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Daily News

October 06, 2003

At the behest of Medicare conference staff, the ambulatory surgical center (ASC) industry has drafted a legislative roadmap for working toward a new ASC reimbursement and coverage system under Medicare, according to industry sources.

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OSHA's 45-day extension July 24 of the comment period for its draft ergonomics guidelines for the poultry processing industry has garnered several last-minute suggestions from industry, labor and other stakeholders.

Among others, the American Association of Occupational Health Nurses (AAOHN), the United Food and Commercial Workers (UFCW) and the National Coalition on Ergonomics (NCE) all weighed in just before the Sept. 18 deadline.

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Nurse practitioners (NPs) will be able to serve as primary caregivers for their patients after they enroll in hospice programs for end-of-life health care if the Medicare bill passes with the agreements recently announced by conferees.

The conference report will include a provision empowering NPs to act as attending physicians for the purposes of hospice care, a congressional aide said. That language is in the House bill only.

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Lawyers representing a coalition of environmental and public health groups plan to file a petition with California regulators to dramatically increase the number of proposed chemicals for listing under the state's toxics labeling law, known as Proposition 65. State officials say they are moving as quickly as possible to add new chemicals to the list, but that staff reductions and budget cuts have slowed their work considerably.

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Sen. Chuck Schumer (D-NY) and the generic drug industry will press Congress to pass a drug patent reform bill this year even if Medicare drug benefit legislation stalls. Schumer is a key architect of the drug patent reform provisions included in the House and Senate Medicare bills now in conference.

The issue of a fallback plan was discussed at the Sept. 30-Oct. 1 Institute for International Research (IIR) generic drug symposium.

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FDA is putting off a decision on whether to sue states pursuing programs to reimport prescription drugs from Canada until it has had further discussions with the states, a senior FDA official says.

If states actually move forward to implement proposed programs to reimport prescription drugs from Canada they would be violating both federal and state laws, the official says. FDA has offered to meet with the governors of states planning such programs, according to the official.

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October 03, 2003

Two of the state of Washington's leading ergonomists have spoken out against the state's yet-to-be enforced ergonomics rule. The certified professionals support a Nov. 4 ballot initiative that would strike the state's ergonomics standard and say that the regulation, as currently constituted, will not reduce repetitive motion injuries through research and analysis and would hamper companies' ability to create effective ergonomics programs by relying on "good engineering."

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A key House Democrat is asking FDA Commissioner Mark McClellan to examine exactly how much it costs on average to develop a brand-name drug, raising concerns that McClellan has simply touted the drug industry's $800 million figure. House Energy and Commerce health subcommittee ranking member Sherrod Brown (OH) is skeptical of the drug industry estimate.

Brown said the agency has not yet had a chance to respond to his request.

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The Justice Department says a federal appeals court should dismiss a bid by two pediatric groups to reinstate FDA's pediatric rule requiring drugmakers to test their products in kids. The Justice Department argues that the groups lack standing to bring the case in light of the government's decision to pursue legislation instead of a court appeal, especially as FDA is not bound by statute to enforce the regulation.

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Environmentalists are praising a new list by the Centers for Disease Control and Prevention (CDC) of chemicals that the agency will likely monitor in its next "body burden" study, saying the agency's first-time inclusion of a controversial group of substances widely used in consumer products is an important step in understanding the extent to which these potential toxins are found in the general population.

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A new study commissioned by Wyeth Consumer Healthcare claims that Medicare would save over $1.6 billion if it covered multivitamins, but the company has no plans to ask CMS to pay for the products.

Instead, the company -- a major multivitamin producer -- hopes the study will encourage lawmakers and the administration to have government health agencies promote the regular use of such supplements, representatives said.

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Medicare conferees have reached a tentative agreement on how to structure a new regional private health plan option, eliminating a cap of three preferred provider organizations per region. CMS Administrator Tom Scully charged the agreement could bust lawmakers' budget for the prescription drug bill and undermine administration support for increased payments to Medicare's current private insurers.

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October 02, 2003

Cases appealing high-profile ergonomic citation cases levied against a Missouri warehouse and an Ohio bottling facility are in nascent stages and sources close to the cases say a hearing date may be as far as a year away. Meanwhile, organized labor and industry officials say they are watching the cases carefully as a bellwether for future OSHA ergonomics policy.

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A patient advocate is recommending that drug advertisements -- including both those that promote a drug product and those that solicit participants for a specific clinical trial -- should include information about a government-run clinical trials databank.

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Several cancer patient representatives are urging FDA to reject a proposal that would allow drug companies to sell drugs at a profit after phase one studies so dying patients can access experimental treatments. However, several cancer patient groups still are developing their position on the "Tier 1" proposal, and the Cancer Leadership Coalition, which includes 29 cancer groups, plans to discuss the proposal at a meeting next month.

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FDA unveiled Oct. 2 a host of new regulatory options the agency is considering to curb the growing problem of counterfeit drugs. The options include requiring tamper-evident packaging and unit-of-use packaging; creating electronic pedigrees; limiting the sale of drugs through a single wholesaler; and using taggants.

FDA released the options in its highly anticipated anti-counterfeiting task force interim report.

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The brand-name and generic drug industries have made progress in reconciling their differences over a provision in Medicare drug legislation that would limit amendments and supplements to generic drug applications. The two groups discussed the issue on Sept. 30.

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A second effort to move tobacco legislation toward a bipartisan markup failed late Wednesday (Oct. 1) with Sen. Edward Kennedy (D-MA) rejecting Senate health committee chair Judd Gregg's (R-NH) final offer. The key players are deadlocked: The tobacco industry is split on whether legislation is even needed, and public health groups and Kennedy charge that Gregg's draft bill has major loopholes that favor the tobacco industry.

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October 01, 2003

A federal appeals court has curbed judicial reviews of federal cleanups at terrorist attack sites, potentially boosting Bush administration efforts to give the Homeland Security Department a greater role in cleanups.

The U.S. Court of Appeals for the Second Circuit recently ruled that the Superfund law's limits on judicial review of cleanup decisions bar private parties from challenging the U.S. Postal Service's (USPS) anthrax cleanup decisions. The plaintiffs say they will not appeal the ruling.

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Ten senators, backed by medical technology and pharmaceutical manufacturers, are asking Medicare conferees to adopt the House bill's provision providing for increased payments for new medical technologies, while warning against attempts to lower the cost of the provision by raising the bar for qualifying new procedures for additional payments.

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