Digital health applications (DiGA)

Are you a manufacturer of apps with therapeutic approaches and would you like to make them available to patients on prescription in the future?

Then welcome to our law office. We help with the important issues both in the approval process as well in the cost negotiations with the specialists of the National Association of Statutory Health Insurance Funds.

 

Why do you need a lawyer?

 

a) “Complicated legal matter“: The application is complicated and extensive.

b) “Timeline“: The procedure is designed to be tightly timed and the price negotiations for the remuneration amount for the second accounting year must be prepared in good time.

c) “Know How”: In the price negotiations, due to the novelty of the procedure, there is little experience with regard to the amount of the remuneration. In your favor and in order to achieve the highest price, a comprehensive explanation of the arguments is necessary.

d) “Liquidation risk“: There is a risk that, in the event of unfavorable negotiations, the remuneration received so far will be reclaimed.

 

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Basics

Even before final studies on positive health care effects are available, the Federal Institute for Drugs and Medical Devices gives you the option of billing DiGAs through statutory health insurance. The pricing is left to the manufacturers themselves in the first accounting year. This “fast-track” procedure enables an early entry into digital care in the health sector, which will be expanded to an increased extent by digital offers in the future. This offers a wide range of opportunities for manufacturers to introduce their products.

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Risks

However, there are a few things to consider. First of all, the application process must be completed quickly with the correct documents. Data protection regulations in particular make this project much more difficult. From the second year onwards, prices for further billing must be agreed with the National Association of Statutory Health Insurance Funds. On the part of the National Association of Statutory Health Insurance Funds, experienced parties are involved in the negotiations. Therefore, negotiating skills in combination with expertise and a lot of experience are required. Overall, the time frame must be kept in mind so that the “fast-track” procedure becomes one. Delays in the process due to a lack of expertise can result in high financial losses. The remuneration amount to be negotiated for the second accounting year also applies retrospectively from the 13th month, which is why a delay in the price negotiations can lead to considerable reclaims.

If you would like to be adviced on the approval of a DiGA, please contact mail@medizinkanzleimohr.de or dial 030 88 91 36 34.

Medizinkanzlei Mohr

Our life is getting simpler and at the same time more complicated. The new digital possibilities simplify a lot, but also question the old and proven. You have to keep your finger on the pulse to be able to correctly classify the current events.

A decision on the right approach to new inventions or new concepts – both in fact and in law – is demanding, also because there are no empirical values.

 

A wide field.

We limit it.

 

The various categories of medical law have one thing in common: mistakes are usually very expensive. We are your full service partner. We punch you out, we protect your legal interests and if something makes no sense, we’ll tell you. Your trust is in good hands with us.

Telephone +49 30 88 91 36 34