Act No. 282 / 2018 Coll.
Act amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended
Valid
Effective from 01.01.2019
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282
THE LAW
of 15 November 2018
amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Public Health Insurance Act
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 the 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., the Constitutional Court's finding, published under No. 231 / 2017 Coll., and Act No. 290 / 2017 Coll., is amended as follows:
1. In Article 1, the dot is replaced by a comma at the end of paragraph 1 and the following point (d) is added:
"(d) the method of determining the reimbursement of medical devices prescribed for the voucher covered by health insurance.";
2. in Article 11 (1) (e):
"(e) for the issue of prescribed medical devices, medicinal products and foodstuffs for special medical purposes, where such medical devices, medicinal products and food for special medical purposes are wholly or partly covered by health insurance to the extent and under the conditions laid down in this Law; This also applies where the healthcare provider has not yet concluded a contract with the health insurance company of the insured person. ';
3. In Section 12, at the end of point (m), the dot is replaced by a comma and the following points (n) and (o) are added:
"(n) to notify the competent health insurance undertaking, if it has previously demonstrated to it, pursuant to Article 16b (1), that it is a beneficiary of a third-degree invalidity pension, of the fact that it has ceased to be an insurer within 8 days of the date on which the decision in question became final, and to provide proof of that fact by a copy of the decision in question,
(o) to notify the competent health insurance undertaking, if it has previously demonstrated to it, pursuant to Article 16b (1), that it has been recognised as an invalid in the second or third stages but has not been granted an invalidity pension for failure to comply with the condition of the insurance period under special legislation (42h), a change to that fact within 8 days of the date on which it became aware of the change and a copy of the relevant health assessment.
42h) Act No. 155 / 1995 Coll., on Pension Insurance, as amended. '
4. Paragraph 15 (11) and (12) read:
"(11) Health insurance shall, when providing the services covered, be covered by medical devices for indications corresponding to the intended purpose of use contained in the instructions for use, if issued by the manufacturer, for the purpose of:
(a) prevention;
(b) diagnostics;
(c) treatment; or
(d) compensation for sickness or disability.
(12) Health insurance is payable on the basis of the prescription for the voucher
(a) medical devices to the extent and under the conditions laid down in Part Seven and Annex 3 thereto;
(b) modifications and repairs of medical devices to the extent and under the conditions laid down in Annex 3 to this Law. ';
5. In Article 15, the following paragraph 13 is inserted after paragraph 12:
"(13) Institute
(a) publish a declaration of inclusion, exclusion or alteration of the medical device in the medical devices' reimbursement group; the reimbursement group of medical devices means the group of medical devices identified in the categorisation tree listed in Annex 3 to this Act by an eight-digit code (hereinafter referred to as the "reimbursement group '),
(b) deliver opinions on the selection of a reimbursement group of medical devices and a group according to functional characteristics and intended purpose of use, in principle, interchangeable medical devices within the reimbursement group (hereinafter referred to as "interchangeable),
(c) decide to remove the notified medical device from the reimbursement group and the interchangeable group;
(d) decide on the establishment, modification or cancellation of groups of interchangeable devices and on the inclusion or change of the inclusion of medical devices in those groups;
(e) issue a list of all medical devices covered by the voucher and publish it;
(f) publishes the price competition and publishes its results;
(g) decide to change the amount of the remuneration under the agreement on the highest price or price competition. "
Paragraphs 13 to 15 shall become paragraphs 14 to 16.
6. In Paragraph 16b (1), the words "and, in the case of insured persons who are beneficiaries of an invalidity pension for a third degree and have documented this fact, a copy of the invalidity pension decision for a third degree disability, for insured persons who have been recognised as disabled in the second or third stages but who have not been granted an invalidity pension for failure to meet the conditions of the insurance period under the special legislation (42h), and they have provided evidence of this fact of a copy of the health assessment report, '.
