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Subjects
Reimbursement and Medical Aids Index
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Succeed in Germanys Medical Aids Market Reimbursement and Medical - - PowerPoint PPT Presentation
Succeed in Germanys Medical Aids Market Reimbursement and Medical - - PowerPoint PPT Presentation
Succeed in Germanys Medical Aids Market Reimbursement and Medical Aids Index Germany Trade & Invest (GTAI) at the Medica fair Dsseldorf, November 13, 2017 Carla Meyerhoff-Grienberger, Head of Unit Hilfsmittel GKV-Spitzenverband
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The Establishment of the Statutory Health Insurance Funds Association
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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.
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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
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The Bodies of the National Association of Statutory Health Insurance Funds
Members’ Assembly ly Admin inis istrat trative ive Council uncil
31 insured representatives 21 employers’ representatives
Board rd Represe sent ntativ atives of
- f
Health th Insura surance nce Funds nds Special alist ist Commit ittee tees Depart rtments ments and nd Unit its
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Recommendation for a resolution Preparing decisions at the specialist level
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Subjects
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Medical al Devices s Act Medizi zinp nprod rodukt uktege egese setz tz (MPG) SGB V* Council ncil Directive ctive 93/42/EE 42/EEC
- n medica
cal l devices es (Medical al Device Direc ective tive - MDD) Richtlini htlinie e 93/42/EW 2/EWG G über Medizinprod inproduk ukte te *Book Five of the Social Code Sozialgesetzbuch (SGB) Fünftes Buch (V)
Medical Device and Medical Aids Regulations
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The new European Medical Device Regulation (MDR) and the EU Regulation on In Vitro Diagnostics replace existing medical device guidelines.
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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, ...
Medical Devices (Chapter I, Article 2, No 1 MDR, previously § 3 MPG)
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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
- f doubtful medical benefit or low sales price)
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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.
No Medical Aids
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Medica cal device ices Protec tectio tion products ducts Ot Other products ducts Overlapping fields
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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.
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§ 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.
Legal basis
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§ 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.
Legal basis
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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
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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
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Products are included in the list of aids/Medical Aids Index at the request
- f 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.
Product overview
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15. . 25. 01 . 01. . 0 1 123
product group area of application specific product subgroup product type
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).
Structure of the individual item number
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National Association
- f Statutory Health
Insurance Funds Medical Aids Index
Product and performance requirements must be based on the contracts at least.
Manufacturer
applies for the inclusion of a product in the Medical Aids Index
Agreement in an individual case
draws up
Negotiation accession Invitation to tender
Possibilities of concluding the contract
Qualification Certificate Supply contract
Application Decision Inclusion of a product in
Technical suitability Professional suitability
Health insurance funds an service providers conclude contracts that form the basis for the care of the insured.
Health insurance fund Care provider
Market access for medical devices through conformity assessment Product may be part of a new treatment method Positive recommendation
The supply system in Germany
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Joint Federal Committee
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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.
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Subjects
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HHVG – Heil- und Hilfsmittelversorgungsgesetz: law of April 4, 2017 The new law “HHVG” regulates the supply of medical aids.
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Improving
- ving the supply
y of medical ical aids.
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New Legal Regulations for the Medical Aids Index
Systematic review of the list of aids and, if necessary, revision by 31.12.2018
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
- f the Medical Aids Index
Possibility of seeking opinions from experts
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Status of the Revision of the Medical Aids Index
Updated product groups 14.10.2013 + 31.08.2015: Product group 13 hearing aids 31.08.2015: Product group 17 Aids for compression therapy 07.03.2016: Product group 15 Incontinence aids 24.10.2016: Product group 08 Deposits 24.10.2016: Product group 06 Irradiation equipment 16.12.2016: Product group 19 Nursing products 16.12.2016: Product group 50 Specific care aids 17.10.2017: Product group 52 Specific care aids (home emergency call devices) 13.11.2017: Product group 21 Body state/function measuring instruments 13.11.2017: 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
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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 www.gkv-spitzenverband.de 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.
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