Why Reimbursement Matters
Patients want to be treated with the most advanced technology yet, when novel medical procedures are not adequately reimbursed, most patients are denied access to treatment. New procedures are likely not affordable for many patients if their insurer does not pay all, or most, of the treatment costs. This creates a roadblock that prevents the widespread, equitable, and timely delivery of innovative treatments to patients. Some creative patients have used crowd-sourced funding or petitioned their insurance company for approval, although this is not possible for everyone.
Since patients largely rely on insurance reimbursement to pay for their focused ultrasound procedures, it is important for them to understand the basics of how reimbursement works.
The Basics of Reimbursement
The concept of ‘reimbursement’ is multifaceted, encompassing several components, including coding, payment levels and coverage. All elements of reimbursement are predicated on regulatory approval. These concepts are described below.
Before a medical procedure can be used on a day-to-day basis by physician, the technology underlying that procedure – in the case of focused ultrasound: the FUS device – must first obtain regulatory approval from the US Food and Drug Administration. Approval is based on clinical data demonstrating that the technology is safe and effective.
There is no good mechanism for reimbursement of a procedure without a billing code. Such codes are assigned by either the Centers for Medicare and Medicaid Services (CMS) or the American Medical Association (AMA). Your physician’s practice will know the proper billing code to use for your FUS procedure.
Once a code is designated for a procedure, a payment level must be assigned to that code. This step is performed by CMS or private insurance companies and is mostly based on the costs incurred by treatment centers when they perform the procedure. This creates a unique situation when a technology is new to the market because the volume of cost data for the related procedure is relatively low. This often initially leads to under- or over-payment for a procedure, until the case rate is high enough for a more informed value to be determined. If the payment level for treatment does not sufficiently cover the costs incurred by your physician, they may not be able to offer the procedure at their practice, limiting your options for treatment.
The establishment of a payment level does not actually guarantee that a treatment center will be reimbursed; it only determines how much they will be paid if coverage is granted.
The final step in the reimbursement process is the granting of insurance coverage, known as a ‘positive coverage determination’. This is the decision by the insurer – government or private – about whether or not they will indeed reimburse treatment centers for a specific procedure at the established payment level. Factors used when determining coverage include efficacy, safety, patient outcomes, utilization (how often the procedure is being performed) and cost-effectiveness. It is not unheard of for a procedure to successfully pass through the coding and payment level stages, only to be ultimately denied coverage.
Based on the above, it is important to confirm with your provider that the treatment you are seeking is covered in by your insurer.
What to Expect
Since coverage of a procedure is not guaranteed, the first thing a patient should do is to contact their provider to determine existing, and possibly upcoming, coverage status. Depending on the insurer, it may be necessary to get preauthorization for the treatment. This ensures that there will be no last-minutes surprises about eligibility. It is also a good idea to inquire about any remaining out-of-pocket expenses, such as copays and coinsurance.
The Foundation's Efforts
The Foundation uses its position as a trusted, independent, unbiased third party to forge collaborations with industry, researchers, clinicians, government, advocacy organizations, patients and other stakeholders, to break down barriers to regulatory approval and reimbursement for new clinical applications of focused ultrasound.
A key aim of the Foundation’s Regulatory Affairs Program is to facilitate dialog with US Food and Drug Administration (FDA) officials—both scientific and clinical regulatory staff—and provide them with information to contribute to the advancement of focused ultrasound clinical studies and also to facilitate development of technical standards for focused ultrasound treatments. The Foundation also supports researchers in developing clinical study protocols that adhere to FDA standards and/or connecting them with regulatory experts for appropriate guidance.
The collaborative relationship between the Foundation and FDA has helped to contribute to the advancement of focused ultrasound therapy. A major milestone was achieved in 2011 when the FDA for the first time officially recognized the field of focused ultrasound and its potential as “a leading-edge technology to perform surgery without incisions,” and as a way to “reduce the number of invasive surgeries that patients need."
Currently, there is limited reimbursement for focused ultrasound therapy. Until government and private payers are willing to cover focused ultrasound therapy, patients will not have widespread and equitable access to this noninvasive treatment alternative.
The Foundation establishes collaborations with key stakeholders in order to raise awareness of the barriers to reimbursement and to start to break down these barriers.
The Foundation encourages all companies and researchers to consider reimbursement when designing new clinical trials; when appropriate the Foundation will advise or offer feedback on the study design. It is critical to ensure that the clinical trial design will not only demonstrate safety and efficacy, but also will meet insurers’ requirements for superior long-term benefits, quality of life, and cost-effectiveness.
The Foundation has been fortunate to collaborate with leading advocacy organizations including the Medical Imaging & Technology Alliance (MITA) and the Advanced Medical Technology Association (AdvaMed) who have the expertise and relationships to help move the needle on reimbursement for novel medical device therapies like focused ultrasound. Through these partnerships we raise awareness of focused ultrasound therapy among policymakers, payers, and medical specialty societies and drive policies to reduce barriers to commercialization and patient access.
Learn more about our advocacy efforts >
See a white paper from our March 2020 Reimbursement Workshop >
We are also partnering with industry representatives and clinicians to design and implement patient registries to track long-term treatment results that insurance carriers can use to evaluate the efficacy of focused ultrasound treatments.
Furthermore, the Foundation sponsors a CMS (OPPS) Reimbursement Education Program that is designed to help clinical treatment sites optimize their billings, in order to ensure appropriate reimbursement in the future.