Performance-based reimbursement for digital therapeutics in Germany: A misconceptualized opportunity

Abstract

Background: Germany has one of the oldest social security systems in the world. Population coverage has subsequently increased, reaching coverage of approximately 90% of the population in the statutory health insurance (SHI) system today. Before this background, Germany has been pioneering the integration of digital therapeutics (DTx) into its SHI system by the introduction of the Digital Healthcare Law (Digitale-Versorgung-Gesetz, DVG) in 2019. Thereby, patients became eligible for digital health applications (Digitale Gesundheitsanwendungen, DiGA), which are available upon prescription by qualified healthcare professionals.

Challenge: As conventional healthcare delivery often lacks direct outcome measures as and is mostly still reimbursed on a fee-for-service basis, DiGA offer the opportunity to continuously provide individual outcome and performance data. They are, therefore, well-suited for a performance-based payment framework. While the DVG introduced the option for performance-based reimbursement components in 2019 already, the ongoing debate about the value of DiGA and to what extent they can contribute to the healthcare system has now been reflected in a 2023 health policy bill by the German Federal Ministry of Health, which aims to introduce a mandatory performance-based reimbursement component for DiGA.

Proposal: In this light, we propose a framework for performance-based reimbursement of DiGA, involving an intervention-specific, performance-linked reimbursement framework with shared accountability between manufacturers and payers. The approach aims to align the often contradicting interests of the involved stakeholders to incentivize the delivery of high-value digital health care. Yet, the proposal also acknowledges the need for further research to establish a robust foundation for implementing such a framework.

Keywords: Digital health; apps; eHealth; electronic; personalized medicine; reimbursement.

Figure 1.

Illustration of the proposed reimbursement framework on a time scale. Upon prescription of the DiGA (1), the payer has the obligation to meet process milestones that are defined in the obligatory reimbursement negotiations between manufacturers and payers (e.g. enabling the activation of the DiGA within a specific number of days). If the payer fails to meet the agreed milestones, the eligibility for a rebate is waived. Once the DiGA is activated (2), manufacturers are entitled to claim the negotiated reimbursement rate (blue arrows), but must deliver outcomes that are likewise subject to the obligatory reimbursement negotiations (e.g. providing a clinically relevant improvement of a specific symptom). If the manufacturer fails to deliver the agreed outcomes, the payer is entitled to claim a rebate. The extent of the rebate can vary between outcomes (shaded orange area). Once the use period of the DiGA expires (3), the accrued rebates are transferred back to the payer (orange arrows). t = time.