Circular No. 22/2020/TT-BYT on the management of antiretroviral drugs procured centrally at the national level for use from the health insurance fund and co-payment support for antiretroviral drugs for people living with HIV who have health insurance cards.

CIRCULAR

PROVISIONS ON THE MANAGEMENT OF HIV ANTIRETROVIRAL DRUGS PURCHASED THROUGH NATIONAL CONCENTRATED PROCUREMENT USING FUNDS FROM THE HEALTH INSURANCE FUND AND SUPPORT FOR CO-PAYMENTS FOR HIV ANTIRETROVIRAL DRUGS FOR HIV-INFECTED PERSONS WITH HEALTH INSURANCE CARDS

Pursuant to the Law on Prevention and Control of Infection with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) No. 64/2006/QH11 dated June 29, 2006;

Pursuant to the Health Insurance Law No. 25/2008/QH12 dated November 14, 2008 and the Law Amending and Supplementing Certain Provisions of the Health Insurance Law No. 46/2014/QH13 dated June 13, 2014;

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

Pursuant to Decree No. 63/2014/NĐ-CP dated June 26, 2014 of the Government detailing certain provisions of the Law on Procurement regarding the selection of contractors;

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

Implementing Decision No. 2188/QĐ-TTg dated November 15, 2016 of the Prime Minister regarding the payment for antiretroviral drugs purchased through national concentrated procurement using funds from the health insurance fund and supporting users of antiretroviral drugs;

At the proposal of the Director of the Department of HIV/AIDS Prevention and Control, the Director of the Department of Health Insurance, Ministry of Health;

The Minister of Health issues this Circular stipulating the management of antiretroviral drugs purchased through national concentrated procurement using funds from the health insurance fund and supporting co-payments for antiretroviral drugs for HIV-infected persons with health insurance cards,

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Circular stipulates on:

a) National concentrated procurement of antiretroviral drugs using the funding specified in point a, Clause 1, Article 35 of the Health Insurance Law (hereinafter referred to as the health insurance fund) includes planning demand, signing contracts with winning suppliers providing antiretroviral drugs (hereinafter referred to as suppliers);

b) Management and use of antiretroviral drugs procured through national concentrated procurement using the health insurance fund;

c) Advance payments, settlement, and final accounting of costs for antiretroviral drugs;

Sources of funding and methods of supporting co-payments for antiretroviral drugs for HIV-infected persons with health insurance cards.

2. This Circular does not apply to antiretroviral drugs purchased through other bidding forms and funding sources not included in the health insurance fund.

3. Matters not regulated in this Circular shall be implemented in accordance with the provisions of Circular No. 15/2019/TT-BYT dated July 11, 2019 of the Minister of Health on drug bidding at public healthcare facilities (hereinafter referred to as Circular No. 15/2019/TT-BYT).

Article 2. Basis for planning the demand for antiretroviral drugs from the health insurance fund at healthcare facilities

1. The estimated number of HIV-infected individuals currently receiving antiretroviral treatment from the health insurance fund according to each treatment regimen at antiretroviral treatment facilities that have signed health insurance contracts (hereinafter referred to as healthcare facilities) as of December 31 of the preceding year of the planning year.

2. Projected changes in the number of HIV-infected individuals receiving antiretroviral treatment from the health insurance fund according to each treatment regimen at healthcare facilities during the planning year.

3. Estimated stock of antiretroviral drugs from the health insurance fund remaining at healthcare facilities according to each treatment regimen as of December 31 of the preceding year of the planning year. Antiretroviral drugs in stock at healthcare facilities at the end of the year can be carried over to the next year for use and deducted from the procurement plan for the next year. The situation of purchasing, using, and stockpiling antiretroviral drugs from other funding sources in the preceding year of the planning year.

4. Projected quantity of antiretroviral drugs from the health insurance fund to be used for each regimen that the healthcare facility plans to implement anew in the following year.

