Thông tư 22/2020/TT-BYT

CIRCULAR

PRESCRIBING MANAGEMENT OF ANTIRETROVIRAL DRUGS SUBJECT TO NATIONAL CENTRALIZED PROCUREMENT WITH FUNDING DERIVED FROM HEALTH INSURANCE FUND AND COPAY SUPPORT FOR HIV PATIENTS WHO HAVE HEALTH INSURANCE CARDS

Pursuant to the Law on HIV/AIDS prevention and control No. 64/2006/QH11 dated June 29, 2006;

Pursuant to the Law on health insurance No. 25/2008/QH12 dated November 14, 2008, and the Law on amendments to the Law on health insurance No. 46/2014/QH13 dated June 13, 2014;

Pursuant to the Law on Bidding No. 43/2013/QH13 dated November 26, 2013;

Pursuant to the Government’s Decree No. 63/2014/ND-CP dated June 26, 2014 providing guidelines for the Law on bidding regarding contractor selection;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

In implementation of the Decision No. 2188/QD-TTg dated November 15, 2016 of the Prime Minister prescribing payment for antiretroviral drugs subject to the national centralized procurement with funding for covered healthcare services and support for patients using antiretroviral drugs;

At the request of Directors of Vietnam Administration of HIV/AIDS Control and Health Insurance Department affiliated to the Ministry of Health;

The Minister of Health promulgates a Circular prescribing management of antiretroviral drugs subject to the national centralized procurement with funding derived from health insurance fund and copay support for HIV patients who have health insurance cards,

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Circular provides regulations on:

a) The national centralized procurement of antiretroviral drugs with funding sources prescribed in Point a Clause 1 Article 35 of the Law on health insurance (hereinafter referred to as “health insurance fund”), including planning for use of antiretroviral drugs and conclusion of contract with the successful bidder for supply of antiretroviral drugs (hereinafter referred to as “contractor”);

b) Management and use of antiretroviral drugs purchased through the national centralized procurement with health insurance funding;

c) Advancing, payment and statement of costs of antiretroviral drugs;

d) Funding sources and method for supporting copay for antiretroviral drugs for HIV patients who have health insurance cards.

2. This Circular shall not apply to antiretroviral drugs which are procured through other bidding forms and with funding sources other than health insurance fund.

3. Other contents which are not prescribed in this Circular shall be performed according to the Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health prescribing bidding for supply of drugs for public health facilities (hereinafter referred to as “Circular No. 15/2019/TT-BYT”).

Article 2. Grounds for planning for use of health insurance fund-covered antiretroviral drugs at health facilities

1. The estimated number of HIV patients who are treated with health insurance fund-covered antiretroviral drugs, sorted by treatment regimens, at the health facilities that provide HIV treatment with antiretroviral drugs and have entered into contracts for provision of covered healthcare services (hereinafter referred to as “health facilities”) as at December 31 of the year preceding the planning year.

2. Estimated changes to the number of HIV patients treated with health insurance fund-covered antiretroviral drugs, sorted by treatment regimens, at health facilities in the planning year.

3. The estimated quantity of antiretroviral drugs covered by heath insurance fund in stock, sorted by treatment regimens, at health facilities as at December 31 of the year preceding the planning year. Antiretroviral drugs in stock at health facilities at the end of the year shall be used in the following year and deducted from the quantity of antiretroviral drugs to be purchased in the following year. The purchase, use and inventory of antiretroviral drugs with other funding sources in the year preceding the planning year.

4. The estimated quantity of health insurance fund-covered antiretroviral drugs to be used according to each treatment regimen that the health facility will apply in the following year.

5. Guidelines for planning for use of antiretroviral drugs with health insurance fund given by Vietnam Administration of HIV/AIDS Control, based on current HIV treatment regimen, orientations for conversion of treatment regimens according to professional guidance of the Ministry of Health, orientations for use of antiretroviral drugs transferred by sponsors and other support sources, list of drugs covered by health insurance fund and granted marketing authorization, list of drugs subject to the national centralized procurement organized by the National centralized drug procurement center (hereinafter referred to as “procuring unit”).

