Pulsed Field Ablation Insurance Coverage

I'm a U.S. citizen living and working in the Middle East; 69 years old with lone Afib (paroxysmal) since 2005; largely asymptomatic until 2019.

I'm an amateur (non-competitive) endurance runner (one marathon or ultramarathon per year), and in 2019 the Afib started to affect my training. It's gotten progressively worse over the past four years, so I've decided to take my EP's advice and go for a catheter ablation.

The closest ablation clinics with experienced and reputable EPs are in Germany, and all of the clinics I have found there are mostly offering pulsed field ablation (PFA) using Boston Scientific Farapulse technology. This suits me fine, since I am convinced that PFA is the way to go, in terms of its high efficacy combined with a lower risk of adverse outcomes. I really don't want to undergo RF or cryoballoon ablation if I can avoid it.

While Farapulse is approved and already mainstreamed in the European Union, in the U.S. it is still in clinical trials. FDA approval of Farapulse is fully expected, but not until the second half of 2024.

I have a platinum U.S. health insurance policy that will fully cover me for an ablation procedure in Germany, but I'm concerned that it may not pay a claim for a procedure using Farapulse technology since it is not FDA approved.

I have not asked my insurer about this yet, because I don't want to risk getting the "wrong answer" on the record, in case there is a way around this potential problem.

Does anyone have experience with U.S. health insurance coverage (or not) for a pulsed field ablation procedure using a non-FDA approved technology such as Farapulse?

I would be most grateful for your advice. Thanks.

I would think that if you have a plan that will cover procedures outside the US, they would use the host country's approval rather than the FDA's. Using the FDA to determine what a non-US doctor can do would lead to all sorts of sticky problems. I don't think calling them and asking is going to have any negative consequences, and I think ultimately you're going to have to anyway.

Thanks Carey for your prompt response, which makes good sense. I'll proceed and see what happens. Worst case I'll just have to wait until next year when (presumbably) FDA approves Farapulse. Thanks again!

MG,
You're lucky you were able to put this off until better technology came along. As good as some EPs can be with the tools of the last 20 years, I believe one day this period of "you had someone burn the inside of your heart with a f'ing soldering iron???" will be a WTF medical embarrassment equivalent to frontal lobotomy.

You and everyone else are fortunate to be able to 'pick' and choose between the procedures available today.

[www.nzherald.co.nz]

Sidenote, I've been offered employment in the Middle East several times and the salaries were outrageously high (300-500k) 20+ years ago but the conditions were equally outrageous. Live in a compound, 14+ hour days, 6 days a week, no 'vices' (you know what I mean) and 2 weeks off shore to what seemed to be Las Vegas style oil rigs where anything and everything goes. Bottom line, a PFA should be a rounding error financially even w/o insurance or am I missing something?

Thanks KingFizzy. I agree with you about the brute force aspects of RF and cryo ablation. It's great that three science and engineering are progressing.

Re. working in the Middle East, I'm not in the oil and gas sector, so the cost of the ablation is not going to be chump change for me. I definitely need the insurance coverage in order to be able to afford this.

Epilogue on my quest for U.S. health insurance coverage for a PFA performed outside of the U.S. The procedure specified by my insurance provider was as follows:

-- Obtain a "letter of medical necessity" from my primary EP making the case for me to undergo catheter ablation. The letter did not specify the type of catheter ablation or the provider - only that I was a good candidate for undergoing the procedure.

-- Obtain a "plan of care" letter from my proposed ablation provider (Dr. Boris Schmidt, CCB Privatklinik, Frankfurt, Germany) outlining what services he will provide. In the letter Dr. Schmidt mentioned that he would "perform a catheter ablation... using pulsed field ablation." (emphasis added)

-- Submit both letters to my insurer for "pre-determination approval."

The critical step in the pre-determination approval process was a "clinical review," which I assume entailed review of the two letters by medical experts retained by the insurance provider to assess my case and certify that both my medical requirement and the proposed solution are legitimate, and thus can be covered by my policy.

It took several weeks and some prodding by me, but they finally said "yes" - with no push-back or even any questions regarding the proposal to use PFA technology. I didn't bring it up, and neither did the insurance company. Whew!

Schmidt's clinic found a slot for me this week, so I'm off to Frankfurt tomorrow (December 19), with the procedure scheduled for December 21. They are telling me that it will be done on an outpatient basis, i.e., I'll report to the clinic at 7am on the 21st, and if all goes well I'll be out by late afternoon of the same day. We'll see...

Thanks again to everyone who brainstormed the potential insurance issue with me.

