Webinar Reimbursement of Innovative
Medical Devices in Germany
Agency for Health Economic Assessment
and Dissemination
MArS - AHEAD
MArS and AHEAD are two separate consulting agencies that
collaborate in order to offer high quality market access and
reimbursement solutions for the European healthcare setting
MArS UG – Market Access & Pricing Strategy
 Market access & pricing as well as global clinical development
strategies from a health care payer's perspective in the various lifecycle
stages of a medical device or pharmaceutical product
 German market access strategies and implementation for
pharmaceuticals and medical devices
AHEAD GmbH
is a specialized consulting agency that supports clients
 in the planning, generation and dissemination of health economic
evidence
 as well as in obtaining market access and reimbursement for both
medical devices and pharmaceuticals in Germany.
MArS - AHEAD
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MArS and AHEAD are two separate consulting agencies that
collaborate in order to offer high quality market access and
reimbursement solutions for the European healthcare setting
Dr. Stefan Walzer
Bjoern Schwander
 9+ years experience in market
access & pricing strategy and its
implementation
 Lecturer at the State University
Baden-Wuerttemberg (Germany)
 Founder & General Manager of
MArS based in Germany
 Master in Economics, PhD in
(Health) Economics, Diploma in
Clinical Trials
 30 full text publications
 > 60 conference presentations
 12 years experience in market access
and health economic consultancy
 Various experience in the planning &
implementation of the reimbursement
of medical devices in Germany
 Founder & General Manager of
AHEAD based in Germany
 Nursing Diploma, BSc in Applied
Health Sciences, Master program in
Health Economics
 > 20 publications & conference
presentations
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79 Mio Germans have either private or statutory health
insurance coverage and in 2012 the healthcare expenditure on
medical devices in Germany reached 25 billion euros
Number of health insured patients in Germany
Private Health
9.0
Insurance
Statutory Health
Insurance
70.0
0.0
50.0
100.0
Insured persons in millions (Status 11/2012)
Healthcare Expenditure on Medical Devices in Germany in
Billion Euros
26
Billion Euros
25
24
23
22
21
20
21
22
25
25
2011
2012
23
19
2008
2009
2010
Reference Year
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For the market access of innovative medical devices in
Germany it plays a key role whether a medical device is
applied in the inpatient or in the outpatient setting
Inpatient
Outpatient
All innovative procedures are permitted
with the reservation of prohibition
(‚Verbotsvorbehalt‘ SGB V §137c)
All innovative procedures are prohibited
until they have been officially approved
(‚Erlaubnisvorbehalt‘ SGBV § 135;1)
Within the hospital (inpatient) new CE
marked medical devices can be applied
as long as they are not actively prohibited
by the joint federal committee
Before a new medical device can be
applied in the outpatient setting a positive
voting from the joint federal committee is
required
The hospitals are allowed to apply all
CE marked innovations
Long application process in order to
gain approval for applying innovations
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There are several possible reimbursement pathways for
innovative medical devices depending on whether a medical
device is applied in the inpatient or in the outpatient setting
CE Mark
Outpatient
Inpatient
Adequate
OPS/DRG
available
New
OPS/DRG
required
‘On-top
payment
required’
Additional
evidence
required
Inclusion
in fee
schedules
Out of
pocket
payments
Individual health
insurance
coverage
Already
reimbursed
OPS/DRG
application
NUB (ZE)
application
Application
Experimental
Coverage
EBM / GOÄ
Application
IGeL
Application
Selective
Contracts
1
2
3
7
4
5
6
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The inpatient reimbursement in Germany depends on whether
adequate coding (OPS) and adequate coverage (DRG) is
available - if not specific applications need to be performed
CE Mark
Inpatient
New
OPS/DRG
required
‘On-top
payment
required’
Adequate
OPS/DRG
available
OPS/DRG
application
NUB (ZE)
application
Already
reimbursed
2
3
1
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For the reimbursement of inpatient services in Germany a
DRG based system is used: Specific DRGs are defined by a
combination of disease (ICD) and procedure (OPS) coding
ICD-GM Coding
OPS Coding
German version of the International
Statistical Classification of Diseases
and Related Health Problems (ICD)
German version of the International
Classification of Procedures in
Medicine (OPS = Operationen- und
Prozedurenschlüssel)
Specific G-DRG
German Diagnosis Related Groups
that are linked to a specific
reimbursement value
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Scenario 2a - after performing an initial coding/coverage
research it is obtained that changes in the OPS system are
required in order to achieve an adequate reimbursement
Application Form
OPS application
2a
DIMDI (German Institute of Medical
Documentation and Information) provides an
application form and is the addressee of the
OPS application
Deadline for OPS changes in the following
year is end of February in the current year
The responsible German Medical
Society should be involved
•
•
•
•
Form is released in December
Submission deadline is end of February
Decision is released end of August
Valid from January of the following year
http://www.dimdi.de/static/de/klassi/ops/vorschlagsverfahren/index.htm#vorschlagsformular
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Scenario 2b - after performing an initial coding/coverage
research it is obtained that changes in the DRG system are
required in order to achieve adequate reimbursement
DRG application
Application Form
2b
InEK (Institute for the Hospital
Remuneration System) provides an
application form and is the addressee for
DRG applications
Deadline for DRG changes in the following
year is end of February in the current year
The responsible German Medical
Society should be involved
•
•
•
•
Form is released end of November
Submission Deadline is end of February
Decision is released end of August
Valid from January of the following year
http://www.gdrg.de/cms/G-DRG-Vorschlagsverfahren
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Scenario 3 - after performing an initial coding/coverage
research it is obtained that an ‘on-top payment’ is required in
order to achieve adequate reimbursement
NUB application
Application Form
3
InEK provides an application form and is the
addressee for NUB (Neue Untersuchungsund Behandlungsmethoden) applications
Deadline for NUB applications in the following
year is end of October in the current year
Each hospital needs to submit an own NUB
application – the InEK decides whether a
‘on-top payment’ can be negotiated
•
•
•
Form is released in September
Submission deadline is end of October
Decision is released end of January of the
following year and the NUB is then valid
http://www.gdrg.de/cms/content/download/3636/30201/version/1/file/NUB.exe
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Obtaining the inpatient reimbursement strategy is a step-wise
approach and in the best case it might be obtained that an
adequate DRG reimbursement is already available
OPS code available?
