Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 10 (2003)

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

Opinion of the Court

coverage of drugs such as "[a]gents . . . used for cosmetic purposes or hair growth." § 1396r-8(d)(2)(C).

Most relevant to this case, Congress allowed States, "as a condition of coverage or payment for a covered outpatient drug," § 1396r-8(d)(5), to require approval of the drug before it is dispensed. Thus, under OBRA 1990, except for a narrow category of new drugs,10 "[a] State may subject to prior authorization any covered outpatient drug," § 1396r- 8(d)(1)(A), so long as the State's prior authorization program (1) provides a response by telephone or other telecommunication device within 24 hours of a request for prior authorization, and, (2) except for the listed excludable drugs, provides for the dispensing of at least a 72-hour supply of a covered drug in an emergency situation, see § 1396r-8(d)(5).

In the Omnibus Budget Reconciliation Act of 1993,11 Congress further amended the Act to allow the States to use formularies subject to strict limitations. That amendment expressly stated that a prior authorization program that complies with the 24-hour and 72-hour conditions is not subject to the limitations imposed on formularies.12 The 1993

amendment reenacted the provisions for state prior authorization programs that had been included in OBRA 1990, omitting, however, the narrow exception for new drugs.

II

In 2000, the Maine Legislature established the Maine Rx Program "to reduce prescription drug prices for residents of the State." Me. Rev. Stat. Ann., Tit. 22, § 2681 (West Supp.

10 "A State may not exclude for coverage, subject to prior authorization, or otherwise restrict any new biological or drug approved by the Food and Drug Administration after the date of enactment of this section, for a period of 6 months after such approval." 104 Stat. 1388-150, § 1927(d)(6).

11 107 Stat. 613.

12 "A prior authorization program established by a State under paragraph (5) is not a formulary subject to the requirements of this paragraph." § 1396r-8(d)(4).

653

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