German Healthcare Law

§137h Consulting and Guidance

What are NUBs?

New Treatment and Diagnostic methods, so called NUBs, often require additional funding above the established DRG level for hospital methods being already standard of care. The annual NUB Inquiry process enables interested hospitals to confirm the need to negotiate supplementary fees for such NUBs with payers. With the newly introduced §137h SGB V the G-BA is obliged to assess NUBs in parallel with the Inquiry submission regarding their potential to be required or damaging and, subsequently, regarding their patient related benefit.

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The G-BA Assessment

G-BA assessment is triggered when NUB Inquiries are first time submitted, which utilize medical devices of high risk classification and realize a new theoretic-scientific concept. The interconnected NUB Inquiry/G-BA review process represents a challenge for every manufacturer, because it requires a good deal more strategic consideration about the hospital market access process for their NUB product.

Such considerations include –amongst many others – the assessment of the requirement to utilize the NUB Inquiry process et al, the sincere assessment of the potential of the method via its so far existing clinical evidence, the timing of a §137h SGB V process and its alignment on the product’s launch planning, the assessment of the balance of risks and opportunities if a NUB is without potential or if a NUB with potential is considered for a benefit assessment study according to §137e SGB V by G-BA.

How we can help you

Kalms Consulting has accompanied manufacturers in these processes and gained comprehensive experiences in counselling manufacturers before a specific market access strategy for a NUB is concluded with or without being involved in processes according the §§137h and e.

Whether you need a new plan or a second opinion,
Kalms has the insight you're looking for

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