Decree No. 97 / 2022 Coll.
Ordinance for the implementation of certain provisions of the Act on Medical Devices relating to electronic vouchers
Valid
Order
Effective from 01.05.2022
Text versions:
01.05.2022
29.04.2022
97
DECLARATION
of 22 April 2022
to implement certain provisions of the Act on Medical Devices relating to electronic vouchers
According to Section 68 of Act No. 89 / 2021 Coll., on Medical Devices and amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Laws (Act on Medicines), as amended, for the implementation of Sections 29 (6) and 31 (4) of the Act on Medical Devices:
Subject matter
This decree provides
(a) the procedure and conditions for communicating with eRecept prescribers and dispensers;
(b) the form of the electronic voucher identifier provided by eRecept to prescribers and patients;
(c) the method of sending requests for the creation, modification and cancellation of an electronic voucher by prescribers;
(d) the scope of the data needed for the creation, modification and cancellation of the electronic voucher and its particulars;
(e) the manner in which identification details of the person authorised to prescribe or issue the device are communicated to the Institute.
Procedure and conditions for communication with eRecept
(1) Communication between the eRecept system and the prescriber or issuer takes place through the data interface of the eRecept system and the information system of the prescriber or issuer, the communication channel being encrypted.
(2) Communication between the eRecept system and the prescriber or issuer also takes place directly through the eRecept web or mobile application under the Drug Act, with the communication channel encrypted.
(3) Data sent to the eRecept system are produced in the form of structured data by the prescriber and the issuer. The technical requirements for the format of structured data are set out in the eRecept operating documentation.
(4) Data sent pursuant to paragraph 3 shall be signed by a recognised electronic signature in accordance with the law governing trust services for electronic transactions; This does not apply if prescribers or editors approach eRecept through the National Identification and Authentication Point.
(5) The Institute shall, upon request, issue to the eye optics operator or to the person with whom the health insurance company has concluded a discharge contract under the Public Health Insurance Act, an access certificate for secure communication with the eRecept system; the application for the issue of an access certificate shall be sent by means of an electronic form published on the Institute's website.
Electronic voucher identifier
The electronic voucher identifier is generated by the eRecept system in an alphanumeric form of a character identifier that is convertible into a two-dimensional or one-dimensional barcode.
Scope of the data needed to create the electronic voucher and its details
(1) The requirement for creating an electronic voucher contains:
(a) the basic information on the electronic voucher referred to in paragraph 2;
(b) data relating to the patient to whom the device is prescribed to the extent specified in paragraph 3;
(c) data relating to the prescribed device to the extent specified in paragraph 4;
(d) data relating to the prescriber and provider of health services to the extent specified in paragraph 5.
(2) The requirement for the creation of an electronic voucher shall indicate the electronic voucher:
(a) the period for the use of the electronic voucher;
(b) the way in which an electronic voucher identifier is delivered to the patient; If the method of sending the identifier is chosen via eRecept by text message or by e-mail, the request shall also include the telephone number or e-mail address to which the identifier is to be delivered,
(c) the "ad sum proprium" flag in case it is a prescriptor's request, which prescribes the funds to itself, his husband, his parents, grandparents, children, grandchildren and siblings under the Public Health Insurance Act (1);
(d) the specification of the requirement to approve the remuneration, including the justification if the reimbursement of the allowance is linked to the approval of the health insurance undertaking concerned.
(3) The requirement to create an electronic voucher should include, in relation to the patient:
(a) the designation of the patient's health insurance undertaking by a code number if the device is to be covered by public health insurance or a sign that the payment of the device results from an international agreement or other legislation for the Ministry of Health;
(b) the name and, where appropriate, the names and surname and address of the patient's residence and, if the place of residence cannot be indicated, the address of the patient's residence;
(c) the patient's telephone number, if it cannot be stated, then the address of the patient's whereabouts;
(d) the insured person's number, if allocated; if the insured person's number has not been assigned to the patient or if the insured person's number cannot be determined by his age, the date of birth of the patient,
(e) the address of the detention centre to which the person was taken if he / she is a person in custody;
(f) the address of the detention centre or detention centre in which the person was placed, if he is a person in the execution of a prison sentence or a detention centre.
(4) In the requirement to create an electronic voucher, in relation to the prescribed device:
(a) in the case of a mass-produced device:
1. the trade name under which the device is marketed;
2. a name supplement indicating the variant of the device, if any,
3. the code allocated by the Institute for Public Health Insurance Compensation, if any, or data relating to the amount and conditions of the public health insurance reimbursement, including an indication other than the first payment according to the list of all medical devices paid under the prescription for a voucher issued under the Public Health Insurance Act; and
4. Number of packages,
(b) an individual design of the characteristics of the device and the code assigned by the Institute for Public Health Insurance Compensation in the case of a contract;
(c) the diagnosis of the patient for whom the device is prescribed to the patient by the International Disease Classification Code;
(d) method of payment of the device, by stating the words:
1. "payable by the patient," if the device is not to be covered by public health insurance or if the prescriber does not have a contract with the patient's health insurance company, unless it is urgent care,
(2) "reimbursement" if the device is to be covered by public health insurance,
3. "remuneration with an employer's supplement" if the supplement is paid by the employer on the basis of a contractual relationship with the health insurance undertaking.
