Succeed in Germany s Medical Aids Market. Reimbursement and Medical Aids Index

Transcription

1 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)

2 Subjects Reimbursement and Medical Aids Index Page 2

3 The Establishment of the Statutory Health Insurance Funds Association Reimbursement and Medical Aids Index Page 3

4 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 Roughly 90 percent of the population of Germany are insured in statutory health insurance funds ( 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 selfgovernment, that is representatives of employers and insured make all decisions of fundamental significance. Reimbursement and Medical Aids Index Page 4

5 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 Page 5

6 The Bodies of the National Association of Statutory Health Insurance Funds Members Assembly Administrative Council 31 insured representatives 21 employers representatives Specialist Committees Recommendation for a resolution Representatives of Health Insurance Funds Board Departments and Units Preparing decisions at the specialist level Reimbursement and Medical Aids Index Page 6

7 Subjects Reimbursement and Medical Aids Index Page 7

8 Medical Device and Medical Aids Regulations The new European Medical Device Regulation (MDR) and the EU Regulation on In Vitro Diagnostics replace existing medical device guidelines. *Book Five of the Social Code Sozialgesetzbuch (SGB) Fünftes Buch (V) SGB V* Medical Devices Act Medizinproduktegesetz (MPG) Council Directive 93/42/EEC on medical devices (Medical Device Directive - MDD) Richtlinie 93/42/EWG über Medizinprodukte Reimbursement and Medical Aids Index Page

9 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 Page

10 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 Page

11 No Medical Aids Products for daily use Products which are already financed by other regulatory mechanisms Products which are only used in hospitals or doctors surgeries Certain products with disputed therapeutic benefit or with low sales price Medical dressings Implants Most of these products are medical devices but, no medical aids. Reimbursement and Medical Aids Index Page 11

12 Overlapping fields Medical devices Protection products Other products Reimbursement and Medical Aids Index Page 12

13 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 Reimbursement and Medical Aids Index Page

14 Legal basis 139 (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 (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 Page

15 Legal basis 139 (3) SGB V The entry of a product in the Medical Aids Index presumes an application of the manufacturer. 139 (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 (5) SGB V Concerning medical devices a product s performance and safety are in principle covered by CE marking. Reimbursement and Medical Aids Index Page 15

16 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. The formation of a product group: 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 Page 16

17 Product Requirements I. Product s performance, technical functionality 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 Page

18 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 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 Page

19 Structure of the individual item number product group specific product area of application product type subgroup The products are entered with product name, article number, manufacturer s name and product-specific information in the Medical Aids Index. They each receive an individual ten-digit item number (Hilfsmittel- Positionsnummer). Their entry into the register must be made public in the German Federal Gazette (Bundesanzeiger). Reimbursement and Medical Aids Index Page 19

20 The supply system in Germany Manufacturer applies for the inclusion of a product in the Medical Aids Index Market access for medical devices through conformity assessment Qualification Certificate Professional suitability Technical suitability Application Decision Inclusion of a product in Positive recommendation Product may be part of a new treatment method National Association of Statutory Health Insurance Funds draws up Medical Aids Index Product and performance requirements must be based on the contracts at least. Supply contract Health insurance fund Care provider Joint Federal Committee Possibilities of concluding the contract Invitation to tender Negotiation accession Agreement in an individual case Health insurance funds an service providers conclude contracts that form the basis for the care of the insured. Reimbursement and Medical Aids Index Page 20

21 Requirements for contractors The requirements of the Medical Aids Index must at least be based on the supply contracts between health insurance companies and service providers. There are three contract types. The service providers must meet the requirements for a sufficient, functional and appropriate manufacturing, supply and application of the medical aids during the term of a contract. The National Association of Statutory Health Insurance Funds works out these requirements. Certain prequalification bodies (or the health insurances in case of 127 (3) SGB V have to check these requirements before the contract is concluded. Reimbursement and Medical Aids Index Page

22 Subjects Reimbursement and Medical Aids Index Page 22

23 Improving the supply of medical aids. HHVG Heil- und Hilfsmittelversorgungsgesetz: law of April 4, 2017 The new law HHVG regulates the supply of medical aids. Reimbursement and Medical Aids Index Page 23

24 New Legal Regulations for the Medical Aids Index Systematic review of the list of aids and, if necessary, revision by Mandatory definition of special quality and supply requirements Regular, time-bound updating of the Medical Aids Index Obligation of manufacturers to indicate product changes New procedure for removing products that no longer meet the requirements of the Medical Aids Index Possibility of seeking opinions from experts Reimbursement and Medical Aids Index Page 24

25 Status of the Revision of the Medical Aids Index Updated product groups : Product group 13 hearing aids : Product group 17 Aids for compression therapy : Product group 15 Incontinence aids : Product group 08 Deposits : Product group 06 Irradiation equipment : Product group 19 Nursing products : Product group 50 Specific care aids : Product group 52 Specific care aids (home emergency call devices) : Product group 21 Body state/function measuring instruments : Product group 34 Hair replacement In commenting procedure Product group 04 Bathing aids Product group 07 Blind aids (including guide dogs) Product group 33 Toilet aids Reimbursement and Medical Aids Index Page 25

26 The Most Important Thing for You summarized Although the Medical Aids Index is not legally binding it is necessary for successful business that the medical aids are entered the index. For this you have to submit an application to the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds). On the website you will receive the essential information on the application. There are also product group specific application forms available. Prices that you can obtain for your products are individually regulated by contract. The Medical Aids Index is updated regularly. You should be aware of the developments. Reimbursement and Medical Aids Index Page 26

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