Payers Want Digital Therapeutics but Reimbursement Still Lags Innovation

Digital therapeutics (DTx) continue to prove their clinical value in areas like mental health, chronic disease, and behavioral modification. Yet in most markets, commercial adoption remains stuck behind slow and inconsistent reimbursement policies. That disconnect is most visible in Europe, where governments are actively studying the regulatory and economic models that will shape the future of DTx integration into care delivery. While Germany and France have created the most advanced pathways to date, even these leading frameworks reveal how much more coordination is needed to align innovation with payment.

Germany’s DiGA program, launched by the Federal Institute for Drugs and Medical Devices (BfArM), has become a bellwether in the global DTx community. Through the DiGA Fast Track, developers can secure provisional access to statutory health insurance reimbursement within weeks, but provided they meet basic safety, functionality, and interoperability standards. Full reimbursement depends on demonstrating positive healthcare effects in real-world use. More than 50 digital apps have been listed on the official DiGA directory since its inception in 2020. However, German officials and manufacturers alike have raised concerns over pricing transparency, data requirements, and the burden of ongoing evidence generation to maintain access.

France has followed with its own digital health acceleration plan. In 2023, the Haute Autorité de Santé (HAS) finalized a new evaluation framework tailored to DTx, which assesses therapeutic value alongside technical performance, user experience, and data protection. The French Ministry of Health is now using this framework to guide national reimbursement decisions for digital tools, especially those in mental health and chronic disease. According to Louisa Stüwe, an advisor with the Ministry of Health, France’s model is intended to strike a balance between access and quality. But she also emphasized in a recent HIMSS briefing that regulatory consistency across Europe is the only path to real scale.

The fragmented nature of reimbursement across EU member states has left DTx developers with costly go-to-market challenges. Every country has different evidentiary standards, privacy rules, and price-setting mechanisms. Developers must often build custom clinical trials and documentation packages for each market. That has effectively constrained most startups to one or two launch territories, slowing cross-border diffusion and chilling investment in multi-national platforms. The European Commission has pledged to make digital health a central pillar of its European Health Data Space (EHDS) initiative, but concrete harmonization tools remain years away.

U.S. regulators are watching. While the Food and Drug Administration has offered a streamlined De Novo pathway for many digital therapeutics, the Centers for Medicare and Medicaid Services (CMS) has yet to propose a formal reimbursement mechanism for standalone software-based interventions. In the absence of CMS leadership, most DTx companies must rely on patchwork commercial contracting and employer arrangements to get to market. Some have partnered directly with Medicaid managed care organizations or integrated delivery networks to create value-based models, but these remain the exception.

As digital therapeutics continue to produce strong clinical evidence, health systems and payers are running out of excuses to delay adoption. The question is no longer whether DTx can deliver results. It is whether reimbursement policy can evolve fast enough to keep pace. Germany and France may offer useful templates, but success will depend on building mechanisms that reward software-driven interventions with the same seriousness given to pharmaceuticals and devices. Until that happens, payers will continue to express enthusiasm for DTx in theory while restricting access in practice.