CPT code 0446U: Lupus cytokine assay, ten biomarkers, plasma2026 Medicare lab fee · Clinical Laboratory Fee Schedule
This plasma immunoassay measures 10 cytokine biomarkers and reports individual results with an algorithmic score of current systemic lupus disease activity.
Medicare pays $840.65 for 0446U under the 2026 Clinical Laboratory Fee Schedule: one national amount, the same in every state and setting.
Medicare lab fee · CLFS 2026 Q4
National CLFS amount
$840.65
In effect since Jan 1, 2026. The same amount in every state, payment locality and setting.
- Geographic adjustment
- None
- Office vs facility
- Same
- Since 2025
- Unchanged
- CMS updates
- Quarterly
Medicare pays the lesser of the lab’s charge and this amount. Patients usually owe no Part B deductible or coinsurance for covered clinical lab tests.
On this page 8 sections
What 0446U covers
0446U identifies a proprietary laboratory test that evaluates 10 soluble cytokine mediators in plasma by immunoassay. The laboratory reports each component result together with an algorithmic risk score reflecting current systemic lupus erythematosus (SLE) disease activity.
Report 0446U for this 10-biomarker assay, with component results and the algorithmic score reported together. Medicare pays the test under the Clinical Laboratory Fee Schedule (CLFS). The 2026 national CLFS amount is $840.65, unchanged from 2025. One national amount applies across states and localities, without geographic or office-versus-facility adjustment.
This summary was written with AI assistance from CMS Clinical Laboratory Fee Schedule data. Amounts on this page come directly from CMS files.
How Medicare pays 0446U
Clinical lab tests aren’t priced like physician services. They’re paid from their own fee schedule, with its own rules. See the whole lab fee schedule.
One national amount
CMS sets a single Clinical Laboratory Fee Schedule amount for 0446U. There’s no geographic (GPCI) adjustment, so it pays the same in every state and payment locality.
No office or facility rate
Lab tests aren’t built from relative value units, so there’s no office and facility split: the place of service doesn’t change the CLFS amount.
Updated every quarter
CMS republishes the CLFS each quarter. New tests, often proprietary laboratory analyses (PLA codes), join during the year; existing amounts are updated each January.
Not on the physician fee schedule
The physician fee schedule doesn’t list 0446U: Medicare pays the test only from the CLFS.
0446U on the lab fee schedule since 2024
0446U · CLFS 2026 Q4 (current)
$840.65
Unchanged since Jan 1, 2025
Every change on file
- Jan 1, 2025 · CLFS 2025 Q1MAC-priced → $840.65
11 quarterly CLFS releases on file, first CLFS 2024 Q2. A code missing from a quarter wasn’t on that release.
0446U compared with similar tests
- 0447UCytokine assayEleven plasma biomarkers$840.65
- 0446U is for the 10-cytokine SLE assay; 0447U is for the 11-cytokine assay. Match the code to the test performed.
- 86225DNA antibodyDouble-stranded DNA$13.74
- 0446U evaluates cytokine biomarkers and reports an algorithmic activity score. 86225 measures anti-dsDNA antibodies.
- 86160Complement antigenEach component$12.00
- 0446U evaluates 10 cytokine biomarkers in plasma for an SLE activity score. 86160 is a complement antigen test.
0446U billing questions
How does 0446U differ from 0447U?
0446U is the 10-cytokine plasma assay; 0447U is the 11-cytokine SLE assay. Select the code that matches the assay performed.
What specimen does 0446U use?
The assay uses plasma and measures the cytokine biomarkers by immunoassay.
How are the biomarker results reported?
The assay reports individual component results together with an algorithmic risk score for current SLE disease activity.
How does Medicare pay 0446U?
Medicare pays 0446U under the CLFS at one national amount, with no geographic or office-versus-facility adjustment.
How does 0446U differ from an anti-dsDNA antibody test?
0446U measures cytokine biomarkers and reports an algorithmic activity score. An anti-dsDNA antibody test measures a different analyte.
Where this amount comes from
FeeBase reads lab amounts directly from the CMS Clinical Laboratory Fee Schedule file for the quarter: one row per code, with its payment indicator and national amount. Contractor-priced tests are labeled, never given a made-up amount. Amounts are Medicare payment limits, not a patient’s bill or a commercial rate.
CMS CLFS 2026 Q4 · effective Oct 1, 2026 through the day before Jan 1, 2027
Show the CMS file line behind this amount
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