I. INTRODUCTION
On July 6, 2005, the Centers for Medicare & Medicaid Services ("CMS") published an interim final rule to implement the competitive acquisition program ("CAP") for outpatient drugs and biologicals covered under Medicare Part B (the "CAP Rule"),1 as mandated by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 ("MMA").
By way of background, the MMA requires CMS to establish the CAP for the acquisition of and payment for competitively-biddable Part B covered drugs and biologicals effective January 1, 2006. Under the CAP, physicians will make an annual election to either: (1) obtain certain covered drugs and biologicals ("CAP drugs") from vendors selected through a competitive bidding process ("CAP vendors"), or (2) continue to directly purchase drugs and biologicals and be reimbursed under the average sales price ("ASP") system....
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