New federal guidelines from the Health Resources and Services Administration (HRSA) now include the option for women ages 30 to 65 years at average risk for cervical cancer to self-collect samples for screening.
The move means that starting in 2027, most private insurers will be required to cover self-collected human papillomavirus (HPV) testing and any necessary follow-up tests without cost-sharing.
"If additional testing (e.g., cytology, biopsy, colposcopy, extended genotyping, dual stain) and pathologic evaluation are indicated, these services also are recommended to complete the screening process for malignancies," the updated guideline from the HRSA-funded Women's Preventive Services Initiative states.
The guideline designates HPV testing as the preferred screening modality in this age group, with no preference for collection by the patient or a clinician.
A recent study found that 43% of surveyed women preferred self-collection, with 70% open to the idea, and the guideline authors hope the expanded option will increase screening uptake.
"Unfortunately, about half of all women diagnosed with cervical cancer have never been screened or are not up-to-date on screening, and these women are more likely to present with regional or distant metastatic disease," noted Ann M. Sheehy, MD, MS, of HRSA, and guideline co-authors in a JAMA viewpoint.
The updated recommendations are in line with other professional groups that have increasingly endorsed self-collection in recent years.
Following the 2024 FDA approval of a new self-collection test to detect HPV, the U.S. Preventive Services Task Force announced draft recommendations that included the option. And at-home HPV sampling was also endorsed by the American Cancer Society this past December.
Adding self-collection reflects "the new evidence and developments supporting the expansion of options for cervical cancer screening through patient-collected [high-risk] HPV testing," according to a Federal Register notice announcing the guidelines.
In a statement, Steven Fleischman, MD, MBA, president of the American College of Obstetricians and Gynecologists (ACOG), said that while the organization recognizes the potential of self-collected testing to expand access to cervical cancer screening, the framework to connect people who test at home to follow-up testing and treatment when indicated must be in place. "Increasing screening access without established systems to provide follow-up testing and treatment could delay diagnosis and treatment and prove detrimental to patients."
He added that the new language in HRSA's recommendation requiring no cost-sharing for additional testing or pathologic evaluation "will reduce cost barriers for patients who previously faced significant out-of-pocket costs for follow-up evaluation."
Courtney Riedinger, MD, a gynecologic oncologist at the University of Tennessee Health Science Center in Knoxville, told MedPage Today that the U.S. is already "behind on the infrastructure for cervical cancer screening in a lot of regards," including infrastructure needed to meet previous recommendations, like HPV-based testing followed by Pap smear.
Under the HRSA guidelines, women ages 30 to 65 can still opt for an in-office Pap smear. Average-risk women ages 21 to 29 are still advised to have Pap smears every 3 years.
Unlike Pap smears, which use a speculum, the self-collected HPV tests are less invasive, with patients swabbing their own vagina with a long cotton swab.
Nikki Zite, MD, MPH, a professor of obstetrics and gynecology at the University of Tennessee Graduate School of Medicine in Knoxville, said self-collection may improve access for patients.
"Any time there are requirements for insurance to cover screening and preventive care, I consider it a win," Zite said. However, she said an even bigger win in the U.S. would be better HPV vaccination coverage "and for the misinformation about this vaccine to be dispelled in a way that encourages uptake."
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