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Kaiser roll: the push for more HPV screening

July 2004
Karen Southwick

In August 2002, Gene Pawlick, MD, got an unexpected call from the executive offices of the Permanente Medical Group Northern California: The Kaiser Permanente Regional Laboratory should prepare to screen for human papillomavirus every woman over 30 on a health plan who comes in for a Pap test.

As director of the regional laboratory in Berkeley, Calif., Dr. Pawlick had responsibility for ramping up to meet the new policy, which meant boosting HPV screening to cover 400,000 women annually. That compared with just 5,000 tests to triage for atypical squamous cells-undetermined significance, or ASC-US, that the laboratory had been performing.

Dr. Pawlick described Kaiser’s relatively new policy for widespread HPV screening, and the pitfalls the lab encountered in implementing it, in a talk he gave in April to the Executive War College, presented by The Dark Report. His topic: "Rapid Transition to DNA-based Cervical Cancer Screening and the Laboratory’s Role in Physician and Patient Education."

The use of HPV as a reflex test for women to triage ASC-US Pap smear results had been widely accepted after consensus guidelines were published in 2002.

But even though the American College of Obstetricians and Gynecologists and the American Cancer Society had acknowledged the value of HPV as a screening test for cervical abnormalities in women 30 and older, "there was a lot of controversy surrounding that use," Dr. Pawlick says.

The Kaiser Permanente HMO model was ideally suited in some ways to making such a drastic change. First, because Kaiser directly cares for paying members, it did not have to convince outside payers to cover the additional test. Second, Kaiser employs its physicians, so if the administration wanted to add a new laboratory test, it could do so without formal buy-in, though implementing the test requires the understanding and cooperation of the ob/gyn providers.

Despite the Kaiser setting, Dr. Pawlick says, "We encountered plenty of land mines trying to launch this initiative."

The change at Kaiser Permanente came about in part as the result of efforts by Kaiser gynecologic oncology surgeon Walter Kinney, MD, whom Dr. Pawlick credits as the organization’s champion of combined Pap/HPV testing.

Using data from Kai ser patients, Dr. Kinney and other Kaiser researchers conducted a study showing how HPV could be used to categorize ASC-US. Because of his work, he was recognized within the Permanente Medical Group for notable contributions to health care, an honor that brought him an invitation to address the Permanente Medical Group board of directors. "He presented his slides and made his case for HPV as an adjunct to Pap smears," Dr. Pawlick recalls.

The decision to implement and support the HPV co-testing of Pap smears in women over 30 was made by Robert Pearl, MD, CEO and executive director of the Permanente Medical Group, with support from Drs. Kinney and Pawlick.

Screening for cervical cancer through Pap testing alone leads to conflicting aims, says Dr. Kinney, who spoke recently with CAP TODAY.

The first goal is to prevent cancer by identifying cervical abnormalities through annual Pap exams. The problem is that most of the positives will be false, Dr. Kinney notes, subjecting women to invasive colposcopies and biopsies. "A positive Pap steers you to do further testing to determine who might be at risk for cervical cancer," he adds.

However, a number of studies of HPV and cervical abnormalities showed "you have to harbor high-risk HPV to get cervical cancer," Dr. Kinney says. And, he adds, on average it takes 10 years to go from high-grade dysplasia to cancer.

Pap and HPV together make for a powerful predictive tool in women age 30 and over, Dr. Kinney says. In fact, those with negative results on both procedures can safely be moved to a three-year screening interval. If the Pap test result is negative but the HPV test is positive, you should stick to annual screening, he says. If the Pap is positive for ASC-US or worse, you perform colposcopy regardless of the HPV test result.

For women under 30, an HPV screen will produce numerous positives for cancer risk because many in that age group harbor the virus but will clear the infection naturally before it leads to dysplasia. So sticking with Pap tests and HPV triage for ASC-US makes sense for the under-30 group, he says.

Dr. Kinney worked with a Northern California group of physicians to draft a set of standards on Pap and HPV screening that were completed in December 2002. Meanwhile, the ACOG and the American Cancer Society had formulated a similar set of guidelines.

Ultimately, Dr. Kinney says, moving to HPV screening for women over 30 can improve quality of care and reduce costs by eliminating unnecessary colposcopies and biopsies. Although the up-front costs—primarily for HPV reagents—can be substantial, "it starts to pay for itself within two to three years," he says, "because you’re not doing any unnecessary tests."

