Regulation - LGIC

Proposed Amendments to Ontario Regulation 45/22 (General) under the Laboratory and Specimen Collection Centre Licensing Act (LSCCLA) and Regulation 552 (General) under the Health Insurance Act (HIA), in order to update the Schedule of Benefits for Laboratory Services (SOB-LS) and Schedule of Benefits for Physician Services (SOB-PS)

Regulation Number(s):
HIA 552
LSCCLA 45/22
Instrument Type:
Regulation - LGIC
Bill or Act:
Laboratory & Specimen Collection Centre Licensing Act; Health Insurance Act
Summary of Proposal:
In 2017, the provincial government confirmed its plans to modernize cervical screening by funding the HPV test and making this test available in primary care and colposcopy settings across Ontario. The HPV test is not currently insured or publicly funded in Ontario.

The HPV test will replace cervical cytology (otherwise referred to as "Pap" testing) as the primary screening test under the Ontario Cervical Screening Program (OCSP), to better identify those who are at highest risk for cervical cancer. HPV testing is reflective of advances in technology that will benefit Ontarians. The HPV test is more accurate than cytology testing and will improve detection of cervical pre-cancer. In addition, new guidance for management and follow-up will minimize repeat testing and support timely discharge from colposcopy.

Implementation of HPV testing as the primary screening test under the OCSP would provide equitable access to best practice of care, leading to improved detection of pre-cancerous changes or cancers at an earlier stage, with fewer patients developing cervical cancer.

To ensure cervical cytology remains accessible to patients, these services will continue to be insured in the community setting under the Schedule of Benefits for Laboratory Services (SOB-LS) and Schedule of Benefits for Physician Services (SOB-PS) when the service is deemed medically necessary for diagnostic purposes outside of the OCSP.

These proposed regulatory amendments would support the changes that Ontario Health is implementing to the OCSP, which aim to promote a coordinated provincial approach to ensure equitable access to HPV testing for individuals who meet the eligibility criteria established by the OCSP.

(a) Proposed Changes to Ontario Regulation 45/22:

The ministry is proposing to amend Ontario Regulation 45/22 (General) under the Laboratory & Specimen Collection Centre Licensing Act (LSCCLA) to:

• Prohibit any laboratory from performing HPV or cervical cytology testing under the OCSP unless the laboratory has an agreement with Ontario Health to participate in the OCSP.
• Require laboratories to report results of a test funded under the OCSP to Ontario Health for the purposes of the Ontario Cancer Screening Registry.

If approved, the regulatory amendments would restrict which laboratories are authorized to perform publicly-funded HPV or cervical cytology testing under the OCSP, so that only laboratories that have an agreement with Ontario Health receive funding for this testing under the OCSP. The proposed regulatory amendments help protect the scope of the OSCP, which would promote a provincially coordinated approach to testing and ensure equitable testing for Ontarians who meet the OCSP's eligibility criteria. Requiring the results of a test funded under the OCSP to be reported to the Ontario Cancer Screening Registry would support OCSP objectives of increasing cervical screening rates and improve detection of cervical pre-cancer. Proposed housekeeping amendments to Ontario Regulation 45/22 would make test names related to cervical cytology consistent throughout the regulation.

(b) Proposed Changes to Regulation 552:

Proposed amendments to Regulation 552 under the Health Insurance Act (HIA) would implement new versions of the SOB-LS and SOB-PS, which would support the transition to the HPV test as the primary screening test under the OCSP.

The following changes are being proposed to the SOB-LS:

• Narrowing criteria for OHIP-insured cervical cytology testing services to instances where the cervical cytology test is deemed necessary for the individual as a diagnostic test outside of the OCSP;
• Excluding the cervical cytology test as an insured service when it is performed under the OCSP. Note that cervical cytology testing performed when medically necessary outside of the OCSP will continue to be publicly funded; and,
• Housekeeping amendments to make related test names consistent throughout the SOB-LS.

The following changes are being proposed to the SOB-PS:

• Updating the eligibility criteria for the insured collection of specimens for cervical screening, in alignment with the OCSP.
• Expansion of colposcopy from an insured service following abnormal cervical cytology results to an insured service following any abnormal cervical screening test (e.g., HPV test or cervical cytology testing).
• Housekeeping amendments to make related test names consistent throughout the SOB-PS.

These proposed changes would clarify eligibility for insured cervical cytology services, as, patients would continue to have access to OHIP-insured cervical cytology and colposcopy services for specialized cancer diagnostic testing.
Analysis of Regulatory Impact:
Implementing HPV testing in cervical screening will more accurately identify those at risk of cervical cancer, leading to timely referrals and reduced incidence and mortality rates.

If the proposed amendments are approved, the ministry expects no new administrative burdens, as the ministry is simply replacing the existing cervical cytology test with the HPV test. Labs funded under the OCSP to perform HPV and cytology testing will continue to report test results in accordance with existing regulatory requirements.

These labs would also be required to report into the Ontario Cancer Screening Registry (OCSR), for the purposes of supporting OCSP objectives, but this additional reporting is not anticipated to create any administrative burdens. Labs already report into the OCSR for cervical cytology and would do the same for HPV testing.

There are no anticipated negative impacts to Ontarians undergoing cervical cancer screening due to these proposed amendments. Individuals will continue to receive screening under the OCSP, but with the more sensitive HPV test, allowing earlier detection of cervical pre-cancers.
Further Information:
Proposal Number:
24-HLTC031
Posting Date:
October 31, 2024
Comments Due Date:
December 15, 2024
Contact Address:
Ontario Ministry of Health
Laboratories and Diagnostics Branch
438 University Avenue
4th Floor
Toronto ON M7A 1N3