German law hinders use of medical devices

11 May 2006

Bonn, Germany. German medical device manufacturers and healthcare providers have demanded a clarification of the legal conditions for the adoption of medical technical aids into the medical technical aids register (Hilfsmittelverzeichnis — HMV). Entry in the register allows the cost of medical devices to be claimed under medical insurance.

At a MedInform conference, “Medical technical aids register put to the test — bureaucratic hurdle or a useful control mechanism?”, in Bonn on the 26 April 2006, Professor Hans-Georg Will from the Federal Ministry of Health announced that legal situation of the medical technical aids register will be clarified. MedInform is the information and seminar service of the German Medical Technology Association, BVMed.

In Professor Will’s opinion, problems have been caused by the German  medical devices law. “In essence, proof required for the granting of a CE-mark should not be systematically demanded once again by the statutory health insurance funds,” said the ministry expert.

Governmental considerations appear to be moving the debate in the direction of “concrete legal guidelines for the adoption of a product into the technical aids register”. This will include the setting out of required and non-required tests and evidence. The time limit for the inclusion of new technical aids into the register could be shortened to three months. In addition, the meaning of the HMV register will be legally clarified. However, at this period of the discussion, “radical changes” are not to be expected.

Representatives from manufacturers and healthcare providers demanded a clarification of the legal conditions for the adoption of medical technical aids into the register and for the legal guidelines to ensure that products that have a similar function or effect are included in the same product category.

This requires a clarification of the terminology, in particular the “therapeutic value” that is demanded, as well as the necessary adaptation to the medtech aids guidelines laid down by the joint federal committee (Gemeinsamer Bundesausschuss = G-BA).

BVMed Director General Joachim M. Schmitt set out the combined aim of guaranteeing patients qualitatively high-value care, whilst ensuring that appropriate reimbursement is on offer. In this respect, high-level co-operation and dialogue with health insurance funds have recently improved. However, there remain in certain cases problems with regional health insurance funds concerning “other requirements”.

Carla Grienberger from the Federal Association of the Guilds’ Health Insurance Funds (IKK) confirmed that contacts with industry had indeed improved. “Applications to the HMV register are well structured. Problems are the exceptions,” she said. The length of the adoption procedure is far less than expected, she added. Problems with hitting the six-month target only occurred when applicants’ documentation was deficient or incomplete as well as in the case of open product groups. “When all the documentation is available on average we manage it within two to three months,” said the IKK expert. Even the health insurance funds are demanding that the government provides “a legally-sound description of the procedure on the adoption of products into the medical technical aids register and the establishment of standards”.

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