Circular No. 16/2021/TT-BYT of the Ministry of Health on the regulation of prices for SARS-CoV-2 testing services

CIRCULAR

REGULATIONS ON PRICES 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 Law on Prices; 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 Law on Prices;

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 Director of the Department of Health Insurance, and the Director of the General Department of Medical Examination and Treatment;

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 stipulates prices for SARS-CoV-2 testing services, including sample collection, sample preservation, testing performance, and result reporting.

2. Scope of Application:

a) This Circular applies in cases where costs for SARS-CoV-2 testing are paid according to laws on health insurance; individuals who pay for SARS-CoV-2 testing services out-of-pocket; and cases where costs are 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 reported in the community and 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. The cost of salaries based on rank and grade, allowances, and contributions under state regulations for public service units according to the basic salary level prescribed in Decree No. 38/2019/NĐ-CP dated May 9, 2019 of the Government prescribing the basic salary level for civil servants, public officials, and members of the armed forces; excluding allowances for epidemic prevention and control of COVID-19 for medical staff.

3. The cost of SARS-CoV-2 testing reagents according to actual usage and purchase price as prescribed by 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 rapid test:

The service price includes direct costs and salaries as prescribed in column 1 of section I of Appendix I issued together with this Circular, plus the cost of SARS-CoV-2 testing reagents as prescribed in Clause 3, Article 2 of this Circular. The maximum payment amount shall not exceed 109,700 VND/test.

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

The service price includes direct costs and salaries as prescribed in column 1 of section II of Appendix I issued together with this Circular, plus the cost of SARS-CoV-2 testing reagents as prescribed in Clause 3, Article 2 of this Circular. The maximum payment amount shall not exceed 186,600 VND/test.

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

- For individual samples: The service price includes direct costs and salaries as prescribed in column 1 of section III of Appendix I issued together with this Circular, plus the cost of SARS-CoV-2 testing reagents as prescribed in Clause 3, Article 2 of this Circular. The maximum payment amount shall not exceed 518,400 VND/test.

- For pooled samples: The service price includes direct costs and salaries as prescribed in column 1 of section IV of Appendix I issued together with this Circular, plus the cost of SARS-CoV-2 testing reagents as prescribed in Clause 3, Article 2 of this Circular, wherein the reagents are evenly distributed among the pooled samples. The maximum payment amount shall not exceed the price for pooled sample testing as prescribed in column 2 of Appendix I issued together with 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-run healthcare facilities in provinces and centrally-administered cities and healthcare facilities directly 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 salaries (excluding testing reagents) set by the competent authority at the local level but shall not exceed the maximum price ceiling for SARS-CoV-2 testing services as prescribed in column 1 of Appendix I issued together with this Circular;

b) For healthcare facilities directly under the Ministry of Health and special-class and first-class hospitals under ministries and central agencies, and public 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. Guidelines for determining prices and payments for SARS-CoV-2 testing services refer to Appendix 2 issued together with this Circular.

2. In cases where healthcare facilities transfer specimens to other healthcare facilities capable of performing tests:

a) For cases within the scope of health insurance fund payments: payments are made according to the regulations on the transfer of clinical support services as prescribed by laws on health insurance;

b) For remaining cases, payments are made according to the price of SARS-CoV-2 testing services performed by the testing facility as prescribed in this Circular and the cost of purchasing testing reagents from the testing facility as prescribed by laws on bidding.

3. In cases where samples are collected or tests are conducted using materials and reagents provided from sources of epidemic prevention funded by the state budget, supported, or donated by organizations, individuals without charge, public healthcare facilities (including healthcare facilities) must deduct the cost of supported materials and reagents when charging users for services, when settling accounts with social insurance agencies, and with the state budget.

4. In cases where the cost of conducting tests exceeds the maximum price prescribed in column 2 of Appendix I issued together with this Circular, public healthcare facilities (including healthcare facilities) may settle these costs from self-managed funds and other legitimate sources of the unit.

