Pathology/Lab Coding Alert

Greet infectious agent antigen detection option.

With myriad nucleic acid tests available to detect SARS-CoV-2 and diagnose COVID-19, the new kid on the block takes a different approach: an immunoassay to detect viral antigens that can lead to the diagnosis.

Read on to see how a new CPT^® code fits into the array of SARS-CoV-2 test alternatives.

Use 87426 to Report SARS-CoV-2 Antigen Immunoassay

The CPT^® Editorial Panel announced a new Category I code (87426, Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARSCoV-2 [COVID-19])) on June 25, for immediate use.

As with other early release code additions “you will need to manually upload [the] code descriptor into your EHR system,” the AMA instructs in the announcement.

Procedure: The test involves using a nasal swab processed with a reagent that releases viral nucleoprotein antigen, if present, reacted with target antibodies for an immunoassay that identifies the presence of a SARS coronavirus such as SARS- CoV or SARS-CoV-2. This is a rapid test of low complexity.

The new code provides a coding solution for infectious agent antigen testing earlier approved by an FDA emergency use authorization (EUA) for COVID-19 diagnosis. The EUA authorizes use of an antigen test “for rapid detection of the virus that causes COVID-19.”

EUA tests: Currently, the FDA has approved two tests: Quidel Corporation’s Sofia SARS Antigen FIA and Becton Dickinson’s BD Veritor™ System for Rapid Detection of SARS-CoV-2. Approval for other individual tests or an umbrella approval for independently validated antigen tests may follow. The tests are authorized for use by facilities operating under a CLIA Certificate of Waiver or higher complexity, including point-of-care (POC) testing.

Use modifier: CMS has instructed that “to be recognized as a test that can be performed in a facility possessing a CLIA certificate of waiver, the modifier QW (CLIA waived test) must be added (87426QW).”

Open Doors to POC Testing

Infectious agent antigen testing can provide a quicker and simpler test for COVID-19 infection that can be deployed as a POC test providing almost immediate results.

“This will be a game-changer for frontline health care workers and their patients to be able to access a quick diagnostic test for COVID-19, offering results in real-time at convenient locations like retail pharmacies, urgent care centers and doctors’ offices,” said Dave Hickey, president of Integrated Diagnostic Solutions for BD in a press release. “Such tests will also help communities be more informed and better prepared to help prevent new spikes and additional waves of COVID-19 by enabling public health workers to quickly identify infectious individuals and trace their contacts.”

HHS steps in: The Department of Health and Human Services (HHS) recently committed to purchasing 2,000 BD Veritor™ Plus Systems and 750,000 SARS-CoV-2 antigen test kits to distribute. This is the latest POC testing advance “that will significantly expand testing in distributed locations for the benefit of all Americans,” said Admiral Brett P. Giroir, M.D., assistant secretary for health and COVID-19 testing coordinator. “This development will help identify community spread of the virus by further enabling rapid diagnosis of COVID-19.”

Place 87426 in COVID-19 Testing Universe

To aid in COVID-19 diagnosis before SARS-CoV-2 antigen immunoassay tests (87426) were available, labs could provide molecular diagnostic tests using polymerase chain reaction (PCR) to detect viral nucleic acids in the patient specimen.

Labs have also been able to provide serological (antibody) tests to determine if the patient has developed an immune response to the virus, indicating past infection with SARS-CoV-2. These tests are not appropriate to diagnose COVID-19.

“Each category of diagnostic test has its own unique role in the fight against this virus,” according to Stephen M. Hahn MD, commissioner of food and drugs, and Jeffrey E. Shuren, MD, JD, director of the center for devices and radiological health, in an FDA statement.

PCR tests are extremely accurate but may require extended time to get results, while immunoassay antigen tests can provide results in minutes, but may have a higher chance of false negatives. “Antigen tests are also important in the overall response against COVID-19 as they can generally be produced at a lower cost than PCR tests and … can potentially scale to test millions of Americans per day …, helping our country better identify infection rates closer to real time,” according to Hahn and Shuren.

Look at the following summary to see which codes are currently available for the various types of SARS-CoV-2 tests. You can read more about many of these codes in past issues of Pathology/Lab Coding Alert.

PCR codes: The initial COVID-19 diagnosis tests used the nucleic acid method, so you have many codes available to use depending on differences such as payer, test volume, number of targets, or manufacturer, as follows:

• 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).
• U0001 (CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel).
• U0002 (2019-nCoV Coronavirus, SARS-CoV- 2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC).
• 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).
• 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).
• 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). This is a Proprietary Laboratory Analysis (PLA) specific for BioFire^® Respiratory Panel 2.1 (RP2.1) by BioFire^® Diagnostics, LLC.
• 0223U. This code has the same definition as 0202U but is a PLA code specific for QIAstat-Dx Respiratory SARS-CoV-2 Panel by QIAGEN Sciences. The AMA introduced this code on June 25 along with 87426.

Antibody codes: Labs have the following codes to report serological testing for SARS-CoV-2 antibodies:

• 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])).
• 86769 (Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])).
• 0224U (Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), includes titer(s), when performed). This is a PLA code specific for COVID-19 Antibody Test from Mount Sinai Laboratory. The AMA introduced this code on June 25 along with 87426 and 0223U.

Resources: To keep up with current codes and EUA tests for COVID-19, you may turn to AMA and FDA resources such as www.ama-assn.org/practice-management/cpt/covid-19-coding-and-guidance and www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.