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Criteria for changing the list of medical devices of the Estonian Health Insurance Fund and evaluation procedures thereof

Issuer:Minister of Social Affairs
Type:regulation
In force from:01.01.2010
In force until: In force
Translation published:09.10.2014

Criteria for changing the list of medical devices of the Estonian Health Insurance Fund and evaluation procedures thereof

Passed 18.09.2008 No. 55
RTL 2008, 78, 1100
Entry into force 26.09.2008

Amended by the following legal instruments (show)

PassedPublishedEntry into force
14.12.2009RTL 2009, 99, 148201.01.2010

The Regulation is established under subsection 481 (5) of the Health Insurance Act.

Chapter 1 GENERAL TERMS 

§ 1.  Scope of application

 (1) The present Regulation establishes more detailed contents of the criteria considered upon the amendment of the list of medical devices (hereinafter the list) of the Estonian Health Insurance Fund (hereinafter Health Insurance Fund), institutions evaluating the compliance with the criteria and the procedures of evaluation.

 (2) For the purposes of the present Regulation, amendment of the list includes entry of a medical device into and deletion thereof from the list of medical devices and amendment of the name, reference price or the limitation of obligation assumed by the Health Insurance Fund and the cost-sharing rate of an insured person and the terms of application thereof.

§ 2.  Initiation of amendment of the list

 (1) Persons listed in subsection 481 (6) of the Health Insurance Act (hereinafter initiator of the proposal) may initiate amendment of the list.

 (2) Amendment of the list is initiated with the following purposes:
 1) for amendment of the name of a medical device entered into the list, reference price entered into the list, limitation of obligation assumed by the Health Insurance Fund and the cost-sharing rate of an insured person, as well as the amendment of the terms of application thereof;
 2) for deletion of a medical device from the list;
 3) for entry of a new medical devices into the list.

Chapter 2 CONTENTS OF THE CRITERIA 

§ 3.  Criteria

 (1) The following criteria shall be taken into account upon the entry of a medical device into the list or deletion thereof from the list:
 1) existence of a medically justified indication for the use of the medical device by the general public and existence of alternative medical devices or treatment methods;
 2) optimal quantity of medical devices necessary for treatment based on the diagnosis, severity of the disease or other circumstances influencing the course of treatment;
 3) compliance with the financial means of health insurance, including the existence of another public source of financing;
 4) cost-effectiveness of the medical device;
 5) conformity of the medical device with the Medical Devices Act.

 (2) If the reference price of a medical device entered into the list is amended, criteria provided in subsection 1 clauses 2 and 3 shall be evaluated.

§ 4.  Existence of a medically justified indication for the use of the medical device by the general public and existence of alternative medical devices or treatment methods

  In evaluation of criterion provided in clause 1 of section 1 of § 3 of the present Regulation, the following circumstances are considered:
 1) existence of a medically justified indication for regular use of the medical device;
 2) treatment result expected from using the medical device, including a short-term and long-term prognosis of effectiveness of the treatment;
 3) an estimation of the number of patients needing the medical device in Estonia;
 4) possible influence of the individuality of a patient to the treatment results;
 5) possible side effects of the treatment;
 6) comparison to alternative medical devices and methods of treatment used in Estonia and internationally, including medicinal products and health care services;
 7) comparison of the medical device with medical devices entered into the list of medical devices, including the possibilities of replacement or supplemental influence of the new device to the valid list;
 8) cause-and-effect relationship of the medical problem solved with the medical device with conscious choices of a potential patient.

§ 5.  Optimal quantity of medical devices necessary for treatment based on the diagnosis, severity of the disease or other circumstances influencing the course of treatment

  In evaluation of criterion provided in clause 1 of section 2 of § 3 of the present Regulation, the following circumstances are considered:
 1) optimal quantity of the medical device necessary for treatment period due to the diagnosis or another indication, severity of the disease or other circumstances influencing the course of treatment;
 2) comparison of the optimal quantity of the medical device necessary for treatment with international experience and existing guidelines;
 3) estimated number of patients needing the medical device in Estonia by diagnosis or another indication, severity of disease or other circumstances influencing the treatment.

§ 6.  Compliance with the financial means of health insurance, including the existence of another public source of financing

  In evaluation of criterion provided in clause 1 of section 3 of § 3 of the present Regulation, the following circumstances are considered:
 1) short- and long-term influence of the medical device to the costs of the health insurance budget, including separately described influence on the costs of health care services, medicinal products and the on the costs of the benefit for incapacity for work;
 2) influence of the use of the medical device on the availability of health care services;
 3) compensation for the medical device from other public funds.

