WASHINGTON _ The House Ways and Means Committee passed itshealth care reform bill on Thursday with a number of provisions stillintact that may cause some in the biotechnology sector to lose sleep.Almost as soon as that was out of the way, on Friday morning, pricecontrol proponent Sen. David Pryor (D-Ark.) circulated some new andburdensome proposals to amend the Senate Finance Committee'shealth care reform package. Chuck Ludlam, vice president forgovernment relations at the Biotechnology Industry Organization(BIO), spent the afternoon at the Finance Committee meeting tomonitor the proceedings.Reacting to the onslaught of onerous legislation, BIO is planning alobbying assault in Washington on July 20, said president CarlFeldbaum. "We're going to have a fly-in. We'll set up all the meetingsCongress can stand." Feldbaum would not predict how many memberswill attend."We plan to lobby state delegations, individual members and keycommittee staffers," he added.Here's what remained intact in the Ways and Means bill that passed onFriday:y The Prescription Drug Payment Review Commission, another versionof the breakthrough drug committee, is included. (See BioWorldToday, July 1, p. 1)y Drug manufacturers must pay a 15 percent rebate to the Health CareFinancing Administration for drugs purchased by Medicare andMedicaid.A new "part C" of Medicare, designed to encompass the uninsured aswell as many people in small businesses with under 100 employees,would raise the total number of people covered under Medicare fromthe present 36 million elderly, who consume a disproportionate shareof drugs, to 91 million."You've got to figure that by the year 2,000, [the Ways and Means bill]would create a largely nationalized health care system run by thegovernment," Feldbaum told BioWorld.y Sector-by-sector, state-by-state caps on health care costs are included,as well. There are 10 sectors including prescription drugs, a staffassistant to a member of the Ways and Means Committee said. Ifannual spending within a sector rises beyond the cap, the next yearprices in that sector must be reduced. Thus, it appears that drug pricesin a state that exceeded its cap would be forcibly reduced, Feldbaumsaid.y Another provision would force drug companies to provide to allpurchasers the largest discount that any large purchaser couldnegotiate. The bill contains other provisions which could aid or harmbiotechnology depending on how they were applied, Feldbaum said."A National Health Cost Commission would analyze the rate of growthin health care spending, and recommend to Congress when so-calledprivate sector cost containment would go into effect or be modified."The secretary of Health and Human Services could modify coverage ofvaccines and other preventive measures, Feldbaum said. "The secretarycould exclude coverage for off-label uses of drugs even if the use isindicated in the literature."The only thing you can predict is that this kind of bill with all itsirresponsible vagueness threatens to further upset the markets," he said.As to how all of this will come out in the wash of the legislativeprocess, "Hardly anybody makes predictions anymore about this,indicating the depth of uncertainty that we are facing," Feldbaumadded.At the time BioWorld went to press Friday evening, Sen. Pryor had notyet offered an amendment. As circulated Friday morning, the documentcontained the same Prescription Drug Payment Review Commissionthat is in the Ways and Means bill. In addition, it would require drugmanufacturers to pay a rebate to Medicare for new drugs, and if theSecretary of Health and Human Services were unable to negotiate asatisfactory rebate, he or she could blacklist the drug from receivingreimbursement under Medicare. n

-- David Holzman Special to BioWorld Today

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