Proton Therapy Insurance Denial – What is it and why?
Cancer is at the root of many claims relating to one’s ability to work, such as ADA claims and medical benefits claims. A frequent reason for denying medical benefit claims is a lack of medical necessity, another is that a procedure is investigational or experimental. A frequently denied claim relates to Proton Beam Therapy.
What is Proton Therapy for Cancer?
Proton Beam Therapy is often used in advanced cancer care treatment for certain cancers. In this type of radiation therapy, small protons are deposited on a targeted area of the tumor with no radiation going beyond that point onto healthy tissue. It thus has fewer side effects on the heart and other organs. It was approved by the Food and Drug Administration (FDA) in 1988. Major medical institutions across the country tout the benefits of this most advanced cancer treatment. The Mayo Clinic, UAB, MD Anderson, and Emory all have Proton Beam Therapy facilities.
Why Does Proton Therapy Insurance Denial Occur?
However, Proton Beam Therapy is more expensive than traditional radiation therapy. As might be expected, insurance companies often balk at approving such treatment or paying claims for it. They usually argue that the treatment is not medically necessary or that it is investigational. How is this possible? The reason lies within the standard of review permitted in ERISA, which is often arbitrary and capricious.
Under the arbitrary and capricious standard, a wrong reason with a somewhat reasonable basis is nonetheless entitled to deference. Thus, most of the evidence may demonstrate that the treatment is reasonable and necessary and not investigational, but if there is some significant piece of evidence, such as the opinion of an in-house physician, that says otherwise, a denial of a claim on that basis may pass muster.
How Do Insurance Companies Deny Proton Therapy Claims?
The 11th Circuit has adopted a counterintuitive six-step process for the analysis, which was first articulated in Williams v. BellSouth Telecoms., Inc., 373 F.3d 1132, 1137-38 (11th Cir. 2004), and then repeated it with some modification in Blankenship v. Metropolitan Life Ins. Co., 644 F.3d 1350, 1355 (11th Cir. 2011):
“For a court reviewing a plan administrator's benefits decision, the present Williams test goes this way:
Apply the de novo standard to determine whether the claim administrator's benefits-denial decision is "wrong" (i.e., the court disagrees with the administrator's decision); if it is not, then end the inquiry and affirm the decision.
If the administrator's decision in fact is "de novo wrong," then determine whether he was vested with discretion in reviewing claims; if not, end judicial inquiry and reverse the decision.
If the administrator's decision is "de novo wrong" and he was vested with discretion in reviewing claims, then determine whether "reasonable" grounds supported it (hence, review his decision under the more deferential arbitrary and capricious standard).
If no reasonable grounds exist, then end the inquiry and reverse the administrator's decision; if reasonable grounds do exist, then determine if he operated under a conflict of interest.
If there is no conflict, then end the inquiry and affirm the decision.
If there is a conflict, the conflict should merely be a factor for the court to consider when determining whether an administrator's decision was arbitrary and capricious.”
Prolow v. Aetna Life Ins. Co.
A court within the Eleventh Circuit considered whether an insurer acted appropriately in denying Proton Beam Therapy, must follow that six-step process. The recent case Prolow v. Aetna Life Ins. Co., No. 20-80545-CIV-MARRA, 2022 WL 263165 (S.D. Fla. Jan. 27, 2022) (Judge Kenneth A. Marra), did just that.
Facts of the Case:
Ms. Prolow and Mr. Lemmerman were cancer patients who were also participants in healthcare plans insured by Aetna Life Insurance Co.
They brought this case for individual benefits under their plans and as a putative class action.
They alleged that Aetna was wrongfully denying their claims and the claims of many others who had sought coverage for Proton Beam Therapy.
They presented evidence from an oncologist that there was no benefit to surrounding tissue, medical or otherwise, in being subjected to radiation. Thus, typical radiation therapy treatments were treating more than the affected area and causing adverse consequences. In contrast, Proton Beam Therapy targeted just the tumor and left the healthy nearby areas of the body “untreated” as they were not infected with cancer cells. This actually allowed higher doses of radiation on the cancer-affected parts of the body making the treatment more efficacious. It also reduced side effects from the treatment of the areas unnecessarily adversely affected.
Aetna refused to pay for the treatment nonetheless and considered it “experimental and investigational” based on its own internal guidelines.
The guidelines were based upon information from medical professionals, but not the FDA, nor any of the respected institutions that were offering Proton Beam Therapy, nor the abundance of medical literature available.
Aetna argued throughout the litigation that the arbitrary and capricious standard of review controlled, based on an administrative services agreement between the various plans and Aetna. Those agreements were not made available to plan participants.
The plaintiffs argued they were not provided the plan documents and could not control the main plan document which was provided to participants. The parties filed cross-motions for summary judgment.
First, the court found de novo that the benefit denials were wrong. The court disliked that Aetna was not following the simple language in the plan document and instead relied on internal guidelines as to whether the coverage was medically necessary.
Aetna scrambled to furnish additional reasons why its decision should be upheld. The court followed Eleventh Circuit guidance in holding that Aetna could not include reasons in addition to those given in its initial denial letter. That letter simply stated, “clinical studies have not proven that the procedure is effective for the treatment of member’s condition.” This was demonstrably false as clinical studies had indeed proven that Proton Beam Therapy was effective for the cancer treatment needed by both individuals. The court properly excluded what the Eleventh Circuit refers to as post hoc rationales.
Since the court found Aetna’s decision was de novo wrong, it then moved to the second step, which was whether discretion was reserved in any plan document. The court found that the administrative services agreements with the various plans were not provided the plan documents and they were not furnished to participants.
Thus, discretion was not properly reserved in any document. The court rejected the arbitrary and capricious standard of review as applicable.
The court thereby found in favor of the plaintiffs as that ended the judicial inquiry.
If the court had found that the arbitrary and capricious standard of review controlled, it would have been required to move on to other steps and examine whether there were reasonable grounds to support Aetna's position. If in fact, Aetna had several physicians supporting its position, the case may have turned out differently. Aetna could be wrong, but still win if it had a reasonable wrong reason. Of course, the court would also have to determine and consider whether conflict played a role in the decision. So even when a decision appears to be wrong, under ERISA and the Eleventh Circuit’s six-step process, the claimant could still lose. That’s troubling.