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Daily News

May 16, 2003

The HHS Advisory Committee on Human Research Protections will have its first meeting sometime between mid-summer and early fall, according to a source closely following the issue. The discussion topics for the meeting are not yet finalized, the source says.

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Secretary of State Colin Powell has issued a directive to U.S. embassies in Europe to tell officials in European Union member states as well as the European Commission that a proposed new system for regulating chemicals is overly burdensome for industries on both sides of the Atlantic and could have "significant adverse trade implications." But the demarche sent to U.S.

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Top FDA management is holding up a controversial good tissue practices (GTPs) regulation that has been six years in the making because it would cost millions of dollars to implement, a former FDA lawyer says. FDA has no doubts about its legal power to issue the rule, despite industry assertions that the agency overstepped its statutory authority when it issued the proposed rule, the source adds.

Meanwhile, a key lawmaker has introduced legislation that would require FDA to finalize the rule within 90 days.

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May 15, 2003

The Bush administration has quietly formalized the role of the White House's Office of Management and Budget (OMB) in a federal task force charged with protecting children's health from environmental risks, raising fears among environmentalists and public health organizations that the White House budget office will apply controversial cost-benefit techniques and budgetary considerations that may weaken the implementation of any task force recommendations.

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The Senate environment committee has cancelled a markup of chemical security legislation that is backed by Republican leaders and the Bush administration. The markup has not been rescheduled, and the abrupt cancellation signals tough negotiations ahead on reaching a committee consensus on the controversial issue.

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Republican backers of new bills to increase subsidies for Medicare+Choice plans are confident their proposals will be included in Medicare reform bills that both chambers will take up this year, but the Democratic cosponsors say the proposals will need more of a push.

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House Speaker Dennis Hastert (R-IL) today said he was open to looking at an alternative Medicare prescription drug plan proposed by a splinter group in the party, even if it delays passage of a drug plan.

"We are not going to be hasty about it. We are going to write the right policy to get it done. If it takes a little longer, and if we need to listen to a few more folks on our side, we will do that," Hastert told reporters May 15.

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The HHS Office of Inspector General gave a Medigap insurer the go-ahead to set up a relationship with a network of hospitals through a preferred provider organization, issuing an advisory opinion that the set-up would not violate the anti-kickback statute.

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The House Energy and Commerce Committee unanimously passed BioShield legislation May 15 that authorizes $5.6 billion for research and procurement of biodefense measure over the next 10 years, but gives Congress instead of the White House control over the purse strings. The White House is unhappy with the committee's bill because it would require Congress to appropriate the funds instead of giving the administration indefinite, unfettered authority to spend on biodefense, according to a congressional source.

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With overwhelming support, the Senate May 15 passed an amendment to its tax legislation that would boost rural Medicare payments by an estimated $25 billion over 10 years. To offset these increases, the amendment would reduce the average wholesale price (AWP) rate, freeze the consumer price index for durable medical equipment (DME) and add a deductible and coinsurance for clinical laboratory services.

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The National Governors Association's (NGA) Medicaid task force is still working to craft a proposal for reforming the Medicaid program and hopes to deliver a recommendation to the Bush administration and Congress by mid-June, a NGA spokesperson says. The news comes a day after NGA Chairman Kentucky Gov. Paul Patton (D) floated his own Medicaid reform proposal among task force members at a May 14 meeting in Washington, DC.

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The Senate voted overwhelmingly May 15 to add language to its tax bill that ensures half of the legislation's $20 billion in state fiscal aid will go directly to state Medicaid programs. The 95-3 vote is a significant step forward for proponents of the long-running campaign for state fiscal relief and a federal Medicaid funding hike.

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May 14, 2003

The Office of Management and Budget (OMB) is asking all agencies to submit their budget requests for fiscal year 2005 by Sept. 8, 2003. OMB directs the agencies to keep the requests within the FY 05 levels included in their FY 04 budgets, and to offset any increases for new initiatives with reductions in lower priority or ineffective programs.

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For at least the next five years employees being transferred from FDA's biologics center to the drug center can expect to keep their positions and pay, and research will continue to be as much a part of the review process as before the reorganization, according to FDA and union sources. For now it appears the union has signed off on the deal.

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House Ways and Means health subcommittee chair Nancy Johnson (R-CT) told Inside CMS today (May 14) a floor vote on Medicare reform will not occur before the Memorial Day recess, predicting a bill will be marked up and passed by the House in June. The House GOP leadership had set a Memorial Day deadline for marking up Medicare reform legislation.

While not providing specifics on the legislation, the lawmaker said the provider relief portion of the bill would be smaller than last year's $30 billion package but she indicated that Medicare+Choice payments would be included.

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GOP members of the House Energy and Commerce Committee are meeting this afternoon to try to close divisions within their ranks that have delayed the markup of a Medicare prescription drug bill, according to Rep. Jim Greenwood (R-PA), who downplayed the possibility the party could rally around a new drug plan proposed by a splinter group in the committee.

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In the latest development over the battle for state fiscal aid, Senate Democrats are seeking to double the relief funding included in the Senate GOP tax plan, and dedicate half of that to state Medicaid programs. The proposal is just one of many amendments Senate Democrats are expected to offer to the Republican stimulus bill, including a measure to postpone certain tax cuts until Congress passes a Medicare prescription drug benefit on par with that available to federal employees.

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May 13, 2003

FDA is contributing to the fight against severe acute respiratory syndrome by developing a list of medical products that need to be in greater supply, and by helping to search for a diagnostic test and therapies, develop a SARS vaccine and safeguard the blood supply. So far there are no marketing applications for a SARS diagnostic, vaccine or treatment because scientists are just beginning to understand the virus, according to Murray Lumpkin, FDA's principle associate commissioner.

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CMS has delayed until July 2 a pending coverage decision on the use of the colorectal cancer drug oxaliplatin but restricted the coverage decision to off-label use of the drug.

That means that the uses for the drug that have been tested and approved by FDA--for patients whose colorectal cancer has recurred or worsened and receive other specific drug treatments--will be covered by Medicare. This is a concession to pressure from cancer care providers and their congressional supporters.

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The Congressional Budget Office (CBO) plans to provide a cost estimate on an alternative prescription drug bill drafted by five key House Energy and Commerce Republicans after it completes a "score" on the closely held main House GOP Medicare reform legislation, sources say. The GOP leadership remains hopeful that drug coverage legislation patterned largely after last year's House-passed bill will move through the chamber by early summer.

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