A seven-year federal investigation recently revealed that thousands of elderly Medicare patients have undergone surgeries to implant cardioverter defibrillators (ICDs) in violation of Medicare’s science-based coverage conditions. On Oct. 30, the U.S. Department of Justice announced it had reached settlements with 70 hospital systems involving 457 hospitals in 43 states for more than $250 million.
Eight Kentucky hospitals are part of the settlements, including Saint Joseph East and London, Central Baptist Hospital, Baptist Hospital East in Louisville, and King’s Daughter’s Medical Center in Ashland.
Two whistleblowers, Leatrice Richards and Tom Schuhmann both from Louisville, brought the violations to light when they filed the case under the False Claims Act. I represented them in this case.
The ICDs at issue were implanted in patients’ chests within days after they had suffered heart attacks or undergone cardiac bypass or angioplasty procedures. Scientific studies have demonstrated that in many patients, implanting an ICD in the weeks after a heart attack is not beneficial and is potentially harmful. Additionally, the heart may recover function in time, rendering an ICD not only premature but never needed.
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The waiting periods – 40 days after a heart attack and three months after a bypass or angioplasty procedure – are generally established in the National Coverage Determination (NCD), Medicare’s requirements for coverage. The NCDs ensure that Medicare patients receive “reasonable and necessary” medical treatment based on science.
Numerous published studies have confirmed the importance of following the established indications and contraindications for implanting an ICD. A major study led by Duke medical researchers reported, “Patients who received a non–evidence-based ICD had significantly more comorbidities … and were at a higher risk of post-procedural complications (including death).”
The DOJ worked with leading cardiology experts to develop a settlement model that permitted the hospitals to present potential evidence justifying the surgeries. Still, there were thousands of ICD surgeries nationally in violation of science-based requirements.
In many of these surgeries, the patient was entitled to receive an advanced beneficiary notice (ABN) prior to the surgery saying Medicare may not cover it. On the ABN form, Medicare’s rules require that hospitals “explain, in beneficiary friendly language, why they believe the items or services described … may not be covered by Medicare.”
In each of these surgeries, the patient wasn’t notified and Medicare was billed.
These settlements reflect the vulnerability of elderly patients and Medicare to unnecessary medical treatment. This case is a prime example of what Donald Berwick, the former Administrator of the Centers for Medicare and Medicaid Services, called “overtreatment”---or “care rooted in outmoded habits, supply-driven behaviors, and ignoring science”---which he estimated cost Medicare and Medicaid $87 billion in 2011.
The federal investigation has resulted in many fewer surgeries to implant ICDs---approximately 20,000 fewer each year. Since the beginning of the DOJ investigation, surgeries to implant ICDs in Medicare patients have decreased approximately 28 percent, representing a savings of over $2 billion to Medicare during the last five years.
Led by Jeffrey Dickstein and Amy Easton of the DOJ, the federal investigation has dramatically influenced cardiac care by requiring adherence to Medicare’s science-based coverage conditions. The impact extends way beyond cardiac care because Justice has demonstrated the commitment and capability of reviewing compliance with such coverage conditions. Without that commitment from public and private sector leadership, unnecessary tests, procedures and surgeries will continue to plague Medicare patients and escalate costs for federal healthcare programs.
Bryan Vroon is an expert on medical fraud and has represented whistleblowers in many federal investigations.