Thông tư 20/2022/TT-BYT của Bộ Y tế về việc ban hành Danh mục và tỷ lệ, điều kiện thanh toán đối với thuốc hóa dược, sinh phẩm, thuốc phóng xạ và chất đánh dấu thuộc phạm vi được hưởng của người tham gia bảo hiểm y tế

CIRCULAR

INTRODUCING NOMENCLATURES AND PAYMENT RATES, CONDITIONS OF CHEMICAL MEDICATIONS, BIOLOGICALS, RADIOPHARMACEUTICALS AND TRACERS UNDER HEALTH INSURANCE POLICYHOLDERS’ RECEIVED COVERAGE

Pursuant to the Law on Health Insurance No. 25/2008/QH12 dated November 14, 2008 that is amended and supplemented by the Law No. 46/2014/QH13 dated June 13, 2014;

Pursuant to the Government's Decree No. 146/2018/ND-CP dated October 17, 2018, elaborating and providing guidance on the implementation of a number of articles of the Law on Health Insurance;

Pursuant to the Government's Decree No. 95/2022/ND-CP dated June 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Upon the request of the Director of the Department of Health Insurance under the Ministry of Health,

The Minister of Health herein promulgates the Circular to introduce nomenclatures and payment rates, conditions of chemical medications, biologicals, radiopharmaceuticals and tracers under health insurance policyholders’ received coverage.

Article 1. Nomenclatures enclosed in this Circular

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2. Nomenclature of radiopharmaceuticals and tracers under health insurance policyholders’ received coverage is given in Appendix II hereto (hereinafter referred to as Appendix II).

Article 2. Structure of Nomenclatures of medications and grading of hospitals providing medications

1. The Nomenclature of chemical medications and biologicals, which are arranged into groups by their medical effects, (Appendix I) is divided into 08 columns as follows:

a) 1^st column: Number of items included in the Nomenclature;

b) 2^nd column: Name of medications. The International Non-proprietary Name (INN) of active pharmaceutical ingredient is used. If INN of a medication is not available, the name of active ingredient obtaining the market authorization or the name specified in the MoH's guidance on diagnosis and treatment may be used instead. All items are arranged according to large groups and ATC (Anatomy, Treatment, Chemistry) codes;

c) 3^rd column: Route of administration, form of administration (method of delivery) of each medication; medication content not specified; dosage forms not specified, except those showing clear difference in medical efficacy or effect. Route of administration or form of administration (method of delivery) of medications included in the Nomenclature of chemical medications and biologicals is understood and accepted as follows:

- Oral administration, including those that are swallowed, chewed or dissolved in mouth;

- Injection administration, including those administered by intramuscular, subcutaneous, intradermal, intravenous, infusion, intravenous, intra-articular, intraocular, intravitreal or intraperitoneal injection;

- Topical administration, including those applied, rubbed, stuck, or sprayed onto the skin; wiping or applied to the mucous membranes;

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- Respiratory administration, including nebulizers, inhalers (formulation of solution, suspension, powder for inhalation), aerosols;

- Ophthalmic administration, those given into the eye by drops, gel or ointment; otic administration, including those given by drops into the ear; nasal administration, including those given into the nose by spray or pump;

- Other routes of administration or forms of administration specified in the Nomenclature, including several medications used in special ways;

d) 4^th, 5^th, 6^thand 7^th column: Grade of the hospital that is authorized to provide listed medications and get paid by the health insurance fund. Below are medications or active ingredients in the Nomenclature (Appendix I) corresponding to the grades of medical establishments that get paid by the health insurance fund:

- 4^th column indicates the special-grade and grade-I hospitals providing the covered medications;

- 5^th column indicates the grade -II hospitals providing the covered medications;

- 6^th column indicates the grade-III and grade-IV hospitals, including general clinics affiliated to general hospitals or medical centers of districts, towns or provincial cities and central cities, general clinics, specialized clinics, or private midwifery facilities that have been professionally classified by competent state agencies as equivalent to grade-III hospitals providing the covered medications;

- 7^th column indicates polyclinics, specialized clinics, private midwifery facilities that have not been professionally classified yet; commune, ward, township health stations, agency health stations, and equivalents (hereinafter collectively referred to as commune health stations) providing the covered medications;

dd) 8^th column: Coverage conditions, rates and notes on several medications.

