2019 Reimbursement of Medical Devices in Germany
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Assessment in Medicine
Reimbursement
of Medical Devices
in Germany
2019
AiM. An IGES Group company.
Finding Your Way into the German Medical Device Market
The German Market General Concept IGES Group
20
and Access to it of Reimbursement
03–09
in Germany Glossary
10–19 21
04 Germany – Europe’s Most 11 Inpatient
Important Destination for
16 Outpatient
Medical Devices
06 European CE Marking
08 Understanding the German
Health Care System
Reimbursement of Medical Devices in Germany 2
AiM has been supporting the medical device
industry for over a decade. We mainly focus
on reimbursement and pricing analysis,
market access consultations, appraisal of
clinical evidence as well as support for study
designs. To date, we have concluded over
600 projects for more than 150 clients.
Since 2014, AiM has been a member of the This guide explains the basic principles
IGES Group, an independent provider of of the German medical device regulations
research and consultancy services for the with a particular focus on reimbursement.
life sciences industry, covering the entire It has been written with utmost care.
range of services from market data,
regulatory, health technology assessment However, no document can replace a face-
(HTA) to the analysis of clinical services. to-face meeting and qualified consultancy.
We look forward to hearing from you.
AiM - Assessment in Medicine, Research
and Consulting
The German Market and Access to it
Reimbursement of Medical Devices in Germany 4
Germany – Europe’s
Most Important
Destination for
Medical Devices
Market Access The world market for medical devices has
a volume of 390 billion USD. The USA have
Germany’s advantages for medical device the largest market with 152 billion USD,
companies are rapid market approval pro- Germany has the second largest market
cesses and the quality and cost-effective- with 39 billion USD, and Japan’s market is
ness of its clinical research. the third largest with 35 billion USD. The
German market is by far Europe’s largest
German hospitals are open to innovation market; it is bigger than the French and
and in favor of medical technology that the UK market combined.
enables them to cure patients better and
more efficiently.
Population (in m) Hospital bed density (beds per
100,000 inhabitants)
EU (all 28 Member States): 512.7 EU (all 28 Member States): 513.66
Germany: 82.9 Germany: 806.26
France: 67.2 France: 604.92
UK: 66.2 Italy: 319.55
Italy: 60.5 Spain: 296.89
Spain: 46.7 UK: 261.01
Source: Eurostat, data for 2018 Source: Eurostat, data for 2016. EU average, Italy and UK: data
for 2015
World Market for Medical Devices (by regions)
Rest of the World 19.8 %
Brasil 1.1 %
India1.2 % USA 38.9 %
Spain 2.0 %
Russia 2.1 %
390.1 bn USD
France 4.0 %
UK 4.0 %
China 8.1 %
Japan 8.9% Germany 9.9 %
Source: SPECTARS, Jahrbuch 2018, data for 2017
Reimbursement of Medical Devices in Germany 6
European CE Marking
Medical devices and IVDs must bear the
CE marking to be brought to the European
Union market. The CE marking indicates
to EU regulators that the device fulfils the
respective requirements of EU Directives,
such as the Medical Devices Directive
(MDD), the In Vitro Diagnostic Device
Directive (IVDD) or the Active Implantable
Medical Device Directive (AIMD).
Medical Devices Classes
Depending on their potential risk, medical devices are divided into
four classes (with the exception of active implantable devices and
in-vitro diagnostic medical devices).
Class I Class IIa Class IIb Class III
Wheelchairs, crutches, Diagnostic ultrasound Dental implants, Coronary stents,
hospital beds, devices, hearing aids, defibrillators, heart valves,
bandages contact lenses, dental respiration and endoprotheses,
fillings dialysis devices absorbable surgical
sutures
How to Obtain CE Marking for Your
Medical Device or IVD
A medical device manufacturer has sole responsibility for
maintaining compliance with the applicable EU Direc-
tives and securing CE marking for his product, regardless
of whether he outsources any or all components of the
manufacturing operation.
The CE Marking Generally Requires
the Following Steps:
Preparation of a CE Establishment and Appointment of a Obtaining the CE (and
Marking Technical File maintenance of a European Authorized QMS) certificates from a
(or a Design Dossier for compliant quality Representative for Notified Body. For some
a Class III device). management system companies with no medical devices
This file must include (typically by imple- physical location in (for instance Class I
data demonstrating menting ISO 13485). Europe. non-sterile, non-
compliance with the measuring devices),
applicable directives self-certification of
(MDD, IVDD, AIMD). compliance with the
applicable directives
is sufficient.Reimbursement of Medical Devices in Germany 8
Understanding the German
Health Care System
Health insurance is mandatory for German
citizens. 72.8 million Germans are covered
by statutory health insurance (Gesetzliche
Krankenversicherung (GKV)) around 8.8
million Germans are covered by private
health insurance (Private Krankenversi-
cherung (PKV)) and via state aid.
Statutory health insurance is provided
by around 100 statutory health insurance
funds. These funds provide comprehensive
health care. The statutory health insurance
is a compulsory insurance system which
may only be left in favor of the private
health insurance if certain requirements
(annual income, liberal profession, etc.)
are met.
5 Largest Statutory Health
Insurance Funds by Members:
Techniker Krankenkasse, TK 10.300.000
Barmer 9.200.000
DAK-Gesundheit 5.800.000
AOK Bayern 4.521.000
AOK Baden-Württemberg 4.268.000
Source: IGES, data for 2018Private and Statutory Health
Insurances by Members
(in millions)
8.8
72.8
Private health insurance members Statutory health insurance members
(Private Krankenversicherung (PKV)) (Gesetzliche Krankenversicherung (GKV))
and citizens insured via state aid
Source: statista.de, data for 2018
Healthcare Expenditure
Total annual healthcare expenditure in Germany is
357 billion euros, of which 207 billion euros are spent
by the statutory health insurance funds. Private health
insurance companies spend 31 billion euros.
Statutory health insurance
healthcare expenditure in
207
billion euros
31
Private health insurance
healthcare expenditure in
billion euros
Total healthcare expenditure in Germany is
357 billion euros
Source: German Federal Statistical Office, data for 2016General Concept of
10
Reimbursement of
Medical Devices in
Germany
A crucial factor for the reimbursement of a
medical device is whether it will be used
in a hospital (inpatient) or ambulatory
(outpatient) setting. In the following, the
reimbursement system for patients with
statutory health insurance (GKV) is explained.Inpatient
11
Reimbursement of Innovative
Medical Devices in the Hospital
There are different medical devices reimbursement
pathways which can be used in inpatient medical
services. These pathways are explained in the
following. However, competition and market
environment play a crucial role in identifying the
ideal solution for bringing a new medical device
to German hospitals.
Both aspects - regulatory pathways and market
situation - have to be considered carefully.Reimbursement of Medical Devices in Germany 12
1 2
Reservation of Prohibition German Diagnosis Related Groups
(G-DRG)
In the inpatient setting, new medical In the inpatient sector, the billing of
services are reimbursed without prior as- services for treating patients is based on
sessment, as long as fundamental princi- the so called German Diagnosis Related
ples of quality and cost-effectiveness are Groups (G-DRG), a fee-per-case-system.
not violated. This is due to the so-called There are roughly 1,300 different DRGs in
reservation of prohibition (Article 137c of Germany. The DRG classification system
the Social Security Code V) which, in prin- uses case related coding rules that apply
ciple, permits immediate provision of to diagnoses (ICD-10 German modification)
new medical services in inpatient settings and procedures (Operations and Procedure
and their reimbursement by the statutory Codes (OPS)).
health insurance. Owing to this reservation
of prohibition, innovative medical devices With the DRG-case-based-flat-rate, all
can generally be applied quickly to clinical costs related to the treatment and the
practice. hospitalization of the patient, including
medical devices, are covered. The G-DRG
system’s contents are revised annually by
the Institute for the Hospital Remuneration
System (InEK). Each DRG compensation
amount is based on empirical data which
is continuously collected from several
hundred German clinics.
