A Medical Device Daily

In a move that proponents say paves the way for improved introduction of new medical technologies, the German parliament last week passed the Hospital Financing Reform Act (Krankenhausfinanzierungsreformgesetz, or KHRG).

In a statement, the German medical technology association, BVMed (Berlin), said the amendment of the innovation clause – Section 6 of the hospital reimbursement act – will offer hospitals the opportunity to request the reimbursement of innovative technologies for a patient of the German health insurance funds in a flexible way, instead of linking it to a set deadline.

“This is an important step,” said BVMed Director General Joachim Schmitt.

While the innovation clause existed previously, BVMed said that in practice, little usage had been made of the reimbursement provided by the clause, “due to problems with its implementation.”

Saying that last week’s vote marked “a significant improvement,” the association said the further step “was needed ... to make the application and assessment procedure [Neue Untersuchungs-und Behandlungsmethoden, or NUB] for new examination and treatment methods more transparent and less bureaucratic.”

BVMed said the change will allow “full benefit of the innovation clause ... [to] be developed.”

At the end of January, the German Institute for Hospital Reimbursement (Institut für das Entgeltsystem im Krankenhaus, or InEK) will publish its assessment of the reimbursement of NUB applications made in 2008.

The applications had to be made individually by those hospitals that wanted to offer innovative therapies to their patients. Under existing regulations, patients often have had to wait for up to a year before they might benefit from a positive InEK decision on new types of therapy.

That was due to the fact that hospitals can submit an application for reimbursement of the NUB with the healthcare funds only once a year at the end of their budget negotiations.

Industry officials have regarded the regulation as a “significant obstacle” for innovation and the cause of “a healthcare gap,” in BVMed’s words.

It added: “This procedure has led to a slowing down of the speed of innovation in Germany.” In addition, it said, “systematic injustice in patient care results. This is due to the fact that innovations are available only for those patients who were lucky to be treated not at the beginning of the year but in autumn after the budgets had been authorized.”

It said lawmakers also noticed “this deplorable state of affairs,” and that last week’s vote means “the application procedure for the financing of innovations in the hospital sector will ... be made more flexible.”

With the passage of the Hospital Financing Reform Act, the association said, “Remunerations can be agreed on earlier and independently of the agreement of the revenue budget.”

BVMed added: “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.”

Plans to enhance UK pathology services

Transforming National Health Service (NHS) pathology services in the UK will improve quality, safety and efficiency in diagnostic tests, according to a two-year review of those services published last week.

The independent review of NHS Pathology Services looked at making services more responsive to patients’ needs and highlights the potential for substantial annual savings.

The UK Department of Health said pathology services “play a key role in around 70% of decisions on diagnosis and treatment.” This includes blood tests for diabetes, biopsies to diagnose cancer, and tests for infections. It said the growing use of genetics for preventive medicine and more personalized care “is likely to increase the need for pathology services.”

Recommendations include:

• Developing pathology networks with a single integrated management structure.

• Improving test turnaround times.

• Rapid adoption of new technology and approaches to delivering; services.

• Enhancing IT connectivity.

• Centralizing non-urgent and specialist work in accredited core laboratories.

Professor Peter Furness, president of the Royal College of Pathologists, said, “We particularly appreciate the recommendations in relation to quality, the development of consolidated networks, and the need for an accreditation process that covers the diagnostic process from the decision to test to the delivery and interpretation of the results.”

An impact assessment on the review’s recommendations will report next summer, with three Strategic Health Authorities looking at the practical implications of the recommendations.

Italian, Russian centers order Neuromag

Elekta (Stockholm, Sweden) reported two orders for Neuromag, which it terms “the world-leading equipment for non-invasive measurement of brain activity using magnetoencephalography (MEG) technology.”

The company said Neromag has been ordered by the Moscow Municipal University of Psychology and Education in Russia and the University of Trento (Trento, Italy).

MEG is a tool for studying normal brain function and brain disorders, providing real-time mapping of brain activity by non-invasively measuring the magnetic fields produced by the brain.

The company said neuroscientists and those in related fields at the Moscow facility plan to use Elekta Neuromag, the first whole-head MEG in Russia, for clinically oriented research applications, such as autism in children. The university also plans to employ MEG technology for cognitive neuroscience and neuropsychology research such as the study of human emotion and brain abnormalities.

Professor Tatiana Stroganova, head of the developmental psychophysiology department at the Moscow facility, said, “We plan to use the MEG extensively to study temporal dynamics of cortical networks underlying normal and aberrant brain organization of perception, attention and emotion.”

Dedicated to brain and cognitive neuroscience research, a large group of researchers at the University of Trento’s Center of Mind/Brain Sciences plans to use Neuromag to explore various fields of neuroscience such as sensory processing, attention and action control, language, formation of concepts and cognitive development.