Law Amending And Supplementing The Law On Health Insurance

Original Language Title: Закон за изменение и допълнение на Закона за здравното осигуряване

Read the untranslated law here: http://parliament.bg/bg/laws/ID/15200/

Name of law Law amending and supplementing the law on health insurance of the Name Bill a bill amending and supplementing the law on health insurance of acceptance Date 16/09/2015 number/year Official Gazette 48/2015 Decree No 112

On the grounds of art. 98, paragraph 4 of the Constitution of the Republic of Bulgaria

I DECLARE:

To be published in the Official Gazette the law amending and supplementing the law on health insurance, adopted by the National Assembly of HLÌÌI 16 June 2015.

Issued in Sofia on 26 June 2015.

The President of the Republic: Rosen Plevneliev

Stamped with the State seal.

Minister of Justice: Hristo Ivanov

LAW

amending and supplementing the law on health insurance (official SG. 70 of 1998; amend., SG. 93 and 153 of 1998, no. 62, 65, 67, 69, 110 and 113 in 1999, issue 1 and 64 in 2000, 41/2001, no. 1, 54, 74, 107, 112, 119 and 120 of 2002, issue 8 , 50, 107 and 114 from 2003, PCs. 28, 38, 49, 70, 85 and 111 in 2004, PCs. 39, 45, 76, 99, 102, 103 and 105 of 2005, St. 17, 18, 30, 33, 34, 59, 80, 95 and 105, 2006, issue. 11 of 2007; Decision of the Constitutional Court No. 3 of 2007 – PCs. 26 of 2007; amend., SG. 31, 46, 53, 59, 97, 100 and 113 of 2007, PC. 37, 110 and 71 of 2008, PCs. 35, 41, 42, 93, 99 and 101 of 2009, PCs. 19, 26, 43, 49, 58, 59, 62, 96, 97, 98 and 100 by 2010, PC. 9, 60, 99 and 100 by 2011, issue. 38, 60, 94, 101 and 102 of the 2012 issue. 4, 15, 20, 23 and 106 by 2013, PCs. 1, 18, 35, 53, and 54 107 by 2014 and PCs. 12 by 2015.)

§ 1. In art. 1, al. 2 the word "charge" is replaced by "purchasing" and after the words "service" and add "pay".

§ 2. In art. 2, al. 1 is hereby amended as follows:

1. In the first sentence, the word "charge" is replaced by "buying".

2. in the second sentence, the word "basic" is deleted.

§ 3. In art. 5, item 9, the word "basic" is deleted.

§ 4. In art. 15, para. 1 is hereby amended as follows:

1. point 12 is replaced by the following:

"12. adopt a decision laying down the list of diseases referred to in art. 45, para. 3 on the proposal of the Governor; '.

2. Section 13 is repealed.

§ 5. In art. 16 is made the following changes and additions:

1. a new paragraph. 5: "(5) for the meetings of the Supervisory Board shall draw up the verbatim reports. The decisions of the Supervisory Board and reports for its meetings shall be published on the website of the NATIONAL HEALTH INSURANCE FUND. Decisions shall be published no later than the day following the day of their making, and protocols – up to 7 days from the date of the meeting. "

2. The current paragraph. 5 it al. 6.

§ 6. In art. 19, para. 7 make the following amendments and additions:

1. an item 4 (a):

"4A. There shall on a monthly basis on the website of the NATIONAL HEALTH INSURANCE FUND during the preceding month paid funds for hospital medical assistance in hospitals, as well as for medicinal products in international non-proprietary name, medical devices, and dietary foods for special medical purposes;".

2. point 12 is replaced by the following:

12. proposed for adoption by the Supervisory Board list under art. 45, para. 4; ".

3. Section 13 is repealed.

4. In paragraph 14, the words "the volumes and prices of medical aid, adopted by the order of art. 55 e, para. 6 ' shall be replaced by "decision under art. 45, para. 4. "

5. Point 15 is replaced by the following:

"15. examine the satisfaction of patients from medical activities related to assistance provided medical care paid for by the NATIONAL HEALTH INSURANCE FUND; the order method and criteria for patient satisfaction survey are determined by an Ordinance of the Minister of health; ".

