§ 48. Scope of insurance cover in case of benefits for medical devices

(1)        The health insurance fund shall, to the extent and pursuant to the procedure provided by legislation, assume an obligation to pay for the medical devices which are necessary for an insured person and are entered in the list of medical devices of the health insurance fund (hereinafter list of medical devices).

(2)        For the purposes of this Act, a medical device is an instrument, apparatus or device, or a material or other product which an insured person, as a member of the general public, can use separately or in combination for one or more purposes prescribed by the producer and whose intended main effect to the insured person is neither pharmacological, immunological nor metabolic and which is needed for:

1)         monitoring, alleviating or treatment of a disease;

2)         alleviating or treatment of an injury.

(3)        The following shall not be regarded as a medical device for the purposes of this Act:

1)         a surgically invasive device;

2)         an implantable device;

3)         an active device for diagnostics.

(4)        The list of medical devices and the procedure for assumption of the obligation to pay for medical devices entered in the list of medical devices shall be established by a regulation of the Minister of Social Affairs on proposal of the supervisory board of the health insurance fund.

(5)        The following information shall be entered in the list of medical devices:

1)         the name of the group of medical devices;

2)         code of the medical device;

3)         name of the medical device:

4)         number of medical devices in the package;

5)         reference price of the medical device or sales packaging of medical devices which shall be the retail price agreed upon in the price agreement;

6)         the limits for the payment obligation of an insured person assumed by the health insurance fund;

7)         the extent of cost-sharing by an insured person;

8)         the conditions for application of the reference price of the medical device or sales packaging of medical devices, the limits for the payment obligation of an insured person assumed by the health insurance fund, and the extent of cost-sharing by an insured person.

(6)        The limits for the payment obligation of an insured person assumed by the health insurance fund shall be 90 % or 50 % of the reference price of the medical device or sales packaging of the medical device entered in the list of medical devices, except in the case specified in subsection 48¹ (3) of this Act.  The limit for the payment obligation of an insured person assumed by the health insurance fund shall be 50 % if there is an alternative method of treatment cheaper than the reference price of the medical device or sales packaging of the medical device, or a cheaper medical device belonging to another group of medical devices or another cheaper medical device available in Estonia.  

(7)        For the purposes of this Act, a group of medical devices joins medical devices with the same effect and intended purpose in the list of medical devices.

(8)        Only medical devices with regard to which the health insurance fund and the manufacturer or the representative thereof have entered into a price agreement may be entered in the list of medical devices.

(9)        A medical device may be entered in the list of medical devices with a condition with the objective to regulate the prescription of the medical device, taking account of the criteria provided in subsection 48¹ (1) of this Act.

(19.06.08 entered into force 1.09.08 - RT I 2008, 34, 210)