CPT code 0478U: NSCLC gene test, nine-gene DNA/RNA analysis2026 Medicare lab fee · Clinical Laboratory Fee Schedule
Digital PCR analysis of DNA and RNA from non-small cell lung cancer tissue identifies actionable variants that can guide therapy selection.
Medicare pays $552.99 for 0478U 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
$552.99
In effect since Jan 1, 2026. The same amount in every state, payment locality and setting.
- Geographic adjustment
- None
- Office vs facility
- Same
- Since 2026
- 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 0478U covers
0478U represents digital PCR testing of DNA and RNA from formalin-fixed, paraffin-embedded non-small cell lung cancer tissue. The assay evaluates nine genes for single-nucleotide variants, insertions or deletions, and gene rearrangements, then reports actionable detected variants to inform therapy selection. It is used in oncology care when molecular findings are needed to guide treatment planning; a molecular laboratory performs and reports the assay.
Report one unit for the nine-gene assay, rather than a separate unit for each gene. Medicare pays 0478U under the CLFS at one national amount across all states and localities, without an office or facility adjustment. The 2026 national CLFS amount is $552.99. The code has no separately payable physician interpretation component.
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 0478U
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 0478U. 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 0478U: Medicare pays the test only from the CLFS.
0478U on the lab fee schedule since 2024
0478U · CLFS 2026 Q4 (current)
$552.99
Unchanged since Jan 1, 2026
Every change on file
- Jan 1, 2026 · CLFS 2026 Q1MAC-priced → $552.99
9 quarterly CLFS releases on file, first CLFS 2024 Q4. A code missing from a quarter wasn’t on that release.
0478U compared with similar tests
- 0473UTumor sequencingMatched-normal analysis$4,500.00
- 0473U describes a 648-gene solid-tumor assay associated with blood or saliva. 0478U is a nine-gene DNA/RNA digital PCR assay for non-small cell lung cancer tissue.
- 0471UKRAS/NRAS test35 variants in tissue$760.00
- 0471U focuses on KRAS and NRAS variants in colorectal cancer. 0478U evaluates a nine-gene DNA/RNA set to support therapy selection in non-small cell lung cancer.
- 81445Tumor gene panel5–50 genes, DNA or DNA/RNA$597.91
- 81445 is a genomic sequencing panel code for 5–50 genes in solid-organ neoplasms. 0478U identifies a specific nine-gene digital PCR assay for non-small cell lung cancer.
0478U billing questions
What specimen and method does 0478U describe?
It describes digital PCR analysis of DNA and RNA from formalin-fixed, paraffin-embedded non-small cell lung cancer tissue.
Should the code be reported once per gene?
No. Report one unit for the nine-gene assay as a whole, rather than separate units for individual genes.
How does 0478U differ from 0473U?
0478U is a nine-gene DNA/RNA digital PCR assay for non-small cell lung cancer tissue. 0473U describes a 648-gene solid-tumor assay associated with blood or saliva.
Can modifier 26 be used for physician interpretation?
No. Medicare pays 0478U through the CLFS as a laboratory test, with no separately payable physician interpretation component.
How does Medicare price 0478U?
Medicare pays one national CLFS amount across states and localities, without an office or facility adjustment.
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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