| Số hiệu | 15/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 20/07/2023 |
| Người ký | Trần Văn Thuấn |
| Ngày hiệu lực | |
| Tình trạng |
|
MINISTRY OF
HEALTH OF VIETNAM |
SOCIALIST
REPUBLIC OF VIETNAM |
|
No. 15/2023/TT-BYT |
Hanoi, July 20, 2023 |
CIRCULAR
ON MAXIMUM PRICES AND COSTS CONTRIBUTING TO PRICES OF QUALIFIED WHOLE BLOOD UNITS AND BLOOD PRODUCTS
Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;
Pursuant to the Law on Prices No. 11/2012/QH13 dated June 20, 2012;
Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
Pursuant to Decree No. 177/2013/ND-CP dated November 14, 2013 of the Government providing detailed regulations and guidance on implementation of the Law on Prices; Decree No. 149/2016/ND-CP dated November 11, 2016 of the Government on amendments to Decree No. 177/2013/ND-CP dated November 14, 2013;
Pursuant to Decree No. 60/2021/ND-CP dated June 21, 2021 of the Government on financial autonomy of public administrative units;
At the request of the Director General of Department of Planning and Finance;
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Article 1. Regulated scope and entities
1. Regulated scope:
This Circular provides for the maximum prices of some qualified whole blood units and blood products covered by state budget and health insurance fund, and costs contributing to the determination of prices of qualified whole blood units and blood products.
2. Regulated entities:
a) Steering committees for blood donation at all levels; regulatory bodies, units and organizations involved in blood donation promotion, encouragement and organization and blood donors;
b) Facilities in charge of blood donor recruitment; receipt of blood and blood components; blood screening; blood product preparation; storage, preservation, provision and use of blood and blood products according to the regulations of the Ministry of Health.
Article 2. Regulations on qualified blood units and blood products
1. A blood unit is considered qualified when it is collected and preserved in a plastic bag containing an anticoagulant and has undergone all mandatory screening tests according to regulations in Circular No. 26/2013/TT-BYT dated September 16, 2013 by the Minister of Health providing guidelines for blood transfusion (hereinafter referred to as “Circular No. 26/2013/TT-BYT).
2. A blood product is considered qualified when it is prepared in compliance with the standards stated in Circular No. 26/2013/TT-BYT.
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1. Whole blood units:
No
Whole blood by volume
Net volume (ml) (±10%)
Maximum price (VND)
1
30 ml whole blood
35
111.000
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50 ml whole blood
55
161.000
3
100 ml whole blood
115
298.000
4
150 ml whole blood
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429.000
5
200 ml whole blood
225
521.000
6
250 ml whole blood
285
661.000
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350 ml whole blood
395
786.000
8
450 ml whole blood
510
894.000
2. Red blood cell products:
No
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Net volume (ml) (±10%)
Maximum price (VND)
1
Packed red cells from 30 ml whole blood
20
116.000
2
Packed red cells from 50 ml whole blood
30
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3
Packed red cells from 100 ml whole blood
70
288.000
4
Packed red cells from 150 ml whole blood
110
414.000
5
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145
536.000
6
Packed red cells from 250 ml whole blood
180
658.000
7
Packed red cells from 350 ml whole blood
230
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8
Packed red cells from 450 ml whole blood
280
874.000
3. Fresh frozen plasma products:
No
Fresh frozen plasma product by volume
Net volume (ml) (±10%)
Maximum price (VND)
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30 ml fresh frozen plasma
30
66.000
2
50 ml fresh frozen plasma
50
96.000
3
100 ml fresh frozen plasma
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163.000
4
150 ml fresh frozen plasma
150
189.000
5
200 ml fresh frozen plasma
200
296.000
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250 ml fresh frozen plasma
250
363.000
4. Frozen plasma products:
No
Frozen plasma product by volume
Net volume (ml) (±10%)
Maximum price (VND)
1
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30
56.000
2
50 ml frozen plasma
50
81.000
3
100 ml frozen plasma
100
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4
150 ml frozen plasma
150
179.000
5
200 ml frozen plasma
200
236.000
6
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250
283.000
5. Platelet-rich plasma products:
No
Platelet-rich plasma product by volume
Net volume (ml) (±10%)
Maximum price (VND)
1
100 ml platelet-rich plasma from 250 ml whole blood
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219.000
2
150 ml platelet-rich plasma from 350 ml whole blood
150
243.000
3
200 ml platelet-rich plasma from 450 ml whole blood
200
268.000
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No
Platelet concentrate product by volume
Net volume (ml) (±10%)
Maximum price (VND)
1
1 platelet concentrate unit (from 250 ml whole blood)
40
145.000
2
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80
301.000
3
3 platelet concentrate units (from 750 ml whole blood)
120
461.000
4
4 platelet concentrate units (from 1.000 ml whole blood)
150
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7. Cryoprecipitate products:
No
Cryoprecipitate product by volume
Net volume (ml) (±10%)
Maximum price (VND)
1
10 ml cryoprecipitate (from 250 ml whole blood)
10
80.000
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50 ml cryoprecipitate (from 1.000 ml whole blood)
50
369.000
3
100 ml cryoprecipitate (from 2.000 ml whole blood)
100
658.000
8. White blood cell products:
No
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Net volume (ml) (±10%)
Maximum price (VND)
1
Pooled granulocytes (5x109cells)
125
349.000
2
Pooled granulocytes (10x109cells)
250
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9. Products requiring additional equipment:
No
Product by volume
Net volume (ml) (±10%)
Maximum price (VND)
1
8 platelet concentrate units (from 2.000 ml whole blood) (excluding pool bags and white cell reduction)
250
1.088.000
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Virus-inactivated Factor VIII cryoprecipitate (excluding virus inactivation kit)
50
733.000
3
Cost of granulocyte apheresis (excluding apheresis equipment)
250
972.000
4
Cost of platelet apheresis (excluding apheresis equipment)
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538.000
5
Cost of platelet apheresis (excluding apheresis equipment)
250
972.000
6
Cost of platelet apheresis (excluding apheresis equipment)
500
1.172.000
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a) Cost of blood transport from the supplier to the user. In case the supplier carries out the transport itself, transport cost of no more than VND 17.000 shall be added to the price of each blood unit or blood product.
b) Cost of testing for abnormal antibodies. In case the blood user conducts these tests, a maximum of VND 17.000 shall be added to the price of each whole blood/packed red cell unit of at least 250 ml and each apheresis platelet, apheresis white blood cell or platelet concentrate product;
c) Costs of nucleic acid tests. In case the blood supplier conducts these tests, a maximum of VND 210.000 shall be added to the price of each whole blood/packed red cell unit of at least 250 ml and each apheresis platelet, apheresis white blood cell or platelet concentrate product;
d) Costs of mandatory tests whose conditions are provided for in Points a, b and c Clause 2 and Points c, g, i and k Clause 4 Article 14 of Circular No. 26/2013/TT-BYT. The blood supplier may conduct these tests when it meets existing regulations on blood transfusion and these tests are indicated by the doctor in charge of the patient.
d) Costs of mandatory tests whose conditions are provided for in Points a, b and c Clause 2 and Points c, g, i and k Clause 4 Article 14 of Circular No. 26/2013/TT-BYT. The blood supplier may conduct these tests when it meets existing regulations on blood transfusion and these tests are indicated by the doctor in charge of the patient.
dd) Costs of blood type testing, compatibility testing, abnormal antibody determination and identification, bedside blood type testing and equipment used to transfuse the blood unit or blood product to the patient.
11. When conducting the tests mentioned in Points d and dd Clause 10 herein, healthcare establishments may charge the patient or be reimbursed by the health insurance fund according to the price approved by the competent authority as per existing regulations.
Article 4. Costs contributing to determination of prices of qualified whole blood units and blood products
Prices of one qualified whole blood unit and qualified blood products shall be determined based on the costs of receipt and screening of blood and blood components and preparation of blood products. To be specific:
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Reimbursement items, specific reimbursement rates and use of this reimbursement amount are provided for in Clause 2 Article 3 of Circular No. 182/2009/TT-BTC dated September 14, 2009 by the Minister of Finance on guidelines for reimbursement items and rates for voluntary blood donation promotion and encouragement.
2. Maximum average cost of food and drinks provided for blood donors (including remunerated and non-remunerated donors) at the donation site: VND 30.000 per person per donation. The blood supplier shall provide food and drinks for blood donors before and after taking their blood in a considerate and transparent manner.
3. Payment for remunerated blood donors:
a) Direct payment for whole blood donors:
- One blood unit of 250 ml: VND 195.000;
- One blood unit of 350 ml: VND 320.000;
- One blood unit of 450 ml: VND 430.000;
b) Direct payment for apheresis donors:
- One product unit from 250 to 400 ml: VND 400.000;
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- One product unit from 500 to 650 ml: VND 700.000;
4. Incentives for voluntary non-remunerated blood donors:
a) Voluntary whole blood donors are entitled to in-kind or medical services incentives with the following minimum value:
- One blood unit of 250 ml: VND 100.000;
- One blood unit of 350 ml: VND 150.000;
- One blood unit of 450 ml: VND 180.000;
b) Voluntary apheresis donors are entitled to in-kind or medical services incentives with the following minimum value:
- One product unit from 250 to 400 ml: VND 150.000;
- One product unit from 400 to 500 ml: VND 200.000;
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c) Travel reimbursement for voluntary blood donors: maximum average of VND 50.000 per person per donation.
