Medicare To Expand Coverage of Implantable Cardioverter Defibrillators Based on Study Results
Medicare is "poised to expand" coverage of implantable cardioverter defibrillators, a move that could increase the number of eligible beneficiaries by one-third to about 500,000, federal officials said Wednesday, the New York Times reports (Pear, New York Times, 1/20). The announcement coincides with a study showing improved survival rates with ICDs in Thursday's New England Journal of Medicine, the Washington Post reports. Currently, Medicare covers ICDs generally only for patients with severe heart failure (Weiss, Washington Post, 1/20).
CMS last year proposed ICD coverage based on the preliminary results of the Sudden Cardiac Death in Heart Failure Trial, which found that defibrillators lowered the risk of death among patients with moderate heart failure (Corbett Dooren/Rosenberg, Dow Jones Newswires, 1/19). Under the initial proposal, coverage of the devices -- which cost between $20,000 and $35,000 -- would be expanded to beneficiaries who have mild to moderate heart failure, defined as a reduction of 30% in the amount of blood pumped by the heart with each contraction.
CMS officials at the time said that Medicare would provide coverage for ICDs for at least 25,000 additional beneficiaries in the first year of the expansion, which could save as many as 2,500 lives. By 2005, about 77,000 Medicare beneficiaries could have coverage for ICDs, CMS officials had said (California Healthline, 9/29/04). Late last year, CMS officials said they would delay a final decision on the rule until the results of the study were published in the New England Journal of Medicine (California Healthline, 1/3).
The NEJM study published on Thursday, led by Dr. Gust Bardy of the Seattle Institute for Cardiac Research, examined 2,521 people with mild to moderate congestive heart failure, some of whom received standard care for heart failure, including ACE inhibitors, beta blockers and statins; standard care plus the heart arrhythmia medication amiodarone; or an ICD manufactured by Medtronic (Washington Post, 1/20). After a median of four years, participants who had received the ICD experienced a 23% reduced risk of death compared with those in the standard care group (Ritter, Chicago Sun-Times, 1/20).
The treatment amiodarone offered "no survival benefit and may have even precipitated some deaths," the researchers found, the Post reports. According to the Post, the findings suggest that "tens of thousands of lives could be saved each year with wider use of ICDs" (Washington Post, 1/20). Bardy and other primary researchers have received research grants and speaking and consulting fees from defibrillator manufacturers, the Sun-Times reports (Chicago Sun-Times, 1/20).
In an editorial accompanying the study in NEJM, Alan Kadish, a cardiologist at the Northwestern University School of Medicine, said the research confirms the effectiveness of ICDs in "prolonging survival among patients with heart failure and coronary disease" (New York Times, 1/20).
In a separate NEJM article, CMS Administrator Mark McClellan and CMS Chief Clinical Officer Sean Tunis said that based on the findings Medicare plans to expand coverage of ICDs to beneficiaries with the same conditions as study participants. "This policy change may increase the number of Medicare beneficiaries who are eligible for an ICD to more than 500,000, two to three times the number who are currently eligible," according to the article by McClellan and Tunis.
The article adds, "These devices can save thousands of lives in our beneficiary population" (New York Times, 1/20). In an interview, Tunis said, "The results (of the study) were pretty clear cut. There's a significant new group of patients who benefit from this device." Unlike the initial proposal, the revised coverage decision would not require physicians to explain why a particular device was used in order to receive reimbursement. The revised coverage proposal, which private insurers are expected to follow, likely will be announced next week and will be finalized after a period of public comment (Dow Jones Newswires, 1/19).
According to the Post, CMS' decision "represents the most aggressive effort yet to use [Medicare] as a backdoor way to learn more about what works and what does not in medicine" (Washington Post, 1/20). As a condition of coverage of ICDs, Medicare also would begin collecting data on patients' health to establish a registry and "allow Medicare and researchers to track how well the devices perform in various groups of patients over time," Dow Jones reports (Dow Jones Newswires, 1/19).
Federal officials have said that because of the large number of Medicare beneficiaries, collection of long-term data by the program "can be a powerful complement to the modest follow-up efforts made by manufacturers and [FDA]" after a treatment is approved, the Post reports. Tunis said, "Hopefully this will both ensure that patients get the best care as quickly as possible and also we'll continue to get smarter and learn more about unanticipated safety problems and how to use these technologies most effectively."
However, experts in medical ethics said the data-collection efforts "would have to be watched closely to ensure they do not cross the line," noting that it is unethical under federal and international human research guidelines to require participation in research as a condition of receiving medical care, according to the Post (Washington Post, 1/20).
CMS spokesperson Gary Karr said that the federal government in recent months has made an effort to link Medicare coverage for new treatments with efforts to collect data on their effectiveness (New York Times, 1/20).
According to the Post, expanded coverage of ICDs "could be the most expensive single decision in Medicare's history." If 20% of eligible beneficiaries received ICDs, the cost would be about $3 billion annually, the Post reports. If all eligible beneficiaries received ICDs under the expanded coverage, the cost of coverage would be $15 billion annually or more, "about equal to all other outpatient Medicare expenditures combined," the Post reports.
Ezekiel Emanuel, chair of the department of clinical bioethics at NIH, said, "Because the number of people can be huge, the effect on the system can be enormous," adding, "That's an issue we haven't been able to grapple with very well. How do you set priorities?" (Washington Post, 1/20).
The study, McClellan/Tunis article and editorial are available online.