Catheter Ablation: From Converting Atrial Fibrillation to Converting Nonbelievers
The Center for Medicare & Medicaid Services (CMS) currently does not have a national coverage policy for reimbursement of catheter ablation of atrial fibrillation (AF). In the absence of national policy, coverage is at the discretion of local Medicare contractors. As a data gathering exercise, Medicare called for a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on October 21, 2009. The objective was to discuss the adequacy of the available evidence for the use of catheter ablative techniques to treat patients with AF. This meeting was held with the background that efforts are underway to develop a national registry for AF ablation analogous to the National Cardiovascular Data Registry (NCDR) Implantable Defibrillator Registry.
The daylong meeting was held at Medicare Headquarters in Baltimore, Maryland. Several presentations were made by physicians and industry representatives to a panel composed of electrophysiologists, a cardiac surgeon, a nurse, and Medicare representatives. Predetermined discussion points addressed what are the appropriate clinical comparison groups, which types of AF should be treated with catheter ablation, should ablation be first- or second-line therapy, what are the outcomes of interest, and what is the available evidence to assess these outcomes. Additional issues that were discussed were related to the devices that are currently available to perform AF ablation and physician training.
The first speaker was Dr. Yves Rosenberg, Acting Branch Chief, Atherothrombotic and Coronary Artery Disease Branch, Division of Cardiovascular Sciences, NHBLI/NIH. He set the stage for the day by reviewing the problem of AF and the therapeutic options that are currently available. His presentation emphasized the importance of the arrhythmia in the aging Medicare population.
A systematic review of the literature related to catheter ablation for AF was presented by a group from Yale. Criteria to be considered for grading were stringent, with only 120 of 400 publications satisfying criteria. They concluded the following.
1. There is moderate evidence to support the use of catheter ablation as a second-line therapy, with data to 12 months of follow-up.
2. The data on ablation as a first-line therapy is insufficient.
3. Complications occur less than 5% of the time.
4. More data is needed regarding long-term follow-up after 12 months and outcomes in Medicare age patients. They pointed out that although AF predominantly affects an older population, the median age of patients in clinical trials is only about 55 years.
Following these presentations, six public speakers were given seven minutes each to present to the panel. Speakers included electrophysiologists and representatives from industry. Drs. David Wilber and Hugh Calkins presented for the Heart Rhythm Society (HRS). They carefully reviewed the clinical trials that support the current societal recommendations that AF ablation is acceptable therapy when a rhythm control strategy is chosen for patients with symptomatic, refractory AF. Dr. Calkins often pointed to the HRS consensus statement on AF ablation.1
Representing the American College of Cardiology, I tried to address that in our field, the physician referral process itself is an important safeguard when new therapies become available. For example, before patients undergo AF ablation, they have usually been referred from an internist to a cardiologist to an electrophysiologist. The electrophysiologist is often outside the cardiologist’s practice. This referral process is important, because a cardiologist will not continue to refer patients for a new therapy such as AF ablation if it is the experience of the referring physician that the therapy is ineffective. This system also provides a screening process that leads to better patient selection. Three messages were sent: AF can be debilitating, there are major limitations of available medical therapies, and there is evidence to support the safety and efficacy of catheter ablation for refractory AF. The following points were made in an effort to support these messages.
1. At least two million Americans have AF. There is significant morbidity and mortality associated with AF.
2. There are significant limitations to currently available antiarrhythmic drugs, including the need to hospitalize patients for drug initiation. Dronedarone is the first new antiarrhythmic drug in ten years, not because available therapies are adequate, but because it is challenging to develop a drug to normalize the atrial rhythm selectively without causing ventricular proarrhythmia or other side effects. Even this newest drug, dronedarone, comes with a black box warning against its use in patients with severe heart failure.
3. There is no dispute that catheter ablation can eliminate AF in some patients with refractory and debilitating AF. This is not worthy of debate. The real questions now are how durable the results are, how often a successful result is achieved, and in which patients is the risk/benefit in favor of ablation.
4. The risks of the procedure are well characterized at this point, and include vascular access complications, stroke, pulmonary embolism, tamponade, atrial-esophageal fistula, phrenic nerve damage, iatrogenic atrial flutter, and death.
5. There is guidance from professional societies related to physician training and proficiency.1
6. Ablation is a reasonable second-line treatment option for patients with and without structural heart disease based on society guidelines. There has been much data published on the topic since the 2006 guidelines, and a focused update of the guidelines is underway.
7. Ablation for AF is performed internationally. Patients with AF should continue to have access to this therapy in the United States. Without the availability of catheter ablation, many patients with refractory AF will be referred for less desirable alternatives such as atrioventricular junction ablation and pacemaker implantation.
There was a background concern amongst some panel members that if CMS makes a national coverage decision in support of reimbursing AF ablation, that this therapy will suddenly be unleashed and cause harm to elderly patients. This concern is unfounded. AF ablation has been reimbursed by most local CMS carriers for over a decade. It is very unlikely that a national coverage decision would lead to anything more than a much needed predicable and uniform policy.
There was also a discussion of the possibility of determining that AF ablation can be reimbursed as long as patients are enrolled in a mandatory national registry — “coverage with evidence development.” There was mixed support for a national AF ablation registry. In the opinion of several participants, it is unlikely that such a registry would be worth the time and effort required to gather the data. A registry would not be able to answer the remaining questions related to AF ablation nearly as well as well-designed randomized trials would. To get the type of information that a registry might be able to provide, other approaches that take advantage of existing CMS databases should be considered. A useful suggestion to make it easier to follow Medicare patient outcomes after AF ablation was to modify the current billing codes so that AF ablation procedures could be differentiated from other types of supraventricular tachycardia ablations.
After a long day of reviewing the literature and discussing the available data, it was clear that many panel members felt that more data is needed to determine the safety and efficacy of AF catheter ablation specific to the Medicare population. To us believers, it seems that there is far more evidence to support AF ablation than many other commonly used therapies in other fields of medicine. However, it looks like we still have a lot of work to do to convert CMS decision makers into believers.