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Coding UpdatesUPDATED 8/17/20

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A new CPT code created by AMA and diagnostic testing requirements.

Over the past several months the American Medical Association (AMA) has been expediting CPT codes to report the various testing methodologies that became available.

The first of these in April followed CMS’ release of two unique HCPCS codes for reporting CDC versus non-CDC testing methodologies:

ü U0001 – CDC 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel, for use with CDC developed testing, and

ü U0002 – 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19) using any technique, multiple types or subtypes (includes all targets), for non-CDC developed testing (e.g., Hospital specific in-house developed testing).

For non-CDC nucleic acid test methodologies providers should report 87635 and utilize U0002 for all other testing methods.1

ü 87635 – 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.

CMS rapidly followed up on the following two HCPCS codes for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 making use of high throughput technologies:2

ü U0003 – 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; and

ü U0004 – 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.

CMS has instructed providers to take note that U0003 should identify tests that would otherwise be identified by CPT code 87635 but for being performed with high throughput technologies.

U0004 should identify tests that would otherwise be identified by U0002 but for being performed with high throughput technologies.

Neither U0003 nor U0004 should be used for tests that detect COVID-19 antibodies.3

Medicare CDC Test Kit Type RC PCR Technique

Non CDC Test Type Any Other Technique

Nucleic Acid Amp Probe Technique

Standard U0001 U0002 87635High Throughput U0004 U0003

High throughput technology uses a platform that employs automated processing of more than two hundred specimens a day. This technology is new and involves highly sophisticated equipment which requires more intensive technician training (to ensure the role of extremely skilled personnel) and more time intensive processes (to assure quality).

This training and these processes represent an increase in resources, bringing the total resources required for these tests to $100 compared to an average payment of $51 for the standard test.4 Medicare will pay laboratories for these tests at the higher amount effective April 14, 2020, through the duration of the COVID-19 national emergency.5

BackgroundThere are three types of tests that might be used for SARS-CoV-2 testing:

1. Molecular tests detect nucleic acid from SARS-CoV-2.

2. Serology tests detect SARS-CoV-2 antibodies present in the blood.

3. Antigen tests detect SARS-CoV-2 antigens present in the blood.

Diagnostic Testing See yellow highlights for updated content from previous published version.

UPDATED INFO

Lists of tests that have FDA approval or that have been issued an Emergency Use Authorization (EUA) may be found at: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.

The FDA also maintains a FAQ page that includes a list of manufactures who have been removed from EUA list and whose tests should no longer be used: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2#offeringtests.

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In response to the need for CPT codes specific for antibodies the AMA also expedited the release of two additional codes on April 14, 2020 differentiating between a single-step and multiple-step method with:6

ü 86328 – Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); and

ü 86769 – Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]). (A parenthetical note has been added to the CPT Manual indicating this is a multi-step method test).

Lastly to provide increased specificity for reporting immunoassay antigen testing the AMA released in June 2020 CPT 87426, severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARSCoV-2 [COVID-19]).

CPT 87426 will be a child code under parent code 87301, Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzymelinked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; adenovirus enteric types 40/41.

As science moves from determining who is currently infected to who has had the infection (antibody testing), the next step during the COVID-19 pandemic is to determine who has mounted neutralizing antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus.

According to the AMA currently, no existing CPT codes were available specifically for tests that measure a patient’s SARS-CoV-2 neutralizing antibodies. There also were not codes related to utilizing a cellular reporter system to measure live virus infection of cells in culture.7

A cellular response to infection is measured using a cellular reporter system as a measure of infection. These tests determine if antibodies present in a patient specimen can directly block infection of cells expressing the viral entry receptor on their surface.

The following codes, effective August 10, 2020 were released for reporting these tests:

ü 86408 – Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]); screen

ü 86409 – Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID19]); titer

In addition to all of these codes, the AMA has also released new proprietary laboratory analyses (PLA) testing codes.8 Effective May 20, 2020, 0202U was released which is applicable to BioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Diagnostics, and BioFire® Diagnostics, LLC.

ü 0202U – Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected.

