On May 29, 2013, CMS issued a Proposed Decision Memorandum (the Memorandum) for reconsideration of its coverage of single-chamber and dual-chamber implanted permanent cardiac pacemakers under a National Coverage Determination (NCD). 

The Memorandum is a response to a formal joint request by the Heart Rhythm Society (HRS) and the American College of Cardiology (ACC) for reconsideration of dual-chamber pacemaker coverage.  In their request, HRS and ACC ask that CMS expand and clarify current coverage for the use of dual-chamber pacemakers to conform with current clinical guidelines.  The letter, which is available here, and its documentary support do not address single-chamber pacemakers.

Prompted by this request, CMS commenced its reconsideration on January 24, 2013.  In the Memorandum, which is available here, CMS proposes that both single and dual-chamber pacemakers “are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia,” subject to certain conditions.  Bradycardia is an abnormally slow heart rate, defined as a heart rate of less than 60 beats per minute in adults, and its symptoms include syncope, seizures, congestive heart failure, dizziness, or confusion.

These proposed criteria combine and unify coverage for single and dual-chamber pacemakers into a single joint category.  Current NCD criteria divide single and dual-chamber pacemaker coverage into two separate categories, with listed indications specific to each.  A copy of the current NCD criteria is available here.  Further, current criteria for single-chamber pacemakers covers fifteen listed indications; with four listed indications covered for dual-chamber pacemakers.  In contrast, the Memorandum proposes to cover only the following two indications for both single and dual-chamber pacemakers:

• Documented symptomatic bradycardia due to sinus node dysfunction; and
• Documented symptomatic bradycardia due to second degree and/or third degree atrioventricular block. 

Additionally, CMS found insufficient evidence to conclude that single or dual-chamber pacemakers are reasonable and necessary for the following indications, and proposes not to cover the following:

• Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia;
• Asymptomatic first degree atrioventricular block;
• Asymptomatic sinus bradycardia;
• Asymptomatic sino-atrial block or asymptomatic sinus arrest;
• Ineffective atrial contractions without symptomatic bradycardia;
• Asymptomatic second degree atrioventricular block of Mobitz Type I unless the QRS complexes are prolonged or electrophysiological studies have demonstrated that the block is at or beyond the level of the His Bundle;
• Prophylactic pacemaker use following recovery from acute myocardial infarction during which there was temporary complete (third degree) and/or Mobitz Type II second degree atrioventricular block in association with bundle branch block;
• Syncope of undetermined cause;
• Bradycardia during sleep;
• Prolonged P-R intervals with atrial fibrillation (without third-degree atrioventricular block);
• Right bundle branch block with left axis deviation (and other forms of fascicular or bundle branch block) without syncope or other symptoms of intermittent atrioventricular block;
• Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy;
• Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of the tachycardia; and
• A clinical condition in which pacing takes place only intermittently and briefly, and which is not associated with a reasonable likelihood that pacing needs will become prolonged, e.g., the occasional patient with hypersensitive carotid sinus syndrome with syncope due to bradycardia and unresponsive to prophylactic medical measures. 

Aside from slight phrasing changes, CMS does not propose to expand what it will not cover, and there are no previously-covered conditions that have been moved to the non-covered list.  The Memorandum substantially expands and clarifies covered indications for dual-chamber pacemakers; however, the proposed reduction in the number of covered indications for single-chamber pacemakers implies that the list of non-covered indications has essentially been significantly expanded.

The Proposed Decision Memo is currently open for public comment. 

Reporters, Beverly H. Lorell, M.D., Washington, D.C., +1 202 383 8937, blorell@kslaw.com, and Katy Lucas, Atlanta, +1 404 572 2822, klucas@kslaw.com.