The revised coverage policy that the Centers for Medicare and Medicaid Services issued in mid-August for permanent cardiac pacemakers should completely eliminate the dual-chamber pacemaker audit problem that plagued many U.S. electrophysiologists and their hospitals in recent years.
The new coverage decision broadly accepts placement of dual-chamber pacemakers in patients who need a permanent pacemaker, replacing 30-year-old coverage rules that had led to many challenges to Medicare coverage brought by Recovery Audit Contractors (RACs) working on behalf of the Centers for Medicare and Medicaid Services. In its decision memo, CMS said that its revisit of the dual-chamber pacemaker issue resulted from a formal request made by the Heart Rhythm Society (HRS) and the American College of Cardiology (ACC).
The coverage decision by CMS for single- and dual-chamber pacemakers is "a tour de force. They did a beautiful job; I’m very pleased with the document," said Dr. Hugh Calkins, a professor of medicine and an electrophysiologist at Johns Hopkins University in Baltimore and president of the HRS.
CMS’s newly stated policy on what pacemaker implants Medicare will cover "basically gives the green light" to all appropriate pacemaker implants. "The only thing CMS asks is that physicians document their thinking. I don’t think that the RAC auditors will go after dual-chamber pacemakers again," Dr. Calkins said in an interview.
The result should be many fewer hassles for electrophysiologists, but the coverage change will probably have little impact on patient care, he said. Until now, cardiologists have been placing dual-chamber devices when necessary despite the threat that RACs could question the implants. "It’s never been an issue that patients weren’t getting optimal treatment. When patients needed dual-chamber pacemakers, I fully believe electrophysiologists have been putting them in. The problem was the RAC auditors went after the pacemaker issue."
Dr. Calkins cited his own experience of having to deal with three cases during the past year in which a RAC questioned his decision to place a dual-chamber pacemaker. Each of these episodes required about 10 hours of work to resolve, said Dr. Calkins, who also directs the Clinical Electrophysiology Laboratory and Arrhythmia Service at Johns Hopkins Hospital. Last year, CMS was billed for about 150,000 pacemaker procedures for Medicare patients (a number that includes generator replacements as well as placement of new devices), according to data supplied by a spokeswoman for the HRS.
The problems that electrophysiologists placing dual-chamber pacemakers had from RAC actions grew widespread once the RAC program went nationwide for CMS at the start of 2010. The HRS took a big step toward solidifying its defense against the dual-chamber audits when, in 2012, an expert panel assembled by the HRS and ACC published a consensus statement on pacemaker device and mode selection (J. Am. Coll. Card. 2012;60:682-703). In testimony before Congress earlier this year, a representative of the HRS said that the society, acting with the ACC, launched creation of the 2012 consensus statement "in response to" the audit issue.
The new decision memo from CMS says that single- or dual-chamber implanted, permanent, cardiac pacemakers are covered for patients with "documented non-reversible symptomatic bradycardia due to sinus node dysfunction," or with "documented non-reversible symptomatic bradycardia due to second-degree and/or third-degree atrioventricular block."
Dr. Calkins said that he has received research support from Medtronic and St. Jude.
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