7. in Article 17 (7) (a) (2) and (3):
"2. other persons with whom the health insurance undertaking has concluded a contract on the issue of medical devices (hereinafter" contractual dispensers "), only individually manufactured medical devices, orthopaedic prosthetic devices, medical devices for instrumental lymph drainage, medical devices for patients with mobility problems, medical devices for patients with hearing impairment, medical devices for the visually impaired, medical devices for respiratory, inhalation and the application of enteral nutrition and the repair and modification of these medical devices as referred to in Annex 3 to this Act;
3. to optics, only medical devices for patients with visual impairment in accordance with Annex 3 to this Act, '.
8. In Paragraph 17 (9), "(d) 'is replaced by" (a) (2) and (3) and (d)';
9. Paragraph 32 (3) reads as follows:
"(3) The health insurance company shall provide the insured person with the voucher prescribed by the medical device in accordance with Annex 3 to this Act.
(a) full or partial reimbursement of the medical device in accordance with Part Seven and Annex 3 to this Act, up to a maximum of the price actually applied to the final consumer; the medical device is transferred to the owner of the insured person at the time of issue,
(b) by providing a fully or partially covered medical device in circulation under § 32a; or
(c) by paying the rent or part of the rent to a third party for a medical device in accordance with Annex 3 to this Law, but up to the amount of the rent actually applied; such medical device shall remain the property of a third party. ';
10. The following Section 32a is inserted after Section 32:
Circulation of medical devices
(1) Circulation of medical devices means a scheme whereby the health insurance company owns a medical device and provides the insured person with to use in respect of their medical condition, repeatedly throughout its lifetime, while maintaining the functional characteristics and intended purpose of use. The health insurance company may provide both a prescribed medical device and a medical device which is essentially interchangeable with it. The remuneration groups for which the health insurance company may choose the circulation scheme are listed in Annex 3 to this Act.
(2) The health insurance company may provide the insured person with a medical device under the circulation regime for which the difference between the price actually applied to the final consumer and the amount of the payment is no more than CZK 2,000. The insurance company will pay the difference. If the health insurance company opts for the circulation scheme within the appropriate remuneration group, all medical devices included in this payment group, where the difference between the price actually applied for the final consumer and the amount of the remuneration does not exceed CZK 2 000, are provided in the circulation scheme.
(3) If the insured person is prescribed a medical device which is included in the remuneration group for which the health insurance company has chosen a circulation scheme and where the difference between the price actually applied to the final consumer and the amount of the payment exceeds CZK 2 000, the insured person with the relevant health insurance company may conclude an agreement to include the medical device in the circulation scheme. If the health insurance undertaking concerned has entered into such an agreement with the insured person, the insured person shall pay the difference between the price actually applied to the final consumer and the amount of remuneration set. If the agreement is not concluded under the first sentence, the procedure laid down in Paragraph 32 (3) (a) shall be followed.
(4) In the case of provision of a medical device under the circulation regime referred to in paragraph 2 or 3 to the other and to each other, the insured person shall no longer participate in the payment of the medical device. ';
11. in Paragraph 39n (5):
"(5) The Institute publishes only in a way that allows remote access to the files of administrative proceedings, which it maintains pursuant to § 39a to § 39l and § 39p. The information marked as the subject matter of the commercial secrecy of the Institute shall not be provided or otherwise published. '
12. the following part seven is inserted after Part Six, including the title and footnote 42g:
CATEGORISATION AND REMUNERATION REGULATIONS OF HEALTH ENVIRONMENTAL INSTALLATIONS
Notification
(1) Unless otherwise specified, the medical devices prescribed for the voucher included in the payment groups shall be reimbursed if the conditions for payment laid down for that payment group are met.
(2) A manufacturer of a medical device, an authorised representative of a manufacturer of a medical device established in a third country, or a person authorised in writing by the manufacturer of a medical device to act pursuant to this Part, or an authorised representative of a manufacturer of a medical device established in a third country, but only one of those persons, hereinafter referred to as "the notifier," shall electronically notify the Institute of the inclusion, disposal or modification of the medical device to the reimbursement group or, where appropriate, to the interchangeable group of devices, if the Institute has been established. A third country shall mean any State other than the Czech Republic, the Member States of the European Union, the Contracting States of the Agreement on the European Economic Area and the Swiss Confederation. The interchangeability of medical devices is not affected by a different person of the manufacturer of the medical device, other colour versions, partial differences in the material composition, appearance differences and similar differences in the design which do not affect the functional characteristics and intended purpose of the medical device.
