UnitedHealthcare part of $9.5M settlement over denied coverage for costly cancer treatment

UnitedHealthcare and two employers are agreeing to pay $9.5 million, including attorney’s fees, in a proposed settlement with patients who allege the nation’s largest health insurer wrongly blocked coverage for an emerging and expensive high-tech cancer treatment called proton beam radiation therapy.

The insurer is denying all wrongdoing as part of the agreement, which was disclosed in court filings late last week.

Proton beam therapy has stoked controversy since it was introduced more than a decade ago, with doctors arguing it offers more precise treatment of tumors even as critics have questioned its considerable expense — particularly as guidance has been evolving on which patients are the best candidates.

Three patients sued UnitedHealthcare and their employers over access to the therapy in 2019, at which point a judge hearing one of the cases recused himself after describing a friend’s struggle to get coverage from United. The judge wrote of the experience: “To deny a patient this treatment, if it is available, is immoral and barbaric.”

Beyond providing money for patients, plaintiffs believe the settlement will improve access to treatment by driving certain changes in medical policy at UnitedHealthcare, which is the gigantic health insurance division of Eden Prairie-based UnitedHealth Group.

The patients brought lawsuits against two divisions of the insurance company, plus two employers who hired United to run health plans for their workers. The cases were consolidated in the U.S. District Court of Massachusetts.

“Plaintiffs ... filed the action against defendants alleging generally that during a period of several years, defendants wrongfully denied precertification requests and post benefit claims,” according to information filed Friday with the court.

“Defendants deny that they did anything wrong, and maintain that they complied with their obligations under the respective ... employee welfare benefit plans and with all applicable laws,” according to the filing. “However, the parties have agreed to settle the action to avoid the cost, delay and uncertainty of continued litigation.”

UnitedHealth Group did not immediately respond to a request for comment. The settlement agreement says “defendants deny each and every claim and contention alleged.”

The court has not yet issued a preliminary approval order for the settlement. If that happens, a final approval hearing would be scheduled at least 130 days later.

Proton therapy is a rapidly growing treatment for malignant and benign tumors, doctors say, with a potential clinical advantage that the accuracy of the proton radiation beams allows nearby organs to avoid exposure. Even so, the treatment is not the optimal option for every patient, nor does it eliminate all radiation-associated toxicities.

Mayo Clinic in Rochester is among the nonprofit specialty centers across the country that have developed the technology, which also was backed early on by a number of investor-owned facilities. (Mayo is not a party to the litigation.)

UnitedHealthcare’s medical policy on proton beam radiation therapy (PBRT) in 2023 said the treatment was proven, medically necessary and definitive for a limited number of indications including eye and certain skull-based tumors. Under the settlement, the insurer’s policy would now say PBRT is proven and considered clinically equivalent to traditional radiation for treating prostate cancer, although “medical necessity will be determined based on the terms of the member’s benefit plan.”

In addition, the policy would no longer include specific references to 13 diagnoses or uses, such as bladder and breast cancer, for which PBRT had been deemed “unproven and not medically necessary,” according to materials filed with the court. In cases where evidence is lacking for broad support of using the therapy, “requests for exceptions will be evaluated on a case-by-case basis” in certain circumstances.

The three patients who sued did so at a time when UnitedHealth Group was facing questions about coverage denials for mental health patients. A federal judge in California issued a scathing ruling in 2019 that found the company‘s guidelines for making such determinations were “tainted” by financial interests, although an appellate court later reversed the ruling.

In the proton beam case, Judge Robert Scola Jr. of the U.S. District Court for the Southern District of Florida wrote in his recusal order that he personally confronted a cancer diagnosis after watching a very close friend seek proton beam therapy at a world-renowned cancer center in Houston.

“His health care provider, UnitedHealthcare, refused to pay for the treatment,” Scola wrote. “Fortunately, he had the resources to pay $150,000 for the treatment and only upon threat of litigation did UnitedHealthcare agree to reimburse him. ... The court’s opinions in this matter prevent it from deciding this case fairly and impartially.”

Anger at United and the broader health insurance industry over coverage denials stormed forward in December, following the killing of then-UnitedHealthcare chief executive Brian Thompson.

The alleged shooter in the case did not have UnitedHealthcare coverage, yet one of the bullet casings at the crime scene allegedly had the word “deny” scrawled on it. Limited data on denials has kept United at the center of the issue, as well.

Filed with the court Friday, the PBRT settlement proposal calls on defendants to pay $6.75 million into a settlement fund where patients could obtain up to $75,000 in coverage for their out-of-pocket costs with proton beam therapy.

Patients are eligible if between March 26, 2016, and Aug. 28, 2023, they received denials for either pre-certification of PBRT treatment or coverage following treatment. Per-person monetary awards could be lower if claims exceed an aggregate cap of $6.75 million.

Plaintiffs’ attorneys will receive $2 million, and could receive $500,000 more. Each of three class representatives would receive $25,000.

Plaintiffs believe the changes “will make it easier for patients to have their PBRT coverage requests properly reviewed for approval,” the filing says.

UnitedHealthcare identified records of 90 individuals who submitted post-service claims for the therapy, according to court records, and another 150 people whose requests for pre-authorization coverage were denied.

“The parties are incapable of determining if all of the individuals actually went forward with PBRT treatment at their own expense or pursued some other type of treatment,” according to a document filed Friday with the court. “They will, however, still receive notice of the settlement and have the ability to provide proof of medical expenses for PBRT treatment.”