Exporting to Germany

1

• Exporting to Germany
• Reimbursement and Hilfsmittelliste
• (Medical Aids Directory)
• By Carla Grienberger
• Federal Association of Craft Guild Health
  Insurances in Germany
• IKK-Bundesverband
• 17th and 18th of March 2008

2
Agenda

• Legal basis and definitions
• medical devices (Medizinprodukte) in the German
  Health Care System GHCS see tabled draft
• medical aids (Hilfsmittel) in the German Health
  Care System GHCS
• Facts and figures about the German market and
  other aspects and market influence
• Medical aids directory (Hilfsmittelverzeichnis)
• legal basis and background
• structure of the register
• administrative procedure concerning the entry of
  products
• manufacturers application

3
Legal basis and definitions
4
Legal basis
National legislation
SGB V
Book Five of theGerman Social Code
Sozialgesetzbuch (SGB)Fünftes Buch (V)
National transpositionof the MDD
Medical Devices Act Medizinproduktegesetz (MPG)
Europeanlegislation
Council Directive 93/42/EECon medical
devices (Medical Device Directive -
MDD) Richtlinie 93/42/EWGüber Medizinprodukte
5
Medical devices (Medizinprodukte) 3 MPG
are all - instruments - apparatus -
appliances - substances or preparations made
from substances or - other articles ..., used
alone or in combination intended by the
manufacturer to be used for human beings, , for
the purpose of - diagnosis, prevention,
monitoring, treatment or alleviation of
disease or - diagnosis, monitoring, treatment,
alleviation or compensation of injuries or
handicaps and which do not achieve their
principal intended action in or on the human body
by pharmacological, immunological or metabolic
means, but which might be assisted in their
function by such means.
6
Medical aids (Hilfsmittel) 33 SGB V
are products like - hearing aids - visual
aids (only in certain cases) -
prosthetic - orthopaedic and - other
medical aids, if they are necessary in
individual cases - to ensure successful
treatment of disease - to prevent an
anticipated disability or - to compensate for
a disability. Medical aids dont include -
products for daily use or - certain products
of doubtful efficacy or low sales price
(these products are mentioned in the legal
regulation according to 34 SGB V).
7
Overlapping fields
protectionproducts
medicaldevices
medical aids
other products
8
Examples of medical devices

• X-ray machines
• Oxygen masks
• Hip-knee joint replacements
• Eye glasses, contact lenses
• Radiotherapy units
• Cardiac pacemakers
• Medical stockings
• Various surgical instruments
• Cardiac stents
• Dialysis cannulae
• Magnetic resonance imaging
• Implants
• Medication infusion systems
• Adult incontinence products

• Wound care surfaces
• Electric patient lifts
• Artificial hearts
• Anti-decubitus aids
• Neurostimulators
• Medical dressings
• Intraocular lenses
• Balloon catheters/catheters
• Defibrillators
• Dentistry tools
• Hearing aids
• Intra-aortic balloon pumps
• Operation tables
• Enteral feeding tubes

Estimated number of medical devices worldwide
400,000 various types
9
Features of medical aids (Hilfsmittel)

• Medical aids serve to substitute, complement or
  improve bodily faculties of the individual, in
  order to carry out daily activities as
  independently as possible.
• According to current legal practice, medical
  appliances must eliminate the effects of the
  disability in daily life or reduce them, thereby
  meeting fundamental requirements of daily life
  (Grundbedürfnisse des täglichen Lebens).
• The SHI is not responsible for compensating
  disadvantages experienced in certain areas, such
  as in occupation, society or leisure time.
• Medical aids are used at home by insured persons.

10
No medical aids (Hilfsmittel)

• Products for daily use (Gebrauchsgegenstände)
• Products which are already financed by other
  regulatory mechanisms
• Products which are only used in hospitals or
  doctors surgeries (Sachkosten,
  Sprechstundenbedarf)

• Certain products of disputed therapeutic
  usefulness or with low sales price (Produkte von
  geringem therapeutischen Nutzen oder Abgabepreis
  - 34 SGB V)
• Medical dressings (Verbandmittel)
• Implants (Implantate)

Most of these products are medical devices
(Medizinprodukte)
11
Sectors of medical aids (Hilfsmittel)
12
Facts and figures about the German market and
other aspects
13
World market for medical devices
medical aids5 billion EUR
Japan
Other countries
Rest of Europe
Germany
Europe
USA
UK
France
Italy
Total expenses 2003 184 billion EUR
Source Eucomed
14
Supply chain
Manufacturer of medical aids
Wholesaler and cooperative groups
Mail-order business
Health care provider/specialized trade
Insured person Payment of the health insurance
funds
15
Specialized trade
16
Market influence and changings
Concentration of the health insurance funds
Entitlement mentality
Reference prices
New distributionchannels
Changes of the SHI range of benefits
Market
New types ofhealthcare
Jurisdiction
Increasing price and quality competition
Increasing import quota
Participantsbehaviour
Legislation
Globalisation
17
Medical aids directory (Hilfsmittelverzeichnis)
18
Legal basis
139 para. 1 SGB V   The National Associations
of the Statutory Health Insurance Funds
(Spitzenverbände der Krankenkassen) jointly and
concerted work out a structural medical aids
directory (Hilfsmittelverzeichnis). The
register must include medical aids (Hilfsmittel)
which are financed by the health insurance funds
(Krankenkassen). . 139 para. 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 orto make the
reuse of the products for other insurees
possible.
19
Background

