BIO Deutschland’s Working Group on Diagnostics

At the invitation of Epigenomics AG, experts from BIO Deutschland’s Working Group on Diagnostics met in Berlin on 11 February 2010. Topics on the agenda included the reform of the Standardised Medical Fee Scale.

In the opinion of the working group’s experts, this reform is not proceeding transparently and is not making noticeable progress. At present, drafts with 1,230 tests, which were submitted by the Association of German Laboratory Doctors for inclusion in the fees catalogue, are being discussed by the local Associations of Public Health Service Doctors, the Federal Association of Public Health Service Doctors, the Laboratory Competence Centre and the statutory health insurance companies. Around 600 of these suggested tests have been submitted for final approval and have received a recommendation for inclusion in Standardised Medical Fee Scale. Concrete details of how this will be put into practice remain currently unclear.

In a letter to the umbrella organisation of the statutory health insurance companies and the Federal Association of Public Health Service Doctors, the working group will ask for greater transparency in this process so that the needs and interests of the developers of innovative diagnostic tests are taken into account in the reform of the Standardised Medical Fee Scale.

During the meeting of the working group, information on the Medical Fee Schedule and the appointment of the Genetic Diagnostics Commission was exchanged. The aim of the reform of the Medical Fee Schedule is to bring the schedule up to date. Among other things, the German Medical Association has recommended that the list of medical services should be adapted to current medical science and based on an up-to-date calculation system that is autonomous in its methods. The main aim of the German Medical Association is to develop the Medical Fee Schedule further in the sense of turning it into a reference fee schedule with an inter-system orientation function for the remuneration of medical services. The relationship with pharmacovigilance companies is another important component of the reform of the Medical Fee Schedule. These companies have called for an opt-out clause that would make it possible for selective contracts to be made with doctors independently of the Medical Fee Schedule.

The Genetic Diagnostics Commission was first appointed for a three-year period by the Federal Health Ministry in November 2009. The commission’s second meeting on 22 January dealt with the terms, “genetic analysis” and “proof” of the consent towards the person or institution charged with tests, but did not lead to the desired clarification.

BIO Deutschland members are welcome to request a copy of the report from the association’s office (tel: +49-30-3450 593-30, e-mail: info@biodeutschland.org).