(3) The applicant may request an opinion from the Institute on the selection of the reimbursement group or, where appropriate, a group of interchangeable devices to which the medical device belongs according to its functional characteristics and the intended purpose of use. Such an opinion of the Institute is a professional act under the Law on Medical Devices.
(4) Individual-made medical devices are not reported and paid at the level and under the conditions laid down in Annex 3 to this Act.
(5) The applicant shall indicate in the declaration, in addition to the formalities laid down in the administrative rules:
(a) the name and address of the registered office of the manufacturer of the medical device, if it is a person different from the notifier;
(b) a copy of the officially certified written mandate to act under this Part by the manufacturer of the medical device or by an authorised representative of the manufacturer of the medical device established in a third country, unless they are notifiers;
(c) the registration number of the manufacturer of the medical device or of the authorised representative of the manufacturer of the medical device established in a third country, provided that it has been assigned by the Institute to the Register of Medical Devices;
(d) the trade name of the medical device;
(e) additions to names indicating each variant of the notified medical device, where there are several variants;
(f) the identification code of each variant of the notified medical device, where it is subject to the notification requirement under the Medical Devices Act;
(g) the remuneration group and the interchangeable group to which the medical device belongs according to the notifier;
(h) the highest price at which the notified medical device is made available on the market within the territory of the Czech Republic, without any trade mark-up and value added tax (hereinafter referred to as "producer price"); the manufacturer's price shall be indicated by the notifier for each variant of the notified medical device;
(i) the estimated amount of reimbursement of the notified medical device, calculated according to the parameters contained in Annex 3 to this Act; the expected level of remuneration shall be indicated by the notifier for each variant of the medical device declared,
(j) the written consent of the Ministry of Health to the payment of the notified medical device if the notifier indicates in the declaration as the reimbursement group "Non-categorised medical devices" with a payment limit of 50%;
(k) a risk-sharing agreement concluded between all health insurance companies and the reporting agent covering all supplies of that medical device to the market in the Czech Republic, provided that the reporting agent indicates in the notification as a reimbursement group "Non-categorised medical devices" with a 100% margin; an analysis of the impact on the budget, the setting of the annual cost ceiling for such a medical device and the allocation of risks between health insurance undertakings and reporting agents in the event of overshooting; and
(l) the number of units of measurement in the package of the notified medical device as referred to in Annex 3 to this Act; the number of units of measurement in the package shall be indicated by the notifier for each variant of the notified medical device.
(6) In the event of a change in one of the reported data affecting the published data pursuant to Paragraph 39t (1), the notifier shall submit the notification of the change of such data no later than 30 days after the date on which the change of data took place.
(7) Written consent under paragraph 5 (b) (j) The Ministry of Health grants and rescues after an assessment of the public interest pursuant to Article 17 (2) and on the basis of the notifier of the submitted cost-effectiveness assessment. Paragraph 15 (8) shall apply mutatis mutandis to the assessment of cost-effectiveness. This evaluation shall also include the justification for the proposal to include a medical device in the reimbursement group "Non-categorised medical devices'. Withdrawal of consent shall be notified to the notifier and to the Constitution.
