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RESOURCES FOR LEGAL CHALLENGES
TO INSURANCE COMPANY DENIALS


In the wake of a jury verdict awarding $25,500,000 to a defendant who believed his wife’s death was caused by wrongly delaying coverage for proton therapy, I was not surprised to receive an email from an attorney looking into more litigation and asking for my opinion and help. I gladly provided some resources and my thoughts on the subject. I am now making information available here for whomever may find a reason to use it.

Insurance carriers deny coverage for proton therapy by taking the following positions.
1. Proton therapy is new and still experimental.
2. There aren’t enough studies to confirm it will do a superior job
3. It is not medically necessary as other modalities do just as well.

Which lead to these questions:
4. What value do they place on reduced side effects and better quality of life?
5. In the long run, is proton therapy that much more expensive?
6. What experts are insurance companies listening to regarding proton therapy?
7. Are those who deny claims knowledgable and qualified to make such a determination?
8. Are claims to cover proton therapy given proper consideration?

And this conclusion:
9. There is no consistency between insurance companies concerning their assessment of proton therapy, for the same diagnosis, or even within the same geographical area.

AETNA VERDICT

https://www.cnn.com/2018/11/10/health/aetna-verdict-oklahoma-orrana-cunningham/index.html
Jury delivers $25.5 million 'statement' to Aetna to change its ways

This CNN Health News article describes the Aetna verdict. The jurors made it clear they did not believe Aetna gave proper consideration to the merits of proton therapy. Its “ways” are the crux of the suit. The case revolved around the 2014 denial of coverage for Orrana Cunningham, who had stage 4 nasopharyngeal cancer near her brain stem. Aetna denied her coverage, calling the therapy investigational and experimental. Cunningham raised the funds to get proton therapy and the treatment showed signs of shrinking the tumor, but the long delay resulted in an infection that killed her.

The jury foreman said she believed that Aetna's medical directors "rubber-stamped" the denials without doing their due diligence. "No one was looking at her specific case," she said. "That's where we decided that obviously they were in breach of contract and should've paid for that treatment. It was medically necessary in her situation.” The jury hoped the verdict would cause Aetna to change its ways. Yet at the end of the trial, the attorney for Aetna bragged that they would win on appeal. Likely the determination will drag out for many years. In my opinion, insurance companies are so used to having their own way, they are haughty and out of touch with reality. Maybe a few verdicts like this will in fact lead to change, as the jury hoped.

HOW PROTON THERAPY WORKS

Before discussing medical necessity, it is important to understand the way proton therapy works. Here is a link to my brief description: http://www.proton-beam-therapy.com.

1. Protons are more accurate than X-rays, less invasive than surgery, and more targeted than chemotherapy.
2. Protons hit their target and then stop, unlike X-rays that go right through the whole body.
3. Protons do minimal damage to surrounding tissue and organs, which makes it the right treatment in places that X-rays and surgery fear to go.
4. Pencil beam scanning (PBS) is a type of proton therapy that delivers the dose in rows and layers of spots conforming to the targets, which do not need to be contiguous. Here is an example.



Note above the two colors of marbles. As long as some form of imaging can distinguish the white from the red marbles, pencil beam scanning could treat all of the red marbles and spare the white ones. Or vice versa. You can't do that with X-rays or surgery.

MEDICAL NECESSITY

It probably won’t stand up to say proton therapy is investigational, as it has a twenty-eight year track record of success and thirty years of research prior to that. So denial must eventually get down to medical necessity. If X-rays can kill the cancer just as well, why pay much more for proton therapy? The answer is: X-rays cause more damage to healthy tissue than proton therapy. Such was the important issue in the Aetna/Cunningham case.

Some jurors said that one of the most convincing experts was radiation oncologist Dr. Andrew L. Chang, who explained why proton beam therapy was the best treatment for Orrana Cunningham. He was not involved in her care but was called as an independent expert by her attorneys. Dr. Chang has extensive experience with proton therapy, currently working at the proton center in San Diego (see https://www.californiaprotons.com/team-member/andrew-chang-md/). From the CNN article:

"The thing I tried to illustrate to the jury is that proton therapy is not a new, experimental technique, like Aetna wants to claim," Chang said. "Proton therapy is a well-established treatment for cancer and has been for decades....Nobody in the oncology community considers proton therapy experimental for the treatment of cancer."

