Testing examination and treatment methods in accordance with SGB V, section 137e

The Federal Joint Committee (G-BA) can pass directives for testing examination and treatment methods whose benefit has not yet been sufficiently proved, but which show potential as essential treatment alternatives. Lawmakers have recently created this provision through the SHI Healthcare Provision Act (in German: GKV-Versorgungsstrukturgesetz, abbreviated GKV-VStG), based on SGB V, section 137e.

Previously the G-BA had no effective means of procuring sufficient evidence when proof of additional benefit was insufficient. Even though it was already possible to place time limitations on methods assessment resolutions if valid studies were expected to be submitted in the near future, there was no possibility to take direct corrective action if study evidence is inadequate. If an examination or treatment method is potentially beneficial, the new testing regulation contained in the GKV-VStG, in accordance with SGB V, section 137e, allows the G-BA to initiate clinical studies as part of a test, and to participate in financing them as allowed by law.

To conduct a test, the G-BA determines the basic points for the test in a corresponding testing directive. These include the indications, interventions and comparator interventions, patient-relevant endpoints, study type, and the material, staffing, and other requirements for the quality of care. An independent scientific institution will be contracted to draft the study protocol and to perform scientific monitoring and evaluation of the test.

In its Rules of Procedure, chapter 2, sections 14 to 28, the G-BA has regulated the details of the procedure to establish and implement the testing directives in accordance with SGB V, section 137e. Details on costs and their payment are regulated in the schedule of costs (65.9 kB).

Potential of examination and treatment methods

The criteria for determining the potential of a method are found in the Rules of Procedure, chapter 2, section 14, paragraphs 3 and 4. The potential of a necessary treatment option can arise when its mode of action and available findings lead to the expectation that it can replace other methods that are more complicated or costly, more invasive for the patient, or not successfully applicable on certain patients, or if the method has fewer side effects, optimizes treatment, or can facilitate better treatment in another manner.

In addition, the potential of a test arises especially when available scientific data are valid enough that a study can be planned that allows the benefit of the method to be assessed with sufficient certainty.

Application for testing a new examination or treatment method by the manufacturer or provider

The G-BA can pass a testing directive not only on the basis of an ongoing methods assessment hearing in accordance with SGB V, section 135 or 137c, but also based on an application in accordance with SGB V, section 137e, paragraph 7.

A request can be submitted by

  • The manufacturer of a medical device whose use significantly depends on the application of a new examination or treatment method
  • Companies that are not providers of a new method, but that have an economic interest in its provision at the expense of statutory health insurance providers

In accordance with the requirements of the Rules of Procedure, the applicants must submit valid data on the potential of the method in question, among other requirements.

Within three months after the application has been submitted, the G-BA must decide whether the application will be accepted and thus the potential of the test determined. However, a positive decision does not constitute a right to an actual test of the method. Because a test may require the financial involvement of the G-BA, the G-BA determines once per year, as part of budget planning for the following year, for which applications it will initiate an advisory procedure for a testing directive. This decision is based on conscientious discretion and in consideration of the current potential determined. The comparison of the potential of the methods assessed and the probability of a successful test are definitive for the decision. Applications that have been accepted, but for which an advisory procedure for a testing directive has not yet been initiated, will be considered again in the following year (Rules of Procedure, chapter 2, section 20, paragraphs 3 and 4).

When testing examination or treatment methods with technical applications based primarily on the use of a medical device, the law stipulates the financial involvement of the manufacturer of the medical device and of the companies mentioned above as the providers of the method in the study. Details are regulated in the schedule of costs (65.9 kB).

To apply for a test, please use the form "Application for testing examination and treatment methods in accordance with SGB V, section 137e" (342.7 kB). The requirements for submitting an application are found in the Rules of Procedure, chapter 2, section 18, and in the "general notes" on page 3 of the application form. You can find a synopsis of these regulations and details on submission in "How to use the application form" (32.4 kB).

Request for consultation before application submission

The G-BA advises manufacturers and companies eligible to submit applications as providers of a method on the preparation of their applications, and on the requirements of providing an examination or treatment method at the expense of the statutory health insurance providers. More information is contained in the Rules of Procedure, chapter 2, section 21. To request consultation, please use the "Request form for consultation in accordance with SGB V, section 137e, paragraph 8" (184.1 kB). Important information on using and submitting the request for consultation can be found in "How to use the request for consultation" (35.0 kB).

Fees are charged for consultation. The amount charged is regulated in the "Schedule of fees for consultation in accordance with SGB V, section 137e, paragraph 8" (52.1 kB).

Email for general questions

General questions on testing can be sent to: