Thông tư 16/2021/TT-BYT

CIRCULAR

ON PRICES FOR SARS-COV-2 TESTING SERVICES

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

Pursuant to the Law on Health Insurance dated November 14, 2008 and the Law on amendments to the Law on Health Insurance dated June 13, 2014;

Pursuant to the Law on Prices dated June 20, 2012;

Pursuant to the Government's Decree No. 60/2021/ND-CP dated June 21, 2021 on autonomy mechanism of public sector entities;

Pursuant to the Government’s Decree No. 177/2013/ND-CP dated November 14, 2013 on elaboration of and guidelines for the Law on Prices; the Government’s Decree No. 149/2016/ND-CP dated November 11, 2016 and the Government on amendments to Decree No. 177/2013/ND-CP dated November 14, 2013 of the Government on elaboration of and guidelines for the Law on Prices;

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

At the request of the Director of the Department of Planning and Finance, the Director of the Department of Health Insurance, the Director of the Department of Medical Examination and Treatment;

The Minister of Health promulgates a Circular on prices for SARS-CoV-2 testing services.

Article 1. Scope and application

1. Scope:

This Circular sets out prices for SARS-CoV-2 testing services, including taking specimens, storing specimens, performing tests and reporting results.

2. Scope:

a) This Circular applies to the following cases: payment for SARS-CoV-2 testing costs in accordance with the law on health insurance; SARS-CoV-2 testing service charges to be paid by users and to be covered by the state budget as prescribed in the Law on prevention and control of infectious diseases, except as provided for in point b hereof;

b) This Circular does not apply to cases that the costs incurred in taking specimens, storing specimens, performing tests and reporting results of SARS-CoV-2 in the community shall be covered by the state budget as prescribed in the Law on prevention and control of infectious diseases.

Article 2. Pricing breakdown of SARS-CoV-2 tests

Pricing breakdown of SARS-CoV-2 tests in this Circular:

1. The direct cost incurred in taking specimens, storing specimens, performing tests, and reporting results of SARS-CoV-2.

2. The cost of salaries and wages by grades and steps, allowances and contributions according to the regime prescribed by the State for public sector entities according to the statutory pay rates specified in Decree No. 38/2019/ Decree-CP dated May 9, 2019 of the Government on statutory pay rates for officials and public employees and the armed forces; excluding allowances for health workers regarding COVID-19 prevention and control.

3. The cost of biologicals for testing SARS-CoV-2 according to actual use and buying prices in accordance with the law on procurement.

Article 3. Prices for SARS-CoV-2 testing services

1. Prices for SARS-CoV-2 testing services that are covered by the health insurance fund:

a) SARS-CoV-2 Rapid Antigen Test:

The service price includes the direct cost, the cost of salaries and wages as prescribed in column 1 section I appendix I issued herewith plus the cost of biologicals for testing SARS-CoV-2 as provided for in clause 3 Article 2 hereof. The maximum price is VND 109,700/test.

b) Testing for SARS-CoV-2 by automatic or semi-automatic immunoassay machine:

The service price includes the direct cost, the cost of salaries and wages as prescribed in column 1 section II appendix I issued herewith plus the cost of biologicals for testing SARS-CoV-2 as provided for in clause 3 Article 2 hereof. The maximum price is VND 186,600/test.

c) Testing for SARS-CoV-2 using Real-time PCR technique:

- For individual specimens: The service price includes the direct cost, the cost of salaries and wages as prescribed in column 1 section II appendix I issued herewith plus the cost of biologicals for testing SARS-CoV-2 as provided for in clause 3 Article 2 hereof. The maximum price is VND 518,400/test.

- For pooled specimens: The service price includes the direct cost, the cost of salaries and wages as prescribed in column 1 section IV appendix I issued herewith plus the cost of biologicals for testing SARS-CoV-2 as provided for in clause 3 Article 2 hereof, in which the biological are divided equally according to the total number of pooled specimens. The maximum price shall not exceed the price of pooled specimen testing as prescribed in column 2 Appendix I issued herewith.

2. Prices for SARS-CoV-2 testing services that are covered by the health insurance fund:

a) For state-owned healthcare facilities affiliated to provinces or central-affiliated cities and healthcare facilities affiliated to Ministries and central authorities located in the locality, except for the provision in point b hereof: The price shall be determined as prescribed in clause 1 hereof, in which the price shall include the direct cost and cost of salaries and wages (exclusive of biological) stipulated by the local competent authority but not exceeding the maximum price of the SARS-CoV-2 testing bracket as prescribed in column 1 Appendix I issued herewith;

b) For healthcare facilities affiliated to the Ministry of Health and special-class hospitals, class-I hospitals affiliated to Ministries and central authorities and public healthcare facilities that provide preventive medicine services: the prices are specified in clause 1 hereof.

