Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 11 (2003)

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654

PHARMACEUTICAL RESEARCH AND MFRS. OF AMERICA v. WALSH

Opinion of the Court

2002). The statute provides that "the State [shall] act as a pharmacy benefit manager in order to make prescription drugs more affordable for qualified Maine residents, thereby increasing the overall health of Maine residents, promoting healthy communities and protecting the public health and welfare." § 2681(1). The program is intended to enable individuals to buy drugs from retail pharmacies at a discount roughly equal to the rebate on Medicaid purchases. See § 2681(4).

The statute provides that any manufacturer or "labeler" 13

selling drugs in Maine through any publicly supported financial assistance program "shall enter into a rebate agreement" with the State Commissioner of Human Services (Commissioner). § 2681(3). The Commissioner is directed to use his best efforts to obtain a rebate that is at least equal to the rebate calculated under the federal program created pursuant to OBRA 1990. See § 2681(4). Rebates are to be paid into a fund administered by the Commissioner, and then distributed to participating pharmacies to compensate them for selling at discounted prices. § 2681(6).

For those manufacturers that do not enter into rebate agreements, there are two consequences: First, their nonparticipation is information that the Department of Human Services must release "to health care providers and the public." § 2681(7). Second, and more importantly for our purposes, the "department shall impose prior authorization requirements in the Medicaid program under this Title, as permitted by law, for the dispensing of prescription drugs provided by those [nonparticipating] manufacturers and labelers." Ibid.

The statute authorizes the department to adopt implementing rules. § 2681(14). The rules that have been proposed would limit access to the program to individuals who

13 A "labeler" is a person who receives prescription drugs from a manufacturer or wholesaler and repackages them for later retail sale. § 2681(2)(C).

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