Act No. 298 / 2011 Coll.
Act amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and other related laws
Valid
Law
Effective from 01.12.2011
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298
THE LAW
of 6 September 2011
amending Act No 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and other related laws
Parliament has decided on this law of the Czech Republic:
Amendment to the Public Health Insurance Act
Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC and Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006 / EC, Act No. 2006 / 2006, Act No. 2006 / 2006, Act No. 2006 / 2006 / 2006, Act No. 2006 / 2006 / 2006, Act No. 2006 / 2006 / 2006 / 2006, Act No. 2006, Act No. 2006 / 2006 / 2006 / 2006, Act No. 2006 / 2006, Act No. 2006 / 2006, Act No. 2006 / 2006, Act No. 2006 / 2006 / 2006 / 2006 / 2006 Coll.
1. in Article 5 (a), the following point 8 is inserted after point 7:
"8th Member of the District Election Commission in the elections to the Parliament of the Czech Republic, the European Parliament and the representatives of the local authorities,"
2. in Article 7 (1) (h):
"(h) persons serving in the armed forces, with the exception of professional soldiers, and persons called for military training,"
3. footnote 13 is deleted, including the footnote references.
4. in Article 11 (1) (a), the words "on the first day of the calendar quarter" shall be replaced by the words "on 1 January of the following calendar year; the application is submitted by the insured person or his legal representative to the selected health insurance undertaking no later than 6 months before the required change date. An application for a change to the health insurance undertaking on 1 January of the calendar year may be submitted only one; any further applications shall no longer be taken into account, even if they are submitted within the prescribed time limit" and the words "in the second or third sentence 'shall be replaced by the words" in this provision'.
5. in Article 11 (1), the following point (f) is inserted after point (e):
"(f) choose the option of providing health care in accordance with § 13,"
Points (f) to (i) shall be renumbered as points (g) to (j).
6. In Paragraph 11, the dot is replaced by a comma at the end of paragraph 1 and the following point (k) is added:
"(k) the time and local availability of health care covered by health insurance provided by the health insurance undertakings concerned."
7. In the fifth sentence of Paragraph 11 (3), the words "in the basic service and the replacement service 'and the words" basic service or replacement service' are deleted.
8. In the seventh sentence of Article 11 (3), the words "basic or replacement service 'are deleted.
9. In Article 11, the following paragraph 4 is inserted after paragraph 3:
"(4) In the event of a merger, the merger of the Military Health Insurance Corporation with another health insurance undertaking under special legislation (28) in which the Military Health Insurance Company ceases to exist, the rights and obligations laid down by this Law of the Military Health Insurance Company, as well as the obligations laid down by the Ministry of Defence and other persons to the Military Health Insurance Company, shall be transferred to the successor health insurance company. The merger information shall be published by the Ministry of Health in a way that allows remote access. '
Paragraph 4 shall become paragraph 5.
10. in Article 11 (5), the words "performing civil service, persons" shall be deleted;
11. in Article 12, at the end of point (m), the dot is replaced by a comma and the following point (n) is added:
"(n) to pay the health care institution or, where appropriate, to another body which has provided health care to the insured, the difference between the price of the health care provided and the amount of the health insurance reimbursement referred to in Article 13.";
12. in Paragraph 13 (1):
"(1) Health insurance shall cover health care provided to the insured person in order to improve or maintain his or her health status or to alleviate his or her suffering if:
(a) corresponds to the health status of the insured person and to the purpose to be achieved by providing him and is reasonably safe for the insured person;
(b) comply with current available medical science knowledge;
(c) there is evidence of its effectiveness for the purpose of providing it. "
13. In Section 13, paragraphs 4 to 9 are added, including footnote 49:
"(4) Where the health care referred to in paragraph 1 can be provided in more than one way, all of which fulfil the conditions laid down in paragraph 1 and have the same therapeutic effect, the healthcare method shall be reimbursed in accordance with the efficient and economical management of the public health insurance resources (hereinafter referred to as the" basic variant '). Other forms of health care, according to the first sentence, which do not meet the condition for the efficient and economical disposal of public health insurance sources (hereinafter referred to as the "more economically demanding option') shall be paid out of health insurance at the level laid down for the reimbursement of such health care in the basic variant.
(5) Only health care, which is thus described in the implementing legislation issued pursuant to § 17, can be regarded as a more economically demanding option of healthcare. A more economically demanding option cannot be identified as health care that can only be provided in one way.
