How to Prepare for Possible Atrial Fibrillation Ablation Coverage Restrictions

Pulmonary vein isolation (PVI) may be an exciting and rewarding procedure to perform. In many cases, physicians gain the sense that they will improve the patient’s quality of life, reduce the risk of stroke, eliminate some medications, and earn a decent chunk of work relative value units (wRVUs). However, the frequency at which PVI is performed may soon decline.

Electrophysiologists who build up their cardiac rhythm management (CRM) patient population and establish atrial fibrillation (AF) clinics will hedge against imminent downticks in the volume of PVI procedures. They will also position themselves to thrive in the value-based reimbursement environment.

This article illustrates this need from multiple angles:

1. Medicare coverage policy favors CRM, not PVI;
2. Non-invasive treatment is poised to disrupt the PVI business;
3. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) incentivizes non-invasive AF treatment;
4. CRM wRVUs are easier to get than PVI wRVUs;
5. The value of a CRM practice is higher than a PVI practice.

Medicare Coverage

Pacemaker and defibrillator implants have been through intense regulatory scrutiny in recent years. Many hospitals and physicians have had to refund millions of dollars. First, there were penalties for primary prevention defibrillator implants that took place within 40 days of an acute myocardial infarction or 3 months of coronary revascularization. Then, there were penalties for implanting dual-chamber pacemakers in cases where Medicare concluded that only single-chamber pacemakers were indicated. Because of concern and confusion related to these penalties, many patients who need devices have not been referred.

Since the audits, hospitals have instituted checks and balances to address the defibrillator wait periods, Medicare policy has changed to allow physicians to choose single- or dual-chamber pacemakers, and defibrillator indications are poised to expand.

Currently, there is a National Coverage Determination that establishes indications for defibrillators. There are also Local Coverage Articles in which Medicare Administrative Contractors (MACs) have vastly expanded coverage guidelines for pacemakers. There is no official coverage policy for left ventricular leads, but Medicare published a Technology Assessment specific to them.

In the absence of a coverage policy, a Technology Assessment is the most reliable indicator of Medicare’s position on the medical necessity for a service. Specifically, if Medicare or another payer were to question the medical necessity of a left ventricular lead implant, this Technology Assessment would be a safe guideline. 

The Technology Assessment for left ventricular leads establishes, “There is convincing evidence that CRT-D is effective with regard to improvements in multiple clinical outcomes compared to an ICD alone in patients with an LVEF≤35% and a QRS duration ≥120ms. Similarly, there is convincing evidence that CRT-P is effective in improving multiple clinical endpoints compared to optimal medical therapy alone in the same population.”¹

Medicare’s position on PVI is in stark contrast to their position on all of the above classes of CRM devices. There is no National Coverage Determination or Local Coverage Article that establishes coverage for PVI. Like left ventricular leads, there is only a Technology Assessment that provides insight regarding Medicare’s impression. Unlike left ventricular leads, Medicare does not have a positive opinion of PVI.

In their PVI Technology Assessment, Medicare stated: “Regarding the longer-term effect of radiofrequency ablation (RFA) versus medical therapy in the general population, low-strength of evidence suggested no statistical differences between groups in all-cause mortality for people with paroxysmal AF … Regarding the short-term (≤12 months) effect of RFA compared with medical therapy, low strength of evidence suggested no significant differences between groups for all-cause mortality regardless of AF type.”² Medicare also acknowledged the high failure rate of PVI procedures by saying, “Reablation ranged from 0 to 53.8 percent across AF types and time frames.”² 

This Technology Assessment leaves the door open for discussion by suggesting, “There was insufficient evidence to draw conclusions regarding the efficacy, effectiveness, and safety of catheter ablation in the Medicare population,” and that “Studies with sufficient sample sizes are needed to effectively determine whether catheter ablation versus other treatments will benefit certain patient subgroups more than others, and whether there are subgroups in which catheter ablation might best be used as a first- versus second-line treatment.”²

Non-Invasive Treatment

This Technology Assessment, suggesting that some patients may benefit from first-line treatment by means other than PVI, may be a harbinger of PVI treatment barriers to come. Medicare has not yet outlined what alternative first-line treatment options might be required. However, the most promising strategies include treatment of obstructive sleep apnea (OSA), weight loss, and lifestyle modification.

Obstructive Sleep Apnea

• Researchers from the NYU Langone Medical Center conducted a meta-analysis of seven studies, finding that CPAP use was associated with a 42% relative risk reduction in atrial fibrillation recurrence in patients with OSA regardless of their primary treatment.³
• Research from Stevenson et al demonstrated that “Over half of AF patients have significant sleep disordered breathing (SDB) compared with a significantly lower prevalence in an age- and sex-matched control population with other (non-AF) cardiac arrhythmias … Furthermore, in the group with paroxysmal AF, the likelihood of significant SDB was coupled to the AF burden with high-frequency AF associated with a higher prevalence of significant SDB.”⁴ 
• During the American Thoracic Society (ATS) 2017 International Conference, researchers from the University of Ottawa presented their findings from a study evaluating the relationship between OSA and AF, stating, “There is strong biologic plausibility that obstructive sleep apnea may increase the risk of developing atrial fibrillation through a number of mechanisms.” Additionally, the study revealed that there is a significant correlation between the intensity of obstructive sleep apnea (number of events and amount of time with oxygen saturation below 90%) and the incidence of atrial fibrillation.⁵

Weight Loss

• According to a study presented by Pathak et al at the American College of Cardiology’s 64th Annual Scientific Session, “Obese patients with atrial fibrillation who lost at least 10 percent of their body weight were six times more likely to achieve long-term freedom from this common heart rhythm disorder compared to those who did not lose weight.”⁶ 

Lifestyle Modification

• After a systematic and comprehensive literature review, Reed et al concluded that, “short-term chronic exercise training of low, moderate, or vigorous intensity in adults with permanent atrial fibrillation significantly improved rate control.”⁷
• Several other lifestyle changes also appear to prevent and/or treat atrial fibrillation: adhering to a Mediterranean diet, reducing stress, improving sleep quality, limiting alcohol intake, quitting smoking, controlling blood pressure, managing diabetes, and eating dark chocolate.  