(8) The applicant shall also provide the declaration in electronic form:
(a) instructions on the use of the notified medical device in the Czech language, in the version current at the date of the notification, if the instructions for use by the manufacturer of the medical device have been issued and are not already available to the Institute in the Register of Medical Devices;
(b) a valid declaration of conformity of the notified medical device and its translation into the Czech language if the Institute is not already available in the Register of Medical Devices;
(c) a valid certificate issued by a notified person for medical devices or a notified body for medical devices pursuant to the directly applicable European Union42g Regulation (in the case of an in vitro diagnostic medical device intended for self-testing, a medical device of hazard class IIa, IIb and III or a medical device of hazard class I sterile or with measuring function and its translation into the Czech language, unless the Institute is already available in the Register of Medical Devices;
(d) a copy of the final clinical trial report or a copy of the final performance evaluation report if the Institute is not already available in the Register of Medical Devices;
(e) the current price list signed by the manufacturer of the medical device or a document certifying the price of the manufacturer of the medical device and its translation into the Czech language; and
(f) an assessment of cost-effectiveness where the notifier indicates in the declaration as a remuneration group "Non-categorised medical devices."
Classification into payment groups
(1) On the 10th day of the calendar month, the Institute shall publish on the electronic official plate all the declarations, including their annexes, provided that they are received by the Institute in the previous calendar month, provided that they contain all the information referred to in Article 39r (5) and the Annex referred to in Article 39r (8). The Institute shall also publish the supporting documents for the decision under this Part.
(2) Where a medical device, having regard to its functional characteristics or its intended purpose of use, does not belong to the payment group or, where appropriate, to the interchangeable group indicated in the declaration, the Institute shall decide that the medical device does not belong to the reimbursement group or to the interchangeable group.
(3) If, within 45 days of the date of publication of the declaration referred to in paragraph 1, the Institute does not initiate the procedure referred to in paragraph 2 or the procedure referred to in paragraph 2, the medical device shall be placed in a payment group or, where appropriate, in a substitutable group, corresponding to the notification from the first day of the second calendar month following the end of the period or termination of the procedure.
(4) The Institute will also decide to exclude the medical device from the reimbursement group or, where appropriate, from the interchangeable group if:
(a) it finds that the medical device which has been included in the reimbursement group referred to in paragraph 3 does not belong to that reimbursement group or, where appropriate, to a substitutable group, according to its functional characteristics or intended purpose of use;
(b) The Ministry of Health shall withdraw its consent pursuant to § 39r (7),
(c) the risk-sharing agreement pursuant to § 39r (5) expires;
(d) the medical device has not been reimbursed by any health insurance undertaking for a period of 12 consecutive calendar months prior to the initiation of the procedure and the notifier has not demonstrated the presence of the medical device on the market for that period;
(e) the notification of a medical device subject to notification under the Law on medical devices has expired or the medical device has been deleted from the Register of Medical Devices;
(f) the certificate of medical device issued by the notified person or notified body for medical devices has expired in accordance with the directly applicable European Union42g Regulation; or
(g) the certificate of the medical device has been suspended or revoked by a notified person or a notified body for medical devices under the directly applicable European Union42g Regulation.
(5) Until such time as the decision to exclude the medical device from the reimbursement group or, where appropriate, from the interchangeable group, or until such a procedure is terminated, the notifier may not submit any other notification of the medical device in respect of which the procedure is conducted.
(6) Where the decision referred to in paragraph 4 becomes final by the 15th day of the calendar month inclusive, its legal effects shall take place on the first day of the following calendar month. If the decision referred to in paragraph 4 becomes final after the 15th day of the calendar month, its legal effects shall take place on the first day of the second calendar month following the acquisition of its legal power.
(7) The parties to the proceedings referred to in paragraphs 2 and 4 shall be the reporting agent and the health insurance undertaking.
Publication of information
(1) The Institute shall, on the 20th day of the calendar month, issue a list listing all medical devices covered by the voucher valid for the following calendar month. This list shall be published by the Institute on the electronic official record. For each medical device, the Institute shall state:
(a) the reporting agent's identification data;
(b) identification details of the manufacturer of the medical device, if different from the notifier;
(c) a numerical indication of each variant of the notified medical device allocated by the Institute for the purposes of this list;
(d) the amount of the remuneration for each variant of the notified medical device referred to in paragraph 3;
(e) a prescription restriction, if provided for in Annex 3 to this Act;
(f) an indication restriction, where provided for in Annex 3 to this law,
(g) quantitative or frequency restrictions, where provided for in Annex 3 to this Law;
(h) the name and number of the remuneration group or, where appropriate, the interchangeable fund group, where the Constitution has been established;
(i) the highest price at which the notified medical device is made available on the market in the Czech Republic after adding the trade premium and value added tax;
(j) information that the decision pursuant to § 39v (3) or § 39x (7) has expired; and
(k) other information identifying the medical device and related to the reimbursement of health insurance.