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a) 1^st column: Number of items included in the Nomenclature;

b) 2^nd column: Name of medications. The International Non-proprietary Name (INN) of medications is used. Where INN is not available, the name of active ingredient obtaining marketing authorization is used;

c) 3^rd column: Route of administration;

d) 4^th column: Dosage form;

dd) 5^th column: Unit of administration.

Radiopharmaceuticals and tracers in the Nomenclature (Appendix II) are not classified according to hospital grades and may only be used at medical establishments permitted by competent authorities to perform medical diagnosis and treatment by application of radiopharmaceuticals and tracers.

Article 3. General principles of coverage of medical costs incurred by patients holding health insurance policies

1. The health insurance fund shall cover costs of the covered medications incurred by patients according to the actual quantity of medications used, except those specified in clause 5 of Article 5 of this Article; the actual procurement prices of these medications defined in law on bidding and the range of health insurance coverage and amounts under law on health insurance.

2. The health insurance fund shall pay for a medication when the prescription for such medication is conformable to the prescription stated in one of the following documents:

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b) The leaflet attached to the dossier of registration of the proprietary medicine or reference biological licensed by the Ministry of Health;

c) The guidelines for diagnosis and treatment adopted by the Ministry of Health;

d) The most updated version of the National Pharmacopoeia of Vietnam.

3. The health insurance fund shall not pay for a medication if:

a) The decision on suspension or recall of the medication or the batch comprising that medication is adopted. Any medication or batch receiving the suspension or recall decision as stated above shall not be covered according to the scope of application of that decision specified in the written notification of or the decision on suspension of marketing authorization or recall of that medication or batch issued by the Ministry of Health;

b) The cost of that medication has been included in the price of technical, medical examination and medical bed service or the lump-sum price per a patient case in accordance with regulations in force;

c) The portion of the cost of that medication is paid by the state budget or other sources of fund;

d) That medication is used in clinical tests or scientific researches.

Article 4. Regulations on payment of reimbursement to several medical establishments

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1. For any public medical establishment signing a contract to provide medical services covered by health insurance, but not graded yet: Based on its human resources, medical equipment, facilities and the list of technical services approved by the competent authority, the Department of Health shall preside over, and cooperate with the provincial Social Insurance in, determining in writing the use of medications by that medical establishment according to its corresponding hospital grade.

2. For any public medical establishment under a People’s armed force that signs a contract to provide the medical services covered by the health insurance fund, but not graded yet: Based on its human resources, medical equipment, facilities and the list of technical services approved by the competent authority, the body directly managing that medical establishment shall preside over, and cooperate with the provincial Department of Health and the social insurance agency which enters into the contract to provide the medical services covered by the health insurance fund in, determining in writing the nomenclature of covered medications provided by that medical establishment according to its corresponding hospital grade.

3. Where any medical establishment renders the technical service approved by the competent authority, it may use covered medications to carry out that technical service (including the covered medications to be provided by any higher-grade hospital). That medical establishment shall compile the list of those medications and submit it to the social insurance agency entering into the contract to provide medical services covered by health insurance with it for use as a proof of payment.

4. With regard to any provincial specialized medical establishment providing medications, not including technical services, based on its human resources, medical equipment, facilities and patient’s needs, and medical treatment and diagnosis and treatment guidelines of the Ministry of Health, the Department of Health shall preside over, and cooperate with the provincial Social Insurance in, determining in writing the list of medications to be provided by a higher-grade medical establishment that it can provide and get paid by the health insurance fund (including those susceptible to conditions regarding grades and specialties of medical establishments in the 8^th column of the Nomenclature of medications specified in Appendix I), on condition that the grade of such higher-grade medical establishment is not higher than the grade of the highest-grade provincial general hospital located in the local area in question.

Article 5. Regulations on payment of reimbursement for covered costs of several medications

The health insurance fund shall cover costs of medications incurred by patients holding health insurance policies when such coverage conforms to Article 3 and 4 of this Circular, and certain regulations in the situations as specified below:

1. Costs of other chemical isomers or other salt forms of active ingredients (even including single components and multi-component combinations, except vitamins and minerals) included in the Nomenclature of medications (Appendix I) shall be covered if they have the same indications as chemical forms or drugs listed in that Nomenclature.

