“I have talked to electrophysiologists who a few months ago might have implanted an ICD in a patient two weeks after a heart attack, and now they're going to wait the full 40 days, because that's what the guidelines say,” said Dr. Rich Fogoros, a retired electrophysiologist in Pittsburgh. “My fear is that electrophysiologists are now following the guidelines in every case to avoid going to jail, even if they believe that's doing harm to patients.”
Boston Scientific, among others, has noted in securities filings that the investigation is expected to hurt sales in the formerly fast-growing ICD market.
The Journal of the American Medical Association published a study Jan. 5, “Non-Evidence-Based ICD Implantations in the United States,” that found 22.5% of 111,000 ICD recipients since 2005 had received their devices outside the timing guidelines stipulated by the CMS. The study noted that non-guideline ICD recipients had a greater likelihood of dying in the hospital and of complications afterward.
Two weeks later, the industry trade group Heart Rhythm Society reported on its website that it was assisting the Justice Department in its ongoing investigation “in an advisory role to lend expertise concerning proper guidelines for clinical decision making.”
The Heart Rhythm Society and the Justice Department declined to comment, as did the three major manufacturers of ICDs: Boston Scientific, Medtronic and St. Jude Medical. All three firms have disclosed receiving information demands from prosecutors in filings with the Securities and Exchange Commission.
The investigation has been ongoing since at least March 2010, though several rounds of information demands have gone out, including one as recently as last month, attorneys with knowledge of the investigation said. The investigation is being run by trial attorneys in Washington and a prosecutor in the U.S. attorney's office in Miami, according to a Justice Department letter about the investigation sent to a U.S. hospital and obtained by Modern Healthcare.
Frank Sheeder III, a partner with Jones Day in Houston who is scheduled to become president of the Health Care Compliance Association on May 1, said that unlike past investigations under the federal False Claims Act, the Justice Department appears to be targeting not only hospitals, but high-volume doctors in the ICD case.
“What we understand is that in certain cases in which there are alleged timing violations, there is also a concern that the implantation was medically unnecessary, and that the government may well look at the physicians who made those decisions,” Sheeder said.
That would contrast sharply with how the U.S. attorney's office in Buffalo, N.Y., has prosecuted the ongoing investigation into fraud in the spinal-surgery procedure kyphoplasty by directly targeting hospitals, even though non-employed physicians made many of the patient-care decisions. The main function of an ICD is to detect irregular cardiac rhythms and deliver electrical shocks to the heart to restart normal activity to prevent sudden cardiac arrest. Unlike basic pacemakers, ICDs are multifunctional machines that can detect many kinds of cardiac arrhythmia and use different electrical impulses to regulate them.
More than 520,000 ICDs have been implanted since the CMS updated its National Coverage Determination in 2005 to include Medicare coverage of ICDs for the prevention of sudden cardiac-related death. The CMS reimburses between $40,000 and $50,000 per device, plus applicable hospital stays, making ICD implantation among the highest-paying procedures a hospital can deliver, experts say.
The timing guidelines in the CMS coverage decision were based on industry clinical trials, which limited their tests to patients who received ICDs at least 40 days following a heart attack, or 90 days after a coronary bypass or angioplasty surgery. Therefore, the CMS is not supposed to pay for ICDs implanted in patients who do not meet those time requirements.
However, the Justice Department investigation has triggered a debate in the cardiac community about whether government guidelines are too rigid given the limitations of the clinical trials they are based on.
“The decision about what is medically necessary is slightly different from what is in the NCD guidelines,” said Dr. Tom Di Salvo, medical director of the Vanderbilt Heart and Vascular Institute. “For these things to be meaningful, there has to be a more refined set of guidelines.”
Fogoros, the author behind “The Covert Rationing Blog,” offered several reasons why physicians might depart from the timing guidelines. Some patients might need a traditional pacemaker immediately, but waiting 40 days before implanting a full ICD would require a second unnecessary surgery to remove the original device. Other patients may get one early because their commercial insurance would run out before the guideline time elapsed.
And in some cases, patients may simply be at risk of sudden death from cardiac arrest inside the 40-day window. “The government's ICD guidelines are imperfect, and there are patients who would be treated improperly if the guidelines were followed in every particular case,” Fogoros said.