CPT code 0661U: HPV 16 cfDNA, whole blood, quantitative ddPCR2026 Medicare lab fee · Clinical Laboratory Fee Schedule
Quantitative digital droplet PCR measures HPV genotype 16 cell-free DNA in whole blood; report 0661U when this proprietary laboratory assay is performed.
Medicare has no national amount for 0661U: it’s on the 2026 Clinical Laboratory Fee Schedule as contractor-priced, so each Medicare Administrative Contractor sets the payment.
Medicare lab fee · CLFS 2026 Q4
Contractor-priced (CLFS indicator L)
Set by your MAC
CMS lists 0661U on the Clinical Laboratory Fee Schedule without a national amount: each Medicare Administrative Contractor prices it for its jurisdiction.
- National amount
- None
- Priced by
- Each MAC
- Fee schedule
- Clinical lab
- CMS updates
- Quarterly
The contractor that processes the claim sets the amount for its jurisdiction. Patients usually owe no Part B deductible or coinsurance for covered clinical lab tests.
On this page 7 sections
What 0661U covers
0661U identifies a proprietary laboratory analysis that quantitatively measures cell-free DNA for HPV genotype 16 in whole blood using digital droplet PCR. The reported analyte is HPV 16 cfDNA, rather than an HPV result for an unspecified group of types. This is a molecular laboratory assay tied to a defined target, specimen, and analytical method. The specified specimen and HPV genotype are central to selecting this assay code.
Medicare added 0661U to the CLFS effective October 1, 2026. It is paid only under the CLFS and is locally priced, with each Medicare Administrative Contractor setting payment. The physician fee schedule has no payment row for 0661U.
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 0661U
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.
Priced by each contractor
0661U carries CLFS indicator L: CMS publishes no national amount, and each Medicare Administrative Contractor sets the payment for its jurisdiction. Ask your MAC for its current amount.
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 0661U: Medicare pays the test only from the CLFS.
0661U compared with similar tests
- 0660UHPV cfDNAGenotypes 18, 31, 33, 35No national amount
- Choose 0661U for HPV 16 cfDNA. 0660U addresses cfDNA testing for genotypes 18, 31, 33, and 35.
- 87625HPV genotypingTypes 16 and 18$40.55
- 87625 tests for HPV genotypes 16 and 18; 0661U specifically measures HPV 16 cfDNA in whole blood using digital droplet PCR.
- 87624High-risk HPVPooled result$35.09
- 87624 is a high-risk HPV test. 0661U measures HPV genotype 16 cfDNA in whole blood using digital droplet PCR.
0661U billing questions
How does 0661U differ from 0660U?
0661U measures HPV genotype 16 cfDNA. 0660U covers cfDNA testing for genotypes 18, 31, 33, and 35.
What specimen and method does 0661U identify?
It identifies quantitative HPV genotype 16 cfDNA testing in whole blood using digital droplet PCR.
How does Medicare pay for 0661U?
The code is paid under the CLFS and is locally priced, with each Medicare Administrative Contractor setting payment.
When did 0661U become effective on the CLFS?
The code was added to the CLFS effective October 1, 2026.
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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