Alternative
Reimbursement Mechanisms for Medical Devices in Germany
(Part 1)
Healthcare systems around the world have undergone major reforms
to cut down their costs. Such reforms usually adapt a system of Disease
Related Group (DRG) codes: a patient classification scheme, which
provides a clinically meaningful way to relate patients treated in a hospital
to the resources required by the hospital. This article,
by Amir Inbar of Mediclever, describes alternative
reimbursement mechanisms in the German market.
Following the shift toward DRG-based hospital reimbursement, it is
essential for a medical device company interested in selling
a new device for an inpatient procedure to indicate a relevant DRG for its product.
In
case an existing relevant DRG code does
This is the first of two parts. The second part will
focus on the criteria required to utilize
each of the alternative mechanisms, their submission process, and their
benefits and disadvantages.
not exist, establishing a new
one could take a long time. Therefore,
to encourage entry of new and innovative technologies into the healthcare system,
the German health care system formed other short-term reimbursement
mechanisms. However, many Israeli medical device companies remain unaware of
these alternative mechanisms, which could shorten their time-to-market
and even increase their chances of obtaining a relevant DRG code in the future.
Reimbursement Codes in Germany -- A General Overview
The German DRG system (G-DRG) groups
together several parameters such as main diagnosis (ICD-10), subdiagnosis (ICD-10),
required procedure (OPS), patient's age, complications, and so on into one
G-DRG code. It then assigns each code a price tag (with
different adaptations that are outside the scope of this article).
The G-DRG system is a "leaning system" that relies on quantitative
data supplied to the Agency for the Hospital Payment System (InEK) by
approximately 200 reporting hospitals throughout the year. The
data gathered during 2004 is applied in the 2006 catalog, therefore there
is an inherent two-year lag. To cope with this, the German
healthcare system has devised the two alternative reimbursement methods,
NUB and integrated care, which are described below.
NUB Reimbursement
Article 6.2 of the Hospital Remuneration Law (KHEntgG) allows
hospitals to submit requests for reimbursement of "new and innovative
diagnosis and treatment methods" that have not yet obtained
a G-DRG code.
Integrated Care Reimbursement
Article 140 of the 5th section in the German Social Law (SGB
V) defines the formation of local Integrated Care (IC) entities. These entities
unite different types of healthcare providers such as GPs, specialists,
labs, rehabilitation facilities, and so on. Such ICs assume full responsibility
for diagnosing and treating a specific medical condition for the local population.
To encourage the formation of ICs, 1% of the overall budget of all
sickness (health) funds is assigned to finance ICs. This represents a total
of €700
million per year. This budget can also be used to finance new medical devices
that do not have G-DRG codes.
In case the €700 million has not been spent on IC projects during
the year, they are not returned to the sickness funds.
In addition to the
sickness funds' incentive, hospitals are encouraged to take part in ICs as
it enables them to benefit from using new technologies that would otherwise
not be available.
About Mediclever Mediclever
manages end-to-end reimbursement projects for Israeli companies selling medical
technology products in the United States and Europe.
Mediclever identifies the availability of existing reimbursement codes (relevant
to the product), and in case such existing mechanisms
do not exist, Mediclever outlines processes and criteria for obtaining coverage,
including the development of new or modified codes and the establishment of favorable
coverage guidelines for such codes.
Mediclever appoints an outsourced reimbursement project
manager for each Israeli client. The manager works at the client's site and leads
the leading the reimbursement project, which saves the company from
hiring and training a full-time reimbursement manager.
