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Focus on Regulation

Digital health solutions in Germany: Detailed requirements for eligibility to reimbursement being fleshed out in draft legislation

Introduction

In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service Act/Digitale-Versorgung-Gesetz – DVG). As reported in our Newsflash on 15 November 2019, reimbursement coverage will be granted for digital health solutions that are medical devices of a low risk class (Class I or IIa) with a main functionality based on digital technologies (apps or mainly software-based solutions). The solutions’ purpose of usage has to be the diagnosis, monitoring or treatment of diseases or improvement of related healthcare provision.

Reimbursement of a digital health solution is triggered by a registration of the solution in a newly established register. Once a product is listed, it can be prescribed for reimbursement by doctors. The new law so far outlined the requirements for the registration in a quite general manner. Recently, the German Federal Ministry of Health submitted its first draft for an ordinance which will regulate in more detail the registration requirements as well as the registration procedure.

This publication provides an overview over these registration requirements under the draft ordinance (Ordinance concerning the procedure and the requirements for the assessment of reimbursability of digital health applications in the statutory health insurance (Verordnung über das Verfahren und die Anforderungen der Prüfung der Erstattungsfähigkeit digitaler Gesundheitsanwendungen in der gesetzlichen Krankenversicherung – Digitale-Gesundheitsanwendungen-Verordnung – DiGAV)). It is expected that some details of the ordinance may change in the course of the legislative process; however, the key aspects will likely remain the same. Thus, the following provides a fair outline of the future requirements for eligibility for reimbursement of digital health solutions in Germany.

Registration

A digital health solution can be prescribed upon reimbursement once the digital solution is registered by the competent authority (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM). The manufacturer of the digital health solution has to apply for the registration and has to demonstrate that the solution meets the requirements of the law and the new ordinance. Generally speaking, the two key requirements are: (1) technical requirements for the device as such; and (2) its positive impact on health care provision. If evidence for the latter is not yet available, manufacturers may apply for a preliminary registration for a 12 months’ testing period.

The reimbursement amount in the first 12 months after registration will be at the manufacturer’s price. During that time period, manufacturers and the National Association of Statutory Health Insurance Funds (“GKV-Spitzenverband“) will negotiate the reimbursement amount which will apply for the future – from the end of the first 12 months onwards.

The first, technical requirements for registration cover a broad range of features which the medical device has to fulfil in order to be registered for reimbursement. Compliance with these requirements has to be proven by submitting the CE marking and the conformity certificates obtained in the medical device conformity assessment procedure, and, with regard to the other technical requirements, by certain confirmations to be given by the manufacturer or certain other certificates.

(For further details on these requirements see also Dr. Matthias M. Schweiger, Stefan Mayr in: Hogan Lovells Newsflash of 14 February 2020, Germany is going to specify safety expectations for reimbursable digital health applications)

The second requirement for registration, the positive impact on health care provision, can be demonstrated either by establishing that the digital solution has a medical (i.e. clinical) benefit or by establishing that the digital solution improves the structure or procedure of healthcare provision in Germany. Fulfilment needs to be demonstrated by clinical evidence, as shown below.

Conclusion

Our first impression is that the level of requirements and respective evidence is quite high, in particular the required quality and sourcing of clinical data. As already indicated in our earlier Newsflash, manufacturers will often need to apply for a preliminary registration until they were able to generate such clinical data in the testing phase based on a robust evaluation concept.

Further, the limitation that the manufacturers will not be allowed to use the personal data generated – upon required user consent – by the digital health solution for any other purpose than basically for operating the solution and certain reimbursement purposes is a substantial limitation; however, it seems that usage of data other than personal data (namely anonymized data) is not restricted.

Still, the reimbursement coverage for digital health solutions is crucial to foster patient treatment by digital solutions in Germany and therefore a good development.