There is a time lag between the availability
of a new procedure code and an adequate
DRG assignment. InEK-conducted G-DRG
updates are based on the above mentioned
empirical data from previous years.13
Reimbursement Timeframe for New Medical Devices
The new medical device is reimbursed immediately
if it is part of an established method that is already
in effect in the reimbursement system. If the device
fully or partially constitutes a new method, exploring
innovation reimbursement pathways such as the
NUB procedure is advisable, particularly if the device is
significantly more expensive than the current standards.
Depending on the setting in question (inpatient or
outpatient) and the evidence available in support of
the new device, establishing reimbursement can be
complex and may take several years.
3 4
Request for a New OPS New Methods of Treatment
and Screening (NUB)
Often, using a novel medical device The NUB procedure (NUB: New Methods
requires a different procedure to that for Treatment and Screening) is a payment
of the standard medical device. For this scheme for remunerating cost-intensive,
reason, new OPS codes for novel procedures innovative services and technologies that
can be requested by actors from the health are used in addition to the procedures
care system. Such requests may be filed included in the valid DRG case-based
at the DIMDI (German Institute of Medical flat rate. This procedure is only open
Documentation and Information) once a to technologies / procedures that are
year. This should be done jointly with a considered new in Germany.
German medical society which confirms
that the new procedure is scientifically in Hospitals can file electronic requests to
line with appropriate medical treatment. the InEK once a year to enquire whether
The DIMDI’s decision will take about one the conditions for negotiations have
year. If successful, the newly created OPS been set for hospital-specific temporary
code will be assigned to a DRG. extrabudgetary payments (NUB payments).
If the request receives a favorable reply,
the hospital can enter into negotiations
with the respective local healthcare payer.
Every hospital must apply separately.
The “on-top” payment, provided the
application is approved, will only >Reimbursement of Medical Devices in Germany 14
5
Additional Charges (Zusatzentgelt)
> be available to the hospital that nego- In addition to the NUB procedure, a
tiated successfully. Approved applications further option for invoicing an extra fee
are subsequently monitored by the InEK. on top of the DRG-case-based flat-rate
And at some point in the future, InEK will exists, which, however, is not restricted
integrate the corresponding procedure into to innovations. This is termed “additional
the standard DRG system. charge” (Zusatzentgelt). In 2019, there
areare a total of 214 additional charges.
This procedure is widely used, but very Hospitals and medical societies can
often unsuccessful: because the requests apply for the implementation of such an
for NUB payments are rejected if the meth- additional charge. If appropriate, the
od at stake has already been InEK will create an additional charge on
included in an existing DRG or is not its own initiative. In most cases, the
considered innovative. monetary value of the additional charge
is based on empirical cost data supplied
It should be noted that the InEK makes no by reference hospitals.
decision on the actual amount of the “on-
top” payment. This is directly negotiated
between the successful hospital applicants
and the GKV.Hospitals and Physicians in Germany
1,942 Total Number of Hospitals in Germany
497,182 Total Number of Hospital Beds
77.8% 19,442,810 894,400
Rate of hospital Total annual number of cases Total hospital staff
bed utilization treated in Germany
Source: German Federal Statistical Office, data for 2017
Structure of Medical Profession in Germany (in thousands)
Retired or
Active physicians not practicing
385.1 120.9
Primary Inpatient Others
(outpatient) care care
154.4 198.5 32.1
Source: IGES based on Bundesärztekammer (German Medical Association), data for 2017
Two Special Regulations
§ 137e SGB V – Testing Regulation: § 137h SGB V – NUB with
The generation of high-quality, clinical Method Assessment:
evidence through clinical trials has been With the introduction of § 137h SGB V in
considered as insufficient in Germany. 2016, some new methods must undergo
As a response to this, a “coverage with an official health technology assessment
evidence development” program has been (HTA) process associated with the NUB
implemented. The evidence generated is scheme. If it is the first NUB application
to be used as a basis for G-BA decisions and the medical device involved belongs
on coverage. The clinical trial can be to class IIb or III, and the new diagnostic
initiated by the G-BA or the medical or therapeutic method provides a new
device manufacturer. This procedure was theoretical scientific concept, an official
introduced in 2013, but has not become method assessment process will be
very popular yet. The entire procedure initiated with a subsequent G-BA
can easily take up to 60 months. decision regarding coverage.Outpatient
16
Reimbursement of Medical Devices
in Primary (Ambulatory) Care
1 2
The Uniform Evaluation Scale (EBM) Authorization Right
Outpatient services (ambulatory services) The so-called “Authorization Right”
are mainly provided by private practi- (Article 135 § 1 of the Social Security Code V)
tioners in the community. There are around applies to all ambulatory medical services:
146,000 physicians working in outpatient Any novel diagnostic and therapeutic
care in Germany. These practitioners are by procedure must be evaluated before
law members of their respective regional being reimbursed. Only procedures which
Kassenärztliche Vereinigung (Association of “show a benefit, are medically necessary
the Statutory Health Insurance Physicians and efficient” can be reimbursed. The
(ASHIP)). The physicians are paid by their decision for accepting a new procedure
respective ASHIP which, in turn, is paid for GKV coverage has to be ratified by the
by the GKVs. Payments by the GKVs to ASHIP Federal Joint Committee (Gemeinsamer
are usually based on a “per physician Bundesausschuss, G-BA, see page 19).
