Enforcement discretion to allow pathologists to review slides remotely without the need of a separate CLIA certificate for their remote locations will continue once the public health emergency for COVID-19 ends later in May. However, reporting of COVID-19 laboratory results to the federal government will no longer have the authority to require this data to be reported from laboratories. The Centers for Medicare & Medicaid Services (CMS) has released guidance detailing how the agency will manage the various flexibilities and temporary measures instituted during the emergency.

With regards to remote sign-out, the CMS states in the document Laboratories: CMS Flexibilities to Fight COVID-19 that it “has exercised enforcement discretion to facilitate pathologists’ ability to review pathology slides remotely without the need for a separate CLIA certificate for the remote location. Enforcement discretion is not contingent on [public health emergency] authority; the CMS will continue to exercise enforcement discretion that allows pathologists to examine digital images and laboratory data at remote locations.” This reference is located on page 7 under the header Clinical Laboratory Improvement Act (CLIA) Guidance. In addition, remote sign-out only applies to pathologists and not non-pathologists or other clinical laboratorians.

On January 30, President Biden announced that the COVID-19 public health emergency will end on May 11. By extending the emergency, states and Medicaid services would continue with affiliated waivers for various sectors of the US health care system until the public health emergency has officially ended. Since the announcement, various federal agencies have been publishing guidance on whether specific waivers would end or continue beyond the public health emergency’s conclusion.

Reporting Will No Longer Be Required

SARS-CoV-2 reporting will no longer be required by the Department of Health and Human Services (HHS) beginning May 12. However, some states or jurisdictions may still require reporting, and hospitals will still have to report weekly, not daily as is currently the case.

Instead of SARS-CoV-2 results, COVID-19 surveillance will still take place but along the same lines that the HHS uses for surveillance of endemic diseases such as influenza (ie, via sampling and wastewater analysis). The CDC has been working to sign voluntary Data Use Agreements, encouraging states and jurisdictions to continue sharing vaccine administration data beyond the public health emergency. Additionally, hospital data reporting will continue as required by the CMS’ conditions of participation through April 30, 2024, but reporting may be reduced from the current daily reporting to a lesser frequency.