Circular No. 05/2015/TT-BYT Issuing the List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines, and Traditional Medical Herbs within the Scope of Payment by Health Insurance Fund

CIRCULAR

Issuing the List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines, and Traditional Medical Herbs thuộc phạm vi thanh toán của quỹ bảo hiểm y tế

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Based on the Health Insurance Law;

Pursuant to the Drug Law;

Pursuant to Decree No. 105/2014/NĐ-CP dated November 15, 2014 of the Government detailing and guiding the implementation of certain provisions of the Health Insurance Law;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

The Minister of Health issues this Circular on the List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines, and Traditional Medical Herbs within the scope of payment by the health insurance fund.

Article 1. List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines, and Traditional Medical Herbs

1. Issuing the List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines, and Traditional Medical Herbs within the scope of payment by the health insurance fund, including:

a) List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines;

b) List of Traditional Medical Herbs.

2. The List of Traditional Eastern Medicine Drugs, Drugs from Herbal Medicines (hereinafter referred to collectively as the Drug List) and the List of Traditional Medical Herbs (hereinafter referred to collectively as the Herb List) issued together with this Circular serve as the basis for the health insurance fund to pay for drug and herb costs used for patients with health insurance cards at medical facilities that provide health insurance services.

Article 2. Structure of the Drug and Herb Lists

1. The Drug List is organized into 11 groups according to traditional medical theory and has 5 columns as follows:

a) Column 1 records the serial number of the drug in the List;

b) Column 2 records the serial number of the drug within each group;

c) Column 3 records the full name of the drug components according to herbal medicine names; components separated by a slash "/" can be substituted for each other; components enclosed in parentheses "()" may be added or reduced;

d) Column 4 records the route of administration, standardized as follows: Oral route includes swallowing, sucking, chewing, sublingual placement; external route includes topical application, external massage, skin patch, spray, inhalation, soaking, fumigation.

đ) Column 5 records some notes needed to be observed within the scope of indications and the medical facilities authorized to use the drugs.

2. The Herb List includes 349 herbs derived from plants, animals, and minerals arranged into 30 groups according to traditional medical theory and has 6 columns as follows:

a) Column 1 records the serial number of the herb in the List;

b) Column 2 records the serial number of the herb in each group;

c) Column 3 records the name of the herb;

d) Column 4 records the origin of the herb: code "B" indicates herbs cultivated and harvested from abroad; code "N" indicates herbs cultivated, grown, or harvested domestically;

đ) Column 5 records the scientific name of the herb;

e) Column 6 records the scientific name of the plant, animal, or mineral used as a herb.

Article 3. Guidelines for Using the Drug and Herb Lists

1. For the Drug List:

a) Drugs listed in the list must be used in medical facilities in accordance with prescription regulations and consistent with the professional capabilities of the medical facility;

b) Drugs covered by the health insurance fund when their components and routes of administration are recorded in the List, including drugs with substitutable components and drugs with components that can be increased or decreased;

Example:

(1) Drug with serial number 3 in Column 1 of the Drug List has components including: Sái Hồ, Tiền Hồ, Xuyên Khương, Chỉ Xác, Khương Hoạt, Độc Hoạt, Phục Linh/Bạch Linh, Cát Cánh, Nhân Sâm/Đảng Sâm, Cam Thảo. The health insurance fund will cover drugs with the following components:

+ Sái Hồ, Tiền Hồ, Xuyên Khương, Chỉ Xác, Khương Hoạt, Độc Hoạt, Phục Linh, Cát Cánh, Nhân Sâm, Cam Thảo;

+ Sái Hồ, Tiền Hồ, Xuyên Khương, Chỉ Xác, Khương Hoạt, Độc Hoạt, Phục Linh, Cát Cánh, Đảng Sâm, Cam Thảo;

+ Sái Hồ, Tiền Hồ, Xuyên Khương, Chỉ Xác, Khương Hoạt, Độc Hoạt, Bạch Linh, Cát Cánh, Nhân Sâm, Cam Thảo;

+ Sái Hồ, Tiền Hồ, Xuyên Khương, Chỉ Xác, Khương Hoạt, Độc Hoạt, Bạch Linh, Cát Cánh, Đảng Sâm, Cam Thảo.

(2) Drug with serial number 45 in Column 1 of the Drug List has components including: Nhân Trần, Trạch Tả, Đại Hoàng, Sinh Địa, Đương Qui, Mạch Môn, Long Đởm, Chi Tử, Hoàng Cầm, (Cam Thảo), (Mộc Thông). The health insurance fund will cover drugs with the following components:

+ Nhân Trần, Trạch Tả, Đại Hoàng, Sinh Địa, Đương Qui, Mạch Môn, Long Đởm, Chi Tử, Hoàng Cầm;

+ Nhân Trần, Trạch Tả, Đại Hoàng, Sinh Địa, Đương Qui, Mạch Môn, Long Đởm, Chi Tử, Hoàng Cầm, Cam Thảo;

+ Nhân Trần, Trạch Tả, Đại Hoàng, Sinh Địa, Đương Qui, Mạch Môn, Long Đởm, Chi Tử, Hoàng Cầm, Mộc Thông;

+ Nhân Trần, Trạch Tả, Đại Hoàng, Sinh Địa, Đương Qui, Mạch Môn, Long Đởm, Chi Tử, Hoàng Cầm, Cam Thảo, Mộc Thông.

