Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 17 (2003)

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660

PHARMACEUTICAL RESEARCH AND MFRS. OF AMERICA v. WALSH

Opinion of Stevens, J.

inflict inevitable or even probable harm" on Medicaid patients, and thus were insufficient to support a pre-emption-based facial challenge. Id., at 78. The court did, however, express concern that the prior authorization requirement might affect the quality of medical care for Medicaid recipients in subtle ways, such as inconveniencing prescribing physicians. It therefore expressly preserved petitioner's right to renew its pre-emption challenge after implementation of the program "should there be evidence that Medicaid recipients are harmed by the prior authorization requirement 'as applied.' " Ibid. The Court also found no violation of the dormant Commerce Clause and vacated the temporary injunction, but stayed its mandate pending our review of the case.

IV

The question before us is whether the District Court abused its discretion when it entered the preliminary injunction. See Doran v. Salem Inn, Inc., 422 U. S. 922, 931-932 (1975). By no means will our answer to that question finally determine the validity of Maine's Rx Program. The District Court did not conduct an evidentiary hearing and did not resolve any factual disputes raised by the affidavits filed by the parties. Accordingly, no matter how we answer the question whether petitioner's showing was sufficient to support the injunction, further proceedings in this case may lead to a contrary result.

Moreover, there is also a possibility that the Secretary may view the Maine Rx Program as an amendment to its Medicaid Plan that requires his approval before it becomes effective.30 While the petition for certiorari was pending,

30 We note that CMS, acting on behalf of the Secretary, see n. 3, supra, sent a letter on September 18, 2002, to all of the state Medicaid directors. In that letter, the CMS Director indicated that "the establishment of a prior authorization program for Medicaid covered drugs to secure drug benefits, rebates, or discounts for non-Medicaid populations is a significant component of a State plan and we would therefore expect that a State

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