(6) Before providing health care, which can be provided both in the basic variant and in the more economically demanding variant, the health care institution shall offer the provision of health care in the basic variant and inform the health care provider of the more economically demanding option, including the difference between the price of the more economically demanding variant established in accordance with the price regulation and stated in the price list of the medical establishment, and the amount of the payment of health care in the basic variant provided for in the implementing legislation issued under § 17 and the price regulation49). The procedure under the first sentence shall not apply if, due to the medical condition of the patient, it is not possible to request his consent and it is urgent to save life or health. The price list for more economically demanding health care options must be published in a public health facility in an accessible location and in a way that allows remote access.
(7) In the cases referred to in paragraph 6, the health care establishment shall record in the health file of the insured person that it has been offered the provision of health care in a basic variant and that it has been informed of the possibilities of providing health care in a more economically demanding variant. Part of the entry in the health file is the consent of the insured person to provide the health care in the basic variant or to provide the health care in the more economically demanding option, if the insured person has decided for such a variant; in that case, the entry in the medical file shall also include the consent of the insured person to pay an amount equal to the difference between the price of the more economically demanding option and the amount of the payment of health care in the basic variant. Such consent shall be signed by the insured person and the treating physician; if the insured person is unable to sign the alert due to his medical condition, he shall confirm his undoubted speech of will with his signature by the attending physician and another witness. The record shall state the manner in which the insured person has shown his will and the health reasons preventing the signature of the insured person.
(8) Health care facilities must not give preference to insured persons who choose an economically more demanding option when providing health care.
(9) For the repeated breach of obligations under paragraphs 6 to 8, the health insurance company shall impose a fine of up to CZK 1 000 000. The determination of the amount of the fine shall take into account the seriousness of the infringement, in particular the manner in which it was committed and the consequences thereof and the circumstances in which it was committed. The fine may be imposed within 1 year of the date on which the relevant health insurance undertaking has established an infringement, but not more than 3 years from the date on which the infringement occurred. The fine is the income of the health insurance company that imposed it. Repeated grant of the fine is the reason for the termination of the contract for the provision and reimbursement of health care without the application of the period of notice referred to in Article 17 (3). A medical establishment shall not be liable for an infringement if it proves that it has made every effort to prevent an infringement.
49) § 2a (1) of Act No. 265 / 1991 Coll., on the competence of the Czech authorities in the field of prices, as amended. Section 10 of Act No. 526 / 1990 Coll., as amended. '
14. In Article 15 (4) of the Introductory Part of the provision, the words "least economically demanding execution 'shall be inserted after the words" reimbursement'.
15. in the first sentence of Article 15 (5), the words "containing active substances from the groups of active substances listed in Annex 2" shall be deleted; in the third sentence, the words "and transfusions" shall be replaced by the words "transfusions, transfusions, advanced therapy medicinal products and tissues and cells," and in the last sentence the words "and transfusions" shall be replaced by "transfusions, medical products, advanced therapy medicinal products and tissues and cells."
16. in Article 15 (6) (e), the words "or the second generic in accordance with § 39b (4) and their holder of the marketing authorisation shall be replaced by the words" similar in accordance with § 39b (4) of the reference group, which has been registered as a biological medicinal product or a generic under the drug law, and the holder of the marketing authorisation with the application in writing. "
17. in Paragraph 15 (6), the dot is replaced by a comma at the end of point (e) and the following point (f) is added:
"(f) whose price for final consumers would be less than or equal to CZK 50 in the case of reimbursement of health insurance."
18. in Article 15 (6), the final part of the provision is deleted;
19. In Article 15, the following paragraphs 7 and 8 are inserted after paragraph 6:
"(7) Therapeutic efficacy means the ability to produce the desired effect using a medicinal product or a food for special medical purposes and under normal clinical practice. Effective therapeutic intervention means health care provided to prevent or treat diseases in order to achieve the most effective and secure treatment while maintaining cost-effective treatment.
