Home 5 National Lab Reporter 5 CMS Recognizes 8 New CLIA-Waived Tests

CMS Recognizes 8 New CLIA-Waived Tests

by | Dec 15, 2022

Labs will be able to bill Medicare and Medicaid for these new CLIA-waived tests, starting on April 1, 2023.

On Nov. 23, the Centers for Medicare & Medicaid Services (CMS) issued Transmittal 11717 to notify its Medicare Administrative Contractors (MACs) of eight new CLIA-waived complexity tests approved by the FDA that labs will be allowed to bill to Medicare and Medicaid. Labs will be able to bill for these new CLIA-waived tests starting on April 1, 2023. Lab compliance officers should brief their billing staff about the changes to avoid claims denials and ensure proper reimbursement of the newly recognized tests.1

How to Bill & Code for New CLIA-Waived Tests

CLIA regulations require labs to be appropriately certified for each kind of test they perform. MACs use payment systems that edit lab claims at the CLIA certificate level to ensure that Medicare and Medicaid only pay for lab tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver. CLIA-waived tests are those determined by the FDA to be so simple that they involve little risk of error. Even so, labs must have a proper CLIA waiver or certification to bill for them.

Compliance Pointer:

You can check the list attached at the end of Transmittal 11717 to confirm that a test is, in fact, CLIA-waived.1

Improper billing and coding of waived complexity tests will result in claims denials. Specifically, labs must list the appropriate Healthcare Common Procedure Coding System (HCPCS) code for the test, along with the QW modifier for the test to be recognized as a waived test. CMS uses the QW modifier to indicate both that a test is CLIA-waived and that the reporting lab has a CLIA certificate that allows the lab to perform and report CLIA-waived tests.

Exceptions: There are currently several codes that describe only CLIA-waived tests and thus are exempt from the QW modifier rules. The chart below lists the CLIA-waived tests that don’t require the QW modifier:

Current Non-QW Modifier CLIA-Waived Tests

HCPCSTestUse
81002Dipstick or tablet reagent urinalysis—non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogenScreening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections
81025Urine pregnancy tests by visual color comparisonDiagnosis of pregnancy
82270
82272
(Contact your MAC for claims instructions)
Fecal occult bloodDetection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)
82962Blood glucose by glucose monitoring devices cleared by FDA for home useMonitoring blood glucose levels  
83026Hemoglobin by copper sulfate – nonautomatedMonitoring hemoglobin level in blood  
84830Ovulation tests by visual color comparison for human luteinizing hormoneDetection of ovulation (optimal for conception)  
85013Blood count; spun microhematocritScreen for anemia
85651Erythrocyte sedimentation rate – nonautomatedNonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia

Monitoring newly approved CLIA-waived tests is also essential to ensure full Medicare and Medicaid reimbursement if your lab provides those tests to Medicare or Medicaid patients. The eight newly recognized tests, all of which are proprietary products that will require a QW modifier, are listed in the chart below:

Newly Recognized CLIA-Waived Tests

(Listed in chronological order of FDA approval date)

CPTManufacturerTest Name
82010QWAmVentureX Inc.BioCoach Blood Glucose and Ketone Monitoring System
80305QWMicro DistributingSTATDIP One Step Drug Test
80305QWMicro DistributingSTATCup II One Step Drug Test Cup
87880QWClarity Diagnostics LLCClarity Strep A Rapid Test Strip
87880QWIndependent Medical Co-op Inc.IMCO Strep A Rapid Test Strip
80305QWInstant Technologies Inc.iSCREEN Urine Test Dx Drug Screen Square Cup
80305QWVerséa Holdings Inc.Verséa THC One Step Marijuana Test Strip
86386QWAbbott Diagnostics Scarborough Inc.NMP22 BladderChek Test (Prescription Home Use) and (Professional Use)

CLIA Number Billing Compliance Pointers

You must list the CLIA number of your lab in Item 23 of the CMS-1500 form or electronic equivalent to avoid having the claim rejected even when billing for a CLIA-waived test. If your lab currently has just one Medicare Part B provider number covering more than one testing site, each of the sites must have a CLIA number and the bill should list the CLIA number of the site where the billed test was actually performed.

References:

  1. https://www.cms.gov/files/document/r11717cp.pdf

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