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December 10, 2010

2010

Washington Letter
December 10, 2010

Congress Passes One-Year SGR Fix

This week, both chambers of Congress passed legislation averting the 24.9% cut in Medicare physician reimbursement. President Obama is expected to sign the bill. The bill extends the 2010 Medicare payment rate through 2011, effectively ensuring flat funding Medicare physician reimbursements for 2011.

The temporarily averted cuts are driven by the sustainable growth rate factor (SGR) - a flawed formula used to calculate the annual Medicare physician payment updates. There is bipartisan agreement that the SGR formula is flawed and needs to be replaced. However, Congress has been unable to agree on how to pay for a permanent solution to the SGR crises. The one-year fix passed by Congress is estimated to cost $19.2 billion dollars.

While the ATS and the rest of the physician community is relieved to have avoided the 24.9 percent cut in Medicare reimbursement, the community is well aware that the fix is not permanent, and further cuts loom for 2012. The ATS will continue to demand that Congress stop addressing the SGR problem with short-term fixes and develop a permanent solution to end this payment crises.

CLEAN AIR

EPA Seeks Delay in Ozone Rule

For the third time this year, the Environmental Protection Agency announced that it is seeking a delay in issuing final rules for the National Ambient Air Quality Standard (NAAQS) for ozone.

The announced 6-month delay was met with concern and opposition for clean air advocates. Noting that just last week, EPA celebrated its 40th anniversary of actions and achievements in improving America's health by cleaning up the environment, ATS President Dean E. Schraufnagel said, "This is an ironic way to celebrate EPA's 40th anniversary. This is the third time this year that the EPA has requested a delay. Meanwhile, ozone is a major contributor to death and sickness, particularly among the elderly and children."

Recent studies have estimated reducing ozone exposures across the U.S. could prevent
more than 8,000 deaths, 6,000 emergency room visits, 5,000 hospitalizations and 3.9 million missed school days each year.

In announcing the delay, the EPA has requested the Clean Air Scientific Advisory
Committee (CASAC), an EPA convened panel of health experts, to review the existing scientific data to provide further guidance. EPA's request for additional analysis is somewhat suspect. CASAC have twice reviewed the available data, once during the Bush Administration and once during the Obama Administration. Both times, CASAC has recommended that EPA issue a stricter standard for ozone, between 60-70 ppb.

A further irony is that EPA and CASAC must base their recommendations on scientific data available before 2008 to justify their decision. So the available evidence - which has been reviewed twice already - will not be augmented by more recent studies that provided even a strong case for a revised ozone standard.

The ATS will continue to push EPA to move forward with a revised ozone standard, advocating for a standard of 60 ppb

RESEARCH FUNDING

Funding Increase for NIH Included in FY2011 Senate Appropriations Bill

The FY2011 omnibus appropriations bill being prepared by Senate Appropriations Committee chairman Sen. Inouye (D-HI), includes a $750 million, or 2.4% funding increase for the NIH in 2011. The omnibus bill comprises all 12 spending bills that have been passed by the Senate Appropriations Committee, including the Labor-Health and Human Services bill which funds NIH. It is not yet clear, however, if Sen. Inouye has the necessary bipartisan support to get the bill passed in the Senate. If the omnibus does not gain passage by the end of next week when the Congress will adjourn for the end of the year, a long term continuing resolution (CR) freezing government program funding at FY2010 levels, which the House has already passed this week, could be enacted. There is also the possibility that a short-term CR could be passed, delaying final 2011 spending until the new Congress, when incoming Republican leaders have vowed to implement spending cuts. The ATS urges all members to contact their two senators to urge their support for passage of the FY2011 omnibus appropriations bill. Click here to send an e-mail to your senators. http://capwiz.com/thoracic/home/

TOBACCO

Funding Increase for NIH Included in FY2011 Senate Appropriations Bill

This week, U.S. Surgeon General Regina Benjamin, MD, released the report, How Tobacco Smoke Causes Disease. The publication is Dr. Benjamin's first Surgeon General's report and it is a comprehensive scientific assessment of all of the effects of tobacco smoke on the human body. Its key finding is that any exposure to tobacco smoke, whether through occasional smoking or through secondhand smoke, causes immediate damage to the body that can cause serious diseases including lung and other cancers, cardiovascular disease, COPD and death. The issue of tobacco use is of strong personal interest to Dr. Benjamin because her mother and uncle died of lung cancer.

Health and Human Services Secretary Kathleen Sebelius, who officially released the report with Dr. Benjamin, explained that the publication is a key element of the Department's priority on reducing tobacco use. Another focus of the study is on why it so difficult for smokers to stop smoking. Dr. Benjamin said, "This report makes clear - quitting at any time gives your body a chance to heal the damage caused by smoking." Along with the Surgeon General's scientific findings, Dr. Benjamin also released an easy-to-read consumer guide on tobacco smoke and disease. The full report and consumer guide can be found at:
http://www.surgeongeneral.gov/library/tobaccosmoke/index.html

US District Court Rules on E-Cigarette

This week, the US DC District Court ruled that e-cigarettes are tobacco products and must be regulated by FDA as tobacco products, not drug delivery devices. The court found that Sottera - the e-cigarette manufacturer and plaintiff in the case - derived its nicotine from tobacco plants and therefore the e-cigarette was a tobacco product and not a nicotine drug delivery device.

E-cigarettes are devices made to look like cigarettes, but use a small battery to heat and vaporize the nicotine held in a small cartridge. Users then inhale the vaporized nicotine product.

The ATS, and many tobacco control advocates, had supported FDA's authority to regulate e-cigarettes as drug delivery devices. The ATS disagrees with the court's ruling and the precedent it sets for the e-cigarette industry. The majority of e-cigarette manufactures are marketing their products as being a healthy alternative traditional cigarettes and a smoking cessation tool. By making these unsubstantiated health claims, e-cigarette manufacturers are effectively marketing these devices as health products and therefore should be regulated as drug delivery devices.

Products that are regulated as drug delivery devices are subject to a higher level of FDA scrutiny and must conduct safety and efficiency testing to support health claims. Products that fail to conduct or meet safety and efficacy testing can be removed from the market. Tobacco products, because they have no known health benefits, fall into a separate regulatory category. While FDA now has the power to regulate tobacco labeling, marketing and advertising, FDA does not have the power to remove tobacco products from the market.

 


The Washington Letter is written by the American Thoracic Society government relations office and emailed to all ATS members living in the United States. The letter keeps clinicians, scientists, and patients abreast of legislative, judicial, and regulatory issues in pulmonary, critical care, and sleep medicine. Each week's edition is archived on the ATS Web site, www.thoracic.org. If you have any questions or one more information about becoming involved in advocacy, please contact the ATS Washington office at 202-296-9770.