Circular 16/2021/TT-BYT prescribing prices for SARS-CoV-2 testing services

CIRCULAR

Prescribing prices for SARS-CoV-2 testing services

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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 Amending and Supplementing a Number of Articles of 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, providing the financial autonomy mechanism applicable to public non-business units;

Pursuant to the Government’s Decree No. 177/2013/ND-CP dated November 14, 2013, detailing and guiding a number of articles of the Law on Prices and the Government’s Decree No. 149/2016/ND-CP dated November 11, 2016, amending and supplementing a number of articles of the Government’s Decree No. 177/2013/ND-CP dated November 14, 2013, detailing and guiding a number of articles of the Law on Prices;

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

At the request of the Directors of the Planning and Finance Department, the Health Insurance Department and the Medical Services Administration;

the Minister of Health hereby promulgates the Circular prescribing prices for SARS-CoV-2 testing services.

Article 1. Scope of regulation and application

1. Scope of regulation:

This Circular provides prices for SARS-CoV-2 testing services, including taking and preserving samples, carrying out tests and returning SARS-CoV-2 test results.

2. Scope of application:

a) This Circular applies in the following cases: Payment for SARS-CoV-2 testing costs in accordance with the law on health insurance; persons using SARS-CoV-2 testing services who pay such costs by themselves and cases where such costs are covered by the state budget under the Law on Prevention and Control of Infectious Diseases, except for the cases specified at Point b of this Clause;

b) This Circular does not apply to costs for taking and preserving samples, carrying out tests and returning SARS-CoV-2 test results in the community that are covered by the state budget under the Law on Prevention and Control of Infectious Diseases.

Article 2. Structure of prices for SARS-CoV-2 testing services

Structure of prices for SARS-CoV-2 testing services stipulated in this Circular includes:

1. Direct costs for taking and preserving samples; carrying out tests and returning of SARS-CoV-2 test results.

2. Costs for payment of salary according to ranks, allowances, and contributions under the regime applicable to public non-business units as prescribed by the state according to the base salary specified in the Government’s No. 38/2019/ND-CP dated May 09, 2019, prescribing the base salary for cadres, civil servants, public employees and armed forces, excluding COVID-19 prevention and control allowances for health staff and officers.

3. Costs for biological products used for SARS-CoV-2 testing according to actual use and purchase price in accordance with the law on bidding.

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

1. Price for SARS-CoV-2 testing services in case it is covered by the health insurance fund:

a) SARS-CoV-2 rapid antigen test:

Service price includes direct costs and costs for salary payment as prescribed in Column 1, Section I in Appendix I attached to this Circular, plus costs for biological products used for SARS-CoV-2 testing as prescribed in Clause 3, Article 2 of this Circular. The maximum payment is VND 109,700/test.

b) Testing for SARS-CoV-2 by automated or semi-automated immunoassay analyzers:

Service price includes direct costs and costs for salary payment as prescribed in Column 1, Section II in Appendix I attached to this Circular, plus costs for biological products used for SARS-CoV-2 testing as prescribed in Clause 3, Article 2 of this Circular. The maximum payment is VND 186,600/test.

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

- Single sample testing: Service price includes direct costs and costs for salary payment as prescribed in Column 1, Section III in Appendix I attached to this Circular, plus costs for biological products used for SARS-CoV-2 testing as prescribed in Clause 3, Article 2 of this Circular. The maximum payment is VND 518,400/test.

- Pooled sample testing: Service price includes direct costs and costs for salary payment as prescribed in Column 1, Section IV in Appendix I attached to this Circular, plus costs for biological products used for SARS-CoV-2 testing as prescribed in Clause 3, Article 2 of this Circular. In which biological products used for testing shall be divided equally according to the number of pooled samples. The maximum payment must not exceed the price for pooled sample testing specified in Column 2 in Appendix I attached to this Circular.

