Successfully integrating human papillomavirus testing into your practice

Archives of Pathology & Laboratory Medicine,  Aug 2003  by Lozano, Richard

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* Integrating human papillomavirus (HPV) testing into the practice of cervical cancer screening is a continuous process that begins and ends with education. An understanding of the basic science and clinical relevance are critical to proper implementation. One must have knowledge of one's own laboratory statistics, clinician awareness, and market forces before the final steps are taken. Additional logistical issues are often laboratory specific or state specific, but are addressed here.

HUMAN PAPILLOMAVIRUS EDUCATION

The process of bringing human papillomavirus (HPV) testing into one's laboratory begins with education. You must educate yourself, other pathologists, and your clinicians, as all of you will face questions about laboratory policy and the clinical significance of HPV results. Your clinicians will ask about costs, turnaround time, and the laboratory rate for atypical squamous cells of undetermined significance (ASCUS). Helpful references include the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines and the ASCUS/Low-Grade Squamous Intraepithelial Lesion (LSIL) Triage Study (ALTS) publications, among others.1-5 Gauging the awareness level of your clinicians is helpful. Are they aware of and are they following the ASCCP guidelines? Knowledge of your own laboratory data is useful, specifically the ASCUS rate and ASCUS-squamous intraepithelial lesion (SIL) ratio. Ideally, if your computer system can produce individualized statistics for each clinician, this becomes a much more powerful report (Table 1). Providing this report to your clinicians will let them identify trends in test ordering and standard of care. Monitoring the data regularly will also help the laboratory identify adverse trends, such as prolonged turnaround time, specimen adequacy difficulties, or ASCUS inflation.

MARKET RESEARCH

Discuss HPV testing with each of your clinician groups, but it may be helpful to choose a few leaders among this group when testing the waters. My experience has indicated that society guidelines and insurance coverage are the determining factors for clinicians when deciding to begin new technologies. The most important questions to discuss are as follows:

* What are the ASCCP-recommended indications for HPV testing?

* What other emerging indications exist?

* What is the expected turnaround time?

* Will insurers cover HPV testing? If not, what are patient costs?

* Will HPV testing be ordered as an automatic reflex or on a case-by-case basis?

The ability to bring HPV testing in house hinges on volume. Total gynecologic cytology volume, conversion to liquid Papanicolaou (Pap) tests (with reflex HPV ordered), laboratory ASCUS rates, and turnaround time all play a critical role in the decision-making process (Table 2). The Food and Drug Administration's 3-week expiration (from the time of collection) means that weekly or biweekly HPV testing will be necessary. There are also emerging indications (primary HPV screening and follow-up after cone biopsy) that may increase the volume to a profitable threshold. If the laboratory volume is initially too low for in-house testing, using a referral laboratory may bridge the gap until volumes increase.

The reimbursement issues that impeded conversion to liquid cytology will not affect HPV testing, because the Current Procedural Terminology (CPT) code for HPV testing has existed for years (CPT code 88621, Medicare $48.50).6 Therefore, HPV testing has not faced the gap-fill process that liquid cytology faced. There are regional variations in reimbursement coverage, but individual payer rates should be established (average reimbursement $41.74; Digene Corporation, unpublished data, 2000). Once you identify your outpatient payer mix (percent Medicare, percent Blue Cross, etc) and individual payer reimbursement rates, you can estimate your average reimbursement. It will cost between $40 and $50 per test for established in-house testing (average $37.00; Digene Corporation, unpublished data, 2001), and $50.00 to $60.00 per test to send out to a reference laboratory. If you plan to send out HPV tests but bill the patient or insurance carrier yourself, you should be aware that the American Medical Association has issued ethical guidelines that address "significant mark-ups" of client bills.7

Based on your laboratory costs and estimated laboratory reimbursement, you can decide whether to use a reference laboratory or bring testing in house. Your ASCUS rate will also impact this determination (Table 2). For turnaround time purposes, you will probably need to run HPV testing at least once a week. Based on average costs and reimbursement rates, the minimum number of tests required for each run to be cost-effective is approximately 26 to 34 (Table 3).

THE ASCUS CULTURE

It will be helpful to realize that there are pressures that may act to maintain or increase the ASCUS rate, despite The Bethesda System 2001 removing "ASCUS favor reactive" as an option.8 Theoretically, if you interpreted every case as ASCUS, your false-negative rate would be zero. Psychologically, none of us want to be wrong, and the ASCUS interpretation offers a perfect middle ground where one is never entirely wrong. Years of increased lababoratory scrutiny have instilled a culture of extreme caution within many laboratories. Many pathologists are reluctant to downgrade a preliminary ASCUS interpretation by their cytotechnologist, reinforcing the use of this interpretation. As a result of these factors, the ASCUS rate may actually increase for many laboratories. Human papillomavirus testing offers an objective method with which to monitor and assess laboratory ASCUS reporting practices.