Article 4. Guidelines for payments

1. Guidelines for determination of prices and payments for SARS-CoV-2 testing services refer to Appendix 2 issued with this Circular.

2. In case the health facility transfers specimens to a health facility qualified for Covid test confirmation:

a) For cases in which medical expenses are covered by the health insurance fund: payments shall be made as in subclinical services as per the law on health insurance;

b) For other cases, payments shall be made according to the prices for SARS-CoV-2 testing services quoted by the testing provider as prescribed in this Circular and the costs of biological quoted by the testing provider as per law on procurement.

3. In case of taking specimens or performing tests using supplies and biologicals funded by the state budget for COVID-19 control sources, sponsored or supported by other agencies, organizations, individuals free of charge, the public health facilities (including medical examination and treatment establishments) shall deduct these costs of supplies and biologicals when charging service users, social security agencies and state budget.

4. If the costs incurred in testing performance are higher than the maximum price specified in column 2 Appendix I issued herewith, the public health facilities (including medical examination and treatment establishments) may use the financially autonomous fund or other legal sources of funds.

Article 5. Entry in force

1. This Circular comes into force as of November 10, 2021 to the end of December 31, 2022.

2. In case any document referred to in this Circular is superseded or amended, the new document shall prevail.

Article 6. Grandfather clause

The prices and payments for SARS-CoV-2 testing services before the effective date of this Circular shall apply as follows:

1. For SARS-CoV-2 rapid antigen tests performed from July 1, 2021 or earlier and SARS-CoV-2 tests using RT-PCR technique from May 28, 2021 or earlier:  the payments shall be made at the prices decided by the competent authorities in accordance with the Circular No. 13/2019/TT-BYT dated July 5, 2019 of the Minister of Health on amendments to Circular No. 39/2018/TT-BYT dated November 30, 2018 of the Minister of Health on the unification of prices for medical examination and treatment services covered by health insurance between hospitals of the same class nationwide and guide for the application of prices and payments for medical examination and treatment costs in certain cases; Circular No. 14/2019/TT-BYT dated July 5, 2019 of the Minister of Health on amendments to the Circular No. 37/2018/TT-BYT dated November 30, 2018 of the Ministry of Health on maximum prices of the price bracket for medical examination and treatment services that are not covered by the health insurance fund in the state-owned healthcare facilities and guide for the application of prices and payments for medical examination and treatment costs in certain cases.

2. For the SARS-CoV-2 rapid antigen test, the antigen test to detect SARS-CoV-2 on the immunoassay machine that have been performed from July 1, 2021 to the time this Circular takes effect and testing for SARS-CoV-2 using RT-PCR technique from May 28, 2021 to the effective date of this Circular:

a) SARS-CoV-2 rapid antigen test:

- The costs incurred in taking specimens and reporting results: consumables, power and water, human resources: the health facility shall pay and then settle these costs based on its delegated state budget regarding Covid-19 funding.

- The testing costs based on actual payments: payments shall be made by each patient based on the actual number of rapid tests used for the patient and the test price according to the procurement result approved by the competent authority as per the law.

For example, the entity is approved by the competent authority for the quick test priced at VND 135,000/test based on the procurement result. If the holder of a health insurance card is eligible for health insurance coverage and is entitled to 80% of medical examination and treatment expenses, the health insurance fund shall, based on the scope and benefit level, cover rapid test expense of VND 135,000 x 80% = VND 108,000.  The co-payment of VND 27,000 and the costs incurred in taking specimens and reporting results shall be covered by the state budget according to current budgetary delegation.

b) Antigen test to detect SARS-CoV-2 on the immunoassay machine:

- If the specimen is taken and stored as it is taken and stored using Real-time PCR, temporarily charge VND 100,000/specimen for “taking and storing specimen”.

- The cost incurred in performing the test shall be paid according to actual payment; in specific: payments shall be made by each patient based on the actual number of rapid tests used for the patient and the test price according to the procurement result approved by the competent authority as per the law.

- Costs incurred in supplies, chemicals, power, water, human resources related to the performance of tests: the health facility shall pay and then settle these costs based on its delegated state budget regarding Covid-19 funding.

c) Testing for SARS-CoV-2 using Real-time PCR technique from oropharyngeal specimens:

- Payments for individual specimens:  applying service price No. 1735: Real-time PCR for bacteria/viruses/fungi/parasites specified in the appendix issued with Circular No. 13/2019 /TT-BYT dated July 5, 2019 of the Ministry of Health is VND 734,000/specimen.  If the entity that takes specimens must send the specimens to another entity for performing tests, the price structure is as follows:

+ Price for taking and storing specimens: VND 117,800/specimen;

+ Price for performing test: VND 616,200/specimen.

- Payments for pooled specimens:

+ Price for taking and storing specimens: VND 100,000/specimen;

+ Price for performing test equals VND 634,000 divided by the number of specimens being pooled; for example:  if 5 specimens are pooled into a test, then divided by 5; if 10 specimens are pooled, then divided by 10.

- In case a pooled specimen is found to be positive so the individual specimens must be further tested, the cost of performing the tests shall be charged for these individual specimens.

Article 7. Implementation

1. Health facilities are responsible for purchasing supplies, chemicals and biologicals for SARS-CoV-2 testing in accordance with the law on procurement and the provisions of Resolution No. 79/NQ-CP dated July 22, 2021 of the Government on procurement of drugs, chemicals, supplies, equipment and means 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 30/2021/QH15 dated July 28, 2021 of the 15th National Assembly and ensure quality, thrift, efficiency, anti-waste, and anti-misconduct.

2. Public health facilities, when performing periodical tests of medical staff, and testing patients and patients' relatives according to health specialized regulations, must perform sample pooling following guidelines of the Ministry of Health and according to their actual circumstances, ensuring thrift and efficiency.

3. In case of voluntary testing upon requests, testing for organizations and enterprises under contracts:  public health facilities shall charge service users or organizations and businesses the prices applicable to those not covered by the health insurance fund and the costs of purchasing biologicals for testing according to regulations.

4. The Departments of Health of the provinces and central-affiliated cities shall, according to their functions and tasks, strengthen the inspection, or report to the provincial People's Committees to strengthen the inspection of the implementation of regulations of law on prices, bidding for health facilities in the area, strictly handle violations if any, eliminate the unreasonable increase of prices for testing services.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health for consideration./.

APPENDIX I

PRICES FOR SARS-COV-2 TESTING SERVICE
(Issued together with Circular No. 16/2021/TT-BYT dated November 8, 2021 of the Minister of Health)

APPENDIX II

DETERMINATION OF PRICES AND PAYMENTS FOR SARS-COV-2 TESTING SERVICES
(Issued together with Circular No. 16/2021/TT-BYT dated November 8, 2021 of the Minister of Health)

1. Guidelines for “SARS-CoV-2 rapid antigen test” with maximum price inclusive of biologicals of VND 109,700/test:

a) Example 1:

- The price including the direct cost, cost of salaries and wages of the health facility based on the medical prices covered by health insurance or approved by the competent authority is 16,400 VND/test.

- The cost of biologicals for testing according to the procurement result of the health facility is 50,000 VND/test.

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

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

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 66,400/test (the health facility may not charge the maximum price VND 109,700/test).

b) Example 2:

- The price including the direct cost, cost of salaries and wages the medical prices covered by health insurance or approved by the competent authority is 16,400 VND/test.

- The cost of biologicals for testing according to the procurement result is 100.000 VND/test.

- Total cost of performing the SARS-CoV-2 antigen rapid test is VND 116.400/test.

- Price for the SARS-CoV-2 antigen rapid test is VND 109.700/test.

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 109,700/test; the remaining cost of VND 6,700 shall be covered by the financially autonomous fund and other legal sources of fund of the health facility.

2. Guidelines for determination of prices and payments for “Testing for SARS-CoV-2 using Real-time PCR technique” with individual specimen:

a) Example 1:

- The price including the direct cost, cost of salaries and wages the medical prices covered by health insurance or approved by the competent authority (exclusive of biologicals) is 166.800 VND/test.

- Cost of biologicals (reactions and extractions) (or separate biological and chemical products for Real-time PCR and extraction biologicals) according to the procurement result of the health facility is VND 300,000/test.

- Total cost of performing SARS-CoV-2 test using Real-time PCR with individual specimen is VND 466.800/test.

- Price for SARS-CoV-2 test using Real-time PCR with individual specimen is VND 466.800/test.

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 466.800/test (the health facility may not charge the maximum price VND 518,400/test).

b) Example 2:

- The price including the direct cost, cost of salaries and wages the medical prices covered by health insurance or approved by the competent authority (exclusive of biologicals) is 166.800 VND/test.

- Cost of biologicals (reactions and extractions) (or separate biological and chemical products for Real-time PCR and extraction biologicals) according to the procurement result of the health facility is VND 400,000/test.