This is key. Those who work with protons, and those who have received proton therapy, know its benefits. The critics, and those who deny coverage, have not had direct personal experience. To them it is theoretical.

In Orrana's case, Chang said, the tumor was right next to her brain stem and optic nerve, and it had been growing up toward the base of her skull. He said he told jurors that standard radiation could've been used, as Aetna wanted, but the "risks were severe."

"She would go blind. She would lose a significant portion of her memory on the left side of her brain and still not have a very good chance at a cure," Chang said. "For her particular tumor, [proton therapy] was extremely valuable."

Does Aetna care if Cunningham goes blind or loses her memory? Or if men getting treated for prostate cancer lose their sexual function or control of their bladder or bowels? Probably not, if it means shelling out more money. This is where many many proton therapy oncologists experience frustration that their expert opinion and recommendations are overruled by the insurance companies. One group of people that may be hard to find are the ones who accepted the treatment demanded by the insurance company instead of receiving proton therapy. What side effects have they had to endure? Delay was what led to the infection that killed Cunningham. I personally know of a man who fought Cigna for months, finally receiving proton therapy, but for him, too, it was too late and he died several months later.

Once diagnosed with cancer, patients are eager to begin treatment and not disposed to go through a long battle. Insurance companies take advantage of that urgency at the patient’s expense.

Aetna said in a written statement. "As our chief medical officer noted in a post earlier this year, it's never easy to tell an individual or family that a treatment or procedure is not approved -- it's the hardest thing we have to do. However, our guiding principles will continue to be proven effectiveness and member safety, as determined by rigorous scientific studies."

The lack of sufficient studies is another tactic used to deny proton therapy. More on that in a moment. Meanwhile, here is a link regarding medical necessity.

https://www.ajmc.com/journals/evidence-based-oncology/2016/august-2016/proton-therapy-eliminates-unnecessary-radiation-exposure-and-is-medically-necessary
August 2016
Proton Therapy Eliminates Unnecessary Radiation Exposure and Is Medically Necessary
Steven J. Frank, MD

(Steven J. Frank, MD, is medical director of the MD Anderson Proton Therapy Center, and associate professor, Department of Radiation Oncology at The University of Texas MD Anderson Cancer Center. He knows what he is talking about. Here are a few slightly condensed paragraphs from his article.)

“Picture yourself as having just received a diagnosis of cancer. After the immense shock of hearing that diagnosis, you consult a doctor about the path that lies ahead. A medical team consisting of a surgical oncologist, a medical oncologist, and a radiation oncologist weigh the most recent clinical evidence to date, and prescribe proton therapy to treat the cancer. This seems like great news because proton therapy is a highly precise form of treatment that can specifically target and destroy cancer cells while eliminating unnecessary radiation exposure to surrounding healthy tissues.

“At that point, the anxiety over the cancer diagnosis and potential outcomes is tempered by having an established treatment plan, but suddenly, your insurance company slams on the brakes. With no reasonable explanation, you discover that your health insurance will not cover proton therapy. Or, worse yet, the company says the treatment—despite the guidance of an informed group of the world’s leading oncologists—is not “medically necessary” and is deemed experimental.” The fear, disappointment, and frustration are indescribable—now, your focus must shift from preparing for a life-changing battle against cancer to fighting your own insurance company.

“Now picture the same scenario from the doctor’s perspective—something I experience time, and again. As a physician, I am frustrated when insurance companies respond with indifference toward what our oncology team, the experts in state-of-the-art cancer care, have considered, reviewed, and recommended. Not only are my patients denied care that is critical to fighting their cancer, but now I must take time away from other patients to get on the phone and start lobbying with the insurance company on my patients’ behalf. For each individual patient denied coverage, I explain our medical team’s cancer care management plan to the insurance company and the published data that support our decision. Insurance company representatives usually have little, if any, experience with oncology, let alone highly advanced forms of radiation or proton therapy. Consequently, patients’ access to cancer treatment is often limited by insurance panels that do not understand proton therapy or have expertise in the field of radiation oncology.”

