CMS Memo Revokes Remote Review of Cytology Digital Images

• CMS is rescinding the remote review of cytology digital images without a CLIA certificate 

• CMS’s new policy does not impact other pathology specialties 

On September 23, the Centers for Medicare & Medicaid Services (CMS) released a memorandum rescinding the remote review of digital cytology images without a CLIA certificate. ASCP has been in touch with CMS officials about the new policy. CMS staff confirmed that the rationale for the policy change is that the agency lacks the statutory authority to make permanent regulatory flexibilities it initially provided in response to the COVID-19 pandemic. The Clinical Laboratory Improvement Amendments requires “that all cytological screening be done on the premises” of a CLIA-certified laboratory. 

The policy does not impact the remote review of digital images for other pathology specialties, like surgical pathology. With the exception of cytology, CMS stated in its memo that it “will continue to exercise enforcement discretion to permit pathologists and other laboratory personnel to review digital laboratory data, digital results and digital images (“digital materials”) remotely without obtaining a separate CLIA certificate for the remote testing site, provided that the designated primary site or home base has such a certificate (using the address of the primary site) and the work being performed at the remote testing site falls within the specialties/subspecialties under the primary site’s certificate.” 

According to the memo, “Effective six months from the date of this revised memo, CMS will discontinue the temporary exercise of enforcement discretion that previously allowed remote review of cytology digital slides at locations separate from their primary CLIA-certified cytology laboratory. After that date, laboratories reviewing digital images of cytology slides at a remote location will need to obtain a separate CLIA certificate to continue reviewing cytology slides.” 

ASCP leaders are currently reviewing CMS’s new policy and are working on an action plan to address the situation.