Circular No. 02/2022/TT-BYT stipulates the price of SARS-CoV-2 testing services

CIRCULAR

Regulations on the price of SARS-CoV-2 testing services

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

Pursuant to the Health Insurance Law dated November 14, 2008 and the Law Amending and Supplementing Certain Provisions of the Health Insurance Law dated June 13, 2014;

Pursuant to the Price Law dated June 20, 2012;

Pursuant to Decree No. 60/2021/NĐ-CP dated June 21, 2021 of the Government stipulating the mechanism of autonomy for public service units;

Pursuant to Decree No. 177/2013/NĐ-CP dated November 14, 2013 of the Government detailing and guiding the implementation of certain provisions of the Price Law; and Decree No. 149/2016/NĐ-CP dated November 11, 2016 of the Government amending and supplementing certain provisions of Decree No. 177/2013/NĐ-CP dated November 14, 2013 of the Government detailing and guiding the implementation of certain provisions of the Price Law;

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

At the proposal of the Director of the Department of Planning and Finance;

The Minister of Health issues this Circular regulating the price of SARS-CoV-2 testing services.

Article 1. Scope of Regulation and Application

2. Applicability:

This Circular regulates the price of SARS-CoV-2 testing services performed by state healthcare facilities, including sample collection, sample preservation, testing, and reporting results.

2. Scope of Application:

a) This Circular applies to cases where the cost of SARS-CoV-2 testing is paid according to laws on health insurance; individuals who pay for SARS-CoV-2 testing services out-of-pocket; and cases where the cost is covered by the state budget according to the Law on Prevention and Control of Infectious Diseases, except for the cases specified in point b of this clause;

b) This Circular does not apply to cases where samples are collected, preserved, tested, and results are reported in the community, which are funded by the state budget according to the Law on Prevention and Control of Infectious Diseases.

Article 2. Structure of the Price of SARS-CoV-2 Testing Services

The structure of the price of SARS-CoV-2 testing services stipulated in this Circular includes:

1. Direct costs for sample collection and preservation; testing and reporting results of SARS-CoV-2.

2. Salary costs based on rank and grade, allowances, and contributions under state regulations for public service units at the basic salary level prescribed in Decree No. 38/2019/NĐ-CP dated May 9, 2019 of the Government stipulating the basic salary for civil servants, public officials, and members of the armed forces; excluding allowances for COVID-19 prevention and control of medical staff.

3. Costs of reagents for SARS-CoV-2 testing (rapid testing reagents, immunoassay reagents, reaction reagents) based on actual usage and purchase prices according to laws on bidding.

Article 3. Level of Price for SARS-CoV-2 Testing Services

1. Level of price for SARS-CoV-2 testing services within the scope of payment by the Health Insurance Fund:

a) SARS-CoV-2 Ag test rapid single sample:

The service price includes direct costs and salary costs as prescribed in column 1 of Section I of the Appendix attached to this Circular plus the cost of SARS-CoV-2 testing reagents as prescribed in Clause 3 of Article 2 of this Circular. The maximum payment amount shall not exceed VND 78,000 per test.

b) SARS-CoV-2 testing using automatic or semi-automatic immunoassay machines for single samples:

The service price includes direct costs and salary costs as prescribed in column 1 of Section II of the Appendix attached to this Circular plus the cost of SARS-CoV-2 testing reagents as prescribed in Clause 3 of Article 2 of this Circular. The maximum payment amount shall not exceed VND 178,900 per test.

c) SARS-CoV-2 testing using Realtime RT-PCR technology:

- For single samples: The service price includes direct costs and salary costs as prescribed in column 1 of Section III of the Appendix attached to this Circular plus the cost of SARS-CoV-2 reaction reagents as prescribed in Clause 3 of Article 2 of this Circular. The maximum payment amount shall not exceed VND 501,800 per test.

- For pooled samples: The service price includes direct costs and salary costs as prescribed in column 1 of Section IV of the Appendix attached to this Circular plus the cost of SARS-CoV-2 reaction reagents as prescribed in Clause 3 of Article 2 of this Circular, with the reaction reagents being evenly distributed among the pooled samples. The maximum payment amount shall not exceed the price of pooled sample testing as prescribed in column 2 of Section IV of the Appendix attached to this Circular.

