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May 6, 1983

Substantial Evidence of Effectiveness

JAMA. 1983;249(17):2329-2330. doi:10.1001/jama.1983.03330410027018

To the Editor.—  Physicians in Rhode Island have recently been notified by the Department of Social and Rehabilitative Services that the Department of Health and Human Services has mandated that, in accordance with provisions of Section 2103 of Federal PL 97-35, payment cannot be made for certain drug products through state Medicaid programs, which the Food and Drug Administration has proposed to withdraw from the market as lacking substantial evidence of effectiveness. Physicians were further advised that, effective immediately, the state must, in accordance with federal requirements, discontinue reimbursement for those drug products classified by the FDA as lacking substantial evidence of effectiveness when provided to eligible recipients of the State Medical Assistance Program. A list of drugs no longer reimbursed under the State Assistance Program was included, and related or similar drugs known by their generic names were also prohibited from reimbursement.On the list of drugs lacking "substantial