The 2012 HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection: Trying to Keep the Medicare National Coverage Decisions Current

Bradley P. Knight, MD, FACC, FHRS
Editor-in-Chief, EP Lab Digest

Bradley P. Knight, MD, FACC, FHRS
Editor-in-Chief, EP Lab Digest

It has been the standard of care for many years now to implant a dual-chamber pacemaker in most patients with bradycardia in the absence of permanent atrial fibrillation. Such evidence-based practice is consistent with the medical literature. Despite this, local Centers for Medicare and Medicaid Services (CMS) providers continue to audit physician practices using the Comprehensive Error Rate Testing (CERT) audits1 to deny payment for implantation of dual-chamber pacemakers based on obsolete Medicare guidelines for pacemaker coverage that dates back to 1985.2 My November 2012 editorial in EP Lab Digest® was devoted to this topic. These audits have also continued despite requests by the Heart Rhythm Society (HRS) in April 2011 to halt the audits until the National Coverage Decision has been reviewed.3 In this request, it is accurately stated that “If a physician adheres to a determination made twenty-six years ago, to ensure payment and avoid the accusation of Medicare fraud, he or she may be forced to provide substandard care to patients, with the potential to cause them harm and to trigger medical-legal action.”3

Fortunately, the Heart Rhythm Society has just published an expert consensus statement on pacemaker device and mode selection.4 While the document is not a formal guideline, the consensus document uses the same classifications for indications and level of evidence that are used in guidelines, and makes recommendations that were agreed upon by at least 81 percent of the writing committee. The consensus statement is intended to supplement the most recent ACCF/AHA/HRS guidelines related to pacemaker implantation that were updated in 2008, by providing indications for the pacing mode for patients who have already been determined to have an indication for pacing. The class I indications related to pacemaker mode selection are as follows:

  1. Dual-chamber pacing (DDD) or single-chamber atrial pacing (AAI) is recommended over single-chamber ventricular pacing (VVI) in patients with sinus node dysfunction (SND) and intact atrioventricular (AV) conduction (Level of Evidence: A).
  2. DDD pacing is recommended over AAI pacing in patients with SND (Level of Evidence: B).
  3. DDD pacing is recommended in patients with AV block (Level of Evidence: C).
  4. Single-chamber ventricular pacing (VVI) is recommended as an acceptable alternative to DDD pacing in patients with AV block who have specific clinical situations that limit the benefits of DDD pacing. These include, but are not limited to, sedentary patients, those with significant medical comorbidities likely to impact clinical outcomes, and those in whom technical issues, such as vascular access limitations, preclude or increase the risk of placing an atrial lead (Level of Evidence: B).
  5. DDD pacing is recommended over VVI pacing in adult patients with AV block who have documented pacemaker syndrome (Level of Evidence: B).

The document goes on to state that DDD pacing or AAI pacing should not be used in patients with AV block in permanent or longstanding persistent AF, in whom efforts to restore or maintain sinus rhythm are not planned (Level of Evidence: C).

The new consensus statement regarding pacemaker mode selection is supported by the last two decades of pacing literature and is in line with current practice. Unfortunately, the recommendations reflect what has already been the standard of care for over two decades. Perhaps the wording in the document would have been more accurate if a class I indication was defined as a condition “for which there has long been evidence…” instead of “for which there is evidence … that a given pacing mode is beneficial, useful and effective.”4

In June 2012, an owner of multiple Chicago-area outpatient surgery centers was arrested on federal fraud and tax charges alleging that he paid bribes and kickbacks to physicians for patient referrals.5 Clearly the government must continue to doggedly seek out fraud related to the practice of medicine. However, trying to nail physicians for implantation of dual-chamber pacemakers in patients with complete heart block using outdated 1985 guidelines is barking up the wrong tree. Let’s hope that the new HRS consensus document on pacing mode stops the rabid madness.

References

  1. CERT Alert: Dual-Chamber Cardiac Pacemaker Insertion Denials. <http://www.medicarenhic.com/providers/articles/CERT%20Dual%20Cardiac%20Chamber%20Denials.pdf>.
  2. Medicare National Coverage Determinations Manual: Chapter 1, Part 1 (Sections 10 – 80.12). Coverage Determinations. <http://www.cms.gov/manuals/downloads/ncd103c1_Part1.pdf>.
  3. Packer, Douglas, MD. “RE: National Coverage Determination, Cardiac Pacemakers, Pub. 100-03, 20.8 Dual Chamber Pacemaker Placement in Medicare Beneficiaries.” Letter to Donald Berwick, MD, MPP. 22 Apr. 2011. Heart Rhythm Society. Web. 15 Aug. 2012. <NCDCardiacPacemakersFinaltoCMS-3.pdf>. 
  4. Gillis AM, Russo AM, Ellenbogen KA, et al. 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.
  5. Raghuveer Nayak, Owner of Area Surgery Centers, Charged with Fraud and Tax Offenses for Allegedly Paying Physicians Hundreds of Thousands of Dollars in Bribes for Patient Referrals. United States Attorney’s Office - Northern District of Illinois, 20 June 2012. Web. 14 Aug. 2012. <http://www.justice.gov/usao/iln/pr/chicago/2012/>.
To see Dr. Knight's editorial from last month, please visit: http://eplabdigest.com/articles/ASSERT-Trial-%E2%80%93-Another-Example-Less-More