American College of Cardiology

House Passes Tobacco Bill

The House on April 2 approved the “Family Smoking Prevention & Tobacco Control Act” (H.R. 1256), which would grant the Food and Drug Administration (FDA) authority to regulate tobacco products, in a 298-112 vote. The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the FDA the authority to restrict tobacco marketing and sales to youth; require detailed disclosure of ingredients; allow FDA to require changes to tobacco products; and require larger, more specific health warnings. The FDA activity would be funded by a user fee on cigarette manufacturers, allocated by market share.

The bill must still be introduced and passed by the Senate. The ACC highly encourages members to contact their senators in support of this important bill, which will be sponsored in the Senate by Sen. Edward Kennedy (D-Mass.). Please call the toll-free Capitol Switchboard at (202) 224-3121 to be connected to your senator.

Medicare Testing Physician Use Reports

Medicare is currently testing confidential Physician Use Reports that will report back to physicians the cost of care for patients with certain chronic conditions, including CHF and CAD. CMS has already sent some test reports to physicians and will contact them to request feedback. If you have received a letter from Medicare saying that you have been selected to receive a confidential Resource Use Report, or if you have received one of the reports themselves in the last couple of months, please contact Brian Whitman. Feedback on these reports will determine their format when they are distributed nationwide later in the year.

UHC Updates Physicians in Premium Designation Program
UnitedHealthcare (UHC) on April 1 posted an updated list to its Web site of physicians who meet the criteria for its Premium Physician Designation Program. Inclusion in the UnitedHealth Premium® Physician Designation exempts physicians from the UHC Radiology prior notification protocol for advanced diagnostic imaging procedures: CT, MRI, PET, and Nuclear Medicine/Cardiology. The ACC, which does not endorse this program, strongly encourages members to carefully review their designations and appeal any inaccurate data on the UHC Website. If reconsideration is necessary it is important to make corrections or changes to the report and provide comments on the patient detail report. This can be done by following the instructions on the Physician Designation Reconsideration section.

The ACC is tracking member complaints or problems regarding this program and following up with the insurer. Contact Henry McCants at 800-435-9203 with any questions or complete the ACC Payer Hassle Form at http://www.acc.org/advocacy/pmr/payer_advocacy.htm. For additional questions on the UHC Premium Designation Program, contact UHC directly by phone (866-270-5588) or email (unitedpremium@uhc.com).

FDA News Updates
The Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has voted to approve a new application for type 2 diabetes drug Onglyza, manufactured by Bristol-Myers Squibb and Astrazeneca. The panel found that the data “were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program,” Cardiovascular Business magazine reports. However, the companies should be required to conduct additional studies of the long-term effects of the drug on the heart in high-risk patients, the panel said. The FDA will make a final decision on the drug by April 30.

The FDA has approved Abiomed Inc.’s AB Portable driver heart device, which is intended for use in heart failure patients who have the AB5000 Circulatory Support System implanted. Use of the device allows patients to recover from heart surgery at home, rather than in a hospital, the company said. More information is available from Forbes.

Defibrillator Safety Warnings
Boston Scientific recently warned physicians that faulty leads in its Cognis and Teligen defibrillators could lead patients to receive inappropriate electrical jolts, the Associated Press reports. Fifteen patients have received inappropriate shocks, and as many as 8,000 patients could be at risk. No deaths have been reported, Boston Scientific said. The shocks can be avoid by turning off a sensor within the devices that make them overly sensitive to irregular heart beats, which is not necessary for treatment, according to a letter by the company.

Zoll Medical Corp. said earlier this month that some of its Automated External Defibrillator Plus models have defective batteries and software, which can cause a failure to deliver a shock. Two patients have died, the company said. On Feb. 12, the company requested that customers download software for 180,000 units to detect the defective battery. The units at the highest risk have been installed for 3 or more years and number around 80,000. More coverage is available from Bloomberg.

Relationships with Industry: ACC Responds to JAMA Article
The ACC responded to a Journal of the American Medical Association article published last week on relationships with industry on its online forum, The Lewin Report. According to the post, the article “laid out some very laudable and responsible recommendations on relationships with industry” but some “were overreaching and would undermine patient-centered, evidence-based care by slowing the actual translation of science to clinical practice and patient care.” Read the response in full and comment.