Cancer cervical pap smear

Running a lab often means you have to wave at Scylla while inching past Charybdis. You may want to offer the newest technology, but will you be able to pay for it?

Recent years have seen a number of technological innovations to the conventional Pap smear. These new methods vary from sample preparation technique to automated screening of slides to slide mapping. As with the introduction of any medical device or procedure, the debate about clinical effectiveness is heated - with manufacturers and supporters pushing for approvals from the Food and Drug Administration and acceptance from the medical community while some third-party payers and other proponents of conventional methods remain unconvinced. Now laboratories are faced with sifting through volumes of research and marketing data to determine whether to offer the new technology and how to offset the higher costs.

Laboratories are traditionally caught between offering the best possible service, which often means keeping up with advances in technology, and not losing money while achieving this goal. The debate about medical necessity could rage on for quite some time; meanwhile, should you not offer what could be a significant improvement to an old test? Here we will discuss the different types of technology available (see "Technology synopsis," p. 46), the issues of assessing and adding value to an undervalued test, and how some laboratories have incorporated these technologies and are dealing with issues of cost effectiveness.

The value of technology

Deciding to offer any of the new testing options begins with studying the new test's value in terms of medical necessity. A big obstacle for the lab to overcome when offering one of these new tests is that many healthcare professionals view the conventional Pap smear screen for cervical cancer as the most successful cancer screening test ever developed. According to the National Cancer Institute, since the test's introduction in the 1950s, the death rate from cervical cancer has declined by more than 70%. Currently in the U.S., approximately 15,000 cases of cervical cancer are diagnosed each year, and approximately 5,000 women die from the disease. Improving an already successful tool is difficult enough; add to it the task of justifying the additional expense of the new technologies, and you've got a full-blown return-on-investment study underway.

Oddly enough, the debate is not whether these new technologies are an improvement of the conventional Pap, because the general consensus seems to suggest that they are more effective in identifying abnormal cells (data varies by product; vendors can provide bibliographical information on clinical studies). The controversy lies in determining exactly how much more effective these technologies are and how this relates to the elevated cost of the new test versus the conventional method. In a July 1998 press release, the American College of Obstetricians and Gynecologists stated that while the new technologies approved to that date improved the sensitivity of the Pap test, their routine use could not be recommended based on costs and lack of sufficient data demonstrating a reduction in incidence of late stage disease or improvement in the survival rate of cervical cancer.

Cervical cancer is a slowly progressing tumor, so even if the new technologies detect a higher rate of low-grade lesions, most of what they detect doesn't progress to disease. In fact, doctors don't always find low-grade lesions dangerous enough to treat. Questions have been raised on the years of life saved using the new technology, and many feel that the additional money would be better spent on educational programs for women on the importance of getting tested every year. It also stands to reason that survival data may not be available for many years.

On the other hand, according to the NCI, cervical cancer is virtually 100% curable if detected early. However, the false-negative rate of the conventional Pap smear is higher than 20%.

Proponents also assert that years of life saved may not be the best measure to use when payers need to consider the shorter-term financial impact. Tests shown to detect more significant lesions mean earlier detection and therefore earlier and less expensive treatment. Fewer false-positive results or uncertain diagnoses mean fewer dollars spent on unnecessary follow-up procedures, not to mention less anguish for the patient.

How do questions of medical necessity affect the laboratory considering this new technology? Again, it goes directly to establishing the value of the service to clients - patients, physicians, hospitals, and payers. The conventional Pap test was often given away for much less than the cost of performing the test as an inducement to the client to send the lab more business. NeoPath, located in Redmond, WA, is the manufacturer of AutoPap, the only automated screener approved for primary screening. The company sent a response letter to ACOG's July press release that stated, "Any undervalued test whose accuracy is only 80% will always appear more cost effective if it is repeated often enough and is cheap enough."

The conflict surrounding medical necessity also directly relates to cost effectiveness in that determining the tests' clinical value impacts the amount of reimbursement established by payers. Now, to offer the newer, better, more expensive service, labs will be faced with the task of "putting the value back in" to this vastly undervalued test.

Dynamics of reimbursement

Despite the many difficulties with obtaining adequate reimbursement, those who believe in the technology believe in it strongly and feel that the situation for payment and acceptance is improving. Vicky Robinson, vice president of marketing for Cytyc, a company located in Boxborough, MA, that manufactures the ThinPrep Pap test, a monolayer slide preparation system, says, "There's been a definite increase in momentum as more payers came on board. You can see the market influence as a competitive reflex when payers look at what other providers are doing." Insurers reimbursing for Cytyc's test account for 100 million covered lives.

The controversy and increased media coverage is also helping to drive the reimbursement debate. From newspapers such as the Wall Street Journal to nighttime TV news programs such as Dateline, the public at large is being made aware of the issues and their options, which in turn is pushing third-party payers and managed care to review carefully decisions about money. Kim Norton, director of reimbursement and government affairs at NeoPath says, "There is a lot of pressure on Medicare to increase reimbursement for Pap smears."

Medicare national limit. Of course, Medicare policies are particularly important in determining reimbursement for new technologies. Many private payers use the Medicare reimbursement rate as the baseline for which they establish their own policies. The Medicare national limit for Pap testing is currently set at $7.15. Jay Marshall, MD and co-medical director of the cytology laboratory at Associated Regional and University Pathologists in Salt Lake City, tells MLO, "Pap testing in general is at a level where it can't get any better without a significant increase in terms of cost."

It appears as though that increased level of service and cost is at hand - now the industry is watching the interplay of various pressures, awaiting an outcome.

Many of the new procedures are listed by Medicare as "gap filled," which means that no national limit has been set. The next few months should determine how those procedures will be priced. The Health Care Financing Administration requires local Medicare carriers to establish a rate for the new procedures based on charges from actual claims. Carriers will look at claims for 3 months - up until March 31, 1999 - after which they will close the books and submit their data to HCFA by May 3, 1999. By September 1999, HCFA should make a decision on national limits for the new procedures.