On September 25th 2020, and in response to the 2019 Novel Coronavirus (“COVID-19”) pandemic, the Centers for Medicare & Medicaid Services (“CMS”) announced a new Quick Start Guide and expedited review process to make it easier for laboratories pursuing Clinical Laboratory Improvement Amendments (“CLIA”) certification to offer COVID testing. These tools will reduce delays in and aid laboratories in understanding the certification process to help address the COVID-19 crisis.
CMS regulates all human laboratory tests through the CLIA program. The intent of the CLIA program is to provide safe, quality testing and ensure that results are accurate regardless of where the test was conducted. In addition to meeting quality assurance and performance standards to show that they can offer reliable and accurate testing, laboratories must also pay CLIA administration fees prior to certification. CLIA fees are calculated depending on the type of certificate requested by the laboratory and the amount and type of tests being performed.
CMS has implemented various measures to address the need to expand laboratory capacity during the COVID-19 public health emergency. CMS now allows pathologists to review laboratory data and results remotely to increase capacity while minimizing exposure risks to healthcare providers. CMS also stated that it will not enforce the requirement to have a separate certificate for laboratories participating at temporary COVID testing sites, as long as the primary location of the laboratory does possess a certificate. Furthermore, laboratories in hospital or university campuses in adjoining buildings and under the same director only need one certificate if located at the same physical location or address. This reduces the number of CLIA certificates labs must apply for, allowing them to begin COVID testing more rapidly.
The new Quick Start Guide will aid laboratories in applying for CLIA certification by concisely outlining the requirements for certification and including useful explanations for each step in the process. The Quick Start Guide also explains the expedited review process put in place at the beginning of the COVID-19 crisis. To aid laboratories in providing COVID-19 testing, CMS advanced its review process for CLIA certificate applications. Under this process, as soon as a laboratory has selected a qualified laboratory director and included all necessary information on the application, the laboratory will be assigned a CLIA number. With this number, the laboratory can start testing prior to receiving a paper certificate, so long as the applicable CLIA conditions have been satisfied. Furthermore, laboratories can now pay their CLIA certification fees online. Online payments have a significantly faster processing time compared to physical checks, helping laboratories reduce paperwork and begin COVID-19 testing more promptly. These changes will help facilitate access to safe and consistent COVID-19 tests during the public health emergency.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments by CMS. Wachler & Associates will continue to stay up to date with all other COVID-19-related news. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or firstname.lastname@example.org.