General information for healthcare professionals about Cervical Cancer Screening
In December 2022, the Interministerial Conference (IMC) of Public Health decided (in line with the IMC’s earlier decisions during the previous reign) to switch from cytology to HPV testing for cervical cancer (from the age of 30 onwards). This decision is based on available scientific evidence ranging from the 2015 KCE report 238 to very recent analyses conducted by the World Health Organisation (WHO) and the International Agency for Research on Cancer (IARC). This shift will become effective as of January 1st 2025.
You will find an overview of information by all contributing actors (together with their respective websites) on the following subjects;
- the clinical guidance accompanying the new screening algorithms,
- the nomenclature changes and reimbursement rules,
- special provisions for accreditation of medical laboratories,
- the list of accepted HPV tests,
- regulations on the registration of the screening results, and
- important implication for laboratories;
1. Clinical guidance for healthcare providers
In collaboration with VVOG / CRGOLGB and Domus Medica / SSMG-PromoSanté, supported by the Commissions Clinical Biology and Anatomic Pathology
Read the complete Clinical Guidance document
The clinical guidance for healthcare providers integrates information on new test schemes, updated screening algorithms, notification forms, and other essential details, distinguishing immunocompromised patients from the general population and categorizing individuals by age groups
GENERAL POPULATION
- For all : primary screening & reflex testing (triage) — New test scheme
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table 1. new test scheme: primary screening & reflex testing (triage) (chapter 2.2.)
1 If no screening was reimbursed in the previous 10 yearsNOTE: Within primary screening (25-64y), there is no place — and no reimbursement — for co-testing (a combined HPV test and cytology) because the added value has not been scientifically demonstrated.
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25-29 year : primary screening, reflex testing (triage) and follow-up in the general population (New screening algorithm)
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figure 1. Screening algorithm for 25-29 year olds, in the general population (version 1 — dd 20241015) (chapter 2.3.)
- 30-64 year : primary screening, reflex testing (triage) and follow-up in the general population (New screening algorithm)
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figure 2. Screening algorithm for 30-64 year olds, in the general population (version 1 — dd 20241015) (chapter 2.3.)
IMMUNOCOMPROMISED PATIENTS
+FU / Clinical testing / High-risk groups
- For all : follow-up, clinical testing (with symptoms), and high-risk groups (New test scheme)
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table 2. new test scheme : follow-up, clinical testing (with symptoms) and high-risk groups (chapter 3.1.)
2 indication: postmenopausal blood loss, abnormal therapy-resistant uterine blood loss, unexplained postcoital blood loss
3 DES=diethylstilbestrol: synthetic estrogen prescribed to pregnant women between 1938 and 1971 to prevent miscarriage. The daughters of DES-treated women are at higher risk of cancers including cervical cancer.
4 AIS=adenocarcinoma in situ
5 UPDATED DEFINITION vs nomenclature: all patients with immunosuppression (HIV positives (CD4 <350/µl or HIV RNA >200 cp/ml), after organ transplantation, after allogenetic stem cell transplantation, systemic lupus erythematosus, congenital primary immune deficiency, or patients under long-term continued immunosuppressants) require more frequent screening, as long as the immunosuppressive treatment is continued.
Cfr 3.4: Screening, triage and follow-up in high-risk populations - 21-29 year : primary screening, reflex testing (triage) and follow-up in immunocompromised patients (New screening algorithm)
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figure 3. Screening algorithm for 21-29 year olds, in an immunocompromised population (version 1 — dd 20241015) (chapter 3.4.)
- >30 year : primary screening, reflex testing (triage) and follow-up in immunocompromised patients (New screening algorithm)
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figure 4. Screening algorithm for ≥30 year olds, in an immunocompromised population (version 1 — dd 20241015) (chapter 3.4.)