6. Paragraphs 16 and 17 are hereby repealed.

§ 7. In art. 24 the following modifications are made:

1. In paragraph 1 the word "charge" is replaced by "buying".

2. In paragraph 8, the word "charge" is replaced by "buying".

§ 8. In art. 35 following amendments and supplements shall be made:

1. The current text becomes paragraph 1 and in point 1, the words "basic package" shall be replaced by "package".

2. a para. 2:

"(2) Compulsorily insured persons are entitled to submit complaints to the Director of the REGIONAL HEALTH INSURANCE FUND when you are not satisfied with the medical activities related to assistance provided medical assistance. The appeal shall be lodged in accordance with chapter two, section X, as it describes the reasons and indicate at least one of the following grounds:

1. read, but neizv″ršena medical activities;

2. the quality of medical aid, which does not comply with the quality criteria set out in the national framework contracts;

3. denied access to medical records;

4. received by the contractor of a medical or dental aid amounts without legal basis. "

§ 9. In art. 40 the following modifications are made:

1. In paragraph 8. 2, after the word "wars" and "the Union" is replaced by a comma, and then the word "military" the comma shall be replaced by ' Union ' and '.

2. paragraph 4 (a) shall be replaced by the following:

"(4A) For the persons referred to in para. 3 the social insurance contribution shall be paid at the rate determined by the law on the budget of the national health insurance fund for the year, on 55 percent of minimum insurance income for the self employed from 1 January 2016 and each subsequent year shall be increased by 5 percent to achieve the minimum insurance income for self-employed persons. "

§ 10. In art. 45 following amendments and supplements shall be made:

1. In paragraph 8. 1 in the text before point 1, the words ' paid for ' shall be replaced by "paid".

2. In paragraph 2:

a) in the first sentence, the word "basic" is deleted;

(b)) the second sentence shall be replaced by the following: "the package is basic and supplementary and determined by an Ordinance of the Minister of health, is updated once a year, and no later than 31 October of the year concerned."

3. Subparagraph 3 shall be amended as follows:

"(3) the Ordinance referred to in para. 2 shall be governed by and the criteria for determining the disease, for which home care HEALTH INSURANCE paid in full or in part, medicinal products, medical devices, and dietary foods for special medical purposes. "

4. Create a new para. 4 and 5:

"(4) the list of diseases referred to in paragraph 1. 3 shall be set by decision of the Supervisory Board of the FUND in accordance with the criteria laid down in the Ordinance referred to in para. 2, which shall be promulgated in the State Gazette.

(5) any changes to the list under para. 4, which provide for an increase in the cost of HEALTH INSURANCE in the case of medicinal products, medical devices, and dietary foods for special medical purposes, shall not take effect earlier than the modification of the law on the budget of the national health insurance fund for the year in question or of the entry into force of the law on the budget of the NATIONAL HEALTH INSURANCE FUND for the following year. "

5. Paragraph 8 shall be repealed.

6. Paragraph 10 shall be replaced by the following:

"(10) For medicinal products for which the value paid by the NATIONAL HEALTH INSURANCE FUND, shall be calculated by grouping in which medicinal products are not involved to other holders of an authorisation for use as well as for those with new international non-proprietary name, or for which an application for inclusion in the positive list under art. 262, para. 6, item 1 of the law on medicinal products for human use, HEALTH INSURANCE and holders of permission for use or their authorized representatives must annually carry out centralized negotiations of concessions under the conditions and criteria laid down in the Ordinance referred to in para. 9. "

7. Paragraph 11 shall be replaced by the following:

"(11) the agreed discount under para. 10 is allocated to the NATIONAL HEALTH INSURANCE FUND and zdravnoosigurenite persons in the criteria and procedures laid down in the Ordinance referred to in para. 9. "

8. Paragraph 13 is replaced by the following:

(13) For medicinal products to health activities under art. 82, para. 2, item 3, of the Act on health and HEALTH INSURANCE holders of permission for use or their authorized representatives must annually carry out centralized negotiations of concessions under the conditions and criteria laid down in the Ordinance referred to in para. 9. "

9. in the Al. 14 the words "para. 9 "shall be replaced by" art. 30 (a), para. 3 of the same law. "

10. in the Al. 15 creates a second sentence: "the procedure for the award of individual contracts include:

1. the conditions to be satisfied by the retailer of medicinal products, and the procedures for the conclusion of contracts with them;

2. rights and obligations of the parties to the treaties;

3. the conditions and procedures for the carrying out of the activities of retailers with medicinal products;

4. the criteria for quality and accessibility of the activities referred to in paragraph 3;

5. the documentation and records;

6. obligations of the parties under the information provision and exchange of information;

7. types of penalties for infringement of the treaties, as well as procedures for the imposition. "

11. in the Al. 17, the words "basic package" shall be replaced by ' the package ' and the words ' art. 55 is "shall be replaced by ' the national framework contract for eventual activities."