§ 7.  Cost-effectiveness of the medical device

 (1) In evaluating the criterion established in clause 4 of section 1 of § 3 of the present Regulation the medical device is compared to listed medical devices or other possible alternative in solving the same medical issue, including the cost of medicinal products and health care services.

 (2) In evaluating medical cost-effectiveness, the following cost aspects are considered as a set for both medical devices to be listed and alternative possibilities:
 1) costs of the medical device (price), including a comparison to an alternative medical device, medicinal products, surgical intervention, etc.;
 2) costs covered by the patient;
 3) costs of health care services and compensated medicinal products;
 4) costs of benefits for temporary incapacity for work;
 5) costs of a need for possible social care;
 6) costs of restoring the ability of the patient to work and influence on his/her incomes.

§ 8.  Conformity of the medical device to the Medical Devices Act

  In evaluation of criterion provided in clause 5 of section 1 of § 3 of the present Regulation, the following circumstances are considered:
 1) conformity of the medical device with the Medical Devices Act and legislation established thereunder;
 2) standards accepted in European countries for the medical device and evidence based usage of the device;
 3) experience on using the medical device in Estonia and European countries.

Chapter 3 PERSONS EVALUATING THE COMPLIANCE WITH THE CRITERIA 

§ 9.  Institutions evaluating the compliance with the criteria

 (1) Institutions evaluating the compliance with the criteria (hereinafter the evaluator) include a relevant association of medical specialists, the Health Insurance Fund and the Health Board.
[RTL 2009, 99, 1482 – entered into force 01.01.2010]

 (2) A relevant professional association gives the following evaluation:
 1) in regard to the existence of a medically justified indication for the use of the medical device by the general public and existence of alternative medical devices or treatment methods;
 2) in regard to the optimal quantity of medical devices necessary for treatment based on the diagnosis, severity of the disease or other circumstances influencing the course of treatment.

 (3) The Health insurance Fund gives the following evaluation:
 1) in regard to the existence of a medically justified indication for the use of the medical device by the general public and in regard to the existence of alternative medical devices or methods of treatment, if the list is amended within a group of medical devices already included in the list;
 2) in regard to the compliance of the device with the financial resources of medical insurance;
 3) in regard to the cost-effectiveness of the medical device.

 (4) The Health Board gives an evaluation in regard to compliance with the requirements established in the Medical Devices Act and legislation established thereunder.
[RTL 2009, 99, 1482 – entered into force 01.01.2010]

 (5) The evaluator gives competent expert opinion of the submitted proposal in the extent provided (hereinafter expert opinion).

 (6) The evaluator gives an expert opinion to the criteria directly connected with the medical device provided in the proposal.

 (7) The evaluator is responsible for the objectivity and correctness of the expert opinion.

Chapter 4 PROCEDURE FOR EVALUATING THE CONFORMITY TO CRITERIA 

§ 10.  Submission of a proposal

 (1) The initiator of a proposal drafts and submits a relevant application to the Health Insurance Fund, including information listed in an Annex to the Regulation, which are supplemented with additional information or references to a relevant source in scientific publications, if necessary, as electronic links at an Internet address, if possible.

 (2) A proposal is considered accepted, if all information for evaluating criteria provided in paragraphs 4 to 8 are included in the application of the initiator, considering the exception provided in section 2 to § 3.

§ 11.  Processing of a proposal

 (1) After the acceptance of a proposal the Health Insurance Fund starts negotiations with the initiator to process the proposal. If the Health Insurance Fund has initiated the proposal, the Health Insurance Fund starts negotiations with the interested manufacturer or manufacturers or representatives thereof.

 (2) The Health Insurance Fund submits the application of the initiator to evaluators in order to obtain an expert opinion.

 (3) The evaluator submits an expert opinion to the Health Insurance Fund within 45 days after having received the application of the initiator.

 (4) During the processing of a proposal an evaluator has a right to request additional information from the initiator of the proposal, if the application of the initiator does not contain enough information for the evaluation of the prescribed criteria.

 (5) The board of the Health Insurance Fund issues an opinion about the accepted proposals at least once every calendar year.

 (6) The board of the Health Insurance Fund submits a proposal to amend the list to the Minister of Social Affairs, enclosing a written opinion of the board of the Health Insurance Fund, application of the initiator, expert opinions and other relevant opinions, if necessary.

§ 12. Processing of a proposal on special terms

  Terms and procedure provided in the present regulation may not be applied, if:
 1) the proposal is based on a legal act;
 2) the name of the listed medical device is corrected linguistically.

5. peatükk ADMINISTRATIVE PROVISIONS 

§ 13. [Excluded from the present text]

Annex APPLICATION FOR ENTRY OF A MEDICAL DEVICE INTO THE LIST OF MEDICAL DEVICES OF THE ESTONIAN HEALTH INSURANCE FUND

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