As part of a new interim rule issued to clarify COVID-19 data reporting requirements, CMS also outlined the monetary penalties entities that fail to do so may face.
As part of the Interim Final Rule published Aug. 24, CMS stated that any healthcare facility (including nursing homes, pharmacies, or other settings) using point-of-care COVID-19 testing devices under a CLIA Certificate of Waiver that fails to report SARS-CoV-2 results to the HHS Secretary within 24 hours of results being known or determined may face civil monetary penalties of up to $1,000 a day for the first day and $500 for each subsequent day.
Labs are being granted a one-time, three-week grace period to begin reporting required test data, according to a press release issued by CMS.
Any lab found to be in violation will also face condition-level noncompliance with CLIA regulations.
While CMS points out it is allowed under statute to impose fines of up to $10,000 per violation (ie: per sample not reported), the agency concedes it is choosing not to enforce the maximum penalty because it could lead to “large CMPs for brief lapses in reporting.”
According to CMS, all COVID-19 diagnostic and screening testing sites must:
- have a Clinical Laboratory Improvement Amendments (CLIA)external icon certificate – compliance, accreditation, waiver, or provider performed microscopy
- meet all requirements to perform testing, including only using FDA-authorized test systems according to their instructions for use, and
- report the results of the COVID-19 diagnostic and screening tests that they perform to the appropriate state or local public health department.
COVID-19 testing sites are defined as:
- laboratories that perform clinical diagnostic or screening testing under CLIA,
- non-laboratory COVID-19 diagnostic or screening testing locations, and
- other facilities or locations offering COVID-19 point-of-care diagnostic or screening tests, or in-home diagnostic or screening tests.
Detailed information on how to report and the required data elements may be accessed here.