From 1 December 2017, pathology MBS items for cervical screening will change. This will have practical implications for service providers, clinicians, and consumers alike.
Key points
- There will be new pathology MBS items for cervical and vaginal screening tests, to reflect changes to the National Cervical Screening Program (NCSP), aligning with clinical best practice. The previously used MBS cervical screening items will be deleted.
- After this date Pap tests will no longer be eligible for Medicare rebates, meaning that patients may be charged if this test is requested.
- Pathology laboratories will assign the correct pathology MBS item number based on the information provided on the request form.
- Appropriate assignment of pathology MBS numbers is important in ensuring that patients avoid unnecessary out-of-pocket expenses for testing. It also enables laboratories to provide the correct clinical management recommendations, and accurate and timely reports on testing rates.1 This will in turn support the ongoing monitoring and evaluation of the new NCSP.
- There are new conventions for requesting tests but any additional clinical information that supports the screening or test type requested should also be written on the form.
Supporting a revised clinical pathway
The Medicare Benefits Schedule (MBS) items for cervical and vaginal pathology testing for cervical pre-cancer and cancer have been updated to support the revised clinical management pathway and renewed National Cervical Screening Program (NCSP). There will be seven new MBS item numbers, and the currently used item numbers will be deleted.
The renewed NCSP now centres on human papillomavirus (HPV) testing with partial genotyping, and reflex liquid-based cytology (LBC), where indicated. This will better identify patients at risk of pre-cancerous abnormalities and cervical cancer.2 The purpose of the change is to deliver a more effective program based on current evidence and best practice.
About the changes
There are several major changes to cervical screening practice in the renewed NCSP.
- Five-yearly routine Cervical Screening Tests (CSTs) are recommended for asymptomatic patients from 25 up to 74 years of age, with a previously normal screening history. Where HPV is not detected, patients aged 70–74 years are eligible to exit the program.
- Testing methodology and pathology MBS item numbers have changed. This means that pathology request forms need to be filled in differently from previously, and it is important that the appropriate test name and supporting patient information is written on the request form.
- The renewed NCSP will be supported by the new National Cancer Screening Register (NCSR), and there are new ‘opt out’ procedures for patients.
One of the components of the renewal of the NCSP will be the introduction of self-collected samples for HPV testing.
The self-collection option has been included in the program to encourage patients who are aged 30 years or over and have never had a screening test, or who are overdue for testing by at least two years and in either case have declined a healthcare provider-collected sample, to participate in cervical screening.
Self-collection will not be immediately offered with the renewed program on 1 December 2017.
What do screening providers need to do?
Healthcare service providers need to become familiar with the changes to the NCSP, and how these changes will affect their patients and practice.
A table titled Pathology Test Guide for Cervical and Vaginal Testing provides further information for healthcare providers on pathology test requirements under the renewed NCSP.
The Australian Government Department of Health National Cervical Screening Program website has a range of practical resources for clinicians and consumers about the new NCSP, and should be consulted for further information about screening, follow-up and clinical management for cervical cancers and pre-cancerous abnormalities.
What are the changes?
In December 2017 the NCSP changes from 2-yearly Pap tests (cervical cytology testing) to a program based on 5-yearly screening using primary HPV testing with partial genotyping (called the Cervical Screening Test) and liquid-based cytology (LBC) triage.
The major changes under the renewed NCSP and their impact on pathology requesting are as follows.
Screening interval
What’s changing?
Routine screening for asymptomatic patients with a previously normal screening history will occur every 5 years, rather than every 2 years.
Patients aged 25–74 years should be offered the Cervical Screening Test when their next Pap test is due, which is usually 2 years after the last negative Pap test. In most patients with a previously normal screening history, the 5-year screening interval starts from the date of their first negative Cervical Screening Test.
HPV vaccination does not preclude cervical screening, as the HPV vaccine does not protect against all the types of HPV that cause cervical cancer.
What’s the evidence?
Predictive modelling of 5-yearly HPV testing has shown that it will be safer and more effective than the current system of 2-yearly Pap tests. It is expected that the new program will result in a 24% to 36% reduction in cervical cancer incidence and mortality in Australian women.3
What to write on the pathology request form: Routine cervical screening
When a routine cervical screening test sample is taken from an asymptomatic patient between 25 and 74 years of age, the pathology request form should state ‘Cervical Screening Test’ or ‘CST’. It is important to remember that only one of this MBS item is claimable in a 57-month period.
Patient age
What’s changing?
Routine screening will be available for patients aged from 25 up to 74 years of age. Patients aged 75 years or over are not part of the target age group but may also screen if they have never had a cervical screening test or if they have not had one in the previous 5 years.
When an asymptomatic patient under the age of 25 years presents for routine cervical screening following a previously negative Pap test, the cervical screening test should be deferred until the patient is aged 24 years and 9 months when they will be invited to screen and are eligible for the MBS rebate.
Patients aged between 70 and 74 years can exit the NCSP if they are asymptomatic and have a Cervical Screening Test in which HPV is not detected. While further routine screening for these patients is not required and invitations to screen will no longer be sent, they are able to screen every 5 years if they choose.
