gms | German Medical Science

11. Jahrestagung 2004 der GAA

Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie

30.09. bis 01.10.2004, Jena

Medical Technical Aids: abuse of Registration Numbers

Meeting Abstract

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  • corresponding author presenting/speaker E. Scharnetzky - Bremen University, Centre for Social Policy Research, Drug Utilization Research Unit
  • B. Deitermann - Bremen University, Centre for Social Policy Research, Drug Utilization Research Unit
  • G. Glaeske - Bremen University, Centre for Social Policy Research, Drug Utilization Research Unit

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA) e.V.. 11. Jahrestagung der Gesellschaft für Arzneimittelforschung und Arzneimittelepidemiologie (GAA) e.V.. Jena, 30.09.-01.10.2004. Düsseldorf, Köln: German Medical Science; 2004. Doc04gaa07

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/gaa2004/04gaa07.shtml

Veröffentlicht: 30. September 2004

© 2004 Scharnetzky et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielfältigt, verbreitet und öffentlich zugänglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Context

Medical technical aids are registered in Germany by the confederation of statutory health insurances if they fulfil defined standards of therapeutic use, quality and safety. Products are listed in the register (Hilfsmittelverzeichnis) with a ten digit registration number, the technical aids registration number (Hilfsmittelpositionsnummer). For accounting purposes a second code is used: the pharmaceutical registration number (Pharmazentralnummer = PZN). When applying for a PZN the applicant is asked whether the product has already been registered as a technical aid.

Aim of the Study

To check whether the Hilfsmittelpositionsnummer is misused.

Material and Method

The data from the Hilfsmittelverzeichnis in January 2004 were compared with the data referring to the PZN (ABDA-Artikelstamm) of January 2004.

Results

The only possibility to compare the two sets of data is the name of the product. The Hilfsmittelverzeichnis does not contain a PZN. Since there are up to 1.473 PZN for one Hilfsmittelpositionsnummer the use of this number is also very limited. Of the 68.723 products with a PZN claiming also to have a Hilfsmittelpositionsnummer only 74 (0.11%) could be identified in the Hilfsmittelverzeichnis with an identical name. Three patterns of abuse could be identified:

• A non existing Hilfsmittelpositionsnummer was used by 16 companies for 59 products.

• One company uses a Hilfsmittelpositionsnummer which has been listed for another company.

• A company uses a Hilfsmittelpositionsnummer for other than the registered products.

Conclusion

There appears to be frequent misuse of the Hilfsmittelpositionsnummer by a number of producing companies.This abuse potentially endangers patients because these products have not been tested according to the accepted standards. Registration in the Hilfsmittelverzeichnis limits insurance coverage to the listed products. Through misuse of a Hilfsmittelpositionsnummer insurances are led to believe that they have to cover the costs for these products. Changes are necessary to stop these practices.

Conflict of interest:This study was funded by a German statutory health insurance, Gmuender Ersatzkasse (GEK).