Amendments To The Cabinet Of Ministers Of 14 June 2005, The Regulation No 418 "outpatient Treatments And Medicines For The Purchase Of Medical Equipment For The Refund Order"

Original Language Title: Grozījumi Ministru kabineta 2005.gada 14.jūnija noteikumos Nr.418 "Ambulatorajai ārstēšanai paredzēto zāļu un medicīnisko ierīču iegādes izdevumu kompensācijas kārtība"

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/131355

Cabinet of Ministers Regulations No. 230 in 2006 (21 March. Nr. 55) 16 amendments to the Cabinet of Ministers of 14 June 2005, the Regulation No 418 "Outpatient treatments and medicines for the purchase of medical equipment for the refund order" Issued in accordance with article 4 of the law on the treatment of the first part of the draw of the Cabinet of Ministers of 14 June 2005, the Regulation No 418 "Outpatient treatments and medicines for the purchase of medical equipment for the refund order" (Latvian journal, 2005, nr. 99; 2005, 210. no) the following amendments : 1. Express an indication on what basis the provisions of the law, issued by the following: "Issued in accordance with article 4 of the law on the treatment of the first part".
2. Supplement with 12.11. bottom point as follows: "No 12.11. number of patients to whom the costs of the medicinal product concerned or the purchase of medical equipment shall be borne by the applicant from its own funds, if the medicinal product or medical device in the list of medicinal products are eligible to be included under this rule 42.1 points."
3. Add to paragraph 23 and 24 by the words "Eligible medicines included in the list of medicinal products and medical devices" with the words "and any of the State budget funds partially or fully pay for medicinal products and medical devices".
4. Make the following point 42.1: "in addition to these rules 42.1, paragraph 42 above to information on medicinal products or medical devices, which cost more than 3000 dollars per patient per year, if it is not possible to apply the medical criteria for drug control, drug-price public agency decision shall indicate the following information: 1. the number of patients to 42.1, which at the same time the costs of the drug or medical device purchasing offsets from the purchase of medicinal products, the compensation for the year allocation;
42.1 2. number of patients to whom the costs of the medicinal product concerned or the purchase of medical equipment shall be borne by the applicant from its own resources. "
5. Express 27.6. subparagraph by the following: "If the applicant does not agree with 27.6. this rule 42.1 2. referred to local conditions."
6. To express the following paragraph 28.3.: 45.6. the applicant does not comply with the provisions of the decision referred to in paragraph 26.2, and this rule 50.2 points of the Treaty referred to in the conditions. "
7. Add to 46 in the second sentence by the following: "the price of a medicinal product, a government agency changes the list of eligible medicines, as well as part of the decision on the inclusion of a medicinal product in the list of medicinal products, the amount exceeding 3000 LVL one patient a year, published in the newspaper" Gazette "."
8. Make a point following 50.2: "50.2 this rule 42.1 in the case referred to in paragraph health compulsory insurance State agency contract with the applicant for specific medicinal products or medical devices quantity free delivery of treatment person's right to prescribe certain medicines or medical devices set out in the contract between the hospital and the health compulsory insurance State Agency."
9. Express 50.5 points as follows: "50.5 health compulsory insurance State Agency shall keep a record of all medical decisions konsilij, received for this rule 42.1 referred to medicines and medical devices, including: 1.50.5, which patients medicines used payment shall be made from the purchase of medicinal products granted compensation funds;
50.5 2. patients, for which medicines used payment is made from the resources of the applicant;
50.5 3. treatment of the person concerned the statement. "
10. Add to 50.4 points behind the words "subject to the following conditions" with the words "excluding this provision referred to the case of 50.8".
11. Delete 50.7 points.
12. Supplement with 50.8 points as follows: "To this rule 50.2 50.8 points for conclusion of the contract referred to in the health compulsory insurance State Agency has the right to start off from the purchase of medicines compensation expenditure allocations for this rule 42.1 medicinal products referred to in paragraph 1, those patients who meet this provision 61. criteria referred to in paragraph 1, is launched using the appropriate therapy, medication, and that such products are prepaid from State budget not exceeding that rule 42.1 prescribed in paragraph 1, the number of patients and ensuring the tracking of these regulations in accordance with the procedure laid down in paragraph 50.5. "
13. Chapter X be expressed as follows: "the purchase of a medicinal product X. compensation for individual patients 61. Health compulsory insurance State Agency, based on the patient's application, with the relevant sectors of the doctor konsilij treatment decision is entitled to take a decision on the purchase of medicines compensation for individual patients. These expenses are offset by the purchase of medicines compensation within the resources allocated in the following cases: 61.1. diagnosis not included in annex 1 of these provisions, but are considered rare (no more than two residents of 10,000), a life-threatening or severe and chronic, and the administration of the need to maintain the function of life;
61.2. diagnosis is included in annex 1 of these provisions, and life sustaining functions do not fit in any of the eligible list of medicinal drugs. (Requires the use of a medicinal product that is not included in the list of medicinal products eligible.)
61.1 treatment sector doctor konsilij approves the composition of the medical industry professionals Association. Konsilij the decision must specify the following information: 1. the patient 61.1 name, surname, personal code, address;
61.1 2. diagnosis (diagnosis code according to the ICD-10 version);
61.1 3. patient treatment previously used medicines (generic name, drug name, dosage, duration of use), including the amount of the medicinal product in the list. If selected for further treatment, medications that are not registered in the Republic of Latvia in the list of medicinal products, indicates that the patient is treated using analog authorised medicinal product;
4. this rule 61.1. no medicinal product referred to in point of use result (effectiveness of medicinal products in the case of the disease, describing values changes as a result of the use of the product);
61.1 5. medicinal products for patient compensation expenditure needs (drug name, generic drug name, dosage forms, required daily intake, the duration of the course);
6. this rule 61.1 61.15. medicinal products referred to in point selection (in comparison with other relevant disease treatment medicinal products and treatment methods, if available), the name of the medicinal product in question the justification of choice, if the name is a general more in the name of the medicinal product;
7. drug compliance 61.1 physician professional association related to the disease or international scheme of treatment guidelines, drug treatment of the disease in question within the site diagram, adding a copy of the publication;
61.1. decision 8, the period of validity.
62. the health compulsory insurance State agency empowered to take the decision on compensation to 100%, if these rules referred to in paragraph 61 diagnosis not included in annex 1 of these rules.
63. If the diagnosis is included in annex 1 of these regulations, the health compulsory insurance State Agency shall adopt a decision on the purchase of medicines compensation rules are set out in annex 1.
64. the health compulsory insurance State Agency is entitled to request the price of medicines the State Agency's opinion on this rule 61.1 konsilij decision referred to in paragraph medicine included in the selection. Drug prices National Agency shall give an opinion within 14 days after the health compulsory insurance State Agency's receipt of the request.
65. the health compulsory insurance State Agency collects and twice a year (until 1 July and 31 December) by the price of the medicinal product by the National Agency for information about received submissions for the purchase of medicines for discharging in the cases provided for in this chapter (also if the medicine was refused compensation), indicating that the submissions diagnosis and medication. The price of the State Agency of medicines shall assess the health compulsory insurance State agency information provided and, if necessary, submit proposals to the Ministry of health for this rule supplement annex 1.
66. the purchase of Medicines compensation in the cases provided for in this chapter are used no more than 2% of the purchase of medicinal products granted compensation features.
67. the health compulsory insurance State Agency is entitled to refuse the purchase of medicines compensation in accordance with the procedure laid down in this chapter, if the price of the medicinal product: 67.1. a government agency has adopted a negative decision on the inclusion of a medicinal product in the list of medicinal products eligible for the specific diagnosis and treatment for eligible medicines list includes other relevant farmakoterapeitisk groups (five marks for anatomical classification of chemical) drugs with the same indications registered no clinically meaningful differences in therapeutic efficacy and side effects;
67.2. the purchase of medicinal products, the compensation of individual cases in the year allocated funds are spent;

