Pathology/Lab Coding Alert

Monitor PHE-related regulations.

As COVID-19 cases are ramping up in many locations, coinciding with the start cold and flu season, you need to stay on top of compliance rules that impact your lab.

Now: In several recent updates, the Department of Health and Human Services (HHS), CMS, and others have rolled out new policies to help you master providing and reporting lab services during the pandemic. Read on for three new updates you need to know.

1. Know the PHE Extension Specifics

With no immediate end in sight for the pandemic, HHS Secretary Alex Azar extended the COVID-19 public health emergency (PHE) for another 90 days effective Oct. 23 and running through Jan. 20, 2021. This is the third PHE extension HHS has made related to the coronavirus since its original declaration on Jan. 27, 2020. The agency first extended the PHE on April 21, and then again on July 23.

Impact: “This renewal extends the wide array of waivers and flexibilities that have been issued by HHS in response to COVID-19,” says attorney Madison Pool with Arnall, Golden, Gregory LLP in online analysis. The waivers include many Medicare policies that impact lab testing and billing. But remember, the feds can roll back policies at any time, and the Secretary can terminate the PHE at his discretion.

Review the PHE particulars at www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-23June2020.aspx.

2. Access Easier Clinical Lab Certification

With COVID-19 cases trending up, CMS moves to speed up the certification process for clinical labs with a new tool that cuts paperwork hassles and streamlines approval.

“An obscure process and outdated modes of payment have too often caused needless delays in certifying lab testing facilities,” said CMS Administrator Seema Verma in a release. A recent update “will allow testing laboratories to promptly and painlessly register with CMS, so they can get to work, focusing on providing reliable information to combat the spread of this disease,” Verma continued.

Now: CMS offers a “quick start guide” that explains, step by step, the updated Clinical Laboratory Improvement Amendments (CLIA) certification process. In addition, labs can now pay their fees online through the CLIA website, which will help labs get up and running more quickly, the release suggests.

Caveat: As soon as labs receive a CLIA number, they can start testing for COVID-19. “Laboratories should be aware, however, that some states may have additional licensing requirements that must be met before testing can begin,” caution attorneys Douglas Grimm and Michele Gipp with Arent Fox in online analysis.

Check out the quick start guide at www.cms.gov/files/document/laboratory-quick-start-guide-cms-clia-certification.pdf.

3. Save ‘High-Throughput’ Lab Bonus With 2-Day Turnaround

If your lab uses a high-throughput platform for COVID-19 testing, you should know that the payment bonus that yields $100 for each test could slip through your fingers beginning January 1, 2021.

Background: CMS issued an Administrative Ruling (CMS 2020-1-R2) last April increasing the Medicare payment to laboratories for high throughput COVID-19 diagnostic tests from approximately $51 to $100 per test.

Update: With an Oct. 15, update, CMS announced that “starting January 1, 2021, Medicare will pay $100 only to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of the specimen being collected. Also effective January 1, 2021, for laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75.”

Here’s why: “As America continues to grapple with the COVID-19 pandemic, prompt testing turnaround times are more important than ever,” said Verma. “Today’s announcement supports faster high throughput testing, which will allow patients and physicians to act quickly and decisively with respect to treatment decisions, physical isolation, and contact tracing.

January details: The amended Administrative Ruling (CMS 2020-1-R2) will lower the base payment amount for COVID-19 diagnostic tests run on high-throughput technology to $75, and Medicare will make an additional $25 add-on payment to laboratories for a COVID-19 diagnostic test run on high throughput technology if the laboratory: a) completes the test in two calendar days or less, and b) completes the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients (not just their Medicare patients) in the previous month.

Impacted codes: CMS requires that you bill one of the following codes for high throughput COVID-19 testing for Medicare beneficiaries, for which the payment rate will be $75 beginning January 1:

• 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)

If your lab meets the two day turnaround time requirement, you’ll need to bill 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)), in addition to the U0003 or U0004 base code. Medicare will pay $25 for U0005.

Resources: Read about the initial April announcement in the article “Don't Lose $49 per SARS-CoV-2 Test” in Pathology/Lab Coding Alert Vol. 21, No. 8.

See the October CMS change announcement at www.cms.gov/newsroom/press-releases/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing and the amended CMS 2020-1-R2 at www.cms.gov/files/document/cms-ruling-2020-1-r2.pdf.