Development and Implementation of the Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project

The goals of this task order are to assist CMS in the design (Phase I) and operation (Phase II) of the demonstration. Phase I will assist with demonstration design and solicitation development. Phase II will assist with the operation of bid sites of the demonstration. Section 302(b) of the Medicare Modernization Act amends section 1847(e) (42 U.S.C. 1395w-3)- Competitive Acquisition of Certain Items and Services, to include a demonstration project for clinical laboratory services. The demonstration must apply competitive acquisition for payment for clinical laboratory services, which would otherwise be made under Medicare Part B fee schedule. The payment basis determined for each competitive acquisition area will be substituted for the payment basis. Under this statute, pap smears and colorectal screening tests are excluded from this demonstration. Requirements under the Clinical Laboratory Improvement Amendments (CLIA) as mandated in section 353 of the Public Health Service Act are applicable. Contracts will be re-competed every 3 years and multiple winners are expected in each competitive acquisition area. The statute does not specify the number or location of demonstration sites. The statute does not specify an implementation date. An initial report to Congress was due not later than December 31, 2005.