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Daily News

April 02, 2003

Senate Democrats are vowing to fight the administration's version of smallpox vaccine compensation legislation on the floor after the Senate health committee voted April 2 along party lines to defeat four Democrat amendments, then passed the bill out of committee. Senate health committee chair Judd Gregg (R-NH) and ranking Democrat Edward Kennedy (MA) failed to even come close to negotiating a plan that both sides could agree to, according to Kennedy.

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April 01, 2003

Medicare regulatory reform legislation that was recently passed out of the House Energy and Commerce Committee with broad bipartisan support includes a provision that would require even those hospitals outside of OSHA's jurisdiction to comply with the bloodborne pathogens standard.

The bill states that failing to comply with the requirement would result in a civil monetary penalty in an amount "similar to the amount of civil penalties under [the OSH Act]." Similar language had been included in previous Medicare regulatory reform bills, which never passed the Senate.

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HHS Inspector General Janet Rehnquist has issued a "special fraud alert" aimed at stopping durable medical equipment (DME) suppliers from making unsolicited phone calls to Medicare beneficiaries. The Office of Inspector General (OIG) is upset that some DME firms are hiring independent marketing firms to conduct improper telemarketing.

"Suppliers cannot do indirectly that which they are prohibited from doing directly," the OIG's new fraud alert warns.

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Responding to a Public Citizen request that a proposed rule on hexavalent chromium be issued as an interim final rule, OSHA says it lacks the authority to do so.

In a March 25 submission to the United States Court of Appeals for the Third Circuit, which is calling for OSHA to finalize a hexavalent chromium standard and is working on the schedule for when the regulation should be completed, the agency says it "lacks statutory authority" to issue a proposed rule as interim final regulation.

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The medical device industry hopes to use a "corrections" bill to fix unworkable third-party-inspection provisions in the new device user-fee/reform law, according to an industry source. Staffers for Senate health committee chair Judd Gregg (R-NH) drafted a corrections bill months after the law was signed, but they postponed work on the bill to deal with more pressing legislation such as Project BioShield and the smallpox vaccine compensation plan, industry sources say.

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Canadian Internet pharmacies are trying to lure small U.S. pharmacies into illegally importing drugs from Canada by offering them lucrative contracts, according to a community pharmacy source. In most cases, the pharmacies are enticed with profits several times what they make off their average prescription orders.

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After facing strong protests from oncologists, CMS has dropped an earlier plan to single out drugs approved by FDA on the basis of surrogate outcomes for possible non-coverage decisions. Cancer groups are applauding CMS' about-face, but remain concerned by the agency's move to conduct national coverage reviews on other FDA-approved cancer drugs.

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The House overwhelmingly approved a motion April 1 that instructs its budget resolution conferees to restore Medicaid cuts included in the House budget resolution for fiscal year 2004. House and Senate conferees are meeting to hammer out a compromise between the House version of the budget resolution, which would cut $94 billion out of Medicaid, and the Senate version, which does not include such cuts.

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March 31, 2003

A plastics industry trade group is complaining to the Office of Management and Budget (OMB) that FDA's rules requiring registration of food contact material makers and prior notice of import go against Congress' intent in the bioterrorism act. The group says the wording of FDA's proposal could be read as covering finished packaging beyond that in direct contact with food.

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Under new chair Rep. Tom Davis (R-VA), the House Government Reform Committee has unveiled its oversight plan for the 108th Congress that includes dietary supplements, OxyContin diversion, drugs sold over the Internet, vaccine safety, the vaccine injury compensation program (VICP) and medical device safety. Several of the FDA-related probes continue work initiated by former chair Dan Burton (R-IN), who will still play a role as the chair of the wellness and human rights subcommittee.

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Sen. Richard Durbin (D-IL) has introduced a long-awaited bill that would give FDA power to require that dietary supplement firms submit adverse event reports (AERs). But the bill does not guarantee that the information will not be available publicly on FDA's website, as is the case with prescription drugs AERs, congressional sources say.

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A multi-state coalition developed to tackle soaring prescription drug prices is inching ahead with its plans to develop a non-profit pharmacy benefit administrator (PBA) aimed at giving state drug programs more bang for their buck.

The initiative is yet another example of deficit-weary states taking action to curb escalating drug costs in the absence of a legislative remedy from Capitol Hill.

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OSHA and two companies it has cited for ergonomics violations under the general duty clause have agreed on settlement terms. The companies vow to work with the agency to better protect employees from musculoskeletal disorders and OSHA in return agrees to significantly reduce the fines levied against the businesses.

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The Medical Device Manufacturers Association (MDMA) is asking that FDA not allow device companies to bundle premarket applications (PMA) -- a position contrary to that of the Advanced Medical Technology Association (AdvaMed). However, the two trade groups agree that device reprocessors should not be allowed to bundle devices from different manufacturers.

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The pharmaceutical industry plans to appeal a federal court ruling upholding CMS' approval of a Michigan Medicaid drug program. A key drug industry trade group had sought a preliminary injunction to quash the Michigan program, which it contends violates Medicaid law and harms Medicaid beneficiaries, and aimed to block HHS from approving similar state initiatives.

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March 28, 2003

Senate Republicans won the first two major votes regarding a prescription drug benefit by defeating an attempt from Sen. Max Baucus (D-MT) to make sure that a drug benefit in fee-for-service will be as good as one through private industry. Earlier, the GOP also thwarted an attempt to add an additional $219 billion to Medicare reform.

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The chair of the Senate committee with CMS jurisdiction and a key House Democrat are asking CMS to ensure that states report all nursing home violations to the agency within 45 days of a citation in order to allow those comparing nursing homes to have the most-recent information available.

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CMS has created a Medical Technology Council (MTC) in a bid to fast-track Medicare's coverage process for new technologies -- a move that could lead to improved coordination between the agency and FDA.

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FDA's lawyers are revisiting whether the agency can force dietary supplement makers to report adverse events, according to a key agency source. An herbal industry trade group added urgency to the debate last week by sending a citizen petition to FDA arguing the agency has authority to force such reporting. And this week legislation was introduced in the Senate that would explicitly give FDA such authority.

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Under expedited review, FDA has cleared a skin lotion for the military to use for preventing chemical burns, according to an FDA release. The agency relied on safety and efficacy tests conducted by the U.S. Army with the help of the Canadian military.

The Army tested the product's safety by with skin irritation, sensitization and photo irritation studies in over 300 people, according to the release. The Army tested the lotion on animals to show it works.

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