Medical necessity, Frank suggests, is compromised when financial considerations get in the way. Inconsistency is another issue. M. D. Anderson conducted a survey of insurance companies in Texas and what their definitions were of medical necessity. Here is the link to that study: http://theijpt.org/doi/pdf/10.14338/IJPT-15-00029.1. In my book I give the following summary:

Purpose: The definition of medical necessity and indications for coverage of proton beam therapy (PBT) for the treatment of cancer can vary greatly among different professional societies (PSs) and payors. Variations in policies introduce substantial inefficiencies and limit access for patients who may clinically benefit from PBT. The purpose of this study was to analyze differences in medical necessity and coverage policies among payors and a PS.

Results: Proton beam therapy coverage in the state of Texas varied among payors and the PS for several disease sites, including the central nervous system, eyes, and prostate. The PS cited more references and higher levels of evidence than payor policies (P < .01). Levels of evidence were inconsistent between policies. Interestingly, only 18% to 29% of cited references overlapped between policies.

Dr. Frank says, “The solution to this part of the problem is clear: 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.”

COST OF PROTON THERAPY

A number of studies have shown that in the long run, because of fewer complications and shorter, more effective treatment, proton therapy costs no more than X-rays. Dr. Frank made this statement:

“Still more frustrating in the ongoing arguments over proton therapy is evidence showing that coverage of proton therapy could actually reduce healthcare costs. The episodic cost of care can be reduced when proton therapy decreases the amount of radiation to parts of the body that are not affected by the cancer by eliminating or reducing the severity of treatment-induced acute and long-term side effects and by reducing the risk of secondary cancers….Using advanced radiation therapy technologies like proton therapy can reduce postoperative complications and shorten hospital stays, which reduces healthcare costs.”

A study by MD Anderson Cancer Center revealed that proton therapy is a cost-effective treatment for early-stage breast cancer, compared to other therapies. The study found that the cost of proton therapy when used for accelerated partial breast irradiation (to decrease overall treatment time and toxicity) was estimated at $13,833. By comparison, intensity-modulated radiation therapy (X-rays) for whole breast irradiation was $19,599. For more information, see: https://www.scripps.org/news_items/5030-study-reveals-proton-therapy-for-breast-cancer-is-cost-effective.

Four proton therapy centers charge the same for proton therapy as for X-rays. They are the two Mayo Clinics, the University of Pennsylvania, and the University of Maryland. Even in such cases, where cost isn’t an issue, the insurance companies still balk, claiming that it is untried, there aren’t enough studies, and that it is not medically necessary. I think they don’t want to say yes and then open the dam. One observer noted that virtually all insurance companies offer coverage for proton therapy to treat pediatric brain cancers, which have not been treated any longer or differently than other forms of cancer. Why is it okay for one cancer and not for another?

Thomas R. Bortfeld and Jay S. Loeffler wrote an article entitaled Three ways to make proton therapy affordable. The three ways are: Shrink accelerators, sharpen beams and broaden health-care coverage so more people can get this type of radiation treatment. Wouldn't it be ironic if by covering proton therapy insurance companies would contribute to their success, which in turn would help to create more efficiencies and lower cost. Here is the link to the article: https://www.nature.com/news/three-ways-to-make-proton-therapy-affordable-1.22660

OTHER PROTON THERAPY RESOURCES

I am not the only proton therapy advocate out there. Ron Nelson received proton therapy and has a website on which he publishes articles. Here are two of his articles regarding insurance coverage.
http://afterproton.com/examining-the-anti-proton-experimental-exclusion-policy/
http://afterproton.com/the-death-of-health-insurance/

In the second article, Ron makes a good point. Why does the decision by insurance companies have to be all or nothing. Why can’t they determine how much they will pay for each kind of cancer and give you that amount. If proton therapy is more than that, you need pay only the difference. When your car or your house are damaged, the insurance company determines the reimbursement, but doesn’t monitor how you spend it. Medical insurance seems to work by completely different rules, which is why Ron questions whether they are insuring anything at all.

