Despite recent actions by the Centers for Medicare and Medicaid Services (CMS) to remove restrictions around MRIs for heart patients with implantable cardiovascular devices, the U.S. government is failing to protect a subset of those patients with fractured, epicardial or abandoned leads, according to an editorial published in JAMA Cardiology this November.
CMS’ policies are rooted in the idea that the agency will cover any medical services deemed “reasonable and necessary” for its beneficiaries, Daniel B. Kramer, MD, MPH, and colleagues wrote, and most services are covered without controversy. But some cases, like those of patients with implantable cardioverter-defibrillators (ICDs) or pacemakers who require MRI imaging, gain national attention and fuel policy change.
In 2011, CMS announced Medicare would reimburse all healthcare professionals and facilities for MRIs in patients with “MRI-conditional” devices, or those deemed safe with professional supervision. Still, the agency received pushback from researchers, whose growing body of evidence suggested MRIs were perfectly safe in patients with implantable devices. CMS finalized a memo in April 2018 removing further restrictions around MRIs for these patients, but Kramer et al. said it also retained a key exclusion to MRI coverage: the presence of any fractured, epicardial or abandoned leads.
Nonfunctioning pacing or defibrillation leads can be either replaced or capped and left in place with the addition of a new lead. Kramer and colleagues said they’re important in cardiac surgeries and resynchronization therapy systems where patients can’t tolerate transvenous lead placement.
“These configurations are common, and in the case of capped leads, may be preferred to avoid potential complications and significant procedural costs associated with lead extraction procedures,” the authors wrote. “Even at experienced centers, lead extraction includes a 2 to 3 percent rate of major complications, including urgent surgery or death—an unacceptable risk if performed merely to facilitate an MRI.”
They said few studies have explored capped and epicardial leads in this context, but “the evidence to date is reassuring.” Preliminary studies have resulted in zero adverse events and no evidence of myocardial injury.
But it’s in the realm of research that Kramer and his coauthors find fault in CMS’ strategy. The agency sunsetted all its previously approved studies in its 2018 memo, effectively barring clinical sites across the U.S. from collecting safety data on outpatients with abandoned or epicardial leads.
“As a result, there may be no new data on which to base future coverage determinations,” the authors said.
They said especially when comparing the risks of MRI with its potential benefits in these patients, the imaging procedure carries a low likelihood of major adverse events. However, an ICD outpatient enrolled in a Medicare fee-for-service plan who’s being considered for an MRI would be responsible for their own procedural costs. Hospitals can’t waive fees for non-hospitalized patients, because it would be considered a violation of federal anti-kickback statutes.
“The new CMS policy...is flawed,” Kramer et al. wrote. “The new policy undermines the important goal of evidence-based coverage decisions in this situation and forces such patients who need MRI studies to choose between compromised care and financial risk.”
The authors suggested CMS amend its coverage memo to allow for physician discretion in individual cases. That way, they argued, the performance of MRI in a patient with an ICD and abandoned lead would remain a clinical decision made by the treating physician in collaboration with a qualified cardiologist or electrophysiologist. They also encouraged the agency to allow for ongoing data collection in studies sunsetted by the 2018 memo.
“We urge CMS to consider realignment of its coverage policy with the tremendous scientific progress made over the past decade,” Kramer and colleagues said. “Doing so would affirm the positive role that CMS coverage decisions can play in balancing scientific inquiry, stewardship of scarce resources and providing access to appropriate clinical care.”
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.