BREAKING: ObamaCare 2012 Consequences? Feds Notify Hospitals of Legal Liability for Implanted Heart Devices. Is This Government Overreach?

By Anthony Smith on August 30, 2012 7:00 PM EDT

Heart
A 3D image of the heart, showing the fibres that control heart rhythm (Photo: Uni of Liverpool)

Is this evidence of the aftermath of the Supreme Court's groundbreaking 2012 Obamacare decision, or just a legal maneuvering set on resolving hundreds of ongoing investigations at the same time? Whatever the case may be, the Justice Department has just gotten in touch with numerous hospitals all across the US today with meticulously written instructions for them to take a look at suspicious implantable defibrillator surgeries on patients covered by Medicare, then get a sense of what potential penalties could as prescribed by the False Claims Act.

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Hospitals are no stranger to a full spectrum of potential damages. At approximately $40,000 per unit, these implanted heart devices, such as pace makers, that make sure that erratic heart rhythm stays regular rank among the most expensive items that healthcare providers have the privilege of billing Medicare for, and lawyers are now reporting that hospitals which see high volumes of cardiac surgeries towards implanting devices are now being asked to provide information on the details of hundreds of cases each.

Up until now, the Justice Department has been using technology to data mine, coupled with collaborative meetings with experts who can view said data and, if necessary, extra mandatory investigative demands to answer the question of whether or not some patients covered by Medicare have received implanted defibrillators outside of the guidelines when such devices can be given.

This new "resolution model" document, which you can read for yourself here, reads that each suspicious ICD incident will be evaluated on a case-by-case basis. Hospitals are now being asked by the Justice Department to self-audit all such cases and estimate what the amount of damages could be. Here, the harshness of the potential penalties will come from whether or not the hospital had any justifiable reasons to justify the very strict CMS guidelines.

Other factors that could increase penalties include whether or not patient harm resulted from these non-guidelines procedures, if the hospital was given prior knowledge of these implants or one can prove that the hospital has a statistical pattern of operating outside these guidelines; and, of course, if there's a hospital compliance program being implanted in the first place.

"This is a novel approach for a few reasons," cited Frank Sheeder III, a DLA Piper attorney, "Firs, the DOJ is articulating standards on clinical and reimbursement issues. And second, they have been working collaboratively with hospitals and their counsels and have expressed an intention to continue to do so in an effort to bring these cases to reasonable resolutions."

The Justice Department e-mail reads that it will not seek to punish every single device that breaks the guidelines set by the 2005 National Coverage Determination rules, but it also says that this new model for damages does not modify the pre-existing CMS coverage rules.

That said, whatever the Justice Department does find, under the False Claims Act, they can pursue it and punish by collecting upwards of three times the actual amount of damages.

Still, others contend that there's a serious lack of solid ground for prosecution at all.

What do you think?

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