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Executive Summary

A list of the home I.V. prescription drugs that will be reimbursed under the Medicare beginning Jan. 1, 1990 will be published in the Federal Register as a regulation by June, HCFA Office of Coverage Policy Director Bob Wren told a March 9 briefing on the catastrophic care outpatient drug benefit in Washington. As described by the Catastrophic Care Act, the list of home I.V. drugs will be composed of two broad categories: all antibiotic drugs except those determined by HHS to be unsafe or ineffective in the home I.V. setting; and all other drugs that HHS has determined are safe and effective. Wren explained that HCFA has subdivided the non-antibiotics group of drugs into five subgroups: anti-infectives; drugs used in fluid replacement; drugs used in pain management; antineoplastic/chemotherapeutic drugs; and "a broad category we call 'other' drugs." The list of covered home I.V. therapies is one of eight separate implementation regulations on the Medicare outpatient drug benefit that will be published by mid-summer, Ross Anthony, HCFA's associate administrator for program development, reported. Seven of the regs, including the home I.V. therapy list, are expected to be published by June, with the remaining one to be issued a month or so later. Anthony characterized three of the upcoming regulations as "written," although he did not specify where they are in the government review and clearance process. The three regs involve prescription drug benefit copayments, coverage of outpatient prescription drugs, and a home I.V. therapy fee schedule. Reportedly, none of the regs have been forwarded yet to HHS. Other regulations further back in the development process relate to drug payment methodology, coverage of home I.V. therapy services, home I.V. drug provider conditions of participation, and the home I.V. list. The eighth regulation addresses Medicare agreements with participating pharmacies. HCFA has had "an awful lot of difficulty in compiling this list," Wren told the meeting. A key issue was the question of providing coverage for off-label uses for therapies such as cancer drugs. Wren indicated that HCFA has apparently decided it will cover such uses. "To facilitate our chore in putting together this list," Wren said, "we recognize the intent of Congress that non-labeled indications be recognized as well as FDA-approved ]uses[ for home I.V. patients." The March 9 briefing was the second informal public meeting held by HCFA on the agency's progress in implementing the catastrophic health care act. HCFA held a similar meeting in Baltimore on Nov. 21 ("The Pink Sheet" Nov. 28, p. 3). The agency currently has no plans for another such meeting, although it will continue to consult with industry. HCFA has decided to use three professional compendia as references for its drug prescribing and dispensing standards, Wren noted. The three compendia -- the U.S. Pharmacopoeia Dispensing Information Compendium, the American Hospital Formulary Service Drug Information Compendium, and the American Medical Association Drug Information Compendium -- were suggested in the conference report to the catastrophic care legislation. The prescribing standards will be part of HCFA's drug utilization review program. "Our current thinking, as a proposal to those above us, will be that we recognize all three of the compendia," HCFA Bureau of Eligibiligy, Reimbursement and Coverage Acting Director Kathy Buto told the briefing. The documents will function as "sources for prescribing standards," she said. However, Buto cautioned, "by no means are we viewing the compendia as the last word." She explained that "there will be uses outside the compendia . . . that will be paid for under the Medicare program." Buto noted that "there are some who would like us to preclude payment for all uses not listed in the compendia. I think the formulary provision ]of the Act[ would preclude us from doing that unless we can make findings that those uses are not safe and effective." She pointed out that the act prohibits the establishment of a formulary. On a compendia-related issue regarding HCFA's coverage criteria, Buto noted a recent HCFA proposal published in the Jan. 30 Federal Register outlining the agency's basis for coverage decisions for all technologies and procedures. "It also goes to the question of what rules and procedures the carriers ought to use in making local judgements," Buto explained. Emphasizing that "our current process and rules are what is reflected in the document," she pointed out that in the proposal, "off-labeled indications are left to the discretion of the carriers." Buto commented that she was "asked recently why we didn't simply adopt the compendia as further guidance of off-label uses: we may well do that. I think it's an open question; it's one that's going to be raised in a comment period." She added: "I hope there is no confusion that this is any way signals that we did not intend to recognize the statutory requirements; that we do recognize these compendia, or some subset of standards, that would go to both labeled and off-labeled uses." On the issue of point-of-sale drug claims processing, HCFA Associate Administrator for Operations Louis Hays reported that the agency has accelerated its plans to solicit proposals from first interested in bidding on claims processing contracts. HCFA had said in the fall that it would issue the REP in mid-August, but the agency has moved up the date to clearly July to provide more time for prospective bidders to put together a proposal, Hays explained. HCFA had originally planned to publish the RFP in late 1989. The agency is planning to issue general notices for comment regarding processor functions and standards one to two months prior to the reg. Charles Booth, HCFA's Office of Reimbursement Policy Director, outlined the fee schedule for the I.V. home therapy benefit. The fee schedule will have two components, he noted, for drugs and services. The payment formulas will be on a per diem basis, as mandated by the act. Payment for drugs and services is not subject to the annual Part B deductible amount. Chart omitted.

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