There are several specific circumstances in which some patients may have an HPV test outside of the 25–74 year age range, or they may require more frequent screening. These are outlined in the 2016 Guidelines for the management of women with screen detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding. HPV testing for these patients will require additional information to be written on the pathology request form, such as whether they are immune-deficient.
The Guidelines advise that for patients who have had an early sexual debut (prior to 14 years of age) and who were not HPV-vaccinated before sexual debut, a single HPV test between the ages of 20 and 24 years may be considered on an individual basis.
Symptomatic patients can be tested at any age, and are recommended to have both an HPV test and an LBC test, irrespective of the HPV test result. This is called a co-test and this is explained in more detail below.
What’s the evidence?
Increasing the age for commencing routine cervical screening from 18 years to 25 years in the new NCSP is supported by the relatively low rates of cervical cancer in patients aged under 25. There is no evidence to suggest that cervical screening is of benefit in this group in terms of improving cervical cancer incidence or mortality.3 In addition, the HPV vaccination has been a major factor in substantially lowering the risks of HPV transmission in both vaccinated and unvaccinated young people.
What to write on the pathology request form: Screening and Investigations in specific populations
For patients who require an HPV test before age 25 years due to early sexual debut and who were not HPV-vaccinated prior to sexual debut, the pathology request form should state ‘HPV Test, Early debut HPV’.
For patients who are immune-deficient, the pathology request form should state ‘HPV Test, Immune-deficient’.
It is important to note that symptomatic patients can be tested at any age. When a test has been taken for the investigation of symptoms such as abnormal bleeding, the pathology request form should state ‘Co-test, Symptomatic’ or ‘HPV & LBC, Symptomatic’.
Testing methodology
What’s changing?
Cytology will no longer be used for routine cervical screening, and Pap tests will be replaced by a Cervical Screening Test which is an HPV nucleic acid test with partial HPV genotyping.
Partial genotyping is used to classify HPV into either ‘oncogenic HPV 16/18’ or ‘oncogenic HPV types not 16/18’ as a pooled result. If HPV is detected, the pathology laboratory will automatically conduct a reflex liquid-based cytology (LBC) test on the same sample, to determine if any cervical cell abnormalities are present. Reflex testing is timely and cost-effective, and has the advantage of not requiring an additional sample to be obtained from the patient. The pathology report will include the combined results and recommend the appropriate clinical management or follow-up pathway.
Where a patient has had a positive cervical screening test result, a 12-month follow-up HPV test should be requested.a Patients undergoing clinical management for a previously abnormal Pap test result should transition to the new pathway in accordance with the 2016 Guidelines for the management of women with screen detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding. Patients who were recommended to have a 12 month follow-up Pap test should be offered the follow-up HPV test at this time, instead.
Patients who have been exposed to diethylstilboestrol (DES) should be offered annual co-testing as per the 2016 Guidelines instead of routine 5-yearly screening.
Co-testing with both the HPV and LBC tests should be requested for post-treatment clinical management of patients who have undergone treatment for high-grade squamous intra-epithelial lesions (HSIL) or adenocarcinoma in situ (AIS).The 2016 Guidelines recommend that patients who have received treatment for HSIL should complete ‘Test of Cure’ surveillance prior to returning to routine screening. This should be performed 12 months after treatment and annually thereafter, until the patient receives negative co-tests on two consecutive occasions. The patient can then return to five-yearly screening.
Co-tests are distinct as the pathology laboratory will always perform an LBC in addition to HPV partial genotyping, whereas for routine Cervical Screening Tests, the reflex LBC is dependent on the result of the HPV test.
Follow-up and post-treatment tests are available for patients of any age.
If the test results are reported as unsatisfactory, repeat testing is available as a separate pathology item. This is only claimable by the patient if it is preceded by another cervical or vaginal MBS item.
What’s the evidence?
Australia is one of the first countries to adopt the HPV test as part of a nationwide screening program. There is a large body of evidence supporting the use of HPV testing in primary screening and it has been shown in several randomised control trials to be superior to cytology in detecting high-grade abnormalities and cervical cancer.2
a The follow-up HPV result will determine the clinical recommendation from the pathologist. A reflex LBC will be also be performed automatically by the pathology laboratory if HPV has been detected, to provide the colposcopist with important cytology information to assist their investigation and further clinical management. More information on clinical management pathways can be obtained from the 2016 Guidelines for the management of women with screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding.
What to write on the pathologyrequest form: follow-up and clinical management
If requesting a 12-month follow-up test for a patient who had a previous positive screening test, the pathology request form should state ‘Follow-up HPV test’. This test is available for patients of any age.
Following treatment of HSIL, patients of any age can be referred for a cervical ‘test of cure’. The pathology request form should state ‘Co-test, Test of Cure’ or ‘HPV & LBC, Test of Cure’.
Following treatment of AIS, patients of any age can be referred for post-treatment cervical testing. The pathology request form should state ‘Co-test, Post-treatment’ or ‘HPV & LBC, Post-treatment’.
