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• W2133539145 abstract "This article deals with the situation of reimbursement and application for reimbursement of diabetes medical devices by statutory sickness funds in Germany, who represent more than 90% of the market.The bases are both the SGB (Social Code), which regulates a sufficient, comprehensive, necessary, and economic social security, and the MPG (Medical Devices Code), which regulates the conditions under which a product may qualify to become a medical device, jurisdictions (BSG case B3KR25/05R and B3KR21/99R), and other sources that can be found in the abbreviations section.There are a total of more than 400 000 different products summarized under “medical devices.” They all have in common—different from pharmaceuticals—that they mainly have a “physical mode of action,” that is, they do not have a pharmacological effect and will not be absorbed and used up by the body. Medical devices are designed for diagnosing, preventing, screening, and treating diseases. They can be pacemakers, ultrasound equipment, insulin pump catheters, surgical dressings, software, and disposable prefilled syringes.A product qualifies as a medical device pursuant to the MPG when the manufacturer offers it for the use of patients and the handicapped. Thus, qualification is based only on the purpose defined and given by the manufacturer. The product has to be certified (CE certification) and must fulfill the conditions of the MPG, ensuring the quality of the product and the safety of patients and users. Through a defined procedure the manufacturer has to prove that the product fulfils all these conditions. Medical devices that under EU law can be legally sold in 1 member state consequently can be sold in all member states. However, this certification is not about the medical benefit of the product.Proof of functionality, safety, and medical benefit of a product through the manufacturer is the prerequisite for the listing of the product as a therapeutic appliance in the list of medical devices of the GKV Spitzenverband.The listing again is the prerequisite for a product to be reimbursed by the statutory sickness funds. Although this list is not binding, it has a steering effect, meaning also that a product may achieve reimbursement by the single decision of an independent sickness fund. However, the list provides overall information about the reimbursement duty of a sickness fund and the quality and variety of products in the market.The manufacturer applies at the GKV Spitzenverband for the listing (see § 139 of SGB V), who can involve the MDK in the decision-making process, for instance, to checkFunctionality and safety of the product (fulfilled by CE certification)The proven medical benefitIndication- or use-related conditionsUser manuals in German to ensure safe handling of the productWeather additional services must be provided by the sickness funds accompanying the use of the productIn case of a positive decision, which can take up to 6 months after filing, the product will receive a so-called medical device number, which shows it classification into the 33 different product groups, (eg, aids for application, surgical dressings, aids for inhalation, and systems to measure body functions).Each product group contains definitions with advice about medical indications that justify a respective use and reimbursement. In addition, minimum quality and conditions under which the product can be provided are fixed to ensure a necessary, high-quality, and reliable social security.The statutory sickness funds provide their services under a binding principle regulated in section 12 of SGB V: The services have to be sufficient, reasonable, and economic and may not exceed necessity.Services that are not necessary or economic cannot be demanded by the insured and may not be provided by sickness funds." @default.
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• W2133539145 date "2014-01-01" @default.
• W2133539145 modified "2023-09-24" @default.
• W2133539145 title "Reimbursement for Diabetes Medical Devices in Germany" @default.
• W2133539145 doi "https://doi.org/10.1177/1932296813516184" @default.
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