For people living with Parkinson’s disease, the second most common neurodegenerative disorder in the world, medication can effectively control their motor symptoms. But as their condition progresses, medication management grows more complex. Patients often cycle between “on periods” when the medication is working and “off periods” when the medication is not adequately controlling their symptoms. Within four to six years of starting a medication, 36.2% of people with Parkinson’s disease develop levodopa-induced dyskinesias. To optimize medications for their patients with Parkinson’s disease, neurologists need objective data about where each patient is in this cycle, as well as insight into the frequency and severity of their symptoms and dyskinesias, or involuntary movements that are common side effects of their medications.
 

Existing methods of tracking medication cycles for those with Parkinson’s disease are not universally effective. When healthcare providers interview patients and caregivers, they often have poor recall of what’s been happening. While symptom diaries are available, some patients fail to complete them prior to each doctor visit—and only 24% of patients report using a previsit diary before seeing a neurologist. After a medication adjustment, the healthcare provider may have no way of knowing how effective that adjustment is until the next visit.
 

Great Lakes NeuroTechnologies Inc. developed an innovative digital health solution, KinesiaU, that automatically measures tremors, slowness and dyskinesia without the patient actively recording their symptoms. This digital therapeutic uses motion sensor data recorded by a smartwatch to measure symptoms throughout the day. It generates an easy-to-read report indicating symptom severities that can be compared to when a patient takes their doses of medication.

Digital health solutions like KinesiaU from Great Lakes NeuroTechnologies offer patients, caregivers and healthcare providers more effective tools for clinical care management. For example, a neurologist could see a KinesiaU report and conclude: “It looks like in the afternoon your symptoms come back an hour before your next dose. Instead of taking pills every four hours, take the afternoon pill after three hours.” A 2018 survey of physicians, patients and care partners about communication around these Parkinson’s disease “off periods” found that 42% of patients and 67% of care partners think using a wearable device would be helpful if they tried it.

The utility of KinesiaU is not limited to Parkinson’s disease. The Great Lakes NeuroTechnologies team has partnered with academic research organizations and pharmaceutical and medical device companies who are using the technology to support clinical trials for other conditions such as essential tremor, neurogenic orthostatic hypotension, Rett syndrome and spinal muscular atrophy.

Historically, Great Lakes NeuroTechnologies had sold its technology to research and clinical organizations as a specialized monitoring technology for clinical studies. After its newest version fully integrated into the Apple Watch and various Android smartwatches, Great Lakes NeuroTechnologies started to prove the value of its technology as a clinical care solution with neurologists. 

With support from the U.S. National Institutes of Health (NIH), Great Lakes NeuroTechnologies engaged ZS to review and strategize commercial pathways and reimbursement opportunities for KinesiaU in clinical care for Parkinson’s disease. ZS began by considering all the potential buyers of the product, including healthcare providers, pharma, life sciences, patients, caregivers and payers, eventually focusing on healthcare providers.
 

The KinesiaU digital health solution delivers direct value to healthcare providers as it allows them to monitor therapy for patients with Parkinson’s disease, potentially saving time and leading to better patient quality of life. In addition, the availability of remote patient monitoring (RPM) billing codes allows for an immediate reimbursement and revenue pathway.
 

In this provider model, Great Lakes NeuroTechnologies offers its remote monitoring hardware and cloud-based dashboard to healthcare providers on a per-patient basis. In turn, healthcare providers bill the Centers for Medicare and Medicaid Services (CMS) or third-party payers using a variety of RPM and remote treatment monitoring (RTM) Current Procedural Terminology (CPT) codes.
 

As with any clinical tool, healthcare provider adoption of KinesiaU software is a cost and benefit consideration. To use the technology with patients, Great Lakes NeuroTechnologies needed to know how healthcare providers perceived the value of the digital health solution to their patients and their practice, as well as the value economics. We used a Willingness to Purchase (WTP) model that considered the per patient cost, current and potential reimbursement through RPM and RTM codes, as well as the additional revenue cycle management time and effort incurred by practices when billing the CMS for the service.
 

The RPM Reimbursement Framework that we applied needed to answer these key questions: 

• What was the optimal price to set for KinesiaU?
• What barriers and concerns did healthcare providers face as they considered using the solution with patients?
• How would healthcare providers optimally generate revenue through CPT codes? Which combination of existing codes would constitute a best-fit into the workflow?
• What were the opportunities for using existing or developing new CPT codes that would be more appropriate and potentially richer for remote patient monitoring of Parkinson’s disease patients?

We started conducting secondary research by developing a baseline understanding of existing pricing of RPM solutions and existing reimbursement rates. For existing pricing, we analyzed the cost of comparable and competitive patient-facing digital health solutions commercialized as direct-to-physician. To examine existing reimbursement, we reviewed the KinesiaU product and workflow, as well as its intended use in clinical care. Then we explored existing CMS CPT codes relevant to monitoring dyskinesia and how those codes would fit into this workflow.
 

Our primary research with physicians included both a willingness-to-pay survey and qualitative interviews. After crafting a product value statement, we explored in a series of interviews with current physician users of KinesiaU the adoption drivers and potential barriers as a determination of the price per patient that would be acceptable to adopt the digital health solution. We also brought in perspectives from Parkinson’s disease advocacy groups.
 

ZS then synthesized and reviewed the options and trade-offs we discovered, exploring whether the product should be reimbursed through Medicare durable medical equipment coverage mechanisms or through RPM and RTM. Over the past few years, the CMS has been expanding coverage for emerging digital technologies, so we explored those options as well, including the benefits, costs and procedures that Great Lakes NeuroTechnologies would need to take on to apply for a new CPT code. 

ZS captured this work for Great Lakes NeuroTechnologies in a customized reimbursement playbook, our tool that offers a structured approach to repeat this coding and reimbursement exercise for future products. This playbook includes a CPT reimbursement landscape that provides a deep dive into CPT code requirements along with a review of national and commercial payer plans. It also features ZS’s Alternate Revenue Model, a business model framework for digital technologies that helps clients explore alternate revenue models beyond traditional reimbursement routes. The playbook gave Great Lakes NeuroTechnologies the support it needed to explore payers and payment methods, code options and ways to deconstruct codes for best use. 

In addition to meeting with Great Lakes NeuroTechnologies throughout this project, our Commercial Alignment Workshop allowed the company’s leadership to review relevant options and prioritize those that would most effectively deliver benefits for product reimbursement. The path to reimbursement is often lengthy and highly complex—requiring the costly process of developing evidence. Payers demand high-quality clinical and economic effectiveness evidence along with consistent adoption numbers for the technology to evaluate whether they will cover a digital health solution. We needed to present options to Great Lakes NeuroTechnologies that could yield both short-term benefits and a path to longer-term options that would help the company grow its revenue.

The workshop confirmed that the company would bill for KinesiaU through a per member per month (PMPM) model. It also determined that the company would publish and deliver a provider’s guide embedded in every customer’s contract to communicate a structured approach to the RPM codes that healthcare providers should bill against. And while Great Lakes NeuroTechnologies deemed the decision to pursue new CMS codes a longer-term strategy, the company prioritized movement toward building a robust evidence story as it wins small or midsize clinics as clients.