Frank Sheeder, a partner at DLA Piper who represented four systems involved in the investigation, called Dickstein and Easton's approach “relatively balanced.” He credited them for considering claims one by one—an enormous task for two lone Justice Department attorneys.
The praise runs both ways. “We really had the pleasure of dealing with 200 of the best healthcare defense lawyers in the country,” Dickstein said.
Dickstein and Easton have since left the Justice Department and are now with Phillips & Cohen, where they represent whistle-blowers. But many hope their approach of employing medical experts to consider medical decisions will be applied to future Justice Department investigations.
With this investigation, the Justice Department showed that it's capable of looking at a situation chart by chart even when many patients in many places are involved. “They can do it, and they have done it, and I think in the appropriate instances they will do the same thing again,” Dickstein said.
That's not to say, however, that hospitals and their attorneys weren't troubled by other aspects of the ordeal. Community Health Systems issued a statement at the time its $13 million settlement was announced in October saying, “The issue involved a highly technical interpretation of a Medicare national coverage determination that was the subject of strong disagreement in the medical community.”
Dr. Michael Gold, president of the Heart Rhythm Society, called the investigation and resulting settlements disappointing, especially given that the national coverage determination for the devices hasn't changed in 11 years. “Physicians are trying to do their best and trying to follow evidence-based guidelines … and we ended up with lots of centers receiving fines because their documents were not in compliance with what was in the CMS payer decisions,” Gold said.
In 2013, the Heart Rhythm Society along with the American College of Cardiology and the American Heart Association published updated recommendations for patient eligibility for the devices. Some of the writers and peer reviewers for those documents have affiliations with device manufacturers, according to their own disclosures.
Adam, a lawyer who represented several targeted systems, said she'd like to see the CMS add more flexibility for physicians to the current national coverage determination, which is now under review, according to the CMS.
But the fact the national coverage determination may not be in accord with the latest professional society guidelines hasn't stopped doctors from limiting their use of the devices in the wake of the investigation. Based on Medicare claims data, physicians billed Medicare for inserting the devices in 49,014 beneficiaries in 2014 compared with 70,969 beneficiaries in 2008, according to Bryan Vroon, an attorney for the whistle-blowers.
Whether that's a good or bad thing depends on perspective. Vroon said that reduction means doctors are more closely basing their decisions on science, which is a win for patient care. Easton said she's never seen data or even anecdotal evidence that patients have suffered from the reduction in implants.