Article 5. Effective Date

1. This Circular takes effect from November 10, 2021 until December 31, 2022.

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

Article 6. Transitional Provisions

The prices and cost payments for SARS-CoV-2 testing before this Circular takes effect shall be implemented as follows:

1. For SARS-CoV-2 Ag rapid tests conducted from July 1, 2021, and for SARS-CoV-2 tests using Realtime RT-PCR technology conducted from May 28, 2021, the costs of testing shall be reimbursed according to the price levels decided by the competent authority as stipulated in Circular No. 13/2019/TT-BYT dated July 5, 2019, issued by the Minister of Health, amending and supplementing certain provisions of Circular No. 39/2018/TT-BYT dated November 30, 2018, issued by the Minister of Health, which unifies the prices of medical services for health insurance between hospitals of the same level nationwide and provides guidance on applying prices and reimbursing costs in certain cases; and Circular No. 14/2019/TT-BYT dated July 5, 2019, issued by the Minister of Health, amending and supplementing certain provisions of Circular No. 37/2018/TT-BYT dated November 30, 2018, issued by the Minister of Health, setting the maximum price range for medical services not covered by the Health Insurance Fund in state-run healthcare facilities and providing guidance on applying prices and reimbursing costs in certain cases.

2. For SARS-CoV-2 Ag rapid tests and antigen detection tests for SARS-CoV-2 on immunological machines conducted from July 1, 2021, until the effective date of this Circular, and for SARS-CoV-2 tests using Realtime RT-PCR technology conducted from May 28, 2021, until the effective date of this Circular:

a) SARS-CoV-2 Ag rapid test:

- Costs related to sample collection and test result delivery, including consumables, electricity, water, and labor, shall be borne and settled by healthcare facilities according to the current state budget classification regarding epidemic prevention expenses.

- Test costs shall be settled based on actual expenditure and reimbursement with each patient according to the number of rapid tests actually used for patients and the purchase price of the tests approved through bidding by the competent authority as stipulated by law.

For example, if the competent authority approves the bidding result for rapid tests at 135,000 VND/test, then for individuals eligible for health insurance coverage and entitled to 80% reimbursement for medical expenses, the Health Insurance Fund will cover the cost of one rapid test at 135,000 VND x 80% = 108,000 VND. The remaining 27,000 VND and other costs related to sample collection and test result delivery will be covered by the state budget according to the current classification.

b) Antigen detection tests for SARS-CoV-2 on immunological machines:

- In cases where the sample collection and preservation process is similar to that required for Real-time PCR tests, the service fee for "sample collection and preservation" shall temporarily be charged and reimbursed at 100,000 VND/sample.

- Test costs shall be temporarily settled based on actual expenditure and reimbursement with each patient according to the number of tests actually used for patients and the purchase price of the tests approved through bidding by the competent authority as stipulated by the Bidding Law.

- Costs related to materials, chemicals, electricity, water, and labor during the testing process shall be borne and settled by healthcare facilities according to the current state budget classification regarding epidemic prevention expenses.

c) SARS-CoV-2 tests using Realtime RT-PCR technology from throat swab samples:

- For single samples, apply the service price number 1735: real-time PCR test for bacteria/virus/fungi/parasites as stipulated in the appendix of Circular No. 13/2019/TT-BYT dated July 5, 2019, issued by the Ministry of Health, at 734,000 VND per test. If the sample must be sent to another facility for testing, the pricing structure is as follows:

+ Service fee for sample collection and preservation: 117,800 VND/sample;

+ Testing fee: 616,200 VND/sample.

- For pooled samples:

+ Service fee for sample collection and preservation: 100,000 VND/sample;

+ Testing fee: 634,000 VND divided by the number of pooled samples; for example, if five samples are pooled into one test, divide by five, and if ten samples are pooled, divide by ten.

- If a positive result is detected in pooled samples, further individual tests must be conducted, and the testing costs shall be calculated according to the individual sample case.

Article 7. Implementation Organization

1. Healthcare facilities are responsible for purchasing testing materials, chemicals, and reagents for SARS-CoV-2 tests in accordance with the legal provisions on bidding, the provisions of Resolution No. 79/NQ-CP dated July 22, 2021, of the Government on drug, chemical, material, equipment, and means procurement for COVID-19 prevention and control, 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, and ensuring quality, economy, effectiveness, and preventing waste and corruption.

2. Public healthcare facilities, when conducting regular testing for medical staff, patients, and their families as stipulated by medical regulations, must pool samples according to the guidelines of the Ministry of Health and the practical conditions of the facility, ensuring economy and effectiveness.

