Federal health officials have updated cervical cancer screening guidelines to add HPV self-collection and require insurer coverage starting in 2027, a shift that could significantly impact testing volumes and workflows for clinical laboratories.
In a move that could significantly reshape testing volumes, workflows, and access strategies for clinical laboratories, the US Health Resources and Services Administration (HRSA) said in a press release that it has issued updated cervical cancer screening guidelines that formally introduce patient self-collection as a new screening option..
Under the updated guidance, high-risk human papillomavirus (hrHPV) testing—using either clinician-collected or patient-collected samples—is now the preferred screening method for average-risk women ages 30 to 65, while Pap testing remains an option. For women ages 21 to 29, Pap testing continues to be recommended.
The guideline also includes a major payer-facing provision that lab leaders should note. HRSA said most insurance plans will be required to cover not only the screening itself, but also any additional testing needed to complete the diagnostic process following an abnormal result. That coverage requirement takes effect January 1, 2027, reducing patient cost barriers that have historically limited follow-up testing volumes.
“These updates represent a significant step forward in cervical cancer screening and will improve screening rates and save lives,” HRSA Administrator Tom Engels said, adding that expanded options and reduced financial barriers allow more women to “take an active role in protecting their health and their future.” (Photo credit: HRSA)
HRSA Update Sets Stage for Insurer-Covered At-Home Testing Starting in 2027
An article from ABC News said the HRSA update aligns federal preventive guidance with recent FDA approvals that now allow both in-clinic and at-home self-collection for HPV testing. The January 2027 deadline for private insurers is expected to accelerate adoption of home-based and alternative specimen collection models.
“The addition of self-collection really empowers women to make this choice for themselves,” Ann Sheehy, MD, HRSA’s chief medical officer, told ABC News. “We do retain the option for Pap smear … this is just an additional choice for women.”
ABC News stated the preferred screening cadence for women ages 30 to 65 is now primary hrHPV testing every five years, whether the sample is collected by a clinician or by the patient. Alternative pathways—co-testing every five years or Pap testing every three years—remain in place if HPV testing is unavailable, preserving flexibility for labs at different stages of HPV test adoption.
HRSA officials emphasized that the goal is expanded access, not replacement of existing workflows. Engels told ABC News that self-collection could help reach women who have “been falling through the cracks,” adding, “By doing that, we’re going to save lives.”
ABC News noted the guidance also clarifies insurer obligations for follow-up diagnostics, including Pap testing, biopsy, and laboratory work, a move designed to prevent cost-sharing from disrupting care pathways. Separate HRSA rules now also require coverage of patient navigation services, which may further increase completed diagnostic testing after abnormal screens.
The American Cancer Society’s (ACS) December 2025 guideline update helped shape the federal move, ABC News said, citing evidence that self-collection improves access without sacrificing accuracy. “The combination of good evidence of the benefits of self-collection, which include increased access to cervical cancer screening, combined with FDA approval, led the ACS and HRSA to include self-collection,” said Robert Smith PhD, senior vice president of early cancer detection science at the ACS.
For lab professionals, HRSA’s announcement underscores a coming shift: broader HPV test demand, increased importance of validated self-collection workflows, and potentially higher follow-up testing volumes as cost barriers fall and screening gaps narrow.
—Janette Wider