As part of the treatment for prostate cancer, a balloon is frequently inserted into the rectum and filled with saline water. Robert Marchini started an organization fifteen years ago entitled Brotherhood of the Balloon (BOB), which has grown to over 7,000 members and frequently covers the subject of insurance. It also has numerous articles about important studies on proton therapy. http://www.protonbob.com

The government keeps tracks of tens of thousands of clinical trials, including proton therapy. These won't have the results yet, but shows the extent of the interest. http://www.clinicaltrials.gov

The National Association for Proton Therapy was founded in 1990 when the first proton therapy center opened in Loma Linda, California. They have a ton of information. http://www.proton-therapy.org

The best source I have found for studies on proton therapy is PubMed, a resource provided by the federal government. https://www.ncbi.nlm.nih.gov/pubmed

I went to the website and searched under proton therapy. There were 19,685 references. Perhaps they are arranged partly by date, as the very top one had been published within the last twenty-four hours. It happened to be about breast cancer. In my report on my visit to the ASTRO convention, and the examination of some of their literature, I note how they have very little to say about proton therapy for breast cancer despite its exceptional suitability. The study I found on PubMed is titled Improved long-term patient-reported health and well-being outcomes of early-stage breast cancer treated with partial breast proton therapy. X-rays often treat the whole breast, as they go in a straight line and continue beyond the target. Proton therapy, since the beam stops at the target, can treat part of the breast. This was a study comparing women who had received either X-rays or protons, asking them five to ten years after treatment about their quality of life. Proton therapy was shown to have far fewer issues and much better quality of life. This is virtually aways the result in such comparative studies. Other studies, that ask patients who have received various modes of treatment whether they would recommend it to others, show a great preference for proton therapy. X-rays are second and surgery the worst.

In San antonio I live at Blue Skies of Texas, West campus, a retirement community. One of the staff members there was treated for cancer in her throat, close to the base of the skull. The first time around she was treated with X-rays and chemo therapy because her husband had read some negative things about proton therapy. It was a very rough ride. Her throat was mincemeat. She had to have a feeding tube, took opioids for pain, etc. She was out of work for four months. Two months after returning, she was diagnosed with the same cancer on the other side of the throat. Due to the scar tissue and damage from the X-ray treatment, she sought proton therapy for her second treatment. Aetna turned her down. She got every kind of important person she could think of to be her advocate, yet Aetna turned down two appeals. For some reason, perhaps from the pressure, they agreed to cover it on the third appeal. The treatment was far less damaging. No feeding tube. No opioids. Returned to work a week after treatment. She did also have the chemo again. Today she is doing just fine, but it almost didn't happen. Here is a report from PubMed on that type of cancer:

Patients diagnosed with head and neck cancer are traditionally treated with photon radiotherapy (X-rays). Proton therapy is currently being used clinically and may potentially reduce treatment-related toxicities by minimizing the dose to normal organs in the treatment of postoperative oropharyngeal cancer. The finite range of protons has the potential to significantly reduce normal tissue toxicity compared to photon radiotherapy. Seven patients were planned with both proton and photon modalities. The planning goal for both modalities was achieving the prescribed dose to 95% of the planning target volume (PTV). Dose-volume histograms were compared in which all cases met the target coverage goals. Mean doses were significantly lower in the proton plans for the oral cavity (1771cGy photon vs 293cGy proton, p < 0.001), contralateral parotid (1796cGy photon vs 1358 proton, p < 0.001), and the contralateral submandibular gland (3608cGy photon vs 3251cGy proton, p = 0.03). Average total integral dose was 9.1% lower in proton plans. The significant dosimetric sparing seen with proton therapy may lead to reduced side effects such as pain, weight loss, taste changes, and dry mouth. Prospective comparisons of protons vs photons for disease control, toxicity, and patient-reported outcomes are therefore warranted and currently being pursued.

(Gy stands for Gray, a measure of electron volts.) Oncologists who treat this kind of cancer are familiar with such studies, which help them to make their informed decision about the use of proton therapy. The person rejecting the claim at the insurance company is almost certain not to have read such studies, because they are not specialists, as are the doctors requesting proton therapy. In the appeal process, many studies are offered as proof, yet still ignored.

PROPER CONSIDERATION

We all pretty much figure that insurance companies always say no first, and relent only after much pressure and multiple appeals. A weak point for insurance companies is whether they properly consider a claim and whether those making the determination are qualified. The state of California decided to investigate Aetna after some shocking revelations turned up in a deposition of a doctor who ruled on claims without ever personally looking at the medical records.

