CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS).
The first letters were sent on Aug. 12 and letters have been sent to other labs each month.
Recently, CMS reported it had sent cease-and-desist letters to 195 companies that include a mix of clinical laboratories, hospitals, physicians’ offices, wellness centers, chiropractors’ offices, urgent care centers, and other entities. By far, most of the letters went to physicians’ offices. In the letters, CMS alleged one of two violations:
Testing without a CLIA certificate, or
Testing under the incorrect CLIA certification.
In each CMS letter, the allegedly offending organization was told to cease testing. The letters to the different organizations were similar, but those sent to labs that were testing without holding a CLIA certificate of any type, read, “Laboratory is required to cease all testing immediately.”
In the letters to labs testing without the appropriate certificate, CMS wrote, “You are required to cease any non-waived and/ or high-complexity testing immediately.”
All but 45 of the companies told to cease testing did so. Of those 45, 28 obtained the correct CLIA certificates, 12 corrected their CLIA certificates, and five did not respond, according to CMS.
In an announcement of the action on Oct. 9, CMS said it conducted a check of CLIA certifications. “Every facility that conducts COVID-19 testing is considered a ‘laboratory’ and must be certified under CLIA,” CMS said.
All 10 regional offices of CMS sent letters to labs in their service areas. By far, the Dallas regional office sent the most letters (120), Chicago was second with 20, followed by Philadelphia 17, Atlanta and San Francisco 11 each, New York six, Kansas five, Seattle three, and Boston one.
Expedited Review Process
To expedite testing when the FDA declared a public health emergency on Jan. 27, CMS implemented an expedited review process for labs applying for CLIA certificates.
Labs must operate within the scope of those certificates, “to prevent false results that could adversely alter diagnosis, treatments, and contribute to the further spread of COVID-19,” CMS added.
The companies were required to provide CMS an attestation within 10 days of receiving the letter certifying they had ceased testing.
“Given that so many of these letters went to physician practices, I’d have to assume that these were physician office labs,” said Jim Flanigan, CAE, Executive Vice President of the American Society for Clinical Laboratory Science. “Typically, those tests would be waived.
“It’s likely that someone sold these physicians some COVID-19 tests and told them no approvals were needed,” he added. “In all the other cases, the situation might be similar, but it’s difficult to tell from what CMS has said about these cases.” TDR
Contact Jim Flanigan at 571-748-3746 or firstname.lastname@example.org.