Registration of medical treatment facilities for outpatient care | Deyan Sotirov

The Medical-Treatment Facilities Act defines the medical treatment facilities as organizationally separate structures on functional principle in which physicians or dentists, individually or with the assistance of other medical and non-medical specialists, carry out diagnostics, treatment and rehabilitation of patients, follow-up care of patients, consultations, prophylactics, etc.

A new type of medical treatment facility has been introduced with the latest amendments to the Medical-Treatment Facilities Act¹ – an organizationally separate structure in which medical assistants, nurses, midwives or rehabilitators provide and carry out independently health care, manipulations and activities related to health promotion, prevention and prophylactics of diseases.

General Information

The medical treatment facilities are established under the Commerce Act in observance of the Medical-Treatment Facilities Act which provides for numerous special requirements – i.e., with regard to the management, name and scope of activity of the company-medical treatment facility.

The medical treatment facilities carry out their activity only upon obtaining a permit or being registered under the conditions and by the procedure set forth in the Medical-Treatment Facilities Act. Medical treatment facilities for outpatient care are subject to registration and those for hospital care need to obtain a permit in order to legally carry out their activity. This article covers the procedure for registration of medical treatment facilities for outpatient care – ambulatories for primary or specialized medical care (individual or group practices), ambulatories for health care, medical centers, diagnostic and consultative centers, independent medical diagnostic laboratories, dental centers, etc.

The procedure is regulated by Art. 40 et seq. of the Medical-Treatment Facilities Act. The registration is performed by the Executive Director of the Executive Agency “Medical Supervision”, keeping public register of the medical treatment facilities. Registered medical treatment facilities are provided with a certificate of registration.

Application and Necessary Documents

The registration procedure commences with an application – in a standard form to be found on the website of the Executive Agency “Medical Supervision”. The application should be submitted to the respective Regional Health Inspectorate personally or through an authorized person – e.g., a lawyer.

The application should contain information about the unified identity code of the company or cooperation from the Commercial Register and the following documents need to be enclosed thereto:

Rules on the organizational structure, activity and internal order of the medical treatment facility;

Names of the persons – shareholders or stockholders of the company or members of the cooperation, establishing group practice;

Diploma for the respective higher education of the persons who will manage or, respectively, work in the medical treatment facility;

Document for acknowledged specialty of the persons who will manage or, respectively, work in the medical treatment facility;

Documents for paid state fees.

Pursuant to the latest amendments to the Medical-Treatment Facilities Act there will be no longer a requirement to present permit by the competent state authority where medical equipment with a source of ionizing radiation will be used in the medical treatment facility; instead, it has been provided that the availability of such permit will be established ex officio as part of the compliance examination process as described here below.

On the day of receiving the application the Regional Health Inspectorate sends ex officio a request to the Bulgarian Medical Association, the Bulgarian Dental Association, the Bulgarian Association of Professionals in Health Care and the Bulgarian Dental Technicians Association, for issuance of certificates for entry in their registers of the physicians, dentists, medical assistants, nurses, midwives, rehabilitators or dental technicians, who will manage and work in the medical treatment facility.

The circumstances regarding criminal convictions of the persons – members of the management and supervisory bodies of the medical treatment facility, when they are Bulgarian citizens, are to be established ex officio². The persons – members of the management and supervisory bodies, who are not Bulgarian citizens, should present a conviction status certificate or other similar document.

Processing of the Application

Within 10 days from submission of the application the Regional Health Inspectorate examines the compliance of the medical treatment facility with the health requirements and the approved medical standards, as well as checks for the availability of license for use of ionizing radiation sources for medical purposes when the medical treatment facility will use medical equipment with ionizing radiation source. Where it finds that the respective requirements in the medical treatment facility have not been met, the Regional Health Inspection gives instructions and provides a time period for their rectification, which may not be longer than three months.

