Background
With the introduction of § 137h SGB V in 2016, the German legislator introduced a systematic early assessment of new medical devices based on high-risk methods in the hospital sector. If a hospital applies for first-time innovation funding (NUB) for a high-risk medical device, the Federal Joint Committee (G-BA) must be notified to carry out an evaluation. Prior to this, new methods were applicable in hospitals without any benefit assessments.
Definition of “high-risk” too narrow?
The National Association of the Statutory Health Insurances (GKV-SV) believes the law in its current form does not go far enough. Originally, the legislator suggested all products of risk class III and IIb should be assessed. However, the definition of “high-risk” was then limited to all class III products, but only IIb products with “especially invasive character”. This term requires the technology to “emit energy or send out radioactive particles, thereby influencing significant functions of organs or organ systems”.
So far, three high-risk methods have been evaluated as requiring an early benefit assessment by the G-BA with the other methods not fulfilling the criteria (see table 1). The GKV-SV believes more of these technologies need to be assessed systematically. For example, the class IIb device VasQ using a scaffold to stabilize an artificial connection between two blood vessels, an anastomosis, is not of “especially invasive character” and will therefore not be assessed. The GKV-SV argues the scaffold could help patients with renal failure, however believes a benefit assessment is necessary to systematically analyze the benefits and possible complications.
Table 1: Overview of § 137h consultations and evaluations
|
Intervention |
Indication |
Decision |
|
Consultations |
||
|
Endoscopic duodenal thermoablation |
Type 2 diabetes |
Ongoing |
|
Vene-Cava-Filter |
Lung embolism prophylaxis |
No assessment |
|
Arterialization of deep veins |
Peripheral arterial occlusive disease |
No assessment |
|
Cerliponase alfa as enzyme replacement therapy |
Neuronal ceroid lipofuscinosis |
No assessment |
|
Targeted lung denervation |
COPD |
Consultation suspended |
|
Electrostimulation of the peripheral nervous system with a partially implantable neurostimulation system |
Chronic pain |
No assessment |
|
Transcervical radiofrequency ablation with intrauterinal ultrasound |
Uterus myoma |
Requires assessment |
|
Evaluations |
||
|
External stabilization in arteriovenous anastomosis using a scaffold |
Shunt implementation |
No assessment |
|
Left-ventricular reconstruction |
Cardiac insufficiency |
No assessment |
|
Ultrasound-guided high-intensive focused ultrasound |
Various neoplasms |
Requires assessment |
|
Targeted lung denervation |
COPD |
Requires assessment |
Conclusions
The first submissions and their results forced the GKV-SV to question how medically plausible the definition of a “high-risk” medical device is. For now, if the GKV-SV wants the G-BA to assess class IIb products which are not considered “especially invasive” in the hospital setting, it must go through the conventional, and lengthier, route, § 137c.
Reference: GKV-Spitzenverband