- Total cost of performing SARS-CoV-2 test using Real-time PCR with individual specimen is VND 566.800/test.

- Price for SARS-CoV-2 test using Real-time PCR with individual specimen is VND 518.400/test.

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 518,400/test; the remaining cost of VND 48.400 shall be covered by the financially autonomous fund and other legal sources of fund of the health facility.

3. Guidelines for determination of prices and payments for “Testing for SARS-CoV-2 using Real-time PCR technique” with pooled specimen:

a) Example 1:

- The price including the direct cost, cost of salaries and wages the medical prices covered by health insurance or approved by the competent authority is the maximum price as prescribed in this Circular.

- Cost of biologicals (reactions and extractions) (or separate biological and chemical products for Real-time PCR and extraction biologicals) according to the procurement result of the health facility is VND 300,000/test.

- Price for SARS-CoV-2 test using Real-time PCR with pooled specimen:

+ If the health facility pools 5 swabs together on site, the price is VND 154,300/test, inclusive of: the cost of taking and storing specimen of VND 31,600/test; the cost of performing test and reporting result of VND 62,700/test; the cost of biologicals of VND 60,000/test (300,000/5 as calculating the cost of a biological divided by 5 specimens):

+ If the health facility pools 8 swabs together on site, the price is VND 113,500/test, inclusive of: the cost of taking and storing specimen of VND 30,200/test; the cost of performing test and reporting result of VND 452,800/test; the cost of biologicals of VND 37,500/test (300,000/5 as calculating the cost of a biological divided by 8 specimens):

+ If the health facility pools 5 swabs together in the lab, the price is VND 199,300/test, inclusive of: the cost of taking and storing specimen of VND 65,900/test; the cost of performing test and reporting result of VND 73,400/test; the cost of biologicals of VND 60,000/test (300,000/5 as calculating the cost of a biological divided by 5 specimens):

+ If the health facility pools 10 swabs together in the lab, the price is VND 152,500/test, inclusive of: the cost of taking and storing specimen of VND 66,800/test; the cost of performing test and reporting result of VND 55,700/test; the cost of biologicals of VND 30,000/test (300,000/10 as calculating the cost of a biological divided by 10 specimens):

b) Example 2:

- The price including the direct cost, cost of salaries and wages the medical prices covered by health insurance or approved by the competent authority is the maximum price as prescribed in this Circular.

- Cost of biologicals (reactions and extractions) (or separate biological and chemical products for Real-time PCR and extraction biologicals) according to the procurement result of the health facility is VND 400,000/test.

- Price for SARS-CoV-2 test using Real-time PCR with pooled specimen:

+ If the health facility pools 5 swabs together on site, the total cost is VND 174,300/test, inclusive of: the cost of taking and storing specimen of VND 31,600/test; the cost of performing test and reporting result of VND 62,700/test; the cost of biologicals of VND 80,000/test (400,000/5 as calculating the cost of a biological divided by 5 specimens).

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 164,600/test; the remaining cost of VND 9.700 shall be covered by the financially autonomous fund and other legal sources of fund of the health facility.

+ If the health facility pools 8 swabs together on site, the total cost is VND 126,000/test, inclusive of: the cost of taking and storing specimen of VND 30,200/test; the cost of performing test and reporting result of VND 45,800/test; the cost of biologicals of VND 50,000/test (400,000/8 as calculating the cost of a biological divided by 8 specimens).

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 119,900/test; the remaining cost of VND 6.100 shall be covered by the financially autonomous fund and other legal sources of fund of the health facility.

+ If the health facility pools 5 swabs together in the lab, the total cost is VND 219,300/test, inclusive of: the cost of taking and storing specimen of VND 65,900/test; the cost of performing test and reporting result of VND 73,400/test; the cost of biologicals of VND 80,000/test (400,000/5 as calculating the cost of a biological divided by 5 specimens)

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 209,600/test; the remaining cost of VND 9.700 shall be covered by the financially autonomous fund and other legal sources of fund of the health facility.

+ If the health facility pools 10 swabs together in the lab, the total cost is VND 162,500/test, inclusive of: the cost of taking and storing specimen of VND 66,800/test; the cost of performing test and reporting result of VND 55,700/test; the cost of biologicals of VND 35,100/test (400,000/10 as calculating the cost of a biological divided by 10 specimens):

The health facility may only charge the person being tested, the health insurance fund (based on given portion),or the state budget VND 157,600/test; the remaining cost of VND 4.900 shall be covered by the financially autonomous fund and other legal sources of fund of the health facility./.