Dr. Stephen Scionti is a board-certified urologist who specializes in prostate cancer treatment and treats record numbers of patients at his practice, the Scionti Prostate Center.

Headshot SciontiHe opened the Center in 2014, just before the US Food & Drug Administration (FDA) approved two high-intensity focused ultrasound (HIFU) transrectal devices: SonaCare Medical’s Sonablate and EDAP’s Ablatherm. Beyond HIFU, Dr. Scionti offers a full range of diagnostic services, including MRI fusion targeted prostate biopsy, and treatment with Profound Medical's transurethral, MRI-guided ultrasound ablation (TULSA-PRO) device, which was approved in the US in 2019. Dr. Scionti is also the Medical Director for Vituro Health, a teaching and training network for physicians.

We spoke with Dr. Scionti about the successes and challenges he has experienced in his commitment to pursuing reimbursement for his prostate patients and learned why he is more optimistic than ever about this goal.

Can you describe the reimbursement landscape for prostate patients who may be unfamiliar with it?
Understandably, every single patient asks about reimbursement, and it can be a complicated process. Let’s talk about HIFU as an example. To date, there’s been no official universally honored code for reimbursement for treating a prostate cancer patient with HIFU. About two and a half years ago, Medicare did issue a “C-code,” which is a temporary code that a facility such as a hospital or surgery center can use to bill Medicare for the technical components – hospital and facility costs, for example – of doing a procedure. The idea being that Medicare will then use that information to formulate a permanent reimbursement code at some point.

Complicating the matter, Medicare does not generally issue a national coverage decision. Medicare coverage in the US is divided into 12 regional MACs that are tasked with administering local Medicare plans. Each MAC has individual discretion to decide whether or not to pay that code. Thus far, the majority of them have not reimbursed that code.

My experience practicing in Florida has been better. Because we do so many treatments here, we have submitted hundreds of codes for HIFU through our local MAC, and they have been honored. This means that the hospital component of the procedure is covered, and that has given our Medicare patients a huge advantage in the Florida market. Patients will travel to Florida from all over the country to take advantage of this.

What can you tell us about the new Current Procedural Terminology (CPT) code for transrectal HIFU?
This is really exciting. A CPT code is a code that's not put out by Medicare, but rather by the American Medical Association (AMA). The AMA decided in 2020 that it would formally create a CPT code for transrectal HIFU treatment to the prostate, and that code goes into effect in just a few months, on January 1, 2021. That’s really big news. It allows for a permanent code from which both a hospital and a physician can bill any private insurance company, and that insurance company or Medicare would know exactly what the procedure was (which can facilitate an approval for payment). Without that, we’ve had to bill with unlisted codes, and those never get paid. So, January begins a whole new chapter for focused ultrasound treatment of prostate cancer; we are now on a path that will ultimately lead to reimbursement.

I do want to clarify that having the mechanism in place to do this, and having them actually pay the reimbursement, are two different things. As of now, Medicare has not yet issued a National Coverage Decision (NCD) on the new CPT code. An NCD of a CPT code means that every Medicare insurance contractor must abide by it and must pay it. In the absence of the NCD, then it's still at their discretion.

For example, the Medicare MAC in Florida is called First Coast Servicing. It has not yet made a determination as to whether it is going to honor the CPT code come January, but at least the code is there, and it allows physicians, hospitals, and surgery centers to attempt to bill Medicare and the commercial insurance companies. That’s progress. As time goes on – as more data are published on HIFU – we will see more positive reimbursement events. I predict that eventually, Medicare will issue an NCD.

How has reimbursement affected your practice as a clinician?
I do a lot of procedures. Between HIFU and TULSA-PRO this year, even with the pandemic, I'll perform approximately 225 procedures. So certainly, there are patients out there who have found a way to afford this. But in terms of applying focused ultrasound across all patients who could benefit from it, it’s been extremely limiting. In my opinion, up to half the patients diagnosed today for prostate cancer could be well treated with focused ultrasound. That's potentially more than 100,000 procedures a year. But obviously we're seeing a very small percentage of that because there's a huge financial barrier to treatment. And that’s a shame.

My position as a clinician is that we're going to work with our patients to appeal their insurance company’s denial of coverage on every single case. Because the only way that we're going to change this is by getting one case at a time, one win at a time. And the more precedent that is set by a company reimbursing a patient, the more likely it is to reimburse the next patient.

As the national medical director for Vituro Health (a men's health company that specializes in bringing new technology for men’s health to patients), I’ve ensured that we have a whole insurance reimbursement assistance program in place to assist our patients with an appeal of the insurance company’s decision after their procedure. It’s really important, because patients don't know how to do this. It's in everyone's best interest for us to help drive that.

Where is the TULSA-PRO device in terms of getting reimbursed?
TULSA-PRO is another novel, high-tech application. The company (Profound Medical) is still in the early stages of launch. It received FDA approval for ablation a little over a year ago, and we were their first commercial site in the United States, treating the first patients starting in early January 2020. We've treated about 60 patients to date, and we’ve seen good outcomes.

Just like in the early days of HIFU of course, the problem is that there's no reimbursement pathway yet. They are where HIFU was many years ago. There is a C-code that is available, which generically describes MRI-guided tissue ablation, but it's not specific to the prostate or cancer. It may or may not have some applicability; we have no idea yet whether or not it will be reimbursed. I think they're probably a couple of years away from that.

But even though there is no reimbursement today for TULSA-PRO, our insurance reimbursement assistance team is advocating with each and every patient with their insurer to try and get reimbursement on an appeal basis, and we've had some early and limited success. It's a one-patient-at-a-time battle. It’s the patients who see the benefit to less invasive treatments, and they're our biggest cheerleaders and best advocates.

Looking into 2021 and beyond, do you think we will achieve widespread reimbursement for focused ultrasound for the prostate?
Absolutely. Ultrasound ablation is a very cost-effective way to treat a patient’s prostate cancer compared to traditional surgery, and certainly at a fraction of the price of radiation therapy.

So, reimbursement is a process, and we have to have a long-term view of it. It’s a changing landscape, and if we were having this conversation six months from now, I think it would already be different. But I'm optimistic that we will see reimbursement first for transrectal HIFU and then eventually for other prostate ultrasound technology. In 2021, we will see some of the MACs across the country reimburse it, and then commercial reimbursements will follow. We are two to three years away from seeing a pattern of consistent reimbursement, but I believe we will get there.

Read Dr. Scionti’s Profile from our May 2020 Newsletter >

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