One Lead Forward, Two Leads Back

The year 1985 was a long time ago. Ronald Reagan was sworn into office for his second term as the President of the United States, and Mikhail Gorbachev became General Secretary of the Soviet Communist Party. Microsoft, Inc. released Windows 1.0, and the Ford Motor Company sold its first Taurus. William Schroeder became the first patient to leave the hospital with an artificial heart, and the Food and Drug Administration approved the first blood test for AIDS. Unfortunately, it appears that 1985 was the same year that the Centers for Medicare and Medicaid Services (CMS) last updated its coverage guidelines for dual-chamber pacemakers.

Cardiologists were recently blindsided by denials for payment for dual-chamber cardiac pacemakers by CMS.¹ The basis of the denials was the Comprehensive Error Rate Testing (CERT) audits of patient records using Medicare guidelines for pacemaker coverage effective May 9, 1985 [Publication 100-03, Medicare National Coverage Determinations Manual (NCD), Chapter 1, Part 1, Section 20.8 Cardiac Pacemakers, Group II: Dual-Chambered Cardiac Pacemakers].²  These guidelines include the following criteria for coverage:

1. Patients in whom single-chamber (ventricular pacing) at the time of pacemaker insertion elicits a definite drop in blood pressure, retrograde conduction, or discomfort.
2. Patients in whom the pacemaker syndrome (atrial ventricular asynchrony), with significant symptoms, has already been experienced with a pacemaker that is being replaced. 
3. 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. 
4. Patients in whom the pacemaker syndrome can be anticipated, e.g., in young and active people, etc. 

Who decides whether or not the patient would be expected to have an “important improvement” in quality of life with a relatively small increase in cardiac efficiency? Who defines “young and active”? The following paragraph is also included in the coverage decision: “Dual-chamber pacemakers may also be covered for the conditions, as listed in Group I. A. [criteria for single-chamber pacemakers], if the medical necessity is sufficiently justified through adequate claims development. Expert physicians differ in their judgments about what constitutes appropriate criteria for dual-chamber pacemaker use. The judgment that such a pacemaker is warranted in the patient meeting accepted criteria must be based upon the individual needs and characteristics of that patient, weighing the magnitude and likelihood of anticipated benefits against the magnitude and likelihood of disadvantages to the patient.”³ What does “adequate claims development” mean? It sounds like the process of challenging a denial. Clearly, physician judgment is not being considered in the CERT audits if physicians who have chosen to implant a dual-chamber pacemaker in an individual patient are being denied payment.

Although it is true that practice guidelines related to cardiac pacing have focused on the indications for pacing rather than on which type of pacemaker should be implanted, there is ample evidence that a dual-chamber pacemaker should be the default device for a patient with heart block. A dual-chamber pacemaker is currently the standard of care for the treatment of heart block, unless the patient has permanent atrial fibrillation (AF) or is severely debillitated. Imagine a physician defending himself in a court of law after a patient in whom he implants a single-chamber pacemaker for heart block dies of sepsis three months after an upgrade to a dual-chamber pacemaker for pacemaker syndrome. What would be his defense be — “I was following the 1985 Medicare reimbursement guidelines”?

Much has been learned since 1985 about the benefits of physiological pacing. One of the largest trials on pacemaker selection was the Canadian Trial of Physiologic Pacing (CTOPP).⁴ In this trial, over 2,500 patients were randomized to a single-chamber ventricular pacemaker versus a dual-chamber pacemaker. About 60% of the patients had heart block. Although there was a higher rate of lead dislodgements in the dual-chamber group, and no significant impact of dual-chamber pacing on the primary combined endpoint of death, stroke, or hospitalization for heart failure after three years, there was a significant reduction in AF. Furthermore, patients under 75 years of age had a trend in a reduction in the primary endpoint with a hazard ratio less than 0.7. Importantly, the authors state, “The decision about whether to use a physiologic pacemaker or a ventricular pacemaker should be made on an individual basis.”⁴ Trials are actually ongoing to determine which patients with heart block should receive a three-lead pacing system to provide cardiac resynchronization therapy. Even a majority of patients with sinus node dysfunction should undergo implantation of a dual-chamber pacemaker. In the DANPACE trial, dual-chamber DDDR pacing did not reduce mortality in patients with sinus node dysfunction compared to atrial-based AAIR pacing.⁵ However, patients randomized to dual-chamber pacing had a much lower incidence of paroxysmal AF and half the rate of reoperation, compared with the patients treated with atrial pacing.

The recent Medicare CERT audits that have led to denials of payment for dual-chamber pacemakers based on reimbursement criteria developed in 1985 are unfair and uninformed. The maneuver puts cardiologists on the defensive, and creates frustration and disappointment by those who have put so much effort into conducting clinical trials to determine what is the best pacing system for patients. It now appears that a formal document from a professional society will be needed to prompt a change in the obsolete 26-year-old CMS pacemaker reimbursement guidelines. One step forward, two steps back.

References

1. CERT Alert: Dual-Chamber Cardiac Pacemaker Insertion Denials. https://www.medicarenhic.com/providers/articles/CERT%20Dual%20Cardiac%20Chamber%20Denials.pdf
2. https://www.cms.gov/manuals/downloads/ncd103c1_Part1.pdf
3. “National Coverage Determination (NCD) for Cardiac Pacemakers (20.8)." Centers for Medicare & Medicaid Services. Web. 18 Oct. 2011. https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=238&ncdver=2&NCAId=16&NcaName=Cardiac+Pacemakers&IsPopup=y&bc=AAAAAAAAIAAA&
4. Connolly SJ, for the CTOPP Investigators. Effects of physiologic pacing versus ventricular pacing on the risk of stroke and death due to cardiovascular causes. N Engl J Med 2000;342:1385-1391.
5. Nielsen JC, Thomsen PE, Højberg S, et al; DANPACE Investigators. A comparison of single-lead atrial pacing with dual-chamber pacing in sick sinus syndrome. Eur Heart J 2011;32:686-696. Epub 2011 Feb 7.