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FROM THE EDITORS

Breaking Down Barriers to Innovation

Three cheers for the German government for ensuring access to innovative medical technologies.

The German government did a smart thing at the end of December to improve patient access to technology. It put a little flex into the innovation clause of its Hospital Financing Reform Act (Krankenhausfinanzierungs­reformgesetz, KHRG).

The amendment to Section 6 of the act enables hospitals to request reimbursement for innovative technologies without linking the request to a specific deadline. That means the patient gets access, and the hospital gets reimbursed right away.

BVMed, the German Medical Technology Association, says the move paves the way for improved introduction of modern medical technologies to patients who receive health insurance funds from the German government.

At the end of January 2009, the German Institute for Hospital Reimbursement (InEK, Institut für das Entgeltsystem im Krankenhaus) will publish its assessment of the reimbursements of the applications made in 2008. The applications will have had to be submitted individually by those hospitals that wanted to offer innovative therapies to their patients.

Prior to passage of the amendment, patients had to wait up to a year to benefit from new types of therapy. Hospitals were required to submit the application for reimbursement only once a year at the end of their budget negotiations with the government.

Experts regarded this regulation as a significant obstacle for innovation and a major obstacle to access to the best possible healthcare. According to the association, the way the clause was originally written actually impeded innovation in Germany.


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New technologies were available only for those patients who were lucky enough to be treated in autumn after the budgets had been authorized, said BVMed. Those who were treated at the beginning of the year did not receive the same access.

“This is an important step toward an efficient and modern type of healthcare,” said Joachim Schmitt, director general and member of the board of BVMed, in a press release.

Fortunately for the people of Germany, the lawmakers have remedied the problem. “Hospitals will now be able to settle new methods and innovative medical technologies independently of their yearly budget negotiations, and in this way can use these methods and offer them to the patient immediately,” said BVMed.

The innovation clause was included in the act initially; however, hospitals had made little use of the provision because of the difficulty in implementing it. According to BVMed, a further step was needed to make the application and assessment procedure for new examination and treatment methods more transparent and less bureaucratic. The amendment removed the obstacle and restored the original intent of the act. Access to medical technology should not be withheld because of red tape. With the passage of the amendment, the intent of the act can be fulfilled.

It is a fact of life that the success or failure of medical devices often rides on whether they are approved for reimbursement in the countries in which they are marketed. Without this amendment, it’s hard to say how many patients might have suffered—or how many suffered waiting for its passage.

Sherrie Conroy for the Editors

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