Johnson & Johnson MedTech's Michael Bodner on How CMS Reimbursement Expansion Will Accelerate PFA Adoption in Ambulatory Surgery Centers

Last month,United StatesMedical InsuranceAnd the Medical Assistance Service Center (CMS)Cardiac catheter ablation for the treatment of atrial fibrillation has been included in the list of covered Ambulatory Surgery Center (ASC) procedures. Prior to this, numerous stakeholders had been actively advocating to offer ablation services within the rapidly growing ASC setting. This decision will take effect on January 1, 2026.

ASCs Provide Same-Day Outpatient Care, Offering a Potentially More Convenient and Cost-Effective Option. As ASCs Become IncreasinglyPopularizing, companies in multiple fields such as orthopedics and surgical robots are currently targeting the ASC market with their products.

With the policy push for PFA technology, current leaders in the pulsed field ablation space—Medtronic, Boston Scientific, and Johnson & Johnson—are likely to benefit significantly. Johnson & Johnson's Varipulse platform has entered the U.S. PFA market following its FDA approval by the end of 2024.

For this reason, the U.S. media reported onInterview with Michael Bodner, Chairman of Johnson & Johnson Medical Technologies' Electrophysiology and Neurovascular Business Group,Michael BodnerExplained how this decision by CMS will push PFA forward.

Interview Content:

1. What is the significance of this CMS decision?

Michael Bodner replied: 

CMS approval reinforces strong clinical evidence that cardiac ablation procedures can be performed safely by well-trained electrophysiologists in well-equipped ASCs. Johnson & Johnson is uniquely positioned to support ASCs. Our flexible product portfolio allows for the treatment of a wide range of patient types, offering a fully integrated suite of products with capabilities unmatched by other companies, proven safety, and robust clinical support—all of which are particularly crucial in the ASC environment.

We are able to offer integrated RF ablation, PFA, ultrasound, and 3D mapping technologies, providing electrophysiologists and their patients with comprehensive solutions. Our experienced clinical team gives us the scale and expertise to collaborate with hospitals and ASCs across the market.

We are confident in collaborating with ASCs across the U.S. to help ensure the delivery of safe, efficient, and cost-effective medical care. This is an important step in expanding access to treatments and supporting the overall healthcare system.

2. ASCs are becoming increasingly popular in the medical technology field. What are the benefits of this environment?

Michael Bodner replied: 

ASCs Provide an Efficient Treatment Environment, Often Reducing Wait Times and Eliminating the Need for Overnight Stays, Allowing More People to Access Necessary Care, Which Can Lead to Higher Overall Patient Satisfaction.

Same-day discharge is a core requirement of ASC, and our proven portfolio of solutions can support this need. A good example is a recent subgroup analysis from the admIRE trial, which examined same-day discharge following pulsed field ablation using our Varipulse platform. This is the only study to date within an Investigational Device Exemption (IDE) trial that has demonstrated the safety and efficacy of the platform, with same-day discharge outcomes comparable to overnight stays.

When we turn to real-world evidence, the REAL-AF registry reflects this trend, with recently published data showing that 84.6% of patients who underwent ablation using the Varipulse platform were discharged on the same day as their procedure. This is exactly the patient-centered progress we are committed to driving, providing electrophysiologists with the tools to deliver safe and efficient arrhythmia treatment wherever they are.

3. Is ASC an important part of the future of medical technology?

Michael Bodner replied:

ASCs Are a Key Component of the Future of Medtech and Are Already Transforming How Care Is Delivered. As more procedures shift to the efficient outpatient setting, ASCs are becoming a major part of the medtech landscape. They are driving demand for simpler, more cost-effective equipment optimized for streamlined environments.

Our integrated product portfolio offers unique advantages by providing physicians with the necessary tools to deliver safe, efficient, and economically sustainable arrhythmia treatment in the ASC environment, thereby supporting high-quality and safe healthcare.

Varipulse has promising growth and success prospects in the ASC environment due to its excellent safety, precise and durable lesion formation capabilities, and efficient workflow. It also offers competitive advantages such as zero fluoroscopy, no need for general anesthesia, and same-day discharge, which we anticipate will drive its adoption in the ASC setting.

4. Regarding cardiac ablation, what is the current proportion of surgeries in ASCs? How much growth do you anticipate?

Michael Bodner replied:

We are at a turning point. Currently, compared to the hospital environment, the number of cardiac ablation procedures performed in ASCs is very low, but we anticipate significant growth once the CMS decision is implemented. Customers who are already performing ablations in ASCs have recognized the value of our Carto system and integrated catheters. With the change in federal policy, we expect broader adoption to occur, driven by the efficiency, safety, and workflow advantages offered by our platform—especially as more physicians and patients seek the benefits provided by the ASC setting.

At Johnson & Johnson Medical Technology, we are deeply involved and prepared to support them by ensuring safe and effective application through clinical education, staff training, workflow planning, and technology integration. Patient selection will remain critical, and healthcare providers will continue to choose the best treatment environment for each patient. But the ultimate outcome is clear: more flexibility for clinicians and more treatment opportunities for patients.

5. Is there anything else you would like to add about Johnson & Johnson Medical Technologies' cardiac ablation business, ASC, or both?

Michael Bodner replied:

We are optimistic that expanding Medicare coverage for ASCs will help improve patient access to treatment while reducing the cost to the healthcare system.

For more than 30 years, Johnson & Johnson Medical Technology has been a leader in advancing the treatment of arrhythmias. Our commitment to progress in this field is reflected not only in our deep scientific expertise and comprehensive support but also in the flexibility of our technology. We are uniquely positioned to integrate diagnostic, mapping, and therapeutic solutions, providing electrophysiologists with flexibility and confidence, particularly in the ASC environment.

As the industry landscape continues to evolve, we will keep providing tools, training, and support to ensure that every clinical setting and every patient has access to safe, efficient, and sustainable arrhythmia treatment. We remain committed to ensuring that our innovations and best practices are fully adaptable to the ASC environment, helping healthcare providers expand treatment accessibility and improve outcomes for more patients.