Globally as care has pivoted to virtual delivery, the appetite for digital health tools has increased. In the digital mental health arena, companies have made products free of charge to meet a growing population’s mental health needs due to pandemic-related stress, anxiety, and depression. Before the pandemic, Germany had engaged in policy reforms to enable more digital tools to be available to the point of care and, as a country, made reimbursement part of their deployment.
In the current issue of Nature Digital Medicine, Sara Gerke and colleagues from Harvard and colleagues provide perspective on early lessons learned in the time of COVID-19. Over 90% of the German population are covered by statutory state-funded health insurance; the remainder leverages private insurance. As of 2019, changes to the healthcare law now enable digital health solutions to be broadly accessible as part of care. The details of the benefit entitlement are shown in the figure below.
Source : https://doi.org/10.1038/s41746-020-0306-7
The law allows for medical devices, sensors, and apps to be provided and divides them into different classes depending on the intended use. For example, it is a digital tool being used to detect, monitor, or support ongoing management of an illness.
One component of the law is establishing an official register for digital health applications maintained by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte—BfArM); this allows digital health companies to understand the pipeline for approval and reimbursement. In this new model, digital tools are prescribed by a doctor or a psychotherapist to support a plan of care. If a manufacturer wants to be part of the register, they can submit their device and enter a three-month path to approval—this new approach launched in April of this year, during the pandemic.
Early learnings suggest the scope of the Act is narrow, as it only applies to lower-risk medical devices, which rules out the broader suite of digital tools available in the marketplace. Challenges also exist with the requirement of the demonstration of positive benefits on care. Most digital health companies are nascent; efficacy and effectiveness are part of their development roadmap, but that often comes when a product is more mature. The model might be better served to allow for real-world testing to explore how the tools can be optimized in the care path in partnership with health care providers.
Pricing has also been challenging; the model plans to use a standardized reimbursement approach where a manufacturer and insurer agree on pricing at the outset. This doesn’t allow for knowledge that may only be gleaned from deployment. In a sense, it may be putting the cart before the horse and doesn’t allow for flexibility and learning. Privacy advocates have also expressed concerns about data use and transparency, which is getting more and more attention as digital health matures as an industry. How can these tools be deployed while maintaining user privacy?
While Germany is a significant health care market with annual spending of 374 billion Euros a year, it isn’t overly digitized. The German experience with this model will be fascinating to track as it matures, and undoubtedly many lessons learned that could be applied in other countries.
Thanks for reading – Trina
(Opinions are my own)
Gerke, S., Stern, A.D. & Minssen, T. Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries.npj Digit. Med. 3, 94 (2020). https://doi.org/10.1038/s41746-020-0306-7