Versorgungsstrukturgesetz (VStG)

  • Berlin/Germany

    In a statement on the healthcare structure bill („Versorgungsstrukturgesetz“ - VSG), the German Medical Technology Association (BVMed) has demanded an earlier, appropriate inclusion of affected medical device companies in the new procedure for testing examination and treatment methods in the hospital sector. When testing a medical technological method according to Art. 137 of the German Social Security Code Book V, the design of the study should be discussed jointly with the industry and healthcare providers in a consensus process. Furthermore, the medtech companies want some imprecise terms in connection with the new regulations to be clarified.

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  • Berlin/Germany

    The trial regulation for new medical examination and treatment methods with medical devices provided by the new German Law on the Stabilization and Structural Reform of the Statutory Health Insurance (Health Reform 2012) should be seen and used as an opportunity, said Dr. Ulrich Orlowski of the German Federal Ministry of Health and Dr. Rainer Hess of the Joint Federal Committee (JFC) at a BVMed conference held in Berlin in the end of January 2012. The medtech companies are confronting the topic of assessment of benefit. But due to the heterogeneity of medical devices, the industry lobbies for distinctions to be made according to risk class and degree of modification.

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  • Cologne

    Medtech companies will have to increasingly address the „benefit analysis“ topic in connection with new examination and treatment methods. The industry should develop a reimbursement scheme for innovations early on in the game, and pursue it strategically. The topic of „benefit analysis“ will at first be restricted to class IIb and III medical devices with higher risk, which make up barely 10 percent of all medical devices. This was the upshot of the „Innovation Access for Medical Technologies“ conference held in Cologne in March 2012.

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  • Berlin

    The Joint Federal Committee (JFC) and the CDU/CSU parliamentary group endorse the establishment of a fund to finance studies to be conducted under the trial regulation of new methods using medical technologies. JFC chairman Dr. Rainer Hess and the CDU member of parliament Dietrich Monstadt expressed their support of the idea at a medtech conference on the benefit analysis of medical devices in Berlin in the end of May. Monstadt mentioned a sum of 36 million Euros (0.02 percent of healthcare spending) now under consideration. This measure aspires to primarily promote the participation of smaller companies in the trial regulations.

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  • Berlin/Germany

    The sales growth rate of medical technology companies in Germany has weakened compared to last year, dropping from 5.3 to 4.4 percent. Because of sustained downward pressure on prices, increased raw material prices and higher receivables, the profit situation has deteriorated. Nonetheless, the medtech industry has continued to create additional jobs in 2012. This is the summary of the Autumn Survey 2012 of the German Medical Technology Association (BVMed) for the world‘s largest medicine trade fair MEDICA in Düsseldorf, in which 101 member companies participated.

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  • Berlin/Germany

    The trial regulation for new examination and treatment methods of medical technologies can help accelerating the pace at which medtech innovations are accepted into comprehensive coverage. The trial regulation offers a simplified and quicker access to the outpatient sector, claimed Olaf Winkler of BVMed on the intention of German legislation at the conference ”The Trial Regulation for Medical Devices in Practice”. Dr. Fülöp Scheibler from the Institute for Quality and Economic Efficiency in Healthcare (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) is optimistic about the trial regulation: ”It is an additional option.

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