More information in Clinical Guidance chapter 3.4Read the complete Clinical Guidance document
GENERAL INFORMATION
- Clinical guidance
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The scientific guidance for therapeutic follow-up:
Clinical Guidance chapter 5 (validated by Sciensano, in consensus with the relevant professional and scientific associations)The quality guideline for colposcopy, incl. the template of the standardised minimal report for colposcopy:
Clinical Guidance chapter 6 - Notification form
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Notification form FR / Notification form NL
It is the responsibility of the requesting physician to send the notification form to the woman’s health insurance fund (mutuality). This is the above paper version sent by regular mail. The insurance fund (IF) ‘flags’ the woman when the form arrives (no approval or rejection, the document should only be delivered). This means the woman will be entitled to additional reimbursements and the NIHDI can check based on these notifications for (temporary) high-risk applications and possible misuse. The lab does not get any confirmation, but can provide an option on their application form where the requesting physician can tick that the notification form was sent to the IF.
The pseudocodes on the notification form are only for internal use at the health insurance fund/NIHDI and should not be used or passed on to anyone else. - Collaborative partners
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More information on our collaborative partners’ websites:
2. Nomenclature and reimbursement
In collaboration with RIZIV/INAMI
Royal Decree declairing the changes in nomenclature and reimbursement: Koninklijk Besluit van 07 mei 2024
NOMENCLATURE
More information on the RIZIV/INAMI website:
- General Practitioners: Introductie van de HPV-test als primaire screeningstest voor de opsporing van baarmoederhalskanker in België | RIZIV
- Laboratories: Introductie van de HPV-test als primaire screeningstest voor de opsporing van baarmoederhalskanker in België | RIZIV
- Adaptations of the nomenclature of Article 3
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The nomenclature of Article 3 for the collection of a cervicovaginal smear is adjusted.To the existing nomenclature (for screening and diagnostic/therapeutic follow-up), a third provision is added for clinical/diagnostic examination (suspicious symptomatology) including screening of high-risk groups – only reimbursed after notification: formulier-notificatie-baarmoederhalsscreening.pdf.
You can find the nomenclature with the application rules (frequency of charging and age category) in NomenSoft — RIZIV
NOMENCLATURE CODES: SMEAR COLLECTION
General practitioner
Gynaecologist
1
Screening
114030-114041
114170-114181
2
Follow-up: diagnostic/therapeutic
149612-149623
149634-149645
3
NEW: clinical/diagnostic + high-risk groups
114192-114203
149656-149660
- Adaptations of the nomenclature of Article 14, g)
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The nomenclature of Article 14, g) is also adjusted (431955-431966), in particular the fee for colposcopy is significantly increased.
At the same time, quality requirements are imposed with:
- mandatory participation in a validated colposcopy course or obtaining a colposcopy certificate for the performing gynaecologist, organised by VVOG/CRGOLFB ;
- mandatory storage of interpretable images in the patient’s medical record ;
- a mandatory standardised report containing the EFC (European Federation of Colposcopy) minimal requirements for describing the colposcopic examination.
The quality guideline for colposcopy:
Clinical Guidance chapter 6 - Transfer of the nomenclature from Article 32 to Article 24bis
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The nomenclature in the context of HPV testing is transferred from article 32 to article 24bis. The nomenclature from article 24bis is accessible to both pathologists and clinical biologists.
The adapted nomenclature of Article 32 provides four separate codes for cytology:
NOMENCLATURE CODES: CYTOLOGY
1
Primary screening by cytology in 25- to 29-year-olds and once in insured women aged 65 and over
589853-589864
2
Reflex cytology after a positive HPV test in 30- to 64-year-olds
591791-591802
3
Diagnostic or therapeutic follow-up: once a year (unless notification and temporary high-risk)
591813-591824
4
With clinical symptoms and testing of high-risk groups (via notification)
591835-591846
The adaptated nomenclature of Article 24bis provides four separate codes for the HPV test:
NOMENCLATURE CODES: HPV-test
1
Primary HPV screening in 30- to 64-year-olds and once in insured women aged 65 and over
553615-553626
2
Reflex HPV test in case of abnormal cytology in 25- to 29-year-olds
553630-553641
3
Diagnostic or therapeutic follow-up: once a year (unless notification and temporary high-risk)
553652-553663
4
With clinical symptoms and testing of high-risk groups (via notification)
553674-553685
CO-PAYMENTS & SUPPLEMENTS
- Co-payments and supplements
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As part of primary screening, the aim is to limit the co-payment to keep the threshold for participation as low as possible. There is no personal share for:
- the collection of the smear, nor for
- the primary cytology/HPV test, nor for
- the reflex tests performed after a positive primary screening.
