Medicines Directive
| Basic data | |
|---|---|
| Title: | Directive on the prescription of pharmaceuticals in statutory health care |
| Short title: | Medicines Directive |
| Abbreviation: | AM-RL |
| Type: | Guideline of the G-BA |
| Scope: | Federal Republic of Germany |
| Issued on the basis of: | Section 92 (1) sentence 2 no. 6 SGB V |
| Legal matter: | Social law , statutory health insurance |
| Issued on: | August 31, 1993, BAnz . No. 246 (p. 11 155) |
| Entry into force on: | January 1, 1994 |
| Last change by: | Decision of August 21, 2014, BAnz AT October 8 , 2014 B1 |
| Effective date of the last change: |
October 9, 2014 |
| Weblink: | Text of the directive |
| Please note the note on the applicable legal version. | |
The Medicines Directive (AM-RL) outlines its efficiency principle for the prescription of medicines as part of the contractual medical care in the public health insurance in Germany and is supported by the Federal Joint Committee decided. Legal basis § 92 , para. 1, sentence 2 no. 6 SGB V . It is updated regularly. The binding force of this directive has been strengthened by the judiciary in recent years.
Medicines are part of the benefits in kind provided by statutory health insurance as part of health treatment ( Section 31 SGB V). They are of the aids ( § 33 SGB V) and the remedies ( § 32 to distinguish SGB V).
The Medicines Directive consists of a general and a special part. The general part outlines the legal basis for the benefit entitlement of the health insured, the general rules for an expedient and economical way of prescribing and the requirements for the documentation of therapy decisions. The special part essentially contains:
- the description of which drugs may not be prescribed at the expense of the statutory health insurance companies: for example, non- prescription drugs (so-called OTC drugs ), so-called lifestyle drugs or those that are considered uneconomical, e.g. B. because a therapeutic benefit has not been proven. The Medicines Directive also describes the cases in which such medicinal products can exceptionally be prescribed at the expense of the health insurance company.
- Therapy advice , especially in order to be able to use new, expensive means economically.
- Regulations on the prescribability of medical devices .
- Regulations on the prescribability of drugs in unapproved or not yet approved application areas, for example in off-label use or in the context of clinical studies .
- the formation of fixed price groups for certain drugs: for drugs in a fixed price group, the statutory health insurance companies only cover the costs up to a certain maximum price .
A contract doctor may only deviate from the provisions in the Medicines Directive in exceptional cases. Then he has to register a so-called practice feature, which has to be granted. In the performance audit ( § 106 SGB V), violations of this guideline can be proven with a recourse , even if the contract doctor adheres to his benchmark .
Demarcation
The Medicines Directive must be distinguished from the so-called European Medicines Directive (actually: Directive 2001/83 / EC (Community Code for Human Medicinal Products) ).
