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Daily News

October 01, 2003

Editor's Note: This article has been modified to reflect a clarification from the American Ambulance Association the group continues to push for across-the-board reimbursement increases for both rural and urban providers.

The American Ambulance Association (AAA) voted last week to lobby Medicare conferees for a conference report that provides payment boosts to ambulance providers for services in all rural areas and increases payments based on population density -- providing higher payments to the more rural areas.

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FDA has asked the Office of Management and Budget (OMB) to review a final rule requiring drug and biologics companies to submit professional labeling information in electronic format. Electronic submission would speed up the labeling review process and the approval of labeling changes, FDA says.

The rule, if cleared by OMB, would changes the submission format for labeling information, which is part of new drug applications, biological license applications, abbreviated new drug applications, supplements and annual reports.

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A final rule on a controversial CMS proposal to limit Medicare reimbursements to nursing homes and other providers for bad debt will be announced in late October, almost a month after the cuts were slated to take effect, an agency spokesperson said.

The rule originally scheduled to go into effect today (Oct. 1) would have cut reimbursements to skilled nursing facilities (SNFs) and other providers by 10 percent immediately and reduced such payments 30 percent from October 2006.

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A decision by the Occupational Safety and Health Review Commission (OSHRC) dismissing a portion of an OSHA asbestos-related citation has enraged organized labor officials who fear the decision will weaken agency enforcement by undermining a controversial agency penalty policy. The commission dismissed OSHA's application of its "egregious" penalty policy, under which the agency levied multiple citations under the asbestos standard to maximize fines.

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September 30, 2003

Key players involved in a secret stakeholder effort to craft a legislative plan for updating OSHA's permissible exposure limits (PELs) charged that politics and lack of resources have hampered attempts to modernize the agency's more-than-thirty-year-old exposure limits. A Sept. 15 informal panel discussion, hosted by the American Industrial Hygiene Association (AIHA), revealed the following major hurdles:

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The HHS Office of Inspector General (OIG) has proposed new standards for excluding providers from the Medicare program if they overcharge Medicare for products and services, such as durable medical equipment, drugs and laboratory tests, signaling the agency's intention to implement its 10-year-old exclusion authority for the first time.

The Sept. 15 proposed rule has drawn criticism from suppliers of durable medical equipment, who already face potential reimbursement cuts in the pending Medicare bills.

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In a position shift, the Council for Responsible Nutrition now backs the idea of requiring dietary supplement manufacturers to report serious adverse events to FDA. But unlike another key supplement group that believes FDA has the authority to set up such a scheme through rulemaking, CRN believes legislation is needed.

CRN's board of directors agreed to back mandatory reporting for serious events at a teleconference in late August, according to a CRN source.

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Medicare's controversial outpatient therapy caps are to remain in effect, at least for the time being, after a federal court Sept. 29 quashed the latest legal effort by three consumer groups to further delay implementation of the rehabilitation limit.

The decision now leaves the chance of a remedy on the $1,590 limit on outpatient physical, speech and occupational therapy, which took effect Sept. 1, up to Congress. Medicare conferees have endorsed a one-year moratorium on the caps, beginning next year, as part of the Medicare conference report lawmakers are trying to craft.

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The Biotechnology Industry Organization (BIO) is urging House lawmakers to swiftly pass legislation that would require sponsors of drug and biologics to test their products in children. The group had earlier opposed the idea of codifying FDA's defunct pediatric testing rule when it was discussed as amendment to legislation reauthorizing the pediatric exclusivity law

In July the Senate passed a bill that reinstates, with some changes, FDA's pediatric rule. A federal court struck the rule last October. BIO is now urging the House to pass the companion version.

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Rep. George Nethercutt (R-WA) has enlisted the support of eight House colleagues in an effort to urge House Medicare conferees to abandon their proposal to purchase durable medical equipment (DME) through competitive bidding or at a minimum include a special carve-out for diabetes monitoring equipment.

A Sept. 23 letter asks conferees to give "every consideration to the Senate language, which would freeze DME payments at the current levels."

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September 29, 2003

Two of Congress' leading nursing home watchdogs have called on HHS to reconsider a new CMS rule allowing workers with eight hours of training to feed residents, charging the policy change could endanger residents. The request comes as several advocacy groups are considering taking legal action to try to overturn the regulation.

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Senate Republicans on the environment panel have reached agreement on contentious chemical security legislation, and plan to move the bill through the committee in October, a GOP aide says.

"We've been working to try and get a deal for some time and think we've got it," a Senate GOP aide says. Committee Chairman James Inhofe (R-OK) appears to have reached an agreement with Sen. Lincoln Chafee (R-RI) on a provision in the bill that would address companies' uses of less toxic materials in their industrial processes.

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The National Advisory Committee on Ergonomics (NACE) has overwhelmingly decided to move forward with an ergonomics symposium aimed at filling in research gaps related to ergonomics. The committee also recommended at its Sept. 24 meeting that five industries be targeted for future ergonomic guidelines: air transport, hospitals, trucking and courier services, grocery wholesale products and motor vehicle equipment.

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A Pfizer official argues that increased spending on direct-to-consumer advertising, while it will increase sales of products within a drug class, does not necessarily guarantee increased sales for the specific brand-name drug advertised.

Neal Masia, assistant director for economic policy at Pfizer, spoke on the issue at FDA's Sept. 22-23 public meeting on DTC advertising. Masia said there is a negative correlation between advertising levels and volume change. Masia argued that sales were actually lower for some advertised drugs.

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Direct-to-consumer (DTC) advertisements do not provide consumers with enough quantitative information about a drug's efficacy and may lead the public to overestimate the advertised drug's efficacy, according to researchers from Dartmouth University's medical school. Researchers suggested including a "prescription drug benefit box" as part of the DTC advertisement to help consumers more accurately gauge the benefit of a drug when compared to a competitor's drug or placebo.

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OSHA Administrator John Henshaw is eschewing a federal chemical investigative board's call for an enhanced process safety management (PSM) standard to address reactive chemicals, saying OSHA will instead provide guidance and outreach to industry and rely on general duty clause enforcement actions to address reactive hazards not covered by current PSM standards.

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Medicare conference negotiations on payments for rural physicians are expected to feature a fresh attempt by Senate staff to convince skeptical House staff of the merits of the Senate's plan to raise rural physicians' reimbursement for their practice expense, industry sources said.

The Senate bill's proposed new floor for the rural practice expense reimbursement index is the most controversial component in the debate on raising Medicare payments for rural physicians.

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September 26, 2003

Seven senators, including Senate health committee chair Judd Gregg (R-NH), and several industry groups who oppose FDA's approach to implementing the bioterrorism law passed last year have renewed their efforts to change proposed requirements that companies would have to meet before importing food to the United States. Without these changes, the FDA's proposed rule to implement the law could cause massive shipping delays and disruption of trade, these critics charge.

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Clinical laboratories are seeking to quash a proposal in the Senate Medicare bill to impose new beneficiary cost sharing for laboratory tests, arguing labs would face high administrative costs collecting relatively minor payments and likely would have to absorb a substantial portion of unpaid bills.

The industry is seeking to wean Senate conferees away from the $18.6 billion savings generated by the proposal with arguments the proposal is unworkable. The labs have already received a positive response from some Senate Medicare conferees.

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A confidential agenda for the remaining three weeks of Medicare conference negotiations groups reimportation, employer retiree coverage and subsidies for state pharmaceutical assistance programs among second-tier issues for work by bicameral, bipartisan staff and eventual decisions by select conferees. However the schedule, which does not specify timelines for these issues, holds open the possibility that these issues will have to be resolved by the full conference.

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