National Breast and Cervical Cancer Early Detection Program

1
National Breast and Cervical Cancer Early
Detection Program

• Review of NBCCEDP Screening Reimbursement
  Policies
• Nikki Hayes, MPH
• Bradley Hutton, MPH
• Herschel Lawson, MD
• April Vance, MPH

2
Objectives

• Develop overview documents of issues and policy
  recommendations (white papers) to be considered
  by CDC.
• Define a framework for future policy reviews and
  decision-making.

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Audience

• Primary audience is CDC
• Secondary audiences include NBCCEDP programs and
  providers

4
Planning Process

• Establish issues framework
• Develop evidence overviews
• Conduct key informant interviews
• Establish expert panels

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Planning Process

• Expert panels
• Develop and refine white papers
• Present white papers to CDC

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Composition of Panels

• Academia
• Industry
• Professional Organizations
• NBCCEDP program providers
• NBCCEDP program directors
• FACA members
• Federal Agencies

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Technologies Reviewed

• Breast Cancer
• Film mammography (conventional)
• Full field digital mammography
• Computer Aided Detection (CAD)
• Magnetic Resonance Imaging (MRI)
• Ultrasound
• Cervical Cancer
• Conventional cytology
• Liquid-based cytology
• HPV testing
• - as replacement for or adjunct to screening
  cytology

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Decision Criteria I

• Reduce Morbidity and Mortality
• Enhance Overall Public Health Benefit
• Sustain Overall Quality of Care
• Sustain Overall Program Operations
• Reduce Overall Health Disparities

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Decision Criteria II

• General considerations
• Accommodate program differences
• Flexibility and consistency
• Relevant
• FDA approved tests and devices
• CMS Medicare reimbursement policies

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Initial Issues Framework

• Scientific evidence
• Public health infrastructure
• Program factors
• Public health impact

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Issues Framework Both Cancers

• Test Characteristics
• Program Factors
• Clinical
• Patient
• Provider

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Framework Recommendations

• Breast Cancer

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Breast Cancer Test Characteristics

• Test Characteristics
• Accuracy
• Reproducibility
• Population characteristics
• Interval
• Cost

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Breast Cancer Public Health Factors

• Clinical
• Patient
• Program

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Breast Cancer Film Mammography

• Continue to reimburse at the conventional rate.
• Rationale
• No new evidence to change policy
• Morbidity and mortality reductions

16
Breast Cancer Digital Mammography

• Reimburse at the conventional rate for film
  mammography.
• Rationale
• Cost
• Accuracy
• Access
• Reproducibility

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Breast Cancer CAD

• CAD should not be reimbursed at this time.
• Rationale
• Cost
• Accuracy
• potentially large downstream program costs

18
Breast Cancer MRI

• MRI should not be reimbursed as a screening
  examination for either normal or high risk women
  at this time.
• Rationale
• Accuracy
• Reproducibility
• Program Operations
• Access

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Breast Cancer Ultrasound

• Ultrasound should not be reimbursed as a
  screening examination for either normal or high
  risk women at this time.
• Continued reimbursement for ultrasound as
  appropriate diagnostic follow-up.
• Rationale
• Accuracy
• Access
• Reproducibility

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Breast Cancer Research Surveillance

• Fund pilot studies in a subset of NBCCEDP
  grantees to assess use of CAD.
• Consider pilot assessments of potential policy
  changes to identify programmatic impact.

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Framework Recommendations

• Cervical Cancer

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Cervical Cancer Test Characteristics

• Performance
• Frequency (interval)
• Test costs (lab costs)

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Cervical Cancer Public Health Factors

• Clinical
• Patient
• Program

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Cervical Cancer Conventional cytology

• Continue reimbursement using conventional
  cytology
• Annually and
• Every three years for women with three
  consecutive normal Pap tests within a five year
  period
• Rationale
• No new evidence to warrant change
• Clinical efficiency and practice patterns
• Patient acceptability

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Cervical Cancer Liquid-based cytology

• Allow reimbursement for biennial screening with
  liquid-based cytology (LBC).
• As opposed to annual screening with conventional
  cytology

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Cervical Cancer Liquid-based cytology contd.

• Rationale
• Patient acceptability
• Clinical efficiency
• Provider familiarity
• Ease of HPV triage by reflex testing
• Clinical efficiencies
• Increased sensitivity
• Decreased specificity

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Cervical Cancer HPV Testing

• Reimbursement for combined cytology and HPV
  testing among normal, asymptomatic women is not
  recommended at this time.
• Continued reimbursement for HPV testing as a
  follow-up to ASC-US cytology is recommended.
• Rationale
• Insufficient evidence - ongoing randomized trials
• Patient/provider education needed
• Practice patterns - low market penetration
• Costs

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Recommendations Research Surveillance

• Demonstration projects to assess
• cost/benefit and implementation challenges of
  biennial LBC.
• patient and provider perceptions and behavior
  related to extended screening intervals.
• extent of clinical practice adherence to
  screening guidelines (e.g., intervals, age,
  etc.), reasons for deviations, and practice
  differences between NBCCEDP and non-program
  patients.

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Recommendations Research Surveillance contd.

• Collect NBCCEDP surveillance data on provider and
  laboratory practices in the use of LBC and HPV
  testing

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Recommendations Education

• Provider education to increase understanding
• of the potential harms of low test
  specificity/high false positive rates, and
• Provider and public education to increase
  understanding
• of the relationship of test intervals to test and
  disease characteristics.

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Recommendations Policy Review

• Annual assessment of whether new evidence and/or
  technologies have emerged that alter clinical
  practice and could change current reimbursement
  policies.
• In the presence of new evidence and/or
  technologies, an expert panel review of policies
  should be conducted.
• A full policy review should be conducted at least
  every 5 years.
• Reviews should be informed by the evidence
  reviews conducted by the USPSTF to prevent
  duplication of effort.

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Next Steps

• Finalize white papers
• CDC review of final recommendations
• CDC establishes policies
• Strategic planning for implementation
• Ongoing assessment

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Contact Information

• Nikki Hayes, MPH
• Public Health Advisor
• CDC, DCPC, PSB
• 770-488-4880
• NHayes2_at_cdc.gov
• Herschel Lawson, MD
• Medical Officer
• CDC, DCPC, PSB
• 770-488-4880
• HLawson_at_cdc.gov

• Bradley Hutton, MPH
• Director, Cancer Services Program
• NY State Dept. of Health
• 518-474-1222
• bjh08_at_health.state.ny.us
• April Vance, MPH
• Public Health Advisor
• CDC, DCPC, PSB
• 770-488-4880
• AVance_at_cdc.gov