Only Four of the new Genomic Sequencing Procedure (GSPs) were priced in the latest gapfilling proposal by CMS and only in limited jurisdictions.

81435          Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis polyposis); genomic sequence analysis panel, must include analysis of at least 7 genes, including APC, CHEK2, MLH1, MSH2, MSH6, MUTYH, and PMS2  $795.95

81436          Hereditary colon cancer syndromes (eg, Lynch syndrome, familial adenomatosis polyposis); duplication/deletion gene analysis panel, must include analysis of at least 8 genes, including APC, MLH1, MSH2, MSH6, PMS2, EPCAM, CHEK2, and MUTYH  $795.95

81445          Targeted genomic sequence analysis panel, solid organ neoplasm, DNA analysis, 5-50 genes (eg, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, NRAS, MET, PDGFRA, PDGFRB, PGR, PIK3CA, PTEN, RET), interrogation for sequence variants and copy number variants or rearrangements, if performed  $90 (AL/GA/TN)

81450          Targeted genomic sequence analysis panel, hematolymphoid neoplasm or disorder, DNA and RNA analysis when performed, 5-50 genes (eg, BRAF, CEBPA, DNMT3A, EZH2, FLT3, IDH1, IDH2, JAK2, KRAS, KIT, MLL, NRAS, NPM1, NOTCH1), interrogation for sequence variants, and copy number variants or rearrangements, or isoform expression or mRNA expression levels, if performed. $90  (AL/GA/TN)

 

The file located on this public website (click to view)  includes mostly the GSP test codes and interim prices, by locality, for clinical diagnostic laboratory tests that CMS determined should be priced by Medicare Administrative Contractors (MACs) for 2015 using the gapfilling methodology.  The criteria and process for gapfilling are specified in 42 CFR 414.508(b).  A reconsideration process for tests that are gapfilled is specified in § 414.509.  The final pricing file will be posted on the CLFS web site around September 2015 and will also include the national limitation amount and midpoint for each test.

The public is invited to submit comments on the preliminary pricing decisions.  Please submit any comments to glenn.mcguirk@cms.hhs.gov by July 20, 2015.