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You plan on getting your product approved in Europe and complete the CE mark process relatively quickly. You know Germany presents the largest market for medical devices in Europe and you already have a few German physicians interested in using your product. But Russell Wilson , how can you get those German Sickness Funds (Payers) to pay for it - fast?

Here is one possible, intermediate mechanism, designed to serve as a gateway for introducing innovative medical devices into the German Inpatient reimbursement system.

1. The Problem
Just as in the US acute care hospital inpatient stays are reimbursed according to Medicare Severity Diagnosis Related Groups (MS-DRGs), in Germany they are reimbursed according to German Diagnosis Related Groups (G-DRGs).
In both cases Seattle Seahawks Jersey , if your new device does not fit into an existing DRG, the hospital may not get paid for using it and thus may not want to use it. On the other hand, forming a new DRG code for your device (in the US or in Germany) requires data collection of procedure utilization. But since your device doesn't currently fit into an existing DRG, hospitals are reluctant to use it Solomon Thomas , and therefore it will never reach sufficient utilization to justify the creation of a new DRG code.

Sounds like a Catch-22, right?
To encourage entry of new and innovative technologies into the German healthcare system, there is a short-term, intermediate reimbursement mechanism that provides hospitals with the required financial incentive to use a new device Dante Pettis , before it is properly reimbursed under the G-DRG system. However, it seems as if most US medical device companies are unaware of this mechanism that could shorten their time-to-market and even increase their chances of obtaining a relevant G-DRG code in the future.

In the next part I will provide a short description of the German G-DRG system, and then discuss the NUB mechanism.

2. German G-DRG System
The German DRG system, or G-DRG system Mike McGlinchey , groups several parameters, such as: the patient's main and sub diagnosis (using ICD-10 diagnostic codes), performed procedures (using OPS procedure codes) as well as additional characteristics including the patient's age, complications and co-morbidities into a single G-DRG code and assigns each code with a price tag (with different adaptations that are outside the scope of this article).

The G-DRG system is a 'leaning system' Matt Breida , relying on quantitative data supplied to the Agency for the Hospital Payment System (IneK) by the ~250 reporting hospitals throughout the year. The data gathered during 2010 is applied in the 2012 catalog.

3. 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 did not obtain a G-DRG code yet.
It should be emphasized that the device manufacturer is not the one applying for NUB reimbursement. Mediclever typically assists the manufacturer in preparing the application and then each relevant hospital receives a copy and submits it on its own.

3.1 Required Criteria
The NUB reimbursement request must 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.

3.2 The Application Process
Any hospital, interested in submitting a request for NUB reimbursement, should fill out a request form, which could be downloaded from the InEK site ( ). The application must be submitted by October 31st and provide information regarding the substituted (old) method George Kittle , date of first applying the new method, 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 replies with a value of 1 to 4 for each application by January 31st.

* 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 Jimmy Garoppolo , 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 31st.
- 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.

3.3 Benefits and D