Pathology/Lab Coding Alert

 Distinguish high-throughput codes.

Many labs have ramped up testing for SARS-CoV-2, the virus that causes COVID-19, but if you don’t know all the codes and rules for using them, you could be losing substantial pay.

The latest addition to the code offerings for SARS-CoV-2 describe tests run on high-throughput platforms. Read on to see how and when to use the following new codes to capture all the reimbursement you deserve:

• U0003 (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, making use of high throughput technologies as described by CMS-2020-01-R)
• U0004 (2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R)

Consider New Codes in Place of 87635 and U0002

The descriptors for both new codes specify that they apply to the use of high-throughput technologies. They also reference the April 14 ruling, CMS-2020-01-R, that announced the codes’ creation.

The ruling states that you should report U0003 when your lab uses high-throughput technology to perform a test that would otherwise fall under CPT^® code 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.

 On the other hand, U0004 is appropriate when reporting the use of high-throughput technology for tests that you would otherwise report using U0002 (2019-ncov coronavirus, sars-cov-2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc).

 Key: Codes U0003 and U0004 do not replace codes 87635 and U0002. The point of U0003 and U0004 is to provide specific, unique codes for SARS-CoV-2 tests performed on high-throughput platforms.

Which Tests Qualify as High Throughput?

Some clinical diagnostic laboratory tests (CDLTs) for SARS-CoV-2 use sophisticated high-throughput instrumentation that allow automated processing of more than 200 specimens per day. These testing platforms require special training and intensive process management for quality purposes. CMS states that these platforms may be particularly useful for broad testing of vulnerable populations such as nursing home patients and staff.

In the ruling, CMS listed the following as examples of high-throughput technology:

• Abbott m2000^TM System
• GeneXpert^® Infinity System
• Hologic Panther Fusion^® System
• NeuMoDx^TM 288 Molecular
• Roche cobas^® 6800/8800 Systems

Not exclusive: The preceding sample of systems that CMS identifies as high-throughput is not a complete list. For instance, Thermo Fisher Scientific Inc.’s expanded emergency use authorization (EUA) announced on May 12 “further increases the number of high-throughput PCR instruments that labs can use to run [SARS-CoV-2] tests. … In addition to the previously approved Applied Biosystems 7500 Real-time PCR series and a version of the Applied Biosystems QuantStudio 5, labs can now run tests on specific configurations of QuantStudio 7 Flex and QuantStudio 5 Realtime PCR instruments,” according to a Thermo Fisher press release concerning the EUA expansion.

Don’t Miss the $100 Rate

CMS announced a payment rate of $100 for U0003 and U0004 in the April 14 ruling. The agency said that the rate provides more accurate payment to account for increased training and quality processes required by these platforms compared to payment for 87635 and U0002. Current payment for the latter codes stands at $51.31, according to a May 19 Medicare Administrative Contractor (MAC) COVID-19 test pricing list.

Notice: If you incorrectly code a high-throughput SARS-CoV-2 test using 87635 or U0002 instead of U0003 or U0004, you stand to lose $48.69 for a single test.

“CMS has made a critical move to ensure adequate reimbursement for advanced technology that can process a large volume of COVID-19 tests rapidly and accurately,” said Seema Verma, CMS Administrator.

Details: Medicare Part B pays for CDLTs using the Clinical Laboratory Fee Schedule (CLFS). Medicare will pay a rate of $100 for CDLTs that meet these criteria:

• Use high-throughput technologies (as the ruling defines them)
• Are administered during the ongoing emergency period, which began March 18, 2020
• Are used “for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19”
• Are CDLT types paid under Medicare Part B using 87635 or U0002

Medicare will continue to pay other CDLTs at their current levels. CMS plans to make quick assessments about payment rates as new COVID-19 tests that use high-throughput technology emerge.

Industry response: “Use of high throughput technologies for the detection of SARS-CoV-2 during the ongoing emergency increases the costs of personnel, quality control, instrument purchase and maintenance, and cost of test kits and reagents, thereby placing burden on the financial resources of clinical laboratories. Therefore, setting reimbursement for these tests at $100 will provide adequate financial support to these laboratories to maintain such testing,” said Omai Garner, Ph.D., D(ABMM), chair of the subcommittee on coding and reimbursement for the American Society for Microbiology (ASM) in an open letter to CMS.

Clarify U0003/U0004 Restrictions

In addition to restricting use of U0003 and U0004 to high-throughput SARS-CoV-2 tests performed during the period of March 18 through the end of the COVID-19 public health emergency, the CMS ruling includes some other restrictions you need to know.

Not for antibody tests: CMS states in the ruling that you should not use U0003 or U0004 to report tests that detect antibodies to SARs-CoV-2. CPT^® provides two distinct codes to describe those tests:

• 86328 (Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]))
• 86769 (Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]))

Clinicians may order one of these antibody tests to identify past SARS-CoV-2 infection, not to diagnose a current case of COVID-19. You can read more about these codes in “Update SARS-CoV-2 Code Options for Antibody Tests,” Pathology/Lab Coding Alert Vol. 21, No. 6.

Disclaimer: Information related to COVID-19 changes rapidly. You should check with your MAC and other payers for coverage and payment details for any COVID-19 testing code. For the latest updates, keep an eye on Pathology/Lab Coding Alert and other official sites such as CMS (cms.gov) and CDC (cdc.gov).