Digital Health in Germany
Earlier this year, the German Medical Assembly removed restrictions on the use of telemedicine, paving the way for greater innovation in the provision of health services in Germany. This move, along with new calls by Germany’s Health Minister, Jens Spahn to increase access to digital health infrastructure, including the reimbursement of health apps through statutory health insurance (SHI), present growth opportunities for the German healthcare market.
Health Ministry Rejects Results of NUB HTAs
Since the beginning of 2017, notably invasive or active implants in risk classes IIb or III must undergo a benefit assessment by the G-BA before being granted a New Methods for Treatment and Screening (NUB) add-on payment.
During the first year of this new requirement, none of the eight products assessed provided sufficient evidence for reimbursement through the NUB process. Two of the eight products were assigned a “potential” benefit, resulting in the government co-sponsoring studies to evaluate the benefit. The other six products were excluded primarily due to lack of clinical evidence. However, the Federal Ministry of Health filed an office action against this decision and contested the assessment criteria, indicating that the evidence requirements for being a “potential alternative” were too high.
The court’s decision will affect the entire benefit assessment for medical devices and diagnostics in Germany, creating uncertainty of coverage for innovative therapies. A decision of the office action is expected in early 2020.
Laboratory Reimbursement Reform
Although Germany has the lowest prices for laboratory tests and a competitive laboratory landscape, cost-containment practices continue.
With a rise in spending on diagnostics tests (5% annual increase), the regional association of SHI accredited physicians (KV) agreed to a reform to keep test costs within budget. The reform has enhanced options available to the KV to control the costs of medical diagnostic tests, including:
- The ability to set individual laboratory budgets and reduce reimbursement amounts, and
- Incentives for physicians to order fewer tests than other comparable medical practices.
Pathology lab services are not currently affected by the reform.
New developments across Germany’s healthcare industry provide significant opportunities for global digital health, medical device, and diagnostics innovators, however many hurdles and barriers to entry still exist. If you are interested in learning more about gaining access to Germany’s healthcare market, please contact us.
The field of DTx has gained traction over the last couple of years, with FDA approvals/clearances, the founding of a DTx specialty society, large-scale acquisitions of DTx firms, pharma investments in DTx, and pharma co-development deals, amongst other key developments.
In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill on the “Law for better provision through digitalization and innovation”, which is expected to be approved by the parliament early November.