Des Moines Register | December 27, 2015
A seven-year federal investigation recently revealed that thousands of elderly Medicare patients have undergone surgeries to implant cardioverter defibrillators in violation of Medicare’s science-based coverage conditions. On Oct. 30, the U.S. Department of Justice announced that it had reached settlements with 70 hospital systems involving 457 hospitals in 43 states for more than $250 million.
The settlements include six hospitals in Iowa. Des Moines-based UnityPoint Health settled for $3.1 million on behalf of Iowa Lutheran Hospital, Iowa Methodist Medical Center, Trinity Bettendorf, Saint Luke’s Hospital, Trinity Regional and Allen Hospital.
Two whistleblowers, Leatrice Richards and Tom Schuhmann, first brought the violations to light when they filed the case under the False Claims Act, which permits whistleblowers to bring a lawsuit on behalf of the Medicare Program. I represented them in this case.
The ICDs at issue were implanted in patients’ chests within days after the patients had suffered heart attacks, 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 to the heart as it heals. Such harm includes worsening heart failure. Additionally, the heart may recover function in time, rendering an ICD not only premature but never needed.
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, Medicare’s requirements for coverage. The National Coverage Determinations 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. For example, a major study led by medical researchers at Duke University reported, “Patients who received a non–evidence-based ICD had significantly more comorbidities than patients who received an evidence-based device and were at a higher risk of post-procedural complications (including death).”
The Department of Justice worked with leading cardiology experts to develop a settlement model that permitted the hospitals to present potential evidence justifying the surgeries at issue. Still there were thousands of surgeries nationally to implant ICDs in violation of science-based medicine or the National Coverage Determination.
In many of these surgeries, the patient was entitled to receive an advanced beneficiary notice prior to the surgery telling him or her that Medicare may not cover it. Those notices are intended to help patients make an informed decision before undergoing the surgery. 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 the Medicare Program 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 alone. The settlements in this case are a window into a much larger problem in health care.
The federal investigation has resulted in major reductions in the numbers of patients undergoing 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 by approximately 28 percent, representing a savings of more than $2 billion to Medicare during the last five years.
Led by Jeffrey Dickstein and Amy Easton of the Department of Justice, 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 the Department of Justice has demonstrated the commitment and capability of reviewing compliance with such coverage conditions important to patient care. Without such 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.
BRYON VROON is an attorney in Georgia and since 2010 has served as lead counsel for whistleblowers in more than 70 settlements involving false claims against federal health care programs.
Contact: [email protected].