Pathology/Lab Coding Alert

Monitor developments for your lab.

With COVID-19 pandemic information changing daily, use this snapshot of laboratory coding and regulatory information as a toolkit to help launch you into April. You’ll also find resource links to help you stay current in this fast-moving situation.

Baseline: “Per the World Health Organization, the official name of the virus is severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), while the name of the disease it causes is coronavirus disease (COVID-19),” according to a special edition of CPT^® Assistant, Vol. 30.

Involved agencies: The groups involved in COVID-19 pandemic control that you’ll read more about here are The Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), the World Health Organization (WHO), the Food and Drug Administration (FDA).

Use New Procedure Codes

The CPT^® Editorial Panel approved 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) as a new Category I Pathology and Laboratory code for novel coronavirus testing. This code was effective March 13, 2020.

Because 87635 is an early-release code, you will need to manually upload this code descriptor into your electronic health record system. Code 87635 will be a child code under parent code 87471 (Infectious agent detection by nucleic acid (DNA or RNA); Bartonella henselae and Bartonella quintana, amplified probe technique) in the 2021 CPT^® code set.

“Moving as quickly as possible to put in place a CPT^® code for a novel coronavirus test will bolster a data-driven response to the COVID-19 disease outbreak in the United States,” said Patrice A. Harris, M.D., M.A., AMA president in a March 10 press release.

HCPCS: For Medicare patients, CMS has established two new HCPCS Level II codes for SARS-CoV-2 testing:

• U0001 (Cdc 2019 novel coronavirus (2019-ncov) real-time rt-pcr diagnostic panel). Reserve this code specifically for CDC testing laboratories to test patients for SARS-CoV-2 and to track new cases of the virus, according to CPT^® Assistant, Vol. 30.
• U0002 (2019-ncov coronavirus, sars-cov-2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc). This code is available for laboratories to report any non-CDC laboratory test for SARS-CoV-2/2019-nCoV (COVID-19).

“Both codes can be used to bill Medicare as well as by other health insurers that choose to utilize and accept the code,” according to the CMS fact sheet available at www.cms.gov/files/document/03052020-medicare-covid-19-fact-sheet.pdf. The document also states that laboratories can also use CPT^® code 87635 to bill Medicare if the laboratory uses the method specified in the code.

Pricing: A CMS fact sheet lists prices for the two HCPCS codes for the 12 different Medicare Administrative Contractor (MAC) jurisdictions. According to the guidance, Medicare will pay a little under $36 for HCPCS code U0001 and about $51 for HCPCS code U0002. For specific MAC information, see the CMS pricing sheet at www.cms.gov/files/document/mac-covid-19-test-pricing.pdf.

Specimen collection: To identify and reimburse specimen collection for COVID-19 testing during the public health emergency for the COVID-19 pandemic, CMS established two HCPCS Level II codes that clinical diagnostic labs can bill. The following codes are effective for services beginning March 1:

• G2023 (Specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]), any specimen source)
• G2024 (Specimen collection for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease [covid-19]) from an individual in a snf or by a laboratory on behalf of a hha, any specimen source)

Notice that the codes are for “any specimen source,” so the codes aren’t limited to nasal swabs.

Expect a fee of about $23.46 for G2023 (for non-hospital inpatients) and $25.46 for G2024, according to the CMS interim final rule for Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, in the April 6 Federal Register.

Collect Data with Diagnosis Codes

The CDC, CMS, and WHO have all issued the following guidance for COVID-19 diagnoses coding.

Confirmed cases of COVID-19: As of April 1, use ICD-10 code U07.1 (2019-ncov acute respiratory disease). The CDC, under the National Emergencies Act, section 201 and 301, announced that it is moving the effective date of the new diagnosis code from Oct. 1, 2020 to April 1, 2020.

“This off-cycle update is unprecedented and is an exception to the code set updating process established under HIPAA,” stresses the CDC in a release (www.cdc.gov/nchs/data/icd/Announcement-New-ICD-code-for-coronavirus-3-18-2020.pdf). The following provides more information from the release:

Never: The CDC instructs you not to use B34.2 (Coronavirus infection, unspecified) for confirmed cases of COVID-19, “because the cases have universally been respiratory in nature, so the site would not be ‘unspecified.’”

Confirmed COVID-19 as the cause of, or associated with, diseases classified elsewhere:

Use B97.29 (Other coronavirus as the cause of diseases classified elsewhere) as the secondary code in addition to the appropriate code for the other condition. For example, you would assign a patient diagnosed with acute bronchitis due to a confirmed case of COVID-19 with codes J20.8 (Acute bronchitis due to other specified organisms) and B97.29.

Suspected or confirmed exposure to COVID-19: Use Z03.818 (Encounter for observation for suspected exposure to other biological agents ruled out) for cases where there is a concern about a possible exposure to COVID-19, but this is ruled out after evaluation.

Report Z20.828 (Contact with and (suspected) exposure to other viral communicable diseases) for cases where there is an actual exposure to someone who is confirmed to have COVID-19.

Coding tip: If the provider documents “suspected,” “possible,” or “probable” COVID-19, do not assign code B97.29. Assign a code(s) explaining the reason for encounter (such as fever or Z20.828), according to the CDC.

Lab Test Development

Lab testing options for SARS-CoV-2 have developed dramatically since the initial test developed and provided to state health labs by the CDC (CDC 2019-nCoV Real Time RT-PCR).

FDA rules in place at the time of the outbreak initially required labs to get approval through the relatively-involved Emergency Use Authorization (EUA) procedure before using any other tests. The requirement slowed testing and prompted requests from industry experts to ease the regulations.

“The American Association for Clinical Chemistry (AACC) requests that the FDA exercise enforcement discretion to permit qualified laboratories to build and utilize laboratory developed tests (LDTs) to detect SARS-CoV-2 and diagnose COVID-19,” stated Carmen L. Wiley, PhD, DABCC, FAACC, AACC president in a Feb. 28 letter to the FDA commissioner.

FDA action: In response to lab industry requests and the growing need for testing, the FDA has provided the following changes:

• Feb. 29: FDA allows CLIA-certified high complexity labs to develop and validate tests before submitting EUA application within 15 days.
• March 12: FDA allows the New York State Department of Health to authorize specific New York labs to validate their tests and begin testing, with 15 days to report validation data to the health department rather than applying for an EUA.
• March 16: FDA allows states to oversee LDTs within their state. The agency also allows commercial test distribution and use before granting an EUA.
• Ongoing: FDA fast-tracks manufacturer EUA kits, such as Hologic, Thermo Fisher, Roche, LabCorps, Quest, and more.

In a March18 Clinical Laboratory News, the American Clinical Laboratory Association (ACLA) stated, “Once these faster testing systems are in place … commercial reference laboratories expect to be able to offer 20,000 tests a day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.”

Funding concerns: Even with recent financial congressional action in the face of the COVID-19 pandemic, laboratory payment for testing remains in limbo. “For the third time, Congress has failed to provide the necessary funds to support ‘free testing’ for all Americans. Our members remain in an untenable situation, absorbing growing, uncompensated costs for testing specimens with no assurance that they will be appropriately or fairly reimbursed for all the tests they are performing,” said Julie Khani, ACLA president in a March 25 statement, responding to the Coronavirus Aid, Relief, and Economic Security Act (CARES).

Editor’s note: Information related to COVID-19 is changing rapidly. This information was accurate at the time of writing. Be sure to stay tuned to future issues of Pathology/Lab Coding Alert for more information. You can also refer to payer websites, CMS (cms.gov), CDC (cdc.gov), and AAPC’s blog (www.aapc.com/blog) for the most up-to-date information.