3. For voluntary testing upon request and testing for organizations and businesses under contracts, public healthcare facilities shall charge users or settle with organizations and businesses according to the prices applicable to non-insured subjects and the costs of purchasing testing reagents as stipulated.

4. Provincial Departments of Health shall strengthen supervision and inspection or report to the provincial People's Committees to strengthen supervision and inspection of the implementation of legal provisions on pricing and bidding for healthcare facilities within their jurisdiction, strictly handle violations if any, and prevent unreasonable increases in testing service fees.

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./.

ANNEX I

LEVELS OF SERVICE FEES FOR SARS-COV-2 TESTING
(Annexed to Circular No. 16/2021/TT-BYT dated November 8, 2021 issued by the Minister of Health)

ANNEX II

GUIDELINES FOR DETERMINING AND PAYING COSTS FOR SARS-COV-2 TESTING
(Annexed to Circular No. 16/2021/TT-BYT dated November 8, 2021 issued by the Minister of Health)

1. Guidelines for the "Rapid antigen test for SARS-CoV-2" service with a maximum level including reagents being 109,700 VND/test:

a) Example 1:

- The price includes direct costs and labor costs of the unit according to the medical examination and treatment fee under health insurance or approved by the competent authority is 16,400 VND/test.

- Reagent cost according to the tender result of the unit is 50,000 VND/test.

- Total cost for performing the rapid antigen test for SARS-CoV-2 service is 66,400 VND/test.

- The service fee for the rapid antigen test for SARS-CoV-2 is 66,400 VND/test.

The unit may collect from the person tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget at 66,400 VND/test (not allowed to collect and settle at the maximum level of 109,700 VND/test).

b) Example 2:

- The price includes direct costs and labor costs of the unit according to the medical examination and treatment fee under health insurance or approved by the competent authority is 16,400 VND/test.

- Reagent cost according to the tender result of the unit is 100,000 VND/test.

- Total cost for performing the rapid antigen test for SARS-CoV-2 service is 116,400 VND/test.

- The service fee for the rapid antigen test for SARS-CoV-2 is 109,700 VND/test.

The unit may collect from the patient, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget at the service fee of 109,700 VND/test; the remaining 6,700 VND is settled into the self-managed funding source and other legitimate funding sources of the unit.

2. Guidelines for determining prices and payments for services Service "SARS-CoV-2 testing using Realtime RT-PCR technique" for individual samples:

a) Example 1:

- The price includes direct costs and labor costs of the unit according to the medical examination and treatment fee under health insurance or approved by the competent authority (excluding reagents) is 166,800 VND/test.

- Reagent cost (reaction and extraction) (or purchasing separate reagents for the Realtime RT-PCR reaction and extraction reagents) according to the tender result of the unit is 300,000 VND/test.

- Total cost for SARS-CoV-2 testing using Realtime RT-PCR technique for individual samples is 466,800 VND/test.

- The service fee for SARS-CoV-2 testing using Realtime RT-PCR technique for individual samples is 466,800 VND/test.

The unit may collect from the person tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget at the service fee of 466,800 VND/test (not allowed to collect and settle at the maximum level of 518,400 VND/test).

b) Example 2:

- The price includes direct costs and labor costs of the unit according to the medical examination and treatment fee under health insurance or approved by the competent authority (excluding reagents) is 166,800 VND/test.

- Reagent cost (reaction and extraction) (or purchasing separate reagents for the Realtime RT-PCR reaction and extraction) according to the tender result of the unit is 400,000 VND/test.

- Total cost for SARS-CoV-2 testing using Realtime RT-PCR technique for individual samples is 566,800 VND.

- The service fee for SARS-CoV-2 testing using Realtime RT-PCR technique for individual samples is 518,400 VND/test.

The unit may collect from the person tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget at the service fee of 518,400 VND/test; the remaining 48,400 VND is settled into the self-managed funding source and other legitimate funding sources of the unit.

3. Guidelines for determining prices and payments for services Service "SARS-CoV-2 testing using Realtime RT-PCR technique" for pooled samples:

a) Example 1:

- The price includes direct costs and labor costs of the unit according to the medical examination and treatment fee under health insurance or approved by the competent authority as stipulated in this Circular.

