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Daily News

March 24, 2003

As part of its Medicare reform legislation, the House Energy and Commerce Committee is considering changing the pass-through payment system of the Medicare hospital outpatient payment structure, according to a committee source. Lawmakers in the House Ways and Means Committee and the Senate Finance Committee are also discussing changes to the system but have not progressed to a stage where they are eyeing legislation, sources in these committees say.

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The chairman of a House subcommittee with CMS oversight has asked the General Accounting Office (GAO) to examine if CMS violated the Administrative Procedure Act (APA) by introducing the term "functional equivalent" in its final hospital outpatient prospective payment system (OPPS) rule and using the term as a reason to drop drugs and devices from the more lucrative pass-through payment system.

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OSHA is pooling its resources with the American Academy of Orthopedic Surgeons (AAOS) in an effort to curb musculoskeletal disorders (MSDs) in the workplace.

The agency announced its new alliance March 10 and OSHA Administrator John Henshaw said, "Perhaps no one is more attuned to the debilitating effects ergonomics-related injuries have on workers than the health care professionals represented by AAOS. They've committed to sharing with us the orthopedic community's vast clinical experience on musculoskeletal injury and disease. We welcome this valuable relationship."

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The Senate health committee is expected to hold a markup on Wednesday (March 26) of a bill that would bar discrimination on the basis of protected genetic information, according to an official involved in the Human Genome Project. The committee was slated to hold the markup last week, but the delay could actually benefit supporters of the bill, as it will give lawmakers a chance to reach agreement on the few remaining areas of disagreement.

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A key Democrat plans to give makers of 'Siberian ginseng' more time to make labeling changes required by last year's farm bill. The senator says the lack of an effective date for labeling changes was an oversight.

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A Senate medical malpractice proposal by Sen. Dianne Feinstein (D-CA) does not offer product liability protections for drug and medical device manufacturers that are included in the House version, according to a Feinstein spokesperson. The proposal does not cap "pain and suffering" damages on lawsuits against drug and device manufacturers, nor does the plan offer an "FDA defense" provision that would shield the manufacturers against punitive damages.

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Physician groups are renewing calls for Congress to replace Medicare's "flawed" physician payment formula following news from CMS that Medicare physician payments are likely be cut by 4.2 percent next year.

Preliminary CMS estimates indicate the Medicare physician fee schedule update for 2004 will be "between --5.8 percent and 0.6 percent with a point estimate of --4.2 percent" and that physician updates will remain negative through 2007, according to a March 20 CMS letter to Medicare Payment Advisory Commission Chairman Glenn Hackbarth.

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March 21, 2003

William Rogers, CMS' Physician Regulatory Issues Team (PRIT) director and a key advisor to agency chief Tom Scully, is taking a leave of absence from CMS to join the nation's war effort.

The emergency physician and Marine Corps reservist has been recalled to active duty, and will leave the agency today (March 21).

In addition to serving as PRIT director, Rogers is also the medical officer in the office of the administrator. He has held both positions since last May, prior to which he worked with the agency on its Emergency Medical Treatment and Labor Act regulations.

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The Office of Management and Budget (OMB) is reviewing an interim final rule describing on how OSHA will protect employees blowing the whistle on corporate fraud. Some stakeholders are not pleased that OSHA has been charged with this task, saying it will divert resources from the agency's ability to deal with occupational safety and health whistleblowers.

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CMS has begun exploratory talks with the Department of Housing and Urban Development (HUD) over a plan that would allow seniors to use their home equity to purchase long-term care insurance.

The proposal is just one of several ideas being floated by CMS to convince Americans to buy long-term care coverage, and in doing so attempt to defray the mounting health care costs of long-term care.

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FDA officials still have not notified the agency's union of their reorganization plans for the drug and biologics centers even though FDA's commissioner said management would meet with the union before the end of phase 3, according to a union official. Murray Lumpkin, who has helped lead the reorganization, said management will meet with the union in the coming weeks.

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An FDA official says the agency is still working on how it will handle therapeutic vaccines under the agency's new organization. FDA is grappling with how to "co-locate" the biologics center staff in charge of therapeutic vaccines with their drug center counterparts and is considering the possibility of using a new clinical consultation process instead.

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March 20, 2003

House Republican leaders have decided to exclude Medicare from a 1 percent across-the-board spending reduction under the House fiscal year (FY) 2004 budget resolution. While the move thwarts an earlier plan to cut roughly $215 billion from Medicare, stakeholders are still alarmed over $93 billion in likely Medicaid reductions.

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The Senate health committee March 19 added a sunset provision before unanimously passing legislation that would allow FDA to force drug companies to study their drugs for use in children when companies do not volunteer to do so. The provision, which was opposed by committee Democrats, would sunset the legislation in 2007.

Committee members voted along party lines, 11-10, with Sen. James Jeffords (I-VT) voting with Democrats against the sunset provision.

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A key Senate Democrat is seeking to secure additional funds for Medicare reform and a prescription drug benefit. While calling the $400 billion earmarked for the legislation "a good starting point," the lawmaker reiterated his call for further funding.

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Just hours before the U.S. invasion of Iraq, FDA issued new guidances urging food and cosmetic makers to institute new security measures to help guard against intentional tampering of the food supply. Food center head Joseph Levitt announced FDA was stepping up inspections of imported food, increasing surveillance of the domestic food industry and collaborating with other agencies to improve outbreak response.

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Powerful House Ways and Means Chairman Bill Thomas (R-CA) strongly supports provider payment recommendations made by the Medicare Payment Advisory Commission (MedPAC), saying providers who want to convince him that MedPAC's recommendations are unfair have a difficult challenge ahead of them. The commission suggested zero updates and modest increases for most Medicare providers.

Discussing the issue with reporters following a speech to the Federal Association of Hospitals (FAH), Thomas noted, "MedPAC's recommendations are the way to go."

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Two key senators are eyeing legislation that would give FDA authority to force food-processing plants to adopt security measures to prevent intentional contamination of the food supply, following a finding by Congress' investigative arm that FDA lacks such authority. FDA this week encouraged companies to voluntarily step up security, but refuses to take a position on whether the agency needs more authority from Congress to regulate food security.

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Alarmed over potential Medicaid cuts under the House budget resolution, provider and advocacy groups as well as the nation's county governments have launched last-ditch grassroots efforts urging lawmakers to oppose reductions to the program.

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March 19, 2003

Identifying ways to find and quantify therapeutic risk from existing systems like FDA's adverse event system should be a top research priority, the Centers for Education & Research on Therapeutics (CERTs) concluded after a series of workshops on risk management. The CERTs steering committee says other research priorities include identifying factors that influence the level of risk that is acceptable to doctors and patients, and finding the most informative ways to inform doctors and patients about the benefit and risk of therapeutics.

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