Diagnostics & Imaging Week
The FDA says it is in the process of drafting new guidance as to which in vitro diagnostic tests are considered waived under the Clinical Laboratory Improvement Amendments (CLIA). While this process has been ongoing for "quite some time," an official in the FDA office in charge of this area said, he expects the guidance will be available for review this summer.
Although the Centers for Medicare & Medicaid Services (CMS; Baltimore) and Centers for Disease Control and Prevention (CDC; Atlanta) also administer CLIA, it is the FDA's role to determine which of three categories tests will fall under: waived, moderate complexity or high complexity.
Laboratories in the U.S. are regulated by CLIA — a regulation originally passed in 1988 — if they perform laboratory testing on human specimens for the purpose of diagnosing, preventing or treatment of disease, as well as for the assessment of the health.
The new guidance is being drafted in response to a proposal by the Advanced Medical Technology Association (AdvaMed; Washington), presented in late 2002 and early 2003 to try to clarify and modify the methods used for waiver determination, according to Steve Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the Center for Devices and Radiological Health at the FDA.
"AdvaMed filed this proposal because the organization felt that the rules being applied to waiver decisions were not as refined as they could be and failed to account for a number of important cutting-edge IVD constructs including traceability in methods and risk management," Gutman wrote in an e-mail response to Diagnostics & Imaging Week.
Congress passed CLIA to establish quality standards for all lab testing, other than for research purposes, to ensure the accuracy, reliability and timeliness of patients tests "regardless of where the test [is] performed," according to the FDA.
In 2004, the agency said it evaluated 2,249 tests, of which 11% were waived, 75% were determined to be of moderate complexity and 14% were considered to be of high complexity.
The definition of a test receiving a CLIA waiver is as follows: "simple laboratory examinations and procedures that have been approved by the FDA for home use or that ... are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result."
The FDA said that in November 1997, the CLIA waiver provisions were revised by Congress "to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver." The agency said that "professional versions" of home tests are not automatically waived.
Gutman noted that since 1994, there have been roughly 100 to 200 waivers per year. Some devices are waived immediately via regulatory means, some are waived because they have become over-the-counter products, and the third method is by a waiver through application.
"The FDA has been working on this guidance for quite some time," Gutman said. "Refining this document has been more challenging than we would have realized. We have been working closely with CMS and CDC in this process."
For example, the total Medicare claims for waived tests during 2003 were 21 million, according to Charles Root, PhD, president of CodeMap Compliance (Barrington, Illinois), a healthcare consulting company. Root estimates the total waived test claims for 2003 to be 105 million, assuming Medicare claims are 20% of total tests. The total Medicare reimbursement for waived tests during that year he estimates at $119 million, with the total waived test reimbursement for 2003 to have been $595 million, again assuming Medicare claims are 20% of the total.
In fact, the Clinical Laboratory Improvement Advisory Committee (CLIAC) — which as its name indicates, plays an advisory role for CLIA regulations to the agencies that administer it — has held discussions on the subject with representatives of AdvaMed. Gutman said in an industry audioconference sponsored by the American Association for Clinical Chemistry (AACC; Washington) in early May that while the FDA is not required to follow CLIAC's suggestions, the agency does "take them seriously."
Although the agency had anticipated the new guidance by late spring, the FDA now expects the guidance to be available this summer. When it is available, it will be published in draft form for a comment period. Then, the guidance will be available in its final form, again with a comment period, Gutman wrote, with the "ultimate plan" being to "convert these into waiver regulations."
"We are very much in the middle of a complicated regulatory story. I would characterize this as sort of being in medias res [Latin for "in the middle of things"] and I'm looking forward to putting the guidance out because it provides targets, yardsticks, clarities, although certainly not absolute requirements on how to move forward," Gutman told listeners on the AACC audioconference.
"It will allow options. There is now 10 years of use, and there are probably anywhere from 100 to as many as perhaps 300 [million] or 400 million waived lab tests done per year, so it is not exactly an arcane practice."
Gutman added, "The critical dangling participle is the tension between the benefit of the increased access for waived tests and the uncertain performance in a waived environment. And FDA has a rich appreciation for this tension. We plan to take a balanced approach and hope to ground the process in good science."
Examples of waived tests include dipstick or tablet reagent urinalysis for bilirubin, glucose, hemogloblin, ketone, leukocytes, nitrite, pH, protein, specific gravity and urobilinogen, according to the FDA. They also include fecal occult blood tests, ovulation tests (visual color comparison tests for luteinizing hormone); urine pregnancy tests (visual color comparison tests); erythrocyte sedimentation rate (non-automated); hemoglobin-copper sulfate (non-automated); and spun microhematocrit.