- Reagent cost (reaction and extraction) (or purchasing separate reagents for the Realtime RT-PCR reaction and extraction reagents) according to the tender result of the unit is 300,000 VND/test.

- The service fee for SARS-CoV-2 testing using Realtime RT-PCR technique for pooled samples is implemented as follows:

+ In case the unit implements the pooling of 5 swabs at the sampling site, the price is 154,300 VND/test, including: sample collection and preservation cost is 31,600 VND/test; testing and result provision cost is 62,700 VND/test; reagent cost is 60,000 VND/test (300,000/5 due to calculating the cost of one reagent divided by 5 samples).

+ In case the unit implements the pooling of 8 swabs at the sampling site, the price is 113,500 VND/test, including: sample collection and preservation cost is 30,200 VND/test; testing and result provision cost is 45,800 VND/test; reagent cost is 37,500 VND/test (300,000/8 due to calculating the cost of one reagent divided by 8 samples).

+ In case the unit implements the pooling of 5 samples in the laboratory, the price is 199,300 VND/test, including: sample collection and preservation cost is 65,900 VND/test; testing and result provision cost is 73,400 VND/test; reagent cost is 60,000 VND/test (300,000/5 due to calculating the cost of one reagent divided by 5 samples).

+ In case the unit implements the pooling of 10 samples in the laboratory, the price is 152,500 VND/test, including: sample collection and preservation cost is 66,800 VND/test; testing and result provision cost is 55,700 VND/test; reagent cost is 30,000 VND/test (300,000/10 due to calculating the cost of one reagent divided by 10 samples).

b) Example 2:

- The price includes direct costs and labor costs of the unit according to the medical examination and treatment fee under health insurance or approved by the competent authority as stipulated in this Circular.

- Reagent cost (reaction and extraction) (or purchasing separate reagents for the Realtime RT-PCR reaction and extraction) according to the tender result of the unit is 400,000 VND/test.

- The service fee for SARS-CoV-2 testing using Realtime RT-PCR technique for pooled samples in this case is implemented as follows:

In the case where the unit implements the plan to combine 5 samples on-site, the total cost for one test is 174,300 VND/test, including: sample collection and preservation costs at 31,600 VND/test; testing and result delivery costs at 62,700 VND/test; testing reagent costs at 80,000 VND/test (400,000/5 due to the calculation of the cost of one testing reagent divided by five samples).

The unit is only allowed to collect from the person being tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget according to the price level of 164,600 VND/test; the remaining 9,700 VND is settled into the self-managed operating funds and other lawful sources of funding of the unit.

In the case where the unit implements the plan to combine 8 samples on-site, the total cost for one test is 126,000 VND/test, including: sample collection and preservation costs at 30,200 VND/test; testing and result delivery costs at 45,800 VND/test; testing reagent costs at 50,000 VND/test (400,000/8 due to the calculation of the cost of one testing reagent divided by eight samples).

The unit is only allowed to collect from the person being tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget according to the price level of 119,900 VND/test; the remaining 6,100 VND is settled into the self-managed operating funds and other lawful sources of funding of the unit.

In the case where the unit implements the plan to combine 5 samples in the laboratory, the total cost for one test is 219,300 VND/test, including: sample collection and preservation costs at 65,900 VND/test; testing and result delivery costs at 73,400 VND/test; testing reagent costs at 80,000 VND/test (400,000/5 due to the calculation of the cost of one testing reagent divided by five samples).

The unit is only allowed to collect from the person being tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget according to the price level of 209,600 VND/test; the remaining 9,700 VND is settled into the self-managed operating funds and other lawful sources of funding of the unit.

In the case where the unit implements the plan to combine 10 samples in the laboratory, the total cost for one test is 162,500 VND/test, including: sample collection and preservation costs at 66,800 VND/test; testing and result delivery costs at 55,700 VND/test; testing reagent costs at 35,100 VND/test (400,000/10 due to the calculation of the cost of one testing reagent divided by ten samples).

The unit is only allowed to collect from the person being tested, settle with the Health Insurance Fund (according to the ratio), and settle with the state budget according to the price level of 157,600 VND/test; the remaining 4,900 VND is settled into the self-managed operating funds and other lawful sources of funding of the unit./.