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Daily News

August 13, 2003

Now that CMS has officially announced long-anticipated payment cuts in its proposed physician fee schedule for 2004, physicians are stepping up their lobby for Congress to help ward off what they call an "impending crisis." Physician groups are urging Medicare conferees to adopt House language calling for physicians to receive a positive update in the next two years as an interim fix.

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FDA's Associate Commissioner for External Relations Peter Pitts has been meeting with marketing companies, advertising agencies and drug companies to find out what FDA can do to encourage industry to put more public health messages in their direct-to-consumer advertisements. Pitts said he is listening to companies' advertising strategies and what they think of including public health message in their ads, but for now the agency has no plans to write guidance or change the way it regulates advertising.

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Sen. Edward Kennedy (D-MA) grilled solicitor of labor nominee Howard Radzely during his July 29 confirmation hearing on what the lawmaker views as OSHA's weak ergonomics enforcement stance. Ultimately, Radzely's nomination was passed out of committee July 30 by voice vote.

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OSHA and one of the leading pharmaceutical manufacturers recently signed an agreement to fight ergonomics injuries by developing and sharing best practices on how to reduce ergonomics hazards. Worksites participating in the program would face lower OSHA penalties for health and safety violations that are quickly abated.

OSHA Administrator John Henshaw and Ather Williams, Johnson & Johnson's vice president for Worldwide Safety and Industrial Hygiene, signed the three-year partnership agreement July 22.

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OSHA's recent decision to extend the comment period by 45 days for its draft ergonomics guidelines for poultry processing responded to two industry requests, including one from the National Coalition on Ergonomics (NCE). OSHA has also changed the date that a public stakeholder meeting will be held.

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The Bush administration and industry officials are looking at new regulations in New Jersey intended to prevent industrial explosions caused by reactive chemicals as a starting point for how the federal government might require chemical facilities across the nation to adopt similar measures. But industry officials warn that New Jersey's regulations could impose high costs on facilities, preventing similar federal rules from passing the administration's strict cost-benefit tests.

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In an unusual sidebar to the Medicare conference debate, community hospitals and their specialty counterparts are waging a battle over Senate language that would restrict physicians from referring Medicare patients to specialty hospitals in which they have a financial stake.

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August 12, 2003

A top Mine Safety and Health Administration (MSHA) official strongly defended the agency's controversial coal dust mine regulation during a recent hearing on Capitol Hill as a mine workers representative reasserted the union's call for the rule to be withdrawn.

MSHA Assistant Secretary David Lauriski defended the agency's rulemaking while testifying before a Senate Appropriations subcommittee July 31. The subcommittee hearing on the rule followed a contentious House floor debate in which an amendment to suspend funding needed to finalize the rule was narrowly defeated.

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Draft tobacco legislation floated by the Senate health committee chair differs in key areas from legislation promoted by the committee's top Democrat, a congressional source says. Unlike Sen. Edward Kennedy's (D-MA) earlier bill, chair Judd Gregg's (R-NH) draft would preempt state laws on tobacco product standards and would explicitly prevent FDA from banning tobacco, the source says.

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The Senate Appropriations Committee is telling FDA to do a better job of ensuring that seafood is safe, according to report language accompanying the Senate FDA spending bill for fiscal year 2004. The report language makes recommendations in the areas of seafood safety, chloramphenicol and mercury.

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Key hospital groups are decrying a CMS Medicare policy change set to cut hospital payments by $205 million next fiscal year, with one industry heavyweight blasting the move as a "backdoor budget cut." Hospitals are now expected to highlight the revenue loss in their campaign against a House call for additional hospital reimbursement reductions.

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The White House Office of Management and Budget (OMB) is in the process of reviewing a proposed rule that would change the criteria CMS applies to establish which facilities qualify as inpatient rehabilitation facilities (IRFs). In the meantime, CMS is extending the moratorium on enforcement of the current provision.

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August 11, 2003

A California state judge last February returned a large chunk of an approximate $8 million seizure of prescription drugs, much of which were counterfeits, back to the company that was repackaging the products. A source at the Los Angeles County District Attorney's office says there was no proof that any of the drugs returned to the company were counterfeit. But congressional investigators question the methods used to verify that the drugs were legitimate and why FDA did not try to stop the release in federal court.

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The White House is urging the Senate to quickly act on legislation implementing a transboundary treaty on air toxics, and a related treaty on persistent organic pollutants (POPs), because the United States will not be able to participate in talks on adding new chemicals to the air toxics treaty unless it is quickly ratified.

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The Bush administration's nominee for solicitor of labor recently told lawmakers he is urging the solicitor's office to rely more widely on a rarely used provision in the OSH Act that allows OSHA to order the courts to force employers to comply with review commission rulings.

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The United States is pushing for a mechanism to review use of a potential future agreement in the World Trade Organization that would provide greater flexibility for developing countries to import generic copies of patented drugs under the Agreement on Trade-Related Aspects of Intellectual Property Rights, according to private-sector sources.

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CMS is planning to again deny pass-through status for Amgen's drug Aranesp in 2004, the agency announced in its proposed Medicare outpatient hospital prospective payment system (PPS) rule.

In last year's final outpatient hospital rule, the agency deemed Aranesp and Ortho Biotech's Procrit "functionally equivalent" and decided to not reimburse Amgen's drug at a higher rate. The decision, which had not been included in last year's proposed rule, triggered a firestorm of controversy.

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August 08, 2003

FDA has met all but one of its deadlines under the medical device user fee law, according to an FDA status report. FDA has done a good job of meeting its deadlines, but the General Accounting Office has yet to issue a report that was due to Congress by July 1 on whether FDA is meeting its performance goals for this fiscal year and whether it will meet future performance goals.

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As part of an agency-wide strategic initiative, FDA is promising to cut medical device approval times. Measuring performance by approval times is a different way of measuring performance than the metrics negotiated in the Medical Device User Fee and Modernization Act (MDUFMA).

Device companies like that FDA is working to shorten approval times, according to an industry source, but they want FDA to stay focused on meeting the MDUFMA goals because that is what industry is paying for.

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A key food industry group is upset with California's proposal to apply Proposition 65 regulations to acrylamide in foods. California's environmental health hazard office is proposing to add acrylamide to the list of Prop. 65 items that require warning labels in light of recent research showing that acrylamide can form when cooking food at high temperatures. If California were to go ahead with its plan, foods containing acrylamide would need to carry a warning label.

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