HHS designates CMS as lead agency on CLIA waivers

Dec. 1, 2001

Growing concern about the quality of work done in laboratories performing certificate of waiver tests,
as we discussed in the October 2001 issue, has lead to some new developments in Washington. The Department of Health and Human Services
(HHS) recently decided to change the oversight of the requirements used to grant waived status for laboratory test devices under the Clinical Laboratory Improvement Amendments

Laboratory tests that receive a waiver from CLIA are the least regulated tests, with no routine oversight under that law. 

To provide more of a centralized approach to the waiver process and the CLIA program, HHS has determined that the Centers for Medicaid and Medicare Services has the overall authority for all the CLIA regulations, says Judy Yost, CMS director of the division of laboratories and acute care services. In light of this change, the Food and Drug Administration is withdrawing the draft guidance documents it published in March 2001. The FDA was seeking comments on an alternative method to obtain CLIA waived status for products. 

As a result, the FDA has returned to the use of the proposed rules regarding waiver criteria that were issued in 1995 and used all along to review applications of tests for waiver by
CDC, says Yost. FDA still has the job of categorizing laboratory tests, determining whether they should be considered waived, moderate, or high complexity. 

Due to these recent developments, CMS now becomes the lead agency with regard to fashioning new guidance on which tests will receive a CLIA waiver. To craft that guidance, CMS, the Centers for Disease Control and Prevention
(CDC) and the FDA are working together on final regulations for waived criteria for the FDA to use, says Yost. 

The three agencies have already met and will continue to do so until the regulation is complete. HHS wants to get the regulation done as quickly as possible. But it has to go through multiple clearances in HHS before it is even published, she points out.

The three agencies are working together so they can be sure to tap the expertise of each one. The FDA, for example, has the expertise in the world of devices, says Yost. CMS wants to be sure to utilize that expertise, and wants to make sure that when devices are approved for waiver they are as accurate as possible, she adds.

Making CMS the lead agency is expected to result in more centralized oversight. The goal is to make sure the CLIA program runs well. Having somebody in charge of the overall effort, regardless of which agency, allows various priorities and resources to be more focused, Yost explains.

Groups representing laboratories expect this recent change to be more positive than the previous arrangement. Many feared that the FDA would be too lenient in granting waivers and that the waiver process was on its way to spinning out of control.

Over the past year, the FDA has granted premarket approval for many new diagnostic kits that are coming to market. Yost says CMS does not want to make the review process impossible for device manufacturers to meet, but sometimes the tests and studies of new devices are done under more ideal conditions. So it is important to assure that before the device is waived, it will be as accurate as possible, she adds. 

More laboratory checkups planned

With regard to the quality in labs doing waived tests, Yost says CMS plans to continue to survey labs nationwide starting sometime in the new year. The agency expects to select about 2 percent of laboratories for continual review, she says. The planned surveys will involve the same type of approach as in they did in the past. There will be information gathering and educational types of visits. They wont be inspections per se, she explains. In addition, CMS will do on-site education when it discovers problems and gaps.

Education remains key in efforts to improve the quality of work performed by laboratories doing certificate of waiver tests. We have found education to be very effective, Yost points out. Preliminary data CMS has received from follow-ups of laboratories that were already visited shows that the laboratories are still making use of the information and guidance that CMS gave them. That feedback was an excellent piece of information to let us know that education on-site is very effective, Yost says. Continuing to survey these laboratories will allow us to have our fingers on the pulse of what is going on in the field. 

In the near future, CMS plans to begin working more closely with manufacturers of medical devices and laboratory test kits. A major priority is to find ways to improve labeling so that the result is clearer and better understood by the test users.

Joan Szabo is a Washington, DC, freelance writer specializing in healthcare issues. She has been writing the Washington Report column for MLO for the past four years.

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