Now I need to get my head around the ablation procedure itself, i.e., what to expect, and how to maximize the chances of success. I have made it clear to the clinic that I am seeking much more than an anatomical “PVI-only” ablation, and moreover that my objective is to achieve durable freedom from ALL atrial arrythmias, including not only PV-triggered atrial fibrillation, but also any and all arrythmias triggered in other parts of both the left and right atria, away from the four pulmonary vein antrum area. I have also requested that they perform extensive real-time electrophysiology investigations to find, disable, and confirm bi-directional block of all ‘Non-PV’ triggers.

I would be most grateful for any further advice. Thanks.

Following is a long overdue update on my quest to undergo a PFA in Germany - my first (and so far only) ablation.

Mission accomplished on 21 December 2023 in Frankfurt am Main, Germany, and it was textbook perfect. The PFA was performed by the CCB Privatklinik team led by Prof. Dr. Boris Schmidt and Prof. Dr. Julian Chun, employing Boston Scientific's Farapulse technology. It was an amazingly positive, utterly satisfying experience in every way. I honestly can't praise Profs Schmidt and Chun and their team enough. I have never received this level of quality care and attention from any medical provider before. I am a physical scientist by training, and I ask a LOT of questions. Profs. Schmidt and Chun were endlessly patient and accommodating, and very generous with their time and attention. CCB Privatklinik averages six (6) ablations per day year round, yet I honestly felt like I was their only patient. It was simply that good.

CCB Privatklinik (https://ccb-privatklinik.de/en/) is associated with Agaplesion Markus Hospital in Frankfurt, and they welcome international patients like me. I'm a U.S. citizen currently based in Egypt.

I was on the ground in Germany for three days. Day 1: Arrived from Egypt; checked into my hotel; and proceeded to the clinic for two hours of consultations and pre-procedure tests. Day 2: Reported to the clinic at 7 AM (on outpatient basis) for the procedure; in the cath lab from 9 - 11:30 AM for the PFA, followed by bed rest until 3 PM, and then Uber back to my hotel. Day 3: AM: one hour appointment for a post-procedure checkup and tests. PM: Sightseeing and shopping in Frankfurt - on foot. Day 4: Flew back to Cairo.

On doctor's orders I went off Flecainide and Metoprolol starting the day of the procedure, and because I've been in constant NSR since the procedure (21 December 2023) my CHA₂DS₂-VASc score is down to 1 (due to age only), so on doctor's orders I stopped the anticoagulant (Apixaban) on 19 February 2024.

Privatklinik's administrative procedures (paperwork and payment) were straightforward and simple - MUCH easier than in the U.S. There were only a few forms to fill out before the procedure. I had paid the estimated cost (EUR 15,000) in advance by wire transfer, and on the day after the procedure I was given an itemized invoice for the services rendered, plus a refund for the difference between my advance payment and the actual cost (which turned out to be lower than the estimate). I promptly filed a claim with my U.S. medical insurance policy (underwritten by Aetna) and they reimbursed me 90 percent of total amount I had paid Privatklinik. So at the end of the day I was about $1,500 out of pocket for the procedure, plus the cost of round trip airfare from Cairo to Frankfurt and hotel/meals/taxis for three days in Germany. Not bad.

All in all, my PFA experience was roughly comparable to undergoing a bit of serious dental work - except for the air travel and hotel stay, and the fact that it was completely painless!

I know it's still early days (only two months out from the procedure), but knock on wood I haven't felt even the slightest quiver in my chest since 20 December 2023 - the day before the procedure, i.e., no "blanking period." It's been NSR all the way since the moment I woke up from the procedure on 21 December. My smartwatch is configured to alert me if I go into afib, but so far nothing. Nevertheless, I'm continuing to rigorously follow all of my afib-busting healthy lifestyle interventions, including but not limited to: no alcohol, tobacco, sugar, caffeine; following a Mediterranean, plant-based diet, 16:8 intermittent fasting 365 days/yr; at least 7 hours of quality sleep per night; 4 hours of vigorous exercise (road/trail running and resistance training) per week; and strictly following the metabolic cardiology supplementation strategy recommended by Jackie Burgess.

So we'll see what happens. If anyone would like any further details or advice based on any aspect of my PFA experience I would be happy to help. Please let me know.

Thanks again to all those who responded to my previous posts and encouraged me along the way. So far it has turned out to be one of the best things I've ever done for myself.

Wow, great outcome and great story! Could be very helpful to our European followers. If you want to copy and paste this to a new topic so it appears on page 1 that would be fine with me. This is an old thread so it appears on page 5 or something like that, so most people won't see it.

I know to look back several pages about once ever few weeks to see if I can offer something, even encouragement, to someone who bothered tor report something of their recent history. So, yeah, it's well past the 'best before' date, but I am happy you are doing well. If you see this, could we have a small update. Even a thumb up?