The ICD Impasse: Medically Right But Legally Wrong

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon
 - businessman illustration

A disconnect between best care and what Medicare is willing to reimburse for it has put some electrophysiologists and their hospitals in a bind. By charging Medicare for what they deem to be medically necessary implantable cardioverter-defibrillators (ICDs) for certain patients, they may be at risk of fraud and its penalties. Last October, that hypothetical scenario became a reality for 457 hospitals. 

Stuck in time

From the medical community’s perspective, the crux of the problem lies in Medicare’s national coverage determination (NCD) for primary prevention ICD therapy. The NCD, revised most recently in 2005, outlines what the Centers for Medicare & Medicaid Services (CMS) deemed reasonable and necessary treatment for its beneficiaries based on evidence from key clinical trials. Like most trials, they excluded some patients for ethical or practical reasons, making the results applicable to only a subset of the patients cardiologists treat in everyday practice. Over the decade, science progressed but the NCD remained unchanged, further widening the gap between regulations and clinical care.

“The problem with ICDs is that our national coverage determination is out of date,” says John D. Day, MD, director of Heart Rhythm Services at Intermountain Medical Center in Salt Lake City and

president of the Heart Rhythm Society (HRS). “Also, 10 to 20 percent of our patients do not fit nicely into these very tightly defined clinical scenarios that the NCD covers. When you have a very legalistic interpretation, it leaves 10 to 20 percent of patients who we know will benefit with this life-saving therapy out of luck because the NCD is either out of date or too tightly defined.”

The Patient Protection and Affordable Care Act included a vow to crack down on fraud and the many billions of dollars it costs the federal government. Using the False Claims Act as its enforcement tool, the Department of Justice (DOJ) expanded its targets from what Isaac D. Buck, JD, describes as conventional fraud to overtreatment, or care that Medicare sees as medically unnecessary. ICDs came under the DOJ’s scrutiny after a study concluded that about one in five implantations fell outside practice guidelines (JAMA 2011;305[1]:43-49). The NCD requires, among other things, that cardiologists wait at least 40 days after a myocardial infarction (MI) and 90 days after revascularization before implanting an ICD.

“This is one of the most perfect examples of the era we are in in healthcare fraud enforcement, where no longer is it defined by intentional fraudulent schemes; it is defined by excessive medical care,” says Buck, an assistant professor at Mercer University’s law school in Macon, Ga., who studies the tension between clinical and legal standards. “The battle becomes who says what is excessive.”

Not so cut & dry

On Oct. 30, 2015, the DOJ announced that it reached 70 settlements totaling $250 million with healthcare systems and their 457 hospitals that the DOJ claimed violated the False Claims Act by implanting ICDs in Medicare patients contrary to the NCD. During the expansive investigation, the agency released medical review guidelines and a resolution model for hospitals that outlined categories, or “buckets,” where it would not enforce penalties or seek repayment, plus the documentation hospitals were required to provide.

The buckets included scenarios such as coding “MI” in the prohibited timeframe that later was determined to not be an MI, and patients who met all of the criteria for a permanent pacemaker and an ICD except for the waiting-period limit. Coders sometimes misguidedly interpret an elevated troponin level as an MI when it actually is due to cardiac arrest, Day explains. Waiting three months after graft surgery to replace a pacemaker with an ICD may prove counter to quality care, adds Andrea M. Russo, MD, co-chair of 2013 ICD appropriate use criteria (AUC)

designed to inform treatment decisions for scenarios not addressed in the guidelines.

“Not only is that not in the best interest of that patient but it can be dangerous for that patient because we know revisions have a higher risk of infections or problems occurring after that,” says Russo, director of the electrophysiology and arrhythmia service at Cooper University Hospital in Camden, N.J. “On top of that, it would cost the healthcare system a lot more money than putting the ICD in upfront.”

The DOJ reviewed “clinical realities on a case-by-case basis,” DOJ spokesperson Nicole Navas