Chapter II

NATIONAL CENTRALIZED PROCUREMENT OF ANTIRETROVIRAL DRUGS WITH HEALTH INSURANCE FUND

Article 3. Process of planning for use of health insurance fund-covered antiretroviral drugs

1. Demands for antiretroviral drugs are determined and consolidated as follows:

a) By February 10 every year, Vietnam Administration of HIV/AIDS Control shall promulgate guidance on planning for use of health insurance fund-covered antiretroviral drugs as prescribed in Clause 5 Article 2 hereof, and send it to provincial Centers for Disease Control and Centers for HIV/AIDS Control (hereinafter referred to as “provincial HIV/AIDS Control Agencies”) that shall then give instructions to local health facilities for implementation;

b) By March 01 every year, each health facility shall complete its plan for use of health insurance fund-covered antiretroviral drugs in the following year, in which the number of HIV patients sorted by treatment regimens, list of drugs and technical criteria categories of drugs must be specified, and send the registration of demands for antiretroviral drugs, accompanied by the documents specified in Clause 3 of this Article, to the relevant provincial HIV/AIDS Control Agency for review and consolidation;

c) By March 20 every year, each provincial HIV/AIDS Control Agency shall complete the review and consolidation of demands for health insurance fund-covered antiretroviral drugs of all health facilities in the province, including those under the management of provincial government and those under the management of Ministries, and submit a report to the provincial Department of Health for appraisal of lists, categories, quantity and demands for antiretroviral drugs of health facilities;

d) By April 01 every year, each provincial Department of Health shall send a proposal, accompanied by its appraisal record, to Vietnam Administration of HIV/AIDS Control for the list and demands for antiretroviral drugs of each technical criteria category of local health facilities;

dd) By April 20 every year, Vietnam Administration of HIV/AIDS Control shall complete the review and consolidation of demands for health insurance fund-covered antiretroviral drugs nationwide and make any necessary adjustments thereof, and send a written proposal to the procuring unit.

In case of adjustments, Vietnam Administration of HIV/AIDS Control shall notify relevant provincial Departments of Health in writing of such adjustments and include reasons for such adjustments in the written proposal sent to the procuring unit. Upon receipt of notification from Vietnam Administration of HIV/AIDS Control, provincial Departments of Health shall notify such adjustments to relevant provincial HIV/AIDS Control Agencies and health facilities.

e) If a health facility has demands for health insurance fund-covered antiretroviral drugs but does not yet consolidate such demands when formulating the contractor selection plan, it shall comply with the provisions in Clause 2 Article 8 of this Circular.

2. At the time of planning for use of antiretroviral drugs, if there are no drugs with valid registration numbers in the suggested technical criteria category, Vietnam Administration of HIV/AIDS Control shall adjust the quantity of drugs and technical criteria category of drugs as follows:

a) Drugs in the next higher technical criteria category where registration numbers are available shall be selected. If none of drugs in higher technical criteria categories has valid registration numbers, drugs in the next lower category where registration numbers are available shall be selected.

E.g. Regarding A drug, the health facility suggests the technical criteria category 4 but, after completion of consolidation of provincial plans, there are no drugs with valid registration numbers in technical criteria category 4. Thus, drugs in technical criteria category 2, 1, or 5 will be taken into consideration accordingly.

b) After adjustment, Vietnam Administration of HIV/AIDS Control shall give a written notification to the relevant provincial Department of Health whose suggested drug is adjusted. Upon receipt of the notification from the Vietnam Administration of HIV/AIDS Control, the provincial Department of Health shall notify the health facility whose suggested drug is adjusted in writing.

3. Documents enclosed with a registration of demands for antiretroviral drugs submitted by a health facility to the provincial HIV/AIDS agency include:

a) The plan for use of antiretroviral drugs formulated according to guidelines given by Vietnam Administration of HIV/AIDS Control, enclosed with the minutes of the meeting of the Drug and Treatment Council of the health facility;

b) The report on receipt and use of antiretroviral drugs in the previous year, the quantity of drugs in stock and the quantity of planned drugs yet to be supplied of health facilities, the estimated number of patients sorted by treatment regimens, and demands for drugs in the planning year sorted by drug categories;

c) If the quantity of drugs in the health facility’s plan increases or decreases by more than 30% compared to that in the previous year, it shall provide specific explanations thereof.

