In 2005, the CMS approved their use for primary prevention, which expanded the population of people eligible to receive them. A study of device-registry data found that nearly 23% of 111,000 devices implanted from 2006 to 2009 did not meet the Medicare definitions for appropriateness, according to a 2011 analysis in the Journal of the American Medical Association.
“ICDs clearly have a role for some patients, but their use goes beyond the populations in which they've been shown to be beneficial,” said Dr. Rita Redberg, a cardiologist and professor at the University of California at San Francisco.
The Justice Department probe, however, has been criticized for relying too heavily on inflexible and out-of-date Medicare eligibility criteria, which were written based on the criteria for participants in the original clinical trials for primary prevention using ICDs.
In January, the Journal of the American College of Cardiology published an opinion column co-written by the president-elect of the Heart Rhythm Society, Dr. Richard Fogel, describing the disconnect between the Medicare coverage guidelines and the clinical guidelines developed by medical societies.
“This leaves physicians in the uncomfortable position of knowing that appropriate clinical recommendations may fall outside the scope” of the Medicare rules, the article says. “This may place practitioners and hospitals at risk for denial of payment or investigation for possible abuse or fraud even when the decision was clinically justified.”
The Justice Department has never publicly acknowledged the ongoing probe, but for-profit hospital chains have revealed it in filings with the Securities and Exchange Commission and lawyers for not-for-profit hospitals have spoken freely about it.
The investigation is said to be mainly concerned with defibrillators that are implanted outside of the Medicare guidelines, which say the program won't pay for ICDs implanted within 40 days of a heart attack or 90 days of bypass surgery, among other restrictions.
Advocates for ICD use say there are good reasons to implant the devices outside of those restrictions, which is why the medical societies' appropriate-use guidelines are more flexible.
Last year, Modern Healthcare obtained a copy of a memo that the Justice Department sent to hospitals in the investigation that showed some cases will not be pursued even though the cases fall outside the Medicare timing rules, citing “DOJ discretion in False Claims Act enforcement.”
Last year, a now-defunct chain of heart hospitals called MedCath Corp. said in a news release that it paid
$6.1 million to settle the cases with six of its hospitals. The company set aside $48 million two years earlier to cover the potential legal costs, before the full extent of the liability was clear.
Attorneys say Justice Department officials have made no secret that they may eventually look past the hospitals where the implantations took place and target the doctors recommending the devices to patients.
Follow Joe Carlson on Twitter: @MHJCarlson
