Guidance Update: Cervical Cancer Screening

SUMMARY:

The Health Resources and Services Administration (HRSA) has released cervical cancer screening guidelines. The guidance addresses screening modalities such as cytology and high-risk human papillomavirus (hrHPV) testing as well as the role of patient self-collection and insurance coverage related to any additional follow-up testing.

CLINICAL ACTIONS:

HRSA Cervical Cancer Screening Guidelines

Screening Approach Based on Age

• 21 to 29 years
  • Screen with cervical cytology (Pap test) every 3 years
  • Co-testing with cytology and hrHPV testing is not recommended
• 30 to 65 years
  • Preferred: primary hrHPV testing every 5 years
  • Acceptable alternative: cytology and hrHPV co-testing every 5 years
  • If hrHPV testing is unavailable: cytology alone every 3 years
  • Patient-collected hrHPV testing is an appropriate option

Screening Frequency and Follow-Up

• Screening interval
  • Average-risk women should not be screened more than once every 3 years
• Additional testing and evaluation
  • May include
    • Cytology | Biopsy | Colposcopy | Extended genotyping | Dual stain testing
  • Pathologic evaluation and follow-up testing are recommended when indicated to complete the screening process for malignancies

Insurance Coverage Requirements

• Applicable plans
  • Non-grandfathered group health plans
  • Health insurance issuers offering group or individual health insurance coverage
• Cost-sharing
  • Required to cover listed services and screenings without cost-sharing
• Plan and policy years
  • Update for most plans will take effect in 2027

Self-Collection for Cervical Cancer Screening

• The ACS recommends the following regarding self-collection
  • Preferred: Clinician-collected cervical specimens
  • Acceptable: Self-collected vaginal specimens
• Repeat testing in 3 years when self-collected vaginal specimens are HPV-negative
• Only use tests kits with FDA indication for primary HPV screening using self-collection
• Only use in settings for which there is FDA approval (clinic or at home)

Note: The ASC provides the following reasoning as to why clinician collection remains preferred at this time

• Provides direct access to the cervical transformation zone (primary site of HPV-related precancerous lesions)
• Allows the same sample to be used for both HPV testing and cytologic evaluation if HPV-positive
• Can be used to screen all patients
• Self-collected vaginal samples
  • Do not directly capture cervical cells
  • A positive HPV result typically requires a follow-up speculum exam for clinician-collected cervical cytology
  • Critical to assess eligibility (e.g., HIV/immunosuppression, exposure to DES in utero or history of cervical cancer must receive appropriate testing)
• The ASC states that “Recommendations are intentionally conservative to provide a margin of safety during implementation” and may be changed to every 5 years once there is sufficient reassuring data (i.e., incidence of CIN3+ is sufficiently low)
• ACOG has responded to the HRSA guidelines and notes potential benefit of self-collection but also risks in the absence of suitable infrastructure

Increasing screening access without established systems to provide follow-up testing and treatment could delay diagnosis and treatment and prove detrimental to patients

SYNOPSIS:

Cervical cancer rates in the United States are low due largely to access to effective screening.  Cervical cancer is believed with a high degree of certainty, to be the delayed consequence of infection with high risk or oncogenic human papillomavirus (HPV).  The majority of HPV infections are transient and do not progress to cervical cancer.  However, the consequences of missing precancerous or early cancerous lesions are potentially lethal and should be avoidable with appropriate screening.

KEY POINTS:

• The goal of cervical cancer screening is to minimize harm and maximize benefit
• The above clinical action items refer to average risk women
• Women at increased risk for cervical cancer require a higher level of surveillance and include those who are
  • Immunocompromised (HIV positive, organ transplant recipient, chronic steroid use)
  • Women with multiple partners or high risk partners
  • Women with a history of abnormal Pap smear or precancerous genital conditions
  • Smokers

Learn More – Primary Sources:

HRSA Cervical Cancer Guidelines

Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society

ASC: Self‐collected vaginal specimens for human papillomavirus testing and guidance on screening exit: An update to the American Cancer Society cervical cancer screening guideline

Human papillomavirus self-collection: The long road from scientific evaluation to implementation in screening programs

ACOG Responds to Updated HRSA Women’s Preventive Services Initiative Guidelines on Cervical Cancer Screening