Thông tư 28/2017/TT-BYT

CIRCULAR

 ON MANAGEMENT OF THE PROCUREMENT OF ANTIRETROVIRAL DRUGS AT COUNTRY LEVEL USING HEALTH CARE FUNDS OF HEALTH CARE INSURANCE AND CO-PAY SUPPORT PROVIDED 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 some articles of the Law on Health Insurance No. 46/2014/QH13 dated June 13, 2014;

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

Implement the Prime Minister’s Decree No. 2188/QD-TTg dated November 15, 2016 on regulations on payments for the procurement of Antiretroviral drugs at country level using healthcare funds of health insurance and other funds provided for HIV patients;

At the request of Director of Vietnam Administration of HIV/AIDS Control and Director of
Health Insurance Department of the MOH;

The Minister of Health promulgates this Circular on regulations on management of the national concentrated procurement of Antiretroviral drugs using healthcare fund and co-pay support provided for HIV patients who have health insurance cards.

Article 1. Scope of regulation

This Circular provides regulations on:

1. Procurement of Antiretroviral drugs (hereinafter referred to as “ARVs”) at country level using the healthcare fund of health insurance (hereinafter referred to as “healthcare fund”)

2. Management of the use of ARVs purchased at country level using the healthcare fund.

3. Advance and payment for ARVs using the healthcare fund.

4. Supportive policy, funding sources and co-pay support for HIV patients who have health insurance cards.

Article 2. Regulated entities

1. Social Security Agencies.

2. The health facilities using ARVs for HIV patients that sign the contracts to provide health-insurance based healthcare (hereinafter referred to as "health facilities").

3. HIV patients who have health insurance cards and are treated by using ARVs.

4. Unit in charge of the procurement of ARVs at country level (Vietnam Administration of HIV/AIDS Control) (hereinafter referred to as “Procurement Unit”)

5. The unit signing the supply contracts which is established by the General Director of Vietnam Social Security (herein after referred to as "Signing Unit”).

6. ARVs suppliers.

7. Other related agencies and organizations.

Article 3. Procurement of ARVs at country level using healthcare fund

1. Criteria for planning ARVs demand:

a. The number of HIV patients at a health facility who have health insurance cards and are treated by using ARVs; there must be a classification of these patients based on the treatment regimen.

b. The changes to be made to the list of numbers of HIV patients who have health insurance cards and are treated by using ARVs in the period in which the plan is made.

c. Estimates of numbers of drugs in stock until December 31 inclusive of the reporting year.

d. The number of HIV patients who are receiving funding from other sources to purchase ARVs.

dd. Support roadmap from other sources according to the announcement of the Ministry of Health (Vietnam Administration of HIV/AIDS Control)

2. The process of planning the ARVs demand:

a. Before July 10 every year, the health facility shall cooperate with the Social Security Agency that signed the contract to provide health-insurance based healthcare to estimate and make a plan on the ARVs demand, then send it to the leading agencies that take charge in preventing and controlling HIV/AIDS in the provinces and central-affiliated cities (hereinafter referred to as “Provincial HIV/AIDS Prevention and Control Agency").

b. Before July 20 every year, the Provincial HIV/AIDS Prevention and Control Agency shall make a plan on the anticipated demand for ARVs of all health facilities in the province and submit this plan to the Procurement Unit.

c. After receiving the written plan from the Provincial HIV/AIDS Prevention and Control Agency, the Procurement Unit shall:

- Make a consolidated plan on the nationwide demand for ARVs and complete a plan on selecting the supplier in accordance with the regulations in Article 4, Circular No. 11/2016/TT-BYT dated May 11, 2016 of the Ministry of Health.

- Take charge and cooperate with the Vietnam Social Security to develop the contents of the framework agreement and carry out the process for selecting the drugs supplier in accordance with the law on bidding.

3. The Procurement Unit shall negotiate and sign the framework agreement with the supplier selected based on the selection results. Within 10 working days, from the date on which the framework agreement is signed, the Procurement Unit shall send the aforesaid agreement to the following units:

a. Vietnam Social Security.

b. Signing Unit.

4. Within 20 working days, from the date on which the framework agreement is signed, the selected supplier shall complete the signing of supply contract with the Signing Unit according to the law on bidding and shall submit:

a. A copy of the supply contract enclosed with all appendixes to the Ministry of Health (Vietnam Administration of HIV/AIDS Control)

b. A copy of the supply contract enclosed with the Appendix of each province to the Social Security Agencies of provinces and central-affiliated cities, Provincial HIV/AIDS Prevention and Control Agency and to the health facilities.

5. The health facilities shall make a quarterly plan on receiving ARVs according to the supply contracts and the demand for treatment of the year; then send the aforesaid plan to the selected supplier and the Provincial HIV/AIDS Prevention and Control Agency for a final plan and send this final plan to the Procurement Unit:

a. Before March 20 for the plan on using drugs in second quarter.

b. Before June 20 for the plan on using drugs in third quarter.

c. Before September 20 for the plan on using drugs in fourth quarter.

d. Before December 20 for the plan on using drugs in first quarter of the following year.

