By Lisa Seachrist
WASHINGTON ¿ When Medicare was established in 1965, the program quite clearly excluded coverage of self-administered medications, which, with the exception of insulin, meant pills.
Since the program¿s inception, medical science has changed so dramatically that patients are routinely prescribed drugs and biologics that they inject themselves, and some medications once available only as injections now come in oral formulations. Indeed, as medicines have become more effective, they have become a much more vital component of standard health care.
In the midst of this health-care revolution largely fueled by the success of the biotechnology industry, the Health Care Financing Administration (HCFA) has struggled over how and whether to cover these new medicines. In response to a drop in the medications Medicare will cover, the Health and Environment Subcommittee of the House Commerce Committee took the issue up in a hearing Thursday.
¿Since Medicare was created, the program has covered physician¿s services and supplies including drugs and biologics which cannot . . . be self-administered,¿ said subcommittee chair Rep. Michael Bilirakis (R-Fla.). ¿The manual for carriers states that the determination of whether a drug or biological can be self-administered is based on the usual method of administration. On Aug. 13, 1997, however, HCFA issued a program memorandum which significantly narrowed coverage for injectable drugs.¿
That memorandum changed the coverage by telling Medicare carriers to base their coverage decisions on whether the drug could possibly be self-administered, without regard to the unique needs of individual patients. Bilirakis noted that meant in his home state of Florida, Blue Cross and Blue Shield of Florida attempted to deny coverage for Amgen Inc.¿s white blood cell growth stimulator Neupogen based on the fact the drug could be self-administered, even though it is usually administered by a physician in conjunction with chemotherapy. In addition, Bilirakis pointed out patients with severe disability as a result of their disease or their treatment are unlikely to be able to self-administer drugs that have been deemed self-administerable.
¿Ironically, the administration has proposed dropping coverage for these lifesaving drugs at the same time Congress is considering ways to expand access to affordable prescription drugs for all Medicare beneficiaries,¿ Bilirakis said.
Michael Hash, deputy administrator for HCFA, noted Medicare coverage for pharmaceuticals is severely restricted outside of hospitals and nursing facilities and Congress has created only a limited number of exceptions.
¿The current situation provides a compelling example of why we must modernize Medicare with an affordable, comprehensive, outpatient prescription drug benefit,¿ Hash said. ¿Medicare¿s longstanding policy for coverage under this exception has addressed only whether a drug can be self-administered, not whether an individual patient can self-administer the drug. And Congress has not provided an explicit exception for those who cannot self-administer drugs.¿
Hash said the August 1997 memorandum, which has since been suspended, was not a reduction in coverage, but rather a slight expansion because the memorandum permitted reimbursement when the physician was training a patient to use a self-injectable drug.
Bilirakis dismissed that notion, pointing out several products that were covered before the memorandum weren¿t afterward. Mariellen Rybicki, a multiple sclerosis patient from Reston, Va., testified that by the time she qualified for Medicare Part B in 1997, the plan had stopped coverage of Biogen Inc.¿s Avonex, which it had covered in 1996.
Hash pointed out ¿the issue is a small part of a much larger problem for which patchwork solutions will not suffice.¿
¿As many Medicare beneficiaries lack drug coverage today as senior citizens lacked hospital coverage when Medicare was created,¿ Hash said. ¿All beneficiaries, regardless of health or income, need access to an affordable, comprehensive outpatient drug benefit, as has been proposed by the president.¿
Bilirakis noted Congress was working on a prescription drug benefit for Medicare and ¿hopefully, we will get it done this year.¿