The Ascendance of CRT-P April 16, 2013Posted by Craig Delaughter, MD, PhD in Cardiac Rhythm Management, Health Policy.
Tags: Centers for Medicare and Medicaid Services, Clinical trials, CMS, Pacemakers
Many implanting physicians are frustrated by the current Centers for Medicare and Medicaid Services (CMS) National Coverage Decision (NCD) regarding single versus dual chamber pacemakers. Last updated in 1985, the NCD often permits only a single-chamber pacemaker when the generally accepted standard of care is to implant a dual-chamber device. This has resulted in more frequent denials for payment both to physicians and to hospitals. Many hospitals have responded by requiring physicians to complete an algorithmic, bureaucratic form justifying every dual-chamber pacemaker implant (click here to see an example).
As an ethical physician, acting in the best interest of my patient, I complete this form every time a dual-chamber pacemaker is needed. I expect most physicians do the same. If we are still implanting a dual-chamber device in the same patients we did prior to these forms’ appearance, what purpose do these forms serve? I suppose some patients who might have benefited from atrio-ventricular synchrony are now receiving single chamber pacemakers as a result of this form, but surely providing a lower quality of care to patients was not CMS’ intention.
Thanks to the efforts of the Heart Rhythm Society and the American College of Cardiology, the pacemaker NCD should be updated this year. CMS has stated that their proposed NCD should be available July 24, 2013 with implementation perhaps by October.
Simply updating the NCD to be more accepting of dual chamber pacing may no longer be adequate. We need to consider several significant studies that, taken together, should advance Cardiac Resynchronization Therapy (CRT) to first line treatment for many pacemaker patients.
It has been nearly a decade since Post-AV Nodal Ablation Evaluation (PAVE) Trial demonstrated that CRT, when compared to RV pacing, preserved LV systolic function in complete heart block patients with an LVEF of <= 45%. The Dual Chamber and VVI Implantable Defibrillator (DAVID) and Mode Selection Trial in Sinus Node Dysfunction (MOST) have also shown that more frequent RV pacing leads to undesirable clinical consequences.
Those of you that attended AHA this year saw the results of the Biventricular versus Right Ventricular. Pacing in Patients with Left Ventricular Dysfunction and Atrioventricular Block (BLOCK-HF), a study that I believe will lead to a change in how most patients with a need for significant ventricular pacing should be treated. BLOCK-HF randomized patients with class I-III CHF, a left ventricular ejection fraction (LVEF) of <=50% and a need for significant ventricular pacing to CRT or RV pacing. The CRT arm demonstrated a statistically significant 26% reduction in its composite endpoint of mortality, HF related urgent care and increase in LVESVI.
While it will take some time for CRT pacing for patients with near-normal LVEFs to be incorporated into our device therapy guidelines, or even the newly created appropriate use criteria, we should begin educating our cardiology, cardiothoracic surgery and primary care colleagues now. I am already looking forward to yet more pre-procedure paperwork and post-procedure letters of medical necessity. Perhaps one of you could upload a form letter we could use? My patients and I thank you in advance!
Craig Delaughter, MD, PhD, FACC, FHRS
Fort Worth, Texas