6. The selected supplier shall supply drugs to the health facility according to the facility's quarterly plan on receiving ARVs:

a. Before April 01 for the plan on using drugs in second quarter.

b. Before July 01 for the plan on using drugs in third quarter.

c. Before October 01 for the plan on using drugs in fourth quarter.

d. Before January 01 for the plan on using drugs in the first quarter of the following year.

Article 4. Management of the use of ARVs

1. The health facilities shall make a monthly enumeration of quantity of the drugs that have been used within a month; of the quantity of drugs being stored at the facilities and the expiration dates of these drugs; and shall use this enumeration as the basis for adjustment when required.

2. If the drugs being stored at the facilities exceed the demand for treatment or are insufficient to meet the treatment demand or are going to expire sooner than 6 months:

a. The health facility shall send a written request for adjustment to the drugs to the Ministry of Health (Vietnam Administration of HIV/AIDS control);

b. Within 05 working days, the Ministry of Health (Vietnam Administration of HIV/AIDS Control) shall send the ARVs distribution document to the selected supplier and the Signing Unit.

c. Within 10 working days, the selected supplier shall distribute the ARVs at the request of the Ministry of Health (Vietnam Administration of HIV/AIDS Control).

3. If the health facility does not have sufficient drugs due to natural disasters or change of treatment regimen or other force majeure (hereinafter referred to as "unexpected events"):

a. Within 24 hours from the moment the unexpected event occurs, the health facility shall notify the Provincial HIV/AIDS Prevention and Control Agency immediately. If the health facility makes a phone call to notify the aforesaid office or sends it a written notification by fax or via email, the health facility shall also send it an official dispatch within 03 working days from the date on which the unexpected event occurs.

b. Within 24 hours from the moment the notification from the health facility is received, the Provincial HIV/AIDS Prevention and Control Agency shall:

- Start distributing drugs from another health facility within the province to the health facility stipulated in point a of this clause.

- Send a written request to the Ministry of Health (Vietnam Administration of HIV/AIDS Control) in order to provide more drugs to the health facility that unexpectedly ran out of drugs.

c. Within 05 working days, from the date on which the written request from the Provincial HIV/AIDS Prevention and Control Agency is received, the Ministry of Health shall send the distribution document of ARVs to the selected supplier and the Signing Unit.

d. If there is any change made to the treatment regimen, the competent agency that made this change shall submit this modified treatment regimen to the competent authority for it to withdraw and dispose drugs that have been stored without use.

4. If the drugs are lost or damaged or expired due to the irresponsibility of the health facility or the supplier, the health facility and the selected supplier shall take full responsibility for these drugs and the health insurance fund is not used to handle this case.

5. If the information about the ARVs in stock was already reported to the Ministry of Health for coordination but there was no health facility agreed to receive these drugs leading to their expiration, the health facility that has been storing the drugs shall take full responsibility for them and the health insurance fund is not used to handle this case.

Article 5. Advance, pay and prepare final accounts for the costs of ARVs

1. Advance, pay and prepare final accounts for the costs of ARVs for the selected supplier.

a. The Signing Unit shall rely on the quantity of drugs which have been provided quarterly by the supplier and the report on the distribution process and on the use of drugs of provinces and cities in order to transfer money for purchasing drugs for each quarter to the supplier. The Signing Unit shall also ensure that the total advance funding of the year does not exceed 80% of the expenditure on ARVs of that year. When the supply contract expires, the Signing Unit and the supplier shall liquidate the contract in accordance with the current laws and the regulations of the framework agreement and of the contract stipulated in clause 3 and clause 4, Article 3 hereof.

b. At the end of the year, the ARVs in stock (stored by the suppliers or by the health facilities) shall be used in the following year and shall be deducted from the quantity of drugs to be purchased in the following year.

c. The health insurance fund shall only be used to advance, pay and prepare final accounts of the costs of the ARVs used for treating HIV patients who have health insurance cards. If the drugs are lost, damaged or expired due to the irresponsibility of the supplier, it shall refund the payment to the Signing Unit.

2. The process of advancing, paying and preparing final accounts of the costs of ARVs:

a. The Vietnam Social Security shall transfer the fund to the Signing Unit to purchase for the amount of ARVs stipulated in the framework agreement and to adjust the drugs when necessary. The Vietnam Social Security shall advance 80% of the fund of each quarter to the Signing Unit according to the contract.

b. When the health facility is about to send the report on final accounts of health care costs, it shall also attach the enumeration of the costs of ARVs provided for HIV patients with the report and send both of them to the Social Security Agency where the health care insurance contracts have been signed (hereinafter referred to as "signing Social Security Agency”). The costs of ARVs paid by the health insurance fund and the co-pay support (hereinafter referred to as “support costs") shall be specified in the treatment contracts.

c. The signing Social Security Agency shall send a written notification of the appraisal results and the final accounts of the costs of ARVs to the health facility. Also, it shall notify the health facility of the appraisal time, appraisal results and final accounts of health care costs.

d. The signing Social Security Agency shall aggregate the expenditures on ARVs which are paid by the health insurance fund, and shall prepare final accounts of the health care costs paid by the health facility. Quarterly, the health facility shall aggregate the co-pays paid by the HIV patients who have insurance cards and the health insurance agency shall use this aggregate report as a basis for its payment.

