The spreadsheet is here. Gapfill prices shown below can be appealed in writing for 30 days (here), until about October 24.
| HCPCS | National Limit | |
| 81161 | $ 140.00 | DMD (dystrophin) (eg, Duchenne/Becker muscular dystrophy) deletion analysis, and duplication analysis, if performed |
| 81246 | $ 82.96 | (FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia), gene analysis; tyrosine kinase domain (TKD) variants (eg, D835, I836)). |
| 81287 | $ 83.01 | MGMT (O-6-methylguanine-DNA methyltransferase) (eg, glioblastoma multiforme), methylation analysis |
| 81288 | $ 159.48 | (MLH1 (mutL homolog 1, colon cancer, nonpolyposis type 2) (eg, hereditary non-polyposis colorectal cancer, Lynch syndrome) gene analysis; promoter methylation analysis). |
| 81313 | $ 260.00 | (PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)). |
| 81435 | $ 795.95 | Hered. colon Ca panel, seq |
| 81436 | $ 795.95 | Hered. colon Ca, dup/del |
| 81445 | $ 597.31 | Targ seq, solid organ, DNA only 5-50 |
| 81450 | $ 647.75 | Targ seq immuno-hemat, DNA/RNA 5-50 |
| 81519 | $ 2,900.00 | (Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score). |
| 0008M | $ 3,416.00 | (Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score). |
(Re 81519, see my comment further below.)
CMS notes the following codes were open for gapfilling, but will not be priced by CMS in CY2016:
81410 |
| 81411 |
| 81415 |
| 81416 |
| 81417 |
| 81420 |
| 81425 |
| 81426 |
| 81427 |
| 81430 |
| 81431 |
| 81440 |
| 81455 |
| 81460 |
| 81465 |
| 81470 |
| 81471 |
| 0006M |
| 0007M |
Comment on 81519
Looking at CMS's Excel spreadsheet, Oncotype DX Breast was priced by 6 MACs: CGS (KY OH) $3416, First Coast (FL PR) $3416, WPS (Indiana, Michigan) $3416, and Palmetto (NC SC VA WV) $3416. Two other MACs priced it lower: Cahaba (AL GA TN) $2900, and NGS (NY zones 1-3, CT, ME, MA, NH, RI, VT), $2062. So at first glance the median price of the 6 MACs is $3416.
However, CMS appeared to calculate the median based on each single zone of the Clinical Lab Fee Schedule, which is usually a state but sometimes more granular (NY has 3 CLFS zones.) Calculating the median based on each zone, we get $2900 as the median of 21 zones reporting. (See figure below).
To my ear, the correct median calculation would be by MAC, or carrier, not by local CLFS zones, or states. The relevant law at 42 CFR 414.508(b)(2) states: "In the second year, the test code is paid at the national limitation amount, which is the median of the carrier-specific amounts." Of the six "carriers" reporting, the median is $3416.
Notably, several large MACs like Novitas and Noridian did not weigh in on the Oncotype DX price, and NGS provided pricing from its Northeastern MAC (oddly omitting Connecticut) and not from its Midwestern one.
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