5. Guidelines for planning the demand for antiretroviral drugs from the health insurance fund issued by the Department of HIV/AIDS Prevention and Control based on current treatment regimens, professional guidance on regimen conversion by the Ministry of Health, guidance on transferring the use of antiretroviral drugs from sponsors and other support sources, the list of drugs covered by the health insurance fund and approved for circulation on the market, and the list of centrally tendered drugs for national procurement conducted by the Central Drug Procurement Unit (hereinafter referred to as the Procurement Unit).

Chapter II

NATIONAL CONCENTRATED PROCUREMENT OF HIV ANTIRETROVIRAL DRUGS FROM THE HEALTH INSURANCE FUND

Article 3. Procedure for establishing plans on the demand for antiretroviral drugs from health insurance funds nguồn bảo hiểm y tế

1. The establishment and consolidation of drug usage demands shall be carried out as follows:

a) Before February 10 each year, the AIDS Prevention and Control Department shall issue guidelines on planning the demand for antiretroviral drugs from health insurance funds as stipulated in Clause 5, Article 2 of this Circular to the Centers for Disease Control and Prevention at provincial and municipal levels, and the AIDS Prevention and Control Centers at provincial and centrally governed municipal levels (hereinafter referred to as the provincial AIDS Prevention and Control focal agencies) to guide healthcare facilities within their jurisdictions to implement these guidelines.

b) Before March 1 each year, healthcare facilities shall complete the plan on the demand for antiretroviral drugs from health insurance funds for the following year, including the number of patients treated according to each regimen, the list of drugs, and technical criteria groups for each drug, and submit registration documents for drug purchase requests along with the documents specified in Clause 3 of this Article to the provincial AIDS Prevention and Control focal agency for review and consolidation.

c) Before March 20 each year, the provincial AIDS Prevention and Control focal agency shall complete the review and consolidation of the demand for antiretroviral drugs from health insurance funds of all healthcare facilities within its jurisdiction, including those under local administration and those under the management of ministries and sectors, and report to the Department of Health for verification regarding the list of drugs, drug groups, quantity of drugs, and the demand for antiretroviral drugs of all healthcare facilities.

d) Before April 1 each year, the Department of Health shall submit a written proposal to the AIDS Prevention and Control Department along with the minutes of the verification meeting of the Department of Health concerning the list of antiretroviral drugs, the demand for each drug according to the technical criteria groups of healthcare facilities within its jurisdiction so that the AIDS Prevention and Control Department can consolidate and submit it to the Procurement Unit.

đ) Before April 20 each year, the AIDS Prevention and Control Department shall complete the review and consolidation of the demand for antiretroviral drugs from health insurance funds nationwide and adjust the demand for antiretroviral drugs of localities (if necessary) and submit a written proposal to the Procurement Unit.

In case there is an adjustment in the demand for antiretroviral drugs of localities, the AIDS Prevention and Control Department shall issue a written notice to the Department of Health about the adjustment while submitting a procurement request proposal to the Procurement Unit, specifying the reasons for the adjustment in the document. Upon receiving the adjustment notification document from the AIDS Prevention and Control Department, the Department of Health shall have the responsibility to notify the provincial AIDS Prevention and Control focal agency and healthcare facilities.

e) In case a healthcare facility generates a demand for antiretroviral drugs from health insurance funds but has not yet consolidated the demand when drafting the tender selection plan for drug procurement, the healthcare facility shall follow the provisions set forth in Clause 2, Article 8 of this Circular.

2. In case at the time of planning the demand, there is no drug with an active registration number in the technical criteria group, the AIDS Prevention and Control Department shall adjust the quantity of drugs and the technical criteria group of drugs as follows:

a) Adjust the drug sequentially to the next higher technical criteria group until reaching a technical criteria group where the drug has an active registration number. If moving up to a higher technical criteria group does not result in an active registration number, then adjust sequentially down to the next lower technical criteria group until reaching a technical criteria group where the drug has an active registration number.