2. With respect to a medication classified into a group of medications that is used for curing the disease cured by another group of medications, such medication shall be covered if the prescription for such medication is conformable to that specified in clause 2 of Article 3 herein.

3. Several medications that patients use are susceptible to regulations on insurance coverage conditions and rates as defined in 8^th column of the Nomenclature of medications (Appendix I).

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5. If some medications in liquid or compressed form (such as pharmaceutical oxygen, nitric oxide) are not packaged separately for use by each individual patient, the health insurance fund shall pay for the amount of medication used according to the actual length of time of breathing of such oxygen per patient multiplied (x) the amount of oxygen breathed per a unit of time (minute or hour).

6. For tracers and radiopharmaceuticals:

a) For tracers: Based on technical services and the number of patients who are directly offered such technical services, the medical establishment providing such services shall calculate the average number of kits or vials used rendering the corresponding technical service. The health insurance fund shall cover costs of the tracer used at the predetermined price multiplied (x) the actual quota of the tracer on average;

b) For radiopharmaceuticals: Based on the rate of radioactive decay, the supply of radiopharmaceuticals, the cycle of import of radiopharmaceuticals and the actual number of patients using radiopharmaceuticals, the medical establishment shall determine the actual rate of radiopharmaceuticals used on average. The health insurance fund shall cover costs of the radiopharmaceutical used at the predetermined price multiplied (x) the actual rate of the pharmaceutical used on average;

c) The statistics and calculation of costs of technical services rendered by using radiopharmaceutical and tracers shall be as defined in Appendix III to this Circular.

7. Medications marked with an asterisk (*) are drugs that may be used after medical consultation, except in case of emergencies. For antibiotics marked with an asterisk (*), the health insurance fund shall pay when the pre-prescription consultation process is carried out as defined in the Instructions of management of antibiotic uses in hospitals given by the Ministry of Health.

8. For cancer drugs and immunosuppressives:

a) They must be used to treat cancer according to prescriptions by doctors who are licensed to practice medical examination and treatment, and have their scope of practice including oncology or nuclear medicine or blood transfusion hematology, and used at medical establishments providing cancer treatment services, except for the case specified at point b of this clause, including:

- Oncology, hematology, blood transfusion, nuclear medicine facilities;

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- Various types of organization tasked with cancer treatment that are specified their operational regulations or the charters approved or recognized by competent authorities.

b) For medications used for treatment of the diseases other than cancer: The health insurance fund shall pay upon receipt of the guidance on diagnosis and treatment from the Ministry of Health or a medical establishment. Where such guidance is not available, the medical consultation with oncology doctors shall be required. If both such guidance and oncology doctors are not available, the medical consultation under the control of the medical establishment shall be needed before the prescription is used.

9. For medications prepared or formulated (including pharmaceutical oxygen and nitric oxide) at a medical establishment:

a) The health insurance fund shall pay when:

- These medications contain ingredients specified in the Nomenclature of medications enclosed herewith. If such medication is made from various active ingredients, each active ingredient of such finished medication must be included in the Nomenclature of medications appended to this Circular in the form of an element or a compound. If such medication is made from various active ingredients, any of which is not included in the Nomenclature of medications appended to this Circular, the instructions given in point d of this clause shall be followed;

- The routes of administration, dosage forms of, or grades of hospitals permitted to provide, these medications must be conformable to those defined in the Nomenclature of medications appended hereto;

- These medications are only used at that medical establishment.

b) Based on the needs for use of a medication, a medical establishment shall take the following actions:

- If that medical establishment is directly under the Ministry of Health, its head shall be responsible for developing the procedures for preparation or formulation of such medication, quality standards, prices or costs of that medication; seeking an agreement with a social insurance agency on the price or cost of the medication in question as a basis for the health insurance fund's coverage or reimbursement;

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- For a medical establishment directly under a Department of Health, and a private medical establishment, regulations regarding prices shall be obeyed.

c) The price and cost of such medication shall be developed according to:

- Costs of each active ingredient of such medication which are based on the price at which the medical establishment purchases that medication.

