Guidance from the Ministry of Health of the Slovak Republic on radiological workplaces for the implementation of mammography

Guidance for radiological workplaces to carry out mammographic examinations on § 2b of Act No. 577/2004 Coll. on the scope of health care paid on the basis of public health insurance and reimbursements for healthcare services as amended (hereinafter "Law No. 577/2004') OJ L 347, 20.12.2013, p. 671.

Subject matter of the Guidelines

The purpose of the guidelines is to harmonise the procedure at radiological sites for performing mammographic examinations by the date of entry into force of the implementing rules under Paragraph 2b (2) of Law No 577/2004. Z. z. The aim of mammography is to ensure high quality of women's treatment during breast cancer screening and diagnostic examination using mammography in women. In order to achieve a high quality and effective implementation of screening or diagnostic mammography, appropriate education of specialists in the specialization field of radiology, compliance with current legislation and elimination of low-value healthcare is essential.

Legal basis

The Ministry of Health of the Slovak Republic issues this Guideline

1. pursuant to § 45 (1) (a). (b) Act No 576/2004 Coll. on health care, health care services and amending certain laws as amended,
2. pursuant to § 4 (3) of Act No 576/2004 Coll. on health care, services related to the provision of health care and amending certain laws,
3. in accordance with the provisions of Act No 87/2018 Coll. on radiation protection and amending certain laws as amended,
4. in accordance with Decree No 99/2018 of the Ministry of Health of the Slovak Republic on the provision of radiation protection,
5. in accordance with Decree No. 101/2018 Coll. of the Ministry of Health of the Slovak Republic laying down details on the provision of radiation protection in the conduct of medical exposure and amending as amended.

Current standard procedures

1. Standard procedure for medical exposure and prevention - screening mammography /Standard procedure for the prevention of breast cancer by population screening - screening mammography, 3rd revision https://www.noisk.sk/files/2022/2022-11-11-skrining-mamography-3-revizia.pdf
2. Screening of breast cancer in a high-risk female population https://health.gov.sk/Sources/documents/SDTP/standards/15-11-2022/2 1-Diag radiol ca-prsnika-Skring-karcinom-prsnika-in-high-risk population-green.pdf

Basic terms

1. Mamography is an X-ray of breasts that is performed using a mammographic device at the workplace of radiology.
2. Screening mammography is an X-ray examination of the breasts of the target group of asymptomatic women for early capture of breast cancer, which is performed by a mammographic device at a screening mammographic workplace and is part of the workplace of radiology.
3. Screening mammography is a workplace of radiology where the healthcare provider performs screening mammography.
4. Breast Ultrasonography is a diagnostic imaging method based on ultrasound.
5. Low-value healthcare is healthcare that represents excessive or excessive provision of healthcare, an inadequate or incorrect indication of an examination that does not provide clinical benefit or can lead to harm to health, and without sufficient evidence of effectiveness that the benefit does not outweigh the risks or costs (according to the European Commission: -Identifying, measuring and reducing low-value care in the context of health system performance assessment.

Performing a mammographic examination

1. The amendment entered into force on 1 July 2025. Act No. 577/2004 Coll. on the scope of health care paid on the basis of public health insurance and reimbursements for health care services, as amended (hereinafter "Law No 577/2004') Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). The new Article 2b provides for the screening of oncology diseases and for the reimbursement of screening of cancer of the colon and rectum, cervix, lungs, prostate and breast from public health insurance and the enabling provision for general binding legislation. Reference: https://www.slov-lex.sk/epiles/legal-regulations/EN/ZZ/2004/577/20250701.html
2. Ministry of Health of the Slovak Republic by § 45 (1) (b) c) Act No 576/2004 Coll. on health care, health care services and amending certain laws (hereinafter "Law No 576/2004') Z. z. z. By § 45 (1) (b) (c) Law No 576/2004 Z. z. z. Standard procedures are a binding part of the correct provision of healthcare. The monitoring of compliance with standard diagnostic and therapeutic procedures in practice is carried out by review doctors of individual insurance companies and the Health Care Supervisory Authority.
3. Within the period until the entry into force of the Decree, the provision applies Article 4 (3) of Law No 576/2004 Z. z. z. –The Provider is obliged to provide healthcare correctly. Health care is provided correctly if all health performances are performed to correctly identify the disease, ensuring early and effective treatment to cure a person or improve the condition of a person, taking into account current knowledge of medical science and in accordance with standard procedures for the performance of prevention, standard diagnostic procedures and standard therapeutic procedures, taking into account individual patient status...
4. Screening of breast cancer by screening mammography with decrees pursuant to § 2b of Law No 577/2004 Z. z. performed according to current Standard procedure for medical exposure and prevention - screening mammography/Standard procedure for the prevention of breast cancer by population screening - screening mammography, 3rd revision (hereinafter referred to as "the standard procedure') Reference: https://health.gov.sk/Sources?/Sources/documents/SDTP/standardy/15-11-2022/14 3-Radiologie-Skringing-mamography 3 revizia.pdf
5. Current standard procedure should be screened for mammographic breast examination perform in a non-symptom group of women aged 45 – 69 years + 364 days with an interval of one every two years and 70 – 74 years + 364 days with an interval of one every three years.
6. High-risk women have a defined interval and age range according to standard practice breast cancer screening in a high-risk female population https://health.gov.sk/Sources/documents/SDTP/standards/15-11-2022/2 1-Diag radiol ca-prsnika-Skring-karcinom-prsnika-in-high-risk population-green.pdf.
7. Current standard procedure should be screened for mammographic breast examination does not perform in a non-symptom group of women aged 40 44 years + 364 days.Mamographic examination for preventive reasons not even under self-payer regime, because the medical indication and justification for medical exposure are not metand such examination is considered medically unjustified exposure. Amendment to Law No 577/2004 The Z. z., which has been in force since 1 July 2025, changed the age criterion for breast cancer screening in a non-symptom group of women, i.e. screening mammography in a non-symptom group of women is carried out at the age of 45-74 years + 364 days.
8. Mamographic examination (performance of 5092 and 5092P) in women aged 45 74 years + 364 days at uncertified mammographic workplace is covered by public health insurance and as a preventive examination indicated in preventive examination with diagnosis Z0.1.4 or Z016. Screening mammography (performance 1301*) is covered by public health insurance only at certified mammographic workplaces. Radiological workplaces shall follow the instructions of the competent health insurance undertaking.
9. In the period from 1 July 2025 until the entry into force of the Decree on the Act 577/2004 Coll. workplaces performing screening mammography are governed by the current standard procedure.
10. Mamographics based on clinically indicated difficulties continues to be implemented as diagnostic mammographic examination and is covered by public health insurance.

Performing separate breast ultrasonography

1. European Radiological Society (ESR) and European Breast Imaging Society (EUSOBI) in view of the results of long-term application practice based on evidence-based medicine clearly does not recommend using a separate ultrasound scan as a preventive breast cancer investigation method.
2. Ultrasonographic breast examination is not an appropriate method for asymptomatic non-symptomed women in preventive and breast cancer screening.
3. Ultrasonographic breast examination an additional screening method for mammographic breast cancer, breast disease with symptoms or breast disease is appropriate. Ultrasonography may be relevant in the diagnostic treatment of mammographically dense glands or established mammographic abnormalities or in women with symptoms of mammary gland disease.
4. Separate ultrasound examination of breasts for preventive reasons is not recommended nor at the request of a woman as self-paying. The conduct of ultrasonographic examination is considered and the responsibility of the physician. The doctor will instruct the woman about the inadequacy of preventive ultrasound examination.