Q&A with Hugo Embert, Chief Marketing Officer, EDAP TMS
What does it take for a medical device manufacturer to fast track reimbursement for a medical procedure that is not covered by insurance? Medical device manufacturer EDAP TMS set out to answer that question immediately following FDA clearance of its robotic high intensity focused ultrasound (HIFU) device for prostate tissue ablation, a process that took 10 years.
In addition to the long road to regulatory clearance, EDAP had to convince urologists and hospitals to take a chance on HIFU since patients would have to pay out of pocket for the procedure. It was not yet covered by Medicare or private insurance. Because urologists saw the potential for HIFU to become a viable alternative to surgery and radiotherapy – the standards of care for treating localized prostate cancer – hospitals across the U.S. were willing to make the investment, knowing the return on investment period was uncertain.
Beginning January 1, 2021, a more certain investment future begins for hospitals as they will be able to assign a Category 1 CPT Code to HIFU and seek reimbursement from both Medicare and private insurers.
Because HIFU is a noninvasive, outpatient procedure that allows the urologist to destroy only the diseased part of the prostate, the risk of losing control of urinary or sexual function — a too frequent consequence of surgery and radiation — is much lower for patients. Patients are now clamoring for this procedure.
Urologists across the country believe the Category 1 CPT Code, issued by the American Medical Association (AMA) for HIFU, is a game changer and patients who have been able to wait several months are looking forward to their HIFU procedure in January. Over the past year, doctors say patients have researched all the options and have affirmed, “[HIFU] is what I want and I’m going to wait!” For more on what the doctors say about the CPT code, please listen to their discussion on YouTube.
Hugo Embert, CMO of EDAP TMS, discusses the company’s accelerated path to winning the CPT Category 1 Code.
Give us some history on EDAP’s pursuit of the CPT Code for HIFU.
First, getting a Category 1 CPT Code is a major step in patients getting coverage for HIFU, making this therapy available to a wide population of patients and hospitals being able to offer HIFU as an option. Category 1 is the most comprehensive CPT code category issued by the AMA. It applies to nearly every medical interaction, including evaluation and care management, pathology, surgery, and myriad medical treatments. It is a lengthy process that takes minimum two years to complete.
In late 2018, shortly after receiving FDA clearance for our Focal One® device, we deployed a reimbursement strategy to achieve the Category 1 CPT code – knowing there were rigorous requirements from the AMA and it would be a long process. We made the choice to avoid short term gains that might have brought us a quick win but would have been an impediment in the long run.
Within four months from filing our application, HIFU was awarded the Category 1 CPT code for a process we anticipated would have taken at least two years.
What were the initial steps involved in the process?
We had to provide significant clinical studies. And the AMA has strict requirements: at least five peer-reviewed publications featuring different patient populations, with at least one presenting the clinical results on a large proportion of American patients, and showing a level of evidence of 2A or higher. In essence, the AMA evaluates the quality of the studies, the number of publications (at least five) and the performance and outcome of the therapy to decide whether it should be made generally available for reimbursement to the American patients.
A few months before we filed our application, we approached the American Urological Association (AUA) and the American Association of Clinical Urologists (AACU), and presented our Category 1 CPT code project to enlist the support of both organizations, since it is far more difficult to achieve this code level for a urological procedure without it. We presented our case and both organizations were on board.
What was the evaluation process once EDAP’s application was ready for the AMA’s consideration?
We appeared before the AMA’s CPT Editorial panel, which is in charge of reviewing, debating and voting on CPT code requests. The panel meets three times a year to discuss and vote on selected applications. Applicants are assigned panel members who present their cases to the entire panel; applicants do not present directly.
Before meeting with the CPT Editorial panel, our information packet was disseminated to dozens of medical societies and, between February 2019 and May 2019, all were invited to submit comments and suggest changes to our code request. This is to make sure a CPT code isn’t assigned erroneously and has a clear and descriptive label. In the case of HIFU, which uses ultrasound to ablate diseased prostate tissue, members wanted to make sure that it was distinguished as a medical procedure from standard ultrasound, commonly used for diagnosis or ablation of non-malignant tissue.
By May 2019, the CPT Editorial panel convened and the designated panel member presented EDAP’s Category 1 CPT code application, affirmed the clinical literature and conveyed support from the AUA and the AACU. Representatives from the AUA were also in attendance and spoke in favor of a Category 1 CPT code for HIFU.
Why was it difficult to get the AMA’s approval for the Category 1 CPT Code?
CPT Editorial panel members tend to decline authorization when they believe the clinical evidence for a procedure is weak. Others might consider the procedure experimental is not yet ready for general availability and recommend a Category 3 CPT code, a temporary code that reflects emerging and experimental technologies, often used for usage tracking purposes, and is typically not covered by insurance.
But in the end the AMA approved the Category 1 CPT code for HIFU. What came next?
Once the AMA approved the Category 1 CPT code, the panel had to assign relative value units (RVU) for HIFU. This includes fees for the physicians. A RUC (RVS Update Committee) researched how much time, effort, concentration, skill level, and resources are required to perform HIFU. In addition, the AUA was asked to survey members to check the level of HIFU experience in the urology community, report their findings and make a value recommendation to the RUC Meeting.
Once the value was approved, the AMA then made a recommendation to CMS, which is responsible for issuing the official payment levels in the annual Medicare Physician Fee Schedule Rule.
So how does the Category 1 CPT code bring hospitals, doctors and patients closer to reimbursement for HIFU?
First, there is currently a degree of coverage for HIFU. One of the Medicare Administrative Contractors (MAC) plus several commercial insurers, including Cigna and Aetna, cover HIFU as a salvage therapy. HIFU was previously granted a temporary C-Code by CMS, which allowed hospitals to request payment from insurers for the facility but it did not include covearge for the physician’s services. And typically, if a CMS C-Code is applied to a newer procedure, private insurers still deny coverage.
But we believe this Category 1 CPT code is a game changer.
That’s because the insurer looks to the AMA for guidance and validation. Insurers are aware that the AMA has gone through an extensive evaluation process and would not have dedicated resources unless there was a high value procedure behind it.
Without the CPT code for HIFU, a patient might try to get authorization from his insurance company, arguing that his doctor and hospital believe HIFU is the best option for his clinical diagnosis. But in the absence of a CPT code, the vast majority of insurers will deny coverage and the patient will have to pay out of pocket. Or he’ll be forced to choose the mainstream procedures which typically include radical surgery or radiotherapy, even if both patient and doctor agree these two procedures are not ideal in his case. But both procedures are covered by insurance.
With a dedicated Category 1 CPT, it is unequivocal that HIFU has been validated by the AMA and CMS, and it is now a “main stream” option that brings patient, doctor and hospital much closer to reimbursement. Some much needed good news going into 2021!
Hugo Embert is Chief Marketing Officer of the EDAP TMS Group. He leads the company’s Strategy in terms of Marketing and Communication, Product Management, and Application and Clinical Affairs. Currently based in the company’s US subsidiary office located in Austin, TX, Embert leads all marketing programs.