CMS-Ruling 2020-1-R1 CMS RulingsDepartment of Healthand Human ServicesCenters for Medicare &Medicaid Services Ruling No.: [CMS-2020-01-R]Date: April 14, 2020 CMS Rulings are decisions of the Administrator that serve as precedent final opinions and ordersand statements of policy and interpretation. They provide clarification and interpretation of complexor ambiguous statutory or regulatory provisions relating to Medicare, Medicaid, Utilization andQuality Control Peer Review, private health insurance, and related matters. They are publishedunder the authority of the Administrator of the Centers for Medicare & Medicaid Services (CMS).CMS Rulings are binding on all CMS components, on all Department of Health and HumanServices components that adjudicate matters under the jurisdiction of CMS, and on the SocialSecurity Administration (SSA) to the extent that components of the SSA adjudicate matters underthe jurisdiction of CMS.This Ruling articulates CMS policy concerning the designation and payment of certain clinicaldiagnostic laboratory tests related to COVID-19 under the Medicare Part B Clinical Laboratory FeeSchedule.MEDICARE PROGRAMPayment under Medicare Supplementary Medical Insurance (Part B) for clinical diagnostic laboratorytests for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 makinguse of high throughput technologies.CITATIONS: Section 1833(h) of the Social Security Act (42 U.S.C. 1395l(h)),Section 1834A of the Social Security Act (42 U.S.C. 1395m-1), and 42 CFR Part 414,Subpart G.
CMS-Ruling 2020-1-R2BACKGROUNDMedicare Part B items and services that are clinical diagnostic laboratory tests (CDLTs) arepaid for on the Clinical Laboratory Fee Schedule in accordance with section 1833(h) and section1834A of the Social Security Act (the Act). CMS and the Medicare Administrative Contractors(MACs) that process Medicare claims for payment make payment based on the Act, regulations, andCMS instructions or guidance. Sections 1833(h) and section 1834A of the Act contain provisionsoutlining the process for determining payment amounts for CDLTs. CDLTs are currently beingused to detect SARS–CoV–2 or for the diagnosis of the virus that causes COVID–19 in manysettings, including nursing homes and other sites where Medicare beneficiaries obtain care or reside.PAYMENT FOR LABORATORY TESTS FOR THE DETECTION OF SARS–COV–2 ORTHE DIAGNOSIS OF THE VIRUS THAT CAUSES COVID–19 MAKING USE OF HIGHTHROUGHPUT TECHNOLOGIESCDLTs making use of high throughput technologies (as defined in this Ruling) and administeredduring the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Actbeginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosis of thevirus that causes COVID–19, are new and involve high throughput machines (which are highlysophisticated equipment) which require more intensive technician training (to ensure the role ofextremely skilled personnel) and more time intensive processes (to assure quality). A highthroughput technology uses a platform that employs automated processing of more than twohundred specimens a day. Examples of high throughput technology as of April 14, 2020 include butare not limited to technologies marketed on that date as the Roche cobas 6800 System, Roche cobas8800 System, Abbott m2000 System, Hologic Panther Fusion System, GeneXpert Infinity System,and NeuMoDx 288 Molecular. This training and these processes represent an increase in resources,bringing the total resources required for these tests to 100 (a more accurate payment than the onecurrently in use via contractor pricing). These tests are a type of CDLT currently paid for under
CMS-Ruling 2020-1-R3Medicare Part B. Specifically, the following codes would identify these tests:U0003: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndromecoronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, makinguse of high throughput technologies as described by CMS-2020-01-R.U0004: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multipletypes or subtypes (includes all targets), non-CDC, making use of high throughput technologies asdescribed by CMS-2020-01-R.It is noted that U0003 should identify tests that would otherwise be identified by CPT code 87635but for being performed with these high throughput technologies. It is further noted that U0004should identify tests that would otherwise be identified by U0002 but for being performed withthese high throughput technologies. Finally, it is noted that neither U0003 nor U0004 should be usedfor tests that detect COVID-19 antibodies.CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that makeuse of high throughput technologies developed after this issuance upon request for payment at anappropriate rate.CONCLUSIONWith regard to CDLTs that make use of high throughput technologies (as defined in this Ruling), areadministered during the ongoing emergency period defined in paragraph (1)(B) of section 1135(g)of the Act beginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosisof the virus that causes COVID–19, and are a type of CDLT currently paid for under Medicare PartB using CPT code 87635 or U0002, such tests, as identified using U0003 or U0004 as appropriate,shall be paid for at the rate of 100. Payment for all other CDLTs remains at the current level.CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that makeuse of high throughput technologies developed after this issuance upon request for payment at anappropriate rate.
CMS-Ruling 2020-1-R4MACs are hereby directed to engage in whatever processes are necessary to make determinations orpolicies to process claims in accordance with this Ruling, including implementing any additionalAgency instructions which refer to effectuating this Ruling. This Ruling expires upon the expirationof the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Actbeginning on or after March 18, 2020.
CMS-Ruling 2020-1-REFFECTIVE DATEThis Ruling is effective April 14, 2020.Dated: April 14, 2020Seema VermaAdministratorCenters forMedicare & Medicaid Services
CMS-Ruling 2020-1-R 2 BACKGROUND Medicare Part B items and services that are clinical diagnostic laboratory tests (CDLTs) are paid for on the Clinical Laboratory Fee Schedule in accordance with section 1833(h) and section