Example: Drug A is proposed by a healthcare facility to be in Technical Criteria Group 4. After completing the consolidation of the plan from the provinces, if there is no active registration number for Drug A in Technical Criteria Group 4, it will be adjusted to Technical Criteria Group 2; if there is no active registration number in Technical Criteria Group 2, it will be adjusted to Technical Criteria Group 1; if there is no active registration number in Technical Criteria Group 1, it will be adjusted to Technical Criteria Group 5.

b) After the adjustment, the AIDS Prevention and Control Department shall notify in writing the Department of Health of the adjusted drugs. Upon receiving the adjustment notification from the AIDS Prevention and Control Department, the Department of Health shall have the responsibility to notify in writing the healthcare facilities of the drugs that need to be adjusted.

3. Documents accompanying the registration document for the demand for centralized national procurement of antiretroviral drugs from health insurance funds submitted by healthcare facilities to the provincial AIDS Prevention and Control focal agencies include:

a) The drug usage demand plan according to the guidelines of the AIDS Prevention and Control Department accompanied by the minutes of the Pharmacy and Treatment Council meeting of the healthcare facility;

b) Report on the situation of receiving and using drugs in the previous adjacent year, the quantity of drugs in stock and the quantity of drugs in the plan that have not been implemented at the time of budget preparation of healthcare facilities, the expected number of patients treated according to each regimen, and the drug demand of the planning year by type and drug group;

c) In case a healthcare facility builds a drug usage plan increasing or decreasing by more than 30% compared to the quantity used in the previous year, it must provide detailed explanations and justifications.

Article 4. Establishment, review, approval of the plan for selecting contractors and organization of contractor selection

1. After receiving the document proposing the need to use antiretroviral drugs for the following year from the HIV/AIDS Prevention and Control Department, before May 20th each year, the Procurement Unit shall establish the plan for selecting contractors in accordance with Circular No. 15/2019/TT-BYT and submit it to the Planning and Finance Department for review and submission to the competent authority for approval.

2. After receiving the plan for selecting contractors sent by the Procurement Unit, the Planning and Finance Department shall review and submit it to the competent authority for approval before June 20th each year.

3. Based on the approved plan for selecting contractors, the Procurement Unit shall complete the organization and implementation of the contractor selection process before September 20th each year, ensuring drug supply to healthcare facilities from January 1st of the following year.

4. In cases where there is no registered drug still valid at the time of establishing the plan for selecting contractors, the Procurement Unit shall issue a notification to the HIV/AIDS Prevention and Control Department, which will adjust the quantity of drugs according to the technical criteria groups specified in Clause 2, Article 3 of this Circular, while also notifying the Provincial Health Departments and provincial AIDS control focal points to make adjustments.

5. In cases where a contractor cannot be selected, the Procurement Unit shall issue a notification to the HIV/AIDS Prevention and Control Department to coordinate in presenting a solution to the Ministry of Health.

Article 5. Signing framework agreements and contracts with contractors

1. The Procurement Unit shall conduct negotiations, approve the results of the contractor selection, and sign a framework agreement with the contractor. Within ten days from the date of signing the framework agreement, the Procurement Unit shall be responsible for sending the framework agreement and the decision approving the results of the contractor selection to the following entities:

a) Vietnam Social Security;

b) The entity contracting with the contractor decided by Vietnam Social Security (hereinafter referred to as the Contracting Entity);

c) HIV/AIDS Prevention and Control Department.

2. Within twenty days from the date of signing the framework agreement, the contractor must complete the signing of the drug supply contract with the Contracting Entity in accordance with the law on bidding.

3. The contractor shall be responsible for sending a copy of the contract along with its appendices to the Procurement Unit, HIV/AIDS Prevention and Control Department, provincial AIDS control focal points, and healthcare facilities.

4. The Contracting Entity shall be responsible for sending a copy of the contract along with the appendices specific to each province to Vietnam Social Security, provincial social insurances (hereinafter referred to as provincial social security), and central cities.

