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Daily News

January 22, 2003

In the wake of congressional pressure, CMS Administrator Tom Scully is reversing a new agency policy that would have allowed states and managed care plans to limit coverage of emergency services. In a Jan. 22 letter to Senate Finance Committee Chairman Chuck Grassley (R-IA), Scully says the agency will be notifying the states it is rescinding the policy and "the previous guidance is to be followed."

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January 21, 2003

CMS, which repeatedly has tried to integrate cost-effectiveness into its Medicare coverage determination process, is now claiming that Congress gave the agency this authority in the Benefits Improvement and Protection Act (BIPA). This policy decision is extremely significant because it could radically change how CMS sets coverage policies.

While agency lawyers have decided CMS has the authority to use cost as a coverage criterion, CMS has not yet done so, an agency official told Inside CMS.

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OSHA's highly anticipated National Advisory Committee on Ergonomics (NACE) will meet for the first time this week (Jan. 22) and sources say that American Society of Safety Engineers-nominee Carter Kerk will likely be named chairman at the meeting.

In its inaugural meeting, the 15-member panel will be addressed by OSHA Administrator John Henshaw and National Institute for Occupational Safety and Health Director John Howard. In addition, the committee will be briefed on OSHA's activities on ergonomics.

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Makers of the extended-release expectorant guaifenesin have been lobbying FDA hard to keep their products on the market without filing a new drug application (NDA). Representatives of several guaifenesin product manufacturers met with FDA Chief Counsel Daniel Troy and the head of the drug centers office of compliance Nov. 26, 2002, then met with representatives of FDA's commissioners office in December, urging the agency to withdraw the 70 warning letters demanding that the manufacturers withdraw their products.

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FDA's Anti-infective Drugs Advisory Committee says antibiotics used in humans as a sole therapy likely should be more strictly limited for use in food animals.

The committee is gathering information to make recommendations to FDA as the agency further develops guidance that establishes a new scheme for assessing the risk of animal-drug use leading to antibiotic resistance in humans.

Committee members heard heated debate this month between the animal-drug industry and those who want antibiotics used in humans to be banned from routine use in animals.

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Prior to the first meeting of OSHA's new National Advisory Committee on Ergonomics (NACE), a key industry coalition says in order to carry out its mission the panel must "grapple with real scientific controversies and unanswered questions."

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Berlin -- European Agriculture Commissioner Franz Fischler says a U.S. decision to challenge a de facto moratorium on biotechnology approvals in the World Trade Organization would have no positive result for the United States even if it were to win the legal case.

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A freshman House member is drafting legislation to replicate Maine's pioneering Maine Rx law on a nationwide basis. Rep. Michael Michaud (D-ME) announced plans Jan. 21 to create "America Rx," a national initiative to rein in pharmaceutical costs for residents without drug coverage.

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January 17, 2003

A new House subcommittee to address health issues under the Committee on Government Reform is in the works, according to congressional sources. The subcommittee was requested by outgoing full committee chairman Rep. Dan Burton (R-IN), who is likely to head the new panel, sources say.

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A key consumer group is touting legislation introduced by Sen. Richard Durbin (D-IL) in late December as a way to plug holes in FDA's authority to regulate transgenic animals. While FDA and the biotechnology industry say the agency's authority is adequate, the consumer group says Congress should clarify FDA's authority to address ecological impacts of transgenic animals and make the regulatory process transparent.

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FDA's food center hopes to publish proposed rules laying out new requirements for food registration and prior notice of imports within the next few weeks, in time for a planned Jan. 29 public meeting on the recently enacted bioterrorism law. However, if the regulations are not published in time, the center will push back the meeting.

The bioterrorism law gives the agency new authority covering food registration, prior notice of imports, administrative detention and recordkeeping. The agency is required to issue regulations to implement these sections of the law.

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The chairman of the Senate Foreign Relations Committee this week said a pending White House decision on whether to bring suit in the World Trade Organization over the European Union's moratorium on approval of new biotechnology products should not be tied to U.S. efforts to win European allies for its Iraq policy.

But Sen. Richard Lugar (R-IA) did not endorse mounting a legal challenge, arguing there remained a slim hope that diplomacy could lead the EU to lift the moratorium. He also cast doubt on whether a legal case would lead to a lifting of the moratorium.

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The United States has publicly outlined a series of conditions that must be met in order for it to continue its unilateral moratorium on mounting legal challenges in the World Trade Organization against countries that export generic copies of patented drugs to treat serious infectious epidemics.

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Prospects appear dim for a new European Union initiative to break a deadlock on World Trade Organization talks on access to medicines, as developing countries, the World Health Organization and health activists criticized last week's proposal by the EU to allow the WHO to decide what diseases should be covered beyond an initial list of 23 infectious diseases.

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Two large unions representing first responders and health care workers yesterday (Jan. 16) asked President Bush to delay the smallpox vaccination of civilians, arguing that unresolved medical and compensation questions need to be addressed before going forward with the project.

In separate letters, Service Employees International Union (SEIU) President Andrew Stern and American Federation of State, County and Municipal Employees (AFSCME) President Gerald McEntee petitioned Bush to delay the smallpox vaccination letter.

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January 16, 2003

The American Hospital Association (AHA) is protesting the Medicare Payment Advisory Commission's (MedPAC) call late yesterday (Jan. 15) for Congress to provide below-inflation payment updates for hospitals. MedPAC voted to give hospitals 2004 Medicare payment updates equal to the market-basket rate minus 0.4 percentage points for inpatient payments and the market-basket rate minus 0.9 percentage points for outpatient payments, according to AHA, which calls the recommendation "misguided."

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CMS Administrator Tom Scully quietly hired a long-time AARP official last month, sparking speculation that the move could help the Bush administration's effort to enact a prescription drug benefit this year.

Marty Corry, who worked for AARP as its director of federal legislation, is now a special assistant to Scully. He will work on long-term care policies as well as other issues, according to an agency official. Several CMS stakeholders who attended recent CMS meetings said they were surprised to learn that Corry joined the agency in December.

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A joint state cooperative developed to tackle soaring prescription drug prices is extending its reach from one side of the nation to the other. Informed sources say Hawaii is in the process of joining forces with the National Legislative Association on Prescription Drug Prices, which to date consists of all six New England states, New York, Pennsylvania and the District of Columbia.

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Congressional officials are refuting recent media articles reporting that Senate Republicans seriously considered naming Sen. Trent Lott (R-MS) chairman of the Senate Finance Committee.

Prior to the start of the new Congress, it was reported that Sen. Chuck Grassley (R-IA) balked at the idea of giving Lott the Finance Committee chairmanship following Lott's resignation as Senate majority leader. But congressional sources say that the news accounts are inaccurate and a spokesperson for Grassley said, "There's nothing to it."

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Rep. Henry Waxman (D-CA) plans to introduce legislation creating a special smallpox vaccine injury compensation program because it is unclear how, or if, someone injured by the vaccine would be compensated. Waxman's staff has spoken to the staff of Sens. Bill Frist (R-TN) and Edward Kennedy (D-MA), but the congressmen themselves have not yet spoken about the possible legislation, according to a congressional source.

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