(8) Cost-effectiveness means the determination of the cost-benefit ratio of a medicinal product or a food for special medical purposes compared to the use of another medicinal product, a food for special medical purposes or a treatment process; cost-effectiveness is assessed in comparison to a therapeutic treatment that is generally accepted as usual. Cost-effective treatment procedures are those which, at comparable costs, produce the same or higher therapeutic effect of extending life, improving the quality of life or improving the essential and measurable criteria of the disease concerned, or which, at least comparable therapeutic effects, entail lower overall costs for the health insurance system, or at higher costs and higher therapeutic effects, this ratio is comparable to other therapeutic practices covered by health insurance funds. The assessment of cost-effectiveness shall be required for medicinal products or food for special medical purposes which are not included in the reference group referred to in Article 39c (1) or for which a prescription or indication restriction is proposed different from in principle therapeutically interchangeable medicinal products or foods for special medical purposes, or for which a further increase in remuneration is required pursuant to Article 39b (11) or, where appropriate, an increase in the reimbursement of the medicinal product or food for special medical purposes compared to the basic remuneration. ';
Paragraphs 7 to 11 shall be renumbered paragraphs 9 to 13.
20. in Article 15 (9) (a), the words "the amount of the payments" shall be replaced by "the fixing, modification and cancellation of the amount of the remuneration."
21. in Paragraph 15 (9) (d), the word "amount" shall be replaced by the words "determination, amendment and cancellation."
22. In Paragraph 15, at the end of paragraph 9, the dot is replaced by a comma and the following point (f) is added:
"(f) basic remuneration of the reference group.";
23. Paragraph 15 (10) reads:
"(10) A medicinal product, the reimbursement of which by decision of the Institute of Health Insurance is conditional on use in a specialised workplace, shall only be covered by the health insurance company with which it has concluded a special contract for the economical use of such medicinal products. Such a contract shall include the indication of the medicinal product and the workplace of the medical establishment. ';
24. In Article 15, the following paragraphs 11 and 12 are inserted after paragraph 10:
"(11) The medical devices listed in Section B of Annex 3 to this Act are not covered by health insurance. The medical devices listed in Section C of Annex 3 to this Act shall be covered by health insurance at the level and under the conditions set out in this Annex.
(12) Medical devices other than those referred to in paragraph 11 shall be covered by health insurance at the rate of 75% of the price of the medical device in the performance of the least economically demanding, depending on the degree and severity of the disability; the price of the least economically difficult execution of the medical device is ascertained by the health insurance company by market research. Health insurance under this paragraph shall be covered by medical devices prescribed for the purpose of:
(a) continue the treatment process;
(b) to encourage or significantly improve the health of the insured person or to eliminate deterioration; or
(c) to compensate or mitigate the consequences of a medical defect, including replacement or modification of the anatomical structure or physiological process. "
Paragraphs 11 to 13 shall be renumbered paragraphs 13 to 15.
25. in Article 16a (1) (d):
"(d) CZK 30 per recipe, whereby the first package of prescribed medicinal products or foodstuffs for special medical purposes was delivered, regardless of the number of medicines or foodstuffs for special medical purposes,"
footnote 27b is deleted.
26. in Paragraph 16a (1) (f), "60" is replaced by "100."
27. in Article 16a (6), "(§ 40 (3))" is replaced by "(§ 40 (4))";
28. in Paragraph 16a (9):
"(9) The medical establishment shall be obliged to levy the regulatory fee referred to in paragraph 1 from the insured person or his legal representative, unless it is an exemption from the payment of the regulatory fee referred to in paragraph 2 or 3. In the event of a repeated and systematic breach of this obligation, the health insurance company is entitled to impose a fine of up to CZK 1 000 000. The fine may also be imposed repeatedly. When imposing a fine, the health insurance undertaking shall take into account the seriousness of the infringement, the level of blame and the circumstances in which the infringement occurred. The fine may be imposed within 1 year of the date on which the health insurance undertaking has established a breach or failure to fulfil the obligation, but not more than 3 years after the date on which the infringement or non-compliance occurred. The fine shall be the income of the health insurance undertaking which imposed it. ';
(29) In Article 16b (1), the second sentence is replaced by the following: "The limit referred to in the first sentence shall include arrears for partially paid medicinal products or food for special medical purposes containing the same active substance and the same route of administration only at the level calculated on the basis of the supplement to the medicinal product or food for special medical purposes, the supplement to which the quantity unit of the medicinal product is the lowest and for which no interruption or termination has been detected." and the last sentence shall be deleted.
30. Paragraph 17 (5) reads:
"(5) The Ministry of Health sets out by decree a list of health performance with point values and the designation of health care variants according to § 13."
