Reimbursement of Medical Devices
Market Access and Reimbursement of Medical Devices
In Germany, reimbursement of innovative medical devices is handled differently in the outpatient and inpatient settings. New medical devices in the outpatient setting will generally only be reimbursed once they have been included into the catalogue of services provided under statutory insurance. In the inpatient setting, there is the possibility of reimbursement, provided (as long as) no new charge (NUB charge) has been applied for regarding this service, but instead reimbursement is possible within the existing DRGs (Diagnosis Related Groups). The differences in handling are related to the differential regulatory mechanisms in outpatient and inpatient care. In outpatient care, there is an authorisation requirement: reimbursement is only granted when a service has been authorised. In inpatient care, on the other hand, the prohibition proviso applies: new services are allowed until they are prohibited. This principle was abandoned with the introduction of § 137h SGB V. § 137h SGB V stipulates that a benefit assessment must be carried out by the G-BA for new medical devices of risk class 2b or 3 as soon as a NUB fee has been applied for in connection with these products by the hospitals at the InEK (Institute for Hospital Remuneration).
Recognition as an NUB (new examination and treatment method) by the InEK at the request of the hospitals is generally aimed at obtaining appropriate remuneration for a new, innovative medical product. The application simultaneously triggers a benefit assessment procedure. The procedure determines whether there is an additional benefit, the potential for an additional benefit or no additional benefit. Reimbursement for the new medical product is only granted if there is an additional benefit. If there is potential, a test can be conducted. A negative decision is made on an NUB, if no additional benefit or no potential for additional benefit is perceived in the innovative medical product. This principle of benefit assessment of new medical devices also applies in the outpatient setting. The manufacturer can apply for a trial at the G-BA under § 137e SGB V in order to review the benefit and additional benefit of the new method with potential.
Reimbursement of Medical Devices
In recent years, medical devices have increasingly become the focus of benefit assessments. The new legal procedures under trial regulations according to § 137e SGB V and the benefit assessment of medical devices according to § 137h SGB V pose new challenges for manufacturers of medical devices in higher risk classes. The procedures for reimbursement of medical devices are complex and generally lengthy making careful planning of the reimbursement process essential.
Medical devices can be reimbursed as medical services (e.g. laboratory tests), as medical aids, as medical devices similar to medicinal products or, e.g. in the context of inpatient treatment. Especially the product diversity in connection with the respective legal framework conditions requires an analysis of the reimbursement process in order to formulate an adequate strategy. Since the authorisation proviso applies in the outpatient setting which is tantamount to a fourth hurdle, new examination and treatment methods can only be used in the medical setting if the competent Federal Joint Committee (G-BA) has explicitly authorised them (§ 135 SGB V).
We advise you on the content requirements of the procedures for reimbursement of medical devices in the outpatient or inpatient setting. We support the development and implementation of your market access strategy.
Digital Health Applications (DiGA)
Digital health applications represent a new service area within statutory health insurance and can be reimbursed by the health insurance funds. Approval by the Federal Institute for Drugs and Medical Devices (BfArM) is a prerequisite which carries out a review of new digital applications prior to reimbursement negotiations with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). This review includes a type of benefit assessment that aims to evaluate the advantages of the digital health application for the benefit of patients. Then price negotiations take place with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband).
We advise you on the legal framework, the benefit assessment process and prepare you for price negotiations with the health insurance funds.
Reimbursement of medicinal products and medical devices in the inpatient setting follows both a consideration of health economics and a benefit assessment. In terms of health economics, new examination and treatment methods (NUB) are assessed to determine whether they are already covered by the applicable flat rates per case of the DRG system (diagnosis related groups). The Institute for the Hospital Remuneration System (InEK) is responsible for this evaluation which is carried out at the request of the hospitals that want to use a new service. The assessment of health economics by the InEK takes place for both medicinal products and medical devices, insofar as hospitals have submitted NUB applications for the financing of these services outside the applicable DRGs (flat rates per case). While the prices for medicinal products or medical devices are negotiated directly between manufacturers and hospitals, the reimbursement is agreed between the hospitals and the statutory health insurance funds.
In addition to the cost assessment, a benefit assessment according to § 137h SGB V takes place for medical devices if NUB applications have been submitted for a new medical device of risk classes 2b or 3. Medicinal products that are mainly or exclusively used in the inpatient setting are generally subject to the early benefit assessment according to AMNOG, provided that the negligibility threshold of € 1 million turnover per year is exceeded. We provide you with all services related to the reimbursement of medicinal products or medical devices in the inpatient setting. This includes advice on NUB applications as well as preparation for the benefit assessment.
Reimbursement Outpatient/ Inpatient Care
In Germany, health services that are not medicinal products are subject to the authorisation proviso in the outpatient setting. These services are only reimbursed once they have been approved by the G-BA as part of a benefit assessment.
In inpatient care, new services / new examination and treatment methods can be reimbursed under the existing DRG system. Companies and hospitals are free to agree on the prices. Services that are not appropriately covered by the existing DRGs may be subject to NUB charges applied for by the hospitals in order to receive additional reimbursement. In the case of medical devices of risk classes 2b and 3 there will also be a need for a benefit assessment.
We advise you on market access for medicinal products and medical devices in the outpatient and inpatient setting with regard to processes, timelines and methodological requirements.
Dressings are a special category of medical devices that are reimbursed as part of the provision of medicinal products without generally requiring a benefit assessment. Market access and reimbursement of dressing materials was re-regulated by the G-BA as part of the Medicinal Products Directive in 2021.
Do you have questions about the reimbursement of dressing materials? Then we will be happy to advise you on the procedures and specificities of these medical devices.
Medical Devices Made of Substances
According to § 31 SGB V, medical devices made of substances can be included in the provision of medicinal products by way of exception. The products are then published on a formulary: Annex V of the Medicines Directive. A prerequisite for the inclusion of a medical product made of substances in Annex V of the Medicines Directive is an application that comprehensively describes its evidence in relation to alternative products.
We will be happy to advise and support you with the application and the preparation of the benefit dossier for medical devices made of substances.