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The purpose of this memorandum is to inform providers that DMAS fee-for-service (FFS) and all contracted managed care plans will be: 1) updating clinical criteria for coverage of 87426 from the memo dated 11/5/2020 “Coverage of COVID-19 Laboratory Tests”, 2) clarifying clinical criteria for coverage of U0003, U0004 and U0005 from the memos dated 11/5/2020 “Coverage of COVID-19 Laboratory Tests” and 2/8/2021 “Updates to Coverage of High-Throughput COVID-19 Testing”, and 3) establishing clinical criteria for coverage of 87635. This memo does not represent any change to the clinical criteria or coverage status of COVID-19 testing codes not listed below.

Updated coverage conditions for select COVID-19 testing codes

DMAS FFS and all contracted managed care plans will ensure coverage of claims for the following COVID-19 testing codes – when claims meet the revised and clarified conditions described in Requirements for Reimbursement – with dates of service on and after the dates listed below:

• 87426 (11/5/2020): Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (e.g., SARS-CoV, SARS-CoV-2, COVID-19).
• U0003 (11/5/2020): Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R.
• U0004 (11/5/2020): 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R.
• U0005 (2/1/2021): Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, CDC or non-CDC, making use of high throughput technologies, completed within two calendar days from date and time of specimen collection. (List separately in addition to either HCPCS code U0003 or U0004)
• 87635 (3/13/2020): Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique.

Requirements for Reimbursement

DMAS and all contracted managed care plans will reimburse providers for the COVID-19 laboratory testing codes outlined above when the test:

• Is recommended by a health care provider; and
• Has an FDA Emergency Use Authorization (EUA) or FDA approval at the time the test is administered.

Providers should follow CMS guidance around COVID-19 testing during the PHE. See the following link for recent guidance: https://www.cms.gov/files/document/clia-sars-cov-2-point-care-test-enfo…;

In addition to the clinical criteria specified above, claims for U0005 will be required to continue to satisfy previously published standards of high-throughput testing (see 2/8/2021 memo “Updates to Coverage of High-Throughput COVID-19 Testing”):

• The COVID-19 Clinical Diagnostic Laboratory Test (CDLT) is completed in two (2) calendar days or fewer from the date of specimen collection; and
• The majority of the laboratory’s COVID-19 CDLTs performed using high-throughput technology in the previous calendar month were completed in two (2) calendar days or fewer for ALL of their patients (not just Medicare or Medicaid patients).

For the codes discussed in this memo, no symptom-based criteria will be imposed at this time. Reimbursement for each code will be limited to a maximum of one (1) per member per day. In keeping with American Medical Association (AMA) guidance, Proprietary Laboratory Analysis (PLA) codes should not be billed in conjunction with any other Category 1 AMA codes.

Claims submitted on or after the coverage dates listed above which were initially denied on the grounds of non-coverage, which providers feel would now meet the updated coverage criteria, may be resubmitted to DMAS FFS or the appropriate managed care plan.

For questions on coverage for members enrolled in a managed care organization, refer to the contact information listed below.

For the codes discussed in this memo, no symptom-based criteria will be imposed at this time. Reimbursement for each code will be limited to a maximum of one (1) per member per day. In keeping with American Medical Association (AMA) guidance, Proprietary Laboratory Analysis (PLA) codes should not be billed in conjunction with any other Category 1 AMA codes.

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