Specifying the regulations for benefit assessment

In a statement on the healthcare structure bill („Versorgungsstrukturgesetz“ - VSG), the German Medical Technology Association (BVMed) has demanded an earlier, appropriate inclusion of affected medical device companies in the new procedure for testing examination and treatment methods in the hospital sector. When testing a medical technological method according to Art. 137 of the German Social Security Code Book V, the design of the study should be discussed jointly with the industry and healthcare providers in a consensus process. Furthermore, the medtech companies want some imprecise terms in connection with the new regulations to be clarified.

The draft of the bill, for instance, stipulates that examination or treatment methods can only be excluded in the hospital by the Joint Federal Committee (JFC) when these methods do not provide the „potential“ of a required treatment alternative because they are harmful or ineffective. „The legislation must provide a clear definition of what the term ‚potential‘ of a required treatment alternative actually means and how this potential is to be determined“, states BVMed. Unclear wording of the legal grounds could result in differing interpretations of various terms. The bill should also specify exactly how the JFC is supposed to stipulate an „adequate study design“. It is important to integrate the affected medical device manufacturers in the process right from the start.

Hospitals that do not participate in this testing phase, but perform these services within the scope of treating patients, should be allowed to agree on paying NUB remuneration. The law should clarify this process as well. Otherwise problems might develop in hospitals whose NUB applications have been positively assessed by the DRG Institute for Hospital Reimbursement (InEK), but which do not participate in the testing.
According to the draft of the bill, the costs of scientific support and assessment during testing the medical technical methods should be assumed by the manufacturers „in appropriate amounts“. The medical technology companies want this vague legal term to be specified more clearly. The interests of others involved, such as hospitals and health insurance funds, must also be considered.

BVMed approves the regulations of the Joint Federal Committee (JFC), that article 91 section 9 Social Security Code Book V should provide the general possibility of an oral hearing at the JFC in addition to a written statement. But an oral hearing of the industry only makes sense if it takes place before a decision is made. The medical technology method experts should be included in the JFC processes right from the beginning.

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