On Thursday, the Department of Justice sent an email to hospitals nationwide asking them to conduct self-audits to identify Medicare fraud involving implantable defibrillators and calculate potential penalties under the False Claims Act, Modern Healthcare reports.
The email is part of a two-year effort by DOJ to investigate whether some hospitals have billed Medicare for implantable defibrillator surgeries that did not meet strict standards for such procedures set by the 2005 CMS National Coverage Determination rules DOJ’s two-year effort has included the use of data-mining technology, civil investigations and meetings with experts.
Hospitals could face a wide range of potential damages, according to Modern Healthcare. The False Claims Act allows investigators to collect up to triple the amount of actual damages, depending on the severity of the violation. The implanted devices can cost up to $40,000 each.
However, DOJ's email said hospitals will not be penalized for every implanted device that falls outside the strict CMS rules. The severity of penalties will be based on:
- Whether there was a medical need for the hospital to violate CMS rules;
- Whether the patient was harmed;
- If the hospital was aware or had a statistical pattern of implanting the devices against CMS guidelines; and
- If the hospital has an established compliance program.
DLA Piper attorney Frank Sheeder III said the email is a "novel approach" because it allows DOJ to clearly state the standards on clinical and reimbursement issues while showing that it intends to continue working collaboratively with hospitals. However, other attorneys have said DOJ does not have a solid legal case to prosecute hospitals (Carlson, Modern Healthcare, 8/30).