- Wastage costs (if any);

- Excipient and auxiliary material costs;

- Disinfection and sterilization costs (if any);

- Preparation or formulation costs, including electricity, water, and fuels;

- Costs of packaging or consumables;

- Costs of materials, supplies, chemicals and auxiliary materials for quality inspection before testing;

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- Participating personnel costs;

- Administrative costs and depreciation costs of machinery: The health insurance fund shall pay the administrative and depreciation costs of machinery according to the roadmap for adjusting the elements constituting the prices of the covered medical services at the same time same-grade hospitals nationwide apply the prices of the covered medical services adopted by the Minister of Health;

d) d) If a medication which is prepared or formulated is made from various active ingredients, any of which is not included in the Nomenclature of medications appended to this Circular, the health insurance fund shall pay in accordance with point a, b and c of this clause, except costs of the active ingredient that is not specified in the Nomenclature of medications appended hereto;

dd) The health insurance fund shall not pay for prepared or formulated medications when there are commercial drugs available on the market that have the same ingredients, content and dosage forms as the prepared or formulated medications, and when the prices of the prepared or formulated medications are lower than the prices or costs thereof at a medical establishment.

10. For medications used in remote consultations

a) The health insurance fund shall pay coverage to the patients who are given emergency care at medical establishments and administer medications according to medical guidance or prescription offered in remote consultations with other medical establishments;

b) The health insurance fund shall pay without depending on the hospital's grade as defined in this Circular (including medications susceptible to regulations on conditions relating to grades and specialties of medical establishments at 8^th column of the Nomenclature of medications (Appendix I)) when the following requirements are satisfied:

- A medical consultation is carried out according to the task of command over the medical establishment network, or the technology transfer contract;

- Medications provided by medical establishments for patients are purchased as per law on bidding;

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11. If a patient cannot go to the medical establishment due to a group-A infectious disease that breaks out, the health insurance fund shall pay as follows:

a) If the patient cannot come to a medical establishment that has issued the appointment form to him/her to receive medical services and medications, the medical establishment or the patient may choose one or more of the following ways:

- The medical establishment issuing the appointment for medical examination delivers medications the other medication establishment where the patient can come to continue the medical treatment and provide medications for him/her. The health insurance fund shall repay the cost of a medication used for treating a patient to the medical establishment receiving that medication at the purchase price quoted by the medical establishment transferring it according to the extent of health insurance benefits and the rate of health insurance benefits enjoyed;

- The patient may authorize his/her representative to act on his/her behalf to receive a medication at the medical establishment issuing the appointment form for re-visit or at another medical establishment receiving the medication from the former.

Such authorization must be granted in writing, which must clearly provide information about the patient's name, date of birth, identity card number or citizen identification number or passport number of the patient and the person authorized to receive the medication. When receiving drugs, the person authorized to receive the medication must present documents showing information consistent with the information given in the authorization document.

Medical establishments shall be responsible for ensuring the information written in the authorization document is consistent with the information shown in the papers presented by the authorized person to receive medications at medical establishments;

- For patients suffering from tuberculosis, latent TB, drug-resistant tuberculosis or patients suffering from HIV/AIDS, and medications used to treat non-communicable diseases, the medical establishment issuing the appointment form for re-visit shall appoint a person or hire a third-party carrier to transport the medication to the patient for continued treatment and drug use.

b) With regard to a patient who is being treated as an inpatient prescribed for referral, if he/she cannot be referred due to the epidemic situation, the health insurance fund shall pay the costs of medications used for his/her treatment which are purchased by the medical establishment in accordance with law on bidding, regardless of the hospital's grade prescribed in this Circular, including the medications susceptible to conditions on grades and specialties of medical establishments specified in the 8^th column of the Nomenclature of medications (Appendix I).

Article 6. Implementation

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2. The Social Insurance of Vietnam shall assume the following responsibilities:

a) Direct, guide and inspect the implementation of this Circular by social insurance agencies in provinces and centrally-affiliated cities;

b) Direct social insurance agencies of provinces and centrally-affiliated cities to reach agreement with medical establishments on the prices or costs of medications prepared or formulated at medical establishments as a basis for payment of covered medical costs.

