November 17, 1999
At the just concluded 2 day national Medicare Advisory Committee meeting in Baltimore to consider human tumor assay systems (following in depth pro and con presentations by me and by other proponents, by the NCI, FDA, HCFA, ASCO, and by outside consultants), the eleven voting members of the expert panel clearly expressed support of cell culture drug resistance testing as a covered service for Medicare beneficiaries. The panel members explained that the data were compelling, if not decisive, and compared favorably with the validation of most other widely-accepted laboratory tests. The committee also felt that the clinical utility of the tests was supported by a preponderance of evidence, if not beyond reasonable doubt. The committee members recommended that the tests be available now to Medicare beneficiaries in situations where the information would be helpful to the clinical management of the patient. Medicare will now consider these recommendations and is expected to revise its national coverage guidelines to include cell culture drug resistance testing as a covered service for Medicare patients. These tests are, in addition, recognized as a covered service by California Blue Shield, virtually all California managed care organizations and HMOs, and by most private indemnity insurance plans on a nation-wide basis.
- Larry Weisenthal