health Inc. vs. Davila, 542 U.S. 200 (2004) elucidates these points:

1. The original idea was to protect the policy holders.

2. ERISA supersedes state laws regarding any employee benefit plan.

3. ERISA preempts state remedies including claims for bad faith.

4. Limits damages to the contract amount providing the insurers actions are arbitrary and capricious.

5. The court only considers the record established through the claims process.

The vast majority of insurance cases fall under ERISA. There are, however, several exceptions. One is for government employees. Ron Cunningham is a fireman, who had been a first responder to the explosion at the Alfred P. Murrah Federal Building in Oklahoma City. There he had endangered his life, yet this is how Aetna treated a hero. So said his attorneys.

The attorneys held out some hope of chipping away at ERISA for other cases, arguing that reconsideration of ERISA is in order. Insurance companies design their policies so as to avoid being “arbitrary and unreasonable,” as required by law. The attorneys gave this advice: To challenge ERISA you must have strong appeal letters, show denial is predetermined, and delve into the terms of the contract. In the process, establish a strong record in the likelihood of a Federal appeal:

1. Show how unreasonable insurance company is.

2. Prove their position is not logical or reasonable if based solely on one flimsy CPB.

3. Ask what studies they use for the same cancer to determine IMRT (x-ray) is the best treatment modalityy. If none, then they are holding proton therapy to higher standard by demanding such studies for it and not for x-rays.

4. Establish strong appeal letters.

5. Include a critical review of the CPB.

6. Confirm and detail peer-to-peer conversations.

Elements of a critical review of the Clinical Policy Bulletins (CPBs) include determining the reason for denial, whether it was investigational/experimental or medical necessity. Sometimes they conflate the two. Look for inconsistencies and outdated studies or literature, and whether the insurance company cherry picked just certain details and left out the conflicting ones.

Peer-to-peer conversations are a step in the appeals process, with the client’s doctor making the case for proton therapy. In such a case, request a doctor from the insurance company with experience in the condition and technology being considered. Confirm qualifications and experience. Depending on sate law, record the conversation. Dictate a letter confirming the conversation. Dictate a note in the medical records/chart confirming the conversation. Further, medical standards change frequently. Confirm the insurance company is using up-to-date information.

In conclusion, the attorneys suggested building a record of support for proton therapy, including:

-- A critical review of the Clinical Policy Bulletin, a documented Peer-to-Peer Review, and a stronger Appeal Letter.

-- In addition to improving chances of reversal on appeal, improving these things builds a record that could ultimately be reviewed by a judge or jury.

-- The goal is to establish the unreasonableness of the insurer, whether it be in a state court case like Cunningham v. Aetna or in ERISA cases that happen much more frequently.

-- More decisions against insurers will result in more coverage, but the record must be strong.

Oklahoma has a law that prohibits proton therapy from being held to a higher standard. Specifically:

36.O.S. | 6060.9b
A health benefit plan that provides coverage for cancer therapy shall be prohibited from holding proton radiation therapy to a higher standard of clinical evidence for medical policy benefit coverage decisions than the health plan requires for coverage of any other radiation therapy treatment.

Insurance companies are lobbying every day to influence favorable circumstances for themselves. So should proton therapy advocates. The above statute passed almost unanimously because the legislature was informed about the benefits of proton therapy.

Efforts are being made in other states to do the same. Tennessee seems on the verge of success, although the bill was weakened somewhat. Recently in the news Monsanto was assessed an $80 million judgment because of the cancer-producing nature of Round-Up weed killer. They have thousands of other similar cases pending. Thousands! At some point, they must decide that it isn’t worth it to defend Round-Up and perhaps take it off the market. The same thing should happen to insurance companies that deny coverage for proton therapy. If they know they are facing determined adversaries, if their denials are challenged in court, and if they lose a few costly suits, they may change their policy. Right after the Cunningham trial, Aetna changed its position on another appeal and approved proton therapy. Let’s all keep up the pressure. United Healthcare recently removed proton therapy from the investigational list for prostate cancer. That’s progress.

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Meanwhile, you may want to check out our two other related websites:
This is dedicated to Robert Ferre's book Best Prostate Cancer Treatment: Proton Beam Therapy. It has updates and additional information, photos, and more.
This site has an up-to-date list of proton therapy centers in operation in the United States, as well as a number planned or under construction.

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