Proposed Federal Rule Would Bar Reimbursement for "Treatment IND"; Public Comment Deadline March 31

A new rule proposed by the U.S. Health Care Financing Administration (HCFA) would effectively sabotage the "treatment IND" (the program used to make aerosol pentamidine available) by forbidding Medicare to pay for any drug approved under that system. (Medicare itself pays for few AIDS expenses, but Medicaid (Medi- Cal) and private insurance companies will probably follow its lead and also refuse to pay, placing the entire burden on the individual.) And even when a drug company provides a drug free under a treatment IND, this proposed rule would probably bar payment for hospitalization and other routine, normally-covered expenses, if a treatment IND is used (see "Insurance/Medicaid Reimbursement Problems", below). The effect will be to deny the treatment IND option to patients and physicians, and delay medical progress for everyone.
The HCFA has asked for public comments on the new rule. Comments must be received at the address below no later than 3 PM on March 31.
The main point of the proposed new rule, called "BERC-432-P", is to codify existing procedure for determining Medicare reimbursement. A single sentence on the treatment IND (which is new and therefore still unresolved, not part of existing procedure), was slipped into 16 pages of fine print, perhaps in the hope that no one would notice in time.
BERC-432-P (the initials stand for Bureau of Eligibility, Reimbursement and Coverage, an office within HCFA) has other problems, too. For example, any drug which has not been approved by the FDA for marketing is not covered -- regardless of medical practice in the community. The only exception is certain cancer drugs. All payment for such treatment for all other diseases would be barred. This rule would probably prevent the system which now allows cancer patients to have access to experimental drugs from being applied to AIDS or any other disease. (For background on the cancer system, see interview with Nathaniel Pier, M.D., in AIDS Treatment News #62, August 12, 1988.)
We just obtained the text of BERC-432-P before press time and have not been able to analyze it fully. The complete text is published in the Federal Register, January 30, 1989, pages 4302-4318.
The most damaging section is the sentence, "Treatment Investigational New Drugs (INDs) are approved by the FDA but are still considered experimental and not covered by Medicare." The whole point of the treatment IND is treatment, not research -- making drugs available sooner for serious or life-threatening conditions when there is no alternative. Because the procedure is new, reimbursement precedents have not yet been set. The above sentence in BERC-432-P goes beyond the ostensible purpose of BERC-432-P -- to codify existing procedures -- by trying to slip in a new policy, without consideration, discussion, or debate.
You can comment on this proposal at the address below. You might also get your Senators or Representative to inquire.
Comments must be received by March 31 at:
Health Care Financing Administration
Department of Health and Human Services
Attention: BERC-432-P
P.O. Box 26676

Baltimore, MD 21207