d) Guidelines on provision of medical services as incentives:
In case of provision of medical services as incentives, the head of the blood user shall publish list of available medical services and prices thereof for the blood donor to choose in accordance with the following rules:
- Total price of the services must be equivalent to the cost of the in-kind incentives mentioned in Points a and b Clause 4 herein;
- If total price of the services chosen by the blood donor is lower than the amount to which they are entitled stated in Point a or b Clause 4 herein, the blood user shall give additional in-kind incentive to the blood donor to ensure that the blood donor receives sufficient incentive according to regulations;
- If total price of the services chosen by the blood donor is higher than the amount to which they are entitled stated in Point a or b Clause 4 herein, the blood user shall charge the difference to the blood donor and give a public explanation to the donor. If such difference does not exceed 10% of the amount to which the blood donor is entitled, the head of the blood user may decide to cover such difference using revenues from blood and blood product provision within their competence.
- The prices of the medical services given as incentives are provided in accordance with regulations applied by competent authorities to medical examination and treatment services outside of the scope of coverage by the health insurance fund at state-owned healthcare establishments.
5. Costs of blood collecting equipment, plastic blood bags, materials, stationery, power and water used for collection, testing and screening of blood and blood products.
6. Salary based upon salary scale and grade or job title, allowances and contributions according to state regulations; specific allowances according to regulations in the Prime Minister’s Decision No. 73/2011/QD-TTg dated December 28, 2011 on some specific allowances for officials, public employees and workers of public healthcare establishments and allowances for epidemic control.
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8. Costs of clinical examination and testing biologicals, chemicals and materials for mandatory tests according to Circular No. 26/2013/TT-BYT.
9. Costs of regular maintenance of property and equipment used for receipt, screening and storage of blood and blood products.
10. Costs of disposal of unqualified blood units.
11. Remuneration for consultation for voluntary blood donors in public healthcare establishments assigned the tasks of blood receipt and screening.
12. Other reasonable and lawful spending on receipt, screening, production, storage and distribution of blood and blood products.
Article 5. Organizing implementation
1. According to regulations in this Circular, actual situation of each blood supplier and reglations of law on prices, the head of the supplier shall develop and promulgate the specific price of each qualified whole blood unit and qualified blood product, price of blood transport from the supplier to the user and prices of the tests mentioned in Points b and c Clause 10 Article 3 herein in compliance with the following rules:
a) For blood units and blood products covered by state budget, revenues from medical services according to regulations of public healthcare establishments or health insurance fund, their prices shall not exceed the maximum prices mentioned in Article 3 herein;
b) For blood units and blood products not covered by the sources mentioned in Point a of this Clause, their prices shall cover actual costs as appropriate, enable accumulation and suit the market's situation.
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In special cases where the blood user collects blood and/or blood products itself for timely blood transfusion, the social insurance authority shall reimburse the transport of the blood and/or blood products at a maximum rate of VND 17.000 per one blood unit or product. The remaining blood collection cost not reimbursed by the social insurance authority (if any) shall be covered by the blood user's recurrent funding.
3. Healthcare establishments shall keep a logbook of receipt and use of funding for receipt, screening, preparation, storage, transport and use of blood and blood products, and publish prices thereof as per the law.
4. Estimate preparation, estimate compliance and funding settlement shall be carried out in accordance with applicable regulations of the Law on State Budget and Law on Accounting and existing guidelines thereof.
5. For excess and unused plasma: the healthcare establishments are entitled to sell them to units eligible for business according to regulations. Purchase prices shall be decided by healthcare establishments after calculating all costs, ensuring minimization of costs of preserving, storing plasma and destroying the expired plasma. Revenues from sale of excess plasma shall be monitored, fully accounted for according to regulations and used only for blood transfusion.
Article 6. Terms of reference
In case any of the documents cited in this Circular is superseded or amended, the newest document shall apply.
Article 7. Effect
1. This Circular comes into force from September 15, 2023.
2. Circular No. 17/2020/TT-BYT dated November 12, 2020 of the Minister of Health on maximum prices and costs contributing to prices of qualified whole blood units and blood products are annulled from the date on which this Circular comes into force.
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PP. MINISTERDEPUTY MINISTERTran Van Thuan
| Số hiệu | 15/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 20/07/2023 |
| Người ký | Trần Văn Thuấn |
| Ngày hiệu lực | |
| Tình trạng |
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| Số hiệu | 15/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 20/07/2023 |
| Người ký | Trần Văn Thuấn |
| Ngày hiệu lực | |
| Tình trạng |