What is Act No 371 / 2021 Coll.?

Act No. 371 / 2021 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, and certain other laws — Act amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and certain other laws.

When it became Act No 371 / 2021 Coll. effectiveness?

Act No 371 / 2021 Coll. became effective 01.01.2022.

Is Act No 371 / 2021 Coll. still valid?

Yes, Act No 371 / 2021 Coll. is still valid and effective.

How many times was it Act No 371 / 2021 Coll. amended?

Act No 371 / 2021 Coll. has 7 time versions of the text.

Act No 371 / 2021 Coll.

Act amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and certain other laws

Valid Law Effective from 01.01.2022

Text versions: 01.01.2025 01.01.2023 31.08.2022 01.01.2022 01.11.2021 All versions (6)

ČÁST PRVNÍ Čl. I „§ 17b „§ 17c § 19 § 20 „§ 38a „§ 39d „§ 39da „§ 39m „§ 40b „§ 44 „§ 44a „§ 44b „§ 53d ODDÍL A ODDÍL B ODDÍL C Čl. II ČÁST DRUHÁ Čl. III ČÁST TŘETÍ Čl. IV Čl. V ČÁST ČTVRTÁ Čl. VI ČÁST PÁTÁ Čl. VII „§ 70a Čl. VIII ČÁST ŠESTÁ Čl. IX „§ 20a § 20b „HLAVA IV § 44b § 44c § 44d § 44e „§ 113a § 113b § 113c § 113d § 113e „ČÁST TŘINÁCTÁ § 113f Čl. X ČÁST SEDMÁ Čl. XI ČÁST OSMÁ Čl. XII „§ 44a Čl. XIII ČÁST DEVÁTÁ Čl. XIV ČÁST DESÁTÁ Čl. XV ČÁST JEDENÁCTÁ Čl. XVI

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371

THE LAW

of 14 September 2021

amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended, and certain other laws

Parliament has decided on this law of the Czech Republic:

ČÁST PRVNÍ

Amendment to the Public Health Insurance Act

Čl. I

Act No. 1 / 2006, Act No. 1 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 6 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5 / 2006, Act No. 5 / 2006, Act No. 5, Act No. 5, Act No. 5, Act No. 2006, Act No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No 2006, No Act No. 47 / 2016 Coll., Act No. 66 / 2017 Coll., Act No. 150 / 2017 Coll., Act No. 183 / 2017 Coll., Act No. 200 / 2017 Coll., Act No. 111 / 2019 Coll., Act No. 262 / 2019 Coll., Act No. 277 / 2019 Coll., Act No. 165 / 2020 Coll., Act No. 205 / 2020 Coll., Act No. 538 / 2020 Coll., Act No. 540 / 2020 Coll., Act No. 569 / 2020 Coll., Act No. 261 / 2021 Coll., Act No. 274 / 2021 Coll.

1. in Article 5 (a) (7), the words "in the elections to the European Parliament, the Senate and the representatives of the local authorities and a member of the District Electoral Commission and the Special District Electoral Commission in the elections to the Chamber of Deputies and the election of the President of the Republic" shall be replaced by the words "or a special District Electoral Commission which performs tasks under the electoral laws."

2. in Article 5 (b):

"(b) is a self-employed person who, for the purposes of health insurance:

1. the person carrying out the activity from which the income is derived from a separate activity under the Income Tax Act;

2. the cooperating person of the person referred to in point 1, provided that the income and expenditure to be achieved, secured and maintained can be distributed to him under the Income Tax Act; ';

3. In Paragraph 10 (6), the last sentence is deleted.

4. Paragraph 10 (7) is deleted.

5. Paragraph 11 (1) (j) reads as follows:

"(j) on the issue of a proof of payment for the issue of a partially paid medicinal product or of a partially paid food for special medical purposes by a pharmacist, for the provision of a partially paid specifically charged medicinal product provided by a health service provider or for the issue of a partially paid medical device by a person authorised to issue medical devices under the Law on Medical Devices,";

6. In Paragraph 11a (1), the following sentence is inserted after the second sentence: "If the last day of this period is Saturday, Sunday or holiday, the last day of the period shall be the next working day."