Article 4. Formulation, appraisal and approval for contractor selection plan and organization of contractor selection

1. Upon receipt of the written proposal for use of antiretroviral drugs in the following year from Vietnam Administration of HIV/AIDS Control, by May 20 every year, the procuring unit shall formulate the contractor selection plan according to the Circular No. 15/2019/TT-BYT , and send it to the Department of Planning and Finance for appraisal and submission to competent authorities.

2. Upon receipt of the contractor selection plan from the procuring unit, the Department of Planning and Finance shall appraise and submit it to a competent authority for approval by June 20 every year.

3. Based on the approved contractor selection plan, the procuring unit shall complete the organization of contractor selection by September 20 every year in order to ensure that drugs will be supplied to health facilities from January 01 of the following year.

4. If there are no drugs with valid registration numbers at the time of formulation of the contractor selection plan, the procuring unit shall give a written notification to Vietnam Administration of HIV/AIDS Control that shall then make adjustments according to Clause 2 Article 3 of this Circular, and notify the relevant provincial Department of Health and provincial HIV/AIDS Control Agency.

5. If the contractor selection is unsuccessful, the procuring unit shall notify it to Vietnam Administration of HIV/AIDS Control in writing for its cooperation in proposing appropriate measures to the Ministry of Health.

Article 5. Conclusion of framework agreement and contract with selected contractor

1. The procuring unit shall carry out negotiation, approval for contractor selection result and conclusion of the framework agreement with the contractor. Within 10 days from the date of conclusion of the framework agreement, the procuring unit shall send the signed framework agreement and decision on approval for contractor selection result to the following entities:

a) Vietnam Social Security;

b) The unit that takes charge of signing the contract with the contractor according to the decision issued by Vietnam Social Security (hereinafter referred to as “contract-signing unit”);

c) Vietnam Administration of HIV/AIDS Control.

2. Within 20 days from the date of conclusion of the framework agreement, the contract is required to complete the conclusion of the drug supply contract with the contract-signing unit in accordance with regulations of the Law on bidding.

3. The contract shall send the copies of the contract and its appendixes to the procuring unit, Vietnam Administration of HIV/AIDS Control, provincial HIV/AIDS Control Agencies and health facilities.

4. The contract-signing unit shall send the copies of contract, enclosed with the appendix of each province, to Vietnam Social Security and Social Security Offices of provinces and central-affiliated cities (hereinafter referred to as “provincial Social Security Offices”).

Chapter III

MANAGEMENT, USE AND PAYMENT, STATEMENT OF HEALTH INSURANCE FUND-COVERED ANTIRETROVIRAL DRUGS

Article 6. Plan for receipt of health insurance fund-covered antiretroviral drugs

1. Based on the signed contract, the plan for use of antiretroviral drugs and treatment demands in the quarter, the health facility shall formulate the plan for receipt of health insurance fund-covered antiretroviral drugs by the 20^th of the last month of the previous quarter, and send it to the contractor and the provincial HIV/AIDS Control Agency for consolidating and reporting Vietnam Administration of HIV/AIDS Control and the contract-signing unit.

2. The health facility may formulate the plan for receipt of an additional amount of antiretroviral drugs which does not exceed 20% of the quantity of drugs to be supplied under the signed framework agreement. If the health facility has demands for an additional amount of antiretroviral drugs exceeding 20% of the quantity of drugs to be supplied under the signed framework agreement, it shall comply with the provisions in Clause 1 Article 7 hereof.

3. If the contractor cannot supply adequate quantity of drugs on schedule as specified in the health facility’s plan for drug receipt:

a) The health facility shall immediately notify the contractor’s failure to supply drugs to the provincial HIV/AIDS Control Agency for notifying Vietnam Administration of HIV/AIDS Control;

b) Within 05 working days from the receipt of the notification from the provincial HIV/AIDS Control Agency, Vietnam Administration of HIV/AIDS Control shall notify the procuring unit and the contract-signing unit to inspect and expedite the contractor to supply drugs to the heath facility;

c) If the contractor is incapable of supplying drugs to the heath facility, the procuring unit and contract-signing unit shall take actions against the contractor’s violation as prescribed and notify the case to Vietnam Administration of HIV/AIDS Control for reporting the Ministry of Health for consideration.

