Reimbursement of tumor marker tests.

The diffusion of new technology is significantly affected by coverage and reimbursement decisions. A variety of agencies (public and private) make decisions as to which technologies or treatments will be covered and what the levels of reimbursement will be. Recently, these agencies' coverage decisions have tended to be strongly affected by whether a technology is cost raising or cost reducing. Historically, a common effect of medical innovation has been improved quality of health care but with a corresponding increase in cost of delivery. The Medicare program has significant influence on the coverage policies of public and private third-party payers. This influence is especially visible in coverage and reimbursement decisions for cancer-related diagnostic procedures and systems. Coverage for these procedures and systems is not widespread because payers have not been convinced of the clinical usefulness of the assays. The industry must take the responsibility of working through the issues surrounding coverage and reimbursement of cancer-related diagnostic procedures with the payers. The ability to successfully negotiate payment for assays requires knowledge of Medicare coverage policies and a grasp of the reimbursement system.