31. in the fifth sentence of Article 17 (6), "90" is replaced by "120."
32. In the second sentence of Article 17 (7), the words "with the exception of medical care facilities, medicinal products containing the active substances listed in Annex 2 to this Act, for which the Institute decides on such a method of reimbursement 'are replaced by the words" providing outpatient health care, medicinal products for which the Institute decides on such a method of reimbursement' and the phrase "at the end of the paragraph, the health insurance company may negotiate a different method of reimbursement of medicinal products in the provision of constitutional care for which it has negotiated the amount and conditions of reimbursement with the marketing authorisation holder or the manufacturer. ';
33. In Article 17, at the end of paragraph 8, the dot is replaced by a comma and the following point (d) is added:
"(d) contracts to persons authorised to distribute medicinal products under the Law on Medicines, medicinal products containing vaccines for periodic vaccination according to the antigenic composition of vaccines established by the Ministry of Health under the Act on the Protection of Public Health.";
34. in Article 30 (2) (a):
"(a) vaccination and reimbursement of medicinal products containing vaccines for regular vaccination according to the antigenic composition of vaccines established by the Ministry of Health under the Public Health Protection Act,"
footnote 35 is deleted.
35. in Article 30 (2) (b), the introductory part of the provision reads: "vaccination and reimbursement of medicinal products containing vaccines in the least economically difficult way."
36. In Article 32, paragraphs 4 and 5 are added:
"(4) A medical establishment authorised to issue medicinal products may not, in connection with the issue of a prescription-related medicinal product covered by public health insurance, provide, offer or promise monetary or non-monetary benefits, benefits or gifts of a property or non-property nature, including through third parties.
(5) In the event of a repeated breach of obligation pursuant to paragraph 4, the health insurance company shall be entitled to impose a fine of up to CZK 1 000 000. The fine may also be imposed repeatedly. When imposing a fine, the health insurance undertaking shall take into account the seriousness of the infringement, the level of blame and the circumstances in which the infringement occurred. The fine may be imposed within 1 year of the date on which the health insurance undertaking has established a breach or failure to fulfil the obligation, but not more than 3 years after the date on which the infringement or non-compliance occurred. The fine shall be the income of the health insurance undertaking which imposed it. ';
37. Paragraph 39a (2) to (4) states:
"(2) The Institute shall fix the maximum price of the manufacturer, with the exception of the procedures referred to in paragraphs 4 to 6, at:
(a) the average of the prices of the manufacturer of the medicinal product or food for special medical purposes of the three Member States of the European Union, with the exception of the Czech Republic, Estonia, Cyprus, Luxembourg, Malta and Germany (hereinafter referred to as the "country of the reference basket"), which have the lowest price for the medicinal product or food concerned for special medical purposes, if the medicinal product or food under consideration is on the market in at least three countries of the reference basket;
(b) the prices of a manufacturer of a medicinal product or a food for special medical purposes contained in a written arrangement concluded in the public interest pursuant to Article 17 (2) by a health insurance undertaking with a marketing authorisation holder of a medicinal product, an importer or a domestic manufacturer of a food for special medical purposes, an importer or a promoter of a specific treatment programme, if the arrangement is concluded for at least 1 year with a notice period of at least 3 months for all supplies of a medicinal product or a food for special medical purposes on the market of the Czech Republic, and if it is not possible to comply with point (a);
(c) producer prices of the nearest therapeutic medicinal product or food for special medical purposes found in the countries of the reference basket or in the Czech Republic, unless they can be followed by (a) and (b). If the nearest therapeutic medicinal product or food for special medical purposes is available in the Czech Republic, the lowest producer price recorded in the Czech Republic shall apply; where, for such a medically comparable medicinal product or food for special medical purposes, the marketing authorisation holder is the same as for the medicinal product or food concerned for special medical purposes, this price shall apply if it has been established in accordance with point (a). If this cannot be done, the lowest producer price recorded in the countries of the reference basket shall be used. When selecting the nearest therapeutic medicinal product or food for special medical purposes, the relevant criteria shall be taken into account in the following order: active substance, pharmaceutical form, strength of the medicinal product, package size.
