Pacemaker National Coverage Determination: A Synopsis of Recent CMS Policy Change

Historical Background

The Medicare National Coverage Determination (NCD) for permanent cardiac pacemakers was initially implemented in 1984 (Document 65.6). This NCD established conditions of coverage and non-coverage for permanent single chamber and dual chamber cardiac pacemakers. In 2004, the NCD was updated (Publication 100-3) when the Centers for Medicare & Medicaid Services (CMS) recognized that pacemaker implantation was no longer an experimental procedure. During this time period, in an effort to control medical costs, the Comprehensive Error Rate Testing (CERT) Program was developed to identify clinical situations associated with improper payments. In 2010, the CERT Program identified a significant number of cases where a dual chamber pacemaker was implanted in patients who only had indications for single chamber pacemakers. Both the 1984 and 2004 NCDs provided separate nationally covered indications for single chamber pacing (Group I) and dual chamber pacing (Group II). The indications for dual chamber pacing were similar for both NCDs.

• "Patients in who single-chamber (ventricular pacing) at the time of pacemaker insertion elicits a definite drop in blood pressure, retrograde conduction, or discomfort.
• Patients in whom the pacemaker syndrome (atrial ventricular asynchrony), with significant symptoms, has already been experienced with a pacemaker that is being replaced.
• Patients in whom even a relatively small increase in cardiac efficiency will importantly improve the quality of life, e.g., patients with congestive heart failure despite adequate other medical measures.
• Patients in whom the pacemaker syndrome can be anticipated, e.g., in young and active people, etc.”¹

These indications arose from original studies in the 1980s for the use of dual chamber pacing and mainly focused on the presence or absence of pacemaker syndrome. The 2004 NCD did not include data from seminal studies such as the Canadian Trial of Physiologic Pacing (CTOPP) and the Mode Selection Trial (MOST) that identified potential clinical benefits associated with physiologic pacing modes that maintained atrioventricular synchrony. In 2012, the Heart Rhythm Society (HRS) and American College of Cardiology (ACC) published an Expert Consensus Statement on Pacemaker Device and Mode Selection, and in December 2012, formally requested CMS to reevaluate and update the NCD for dual chamber pacemaker coverage. The request emphasized the misalignment between the Medicare coverage policy and current clinical guidelines for the use of dual chamber pacemakers. 

New Revisions to the Pacemaker NCD 

On January 25, 2013, CMS announced that it would open a reconsideration of this policy. After an initial one-month public comment period in which they received 98 separate comments from individual physicians, hospitals, and professional societies, CMS began their evaluation of the NCD.

It is worth mentioning the methodology used in performing an update to a NCD. CMS searched PubMed from February 2004 (date of the last NCD revision) to December 2012 using the key words pacemakers, single and dual. They focused the search on randomized controlled trials and large prospective observational studies that evaluated adults ≥65 years. Small observational studies with sample sizes less than 50 cases, abstracts, and presentations were excluded. Using these criteria, CMS developed an evidence base that included 17 articles (five randomized trials, one randomized controlled comparison, one technology appraisal, one meta-analysis, two evidence reviews, one follow-up analysis of a randomized trial, one registry analysis, one secondary outcome analysis, three evidence-based guidelines, and one consensus statement). CMS published a proposed decision memo² on May 29, 2013 and issued the final decision memo³ on August 13, 2013.

Decision Summary (CAG-00063R3): 

“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:

1. Reversible causes of bradycardia such as electrolyte abnormalities, medications or drugs, and hypothermia. 
2. Asymptomatic first degree atrioventricular block.
3. Asymptomatic sinus bradycardia. 
4. Asymptomatic sino-atrial block or asymptomatic sinus arrest. 
5. Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left atrium) without symptomatic bradycardia.
6. 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).
7. Syncope of undetermined cause. 
8. Bradycardia during sleep. 
9. 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.”³

The new decision summary represents an important fundamental change from prior iterations of the NCD that separated clinical conditions that would be reimbursed for single chamber pacing and dual chamber pacing. The clinician can now choose the appropriate pacemaker type taking individual patient needs into account. For example, an atrial lead generally would not be appropriate for a patient with symptomatic bradycardia and persistent atrial fibrillation, but in the patient the clinician feels will benefit from eventual restoration of sinus rhythm, a dual chamber pacemaker can be placed initially.

It is also useful to compare noncovered indications in the May 29, 2013 proposed decision memo and the August 13, 2013 final decision memo. The final decision summary removed a proposed noncovered indication for pacing after myocardial infarction and removed a specific reference to carotid sinus hypersensitivity. Both of these changes are important because pacing for carotid sinus hypersensitivity has a Class IIa indication for pacing therapy in the 2008 ACC/AHA/HRS device-based therapy guidelines,⁴ and there are two Class I indications for permanent pacing in some patients after myocardial patients, irrespective of symptoms.

Coverage Policy Gaps

Obviously there are a number of conditions that the clinician is confronted with that are not specifically addressed in the final decision summary where pacing therapy is recommended by clinical guidelines (Table 1). For example, patients with asymptomatic third degree AV block or asymptomatic Mobitz II second degree AV block are not explicitly covered in this situation. Another example would be permanent pacing for hypertrophic cardiomyopathy. Although this situation receives a IIa recommendation in the 2008 ACC/AHA/HRS device-based
therapy guidelines,⁴ in the 2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy,⁵ permanent pacing receives a IIb recommendation and applies only to those patients who are suboptimal candidates for septal reduction therapies. For all of these conditions the local coverage contractors will determine coverage, and it is incumbent on the physician to completely document and support the reasoning for permanent pacing and pacing modality in the individual patient.

Conclusions

The goal of any well-orchestrated health policy is to ensure patients’ access to high-quality medical care, and advocate for a productive and sustainable work environment for healthcare professionals. Thanks to a multisociety-led effort in conjunction with thoughtful consideration from CMS, the revised national coverage determination governing pacemakers went into effect on August 13, 2013. Unfortunately, it is not retroactive. However, it is more in line with currently accepted clinical guidelines.

Disclosures: The authors report no conflicts of interest regarding the content herein. 

References

1. National Coverage Determination (NCD) for Cardiac Pacemakers (20.8). CMS.gov. Published April 30, 2004. Available online at https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=238&ncdver=2&NCAId=16&NcaName=Cardiac+Pacemakers&IsPopup=y&bc=AAAAAAAAIAAA&. Accessed October 15, 2013. 
2. Proposed Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3). CMS.gov. Published May 29, 2013. Available online at https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=267. Accessed October 15, 2013. 
3. Decision Memo for Cardiac Pacemakers: Single-Chamber and Dual-Chamber Permanent Cardiac Pacemakers (CAG-00063R3). CMS.gov. Published August 13, 2013. Available online at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=267. Accessed October 15, 2013. 
4. Epstein AE, Dimarco JP, Ellenbogen KA, et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Thoracic Surgeons. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities. Heart Rhythm. 2008;5:e1-62. 
5. Gillis AM, Russo AM, Ellenbogen KA, et al; Heart Rhythm Society; American College of Cardiology Foundation. HRS/ACCF expert consensus statement on pacemaker device and mode selection. Developed in partnership between the Heart Rhythm Society (HRS) and the American College of Cardiology Foundation (ACCF) and in collaboration with the Society of Thoracic Surgeons. Heart Rhythm. 2012;9:1344-1365. 
6. Gersh BJ, Maron BJ, Bonow RO, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011;58:e212-260.