Chapter III

MANAGEMENT, USE AND SETTLEMENT OF ANTIRETROVIRAL DRUGS FROM HEALTH INSURANCE FUNDS

Article 6. Plan for receiving antiretroviral drugs from health insurance funds

1. Based on signed contracts, drug usage plans, and treatment needs in the quarter, healthcare facilities shall establish a plan for receiving antiretroviral drugs from health insurance funds before the 20th day of the last month of the preceding quarter and send it to the contractor, while simultaneously submitting it to the provincial AIDS control focal point for consolidation and reporting to the HIV/AIDS Prevention and Control Department and the Contracting Entity for monitoring.

2. Healthcare facilities may build plans for receiving additional drugs from the contractor not exceeding 20% more than the quantity of drugs allocated in the signed framework agreement. In cases where healthcare facilities have a need for additional drugs exceeding 20% of the quantity allocated in the framework agreement, they shall follow the guidance provided in Clause 1, Article 7 of this Circular.

3. In cases where the contractor fails to provide drugs in full and on time according to the healthcare facility's reception plan:

a) The healthcare facility shall immediately notify the provincial AIDS control focal point about the contractor's failure to supply drugs as required, so that the focal point can inform the HIV/AIDS Prevention and Control Department;

b) Within five working days from the date of receipt of the notification from the provincial AIDS control focal point, the HIV/AIDS Prevention and Control Department shall notify the Procurement Unit and the Contracting Entity to inspect and urge the contractor to supply drugs to the healthcare facility;

c) In cases where the contractor is unable to supply drugs to the healthcare facility, the Procurement Unit and the Contracting Entity shall handle the contractor's violation according to regulations and notify the HIV/AIDS Prevention and Control Department to report to the Ministry of Health for a unified resolution plan.

Article 7. Procedure for regulating medicines within the province

In cases where healthcare facilities have a need to use additional medicines exceeding 20% of the quantity allocated under the framework agreement or the stock of medicines is insufficient for treatment needs and the contractor cannot provide them in a timely manner according to the reception plan:

1. The healthcare facility shall submit a written request for medicine regulation to the provincial AIDS Control Center.

2. Within 10 working days from the date of receipt of the healthcare facility's written request for medicine regulation, the provincial AIDS Control Center shall be responsible for reviewing the quantity of medicines used, the remaining stock of medicines, and the remaining quantity of medicines under the framework agreement of healthcare facilities in the locality to decide on the regulation and issue a written notice to:

a) The healthcare facility expected to be regulated (receiving and transferring);

b) The contractor to implement the regulation;

c) The contracting unit to regulate the quantity of medicines of the healthcare facility on the health insurance claim adjudication information system and monitor and aggregate;

d) The National AIDS Control Center to monitor and aggregate.

3. Within 10 working days from the date of receipt of the written notice from the provincial AIDS Control Center, the contractor shall be responsible for regulating medicines in accordance with the requirements of the provincial AIDS Control Center.

4. The provincial AIDS Control Center shall only regulate additional quantities of medicines not exceeding 20% of the total quantity of medicines allocated under the framework agreement for all healthcare facilities in the locality.

Article 8. Procedure for regulating antiretroviral medicines from health insurance funds nationwide

1. In cases where the quantity of medicines required for regulation exceeds the quantity specified in Clause 4 of Article 7 of this Circular:

a) The provincial AIDS Control Center shall submit a written request for medicine regulation to the National AIDS Control Center within 5 working days from the date of receipt of the healthcare facility's written request for medicine regulation;

b) Within 10 days from the date of receipt of the written request from the provincial AIDS Control Center, the National AIDS Control Center shall be responsible for reviewing the quantity of medicines used, the remaining stock of medicines, and the remaining quantity of medicines under the framework agreement of healthcare facilities nationwide to decide on the regulation and issue a written notice to the provincial AIDS Control Center expected to be regulated (receiving and transferring); the contractor to implement the regulation; the contracting unit to regulate the quantity of medicines of the healthcare facility on the health insurance claim adjudication information system and to monitor and aggregate; the procurement unit to monitor;

c) Within 10 working days from the date of receipt of the written notice from the National AIDS Control Center, the contractor shall be responsible for regulating medicines in accordance with the requirements of the National AIDS Control Center.

