Emergency Justification Memo

DATE:

October 14, 2020

TO:

Paul Ray
Administrator, OIRA

FROM:

Lee Fleisher, MD
Director, CCSQ

SUBJECT:

Request for Emergency Clearance for the Information Collection Request Related
to SARS-CoV-2 Test Results Reporting

Emergency Justification
The Centers for Medicare & Medicaid Services (CMS) is requesting that a new information
collection request associated with the CMS-3401-IFC be processed as an Emergency in
accordance with the implementing regulations of the Paperwork Reduction Act of 1995 at 5 CFR
1320.13(a)(2)(i). The CLIA information collection request is related to SARS-CoV-2 Test
Results Reporting, which is associated with the COVID-19 Public Health Emergency (PHE).
CMS will be unable to assess laboratory compliance with CLIA SARS-CoV-2 CLIA reporting
requirements if the normal, non-emergency clearance procedures are followed. Laboratories will
need to develop a mechanism to track, collect, and report SARS-CoV-2 test results. CMS’ needs
to have the ability to collect the SARS-CoV-2 test result reporting information from laboratories
in order to determine compliance. This collection is of utmost importance in order to meet the
Administration’s priorities.
CMS will not be able to assure a rapid and thorough public health response to the COVID-19
pandemic unless we have complete and comprehensive laboratory testing data that can improve
both the response to SARS-CoV-2 and treatment of COVID-19. These data can contribute to
understanding disease incidence and trends: initiating epidemiologic case investigations,
assisting with contact tracing, assessing availability and use of testing resources, and identifying
supply chain issues for reagents and other material. Laboratory testing data, in conjunction with
case reports and other data, also provide vital guidance for mitigation and control activities.
We believe that public harm is reasonably likely to result if normal clearance procedures are
followed.
Specifically, we are requesting emergency approval for information collection requirements
(ICRs) related to SARS-Co-V-2 test result reporting requirements (42 CFR 493.41, 42 CFR
493.555 and 42 CFR 493.1100(a)). In accordance with 5 CFR 1320.13(a)(2)(ii), we believe that
the unanticipated public health emergency (PHE) justifies the requirements for CLIA-certified
laboratories and Accreditation Organizations (AOs) to collect this information.

1
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not
authorized to receive the information. Unauthorized disclosure may result in prosecution to the fullest extent of the law.

Background
On March 13, 2020, the President declared a national emergency in response to the public health
emergency (PHE) caused by the SARS–CoV–2 virus, otherwise known as COVID-19. The
CARES Act was published in response to the PHE that requires “every laboratory that performs
or analyzes a test that is intended to detect SARS–CoV–2 or to diagnose a possible case of
COVID–19 shall report the results from each such test.” Consistent with the CARES Act
laboratory reporting requirements, CMS has made modifications to the CLIA regulations. The
September 2, 2020 interim final rule with comment (CMS-3401-IFC) requires laboratories to
report SARS-CoV-2 test results in a manner and frequency specified by the Secretary. These
regulatory changes update the Clinical Laboratory Improvement Amendments laboratory
requirements to meet the SARS-CoV-2 test result reporting provisions related to the Secretary’s
Public Health Emergency declaration with respect to COVID-19.
All CLIA-certified laboratories that perform or analyze any test that is intended to detect SARSCoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) are
required to report, regardless of the type of laboratory (type of CLIA certificate) performing the
testing. All negative and positive SARS-CoV-2 results must be reported irrespective of the
method (e.g., molecular, lateral flow) used.
The regulatory amendments at §§ 493.41 and 493.1100(a) require all CLIA-certified
laboratories, including those holding a Certificate of Waiver (CoW) and Certificate for Provider
Performed Microscopy (PPM), to report SARS-CoV-2 test results to the Secretary for the
duration of the PHE for COVID-19, and, that failure to do so will result in a condition level
violation of the CLIA regulations. If a laboratory does not report required SARSCoV-2 test
results, CMS will impose a CMP as required under §§ 493.1804 and 493.1834.
The Exempt States (ESs) (i.e., Washington and New York (partial exemption) are generally
approved by CMS to operate their own oversight programs so we would expect that the ESs
would report those laboratories that fail to report SARS-CoV-2 test results as required to CMS.
In this case, the ES would impose the CMPs based on their updated CMS-approved standards.
We would expect ESs to have an equivalent CMP imposition structure to CMS.
The CDC has an information collection request (OMB Control Number 0920-1299) in order to
collect laboratory data related to the COVID-19 Pandemic Response. The CMS package (ICR)
is for laboratory implemention and CMS monitoring of compliance with the CMS-3401-IFC
CLIA-certified laboratory reporting requirements.
Timeline
October 15, 2020
• Emergency Information Collection Request formally submitted to OMB.
October 20, 2020
• OMB approval received.
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INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not
authorized to receive the information. Unauthorized disclosure may result in prosecution to the fullest extent of the law.

October 22, 2020
• 15-day FR notice submitted to the Office of the Federal Register (OFR) for publication.
October 27, 2020
• Target publication date for 15-day FR notice to initiate standard OMB approval process.
• Start of the 15-day public comment period.
• PRA package posted for public review on the CMS PRA web site.
November 10, 2020
• End of 15-day comment period.
• CMS reviews and responds to comments, as needed.
• PRA package revised as needed.
November 17, 2020
• OMB approval received.

3
INFORMATION NOT RELEASABLE TO THE PUBLIC UNLESS AUTHORIZED BY LAW: This information has not been publicly disclosed
and may be privileged and confidential. It is for internal government use only and must not be disseminated, distributed, or copied to persons not
authorized to receive the information. Unauthorized disclosure may result in prosecution to the fullest extent of the law.