Medicinal and auxiliary products
In the field of medical and auxiliary law, we advise you on the following topics:
Medical Device Law (MPG), legal requirements for the regulation of medical devices, design of declarations of conformity, regulation of medical devices in off-label use, inclusion of medical devices in the legal catalogue, fee requirements for service providers and advice on clinical trials
Auxiliary law
Aids within the meaning of § 33 SGB V are material means that are needed by insured persons to ensure the success of a medical treatment, to prevent an imminent disability or to compensate for a disability.
These include hearing aids, orthopaedic insoles, electrostimulation devices, prostheses as well as software. Medical aids are usually reimbursed by the statutory health insurance companies on medical prescription. The list of aids according to § 139 SGB V provides as an important control tool an overview of the aids that can be prescribed at the expense of the health insurance funds, even if it is not conclusive.
Auxiliary legal issues
Providers of services (such as hearing care professionals, orthopaedic shoemakers, paramedics) may only hand over aids to insured persons if they meet the requirements for sufficient, appropriate and functional manufacture, delivery and adaptation of the aids and this has been confirmed in the context of a so-called prequalification procedure. In addition, they must conclude an appropriate insurance contract with the statutory health insurance funds entitling them to supply the aids in question.
Ehlers, Ehlers & Partner advises individual service providers and their associations on all issues related to auxiliary law, particularly in the context of tenders and in the design and negotiation of health insurance contracts.
We cover all related legal matters, such as competition law, advertising law, data protection law, trade law and also criminal law. For the service providers, we also enforce compensation claims vis-à-vis the cost providers.
In particular, we have many years of expertise in the inclusion of innovative medical devices in the list of auxiliary devices.
Remedial law
Remedies in accordance with § 32 SGB V are all medically prescribed services that serve a healing purpose or ensure a healing success and may only be provided by appropriately trained persons. This includes in particular measures of physical therapy as well as services of voice, speech and speech therapy as well as occupational therapy.
In order to provide the treatment, the therapists need an authorisation (§ 124 SGB V), which is granted by the state associations of health insurance funds and the substitute funds. Further general conditions and remuneration are regulated in pension contracts between health insurance companies and service providers or their associations.
Ehlers, Ehlers & Partner represents service providers and their associations in all matters of medical remedy law, in particular in connection with authorisation procedures and in the drafting and negotiation of health insurance contracts or in the defense of claims of health insurance companies for compensation already paid.
