Germany: Effective activation of apps on prescription: Regulator tells off insurance funds and requests process changes

On 26 February 2024 a deadline ended that could prove important to manufacturers of digital health applications (DiGA) in Germany. The German regulator in this space, the Federal Office for Social Security (Bundesamt für Soziale Sicherung, BAS), had urged health insurance funds to amend their operating procedures to ensure that apps on prescription can be activated effectively by patients.

The claim of patients to DiGA was implemented in German law by the Digital Healthcare Act of 3 June 2021. DiGA supplement the catalogue of possible treatments in the event of illness for which the costs are covered by the public health insurance funds. A DiGA can be provided either after a doctor's prescription or after approval by the health insurance fund. Even if a DiGA is prescribed by a doctor, the respective health insurance fund is still involved in the process. Because the patient receives the activation code for the prescribed DiGA from the health insurance fund on presentation of the prescription. Only then can the insured person download the app or open the web application.

It has become established practice for health insurance funds companies to check the economic necessity of prescribing the DiGA, and, if it considers the provision of the DiGA not economically reasonable, to restrict the insured person's access to the DiGA. This may obviously be contradictory to the prescription made by the treating doctor and this clash with the medical assessment. For patients, such subsequent and unpredictable access restriction can lead to a negation of care, although the legislator originally intended that insured persons should be able to contact the developer directly without the intermediary of the health insurance fund. For DiGA manufacturers the practice can entail a potential loss of revenue.

The practice established by several public health insurance funds had been controversially discussed in 2023 already. In June 2023 the BAS published a first statement in this context (see here: Vermerk RL-SB (bundesamtsozialesicherung.de). In November 2023 it reiterated its position, pointing out that health insurance funds are generally prohibited from interfering with the doctor's decision to prescribe (see here: Prüfung der Notwendigkeit von verordneten Digitalen Gesundheitsanwendungen (DiGA) nach § 33a SGB V - www.bundesamtsozialesicherung.de). In individual cases - if there are justified doubts about the necessity or cost-effectiveness of the prescription - they have the option of submitting the doctor's prescription to the independent Medical Service (Medizinischer Dienst) for examination as to its necessity. However, they do not have their own substantive right of review. This is a strong and unusual signal to  the health insurance funds.

The BAS has explicitly asked them to amend their operating procedures and to hand in their modified procedures to BAS by 26 February 2024. It will be interesting and of high practical relevance to see how the insurance funds react and whether the process of activating apps on prescription will be run more smoothly soon.