Responsibilities and methods

Around 73 million people are insured under statutory health insurance in Germany. By law, they are entitled to healthcare that is adequate, expedient, and economical. The G-BA plays a vital role in defining what “adequate, expedient, and economical” means. Lawmakers have stipulated the exact responsibilities of the G-BA and what requirements it must follow when taking its decisions in the German Social Code, Book Five (SGB V).

Responsibilities

Within the framework already determined by law, the G-BA defines which specific healthcare services are paid for by statutory health insurance (SHI). The G-BA also has responsibilities in the areas of quality management and quality assurance of SHI medical, dental, and inpatient care.

The G-BA fulfils its duties mainly by passing directives: nonlegislative standards that are legally binding for all stakeholders and persons insured under SHI. The G-BA carries out its tasks under the legal supervision of the Federal Ministry of Health.

The passage of the SHI Healthcare Improvement Act also gave the G-BA the responsibility of funding projects on new forms of healthcare delivery and healthcare research. The Innovation Committee established at the G-BA defines the emphases and criteria for funding in funding notices, conducts statement of interest procedures, and takes decisions on funding applications received.

Methods

The structures, deadlines, and processes for G-BA decision-making are set forth in the bylaws and the Rules of Procedure. The purpose is to take decisions that are transparent and legally sound, and that reflect the generally recognized medical state of the art. The law calls for the legitimate interests of those affected to be taken into due consideration and for the principle of cost-effectiveness to be followed, as defined by SGB V, section 12, paragraph 1.

The bylaws also regulate:

  • the appointment of subcommittees to prepare resolutions
  • the exceptions to the public access to plenary sessions
  • the responsibilities of the staff office

The Rules of Procedure also regulate:

  • the initiation of a consultation process
  • the workflows to be followed
  • the role of evidence-based medicine
  • the hearing procedure
  • the involvement of external scientific opinions
  • the tracking of bureaucracy costs
  • the completion and documentation of a consultation procedure

The concrete regulations the G-BA must follow in its work can vary widely. That is because such different fields as pharmaceuticals, quality assurance, and methods assessment cannot be addressed using one uniform procedure. For that reason the Rules of Procedure has not only a general section in chapter 1, but also separate chapters for:  

  • the assessment of medical methods (chapter 2)
  • procedures for passing directives on highly specialized outpatient care (chapter 3)
  • the assessment of medicinal products and medical devices (chapter 4)
  • the benefit assessment of pharmaceuticals with new active ingredients (chapter 5)
  • procedures for passing directives on disease management programmes (chapter 6)
  • procedures for passing directives on vaccinations (chapter 7)
  • procedures for passing directives on quality assurance (chapter 8)