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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 40/2014/TT-BYT
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Hanoi, November 17, 2014
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CIRCULAR
PROMULGATION
AND GUIDELINES FOR LIST OF MODERN MEDICINES COVERED BY HEALTH INSURANCE
Pursuant to the Law on Health insurance No. 25/2008/QH12
dated November 14, 2008 and the Law No. 46/2014/QH13 dated June 13, 2014 on
amendments to the Law on Health insurance;
Pursuant to the Government's Decree
No. 63/2012/NĐ-CP dated August 31, 2012 defining the functions, tasks, powers
and organizational structure of the Ministry of Health;
Pursuant to the Government's Decree No. 105/2014/NĐ-CP
dated November 15, 2014 on guidelines for the Law on Health insurance;
The Minister of Health promulgates a Circular on
promulgation and guidelines for List of modern medicines covered by health
insurance.
Article 1. List of modern medicines
1. A List of modern medicines covered by health insurance
is promulgated together with this Circular, which consists of: 845 active
ingredients, 1064 modern medicines; 57 radiopharmaceuticals and tracers.
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Article 2. Structure of the List of modern
medicines and classes of hospitals
1. List of modern medicines
a) The medicines or active ingredients are divided into 27
large groups according to ATC (anatomical, therapeutic, chemical)
classification system Some medicines or active ingredients having more than one
ATC codes or indications shall be put into the most suitable group to avoid
repetition;
b) Names of medicines and active ingredients shall be
international nonproprietary names and the names in National Pharmacopoeia
Vietnam’s; only administration routes and dosage forms shall be written;
content shall be omitted.
2. Administration routes of medicines on the List shall be
written as follows:
a) Orally administered medicines include: tablets to
swallow, chew, lozenges, sublingual tablets;
b) Injection includes intramuscular injection, subcutaneous
injection, intradermal injection, intravenous injection, intravenous infusion,
intra-articular injection, intravitreal injection, intraperitoneal injection;
c) Topically administered medicines include topical cream,
transdermal patches, transdermal spray;
d) Suppositories include vaginal suppositories, rectal
suppositories, and enema;
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e) Ocular medications include eye drops and eye ointment
3. Each class of hospitals is permitted to use certain
medicines and active ingredients on the list of modern medicines as follows:
a) Special-class and Class I hospitals shall use medicines
in column 5;
b) Class II
hospitals shall use medicines in column 6;
c) Class
III and Class IV hospitals, including general clinics of general hospitals or
medical centers of districts/provincial cities shall use medicines in column 7;
d) Medical
stations of communes, wards and towns and equivalent administrative divisions shall
use medicines in column 8;
dd) Any
unclassified medical facility that signs contracts for medical services covered
by health insurance: Depending on the professional capability, medical
equipment, and the list of medical techniques approved by a competent
authority, the Service of Health shall take charge and cooperate with a social
insurance organization in deciding the medicines may be used by such medical
facility similarly to state-owned medical facilities.
4. The names of radiopharmaceuticals
and tracers shall be international nonproprietary names. Radiopharmaceuticals
and tracers may only be used at nuclear medicine facilities, oncology
hospitals, oncology facilities, nuclear medicine wards, oncology or
radiotherapy wards of general hospitals or specialized hospitals.
Article 3. Compilation of the List of modern
medicines covered by health insurance used as medical facilities
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2. The purchase and use of the
following medicines shall be preferred: generic medicines, single-substance
medicines, locally manufactured medicines
Article 4. Rules for covering medicine costs
incurred by patients having health insurance cards
1. Health
insurance fund shall pay for medicine costs according to the use quantity and
buying prices of the medical facility in accordance with regulations of law on
medicines bidding in order to ensure the benefits of patients prescribed by the
Law on Health insurance, the Law on amendments to the Law on Health insurance
and their guiding documents.
2. Medicine
costs shall not be covered by health insurance fund in the following cases:
a) Medicine
costs are included in prices for medical techniques or daily inpatient charge
(e.g. general anesthetics, local anesthetics, intravenous fluids used during
operations, medical procedures, or radiocontrast media used for medical
imaging; disinfectants and antiseptics), or all-inclusive charge for a patient
according to applicable regulations;
b) The medicines are on the list of medicines covered by government
budget;
c) The medicines are on the list of medicines used for clinical testing
or scientific research;
d) A competent authority has issued a
decision on recall of the batch of medicines;
dd) Medicines are not used in
accordance with indications in the application for medicine registration which
is granted.
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1. Isomers or other salts of the
active ingredients shall be covered by health insurance if their therapeutic
effects are the same with the chemical forms or medicines on the list.
2. Medicines in one group used for treatment of diseases in
another group shall be covered by health insurance if their indications are
consistent with those in the application for medicine registration which is
granted.
3. Some medicines of which payment conditions and insurance
coverage ratio are specified in column 9 of the list of modern medicines
according to the rules in Clause 1 Article 4 of this Circular.
4. Any medicine that contains multiple active ingredients
(hereinafter referred to as combined medicines) that are not enumerated on the
list shall be covered by health insurance if it exist in the element form
(except for vitamins and minerals) and has the same administration route as
prescribed in Clause 2 Article 2 of this Circular. Combined medicines
chosen must ensure safety, effectiveness, and suit the capacity of health
insurance fund.
If a medicine contains multiple active
ingredients sorted into different classes of hospital, they shall be paid for
according to the highest class. If a medicine contains multiple active
ingredients with different insurance coverage ratios, the lowest coverage ratio
shall apply.
5. If the patient only uses the amount of medicine in the
smallest package unit according to indications (e.g. pediatrics or oncology
medicines) and the residual amount cannot be used (e.g. there are not patients
with the same indications, the residual amount is not sufficient to make a
dose, the medicine is expired), the price of the smallest package unit shall be
covered by health insurance.