(3) Drug with serial number 108 in Column 1 of the Drug List has components including: Nhân Sâm/Đảng Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, (Sinh Khương), (Đại Táo). The health insurance fund will cover drugs with the following components:

+ Nhân Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo;

+ Nhân Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, Sinh Khương;

+ Nhân Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, Đại Táo;

+ Nhân Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, Sinh Khương, Đại Táo;

+ Đảng Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo;

+ Đảng Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, Sinh Khương;

+ Đảng Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, Đại Táo;

+ Đảng Sâm, Hoàng Kỳ, Đương Quy, Bạch Truật, Thăng Ma, Sái Hồ, Trần Bì, Cam Thảo, Sinh Khương, Đại Táo.

c) Drugs are specifically recorded by herbal medicine names. These drugs are covered by the health insurance fund if they have components listed in the Drug List, including different forms of extraction and preparation of herbal medicines;

d) Drugs classified in this group used to treat diseases in another group are covered by the health insurance fund if the drug has indications as registered in the drug registration dossier approved by the Ministry of Health.

2. For the Herb List:

a) Herbs listed in the list must be used in medical facilities in accordance with prescription regulations, consistent with the professional capabilities and prescription authority of traditional medical doctors, traditional medical assistants, or licensed traditional medical practitioners working at medical facilities;

b) Herbs marked with the letter "B" in column 4 of the list shall be covered by the health insurance fund for herbs of domestic or foreign origin from breeding, cultivation, or extraction.

c) Foreign-origin Ganoderma lucidum, Ginseng, and Notoginseng prescribed individually or in formulas containing only two or three of these herbs must be reviewed before being prescribed. The review process shall follow the regulations on consultations issued by the Ministry of Health.

Article 4. Construction of the List of Medicines and Herbs Used at Medical Examination and Treatment Facilities and Self-prepared Medicines by Such Facilities within the Scope of Health Insurance Fund Reimbursement

1. Medical examination and treatment facilities shall base their construction of the List of Medicines and Herbs used at such facilities and self-prepared medicines (if any) on the List of Medicines and List of Herbs issued together with this Circular, the disease profile, and the scope of professional activities to meet treatment needs and serve as the basis for reimbursement by the health insurance fund according to the provisions of the law on public bidding.

2. The selection of medicines and herbs from the Lists of Medicines and Herbs issued together with this Circular shall be carried out based on the principle of prioritizing domestically produced medicines; medicines from pharmaceutical enterprises meeting Good Manufacturing Practice (GMP) standards; herbs of domestic origin from breeding, cultivation, or extraction; and medicines and herbs that are effective and cost-effective.

3. Based on specific medicines and herbs purchased, medical examination and treatment facilities shall compile the List of Medicines and Herbs used at such facilities and self-prepared medicines to send to social insurance organizations for reimbursement purposes.

Article 5. Reimbursement of Medicine and Herb Costs Used at Medical Examination and Treatment Facilities and Self-prepared Medicines by Such Facilities

1. General Principle: The health insurance fund shall reimburse medicine and herb costs, including self-prepared medicines by medical examination and treatment facilities, based on the actual quantity used for patients and the purchase price of the facility in accordance with the provisions of the law on public bidding, consistent with the scope of benefits and entitlement levels stipulated by the Health Insurance Law and related implementing documents.

2. For herbs: The health insurance fund shall reimburse the cost based on the price of medicinal materials and herbs purchased by medical examination and treatment facilities in accordance with the law on public bidding, plus allowable losses as specified by the Ministry of Health (if applicable).

3. For decoctions composed of herbs listed in the List of Herbs issued together with this Circular: The health insurance fund shall cover costs including herb costs under the principle set forth in Clause 2 of this Article, packaging costs, and decoction costs including electricity, water, and fuel. Medical examination and treatment facilities shall be reimbursed for packaging and decoction costs when they perform decoction at the facility.

4. For self-prepared medicines by medical examination and treatment facilities:

a) The herbs in the composition of the medicine must be included in the List of Traditional Medicine Herbs issued together with this Circular.

b) The health insurance fund shall reimburse based on the production cost, which includes: raw material costs for making the medicine, allowable losses as specified by the Ministry of Health, packaging costs, compounding costs including electricity, water, and fuel, and other costs including excipients, auxiliary materials for making the medicine, and testing costs (for packaging, raw and auxiliary materials, semi-finished products, and finished products).

c) The head of the medical examination and treatment facility shall be responsible for approving the production process, quality standards, and prices of self-prepared medicines, and coordinating with social insurance organizations to establish the basis for reimbursement.