member” or a “per insured person” basis. During the evaluation procedure, the
ASHIP funds pay their members on the Federal Joint Committee may request
basis of the “Uniform Evaluation Scale” a health technology assessment (HTA)
catalogue, also known as EBM (Einheitli- from the Institute for Quality and
cher Bewertungsmaßstab). Physicians are Efficiency in Healthcare (IQWiG = Institut
only able to invoice services that appear für Qualität und Wirtschaftlichkeit im
on the EBM. The EBM is set by a committee Gesundheitswesen). It should be noted
of GKV and ASHIP representatives called that setting the actual payment amount
Evaluation Committee (Bewertungsauss- for an EBM listed procedure is the
chuss). The payment scheme for outpatient responsibility of the Evaluation Committee.
physicians is based on the mix of services If the G-BA evaluation is positive, the
delivered, the number of patients served, medical service must be covered by
and a fixed budget distribution system. the GKV. The medical service is then
reimbursed throughout Germany by all
GKV-funds.Federal Joint Committee (G-BA)
Highest decision-making body of the joint self-government of It issues directives for the GKV benefit catalogue and therefore
physicians, hospitals and health insurance funds in Germany. specifies which services in medical care are reimbursed.
Lawmakers
the
Fede
gh e, ral
ou d l Min
hr l Co ega is
te t ocia V) L es Legal tr y
da S (SGB recti v
su p
an an
M rm Five on d
i erv
isio
of
Ge ok visi w) n He
Bo per vie a
su r re
lth
(fo Di
re
c
tiv
es
(fo
r
rev
iew
partial members,
3 im
)
ing 1 chair
includ
5 representatives
from statutory health 5 care provider
insurance providers (GKV) Plenum representatives
GKV-Spitzenverband DKG, KBV, KZBV**
5 patient
representatives*
Prep
are d
ecision
9s s IQWiG
ubc
om m
ittees
* Entitled to take part in discussions and submit petitions, Abbreviations:
but not to vote GKV-Spitzenverband = National Association of Statutory Health Insurance Funds
** Care providers are entitled to vote only on issues affecting their DKG = German Hospital Federation
area of expertise. Otherwise these votes are allocated propor- KBV = National Association of Statutory Health Insurance Physicians
tionally in accordance with the bylaws, section 14a, paragraph KZBV = National Association of Statutory Health Insurance Dentists
3.Reimbursement of Medical Devices in Germany 18
3 4
Individual Contracts Individual Healthcare Services
(IGeL)
There are high demands placed on Some procedures which are neither listed
the clinical evidence for evaluating a in the EBM nor covered by individual
new procedure. For this reason, many contracts between provider and payers can
innovative medical services are first be received by the patients, but have to
reimbursed on the basis of individual, be paid out of the pocket. These services
regional and time-limited contracts are called IGeL (short for Individuelle
between the providers and payers, which Gesundheitsleistungen; individual
typically have lower demands on the healthcare services). In general, they
clinical evidence. are paid entirely by the patients, as GKV
does not consider them as “necessary,
appropriate, and economic”. Illustrative
IGeL services are intraocular tension
measurement, some ultrasound diagnostic
methods and cosmetic therapies. The
annual total volume of the IGeL services
performed in Germany is 1 billion euros.19
5 6
Budget Constraints Medical Devices for Home-Use:
List of Assistive Devices
The precise amount which physicians Medical devices that are used at home
receive for their medical services varies (for instance hearing aids, surgical
as it is linked to the actual annual stockings, orthopedic insoles) and are
budget of their respective Kassenärztliche reimbursed under GKV schemes are listed
Vereinigung (Association of the Statutory in a specific directory, the Catalog of
Health Insurance Physicians (ASHIP)). Assistive Devices (Hilfsmittelverzeichnis).