(3) The Ministry of Health provides for implementing legislation
(a) rules for the selection of the relevant period for the conversion of foreign foreign exchange prices;
(b) the applicable period and rules for establishing the manufacturer's price and assessing the availability of the medicinal product or food for special medical purposes;
(c) the method of calculating the maximum price for a similar preparation in accordance with paragraphs 4 to 6;
(d) the rules for excluding the manufacturer's foreign price as determined in accordance with paragraph 2 from the use for setting the maximum price;
(e) a tolerance in the package size in search of the manufacturer's foreign price referred to in paragraph 2;
(f) rules for increasing the maximum price in the public interest pursuant to Article 17 (2);
(g) the method of setting the maximum price for highly innovative medicinal products for which an application is made for a maximum price equal to that for all strengths of the medicinal product, irrespective of the content of the active substance;
(h) the rules for notification of the highest price at which the marketing authorisation holder of a medicinal product, importer or domestic manufacturer of a food for special medical purposes or of an unregistered medicinal product used in a specific treatment programme intends to place a medicinal product or a food for special medical purposes on the market for medicinal products or foodstuffs for special medical purposes which are not subject to regulation of the producer price by setting the maximum price.
(4) The Institute fixes the maximum price for a similar product according to the maximum price for a medicinal product to which the medicinal product under consideration is similar, in the event that:
(a) a maximum price is not required beyond the maximum price for a medicinal product to which the medicinal product under consideration is similar in accordance with an application under Paragraph 39f (8);
(b) in an application for a maximum price for a similar product, the applicant shall apply for a maximum price for the procedure referred to in Paragraph 39g (9); and
(c) the fixing of remuneration shall not preclude the conditions laid down in Article 15 (6) (e) or Article 39g (10). ";
38. In Paragraph 39a, the following paragraphs 5 to 7 are inserted after paragraph 4:
"(5) The Institute shall calculate the maximum price of the first similar preparation in the reference group referred to in paragraph 4 and shall further reduce that price by:
(a) 15% in the case of a medicinal product that has been authorised as a biological medicinal product under the drug law, in a situation where there is only 1 similar medicinal product that has been authorised as a biological medicinal product in the health insurance reimbursement scheme ("reimbursement scheme"),
(b) 32% in the case of a medicinal product that has been registered as generic under the drug law in a situation where there is only 1 similar product in the reimbursement system that has not been authorised as generic;
(c) 15% in the case of a medicinal product that has not been registered as a generic under the drug law, in a situation where there is only 1 similar product in the reimbursement system that has not been registered as a generic.
(6) The Institute shall calculate the maximum price of the first like preparation in the reference group for which the conditions laid down in paragraph 4 are not met, in accordance with the procedure laid down in paragraphs 2 and 5, and shall fix the maximum price at the lowest rate of that calculation.
(7) The maximum price of the medicinal product determined in accordance with paragraphs 5 and 6 cannot be increased until the first subsequent in-depth revision is carried out in accordance with § 39l. '
Paragraph 5 shall become paragraph 8.
39. In the second sentence of Paragraph 39a (8), "prices recorded in at least one country of the reference basket or at the level of the average of production prices' are replaced by" average of producer prices'.
40. in Paragraph 39b (2) (c):
"(c) a participant in the procedure submitted an assessment of the cost-effectiveness and impact on health insurance funds caused by the use of a medicinal product or a food for special medical purposes, expressing the costs per patient and the estimated number of patients treated per year, in cases where the level and / or change of payment conditions or in-depth or shortened revision of medicinal products or special medical foods are required to extend the conditions of reimbursement leading to an increase in the number of patients treated, an increase in remuneration compared to the basic payment or 1 additional increase in remuneration compared to the current situation or to other medicinal products or to foods for special medical purposes in the reference group,"
41.Paragraph 39b (4) reads as follows:
"(4) For the purposes of this Act, a medicinal product which has the same active substance or active substances and the same or similar pharmaceutical form with a covered medicinal product with which it is essentially interchangeable. Furthermore, a similar product means a biological medicinal product that has a similar biological substance or biological substance and an identical or similar pharmaceutical form with a covered medicinal product with which it is essentially interchangeable. The first similar product shall mean a similar product for which an application is made for the setting of a maximum price or the amount and conditions of payment as first in order. ';
42. In Paragraph 39b, the following paragraphs 5 to 9 are inserted after paragraph 4:
"(5) The Institute shall determine the level of reimbursement of the product under consideration according to the level and conditions of reimbursement of the medicinal product to which the medicinal product under consideration is similar, where:
(a) the amount and conditions of payment are not required in addition to those of the medicinal product to which the medicinal product under consideration is similar in accordance with § 39f (8);
(b) in the application for the amount and conditions of reimbursement of a similar product, the applicant shall apply for the amount and conditions of reimbursement in accordance with Article 39g (9),
(c) the setting of remuneration does not preclude the conditions laid down in Article 15 (6) (e) or Article 39g (10); and
(d) an application is also made for the establishment of a maximum price in accordance with Paragraph 39a (4) or (5) where the medicinal product or food for special medical purposes is subject to price regulation.
