Your technology has received NUB status 2? What is the next step?

Even with a NUB status 2, appropriate reimbursement for innovative medical devices can be achieved.

For expensive and innovative technologies (e.g., medical devices) for which it has not yet been possible to achieve appropriate reimbursement in the aG-DRG system, the so-called NUB application process was established in accordance with Section 6 (2) KHEntgG.

Hospitals submit a request to InEK (Institute for the hospital remuneration system) for innovative technologies and then receive a procedure-specific response. If the procedure has been assigned NUB status 1, hospitals can negotiate individual reimbursement with the health insurances.

If the technology has been assigned NUB status 2, then no individual reimbursement can be agreed with the payer.

The company marketing the technology in Germany is now required to take the next steps to secure reimbursement for the technology in the German healthcare system. For this purpose, we recommend a professional assessment of whether the technology is at all suitable for a NUB application procedure.

For this purpose, the following questions should be answered, for example:

  • Is the procedure new enough from the self-administration point of view to obtain status 1?
  • What are the costs of the procedure? Are they appropriate to support the status 1 assessment?
  • How is the procedure coded? Are there other procedures in the German health care market that are coded with the same service identifiers?
  • How many cases have been or are expected to be performed with the procedure in Germany?
  • Who has already submitted a NUB application? What information has been communicated to the InEK about the submitted NUB applications?
  • What other information is available to the InEK via other sources that may be taken into account in the application process?
  • What is the approval status of the method on the German market, what is the status of the clinical evidence, and are there already evaluations by the G-BA that could play a role in this regard?

These and numerous other questions must be answered before the question of whether it makes sense to submit another application can be answered.

What should be done to increase the chance of a Status 1 with a further application or does it make sense to aim for reimbursement outside the NUB process in the next step?

Here you can find more information.

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