CMS change to reporting and reimbursement for high throughput COVID-19 testing

March 24, 2021 / By Bobbie Starkey

Some of you may be aware that CMS implemented some add-on payments for COVID-19 high throughput testing effective January 1, 2021. The add-on payments are being implemented to support laboratories in providing faster, more timely reporting of COVID-19 test results. In turn, patients who test positive can self-isolate and receive treatment sooner, which can help slow the spread of COVID-19. The intent is good; however, the requirements that must be met are complex, as are the processes needed to achieve timely results reporting and obtain the add-on payments. Let’s review the changes and the challenges. 

CMS began supporting the need for expedited COVID-19 test results early on during the pandemic. In April 2020 they increased the reimbursement for high throughput COVID-19 testing from $51 to $100 per test. High throughput testing technology can process more than 200 COVID-19 tests per day.

On October 15, 2020 CMS amended the Administrative Ruling (CMS 2020-1-R2) which reduced payment for the high throughput COVID-19 diagnostic testing from $100 per test to $75 per test effective January 1, 2021. The ruling also provided a potential additional $25 add-on payment per test for laboratories that run COVID-19 diagnostic tests on high throughput technology, provided certain criteria are met.

This is good news, but laboratories must jump through a few hoops to qualify for the add-on payment. First, the laboratory must be able to complete the test in two calendar days or less from the collection of the specimen. A completed test means the results of the test are finalized and ready to be released. Second, the laboratory must complete the majority—that is, 51 percent of their COVID-19 high throughput testing—in two calendar days or less for all their patients (not just Medicare patients) in the month prior to the test collection/result date. 

For example, if a laboratory wants to receive add-on payments for high throughput testing performed in February 2021, they will need to be certain that they produced completed tests within the two-day timeframe for at least 51 percent of the high throughput COVID-19 tests they performed in January, 2021. We will come back to this shortly.

Does the add-on payment ruling change the way high throughput COVID-19 diagnostic tests are coded? Continue to report U0003 or U0004 for the specific high throughput test performed which has been in effect since April 14, 2020. 

  • 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.

What is new is that laboratories that meet the two requirements for the add-on payment must report HCPCS code U0005 in addition to the appropriate U0003 or U0004 code effective January 1, 2021. 

  • U0005: 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, CDC or non-CDC, making use of high throughput technologies, completed within two calendar days from date and time of specimen collection. (List separately in addition to either HCPCS code U0003 or U0004)

CMS indicated that laboratories would be subject to audit of their high throughput COVID-19 testing and reporting. They indicated that laboratories would need to provide documentation to support the timeliness of complete testing for the month preceding the date of service that the U0003 or U0004 is reported in conjunction with U0005. Also, CMS has made some exceptions to the requirement that laboratories needed to maintain physician orders during the Public Health Emergency; however, in the event of audit for this situation, laboratories will need to provide a physician order for each high throughput test performed. CMS also states in the ruling that Medicare Administrative Contractors will be monitoring these claims for potential abuse. Thus, laboratories would need to retain records that support compliance with the required timeframes for both Medicare and non-Medicare records and be able to produce these records in the case of an audit. 

Let’s return to the prior month stipulation. Laboratories need to determine if they are completing 51 percent or more of their high throughput testing for all payers in the two-day window.  If they are uncertain about whether they meet this requirement or know they are not, work will need to be done before they can qualify for the add-on payment.

Another issue to consider is that laboratories who qualify for the add-on payment will have to consider how they will apply the U0005 HCPCS code to the claim. This may not be able to be done via an entirely automated process due to all of factors involved. For example, if U0005 is automated via the charge entry process and the laboratory does not meet the 51 percent requirement for the prior month, all the U0005 line items would need to be reversed.

Rise to the challenge! 

Until next time, stay safe!

Bobbie Starkey, RHIT, CCS-P, is an outpatient consultant with 3M Health Information Systems.

Zero in on key quality issues you team may be facing.

CMS Administrative Ruling (CMS 2020-1-R2)


CMS Press Release