(2) In the event of an error in the list referred to in paragraph 1, the Institute shall delete the error within 10 working days at the latest by issuing a correction list.
(3) The medical device prescribed for the voucher shall be paid from the health insurance at the level of the notified producer price, calculated according to the technical parameters contained in Annex 3 to this Act, to which the trade premium and value added tax shall be added, but not more than:
(a) the remuneration limit set out in Annex 3 to this Act plus value added tax;
(b) the prices referred to in the decision under Paragraph 39v (3) plus value added tax; or
(c) the auction values referred to in the decision referred to in Article 39x (7) plus value added tax.
Creation of interchangeable funds groups
(1) In the case of a health insurance undertaking's intention to enter into an agreement on the highest price pursuant to § 39v (3) or the intention of one or more health insurance undertakings representing at least 30% of the insured persons to apply for a price competition pursuant to § 39w (1), that health insurance company or health insurance company shall request the Institute:
(a) establishing or amending groups of interchangeable funds within the appropriate remuneration group; and
(b) to include or modify the inclusion of medical devices in interchangeable funds groups within the appropriate remuneration group.
(2) The request referred to in paragraph 1 shall not be made if, within the framework of the appropriate remuneration group, the Institute has already decided on the establishment of groups of interchangeable devices and the inclusion of medical devices in them and no amendment is required.
(3) The application referred to in paragraph 1 shall contain, in addition to the general requirements laid down in the administrative rules:
(a) a proposal for the breakdown of the remuneration group referred to in Annex 3 to this Act into groups of interchangeable funds;
(b) the technical characteristics of each group of interchangeable funds within the remuneration group; and
(c) a proposal for the inclusion of medical devices declared in the relevant reimbursement group in interchangeable funds groups.
(4) The Institute shall decide on the application referred to in paragraph 1 within 90 days.
(5) The parties to the application procedure referred to in paragraph 1 shall be all health insurance undertakings and notifiers of all medical devices included in the relevant reimbursement group.
(6) If no medical device is included in the interchangeable group, the Institute may cancel the interchangeable group.
The highest price agreement
(1) The health insurance undertaking and the reporting agent may, in the public interest referred to in Article 17 (2), enter into a written arrangement containing an undertaking by the reporting agent to supply medical devices included in the payment group or, where applicable, to a group of interchangeable means at the price specified in the arrangement ("the highest price agreement"). The applicant shall fulfil the obligation under the first sentence laid down in the highest price agreement. The price specified in the highest price agreement shall be the price excluding value added tax.
(2) The sickness insurance company shall send the Institute a maximum price agreement no later than 10 days after its conclusion. The highest price agreement applies to all supplies of the medical devices listed therein on the market in the Czech Republic.
(3) Where the highest-price agreement also includes an obligation on the notifier to supply the highest-price medical devices referred to in the highest-price agreement to at least half of the consumption of essentially interchangeable medical devices included in the group of interchangeable devices distributed on the market in the Czech Republic and paid from health insurance for the 1 calendar year preceding the signature of the highest-price agreement (hereinafter referred to as "the undertaking agreement '), and the decision under Paragraph 39u relating to the relevant reimbursement group has acquired legal authority, the Institute shall initiate proceedings for a temporary reduction of the remuneration for the substitutable group and shall invite health insurance undertakings to submit any other agreements with commitment within 20 days of the publication of this call. An agreement with a commitment may be concluded only for a period of 1 year without the possibility of termination. A commitment agreement may be renewed repeatedly by 1 year. Where the Institute receives more than one commitment agreement within the specified time limit relating to the same group of interchangeable funds, it shall reduce the remuneration under an agreement with the lowest price obligation. If the Institute receives more than one undertaking with the same lowest price, it shall issue a decision on the basis of an agreement with the first commitment. The Institute shall provide in the Decision:
(a) the amount of the remuneration for a group of interchangeable funds to the level of the price specified in the agreement with the undertaking containing the lowest price translated according to the technical parameters contained in Annex 3 to this Act, after adding value added tax, for the period of validity of that agreement; and
(b) the obligations of the notifier in accordance with its obligations under paragraph 1 and under this paragraph.
