Thông tư 22/2024/TT-BYT ngày 18/10/2024 quy định về thanh toán chi phí thuốc, thiết bị y tế trực tiếp cho người có thẻ bảo hiểm y tế đi khám bệnh, chữa bệnh do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

ON REIMBURSEMENT OF DRUG AND MEDICAL DEVICE COSTS DIRECTLY TO HOLDERS OF HEALTH INSURANCE CARDS FOR MEDICAL EXAMINATION AND TREATMENT

Pursuant to the Law on Health Insurance dated November 14, 2008, as amended by the Law on Health Insurance dated June 13, 2014;

Pursuant to Decree No. 146/2018/ND-CP dated October 17, 2018 of the Government on elaboration of and guidelines for the Law on Health Insurance; and Decree No. 75/2023/ND-CP dated October 19, 2023 of the Government on amendments to Decree No. 146/2018/ND-CP dated October 17, 2018 on elaboration of and guidelines for the Law on Health Insurance;

Pursuant to Decree No. 95/2022/ND-CP dated November 15, 2022 of the Government on the functions, duties, powers, and organizational structure of the Ministry of Health;

At the request of the Director of the Department of Health Insurance,

The Minister of Health hereby issues this Circular on reimbursement of drug and medical device costs directly to holders of health insurance cards for medical examination and treatment.

Article 1. Scope

This Circular stipulates the direct reimbursement of drug and medical device costs within the scope of entitlement for participants in health insurance when undergoing medical examination and treatment as prescribed in Point c, Clause 2, and Clause 3, Article 31 of the Law on Health Insurance at medical facilities that have signed contracts for health insurance-covered medical examination and treatment with the health insurance fund, including:

1. Cases of drugs and medical devices eligible for reimbursement.

2. Reimbursement conditions.

3. Reimbursement amounts.

4. Documentation and procedures for reimbursement.

Article 2. Cases of drugs and medical devices eligible for reimbursement

1. Drugs listed in the Rare Drug List issued together with Circular No. 26/2019/TT-BYT dated August 30, 2019 of the Minister of Health on the Rare Drug List.

2. Class C or D medical devices, except for in vitro diagnostic medical devices, personalized medical devices, and medical devices listed as commodities that are purchased and sold as regular goods under the provisions of Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on the management of medical devices, and Decree No. 07/2023/ND-CP dated March 3, 2023, of the Government on amendments to Decree No. 98/2021/ND-CP dated November 8, 2021 of the Government on the management of medical devices.

Article 3. Reimbursement conditions

At the time of prescribing drugs or indicating the use of medical devices, the following conditions must be ensured:

1. Absence of drugs or medical devices due to the ongoing process of selecting a contractor according to the approved contractor selection plan under one of the following methods: open bidding, restricted bidding, shopping method, or direct procurement, contractor selection in special cases, online bidding, or e-procurement. In cases where contractor selection has been conducted under simplified procedures as prescribed in Point c, Clause 1, and Clause 2, Article 23 of the Law on Procurement and Clause 1, Article 94 of Decree No. 24/2024/ND-CP dated February 27, 2024 on elaboration of and measures for implementing the Law on Procurement regarding contractor selection but a contractor has not been selected, the following additional conditions at the medical facility must be met:

a) For drugs: There are no commercial drugs containing the active ingredient prescribed for the patient, or there are no drugs with the same active ingredient but in different concentrations, dosages, pharmaceutical forms, or administration routes that could be substituted for the prescribed drug;

b) For medical devices: There are no medical devices that the patient is indicated to use, nor are there replacement medical devices available.

2. Non-referral of the patient to another medical facility under any of the following circumstances:

a) The patient’s health condition or illness is determined to be insufficient for transfer;

b) The medical facility where the patient is being treated is under a medical isolation period as prescribed by regulations on infectious disease prevention and control;

c) The medical facility where the patient is being treated is a specialized medical facility.

3. The inability to transfer drugs or medical devices between medical facilities in accordance with legal regulations.

4. Drugs and medical devices prescribed or indicated for use must comply with the professional scope of the medical facility and must have been covered under health insurance for medical examination and treatment at one of the medical facilities nationwide.

5. Drugs and medical devices prescribed or indicated for use must fall within the benefit scope of health insurance participants.

