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Diagnostic Laboratory Industry Negotiates FDA’s Revised Standards

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As the laboratory testing community continues to weather recent policy changes in both regulatory and reimbursement areas - there has been yet another development.
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What may be perceived as an apparent obscurity of this policy issue is inversely proportional to the likely impact it will have on the larger laboratory testing community.

A group of firms within the diagnostic testing community formed the Coalition for CLIA Waiver Reform last month, in an attempt to persuade the U.S. Food and Drug Administration (FDA) to change its thinking on how it grants Clinical Laboratory Improvement Amendments (CLIA 1988) waivers. A CLIA waiver may be granted to low complexity tests, a designation indicating that the tests are simple and robust enough that they perform equally well even if performed in labs that are not CLIA certified and when conducted by non-expert or untrained users and trained technicians alike. The difference in point of view between the FDA and the laboratory community is over how the complexity or simplicity of that test is defined.

FDA began administering the review of test complexity – high, moderate or low – following legislative changes in 1997. The Centers for Disease Control (CDC) and Centers for Medicare & Medicaid Services (CMS) jointly administer additional CLIA oversight, including lab certification.

A survey conducted by the Centers for Disease Control in 2005 identified potential issues with lack of quality in CLIA-Waived laboratories. Soon after, FDA issued a Draft Guidance (finalized in 2008) which changed its standard for CLIA-waived tests to include a gold standard test for comparison. This has been perceived as unilaterally raising the evidentiary burden largely ignoring the effect of the test user, running counter to the letter and spirit of the 1997 legislation.

According to industry figures, 6.8 billion laboratory tests are performed per year in the U.S., and 60% of clinical laboratories in the country are CLIA-waived labs which only conduct low complexity tests. As public and private payers seek savings in laboratory testing, point-of-care testing (in CLIA Waived settings) plays an important role in getting at those savings. Laboratory industry figures suggest that the cost of obtaining a CLIA waiver has multiplied by as much as 20 times since the 2008 Guidance issuance and with cuts in laboratory testing rates most recently, the industry is feeling the economic pinch now more than ever before.

Industry pushback may result in FDA 1) reviewing its current Guidance, or 2) engaging in a meeting with the concerned coalition stakeholders to explore methods to meet public health considerations without being overly burdensome.

Nevertheless, one may not expect FDA to significantly alter its position considering it has increasingly demonstrated a growing trend that laboratory testing standards need to be raised. For example, recent blood glucose monitoring Draft Guidances also raised the evidentiary standard, which was met with industry and lawmaker pushback. The congressional Diabetes Caucus wrote in a letter to FDA Commissioner Margaret Hamburg this May that the glucose meter Draft Guidances “may lead to burdensome and potentially dangerous treatment delays.”

FDA has so far resisted any changes to its laboratory and device evidentiary structure. However, increased industry pressure may force a response sooner rather than later.

For more information on the diagnostic laboratory industry, contact Lakshman at

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