Current Procedural Terminology (CPT), refers to a set of medical codes used by American physicians and healthcare professionals to describe the procedures and services they perform. These codes are reported to federal and private payers so that reimbursement for care provided can occur, known as Reimbursement.
American Medical Association (AMA) created the CPT code system in 1966 to standardize the reporting of medical, surgical, and diagnostic services in both outpatient and inpatient settings. Each CPT code represents a written description of a procedure or service, intended to avoid subjective interpretations of exactly what was provided to the patient.
New CPT code benefits BrainCool
CPT codes are updated annually to adapt to the ever-evolving healthcare sector. Recently, the AMA published such an update regarding oral mucositis, one of BrainCools focus areas.
In a press release, the company states that the new CPT code, which is the result of the AMA's latest meeting, will be effective for use on July 1, 2024, establishing a path for widespread use and insurance reimbursement. The company also intends to apply for Medicare reimbursement based on the code and is moving the launch date forward to mid-2024, regardless of whether or not the so-called fast track TCET system is decided for Cooral.
BrainCool's focus on oral mucositis
Coral System has been developed for the medical cooling of oral mucositis (OM), a painful side effect of cancer treatment on the oral mucosa. BrainCool has received a so-called De Novo 510 (k)-approval for Cooral System in the US. It is a market approval given to products when there are no comparable established alternatives on the market.
BrainCool has also secured the designation Breakthrough device from the US Food and Drug Administration FDAThis designation is awarded to products that are considered to offer a more effective treatment than current treatment options.
Comments from the CEO
To learn more about the significance of the new CPT code, BioStock contacted BrainCool's CEO Martin Waleij for a comment.
Martin – can you first tell us about the PCT code for oral mucositis and what it means for BrainCool?
– This is a completely new unique code developed for our product, which is the first product to reach the market for oral mucositis. The FDA process has created protection for a controlled temperature regulation that is part of our product, which creates a good basis for obtaining a good level of reimbursement.
Are there any synergies with you having Breakthrough device designation for the product?
– The background is that BrainCool is currently conducting two processes in the US within insurance compensation, partly within stroke, which is a so-called "inpatient" category (inpatient care, which requires the patient to stay in the hospital for at least one night), and partly Cooral, which is an "outpatient" (outpatient care, where the patient can go home immediately after a procedure).
– Although the TCET fast track system has not yet been decided, we have been able to position and present both of our breakthrough products for Medicare. Regarding stroke, we are aligning with the Cottis 2 protocols to pave the way for future reimbursement and regarding Cooral of course, as it is de facto one of the first 30 breakthrough devices to reach market approval. Both products, in stroke and oncology, are “spot on” for Medicare patient groups.
How do you view the opportunities for BrainCool to obtain Medicare reimbursement for the Cooral System in the USA?
– We can conclude that, although the fast track process TCET has not yet been decided, it has opened several doors. The need for a product for OM is great and we will apply for reimbursement through Medicare as soon as the CPT 3 code goes into operation, and we see good prospects for obtaining a first level of reimbursement.
How does this affect the strategy of establishing a study?
– In the longer term, a US study is of great importance. The basic plan is to complete the protocol and select clinics during Q4 2023. The start of the study will to some extent depend on other processes. In the event that TCET is decided and Cooral formally falls within the framework, there may be a need to postpone the start of the study. We are currently analyzing whether the strategy of obtaining compensation through CPT 3 can be reversed for partial funding of the study, then the start of the study will be adjusted accordingly.
How much money could BrainCool be involved in?
– We cannot comment on our processes or strategy on this issue publicly. I can state like everyone else that it is an unmet medical need with high healthcare costs and we are the only option.
Are there any special adaptations or preparations that BrainCool plans to make to ensure that the Cooral System meets the safety and effectiveness requirements set by the Centers for Medicare and Medicaid Services (CMS)?
– The clinical protocol for the study that will be conducted in the USA is thoroughly coordinated with, among others, Medicare.
What is the difference between the CPT I and CPT III codes and your strategy for securing a CPT III code, and later a CPT I code, for the Cooral System?
– The CPT 3 code does not stipulate reimbursement but allows for negotiation with individual insurance companies for five years, and for clinics to submit applications for reimbursement. It is valid for an interim period of five years, when more thorough evidence can also be developed and a use of the product in the US can be established to establish a permanent code (CPT 1).
– What BrainCool is now doing is working to establish an “own” fast track with Medicare as we are already in the pipeline.
How do you plan to conduct a US clinical trial to ensure robust health economic data supporting market pricing and standard reimbursement?
– In 2023, the protocol and selection of clinics will be completed and the ethics application will then be submitted. The timing to start depends partly on funding and potential collaborations with partners, and partly on the possibility of obtaining funding from various reimbursement tracks.
Are there any other reimbursement pathways, besides the conventional CPT codes, that you are considering to secure reimbursement for the Cooral System in the US?
– Yes, the TCET process can create opportunities, but we have created our own ways to increase the pace. You probably can't completely rely on political processes, but one thing is clear – we have great advantages from being one of the first devices approved with the Breakthrough Device Designation.
How do you see the launch in the US happening in oncology?
– It is no secret that BrainCool's focus is on rolling out the collaboration with ZOLL and for our clinical projects Cottis 2 and Princess 2 we have soft financing.
– In oncology, we are evaluating various options, which have not been communicated. What is available in the toolbox are various forms of partner agreements, as we continue to build value, perhaps an exit is preferable. What we can conclude is that we continue to build value cost-effectively.
Does BrainCool have the capacity to also establish itself in oncology?
– BrainCool has consistently invested in the organization and quality but also IR in recent years. The first priority is to increase sales.
– BrainCool's intangible assets in oncology are just north of SEK 30 million. What other medical device in oncology has built for an area with unmet medical need:
- Global patent approval
- Conducted a multicenter RCT of 180 patients published in Nature BMT, and formed the basis for market approval through the De Novo 510 k process with the FDA
- Breakthrough device designation
- Clear roadmap for insurance compensation
– And in the event that you find a company that has built it, the investments in the projects are north of SEK 300 million.
How do you view the investments you have made to date?
– We have invested in several projects and exploited synergies between the projects, but all three main technologies seem to be achieving success. BrainCool's DNA is to be groundbreaking, but I admit that we have consistently received higher ratings from industrial companies than from the investor community. Perhaps that is where we will find the way to the market.
How do you view the financing climate for healthcare in Sweden?
– The industry is in a state of flux right now. However, I like difficult challenges and despite a difficult climate, we have navigated well and made wise choices, as the agreement with ZOLL shows. We have also built value in stroke and oncology. Starting next year, I hope we will be able to reap the rewards of many years of hard work.
See also: Martin Waleij presents BrainCool during BioStock Life Science Fall Summit 2023.