American College of Cardiology

Medical Liability Reform Fails in Senate, But Likely to Return in Fall
A Senate vote to bring up an ACC-supported medical liability reform bill failed last week by a party line 49-48 vote, well short of the 60 votes that were needed to proceed. Every Democrat—with the exception of three who didn’t vote—and two Republicans voted against bringing the bill up for formal consideration on the Senate floor. While the vote is a setback for the physician community, it is not the end of the battle. Senate GOP leaders have promised to return to the bill in the fall. The Alliance of Specialty Medicine issued a statement expressing its disappointment over the failed vote and urging the Senate to pass a bill this year. “To let patients down because of partisan politics would be inexcusable,” said Stan Pelofsky, MD, past president, American Association of Neurological Surgeons, on behalf of the Alliance.

Meanwhile, Sens. Richard Durbin, D-Ill., and Lindsey Graham, R-S.C., have offered an alternative medical liability reform bill that does not include noneconomic damage caps. Instead, it would provide tax credits to physicians in high-risk specialties and other facing above-average premium increases; protect physicians from punitive damages whose patient mix is made up of at least 25 percent Medicare, Medicaid, or SCHIP patients, with exceptions for egregious behavior; and repeal insurance companies’ antitrust exemptions. The ACC and the Alliance are reviewing the legislation and will continue to work with Senate leaders on this issue.

Survey: Are You Ready for the HIPAA Transaction Regs Deadline?
ACC members are urged to complete a short survey to help the College in its efforts to ensure that the approaching deadline for compliance with the HIPAA transaction and code set standards does not disrupt reimbursement and patient services. Please click here for more information.

Crestor Gets Nod From FDA Advisory Committee
The FDA Endocrinologic and Metabolic Drugs Advisory Committee has unanimously recommended that the agency approve rosuvastatin (Crestor) for doses from 10 to 40 mg for the treatment of various lipid disorders, including hypercholesterolemia, mixed dyslipidemia, and isolated hypertriglyceridemia. The panel also recommended that patients on the 40 mg dose be closely monitored for adverse effects, including periodic evaluation of renal function. AstraZeneca, which manufactures rosuvastatin, had initially applied for FDA approval for doses ranging from 10 to 80 mg. According to background material for the committee meeting, review of the original application revealed safety concerns at the 80 mg dose and led the FDA to conclude that the risks of treatment at 80 mg outweighed the benefits associated with the modest incremental reduction in cholesterol. AstraZeneca subsequently resubmitted for approval at the lower dose range.

Democrats Provide Conditions for Approval of Medicare Reform Bill
With the members of the conference committee to resolve the differences between the House and Senate-passed Medicare reform bills decided late last week, 40 Democrats have sent a letter to President Bush laying out conditions for their support of a final bill. Included is a condition that the bill not “give seniors false choices that coerce them into leaving conventional Medicare to enroll in HMOs and private plans.” The letter also calls for a back-up plan to provide coverage to seniors in areas where private plans are not able or willing to provide a comprehensive drug benefit. Capitol Hill watchers are predicting a long and contentious conference.

As reported previously, the House bill includes a provision that would prevent a projected 4.2 percent cut in physician Medicare payments from taking effect next year. The provision provides for a 1.5 percent increase in 2004 and 2005, but, because of cost constraints, future steep reductions would compensate for those increases in 2006 and beyond. The ACC and other physician groups will be lobbying the conference committee to improve upon the existing House physician payment provision and, ultimately, ensure something to prevent further cuts remains in the bill. ACC members are encouraged to contact their legislators about this issue and let them know that they expect their support in preventing further Medicare cuts. ACC members can easily send a message to their legislators using the College’s Web-based grassroots advocacy tool. Go to the ACC Web site and click on the “Take Action Now” icon, or call the ACC Advocacy Division hotline for assistance at (800) 435-9203.

Cordis Issues “Dear Colleague” Letter on Cypher Stent
Cordis Corp. has issued a “Dear Colleague” letter to inform interventional cardiologists of the potential risk of thrombosis associated with the use of the CYPHER sirolimus-eluting coronary stent. Since its approval in April, it is estimated that more than 50,000 patients have received a CYPHER stent. To date, 47 instances of stent thrombosis occurring at the time of implantation or within a few days of implantation have been reported to the FDA. According to an agency statement, it is unclear what effect the CYPHER stent has on thrombosis risk and what factors may contribute to the risk. In the “Dear Colleague” letter, Cordis offers several recommendations to reduce the risk of thrombosis, including selection of the appropriate stent size and use of an adequate antiplalelet regimen.

Hospital Payment Tied to Quality Under Medicare Demonstration Project
Under a Medicare demonstration project being launched this fall, Medicare payments to hospitals will be tied to their performance on 35 quality measures based on five clinical conditions. Three of the five conditions are cardiac related: heart attack, heart failure, and coronary artery bypass graft surgery. Under the program, hospitals scoring in the top 20 percent for a given condition will receive a 1 percent to 2 percent bonus on their Medicare payments. After the first year, a benchmark would be established using the performance measure data for that year. Hospitals that fall below that benchmark would see a 1 percent to 2 percent decrease in their Medicare payments. Approximately 300 to 500 hospitals affiliated with the group purchasing organization Premier Inc. are expected to participate.

Missouri Gov. Vetoes Medical Liability Reform Bill
In Missouri, Gov. Bob Holden, D, has vetoed a medical liability reform bill that would have capped noneconomic damages at $350,000. In vetoing the bill, Holden cited concerns over provisions in the bill that would provide “special protections” for certain industries, including, he argued, insulating “nursing homes from accountability when they wrongfully injure or neglect our loved ones.” Missouri physicians expressed bitter disappointment with the veto. “This bill not only was fair and reasonable, but was critical to the future of Missouri’s health care system,” said Missouri State Medical Association President Frederick DeFeo, MD.

FDA To Require Food Labels to List Trans Fat
Under new FDA regulations released last week, food labels will be required to list the amount of trans fat they contain. The requirement goes into effect on Jan. 1, 2006. Under the regulation, trans fat will be listed on food nutrition labels directly under the saturated fat content listing. The new information is the first significant change on the Nutrition Facts panel since it was established in 1993.

State Medical Liability Damage Caps Linked to More Physicians Per Capita
States with caps on noneconomic damages in medical liability lawsuits have approximately 12 percent more physicians per capita than states without such a cap, according to a new study from the Agency for Healthcare Research and Quality (AHRQ). The study looked at the growth of the physician supply since 1970, before any state had enacted caps, and found that physician supply has grown more in states with caps than in states without caps. In 1970, there was no statistically significant difference between states in their per capita supply of physicians. But by 2000, states that had enacted caps had a significantly higher number of doctors per 100,000 county residents (135) compared to states that didn't have caps (120).

AED Programs, Availability in Schools Should Expand Under New Law
President Bush has signed into law a bill that authorizes $25 million in grants to help states set up training programs for AEDs. The bill, the "Automatic Defibrillation in Adam's Memory Act," will also create clearinghouses to provide training for schools on how to raise money to buy defibrillators. According to an Associated Press report, the impetus for the bill was a 13-year-old Illinois boy who went into cardiac arrest after being hit with a baseball and whose life was saved by a police officer using an AED.