12. in the Al. 18 the words "basic package" shall be replaced by "package".

13. Paragraph 19 is amended as follows:

(19) the national health insurance fund and the holders of permission for use or their authorized representatives must annually carry out centralized negotiations of concessions applicable to medicinal products in the treatment of malignancy, paid medical assistance in a hospital outside the value of our medical services, for which the amount to be paid by the NATIONAL HEALTH INSURANCE FUND, shall be calculated by grouping in which medicinal products are not involved to other holders of permission for use and for those with new international non-proprietary name, or for which an application for inclusion in the positive list under art. 262, para. 6, item 2 of the law on medicinal products for human use. The conditions, rules and criteria for the cost of medicinal products and to negotiate discounts are determined by the Ordinance under para. 9. "

14. Al are created. 20, 21, 22 and 23:

(20) following completion of negotiations under para. 10, 13 and 19 shall conclude contracts with holders of authorisations for the use of the medicinal product concerned or by their authorized representatives. Agreed rebates are required for the duration of the contract and may not be amended in a way that adds to the cost of HEALTH INSURANCE.


(21) the medicinal products referred to in paragraph 1. 10, 13 and 19, which are negotiated discounts are not paid for by the NATIONAL HEALTH INSURANCE FUND.

(22) Ongoing discounts under para. 10, 13 and 19 may not be lower than the agreed discounts during the previous year.

(23) the executors of medical aid unable to purchase medicinal products under para. 19 at prices higher than the prices resulting from the negotiated discounts on al. 19. "

§ 11. In art. 46, para. 2 the word "paid" shall be replaced by "see".

§ 12. In art. 47 the words ' payment for ' shall be replaced by "purchasing", and after the abbreviation ' ECONOMIST ' is a comma and add "as the funds are transferred.

§ 13. In art. 51 the word "payable" is replaced by "purchasing".

§ 14. In art. 54 following amendments and supplements shall be made:

1. In paragraph 8. 6 Add "and should comply with the budget of the NATIONAL HEALTH INSURANCE FUND for the year.

2. in the Al. 10 the words "basic package" shall be replaced by "package".

§ 15. In art. 55 following amendments and supplements shall be made:

1. In paragraph 8. 2:

and so is created):

"3A. volumes, pricing and costing methodologies and the purchase of the types of medical assistance referred to in paragraph 2;"

(b)) that are created 6a and 6B:

"6a. conditions and procedures for the control of the implementation of the treaties;

6B. penalties for non-performance of the contract; ".

2. in the Al. 3:

a) in paragraph 3 the words "basic package" shall be replaced by "package";

(b)) section 6 is repealed.

§ 16. New art. 55: "art. 55. The national health insurance fund plans, negotiate and purchase for zdravnoosigurenite persons medical aid under art. 55, para. 2, item 2, in the framework of the volumes agreed within the national framework contracts. "

§ 17. Articles 55 (d), (e) and 55 55 is are repealed.

§ 18. In art. 56 para. 3 is repealed.

§ 19. In art. 59 following amendments and supplements shall be made:

1. In paragraph 8. 1 the words "and/or" shall be replaced by a comma and add "and with this law".

2. in the Al. 11:

(a)) in the text before paragraph 1, after the word "assistance" insert "or impose a financial penalty specified in the current R & D";

b) in point 1 the words "basic package" shall be replaced by "package";

in t. created) 3 and 4:

"3. the systematic violation of the criteria for quality of medical assistance set out in the national framework contracts;

4. in the system of patients ' frustration rendered medical activities related to assistance provided medical assistance paid from the budget of the NATIONAL HEALTH INSURANCE FUND, established in accordance with the Ordinance under art. 19, para. 7, p. 15, and after evaluating the criteria for quality of medical assistance set out in R & D, and their infringement. "

3. a para. 13:

(13) the Director of the regional health insurance fund terminated the contracts with the contractors of medical aid in the cases referred to in para. 11, paragraphs 1 and 2 and, in the cases referred to in para. 11, item 3 and 4 impose a financial penalty under the NFA. "

§ 20. In art. 59 (b) create al. 4-6:

"(4) the Director of the REGIONAL HEALTH INSURANCE FUND may not conclude agreements, additional agreements, respectively, with hospitals, which are not applied in the terms of art. 59A, al. 1, 4, 5 and 6, regardless of the reasons.

