Pathology/Lab Coding Alert

87593 captures orthopoxvirus assay.

After years of focus on SARS-CoV-2, there’s a new virus in town to worry about. On Aug. 8, the Department of Health and Human Services (HHS) Secretary Xavier Becerra declared the ongoing spread of monkeypox virus in the United States a public health emergency (PHE).

The virus: Monkeypox is caused by a virus in the orthopoxvirus genus, which includes monkeypox virus, cowpox virus, vaccinia virus, and the eradicated variola virus, which caused smallpox. Infection typically results in a rash or skin lesions that shed the monkeypox virus.

Make sure you learn the testing, coding, and reporting expectations when your lab performs an assay to help clinicians diagnose patients with monkeypox.

Learn Actions That Facilitate Monkeypox Testing

Multiple actions by different agencies have rushed in to fill the void of information and resources to meet the monkeypox challenge.

On June 24, the Food and Drug Administration (FDA) approved the Centers for Disease Control and Prevention (CDC) nonvariola orthopoxvirus (NVO) real-time polymerase chain reaction (RT-PCR) test. On the heels of that approval, HHS, through the CDC, announced a list of five commercial labs that will perform the FDA-approved test. These labs comprise the Laboratory Response Network (LRN) for monkeypox: Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare.

“The ability of commercial laboratories to test for monkeypox is an important pillar in our comprehensive strategy to combat this disease,” said CDC Director Rochelle Walensky, MD, MPH. “This will not only increase testing capacity but also make it more convenient for providers and patients to access tests by using existing provider-to-laboratory networks.”

In an interview with Matthew Binnicker, PhD, director of clinical virology at Mayo Clinic Laboratories (www.medtechdive.com/news/mayo-clinic-covid-monkeypox-testing/627398/), Binnicker stated, “The five participating labs all have to perform the test exactly as it was cleared by the FDA. So there’s specific instrumentation that the labs need to have and use, and all of the amounts of sample, the types of sample, the incubation steps, the protocol has to be followed exactly.”

Now other labs are gearing up different Laboratory Developed Tests (LDTs) for orthopoxvirus testing, which will each need to undergo an appropriate validation process. To “seed” the LDTs, the CDC on June 6 published a procedure that includes sequence information for developing primers and probes, available at www.cdc.gov/poxvirus/monkeypox/lab-personnel.

Check Out Coding and Reporting Expectations

If your lab performs a monkeypox test, you’ll need to know how to report the service for payment and for disease surveillance.

New code: The AMA introduced the following new code, effective July 26: 87593 (Infectious agent detection by nucleic acid (DNA or RNA); orthopoxvirus (eg, monkeypox virus, cowpox virus, vaccinia virus), amplified probe technique, each).

In CPT Assistant Special Edition: July Update (www.ama-assn.org/system/files/cpt-assistant-guide-monkeypox-july-2022.pdf), the AMA states that the code “will help streamline the tracking of and reimbursement for testing services related to monkeypox in the United States.”

The specimen: Labs will receive a specimen from a suspicious lesion, such as a fluid swab in transport media or on a slide, a dry swab, or a lesion crust or roof.

Typical procedure: The lab extracts DNA from the lesion specimen and performs RT-PCR to “amplify” (increase) the number of copies of target orthopoxvirus DNA sequences, if present. The procedure uses nucleic acid probes that are complementary (matched) to the target DNA sequences and labeled with a visual indicator such as a fluorescent tag. A positive test involves the probes “hybridizing” (joining) with target DNA from the specimen in a detectable way. The assay detects target DNA at varying concentrations, and provides a qualitative result of either positive, negative, or inconclusive for the identification of orthopoxvirus infections. Although 87593 doesn’t specify which orthopoxvirus the test interrogates, a typical test at this time involves DNA from all species other than the eradicated variola virus, which caused smallpox.

Coding: Code 87593 describes the CDC NVO test or other tests that fit the code descriptor. Depending on the assay performed, the findings may be for any virus in the orthopoxvirus genus, or for an individual species. Report one unit of 87593 for each unique amplified probe test for each general or specific orthopoxvirus assay.

Reporting: Any lab that performs monkeypox virus testing should report test results to the appropriate state, local, or other required health department, according to CDC guidance. That includes tests with positive, negative, or equivocal results, according to the guidance, although positive results have a more stringent reporting requirement. Read the guidance at www.cdc.gov/poxvirus/monkeypox/lab-personnel/report-results.html.

Do this: Following a positive test result, commercial LRN labs should send the specimen directly to the CDC for characterization testing. Labs performing monkeypox virus LDTs should contact the state public health lab to determine if you need to send positive specimens to an LRN lab for testing and reporting.

Payment: Check your payers for how they’ll reimburse labs for these tests. For instance, First Coast Service Options (FSCO) Medicare states that 87593 “is effective for dates of service on or after July 26 and the payment rate for our jurisdiction for Part A and Part B has been set at $51.31” (medicare.fcso.com/Billing_news/0498060.asp).