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  Alternative Reimbursement Mechanisms for Medical Devices in Germany (Part 1)
 
Healthcare systems around the world have undergone major reforms to cut down their costs. Amir Inbar of Mediclever describes alternative reimbursement mechanisms in the German market.

In the first part of this series, Amir described G-DRG reimbursement and outlined two less well known alternative mechanisms: NUB and Integrated Care. In this article, Amir details the required criteria to utilize each of the alternative mechanisms, their submission process, and their benefits and disadvantages.

NUB Reimbursement

Read Part 1 of this series in English. Read Part 1 in Hebrew.

Read Part 2 of this series in Hebrew.
Article 6.2 of the Hospital Remuneration Law (KHEntgG) enables hospitals to submit requests for reimbursement of "new and innovative diagnosis and treatment methods" that did not obtain a G-DRG code yet.

NUB Required Criteria

To submit a NUB reimbursement request, the hospital should fulfill the following criteria:

  • The new and innovative method affects several existing G-DRGs.
  • The new and innovative method can be clearly defined.
  • The cost of using this new and innovative method affects the cost structure of the relevant procedure and the overall cost structure of the hospital.
  • The requesting hospital's financial situation would be worse if the request is rejected.

The NUB Application Process
Any hospital interested in submitting a request for NUB reimbursement should fill out a request form, which can be downloaded from the InEK site.

The application must be submitted by October 31 and provide the following:
--information regarding the substituted (old) method,
--date of first applying the new method, and
--number of patients treated and expected number of patients that will be treated according to this new and innovative method.

Furthermore, a cost analysis comparing between the old and new methods should be added.

InEK checks all submitted applications and assign a value of 1 to 4. Replies, which includes the value, are received by for each application by January 31.

Value 1: The innovative method corresponds with the requirements and will be reimbursed. Usually, InEK will not have a national database that enables a uniform reimbursement rate, therefore each hospital and local GKV negotiation committee will negotiate the reimbursement rate. InEK will also check if the innovative method can be adapted into the G-DRG framework

Value 2: The innovative method does not correspond with the requirements. The hospital is not allowed to negotiate reimbursement with any sickness fund.

Value 3: InEK is overloaded and cannot reply to the submitted application until the deadline of Jan 31. The hospital may negotiate NUB reimbursement with interested sickness funds.

Value 4: The application was not clear or did not explain clearly why NUB reimbursement is needed. The hospital may negotiate NUB reimbursement with interested sickness funds.

NUB Benefits & Disadvantages
Benefits
Obtaining NUB reimbursement takes a relatively short time. This could lead to immediate increase in procedure and sales volume.

There are no risks in receiving a rejection and a negative reply will not affect chances of obtaining another reimbursement mechanism in the future.

Disadvantages
NUB reimbursement only applies to submitting hospitals and requires bilateral negotiations between each hospital and the local sickness funds.

Each agreement is only valid for one year, but may be renewed, relatively easy, unless it has become a part of the G-DRG system.

In recent research conducted by the Institute of Health Economics (IFG), it was suggested that hospital submissions will be available throughout the year and innovative methods that received a value 1 reply will automatically be reimbursed until included in G-DRG and apply to all relevant hospitals.

During 2006, 3,857 requests were submitted. Out of which, 1,498 requests received a Value 1 reply for 54 new methods.

Integrated Care Reimbursement

Until recently there was a strict division between in-patient and out-patient care in Germany. This resulted in massive duplication of services and (diagnostic) procedures, wasted resources, and lacked coordination between in- and out-patient care. The concept of Integrated Care (IC) aims to bridge the gap between ambulatory and hospital care.

IC Entities unite different types of healthcare providers (GPs, specialists, labs, rehabilitation facilities, etc.) to facilitate Disease Management Programs (DMPs). These IC entities are entitled to freely negotiate reimbursement rates with the sickness funds. To provide a financial incentive to form these entities, the German law allocates 1% of total annual reimbursement amount towards IC projects.

IC Required Criteria
Formally, there are no preconditions, however, sickness funds will require to understand how will the IC project improve patient care and save overall costs.

There is no formal process, but some sickness funds have downloadable request forms on their website. A typical application should include --

--treated clinical indications, provided services and their location;
--expected number of treated patients;
--roles and responsibilities of managing entity; and
--benefits of the IC project in terms of patient care and cost savings.

IC Benefits & Disadvantages
Benefits
Setting up an IC project takes a relatively short amount of time. As in the case of NUB, this could lead to immediate increase in procedure and sales volume.

There are no inherent risks involved, and there are integrated financial incentives for all participants.

Disadvantages
Local agreements requiring bilateral negotiations.

As of the beginning of 2006, more than 1,400 IC contracts were signed with a value of €375 million.

Summary
The German healthcare system is trying to cope with the built-in delays of integrating innovative diagnostic and therapeutic treatments into the system by facilitating different types of intermediate short-term reimbursement mechanisms. Some of those mechanisms are described in this article. Utilizing these mechanisms can help Israeli companies obtain reimbursement faster, bring their products to market sooner, and increase their chances of obtaining a G-DRG code at a later stage.

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.


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