Status of remote pathologist interpretations after PHE: Does it affect your current workflows?
The COVID-19 Public Health Emergency (PHE), declared by the U.S. Secretary of the Department of Health and Human Services (HHS) on January 31, 2020, came to end at 11:59 PM on May 11, 2023, shortly after the COVID-19 National Emergency was declared over via the action of Congress on April 10, 2023. Numerous changes went into effect during these two emergencies in order to protect access to healthcare during the global pandemic.
One important change that took place was a temporary allowance for pathologists to review slides and laboratory data from a remote location. This was beneficial to pathology groups attempting to reduce exposure and transmission within the group by reducing in-person interactions. Two separate flexibilities impacted the ability to perform remote interpretations. The first was a relaxation of the requirement that any location where a pathology interpretation takes place must hold a CLIA certificate. The second flexibility arose from the Stark Law Blanket Waivers (Blanket Waivers), which allowed pathologists to perform off-site review of slides for specialty practices, like gastrointestinal and dermatology practices, without violating the Stark Law on-site requirement.
The Stark Law waiver that permitted off-site pathology interpretations expired with the PHE, but questions remained about pathologists reading remotely under the CLIA regulations. It appeared that the Centers for Medicare & Medicaid Services (CMS) was going to extend the CLIA certificate flexibilities past the expiration of the PHE on May 11, 2023. That was clarified on May 11, 2023, when CMS released updated guidance [Clinical Laboratory Improvement Amendments of 1988 (CLIA) Post-Public Health Emergency (PHE) Guidance (“CLIA Post-PHE Guidance”)] clarifying the changes that occurred with the expiration of the PHE that same day.
Importantly, CMS ended the ability for pathologists to review physical slides from a remote location if the location does not have a CLIA certificate. This marks a return to the pre-COVID requirement that any remote location, including, for example, a pathologist’s home, must hold a CLIA certificate if interpretations are performed at the location.
Considering these changes in enforcement and other changes resulting from the PHE, pathology groups, other physician specialty groups, and laboratories that are involved in performing remote services in any capacity should take time to review all applicable regulations to determine if the delivery of remote services remains compliant in the post-PHE regulatory landscape. When performing that review, special consideration should be given to the below regulations that affect the remote review of slides and laboratory data.
Typically, a valid CLIA certificate is required for each location where laboratory services are performed. However, during the COVID-19 pandemic, CMS exercised enforcement discretion with regard to this requirement, permitting pathologists to review slides and laboratory data from a remote location without a separate CLIA certificate for that location so long as the primary practice location for which the pathologist provided services held a valid CLIA certificate and all other applicable laws were being followed. This flexibility allowed pathologists to perform services from any other location—including their homes. Notably, CMS had held the position up until May 11, 2023, that such enforcement discretion was not tied to the status of the PHE. However, as discussed above, on May 11, 2023, in the CLIA Post-PHE Guidance, CMS stated that pathologists are no longer able to review physical slides from a remote location without a CLIA certificate at the remote site. Digital images and other digital laboratory data are still able to be reviewed remotely without a CLIA certificate at a remote site so long as all other applicable requirements are satisfied. As long as there is a valid CLIA certificate for the primary location that the remote location is associated with, pathologists may continue this practice for digital pathology. As the post-PHE landscape takes shape, pathologists should continue to monitor CMS for guidance updates regarding the remote provision of laboratory services.
Stark Blanket Waivers
When the National Emergency was declared shortly after the PHE, the authority to waive requirements of certain statutes was granted to HHS. One major collection of waivers involved the physician self-referral law, known as the Stark Law. As a group, these were referred to as the Blanket Waivers. Prior to the COVID-19 emergency, pathologists were required to perform services in the “same building” or “centralized building” of the referring provider when seeking to structure an arrangement in compliance with the in-office ancillary services exception to the Stark Law. During the PHE, this requirement was waived, allowing pathologists to review slides and laboratory data from a remote location. Unlike the CLIA enforcement discretion discussed above, CMS had indicated that the Blanket Waivers would end with the PHE. CMS made clear that immediate compliance with Stark Law was required as soon as the PHE terminated. For pathologists providing services remotely to specialty groups that have in-office laboratories, this means that the services should be performed on-site. Arrangements that were put in place during the PHE should be reviewed for compliance with the Stark Law. If the “same” or “centralized” building location requirement of the in-office ancillary services exception is not satisfied, the arrangement should be evaluated or groups may face liability under the federal False Claims Act for submitting claims for services that violate the Stark Law.
What Happens Now?
If a pathologist or pathology group began to provide services remotely as a result of the pandemic, it is likely that the pathologist now needs to return to work in an established physical location. While an arrangement can be structured to comply with CLIA regulations and the Stark Law, an arrangement based on the flexibilities of the PHE is no longer viable and such arrangements should be carefully reviewed by a qualified healthcare attorney. By continuing to provide remote services for even a short time after the PHE ends, remote pathologists could face significant risk.
If you have any questions or concerns regarding remote pathologist arrangements, please reach out to one of the attorneys in McDonald Hopkins’ National Healthcare Practice Group.