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Biotech / Medical : Biogen -- Ignore unavailable to you. Want to Upgrade?


To: Pseudo Biologist who wrote (569)1/22/1998 3:11:00 PM
From: Scott  Read Replies (3) | Respond to of 1686
 
PB, I just looked around on the web for posted policies on reimbursement by HMO's for off-label uses. The following is pretty typical, and is from a post by Blue Cross/Blue Shield. It seems to agree with my interpretation of Dr. Eddy's paper. Looking forward to your thoughts.

Off-Label Drug Use

FDA-approved drugs used for off-label indications will be provided only if recognized as effective for treatment 1) in one of the
standard reference compendia; 2) in the majority of relevant peer-reviewed medical literature if not recognized in one of the standard
reference compendia; 3) by the federal Secretary of Health and Human Services. No benefits will be provided for any drug when the
FDA has determined its use to be contra-indicated.

a."Off-label" means the prescribed use of a drug which is other than that stated in its FDA-approved labeling.

b."Standard Reference Compendia" means:
1.The American Hospital Formulary Service-Drug Information;
2.The American Medical Association Drug Evaluation;
3.The United States Pharmacopoeia-Drug Information;
4.Other authoritative sources as identified by the Federal Secretary of Health and Human Services or the Insurance
Commissioner.

c."Peer-reviewed Medical Literature" means scientific studies printed in journals or other publications in which original
manuscripts are published only after having been critically reviewed for scientific accuracy, validity, and reliability by unbiased
independent experts. Peer-reviewed medical literature does not include in-house publications of pharmaceutical manufacturing
companies.