(5) the scope of the treaties and ancillary agreements concluded with BUSINESS, may not be extended.

(6) the prohibitions of al. (4) and (5) apply for the duration of the R & D and decisions under art. 54, para. 9 and 10, applicable during the period concerned. "

§ 21. In art. 61 the word "charge" is replaced by "buying".

§ 22. In art. 63, para. 1 creating item 3 (a):

"3A. the register of specialists, working in medical institutions in the implementation of contracts with the national health insurance fund, with the names and professional data; specialty, contracts with the national health insurance fund, in the performance of that work; type of medical assistance in the performance of the contract; number of contracts on which they are working; ".

§ 23. In art. 64 a, para. 1, item 2, the words "which pays for the NATIONAL HEALTH INSURANCE FUND" shall be replaced by the words "of which NHF purchased".

§ 24. In art. 68, para. 2, item 2, the word "charge" is replaced by "buying".

§ 25. In art. 72 following amendments and supplements shall be made:

1. Create a new para. 3, 4 and 5: "(3) the immediate control of the Al. 2 is a recurring and for carrying out checks on complaints from aggravated in the cases under art. 35, para. 2.

(4) the Appeal under para. 3 shall be submitted within 7 days of the establishment of any of the grounds under art. 35, para. 2.

(5) the checks referred to in para. 3 shall be carried out within one month of receipt of the complaint, as the results of the inspection shall be notified to the applicant. "

2. The current paragraph. 3 it al. 6.

3. The current paragraph. 4 it al. 7 and shall be replaced by the following: "(7) the performance of the contracts for the distribution of medicinal products, medical devices, and dietary foods for special medical purposes, paid in full or in part by the national health insurance fund for home treatment in the territory of the country is carried out by the persons referred to in para. 2 in the order provided for in the Act of art. 45, para. 15, laying down the terms and conditions for the award of individual contracts to pay for the medicinal products referred to in art. 262, para. 6, item 1 of the law on medicinal products for human use. "

4. The current paragraph. 5 it al. 8 and shall be amended as follows:

(8) the conditions and procedures for the control of Pará. 2, 3, 4, 5, 6 and 7 shall be determined by instructions issued by the Manager of the NATIONAL HEALTH INSURANCE FUND. "

§ 26. In art. Al 73. 4 shall be amended as follows:

"(4) in respect of the activities of financial inspectors, the finding of violations, disputing the findings of the arbitration commissions and penalties shall apply accordingly procedures under art. 74, para. 2 – 4, art. 75 and 76 in which doctors work-controllers and doctors of dental medicine-controllers. "

§ 27. In art. 74 following amendments and supplements shall be made:

1. In paragraph 8. 1: a) in text before paragraph 1, after the word "medical" insert "or" dental ", after the words" doctors-controllers ' shall be added "or dental practitioners-controllers";

b) in paragraph 2, after the word "medical" insert "or" dental ";

c) in item 4, after the word "medical" insert "or" dental ".

2. Paragraphs 3 and 4 are hereby amended:

"(3) in establishing an offence under para. 1, item 2 – 4 doctor-controlled or doctor of dental medicine-controller shall draw up a report describing the findings. The minutes shall be signed by the doctor-controlled or doctor of dental medicine-controller. A copy of the record shall be provided to the cleared person against signature and copies thereof shall be forwarded to the Director of the REGIONAL HEALTH INSURANCE FUND and the District Council of the professional organization of doctors or doctors of dental medicine.

(4) the person – the subject of the verification, shall be entitled to give a written statement to the Director of the REGIONAL HEALTH INSURANCE FUND by the doctor-controlled or doctor of dental medicine-controller findings within 7 days of the service of the Protocol referred to in paragraph 1. 3. "

3. a para. 5:

"(5) where a person – the subject of verification, has not delivered an opinion on the Al. 4 or opinion expressed by it does not contain any objections made by the doctor-controlled or doctor of dental medicine-controller findings, the Director of the REGIONAL HEALTH INSURANCE FUND issued an order by which the penalty. "

§ 28. Create new art. 75 and 76:

"Art. 75. (1) in cases where the person challenged the findings of the physician-controlled or doctor of dental medicine-controller, the Director of the REGIONAL HEALTH INSURANCE FUND within 7 days of receipt of the written opinion on the art. 74, para. 4 send the dispute to the Arbitration Committee.