Article 7. Procedures for provincial circulation of antiretroviral drugs

Where a health facility has demands for an additional amount of antiretroviral drugs exceeding 20% of the quantity of drugs to be supplied under the signed framework agreement or its quantity of drugs in stock is not enough to meet its treatment demands but the contractor is incapable of supplying drugs on time according to the plan for drug receipt:

1. The health facility shall send a written request for circulation of drugs to the provincial HIV/AIDS Control Agency.

2. Within 10 working days from the receipt of the request from the health facility, the provincial HIV/AIDS Control Agency shall review the quantity of drugs used, in stock and yet to be supplied to local health facilities under the framework agreement for issuing a drug circulation decision, and send written notifications to the followings:

a) Health facilities among which drugs will be circulated (transferring and receiving health facilities);

b) The contractor for implementation;

c) The contract-signing unit for adjusting the quantity of drugs of health facilities on the health insurance assessment-related information system and monitoring;

d) Vietnam Administration of HIV/AIDS Control for monitoring.

3. Within 10 working days from the receipt of the notification from the provincial HIV/AIDS Control Agency, the contractor shall make circulation of drugs at as requested.

4. The provincial HIV/AIDS Control Agency shall only circulate an additional amount of drugs which does not exceed 20% of total quantity of drugs to be supplied to all local health facilities under the framework agreement.

Article 8. Procedures for national circulation of health insurance fund-covered antiretroviral drugs

1. If the quantity of drugs to be circulated exceeds the one prescribed in Clause 4 Article 7 hereof.

a) The provincial HIV/AIDS Control Agency shall send a written request for circulation of drugs to Vietnam Administration of HIV/AIDS Control within 05 working days from the receipt of the written request for circulation of drugs from the provincial Department of Health;

b) Within 10 days from the receipt of the written request from the provincial HIV/AIDS Control Agency, Vietnam Administration of HIV/AIDS Control shall review the quantity of drugs used, in stock and yet to be supplied to health facilities nationwide under the framework agreement for issuing a drug circulation decision, and send written notifications to provincial HIV/AIDS Control Agencies among which drugs will be circulated (receiving and transferring provincial HIV/AIDS Control Agencies), the contractor for implementation, the contract-signing unit for adjusting the quantity of drugs of health facilities on the health insurance assessment-related information system and monitoring, and the procuring unit for monitoring;

c) Within 10 working days from the receipt of the notification from Vietnam Administration of HIV/AIDS Control, the contractor shall make circulation of drugs as requested.

2. If there are health facilities having demands for health insurance fund-covered antiretroviral drugs but such demands are not yet consolidated when formulating the contractor selection plan:

a) The provincial HIV/AIDS Control Agency shall consolidate demands for health insurance fund-covered antiretroviral drugs of health facilities, written requests for circulation of drugs and documents proving the health facility’s satisfaction of requirements for provision of covered healthcare services with antiretroviral drugs sent to the provincial Department of Health for appraisal and send a written request for circulation of drugs to Vietnam Administration of HIV/AIDS Control;

b) Within 10 days from the receipt of the request from the provincial HIV/AIDS Control Agency, Vietnam Administration of HIV/AIDS Control shall consolidate and review demands for health insurance fund-covered antiretroviral drugs of the requesting province and other provinces nationwide for making circulation, and send written notifications to the procuring unit, the contract-signing unit and provincial HIV/AIDS Control Agency for adding such health facilities to the list of health facilities using health insurance fund-covered antiretroviral drugs, and send a notification to the contractor for implementation;

c) Within 07 working days from the receipt of Vietnam Administration of HIV/AIDS Control, the contract-signing unit shall enter into a contract for supply of additional drugs to health facilities having demands with the contractor in accordance with regulations of the Law on bidding;

d) The contractor shall send the copies of the contract, enclosed with the appendix of health facilities having demands, to the procuring unit, Vietnam Administration of HIV/AIDS Control, provincial HIV/AIDS Control Agency and health facilities;

dd) The contract-signing unit shall send the copies of the contract, enclosed with the appendix of each province, to Vietnam Social Security and provincial social security offices.

e) Within 07 working days from the date of conclusion of the contract for supply of additional drugs to health facilities having demands, the contractor shall make circulation of drugs at the request of Vietnam Administration of HIV/AIDS Control and the contract-signing unit for monitoring.