2. Price for SARS-CoV-2 testing services in case it is not covered by the health insurance fund:

a) For state-owned medical examination and treatment establishments at provinces and centrally-run cities, and medical examination and treatment establishments affiliated to ministries and central agencies that are located in localities, except for the cases specified at Point b of this Clause: The determination of the price shall comply with Clause 1 of this Article, in which, the price includes direct costs and costs for salary payment (excluding biological products used for testing) as prescribed by the competent local authorities but must not exceed the maximum price framework for SARS-CoV-2 testing services as prescribed in Column 1 in Appendix I attached to this Circular;

b) For medical examination and treatment establishments affiliated to the Ministry of Health, special hospitals and level-1 hospitals affiliated to ministries, central agencies, and public health establishments providing preventive medical services: The price shall comply with Clause 1 of this Article.

Article 4. Guidance on payment

1. The determination of price and payment of costs for SARS-CoV-2 testing services are guided in Appendix 2 attached to this Circular.

2. In case health establishments transfer samples to the health establishments eligible for testing:

a) For the cases within the payment range of the health insurance fund: Costs for transferring to para-clinical services shall be paid according to the law on health insurance;

b) Other cases shall be paid according to the prices for SARS-CoV-2 testing services conducted by testing units under this Circular and costs for purchasing biological products used for testing of testing units under the law on bidding.

3. In case of taking samples or testing using materials and biological products granted from the pandemic prevention and control sources covered by the state budget, and supported, sponsored by agencies, organizations, and individuals free of charge, public health establishments (including medical examination and treatment establishments) shall exclude costs for supported testing materials and biological products when settlement and finalization with social insurance agencies or state budget.

4. In case costs for testing are higher than the maximum price specified in Column 2 in Appendix I attached to this Circular, the public health establishments (including medical examination and treatment establishments) may account such costs into the independent funding source and other lawful funding sources of the units.

Article 5. Effect

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

2. In cases where any of the documents referred to in this Circular is amended, supplemented, or replaced, the newest one shall prevail.

Article 6. Transitional provisions

The prices and payment of costs for SARV-CoV-2 testing services before the effective date of this Circular shall be implemented as follows:

1. For SARS-CoV-2 rapid antigen tests conducted on July 01, 2021 or earlier, and SARS-CoV-2 Real-time RT-PCR tests conducted on May 28, 2021 or earlier: Testing costs shall be paid according to the prices decided by competent agencies under the Minister of Health’s Circular No. 13/2019/TT-BYT dated July 05, 2019, amending and supplementing a number of the Minister of Health's Circular No. 39/2018/TT-BYT dated November 30, 2018, unifying prices of medical examination and treatment services covered by health insurance among hospitals of the same levels across the country and guidelines for applying prices and payment for medical services in certain cases; the Minister of Health's Circular No. 14/2019/TT-BYT dated July 05, 2019, amending and supplementing a number of the Minister of Health’s Circular No. 37/2018/TT-BYT dated November 30, 2018, prescribing ceilings of price framework of medical examination and treatment services not covered by the health insurance fund at state-owned health establishments and providing guidance on pricing and payment of costs of medical examination and treatment services in certain cases.

2. For SARS-CoV-2 rapid antigen tests, and SARS-CoV-2 antigen tests using immunoassay analyzers that are conducted from July 01, 2021, to the effective date of this Circular, and SARS-CoV-2 Real-time RT-PCR tests conducted from May 28, 2021, to the effective date of this Circular:

a) SARS-CoV-2 rapid antigen test:

- Costs related to the sampling and returning test results: consumable supplies, water, electricity, labor: Health establishments shall make payment and settle according to the current state budget decentralization on funding for pandemic prevention and control.

- Testing costs that are paid and spent: Payment and spending for each patient according to the number of rapid test kits actually used for such patient and price for purchasing test kits according to the bidding results approved by the competent authorities in accordance with law provisions.

