Thông tư 36/2015/TT-BYT sửa đổi Thông tư 40/2014/TT-BYT hướng dẫn thực hiện danh mục thuốc tân dược thuộc phạm vi thanh toán của quỹ bảo hiểm y tế do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

AMENDING A NUMBER OF ARTICLES OF CIRCULAR No. 40/2014/TT-BYT DATED NOVEMBER 17, 2014 PROMULGATING AND GUIDING THE IMPLEMENTATION OF THE LIST OF MODERN MEDICINES COVERED BY HEALTH INSURANCE

Pursuant to the Law on Health insurance;

Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 by the Government defining the functions, tasks, entitlements and organizational structure of the Ministry of Health;

Pursuant to Decree No. 105/2014/ND-CP dated November 15, 2014 by the Government providing guidance on the implementation of a number of articles of the Law on Health insurance;

The Minister of Health hereby promulgates the Circular amending a number of articles of Circular No. 40/2014/TT-BYT dated November 17, 2014 promulgating and guiding the implementation of the list of modern medicines covered by health insurance.

Article 1. Amendments to a number of articles of Circular No. 40/2014/TT-BYT dated November 17, 2014:

1. The List of modern medicines enclosed with Circular No. 40/2014/TT-BYT dated November 17, 2014 is amended as follows:

a) “Anti-human thymocyte immunoglobulin” (No. 340, column 2) is changed to “Anti thymocyte globulin”;

b) “Hydroxycarbamid” (No. 370, column 2) is changed to “Hydroxycarbamid / Hydroxyurea”;

c) “Methoxy polyethylene glycol epoietin beta” (No. 474, column 2) is changed to “Methoxy polyethylene glycol epoetin beta”;

d) “S-bioballthrin + piperonylbutoxid” (No. 605, column 2) is changed to “S-bioallethrin + piperonyl butoxid”;

dd) “Activated attapulgite mormoivon + magnesium carbonate - aluminum hydroxide mixture” (No. 663, column 2) is changed to ““Activated attapulgite mormoiron + magnesium carbonate - aluminum hydroxide mixture”;

e) “Acid thioctic; Meglumin thioctat” (No. 940, column 2) is changed to “Acid thioctic/ Meglumin thioctat”;

g) The note “Health insurance covers the treatment of stroke, posttraumatic treatment and traumatic brain injury surgery and cranial nerve postoperative treatment” (Column 9 of Peptid (Cerebrolysin concentrate), No. 561, column 2; Choline alfoscerat, No. 562, column 2 and Citicolin, No. 563, column 2) is changed to “Health insurance covers the treatment of acute stroke, posttraumatic treatment and traumatic brain injury surgery and cranial nerve postoperative treatment”;

h) The note “Health insurance covers the treatment of hurt caused by arteritis; visual disturbances (diabetic retinopathy); neurosensory disorders caused by ischaemia; Raynaud” (No. 566, Column 9) is changed to "“Health insurance covers the treatment of hurt caused by arteritis; visual disturbances (diabetic retinopathy); otorhinolaryngology (vertigo, tinnitus, hearing loss), neurosensory disorders caused by ischaemia; Raynaud";

i) “The health insurance covers the treatment of blood ammonia increase and brain and liver disease when having clear signs, cancer patients undergoing assigned chemotherapy or have history of viral hepatitis” (No. 747, column 9) is changed to  “The health insurance covers the treatment of blood ammonia increase in brain and liver disease when having clear signs, cancer patients undergoing assigned chemotherapy or have history of viral hepatitis”;

k) The note “Health insurance covers the treatment of immune thrombocytopenic purpura, Guillain Barre syndrome, Kawasaki disease; alternative treatment for patients with IgG deficienc, treatment of hand, foot and mouth diseases according to the guidance of the Ministry of Health, treatment of severe contamination” (No. 821, column 9) is changed to “Health insurance covers the treatment of immune thrombocytopenic purpura, Guillain Barre syndrome, Kawasaki disease; alternative treatment for patients with IgG deficienc, treatment of hand, foot and mouth diseases according to the guidance of the Ministry of Health, treatment of severe infection”;

l) The note “Health insurance covers Ringer acetat; Ringer acetat; Ringerfundin” (No. 1026, column 9) is changed to “Health insurance covers Ringer lactat; Ringer acetat; Ringerfundin”;

m) Regarding the limit of diagnosis and limit of hospitals for Alendronat natri + cholecalciferol (Vitamin D3), oral form (No. 66, column 2): Health insurance covers the treatment of osteomalacia at musculoskeletal department in special-grade or grade I hospitals;

n) Gatifloxacin, in eyedrops form (No. 863, column 2) is removed from the list of modern medicines enclosed with Circular No. 40/2014/TT-BYT dated November 17, 2014.

