By: Maureen Kingsley

A report issued in September by the Lewin Group and cofunded by AdvaMed and ACLA finds the contributions of clinical lab screening and diagnostic tests to overall healthcare quality and outcomes “substantial.” The authors state that “innovation, demonstrated clinical benefit, and appropriate use of laboratory screening and diagnostic tests are essential for achieving the goals of health system reform.” They also cite the importance of clinical lab testing in making evidence-based improvements to healthcare, patient outcomes, efficiency, and accountability.

The report updates a similar study published in 2005 by the Lewin Group and draws its conclusions from four case studies: one on MRSA testing, one on hemoglobin A1c testing, one on KRAS gene-mutation testing, and one on HPV testing to screen for cervical cancer.

“The reason for doing this particular report was that diagnostics are often overlooked in the healthcare system,” says Teresa Lee, vice president, Payment and Health Care Delivery Policy for AdvaMed. Yet the value of the technologies is so critical, she adds. She hopes that the report raises both the visibility and the perceived value of screening and diagnostic tests, especially in this historic time of Washington-led healthcare reform.

Lee says that clinical diagnostics have garnered the attention of policymakers recently—but not the kind of attention AdvaMed would like. She points to an attempted imposition of a Medicare clinical lab coinsurance, a discussion of taxing clinical laboratory revenues, and suggested cuts to the clinical lab fee schedule. The latter, she says, “is actually a better way to think about clinical laboratory diagnostics in the context of overall health reform. Of course, a cut's never good, but in our minds it's better than a coinsurance or a tax.”

AdvaMed sent copies of the report to members of Congress and their staff. The association is “very interested in trying to achieve reform of the way Medicare sets new test payment rates,” Lee says, “and we think that a report like this really goes a long way to showing how valuable these tests are and how the value should be taken into account in setting the payment rates of these tests.” She says that AdvaMed has been trying to help insurance companies and other payers better understand diagnostic tests, their potential, and their value, so that these entities can “get comfortable” with diagnostics and make appropriate policy decisions. “We are trying to reform the payment system for new clinical lab diagnostic tests,” Lee says. “Right now, they are just not geared toward facilitating innovation in this area, which is critical toward realizing personalized medicine.” Insufficient healthcare-provider awareness of diagnostic tests and when to use them is yet another barrier for the pro-diagnostics community, she says.

Lee also points to this report as helping to explain comparison-effectiveness research in the context of diagnostics. “I think it's a very useful document because it pulls together many critical considerations that one would want to think about that are unique to diagnostics.” For diagnostics, finding a direct connection between a test and an ultimate patient outcome is challenging. The report expounds on, for example, the problems of trying to perform a randomized-control clinical trial on a diagnostic test, and it “brings to light” the idea that a “more open-minded approach” to study design for clinical-lab diagnostics is warranted.

The report is “a good tool” for IVD manufacturers as they independently and with AdvaMed work toward paving the way for ensuring that the value of their technologies is recognized, Lee says. She suggests that they use this report to bolster their cases.

“I do think, too, that it's a guide for all of us in the industry to get a better handle on what the demands are for evidence in trying to demonstrate the value of clinical lab diagnostic tests and IVD technologies. My sense is that it's an ongoing policy debate that we're all going to be dealing with.”

Screen for disease

Screen to determine risk for developing disease

“Rule in” of a diagnosis

“Rule out” of a diagnosis

Start an intervention

Adjust an intervention

Stop an intervention

Assess efficacy of an intervention

Assess compliance with an intervention

Assess prognosis

Source: “The Value of Laboratory Screening and Diagnostic Tests for Prevention and Health Care Improvement,” prepared by The Lewin Group, September 2009. Page 3.