Introduction

The financing of the Austrian healthcare system by the social security institutions differs between the inpatient and the outpatient sector: In the inpatient sector social security pays a case rate to the hospitals, which covers the complete medical services provided by the hospitals including medicines. In the outpatient sector social security pays for medical attendance, medical devices and medicines provided these medicines are included in the reimbursement code established by the umbrella organization of social security institutions. The umbrella organization also has to establish a list of medicines which are in general not paid for, because they are administered predominantly in hospitals.

Facts

By decision of June 22, 2018 social security refused the inclusion of the medicine OnPro Kit for the treatment of chemotherapy-induced leucopenia. The reason for the refusal was that social security qualified OnPro Kit as a medicine designated for the treatment in hospitals. Since chemotherapies are an inpatient treatment the administration of OnPro Kit has to be attributed also to the intramural sphere. A medicine for the treatment in hospitals is excluded from the inclusion into the reimbursement code.

Decisions

The Federal Administrative Tribunal rejected the applicant's appeal against this decision.1 The tribunal held that the umbrella organization of social security institutions must establish a list of medicines which are in general administered only in hospitals. Following chemotherapy OnPro Kit is administered to the patient. After approximately 27 hours the OnPro Kit releases the active ingredient by an automatic injection. Administration to the patient is the application of the kit to the patient and not the release of the active ingredient. Therefore, the OnPro Kit is not administered by physicians in private practice which is a precondition for the inclusion into the reimbursement code.

Upon appeal the Supreme Administrative Court2 set the decision aside. The court held that medical treatment comprises medical attendance by physicians in private practice, medicines and medical devices. Medical treatment must be sufficient and appropriate but must not go beyond the necessary.3 Concerning medicines social security has to establish a reimbursement code for the administration of medicines in the outpatient sector. This code has to include medicines with a marketing authorization in Austria which are reimbursable, securely available and according to the state of the art therapeutically effective. For the list of non-reimbursable medicines for treatment in hospitals the distinction between allocation of costs for inpatient treatment and outpatient treatment has a decisive role. The financing of the Austrian healthcare system provides that social security contributions to the financing of hospitals covers inpatient treatment. The accounting of medical services is based on case rates which includes all administered medicines during hospitalization. In the outpatient sector social security provides medical treatment as in-kind benefit by panel doctors and panel pharmacies. These benefits in kind are paid according to the tariffs of social security. Accordingly, there is a distinction between the intramural ambulant sphere (hospitals) and extramural ambulant sphere (panel doctors). Not only inpatient care but also services in outpatient departments of hospitals such as chemotherapies are part of the intramural sphere.

Medicines which can be administered also in the extramural sphere (notwithstanding their predominant use in the intramural sphere) are reimbursable. The reason for the "flat tuning" of the possibility of an inclusion into the reimbursement code by the criteria of reimbursability respectively the list established on that basis is that the inclusion of a medicine into the reimbursement code which is practically used only in the inpatient sector were of no use. A reimbursement of costs for such medicines by social security is ineligible. Social security only has to pay the case rate, for medicines used in hospitals and the reimbursement code is not applicable.

Also, in case of a predominant use in hospitals social security has to assess if a medicine can be applied lege artis also in the outpatient sector. If evidence shows that a medicine is also used in the outpatient sphere for medical treatment, it can be included into the reimbursement code subject to the prior approval of prescriptions by the supervisory service of social security. Although the predominant use of a medicine for treatment in hospitals indicates its lack for medical treatment in the outpatient sector, further evidence must be taken if a lege artis administration in the outpatient sector is appropriate without going beyond the necessary. If this evidence is provided the social security may establish reimbursability.

According to the established facts OnPro Kit is applied after chemotherapy in hospitals. This application to the patient's body is the administration of the medicine (and not the automatic release more than 24 hours later). The earlier administration of the medicine respectively the deferred release of the active ingredient saves the patient to set off for the hospital again or a panel physician. The application of OnPro Kit therefore is intramural if also the immediately preceding chemotherapy was provided intramural.

The administration in the outpatient sector therefore depends if the chemotherapeutic treatment (except for irrelevant emergency situations) is also administered in the outpatient sector. In this case the administration of the OnPro Kit is attributed to the outpatient sector so that reimbursability has to be affirmed. Since the Federal Administrative Tribunal only established that tumor therapies are provided in the inpatient sector, the tribunal will have to assess whether there are also out-patient chemotherapies.

Comment

By this landmark decision the Supreme Administrative Court approaches the question of inclusion of a medicine into the reimbursement code. The court examines the special case when a medicine is not appropriate to be used by a panel doctor in the course of medical treatment, because it predominantly serves for the treatment in hospitals. Not the factual predominant application in the inpatient sector is decisive, but the clarification of the question if an appropriate and effective administration is suitable also in the outpatient sphere without going beyond the necessary. For the qualification of medicines therefore also aspects of financing are important.

Even if included to the reimbursement code administration of the medicine is subject to the prior approval by the supervisory service of social security. If the supervisory service refuses reimbursement, this decision is subject to appeal to the social and labour courts.

Footnotes

1. Federal Administrative Tribunal April 2, 2019, W147 2201482-1/11E.

2. Supreme Administrative Court September 11, 2019, RO 2019/08/0013.

3. Sec 133 (2) General Social Security Act.

Originally published February 24, 2020

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