5. For herbs, decoctions, and self-prepared medicines: In cases where additional costs arise outside the provisions of Clauses 2, 3, and 4 of this Article, the medical examination and treatment facility shall prepare a detailed explanation to coordinate with the social insurance organization for reimbursement purposes. If the medical examination and treatment facility cannot reach an agreement with the social insurance organization, facilities subordinate to the Ministry or Sector shall report to the Ministry of Health, and those subordinate to the Department of Health shall report to the Department of Health for consideration and resolution.

6. The health insurance fund shall not reimburse for medicines and herbs already paid for by the state budget.

Article 6. Implementation Organization

1. The Ministry of Health shall be responsible for:

a) Direct, guide, inspect, and audit the construction of the lists of medicines and herbs, procurement through public bidding, management, use, and reimbursement of medicine costs by medical examination and treatment facilities;

b) Take the lead and cooperate with relevant agencies to resolve issues arising during implementation;

c) Take the lead and cooperate with relevant agencies to update, adjust, amend, and supplement the lists of medicines and herbs issued together with this Circular to meet treatment needs and be consistent with the health insurance fund's payment capacity.

2. Vietnam Social Security shall be responsible for:

a) Implement and direct provincial social insurance organizations to cooperate with the Department of Health and medical examination and treatment facilities in organizing implementation and reimbursement of medicine costs in accordance with this Circular and other related legal regulations.

b) Coordinating with related agencies to resolve issues arising during implementation.

3. Provincial Departments of Health have the responsibility to:

a) Direct and guide medical examination and treatment facilities within their jurisdiction to construct the Lists of Medicines and Herbs and self-prepared medicines; procure medicines through public bidding; and reimburse costs for medicines used by medical examination and treatment facilities under their management.

b) Inspect, audit, and promptly address violations and issues in public bidding, supply, prescription, and use of medicines for patient treatment.

4. Healthcare facilities shall be responsible for:

a) Construct the List of Medicines and Herbs used at the unit and self-prepared medicines by medical examination and treatment facilities, and submit them to social insurance organizations for reimbursement purposes according to the model attached as Appendix 1 to this Circular. In case of changes or additions to the list, medical examination and treatment facilities shall be responsible for supplementation in accordance with Clause 3 of Article 4.

b) Implement management, supply, and use of medicines in accordance with current regulations, ensuring adequate and timely supply of medicines as prescribed, meeting the treatment needs of insured patients according to the established list, without requiring patients to purchase their own medicines. The procurement of medicines shall be carried out in accordance with the legal provisions on tendering;

c) Comply with the prescription and use of medicines in accordance with the relevant regulations, ensuring safety, rationality, effectiveness, economy, and the quality of medicines and herbal medicines used at the facility; conduct consultations when using the herbal medicines specified in Point c Clause 2 Article 3;

d) In cases where it is necessary to propose amendments, removals, or additions of new medicines or herbal medicines to the list of medicines covered by the health insurance fund, healthcare facilities shall submit written requests in the format provided in Appendix 2 and Appendix 3 accompanying this Circular to the Ministry of Health or the Health Departments of provinces and centrally-administered cities for consolidation and submission to the Ministry of Health;

5. Provincial Social Insurance Departments have the responsibility:

a) To coordinate with healthcare facilities in the development of the list of medicines, herbal medicines, and self-manufactured medicines by healthcare facilities that are eligible for reimbursement by the health insurance fund;

b) To coordinate and unify with healthcare facilities in implementing the reimbursement of the contents stipulated in Article 5 of this Circular;

Article 7. Transitional Provisions and Cross-References

1. In cases where insured patients enter hospitals before this Circular takes effect but are still undergoing treatment at healthcare facilities from May 1, 2015, they shall continue to be governed by the provisions of Circular No. 12/2010/TT-BYT dated April 29, 2010, of the Ministry of Health until the patient is discharged;

2. For medicines and herbal medicines within the scope of reimbursement by the health insurance fund as stipulated in Circular No. 12/2010/TT-BYT dated April 29, 2010, the health insurance fund will continue to reimburse them until the contracted quantity of medicines won through the tender process for medicine supply and signed by the healthcare facility with the supplier before the effective date of this Circular is exhausted;

3. For medicines within the scope of reimbursement by the health insurance fund as stipulated in Circular No. 12/2010/TT-BYT dated April 29, 2010, but with restricted indications as specified in this Circular, the health insurance fund will reimburse them according to the conditions set forth in this Circular starting from May 1, 2015, except for the cases specified in Clause 1 of this Article;

4. For herbal medicines, decoctions used at healthcare facilities, and self-manufactured medicines by healthcare facilities, the health insurance fund will reimburse them according to the provisions of Article 5 of this Circular from the date this Circular takes effect;

Article 8. Effective Date

1. This Circular takes effect from May 1, 2015;

2. Circular No. 12/2010/TT-BYT dated April 29, 2010, issued by the Minister of Health, listing main traditional medicines used at healthcare facilities, shall cease to be effective from the date this Circular takes effect. During the implementation process, if there are difficulties or obstacles, units are requested to report to the Ministry of Health (Health Insurance Department) for consideration and resolution.

During the implementation process, if there are difficulties or obstacles, units are requested to report to the Ministry of Health (Health Insurance Department) for consideration and resolution./.