6. Any medicine marked with an asterisk (*) shall only be
used when other medicines in the group are not effective and a medical
consultation must be held before use. If such medicine is used for emergency
treatment, the medical consultation must be held within the next working day on
the latest.
7. Antineoplastic medicines:
a) Antineoplastic medicines may only be used for cancer
treatment at medical facilities licensed to treat cancer (including oncology
facilities, blood transfusion facilities, and nuclear medicine facilities;
oncology wards, hematology and blood fusion wards, and nuclear medicine wards
of general hospitals or specialized hospitals) and must be prescribed by
licensed physicians specialized in oncology or hematology;
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Such medicines shall be covered by
health insurance according to the guidance on diagnosis and treatment of the
Ministry of Health or the hospital. If guidance on diagnosis and treatment is
not available, a medical consultation with physicians specialized in oncology
must be held. If guidance on diagnosis and treatment and physicians specialized
in oncology are not available, a medical consultation chaired by the head of
the hospital must be held before use (except for the medicines exempt from
medical consultation with oncology ward in column 9).
8. If the medical facility provides medical techniques of
superior hospitals, it may use the medicines on the list of medicines for the
superior hospital which suit the medical techniques approved by a competent
authority. Each medical facility shall compile and send a list of to the health
insurance authority as the basis for payment.
9. Any medicines prepared by the medical facility itself
shall be covered by health insurance if they are used at that same medical
facility. The medicine prices shall be determined according to the product
prices decided by the Director of the hospital after reaching an agreement with
the social insurance authority. The Director of the hospital shall bear the
legal responsibility for such prices.
Article 6. Implementation
1. The
Ministry of Health has responsibilities to:
a) Provide
instructions and carry out inspection of medicine list compilation, bidding for
medicines supply, management, use of medicines, payment for medicines by
medical facilities;
b) Take
charge and cooperate with relevant agencies in resolving difficulties during
the implementation;
c) Take
charge and cooperate with relevant agencies in updating, adjusting the list of
medicines promulgated together with this Circular every 02 years to meet
treatment demands and suit the capacity of health insurance fund.
2. Social
Insurance Office has the responsibilities to:
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b)
Cooperate with relevant agencies in resolving difficulties during the
implementation.
3. Services
of Health have responsibilities to:
a) Compile
lists of medicines, provide instructions and carry out inspection of medicine
list compilation, bidding for medicines supply, management, use of medicines,
payment for medicines by medical facilities within the scope of their
competence;
b) Provide
instructions and consider approving the lists of medicines used at local
medical clinics without physicians and medical stations of communes, wards and
towns.
4. Medical
facilities have responsibilities to:
a) Compile
lists of medicines they use, including those used for provision of medical
techniques of superior hospitals and medicines prepared by the medical
facilities themselves;
b) Provide
medicines adequately, promptly, and properly to meet treatment demands of
patients having health insurance according to the list of medicines compiled.
Do not let insured patients buy such medicines at their own expense.
Medical facilities shall send social insurance authorities the results of
medicine bidding; lists of commercial medicines used at medical facilities,
including: medicines to be purchased, medicines for provision of medical
techniques of superior hospitals, and medicines prepared by the medical
facilities themselves. These are the basis for social insurance authorities to
make payments;
c) Manage the prescription of medicines, ensure safety, rationality,
thriftiness; ensure quality of medicines used therein; hold medical
consultations when using medicines marked with an asterisk (*); make payments
in a timely manners with correct categories, quantities, and prices;
dd) Comply
with current regulations on management and use of medicines; comply with
regulations of law on radiation safety an control with regard to management,
supply, use of radiopharmaceuticals and tracer on the list of medicines;
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e) If the
list of medicines that need adjusting, the medical facility shall submit an
application using the form in Appendix 02 hereof to the Ministry of Health
(Health Insurance Administration) or the Service of Health.
Article 7. Transition and terms of reference
1. If an
insured patient is admitted before the effective date of this Circular but
still undergoing treatment at the medical facility, regulations of Circular No.
31/2011/TT-BYT dated July 11, 2011 and Circular No. 10/2012/TT-BYT dated June
08, 2012 shall apply until the patient discharged.
2. If any
medicines on the list promulgated together with Circular No. 31/2011/TT-BYT
dated July 11, 2011 and Circular No. 10/2012/TT-BYT dated June 08, 2012 are not
on the list of medicines covered by health insurance promulgated together with
this Circular, they shall be paid for by health insurance until the medicines
supplied by the successful bidder are used up according to the medicine bidding
result and the contract between the medical facility and the supplier signed
before the effective date of this Circular.
3. With
regard to any medicines on the list promulgated together with Circular No.
31/2011/TT-BYT dated July 11, 2011, the payment conditions and coverage ratios
of which are specified in this Circular, health insurance fund shall make
payments according to the payment conditions and coverage ratios prescribed in
this Circular from January 01, 2015, except for the case in Clause 1 of this
Article).
Article 8. Effect
1. This Circular takes effect on January 01, 2015.
2. Circular No. 31/2011/TT-BYT dated July 11, 2011 on
promulgation of the List of essential medicines at medical facilities covered
by health insurance and Circular No. 10/2012/TT-BYT dated June 08, 2012 on
amendments to Circular No. 31/2011/TT-BYT are annulled from the effective dated
of this Circular.
All units are recommended to report the difficulties that
arise during the implementation of this Circular to the Ministry of Health for
consideration./.
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PP MINISTER
DEPUTY MINISTER
Nguyen Thi Xuyen