Article 4. Direct reimbursement amounts for medical costs

1. The social insurance agency shall make direct reimbursements to the patient as follows:

a) For drugs: The reimbursement amount is based on the quantity and unit price listed on the invoice issued by the pharmacy where the patient purchased the drugs. In cases where specific reimbursement rates or conditions apply to the drug, reimbursement shall adhere to these rates or conditions;

b) For medical devices (including reusable devices): The reimbursement amount is based on the quantity and unit price listed on the invoice from the medical device vendor. In cases where medical devices have a specified maximum reimbursement limit, reimbursement shall not exceed the prescribed reimbursement limit for those devices.

2. The unit price of drugs and medical devices used as the basis for determining the reimbursement amount must not exceed the most recent reimbursement price for drugs and medical devices that were successfully procured at the medical facility where the patient received treatment.

If the drugs or medical devices have not been procured at the medical facility where the patient received treatment, the unit price used to determine the health insurance reimbursement amount will be based on the most recently valid contractor selection result, prioritized in the following order:

a) Results from national centralized procurement or price negotiation outcomes;

b) Results from local centralized procurement within the relevant locality;

c) Results from the lowest contractor selection at the time of reimbursement from specialized or basic public medical facilities or facilities of equivalent technical expertise levels within the locality;

d) Results from the lowest contractor selection at the time of reimbursement from specialized or basic public medical facilities or facilities of equivalent technical expertise levels in Hanoi or Ho Chi Minh City.

3. The social insurance agency shall deduct the health insurance-covered costs from the medical facility providing care to the patient as follows:

a) For drug and medical device costs included in the service price for medical examination and treatment: Deduct these costs from the health insurance-covered medical examination and treatment service costs at the medical facility based on the reimbursement levels specified in Clauses 1 and 2 of this Article;

b) For drug and medical device costs not included in the service price structure for medical examination and treatment: These costs shall not be deducted from the health insurance-covered medical examination and treatment service costs at the medical facility;

c) The costs of drugs and medical devices directly reimbursed by the social insurance agency to the patient shall be accounted for in the budget projections of the medical facility.

Article 5. Documentation and procedures for direct reimbursement

1. Documentation for direct reimbursement shall comply with the provisions of Article 28 of Decree No. 146/2018/ND-CP dated October 17, 2018 of the Government on elaboration of and guidelines for the Law on Health Insurance (hereinafter referred to as Decree No. 146/2018/ND-CP).

2. Procedures for direct reimbursement shall comply with the provisions of Article 29 of Decree No. 146/2018/ND-CP.

Article 6. Implementation

1. The Department of Health Insurance is responsible for providing guidance and overseeing the nationwide implementation of this Circular.

2. Vietnam Social Security is responsible for directing, guiding, and supervising the implementation of this Circular within its jurisdiction.

3. The Departments of Health of provinces and centrally-affiliated cities shall:

a) Organize dissemination, implementation, inspection, and supervision of this Circular within their jurisdiction;

b) Strengthen supervision and inspection of procurement activities to ensure the availability of drugs and medical devices for health insurance-covered medical examination and treatment at medical facilities under their management. They shall take measures in accordance with legal regulations on medical examination, treatment, and health insurance against medical facilities that fail to meet the requirements stipulated in their operational licenses and health insurance contracts regarding the supply of drugs and medical devices;

c) Strengthen inspections and supervision of medical facilities under their management to ensure there is no abuse or exploitation in prescribing and instructing patients to independently purchase drugs and medical devices; strictly handle violations in accordance with legal regulations.

4. Responsibilities of medical facility heads:

a) Issue regulations or guidance documents to implement this Circular within their healthcare facilities;

b) Provide instructions for medical practitioners to specifically note the unavailability of drugs and medical devices in the cases specified in Clauses 1, 2, and 3 of Article 3 of this Circular on prescriptions or medical records for patients to independently purchase;

c) Organize communication, guidance, and counseling on patients' health insurance entitlements and coverage; inform patients specifically about the unavailability of drugs and medical devices and relevant provisions of this Circular to enable informed decision-making.

5. Medical practitioners must strictly comply with the provisions in Points b and c, Clause 4 of this Article and ensure there is no abuse or exploitation in prescribing or instructing patients to independently purchase drugs and medical devices.

6. Patients or their legal representatives are responsible for ensuring the legality and completeness of the documentation submitted for direct reimbursement requests.

Article 7. Reference provisions

In cases where the documents referenced in this Circular are replaced or amended, the replaced or amended documents shall apply.

Article 8. Entry into force

1. This Circular comes into force as of January 1, 2025.

2. In cases where a patient is admitted to a medical facility for examination and treatment before the effective date of this Circular but completes treatment after its effective date, the provisions of this Circular shall apply.

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

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