3. The additional amount of drugs to be circulated by Vietnam Administration of HIV/AIDS Control shall not exceed 30% of total quantity of drugs to be supplied to health facilities nationwide under the framework agreement.

4. If the quantity of circulated drugs exceeds the quantity prescribed in Clause 3 of this Article, Vietnam Administration of HIV/AIDS Control shall send a written request to the procuring unit for carrying out procedures for additional procurement.

Article 9. Other cases of circulation of antiretroviral drugs covered health insurance fund

1. If the drugs in stock of a health facility are redundant or have less than 6 months shelf life (including those transferred from the previous year):

a) The health facility shall send a written request for circulation of drugs to the provincial HIV/AIDS Control Agency;

b) Within 05 working days from the receipt of the request from the health facility, the provincial HIV/AIDS Control Agency shall review demands for treatment of local health facilities.

If drugs may be circulated within the provincial scope, the provincial HIV/AIDS Control Agency shall give written notifications to relevant health facilities and contract for making circulation. Within 05 working days from the receipt of the written notification from the provincial HIV/AIDS Control Agency, the contractor shall make circulation of drugs at the request of the provincial HIV/AIDS Control Agency and send written notifications to Vietnam Administration of HIV/AIDS Control and the contract-signing unit for monitoring;

If the circulation of drugs may not be made within the provincial scope, the provincial HIV/AIDS Control Agency shall send a written request for circulation of drugs to Vietnam Administration of HIV/AIDS Control.

Within 07 working days from the receipt of the written request from the provincial HIV/AIDS Control Agency, Vietnam Administration of HIV/AIDS Control shall send a written notification to the contractor for transferring the redundant quantity of drugs to health facilities that are capable of receiving such drugs.

Within 05 working days from the receipt of the written notification from Vietnam Administration of HIV/AIDS Control, the contractor shall make circulation of drugs at the request of Vietnam Administration of HIV/AIDS Control, and send written notifications to Vietnam Administration of HIV/AIDS Control for monitoring and the contract-signing unit for making circulation of drugs on the health insurance assessment-related information system.

2. If a request for circulation of drugs is refused, Vietnam Administration of HIV/AIDS Control shall give written response to the relevant provincial HIV/AIDS Control Agency for giving notification thereof to the requesting health facility.

Article 10. Regulations on lost, damaged or expired drugs

1. The health facility or contractor shall be responsible for the quantity of lost, damaged or expired drugs and receive no payment from health insurance fund if such loss, damage or expiring of drugs is at their fault.

2. If the quantity of antiretroviral drugs in stock has been reported to Vietnam Administration of HIV/AIDS Control for circulation but no health facility has demand for such drugs or if the health facility fails to comply with the circulation request or fails to submit a request for circulation of drugs within the time limit prescribed in Clause 1 Article 9 hereof resulting in expired drugs, the health facility having drugs in stock shall assume responsibility for such quantity of expired drugs and receive no payment from the health insurance fund.

Article 11. Advancing, payment and statement of drug costs between contract-signing unit and contractor

1. The contract-signing unit shall make an advance payment equal to 80% of the value of health insurance fund-covered antiretroviral drugs under drug receipt plans of health facilities in the first quarter to the contractor. In the second quarter onwards, the advance payment shall equal 80% of costs of health insurance fund-covered antiretroviral drugs used by patients in the previous quarter until the contract is properly terminated. The contract-signing unit shall carry out termination of the contract signed with the contractor after the quantity of health insurance fund-covered antiretroviral drugs supplied to health facilities have been used up by patients. The contract-signing unit and the contractor shall carry out termination of contract in accordance with regulations of law and terms and conditions of the signed framework agreement and contract under this Circular.

