Friedrich v. HHS

Chelation therapy consists of intravenous injections of disodium edetate. As early as 1970, the Food and Drug Administration (FDA) approved labeling for using disodium edetate for certain severe condition, but specifically not for the treatment of generalized arteriosclerosis associated with advanced aging. In 1980, the Secretary of Health and Human Services issued new criteria for Medicare Part B drug coverage, permitting payment for any user of an FDA-approved drug determined by the carrier to be reasonable and necessary, except for those uses specifically disapproved by the FDA or for which coverage might be precluded by national instruction. In 1982, after publishing notice in the Federal Register, an extensive assessment was conducted that included evaluation from numerous professional organizations and medical-specialty groups and resulted in a comprehensive report recommending that the Medicare Part B program not cover chelation therapy. The recommendation was adopted, and a national coverage determination was issued instructing intermediaries and carriers not to pay for chelation therapy under Medicare Part B. In 1983, Michael J. Friedrich (plaintiff), a Medicare Part B recipient, sought reimbursement for chelation therapy. Friedrich’s carrier refused to reimburse Friedrich for those expenses. Friedrich sought review from his carrier, and his claim was again denied. Friedrich then requested and was granted a carrier hearing review during which his physician testified about the benefits of chelation therapy for coronary artery disease. The hearing officer nevertheless followed the national coverage determination and denied reimbursement. A lawsuit against the Secretary of Health and Human Services followed in which the district court entered judgment for Friedrich after invalidating the national coverage determination not to pay for chelation therapy. The secretary appealed. Friedrich argued that the national coverage determination constituted a legislative rule that departed from Medicare’s general coverage policy for FDA-approved drugs and that he had a due-process right to have his individual claim considered de novo.