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Update: Guidance for Reporting Coronavirus Lab Tests

UPDATE:  On April 14, 2020, CMS released Ruling No. CMS-2020-01-R that describes its payment policy for clinical diagnostic laboratory tests used for the detection of SARS-Co-V-2 or the diagnosis of the virus that causes COVID-19 making use of high throughput technologies.

In consideration of the increased resources required of high throughput testing, these tests will be paid at the rate of $100.00 during the ongoing emergency period, with an effective date of March 18, 2020.

In addition to the new HCPCS codes developed for this testing, the CMS Ruling provides guidance for their correct reporting:

U0003    Infectious agent detection by nucleic acid (DNA or RNA); sever 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

•    U0003 should be used to identify tests that would otherwise be identified by CPT code 87635 but for being performed using high throughput technologies.

U0004    2019-nCoV Coronavirus, SARS-Co-V-2/2019-nCoV (COVID-19), any technique, multiple types of subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01R

•    U0004 should be used to identify tests that would otherwise be identified by U0002 but for being performed using high throughput technologies.

This ruling clarifies that U0003 and U0004 are used for reporting testing that identifies active infections and neither U0003 nor U0004 should be used to report testing specifically developed for the purpose of detecting COVID-19 antibodies.

Details of the Ruling may be found at: https://www.cms.gov/files/document/cms-2020-01-r.pdf

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Both the American Medical Association (AMA) and CMS have acted quickly to develop billing codes for reporting lab testing for COVID-19.  

1.  On March 16, 2020, the AMA announced that the CPT Editorial Panel had approved new CPT code 87635 for use as the industry standard for reporting of tests for the novel coronavirus across the nation’s health care system.  In general, we would look to bill this code to commercial insurers unless individual carrier policies direct otherwise.

87635    Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-Co-V-2) (Coronavirus disease [COVID-19]), amplified probe technique

According to the AMA, the code is effective immediately.

2.  CMS has developed two Healthcare Common Procedure Coding System (HCPCS) codes for laboratories to use in billing COVID-19 testing of Medicare patients, rather than the new CPT code described above.  CMS cites the opportunity for improved tracking by having specific codes for these tests as described below.

Laboratory testing of Medicare patients using the Centers for Disease Control and Prevention’s (CDC) 2019 Novel Coronavirus Real Time RT-PCR Diagnostic Test Panel, will be billed with HCPCS code U0001.  This code will only be used for tests developed by the CDC.

Laboratories performing non-CDC laboratory tests of Medicare patients for COVID-19 will bill for them using a different HCPCS code, U0002.

According to CMS, the Medicare claims processing systems will be able to start accepting these codes on April 1, 2020, for dates of service on or after February 4, 2020.

Until national payment rates are established, local Medicare Administrative Contractors (MACs) are responsible for developing the payment amounts for these newly created codes in their respective jurisdictions.  Published on March 12, 2020, these payment rates are listed in the below PDF.

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