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DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop C2-21-16
Baltimore, Maryland 21244-1850
Center for Clinical Standards and Quality/Quality, Safety & Oversight Group
Admin Info: 20-06-CLIA
DATE: April 30, 2020
TO: State Survey Agency Directors
FROM: Director
Quality, Safety & Oversight Group
SUBJECT: CMS SARS-CoV-2 Laboratory Testing Comparison
Background:
CMS is committed to taking critical steps to ensure America’s clinical laboratories can respond to the threat of COVID-19 and other respiratory illnesses to protect patient health and safety. The intent of the CLIA program is to ensure that test results provided to individuals and their health care providers are accurate and reliable.
Laboratories need a CLIA certificate to perform SARS-CoV-2 testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. Clinical laboratories and facilities such as academic laboratories, research laboratories, pharmacies, physician offices, urgent care clinics, and veterinary laboratories need CLIA certification to perform SARS-CoV-2 testing on human specimens.
Memorandum Summary
• CMS is committed to taking critical steps to ensure America’s clinical laboratories can respond to the threat of the 2019 Novel Coronavirus (COVID-19) and other respiratory illnesses to ensure patient health and safety.
• Laboratories need a Clinical Laboratory Improvement Amendments (CLIA) certificate to perform severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. This also applies to facilities not typically considered to be laboratories that are performing SARS-CoV-2 testing.
• This guidance is a part of the Centers for Medicare & Medicaid Services (CMS) effort to clarify:
o The types of severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) testing and whether the tests are being offered under an Emergency Use Authorization (EUA) issued by FDA or as described in FDA’s COVID-19 Test Guidance
o The CLIA certifications under which each test can be performed
o An explanation of requirements under each testing scenario
o Information for Medicare beneficiaries on testing services and coverage
This guidance is part of the CMS effort to clarify the types of SARS-CoV-2 testing, whether the tests are being offered under an EUA issued by FDA or as described in FDA’s COVID-19 Test Guidance, the CLIA certifications and requirements under which testing can be performed, and information for Medicare beneficiaries on testing services and coverage.
Guidance:
This guidance is intended to clarify the different types of testing available for laboratories, whether the tests are being offered under an EUA issued by FDA or as described in FDA’s COVID-19 Test Guidance for these tests systems, and the CLIA certificates under which testing can be performed. As of today, there are two different types of SARS-CoV-2 testing. One type is molecular, which detects nucleic acid from SARS-CoV-2. The other type is serology, or antibody testing, which measures SARS-CoV-2 antibodies present in the blood. There is a third type of SARS-CoV-2 test which detect antigens present in the blood. As of today, no antigen tests for SARS-CoV-2 have been authorized by FDA. Such tests will be added to the FDA website when authorized.
Currently, COVID-19 tests are being offered that have been FDA authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (these are listed on the FDA website here.) or under the policies outlined in the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 (“COVID-19 Test Guidance”). This document discusses policies applicable to testing for COVID-19, including Laboratory Developed Tests (LDTs). “FDA notification” means that the laboratory or manufacturer has provided FDA with notification that it has validated its test as described in the policies outlined in FDA’s COVID-19 Test Guidance and is now listed on the FDA website here.
Further, an explanation of covered testing services for beneficiaries and payment rates for SARS-CoV-2 tests under Medicare is included with this information.
CMS has received many questions about which assays can be performed under which type of CLIA certificate. This document delineates which assays offered can be performed by laboratories under each of the CLIA Certificate types. CLIA has four different certificate types, which are Certificate of Waiver, Certificate of Provider-Performed Microscopy, Certificate of Compliance, and Certificate of Accreditation. The required certificate type depends on whether the test was issued an EUA, and if so, the authorized settings included in the Emergency Use Authorization (EUA).
For information about CMS’ response to the COVID-19 public health emergency, please refer to our CMS QSO 20-21-CLIA guidance document and CMS CLIA COVID-19 FAQs
Contact: For questions or concerns relating to this memorandum, please contact LabExcellence@cms.hhs.gov
Effective Date: Immediately. This policy should be communicated with all survey and certification staff, their managers and the State/Regional Office training coordinators within 30 days of this memorandum.