NO
YES
Relevant DRG available?
OPS
application
2a
NO
YES
DRG fee adequate?
DRG
application
2b
NO
3
NUB (ZE)
application
YES
1
Reimbursement is already available!
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The inpatient reimbursement process is clearly structured
and there is no need to provide any specific clinical or health
economic evidence during the application process
 For the application of a new medical device in the inpatient
sector only a CE mark is required.
 The reimbursement fee of a new medical device depends on the
available coding, grouping & coverage options.
 In a first research step an initial coding/coverage research
should be performed in order to identify the best strategy for an
innovative medical device.
 For each reimbursement pathway there are specific application
procedures available – with a clear process & timing structure.
 There is no need to provide any specific clinical or health
economic evidence during the inpatient reimbursement
application process.
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For the outpatient reimbursement there are different strategies
available – the best one would be obtaining inclusion in the
official fee schedules for outpatient services
CE Mark
Outpatient
Inclusion
in fee
schedules
Out of
pocket
payments
Individual health
insurance
coverage
EBM/GOÄ
Application
IGeL
Application
Selective
Contracts
4
5
6
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Scenario 4 – the fee schedule of the statutory health
insurance (EBM) and the private health insurance (GOÄ) are
valuable reimbursement options for outpatient services
Fee Schedules
GOÄ inclusion
EBM inclusion
4
The joint federal committee decides on
ambulatory procedures covered by the
statutory health insurance
The German Medical Association
(Bundesärztekammer) is responsible for
applications related to the private health
insurance fee schedule (GOÄ)
An application needs to present the clinical
and economic consequences and should be
submitted via the association of statutory
health insurance physicians (KBV)
An application needs to outline the clinical
and economic consequences of the
procedure
A value dossier (rapid HTA) for Germany
needs to be submitted to the KBV
The application should be
submitted by a medical KOL
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Scenario 5 ‘IGeL Inclusion’ and scenario 6 ‘Selective
Contracts’ represent alternative reimbursement scenarios for
outpatient procedures in Germany
5
6
IGeL Inclusion
Selective Contracts
IGeL – stands for individual health services
(Individuelle Gesundheitsleistungen) that
have to be paid out of pocket by the patients
From 1st January 2012 on the statutory health
insurances are allowed to reimburse innovative
outpatient procedures (SGB V § 11(6))
The usual way of including a new service to
the IGeL list is applying for inclusion to the
GOÄ schedule
Precondition is that a procedure has not been
excluded from reimbursement by the joint
federal committee (see EBM inclusion)
Once a service is listed in the GOÄ schedule it
can be offered by each German physician as
IGeL service
A strong clinical and economic argumentation
is required in order to convince individual
health insurance funds
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EBM Inclusion: Before a method for examination or treatment
can be discussed in the Federal Joint Committee (G-BA), an
application must be made by one of the G-BA members
•
Such an application may be made by
the neutral members of the G-BA, the
Federal Association of Statutory Health
Insurance
Funds,
the
National
Association of Statutory Health
Insurance Physicians (KBV), the
National Association of Statutory Health
Insurance Dentists (KZBV), the German
Hospital Federation (DKG) or the patient
representatives.
•
Each application for discussion must
contain a detailed justification,
including
information
on
the
benefits, medical necessity and costeffectiveness of the method (i.e.
diagnostic or therapeutic medical
technology) to be discussed, together
with a comparison to methods
already available.
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An application for inclusion of a medical device in the EBM fee
schedule requires a rapid HTA report that outlines the clinical
and economic consequences of the new procedure
Submission of a Rapid HTA Report to the KBV
Is the available evidence regarded as adequate?