2. In cases where new healthcare facilities have a need to use antiretroviral medicines from health insurance funds but were not included in the demand when building the tender selection plan for purchasing medicines:

a) The provincial AIDS Control Center shall aggregate the demand for antiretroviral medicines from health insurance funds of healthcare facilities, the written request for medicine regulation, and documents proving that the healthcare facility meets the requirements for health insurance medical services using antiretroviral medicines, and submit these to the Department of Health for review and issue a written request to the National AIDS Control Center for regulation;

b) Within 10 days from the date of receipt of the written notice from the provincial AIDS Control Center, the National AIDS Control Center shall aggregate and review the demand for antiretroviral medicines from health insurance funds proposed for regulation by the province and other provinces nationwide to regulate, and issue a written notice to the procurement unit, the contracting unit, and the provincial AIDS Control Center to supplement the list of healthcare facilities using antiretroviral medicines from health insurance funds and notify the contractor to implement the regulation;

c) Within 7 working days from the date of receipt of the written notice from the National AIDS Control Center, the contracting unit shall perform the supplementary contract signing procedure for supplying medicines to newly emerging healthcare facilities with the contractor in accordance with the law on bidding;

d) The contractor shall be responsible for submitting copies of the supplementary contracts along with appendices of each healthcare facility to the procurement unit, the National AIDS Control Center, the provincial AIDS Control Center, and the healthcare facility;

đ) The contracting unit shall be responsible for submitting copies of the supplementary contracts along with appendices of each province to the Vietnam Social Security and the provincial social security;

e) Within 7 working days from the date of signing the supplementary contract for supplying medicines to newly emerging healthcare facilities, the contractor shall implement the regulation of medicines in accordance with the requirements of the National AIDS Control Center and send a written notice to the National AIDS Control Center and the contracting unit for monitoring and aggregation.

3. The additional quantity of medicines regulated by the National AIDS Control Center shall not exceed 30% of the total quantity of medicines allocated under the framework agreement for all healthcare facilities nationwide.

4. In cases where the quantity of medicines after regulation exceeds the quantity specified in Clause 3 of this Article, the National AIDS Control Center shall issue a written notice to the procurement unit to proceed with additional procurement procedures.

Article 9. Other cases in regulating antiretroviral drugs from health insurance funds

1. In the case where the quantity of drugs remaining in stock at healthcare facilities exceeds the treatment needs or the drugs have less than six months remaining before their expiration date (including drugs transferred from the previous year):

a) The healthcare facility shall be responsible for submitting a written request for drug regulation to the lead agency for HIV/AIDS prevention and control at the provincial level;

b) Within five working days from the date of receiving the written request for drug regulation from the healthcare facility, the lead agency for HIV/AIDS prevention and control at the provincial level shall review the treatment needs of healthcare facilities within its jurisdiction.

If it is possible to regulate within the province: The lead agency for HIV/AIDS prevention and control shall issue a notification to the healthcare facility and the contractor to implement the regulation. Within five working days from the date of receiving the request from the lead agency for HIV/AIDS prevention and control at the provincial level, the contractor shall carry out the drug regulation according to the requirements of the lead agency for HIV/AIDS prevention and control at the provincial level and notify the National AIDS Control Center and the contracting unit for monitoring and summarizing.

If it is not possible to regulate within the province: The lead agency for HIV/AIDS prevention and control shall submit a written request to the National AIDS Control Center to implement the regulation.

Within seven working days from the date of receiving the written request from the lead agency for HIV/AIDS prevention and control at the provincial level, the National AIDS Control Center must send a written notice to the contractor to regulate the drugs for healthcare facilities that can accept the regulated drug quantities.