7. In Article 12 (o), the words "but he has not been granted an invalidity pension for failure to fulfil the insurance period condition under special legislation 42h 'are replaced by the words" but he is not a beneficiary of an invalidity pension for other reasons'.

footnote 42 is deleted.

8. in Article 15 (3) (a) and (b), the words "the 37th" shall be replaced by the words "the 40th."

9. In Article 15 (5), the words "including advanced therapy medicinal products and specifically charged medicinal products' and the words" transfusions, advanced therapy medicinal products and tissues and cells' are replaced by the words "transfusions, tissues and cells and individually manufactured advanced therapy medicinal products with the exception granted to allow the use of an unregistered advanced therapy medicinal product in a bed-care facility under the Law on Medicines';

10. In Article 15 (6) of the Introductory Part of the provision, the words "and third 'shall be inserted after the words" and, if', the words "to them 'and the words" by decision' shall be deleted.

11. in Article 15 (6), the word "which" shall be inserted at the beginning of points (c) and (d).

12. in Article 15 (6) (d), the word "or" shall be deleted;

13. in Article 15 (6) (e), the words "which have been registered as a biological medicinal product or generic under the drug law," shall be deleted; the words "market after" shall be replaced by the words "market in the case of existing demand all over" and the word "or" shall be added at the end of the letter. "

14. In Article 15, at the end of paragraph 7, the following sentence is added: "Where medicinal products intended for the treatment of rare diseases under § 39da are used, effective therapeutic intervention shall mean health services provided for the prevention or treatment of rare diseases in order to achieve the most effective and secure treatment, provided that the pharmacological effect of the disease is of social importance and that the financial impact on the health insurance system (hereinafter referred to as the" budgetary impact ') is consistent with the public interest under § 17 (2). "

15. The last sentence of Paragraph 15 (8) shall be replaced by the following: "The amount of the impact on the budget shall be determined as the difference between the costs of the treatment of the disease in question associated with the use of the medicinal product or food for special medical purposes which would be covered by health insurance and the costs of treatment using another medicinal product, food for special medical purposes or treatment which is already covered by health insurance. The budgetary impact must be in line with the public interest under Article 17 (2). '

16. In Article 15, the following paragraph 9 is inserted after paragraph 8:

"(9) Where the estimated impact on the budget of a medicinal product or a special medical food is showing an increase in expenditure under the health insurance scheme, a cost-effectiveness assessment and an analysis of the impact on the budget shall be required for the determination or change of the amount and conditions of reimbursement of the medicinal product or food for special medical purposes or in an in-depth review pursuant to § 39l where the party to the proceedings removes from the situation prior to the initiation of such proceedings

(a) a remuneration higher than the level of payments of the other products, taking into account differences in dosage and package size,

(b) a remuneration higher than that calculated on the basis of the basic remuneration provided for in Article 39c (2) to (5);

(c) the wording of the prescriptive or indication restrictions different from, in principle, therapeutically interchangeable medicinal products or foodstuffs for special medical purposes;

(d) the determination of further increased remuneration under Paragraph 39b (11); or

(e) the setting or modification of the amount and conditions for reimbursement of a medicinal product or foodstuff for special medical purposes which are not, in principle, interchangeable with any other medicinal product or food for special medical purposes covered by health insurance. "

Paragraphs 9 to 16 shall be renumbered paragraphs 10 to 17.

17. in Article 15 (10) (e), "o" is deleted;

18. in Paragraph 15 (10) (f), the words "basic remuneration" are replaced by the words "fixing, changing and cancelling the basic remuneration."

19. in Article 15 (13) (b):

"(b) the treatment and repair of medical devices and the individual therapeutic treatment of articles of the personal need of insured persons to the extent and under the conditions laid down in Annex 3 to this Act.";

20. In Article 15 (16), the words "health establishments' are replaced by the words" providers' and the words "a list of health performance with point values 25) 'are replaced by the words" a decree issued pursuant to Article 17 (4)'.

footnote 25 is deleted.