CNN Exclusive: California launches investigation following stunning admission by Aetna medical director
https://www.cnn.com/2018/02/11/health/aetna-california-investigation/index.html

In the Aetna case at the beginning of this article, the foreman of the jury believed the expert testimony that declared proton beam therapy was not experimental at all. She said jurors were turned off by one Aetna medical director who acknowledged handling eighty cases a day and by the fact that all three medical directors acknowledged they spent more time preparing for the lawsuit than on the medical case. The jury believed Aetna's medical directors "rubber-stamped" the denials without doing their due diligence.

The above article describes California's insurance commissioner launched an investigation into Aetna after learning a former medical director for the insurer admitted under oath he never looked at patients' records when deciding whether to approve or deny care. "If the health insurer is making decisions to deny coverage without a physician actually ever reviewing medical records, that's of significant concern to me as insurance commissioner in California -- and potentially a violation of law," he said.

Dr. Jay Ken Iinuma served as medical director for Aetna for Southern California from March 2012 to February 2015. During a deposition, the doctor said he was following Aetna's training, in which nurses reviewed records and made recommendations to him. During the entire course of time he was employed at Aetna, he never once looked at patients' medical records himself.

Questioned about the plaintiff’s condition, Iinuma said he wasn't sure what the drug of choice would be for people who suffer from his condition. Iinuma further said he wasn’t sure what the symptoms are for the disorder or what might happen if treatment is suddenly stopped for a patient. "Do I know what happens?" the doctor said. "Again, I'm not sure. ... I don't treat it."
Iinuma said he never looked at a patient's medical records while at Aetna. He said that was Aetna protocol and that he based his decision off "pertinent information" provided to him by a nurse. Working from home, less than once a month he might call a nurse with a question. Aetna replied as follows:

"In addition to applying their clinical judgment, the Aetna doctors and nurses use Aetna's Clinical Policy Bulletins ('CPBs') to determine what medical records to request, and whether those records satisfy medical necessity criteria to support coverage. These CPBs reflect the current standard of care in the medical community. They are frequently updated, and are publicly available for any treating physician to review."

Dr. Arthur Caplan, founding director of the division of medical ethics at New York University Langone Medical Center, described Iinuma's testimony as "a huge admission of fundamental immorality."

Determining as many as eighty cases a day, for many types of medical conditions, means the person ruling on the claim has only a few minutes to look at the company policy and the nurse's recommendation. I can imagine a line of questioning in which the insurance doctor is asked under what circumstances he would go against the company guidelines for coverage. Perhaps he would foolishly say "never," which would be a game winner right there. But even if he says "because of unique circumstance," how is he able to determine those circumstances in the five or six minutes he gives to each case? Especially if he doesn't even read them? And what weight does he give to the evidence presented by the patient's doctors? Accordiing to most oncologists, not much credence at all. They are routinely overruled. On what basis?

The fact is, a fair determination is impossible. It would take too many employees and too much time and money. Additionally, the doctor who gave the deposition in California said that he worked from home. Is he salaried or paid by the case? Either way, if he completes his work in four hours rather than eight hours, it is more profitable for him. So both the one making the determination and the insurance company both benefit from a rapid response, according to previously determined guidelines.

If I were defending the insurance company, I would say that's just the way it is. That's the nature of our for-profit healthcare system. In Great Britain, where they have universal healthcare, proton therapy has been much refused and abused in the past. There have been several celebrated cases in that regard. Now they are building half a dozen proton therapy centers in England, so perhaps that will change. You just can't give millions of people a fair hearing. But of course, a trial, unless it is a class action suit, would be for one specific person, in which that is almost certain to be the case, which will outrage the jury. Hence, twenty-five million dollars for Aetna to teach them a lesson. Insurance companies are caught in a really bad situation.

Here is an article that questions the credentials of the doctors ruling against a claim for proton therapy.

https://www.cnn.com/2018/08/15/health/cancer-survivor-insurance-denial-battle/index.html

When insurance wouldn't pay, the patient's parents funded proton therapy at a cost of $95,000. In 2015 Kate Weissman, then 31, was treated for cervical cancer using traditional modalities. Subsequently cancer was found in the lymph nodes that lay behind her bowels and in front of the lumbar vertebrae. After her lymph nodes were removed, her team of doctors wanted to target the cancerous area with proton beam therapy. Weissman had six highly esteemed oncologists advocating on her behalf, including five who also teach at Harvard Medical School and a sixth who was once named among America's top doctors by Newsweek. Aides in the offices of Sens. Elizabeth Warren and Ed Markey also pressed UnitedHealthcare about covering Weissman's proton treatment. Her doctors believed that proton therapy would be the most effective treatment in curing her cancer because it could pinpoint the area around her lymph nodes without causing damage to nearby organs.

