Reforming Laboratory Reimbursement: Issues, Impact and Innovations. A Summary of the Clinical Chemistry Forum Held on November 15, 2001

The focus of the American Association for Clinical Chemistry’s 11th Clinical Chemistry Forum, held in Alexandria, VA, on November 15, 2001, was on current and future direction of Medicare reimbursement. Reimbursement issues involve coverage policies, particularly as they relate to new tests, and coding system changes, with the continued influence of the Office of the Inspector General (OIG)1 in subtly defining laboratory policies. The speakers included representatives from the Centers for Medicare and Medicaid Services (CMS), the profession of clinical chemistry, and experts on new test approval and coding issues as well as members of the legal profession with interests in laboratory-related fraud and trends in reimbursement. Appropriately, the lead-off speaker was Jeffrey Kang, Chief Clinical Officer and Director of Office of Clinical Standards and Quality, CMS. Kang, who envisages an expanded role for clinical laboratories in providing physician performance monitoring, discussed CMS’s priorities for clinical laboratories. These include coverage for tests, coding and reimbursement, medical review, enforcement of CLIA, and using laboratory data to measure physician performance. Coverage defines which items or services are eligible for reimbursement. Medical review defines when covered services are deemed medically necessary. CMS is moving toward an evidential approach to coverage and, therefore, expects evidence from those seeking coverage that use of a new technology leads to a health outcome at least as good as, if not better than the outcome with existing technology. Although CMS expects laboratory tests to have clinical validity and utility, it also recognizes that this is more difficult to demonstrate for laboratory tests than for medications or treatments. In response to the Balanced Budget Act of 1997 and the negotiated rule-making it required, CMS expects to implement 23 national coverage policies embracing 66 Current Procedural Terminology (CPT) codes covering ∼60% of laboratory tests currently billed to the Medicare …