Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 12 (2003)

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Cite as: 538 U. S. 644 (2003)

Opinion of the Court

do "not have a comparable or superior prescription drug benefit plan." 14 The proposed rules also explain that Maine intends to appoint a "Drug Utilization Review Committee," composed of physicians and pharmacists who will evaluate each drug manufactured by a company that has declined to enter into a rebate agreement to decide whether it is clinically appropriate to subject the drug to prior authorization.15

The State represents that it "certainly will not subject any single-source drug that fulfills a unique therapeutic function to the prior authorization process" even if its manufacturer does not enter into a rebate agreement.16 The determination "whether a particular drug should be subjected to a prior authorization requirement will be based firmly upon considerations of medical necessity, and in compliance with the State's responsibilities as the administrator of the Maine Medicaid Program." 17

III

Several months before January 1, 2001, the intended commencement date of the Maine Rx Program, the Commissioner, then Kevin Concannon, sent a form letter to drug manufacturers enclosing a proposed rebate agreement.18

14 App. 317. The statute authorizes coverage for all "qualified Maine residents," Me. Rev. Stat. Ann., Tit. 22, § 2681(1) (West Supp. 2002), and defines a qualified resident as one "who has obtained from the department a Maine Rx enrollment card," § 2681(2)(F). In describing program goals, it provides: "It is not the intention of the State to discourage employers from offering or paying for prescription drug benefits for their employees or to replace employer-sponsored prescription drug benefit plans that provide benefits comparable to those made available to qualified Maine residents under this subchapter." § 2681(1). In their brief, respondents state: "It would be economically irrational for a person with prescription drug coverage to use Maine Rx, but if any patient mistakenly attempts to do so, [the] proposed regulations . . . will not allow it." Brief for Respondents 7.

15 See App. 268, 278.

16 Id., at 149.

17 Ibid.

18 See id., at 62-74.

655

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