Reimbursement for Diabetes Medical Devices in Germany

This article deals with the situation of reimbursement and application for reimbursement of diabetes medical devices by statutory sickness funds in Germany, who represent more than 90% of the market.

The bases are both the SGB (Social Code), which regulates a sufficient, comprehensive, necessary, and economic social security, and the MPG (Medical Devices Code), which regulates the conditions under which a product may qualify to become a medical device, jurisdictions (BSG case B3KR25/05R and B3KR21/99R), and other sources that can be found in the abbreviations section.

There are a total of more than 400 000 different products summarized under “medical devices.” They all have in common—different from pharmaceuticals—that they mainly have a “physical mode of action,” that is, they do not have a pharmacological effect and will not be absorbed and used up by the body. Medical devices are designed for diagnosing, preventing, screening, and treating diseases. They can be pacemakers, ultrasound equipment, insulin pump catheters, surgical dressings, software, and disposable prefilled syringes.

A product qualifies as a medical device pursuant to the MPG when the manufacturer offers it for the use of patients and the handicapped. Thus, qualification is based only on the purpose defined and given by the manufacturer. The product has to be certified (CE certification) and must fulfill the conditions of the MPG, ensuring the quality of the product and the safety of patients and users. Through a defined procedure the manufacturer has to prove that the product fulfils all these conditions. Medical devices that under EU law can be legally sold in 1 member state consequently can be sold in all member states. However, this certification is not about the medical benefit of the product.

Proof of functionality, safety, and medical benefit of a product through the manufacturer is the prerequisite for the listing of the product as a therapeutic appliance in the list of medical devices of the GKV Spitzenverband.

The listing again is the prerequisite for a product to be reimbursed by the statutory sickness funds. Although this list is not binding, it has a steering effect, meaning also that a product may achieve reimbursement by the single decision of an independent sickness fund. However, the list provides overall information about the reimbursement duty of a sickness fund and the quality and variety of products in the market.

The manufacturer applies at the GKV Spitzenverband for the listing (see § 139 of SGB V), who can involve the MDK in the decision-making process, for instance, to check

• Functionality and safety of the product (fulfilled by CE certification)

• The proven medical benefit

• Indication- or use-related conditions

• User manuals in German to ensure safe handling of the product

• Weather additional services must be provided by the sickness funds accompanying the use of the product

In case of a positive decision, which can take up to 6 months after filing, the product will receive a so-called medical device number, which shows it classification into the 33 different product groups, (eg, aids for application, surgical dressings, aids for inhalation, and systems to measure body functions).

Each product group contains definitions with advice about medical indications that justify a respective use and reimbursement. In addition, minimum quality and conditions under which the product can be provided are fixed to ensure a necessary, high-quality, and reliable social security.

The statutory sickness funds provide their services under a binding principle regulated in section 12 of SGB V: The services have to be sufficient, reasonable, and economic and may not exceed necessity.

Services that are not necessary or economic cannot be demanded by the insured and may not be provided by sickness funds.

An Example From Daily Operative Practice

The patient was a type 1 diabetic, 28 years old, insured with a statutory sickness fund, first diagnosed 2001, with multiple daily injections (MDI) of insulin, last HbA1c 8, 0. The problem was dawn phenomenon. The diabetologist prescribed an insulin pump; a cost estimate from a wholesaler was provided concurrently.

For the sickness fund to reimburse the patient, they will check that

• A prescription by a diabetologist approved by statutory sickness funds is provided

• A cost estimate from a wholesaler is provided

• The wholesaler is a qualified service provider of the sickness fund

• The insulin pump is listed on the list of medical devices of the GKV Spitzenverband and the cost estimates are in line with the listed price

Formally a reimbursement is possible. Now the sickness fund will check weather a reimbursement is indicated under the social security conditions of the SGB as described above.

On the basis of the list of medical devices of the GKV Spitzenverband an insulin pump can be reimbursed by a sickness fund under the following circumstances:

• For diabetics who are under an MDI treatment regime, but still do not achieve a normoglycemic blood glucose level and/or

• For diabetics who suffer from heavy hypoglycemic events, especially at nighttime and/or

• For diabetics with highly increased insulin need in the morning (eg, dawn phenomenon)

Treatment with an insulin pump is very expensive and requires a high level of compliance from the patient including long-term blood glucose self-control, monitoring, and documentation. Consequently, compliance of the patient to the following rules and measures are regarded as mandatory by sickness funds for receiving a reimbursed insulin pump:

• Through participation in a general diabetes training program, the patient has to gain broad knowledge about the disease and its treatment and the MDI therapy regime must be thoroughly known

• Through further participation in a special training program for insulin pumps, the patient must learn to correctly use the insulin pump and follow the rules of this specific treatment

• An adequate ambulant follow-up treatment through a pump center or pump ambulance must be secured, which can be contacted anytime in case of problems with the pump therapy

The MDK will check and monitor these morning procedures. When all prerequisites are fulfilled, there will be an initial probation phase of 3 to 4 months. Afterward this phase will be reviewed and a long-term final reimbursement is possible.

However, these measures and decision-making processes can be handled differently by the sickness funds, so it is vital to provide all necessary and requested evidence as early as possible and to communicate with the sickness funds intensively and constructively from the beginning to pave the way for a diabetes device reimbursement in Germany.