However, you can’t simply replace Pap tests with HPV screening for women over 30, he cautions. "The Pap provides you with additional specificity. A lot of people have HPV. The Pap helps you differentiate as to whether a woman also has dysplasia."

Unlike many gynecological practices, Kaiser Permanente has chosen to stick with a dry (traditional) Pap test rather than move to liquid-based cytology, which also can be used to screen for HPV. "We take two samples from every patient," Dr. Kinney says. do a dry Pap on one and HPV on the other."

The two smears are taken even on women under 30 because the HPV sample can be stored and, down the road, pulled and tested. Says Dr. Kinney, "If I were going to be screened for cervical cancer, this is how I would like to be screened."

Dr. Pawlick says the easy part was getting top-down support to initiate HPV screening. The cost was substantial: in the multimillion-dollar range, mostly for reagents and additional laboratory personnel. Thus, championship at the top was needed to overcome resistance lower in the organization.

The regional lab in Berkeley, which Dr. Pawlick oversees, handles testing for 3.2 million members who use 18 hospitals and 35 clinics. It processes about 22,000 specimens per day. The laboratory has 500 employees and operates 24/7.

Using the Pap test as primary screen leads to "profound sampling error," Dr. Pawlick cautions. Although the U.S. health care system spends $6 billion annually on Pap screening, 4,500 women die unnecessarily of cervical cancer.

HPV "is increasingly becoming recognized as having a role in cervical disease, if not the cause," Dr. Pawlick notes. The virus, present in the DNA of cervical cancers, also has a high incidence in young women. "It’s women past 30 with an atypical variant who become the target," he says. Infections become persistent in only about 10 percent of women who don’t clear at 30.

The up-front costs of moving to HPV screening included having to work around an ongoing shortage of cytotechnologists. "I’m a devotee of technology," Dr. Pawlick says. "It becomes a cornerstone in trying to deliver good health care."

But Kaiser’s staff clinicians weren’t convinced of the need for HPV screening. "Some felt this initiative was an injudicious use of the health plan’s power," Dr. Pawlick recalls. Thus, while he had a mandate from the top to carry out the screening, "we had no consensus," he says.

As the laboratory geared up, Dr. Pawlick worked with Digene Corp. to improve automation of its Hybrid Capture 2. Kaiser Permanente already was familiar with the product, which it had used for HPV triage. "Our treatment protocols were built around it, the FDA had approved it, and our ob/gyns were familiar with it," he says.

But moving from 5,000 annual screens to 400,000 on manual equipment would have been prohibitively expensive. "At first we thought we would have to add 10 clinical lab scientists and two lab assistants," Dr. Pawlick says. "And we were already having problems recruiting."

Digene devised a rapid-capture system that automated most of the steps. "As a result of going automated, instead of using 10 people we were able to do this with two clinical lab scientists and one lab assistant," he says.

Kaiser also sponsored an educational program with experts from the National Cancer Institute and University of Washington to talk about cervical cancer guidelines. About 400 Kaiser Permanente physicians attended and received CME credit.

"Finally, we created a new Pap smear requisition that allowed clinicians to order the co-test," Dr. Pawlick says. "This allowed co- reporting of both results."

Despite their efforts, "we had this huge hue and cry among ob/gyns that we were misspending health plan dollars," he recalls. "We stopped the rollout in midstream and created a committee with clinicians, pathologists, cytotechnologists, laboratorians. They went over this for three months, and then we started up again."

What’s the lesson learned? "You must give people time to grasp major changes like this," he says. "But it can be done."

Today Kaiser performs about 24,000 HPV tests each month. "The projection of 400,000 a year won’t be met right away," Dr. Pawlick says, because patients, too, must be brought on board. Women who are encouraged to be screened for HPV are accepting at a rate of 75 to 80 percent, he says.

By lengthening the intervals between testing, Kaiser will eventually save money, Dr. Pawlick says. Many of its medical centers have moved to screening every two years and expect to go to three, "allowing patients better access to ob/ gyn appointments." And as clinicians realize the advantages, he hopes they will embrace the change.

Karen Southwick is a writer in San Francisco.