Within five working days from the date of receiving the written request from the National AIDS Control Center, the contractor shall carry out the drug regulation according to the requirements of the National AIDS Control Center, notify the National AIDS Control Center for monitoring and summarizing, and the contracting unit to adjust the drug quantity of the healthcare facility on the health insurance claim information system.

2. For other cases that cannot be regulated, the National AIDS Control Center shall issue a response to the lead agency for HIV/AIDS prevention and control at the provincial level to inform the healthcare facility.

Article 10. Provisions regarding lost, damaged, or expired drugs

1. In the case where drugs are lost, damaged, or expired due to the healthcare facility or the contractor, the healthcare facility and the winning contractor shall bear responsibility and will not be reimbursed from the health insurance fund.

2. In the case where antiretroviral drugs in stock have been reported to the National AIDS Control Center for coordination but there is no healthcare facility to accept them, or if the healthcare facility does not implement the regulation or requests the regulation outside the time limit specified in Clause 1 of Article 9 of this Circular, leading to expiration, then the healthcare facility with the drugs in stock shall bear responsibility and will not be reimbursed from the health insurance fund.

Article 11. Advance payment, settlement, and final settlement between the Contracting Unit and the Contractor

1. The Contracting Unit shall advance 80% of the value of antiretroviral drugs from the health insurance fund based on the first quarter's plan for drug reception by healthcare facilities, and from the second quarter onwards, advance 80% of the cost of antiretroviral drugs from the health insurance fund based on the previous quarter's usage by insured patients. The advance payment shall continue to be made to the contractor until the contract is terminated. The Contracting Unit shall be responsible for terminating the contract with the contractor after the antiretroviral drugs supplied to healthcare facilities from the health insurance fund have been fully utilized by insured patients. The Contracting Unit and the contractor shall terminate the contract in accordance with the law and the terms stipulated in the framework agreement and contract signed in accordance with this Circular.

2. Quarterly, based on the settlement of costs for antiretroviral drugs from the health insurance fund used by insured patients in the previous quarter, the Contracting Unit shall pay the contractor the remaining costs after deducting the advance payments for that quarter. If the advance payment exceeds the amount to be settled, it shall be deducted from the advance payment of the following quarter.

Article 12. Settlement of Costs for Antiretroviral Drugs from Health Insurance Fund between Healthcare Facilities and Social Insurance Authority

1. Periodically, along with the time of submitting reports on settlement of costs for health insurance medical examination and treatment, healthcare facilities shall prepare Statistical Reports on Costs for Antiretroviral Drugs from the Health Insurance Fund provided to patients and submit them to the Social Insurance Authority where the medical examination and treatment health insurance contracts were signed (hereinafter referred to as the Social Insurance Authority), including separately the costs for antiretroviral drugs under the responsibility of the health insurance fund and the co-payment costs for antiretroviral drugs under the responsibility of insured patients (hereinafter referred to as co-payment costs for antiretroviral drugs).

2. Quarterly, the Social Insurance Authority shall implement notifications of the results of appraisals and the amounts of settlement of costs for health insurance medical examination and treatment of healthcare facilities, simultaneously reducing the costs for antiretroviral drugs used for insured patients (including costs for antiretroviral drugs under the responsibility of the health insurance fund and co-payment costs for antiretroviral drugs arising during the period) from the costs for health insurance medical examination and treatment that need to be settled for healthcare facilities.

Article 13. Payment of Co-Payment Costs for Antiretroviral Drugs to Healthcare Facilities

1. Local budgets shall ensure funding to support co-payment costs for antiretroviral drugs through units designated by the Provincial People's Committee according to budget levels and ensuring compliance with functions and tasks (hereinafter referred to as the supporting authority) following the procedures as follows:

a) Healthcare facilities shall prepare budget estimates for co-payment costs for antiretroviral drugs of insured patients at the same time as preparing unit budget estimates according to the State Budget Law and send them to the Department of Health for consolidation and submission to the competent authority to allocate annual budget estimates for the supporting authority;

