May 10, 2006

HEADLINE

Medical Malpractice Reform Bill Loses Vote in the Senate

This week, medical malpractice reform legislation lost key procedural votes in the Senate. Legislation to put a $750,000 cap on non-economic damages or “pain and suffering� lost by a vote of 48-42, failing to get the 60 votes needed to prevent a filibuster of the legislation. Similar legislation covering obstetricians and gynecologists failed by a similar margin. The vote followed largely partisan trend with all Democrats voting against the legislation and all but three Republicans voting in support of the legislation. The three Republican Senators voting in opposition to the legislation were Shelby (R-AL), Graham (R-SC) and Crapo (R-ID).

The House of Representatives has passed similar legislation along largely partisan lines. Action on the malpractice legislation has remained stalled in the Senate. The last time the Senate addressed the malpractice issue was in 2004 when a similar proposal to cap non-economic awards failed by a similar margin.

RESEARCH

House Flat Funds VA Research Program

Last week, the House Military Quality of Life/Veterans Affairs Appropriations Subcommittee provided $412 million for the VA research program in the FY07 appropriations bill. The committee recommendation of $412 million is level funding compared to the FY06 appropriations bill which included an increase of $13 million over the President’s budget request. In addition to level funding the VA research program, the Subcommittee provided $12 million in minor construction funds to renovate existing VA laboratory space. By providing funds for VA laboratory space renovation, the Subcommittee is responding to concerns expressed by the ATS and others that the VA research infrastructure is deteriorating and in need of funds to refurbish existing facilities.

Action by the full House Appropriations Committee is expected later in May.

CLINICIAL PRACTICE

ATS Comments on CMS Nebulized Drugs Policy

The Centers for Medicare and Medicaid Services (CMS – which administers the Medicare program) has issued draft policy regarding which nebulized medications will be covered under Medicare’s durable medical equipment policy. The draft policy outlines covered drugs, clinical limitations on some drugs, describing when they will be covered and in some cases, proposes changing reimbursement levels for nebulized drugs.

The ATS, in conjunction with the American College of Chest Physicians (ACCP), has reviewed the proposed rule and submitted comments pointing out several concerns with the proposal, focusing our comments on drugs excluded from the coverage list that are frequently used to treat pulmonary conditions. The ATS and the ACCP also expressed concern with the proposal as it tries to significantly reduce reimbursement for selected pulmonary drugs, and clinical limits for certain pulmonary medications.

PUBLICATIONS POLICY

Senators Lieberman and Cornyn Introduce Open Access Bill

Senators Cornyn (R-TX) and Lieberman (D-CT) recently introduced legislation to require all federal agencies that sponsor over $100 million in federal research funding to make research funding publicly available after six months. The policy would ensure that articles generated through research funded by that agency are made available online within six months of publication.

Specifically, the legislation would:

• Require each researcherâ€â€�funded totally or partially by the agencyâ€â€�to submit an electronic copy of the final manuscript that has been accepted for publication in a peer-reviewed journal;
• Ensure the manuscript is preserved in a stable, digital repository maintained by that agency or in another suitable repository that permits free public access, interoperability, and long-term preservation
• Require that free, online access to each taxpayer-funded manuscript be available as soon as possible and no later than six months after its publication in a peer-reviewed journal.

The legislation (S.2695) represents a significant expansion of the open access policy recently adopted by the National Institutes of Health (NIH). As you may recall, the NIH policy requests - but does not require - NIH funded researchers to provide NIH with a copy of manuscripts that have been accepted for publication in peer reviewed journals. The manuscripts would be held in an NIH archive that is accessible to the public. A recent NIH report noted that less than four percent of eligible manuscripts are being voluntarily submitted by researchers.

While there is little immediate prospect that the Cornyn/Lieberman bill will be enacted, the legislation does indicate continued Congressional interest in making research studies freely available to the public. If enacted, the legislation introduced by Senators Cornyn and Lieberman would complicate a pilot project initiated by the American Thoracic Society and selected other academic not-for-profit publishers and the NIH to develop a system where participating journals provide NIH with copies of NIH funded articles. While functional details of the pilot program are still under discussion, the pilot is expected to launch this summer.

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