Little v. PreferredOne Insurance Company

Background

Patrick Little brought an action under the Employee Retirement Income Security Act (ERISA), specifically 29 U.S.C. § 1132(a)(1)(B), against PreferredOne Insurance Company (PIC). Little was employed by L&K Tree & Shrub, which maintained an employee benefit plan. PIC both insured the plan and administered it.

The plan covered eligible organ-transplant procedures but excluded “investigative” treatments. The plan defined an investigative treatment as one for which reliable evidence did not permit conclusions about safety, effectiveness, or health outcomes. The plan also gave PIC discretionary authority to determine benefit eligibility and interpret the plan’s terms.

Little was diagnosed with stage IV colorectal cancer in September 2017. After surgery and the discovery that the cancer had spread to his liver, he received chemotherapy. His liver cancer was unresectable. In February 2019, the Cleveland Clinic determined that he was a suitable candidate for a liver transplant and placed him on its transplant waitlist.

PIC denied prior authorization in March 2019, stating that peer-reviewed medical literature did not sufficiently demonstrate the proposed procedure’s safety and effectiveness. After the Cleveland Clinic supplied additional information and medical studies, PIC obtained an independent review from AllMed Health Care Management. Dr. Gary Barone concluded that the procedure was investigative under the plan and that Little faced a substantial likelihood of cancer recurrence. PIC again denied authorization. The Minnesota Department of Commerce later selected MAXIMUS Federal Services to conduct an independent medical review, and MAXIMUS upheld PIC’s decision.

The Cleveland Clinic continued to support the transplant. Dr. Federico Aucejo cited medical studies and the clinic’s experience with three similar procedures. The opinion also notes that one of those three patients experienced a recurrence within a year, while the other two remained cancer free. PIC did not change its determination.

Motion and legal standard

Little moved for a preliminary injunction under Federal Rule of Civil Procedure 65(a). He asked the court to stop PIC from denying coverage for the proposed transplant. The court had remanded the matter to PIC for reconsideration on June 17, 2019, and PIC notified the court on June 21 that the matter was again ready for judicial determination.

A preliminary injunction is an extraordinary temporary remedy. The party seeking one must show all four of these factors: a likelihood of success on the merits, a threat of irreparable harm without relief, a favorable balance between the parties’ harms, and consistency with the public interest. The court stated that the likelihood-of-success factor was the most significant.

Because the plan granted PIC discretionary authority, the court reviewed PIC’s benefit determination under an abuse-of-discretion standard. That standard asks whether PIC’s decision was unreasonable under the plan and the information available to it. The court also considered PIC’s potential conflict of interest because PIC both administered the plan and insured it.

Court’s analysis

The court concluded that PIC had not abused its discretion. PIC relied on the plan’s investigative-treatment criteria, including the lack of peer-reviewed evidence establishing the proposed transplant’s safety and effectiveness. The court found that PIC sufficiently addressed its potential conflict by obtaining an independent medical review from AllMed.

The court recognized that the Norwegian study and other medical literature cited by Little appeared promising. But it found that the evidence did not establish the medical consensus required by the plan. The court noted that Dr. Dimitrios Moris’s article described the procedure as potentially useful but said that further study involving a larger patient population was needed. The Cleveland Clinic’s experience with only three similar procedures also did not establish the required consensus.

The court further noted that the Cleveland Clinic and Dr. Aucejo supported the transplant but did not specifically predict how long Little would survive after surgery. By contrast, Dr. Barone’s concern about recurrence was supported by the cited article’s discussion of recurrence after twenty-eight months. The court stated that ERISA did not require PIC to credit Dr. Aucejo’s opinions over those of Dr. Barone or the MAXIMUS reviewing surgeon.

Disposition

The court held that Little had not shown a likelihood of success on the merits of his ERISA claim. It therefore ruled that he was not entitled to a preliminary injunction and ordered that his motion for a preliminary injunction was denied. The opinion does not state a final disposition of the underlying ERISA action.