Testing! Testing! CMS Issues Guidance to Help Laboratories During the COVID-19 Pandemic

In an effort to ensure that America’s clinical laboratories are prepared to respond to the COVID-19 pandemic, CMS issued a memo providing guidance during these uncertain times. In their discretion, CMS issued guidance on:

(1) how pathologists may review pathology slides remotely;

(2) the expedited review of CLIA applications;

(3) the use of one CLIA certificate for laboratories in contiguous buildings under common direction;

(4)how proficiency testing will be done during the public health emergency;

(5) the use of alternate specimen collection devices for COVID-19 testing; and

(6) the use of laboratory-developed tests approved by a state to expedite COVID-19 testing.

Background

On March 13, President Trump declared a national emergency due to the 2019 Novel Coronavirus (“COVID-19”). Since then the Department of Health and Human Services (“HHS”) and the Centers for Medicare & Medicaid Services (“CMS”) have been issuing memos providing guidance to different health care sectors in order to help them more effectively combat COVID-19 pandemic without having to worry about some of the federal administrative burden. On March 26, CMS issued Clinical Laboratory Improvement Amendments (“CLIA”) Laboratory Guidance During COVID-19 Public Health Emergency. The guidance answered some questions CMS had been receiving from CLIA laboratories and detailed the enforcement discretion CMS would be using for CLIA laboratories for the duration of the public health emergency. CMS states that they are “committed to taking critical steps to ensure America’s clinical laboratories are prepared to respond to the threat of COVID-19 and other respiratory illnesses to ensure reliable testing as well as ensuring patient health and safety.” It is important to note that this guidance does not waive any of the federal CLIA requirements, and the guidance provided is only applicable during the duration of the public health emergency. The following sections summarize the various guidance provided by CMS.

Remote Review of Clinical Laboratory Data, Results and Pathology Slides

Due to the public health emergency and the urgent need to expand laboratory capacity, CMS is exercising its enforcement discretion to adopt a temporary policy of relaxed enforcement in connection with laboratories located at temporary testing sites. Temporary testing sites are any non-fixed or permanent locations that perform laboratory testing (e.g., the pathologist’s home).

Specifically, CMS is using its discretion to ensure that pathologists may review pathology slides remotely. Typically, under CLIA regulations, cytology slides must be evaluated on the premises of a laboratory certified to conduct testing in the subspecialty of cytology. If an individual wants to evaluate these slides at a temporary site, they would need a separate CLIA certificate. However, given the current public health emergency, CMS is using their discretion to not enforce this separate certificate requirement, so long as the temporary testing site’s primary site has such a certificate and the work being performed in the temporary testing site falls within the parameters of the primary site’s certificate. However, even waiving this requirement, the following criteria must be met in order to utilize a temporary testing site:

Cytology slide preparations must be retained for at least 5 years from the date of examination; Histopathology slides must be retained for at least 10 years from the date of examination; Pathology specimen blocks must be retained for at least 2 years from the date of examination; and Remnants of tissue for pathology examination must be preserved until a diagnosis is made on the specimen;
Equipment, supplies, and reagents, and other similar items needed at the temporary site are not kept at a temporary testing site on a permanent basis;
The temporary site complies with other applicable federal law, including HIPAA; and
The primary site must have a written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel.

Expedited Review of CLIA Applications

Laboratories need a CLIA certificate to perform COVID-19 testing. Therefore, in order to ensure that laboratories wishing to perform COVID-19 testing can begin testing as quickly as possible, CMS has expedited the CLIA application process. They have not waived any of the CLIA requirements, rather they have stated that once the laboratory has identified a qualified laboratory director and has provided all required information on the CLIA application, a CLIA number will be assigned and they can begin testing without having to wait for the hard copy CLIA certificate in the mail.

Laboratories Located at Contiguous Buildings on the Same Campus

CMS clarified that laboratories within a hospital system that are located in a contiguous building that is under common direction may hold a single CLIA certificate for the laboratory sites within the same physical location or street address.

Proficiency Testing

Proficiency Testing (“PT”) for CLIA laboratories during the public health emergency is still required. However, CMS has provided some guidance for PT providers and CLIA laboratories regarding PT postponements, cancellations, or suspensions during the public health emergency.

