NCA - Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3)

[MCDMedicare Coverage Database](https://www.cms.gov/medicare-coverage-database) - [Help & Resources](https://www.cms.gov/medicare-coverage-database/help/help-and-resources.aspx) - [Page Help](https://www.cms.gov/www.cms.gov) - [Tour the Search](https://www.cms.gov/www.cms.gov) - [Tour the Reports](https://www.cms.gov/www.cms.gov) - [Contact Us](https://www.cms.gov/www.cms.gov#submitFeedbackModal) - [Reset Search Data](https://www.cms.gov/www.cms.gov) [Archive](https://www.cms.gov/www.cms.gov) [API](https://www.cms.gov/www.cms.gov) [Back to Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers](https://www.cms.gov/medicare-coverage-database/view/nca.aspx?ncaid=267&keyword=pacemaker&keywordType=starts&areaId=s56&docType=NCA%2CCAL%2CNCD%2CMEDCAC%2CTA%2CMCD%2C6%2C3%2C5%2C1%2CF%2CP&contractOption=all&sortBy=relevance&bc=1) [**Contents**](https://www.cms.gov/www.cms.gov) National Coverage Analysis (NCA)Proposed Decision Memo # Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers CAG-00063R3 [Expand All](https://www.cms.gov/www.cms.gov) \| [Collapse All](https://www.cms.gov/www.cms.gov) Download Links in PDF documents are not guaranteed to work. To follow a web link, please use the MCD Website. ## Decision Summary The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block.  Symptoms of bradycardia are symptoms that can be directly attributable to a heart rate less than 60 beats per minute (for example:  syncope, seizures, congestive heart failure, dizziness, or confusion). Therefore, the following indications are covered for implanted permanent single chamber or dual chamber cardiac pacemakers: 1. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction. 2. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block. The following indications are non-covered since there is insufficient evidence to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary: 01. Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia. 02. Asymptomatic first degree atrioventricular block. 03. Asymptomatic sinus bradycardia. 04. Asymptomatic sino-atrial block or asymptomatic sinus arrest. 05. Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia. 06. 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 (a component of the electrical conduction system of the heart). 07. Syncope of undetermined cause. 08. Bradycardia during sleep. 09. 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. 10. Asymptomatic bradycardia in post-myocardial infarction patients about to initiate long-term beta-blocker drug therapy. 11. Frequent or persistent supraventricular tachycardias, except where the pacemaker is specifically for the control of the tachycardia. 12. 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. Medicare Administrative Contractors will determine coverage under section 1862(a)(1)(A) of the Social Security Act for any other indications for the implantation and use of single chamber or dual chamber cardiac pacemakers that are not specifically addressed in this national coverage determination. ## Proposed Decision Memo ``` To: Administrative File: CAG-00063R3 From: Louis Jacques, MD Director, Coverage and Analysis Group Tamara Syrek Jensen, JD Deputy Director, Coverage and Analysis Group Jyme Schafer, MD, MPH Director, Division of Medical and Surgical Services Joseph Chin, MD, MS Lead Medical Officer Jamie Hermansen, MPP Lead Health Policy Analyst Subject: Decision Memorandum for Reconsideration of Coverage of Cardiac Pacemakers: Single Chamber and Dual Chamber Permanent Cardiac Pacemakers. Date: August 13, 2013 ``` #### I. Decision The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or dual chamber, are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction and second and/or third degree atrioventricular block.

Indicated for patients with symptomatic bradycardia due to sinus node dysfunction. Recommended for patients with advanced heart block with symptoms. Implanted permanent cardiac pacemakers are reasonable and necessary for the treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction. Implanted permanent cardiac pacemakers are reasonable and necessary for second and/or third degree atrioventricular block. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block. Reversible causes of bradycardia such as electrolyte abnormalities, medications, or drugs must be ruled out. Asymptomatic first degree atrioventricular block. Asymptomatic second degree atrioventricular block of Mobitz Type I is covered unless QRS complexes are prolonged. Syncope of undetermined cause. Bradycardia during sleep. Right bundle branch block with left axis deviation is covered in the absence of syncope. Coverage for asymptomatic bradycardia in post-myocardial infarction patients initiating long-term beta-blocker therapy. Coverage for frequent or persistent supraventricular tachycardias unless the pacemaker is specifically for controlling the tachycardia. Coverage for clinical conditions requiring intermittent and brief pacing not likely to become prolonged. Implantation and use of single chamber or dual chamber cardiac pacemakers are covered for indications specifically addressed in this national coverage determination. Additional indications may be determined by Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act. Implanted permanent cardiac pacemakers are covered for treatment of non-reversible symptomatic bradycardia due to sinus node dysfunction. Coverage includes treatment for second and/or third degree atrioventricular block.

Not covered for patients with transient bradycardia due to reversible causes. Will not cover when used solely for the purpose of improving exercise capacity in asymptomatic patients. Insufficient evidence to conclude that implanted permanent cardiac pacemakers are reasonable and necessary. Not covered for asymptomatic sinus bradycardia. Not covered for ineffective atrial contractions without symptomatic bradycardia. Asymptomatic sino-atrial block or sinus arrest without symptoms is not covered. Indications not specifically addressed in this national coverage determination are subject to review by Medicare Administrative Contractors.

Clinical documentation proving the necessity for implantation. Results of electrophysiological studies that support the indication.