Her doctors believed that standard radiation could damage her small intestines, leading to "life-threatening complications later, including ulceration, bleeding, and severe narrowing of the bowel that could cause bowel perforation/rupture, which can be fatal if not treated in a timely fashion," said Dr. Andrea Russo, Weissman's primary oncologist at the time. It could also damage her kidneys and cause long-term bone marrow issues.

Once again the doctors were highly skilled yet their determination was thwarted when
United Healthcare denied Weissman coverage for proton beam therapy, even after multiple appeals. Typically, the insurance company claimed "there is not enough medical evidence to show proton beam therapy is effective for your particular condition."

"Physicians are increasingly alarmed by reports that their patients are being denied medically necessary care despite having insurance," Dr. Barbara L. McAneny, president of the American Medical Association, told CNN. "Health insurers are making these determinations of non-coverage without any transparency, hiding behind internal, opaque policies and processes. It is not the insurer role to determine when covered care is needed. Those decisions must be made by patients and their physicians, who have critically important medical expertise and firsthand knowledge of the patient's unique clinical situation."

Dr. Karen Winkfield, associate director of the Office of Cancer Health Equity at Wake Forest Baptist Health, echoed that sentiment: "Much of what we do is oftentimes dictated by insurance companies. In many ways, particularly with respect to oncologic care, what you can and cannot do for a patient can be superseded by the insurance company."

UnitedHealthcare said that there is "no credible evidence that proton beam therapy is safer or more effective than the proven and covered treatments that are the standard of care for cervical cancer."

In Weissman's case, one of the UnitedHealthcare medical directors who twice reviewed her appeals was Dr. Gwendolyn Yates, who is a licensed and board-certified obstetrician/gynecologist. The American Board of Obstetrics and Gynecology told CNN that although Yates is a board-certified ob/gyn, she "is not board certified in Gynecologic Oncology (care of women with cancers of the reproductive system)."

I would add that it is even less likely that she has experience or knowledge with proton therapy, other than following the insurance company’s policy. Despite all of the high-powered figures who lobbied for proton therapy and the five weeks Weissman’s husband took off from work to fight the insurance giant full time, the claim was never approved. Weissman’s parents spent their retirement savings to pay for proton therapy. Now, two years later, Weissman is in excellent health, with none of the damage or side effects that would have been caused by the covered treatment. United Healthcare never paid a cent. It is a story repeated over and over again.

APPEALS REQUIRED

Some medical insurers even deny proton therapy for pediatric cases because, they claim, randomized clinical trials haven’t proven protons to be superior to conventional radiation. Bullroar. Poppycock. After the theoretical benefits of treating young children with protons are explained to reviewers, almost all denials are overturned. Pediatric Blood & Cancer investigators reported that between 2010 and 2015, 97% of pediatric proton denials at the University of Pennsylvania Roberts Proton Therapy Center were overturned on appeal. (See https://www.specialtypharmacytimes.com/news/majority-of-insurance-coverage-denials-for-pediatric-proton-therapy-approved-on-appeal). That means it was still necessary to make such an appeal, reflecting the policy of automatic denial.

The Alliance for Proton Therapy Access, funded by the proton therapy industry, lobbies for insurance coverage. Their motto for patients is “Fight Cancer Not Me.” Here’s my blog article about them: https://proton-beam-therapy.com/blog.InsurersFightCancer.html. Here is a link to the organization itself: www.allianceforprotontherapy.org. A recent article there reports that a man in Texas was finally able to get Blue Cross Blue Shield to pay for his proton therapy treatment. I don’t get the feeling this organization has a very large staff, so I don’t know how much help they might be in litigation, other than their efforts to get consistent and favorable laws regarding coverage.

