NUB Benefit Assessment for Medical Devices

 

What are the basic requirements for a positive evaluation of a NUB application in order to make it successful? What happens after the CE marking and the German Institute for the Hospital Remuneration (InEK) assessment?

 

Innovations replace standard procedures or improve them significantly. All benefits paid by the statutory health insurance (GKV) should serve the well-being of the patient. NUB fees can be used to reimburse the costs of innovations that have not yet been properly portrayed via the G-DRG System. In order to realize these NUB fees, it requires close cooperation between manufacturers and hospitals. Timely planning and examining is essential to make an innovation a success!

What is the NUB benefit assessment for?

 

In the interests of patient safety and solidary community, every innovation is tested before an inclusion in the GKV service catalog in accordance with the criteria of evidence-based medicine (ebm).

Ever since the introduction of the NUB application procedure by the InEK, new medical devices, which have a NUB status 1 or 4, have undergone a short evaluation by the Medical Service of the Central Association of Health Insurance Funds (MDS). Since 2016, the early benefit assessment for high-risk medical devices in accordance with § 137h SGB V has been added.

The benefit assessment* in the form of a short report by the MDS includes the following steps:

  • Research of medical device(s)
    • CE certificate, instructions for use, possibly further product information
  • Bibliographic literature search
    • Cochrane Library, NLM PubMed, NHS CRD, ClinicalTrials.gov and WHO ICTRP
  • Study selection and information evaluation
    • 2-step-screening: title/abstract, full text
    • Assessment of the bias potential of included studies
    • Information synthesis
  • Social medicine recommendation

The results of the created reports help the health insurance companies in the budget negotiations with the service providers. The use of innovative medical devices in the inpatient sector is also possible in case of a negative assessment (permission with the reservation of prohibition). However, due to the non-negotiability and the resulting lack of compensation for the hospitals, any use is only possible in exceptional cases.

Since 2016, the newly introduced § 137h SGB V provides an early benefit assessment for high-risk medical devices. This is carried out by the Joint Federal Committee (G-BA). As a result, there are three variants:

  • Benefit is sufficiently documented: remuneration is regulated (if necessary → G-BA guideline) = quality
  • Benefit is not sufficiently proven, but potential exists: trial study to determine the benefits pursuant to § 137e SGB V
  • No potential and no benefit: the procedure is harmful or ineffective = exclusion

 

Conclusion: the evidence of patient-relevant additional benefit has to be collected before applying for the reimbursement!