21. In Article 16 (1), the words "in accordance with the procedure laid down in Article 19 (1) (a)" shall be inserted after the words "to be replaced" and the words "by a health insurance undertaking" shall be replaced by "from health insurance."

22. Paragraph 16 (2) is deleted and paragraph 1 is deleted.

23. in the first sentence of Article 16b (1), the words "but an invalidity pension has not been granted to them for failure to fulfil the conditions of the insurance period under the special legislation 42h" shall be replaced by the words "but they are not beneficiaries of an invalidity pension for other reasons."

24. In Article 16b (2), the amount "50 CZK" is replaced by "200 CZK" and the words "the last calendar quarter in the calendar year" are replaced by the words "the quarter in which the limit referred to in paragraph 1 was exceeded by at least 200 CZK in the sum of this amount."

25. Paragraph 17 (2) reads:

"(2) The contract referred to in paragraph 1 between the health insurance undertaking and the provider shall be governed by the framework contract. The framework agreement shall always contain a provision concerning the period of effectiveness, the manner and the reason for the termination of the contract referred to in paragraph 1, with a minimum notice period of six months being available on 1 January of the following year. This period of notice shall not apply in cases where, as a result of serious circumstances, a further performance of the contract cannot reasonably be expected. In addition, the framework contract shall include the arrangements for making the payment of the services paid, the rights and obligations of the parties to the contract referred to in paragraph 1, unless they are laid down by law, the general conditions of quality and the effectiveness of the provision of the services paid, the conditions necessary for the performance of the contract referred to in paragraph 1, the control mechanism for the quality of the services provided and the accuracy of the amounts charged, as well as the obligation to communicate to each other the data necessary to check the performance of the contract on the provision and reimbursement of the services paid, the provisions on arbitration. The Framework Agreement is the result of a conciliation procedure between representatives of the General Health Insurance Company of the Czech Republic and other health insurance companies and representatives of the relevant professional associations of providers as representatives of the contractual providers. The conciliation procedure may be initiated by either party or by the Ministry of Health. Individual framework contracts shall be submitted to the Ministry of Health, which shall assess them in terms of compliance with the legislation and public interest in ensuring the quality and availability of the services paid, the functioning of the health system and its stability within the financial possibilities of the public health insurance system (hereinafter referred to as the" public interest ') and shall then be issued as a decree. Where there is no agreement between the parties to the conciliation procedure on the content of the framework contract within 6 months or where the framework contract submitted is contrary to legislation or public interest, the content of the framework contract shall be determined by a decree in accordance with the sentence of the second to fourth Ministry of Health. The contract referred to in paragraph 1 shall be governed by this Order.';

26. in Article 17 (4) and (5):

"(4) The list of health performance and other performance related to the provision of paid services, to point values and to reporting rules (hereinafter referred to as" the list of health performance ") shall be laid down by the Ministry of Health by decree. The list of health performance shall be used for reporting health performance and other performance related to the provision of the services to be paid and reported for the purpose of making payments to providers and other entities providing the services to be paid, ensuring the continuity of the services to the insured or evaluating the effectiveness of the provision of the services to be paid (hereinafter referred to as" point-value performance '). The provider or other body providing the services covered and the health insurance undertaking may agree on a different reporting method.

(5) Save as otherwise provided for in this Act, the value of the item, the amount of the payment of the services paid, the amount of the advances for the payment of the services paid and the regulatory restrictions shall be agreed in the conciliation procedure between representatives of the General Health Insurance Agency of the Czech Republic and other health insurance companies and the relevant professional associations of providers as representatives of contractual providers. The Director of Conciliation is the Ministry of Health. If an agreement is reached, the Ministry of Health will assess its content in terms of compliance with legislation and public interest. If the agreement is legal and public interest, the Ministry of Health shall issue it as a decree. If the conciliation procedure fails to reach agreement by 30 June of the relevant calendar year, or if the Ministry of Health finds that the agreement is not in accordance with legislation or public interest, it shall determine the value of the point, the amount of the payment of the services paid, the amount of the advances for payment of the services paid and the regulatory limits for the following calendar year by a decree by 31 October of the calendar year. The decree referred to in the fourth and fifth sentences shall apply unless the provider and the health insurance undertaking agree otherwise, subject to compliance with the health insurance plan, on the method of payment, the amount of remuneration, the amount of advances to cover the services paid and the regulatory restrictions. ';

27. in Article 17 (7) (a) (2), "individually manufactured medical devices" is replaced by "custom-made medical devices."

