CPT code 0335U: Fetal genome test, rare disease analysis2026 Medicare lab fee · Clinical Laboratory Fee Schedule
Whole-genome analysis of a fetal sample detects abnormalities and identifies and categorizes genetic variants for rare constitutional or heritable disorders.
Medicare pays $5,224.60 for 0335U 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
$5,224.60
In effect since Jan 1, 2026. The same amount in every state, payment locality and setting.
- Geographic adjustment
- None
- Office vs facility
- Same
- Since 2023
- 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 0335U covers
0335U reports whole-genome sequence analysis of a fetal sample to detect abnormalities and identify and categorize genetic variants. The analysis can assess small sequence changes, copy-number variants, deletions, duplications, mobile-element insertions, uniparental disomy, inversions, aneuploidy, mitochondrial sequence findings including heteroplasmy and large deletions, and short tandem repeat expansions. The fetal sample distinguishes this service from the related blood-or-saliva whole-genome analysis in code 0336U.
Report 0335U for the fetal-sample analysis rather than 0336U for blood or saliva. Medicare pays 0335U through the CLFS at one national amount across states and localities, without geographic or office-versus-facility adjustment. The 2026 national CLFS amount is $5,224.60, unchanged from 2023 through 2025. The code is paid only through the CLFS; no separate physician fee schedule payment is listed.
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 0335U
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 0335U. 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 0335U: Medicare pays the test only from the CLFS.
0335U on the lab fee schedule since 2022
0335U · CLFS 2026 Q4 (current)
$5,224.60
Unchanged since Jan 1, 2023
Every change on file
- Jan 1, 2023 · CLFS 2023 Q1MAC-priced → $5,224.60
17 quarterly CLFS releases on file, first CLFS 2022 Q4. A code missing from a quarter wasn’t on that release.
0335U compared with similar tests
- 0336UParent genomeComparator genome$2,574.65
- Both are whole-genome analyses for rare disease evaluation. Choose 0335U for a fetal sample and 0336U for blood or saliva.
- 81425Genome sequencingConstitutional or heritable disorders$5,031.20
- 81425 is genome sequence analysis for constitutional or heritable disorders; 0335U identifies the fetal-sample analysis.
- 81415Exome analysisInitial sequence analysis$4,780.00
- 81415 is exome sequencing, while 0335U is whole-genome analysis of a fetal sample.
0335U billing questions
When should 0335U be chosen over 0336U?
0335U is for whole-genome analysis of a fetal sample. 0336U is the related whole-genome analysis for blood or saliva.
How does 0335U differ from 81425?
Both involve genome sequencing for constitutional or heritable disorders. 0335U identifies the fetal-sample analysis; select the code that describes the service performed.
What specimen should be documented?
Document that the analysis was performed on a fetal sample. The related 0336U analysis is for blood or saliva.
Is a separate physician interpretation payment listed for 0335U?
No separate physician fee schedule payment is listed; 0335U is paid through the CLFS.
Which payment schedule applies to 0335U?
Medicare pays 0335U through the CLFS, using one national amount across states and localities without an office or facility difference.
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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