However, there is a co-payment for the consultation with the gynaecologist or GP.
The Royal Decree of 30 October 2017 (BS 30/10/2017, numac 2017013750) stipulates that no supplements will be charged for medical services provided in the context of organised screening programmes. Thus, supplements are not allowed in primary screening nor reflex testing.
The federal government justice department: NL / FR
3. Special provisions for accreditation of medical laboratories
In collaboration with Belgische Accreditatie-Instelling (Belac)
- Quality of the HPV tests and analyses (BELAC)
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To ensure the quality of the HPV tests and analyses, the HPV tests must be performed in a laboratory recognised as a clinical biology or pathological anatomy laboratory by the Minister of Public Health. The laboratory must also hold ISO 15189 accreditation for the molecular tests performed from art24bis. The laboratory must submit to the quality controls carried out by Sciensano. Moreover, labs should be specifically accredited for a validated HPV test from the NRC-HPV list.
Visit the National Reference Center (NRC) for Human papillomavirus
As for cytology, BELAC accreditation according to ISO 15189 cannot be imposed by law. The quality of gynaecological cytology is again monitored by Sciensano.
BELAC will incorporate and publish a guideline within the body of 2-405 documents, making these provisions binding on laboratories seeking ISO 15189 accreditation for the respective services within cervical cancer screening and triage that fall within the scope of the ISO 15189 standard.
4. List of accepted HPV tests
In collaboration with National Reference Center for Human Papillomavirus (NRC-HPV)
- Internationally validated high-risk HPV tests
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The list of internationally validated high-risk HPV tests that can be used in Belgian cervical cancer screening can be found here:
National Reference Center (NRC) for Human papillomavirus | sciensano.be
This table contains a dynamic list of molecular tests for the detection of high-risk HPV and will be updated at least twice a year as new scientific evidence becomes available.
5. Registration of screening results
In collaboration with the Belgian Cancer Registry (BCR)
- Belgian Cancer Registry
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Both the laboratories for Pathological Anatomy and the laboratories for Clinical Biology are legally required to each register data regarding the results of early diagnosis of cancer at the Belgian Cancer Registry (BCR). As such, the law provides a legal basis for BCR to collect cervical sample data and to include them in its cyto-histo-pathology register (CHP register). Moreover, the results of screening are required to be registered, in accordance with Article 5a) of Article 24bis of the nomenclature.
The practical modalities of this data registration are maximally aligned with already existing or future data flows, in consensus with the relevant professional associations. Once validated, they will be available at Data on screening | Belgian Cancer Registry. This registration is required for all results for cervical samples, not restricted to those in the context of screening.
Laboratories for Clinical Biology to BCR
BCR receives a copy of all validated results when they are sent to the requesting physician (= continuous delivery). For this purpose, individual results are sent as structured messages, conforming to the HL7-FHIR standard.
Laboratories for Pathological Anatomy to BCR
Laboratories deliver 2 separate files: a structured file with all variables and a file with the written reports (protocols) monthly to BCR. BCR will implement a minimal extension to the current Cervibase coding, to allow reporting on ‘HPV-only (i.e. cytology not performed)’ in the CODAP/SNOMED lesion codes. In the future, this registration should also evolve to continuous delivery of individual results through structured messages, conforming to the HL7-FHIR standard.Art. 138, §2, 3°, a) Coordinated Law of 10 May 2015 on the exercise of health care professions, Off. B. J. 18 June 2015 (previously art. 45quinquies, §2, 3° Royal Decree n° 78 of 10 November 1967 on the exercise of health care professions).
For the laboratories for anatomical pathology, this registration requirement is also included in their accreditation rules: art. 35, 6° Royal Decree of 5 December 2011 regarding the accreditation of the laboratories for anatomical pathology by the Minister competent for matters of public health, Off. B. J. 13 February 2012.