(5) The requirement to create an electronic voucher should include, in relation to the prescriber and the health service provider:
(a) identification of the health service provider to the extent
1. the name and / or surname of the health service provider, the address of the place where the health services are provided, the workplace identification number assigned by the health insurance undertaking, if any, and the contact number, if applicable, of the person involved; or
2. the name or business name, the address of the head office and the place where the health services are provided, the workplace identification number assigned by the health insurance company, where the health insurance company has been assigned, and the contact telephone number, if it is a legal person,
(b) the name and, where applicable, the name and surname of the prescriber where the healthcare has been provided to a provider who is a legal person or who is a natural person,
(c) the name, names and surname, address of the place of residence and telephone number of the prescriber, if applicable, if it is a prescriber who prescribes means to himself, his spouse, his parents, grandparents, children, grandchildren and siblings under the Public Health Insurance Act 2),
(d) by the health insurance undertaking, the identification number of the premises of the deleting treating physician, in the case of a delegated prescription.
Method of sending requirements for creating an electronic voucher
(1) The request for the creation of an electronic voucher is sent by the prescriber of the eRecept system, indicating the data referred to in Section 4.
(2) After receiving a set of data necessary to create an electronic voucher, eRecept will create an electronic voucher and assign an electronic voucher identifier.
(3) The eRecept system will immediately send a confirmation of the creation, processing and storage of an electronic voucher to the prescriber through its information system, web or mobile application. The identifier referred to in paragraph 2 of this Article shall be included in the certificate and shall include information on whether the patient has been successfully identified against the population register.
Change of electronic voucher
(1) In order to correct the data on the electronic voucher, the prescriber may make a change to the electronic voucher stored in the eRecept system for which the eRecept system has been confirmed to have created it, unless an eRecept is sent to the eRecept system to record the issue of the device, to start preparation, to start the issue of the device or to submit it for approval to the health insurance undertaking, while the time for the use of the electronic voucher has not expired. The prescriber cannot make a change to the electronic voucher for which approval of the remuneration has been indicated by the health insurance company.
(2) The requirement to change the electronic voucher is sent by the prescriber of the eRecept system, indicating the identifier of the electronic voucher to which the change relates and the data to which it is amended. After the creation of an electronic voucher, the identification of the prescriber, the health service provider and the date of its issue cannot be changed in the electronic voucher.
(3) The eRecept system shall store and return information on the change of the electronic voucher data to the prescriber via his information system, web or mobile application, a confirmation of making the required change to the electronic voucher.
Cancellation of electronic voucher
(1) An electronic voucher created in eRecept may be cancelled by the prescriber if new facts are found unknown at the time of the prescription or in case of incorrect sending of structured data for the purpose of creating an electronic voucher into the eRecept system, unless an eRecept is sent to the eRecept system to record the output of the device, start of preparation, start of output or submit for approval to the health insurance undertaking, while the time for the use of the electronic voucher has not elapsed. The electronic voucher for which an eRecept is sent to the eRecept system for submission to the health insurance undertaking for approval, and at the same time for which approval or non-approval has been indicated by the health insurance undertaking, may be cancelled by the prescriber.
(2) The request for cancellation of an electronic voucher is sent by the prescriber of the eRecept system, indicating the identifier of the electronic voucher that is cancelled.
(3) The eRecept system shall be marked as cancelled and cannot be issued on the basis of an electronic voucher for which a cancellation request has been sent.
(4) The eRecept system will send a confirmation to the prescriber via its information system, web or mobile application of the cancellation of the electronic voucher.
Communication of identification data
(1) The health service provider, the eye optics operator or the person with whom the health insurance company has concluded a delivery contract under the Public Health Insurance Act, shall communicate to the Institute the identification details of the person authorised to prescribe or issue the device through a self-service portal available on the Institute's website.
(2) The health service provider shall accede to the portal referred to in paragraph 1 by means of the health service provider's access certificate issued under the health2 Act.
(3) An eye optics operator or a person with whom a health insurance undertaking has concluded a discharge contract under the Public Health Insurance Act shall accede to the portal referred to in paragraph 1 by means of an access certificate issued pursuant to Article 2 (5).
Efficacy
This Decree shall take effect on 1 May 2022.
Minister for Health:
Prof. MUDr. Válek, CSc., MBA, EBIR, v. r.
1) Paragraph 17 (7) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended.
2) Paragraph 81a (1) of Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended.
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Regulation Information
| Citation | Decree No. 97 / 2022 Coll., for the implementation of certain provisions of the Act on Medical Devices relating to electronic vouchers |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.04.2022 |
|---|---|
| Effective from | 01.05.2022 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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