Pathology/Lab Coding Alert

Even if your lab doesn’t currently test for COVID-19, the pneumonia-like illness caused by the novel coronavirus from China (severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2), you can’t afford to ignore the outbreak.

Do this: Read on to learn how interaction with possible COVID-19 cases could impact your lab testing and management protocols.

Identify/Refer Potential Cases

In the midst of cold and flu season, your lab must respond to the need for testing and monitoring COVID-19 cases by sharing knowledge with clinicians, using infection control measures, and implementing appropriate testing.

“Our goal is early detection of new cases and to prevent further spread of the coronavirus,” said Robert R. Redfield, MD, director of the Center for Disease Control and Prevention (CDC) in a press release.

Testing criteria: Your lab should communicate to clinicians who request testing for flu or other respiratory illnesses to be on the alert for cases that require COVID-19 testing.

“The criteria for testing in the United States focuses on people who are ill with the [associated] spectrum of symptoms, which is fever, respiratory symptoms, cough, shortness of breath, who have appropriate travel history, or who have been identified as contacts of a confirmed patient,” stated Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases in a press briefing.

The appropriate travel history includes locations of known outbreak, including Hubei Province and mainland China, within the previous 14 days. The CDC has established the incubation period for COVID-19 as 14 days, expecting symptoms and viral shedding within that period following exposure. The CDC does not recommend routinely testing asymptomatic patients, because “testing people too early can potentially miss infections,” Messonnier explained in the briefing.

Refer: For patients who meet the CDC testing criteria, you should refer testing to an authorized lab. Currently, the CDC has sent about 200 test kits to qualified domestic laboratories, mostly local or state public health labs. The labs are CLIA-certified to perform high complexity tests. If you operate in one of the testing labs, personnel should follow recommended infection prevention and control procedures available at www.cdc.gov/coronavirus/2019-nCoV/hcp/infection-control.html.

Know the Definitive COVID-19 Test

The CDC test kit for SARS-CoV-2, the virus that causes COVID-19, is called “2019-Novel Coronavirus (2019-nCov) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (CDC 2019-nCoV Real Time RT-PCR),” and can be run on the same RT-PCR testing instrument used for influenza testing. For full description of testing, visit www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html and www.fda.gov/media/134922/download.

The appropriate test specimen is upper and lower respiratory specimens, including nasopharyngeal and oropharyngeal swabs, and sputum or bronchoalveolar lavage (BAL).

The test kits are not cleared or approved by the Food and Drug Administration (FDA), but are authorized for use by qualified labs under the FDA Emergency Use Authorization (EUA) during the period of the public health emergency declared on Jan. 31, unless revoked earlier.

The CDC continues to perform initial and confirmatory testing, and the agency is also engaging a few state health labs for COVID-19 surveillance using existing flu surveillance systems.

Coding: CMS developed U0001 as a new Healthcare Common Procedure Coding System (HCPCS) code for the CDC 2019-nCoV Real Time RT-PCR test. Labs that conduct the test should use this specific code for billing, to allow better tracking of public health response to SARS-CoV-2. The Medicare claims processing system will be able to accept this code on April 1, 2020 for dates of service on or after February 4, 2020.

Look for New Tests

Although the CDC test kit is the only test currently approved for COVID-19 testing in the US, other testing procedures are in the pipeline.

The CDC is working on serology testing, currently taking blood specimens from COVID-19 patients over time to define the immune response and “set the right metrics in order to … use [serology testing] in patients who aren’t yet diagnosed,” Messonnier said in the briefing. The test would help understand the spectrum of illness, such as no symptoms or mild symptoms, in individuals who show serologic evidence of exposure to the virus.

Several commercial labs have also announced tests in the pipeline, including Labcorp, which is developing a test for commercial labs to identify the virus in patient specimens; Co-Diagnostics, which has launched a research-use-only test; and Qiagen, which should have a targeted test for the novel coronavirus ready in February.

Know Your Lab’s Testing Limitations

Many labs already perform tests for a panel of respiratory pathogens. During this peak season for colds and flu, plus heightened awareness of the novel coronavirus, labs may be seeing increased demand for these tests.

For instance: CPT^® 2020 includes seven codes for respiratory pathogen panels that include coronavirus, and your lab might perform one of the following tests:

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 …) for 3-5 targets, 6-11 targets, or 12-25 targets, respectively. Each of these tests includes coronavirus, among other listed pathogens.

Similarly, CPT^® 2020 lists four proprietary laboratory analyses (PLA) panels with various targets, including coronavirus, by BioFire^® Diagnostics:

• 0098U-0100U (Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes …) for 14, 20, and 21 targets, respectively for BioFire^® FilmArray^® Respiratory Panel …
• 0151U (IInfectious disease (bacterial or viral respiratory tract infection), pathogen specific nucleic acid (DNA or RNA), 33 targets, real-time semi-quantitative PCR, bronchoalveolar lavage, sputum, or endotracheal aspirate, detection of 33 organismal and antibiotic resistance genes with limited semi-quantitative results) for BioFire^® FilmArray^® Pneumonia Panel.

Alert: Although many labs offer multiplex respiratory panels that include a coronavirus assay, “we don’t think those coronavirus tests on those panels detect this novel coronavirus strain,” said Matthew J. Binnicker, PhD, director of clinical virology and vice chair of practice in the department of lab medicine and pathology at Mayo Clinic in Rochester, Mn, during the Mayo Clinic Talks Podcast #126.

Problem: “Physicians likely will see positive results for patients for coronavirus [on these panels], but that doesn’t mean the patient has this new strain,” Binnicker cautioned. That also means a patient could have COVID-19, but get a negative result for coronavirus on the panel test.

Key: Make sure physician clients and your lab are screening patients for the CDC’s COVID-19 testing criteria, communicating about suspected cases, and taking the following steps for evaluating and reporting any person who meets the criteria:

• Contact internal infection prevention and control group.
• Contact the public health lab for epidemiological screening and testing, if needed.
• Follow lab safety protocols.

For updates and additional information, visit CDC website www.cdc.gov/coronavirus/.