Opinion ID: 3052774
Heading Depth: 4
Heading Rank: 1

Heading: Coverage Determinations

Text: [10] The Act provides that disputes between PDP sponsors and enrollees will be resolved through the coverage determination process. See 42 U.S.C. § 1395w-104(g). The regulations define a coverage determination as:
drug (including a decision not to pay because the drug is not on the plan’s formulary, because the drug is determined not to be medically necessary, because the drug is furnished by an out-of-network phar- macy, or because the Part D plan sponsor determines that the drug is otherwise excludable under section 1862(a) of the Act if applied to Medicare Part D) that the enrollee believes may be covered by the plan; (2) Failure to provide a coverage determination in a timely manner, when a delay would adversely affect the health of the enrollee; is further supported by the proposed regulation—before it was amended to clarify the inclusion of dual-benefit individuals—which read: “Enrollee means a Part D eligible individual, or his or her authorized representative, who has elected a prescription drug plan offered by a PDP sponsor.” 69 Fed. Reg. 46632, 46841 (Aug. 3, 2004). UHM v. HUMANA INC 11567 (3) A decision concerning an exceptions request under § 423.578(a); (4) A decision concerning an exceptions request under § 423.578(b); or (5) A decision on the amount of cost sharing for a drug. 42 C.F.R. § 423.566(b). [11] Although the Uhms argue that their claim is antecedent to the coverage determination process—that is, their complaint is that they were never able to request drug benefits in the first instance, let alone dispute the plan’s potential denial of a particular drug—we agree with Humana that the plaintiffs raise a “classic” coverage dispute. The Uhms’ primary complaint, and the basis of their breach of contract and unjust enrichment claims, is that despite having paid their monthly premiums and filed the appropriate enrollment documents, Humana failed to provide them with drug benefits. See, e.g., Comp. ¶ 4.12 (“Plaintiffs Uhm bring this action against Defendants on behalf of all persons who paid and/or were billed by Humana, for enrollment in the Humana Part D PDP and (a) did not receive benefits under the Humana Part D PDP . . .” ); ¶ 6.4 (“Defendants breached each contract with Plaintiffs and with each Class member when they failed to provide prescription drug benefits as promised.”); ¶ 8.2 (“Defendants received monies as a result of payments made by Plaintiffs and Class member for prescription drug benefits that Defendants failed to provide to Plaintiffs and Class members.”). [12] The appropriate recourse under the Act was for the Uhms to file with Humana a request for a coverage determination, requesting reimbursement for the drugs they purchased out-of-pocket. See § 423.568(a), (b) (allowing for 11568 UHM v. HUMANA INC either a request for drug benefits or payment).14 The coverage determination procedure and its related regulations preempt the Uhms’ breach of contract and unjust enrichment claims.