28. in Article 17 (7) (a) (3):

"3. optics with which the health insurance company has concluded a contract for this purpose, only medical devices for the treatment of malaise in children, medical devices for the faint-sighted and medical devices for the correction of vision in accordance with Annex 3 to this Act, '.

29. in Paragraph 17 (9), the words "contracts under the first sentence" shall be replaced by "such agreements."

30. § 17b reads:

„§ 17b

(1) The inclusion, modification or elimination of performance with a point value from the list of health performance are proposed by the Ministry of Health, Health Insurance or the relevant professional company, which is the relevant professional company, associated with the Czech Medical Society Jan Evangelist Purkyně, a professional organisation or a professional company, which brings together natural persons with professional or specialised competence in the medical profession.

(2) The proposal referred to in paragraph 1 shall include a draft registration sheet containing at least the name of the power at point value, the justification of the design, the description of the power at point value and its execution, the rules for its reporting and the supporting documents for calculating its point value. When proposing the inclusion of a new power with a point value, an assessment of the efficiency of the power with a point value and a comparison with the proven therapeutic benefit of existing procedures in the same or similar indication is also included in the registration sheet if such comparison is possible. The model of the draft registration sheet, the instructions for filling it in and the calculation formula for calculating the point power value with a point value shall be published by the Ministry of Health on its website. Furthermore, the Ministry of Health shall publish its own proposals and proposals on its website for at least 30 days.

(3) In order to evaluate the proposal from a technical point of view, the Minister for Health, as his advisory body, establishes a working group on the list of health performance. The Working Party on the list of health performance issues gives opinions on individual proposals.

(4) The members of the Working Party on the list of health performance are appointed and withdrawn by the Minister for Health. A representative of the relevant expert company who submitted the proposal shall always be invited to the meetings of the working group on the list of health performance. The working group's activities on the list of health performance are governed by the Rules of Procedure published by the Ministry of Health in the Ministry of Health Bulletin.

(5) The Ministry of Health shall continuously review the performance with the points contained in the list of health performance to ensure that performance with the points is consistent with developments in the provision of health services and cost development. If the Ministry of Health finds, in accordance with the first sentence, that the performance at point value does not correspond to developments in the provision of health services and the development of costs, it shall proceed in accordance with paragraphs 1 and 2.

(6) The register of performance sheets with the points listed in the health performance list and the dates of all revisions made to each performance with the points referred to in paragraph 5 shall be published by the Ministry of Health on its website. "

31. the following Article 17c is inserted after Article 17b:

„§ 17c

(1) The associations of providers representing providers in the conciliation procedures referred to in Article 17 (2) and (5) shall provide the Ministry of Health with a list of all providers they represent in the conciliation procedure and full authority dates within 5 working days of the opening of the relevant conciliation procedure.

(2) The participants in the conciliation procedure shall provide the Ministry of Health with a report on the outcome of the conciliation procedure within 5 working days of the conclusion of the conciliation procedure, showing who and for which party of the conciliation procedure was present at the hearing, what proposals were discussed and whether and what resolutions were adopted on the individual proposals.

(3) The Ministry of Health shall, upon receipt of the data referred to in paragraphs 1 and 2, publish immediately on its website. ';

32. in Paragraph 18 (1):

"(1) Save as otherwise provided for in this law, the services paid shall be provided by health professionals other than doctors, only on the basis of the indication by the treating physician of the insured person (hereinafter referred to as" the treating physician '); This does not apply if they are midwives, if they are physiological childbirth in a bed care facility and in the case of clinical psychologists and pharmacists.'