(4) Information on the consumption of essentially interchangeable medical devices included in a given reimbursement group distributed on the market in the Czech Republic will be provided at the request of the Institute or health insurance company by the Institute of Health Information and Statistics of the Czech Republic (hereinafter referred to as the "Institute of Health Information") from the National Register of Paid Health Services.
(5) The legal effects of the decision referred to in paragraph 3 shall take place on the first day of the second calendar month following the acquisition of its legal power. In the event of an extension of an agreement with an undertaking, the validity of the decision referred to in paragraph 3 shall be extended by the same period, unless the Institute receives no agreement with a commitment relating to the group of interchangeable funds for which a decision on a temporary reduction of remuneration has been issued containing a lower price at the latest 1 month before its expiry; otherwise the decision referred to in paragraph 3 shall not be extended and the Institute shall initiate a new procedure for the temporary reduction of payments.
(6) The agreement with the undertaking on the basis of which the decision referred to in paragraph 3 has been given shall be published by the health insurance undertaking in a manner that allows remote access not later than 60 days from the date of the decision referred to in paragraph 3. Paragraph 17 (9) fifth and sixth sentences shall apply mutatis mutandis. Such agreements shall take effect on the date on which the legal effects of the decision referred to in paragraph 5 arise.
(7) During the period of validity of the decision to temporarily reduce the remuneration referred to in paragraph 3, price competition in the relevant remuneration group may not be initiated.
(8) The medical devices referred to in the agreement with the undertaking on the basis of which the Institute issued the decision referred to in paragraph 3 shall not be included in the regulatory restrictions applied by the health insurance undertaking towards the provider and health insurance undertakings shall support their prescription through their contractual policy.
(9) Where the Institute has taken a final decision on an infringement pursuant to Paragraph 39za (1) (b), the group of interchangeable devices in which the medical device in which supplies were subject to an infringement shall be reimbursed at the rate laid down in Annex 3 to this Law, from the first day of the second calendar month following the acquisition of the legal power of the infringement decision; the decision referred to in paragraph 3 shall expire on the same date.
Price competition
(1) In order to ensure fully paid medical devices and the savings of health insurance funds, the Institute shall issue a price competition (hereinafter referred to as competition). The competition can be written if one or more health insurance companies representing at least 30% of the insured persons so request, there is a presumption of at least 5% saving of health insurance funds, but at least 5 000 000 CZK per year, within the remuneration group and the decision according to § 39u in relation to the relevant reimbursement group has become legal.
(2) The application for a competition always contains:
(a) the designation of the remuneration group under which the tender is requested;
(b) the calculation of the expected savings of health insurance funds within the remuneration group referred to in Annex 3 to this Act;
(c) a commitment by health insurance companies to support through their contractual policy of prescribing the medical devices of winners; and
(d) consent of the Ministry of Health to the award of a competition awarded on the basis of an assessment of the public interest pursuant to § 17 (2) and the applicant health insurance companies submitted calculations of the savings of health insurance funds under the remuneration group.
(3) The Institute shall publish on the electronic official plate a notice of initiation within 15 days of the date of the request. The notification shall include:
(a) the designation of the remuneration group under which the competition is announced;
(b) a calculation of the expected savings of health insurance funds within the remuneration group;
(c) a commitment by health insurance companies to support through their contractual policy of prescribing the medical devices of the winners;
(d) consent of the Ministry of Health to the publication of the competition;
(e) the allocation of all medical resources of a given reimbursement group into each interchangeable group;
(f) the time limit by which it is possible to enter into competition which shall be at least 15 days from the date of publication of the notice;
(g) lessons learned about the course of the competition; and
(h) information on how to apply to participate in the competition and on the elements of the application.
