Paving the way for scalable reimbursement of a wearable-integrated digital therapeutic in Parkinson’s care
Clinical insights and physician input guided a reimbursement and evidence strategy aligned with payer demands and practice realities—clearing the path to adoption and long-term viability.
Challenge
Despite strong clinical potential, the digital therapeutic faced barriers to adoption due to unclear reimbursement pathways, limited precedent for software-based Parkinson’s interventions, and misalignment between the business model and neurologist workflows.
Approach
We took a multi-pronged approach—conducting a reimbursement landscape analysis, mapping stakeholder priorities, and closely collaborating with neurologists to surface adoption barriers and define payer-aligned evidence requirements.
Results
Enabled the client to shift from early deployment to a viable commercialization strategy by identifying reimbursement entry points, clarifying evidence generation priorities, and aligning their business model with real-world clinical and payer dynamics.
Challenge
No reimbursement precedent, no defined evidence path, and no clear buyer.
A digital health startup developed a software platform that leverages data from widely available consumer wearables to monitor tremors in individuals with Parkinson’s disease. By correlating symptom patterns with medication timing, the tool aims to optimize treatment regimens and improve patient outcomes. Initially offered free to users, the company set its sights on commercializing the product through clinical neurologists and movement disorder specialists.
Despite promising clinical utility, the founder faced a fragmented reimbursement landscape, unclear coding pathways, and limited precedent for software-based Parkinson’s interventions—making it difficult to define a viable business model, secure physician adoption, or generate the evidence required to gain payer support.
Approach
Cutting through complexity to unlock scalable adoption.
To chart a viable path to market, we conducted a comprehensive analysis of the U.S. reimbursement landscape—including Medicare, Medicaid, and commercial payer models—for digital health and software-as-a-medical-device (SaMD) platforms. This included exploring relevant HCPCS Level II codes, assessing inpatient use cases through DRG frameworks, and evaluating pathways for new CPT code creation based on CMS and AMA criteria.
In parallel, we mapped the value chain across key stakeholders—payers, clinicians, and patients—to identify decision-making levers, clinical utility perceptions, and workflow considerations. Through targeted interviews with neurologists, we surfaced insights on current PD management practices, reactions to the digital solution, and barriers to adoption ranging from integration challenges to reimbursement uncertainty. These inputs informed a focused strategy aligned with both payer expectations and real-world clinical needs.
Results
Refined strategy aligned with payer expectations and market reality.
Neurologists validated the clinical promise of the platform, recognizing its potential to improve treatment by aligning tremor data with medication timing. But their feedback exposed operational roadblocks—concerns around data overload, workflow fit, and patient usability—that would stall adoption without strategic changes.
We clarified the reimbursement landscape and identified a viable path forward. Existing RPM codes offered an entry point, while new CPT code development presented a longer-term opportunity. These findings enabled the client to prioritize evidence generation and pursue the right validation milestones for payer alignment.
Most critically, we helped the client reframe their business model. The initial approach—physicians as buyers—conflicted with clinician expectations and market norms. By shifting to a payer-funded model with potential chronic care alignment, the company gained a clear, credible path to commercial scale.
Key Learnings
Evidence, access, and adoption—sharpened by real-world insight.
✅ Launch focused pilots with clinical champions
Generate real-world insight into usability, workflow integration, and patient engagement to de-risk scale-up.
✅ Develop a payer-aligned evidence strategy
Prioritize outcomes that matter—tremor reduction, medication adherence, and patient-reported impact—to meet reimbursement thresholds.
✅ Pursue reimbursement now, not later
Use existing RPM codes as an interim path while building the case for scalable CPT code submission.
✅ Target high-leverage entry points
Focus on neurologists in academic and integrated systems—early adopters best positioned to validate and champion innovation.