For PT providers, if they would need to postpone, suspend, or cancel, a PT event during the public health emergency, they must notify CMS, accrediting organizations, exempt states and participating laboratories. Additionally, they should submit a plan to CMS to resume testing in a timely manner after the public health emergency. However, a PT provider may not permit a lab to opt out of participating in a PT event while continuing to test patient specimen; only CMS may allow such postponement, suspension or cancellation. If CMS determines that a PT should be postponed, suspended or canceled, the PT program should use reason code 10 (“natural Disaster/Emergency”) when documenting such decision. CLIA laboratories will not be penalized for lack of PT results in the event a PT provider postpones, suspends or cancels a PT so long as it is properly documented, and the PT is conducted in after the public health emergency. However, CMS states that labs should consider performing their own self-assessment to ensure reliable testing.

For CLIA laboratories, CMS stated that if a CLIA laboratory suspends performing a specific test due to staffing shortage, supply shortage or regent shortage, the lab must document when the test will not be performed and why. Additionally, the laboratory must notify the inspecting agency and PT provider within the timeframe of submitting PT results that it has ceased the specific testing and why.

Alternative Specimen Collection Devices

CMS received many questions about the use of alternate specimen collection devices for testing COVID-19. In response, they highlighted that CLIA regulations are not prescriptive about the type of transport or collection device a laboratory used to perform a test. The regulation only requires that the laboratory (1) follow the manufacturer’s instructions; or (2) if the lab modifies the manufacturer’s instructions, they must establish performance specifications and validate the assay prior to performing testing. The Food and Drug Administration (“FDA”) had provided information regarding the use of viral transport media (“VTM”) on its FAQs for Diagnostic Testing for COVID-19. Although the FDA states that VTM is the preferred method, alternative transport media could be used, or VTM could be made using CDC’s posted recipe. FDA has posted information regarding the various alternative forms of collection and transport methods and modifications on their website so that CLIA laboratories can refer to the validation for their testing, without having to waste time conducting their own study. However, CMS states that even when the FDA has indicated that certain alternative collection devices and specimen transport media could be used, the laboratory direction will need to decide if additional validation studies are needed to be conducted before they begin performing tests.

Laboratory Developed Tests

FDA published guidance on March 16, 2020 that explained that states may take responsibility for tests developed and used by laboratories in their states. If they do so and set up a system in which they take responsibility for authorizing such test, the laboratory will not engage with the FDA. If a State chooses to use this flexibility to expedite COVID-19 testing, they should notify the FDA.

FAQs

Also attached to the memo is a set of frequently asked questions. These frequently asked questions restate most of what has been stated in the memo, but it also clarifies the following:

Laboratories can find payment information to use when reporting COVID-19 testing on the Medicare CoVID-19 Testing Fact Sheet or the 2 new CMS FAQs found here and here.
As long as a facility has the appropriate CLIA certification and follows applicable CLIA regulations, state regulations and guidelines, the laboratory may perform testing of COVID-19 in the parking lot or any other designated overflow location in its facility.

Practical Takeaways

CMS is not waiving any of the CLIA requirements, but they are using their discretion on how their enforcement discretion in various ways to help laboratories testing for COVID-19.
Temporary testing sites without a CLIA certificate may be used for pathologists to review pathology slides so long as (1) the primary site has a CLIA certificate; (2) the temporary site’s slides are retained for the appropriate amount of time; (3) the equipment used is only temporarily at this location; (4) the temporary site personnel follow the policy manual for procedures created by the primary site; and (5) the temporary site complies with all other federal and state laws.
New CLIA applicants can begin testing for COVID-19 once they have received their CLIA number and prior to receiving their certificate in the mail.
Separate laboratories within a contiguous building or on the same street address may hold one CLIA certificate so long as they are under common direction.
PT testing will continue as required under CLIA regulations. However, if the PT provider must postpone, cancel or suspend the test, they must notify CMS, accrediting organizations, exempt states and participating laboratories. If a laboratory stops testing due to the public health emergency, they must document when they are stopping testing and why, and they must notify their PT provider with this information.
Alternative specimen collection devices may be used to collect and transport COVID-19 specimens so long as they comply with the general guidance provided by the CLIA regulations. FDA has posted various alternative specimen collection devices and methods to their website for laboratories to reference when deciding on whether to use an alternative method.
In accordance with FDA guidance, states may take responsibility for tests used to expedite COVID-19 testing in their state.

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