Pharmaceutical Research and Mfrs. of America v. Walsh, 538 U.S. 644, 25 (2003)

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668

PHARMACEUTICAL RESEARCH AND MFRS. OF AMERICA v. WALSH

Opinion of the Court

number of patients' medical needs—indeed, any patient's medical needs—will be adversely affected.

The record does demonstrate that prior authorization may well have a significant adverse impact on the manufacturers of brand name prescription drugs and that it will impose some administrative costs on physicians. The impact on manufacturers is not relevant because any transfer of business to less expensive products will produce savings for the Medicaid program. The impact on doctors may be signifi-cant if it produces an administrative burden that affects the quality of their treatment of patients, but no such effect has been proved. Moreover, given doctors' familiarity with the extensive use of prior authorization in the private sector, any such effect seems unlikely.

We therefore agree with the Court of Appeals' resolution of the pre-emption issue based on the record before us. We again reiterate that the question whether the Secretary's approval must be sought before Maine Rx Program may go into effect is not before us. Along these same lines, we offer no view as to whether it would be appropriate for the Secretary to disapprove this program if Maine had asked the Secretary to review it. We also offer no view as to whether it would be proper for the Secretary to disallow funding for the Maine Medicaid program if Maine fails to seek approval from the Secretary of its Maine Rx Program. Based on the CMS letter of September 18, 2002,38 it appears that the Secretary is likely to take some action with respect to this program. Until the Secretary does, however, we cannot predict at this preliminary stage the ultimate fate of the Maine Rx Program, and we limit our holding accordingly.

VI

Whereas petitioner's pre-emption challenge focused on the effects of the prior authorization requirement that would fol-38 See n. 30, supra.

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