33. in Paragraph 18 (2) (d), the words "with specialised competence" shall be deleted;

Article 34 (19) and (20), including the title above Article 19 and footnote 25, read:

"Decision to provide health services as covered by health insurance

§ 19

(1) Before providing health services, the health insurance company shall assess the fulfilment of the conditions of entitlement of the insured person to the provision of such services as paid in the case of:

(a) health services otherwise from health insurance not covered by § 16;

(b) the residence of the insured person's guide over 6 years of age pursuant to § 25;

(d) health care provided in children's professional hospitals and health care centres in accordance with § 34, except for the transfer of an insured person from hospitalisation to a children's professional hospital;

(e) necessary air transport pursuant to § 36 (3) (a);

(f) medicinal products for which the condition for reimbursement has been laid down in the procedure laid down in Part Six;

(g) the listed health performance referred to in Annex 1 to this Act;

(h) the listed medical devices prescribed for the voucher referred to in Annex 3 to this Act;

(i) the listed dental products referred to in Annex 4 thereto,

(j) a medicinal product containing medicinal hemp if it exceeds the limit laid down in Section 32b (1).

(2) The health services referred to in points (a) and (f) of paragraph 1 shall be provided by the provider without prior consideration by the health insurance undertaking in the case of emergency care. The provider shall inform the health insurance undertaking concerned without delay. The health insurance company shall pay the health services thus provided to the provider if the conditions laid down for their reimbursement have been met, except for the prior assessment by the health insurance undertaking.

(3) Save as otherwise provided in this law, the competent provider or the insured person whose entitlement is to be assessed shall submit an application to assess the fulfilment of the conditions of the insured's entitlement to the provision of health services as paid (hereinafter referred to as the "claim application ').

(4) If the health insurance undertaking complies fully with the claim assessment, it shall immediately give its consent to the provision of health services as paid and notify the person who made the claim. Health services may be provided as covered by the date of issue of the consent. Consent is not an administrative decision.

(5) If the health insurance undertaking does not comply with the claim application in accordance with the procedure referred to in paragraph 4 or if it does not give its consent within 15 days of the date of receipt of the claim application, it shall take a decision in the administrative procedure. This fact shall be notified to the insured person and to the person who made the application. The procedure shall be deemed to have begun on the date on which the application for assessment of the entitlement is lodged.

(6) The party to proceedings shall be the insured person whose claim is decided upon. The provider who provides health services to the insured person shall be obliged to provide the insured person and the health insurance undertaking with synergies for the purpose of conducting the proceedings.

(7) The decision shall also be notified by the health insurance undertaking to the provider who made the proposal. A decision to which the health insurance undertaking has fully complied with the claim application shall not be subject to appeal, renewal or review.

(8) The health insurance undertaking shall, within the framework of the consent given pursuant to paragraph 4 or the operative part of the decision referred to in paragraph 5, provide that it shall also apply to cases of repeated need for the provision of health services as covered, where the application for assessment of entitlement gives reasons or proves such reasons in the proceedings. Together with this, the health insurance company shall determine the period during which health services may be provided repeatedly as paid.

§ 20

(1) The health insurance company shall set up at least one review committee. The review committee shall have four members appointed by the director of the relevant health insurance company and one member appointed by the Minister for Health. The maximum of 2 members of the review committee may be employees of the relevant health insurance undertaking in employment. A member of the review committee must be a graduate of the Master's study programme of law and legal science or must be competent to pursue a medical profession under another legislation25). At least one member of the review committee shall be a graduate of the Master's study programme of general medicine and at least one member of the Review Committee shall be a graduate of the Master's study programme of law and legal science.

(2) The Revision Committee decides on the appeal against the decision of the health insurance company in respect of:

(a) the granting of prior consent pursuant to § 14b;

(b) the granting of authorisation under the coordination regulations;

(d) reimbursement of costs pursuant to Paragraph 14 (2) to (4);

(e) an application for an assessment of entitlement pursuant to Article 19.

(3) The Revision Committee shall elect a chairperson, unless otherwise specified.

(4) The resolution, with the exception of the order terminating the procedure and the action which is not a decision, may be given or carried out by the President or, where appropriate, by a chairman appointed by a member of the review committee.

(5) The decision of the review committee shall require the consent of an absolute majority of its members. Consent or disagreement with the draft decision shall be expressed by a member of the review committee in a voting protocol which shall be excluded from consultation of the file.

