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Originally Published IVD Technology July/August 2005
INDUSTRY NEWS
Changes in CLIA-waiver market create opportunities, concerns
Matt Grebow
As IVD manufacturers continue to await FDA’s release of new guidance for obtaining waived-complexity status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), questions about how FDA will react to the growing CLIA-waiver test market remain a topic of much speculation and consternation. In particular, many industry observers have expressed concern that a failure to adequately revise procedures for determining IVD accuracy could hinder manufacturers at a time when the number of CLIA-waived labs is booming.
At a May 4 audioconference on the new CLIA-waiver criteria sponsored by the American Association for Clinical Chemistry (AACC; Washington, DC), Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety, tried to put some of these anxieties to rest. “The critical dangling participle is the tension between the benefit of the increased access of the waived tests and the uncertain performance in a waived environment,” he said. “FDA has a rich appreciation for this tension. We plan to take a balanced approach and hope to ground the process in good science.”
This “tension” has arisen, in part, from the high percentage of laboratories enrolled in CLIA that possess Certificates of Waiver (COWs). According to data provided by the Centers for Medicaid and Medicare Services (CMS; Baltimore), the percentage of CLIA labs with COWs now stands at 56.3% and continues to increase.
“This was a category of testing that was not anticipated to grow at the rate it did,” said Charles Root, PhD, president of CodeMap Compliance (Barrington, IL), at the conference. “On the other hand, technology, and the usefulness of the results being obtained quickly and easily, has certainly created a market, and we’re seeing the growth that has resulted from the need out there.” Root estimated that 105 million waived-test claims were made in 2003, assuming that Medicare claims make up 20% of total testing. He added that the number of waived tests administered today is likely much higher.
Root went on to say that Medicare statistics show that 47.8% of immunoassay tests for infectious-agent antibodies and 45.7% of strep A antigen tests conducted in 2003 were waived. He expected that for 2005 these percentages would top 50%. For prothrombin time (PT) testing—the largest category of Medicare IVD claims—36.8% of tests performed in 2003 were waived. More telling, though, is that the number of waived PT tests grew 180.8% between 2000 and 2003. Nonwaived PT testing grew 9.8% during the same period.
“The direction of waived-testing increases is good for IVD manufacturers—that is, if they manufacture this type of device or test system,” said Judy Yost, director of the Division of Laboratory Services at CMS, and another participant in the AACC conference, in May. “Maybe not as good for manufacturers of testing that must be performed in a central laboratory, because [the waived tests are] more cost-effective or can provide equivalent services.”
Despite the strong market for IVD manufacturers, Yost cautioned that the current number of COWs issued has raised additional concerns about testing accuracy.
A yearly survey of waived labs initiated by CMS found that, in 2004, approximately one-fifth of the labs surveyed were not performing quality control procedures required by the manufacturer. Although this was down from the almost one-third of labs found not to be following manufacturer procedures in 2002, she said it is still cause for concern. “Test systems are not 100% perfect, testing personnel are not trained in or familiar with good laboratory practices, no one oversees this testing, and there is a lot of personnel turnover in these laboratories,” she said. “This can be a recipe for problems.”
Yost explained that while waived-laboratory deficiencies are likely due to a lack of education and training, and not willful negligence, they do speak to the benefits of regulatory oversight. In fact, she said the existence of the waived-lab survey itself may have played a significant part in the improvements observed. As the amount of waived testing continues to increase, though, CLIA revenues, and the ability to carry out such surveys, will decrease. An inability to ensure that waived labs are obtaining accurate test results, said Yost, should be troubling to manufacturers. “Test results from point-of-care-testing settings need to be accurate because they are used to diagnose, treat, and monitor patients, just as those from large regulated labs are used.”
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