Succeed in Germany’s Medical Aids Market Reimbursement and Medical Aids Index Germany Trade & Invest (GTAI) at the Medica fair Düsseldorf, November 13, 2017 Carla Meyerhoff-Grienberger, Head of Unit „Hilfsmittel“ GKV-Spitzenverband (National Association of Statutory Health Insurance Funds)
Subjects Reimbursement and Medical Aids Index 13.112017 Page 2
The Establishment of the Statutory Health Insurance Funds Association Reimbursement and Medical Aids Index 13.112017 Page 3
The Organization and Role of the Statutory Health Insurance Funds Association The National Association of Statutory Health Insurance Funds represents all statutory health and care insurance funds at federal level as well as European and international level. Its establishment is a result of the health reform in 2007. Roughly 90 percent of the population of Germany are insured in statutory health insurance funds (70.000.000 insured). The fundamental structural principles of statutory health insurance are the solidarity principle and the principle of benefits in kind. The National Association of Statutory Health Insurance Funds is a public-law corporation. It is organized in accordance with the principle of self- government, that is representatives of employers and insured make all decisions of fundamental significance. Reimbursement and Medical Aids Index 13.112017 Page 4
Our Responsibilities are To carry out statutory tasks to conclude framework contracts and remuneration agreements to support the health insurance funds and their subnational associations in carrying out their tasks to represent the interests of statutory health insurance funds at federal level in joint self-government with the health care providers (e.g. in the Federal Joint Committee) and vis-à-vis the Federal Ministry of Health to represent the interests at EU level to set reference prices for medicines and medical aids to define principles for prevention, self-help and rehabilitation creating a Medical Aids Index Reimbursement and Medical Aids Index 13.112017 Page 5
The Bodies of the National Association of Statutory Health Insurance Funds Admin inis istrat trative ive Council uncil Special alist ist 31 insured representatives Commit ittee tees Members’ Assembly ly 21 employers ’ representatives Recommendation for a resolution Depart rtments ments Represe sent ntativ atives of of Board rd and nd Unit its Health th Insura surance nce Funds nds Preparing decisions at the specialist level Reimbursement and Medical Aids Index 13.112017 Page 6
Subjects Reimbursement and Medical Aids Index 13.112017 Page 7
Medical Device and Medical Aids Regulations *Book Five of the Social Code Sozialgesetzbuch (SGB) Fünftes Buch (V) SGB V* The new European Medical Device Regulation (MDR) and Medical al Devices s Act the EU Regulation on Medizi zinp nprod rodukt uktege egese setz tz (MPG) In Vitro Diagnostics replace existing Council ncil Directive ctive 93/42/EE 42/EEC medical device on medica cal l devices es guidelines. (Medical al Device Direc ective tive - MDD) te Richtlini htlinie e 93/42/EW 2/EWG G über Medizinprod inproduk ukte Reimbursement and Medical Aids Index 13.112017 Page 8
Medical Devices (Chapter I, Article 2, N o 1 MDR, previously § 3 MPG) The term "medical device" means an instrument, object, device, software, implant, reagent, material or other article which, according to the manufacturer, is intended for human beings alone or in combination to fulfill one or more of the following specific medical purposes: - Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of diseases, - Diagnosis, monitoring, treatment, alleviation or compensation for an injury or a disability, ... Reimbursement and Medical Aids Index 13.112017 Page 9
Medical Aids (§ 33 SGB V) are products like hearing aids, visual aids, prostheses, orthopedic and other medical aids, that are required in individual cases - to ensure successful treatment of disease - to prevent an anticipated disability or - to compensate for a disability. Medical aids don‘t include - products of daily use or - products excluded according to § 34 SGB V (certain products of doubtful medical benefit or low sales price) Reimbursement and Medical Aids Index 13.112017 Page 10
No Medical Aids Products for daily use Certain products with disputed therapeutic benefit or with low Products which are already sales price financed by other regulatory mechanisms Medical dressings Products which are only used in Implants hospitals or doctors’ surgeries Most of these products are medical devices but, no medical aids. Reimbursement and Medical Aids Index 13.112017 Page 11
Overlapping fields Protec tectio tion products ducts Medica cal device ices Ot Other products ducts Reimbursement and Medical Aids Index 13.112017 Page 12
The Medical Aids Index (Hilfsmittelverzeichnis) As a matter of principle, costs for medical aids can only be met by statutory health insurance if the products are included in the list of medical aids (Medical Aids Index). The list of medical aids is not binding in the legal sense, but it has a market-steering effect, as has been found by the established case-law of the highest courts. It provides comprehensive information on the obligation of the health insurance funds to pay, as well as on the nature and quality of the products that are available on the market. The National Association of Statutory Health Insurance Funds has developed an online version of the aids list. This web-based application enables to call up all the information from the medical aids index. See www.gkv-sp spit itzen zenverban verband.de .de. Reimbursement and Medical Aids Index 13.112017 Page 13
Legal basis § 139 9 (1) ) SGB V The National Association of Statutory Health Insurance Funds works out a structural register of medical aids. The register must include medical aids which are financed by the health insurances. § 139 9 (2) ) SGB V In order to ensure a reasonable, appropriate and efficient supply there can be formulated special indication-based and application-oriented quality requirements concerning the medical aids. There can also be formulated special quality requirements to render a sufficiant period of operating life of the products or to make the reuse of the products for other insured possible. Reimbursement and Medical Aids Index 13.112017 Page 14
Legal basis § 139 9 (3) ) SGB V The entry of a product in the Medical Aids Index presumes an application of the manufacturer. § 139 9 (4) ) SGB V The medical aids must be listed if the manufacturer has proved their performance and safety, and their conformity with the quality requirements according to the requirements of the Medical Aids index and if necessary the medical value. § 139 9 (5) ) SGB V Concerning medical devices a product’s performance and safety are in principle covered by CE marking. Reimbursement and Medical Aids Index 13.112017 Page 15
Structure of the Medical Aids Index Depending on the area of indication or intended use, the products available on the market are assigned to different product groups. Th The e forma rmation tion of a p a produc duct t group: up: Structure, outline, table of contents definition with universal indications that justify the use of the products in medical terms in general sub-product groups (requirements acc. to section 139 of Book Five of the Social Code) product type descriptions including a list of the specific indications justifying their use product overview Reimbursement and Medical Aids Index 13.112017 Page 16
Product Requirements P roduct’s performance, technical functionality I. II. Safety (Evidence covered by CE marking) III. Special quality requirements for the products III.1 Indication-based and application-oriented requirements for quality III.2 Requirements for the period of service life III.3 Requirements for reuse IV. Medical benefit if necessary V. Product information VI. Other requirements Reimbursement and Medical Aids Index 13.112017 Page 17
Product overview Products are included in the list of aids/Medical Aids Index at the request of the manufacturers (or of third parties empowered by them) if they have specific characteristics and meet certain quality criteria. There are specific application forms per product group on the website www.gkv-spitzenverband.de, that show which proofs have to be provided. Products for which the medical value, the product’s performance and the quality [i.e. the product requirements that are mentioned in the Medical Aids Index] have been proved, are listed, according to the appropriate decision of the National Association of Statutory Health Insurance Funds in the product overview of the register. The costs of the supply provided are generally be assumed by the health insurance funds when the medical aids are listed in the index. Reimbursement and Medical Aids Index 13.112017 Page 18
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