As the COVID-19 public health emergency ended May 11, the Centers for Medicare & Medicaid Services (CMS) updated its guidance to allow pathologists the ability to review digital slides and data remotely as long as they meet specific criteria. In addition, CMS changed its policy to allow clinical laboratory personnel (non-pathologists) to also review digital images and data remotely. This flexibility was granted during the early days of the pandemic and the CAP had advocated for it to continue once the public health emergency ended.

Read the latest version of the CMS’s guidance

The CMS terminated many of the enforcement discretion flexibilities that were implemented during the emergency, such as issuance of expedited CLIA certificates, use of expired reagents, and use of molecular and point of care tests on asymptomatic patients. Federally mandated reporting of COVID-19 test results is also ending but some states may still require laboratories to provide state health departments with data.

What is Required for Remote Sign-Out

With regards to remote sign-out of cases, physical slides read under a microscope cannot be read remotely under a primary location CLIA certificate. This would be considered a secondary site and would need a separate CLIA certificate. To review digital slides and data remotely, pathologists and personnel must meet the following criteria:

• The primary, home site, laboratory has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation.
• The primary laboratory complies with other applicable federal laws, including HIPAA.
• The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely.
• Survey findings will be cited under the primary laboratory’s CLIA certificate. Enforcement actions, if taken, will affect the primary laboratory’s CLIA certificate.
• The primary laboratory’s test reports must indicate the remote site location where the testing is performed. The laboratory may use a coding system rather than the remote site address, eg, personnel residence, on the final report. This coding system must be available upon request.
• The primary laboratory must be certified in the specialties and/or subspecialties of the work performed at the remote site.
• The primary laboratory must provide the CMS with a list of all staff working remotely, upon request.
• The primary location is responsible for retaining all documentation, including testing performed by staff working remotely.

Testing on Asymptomatic Patients

Enforcement discretion for using molecular and antigen SARS-CoV-2 tests for asymptomatic individuals ends; however, clinical laboratories can continue using these tests if they are following the manufacturer’s instructions for use, including for SARS-CoV-2 testing. If a test’s intended use is modified from what is required by the manufacturer’s instructions, the test becomes high complexity and clinical laboratory must meet all high-complexity requirements. The CMS will not consider the tests modified when testing is done for individuals suspected of COVID-19 by their health care provider.