67.3. this rule 61.1 konsilij decision referred to in paragraph does not contain all the required information;
41.9. patient under these rules referred to in annex 1. diagnosis are available other eligible list of medicinal products with the same general name of the medicinal product;
67.5. in accordance with the provisions of paragraph 61 requested medicines are included in the list of medicinal products with the compensated other indications;
67.6. specific registered medicinal indications do not correspond to the patient's diagnosis;
67.7. medicinal products or medical devices cost exceeds 5000 lats for one patient a year;
mm. drugs are paid for other State budget within the sub-programmes;
67.9. in accordance with the provisions of paragraph 64 of the medicinal products the price of State Agency has acknowledged that the choices are not justified.
67.1 health compulsory insurance State Agency requires the State Agency of medicines information on the sales price of the medicinal product in Latvia, which is not included in the list of eligible medicines and medicinal products for which the manufacturer or his authorized representative in accordance with the laws and regulations on drug pricing principles, provide information to the State Agency of medicines. The State Agency of medicines shall forward that information within five days of receipt of the request. Health compulsory insurance State Agency for the purchase of medicinal products the cost of compensation calculated in accordance with the provisions of paragraphs 23 and 24. "
14. Express of annex 1 section 14.2.1 the following: 14.2.1. "
Multiple sclerosis G35 100 ' 15. Express 3 and annex 7 paragraph 4 by the following: "3. the January 1, 2007 medicine group (three anatomical signs chemical classification), which contained the General name of the medicinal product are included in the list of medicinal products eligible to diagnoses 90% of the refund amount, 75% or 50%, if within a group of medicinal products contain more than one manufacturer's name 4.
on 1 July 2007 of the Group (three anatomical signs chemical classification), which contained the General name of the medicinal product are included in the list of medicinal products eligible to compensation of diagnosis with 100%, if within a group of medicinal products contain more than one manufacturer's name "Prime Minister a. Halloween Health Minister g. Smith Editorial Note: the entry into force of the provisions by 29 March 2006.