Within three days after the check has been performed and the requested certificates have been obtained, the Director of the Regional Health Inspectorate sends the documents to the Executive Agency “Medical Supervision”. In case of incompleteness of the presented documents the Executive Agency “Medical Supervision” informs the applicant about that (in writing and within 10 days) and provides a time period for its rectification.

Within one month from the receipt of the documents, the Executive Director of the Executive Agency “Medical Supervision” issues a certificate of registration of the medical treatment facility or gives a motivated refusal to register the medical treatment facility.

Fees

Pursuant to the Tariff on the Fees Collected under the Medical-Treatment Facilities Act for obtaining a certificate of registration as a medical treatment facility for outpatient care a state fee in the amount of 52 Levs is due upon initial entering into the register.

Pursuant to the Tariff on the Fees Collected by the State Health Control Authorities and the National Centers for Public Health Affairs under the Health Act upon registration of a medical treatment facility a state fee in the amount of 92 Levs is due for carrying out an examination for observance of the health requirements.

Footnotes:

¹ The article has been updated on 13.07.2020 in connection with amendments to the Medical-Treatment Facilities Act (effective as of 16.06.2020).

² The article has been updated on 14.01.2018 in connection with amendments to the Medical-Treatment Facilities Act (effective as of 01.01.2018).

Questions and Answers on the topic:

QuestionV.05.06.2012, 16:11

Can a dental technician open a dental center?

Hello, I would like to open a dentist office or a dental center. I am a dental technician by education. I am an owner of a dental-technicians laboratory – SMTL. Am I eligible to register for carrying out such activity given the fact that I am not a specialist (dentist)? Thank you in advance!

AnswerAttorney Sotirov05.06.2012, 19:46

Pursuant to Art. 36, par. 1 of the Medical-Treatment Facilities Act: “The medical treatment facilities under Art. 10, par. 5 and the medical treatment facilities for outpatient care, other than those under Art. 8, par. 1, it. 1, letter (a) and it. 2, letter (a), shall be founded as trade companies or co-operatives, as well as companies under the legislation of a European Union Member State, or of a state which is a party to the European Economic Area Agreement, upon which they shall be registered by the order of Art. 40.” Pursuant to Art. 16, par. 2 of the Medical-Treatment Facilities Act: “Dental center means a medical treatment facility, in which at least three dentists of different acknowledged specialties provide primary and specialized outpatient dental care.” Considering the said provisions, my opinion is that there is no obstacle to establishing a dental center as a commercial company whose capital is owned by a natural person who personally is not a dentist.

QuestionDimiter Kolev16.08.2013, 16:41

What transactions are commercial according to the Medical-Treatment Facilities Act?

Mr. Sotirov, please help me find a law, instructions by the Ministry of Health or other similar document that explains how to define transactions as commercial or non-commercial within the meaning of Art. 3, par. 4 of the Medical-Treatment Facilities Act! For example, if a municipal hospital operates a diet restaurant with a view to the prophylactics of healthy persons and the provision of dietetic nutrition to chronically ill persons (diabetes, ulcer, etc.), would such commercial activity be permissible under Art. 4 of the Medical-Treatment Facilities Act? Thanks!

AnswerAttorney Sotirov09.09.2013, 07:40

You could download an example opinion on the issue from the following web address: https://rzibl.org/dokumenti/admin_uslugi/4_Procedura.doc. For example, it is said on page 3 that: “Art. 3, par. 4 of the Medical-Treatment Facilities Act prohibits the medical treatment facilities to carry out commercial transactions, except for the needs of the medical activities performed by them and for services to the patients. By virtue of Art. 286, par. 2 of the Commerce Act, a commercial transaction is any transaction listed in Art. 1, par. 1 of the Commerce Act, regardless of the capacity of the persons who carry them out. For a transaction to be out of the scope of Art. 3, par. 4 of the Medical-Treatment Facilities Act, there should be particular legal or other actions available, aimed at certain economic result which is not in any direct relation to the medical practice of the medical treatment facility. To find that the medical treatment facility has violated Art. 45, par. 1, it. 2 of the Medical-Treatment Facilities Act, it would be necessary to establish that actual commercial transactions have been carried out, where such transactions have not been needed for the medical activity to be performed. Establishing that such transactions have been carried out would constitute grounds for deletion of the medial treatment facility under Art. 45, par. 1, it. 2 and the already above mentioned procedure.” In my opinion, “for services to the patients” is rather general as a concept and could cover additional activities as those included in the example situation outlined in your question.

