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Daily News

January 07, 2003

The Bureau of Labor Statistics (BLS) has announced that occupational injury and illness rates have dropped to an historic low. While DOL Secretary Elaine Chao applauded the data, an organized labor official said the numbers do not match other indicators measuring workplace injuries and illnesses.

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Upcoming revisions to the tripartisan drug plan could include higher beneficiary cost-sharing to reflect current fiscal confines judging by recent comments from the top health aide to incoming Senate Finance Committee Chairman Chuck Grassley (R-IA).

Speaking at a Dec. 19 Alliance for Health Reform briefing, Finance Committee Republican health policy director Linda Fishman indicated that while the costs associated with providing a drug benefit have escalated, cost-sharing levels have remained static.

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House Ways and Means Committee Chairman Bill Thomas (R-CA) Jan. 7 introduced legislation that would overturn CMS' physician payment rule, which is slated to go into effect March 1. Thomas is using a provision under the Congressional Review Act of 1996 (CRA) to reject the rule. Only one federal regulation, OSHA's ergonomics standard, has been overturned through a CRA joint resolution of disapproval. -- Bob Cusack

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A prominent law firm in Washington, DC has hired Jason Poblete, who has been a key strategist for Rep. Bill Thomas (R-CA). Poblete started this month at the law firm Reed Smith LLP and will work on a range of issues, including health care and trade.

Poblete was a member of Thomas' trusted inner circle and his opinion "mattered in Thomas' office," according to a House GOP official. Poblete was Thomas' communications director for over five years.

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Senate Minority Leader Thomas Daschle (D-SD) Jan. 7 unveiled his party's legislative agenda for the 108th Congress, and swiftly introduced Democratic bills to provide Medicare prescription drug coverage, bolster homeland security and expand health care coverage. The Democrats' prescription drug bill would also reform drug patent law and allow reimportation of drugs from Canada -- two proposals passed by the Senate last year but never taken up by the House.

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Sen. Debbie Stabenow (D-MI) plans to introduce a bill Wednesday (Jan. 8) that would strip a provision from the new homeland security law protecting producers of thimerosal from class-action suits, according to a Stabenow spokesperson. Stabenow plans to hold a press conference Jan. 8 to rally support for her bill, which she may try to attach to an omnibus appropriations bill.

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January 06, 2003

Despite the Bush administration's three-month delay of another round of physician payment cuts, most health care observers believe that Congress will not act to reform the payment system before the cuts become effective March 1.

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The California Department of Justice (DOJ) is investigating high cancer incidence rates in the state's high technology industry in order to determine whether companies have violated California law and if new laws and/or regulations are needed to address the issue, Inside OSHA has learned.

DOJ has launched an investigation entitled "Worker Safety and Health in the High Technology Industry" to ascertain whether working conditions are at fault for increased cancer rates and reproductive health problems experienced by employees in the area.

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The General Accounting Office (GAO) has found that freestanding skilled nursing facilities (SNFs) on average received more Medicare funds than they spent on caring for Medicare beneficiaries. However, GAO also found that 90 percent of hospital-based SNFs are paying more money for Medicare beneficiaries than they are recovering from the program.

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Brand-name drug company Organon says FDA should allow in the Orange Book method-of-use patents that claim unapproved uses of a company's already approved drug. The company maintains that the agency's stance that these patents cannot be listed is at odds with the goals of drug patent law.

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Johnson & Johnson wants FDA to require generic drugmakers to provide innovators with samples of generic drugs so that brand-name companies can determine if the generic drugs infringe on their patents. J&J argues that such a requirement would reduce unnecessary patent infringement litigation, and that it is unfair that generic drug companies can sample brand-name products but brand-name companies cannot sample generic products.

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The trade associations representing the generic and brand-name drug industries are clashing over FDA's plan to allow drug substance patents that do not claim the drug substance used in the approved drug (such as different crystal forms known as polymorphs) to be listed in the Orange Book. While the generic drug trade association says these patents should not be allowed in the Orange Book, the brand-name drug company says FDA already allows such listings and should acknowledge that it does.

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CMS Chief Operating Officer Ruben King-Shaw last week announced a new agency role for Office of Information Services (OIS) Deputy Director for Management and Acting Director Tim Love. In a Jan. 1 e-mail sent to agency employees, King-Shaw said Love has been appointed as CMS' new chief information officer and OIS director.

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January 03, 2003

In a new guidance FDA urges blood banks to defer donations from persons who have received the smallpox vaccination until the vaccine scab has spontaneously separated from the skin or until 21 days after the vaccination, whichever comes later. The guidance goes into effect immediately: FDA has said it is not feasible to seek public input before implementing the guidance because vaccination programs will start soon and blood banks need immediate guidance to determine the suitability of donors.

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A key consumer group has informed the Senate health committee's top Democrat that FDA inspectors found "flagrant" violations of FDA regulations by the American Red Cross (ARC), and urged the lawmaker to investigate the matter. The group states that the violations, totaling 213, are some of the worst and show a "reckless disregard" for terms of the 1993 consent decree. ARC says that it has already begun tackling the concerns raised in FDA's inspection report through a quality-oriented program.

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AARP is strongly criticizing CMS' proposed implementation of a new Medicare appeals system, claiming the agency's rule is contrary to congressional intent. The seniors' group says the proposal "would create almost insurmountable barriers to successful appeals and thus fails to provide the rights beneficiaries need."

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In a surprise move, the generic drug industry trade group has decided to oppose a key element of the president's generic drug reform plan -- a proposal for a single 30-month stay per generic drug application. The Generic Pharmaceutical Association (GPhA) says the administration's 30-month stay proposal, which the White House touts as a move to increase generic drug access, could instead delay generic drug entry.

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A deputies-level interagency meeting late last month arrived at no recommendations for members of the Bush cabinet on whether to mount a World Trade Organization challenge to the European Union's moratorium on approval of new genetically engineered crops, according to informed sources.

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January 02, 2003

With the fate of a voluntary ergonomics rule pending, organized labor is threatening that it will not support an international safety meeting hosted by the National Safety Council (NSC) if the group scraps the voluntary rule, while industry sources say if the rule is approved business leaders will not be as enthusiastic to support the safety and health summit.

NSC President Alan McMillan said any threats to the group because of its work on the voluntary ergonomics standard are "outrageous."

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The incoming chairman of the Senate Finance Committee is considering legislation that would amend provisions in federal law that require trade advisory committees to be "fair and balanced," a key congressional source says. The revisions could limit statutory requirements that have been used by environmentalists to alter the makeup of several all-industry committees through court challenges, and a settlement in one case has prevented an important chemical sector trade advisory committee from meeting until the Bush administration appoints an environmentalist.

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