German benefit assessment

Germany has clarified the timing of the planned expansion of the §137h early benefit assessment. For the current NUB application period, the procedure will continue to apply only to new inpatient methods involving high-risk medical devices. Once the amended G-BA Rules of Procedure take effect, expected from the next application cycle, the assessment will broaden to new methods based on a new theoretical scientific concept and will no longer be limited to high-risk devices.

On July 30, 2026, the Statutory Health Insurance Contribution Rate Stabilization Act (GKV-Beitragssatzstabilisierungsgesetz) entered into force, introducing important changes to the assessment of new examination and treatment methods associated with NUB applications under §137h SGB V.

On January 3, 2023, the Federal Joint Committee (G-BA) initiated the evaluation procedure concerning the method of renal denervation using ultrasound ablation in treatment-resistant hypertension (Paradise-System™ by ReCor Medical) within the framework of the early benefit assessment (in line with § 137h SGB V).

On January 20, 2022, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for the use of a stent retriever (pRELAX by femtos) to treat vasospasm of cerebral arteries after subarachnoid hemorrhage.

In early-mid November 2021, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for early benefit assessment for two new cardiovascular technologies (Revivent TC™ by BioVentrix and Trilogy™ Heart Valve System by JenaValve Technology) in heart failure, and aortic valve insufficiency and stenosis, respectively.

On July 7, 2021, the Federal Joint Committee (G-BA) has launched an online database of method evaluations for conceptually new diagnostic and treatment methods (§135 SGB V), diagnostic and treatment methods in hospital settings (§137c SGB V) and within the framework of co-funded studies (§137e SGB V).

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

On November 9, 2020, in accordance with §137h Paragraph 6 SGB V, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency within the framework of the early benefit assessment.

Patients with a newly diagnosed glioblastoma will have an opportunity to benefit from the therapy with tumor-treating fields (TTF) at the expense of statutory health insurance. The Federal Joint Committee (G-BA) decided on March 20, 2020, the details concerning the indications and the quality assurance measures that will apply when prescribing this outpatient treatment method.

Balneophototherapy becomes covered by the National Association of Statutory Health Insurance Funds (GKV) for patients suffering from moderate to severe neurodermatitis. The Federal Joint Committee (G-BA) decided to include this treatment option to contract medical care on March 20, 2020.

In severe cases of lipedema, the costs for liposuction will be covered by the statutory health insurance companies from January 2020. The National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV) have added several new fee order items to the EBM (German Uniform Evaluation Standard) and set the reimbursement.

With the preventive program for pregnant women, "Hello Baby," premature births and infection-related birth complications should be minimized. Now, the program has been established nationwide: 60 health insurance companies offer to their approximately 6.5 million insured since July 1, 2019, the additional tests contained therein.