(6) The Institute shall calculate the amount of the payment of the first similar preparation in the reference group referred to in paragraph 5 and shall further reduce that remuneration in the manner laid down in Paragraph 39a (5).
(7) In the event that the first like product in the reference group does not meet the conditions set out in paragraph 5, the Institute shall calculate the amount of the remuneration referred to in Paragraph 39c (8) and shall further reduce that remuneration in accordance with paragraph 6.
(8) The Institute shall without delay initiate the procedure laid down in Article 39c (9) following the acquisition of legal power in respect of the decision to determine the amount and conditions for reimbursement referred to in paragraph 6 or 7.
(9) The amendment of a marketing authorisation or the transfer of a marketing authorisation for a medicinal product shall not affect the maximum price or amount and the conditions for payment of the authorised medicinal product, unless the change of the marketing authorisation or transfer of the marketing authorisation has also resulted in a change which may have a direct effect on the maximum price or amount or conditions of payment. ';
Paragraphs 5 to 7 shall be renumbered paragraphs 10 to 12.
43. In Paragraph 39b, the following paragraphs 12 and 13 are inserted after paragraph 11:
"(12) The level of reimbursement of medicinal products consisting of 2 or more active substances for which more than 1 active substance is separately covered shall be determined by:
(a) the sum of the payments for the usual daily therapeutic dose of the active substances separately paid, determined in accordance with Paragraph 39c (7);
(b) the highest producer price contained in the written arrangement referred to in Article 39a (2) (b) if the price is lower than the remuneration calculated in accordance with (a);
(c) the amount of the remuneration contained in the written arrangement referred to in Article 39c (2) (d), if the remuneration is less than the remuneration calculated under points (a) and (b).
(13) The level of reimbursement of medicinal products consisting of 2 or more active substances for which only 1 active substance is separately covered shall be determined by:
(a) according to the remuneration for the usual daily therapeutic dose of the active substance covered separately, determined in accordance with § 39c (7);
(b) the highest producer price contained in the written arrangement referred to in Article 39a (2) (b) if the price is lower than the remuneration calculated in accordance with (a);
(c) the amount of the remuneration contained in the written arrangement referred to in Article 39c (2) (d), if the remuneration is less than the remuneration calculated in accordance with points (a) and (b). ";
Paragraph 12 shall become paragraph 14.
44. in Paragraph 39b (14):
"(14) The Ministry of Health provides for implementing legislation
(a) the rules and limits for increasing or reducing the remuneration referred to in paragraph 2 against a fixed basic remuneration, taking into account the characteristics of the medicinal product or food concerned for special medical purposes as compared to others, in principle, medically interchangeable medicinal products or foodstuffs for special medical purposes;
(b) the method of calculating the amount of payment of a similar preparation in accordance with paragraphs 5 to 7;
(c) the use of procedures under Sections 39b to 39i for the determination or modification of the amount and conditions of reimbursement of medicinal products consisting of 2 or more active substances;
(d) the use of procedures under Sections 39b to 39i to determine or alter the amount and conditions of reimbursement of medicinal products and foodstuffs for special medical purposes in the form of liquid undivided pharmaceutical forms;
(e) the method of determining the remuneration for highly innovative medicinal products for which an application is made for a refund of the same amount for all strengths, irrespective of the content of the active substance,
(f) rules for determining the conditions for reimbursement in the form of descriptive and indicative restrictions and methods of payment. ";
45. in Paragraph 39c (1), at the end of the first sentence, the words "unless it is established during the proceedings that it does not belong to the reference group" shall be added, and in the second sentence, the words "The basic payment of the medicinal product is equal to the basic payment" shall be replaced by the words "The reimbursement of the medicinal product shall be determined on the basis of the basic remuneration."
