Opt-Out Hepatitis C Testing
Risk-based testing for hepatitis C, like HIV, may fail to identify people with hepatitis C infection. As a result, many people with hepatitis C are not diagnosed until they have advanced stage disease or upon death. New York State Department of Health strongly recommends health care providers implement an opt-out hepatitis C testing approach and policy as a way to increase the number of New Yorkers who know their hepatitis C status.
Opt-out testing, sometimes referred to as “routine” or “universal screening”, has proven to be highly effective because it:
- removes the stigma associated with hepatitis C testing,
- fosters earlier diagnosis and treatment,
- reduces chances of transmission,
- addresses structural barriers that disproportionately affect marginalized populations.
Opt-out screening means a patient is notified that testing will be performed unless the patient declines.A separate written consent for testing is not required as the general consent for medical care is sufficient to encompass consent for hepatitis testing.
Conversely, opt-in screening means a patient needs to take a specific action to provide consent and usually relies on provider knowledge or awareness of testing recommendations and risk factors. Opt-in testing results in less people getting tested and is often stigmatizing to the individual as they may need to disclose risk behavior.
Implementation of “opt-out” hepatitis C screening (where all patients are informed and then tested unless they choose to opt-out) is an evidence-based approach to routine hepatitis C (and HIV) testing. The success of opt-out hepatitis C testing relies on strong patient communication and education, which in turn relies on provider confidence and buy-in. As such, health care organizations should engage its providers and care teams throughout the process of opt-out hepatitis C testing implementation to ensure seamless adoption.
Examples of opt out testing language:
- I/We recommend all patients be tested for: [include Hep C along with the other “panel” of tests to be ordered]. Do you have any concerns or questions for me?
Or
- We test everyone for [insert tests]. Do you have any concerns or questions?
Or
- New York State law requires all adult persons be screened for hepatitis C at least once in their lifetime. This will be included in your regular bloodwork today. Do you have any questions?
Opt-out language should include:
- Recommendation that all patients get tested,
- Assumption that all patients consent to testing and the option to refuse is in asking if they have questions or concerns about the recommendation/test,
- If a patient asks, do I have to be tested? Answer is “No, but we recommend all of our patients be tested” to reinforce the recommendation. By asking patients what their concerns are about getting tested may help dispel a concern that is not necessarily related to consent, but in how the test is conducted (i.e., the patient doesn’t like needle-sticks/venipuncture; however, a fingerstick test may be acceptable).
- Consent is not separate and is included in the agency’s general consent to testing/services. Documentation of refusal is the only thing needed.
References and Resources
Opt-Out HIV/HCV Screening: Evidence-Informed Structural Intervention
2023 Amendment of New York Public Health Law S2171
New York State Department of Health Hepatitis C Testing Law Guidance and Resources
Centers for Disease Control Clinical Screening and Diagnosis for Hepatitis C
