CPT code 86305: HE4 assay, ovarian tumor marker2026 Medicare lab fee · Clinical Laboratory Fee Schedule
The HE4 assay measures a tumor-associated protein and is reported when clinicians evaluate malignancy risk in women with an adnexal mass.
Medicare pays $20.81 for 86305 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
$20.81
In effect since Jan 1, 2026. The same amount in every state, payment locality and setting.
- Geographic adjustment
- None
- Office vs facility
- Same
- Since 2020
- 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 86305 covers
This laboratory immunoassay measures human epididymis protein 4 (HE4), a tumor-associated marker used in evaluating women with an adnexal mass or suspected ovarian malignancy. Clinicians may interpret the result with CA125 and menopausal status in a risk assessment such as ROMA. The result supports risk assessment and is not a standalone diagnosis. Clinical laboratories commonly perform the assay on serum specimens.
Report 86305 for the HE4 assay performed; report a separately performed CA125 assay under 86304. The assay is reported by test, not by multiplying units for the measured concentration. Medicare pays 86305 only through the CLFS. The 2026 national CLFS amount is $20.81, unchanged from 2020 through 2026, and applies across localities and office and facility settings. The code has no separate physician-fee-schedule payment.
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 86305
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 86305. 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.
Excluded from the physician fee schedule
The physician fee schedule lists 86305 with status X (excluded by statute), so the test itself is paid only from the CLFS.
86305 on the lab fee schedule since 2020
86305 · CLFS 2026 Q4 (current)
$20.81
Unchanged since Jan 1, 2020
27 quarterly CLFS releases on file, first CLFS 2020 Q1. A code missing from a quarter wasn’t on that release.
86305 compared with similar tests
- 86304CA 125Quantitative tumor antigen$20.81
- 86304 measures CA125; 86305 measures HE4. Both may be ordered for an ovarian malignancy risk assessment, but each assay is reported separately.
- 86316Tumor markerQuantitative, each antigen$20.81
- 86316 is for another tumor-associated antigen measured by immunoassay when a more specific code does not apply. Use 86305 when the assay measures HE4.
86305 billing questions
When should 86305 be used instead of 86304?
Use 86305 for the HE4 assay and 86304 for CA125. They measure different markers and may be ordered together for an ovarian malignancy risk assessment.
Can HE4 and CA125 be reported on the same claim?
Yes, when both assays are performed, report each under its own code. The combined risk assessment does not make the two laboratory tests the same service.
How should units be reported?
Report the HE4 assay performed; do not convert the measured concentration into additional claim units.
Does Medicare pay 86305 under the physician fee schedule?
No. Medicare pays 86305 through the CLFS, with one national amount that applies across localities and office and facility settings.
Is there a separately payable physician interpretation for 86305?
The code is paid only through the CLFS and has no separate physician-fee-schedule payment.
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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