CPT code 0578U: Melanoma profile, 10-gene RNA qPCR2026 Medicare lab fee · Clinical Laboratory Fee Schedule

This 10-gene RNA assay profiles cutaneous melanoma tissue and reports a low- or high-risk result for sentinel lymph node metastasis and recurrence.

CMS CLFS 2026 Q4Effective Oct 1, 2026Same amount nationwide

Medicare pays $3,873.00 for 0578U 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

$3,873.00

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
  1. Medicare lab fee
  2. What 0578U covers
  3. How it’s paid
  4. Amount history
  5. Similar tests
  6. Related codes
  7. Billing questions
  8. Sources

What 0578U covers

0578U identifies a 10-gene RNA expression profile in cutaneous melanoma tissue using real-time quantitative PCR. The assay uses formalin-fixed, paraffin-embedded tissue, and its algorithm classifies the result as low or high risk for sentinel lymph node metastasis and recurrence. The 10 genes include eight content genes and two housekeeping genes. The reported result is a molecular risk assessment for cutaneous melanoma.

Report the code for the 10-gene profile as one assay rather than counting the individual genes as separate tests. Medicare pays 0578U through the CLFS at one nationally set amount that applies across states and localities, with no geographic or office/facility adjustment. The 2026 national CLFS amount is $3,873.00.

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 0578U

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 0578U. 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 0578U: Medicare pays the test only from the CLFS.

0578U on the lab fee schedule since 2025

0578U · CLFS 2026 Q4 (current)

$3,873.00

Unchanged since Jan 1, 2026

Amount in each year’s latest CLFS release · bars start at $0

Every change on file

  1. Jan 1, 2026 · CLFS 2026 Q1MAC-priced → $3,873.00

5 quarterly CLFS releases on file, first CLFS 2025 Q4. A code missing from a quarter wasn’t on that release.

0578U compared with similar tests

81529Melanoma assay31-gene mRNA analysis$7,193.00
81529 represents a different cutaneous melanoma RNA expression assay. Distinguish the codes by the assay performed, not simply by the melanoma diagnosis.

0578U billing questions

What specimen is used for 0578U?

The assay uses formalin-fixed, paraffin-embedded cutaneous melanoma tissue for RNA expression profiling.

What does the assay report?

Its algorithm reports a low- or high-risk result related to sentinel lymph node metastasis and recurrence.

How does 0578U differ from 81529?

0578U is a 10-gene real-time quantitative PCR assay; 81529 is a different cutaneous melanoma RNA expression assay. Select the code for the assay performed, not simply for the melanoma diagnosis.

Should the 10 genes be reported as separate units?

No. 0578U represents the 10-gene profile; the individual genes are not separately reported under this code.

How does Medicare pay 0578U?

Medicare pays 0578U under the CLFS at one nationally set amount across localities and settings, without geographic or office/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
CLFS row for 0578UPUF_CLFS_CY2026_Q4V1.csv, line 520 (CLFS 2026 Q4)

Open CMS sourceHow we source rates

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