REQUIRING MORE EVIDENCE

In his statement about medical necessity, Dr. Frank made this comment: ”I explain our medical team’s cancer care management plan to the insurance company and the published data that support our decision.” Oh, published data. Imagine that. Scott Warwick at the National Association for Proton Therapy has stated that in the last two years alone there have been almost three hundred published studies. I think of pharmaceutical companies, who, when a newly tested drug is effective 20% of the time find that statistically relevant, and subsequently embraced by the medical establishment, whereas proton therapy typically gets results more than four times that great, and yet is rejected for lack of proof.

There is no paucity of studies that report excellent results for proton therapy. What the critics demand are more face-to-face random studies directly comparing protons and X-rays. They concede the results for proton therapy, but then wrongly say X-rays are just as good. The American Society for Radiation Oncology, which has more than 10,000 members, most of whom utilize X-rays in their work, has produced guidelines for insurance companies in which they say proton therapy is no better than X-rays and not worth the cost. They suggest it should not be covered in most instances until more evidence shows it to be superior. Here is a paragraph from my book:

“Because a study in 2009 by the American Society for Radiation Oncology (ASTRO) concluded proton therapy isn’t any better than less expensive alternatives, Aetna, United Healthcare, and Cigna stopped covering proton therapy for prostate cancer. Cigna announced proton therapy was not considered “medically necessary.” The study stated that the benefits of proton therapy when compared to other options is unclear and should not be used routinely on patients. That was quite a blow for both patients and the budding new technology.”

Proton therapy was covered in many cases originally, and is now no longer covered, thanks to ASTRO’s guidelines. ASTRO membership does include proton radiologists, but they are a tiny fraction of the membership.

The more recent ASTRO guidelines, published in 2017, aren’t much better, saying proton therapy is suitable only for a very small number of situations. This stance by a very influential organization is a huge obstacle for proton therapy to overcome. In a legal case, I presume it would be a battle between expert witnesses, the critics and the proponents. In the end, I don’t know if ASTRO gives proton therapy any greater consideration than do the insurance companies, since traditional radiologists also have an ax to grind. Just like the insurance companies, radiologists could lose money if protons become too popular.

Part and parcel to this policy is an almost across-the-board refusal to refer patients for proton therapy. Traditional radiologists would lose their livelihood if they referred away all of their clients. Plus, they have confidence in their modality. I know of several cases in which family doctors referred patients to see a radiologist for cancer treatment to centers that have proton therapy (M. D. Anderson in one instance), yet the radiologist treated them with X-rays, in one case resulting in cognitive damage that would have been avoided with protons. So even within a single medical institution there is a divide that is hard to cross.

The demand for more evidence can be defeated. There is plenty of evidence. That being said, there is a difficulty filling double blind studies because participants don’t want to be chosen for X-rays. My wife’s cousin turned down such an opportunity, because he wanted his prostate cancer to be treated with proton therapy. He didn't want to risk that he would be randomly chosen to receive X-rays. As a retired postal worker, his insurance covered it.

There are several high-powered well-constructed studies currently underway which will satisfy this need. Then, when the results are reported, the X-ray community will say it is only one study, and even more are needed. Eventually, they will need to drop their argument. Meanwhile, every proton center tracks its results for proton therapy. They are no secret. Further, since success is caused by the technology itself, namely therapy’s accuracy and sparing of adjacent organs, that ability can be inferred for other types of cancer.

While at the ASTRO convention I perused the poster presentations, finding two (out of more than 2,000) which pertained to proton therapy. They had to do with quality of life after treatment, showing that protons were superior in that regard. Again, such considerations don’t mean much to the insurance companies, who put profit over suffering. I reported my visit to the ASTRO convention in a blog article entitled A Drop In The Bucket: Proton Therapy at the ASTRO Convention. Here’s the link: http://www.proton-beam-therapy.com/blog.DropintheBucket.html.

Dr. Brian D. Kavanaugh, MD, MPH, FASTRO, chairman of the board of directors, wrote an article in ASTRO News about patient-centric indications, saying. “We have always known about mucositis and pneumonitis and all of the other radiation-itises associated with therapy, and we try our best to mitigate them.” Try their best? With my prostate cancer treatment I had no “-itises” except for a tiny bit of temporary swelling in the prostate itself, most likely from inflammation.

