Health Law Daily Wrap Up, PRESCRIPTION DRUGS—D.D.C.: Coverage denial claims bound to fail based on categorical exclusion for weight loss drugs, (Jun 12, 2026)

By Justin Marcus Smith, J.D.

The patient could not recast Zepbound as a sleep apnea drug because the FDA approval for treatment of sleep apnea only pertained to overweight adults.

A categorical exclusion of health plan coverage for weight loss drugs meant an insurer and its pharmacy benefits manager (PBM) had no obligation to respond to a patient’s claims of “medical necessity,” held the federal district court in Washington, D.C. The insurer was on firm contractual ground in explaining that the denial of coverage did not involve any determination of medical judgment. The court held this was so even though Zepbound, the drug in question, was on the PBM formulary, because the formulary classified it as an anti-obesity drug. The court rejected the patient’s attempt to recast Zepbound as a sleep apnea drug because the FDA authorization to use Zepbound for sleep apnea only pertained in the clinical context of obesity. The patient’s second claim, that the insurer breached a fiduciary duty under the Employment Retirement Income Security Act (ERISA) in denying coverage for Zepbound, failed in two distinct ways. First, ERISA did not permit this claim to proceed in tandem with the denial of benefits claim because they both called for the same relief. Second, the patient did not state a plausible breach of fiduciary duty because the coverage denial comported with the terms of the health plan group contract. The court granted the insurer’s Fed. R. Civ. P. 12(b)(6) motion to dismiss all claims (Hamburger v. CareFirst BlueCross BlueShield, No. 1:25-cv-03000-TNM (D.D.C. Jun. 10, 2026)).

Background. A physician prescribed a patient Zepbound, a GLP-1 weight-loss drug, after the FDA approved the drug in 2024 for treating obstructive sleep apnea in overweight people. The patient wanted his health insurer to cover the drug, but the insurer refused. More specifically, the insurer’s pharmacy benefits manager (PBM) denied the request. The PBM denial letter (initial adverse determination notice) stated the patient’s prescription benefit plan did not cover the requested medication.

The patient’s attorney appealed the denial, but the PBM did not reconsider, and in another denial letter (final adverse determination notice), it repeated the lack of coverage for Zepbound.

After the final adverse determination notice, the patient brought a putative class action against the insurer under ERISA for denial of benefits, 29 U.S.C. § 1132(a)(1)(B), and breach of fiduciary duty, 29 U.S.C. § 1132(a)(3).

The court granted the insurer’s Fed. R. Civ. P. 12(b)(6) motion to dismiss both claims because (1) the patient’s health plan excluded Zepbound and (2) the patient did not plausibly allege any breach of fiduciary duty.

Benefit denial. The patient’s denial of benefits claim depended on the group contract, but the dispute centered on a prescription drug benefits rider that amended the group contract. The court found the rider contained additional specific exclusions which also applied to the PBM formulary. When the patient sought coverage, Zepbound was included on the formulary among “anti obesity agents.”

The patient’s argument rested on one rider provision that stated benefits would be provided for a prescription drug dispensed by a pharmacist for self-administered use on an outpatient basis for the treatment of a condition as provided under the terms of the group contract evidence of coverage. “Without any further contractual anchor,” the patient contended the health plan covered the medical condition of obstructive sleep apnea, and that he was therefore entitled to coverage for Zepbound in treating it.

The court disagreed based on the rider “exclusions” section, which specifically disclaimed coverage for prescription drugs for weight loss. The court construed the exclusion applied to Zepbound because the PBM formulary designated Zepbound as an “anti-obesity agent.”

The patient countered that the rider provided a generic grant of prescription drugs for covered conditions, but the court distinguished that even if sleep apnea were a covered condition, the specific exclusion of Zepbound still applied as a cardinal principle of contract construction.

The court rejected the patient’s attempt to recast Zepbound as something other than a weight-loss drug. The patient argued the FDA authorization of Zepbound to treat obstructive sleep apnea was distinct from its original approval as an anti-obesity medication, but the court found the sleep apnea authorization only pertained to adults with obesity. In that core context of obesity, the drug was to be used for obesity -related sleep apnea in combination with a reduced-calorie diet and increased physical activity. The court concluded that invocation of the FDA approval for sleep apnea only confirmed Zepbound as a weight-loss drug.

The patient pointed out next that the PBM covered GLP-1 medications that treat diabetes, even Mounjaro, which he argued was “chemically identical” to Zepbound. The court said the patient’s attempt to equate Zepbound with Mounjaro failed because the FDA only approved Mounjaro for treating diabetes. In general, the patient conflated direct and indirect effects. For example, GLP-1 drugs might indirectly alleviate depression, but that alone would not make Zepbound an antidepressant.

Fiduciary breach. The ERISA § 1132(a)(3) breach of fiduciary duty claim sought recovery for the same alleged denial of coverage injury. The court said ERISA forbade the patient’s “attempt to double dip.”

Although there was no D.C. Circuit precedent on-point, the court explained that judges in the district have followed the majority view that a breach of fiduciary duty claim under § 1132(a)(3) cannot stand when a plaintiff has an adequate remedy for injuries under § 1123(a)(1)(B). Again, contracts should be read such that general provisions do not nullify more specific ones. The court construed that “[a]llowing benefits claims under § 1132(a)(1)(B) and ‘catchall’ claims under § 1132(a)(3) to proceed in tandem would defy this canon and misread ERISA.”

The § 1132(a)(3) claim additionally failed because the patient did not state a plausible breach of fiduciary duty where the coverage denial comported with the terms of the group contract. Nor was there merit to the patient’s claim that the PBM failed to consider the health plan procedure for non-formulary exception requests when reviewing the patient’s internal appeal. Zepbound was on the relevant formulary at the time.

Last, the patient claimed the insurer failed to give him adequate notice of coverage denial, but this claim was also unsuccessful because the denial notice sufficed. The initial letter explained the prescription benefit plan did not cover the requested medication. In response to the patient’s appeal, the PBM reiterated no coverage for Zepbound. The notices sufficed because they articulated reason for the denial and its basis in the health plan.

The case is No. 1:25-cv-03000-TNM.

Judge: McFadden, T.

Attorneys: Anna P. Prakash (Nichols Kaster PLLP) for Martin Hamburger. Tracy Ann Roman (Crowell & Moring LLP) for CareFirst BlueCross BlueShield and Group Hospitalization and Medical Services, Inc. Emily Seymour Costin (Alston & Bird LLP) for CVS Caremark.

Companies: CareFirst BlueCross BlueShield; Group Hospitalization and Medical Services, Inc.; CVS Caremark.

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