NILA: CLIA Proposal Doesn’t Address Flaws

Areas needing attention include the proliferation of waived tests, number of analytes for PT tests

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CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive overhaul of the CLIA regulations in other areas, including adding more analytes requiring proficiency testing and the proliferation of waived tests, according to NILA Administrator Mark Birenbaum.

WHEN PREPARING COMMENTS ON PROPOSED changes to the CLIA regulations, per the recent request for information (RFI), clinical lab directors might want to mention that the proposed revisions do not go far enough, recommended Mark Birenbaum, PhD, Administrator of the National Independent Laboratory Association.

Comments are due to the federal Centers for Medicare and Mediciad Services by March 12. While CMS has made minor changes in the past 26 years, the RFI is the first time since 1992 that CMS has sought to revise the rules significantly. (See “After Two Decades, CMS Wants to Update CLIA Lab Regulations,” TDR, Jan. 22).

Urged To Make Changes

For many years, NILA has urged CMS to make several significant changes in its CLIA regulations. Yet, when CMS issued proposed revisions in a request for information published in the Federal Register on Jan. 9, none of the changes that NILA requested were included, Birenbaum said in an interview with THE DARK REPORT.

“In this proposal, CMS will consider only five areas for revisions, and these five areas are not nearly as important as some other areas they don’t even mention,” Birenbaum said. “Lab directors should be aware that CMS is considering some changes to the CLIA regulations but not a comprehensive overhaul.

“The RFI does not address such issues as proficiency testing and the need to update and revise the list of analytes subject to CLIA’s PT requirements,” he added. “A second significant area of concern involves the proliferation of waived tests.

“I was on a CLIA steering committee before CMS drafted the 1992 CLIA regulations,” he said. “When the ‘waived, moderate complexity, high complexity system’ was first considered, only eight tests were in the waived category. At the time, no one envisioned there would eventually be thousands of waived test systems.”

In the RFI, CMS also is considering revisions to personnel regulations, proficiency testing referral, histocompatibility regulations, and fees that labs pay to keep the CLIA program running. About those fees, Birenbaum urged lab directors to request that CMS publish annual financial reports for the CLIA program. These fees should not generate a significant surplus, he added.

Use this link to view the RFI:

More Alternative Sanctions?

”One significant issue that CMS overlooked involves the consequences when one lab refers PT specimens to another lab,” he explained. “Labs know they can’t do that. If they do, they could lose their CLIA certificate.

“In 2012, CMS adopted alternative sanctions for moderate and high-complexity labs,” he added. “In the RFI, CMS said it is considering alternative sanctions for certificate-of-waiver labs. That sounds reasonable, because CMS should be able to apply alternative sanctions to all labs. Under current CLIA regulations, however, most certificate-of-waiver labs aren’t required to do PT. So, this seems to be a solution in search of a problem.

“What’s more, CMS is overlooking the bigger issue regarding PT, which is that CMS has not updated the list of analytes covered by PT since 1992,” noted Birenbaum. “Everyone knows the list of analytes most labs use has changed substantially in the past 26 years.

Additions To PT Analyte List

“The fact that the RFI left out the issue of updating and revising the list of analytes in the PT program is surprising because not long ago, CMS invited PT providers to a meeting about updating the analytes subject to CLIA-required proficiency testing,” Birenbaum explained. “Along with other PT providers, we attended, but nothing happened, and this is not mentioned in the RFI. CMS needs to decide which additional analytes need to be included in PT requirements.

“Another area that needs updating is the proliferation of waived tests and the fact that the certificate-of-waiver labs don’t have to do PT,” he said. “PT is not required under CLIA for certificate-of-waiver labs, although a few states have laws requiring it. Thus, the great majority of certificate-of-waiver labs don’t have to do PT.

“Why is this important today?” asked Birenbaum. “When CLIA regulations were issued in 1992, there were eight waived tests. Now, there are close to 200 waived analytes, and the number of waived test systems is in the thousands and growing.

“That means there is no PT data on these systems before they are waived,” Birenbaum warned. “Time and again, we’ve advised CMS that it needs to gather data on how these devices and instruments work in the field before they are waived.

Many Proposals; No Results

“Many times, we’ve made proposals to CMS about how this could be done,” he added. “We’ve suggested that CMS require two to three years of proficiency testing data. CMS would designate these instruments and systems as moderate complexity, at least initially. Moderate complexity tests require PT.

“Then, if the PT data is excellent, CMS could designate the instrument as waived,” he said. “But if there’s significant variation and the PT data isn’t excellent, CMS could keep that instrument in the moderate complexity category and continue to gather PT data.

“That way CMS would have some idea about how those instruments and systems perform in the field. That’s just common sense,” he added.

“After gathering two to three years’ worth of data on how these systems work as moderate complexity tests, CMS would have enough PT data,” he explained. “With that amount of data, CMS would know whether to designate those instruments and systems as waived.

“Instead, as it stands today, the only performance data for these waived systems is primarily what the manufacturer supplies,” Birenbaum said. “But manufacturers are producing that data under controlled conditions. Data from controlled conditions do not necessarily predict how that instrument or system will operate in the field in clinical settings.

“This proliferation of waived tests is a problem because it basically deregulates laboratory testing by allowing thousands of test systems to operate with no proficiency testing data at all,” he commented.

“It’s ironic that CMS says it now wants to make the penalties for certificate-of-waiver labs that refer PT specimens to other labs the same as the penalties for other labs, but CMS doesn’t mention that most certificate-of-waiver labs are not required to participate in PT,” he added.

“Here is why that is a big deal: CMS waived a Theranos test procedure before the surprise inspections at Theranos revealed problems there,” stated Birenbaum. “To my knowledge, there was no PT data on the Theranos waived test before (or after) it was waived.”

Contact Mark Birenbaum at or 314-241-1445.

Lab Lawsuit Involving NY State Lab Fees Shows Reason for Increased Caution on CLIA Fees

BEFORE LAB DIRECTORS provide meaningful comments about CLIA fees, they need to know how the federal Centers for Medicare and Medicaid Services accounts for the fees it collects, stated Mark S. Birenbaum, PhD, Administrator of the National Independent Laboratory Association (NILA).

In a request for information CMS published last month, the agency asked for comments from lab directors and pathologists about the fees labs pay to keep the CLIA program running. Birenbaum suggests that labs should have information about the finances of the CLIA program before they submit comments in response to the RFI.

“CMS needs to publish the financial results from the CLIA program over the past few years. How much does it collect overall and how much is it spending?” he asked. “Is CMS making money or losing money on CLIA fees? If it’s making money, how much is it making? If it’s losing money, what activities are the most costly?

“Only when these details are known can lab directors comment on changes in fees,” added Birenbaum.

In this argument, Birenbaum has the benefit of history. The RFI also seeks comments on CLIA compliance fees for laboratories holding a certificate of compliance or a certificate of accreditation, fees for revised certificates, follow-up visits, complaint investigations, and activities related to imposing sanctions.

In 2013, NILA won a multimillion- dollar refund for overpayment of fees charged to approximately 230 New York and out-of-state laboratories under the New York Department of Health’s Clinical Laboratory Evaluation Program (CLEP).

“In New York, we sued the state Department of Health, which runs CLEP, three times and got $23 million back for our labs because New York overcharged on the CLEP program,” he explained.

“The CLEP program was supposed to collect the money to run the inspection and certificate program in New York State but state officials had built up a surplus for which some of the expenses (at least $23 million) were not justified,” he said. “The finances of the CLIA program should be much more transparent than New York’s CLEP program was.”


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