(2) the Arbitration Board shall consist of representatives of the REGIONAL HEALTH INSURANCE FUND, the relevant regional associations of professional organizations of doctors and dental practitioners, the relevant regional associations of professional organisations of master-pharmacists and nurses, midwives and associated medical professionals.

(3) the Arbitration Board shall be included for each particular case representatives of these organisations, which have a bearing on the facts and the findings described in the Protocol of the physician-controlled or doctor of dental medicine-controller under art. 74, para. 3.

(4) the number of the representatives of the REGIONAL HEALTH INSURANCE FUND in the composition of any Arbitration Commission is equal to the total number of representatives of the professional organisations in the Al. 2.

(5) the establishment of an Arbitration Commission on a case-by-case basis is organized by the Director of the REGIONAL HEALTH INSURANCE FUND and it carries out its activities under the conditions and in accordance with the procedure laid down in the R & D, as well as under the conditions and procedures for the award of individual contracts to pay for the medicinal products referred to in art. 262, para. 6, item 1 of the law on medicinal products for human use under art. 45, para. 15.

(6) the Arbitration Board shall take a decision within one month of receipt of the file.

Art. 76. (1) in the event that the Arbitration Committee confirm the findings of the physician-controlled or doctor of dental medicine-controller, apply the penalties provided for in the contract between the contractor and the REGIONAL FUND of medical or dental help.

(2) the sanctions under para. 1 shall be imposed by an order of the Director of the REGIONAL HEALTH INSURANCE FUND, which shall be issued within one month of the notification of the Arbitration Committee the Director of BRANCHES that are confirmed the findings of the physician-controlled or doctor of dental medicine-controller, and shall be communicated to the person.

(3) the penalties shall be subject to judicial review under the administrative code.

§ 29. In art. 76 a, para. 1, after the words "under this Act" there shall be added "or the R% AMP% D".

§ 30. Article 76 (b) shall be replaced by the following:

"Art. 76 (b) (1) where the contractor for medical and/or dental aid amounts received without legal basis as a result of misconduct under this Act or of the NFA, the Director of the REGIONAL HEALTH INSURANCE FUND unjustifiably withheld the amounts paid by the offender shall impose penalties specified in this Act or in the NFA.

(2) in the cases referred to in para. 1 the Director of the REGIONAL HEALTH INSURANCE FUND shall issue a written invitation for recoveries obtained without legal basis following the entry into force of the Penal Decree and/or an order imposing a sanction. "

§ 31. Art is created. 76 in:


"Art. 76. (1) the control of compliance with the rules of good medical practice, rules of good pharmaceutical practice, rules of good practice, the established medical standards, of this law and of the r & d is carried out through joint inspections by the ECONOMIST, Executive Agency, medical centres and professional organizations of doctors, dental doctors, master-pharmacists and nurses , midwives and associated medical professionals.

(2) the checks shall be carried out in a preliminary annual plan, approved by the beginning of the year jointly by the NATIONAL HEALTH INSURANCE FUND, the Executive Agency "Medical audit", centres and organisations from Guild al. 1.

(3) upon finding violations sanctions by the authorities, who by law are assigned to the relevant control powers. "

§ 32. In section x of chapter II established a new art. 80:

"Art. 80. The Division on the implementation of the AGREEMENTS and contracts between performers of medical or dental assistance shall be decided by a court order, if we do not reach agreement by arbitration. "

§ 33. In art. 101, item 1 the words "basic package" shall be replaced by "package".

§ 34. Articles 105a, 105b, 105 (b), (c), (d) and (g) 105 105 is repealed.

§ 35. In art. 105 h, para. 1 the words "105a-105 (g)" shall be replaced by ' 105 d and 105 is. "

§ 36. In art. 106 following amendments and supplements shall be made:

1. In paragraph 8. 3 the words "105a-105 (g)" shall be replaced by ' 105 d and 105 is. "

2. a new paragraph. 4:

"(4) where the infringement under para. 3 is committed by a legal person or sole proprietor, a penalty payment in the amount of 500 to 1000 BGN, and for repeat offenders, from 1000 to 2000 euro. "

3. The current paragraph. 4 it al. 5 and in her words "1, 2 and 3 ' shall be replaced by" 1, 2, 3 and 4 ".

§ 37. In art. 109, para. 2 the words "the last 36 months" are replaced by "the past 60 months.