2. Quarterly, based on the statement of costs of health insurance fund-covered antiretroviral drugs used by patients in the previous quarter, the contract-signing unit shall make payment of remaining costs to the contractor after deducting the payment advanced in that quarter. If total advance payment is greater than the amount payable, the advance payment will be deducted from costs in the following quarter.

Article 12. Payment and statement of costs of health insurance fund-covered antiretroviral drugs between health facilities and social security offices

1. At the same time when the statement of costs of covered medical services is sent, each health facility shall prepare and send the statistical report on costs of health insurance fund-covered antiretroviral drugs provided for patients to the social security office that it has entered into the contract for provision of covered healthcare services with (hereinafter referred to as “social security office”) in which the costs of antiretroviral drugs to be covered by health insurance fund must be separated from those to be copaid by patients holding health insurance cards (hereinafter referred to as “copay for antiretroviral drugs”).

2. Quarterly, the social security office shall issue a notice of assessment result and verified costs of covered healthcare services to the heath facility, and deduct the costs of antiretroviral drugs on patients having health insurance (including those covered by the health insurance fund and copay for antiretroviral drugs incurred in the period) from the costs of medical services for the health facilities are reimbursed by the health insurance fund.

Article 13. Payment for supported copay for antiretroviral drugs to health facilities

1. Funding derived from local-government budget for supported copay for antiretroviral drugs shall be provided through a unit designated by the provincial People's Committee according to decentralized management of state budget and its functions and tasks (hereinafter referred to as “supporting unit”) as follows:

a) Each health facility shall make the estimate of copay for antiretroviral drugs of patients holding health insurance cards at the same time when its cost estimate is made in accordance with regulations of the Law on state budget, and send it to the relevant provincial Department of Health for consolidating and requesting competent authorities to allocate estimated funding for annual state budget expenditures to the supporting unit.

b) At the same time when the health facility sends the statement of costs of covered healthcare services to the social security office, it shall also send a written request for payment of copay for antiretroviral drugs to the supporting unit, enclosed with the statistical report on costs of antiretroviral drugs provided for patients holding health insurance cards in the period;

c) Within 10 days from the receipt of the request from the health facility, the supporting unit shall make payment of copay for health insurance fund-covered antiretroviral drugs directly to the health facility;

d) After the social security office has verified the costs of antiretroviral drugs used in the year, if there are any changes to the payment made, the health facility shall send a written request for adjustments to payment and statement of costs to the supporting unit for consolidating, adjusting and adding to the cost estimate in the following year;

dd) Patients holding health insurance cards shall have their copay for antiretroviral drugs supported when receiving healthcare services from provincial health facilities that are their registered initial providers of covered healthcare services, unless a patient’s registered initial provider of covered healthcare services is located in another province or his/her health insurance card is issued by a Ministry. If the provincial People’s Committee, depending on its conditions, approves the budget for supporting patients whose registered initial providers of covered healthcare services are located in other provinces or who have health insurance cards issued by Ministries, health facilities shall make estimates and receive payment of supported copay for antiretroviral drugs according to Clause 1 of this Article.

2. Funding for supporting copay for health insurance fund-covered antiretroviral drugs from aid programs/projects (hereinafter referred to as “projects”) shall be provided as follows:

a) Health facilities shall make and send estimates of copay for antiretroviral drugs of patients holding health insurance cards to provincial HIV/AIDS Control Agencies for consolidating and reporting Vietnam Administration of HIV/AIDS Control and including them into the annual support plan of projects which is sent to sponsors and Ministry of Health for approval;

b) At the same time when the health facility sends the statement of costs of covered healthcare services to the social security office, it shall also send a written request for payment of copay for antiretroviral drugs to the provincial HIV/AIDS Control Agency, enclosed with the statistical report on costs of antiretroviral drugs provided for patients holding health insurance cards in the period for submission to the project for making payment to the health facility;

c) After the social security office has verified the costs of health insurance fund-covered antiretroviral drugs used in the year, if there are any changes to the payment made, the health facility shall send a written request for adjustments to payment and statement of costs to the program/project for consolidating, adjusting and adding to the cost estimate in the following year;

d) Every year, Vietnam Administration of HIV/AIDS Control shall announce the list of provinces/cities eligible for funding for supported copay for antiretroviral drugs from projects;

dd) By January 20 every year, provincial HIV/AIDS Control Agencies shall submit consolidated reports on payment of copay for antiretroviral drugs used by patients holding health insurance cards in the previous year to Vietnam Administration of HIV/AIDS Control for review and verification with Vietnam Social Security.

