The Centers for Medicare & Medicaid Services (CMS) issued a memorandum, allowing pathologists to work remotely during the COVID-19 pandemic. The memorandum also addresses requirements for a CLIA certificate, proficiency testing and alternate collection devices.
In the memorandum, CMS says pathologists may review pathology slides remotely if the primary lab is certified to conduct testing in cytology; the temporary site, which can be a physician’s home, complies with applicable federal laws including HIPAA; and equipment and supplies are not kept at the temporary site permanently.
Pathology groups, such the College of American Pathologists (CAP) and the Digital Pathology Association (DPA), advocated to CMS for the temporary policy change, saying it would protect physicians from exposure to COVID-19.
CMS officials addressed other issues as well. To expand the availability of testing, CMS said labs that have applied for CLIA certification, may begin testing for COVID-19 as soon as CMS assigns them a CLIA number—as opposed to waiting for a paper copy of the CLIA certificate to arrive in the mail.
CMS officials also said labs still must complete proficiency testing during the COVID-19 crisis. However, the agency will not penalize labs for a lack of PT results if an event is canceled, postponed or suspended as along as CMS authorizes the action. “Only CMS may allow postponement, suspension, or cancelation of CLIA-required PT activities while patient testing continues,” agency officials wrote.
With regards to alternate specimen-collection devices, CMS officials said the CLIA regulations require that labs follow manufacturers’ instructions. “If a laboratory modifies the manufacturer’s instructions, the laboratory must establish performance specifications and validate the assay prior to performing patient testing,” CMS officials wrote.
CMS officials also clarified in the memorandum that the agency does not have the authority to relax CLIA requirements during a national public health emergency, such as the COVID-19 pandemic, even though it may do so in some other programs that it oversees.