Although the HMV position number (German Medical Technical Aids Register.) is no guarantee of commercial success, it opens doors and is often a necessity in order to play a role in the German medical aids market at all.
Experienced applicants are very familiar with their own product segment and usually know how to apply to the GKV Spitzenverband . They are also not shocked if, despite all their routine, they receive a hearing letter.
Hearing letter for your HMV application
The hearing letter will state that there are still open questions regarding the application process that need to be clarified and that the National Association of Statutory Health Insurance Funds is therefore requesting further information or documents before a decision is made. In terms of content, the hearing letter can deal with minor details such as, missing information in the operating instructions or major issues such as missing or insufficient medical evidence.Formally, a hearing letter can be a challenge for inexperienced applicants.
A thought experiment: You read the initial response from the GKV Spitzenverband to your HMV application
Before the actual deviations are briefly described, for formal reasons some rights and obligations are pointed out:
‘(...) within the meaning of Section 3 No. 1 of the Medical Devices Act, proof of functional suitability and safety is generally deemed to have been provided by the CE marking (cf. Section 139 (3) and (4) SGB V).’
What does that mean? Do I fulfil this requirement or not? Is something missing?
You skip this part first and are formally informed that you have submitted an application for inclusion in the list of medical aids. In the following paragraphs you will then also find the supposed Variations with the friendly request ‘...to submit significant documents’.
It is clear that the assessors at the GKV Spitzenverband cannot do the work of the applicant, but you as the applicant may be wondering:
What are significant documents? I have submitted everything I have!
In the following paragraph you will find a very similar, friendly request and so on and so forth. You're beginning to think that it might be a bit more difficult to answer this letter in the given time .
That's right, there's also the deadline for replying!
If possible, there should be no further delays of weeks or even more. At this point, it is advisable to ask questions.Feel free to seek constructive dialogue with the GKV umbrella association or ask third parties, who may have already done this several times, to help you.
At any time during the application process, you have many opportunities to positively influence the process or to hand over the entire procedure. In many cases, this is a very cost-effective step, as it saves time and possibly even avoids the need for unnecessary checks and the like. As a rule, there are several solutions to a problem and some solutions are not directly visible.
(1 Rating(s), average: 5.00 out of 5)
Loading...