This means that physicians in one part of This directory sets the list of recommen-
Germany may receive a different amount dations for such devices and is almost
for an identical service than physicians binding. Manufacturers can apply to have
working in another part of Germany medical devices included on this list. The
who are members of a different ASHIP. application is submitted to the Federal
Furthermore, in certain cases, the EBM Association of Statutory Insurances
amount per doctor may also be restricted, (GKV-Spitzenverband Bund).
for instance a doctor who performs a
certain medical procedure too often may
receive a partial deduction of EBM points.IGES Group
20
The knowledge corporation
Independent and innovative since 1980,
the IGES Group focuses on research,
development and consulting for life
sciences and health care.
The IGES Institute is the core of the IGES Group. It AiM (Assessment in Medicine) is a health-economic
offers comprehensive services based on expertise: consulting agency for the medical device industry,
studies, reports, publications, evaluations, concepts dedicated to reimbursement programs. Health
and strategies. Since its foundation, it has conduct- technology assessment dossiers are founded on
ed over 2,000 research and consulting projects. scientific methodologies.
AiM’s Services
Health Economics & Outcomes Research ▪
• Value demonstration
• Health technology assessment (HTA)
CSG (Clinical Study Group) is a full-service
• Health economic evaluation
contract research organization, offering services
in planning, implementing and analyzing
Real-World and Care Provision Analyses
clinical-scientific studies.
• Demand and access
• Quality of care
• Utilization and expenditure
Market Analysis
IMC clinicon is a consulting and services institute • Assessment of inpatient and ambulatory
for the hospital sector, providing in-depth data sector potentials
and analysis on German hospitals. • Competition and regulation analysis
Strategic Consultation
• Pricing and market access
• Portrayal of individual product
reimbursement pathways
HealthEcon, based in Basel, Switzerland is a • Assistance with review process conducted
consulting firm for health technology assessment, by the Federal Joint Committee (G-BA) /
European market access and value strategy for the Institute for Quality and Efficiency in
pharmaceutical industry with almost 40 years of Healthcare (IQWiG); consulting for new
experience. examination and treatment methods (NUB)Glossary
21
DIMDI: Deutsches Institut für Medizinische IQWiG: Institut für Qualität und Wirtschaft-
Dokumentation und Information (German lichkeit im Gesundheitswesen (Institute for
Institute of Medical Documentation and Quality and Efficiency in Healthcare)
Information)
NUB: Neue Untersuchungs- und Behand-
EBM: Einheitlicher Bemessungsmaßstab lungsmethoden (New Methods for Treat-
(Uniform Evaluation Scale) ment and Screening)
G-BA: Gemeinsamer Bundesausschuss OPS: Operationen- und Prozedurenschlüssel
(Federal Joint Committee) (Surgery and Procedure Code)
G-DRG: German Diagnosis Related Groups PKV: Private Krankenversicherung
(Private Health Insurance)
GKV: Gesetzliche Krankenversicherung
(Statutory Health Insurance)
HTA: Health Technology Assessment
IGeL: Individuelle Gesundheitsleistungen
(Individual Healthcare Services)
InEK: Institut für das Entgeltsystem im
Krankenhaus (Institute for the Hospital
Remuneration System)AiM GmbH
Marie-Curie-Straße 8
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Germany
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