When a German hospital first asks for extra funding for a new method, the Federal Joint Committee can test the evidence behind it within three months. From November 2026 that test reaches far beyond high-risk devices — and manufacturers who ask for a trial will pay for it.
§137h SGB V is a fast, mandatory benefit assessment by the G-BA. It is triggered when a hospital files the first NUB request for a method with a new scientific concept. The G-BA decides within about three months whether the benefit is proven, whether the method has potential (which leads to a trial and restricts who may be paid), or whether it has no potential (no NUB money, possible exclusion). A 2026 law (BStabG) and a G-BA rule change dated 15 October 2026 extend it from high-risk devices to any new method not based solely on a drug, and make manufacturers fund trials they apply for.
German inpatient care works on a “permitted unless prohibited” principle: a hospital may use a new method until it is excluded. §137h, introduced in 2015, adds a checkpoint for new, invasive and costly methods.
It obliges the Federal Joint Committee (G-BA) to assess the evidence for a new method on a short, fixed clock — and ties the result directly to whether hospitals may be paid extra for it under the NUB procedure. The legal bases are §137h SGB V, the Methods Assessment Ordinance and Chapter 2, Section 8 of the G-BA’s Rules of Procedure. In practice the Institute for Quality and Efficiency in Health Care (IQWiG) reviews each submission for the G-BA under a standing commission.
| Step | Timing | What happens |
|---|---|---|
| Submission | With the first NUB request (by 31 Oct) | Hospital submits evidence; manufacturer agreement for device methods |
| Publication | Within 2 weeks | G-BA publishes a notice online |
| Additional information | Usually 1 month | Other hospitals and affected manufacturers may add data |
| Evidence review | In parallel | IQWiG assesses the submission and recommends |
| G-BA decision | Within 3 months of the submission | Benefit proven, potential, or no potential |
If the information is seriously incomplete, the G-BA sets a deadline to complete it and the clock pauses. Lawsuits against the decision do not suspend it.
The GKV contribution-stabilisation act (BStabG), in force since late July 2026, rewrote §137h. The G-BA set out the details in a Rules of Procedure amendment dated 15 October 2026, effective the day after publication in the Federal Gazette but not before 3 November 2026 (it still needed approval by the Health Ministry when we published this).
Because the new rules arrive just after the 31 October 2026 NUB deadline, the wider scope will in practice bite first in the NUB cycle that closes on 31 October 2027. Track the latest steps in our Regulatory Digest.
Hospitals and manufacturers can ask the G-BA for advice before an NUB request is filed, optionally with BfArM or InEK taking part. On request the G-BA can decide, after a public comment procedure, whether a method falls under §137h at all — a binding answer worth having before a launch plan depends on it.
Counselling for manufacturers is charged in four fee categories, currently EUR 825, 3,300, 11,550 and 16,500, with a EUR 3,000 advance; the bare decision on whether §137h applies is free. The fee schedule still uses the old high-risk wording and may be updated.
A mandatory, time-limited benefit assessment by the G-BA for new hospital methods. It is triggered when a hospital files the first NUB request for a method with a new scientific concept, and its result decides whether and which hospitals may be paid extra for the method.
A hospital, by filing the first NUB request and sending the G-BA the evidence. For methods that rely mainly on a medical device, the hospital needs the manufacturer’s agreement and the manufacturer’s complete clinical data.
The G-BA must decide within three months of the submission. If the method shows potential, it sets quality requirements within three months and decides on a trial within six months.
A G-BA rule change dated 15 October 2026, effective no earlier than 3 November 2026, removes the high-risk-device limit: any new method not based solely on a drug can be assessed. The “potential” outcome returns, and manufacturer-requested trials must be funded by the manufacturer.
Not directly. It governs NUB payment and use in hospitals. Outpatient reimbursement still requires a G-BA method assessment and inclusion in the EBM catalogue.
In a focused session we check whether §137h will apply to your method, what evidence it needs, which hospitals should file first, and what a trial would cost you.