/s/
David R. Wright
cc: Survey & Operations Group (SOG) Management
Attachments: CMS COVID-19 Testing Infographic
TYPE OF SARS-CoV-2
TESTING
FDA AUTHORIZATION/
NOTIFICATION
CLIA CERTIFICATES
UNDER WHICH TESTING
CAN BE PERFORMED REQUIREMENTS
Test authorized under EUA for
point-of-care (deemed Waived)
May be performed under all
certificate types
• Perform testing as per
Manufacturer’s Instruction (MI)
• Perform Quality Control as per MI
• No personnel requirements
Test authorized under EUA
for high and/or moderate
complexity
Certificate of Compliance
Certificate of Accreditation
Must meet requirements for Moderate
or High Complexity Testing, depending
upon test complexity or setting, as
authorized in EUA
FDA notified,** but test is not
FDA authorized under EUA
Certificate of Compliance
Certificate of Accreditation
Must meet requirements for High
Complexity Testing (regardless of
whether manufacturer intends for test
to be point-of-care/waived)
Test not authorized under
EUA and FDA NOT notified
LDT authorized under EUA Certificate of Compliance
Certificate of Accreditation
Must meet requirements for
High Complexity Testing
FDA notified, ** but LDT not
authorized under EUA
Certificate of Compliance
Certificate of Accreditation
Must meet requirements for
High Complexity Testing
LDT authorized by State
Authority through a
State Approved Program
Certificate of Compliance
Certificate of Accreditation
Must meet requirements for
High Complexity Testing
LDT not authorized under
EUA or State Authority and
FDA NOT NOTIFIED
AT-HOME At-Home Specimen Collection
and Testing
Email: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov
Home specimen collection or home testing is not permitted unless explicitly
authorized under EUA
LABORATORY
DEVELOPED
TESTS (LDTs)
In vitro diagnostic
test that is designed,
manufactured and
used within a single
laboratory; can be
a molecular, serology,
or antigen test
CMS CLINICAL LABORATORY
IMPROVEMENT AMENDMENTS (CLIA):
TESTING
REQUIREMENTS
FOR SARS-CoV-2
Last updated April 29, 2020; information subject
to change based on FDA authorizations and updates
Laboratories performing testing must be CLIA certified.*
To apply for CLIA certification, refer to our brochure
See pages 2 and 3 for more on expansion of testing
and specimen collection sites and Medicare
payment updates
TEST KITS
Molecular tests detect
nucleic acid from
SARS-CoV-2
Serology tests detect
SARS-CoV-2 antibodies
present in the blood
Antigen tests detect
SARS-CoV-2 antigens
present in the blood
Required certificate type
depends on authorized
settings included
in Emergency Use
Authorization (EUA)
*Laboratories and facilities such as academic laboratories, research laboratories, pharmacies, and veterinary laboratories would need CLIA certification to perform SARS-CoV-2 testing
**FDA notified means that the laboratory or manufacturer has notified FDA as described in FDA’s COVID-19 Test Guidance and is now listed on the FDA website here
Email: FDA-COVID-19-Fraudulent-Products@fda.hhs.gov
DOCTOR’S OFFICE,
HOSPITAL
• Medicare is separately paying hospitals and practitioners to assess patients and collect
laboratory samples for COVID-19 testing even when that is the only service the patient receives.
This approach supports both hospitals and physician practices to operate testing sites.
• To ensure that Medicare beneficiaries have broad access to testing, for Medicare payment
purposes, Medicare no longer requires an order from the treating physician or other
practitioner for beneficiaries to get both COVID-19 testing and laboratory tests for influenza
and respiratory syncytial virus that may be part of a COVID-19 diagnosis. COVID-19 tests may
be covered when ordered by any healthcare professional authorized to do so under state law.
• Medicare is covering serology (or antibody) tests, which may be helpful for patients,
practitioners, and communities in making decisions on medical treatment and responsible
social distancing policies.
HOME (INCLUDING
NURSING HOMES)
• For beneficiaries who are homebound and unable to travel, Medicare pays labs to send
technicians to a beneficiary’s home, including a nursing home when a beneficiary is not in a
Part A skilled nursing stay, to collect a lab sample.
• A home health nurse could collect a lab sample as part of a normal visit for beneficiaries
receiving home health services.
• A visiting nurse working for a Rural Health Clinic or Federally Qualified Health Center and
making a home visit can collect a lab sample under certain conditions.
PHARMACY • Medicare will pay for COVID-19 tests performed by pharmacists as part of a Medicareenrolled
laboratory.
• A pharmacist also may furnish basic clinical services, such as collect lab samples, under
contract with a doctor or practitioner, in accordance with a pharmacist’s scope of practice
and state law.
• Beneficiaries can get tested at “parking lot” test sites operated by pharmacies consistent
with state requirements.
DRIVE-THROUGH
TESTING OR
ALTERNATIVE SITES
• Healthcare facilities like hospitals, doctor’s offices, labs can set up off-site locations like
drive- through testing to collect samples. Medicare pays these healthcare providers as they
normally would.
CMS ACTIONS
TO EXPAND
SARS-CoV-2
TESTING
WHERE MEDICARE BENEFICIARIES CAN GET TESTED
LAB SERVICE MEDICARE PAYMENT BILLING CODE
CDC RNA Based Lab Test Approx. $36 HCPCS code U0001
Non- CDC Lab Test that uses any
technique, multiple types or subtypes
(includes all targets)
Approx. $51 HCPCS code U0002
Non CDC Lab Test using RNA
based technique
Approx. $51 CPT code 87635
Serology (antibody) test TBD CPT code 86328
CPT code 86769
Lab Test Using High
Through-Put Technology
$100
(effective 4/14)
HCPCS code U0003;
HCPCS code U0004
Lab Specimen Collection
from a Patient
Approx $23-$25 HCPCS code C9803 billed by hospital
outpatient department
HCPCS code 99211 billed
by a physician office
HCPCS code G2023/G2024
for home/nursing home collection
by a lab or on behalf of a home
health agency
MEDICARE
PAYMENT FOR
LAB SERVICES
MEDICARE PAYMENT FOR LAB SERVICES

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