House Passes Tobacco Bill
The House last week approved the Family Smoking Prevention and Tobacco Control Act (H.R. 1108), which would grant the Food & Drug Administration (FDA) the authority to regulate the manufacture, marketing and sale of tobacco products. Among other things, the bill would allow the FDA to: restrict tobacco marketing and sales to children; require changes in tobacco products to make them less toxic and less addictive; and stop misleading marketing tactics by tobacco manufacturers. Although the bill has strong support in the Senate, the White House has said it opposes the bill, and it is unclear if the Senate could override a presidential veto. This legislation has been endorsed by more than 640 public health and other organizations across the country. The ACC supports FDA regulation of the tobacco industry given it is the only agency with the combination of scientific expertise and regulatory authority to carry out this mission.

Small Practices, Sole Practitioners Face Barriers in Adopting HIT, Panel Told
At a House Small Business Committee hearing on July 31, several physicians discussed the barriers facing small health care practices or sole practitioners in implementing health information technology (HIT) systems. The physicians asked for federal support to offset the high implementation costs. Witnesses at the hearing testified to several difficulties in implementing and maintaining HIT systems, including a lack of interoperability between systems, privacy and security issues and the lack of software that meets the needs of specialty groups. Although the committee does not have jurisdiction over the HIT legislation that recently passed in the House Energy and Commerce Committee, it held the hearing to gather information about the effects of HIT on physicians, who are considered members of the small business community. The ACC supports the adoption of HIT by health care practices, and offers tools to assist in the selection and implementation of HIT systems. To learn more, visit: http://www.acc.org/HealthIT.

Senators Introduce Comparative Effectiveness Bill
Senate Finance Committee Chair Max Baucus (D-Mont.) and Senate Budget Committee Chair Kent Conrad (D-N.D.) on July 31 introduced a bill (S. 3408) that would create a comparative effectiveness center to research and distribute information about which health care treatments have the best clinical outcomes. The medical treatments compared by the private not-for-profit Health Care Comparative Effectiveness Research Institute would include surgeries, pharmaceuticals and medical devices. The institute would develop research priorities based on the following factors: disease incidence, prevalence and U.S. burden; gaps in evidence for clinical outcomes; practice variations; the potential of better evidence to improve quality of care; and expenditures associated with a health care strategy or health condition. The Institute would be funded by a Comparative Effectiveness Research Trust Fund, which would be composed of a mix of private and public funding, such as the Medicare Trust Funds and new fees assessed on health plans. The bill was referred to the Senate Finance Committee.

FDA News Update
FDA recently reminded health care professionals to evaluate left ventricular ejection fraction (LVEF) prior to initiating treatment and administering each dose of mitoxantrone hydrochlorine in patients with multiple sclerosis (MS). Recommendations for treating MS patients with mitoxantrone were developed in 2005 after post-marketing and case reports appearing in medical literature indicated decreases in LVEF or frank congestive heart failure in patients who had received cumulative doses that were lower than 100 mg/m2. To read more, click here.

FDA in late July announced that EG Labs LLC is recalling all lots of the 375 mg capsules of Viapro, an erectile dysfunction supplement, because it contains a potentially harmful undeclared ingredient, thio-methisosildenafil. The chemical poses a threat because it may harmfully interact with nitrates found in some prescription drugs commonly prescribed to patients with diabetes, high blood pressure or cholesterol or heart disease, and may lower blood pressure to dangerous levels. For more information about the recall, click here.

NCD for Carotid Artery Stenting Released
On July 31, the Centers for Medicare & Medicaid Services (CMS) proposed to make no changes to the national coverage determination (NCD) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting (CAS). According to the agency, clinical studies and Technology Evaluation Center assessments do not clearly demonstrate that CAS should be used as an alternative to carotid endarterectomy (CEA).  The agency stated the need for randomized clinical trials comparing CAS with other therapeutic options, including CEA. According to the decision, "As a result of the inadequate peer-reviewed, published evidence, CMS has determined that expanding coverage is not reasonable and necessary and is proposing to make no changes to the NCD." CMS is accepting public comments and, after consideration, will issue a final decision memorandum. ACC had joined with SCAI, the Society for Vascular Medicine, and the Society for Vascular and Interventional Neurology to request that CMS reconsider its NCD to expand coverage. ACC will review CMS' decision closely and work with other stakeholders to respond. To view the NCD in full, click here.

LAST CHANCE To Register for 2008 Legislative Conference
Registration closes August 8 for ACC's 2008 Legislative Conference in Washington, D.C.This year’s conference will take place Sept. 14 – 16 at the Fairmont Hotel. Don't miss this unique opportunity to help advocate for fair and sound policies that ensure cardiovascular specialists can practice medicine in a manner that provides the greatest value for patients. Participants will learn about key issues facing the cardiovascular community and be able to educate their respective lawmakers about the need for the cardiovascular community to be at the table when it comes to improving patient access, reforming Medicare and ensuring any new health care system moves beyond process to focus on outcomes. For more information, click here.