November 2004 Newsletter

Lab Demo Design

By: Catherine Sicker, Compliance Officer, Partner

Medicare Laboratory Services Competitive Bidding Task Order Awarded

The Centers for Medicare & Medicaid Services (CMS) awarded a task order contract to RTI International and their subcontractor Palmetto GBA on September 30, 2004. (RTI was previously involved with a lab competitive bidding project for CMS in 1997 and is currently involved in designing the nationwide implementation of DME competitive bidding.) The task order was issued as part of implementing the competitive bidding demonstration project for laboratory services as mandated by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The project includes laboratory tests performed by entities without face to face encounters with patients. The statute does not specify an effective date, but an initial report is due to Congress by December 31, 2005.

The purpose of the task order is to assist CMS in the design and operation of the demonstration project:

Phase I-Design

• Management Plan
  • Development of the design
  • Solicitation
  • Bid process
  • Claims processing
  • Quality assurance
• Demonstration Design
  • Technical expert panel
  • Criteria for site collection
  • Lab eligibility criteria
  • Data collection and data analysis plan
  • Education
  • Complaint and inquiry mechanism
  • Liaison with lab regulatory agencies
• Solicitation and Bid Process
  • Solicitation process and materials
  • Data collection
  • Bidding process
  • Determination of payment amounts
• Claims Processing Plan
  • Supports CMS systems changes
  • Works with carriers and systems maintainers

Phase II-Operation

• Management of beneficiary and provider relations
• Claims submission and processing
• Financial settlements or payment adjustments
• Data collection

CMS launched a new web site for "one stop shopping" for clinical laboratory resources last October. The status of the demonstration project will be available on that web site.