• The costs of the supply provided are generally be
  assumed by the health insurance funds when the
  medical aids are listed in a special register,
  the medical aids directory (Hilfsmittelverzeichnis
  ).
• Although the register is not legally binding it
  is necessary for successful business that the
  medical aids are entered the register.
• This is drawn up under the observation of the
  relevant legal regulations by the National
  Associations of the Statutory Health Insurance
  Funds (Spitzenverbände der Krankenkassen) under
  the auspices of the Federal Association of Craft
  Guild Health Insurances (IKK-Bundesverband).

20
Structure of the register

• The medical aids directory (Hilfsmittelverzeichnis
  ) is divided into 33 product groups
  (Produktgruppen) according to the types of
  products e.g. bandages, ostomy articles,
  orthopaedic soles, walking aids, visual aids,
  communication products.
• The product groups are divided into subgroups
  (Untergruppen).
• The quality requirements (Qualitätsanforderungen)
  have each been determined for a subgroup.
• They describe the medicinal and technical
  characteristics of the products which must be
  observed and verified according to scientific
  standards.

21
Product overview (Einzelproduktliste)

• Medical aids are registered in the medical aids
  directory (Hilfsmittelverzeichnis) upon the
  manufacturers application.
• Products for which the medical value, the
  products performance and the quality i.e. the
  product requirements of the medical aids
  directory have been proved, are listed,
  according to the appropriate decision of the
  National Associations of the Statutory Health
  Insurance Funds (Spitzenverbände der
  Krankenkassen) in the product overview of the
  register.

22
Structure of the individual item number
15. 25. 01. 0 123
product group
specific product
area of application
product type
subgroup
The products are entered in the medical aids
directory (Hilfsmittelverzeichnis) with product
name, manufacturers name and product-specific
information. They each receive an individualten
digit item number (Hilfsmittel-Positionsnummer).
Their entry into the register must be made
public in the German Federal Gazette
(Bundesanzeiger). See also http//www.g-k-v.de/g
kv
23
Product requirements (standards)

• I. Products performance, technical
  functionality
• II. Safety (Evidence covered by CE-marking)
  
• Special quality standards
• III.1 indication-based and application-oriented
  requirements for quality
• III.2 Requirements for period of operating
  life
• III.3 Requirements for reuse
• IV. Therapeutic/medical value
• Product information
• Other requirements

24
Legal basis
139 para. 3 SGB V  The entry of a product in
the medical aids directory (Hilfsmittelverzeichnis
) presumes an application of the manufacturer.
The National Associations of the Statutory
Health Insurance Funds (Spitzenverbände der
Krankenkassen) come to a decision jointly and
concerted concerning the applicaton. They can
involve the medical review board (Medizinischer
Dienst) in advance. 139 para. 4 SGB V The
medical aids must be listed if the manufacturer
has proofed their performance and safety, and
their conformity with the quality requirements
according to para. 2 and if necessary the medical
value . 139 para. 5 SGB V Concerning medical
devices (Medizinprodukte) a products
performanceand safety are categorically covered
by CE marking. Therefore the National
Associations of the Statutory Health Insurance
Funds (Spitzenverbände der Krankenkassen) check
theCertificate of Conformity (Konformitätserkläru
ng) formally .
25
Administrative procedure
26
Manufacturer's application

• The manufacturers application must be submitted
  in writing to the IKK Federal Association
  (IKK-Bundesverband), in German language.
• For this purpose there are product group specific
  application forms available, which may be
  requested from the IKK Federal Association
  (IKK-Bundes-verband) or downloaded from the
  Internet.
• The applicant must prove the product requirements
  of the medical aids directory.
• In some cases it is useful, if evidence is drawn
  up by appropriate, independent persons or
  institutions (e.g. well-known offices or
  accredited inspection institutes).

27
Manufacturer's application

• The application forms must be completed in full
  and all required documents and verification must
  be attached.
• All evidence (statements, experts reports etc.)
  must be current and valid.
• In the event that not all these requirements are
  fulfilled or certain issues are inapplicable for
  the product applied for, this must be thoroughly
  explained and noted.
• Incomplete applications are rejected.
• Should evidence be missing, the applicant will be
  required to supply the missing documents before
  the final decision is made (hearing).

28
Thank you for your attention!