dd. The Social Security Agencies in the province shall aggregate the final accounts of expenditures on ARVs within a quarter or a year (based on the expenditures of each health facility within the area, the expenditures on ARVs paid by the health insurance fund and the co-pays paid by the HIV patients who have health insurance cards), and send this aggregate report to the Provincial HIV/AIDS Prevention and Control Agency, Signing Unit and Vietnam Administration of HIV/AIDS Control; the Social Security Agencies shall also aggregate the expenditures on ARVs paid by the health insurance fund and include these expenditures in the final accounts of health care costs of the province.

e. The Signing Unit shall report the implementation process of the contract for purchasing ARVs as guided by the Vietnam Social Security.

Article 6. Regime, funding source and co-pay support for HIV patients who have insurance cards

1. In the provinces where the Healthcare Funds for the Poor or Support Funds for HIV/AIDS Infected People are established (hereinafter referred to as “Funds”):

a. The health facilities shall send to the Department of Health the budget estimate of expenditures on co-pay support for HIV patients and the notification of the specific time for making such estimate according to the Law on state budget, in order to make an annual budget estimate of the Funds.

b. According to the local budget decentralization, quarterly, the health facility shall aggregate the co-pay support expenditures based on the amount of money already paid by the HIV patients who have health insurance cards assessed by the Social Security Agency and notification specified in point c, clause 2, Article 5 hereof, and shall send this aggregate report to the Funds within the area and the Social Security Agencies of province or central-affiliated city within 10 working days from the date on which the appraisal results from the Social Security Agencies are received.

Within 10 days from the date on which the aggregate reports from the health facilities are received, the Funds shall make the co-payments for ARVs to the Social Security Agencies of provinces or central-affiliated cities.

2. In the provinces where there are no Healthcare Funds for the Poor and Support Funds for HIV/AIDS infected people:

a. The local budget shall cover the co-pays of ARVs paid by the HIV patients who have health insurance cards and shall include this cover in the annual enterprise expenditure estimate of the Department of Health.

b. The health facilities shall make a budget estimate of co-pay support for HIV patients who have health insurance cards at the same time making its budget estimates according to the Law on State Budget, and send this budgeting report to the Department of Health to make an annual report on budget estimates.

c. After receiving the appraisal results from the Social Security Agency, within 10 working days, the health facility shall aggregate the expenditures on co-pay support for HIV patients and send these aggregate reports to the Department of Health and the Social Security Agency of province or central-affiliated city.

Within 10 days from the date on which the aggregate reports from the health facilities are received, the Department of Health shall return the co-pay to the Social Security Agency in the province or the central-affiliated city.

Article 7. Implementation

1. Responsibilities of the Social Security Agencies:

a. Vietnam Social Security.

- Make a decision on selecting the Signing Unit to sign the contract with the selected supplier.

- Guide the affiliated units to aggregate, report and make final accounts of the expenditures on ARVs which are paid by the healthcare funds of healthcare insurance as prescribed by laws.

b. The Social Security Agencies in the provinces or central-affiliated cities shall make final payment for the expenditures on ARVs according to the Law on Health Insurance.

c. The Social Security Agencies signing the contracts with the health facilities shall cooperate with them to provide sufficient ARVs in order to meet the demands on using these drugs of the health facilities within a year.

2. Responsibilities of the Vietnam Administration of HIV/AIDS Control:

a. Take charge to guide the Provincial HIV/AIDS Prevention and Control Agency to make a report on the ARVs demand and the process of using and distributing these drugs as prescribed by laws.

b. Manage the process of adherence to the framework agreement and the supply contract and ensure the quality of ARVs provision service provided by the selected supplier.

c. Notify the health facilities of the program’s or project’s schedules for providing ARVs.

3. Responsibilities of the Department of Health:

Estimate the funds used for supporting HIV patients every year and send the estimate report to the competent authority for approval according to the Law on state budget.

4. Responsibilities of the Provincial HIV/AIDS Prevention and Control Agency:

a. Manage the use of ARVs within the area.

b. Make an aggregate report on the use of ARVs, the distribution and adjustment processes of the health facilities within the area of Vietnam Administration of HIV/AIDS Control.

Article 8. Terms of reference

If the documents which are referred to in this Circular are amended or supplemented, the replaced or amended documents shall apply.

Article 9. Entry into force

This Circular shall come into force from August 15, 2017.

Article 10. Transitional regulations

1. If the procurement of ARVs at country level using healthcare funds and health care insurance given to HIV patients has not been completed, the procurement and management of ARVs shall be carried out according to the current regulations.

2. The regulations on management of the use of ARVs; on the advances and payments for ARVs made by using healthcare fund s and health care insurance; on the regimes, funding sources and co-pay support for HIV patients who have insurance cards shall be implemented from the date on which the framework agreements stipulated in clause 4, Article 3 of this Circular takes effect.

If there is any difficulty during the implementation process, the related agencies, organizations and individuals shall notify the Ministry of Health for consideration and decision-making.