UNFOUNDED CRITICISM

Several journalists have jumped into the fray, writing critical articles saying proton centers are “riddled with failure” and going bankrupt, the treatment is too costly, repeating that it is unproven and no better than X-rays. One particularly egregious example written by Jay Hancock for Kaiser Health News was reprinted in the New York Times. I now find frequent references that say “according to the New York Times” as if that article were a reliable source. It seeks out quotations by critics of proton therapy in a very biased way. I responded at some length on my blog with an Open Letter to Jay Hancock (see https://proton-beam-therapy.com/blog.Letter.html). So onerous are the outdated and unfounded articles against proton therapy that I know of two planned proton centers that have been delayed because potential partners withdrew, citing that the treatment is unproven. Searching on the internet brings up critical articles that are ten or more years old and out of date compared to new improvements to the technology. Yet it is these sources that the insurance companies embrace.

BREAKING THE LAW

The state of California is investigating if Aetna did not properly consider proton therapy claims, which it said would violate the law. Further than that, a few states have passed laws to prevent discrimination against proton therapy. In Oklahoma, the law says it can not be saddled with extra requirements to gain approval not demanded of other modalities. The proton center at Hampton University sued to force insurance companies to obey the law. I have a blog article on this subject, tactfully titled, Recalcitrant Insurance Companies Break the Law and Kill People. You can find the blog here: https://proton-beam-therapy.com/blog.InsuranceCriminals.html. The article includes several links to other legal cases.

MY EXPERIENCE

When I was investigating my options to get proton therapy for my prostate cancer in 2016, I called M.D Anderson in Houston and mentioned that I had United Healthcare's popular AARP HMO Secure Horizons Advantage Plan. The receptionist said that to her knowledge, proton therapy for prostate cancer was not covered by United Healthcare. She was so sorry. End of conversation. Goodbye and good luck. How many people are stopped in their tracks right there!

Prostate cancer is fairly easy to treat with X-rays. But even then, the exit dose can damage healthy tissue. For cancers in more sensitive areas, protons are far more advantageous than the alternatives. I met a man when I was being treated who had fought Cigna for six months, even getting his congressman involved. Finally they relented. Unfortunately, as in the Aetna case, too much time had passed during the approval battle and he died four months later.

When I called Provision CARES Proton Therapy Center in Knoxville, TN, I was told that I could get coverage for proton therapy if I was willing to be on a registry that would follow me for the rest of my life. Medicare has two categories of coverage. Group I is covered outright. Group II is covered only if you are in a trial or registry. Prostate cancer is in that group. I went to Provision, joined the registry, and Medicare paid 80% of the cost. Then Provision got United Healthcare to pay the other 20%. As far as I know the cost for my treatment was close to six figures. 

LITIGATION

Insurance companies have big bucks (our bucks) and will fight tooth and nail to be able to deny claims whenever they want, for whatever reason. They will always say the right thing, that they give claims fair consideration, that the reviewer is qualified, that they have the patient’s best interest in mind, that they demand the best science. But behind the scenes is a whole other story, one which can be exposed in court and through depositions. With a few more serious judgements against them, perhaps the insurance industry will change its mind about resisting proton therapy. With regards to litigation, we can see the salient issues:
1. Proton therapy is NOT experimental or unproven.
2. There are plenty of studies verifying the superiority of proton therapy.
3. ASTRO, critics, and other nay sayers will need to be addressed and countered.
4. Insurance companies reject claims as standard policy without giving regard to individual circumstances, and ignoring expert medical advice.
5. The decision makers at insurance companies are largely unqualified to determine the efficacy of proton therapy.

I also think people denied proton therapy who experienced side effects from the treatment demanded by insurance companies may have a case for their needless suffering. There must be thousands of them. Class action suit anyone?

I am happy to be of assistance in any way in this effort. Feel free to respond at this email address, or call me at (314) 517-6543.

Robert Ferre

BOOKS
Best Prostate Cancer Treatment: Proton Beam Therapy
Ebook
Print

Proton Therapy: Revolutionary Treatment for 80% of ALL Cancers
Ebook
Print

My websites:
www.ProtonTherapyBook.com (books)
www.proton-beam-therapy.com/blog.html (blog)
www.proton-therapy-centers.com (centers)

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