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Executive Summary

HCFA UNDECIDED ON CANCER DRUG MEDICARE COVERAGE UNDER HOME I.V. provisions scheduled to begin Jan. 1, 1990. Explaining the Catastrophic Health Care Act I.V. drug provisions at a recent workshop, Thomas Hoyer of HcFA's provider services division within the Office of Coverage Policy noted that unapproved indications for cancer drugs may create a problem for HCFA. The workshop was held by the Association of Biotechnology Companies in Washington, D.C. Oct. 13. Under the law, HCfA is required to publish a list of those home I.V. drugs that it will cover. Hoyer reported that HCFA has hit a snag regarding such therapies as cancer drugs, which are often prescribed for unapproved uses. "I gather for most cancer drugs," administered by home I.V., "maybe 50% of them are for non-approved uses," Hoyer noted. "We really have, at this point, a kind of dilemma facing us . . . We're a little nervous about publishing a list of drugs that we'll pay for to be used for unapproved uses, " he stated. The Pharmaceutical Manufacturers Association has been lobbying HCFA for coverage of cancer therapies, Hoyer said. He added that the agency is "open" to outside advice and opinions on the issue. "We don't know the solution, I don't have the answer, [but] clearly we'll have to do something," he said. Hoyer added that HCFA expects to have "at least an initial idea of what we're going to do " before the end of the calendar year. Separately, HCFA's Office of Reimbursement is working on a per diem fee schedule for ancillary services associated with I.V. drug delivery under Medicare and expects to have proposed regs ready by the spring of 1989 ("The Pink Sheet" Sept. 19, p. 12). Noting that the law presents a situation where "for the first time, we have to produce a list of things we can cover," Hoyer indicated the possiblity that coverage may be limited by the difficulty of defining such a list. "It is fairly clear from the legislative history that if we don't manage to get two drugs on it, that is all we will cover," he said. Under the law, home I.V. antibiotics are automatically covered except for those HCFA specifically decides against, Hoyer pointed out. The agency must therefore prepare a list of antibiotics which it will not cover. In a separate presentation to the workshop, Prospective Payment Commission (Pro-PAC) staffer Nancy Merrick, MD, discussed HCFA's decision last spring regarding TPA. Noting that HCFA rejected ProPAC's recommendation that the prospective payment schedule hospital update factor be increased to account for the cost of the drug ("The Pink Sheet" April 4, p. 3), she maintained that TPA remains "an important issue" at ProPAC. "We are presently collecting information of costs to patients whho receive thrombolytic agents; it is on our agenda and it is a difficult issue," she said.

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