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Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Analysis: Coding and Claim Submission Guidelines

Genetic testing for cystic fibrosis (CF) transmembrane conductance regulator (CFTR) is typically performed to screen adults with a positive family history of CF. Effective for dates of service on and after January 1, 2013, CGS has determined that CFTR gene testing to identify parents at risk is not a Medicare benefit and is considered a statutorily excluded test. In addition to single disease testing, CGS will also deny panels of tests that include the CFTR gene test for CF as statutorily excluded tests.

The following tests have been identified as non-covered:

Test CPT Code
CF DNA ANALYSIS - FETUS 81220
CYSTIC FIBROSIS MUTATION PANEL 81220
Cystic Fibrosis Cis-Trans (CFTR) R117H & 5T Mutations 81220
Cystic Fibrosis (CFTR) 32 Mutations 81220
Cystic Fibrosis (CFTR) 32 Mutations, Atypical 81220
Cystic Fibrosis (CFTR) 32 Mutations, Fetal 81220
Cystic Fibrosis (CFTR) 5T Mutation 81220
Cystic Fibrosis Profile 81220
CYSTIC FIBROSIS MUTATION PANEL 81220
Cystic Fibrosis Mutation Screen 81220
CYSTIC FIBROSIS 23 MUTATION ANALYSIS 81220
Cystic Fibrosis 32 Mutation Study, Non-Blood 81220
Cystic Fibrosis (CFTR) 32 Mutations 81220
Cystic Fibrosis (CFTR) 5T Mutation 81479
Molecular Cystic Fibrosis Mutation Screen 81220
CYSTIC FIBROSIS CARRIER SCREENING 81220
Cystic Fibrosis Targeted Mutation Panel 81220
Cystic Fibrosis Genotype 23 MUTATIONS 81220
CYSTIC FIBROSIS DNA 81220
C. FIBROSIS RARE MUTATION 81221
CYSTIC FIBROSIS 2 EXON 81221
CYSTIC FIBROSIS D1152H 81221
Cystic Fibrosis Known Familial Mutation One exon 81221
CFTR Gene, Known Mutation 81221
Cystic Fibrosis Diagnostic Sequencing Assay (One Exon) 81221
Cystic Fibrosis Diagnostic Sequencing Assay (Two Exons) 81221
Cystic Fibrosis (CFTR) 3199del6 Mutation 81222
CYSTIC FIBROSIS CFTR GENE 81222
Cystic Fibrosis (CFTR) Deletion/Duplication 81222
CFTR Gene, Known Mutation 81222
CFTR Gene, Full Gene Analysis 81222
CFTR Deletion/Duplication Analysis by MLPA, blood 81222
CYSTIC FIBROSIS RARE MUT 81223
Cystic Fibrosis Full Gene Sequencing 81223
Cystic Fibrosis (CFTR) Sequencing 81223
CFTR Gene, Full Gene Analysis 81223
Cystic Fibrosis Diagnostic Sequencing Assay 81223
Cystic Fibrosis Diagnostic Sequencing Assay (Two Exons) 81223
Cystic Fibrosis CFTR Full Gene Sequencing 81223
Cystic Fibrosis (CFTR) 5T Mutation 81224
CFTR INTRON 8 POLY-T ANALYSIS 81224
CF Poly-T Analysis 81224

Health care providers are not required to submit claims to Medicare for statutorily non-covered services; however, you may choose to submit claims (e.g., at the patient's request). Claims for CFTR must include:

  • Appropriate CPT code for the test (see above table)
  • HCPCS modifier GY (statutorily non-covered service)
  • The appropriate ICD-9-CM code(s)
  • The name of the test:
    • Electronic claims: Loop 2400, NTE02, or SV101-7 field
    • Paper claims: Block 19

Reference:

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