American College of Cardiology

House Approves HEART for Women Act
On Thursday the House overwhelmingly approved the HEART for Women Act (H.R. 1014) by a vote of 418 to 4. The legislation, which the ACC strongly supports, was introduced by Reps. Lois Capps (D-CA) and Barbara Cubin (R-WY) to improve the prevention, diagnosis, and treatment of heart disease, stroke and other forms of cardiovascular disease in women. The legislation would:

• Require that safety and efficacy information for drugs and medical devices already being reported to the federal government be stratified by sex, race and ethnicity to help doctors, researchers, and patients better understand why certain treatments work better (or worse) in some groups of people than in others
• Expand the CDC WISEWOMAN program to all 50 states. The program provides free heart disease and stroke prevention screening to low-income, uninsured women
• Help raise awareness among women about their risk for heart disease and stroke

In the Senate, the HEART for Women Act (S. 573) was introduced by Sen. Debbie Stabenow (D-MI) and has strong bipartisan support with 47 cosponsors. While it is not clear if it will move through the Senate this year, House passage in this session of Congress is an important step forward for the legislation. The ACC has worked with the AHA and many other organizations in support of the HEART for Women Act. The full text of the bill is available here.

FDA News Updates
The Food & Drug Administration (FDA) for the second time has delayed a decision on market approval for the blood thinner prasugrel, intended to treat patients with acute heart problems. In June, the FDA first delayed approval of the drug, saying it needed more time to review the information submitted by its developers, Eli Lilly & Company and Daiichi Sankyo. FDA offered no comments on the most recent delay, according to the Associated Press.

Radiopharmaceutical firm Covidien has launched a generic version of its kit for the preparation of Technetium Tc 99m Sestamibi Injectionl for SPECT MPI, the generic equivalent of Cardiolite. The generic product also has recently received final regulatory approval in Denmark, Germany and the U.K. More information is available on the Covidien Web site.

The preliminary safety findings from a clinical trial in Germany investigating the use of epoetin alfa to treat acute ischemic stroke have been made available to the FDA. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia. Over a period of ninety days, there were more deaths in the group of patients who received epoetin alfa (16 percent) versus patients who received the placebo (9 percent). FDA anticipates the receipt of additional data within the next several weeks and will communicate recommendations at that time. Visit the FDA Web site for more information.

ACC, AMA Comment on DEA Proposed E-Rx Rule

In a comment letter led by the American Medical Association, the ACC last week provided comments to the Drug Enforcement Administration (DEA) on its proposed rule on e-prescriptions for controlled substances. Under the rule, the DEA proposes a process for e-prescribing of controlled substances that supplements existing prescribing and dispensing requirements. Currently, prescribers are prohibited from e-prescribing controlled substances. However, according to the letter, when properly implemented, an e-prescribing process and system for controlled substances will assist physicians in improving patients’ quality of life in a safer, more secure, and efficient manner. The letter expresses concern that the proposed rule contains overly stringent security requirements. It recommends that DEA establish an advisory panel comprised of key stakeholders, including physicians, to develop a process for e-prescribing that properly balances efforts to minimize drug diversion and the nonmedical use of prescription drugs while maintaining a clinical practice environment conducive to safer, efficient and high quality care. View the letter in full here.

Eli Lilly, Merck to Disclose Physician Payments in 2009

Beginning in 2009, Eli Lilly & Company and Merck & Company will publicly report payments made to physicians, the companies said last week. Eli Lilly CEO John Lechleiter said that his company in 2009 will post online its payments to physicians for speaking and consulting services, which will “likely include” the names of physicians or some sort of identifying information and the reason for the payment. Merck also said last week it will disclose the payments made to physicians for speaking engagements in 2009. According to The Hill, “Drug makers’ financial relationships with physicians and their sales practices have attracted scrutiny from the Democratic Congress and state legislatures across the country, prompting the industry to reconsider its activities in these areas.” Congress is also expected next year to consider legislation, called the Physician Payments Sunshine Act, which would require drug manufacturers to create registries to track physician payments.

Newest GAO Report Fails to Address Appropriateness in Imaging

The Government Accountability Office (GAO) on September 26 released a report titled “Medicare: Trends in Fees, Utilization and Expenditures for Imaging Services before and after Implementation of the Deficit Reduction Act [DRA] of 2005.” The report examined the effect of a provision of the DRA that mandated that Medicare fees for certain imaging services covered by the physician fee schedule may not exceed what Medicare pays for these services under the hospital outpatient prospective payment system (OPPS). The provision took effect on Jan. 1, 2007. The report found expenditures in 2007 on imaging tests declined although utilization continued to increase, unlike from 2000 to 2006, where both utilization and expenditures rose.

The ACC feels that the wide-scale cuts implemented through the DRA do not address appropriateness in imaging, nor are the levels of appropriateness addressed in the GAO’s new report. The blunt cuts to imaging implemented by the DRA do not improve the quality of care given to patients, which should be a factor in any changes to Medicare. The ACC believes that the best way of ensuring cost-effective imaging is to encourage the use of appropriateness criteria. The ACC also supports the use of accreditation to improve quality in imaging services. Read more about the study.

Anthem Receives Award for Work with Virginia Chapter

The National Quality Forum and the Joint Commission in late September awarded the 2008 John M. Eisenberg Patient Safety and Quality Award to Anthem Blue Cross and Blue Shield (BCBS) of Virginia for their work with the Virginia Chapter of the ACC on “Innovation in patient safety and quality at the local level.” Specifically, Anthem received the award for its Quality-In-Sights®: Hospital Incentive Program (Q-HIP) and Quality Physician Performance Program (Q-P3). These programs reward hospitals and physicians for practicing evidence-based medicine and implementing other nationally recognized best practices. By aligning hospital and physician goals, these unique programs foster collaborative efforts to improve care across the health care system. By using the metrics based on all-payer, non-administrative data, Q-HIP and Q-P3 endeavor to bring high quality care to all patients and communities.

According to Virginia Chapter President John Brush, M.D., F.A.C.C., "Anthem's partnership with the American College of Cardiology and its Virginia Chapter resulted in the creation of a unique, effective, and clinically relevant quality improvement program that is certainly deserving of this prestigious award."