For example: The result of rapid test bidding of the unit approved by the competent authority is VND 135,000/test. If the health insurance card holder is eligible for health insurance payment and entitled to 80% of medical examination and treatment costs, he/she shall receive payment from the health insurance fund within the scope of enjoyment and the payment for one rapid test is VND 135,000 x 80% = VND 108,000. The co-payment of VND 27,000 and costs related to the sampling and returning test results shall be covered by the state budget according to the current decentralization.

b) SARS-CoV-2 antigen test by immunoassay analyzers:

- In case the sample collection and specimen preservation procedure to be required is similar to the one applicable to cases of testing by Real-time RT-PCR technique, to temporarily collect and pay cost for the service of “collecting samples and preserving specimens” at the price of VND 100,000/sample.

- Testing costs that are temporarily paid and spent, to be specific: Payment and spending for each patient according to the number of test kits actually used for such patient and price for purchasing test kits according to the bidding results approved by the competent authority in accordance with the Bidding Law.

- Costs for materials, chemicals, electricity, water, labor related to the testing process: Health establishments shall pay such costs and perform the settlement according to current state budget decentralization on funding for pandemic prevention and control.

c) Testing for SARS-CoV-2 by Real-time RT-PCR technique, for oropharyngeal specimens:

- Payment for single sample testing: to apply the price of the service No. 1735: testing for bacteria/viruses/fungi/parasites by Real-time RT-PCR specified in the Appendix issued together with the Ministry of Health’s Circular No. 13/2019/TT-BYT dated July 05, 2019: VND 734,000/1 testing sample. In case the sampling unit must send samples to another unit for testing, the price constituents shall be as follows:

+ Price for the service of taking and preserving specimens: VND 117,800/sample;

+ Price for carrying out the test: VND 616,200/sample.

- Payment for pooled sample testing:

+ Price for taking and preserving specimens: VND 100,000/sample

+ Price for carrying out the test equals VND 634,000 divided by (:) the number of pooled samples; for example: In case of a test with 5 samples to be pooled, the price equals VND 634,000 divided by 5; In case of a test with 10 samples to be pooled, the price equals VND 634,000 divided by 10.

- In case the result of pooled sample testing is positive, single sample testing is required, the costs of carrying out the test shall be calculated according to the case of single sample testing.

Article 7. Organization of implementation

1. Health establishments shall be responsible for purchasing supplies, chemicals and biological products for SARS-CoV-2 testing in accordance with the law regulations on bidding, regulations of the 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, the Resolution No. 86/NQ-CP dated August 06, 2021 of the Government on urgent COVID-19 pandemic prevention and control measures to implement the Resolution No. 30/2021/QH15 dated July 28, 2021 of the 15^th National Assembly, ensuring the quality, thrift, efficiency, avoiding waste and negative issues.

2. When performing periodic testing for their health staff, and testing for their patients and patients' relatives in accordance with professional regulations, public health establishments must pool samples according to the Ministry of Health’s guidance and in line with the situation of the units, ensuring thrift and efficiency.

3. In case of providing voluntary testing services upon request, testing services for organizations and enterprises under contracts: Public health establishments shall collect the payment from service users or demand the payment of organizations and enterprises, applying the prices applicable to subjects other than eligible health insurance fund beneficiaries and the cost of purchasing biological products for testing according to regulations.

4. Departments of Health of provinces and centrally-run cities shall, within their functions and tasks, strengthen the inspection and examination of, or report to provincial-level People's Committees to strengthen the inspection and examination of, the implementation of law regulations on prices and on bidding of health establishments in the localities, strictly handle violations, if any, prevent the unreasonable increase in prices for testing services.

Any difficulty and problems arising in the course of implementation should be promptly reported in writing to the Ministry of Health for consideration and settlement./.

APPENDIX I

PRICES FOR SARS-COV-2 TESTING SERVICES
(Attached to the Circular No. 16/2021/TT-BYT dated November 08, 2021, of the Minister of Health)

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* Other Appendices are not translated herein.