Effective June 25, 2020 the AMA released two additional PLA codes.

ü 0223U applicable to QIAstat-Dx Respiratory SARS CoV-2 Panel, QIAGEN Sciences, and QIAGEN GmbH:

– Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen reported as detected or not detected.

ü 0224U applicable to COVID-19 Antibody Test, Mt Sinai, Mount Sinai Laboratory:

– Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), includes titer(s), when performed

The CPT Assistant article published indicates that 0223U describes a novel type of fully automated molecular assay that provides simultaneous qualitative detection and identification of multiple respiratory pathogens based on viral and bacterial nucleic acids obtained via nasopharyngeal swabs.

While 0224U describes qualitative and quantitative detection of antibodies in serum and plasma. The test may aid in determining whether an individual suspected of significant exposure or prior infection with SARS-CoV-2 virus has a high titer of IgG antibodies against this virus when performed.

Effective August 10, 2020 two additional PLA codes were released.

ü 0225U applicable to ePlex® Respiratory Pathogen Panel 2, GenMark Dx, GenMark Diagnostics, Inc:

– Infectious disease (bacterial or viral respiratory tract infection) pathogen-specific DNA and RNA, 21 targets, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected.

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ü 0226U Tru-Immune™, Ethos Laboratories, GenScript® USA Inc:

– Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) (Coronavirus disease [COVID-19]), ELISA, plasma, serum.

The August 2020 CPT Assistant update describes 0225U as an infectious agent detection by nucleic acid (DNA and RNA) by amplified probe technique through polymerase chain reaction and electrochemical detection that generates a result of detected or not detected for each of the analytes. In turn, code 0226U describes a high-throughput quantitative blocking ELISA assay to assess the patient’s viral neutralization capacity to SARS-CoV-2.

To report a PLA code, the analysis performed must fulfill the code descriptor and must be the test represented by the proprietary name listed in Appendix O of the AMA CPT Manual.9

During the Public Health Emergency (PHE) CMS released guidance on April 30, 2020 eliminating the need for a physician order for COVID-19 and related testing:

“Medicare will not require an order from a treating physician or nonphysician practitioner as a condition of Medicare coverage of COVID-19 and other related diagnostic laboratory testing during the PHE. CMS similarly removed these requirements for an influenza virus diagnostic laboratory test and any other diagnostic laboratory test that is necessary to establish or rule out a COVID-19 diagnosis. FDA requirements for an order and state requirements around ordering diagnostic tests would still apply.”

A complete list of tests that do not require a physician order is found at: https://www.cms.gov/files/document/covid-ifc-2-flu-rsv-codes.pdf.

CMS still requires laboratories to furnish the results of COVID-19 tests to the beneficiary.

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Further information regarding laboratory testing and waivers:

The Interim Final Rules and waivers can be found at: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency can be found at: https://www.cms.gov/files/document/qso-20-21-clia.pdf-0.

COVID-19 Frequently Asked Questions (FAQ) on Medicare Fee-for-Service (FFS) Billing: https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.

Guidance ü Determine test methodologies used by the Lab.

ü Ensure all applicable codes are added to the CDM for testing reported by the hospital.

ü Link CDM charge codes to Laboratory testing orders.

Sources1. https://www.cms.gov/files/document/03052020-medicare-

covid-19-fact-sheet.pdf2. https://www.cms.gov/files/document/cms-2020-01-r.pdf3. https://www.cms.gov/files/document/cms-2020-01-r.pdf4. https://www.cms.gov/newsroom/press-releases/cms-

increases-medicare-payment-high-production-coronavirus-lab-tests-0

5. https://www.cms.gov/newsroom/press-releases/cms-increases-medicare-payment-high-production-coronavirus-lab-tests-0

6. CPT® Assistant Special Edition, April Update, Volume 30.7. CPT® Assistant Special Edition, August Update, Volume 30, 2020.8. https://www.ama-assn.org/system/files/2020-06/coronavirus-

long-descriptors.pdf9. https://www.ama-assn.org/system/files/2020-06/cpt-

assistant-guide-coronavirus-june-2020.pdf n