Reimbursement of biotherapy: present status, future directions--perspectives of the third-party payer

The mission of insurers is to provide defined financial support for health care therapies deemed appropriate for use in specific clinical situations. In the current health care financial crisis, insurers are faced with keeping costs to a minimum and premiums reasonable. While insurers wish to finance the best available treatment, it is not always fiscally responsible or realistic to fund care provided in investigational therapies. The Blue Cross and Blue Shield Association (BCBSA), as the national coordinating body for local Blue Cross and Blue Shield Plans, assesses the status of new technologies, such as the biotherapy of cancer, through its Technology Evaluation and Coverage (TEC) Program and its Medical Necessity Program. Fundamental to both programs is whether a technology is effective: Does it improve health outcomes? And, if it does, what are its appropriate conditions of use? New technologies demonstrated by clinical research to improve health outcomes and found consistent with other related criteria are considered eligible for coverage by the TEC Program. New technologies not yet established as effective by clinical research and approved through the TEC Program are considered investigational. Most Blue Cross and Blue Shield Plan contracts exclude coverage for such investigational technologies. Most plan contracts also have medical necessity clauses, whereby only medically necessary technology uses are covered. Central to this is clinical research on appropriate medical conditions of use--the focus of the Medical Necessity Program. Valid conclusions on whether a technology works and where and when it works the best presuppose well-designed scientific studies.(ABSTRACT TRUNCATED AT 250 WORDS)