(6) Paragraph 134 (4) and (5) of the Administrative Regulation shall apply to the activities of the Review Commission.

(7) A member of the review committee may be remunerated for the performance of his duties, as decided by the Board of Directors of the sickness insurance undertaking.

25) Act No. 95 / 2004 Coll., on the conditions for obtaining and recognising professional competence and specialised competence for the exercise of the medical profession of doctor, dentist and pharmacist, as amended. Act No. 96 / 2004 Coll., on the conditions for obtaining and recognising eligibility for the pursuit of non-medical medical professions and for carrying out activities related to the provision of medical care and amending certain related laws (Act on non-medical medical professions), as amended. '

35. In Section 22 of the introductory part of the provision, the words "Paid services' are replaced by the words" Paid services'.

36. in Article 22 (a):

"(a) home care provided on the basis of recommendations

1. a doctor registering an outpatient care provider in the field of general practical medicine or in the field of practical medicine for children and adolescents, the care thus recommended may be paid for no more than 3 months; it can also be recommended repeatedly,

2. the medical practitioner of the outpatient care provider not referred to in point 1 who has treated the insured person, the care thus recommended may be paid for a maximum period of 14 days,

3. the medical practitioner of the medical emergency service provider who has treated the insured person, the care thus recommended may be covered for a maximum period of 14 days,

4. the medical practitioner of the health service provider on an urgent income which he has treated the insured person, the care thus recommended may be paid for a maximum period of 14 days;

5. the treating physician of the bed care provider, the care thus recommended may be paid for a maximum period of 14 days; or

6. the treating physician, if it is for palliative care of the insured person in the final state, the recommended care can be paid for a maximum period of 3 months; it can also be recommended repeatedly, '.

37. in Paragraph 22, the dot is replaced by a comma at the end of point (e) and the following point (f) is added:

"(f) health care of insured persons with a mental or behavioural disorder, provided that they are provided by a doctor with specialised competence in the field of psychiatry or children's psychiatry, or on the basis of his recommendation, unless such care can be provided under (a).";

38. in Paragraph 25 (1):

"(1) If there is a guide present throughout the day when the insured person is hospitalized at the hospital in the hospital, the tour guide is present until the sixth year of age accompanied by the insured person, including the paid service; the residence of an insured person older than 6 years is paid by the service only with the consent of the health insurance company. ';

39. in Article 30 (2) (b) (4), the words "for health professionals and other health professionals" and the words "for insured persons over 65 years of age, for those who have had a splenectomy or a haematopoietic cell transplant," shall be deleted;

40. in Paragraph 30 (2) (b), point 6 shall be deleted;

Points 7 and 8 shall become points 6 and 7.

(41) In Paragraph 30 (2) (b) (6), the words "or insured persons with indicated or performed splenectomy," "post-autologous" shall be replaced by "autologous" and "transplantation" shall be replaced by "transplant."

42. In Paragraph 30 (2) (b) (7), the words "the sixth month of age" shall be replaced by the words "the twelfth month of age or from the 14th to the 15th year of age" and the words "the second year of life" shall be replaced by the words "from the first to the second year of age or from the 14th to the 15th year of age of the insured person; the paid service is also the vaccination carried out after the time limits laid down in this provision, where one or more doses of vaccines have been postponed due to the health status of the insured person, ';

43. In Paragraph 30 (2), the following point 8 is added at the end of point (b):

"8. against tick encephalitis in insured persons over 50 years of age,"

44. in Article 30 (2), at the end of point (g), the dot is replaced by a comma and the following points (h) and (i) are added:

"(h) vaccination and reimbursement of medicinal products containing vaccines for vaccination against human papillomavirus, if the vaccination starts from the 13th to the 14th year of age of the insured person; the paid service is also the vaccination carried out after the expiry of the period provided for in this provision, provided that one or more doses of vaccines have been postponed due to the health condition of the insured person, approved by the Ministry of Health and published by means of a communication in the Collection of Laws,

(i) vaccination and reimbursement of medicinal products containing vaccines for vaccination of insured persons over 65 years of age against influenza; paid vaccines are approved by the Ministry of Health and published by means of a communication in the Collection of Laws. ';

45. in Paragraph 32 (4), the words "or medical devices and contractual dispensers" shall be inserted after the words "medicinal product," the words "medical prescription," and the words "public health insurance," shall be replaced by "medical insurance."

