Through its Comprehensive Error Rate Testing (CERT) Program, CMS discovered a large number of errors related to the implantation of cardiac pacemakers. The CERT Program randomly selects a small sample of Medicare fee-for-service claims to produce a national error rate and a provider compliance error rate. In the case of cardiac pacemaker implantation, the CERT Program revealed that patients who had an indication for a single-chamber pacemaker nevertheless often received dual-chamber devices. In response, CMS issued a fact sheet on the topic, available by clicking here.

The CERT review of cardiac pacemaker implantations revealed two common errors. First, claims often lacked documentation to support the choice of a dual-chamber, rather than a single-chamber, pacemaker. CMS noted, “Physicians must clearly state, in the patient’s medical record, the reasons for choosing a dual-chamber pacemaker rather than a single-chamber pacemaker.” Second, claims often revealed the implantation of a dual-chamber pacemaker in patients with a clear contraindication, such as chronic atrial fibrillation.

The CMS fact sheet lists four indications for a dual-chamber pacemaker that are listed in the Medicare National Coverage Determinations Manual, available by clicking here:

  • Patients in whom a single-chamber pacemaker elicits a drop in blood pressure, retrograde conduction, or discomfort;
  • Patients who have already experienced significant symptoms of pacemaker syndrome;
  • Patients in whom even a small increase in cardiac efficiency will improve quality of life (e.g. patients with congestive heart failure despite adequate other medical measures); or
  • Patients in whom pacemaker syndrome is anticipated (e.g. young and active patients).

CMS Pub. 100-03, ch. 1, § 20.8. In addition, the fact sheet notes that dual-chamber pacemakers are never covered when certain conditions are present. These overriding contraindications, which include all other indications for which CMS has not specifically indicated coverage, are:

  • Ineffective atrial contractions;
  • Persistent or frequent supraventricular tachycardias, except when the pacemaker is specifically for the control of the tachycardia;
  • A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood of prolonged pacing needs; or
  • Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was second-degree and/or third-degree AV block in association with bundle branch block.

Hospitals should take CMS’s instructions on pacemaker coverage seriously. In a very similar area—Medicare coverage for implantable cardiac defibrillators—there is a large number of ongoing investigations where the government presumably is considering penalties under the False Claims Act. It is important that hospitals be mindful of CMS’s coverage policy for pacemakers (and all other services) to minimize compliance risk.