American College of Cardiology

Claims Losses Primary Driver of Medical Liability Hikes
Losses on medical liability claims have been the chief cause of the dramatic increases in medical liability premiums over the past three years, according to a General Accounting Office (GAO) report released last week. To conduct the study, the GAO analyzed the changes in the medical liability markets in seven states—California, Florida, Minnesota, Mississippi, Nevada, Pennsylvania, and Texas—since 1999. Although reduced investment income and increasing reinsurance costs have played a factor in the large premium increases, the GAO found, losses on claims was the primary driver. The agency recommended that the National Association of Insurance Commissioners and state insurance regulators “identify and collect additional, mutually beneficial data necessary for evaluating the medical malpractice insurance market.”

FDA Warns Biotronik on Failure to Recall ICDs
The FDA has issued a warning letter to Biotronik, Inc. for failing to initiate a recall of two of its ICDs after the company issued a “Dear Doctor” letter in March about abnormal charging times potentially associated with the devices. During an April inspection, the warning letter explains, the FDA found that Biotronik had sent a March 21 letter to physicians who had implanted the Belos VR and Belos VR-T ICDs advising them to immediately schedule a follow-up visit with each patient to check for an abnormal charging time (16 seconds). If an abnormal charging time was detected, the company advised that “the device should be replaced immediately because the full programmed energy may not be delivered.” This action should have prompted a class II recall, the FDA said, because the device may cause temporary adverse health consequences.

Medicare Conferees Making Slow Progress, Long Road Still Predicted
The conference committee working to resolve differences between the House- and Senate-passed Medicare reform packages has reached agreements on ACC-supported measures that will ease the regulatory burden on physicians. But Democrats and Republicans continue to be at odds over a prescription drug benefit, leading some to predict the conference committee’s work could drag on until the holidays. In related news, the Congressional Budget Office (CBO) has revised its estimate of the cost of a provision in the House bill that would provide coverage of treatment for Medicare patients participating in “breakthrough” medical device trials. According to a Health News Daily report, AdvaMed, which represents device manufacturers, helped to convince the CBO to revise its estimate from $4 billion to $700 million over 10 years. In its comments to the conference committee, the ACC expressed its opposition to this provision unless it was amended to ensure that the coverage expansion would not be funded through reductions in Medicare fees for other procedures.

Final Inpatient Rule Provides Slight Increase in Drug-Eluting Stent Payments
The final 2004 Medicare hospital inpatient payment regulation released last week includes an average increase of 3.5 percent in facility payments and contains few changes for cardiovascular services. The CMS did not significantly change payment rates for cardiac catheterization procedures with drug-eluting stents, despite the submission of data by an independent auditor which showed that Medicare payments were not covering the full cost of the new devices. The rule also establishes two DRGs for ICD implantation performed with or without cardiac catheterization (514 and 515, respectively), and included codes for heart failure treatment in neonates.

Mass. Blues Plan To Pay $16 Million in Performance Bonuses
Primary care physicians participating in a pay-for-performance program with Blue Cross and Blue Shield of Massachusetts will receive $16 million in bonuses in 2003. Under the incentive program, which was launched in 2000, participating physicians can earn bonus payments based on how they perform on quality measures for adult and pediatric care. Among the adult measures is LDL measurement after a cardiac event. Physicians will receive half the payment in July and the other half in December. BCBSMA also launched an incentive program for specialty group practices this year, with groups measured in three categories: patient satisfaction and access, quality of care, and cost.

FDA Weighing Ephedra Ban
The FDA is considering banning the herbal supplement ephedra, the agency’s commissioner said during a congressional hearing last week. Banning the supplement—which has been linked to a number of deaths and other problems, including myocardial infarction and stroke—“is in the range of options we are considering,” FDA Commissioner Mark McClellan, MD, PhD, said before a joint meeting of two House Energy and Commerce Committee subcommittees. According to an Associated Press report, McClellan’s statement marks a reversal from previous FDA claims that it does not have the authority to ban herbal supplements. A ban could be implemented if the agency reviews the available evidence and determines that the supplement is harmful.

Drug Reimportation Bill Passes House
Despite heavy opposition from the pharmaceutical lobby, the House, led by Republicans, has passed a bill that would allow the reimportation of prescription drugs from 25 industrialized countries. The legislation is aimed at reducing consumers’ drug costs, as the same prescription drugs typically cost far less in foreign countries than they do in the United States. The strong GOP support for the bill was surprising because the Bush administration and House Republican leaders strongly opposed it. As a “stand-alone” bill, the legislation appears to have little chance of passing the Senate.

Proponents of the bill have said that they hope to fold it into the final Medicare reform package. The pharmaceutical industry, led by the trade group PhRMA, strongly opposed the legislation, arguing that it would increase the risk of unsafe counterfeit drugs entering the country and that it would hurt research and development through reduced profits.