46. Paragraph 32 (5) is deleted.

47. in Article 32a, the following paragraphs 5 and 6 are added:

"(5) If the provision of a medical device under the circulation scheme referred to in paragraph 2 or 3 is made to the other and to any other insured person, the health insurance undertaking may also provide that insured person with the prescribed medical device, which is not included in the reimbursement group, provided that the medical device was covered by the health insurance scheme before 31 December 2018 and was provided to the first insured person at that time, or that it was included in the reimbursement group at the time it was provided to the first insured person.

(6) A medical device may not be provided under the circulation regime referred to in paragraph 2, 3 or 5 to the other and to any other insured person as regards a medical device which has been withdrawn because of its unacceptable risk to the health and safety of persons. ';

48. in § 32b (3), the words "Revision doctor" are replaced by the words "Health insurance company."

49.Paragraph 33 (1) reads:

"(1) The designated service is a rehabilitation treatment, provided as a necessary part of the treatment process, the provision of which was recommended by the treating doctor and approved by the health insurance company. The application for medical rehabilitation care as covered by the health insurance shall be submitted by the doctor of the registrar, the doctor of the outpatient provider who recommended it, or by the attending doctor at the hospital; The proposal shall also specify the order of urgency when providing spa rehabilitation care. The approval of a health insurance company shall not be required in the case of outpatient rehabilitation treatment, acute bed rehabilitation care and in the case of direct translation from acute bed care to the provider of spa rehabilitation care or the provider of subsequent rehabilitation care. '

50. In Article 33 (4), the words "from the date of issue of the proposal, where applicable 'shall be replaced by the words" from the date of approval of the draft by a health insurance undertaking, unless otherwise provided in Annex 5 to this law, where appropriate, "," from the date of issue of the proposal, "shall be replaced by the words" from the date of approval of the draft by a health insurance undertaking, unless otherwise specified in Annex 5 to this law'.

51. in Paragraph 33 (5), the words "the medical examiner" shall be replaced by the words "the health insurance company."

52. In Article 33 (6), the words "the medical examiner 'are replaced by the words" the health insurance company';

53. In Paragraph 33, the sentence "Retreated treatment is paid after approval by the health insurance company 'is added at the end of paragraph 8.

54. In Paragraph 33 (10) and (11), the second sentence is replaced by the sentence "The extension of the medical stay and its duration shall be approved by the health insurance undertaking concerned."

55. In Paragraph 34 (1), the first sentence is replaced by the sentence "Health care is provided as a necessary part of the treatment process for children and adolescents under 18 years of age in professional childcare and rehabilitation centres. ', the words" on a health insurance form' are deleted and the third sentence is deleted.

56. In Paragraph 34 (3), the words "health insurance company's medical examiner 'are replaced by the words" health insurance company' and the words "health insurance company 'are replaced by the words" health insurance company'.

57. In Paragraph 36 (3) (a), the words "the health insurance undertaking shall, on the basis of the indication of the treating physician and the approval of the medical practitioner and the necessary air transport," shall be replaced by the words "the indication of the treating physician and the approval of the health insurance undertaking shall be replaced by the necessary air transport."

58. The following Section 38a is inserted after Section 38:

„§ 38a

Health insurance shall cover methods and procedures for the collection, handling and storage of germ cells for a maximum period of 10 years, in order to maintain the possibility of artificial insemination if the insured person is to undergo an indicated treatment which may jeopardise the fertility of the insured person. If, within 1 year of collection of germ cells according to the first sentence, the insured person does not undergo a treatment that causes infertility, the health insurance shall not be paid for further storage of germ cells taken after the end of that period. '

59. in Paragraph 39a (2) (a), the word "Germany," shall be deleted;

60. in Paragraph 39a (2) (c), the words "the manufacturer's lowest price" shall be replaced by the words "the manufacturer's lowest price of the nearest package size."