Asymptomatic patients who have been exposed to DES in utero can be referred for cervical testing. The pathology request form should state ‘Co-test, DES’ or ‘HPV & LBC, DES’.
When a test is reported as unsatisfactory by the pathology laboratory, repeat testing should be performed and the pathology form should state ‘HPV test, previous result unsatisfactory’ or ‘LBC, previous result unsatisfactory’. The form should also state whether the sample is cervical or vaginal. This test is only claimable if preceded by a prior cervical or vaginal MBS item.
Testing after total hysterectomy
Patients who have had a total hysterectomy have different clinical recommendations depending on the indication for the hysterectomy and whether there was any evidence of cervical pathology in the histology specimen. These are outlined in the 2016 Guidelines.3
Samples taken from the vaginal vault need to be identified as such; whether the patient has a previous history of cervical pathology will determine the type of test that should be performed.
What to write on the pathologyrequest form: testing after total hysterectomy
Samples taken from the vaginal vault from patients who have had a total hysterectomy should be written as ‘Vaginal Vault HPV’ on the pathology request form.
If the patient’s hysterectomy specimen shows unexpected low-grade squamous intraepithelial lesions (LSIL) or HSIL, or if there is a known history of HSIL for the patient and they are undergoing surveillance before returning to routine screening, the pathology form should state ‘Vaginal vault Co-test’ or ‘Vaginal vault HPV & LBC’.
What does this mean for healthcare providers?
MBS pathology items have changed to reflect structured testing for screening, follow-up and clinical management of patients.
This means it is very important to provide all of the necessary patient information on the pathology request form, to ensure the appropriate test is applied and the patient is managed accordingly. The patient’s age, previous screening history, medical background and presenting symptoms should all be considered.
Providers will need to specify on the pathology request form:
- the name of the test required and
- whether the collection is part of routine screening or is for clinical management or for screening symptomatic women and
- other relevant clinical information, eg, screening history, exposure to DES.
Additionally, there are restrictions to the new MBS items, particularly with regard to testing intervals. For example, for most asymptomatic patients, routine HPV screening will be available once in a 57-month period.
Healthcare service providers should also be aware of the importance of HPV screening in specific populations, such as patients who are immune-deficient or who have had an early sexual debut.
The table below outlines the new conventions to use when completing pathology request forms.
| Aspect of testing | What to write on the pathology request form |
|---|---|
| Screening | Cervical Screening Test (CST) HPV test, Immune deficient HPV test, Early debut HPV |
| Investigation | Co-test, Symptomatic OR HPV & LBC, Symptomatic |
| Follow-up | LBC Follow-up HPV test Co-test, Test of cure OR HPV & LBC, Test of cure Co-test, Post treatment OR HPV & LBC, Post treatment Co-test, DES OR HPV & LBC, DES |
| In patients with total hysterectomy | Vaginal vault HPV Vaginal vault Co-test OR Vaginal vault HPV & LBC |
| Repeat test following unsatisfactory testing | HPV test, previous result unsatisfactory LBC, previous result unsatisfactory |
Why is a detailed pathology request form so important?
Providing sufficient clinical information on the pathology request form will:
- support the appropriate clinical management or follow-up plan
- help minimise queries back to the healthcare provider from the laboratory
- limit delays in sample processing by the laboratory
- enable the pathology laboratory to identify the appropriate MBS item number to use
- minimise the possibility of the patient needing to return for repeat testing, or being inadvertently charged for testing for which they were not eligible.
Applying the most appropriate test for the patient may also help improve patient engagement with the cervical screening program, particularly in specific populations such as patients who are immune-deficient or have had an early sexual debut. This may in turn improve patient care and outcomes.
It is also important because pathology laboratories have reporting requirements for testing and results from the renewed cervical screening program. These reports will help provide additional evidence for best practice, and assist in the monitoring and evaluation of the NCSP.
Refer to the Pathology Test Guide for Cervical and Vaginal Testing table for further information.
The new National Cancer Screening Register
The renewed NCSP will be supported by the new National Cancer Screening Register (NCSR). The Register will send invitations and reminder letters to patients 3 months in advance of their screening due date on behalf of the NCSP.
There will also be changes to the way patients can opt out of the NCSR. After 1 December 2017 writing (or placing a sticker) ‘Not for Register’ on the pathology form will no longer be accepted. If a patient chooses to opt out of the Register they can arrange this by calling 1800 627 701. Alternatively, with the consent of the patient, this can be arranged by their healthcare provider or personal representative.
Opting a patient out of the Register for cervical screening will not opt them out of other screening programs (eg, bowel screening), and they can opt back in at any time, also by calling 1800 627 701.
References
- Commonwealth of Australia Department of Health National Pathology Accreditation Council. Requirements for laboratories reporting tests for the National Cervical Screening Program Canberra: Commonwealth of Australia Department of Health, 2017.
- NPS MedicineWise. Changes to the National Cervical Screening Program. NPS Radar. Sydney: NPS MedicineWise, 2015.
- Cancer Council Australia Cervical Cancer Screening Guidelines Working Party. National Cervical Screening Program: Guidelines for the management of screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding. Sydney: Cancer Council Australia, 2016.