(4) The competition shall be carried out by means of an electronic auction for each individual group of interchangeable funds in the remuneration group for which the competition is announced. Electronic auction means the process used to evaluate tenders in which a participant uses electronic tools to submit new reduced tender values within a group of interchangeable means. The electronic auction has 1 round. Only the announcer of medical devices included in the interchangeable groups within the remuneration group for which the competition is announced may be a participant in the competition. In the competition, the notifiers offer the lowest price excluding value added tax per unit of pay within the interchangeable fund group.
(5) The condition for participation in the competition is a written declaration containing an obligation to supply competing medical devices at prices for the final consumer in the event of a win-win in the Czech Republic at prices not exceeding the sum of the second lowest auction value (hereinafter referred to as "the accepted auction value ') and the value added tax equally for the 12 calendar months following the date on which the legal effects of the decision in the competition in accordance with § 39x (7) occur, and to a minimum of one third of the consumption essentially interchangeable medical devices included in the group of interchangeable devices distributed on the Czech Republic market and covered by health insurance for the 1 calendar year preceding the start of the competition.
(6) Information on the consumption of essentially interchangeable medical devices included in a given reimbursement group distributed on the market in the Czech Republic will be provided at the request of the Institute or health insurance company by the Institute of Health Information from the National Register of Paid Health Services.
(1) If at least 3 participants do not participate in the competition within at least one interchangeable group, the Institute shall stop the competition by a resolution.
(2) The Institute shall notify the tenderers at least 7 days before the date of the electronic auction. The Institute shall publish the notice on the electronic official plate. The notification shall also include:
(a) information on the number of participants;
(b) the opening auction value corresponding to the remuneration limit applicable to the remuneration group;
(c) information concerning the electronic means used and other technical information necessary for electronic communication within the electronic auction;
(d) fixing the minimum difference for individual submissions reducing the auction value; and
(e) the particulars referred to in § 39w (3) (e) and (g).
(3) The Institute may not disclose the identity of the tenderers until the decision is taken.
(4) The electronic auction lasts at least 30 minutes. Any submission reducing the auction value for the twenty-ninth minute shall extend the duration of the electronic auction by a further minute after that submission.
(5) Where the second lowest auction value achieved in the electronic auction is not at least 10% lower in at least one interchangeable group than the opening auction value, the Institute shall stop the competition by a resolution.
(6) The order to stop the competition referred to in paragraph 1 or 5 shall be published by the Institute on an electronic official record. There is no appeal against the order to stop the competition.
(7) If the competition is not stopped, the Institute shall, within 7 days of the end of the electronic auction, issue a decision indicating the amount of the auction value received for each group of interchangeable funds. It shall publish the decision on the electronic official plate. In the operative part of the decision, the Institute shall state:
(a) a list of participants in the electronic auction for each group of interchangeable funds;
(b) the names of the participants who have offered the two lowest auction values (hereinafter the winners) in each group of interchangeable means,
(c) the auction value adopted for each group of interchangeable devices, if the auction value has been accepted;
(d) the designation of all variants of the winning medical devices that will be marketed in the Czech Republic at a price corresponding to the accepted auction value after adding value added tax; and
(e) setting out the obligations of the winners in accordance with their obligations under Paragraph 39w (5).
(8) The legal effects of the decision referred to in paragraph 7 shall arise on the first day of the second calendar month following the acquisition of the legal power of that decision.
(9) After the adoption of the decision referred to in paragraph 7, the Institute shall publish the result of the competition on the electronic official plate within 5 days.
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Regulation Information
| Citation | Act No. 282 / 2018 Coll., amending Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 13.12.2018 |
|---|---|
| Effective from | 01.01.2019 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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