Few would suggest that the Justice Department didn't have sound reasons to look into the use of ICDs.
Several clinicians have described in interviews a widespread belief in the cardiology community that at least some physicians have abused the guidelines or even overused ICDs in some circumstances.
Dr. Jonathan Steinberg, a Columbia University professor and director of the Arrhythmia Institute of the Valley Health System, in New York and New Jersey, said he has seen questionable implantations while working as a consultant and inspecting other hospitals' records.
He acknowledged investigators' concerns about violations of the CMS national coverage determination, or NCD, based on some practices in the industry.
“They're not creating something out of whole cloth,” Steinberg said of the investigators. “No, there is some concern that there were a significant number of implantations that violated the NCD. There are some that are unjustifiable, and some that, despite the violation of the NCD, are justifiable.”
At his own employer, Valley Health System, he said the Justice Department mandated reviews of 229 defibrillator implantations, or about 9% of the hospital's cases over eight years. Of those, he said 34 turned out to be potential violations of the CMS timing rules for implantation and could possibly lead to the hospital having to repay its reimbursements on those cases.
But unlike Lindsay at the Cleveland Clinic, Steinberg did not think the physicians involved in the 34 potential cases of timing-rule violations—who have since left the hospital—would make the same decisions again today if they had to do it all over again. And he doesn't think he's alone in that belief, either.
“After the Justice Department started their rounds of investigations around the country, the implantation rate of ICDs went down 20% nationally,” he said. “Most people became a little more circumspect about doing implantations.”
Cardiac medicine in general is no stranger to overuse allegations. Just last year, a study in the Journal of the American Medical Association reported that 12% of coronary stents in stable patients appeared inappropriate, despite the risks associated with angioplasty.
But in January 2011, JAMA published a study titled “Non-evidence-based ICD implantations in the United States” that roiled the cardiac-implant community.
It concluded that about 23% of all implantable defibrillators studied in the national ICD Registry between 2005 and 2010 did not appear to meet the Medicare timing criteria.
The study called these cases “non-evidence-based ICDs”—a finding interpreted by many observers as a form of overuse: “One in five patients who receive the heart-shocking, life-saving devices known as implantable cardioverter-defibrillators, or ICDs, may be getting them unnecessarily,” ABC News reported after the JAMA study was published.