QuestionTeodora Poryazova04.10.2013, 16:04

How to change the scope of activity of a group practice?

Hello, we are two dentists about to register a limited liability company. In the name of the company we included “Ambulatory for group practice for primary dental care” and in the description of the scope of activity we inserted the following: “diagnostics, treatment and follow-up care of patients, prophylactics, consultations, expert assessment of temporary incapacity, prescription of laboratory and x-ray examinations, direction of patients to consultative and hospital care and issuing documents relating to dental diseases, as well as any other activities and services, not prohibited by the law (after obtaining the respective permits and licenses)”. We have been given instructions (published on the website of the Registry Agency), as follows: “Pursuant to Art. 36, par. 2 of the Medical-Treatment Facilities Act, medical treatment facilities, including group practices for primary medical care under Art. 8, par. 1, it. 1, letter (b), are subject to registration following the procedure of Art. 40 of the Medical-Treatment Facilities Act. Par. 3 of Art. 36 requires that the scope of activity of the health care facilities, as defined in par. 2 of the same provision, includes only the carrying out of outpatient care. The scope of activity of the company requested for registration should comply with the said legal restriction. In the particular case, as evidenced by the submitted application, it is included in the scope of activity of the group practice for primary dental medicine the following: “other activities and services, not prohibited by the law (after obtaining the respective permits and licenses)”, thus failing to observe the requirement of Art. 36, par. 3 of the Medical-Treatment Facilities Act.” My question to you is how exactly are we supposed to change the scope of activity and whether or not the company name also needs to be changed by adding “outpatient care”? We would be very grateful for your answer.

AnswerAttorney Sotirov05.10.2013, 15:37

The scope of activity should be updated by means of a new decision of the founders, taken in connection with and in execution of the given instructions (you need to change the part of the text that fails to meet the legal requirements as per the given instructions). You should also take another decision for adopting new Articles of Association containing the updated scope of activity. Pursuant to Art. 36, par. 4: “The commercial registration of the company shall obligatorily contain the full indication of the respective type of medical establishment under Art. 8 and Art. 10, par. 4 and par. 5.” The term “outpatient” itself is not a part of the name of the medical treatment facilities and in my opinion it will not be problematic to leave such term out of the name of your group practice.

QuestionNikolai Shterev03.10.2020, 17:53

Am I allowed to open an IMDL for conducting ultrasound tests only?

Hello! I am interested in knowing whether or not a physician who is a specialist in image diagnostics may open his own specialized medical diagnostic laboratory for conducting ultrasound tests ONLY – by using an ultrasound unit and no x-ray or any other equipment whatsoever. Thanks in advance!

AnswerAttorney Sotirov05.10.2020, 16:15

I think that it should be permissible. The Medical-Treatment Facilities Act (Art. 18) states that an independent medical and diagnostic laboratory is a medical treatment facility where specialized medical tests in one or more medical subjects are conducted; at least one physician holding a recognized specialization in the field relevant to the profile of the laboratory should be employed by the latter. The law does not set forth requirements regarding the available equipment; it instead refers to the relevant medical standards determining the requirements for carrying out the activities of the laboratories. According to my review of the “Image Diagnostic” medical standard, there is no mandatory requirement in terms of the medical treatment facilities for outpatient care for having more than one piece of equipment, i.e. it should be deemed permissible for an IMDL to be equipped only with an ultrasound diagnostic unit for conducting the respective image diagnostic tests.