The Position of Health Insurers: More Control, Less Spending

The AOK Federal Association considers the current system for DiGA approval to be structurally flawed. At the heart of the criticism are the prices in the first year following approval, which are set freely by the manufacturers and, according to the AOK, are out of proportion to the benefits. The association is therefore calling for price negotiations to begin immediately upon inclusion in the DiGA directory.

In addition, the AOK aims to tighten the approval criteria: The current pilot program, which allows for reimbursement even before final proof of efficacy has been established, is to be eliminated without replacement. In the future, the assessment of medical benefit will no longer be conducted by the Federal Institute for Drugs and Medical Devices (BfArM), but by the G-BA. To reduce dropout rates, the health insurance provider proposes a 14-day trial period and a 10 percent copayment by insured individuals. Commercial prescription and prescription-filling services are to be prohibited by regulatory measures.

The association, which represents the eleven AOKs, believes that,

"that the legal regulations governing digital health applications must be fundamentally strengthened."

The position paper further states: “Only through precise and targeted legal requirements can we ensure that digital health applications (DiGA) actually provide measurable, sustainable benefits for insured individuals, are reliably integrated into healthcare—in line with the Federal Ministry of Health’s digitalization strategy—and are managed in a transparent and accountable manner with regard to reimbursement.”

Reactions to the AOK's Demands

The National Association for Digital Healthcare rejects the AOK's demands. It argues that, due to the current price caps, free pricing does not exist in practice; furthermore, it contends that transferring authority to the G-BA would be driven by vested interests, given that health insurance plans hold voting rights on that body.

Nevertheless, the umbrella organization also continues to see a need for action:

"In order for the vast majority of insured individuals to become familiar with this type of care, targeted outreach is needed at several levels."

This applies not only to DiGA companies but also to “the support of other stakeholders in the healthcare system.” For example, professional associations and chambers, as well as peer review groups and quality circles, can help raise awareness of DiGA among physicians and psychotherapists, who in turn serve as important points of contact for patients. Patients themselves can raise awareness of DiGA through patient associations, active exchanges with other affected individuals, or self-help groups; in particular, however, they should also be encouraged to discuss their experiences with DiGA with their treating professionals. Ultimately, however, health insurance companies actively reaching out to their own enrollees holds the greatest potential for educating people about DiGA, regardless of age, location, or gender. This potential should be harnessed to further support patients.”

Dominik Burziwoda-von Papen, CEO of Perfood, criticizes the AOK’s proposals as being based on a planned economy. On LinkedIn, he proposes market-based mechanisms instead to improve quality and reduce costs. Approval modeled after the FDA’s U.S. “Predicate Device” approach could create a class of “generic DiGAs,” in which clinical trials for already known functions would no longer be required and prices would automatically fall due to competition. To justify premium prices, direct comparative (head-to-head) studies would have to become the standard. Bilateral approval agreements between countries could also facilitate scaling and enable discounts for German health insurers.

Magnus Schückes, CEO of Elona Health, criticizes the AOK’s move as a case of double standards. The AOKs demanded the strictest evidence and certifications, yet on their own platforms they offer digital “coaches” with medical claims for which there are no medical device registrations or BSI certifications.

BfArM's Regulatory Framework

The current legal requirements strike a balance: The BfArM procedure recognizes both medical benefits and structural and procedural improvements (such as adherence or health literacy) as positive outcomes for patient care. The trial period for manufacturers who cannot yet provide sufficient data is set by law at 12 to a maximum of 24 months. The manufacturer’s price is binding for the first year; starting in the 13th month, the negotiated price takes effect.

DiGA in Medical Practice

Beyond the regulatory debate, the value of DiGA is determined in everyday clinical practice. Dr. Alexandra Widmer, a physician, neurologist, and medical psychotherapist, has been involved in the development and application of digital health applications since 2017. She repeatedly emphasizes at conferences, in interviews, and on her own LinkedIn channel that physician communication is crucial to the success of DiGA. This is because the therapy requires behavioral changes and self-reflection. Phrases like “Try this to pass the time while you wait” are counterproductive. Only when the treating physician is convinced of the relevance of digital therapy can the necessary trust be established.

The current focus is on chronic conditions, mental health challenges, and post-treatment care. To avoid frustration on both sides, Widmer uses tools such as the “WID-Check” (Effectiveness, Integration, Feasibility) to assess her patients’ motivation and digital literacy in advance. In a future AI-supported healthcare system, Widmer believes the medical profession has a duty to serve as “translators and guides” between technology and patients.

When I explain clearly and confidently that this digital therapy is just as important as medication or other treatments, it has a completely different effect. The patient feels that he or she is an essential part of the treatment.

Dr. Alexandra Widmer

A Move Toward the Traditional Pharmaceutical Market?

The current debate over DiGA regulation shows clear parallels to traditional pharmaceutical care: for example, health insurers’ demands for immediate price negotiations and strict evidence requirements from day one—practices that are already established in the AMNOG process for new drugs. For the pharmaceutical industry itself, DiGA have long since become a strategic growth area. Under the “Beyond the Pill” approach, companies are making targeted investments in digital adjunct therapies to, for example, increase medication adherence or improve the management of side effects.

If calls for costly, large-scale clinical trials prior to market approval gain traction, this is likely to fundamentally alter market dynamics: While financially strong pharmaceutical companies can muster the resources to overcome these regulatory hurdles, smaller developers and startups face the risk of being forced out of the market. The market structures of digital healthcare would thus inevitably come to resemble those of the traditional pharmaceutical market.