Pathology/Lab Coding Alert

Mesh use with existing test codes.

In an off-cycle move, the AMA issued a new Proprietary Laboratory Analyses (PLA) code for a respiratory panel test that includes detection of SARS-CoV-2, the virus that causes COVID 19.

Effective May 20, the new code is 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).

Read on to see how to use this code in the context of existing test options.

Understand PLA Coding Boundaries

Unlike Category I CPT^® lab codes that you can use to report any test that fulfills the code definition, you can report a PLA code only for the specific proprietary clinical lab analysis provided by a specific lab or by labs that purchase or are licensed to perform the test.

For 0202U, the proprietary test is BioFire^® Respiratory Panel 2.1 (RP2.1), by BioFire^® Diagnostics, LLC, which can be performed by labs using the BioFire^® FilmArray^® System.

Similar tests: As part of the regular quarterly update to PLA codes, the AMA introduced three new respiratory pathogen panel codes for varying targets by BioFire^® Diagnostics, effective July 1, 2019, none of which included the SARS-CoV-2 virus, unknown at the time: 0098U-0100U (Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes …).

Fast forward: New code 0202U was introduced and made effective between the AMA’s typical quarterly PLA code cycle to describe a similar respiratory pathogen panel using the BioFire^® FilmArray^® System that includes testing for SARS-CoV-2.

The AMA has accelerated implementation of this and other CPT^® codes to “streamline the novel coronavirus testing currently available on the United States market,” according to the agency. “The current outbreak has taught us what can occur if adequate diagnostic testing is not available in the early stages of a rapidly emerging and serious public health threat,” said James L. Madara, MD, AMA CEO and EVP in a press release.

Drill Down to Test Specifics

Code 0202U describes a respiratory panel test that takes a syndromic approach, meaning that the assay seeks to identify the causative organism or organisms responsible for the signs and symptoms characteristic of a respiratory syndrome.

“The BioFire^® RP2.1 panel represents our syndromic solution to this unprecedented COVID-19 pandemic,” said Andrea Kendell, ad interim CEO at BioFire^® Diagnostics in a press release. “We believe the syndromic BioFire^® RP2.1 panel will play a key role now and in the upcoming respiratory season as healthcare providers and patients will likely face the regular group of respiratory pathogens as well as SARS-CoV-2.” Kendell further highlighted the need for BioFire’s syndromic approach by pointing out that emerging data suggests patients with COVID-19 may frequently be co-infected with other viruses and/or bacteria.

Code 0202U describes a test using multiplex amplified probe technique to qualitatively identify (detected or not detected) the following 22 respiratory viral and bacterial pathogen nucleic acid targets from a single nasopharyngeal swab specimen:

• Adenovirus
• Coronavirus 229E
• Coronavirus HKU1
• Coronavirus NL63
• Coronavirus OC43
• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
• Human rhinovirus/enterovirus
• Human metapneumovirus
• Influenza A (subtype) H3
• Influenza A (subtype) H1
• Influenza A (subtype) H1-2009
• Influenza A
• Influenza B
• Parainfluenza virus 1
• Parainfluenza virus 2
• Parainfluenza virus 3
• Parainfluenza virus 4
• Respiratory syncytial virus
• Bordetella parapertussis (IS1001)
• Bordetella pertussis (ptxP)
• Chlamydia pneumoniae
• Mycoplasma pneumoniae

Caution: The 0202U test is currently authorized by the FDA under the Emergency Use Authorization (EUA) for performance by authorized laboratories for the duration of the COVID-19 public health emergency (PHE), and has not been FDA approved as of the code’s effective date. The parent company, bioMérieux, plans to submit the BioFire^® RP2.1 panel for FDA de novo clearance.

Contrast 87635: CPT^® introduced a different code for SARS-CoV-2 detection by amplified probe technique, effective March 13, 2020: 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).

If labs perform an 87635 test for SARS-CoV-2 detection along with a different test for other respiratory pathogens, such as one of the codes describing a different number of targets (87631-87633, Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, …), you can report the codes together.

The AMA states in the March 13 CPT^® Assistant special edition that “There are no known restrictions on the reporting of code 87635, if performed as a separate assay, with code 87631, 87632, 87633, 0098U, 0099U, 0100U, 0115U, or 0151U. Codes selected should accurately describe the service provided.”