Chapter IV

IMPLEMENTATION

Article 14. Implementation

1. Responsibilities of Vietnam Administration of HIV/AIDS Control:

a) Direct and instruct provincial HIV/AIDS Control Agencies in planning for health insurance fund-covered antiretroviral drugs and preparing reports on use and circulation of health insurance fund-covered antiretroviral drugs;

b) Cooperate with the procuring unit and contract-signing units to supervise the implementation of framework agreements and contracts for supply of health insurance fund-covered antiretroviral drugs.

2. Responsibilities of Vietnam Social Security:

a) Instruct its affiliated units to consolidate, report and pay for health insurance fund-covered antiretroviral drugs as prescribed;

b) Give authorization to search for data about use and payment for health insurance fund-covered antiretroviral drugs of provincial health facilities to Vietnam Administration of HIV/AIDS Control.

3. Each contract-signing unit shall cooperate in circulating and supervising the execution of the signed contract.

4. Each provincial Department of Health shall make and send the annual estimate of funding for copay for antiretroviral drugs to competent authorities for approval according to the Law on state budget.

5. Responsibilities of each provincial HIV/AIDS Control Agency:

a) Manage the use of health insurance fund-covered antiretroviral drugs in the province; make provincial circulation of antiretroviral drugs according to Article 7 of this Circular;

b) Prepare and submit consolidated reports on distribution, use and circulation (if any) of health insurance fund-covered antiretroviral drugs of local health facilities to Vietnam Administration of HIV/AIDS Control.

6. Responsibilities of the procuring unit:

a) Organize bidding and signing the framework agreement with the successful bidder;

b) Play the leading role, supervise and manage the contractor’s supply of health insurance fund-covered antiretroviral drugs according to the signed framework agreement.

7. Responsibilities of each health facility:

a) Update costs of covered healthcare services provided to HIV patients according to the Circular No. 48/2018/TT-BYT dated December 28, 2017 of the Minister of Health prescribing transfer of electronic data in management and payment for covered healthcare services;

b) Submit reports on the quantity of drugs used in the month and the quantity of drugs in stock and their expiry date to the provincial HIV/AIDS Control Agency for making circulation of drugs to other health facilities in the same province;

c) The head of the health facility and the contractor shall assume responsibility to implement at least 80% of value of each part of the signed contract according to Clause 3 Article 37 of the Circular No. 15/2019/TT-BYT .

8. Responsibilities of each contractor:

a) Fully implement provisions of the signed framework agreement and contract;

b) Ensure adequate and timely supply of drugs according to the framework agreement and the contract signed with the health facility;

c) Submit reports on health insurance fund-covered antiretroviral drugs supplied to health facilities according to guidelines of the Ministry of Health (via Vietnam Administration of HIV/AIDS Control) and Vietnam Social Security.

Article 15. Effect

1. This Circular comes into force from January 20, 2021.

2. The Circular No. 28/2017/TT-BYT dated June 28, 2017 of the Minister of Health and the Circular No. 08/2018/TT-BYT dated April 08, 2018 of the Minister of Health shall cease to have effect from the date of entry into force of this Circular.

Article 16. Transition

Health insurance fund-covered antiretroviral drugs supplied under contracts signed before the effective date of this Circular shall continue to be used. Contract-signing units shall carry out procedures for termination of contracts according to Clause 1 Article 11 of this Circular.

Article 17. Reference

If any legislative documents referred to herein are superseded or amended, the new ones shall apply.

Article 18. Responsibility for implementation

Directors of Vietnam Administration of HIV/AIDS Control, Department of Planning and Finance and National centralized drug procurement center, heads of units affiliated to the Ministry of Health, Directors of provincial Departments of Health, and relevant agencies, organizations and individuals are responsible for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (Vietnam Administration of HIV/AIDS Control) for consideration./.