CMS Recognizes 8 New CLIA-Waived Tests
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.
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
|Dipstick or tablet reagent urinalysis—non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen
|Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections
|Urine pregnancy tests by visual color comparison
|Diagnosis of pregnancy
(Contact your MAC for claims instructions)
|Fecal occult blood
|Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)
|Blood glucose by glucose monitoring devices cleared by FDA for home use
|Monitoring blood glucose levels
|Hemoglobin by copper sulfate – nonautomated
|Monitoring hemoglobin level in blood
|Ovulation tests by visual color comparison for human luteinizing hormone
|Detection of ovulation (optimal for conception)
|Blood count; spun microhematocrit
|Screen for anemia
|Erythrocyte sedimentation rate – nonautomated
|Nonspecific 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)
|BioCoach Blood Glucose and Ketone Monitoring System
|STATDIP One Step Drug Test
|STATCup II One Step Drug Test Cup
|Clarity Diagnostics LLC
|Clarity Strep A Rapid Test Strip
|Independent Medical Co-op Inc.
|IMCO Strep A Rapid Test Strip
|Instant Technologies Inc.
|iSCREEN Urine Test Dx Drug Screen Square Cup
|Verséa Holdings Inc.
|Verséa THC One Step Marijuana Test Strip
|Abbott 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.
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