NO
YES
NEGATIVE
G-BA application
POSITIVE
EBM Inclusion
Consider
IGeL Inclusion
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Consider
Selective Contracting
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The outpatient reimbursement process is quite diverse and
requires the presentation of specific clinical and health
economic evidence during the application process
 For the application of a new medical device in the
outpatient sector a positive reimbursement decision is
mandatory.
 The first strategy should be to apply for inclusion in the
EBM (statuary health insurance) and GOÄ (private health
insurance) fee schedules.
 The ‘IGeL inclusion’ (out-off pocket payment) and the
‘Selective Contracting’ (coverage by single/local health
insurances) should be seen as fallback strategies.
 It is mandatory to provide specific clinical and health
economic evidence during the application process.
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In case that a new medical device has a strong innovative
potential and there is an need for obtaining additional evidence
there is the possibility to apply for an ‘experimental coverage’
CE Mark
Outpatient
Inpatient
Additional evidence required
Application for
Experimental Coverage
7
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Scenario 7 – a very new strategy to obtain (in- or outpatient)
reimbursement for innovative medical devices in Germany is
the application for an ‘Experimental Coverage’
EpCo application
Application Form
7
The joint federal committee (G-BA) decides
on whether a medical device is suitable for
the ‘EpCo programm’
An ‘EpCo’ application needs to point out a
strong innovative potential and a high unmet
need; the manufacturer needs to carry a
specific part of the clinical research costs
Medical device manufacturers are allowed to
apply for such a experimental coverage by
using the specific forms provided by the G-BA
http://www.g-ba.de/downloads/39-261-1608/2012-1122_VerfO_137e_Anlagen_I-III.pdf
The detailed process, proposed by the G-BA’ is
currently reviewed and commented by the German
Ministry of Health
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Especially for medical devices applied in the outpatient sector
the ‘experimental coverage’ program provides an additional
valuable reimbursement access strategy
Submission of a Rapid HTA Report to the KBV
Is the available evidence regarded as adequate?
YES
NO
NEGATIVE
Strong innovative potential
& unmet medical need?
G-BA application
POSITIVE
EBM Inclusion
YES
Experimental Coverage
Application
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NO
Consider IGeL Inclusion
[Selective Contracting]
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The ‘Experimental Coverage’ program is a new strategy
intended to be used for new medical devices with a strong
innovative potential combined with a high unmet need
 The ‘Experimental Coverage’ program allows medical device
manufactures (the first time) to apply for reimbursement directly at
the G-BA (usually applications were only possible by G-BA
members).
 From the manufacturer perspective this strategy is only valuable for
medical devices applied in the outpatient sector – as there are
currently no strict evidence requirements for the ‘inpatient sector’.
 It needs to be taken into account that the manufacturer has to cover
a part of the research costs.
 A new medical device needs to show a strong innovative potential
in a patient population with a high unmet medical need in order to
be eligible for reimbursement under the ‘Experimental Coverage’
program.
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There are several opportunities to obtain reimbursement for an
innovative medical device in Germany but there are great
difference in the time and evidence requirements
CE Mark
Outpatient
Inpatient
Adequate
OPS/DRG
available
New
OPS/DRG
required
‘On-top
payment
required’
Additional
evidence
required
Inclusion
in fee
schedules
Out of
pocket
payments
Individual health
insurance
coverage
Already
reimbursed
OPS/DRG
application
NUB (ZE)
application
Application
Experimental
Coverage
EBM/ GOÄ
Application
IGeL
Application
Selective
Contracts
1
2
3
7
4
5
6
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Evidence Requirement
In summary the German reimbursement process for inpatient
medical devices is faster and requires less clinical evidence
compared to outpatient medical devices
EBM
Selective
Contracts
GOÄ
(IGeL)
Outpatient
Experimental
Coverage
NUB
Inpatient
OPS/DRG
Time Demand for obtaining Reimbursement
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MArS and AHEAD are two separate consulting agencies that
collaborate in order to offer high quality market access and
reimbursement solutions for the European healthcare setting
We can support you by performing product specific
analyses, developing strategies and implement
reimbursement
 European Market Access, Pricing and Reimbursement
Strategies
 Realization of market access, pricing and reimbursement
solutions for Germany (and other European countries)
 Value Dossiers and HTA Reports
 Systematic Literature Reviews
 Value based Pricing
 Health Economic Evaluations
…
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Please use our more than 20 years of combined experience in
market access, reimbursement, payer strategy and in health
economics in order to bring your product ahead
Contact: Stefan Walzer
General Manager
E-mail: stefan.walzer@marketaccess-pricingstrategy.de
Homepage: www.marketaccess-pricingstrategy.de
MArS - AHEAD
Contact: Bjoern Schwander
General Manager
E-mail: bjoern.schwander@ahead-net.de
Homepage: www.ahead-net.de
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