2. Level of price for SARS-CoV-2 testing services outside the scope of payment by the Health Insurance Fund:

a) For state healthcare facilities under provinces and centrally-administered cities and healthcare facilities under ministries and central agencies located in local areas, except for the cases specified in point b of this clause: The pricing level is determined according to the provisions of Clause 1 of this Article, wherein the price includes direct costs and salary costs (excluding reaction reagent costs) set by the competent authority of the locality but not exceeding the maximum price ceiling for SARS-CoV-2 testing services as prescribed in column 1 of the Appendix attached to this Circular;

b) For healthcare facilities under the Ministry of Health and special-class and class-I hospitals under ministries and central agencies and state healthcare facilities providing preventive healthcare services: the pricing level is determined according to the provisions of Clause 1 of this Article.

Article 4. Some Guidelines on Payment

1. In cases where healthcare facilities transfer patient samples to other healthcare facilities that have the necessary conditions to perform tests:

a) For cases within the scope of payment by the Health Insurance Fund: payment shall be made for clinical diagnostic service cases transferred according to the laws on health insurance;

b) For cases not within the scope of payment by the Health Insurance Fund: payment shall be made at the level of the SARSCoV-2 testing service fee set by the implementing unit in accordance with this Circular and the cost of purchasing testing reagents in accordance with the law on bidding.

2. In cases where sample collection or testing uses materials and reagents provided from sources funded by the state budget or supported, sponsored, or provided free of charge by organizations, agencies, or individuals, state-owned healthcare facilities must deduct the costs of materials and reagents when collecting fees from service users and when settling accounts with social insurance agencies and the state budget.

3. In cases where the cost of performing tests exceeds the maximum price specified in Column 2 of the Appendix issued together with this Circular, state-owned healthcare facilities may settle the costs from self-managed funds or other legitimate sources and shall not collect fees from service users.

4. In cases where pooled samples are found to be positive, further tests must be conducted to identify positive samples, and the costs of performing these tests shall be calculated based on each specific case to ensure that there is no duplication of expenses already incurred.

Article 5. Effective Date

1. This Circular takes effect from February 21, 2022.

2. Circular No. 16/2021/TT-BYT dated November 8, 2021, issued by the Minister of Health, which sets the prices for SARSCoV-2 testing services, ceases to be effective from the date this Circular takes effect.

Article 6. Reference Provisions

In cases where referenced documents in this Circular are replaced or amended, they shall be applied according to the replaced or amended documents.

Article 7. Implementation Organization

1. Healthcare facilities are responsible for purchasing materials, chemicals, and testing reagents for SARSCoV-2 in accordance with the law on bidding and Resolution No. 79/NQ-CP dated July 22, 2021, of the Government on purchasing medicines, chemicals, materials, equipment, and means to serve the prevention and control of COVID-19, Resolution No. 86/NQ-CP dated August 6, 2021, of the Government on urgent measures to prevent and control the COVID-19 pandemic to implement Resolution No. 30/2021/QH15 dated July 28, 2021, of the National Assembly's 15th term, ensuring quality, economy, efficiency, and preventing waste and corruption.

2. State-owned healthcare facilities, when conducting regular tests for medical staff, patients, and their families as stipulated by medical regulations, must pool samples according to guidelines from the Ministry of Health and the actual situation of the facility, ensuring economy and efficiency.

3. In cases of voluntary testing upon request or testing for organizations and businesses under contracts: state-owned healthcare facilities shall collect fees from service users or settle accounts with organizations and businesses at the price applicable to those not covered by the Health Insurance Fund and the cost of purchasing testing reagents as prescribed.

4. Provincial Departments of Health shall strengthen supervision and inspection or report to provincial People's Committees to strengthen supervision and inspection of the implementation of laws on pricing and bidding by state-owned healthcare facilities in their jurisdictions, strictly handling violations if any, to prevent unreasonable increases in testing service fees. During implementation, if difficulties arise, units and localities should reflect them in writing to the Ministry of Health for consideration and resolution.

In the course of implementation, if there are difficulties or obstacles, units and localities are requested to report in writing to the Ministry of Health for consideration and resolution./.