3. Departments of Health of provinces and centrally-affiliated cities shall be responsible for directing, guiding, disseminating, examining, evaluating, preliminarily and finally reviewing the implementation of this Circular under their authority.

4. Medical establishments shall assume the following responsibilities:

a) Develop Nomenclatures of chemical medications, biologicals, radiopharmaceuticals and tracers used there, including medications prepared or formulated by themselves (if any), and send them to social insurance agencies signing contracts for provision of medical services covered by the health insurance fund, enclosing contractor selection plans, contractor selection results and preparation or formulation procedures, quality standards, prices or costs of medications prepared or formulated by themselves as a basis for payment of medical costs and expenses covered by the health insurance fund;

b) Where there is any change or addition to the Nomenclatures of medications that they provide, they shall send the updated Nomenclatures to the social insurance agencies signing contracts for provision of covered medical services as a basis for payment of health insurance benefits;

c) Where any medical establishment is not capable of continuing to provide technical services and approved medications, they shall have to report to competent authorities and social insurance agencies signing contracts for provision of medical services covered by the health insurance fund to seek their approval of suspension of these technical services, use of these medications and health insurance coverage.

Article 7. Entry in force

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2. The Circular No. 30/2018/TT-BYT dated October 30, 2018 of the Minister of Health, introducing Nomenclatures, rates, conditions of payment of costs of chemical medications, biologicals, radiopharmaceuticals and tracers under health insurance policyholders’ received coverage; the Circular No. 01/2020/TT-BYT dated January 16, 2020 of the Minister of Health, amending and supplementing the Circular No. 30/2018/TT-BYT; the Circular No. 20/2020/TT-BYT dated November 26, 2020 of the Minister of Health, amending and supplementing the Circular No. 30/2018/TT-BYT shall be invalidated as from the entry into force of this Circular.

Article 8. Grandfather clause

1. Where patients holding health insurance cards are hospitalized as inpatients before the effective date of this Circular and have to continue to receive such inpatient treatment at medical establishments after the effective date of this Circular, the regulations laid down herein shall be applied to the entire period of their inpatient treatment.

2. For cancer patients who used doxorubicin administered by injection in liposome dosage form; erlotinib administered orally; gefitinib administered orally; sorafenib administered orally (for treatment of advanced hepatocellular carcinoma) before January 1, 2015 and remain to use them after the effective date of this Circular, they shall be entitled to 100% coverage. For cancer patients who used everolimus administered by injection or orally; L-asparaginase erwinia administered by injection; paclitaxel administered by injection in liposomal and polymeric micelle dosage form before January 1, 2019 and remain to use them after the effective date of this Circular; or sorafenib administered orally (for treatment of advanced renal cell carcinoma) after January 1, 2015 and remain to use them after the effective date of this Circular, they shall continue to be entitled to coverage by the health insurance fund at the rate specified in the Circular No. 40/2014/TT-BYT dated November 17, 2014 of the Minister of Health, introducing and providing instructions on the implementation of the Nomenclatures of modern drugs under the health insurance fund’s coverage. This regulation shall apply in the following cases:

a) A patient uses the aforesaid medications until the end of the treatment course (from the time of clinical diagnosis and start of the treatment to the time of end of treatment);

b) After being treated at a medical establishment, the patient is referred to another medical establishment, and is prescribed by a doctor to use the aforesaid medications within the course of treatment (except as he/she receives treatment provided by the out-of-network medical establishment);

c) With regard to the patient who has been recovered to a fairly stable state and allowed to end the treatment, if his/her health condition recurs, the doctor may prescribe him/her the previous medications to cure such recurring health condition;

d) During the course of treatment, the patient does not make a re-visit at the appointed time or does not take medicines regularly;

dd) The patient suffers side effects during use of erlotinib administered orally, or switches from use of erlotinib administered orally to use of gefitinib administered orally or vice versa as prescribed by the doctor because the medical establishment runs out of the medication in question.

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In case where referenced instruments mentioned in this Circular are replaced, revised or amended, the new or updated instruments shall govern.

In the course of implementation of this Circular, if there is any difficulty that arises, entities concerned should promptly inform the Ministry of Health (Department of Health Insurance) for its review and decision on possible actions./.

PP. MINISTER
DEPUTY MINISTER




Tran Van Thuan