On approval of the Rules for implementation of co-payment for medicines and medical devices

New Unofficial translation

Order of the Minister of Healthcare of the Republic of Kazakhstan dated December 31, 2019 No. ҚР ДСМ-154. Registered with the Ministry of Justice of the Republic of Kazakhstan on December 31, 2019 No. 19814. Abolished by order of the Minister of Health of the Republic of Kazakhstan dated July 16, 2021 No. ҚР DSM-61.

      Unofficial translation

      On approval of the Rules for implementation of co-payment for medicines and medical devices

      Footnote. Abolished by the order of the Minister of Health of the Republic of Kazakhstan dated July 16, 2021 No. ҚР DSM-61 (shall be enforced after ten calendar days after the day of its first official publication).

      In accordance with subclause 83-2) of clause 1 of article 7 of the Code of the Republic of Kazakhstan dated September 18, 2009 "On Public Health and Health Care System" I HEREBY ORDER:

      1. To approve the attached Rules for implementation of co-payment for medicines and medical devices.

      2. Department of Pharmaceutical Provision and Standardization of the Ministry of Healthcare of the Republic of Kazakhstan in accordance with the procedure, established by the legislation of the Republic of Kazakhstan shall ensure:

      1) state registration of this order with the Ministry of Justice of the Republic of Kazakhstan;

      2) placement of this order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication.

      3) within ten working days after the state registration of this order, submission to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan of information about execution of measures, stipulated by subclauses 1) and 2) of this clause.

      3. Control over execution of this order shall be entrusted to Vice Minister of Healthcare of the Republic of Kazakhstan Nadyrov K.T.

      4. This order shall come into force from January 1, 2020.

      Minister of Healthcare
of the Republic of Kazakhstan
      Ye. Birtanov

  Approved by the order
of the Minister of Healthcare
of the Republic of Kazakhstan
dated December 31, 2019
No. ҚР ДСМ-154

Rules for implementation of co-payment for medicines and medical devices
Chapter 1. General provisions

      1. These Rules establish the procedure for implementation of co-payment for medicines and medical devices.

      2. In the field of circulation of medicines and medical devices, when paying the difference in the cost of medicines, medical devices and the established marginal price of their reimbursement within the guaranteed volume of free medical care (hereinafter referred to as the GVMC) and in the system of compulsory social health insurance (hereinafter referred to as the CSHI), shall be carried out by the authorized body in the field of health by co-payment of the difference in the cost of medicines, medical devices and the established marginal price of their reimbursement.

      3. The following basic concepts are used in these Rules:

      1) the outpatient drug provision accounting information system (hereinafter referred to as the DPAIS) – an information system determined by the authorized body in the field of healthcare to automate the accounting of prescriptions, dispensing of goods to suppliers of pharmaceutical services or services for accounting and sales within the framework of GVMC and in the CSHI system;

      2) Social Health Insurance Fund (hereinafter referred to as the Fund) – a non-profit organization that accumulates deductions and contributions, as well as purchases and pays for the services of healthcare entities providing medical care in the volumes and on the conditions provided for by the contract for the purchase of medical services, and other functions determined by the laws of the Republic of Kazakhstan;

      3) co-payment – payment of the difference in the cost of medicines, medical devices and the established marginal price for their reimbursement within the framework of GVMC and in the CSHI system;

      4) a list of medicines and medical devices for free and (or) preferential outpatient provision of certain categories of citizens with certain diseases (conditions) (hereinafter referred to as the List) – the list of medicines and medical devices within the framework of GVMC including specific categories of citizens with certain diseases (conditions) with free of charge and (or) preferential medicines and medical devices at the outpatient level, approved by order of the Minister of Healthcare of the Republic of Kazakhstan dated August 29, 2017 No. 666 (registered in the Register of State Registration of Regulatory Legal Acts of the Republic of Kazakhstan under No. 15724);

      5) the international non-patented name of a medicinal product (hereinafter referred to as the INPN) – a name of a medicine recommended by the World Health Organization;

      6) reimbursement within the framework of GVMC and in the CSHI system – payment of the cost of using medicines and medical devices within the framework of GVMC and the CSHI system at the expense of budgetary funds and assets of the social health insurance fund, with the formation of an appropriate economically justified tariff or marginal price;

      7) marginal price for the trade name of a medicine or a medical device within the framework of GVMC and in the CSHI system – the price for a trade name of a medicinal product or medical device, above which procurement cannot be made within the framework of GVMC and in the CSHI system;

