(Chapter B – Review and Update of the HMV; Section I: Deadlines for reviewing and updating the HMV product groups)
Health and Medical-aid Supply Law (HHVG) stipulated that the National Association of Statutory Health Insurance Funds (GKV) should adopt rules of procedure (RoP) by the end of 2017. This regulates the details of the procedure for including medical aids in the List of Reimbursable Medical Devices (HMV) and for updating the HMV. The RoP was finally published in November last year. So far there are no further regulations in the RoP regarding the handling of medical devices and aids, which do not fit into the order of the HMV “yet”- due to their construction, but without using a new active principle, that would not be a “new examination and treatment method” (NUB). This remains an essential issue, that may be taken into account in the next update of the HHVG.
BEO BERLIN® will intermittently go into details of the RoP and will illuminate information relevant for the manufacturers. The RoP consist of 4 chapters (A – D), with chapter A only describing the purpose and scope in a short form.
We will begin with Section I of Chapter B of the RoP “Review and Update of the HMV”. This first part of the RoP, “Deadlines for the review and update of the product groups of the HMV”, includes the obligation of the GKV to regularly update the individual product groups of the HMV. The first wave of updates was completed after the HHVG came into force in April 2017. BEO BERLIN® has already reported on some updates, which you can find in News & Events.
After this first wave, the GKV must check every single product group every 5 years and determine whether there is a need for updating. Three months before the end of this 5-year period, the GKV must inform the organizations concerned (e.g. industry associations, patient representatives) of the respective product group about the upcoming review and query their need for updating. The organizations contacted, in turn, have 2 months after receiving the letter (the GKV provides a specific date) to indicate their need for updating.
If it is determined that a product group has to be updated, response proceedings must be initiated no later than 6 months after the date of the review by the GKV. This period can be extended if there is not enough information (“expertise”) on special issues, the testing effort is extremely high or the organizations want to explain their suggestions verbally, etc. If there is no need for updating, this must also be determined within the 6 months by decision of the GKV.
For the manufacturers of listed products it is crucial that they can be contacted by the GKV during a review of a product group, for example to confirm that the entries are up-to-date (product information, manufacturer, etc.). The manufacturer has 3 months to submit the required documents to the GKV. If they fail to respond, they run the risk of product entries being deleted.
Should requirements change for a product group due to an update (e.g. new test methods, increased evidence of medical benefits or similar), the manufacturer has 6 months to prove their product fulfill the new requirements. Again, if the manufacturer fails to comply, their product will be deleted from the HMV.
To avoid this danger, BEO BERLIN® has established the service of the HMV Representative. BEO BERLIN® acts as a constant contact for the GKV and ensures you do not miss any notification / update of the GKV.
If you are interested, please ask our experts.