A Medicare advisory panel recommendation to cover implantable cardioverter defibrillators (ICDs) could be a major victory for companies such as Guidant (Indianapolis, Indiana), Medtronic (Minneapolis, Minnesota) and St. Jude Medical (St. Paul, Minnesota). The Medicare Coverage Advisory Committee, an independent advisory group to the Centers for Medicare & Medicaid Services (CMS), made the recommendation at a mid-February meeting.

Medicare currently covers ICDs for an estimated 27,000 beneficiaries who've had heart attacks and considered at highest risk for sudden death due to rapid heartbeats.

The expanded recommendation means that an additional 60,000 beneficiaries could be eligible for the device, according to CMS acting chief clinical manager Sean Tunis, MD. The agency will issue a formal coverage ruling following a 60- to 90-day period.

CMS officials, however, may closely scrutinize the expanded coverage because the devices cost Medicare around $30,000 each and could further burden a system already under stress, Tunis said. Local fiscal intermediaries can establish independent coverage decisions, but a national coverage determination establishes uniform policy for regional administrators. Private insurers usually follow Medicare coverage decisions once they are announced.

The unanimous decision was bolstered by results reported in March 2002 from a study that found ICDs reduced death rates by 31% for patients who had previous heart attacks and impaired blood-pumping ability but no rapid heartbeats. The Multicenter Automatic Defibrillator Implantation Trial (MADIT) II was funded by Guidant. "We are gratified that the committee unanimously recommended a positive national coverage decision by CMS," said Fred McCoy, president of Guidant's Cardiac Rhythm Management business. "The Medicare Coverage Advisory Committee's recommendation affirms the pivotal role of sound clinical research policy decisions," he added.

Arthur Moss, MD, professor of medicine and director of the Heart Research Follow-Up Program at the University of Rochester Medical Center (Rochester, New York), said, "I am pleased by MCAC's decision, since the clinical trial data clearly indicate the lifesaving nature of ICD therapy in patients with a prior heart attack and compromised heart function." Moss was the primary investigator of the MADIT II trial.

The expanded CMS coverage would usher in a "new era of growth for defibrillators," said Bank of America Securities (San Francisco, California) med-tech analyst Kurt Kruger. He predicts that a positive decision from CMS is all but assured. "CMS's decision will open up defib therapy to as many as 300,000 additional patients a year in the U.S. and will essentially double the patient pool to 600,000," Kruger said. He estimates the market will grow 20.2% in 2003 and 19.3% in 2004.

Kudos for Bush on healthcare stance

President George Bush gained widespread support from healthcare organizations within and outside the beltway with proposals for malpractice liability reform and changes to the ailing Medicare program, both put forth during his late-January State of the Union address.

The Advanced Medical Technology Association (AdvaMed; Washington) welcomed Bush's call for broad reforms for Medicare. "Highlighting the need for reform in the State of the Union opens a healthy debate on how best to bring Medicare into the 21st century," Pamela Bailey, AdvaMed president, said following the address. "America's seniors deserve the best treatments available. The president realizes, as do many health experts, that Medicare does not keep pace with the rapid advances in medicine," she added. "Too often Medicare patients do not have access to the highest quality of care possible."

Bailey said Congress needs to consider the following during the current session:

Medicare patients wait between 15 months and up to five years for Medicare to approve access to FDA-approved treatments.

Americans with private health insurance have access to new technologies, such as positron emission tomography (PET), years before Medicare beneficiaries gain access to the technology.

It literally takes an act of Congress before Medicare patients get access to new diagnostic technologies, particularly for diabetes and heart disease.

Medicare patients currently wait up to two years to have an appeal heard when Medicare denies a claim.

The Coalition for Affordable and Reliable Health Care (CARH; Washington) hailed Bush's call for action to resolve the patient access crisis "by promoting a reasonable legal approach to skyrocketing healthcare liability costs, based on proven solutions," the organization said. "Clearly the president understands the pain and fear being inflicted on patients, many of them elderly and uninsured, by a system that allows trial lawyers to seek outrageous jury verdicts, drive healthcare liability costs out of sight and force doctors and healthcare facilities to close their doors or move out of state," CARH chairman John Thomas said.

The American Medical Association (AMA; Chicago) also commended Bush for recognizing medical malpractice liability reform. "As the president stressed, we are all threatened by a legal system that is out of control," said Yank Coble Jr., MD, president of the AMA. "Because of the sky-high cost of liability insurance, physicians throughout the country have been forced to limit their practices, stop delivering babies, and some are even leaving the practice of medicine completely." The AMA also voiced its support for strengthening Medicare and ensuring that seniors have access to prescription drugs.

New guidance for race, ethnicity data

The FDA has expanded the list of required data that device manufacturers should include in clinical trial information, now more specifically for ethnic and racial groups. FDA regulations require clinical trials to include data analysis for age, gender and race, but until late last month, the agency had not provided clear guidance on how to collect and analyze the data for racial and ethnic groups or related ethnic information. The new guidance is based on a 1997 directive from the federal Office of Management and Budget that requires federal agencies to include racial and ethnicity data collection.

Medical products affect distinct groups differently due to intrinsic factors, the agency states in the guidance document. Factors such as diet, environment, socio-cultural issues and possible interactions between these factors can determine how a device interacts with different patient groups, the FDA said.

For instance, Caucasians in the U.S. are more likely than those of African or Asian heritage to have low levels of an enzyme that metabolizes antidepressants, antipsychotics and beta blockers, according to the FDA. Other tests have shown that African Americans do not respond as well to classes of anti-hypertensive medications or angiotensin-converting enzyme inhibitors, the agency added. Additionally, racial differences in skin structure and physiology can affect a person's response to dermatological and topically applied products, it said.

"Collecting race and ethnicity data using standard categories will enhance the early identification of differences in response among racial and ethnic groups during the evaluation of safety and effectiveness of FDA-regulated products," the agency wrote in the guidance document. The document failed to address, however, how many studies should be conducted to include specific patient groups. It also did not specify a total number of participants in various ethnic categories a trial should include.