There are upcoming changes to reimbursement and documentation requirements for high throughput technology COVID-19 lab tests pursuant to the CMS-2020-1-R2 Ruling effective January 1, 2021, which amends the April 14, 2020 Ruling, outlined Medicare Part B Clinical Laboratory Fee Schedule (“CLFS”) payment of certain clinical diagnostic laboratory tests (“CDLTs”) related to COVID-19.
Under the existing guidance, CMS established a payment of $100 for CDLT HCPCS making use of high throughput technology which utilized a platform to employ automated processing of more than two hundred (200) specimens per day. The higher payment for the following HCPCS recognized the sophistication of high throughput technology, which requires more intensive technician training and processes to ensure quality results:
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; and
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.
In the new ruling, CMS cited the importance of completing these high throughput tests in a timely fashion, thereby modifying the payment for HCPCS U0003/U0004 and establishing a new HCPCS for add-on payment when tests are performed within two (2) calendar days effective January 1, 2021:
Payment for U0003 and U0004 will be decreased from $100 to $75.
New HCPCS U0005 will allow a $25 add-on payment when reported with U0003/U0004 only if the following requirements are met:
The laboratory completes the test within two (2) calendar days of specimen collection from the patient; AND
The majority (51%) of a laboratory’s CDLTs making use of high throughput technology for the detection of SARS-CoV-2 or the diagnosis of the virus that causes COVID-19 for all patients (including non-Medicare patients) in the previous month must have been completed in two (2) calendar days or less from the date of specimen collection.
The new Rule directs Medicare Administrative Contractors (“MACs”) to ensure laboratories are compliant, to include monitoring claims data for potential abuse, conducting medical review of claims and referring cases of suspected fraud or abuse for further investigation. In the event of an audit or medical review, laboratories will need to produce documentation of timeliness in the month preceding the date of service for the reported CDLT represented by U0003 or U0004 in conjunction with U0005.
Education regarding the upcoming reimbursement changes, along with associated audit/compliance implications is paramount to accurately reporting CDLTs utilizing high throughput technology. Conducting an evaluation of current workflows, as well as monthly assessments of result timeliness, will allow facilities to continue to receive the higher $100 payment rate.
SunStone offers services specifically geared towards helping facilities navigate the COVID-19 regulatory changes. If you have any questions relative to the upcoming changes please contact any of our team listed below:
Vonda Moon, Joli Fitzgibbons, Danielle Wyld, or Cathy Archuleta