6. Important implications for laboratories
In collaboration with Clinical Biology Committees, Anatomic Pathology Committees and Professional Associations
- Clinical biology
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Some important implications for daily practice:
1. An integrated advice should be formulated by the laboratory that performed the primary HPV test.
The reflex cytology result is transferred to the healthcare provider who performed the primary HPV test. Based on the results of both the primary HPV test and the additional cytology, the laboratory that performed the primary HPV test will provide a recommendation regarding the further therapeutic approach to follow.
- Integrated advice - 25-29 and 30-64y in the general population
≥ASC-H/AGC = ASC-H or a more severe abnormality (HSIL, SCC, AIS, AC) or AGC
INSU: insufficient cytology, not representative sample (lack of epithelial cells/insufficient cellular material, cell lysis, abundant blood, ..)
HPVi: inconclusive HPV test result
NB: Immediate referral for colposcopic examination is understood within 3 months or faster, according to the severity of the screen-positive result (cfr. 5.3.1)
Cave: If on cytological examination normal endometrial cells are found in an entitled person > 45 years, additional advice is given: ‘Correlation with clinic is indicated to exclude endometrial pathology in post-menopausal women’.
Cave: If on cytological examination abnormal endometrial cells are found at any age, additional advice is given: ‘Exploration to exclude endometrial pathology’.
In bold: the actual integrated advice, after samples were send for reflex testingMore information in
Clinical Guidance chapter 2.4 ANNEX 1
- advice: ≥65y, in case of no reimbursed screening in the last 10 years
More information in
Clinical Guidance chapter 2.5 ANNEX 2
2. Prompt reporting to the Belgian cancer registry is required (Cfr. Registration of screening results).
- Anatomic pathology laboratories
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For the anatomic pathology laboratories, there is no immediate change in the way data should be extracted and delivered to the Belgian Cancer Registry. However, the frequency will be increased from 1x per quarter to 1x per month. An extension of the CODAP codes for coding the HPV tests (i.e. primary HPV tests) is also foreseen: HPV+, HPV- and HPVi will be added to the CODAP codes as part of the Cervibase codes.
In the future however, maximum efforts will be made for continuous delivery of individual results; processing via new FHIR architecture (Cfr. Registration of screening results).
An integrated advice should be formulated by the laboratory that performed the primary screening test.
Integrated advice - 25-29 and 30-64y in the general population
The reflex test result is transferred to the healthcare provider who performed the primary screening test. Based on the results of both the primary test and the additional reflex test result, the laboratory that performed the primary screening test will provide an integrated recommendation regarding the further therapeutic approach to follow.≥ASC-H/AGC = ASC-H or a more severe abnormality (HSIL, SCC, AIS, AC) or AGC
INSU: insufficient cytology, not representative sample (lack of epithelial cells/insufficient cellular material, cell lysis, abundant blood, ..)
HPVi: inconclusive HPV test result
NB: Immediate referral for colposcopic examination is understood within 3 months or faster, according to the severity of the screen-positive result (cfr. 5.3.1)
Cave: If on cytological examination normal endometrial cells are found in an entitled person > 45 years, additional advice is given: ‘Correlation with clinic is indicated to exclude endometrial pathology in post-menopausal women’.
Cave: If on cytological examination abnormal endometrial cells are found at any age, additional advice is given: ‘Exploration to exclude endometrial pathology’.
In bold: the actual integrated advice, after samples were send for reflex testingMore information in
Clinical Guidance chapter 2.4 ANNEX 1
Integrated advice ≥65y, in case of no reimbursed screening in the last 10 years
More information in
Clinical Guidance chapter 2.5 ANNEX 2
7. Region specific details regarding population screening
- Population screening organisations
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Flanders*
Departement Zorg & CvKO
Brussels
Vivalis & BruPrev
Wallonia
AVIQ & CCRef
Communauté Germanophone
CCRef
* The Centre for Cancer Screening (CvKO) sends an invitation letter to all women in the target group (25-64y) and also forwards the screening result, date of last screening, date next invitation and (integrated) advice to the woman’s GMD physician (physician who manages the Global Medical Record) and mijngezondheid.be; to be consulted by the women and/or other attending physicians.
Read the complete Clinical Guidance
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