George Breen Quoted in Article, “Hospitals Anxious They Could Face Hefty False Claims Penalties in Implanted Cardiac Defibrillator Cases”


George Breen, a Member of the Firm in the Health Care and Life Sciences and Litigation practices, in the Washington, DC, office, was quoted in an article titled "Hospitals Anxious They Could Face Hefty False Claims Penalties in Implanted Cardiac Defibrillator Cases," by Joe Carlson.

Following is an excerpt:

The U.S. Justice Department has waged an extensive, patient-by-patient investigation into thousands of implantable cardioverter defibrillators (known as ICDs) for Medicare beneficiaries between 2003 and 2010 at hospitals across the country.

The investigation depressed sales of the expensive advanced heart devices nationally by as much as 20% and has forced physicians to consider whether their independent medical judgment conflicts with federal guidelines outlining exactly when the devices may be used.

Hospital lawyers say the Justice Department is looking to enforce Medicare's coverage rules through the lens of the False Claims Act, an anti-fraud statute, which is not how reviews of medical-necessity have been conducted. ?...

The Justice Department is specifically looking at cases that appear to violate the timing rules in the CMS guidelines. ?...

George Breen, a healthcare and litigation lawyer with Epstein Becker & Green who has clients facing ICD investigations, said the conflicts between the CMS timing rules and a physician's medical judgment can create difficult situations.

"You have a patient who you believe has a risk of death if you don't implant this device, but the device falls outside the government's timing window," Breen said. "It makes it a very challenging scenario for the physician. But I do think you also look at how the science has developed over time. There are more reasons to implant that the (CMS rule) just does not address. So what do you do in that situation?" ?...

Several observers, including Breen and [Dr. Bruce] Lindsay, noted that while the investigation has dragged on, they have been satisfied that prosecutors seemed to be studying the medicine before issuing sweeping statements on the rules or enforcement actions.

"I will say that in this matter, DOJ has taken a very thoughtful approach," Breen said. "They are taking time to make sure they understand the science, and they are engaging defense counsel."