46. in Paragraph 39c (2):
"(2) The basic remuneration shall be set at the rate of:
(a) the lowest producer prices for the daily therapeutic dose of a medicinal product or a food for special medical purposes included in the reference group established in any country of the European Union for a medicinal product or a food for special medical purposes available in the Czech Republic; the medicinal product or food for special medical purposes available on the market in the Czech Republic means a medicinal product or food for special medical purposes whose share in the total volume of sales, in principle, of therapeutically interchangeable medicinal products or special medical food containing the same active substance, during the relevant period, was at least 3%, except for the first to third like product in the medicinal product in the order of the application for the level and conditions of reimbursement, or a medicinal product for which the highest price of the manufacturer or reimbursement was concluded; such medicinal products are always considered available on the market in the Czech Republic,
(b) the daily costs of other therapy reduced by trade surcharges and value added tax applied, where it is comparable and cost-effective compared to the use of the medicinal product or food for special medical purposes referred to in point (a), and these facts are known to the Institute when determining the basic remuneration, taking into account the required duration of treatment with the medicinal product or food for special medical purposes and the need for comparable treatment;
(c) the highest producer price contained in the written arrangement referred to in Article 39a (2) (b), if the price is lower than the payment calculated in accordance with points (a) and (b), if the holder of the marketing authorisation for the medicinal product, importer or domestic food producer for special medical purposes, importer or the promoter of a specific treatment programme has not committed an administrative offence under Article 39q (1) (b) in the last 2 years;
(d) the remuneration contained in a written arrangement concluded in the public interest by all health insurance companies with a marketing authorisation holder for a medicinal product, an importer or a domestic producer of a food for special medical purposes, unless it has been committed within the last 2 years of an administrative offence under Paragraph 39q (1) (c) for all supplies of the medicinal product or food for special medical purposes on the Czech Republic market, and the obligation that the medicinal product or food for special medical purposes is available on the Czech Republic market for at least 1 year and the final consumer price for the final consumer does not exceed the highest possible remuneration for the final consumer. "
47. in Article 39c (4) and (5):
"(4) The provisions on reference groups shall apply mutatis mutandis to a medicinal product or a food for special medical purposes that cannot be included in a reference group or a group of medicinal products or foods for special medical purposes, in principle, which cannot be classified in any reference group.
(5) In the event that, when determining the remuneration provided for in Sections 39b to 39e, a group of active substances listed in Annex 2 to this Act would not be fully covered, irrespective of the therapeutic interchangeability of at least 1 medicinal product, the Institute shall adjust the reimbursement decision so that the least expensive medicinal product from the group of medicinal products under consideration is fully covered. ';
48. in § 39c paragraphs 7 and 8 read:
"(7) The basic remuneration of the reference group shall be determined in the context of an in-depth or shortened revision of the payments and shall be valid until the change in the subsequent revision of the payments. Similarly, a further increase in remuneration pursuant to Paragraph 39b (11) shall be applied.
(8) Unless otherwise provided for in this Law, in the procedures for determining or amending the amount and conditions for payment, the amount of the basic payment made in the subsequent revision of the system shall be used to determine or alter the amount of reimbursement of all essentially interchangeable medicinal products and foodstuffs for special medical purposes, the amount of the basic remuneration of the reference group determined in accordance with paragraph 7; this shall not apply where the applicant referred to in Article 39f (2) (a) or (b) has been proposed in a more cost-effective manner. ';
49. In Paragraph 39c, paragraphs 9 to 11 are added:
"(9) Where, in accordance with Article 39b (6) or (7), a payment of the first similar product has been made in a reference group which:
(a) has been registered as generic under the drug law, the basic remuneration fixed in accordance with paragraph 7 shall be reduced by 32%,
(b) it has not been registered as generic under the drug law, the basic remuneration fixed under paragraph 7 shall be reduced by 15%;
(c) it has been registered as a biological medicinal product under the drug law, the basic payment referred to in paragraph 7 is reduced by 15%.
(10) A reduction in the basic remuneration referred to in paragraph 9 shall be made in accordance with the procedure laid down in Paragraph 39p.
(11) The Ministry of Health provides for implementing legislation
(a) the procedure for calculating the lowest producer price referred to in paragraph 2 (a);
(b) details of the determination of the basic remuneration;
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Regulation Information
| Citation | Act No. 298 / 2011 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, and other related laws |
|---|---|
| Regulation Type | Law |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.10.2011 |
|---|---|
| Effective from | 01.12.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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