Diabetes test strip regulation restricted

Federal Committee restricts diabetes test strip prescription

19/03/2011

Diabetics who are not subject to insulin obligation, have to pay in the future blood sugar level and urine test strips out of pocket. A reimbursement by the health insurance companies, it is expected from October this year no longer exist. This was agreed by the Federal Joint Committee of drug experts, doctors and health insurance companies on Thursday. A medical benefit of the self-measurement is not given, so the reasoning.

No refund of test strips for oral therapy
Diabetes Patients who are not insulin-dependent but who are being treated with oral medication will not be reimbursed for blood sugar test strips in the future. This was decided by the Federal Joint Committee of representatives of the health insurances, drug experts and physicians. The basis for this decision was a report from the Institute for Economic Efficiency and Quality in Health Care (IQWiG). The Institute concluded that diabetes test strips are not a medical indicator of diabetes treatment. In the future, doctors will only be able to prescribe test strips if, for example, due to the conversion of a special medicine, the blood values ​​have to be checked regularly in order to rule out possible side effects. However, a continuous measurement of the values ​​does not provide any benefit in terms of diabetes therapy. Of the approximately 4.5 million diabetes patients in Germany, around three million patients are affected by the new regulation.

Decision is expected from October 2011
The exclusion of the ordinance should come into effect as early as the fourth quarter of 2011, as Dr. Ing. med. Rainer Hess confirmed. In patients who inject insulin, the restriction does not apply. The health insurance companies will continue to reimburse the costs for this group of patients, as the Federal Committee assured.

Test strips reimbursement in exceptional cases
The Federal Joint Committee (G-BA) in Berlin has created individual exemptions, in which, despite an orally prescribed therapy, a reimbursement of costs is still permitted. The exception applies, for example, to pregnant women who have gestational diabetes. Depending on the indicators, physicians may prescribe 50 test strips for reimbursement if there is an unstable metabolic state. It is discussed whether a Erstgattungspflicht exists for professional drivers or train drivers. Professional drivers are required by law to check the blood sugar level at regular intervals to ensure road safety. The EESC believes that it can not be the job of health insurance companies to provide financial resources for this purpose. In the opinion of patient associations, it should also be checked whether enrolled patients in the „Disease Management Program“ excluded from the regulations.

Patient groups and associations criticize prescription exclusion
The measures are criticized above all by patient associations and the diagnostics industry. So the association chairman Dr. Martin Walger, it was noted with concern the result of the G-BA. „Hundreds of people affected the most important tool for self-management of their disease taken from the hands“ criticized Walger. Now one hopes for a redress of the Federal Minister of Health Philipp Rösler (FDP). In the last instance, the Minister of Health can still overturn the decision. After all, diabetics without blood glucose self-monitoring can no longer check whether their own way of life must be optimized by means of diets or exercise programs. „Without the test results, the treating physician lacks an important basis for adjusting therapy. "The blood glucose test strips are not a medicine but an important diagnostic tool that provides the basis for meaningful therapy, according to the association's director.

Financial losses for manufacturers
It's also about a lot of money. With the sale of test strips, the industry generates annual sales of around 1.2 billion euros. If the strips are no longer cash-in-transit, high losses for the manufacturers could follow. Currently, the health insurance companies provide about 900 million euros per year for urine and blood sugar test strips. (Sb)

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Image: Michael Horn