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Daily News

July 28, 2003

From weight loss management to money for Hawaii's Medicaid program, a slew of Medicare odds and ends that gained last-minute passage in the Senate Medicare plan must now be addressed by conferees hammering out a final Medicare reform bill.

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Industry lawyers are requesting that the American National Standards Institute (ANSI) withdraw the accreditation for a voluntary standards-setting committee (Z365) that is in the process of crafting an ergonomics rule, charging the committee violated ANSI rules.

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A key House lawmaker has launched a Republican bid to stymie a proposed Medicare policy change that would cut hospital payments by an estimated $160 million in fiscal year 2004. Rep. Nancy Johnson (R-CT) claims CMS' proposed expansion of Medicare's post-acute care transfer policy would penalize hospitals for efficient treatment and would undermine the principles of the prospective payment system (PPS).

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In a major policy shift, the nation's largest seniors organization is willing to support legislation allowing pharmacists and wholesalers to reimport prescription drugs from Canada, without broad HHS certification, an AARP official told Inside CMS. The group's position may provide middle ground for Medicare conferees, who must decide whether to maintain the "poison pill" provision in the House and Senate Medicare bills or go along with a newly passed House bill allowing reimportation from 25 countries without HHS certification.

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July 25, 2003

The House vote easing restrictions on pharmaceutical reimportation may force Medicare conferees to reach compromise solution that accommodates safety concerns, House Speaker Dennis Hastert (R-IL) told reporters July 25, even as Majority Leader Tom DeLay (R-TX), a Medicare conferee, said he remains opposed to the measure.

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The House fiscal year 2004 Labor appropriations bill includes report language criticizing OSHA for its "lack of progress" on a rule that would require employers to pay for workers' personal protective equipment (PPE). The House passed the spending bill July 10.

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Congress may extend the application of OSHA's bloodborne pathogens standard to hospitals currently not covered by the regulation this year. The extension is called for in House Medicare regulatory reform language that has been attached to the Medicare reform bill now moving through Congress.

While the Senate version of the legislation does not include any provision to expand the application of the standard, it is likely that it would be added in conference.

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The Senate plans to adopt the House BioShield funding provision during conference, according to a key congressional source. The source says Sen. Robert Byrd (D-WV) will accept the House funding scheme, which would establish a special fund for purchasing biodefense products and would authorize Congress to appropriate $5.6 billion to the fund for the next 10 years without requiring annual appropriations.

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A major effort by Philip Morris to generate congressional momentum behind tobacco legislation combining new FDA authority with a federal buyout is likely to stall in the House, and may face obstacles in the Senate. The idea of giving FDA explicit jurisdiction over tobacco has hit a roadblock with House Energy and Commerce Committee chair Billy Tauzin (R-LA) opposing legislation, sources say. In the Senate, health committee chair Judd Gregg (R-NM) and ranking committee Democrat Edward Kennedy (MA) are haggling over how to fashion a bill giving FDA oversight of tobacco.

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Sen. Richard Durbin (D-IL) is asking dietary supplement makers who advertise their products as "ephedra free" to provide safety information about their products. Durbin charges that supplement makers are substituting chemical ingredients similar to ephedra in their products. Durbin also criticizes HHS for not banning ephedra despite having received the results of the RAND study and comments on the ephedra proposed rule.

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July 24, 2003

The Senate health panel unanimously passed patient safety legislation July 23 after committee chair Judd Gregg (R-NH) and ranking Democrat Edward Kennedy (MA) brokered a compromise hours before the markup. Unlike the earlier version of the bill, the chairman's mark does a better job of providing whistleblower protection to state hospital employees who report medical errors to patient safety organizations (PSOs), a Senate Democratic staffer says. The revised bill also more narrowly defines what information PSOs could make confidential, congressional staffers say.

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Late Wednesday (July 23), the Senate unanimously passed a modified version of legislation passed earlier by the Senate health committee that would reinstate FDA's controversial pediatric rule. The revised bill closes a possible loophole in the committee-passed bill that pediatric groups said would have let hundreds of deferred and pending pediatric studies slip through the cracks. The pediatric rule, struck down by the courts, allows FDA to force drug companies to conduct pediatric trials on their products.

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House Republicans passed three OSHA reform bills on a party-line vote July 24, despite Democratic charges the bills would help employers avoid OSHA citations and create additional costs to the government. But Democrats did not offer any amendments to the legislation during the subcommittee markup.

In a move aimed at helping small businesses, the bills would increase the size of the Occupational Safety and Health Review Commission (OSHRC), offer companies more leeway in filing objections to agency citations and clarify the commission's role as an independent arbiter.

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FDA Commissioner Mark McClellan resisted lawmakers' efforts to get the agency on record as needing more statutory authority to regulate dietary supplements during a House Energy and Commerce Committee hearing Thursday (July 24). McClellan said FDA has never tested the "unreasonable risk" standard of the dietary supplement law, and the agency wants to make sure it has a solid case before taking additional action.

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Medicare conferees today (July 24) reached a tentative deal on the bulk of differences between the House and Senate regulatory reform packages.

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In the latest missive on Medicare reform legislation, a group of centrist Senate Democrats and House Blue Dogs have teamed up to urge congressional leaders to forge a conference report adopting key elements of the Senate-passed plan in order to gain strong bipartisan backing rather than a slim majority. The lawmakers repeat previous Democratic calls for the retention of the Senate government fallback option and added low-income protections, among other demands.

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July 23, 2003

The U.S. Chamber of Commerce and other industry groups are worried that mold litigation will become "the next asbestos" controversy. Strongly criticizing trial lawyers and the media, the Chamber says science does not support the public's perception "that mold causes 'toxicity' in doses found in home environments."

Employers link asbestos litigation to numerous bankruptcies and the Senate is currently working on litigation that would establish an industry-sponsored trust fund exceeding $100 billion to pay off pending asbestos claims.

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Medicare legislation passed by the House and Senate last month both cost more than the allotted $400 billion budget mark, new cost estimates reveal, worsening the headache for Medicare conferees tasked with melding the competing bills. Tagged at $461 billion over 10 years, the Senate score was boosted in large part by a lone $40 billion pharmacy benefit manager (PBM) disclosure provision -- casting serious doubt over the amendment's future.

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A group of occupational health professionals is calling on the author of House OSHA reform legislation to limit the scope of the bill to small businesses. The group, however, supports most of the professions to be marked up tomorrow (July 24).

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FDA will receive $5 million to support a new food security research program, HHS Secretary Tommy Thompson and FDA Commissioner Mark McClellan announced Wednesday (July 23). The agency will use the new funds to develop prevention and mitigation technologies and strategies; identify agent characteristics needed to develop these prevention technologies; and craft ways to assess foods for contamination with chemical, microbiological and radiological agents.

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