American College of Cardiology

Senate Committee Approves Imaging Tech Standards Bill
The Senate Health, Education, Labor and Pensions (HELP) Committee on March 13 approved the Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2007 (S. 1042 or CARE bill), sponsored by Sens. Edward Kennedy (D-MA) and Michael Enzi (R-WY). The CARE bill would require the Department of Health and Human Services to create standards for technicians who operate imaging technology. As written, physicians would be exempted from the new requirements but technicians under the direct/personal supervision of physicians, such as those working in cardiac catheterization and electrophysiology labs, would not be. The ACC supports an exemption for technicians working under the direct/personal supervision of a physician, and last month signed onto a letter led by HRS and SCAI to advocate for such an exemption. The House is not expected to act on its version of the CARE bill this year.

Bill Introduced to Eliminate Medicare Payment Cuts
Sen. Debbie Stabenow (D-MI) has introduced the "Save Medicare Act of 2008" (S. 2785), to eliminate the 10.6 percent Medicare physician payment cut scheduled for July 1. The legislation would replace the cut with a 0.5 percent update for the second half of 2008 and a 1.8 percent update for 2009. The Physician Quality Reporting Initiative (PQRI) would remain funded at 1.5 percent for participating physicians in 2009. In addition, the legislation would extend certain rural provisions through 2009. Under the bill, the payment update for the remainder of 2008 and 2009 would be fully funded and would not increase the size or duration of future cuts. ACC members are urged to contact their Senators and ask them to cosponsor this bill.

On the House side, ACC members are encouraged to contact their Representatives and ask them to sign on to a letter to House Energy and Commerce Committee Chair John Dingell (D-MI) and Ranking Member Joe Barton (R-TX), and House Ways and Means Committee Chair Charles Rangel (D-NY) and Ranking Member Jim McCrery (R-LA). The letter requests congressional action to stop the slated payment cut and stresses the need for a positive payment update to allow time for Congress to enact long-term reforms and to create stability for patients and providers. To contact your lawmakers directly, call the ACC toll-free grassroots hotline at 1-800-210-7193. To sign the letter, Representatives should contact Lauren Finkelstein in the office of Rep. Mark Kirk at (202) 225-4835 or Dana Lichtenberg in the office of Rep. Bart Gordon at (202) 225-4231.

House Committee Expected to Vote on Tobacco Legislation
The House Energy and Commerce Committee on April 2 is expected to vote on legislation (H.R. 1108) that would grant the FDA authority over tobacco products. The full committee markup is expected to include several amendments supported by convenience stories and small tobacco manufacturers in an attempt to weaken the bill. The ACC opposes these amendments and is working with a coalition of public health groups, including the AMA, American Dental Association, and American Academy of Pediatrics, to lobby all committee members to support the bill without amendments. ACC members are encouraged to contact their lawmakers and express their support for the bill. To contact your lawmakers directly, call the ACC toll-free grassroots hotline at 1-800-210-7193.

FDA News Updates
The FDA on March 17 issued a public health notification for Medtronic Vascular's AneuRx® Stent Graft to update health care providers on past notifications for the product. The FDA has issued warnings in the past notifying providers of serious adverse events associated with the device in abdominal aortic aneurysm (AAA) patients. The current notification reemphasizes earlier warnings that continued surveillance of patients with endovascular grafts is necessary and provides updated mortality rates associated with the use of the AneuRx® Stent Graft to prevent AAA rupture.

The FDA on March 18 issued an early communication about an ongoing safety review of tiotropium, marketed as Spiriva HandiHaler by Boehringer Ingelheim and approved to treat bronchospasm associated with chronic obstructive pulmonary disease (COPD). According to FDA, a preliminary analysis has identified an increased risk of strokes in patients using the inhaler. In 29 placebo-controlled clinical studies involving approximately 13,500 patients treated with either Spiriva HandiHaler or Spiriva Respimat, a European formulation, there was an increased risk of stroke of two patients for each 1,000 taking the drug over a one-year period, compared to a placebo. Additional information is needed to further evaluate the results.

The FDA has recommended labeling revisions for Baxter International's anesthesia treatment Suprane, generically known as desflurane, after three reports of pediatric cardiac arrest, according to documents released on Friday in preparation for an FDA advisory panel. The advisory panel met on Tuesday to discuss the safety of Suprane and other drugs in children. According to the document, "The contributory role of desflurane could not be excluded" in the three reports; however, the "simultaneous use of concomitant medications during anesthesia confounded the causality assessment of these cases." Suprane's labeling currently includes warnings about other cardiac events, including myocardial infarction, irregular heart beat and fluctuating blood pressure.

Medtronic Updates Labeling for Certain Implantable Infusion Pumps
Medtronic recently updated the labeling for certain models of the SynchroMed El, SynchroMed II and IsoMed implantable infusion pumps after the reported rate of inflammatory mass formations increased. The labeling revisions include information on patient management, along with treatment recommendations.

Put Quality First at ACC.08
On Sunday, March 30, the ACC.08 Quality Spotlight will focus on "Practice Innovation: Driving Revenue, Quality and Value." Topics include future payment models, comparative effectiveness, challenges of translating science into practice and recommendations for reforming health care. The session will take place in McCormick Place, Room S403 from 8 a.m. to 5:45 p.m. Also Sunday, plan to attend the ACC.08 Scientific Showcase in McCormick Place, North Hall B1 from 11:30 a.m. to 1 p.m. The quality-themed event features the Simon Dack Lecture by Donald M. Berwick, M.D., IHI CEO; presidential address by ACC President James T. Dove, M.D., F.A.C.C.; an ENHANCE trial presentation including a panel discussion; and more. Finally, on Monday, March 31, start your morning with "Quality First" by attending the Louis F. Bishop Lecture, featuring former CMS Administrator Mark McClellan, M.D. The lecture will take place at McCormick Place, Lakeside Building from 10 a.m. to 11 a.m. McClellan will address the question: “Will Quality Come First in Health Care System Reform?”