Based on the PVI Technology Assessment, Medicare might require patients to fail treatment in an AF clinic prior to qualifying for PVI. AF clinics would focus on facilitating lifestyle modification, identifying/treating OSA, weight loss, and administering appropriate dosages of antiarrhythmic medications for appropriate durations. Those who operate these AF clinics will be the gatekeepers to PVI.

MACRA

Under MACRA, physicians receive bonuses when they provide quality care for less total expense than the average. The costs that are counted against physicians include facility expenses, medication expenses, physician fees, etc. Successfully treating atrial fibrillation in an AF clinic will have a much lower cost than PVI, because there will not be any surgical or facility expenses. Because patients will be chronically followed in an AF clinic, the bonuses associated with high-quality, low-cost atrial fibrillation management will be recurring.

Work RVUs

A typical PVI procedure generates 32.41 wRVUs based on what Medicare estimates is a 7-hour procedure. Defibrillator implants without defibrillation threshold testing generate 14.92 wRVUs based on an estimated 2-hour procedure time. Both of Medicare’s time estimates may be on the high side, but at the current levels, physicians receive 4.63 wRVUs for each hour spent performing PVIs and 7.46 wRVUs for each hour spent implanting defibrillators — that’s a 61% premium!

The RVUs generated after a CRM procedure are more impressive than the premium assigned to the procedure itself. Following a PVI procedure, an electrophysiologist might not receive any additional compensation for taking care of the patient. A defibrillator patient will typically be seen in the office for a visit and a device check twice a year, and have remote monitoring billed four times a year. These routine services add up to 10.46 wRVUs ($765 in professional fees) per year, per patient.

The recurring revenue described above can be earned, in large part, by ancillary staff and mid-level providers. Because of this, physicians can earn exponentially more while working fewer hours. Additionally, the amount of radiation exposure and time spent wearing a lead apron to earn each CRM related wRVU is substantially less than each PVI-related wRVU. 

Practice Value

While valuation specialists calculate the value of a physician’s practice from many angles, cash flow is king. A CRM-intense practice has an established revenue stream that will seamlessly transfer to the purchaser. This includes routine patient management of about $765 per year per patient, and the generator change outs and system upgrades that will be required. This helps to bolster a high valuation.

In contrast, a PVI-intense practice has much less recurring revenue that will seamlessly transfer to the purchaser. Because PVI work is non-recurring in nature, the earning potential of the practice is limited to the purchaser’s ability to secure and maintain referral relationships. This unknown variable will drive down the value of the practice.

Summary

Electrophysiologists should brace for possible Medicare policy changes that would restrict their ability to perform pulmonary vein isolation. Establishing atrial fibrillation clinics and growing cardiac rhythm management device service lines will position physicians for financial and clinical success.

Jim Collins, CPC, CCC is the President of CardiologyCoder.Com, Inc. He provides annual compliance services (auditing & education) and he spearheads the Cardiology Billing Center of Excellence for multiple billing companies dedicated to the unique needs of cardiology practices and service lines. Jim also posts insightful articles specific to his field on Twitter: @CardiologyCoder

References

1. Rickard J, Michtalik H, Sharma R, et al. Use of Cardiac Resynchronization Therapy in the Medicare Population. Technology Assessment Report. Project ID: CRDT1013. CMS.gov. Published March 24, 2015. Available online at https://go.cms.gov/2rSVhFG. Accessed June 12, 2017.
2. Skelly A, Hashimoto R, Al-Khatib S, et al. Catheter Ablation for Treatment of Atrial Fibrillation. Technology Assessment Report. Project ID: CRDT0913. CMS.gov. Published April 20, 2015. Available online at https://go.cms.gov/2tdRiBj. Accessed June 12, 2017.
3. Atrial Fibrillation Recurrence Lower with CPAP. Sleep Review. Published April 20, 2015. Available online at https://bit.ly/2rbsRnt. Accessed June 12, 2017.
4. Stevenson IH, Teichtahl, H, Cunnington D, Ciavarella S, Gordon I, Kalman JM. Prevalence of sleep disordered breathing in paroxysmal and persistent atrial fibrillation patients with normal left ventricular function. Eur Heart J. 2008;29(13):1662-1669. 
5. Sleep apnea may increase atrial fibrillation risk. EurekAlert! Published May 22, 2017. Available online at https://bit.ly/2qcSWC2. Accessed June 12, 2017. 
6. Casteel B. Losing Weight Substantially Reduces Atrial Fibrillation. ACC.org. Available online at https://bit.ly/2suyK2O. Accessed June 12, 2017.
7. Reed JL, Mark AE, Reid RD, Pipe AL. The effects of chronic exercise training in individuals with permanent atrial fibrillation: a systematic review. Can J Cardiol. 2013;29(12):1721­1728.