      8) marginal price for the INPN of a medicine or technical specification of a medical device within the framework of GVMC and in the CSHI system – the price for the INPN of a medicine or technical specification of a medical device, above which it cannot be procured within the framework of GVMC and in the CSHI system;

      9) marginal price of reimbursement of medicines according to the INPN, medical devices according to technical characteristics and / or composition within the framework of GVMC and in the CSHI system - the cost of one package of a medicinal product, with a certain dosage, form of release according to INPN of the medicinal product and / or according to technical characteristics and / or a certain composition of a medical device, which is fully or partially reimbursed by the Fund for Objects in the field of drug circulation, calculated by multiplying the purchase price according to the price list of the Single Distributor by the INPN of the drug within the framework of GVMC and in the CSHI system per unit of measurement when purchasing by the number of measuring units in consumer packaging.

      10) an electronic prescription – a document, formed by a healthcare worker in an electronic format by means of an electronic health passport in the DPAIS, containing information on the prescription of a drug and a medical device to a patient for further dispensing by the objects in the field of drug circulation that have a permit (license) to carry out pharmaceutical activities for the retail sale of drugs and medical devices, obtained in accordance with the legislation of the Republic of Kazakhstan on permits and notifications (hereinafter referred to as the Objects in the field of DC) and signed by the electronic digital signature of the doctor;

Chapter 2. Procedure for implementation of co-payment

      4. Co-payment of difference in the cost of a medicine and a medical device, and the established marginal price for their reimbursement, shall be carried out in provision of outpatient care of the population in accordance with the List in the Objects in the field of DC, providing accounting and distribution services and / or pharmaceutical services within the framework of GVMC and CSHI with the possibility of choosing a more expensive medicine with co-payment, if the patient does not agree to receive the trade names of medicines and medical devices provided for by the free vacation within the maximum reimbursement price, replacing them with more expensive trade names of their own choice.

      5. All trade names of medicines and medical devices registered in the Republic of Kazakhstan and included in the List of medicines according to INPN, as well as medical devices according to technical characteristics and / or composition, the cost of which exceeds the maximum reimbursement price shall be subject to co-payment, except for those purchased from international organizations and domestic manufacturer under long-term supply contracts.

      6. An electronic prescription for a medicine or medical device within the framework of GVMC and / or CSHI, subject to co-payment, shall be ordered in the DPAIS by medical workers of health care organizations providing outpatient, preventive, diagnostic, curative, rehabilitative or palliative care on prescription forms for free dispensing in the form approved by the order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated November 23, 2010 No. 907 "On Approval of Forms of Primary Medical Documentation of Health Care Organizations" (registered in the Register of State Registration of Regulatory Legal Acts of the Republic of Kazakhstan under No. 6697).

      7. Dispensing of medicines and medical devices with co-payment to patients shall be carried out by prescription, which are valid within the administrative-territorial unit of the republic (district, city, region) for 3 months from the date of their prescription in accordance with the Rules for Prescribing, Accounting and Storage of Prescriptions approved by the order Minister of Health and Social Development of the Republic of Kazakhstan dated May 22, 2015 No. 373 (registered in the Register of State Registration of Regulatory Legal Acts under No. 11465), upon presentation of an identity document.

      8. Patients wishing to choose more expensive trade names of medicines and medical devices with co-payment shall be provided by the specialist of the Object in the field of DC in an accessible form with complete and reliable information about the possibility of obtaining appropriate medicines and medical devices free of charge within the framework of GVMC and in the CSHI system.

      9. If it is possible to dispense a more expensive medicine or medical device, with co-payment of the cost by the patient, the specialist of the Object in the field of DC shall offer the patient possible options for trade names of medicines or medical devices that correspond to the prescribed INPN of a medicine or technical characteristics and / or composition of the medical products, taking into account the dosage form and dosage of a medicinal product or a complete set of a medical device available in the assortment, starting with a medicine or a medical device at the lowest price.

      10. If the patient chooses to dispense trade names of a medicine and medical device with co-payment, the patient shall fill out a written voluntary consent with the co-payment of the cost on the part of the patient for these trade names of medicines or medical devices.

      11. When choosing a more expensive medicine or medical device, citizens shall perform co-payment for the difference in the cost of the same names of medicines or medical devices received by them during outpatient provision in excess of the maximum reimbursement price for the INPN of the medicine and the technical characteristics and / or composition of the medical device. At the same time, on the back of the prescription, the specialist of the Object in the field of DC indicates the trade name of the dispensed medicine and medical device, signs and writes the date of issue.

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