Germany currently has circa 82.5 million inhabitants and utilizes a “Bismarck” Insurance Fund-based system of healthcare provision which covers the vast majority of the population. Statutory Health Insurance Funds (SHIs) are responsible for the costs of healthcare provision to their insured population. Being insured is legally mandatory and 92% of the population are members of a SHI. Private insurance coverage can only be used in addition for improved services or if the yearly income exceeds a defined level. Medical Devices and Diagnostics are used both in the inpatient and the ambulatory sectors with markedly different reimbursement and funding mechanisms.
The partition of inpatient and ambulatory care in Germany is large. Traditionally, hospitals are public institutions providing only inpatient care, while ambulatory care is supplied by private practices which are paid by SHIs and private insurances. Increasingly, hospitals are also providing ambulatory care which is regulated by a Committee for Ambulatory Care in the Hospital. There is a trend towards foundation of policlinics (outpatient clinics or healthcare centers) or so called Medical Supply Centers (Medizinisches Versorgungszentrum), both, on a private business level or in a public hospital setting. Also, hospitals are increasingly privatized. The process for successful market access of different medical device or diagnostic products will be highly dependent on the setting the product should be used in.
Ambulatory care procedures will need to be approved by the Ambulatory Care Committee and the Federal Joint Committee if they are to become listed on the EBM and offered to German patients through private physicians. This may involve an HTA by IQWiG which closely resembles the process used for the evaluation of pharmaceutical products. The IQWiG methodology has been recently updated. To date, no medical devices or diagnostics have been subjected to such an HTA.
The CE mark is required for a new technology before it can be marketed and reimbursed.
Specific diagnostic and procedure codes are used for prospective (hospital) or retrospective (ambulant) reimbursement. However, coding does not automatically lead to reimbursement.
There is a time lag between the availability of a new procedure and the correct coding. The update of the G-DRG by InEK is done yearly based on the data from the previous 2 years.
Hospitals can apply individually for using a new procedure under the NUB process (see below). The adequate uptake and correct coding of a new technology by the hospitals that participate in InEK’s calculation system is surveyed by InEK. The reimbursement for NUBs is negotiated with the SHI.
In addition to the CE mark, ambulatory care procedures need a listing in the EBM and to be reimbursed by the SHI. Private physicians can only charge for services listed in the EBM, which is edited and administrated by DIMDI.
Funding of hospitals:
The State covers large investment costs and the procurement of assets with a long economic life (> 3 years) – investments are negotiated between the State and each hospital.
The statutory health insurance (SHI) or private insurer covers inpatient hospital activities – according to G-DRG.
Diagnostics and medical devices for hospital use are usually part of the procedure (flat rate per case) and therefore do not necessarily lead to a new coding. The flat rate and the time lag to rate adaptation may hamper the adoption of new procedures (e.g., additional diagnostic test).
Market-Access is increasingly becoming the key to sustainable market-success for medical devices within Germany.
For the healthcare industry we offer our market access services German-wide following a proven growth strategy that identifies and develops new markets or new market segments for your products.