b) Periodically, along with the time of submitting reports on settlement of costs for health insurance medical examination and treatment to the Social Insurance Authority, healthcare facilities shall send requests for payment of co-payment costs for antiretroviral drugs to the supporting authority together with Statistical Reports on Costs for Antiretroviral Drugs provided to insured patients arising during the period;

c) Within ten days from the date of receipt of the request for payment from healthcare facilities, the supporting authority shall be responsible for directly paying the co-payment costs for antiretroviral drugs from the health insurance fund to healthcare facilities;

d) After receiving the appraisal results from the Social Insurance Authority regarding the costs for using antiretroviral drugs in the year, if there are changes compared to the paid funds, healthcare facilities shall send requests for adjustment and settlement to the supporting authority for consolidation, adjustment, and inclusion in the next year's budget estimate;

đ) Insured patients are eligible for support for co-payment costs for antiretroviral drugs when undergoing medical examination and treatment at healthcare facilities within the province where they have registered for initial medical examination and treatment, except in cases where they have registered for initial medical examination and treatment outside their province or are patients issued health insurance cards by Ministries or sectors. In such cases, if the Provincial People's Committee approves the budget based on local conditions to support patients who have registered for initial medical examination and treatment outside their province or patients issued health insurance cards by Ministries or sectors, healthcare facilities shall follow the procedures for preparing budget estimates and paying co-payment costs for antiretroviral drugs as stipulated in Clause 1 of this Article.

2. Funding sources to support co-payment costs for antiretroviral drugs from the health insurance fund from programs and projects (hereinafter referred to as projects) shall be implemented according to the following procedures:

a) Healthcare facilities shall prepare budget estimates for co-payment costs for antiretroviral drugs of insured patients for the provincial lead agency for HIV/AIDS prevention and control to consolidate and send to the National Center for HIV/AIDS Prevention and Control for inclusion in the annual support plan of the projects to be submitted for approval by the project sponsors and the Ministry of Health;

b) Periodically, along with the time of submitting reports on settlement of costs for health insurance medical examination and treatment to the Social Insurance Authority, healthcare facilities shall send requests for payment of co-payment costs for antiretroviral drugs to the provincial lead agency for HIV/AIDS prevention and control together with Statistical Reports on Costs for Antiretroviral Drugs provided to insured patients arising during the period for payment to the healthcare facilities by the projects;

c) After receiving the appraisal results from the Social Insurance Authority regarding the costs for using antiretroviral drugs from the health insurance fund in the year, if there are changes compared to the paid funds, healthcare facilities shall send requests for adjustment and settlement to the projects for consolidation, adjustment, and inclusion in the next year's budget estimate;

d) Annually, the National Center for HIV/AIDS Prevention and Control shall be responsible for notifying the list of provinces and cities supported by the projects for co-payment costs for antiretroviral drugs for the provinces to base their implementation on;

đ) Before January 20 each year, the provincial lead agency for HIV/AIDS prevention and control shall consolidate the situation of payment of co-payment costs for antiretroviral drugs of insured patients from the previous year and submit it to the National Center for HIV/AIDS Prevention and Control for review and comparison with the Vietnam Social Security.

Chapter IV

IMPLEMENTING PROVISIONS

Article 14. Responsibility for implementation

1. Responsibilities of the National Center for HIV/AIDS Prevention and Control:

a) Directing and guiding provincial lead agencies for HIV/AIDS prevention and control to implement planning for needs, reporting on usage, and regulating antiretroviral drugs from the health insurance fund;

b) Cooperating with the Procurement Unit and the Contract Signing Unit to monitor the implementation of framework agreements and supply contracts for antiretroviral drugs from the health insurance fund.

2. Responsibilities of the Vietnam Social Security:

a) Guiding subordinate units to consolidate, report, and settle costs for using antiretroviral drugs from the health insurance fund according to regulations;

b) Implementing the delegation of data access rights regarding the situation of usage and settlement of costs for antiretroviral drugs from the health insurance fund of healthcare facilities in provinces to the National Center for HIV/AIDS Prevention and Control.

