Design and Implementation Support for the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration Project

The purpose of this Task Order is to assist the Centers for Medicare & Medicaid Services (CMS) in meeting the requirements of Section 3113 of the Affordable Care Act of 2010 which mandates a demonstration project under Part B title XVIII of the Social Security Act under which separate payments are made for complex diagnostic laboratory tests. Under the demonstration project, the Secretary shall establish appropriate payment. Specifically, the purposes of this task order are to assist CMS in the design and implementation of the demonstration. The term "separate payment" means direct payment to a laboratory (including a hospital-based or independent laboratory) that performs a complex diagnostic laboratory test with respect to a specimen collected from an individual during a period in which the individual is a patient of a hospital if the test is performed after such period of hospitalization and if separate payment would not otherwise be made under title XVIII of the Social Security Act. A complex diagnostic laboratory test means a diagnostic laboratory test that: 1) is an analysis of gene protein expression, topographic genotyping, or a cancer chemotherapy sensitivity assay; 2) has no alternative test having equivalent performance characteristics; 3) is billed using a Health Care Procedure Coding System (HCPCS) code other than a not otherwise classified code; 4) is approved or cleared by the Food and Drug Administration or is covered under title XVIII of the Social Security Act; and 5) is described in section 1861(s)(3) of the Social Security Act (42 U.S.C. 1395x(s)(3)). The demonstration project begins on July 1, 2011, and operates for a 2-year period. The statute provides a maximum of $1,000,000,000 for direct payments to laboratories. A Report to Congress is required not later than 2 years after the completion of the demonstration project. The report will assess of the impact of the demonstration project on access to care, quality of care, health outcomes, and expenditures under title XVIII of the Social Security Act. Work performed under this Task Order shall address design and operational approaches to: 1) determining payment rates for laboratory services under the demonstration; 2) monitoring payment to laboratories for services under the demonstration; and 3) collaborating with CMS staff experts and the CMS evaluation contractor.