Category (DRGs) to determine these fees, whereas

Category
I: Medical aids (e.g. wheelchairs and incontinence products):- In all three countries, relatively strict
reimbursement levels have been set for outpatient care. In general, these
levels do not apply to a particular product, but to a category of products. The
mechanisms for setting reimbursement levels vary between the three countries.
In France, and for some categories in Germany, reference prices are used to cap
the amount that may be reimbursed from public sources. It is important to note
that these reference prices are not necessarily identical to the actual selling
prices. If the selling price of a device exceeds the reimbursement cap,
patients must pay the difference. Reimbursement levels for categories that are
not subject to reference pricing in Germany are derived from competitive
bidding. Even for medical aids with a reference price, competitive bidding is
an opportunity. Nevertheless, these

Tenders have been implemented very rarely so far.

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Category
II: Implants and other artificial body parts (e.g. total joint replacements,
implantable defibrillators, and stents): – In
the majority of cases, this category is associated with inpatient care. Similar
to Medicare and other large insurance providers, most reimbursement systems for
inpatient care in Europe are based on case fees. France and Germany use
diagnosis-related groups (DRGs) to determine these fees, whereas the UK uses
DRG-like health-care resource groups (HRGs).

Category
III: Technical equipment for professionals (e.g. diagnostic imaging devices, therapeutic
devices such as equipment for laparoscopic surgery): – case fees are in general meant to include running
costs. In Germany, as in other countries, disposable or reusable devices as
well as costs associated with using the technical equipment are included in the
applicable DRG, whereas long-life equipment that can be viewed as a capital
investment is not reimbursed by SHI. These investments are funded by the
federal states.

Innovative medical devices are usually evaluated in
relatively small clinical trials and have thus not been tested in large numbers
of patients. As a result, estimates of the efficacy or even cost-effectiveness
of innovative technologies are often still vague at the point when decisions on
coverage are being made. Moreover, the use of innovative technologies can lead
to higher costs for providers long before DRGs or other reimbursement
mechanisms have been adapted to the new technologies. Clearly, this can slow
down the process of adopting innovations. By the same token, creating economic
incentives for healthcare providers to use these innovative technologies can
lead to a sharp rise in expenditures, thus taking resources from other parts of
the healthcare system where they might have led to greater benefits. This is a
dilemma faced by every healthcare system.

Today most European countries have developed
standardized approaches to deal with new technologies in a balanced way. DRG
systems pay additional reimbursement components (e.g. for wage differences,
teaching status, or the use of new technologies or drugs), which account for a
substantial share of the overall inpatient expenditure (i.e. up to 30%). After
a new medical device is launched, it is often covered by additional
reimbursement components at first and, if sufficient evidence for effectiveness
is provided (e.g. Germany), later incorporated as a separate DRG into the DRG
systems. This approach facilitates, but does not force, the adoption of
innovative medical devices. Moreover, although price decreases under this
approach may occur more slowly, expenditures tend to be more predictable and
controllable.

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