§ 38. In § 1 of the additional provisions are made the following amendments and additions:

1. In paragraph 2, the words "basic package" shall be replaced by "package".

2. a new item 19:

"19." Systematic violation "is carrying out three or more violations of the quality requirements set out in R & D, for a period of six months for the duration of the R & D and of the resolutions under art. 54, para. 9 and 10. "

3. an item 19 (a):

"19." Systematic frustration "is three or more times down frustration under the Ordinance under art. 19, para. 7, item 15 of the patients from the activity of the contractor of medical assistance for a period of six months for the duration of the R & D and of the resolutions under art. 54, para. 9 and 10. "

4. an item 19B:

"19B." the patient's Satisfaction of medical activities related to assistance provided medical help "achieve e match between the expectations of the patient, his/her needs and real assistance provided medical assistance and his e indicator for the evaluation of quality of medical care, based on a survey of the attitudes and opinions of the patient."

Transitional and final provisions

§ 39. In the law on medicinal products for human use (official SG. 31 of 2007; amend., SG. 19 of 2008; Decision of the Constitutional Court No. 5 of 2008-65/2008; amend., no. 71 of 2008, no. 10, 23, 41, 88 and 102 of 2009, 59/98, and by 2010, issue 9, 12 , 60 and 61 by 2011, issue. 38, 60 and 102 by 2012 PCs. 15 by 2013, PCs. 1 and 18 by 2014; Decision No. 1 of the Constitutional Court by 2015 – PCs. 12 by 2015.) make the following changes and additions:

1. In art. 228:

(a)) in the Al. 1 point 7 shall be repealed;

(b)) are al. 8 and 9:

"(8) on the day of receipt of the application referred to in para. 1 and 5 BDA sent by work order request to the Managing Board of the Bulgarian pharmaceutical Union for issuing of certificate for registration in the national electronic register of members of the Bulgarian pharmaceutical Union – for pharmacists, pharmacy manager, as well as to provide information concerning the penalties imposed pursuant to the Act on professional organization of master-pharmacists and health law.

(9) the Management Board shall provide the documents referred to in para. 8 within 5 working days of receipt of the request. "

2. In art. 259:

(a)) in the Al. 1:

AA) in paragraph 4, the words "the efficacy of" shall be replaced by the words "outcome of the";

BB) are point 7 and 8:

7. maintain status reimbursniâ of medicinal products every three years by their inclusion in the positive list;

8. assist in negotiating discounts in the cases under art. 45, para. 10, 13 and 19 of the law on health insurance for the medicinal products for which applications have been submitted for inclusion in the positive list. ";

(b)) in the Al. 5 item 2 is amended as follows:

"2. the inclusion, modification or maintenance of the status of the reimbursniâ included in the list under art. 262, para. 1 medicinal product. "

3. In art. 259 b, para. 1 create item 6 and 7:

"6. ninety days, when an application is submitted for inclusion in a positive list of medicinal products with a new international non-proprietary name;

7.60 days, when an application has been made to maintain the reimbursniâ status of medicinal product included in a positive list of medicines. "

4. In art. 262:

(a)) in the Al. 4 Finally adds "as for medicinal products with new international non-proprietary name is performed and health technology assessment" and the second sentence: "health technology assessment is carried out under conditions and by an order determined by an Ordinance of the Minister of health.";

(b)) in the Al. 9, after the word "list" and "be added to maintain the reimbursniâ status of medicinal products ';

in Al are created.) 10 and 11:

"(10) medicinal products under art. 45, para. 10, 13 and 19 of the law on health insurance, which are not negotiated discounts are not included in the positive list. Contracts for the provision of rebates received in the Council in the order determined by the Ordinance under art. 261, para. 5.

(11) the medicinal products for which the procedure referred to in art. 259, para. 1, item 7 shall not prove positive assessment in their turn, are excluded from the positive list of medicines. "

5. § 1 of the additional provisions:

and so is created) 42 (b):

' 42B. "health technology assessment" is:

(a)) form of policy in the field of research, which examines the short-and long-term outcomes related to the application of health technologies, and aims to provide information on alternative health strategies;

(b)) a multi-disciplinary activity which systematically assesses the technical characteristics, safety, clinical efficacy and efficiency, costs, value efficiency, organizational, social, legal and ethical implications of the application of medicinal products in health and focus on value – clinical and economic, as the analysis is comparative to the existing or the best alternative currently. ';

(b)) shall be that:

"44A." keeping the reimbursement status "is the assessment of the medicinal product on the basis of evidence for efficacy, therapeutic efficacy, safety and pharmaco-economic analysis of the indicators."

