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January 05, 2026
4 min read
Key takeaways:
- HHS designated HPV testing, either clinician- or self-collected, as the preferred screening method for women at average risk.
- The guidance requires most insurers to cover testing without beneficiary cost sharing.
HHS’s Health Resources and Services Administration released updated guidance for cervical cancer screening, which includes a new option for average-risk women to self-collect vaginal samples for HPV testing.
The guidance, published in JAMA, “is designed to help close the screening gap by expanding access and reducing cost barriers,” HRSA told Healio.
HHS designated HPV testing, either clinician- or self-collected, as the preferred screening method for women at average risk. Image: Adobe Stock
According to Brian Christine, MD, the assistant secretary for health at HHS, and colleagues, early detection of cervical cancer can greatly improve survival rates, but over half of all cervical cancer diagnoses “are made beyond an early stage.”
“The direct link between screening and survival illustrates a clear and urgent need to improve cervical cancer screening rates in the U.S.,” they wrote in JAMA. “New self-collection options approved by the FDA provide an opportunity to do so.”
Updates to guidance
The guidance now designates primary high-risk HPV testing every 5 years, either administered by a patient or clinician, as the preferred method of screening for women aged 30 to 65 years at an average risk, while retaining the option of co-testing using HPV tests and cytology every 5 years.
The guidance recommends continuing cytology testing alone every 3 years if HPV testing is unavailable.
The guidelines do not apply to women at a higher risk for cervical cancer, like women “infected with human immunodeficiency virus, women who are immunocompromised because of another etiology, women exposed to diethylstilbestrol in utero, or women treated for cervical intraepithelial neoplasia grade 2 or higher within the past 20 years,’” Christine and colleagues wrote.
The guidelines also include new language requiring health insurance companies to cover without patient cost sharing for additional testing possibly needed, like biopsy or cytology, “to complete the screening process for malignancies,” the researchers noted.
Insurers are required to begin coverage under the new guidance starting Jan. 1, 2027.
“Under the Public Health Service Act, most private health insurers are required to cover the preventive services listed in the HRSA’s evidence-based guidelines without beneficiary cost sharing, including co-payments or deductibles,” Christine and colleagues wrote.
The guidelines align with those recently published by the American Cancer Society (ACS), which also include the option of self-collection for HPV testing.
“Numerous studies have demonstrated the potential for self-collection to increase screening rates, including in historically hard-to-reach population,” they wrote. “Self-collection may also help increase screening by making the process less uncomfortable and more accessible, especially for women in rural areas or those facing transportation or scheduling barriers.”
The self-collection can either occur at a patient’s home or a clinician’s office depending on which FDA-approved test is selected.
“Women who choose home testing may be prescribed a test, collect a vaginal swab at home and mail the test to the company that processes the result,” Christine and colleagues wrote. “This process is similar to that used by patients for home stool collection in colorectal cancer screening.”
A ‘vital step forward’
Andrew M.D. Wolf, MD, FACP, Professor Emeritus of Medicine at the University of Virgina School of Medicine and chair of the ACS Screening Guidelines Development Group, told Healio he is “very pleased” with the updated guidance.
“The recommendation to offer self-testing with HPV is a vital step forward in broadening access to cervical cancer screening,” he said. “In addition, the emphasis on considering the follow-up testing required for abnormal HPV or cytology results as part of a two-step screening process is critical to ensuring that private health care plans fully cover the costs of follow-up testing as preventive care.”
While ACS’ and HRSA’s guidelines “have more commonalities than differences, there are several areas where they diverge,” Wolf said.
For example, for clinician-collected tests, ACS recommends primary HPV testing every 5 years for women aged 25 to 65 years at an average risk — with either cytology alone every 3 years or co-testing every 5 years as approved alternatives. However, HRSA recommends cytology screening at age 21 years and every 3 years up to age 30 years, and then primary HPV testing every 5 years, Wolf said.
“The ACS found in its evidence review for its 2020 update that the risk of cervical cancer is extremely low below the age of 25, and given the clear superiority of primary HPV testing over cytology in terms of detection, updated its guideline to recommend HPV as the preferred screening method for all average-risk women, beginning at age 25,” he added.
Another notable difference is the recommended screening interval for a self-collected test.
“Whereas the HRSA guideline recommends a 5-year interval (same as for clinician-collected), the ACS has taken a more conservative approach, recommending a 3-year interval, until there is more longitudinal data on the performance of self-collected screening in detecting cervical cancer and pre-cancer,” he said. “We anticipate extending the interval to 5 years if the evidence confirms that self-collection is as efficacious as clinician collection.”
Wolf said he anticipates “that as self-collection becomes more widely available — particularly at-home collection — we will see a significant jump in screening rates and a decline in cervical cancer rates and in deaths from cervical cancer.”
At-home testing requires ‘appropriate infrastructure’
ACOG President Steven J. Fleischman, MD, MBA, FACOG, also said that self-collection has the potential to expand screening. However, he warned that “appropriate infrastructure must be in place to promptly connect people using at-home testing to follow-up testing and treatment when indicated.”
“Increasing screening access without established systems to provide follow-up testing and treatment could delay diagnosis and treatment and prove detrimental to patients,” Fleischman said in a statement. “Screening is critical, but for many patients, it is just one step of the process when it comes to identifying cervical cancer and receiving the treatment they need.”
He also stressed the importance of HPV vaccination, which ACOG recommends at age 11 to 12 years. For girls and women who did not receive an HPV vaccine during the target age, ACOG recommends that OB/GYNs vaccinate those aged 13 to 26 years and consider vaccination for those up to age 45 years.
“Compared with many other countries, HPV vaccination rates in the United States are unacceptably low,” Fleischman said. “HPV vaccines are among the most effective vaccines available worldwide, and one of our most powerful tools in preventing HPV-associated cancers such as cervical, vaginal, vulvar, penile, anal and oropharyngeal cancers.”
*Editor’s note: Wolf’s interview reflects his own views and opinions, not his affiliations or institutions.
For more information:
Andrew M.D. Wolf, MD, FACP, can be reached at primarycare@healio.com.
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