61.Paragraph 39a (5) reads as follows:

"(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) 30% in the case of a biological medicinal product, where there is only 1 similar biological product in the health insurance reimbursement scheme ("payment scheme"),

(b) 40% if it is a generic under the drug law in a situation where there is only 1 similar product in the reimbursement system that is not a generic;

(c) 15% if it is not a generic in accordance with the Drug Act in a situation where there is only 1 similar product in the reimbursement system that is not a generic. "

62. In Paragraph 39a (7), the words "in-depth revisions under Paragraph 39l" are replaced by the words "shortened revisions under Paragraph 39p."

63.In Paragraph 39b (2) (c):

"(c) a participant in the procedure submitted an evaluation of the cost-effectiveness and impact on the budget, expressing costs per patient and the estimated number of patients treated per year, in the cases referred to in Article 15 (9);"

64. In Article 39b (5) of the Introductory Part of the provision, the words "and the conditions' are inserted after the word" similar ', the comma is replaced by a dot, and the words "where' are replaced by the words" similar products are deemed to meet the conditions for effective therapeutic intervention provided for in Article 15 (6) (d) and are not assessed by the Institute, except where the Institute of Offices is aware of the existence of a contract between health insurance companies and the holder of a marketing authorisation for a medicinal product which is similar to the product under consideration and the contract was relevant for the reimbursement of a medicinal product which is similar to the product under consideration. That is true if '.

65.In Paragraph 39b (5) (a), the words' and the conditions' are deleted.

66. in Article 39b (5), the following point (c) is inserted after point (b):

"(c) in the application for the level and conditions of payment of a similar product, the applicant shall apply for the same conditions of reimbursement as the medicinal product which is similar to the product under consideration, or for the establishment of more restrictive conditions of reimbursement, but only in order to avoid any conflict with the summary of the product concerned,"

Points (c) and (d) shall be renumbered points (d) and (e).

67. In Paragraph 39b, at the end of paragraph 6, the sentence "This does not apply to a medicinal product consisting of 2 or more active substances."

68. in Paragraph 39b (7), the words "under paragraph 6" shall be replaced by the words "in the manner laid down in Paragraph 39a (5)," and at the end of the paragraph the sentence "This shall not apply to a medicinal product consisting of 2 or more active substances."

69. in § 39b (12) (d) and § 39b (13) (a), the words "available on the market in the Czech Republic" shall be inserted after the words "medicinal product."

70. In Paragraph 39b, the following paragraph 14 is inserted after paragraph 13:

"(14) Paragraph 39c (2) (a) shall apply mutatis mutandis for the assessment of availability under paragraphs 12 and 13. ';

Paragraph 14 shall become paragraph 15.

711. in § 39c (2) (a):

"(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 is a medicinal product whose share in the total volume of sales, in principle, of therapeutically interchangeable medicinal products containing the same active substance in the relevant period was at least 3%, or a food for special medical purposes whose share in the total volume of sales, in principle, of therapeutically interchangeable foods for special medical purposes, calculated on the basis of the data received by the Institute from a notification under Paragraph 39m, was at least 3% in the relevant period, when the first similar medicinal product was placed in the order at the time of the request for the setting of the level and conditions of reimbursement, or the food for special medical purposes, the highest price of the manufacturer or reimbursement was made in writing; such medicinal products or foodstuffs for special medical purposes shall be considered to be available on the market in the Czech Republic for a period of 12 months from the date of enforceability of the decision determining the amount and conditions of payment of the first similar product or from the date of effective written arrangement; ';

72. in § 39c (2) (c), the text "§ 39q (1) (b)" is replaced by "§ 44 (3) (b)."

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Regulation Information

Citation	Act No. 371 / 2021 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance, and amending and supplementing certain related laws, as amended, and certain other laws
Regulation Type	Law
Author	-
Collection	Code of Laws

Date of Promulgation	12.10.2021
Effective from	01.01.2022
Effective until	-
Status	Valid

Legal Areas: Civil law Civil law substantive