§ 40. (1) the Minister of health shall establish criteria under art. 45, para. 3 within three months of the entry into force of this law.

(2) the Supervisory Board of the HEALTH INSURANCE FUND shall establish the list referred to in art. 45, para. 4 within three months of the determination of the criteria listed in para. 1.

(3) within one month from the entry into force of the list under art. 45, para. 4 the National Council for pricing and reimbursement of medicinal products officially excluded from the positive list medicinal products intended to treat diseases that are not included in the list.

(4) the national health insurance fund pays for medicinal products, medical devices, and dietary foods for special medical purposes for Disease Ordinance referred to in the previous article. 45, para. 3, which are prescribed by the expiry of the time limit under paragraph 1. 3.

(5) the appeal of the acts and actions of the National Council on pricing and reimbursement of medicinal products under para. 3 do not have suspensive effect.

§ 41. To determine the basic and additional package by the procedure of art. 45, para. 2 apply the basic package, to the entry into force of this law.

§ 42. (1) For medicinal products under art. 45, para. 10, 13 and 19, included in a positive list of medicines for which no agreed discounts, negotiated discounts, within 6 months of the entry into force of this law.

(2) within one month of the expiry of the period referred to in para. 1 the National Council for pricing and reimbursement of medicinal products officially excluded from the positive list of medicinal products which have not been agreed upon concessions.

(3) appeals against the acts and actions of the National Council on pricing and reimbursement of medicinal products under para. 2 not have suspensive effect.

§ 43. Under contracts between hospitals and suppliers of medicinal products for the treatment of malignant diseases in terms of hospital medical care HEALTH INSURANCE pays the cost of medicinal products, whether they are negotiated concessions until expiry of the period agreed in the contracts at the time of the entry into force of this law, but not more than 6 months.

§ 44. (1) national framework contracts, the volumes and prices of the medical and dental activities, methodologies for costing and cost of medical care and decisions under art. 54, para. 8 and/or 9 which act at the time of the entry into force of this law shall apply to the adoption of new national framework contracts.

(2) pending the adoption of new national framework contracts NHIF pays for medical aid under art. 55, para. 2, item 2, in the framework of the volumes, operating at the time of the entry into force of this law.

§ 45. (1) pending the adoption of new national framework contracts under art. 53, para. 1 checks by inspectors, financial controllers and doctors-doctors of dental medicine – controllers, imposition of sanctions and their appeal is made on the previous line.


(2) the checks referred to in paragraph 1. 1, the imposition of sanctions and their appeal, which began to adopt new national framework contracts under art. 53, para. 1 shall be completed on the previous line.

§ 46. (1) within three months of the entry into force of this law the medical scientific societies shall submit to the National Council on pricing and reimbursement of medicinal products guidelines and algorithms under art. 259, para. 1, item 4 of the law on medicinal products for human use.

(2) where, within the period referred to in paragraph 1. 1 medical scientific societies do not submit the guidelines and algorithms under art. 259, para. 1, item 4 of the law on medicinal products for human use, the National Council for pricing and reimbursement of medicinal products organized their preparation of national consultants or from other medical professionals who have experience in the relevant field.

(3) the National Council for pricing and reimbursement of medicinal products establishes the guidelines and algorithms under art. 259, para. 1, item 4 of the law on medicinal products for human use shall, within two months of expiry of the period referred to in para. 1.

§ 47. (1) within three months of the entry into force of this Act, the Minister of Health issued the Ordinance under art. 262, para. 4 of the law on medicinal products for human use.

(2) within 6 months of the entry into force of this law in a positive list of medicines may include medicinal products with new international non-proprietary names without an evaluation of health technologies.

§ 48. Paragraph 9, item 2 shall enter into force on January 1, 2016, and § 37 shall enter into force six months after the promulgation of the law in the Official Gazette.

The law was passed by the National Assembly-43 on 16 June 2015 and is stamped with the official seal of the National Assembly.

 President of the National Assembly Tsetska Tsacheva:

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