Government has approved a set of documents related to reimbursement of medicines

On February 27^th, 2019 the Cabinet of Ministers of Ukraine approved a set of documents introducing new mechanism of reimbursement of medicines. The government passed the following acts:

- Resolution of the Cabinet of Ministers of Ukraine “Some Issues of Reimbursement of Medicines” No. 135 as of February 27^th, 2019;

- Resolution of the Cabinet of Ministers of Ukraine “Some Issues of Reimbursement Agreements” No. 136 as of February 27^th, 2019;

- Resolution of the Cabinet of Ministers of Ukraine “On Approval of the Procedure for the Use of Funds Allocated in the State Budget for Reimbursement of Medicines for Treatment of Some Diseases” No. 1141 as of February 27^th, 2019.

The mentioned acts delegate functions of administrating the reimbursement program to the National Healthcare Service of Ukraine, and all document flow related to conclusion, change and termination of reimbursement agreements will take place through the healthcare electronic system regardless of the patient’s residence or place of medical services provision.

Further, one of the main changes introduced in the documents is electronic prescriptions to be launched under the program “Affordable Medicines”. It has been established that costs of medicines released based on paper prescriptions will be reimbursed against subvention from the state budget to local budgets allocated to reimburse medicines for treatment of some diseases as prescribed in the Law of Ukraine “On State Budget of Ukraine for 2019” by March 31^st, 2019 (inclusive). From April 1^st, 2019 medicines will be reimbursed exclusively based on electronic prescriptions issued through the electronic healthcare system.

Resolution of the Cabinet of Ministers of Ukraine No. 135 as of February 27^th, 2019 set out the Procedure for Reimbursement of Medicines, Procedure for Determining the Medicines Reimbursement Amount, as well as the List of INN covered by the government program (not changed, previously contained in Resolution of the Cabinet of Ministers No. 863 which expired upon approval of Resolution No. 135). It should be noted that approval of the reimbursement procedure is prescribed by the Law of Ukraine “On State Financial Guarantees of Medical Care Provision to the Population” within the medical reform introduction.

The approved regulatory acts established financial fuses, namely specified that electronic prescriptions should be issued not to exceed the general amount of budget allocations on reimbursement of medicines under the reimbursement agreements as established in cost estimates for a corresponding month. In case general cost of medicines of all issued electronic prescriptions in the corresponding month is equal to the amount of budget allocations on reimbursement of medicines under the reimbursement agreements as provided in the cost estimate for the corresponding month, issue of electronic prescriptions through the electronic healthcare system is suspended till the beginning of the next month. It means doctors in this case will not be able to issue new electronic prescription.

The National Healthcare Service of Ukraine will be obliged to publish information on the reimbursement program implementation progress regularly. The information can be obtained at the official website of the National Healthcare Service of Ukraine.

The mechanism of determining medicines reimbursement amount has remained unchanged, except for the provision that calculation will be performed by the National Healthcare Service of Ukraine. Like now, the register will be approved by the Ministry of Health of Ukraine. It should be noted that by July 1^st when the Ministry of Health of Ukraine will approve the updated Register of Medicines Subject to Reimbursement, the current order of the Ministry No. 148 as of January 21^st, 2019 will be effective.

Resolution of the Cabinet of Ministers of Ukraine No. 136 as of February 27th, 2019 approved the Procedure for Conclusion, Changing and Termination of Reimbursement Agreement and Standard Reimbursement Agreement form, under which a commercial entity wishing to enter into agreement with the National Healthcare Service must:

• register in the system and ensure registration there of its authorized persons to be engaged in the agreement performance in accordance with the legislation and ensure that they obtain qualified electronic signature;
• have computer equipment and software necessary to work in the system, with Internet access in every pharmacy where medicines are released under the agreement.

Besides, pharmacies which take part in the program “Affordable Medicines” will have to ensure constant availability of at least one medicine 100% subject to reimbursement and offer consumers from the list of trade names first of all the medicines subject to full reimbursement from the state budget.

Regarding the procedure for use of funds allocated from the state budget on reimbursement of medicines for treatment of some diseases, it has been established that the main manager of budget funds is the Ministry of Health, the lower level manager of budget funds and responsible executor of the budget program is the National Healthcare Service of Ukraine. UAH 750,000 has been allocated for implementation of the state budget program in 2019.

The budget funds will be used for:

• reimbursement of medicines to commercial entities which have concluded reimbursement agreements with the National Healthcare Service of Ukraine;
• payment of expenses related to ensuring prescription issue and registration of medicines release through the electronic healthcare system.

It should be noted that medicines will be reimbursed based on reports on released medicines. Pharmacies will file reports several times per month within the periods from 1^st to 15^th day of a month inclusive; from 16^th to the last day of a month inclusive (in December – to 22^nd day). The cost of medicines released from 23^rd to 31^st December must be included to the first report for January of the next year.