2. Clause 4 Article 5 is added as follows:

“4.

…

Any medicine that contains multiple active ingredients, one of which is subject to certain conditions or prescriptions for payment, then such medicine shall be paid according to the active ingredient subject to conditions/prescriptions for payment.

Any medicine that contains multiple active ingredients, two or more of which is subject to certain conditions for payment, all the limits of conditions and prescriptions for payment shall be concurrently applied.”

3. Clause 1 and clause 2 Article 7 are amended as follows:

a) Clause 1 Article 7 is added as follows:

“1.

…

If a patient with cancer is treated with Pegylated liposomal Doxorubicin (injectable form); Erlotinib (oral form); Gefitinib (oral form), Sorafenib (oral form) at a medical facility before the Circular No. 40/2014/TT-BYT dated November 17, 2014 comes into effect and is discharged from the hospital after 01/01/2015, 100% charges for  these medicines shall be covered by health insurance according to regulations in Circular No. 31/2011/TT-BYT dated July 11, 2011 in the following cases:

- Such medicines are used during the whole course of therapy (from the time the diagnosis is made to the time the treatment finishes).

- After receiving treatment at a medical facility, the patient moves to another medical facility and such medicines are prescribed  according to the same course of therapy, then the health insurance shall fully cover the treatment charges within his/her right according to regulations (excluding  outpatient treatment at an uncovered facility).

- Where the patient  suffers a side effect of the medicine or the medical facility runs out of such medicine and the doctor prescribes another medicine (for example change from Erlotinib (oral form) to Gefitinib (oral form) and vice versa).

- The  patient’s condition was stable and the patient stopped receiving treatment; when the patient suffers a relapse, the doctor prescribes the same medicines used before.

- During the treatment using any of these medicines, the patient fails to  adhere to the follow-up examination schedule or  fails to use the medicines continuously as prescribed."

b) Clause 2 Article 7 is amended as follows:

“ Medicines covered by health insurance according to regulations in Circular No. 31/2011/TT-BYT dated July 11, 2011, Circular No. 10/2012/TT-BYT dated June 08, 2012 and medicines for treatment of cancers and immunosuppressive drugs other than those listed according to Clause 4 Article 7 of Joint Circular No. 09/2009/TTLT-BYT-BTC dated August 14, 2009 are still covered 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 January 01, 2015.

Medicines covered by health insurance according to regulations in Circular No. 31/2011/TT-BYT dated July 11, 2011, Circular No. 10/2012/TT-BYT dated June 08, 2012 and medicines for treatment of cancers and immunosuppressive drugs other than those listed according to Clause 4 Article 7 of Joint Circular No. 09/2009/TTLT-BYT-BTC dated August 14, 2009 that are limited within certain grades of hospitals, are covered by health insurance according to hospital grade specified in Circular No. 31/2011/TT-BYT dated July 11, 2011, Circular No. 10/2012/TT-BYT dated June 08, 2012 and Joint Circular No. 09/2009/TTLT-BYT-BTC dated August 14, 2009 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 January 01, 2015.

 Lysine hydrochloride + Calcium glycerophosphate + Glycerophosphoric Acid + Vitamin B1 + B2 + B6 + E + PP, oral form (No. 1116, column 2); sulfate + lysine hydrochloride + Vitamin A + B2 + B2 + B3 + B6 + B12 + D + Calcium glycerophosphate + Magnesium gluconate, oral form (No. 118, column 2) and Vitamin A + B1 + B2 + B6 + C + D3 + Calcium gluconate + zinc + lysine + PP, oral form (No. 1135, column 2) mentioned in Circular No. 31/2011/TT-BYT dated July 11, 2011, are still covered by health insurance regardless of ages and grades of hospitals according to regulations in Circular No. 31/2011/TT-BYT dated July 11, 2011 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 January 01, 2015.

Regarding lysine hydrochloride + Calcium glycerophosphate + Glycerophosphoric Acid + Vitamin B1 + B2 + B6 + E + PP, oral form (No. 1116, column 2) in Circular No. 31/2011/TT-BYT dated July 11, 2011: Are Lysine + Vitamin + Minerals, oral form (No. 1042, column 2) in Circular No. 40/2014/TT-BYT dated November 17, 2014, health insurance shall cover treatment for children younger than 6 years old who are undernourished provided in special-grade hospitals, grade I and grade II hospitals according to regulations in Circular No. 40/2014/TT-BYT dated  November 17, 2014 according to the medicine bidding result and the contract between the medical facility and the supplier signed before January 01, 2015.

Article 2. Effect

This Circular comes into effect from December 15, 2015.

Difficulties arising during the implementation of this Circular should be reported to the Ministry of Health (via Department of Health Insurance) for consideration and solution./.

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