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Demonstration Project For Competitive Bidding of
Clinical Laboratory Services
Summary of Legislation
Section 302(b) of the 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. 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. The statute does not specify an implementation date. An initial report to Congress is due not later than December 31, 2005. Progress reports and final reports are required. The total amounts to be paid to contractors in a competitive acquisition area are expected to be less than the total amounts that would otherwise be paid. The payment basis determined for each competitive acquisition area will be substituted for the payment basis. Contracts are to 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.
Current Status
CMS awarded a task order contract to RTI International (and their subcontractor Palmetto GBA, LLC) on September 30, 2004. John Kautter, Ph.D. is the Project Director.
The purposes of this task order are to assist CMS in the design (Phase I:
demonstration design, develop solicitation and bid process, claims processing
plan, management), and operation (Phase II: operate bid sites of the demonstration.
CMS will hold an Open Door Forum later this fall to gather input and information
from the public regarding the initial phase of the contract. There is also an
ongoing dedicated email box (lab_bid_demo@cms.hhs.gov)
that provides a way to the public for ongoing and direct communication with
CMS regarding this demonstration project.
Submission of written materials pertaining to this demonstration
Anyone wishing to share information should send written materials to Linda Lebovic, the project officer for the demonstration, via email at: LAB_BID_DEMO@cms.hhs.gov or through the US mail at:
Linda Lebovic
Mailstop C4-17-27
Demonstrations Group
CMS - ORDI
7500 Security Blvd
Baltimore, MD 21244-1850
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