The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your application is reimbursed by health insurance companies, you are not free to set the pricing of your DiGA for all eternity. Sooner or later, you will have to agree on a reimbursement amount with the GKV-Spitzenverband , which will replace the manufacturer’s price (also known as the “actual price”) defined by you after one year. Here you will find the most important information on DiGA pricing negotiation.
The information in this article is taken from the since 02/28/2024 valid framework conditions of the GKV-Spitzenverband. Another important source was the law passed by the Bundestag on June 3, 2021, the Digital Supply and Care Modernization Act (DVPMG).
Update 11/08/2023: The draft Digital Act (DigiG) includes the introduction of 20% performance-related price components, which represents an additional ambitious remuneration component. You can read everything you need to know about this and all other new features in our blog article.
The DiGA price negotiation timeline
It makes a difference whether you apply for permanent or temporary admission for your DiGA. Depending on the application, negotiations start earlier or later.
If your DiGA is accepted permanently (without a trial year):
- The negotiation period begins after your DiGA has been listed in the directory for 4 months.
- Note: The original plan was 6 months. By amending the deadline in § 134 para. 2 S. 1 SGB V (from 12 to 9 months), however, this was shortened to 4 months.
- You submit all the necessary documents to the GKV-Spitzenverband.
- After 5 more months, the DiGA price negotiation is completed.
- If no agreement is reached, the arbitration board will decide on the amount of remuneration in a further 3 months.
- The final remuneration amount applies from the 13th month in which the DiGA is listed in the directory. Until this time, your manufacturer’s price/actual price applies.
If your DiGA is provisionally accepted first (with a trial year):
- After 12 months at the latest, send the BfArM all documents proving the positive supply effect.
- After a further 3 months at the latest, you will receive a notification from the BfArM about the permanent admission and the negotiation period will begin.
- They submit all necessary documents to the GKV-Spitzenverband and agree on negotiation dates.
- After a further 5 months, the DiGA price negotiation is completed. If no agreement is reached, the arbitration board will decide on the amount of remuneration in a further 3 months.
- The final remuneration amount applies from the 13th month in which the DiGA is listed in the directory. Your manufacturer’s price/actual price applies until a decision is made on the amount of compensation. However, you must subsequently refund the difference between the manufacturer’s price and the reimbursement amount from the 13th month onwards.
When does which pricing apply to the DiGA?
The price set by you (manufacturer) is valid from the date of listing in the DiGA directory until the date on which
- a remuneration amount has been agreed with the GKV-SV,
- the Arbitration Board has determined the amount of compensation, or
- your DiGA is listed for 12 months.
If all deadlines are exhausted, the self-determined price can be called up for a maximum of 12 months for provisionally accepted DiGA.
The maximum period is 9 months for direct permanent admission to DiGA.
If the negotiations are not concluded before the 13th month, you will still receive the price you have set. However, you must repay the difference for this period retrospectively.
Pricing negotiations with the National Association of Statutory Health Insurance Funds
Start of negotiations
The start of the DiGA price negotiation with the GKV-Spitzenverband depends on whether your DiGA has been included in the list with or without a trial year. For this reason, there are two cases:
1. Your DiGA is permanently listed from the start
In this case, the price negotiation begins 4 months after inclusion in the DiGA directory.
Note: Due to the entry into force of the DVPMG on June 3, 2021, the start of negotiations was shortened from 6 to 4 months.
2. Your DiGA is provisionally listed
If your DiGA has only been provisionally included in the list, price negotiations will only begin as soon as you have received notification of final inclusion. This is the case after the 15th month at the latest (unless you have a positive decision on an extended trial phase).
Required documents
- BfArM decision on inclusion in the DiGA directory
- CE conformity marking or the CE marking
- Declaration on all points listed in DiGAV Annex 1 and Annex 2 (if available, also corresponding certificates)
- Study reports to demonstrate the positive effects of supply (including publications where applicable)
- Number of activation codes/prescription codes redeemed up to 5 days before transmission of the documents
- Information on prices for the DiGA when dispensed to self-payers
- Information on prices for DiGA in other European countries, which are covered by payers there
- For DiGA that have been provisionally included: the specified evidence for evaluation, which you have also submitted to the BfArM
You can also submit other documents that are useful for negotiating a compensation amount. For example, you can submit the following documents up to 10 days before the first or second hearing date:
- DiGA evaluations accompanying the application
- Studies on positive supply effects
- Evaluations of performance and billing data
Duration of the negotiations
The DiGA price negotiations with the GKV-Spitzenverband take 5 months. Within these five months, there will be 3 hearings lasting a maximum of 3 hours. It is possible to agree on an additional fourth date.
Note: Due to the entry into force of the DVPMG on June 3, 2021, the negotiation period was shortened from 6 to 5 months.
If no agreement is reached, the arbitration board is called in after the negotiation phase, which examines all documents and decides on a compensation amount after 3 months at the latest. The costs of the arbitration proceedings are divided between the DiGA manufacturer and the GKV-Spitzenverband.
Important factors for determining the remuneration amount
The remuneration amount is determined on the basis of all price-relevant documents and the information published in the directory. For you as a manufacturer, however, it is important to know that the strength of the supply effect plays a special role in the amount. Meaningful data, studies and publications should therefore give you the most advantages here.
You can find out what you need to bear in mind when demonstrating positive supply effects here: DiGA: Guidelines for demonstrating positive supply effects
The prices of comparable DiGA and applications will also have an influence on your remuneration amount. So also develop arguments that emphasize the added value of your DiGA compared to other offers.
However, the amount of remuneration may be limited by group-specific maximum amounts.
Any further questions?
As a service provider for the development of DiGA and medical apps, we are very familiar with the current legal requirements for DiGA. You will therefore find numerous interesting articles on DiGA development in our blog. For example, you can find out more about the criteria for a DiGA, a guide to the DiGAV and much more.
Are you planning to develop a DiGA? Please feel free to contact us! As an app agency, we specialize in the development of medical apps.
Phone: +49 (0) 89 54998380
E-Mail: kontakt@quickbirdmedical.com