3. Responsibilities of the Contract Signing Unit: coordinating regulation and monitoring the implementation of contracts with winning contractors.

4. Responsibilities of the Department of Health: prepare the budget estimate for the co-payment of antiretroviral drugs annually and submit it to the competent authority for approval in accordance with the分级权限规定的《国家预算法》。

5. Responsibilities of the Lead Agency for HIV/AIDS Prevention and Control at the provincial level:

a) Manage the situation of antiretroviral drug usage from health insurance funds within its jurisdiction; implement drug regulation within the province as stipulated in Article 7 of this Circular;

b) Compile reports on the distribution, usage, and adjustments (if any) of antiretroviral drugs from health insurance funds by facilities within its jurisdiction and report them to the National Center for HIV/AIDS Prevention and Control.

6. Responsibilities of the Procurement Unit:

a) Organize bidding and sign framework agreements with winning contractors;

b) Take the lead, supervise, and manage the supply of antiretroviral drugs from health insurance funds by contractors to ensure timely and adequate supply in compliance with the framework agreement.

7. Responsibilities of healthcare facilities:

a) Update the costs of medical examinations and treatments covered by health insurance for people living with HIV in accordance with Circular No. 48/2018/TT-BYT dated December 28, 2017, issued by the Minister of Health, which stipulates the electronic data transfer in the management and payment of health insurance examination and treatment costs;

b) Report the quantity of drugs used monthly, the quantity and expiration date of stored drugs to the Lead Agency for HIV/AIDS Prevention and Control at the provincial level for the purpose of regulating drug supplies for other healthcare facilities within the province's supply range;

c) The head of the healthcare facility and the winning contractor shall be responsible for implementing at least 80% of the value of each part of the signed contract in accordance with Clause 3, Article 37 of Circular No. 15/2019/TT-BYT.

8. Responsibilities of the Contractor:

a) Fully fulfill the responsibilities stipulated in the framework agreement and signed contracts;

b) Ensure the full and timely supply of drugs as specified in the framework agreement and signed contracts with healthcare facilities;

c) Report the quantity of antiretroviral drugs supplied from health insurance funds to healthcare facilities according to the guidelines of the Ministry of Health (National Center for HIV/AIDS Prevention and Control) and the Vietnam Social Security.

Article 15. Effective Date

1. This Circular takes effect from January 20, 2021.

2. Circular No. 28/2017/TT-BYT dated June 28, 2017, issued by the Minister of Health, concerning the management of antiretroviral drugs procured centrally at the national level using the examination and treatment fund of health insurance and co-payment support for antiretroviral drugs for people living with HIV who have health insurance cards, and Circular No. 08/2018/TT-BYT dated April 8, 2018, amending and supplementing certain articles of Circular No. 28/2017/TT-BYT dated June 28, 2017, issued by the Minister of Health, concerning the management of antiretroviral drugs procured centrally at the national level using the examination and treatment fund of health insurance and co-payment support for antiretroviral drugs for people living with HIV who have health insurance cards, shall cease to be effective from the date this Circular takes effect.

Article 16. Transitional Provisions

Antiretroviral drugs from health insurance funds under supply contracts prior to the effective date of this Circular shall continue to be used until exhausted. The contracting unit shall proceed with the contract termination procedures as stipulated in Clause 1, Article 11 of this Circular.

Article 17. Reference Provisions

In cases where the referenced documents in this Circular are replaced or amended, the replacement or amended documents shall apply.

Article 18. Responsibility for Implementation

The Director of the HIV/AIDS Prevention and Control Department, the Head of the Planning and Finance Department, the Director of the National Medicines Central Procurement Center, the Heads of units under the Ministry of Health, the Directors of Health Departments of provinces and centrally governed cities, and relevant agencies, organizations, and individuals are responsible for implementing this Circular.

During implementation, if there are any difficulties, agencies, organizations, and individuals are requested to report them to the Ministry of Health (HIV/AIDS Prevention and Control Department) for consideration and resolution./.