HHS Officials Officially Expand Medicare Coverage for ICDs

Main Category: Public Health
Article Date: 31 Jan 2005 - 14:00 PDT

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As expected, Medicare officials on Thursday announced plans to expand coverage of implantable cardioverter defibrillators to a larger group of beneficiaries, the Wall Street Journal reports (Burton, Wall Street Journal, 1/28). Previously, Medicare covered ICDs only for beneficiaries with more severe heart failure who have experienced "possibly fatal heart rhythms," the AP/Las Vegas Sun reports. Based on a study published Jan. 19 in the New England Journal of Medicine, CMS decided to expand Medicare coverage of the devices to patients with more moderate heart failure who have not yet suffered a potentially fatal heart arrhythmia (Kellman, AP/Las Vegas Sun, 1/28). The study showed that the devices reduced risk of death in "moderately to somewhat severely ill heart failure patients" by 23% over five years, the Wall Street Journal reports (Wall Street Journal, 1/28).

Eligibility, Cost
An estimated 500,000 Medicare beneficiaries are expected to be eligible for ICD coverage under the new rule, two to three times the number of people currently eligible, according to CMS Chief Clinical Officer Sean Tunis (Dow Jones, 1/27). Medicare officials estimate that in the first year of coverage, some 25,000 beneficiaries will receive the devices, potentially saving up to 2,500 lives. Medicare expects the new rule to cost about $2 billion over five years (Pugh, Knight Ridder/Contra Costa Times, 1/28). To be eligible, Medicare beneficiaries must agree to release details about their cases to a database, which aims to allow medical professionals to determine which patients benefit most from the devices (AP/Las Vegas Sun, 1/28). Some analysts say coverage of the devices, which cost about $30,000, could increase Medicare spending by as much as $3 billion annually (Dow Jones, 1/27). CMS will accept public comment on the decision until Feb. 14 as it drafts guidelines on linking coverage to data collection (AP/Las Vegas Sun, 1/28).

Comments
"By increasing the use of defibrillators, we are striking a blow against the leading cause of death among older Americans," CMS Administrator Mark McClellan said. According to the Knight Ridder/Times, McClellan "discounted concerns about the cost of the expanded coverage" and the new prescription drug benefit. He said, "You can't deliver modern medicine today, efficiently, without prescription drug coverage or preventive benefits" (Knight Ridder/Contra Costa Times, 1/28). McClellan also addressed Medicare's decision that beneficiaries who receive the devices must provide details about their cases to a database to be shared by hospitals. He said, "It's done in a way that preserves patient confidentiality," adding that the data would help the medical community determine who is most helped by ICDs (AP/Las Vegas Sun, 1/28).

Reaction
Joseph Smith, chief medical adviser at Guidant's Cardiac Rhythm Management division, said, "It's a bellwether signal for health care in this country when the biggest insurance company in the world responds to the best clinical science that's available" (Moore, Minneapolis Star Tribune, 1/28). He predicted relatively rapid adoption of the devices, adding that "physicians were waiting for Medicare's opinion." One of the NEJM study authors, Dr. Richard Luceri of Holy Cross Hospital in Florida, said he is "very pleased" with the decision, adding, "This will streamline the recruitment and management of these patients and reduce the complexity of decision-making in that regard. It will get the therapy to a greater number of patients." He added that the cost impact would not be severe because increased use of ICDs "will be a progressive phenomenon" (Dow Jones, 1/27). Meanwhile, insurers "applauded" CMS' decision, noting that the collection of data from beneficiaries who receive ICDs "would better direct the best treatment to the right people, improve care and save money," the AP/Sun reports. Karen Ignagni, CEO of America's Health Insurance Plans, said the decision is an important step toward evidence-based medicine, adding, "We hope that today's announcement paves the way for future post-marketing surveillance of medical devices and drugs" (AP/Las Vegas Sun, 1/28).

Other Actions
Medicare on Thursday also proposed expanding its coverage of ultrasound stimulation for beneficiaries with fractures that are not healing properly who agree to enroll in clinical trials to monitor, evaluate and improve treatments. According to the Knight Ridder/Times, the proposal eliminates a requirement that surgery fails to fix the problem before ultrasound treatment is covered. In addition, Medicare issued proposed guidelines for physician use of electronic prescribing technology for Medicare beneficiaries under the new prescription drug benefit (Knight Ridder/Contra Costa Times graphic, 1/27). CMS will accept public comment on the decision for 30 days before publishing a final decision within 90 days (CQ HealthBeat, 1/27).

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