CORRECTION: Molecular Assays Stave Off Big Cuts in 2017 Clinical Laboratory Fee Schedule


Editor’s Note: The lead story in the November 25, 2016 issue of LIR is about changes to the 2017 Clinical Laboratory Fee Schedule affecting reimbursement for clinical laboratory tests. The first section of the story discusses new molecular tests added to the CLFS in 2017, specifically the seven tests that were in line for major price cuts. The punchline was that the price cuts CMS proposed were never made. The Problem: Although the analysis was correct, the article listed the wrong pricing information for these and other molecular tests contained in the CLFS. Here is a revised version of the affected parts of the article listing the correct prices, including a chart providing a clearer comparison between the CMS proposed and final National Limitation Rate for each test. G2 apologizes for the error and thanks our loyal and attentive users for bringing it to our attention.

1. Seven Molecular Assays Stave Off Big Cuts
[For many labs, the most significant aspect of the 2017 CLFS is reimbursement for] the 15 CPT codes for molecular tests that CMS added to the CLFS this year. The question: How much should Medicare pay for these esoteric and pricey assays? In June, CMS proposed interim gapfill prices at a discount from their regionalized prices. Led by providers of the assays highlighting the inconsistencies between the proposed gapfill rates and the rates established by the Medicare Administrative Contractors who approved the tests, the industry asked CMS to reconsider the interim rates. "The proposed gapfill rates are inconsistent with rates established by commercial payers and the Protecting Access to Medicare Act of 2014," contended The Coalition for 21st Century Medicine.

CMS apparently took heed, dropping the rate cuts and restored or increasing the regional prices for seven of the tests listed increased by the annual CLFS modifications. Companies benefiting from the change of course included:

  • CareDx, which instead of a 77 percent cut got its rate restored to the original rate on its AlloMap test to identify heart transplant recipients at low risk of rejection (CPT 81595);
  • Biodesix, which got the rate restored for its VeriStrat lung cancer aggressiveness test (81538);
  • Genomic Health, which got the rate restored on its Oncotype DX colon cancer recurrence test (81525);
  • BioTheranostics, which got the rate restored for its metastatic tumor origins diagnostic test (81540);
  • Invitae, which avoided a 33 percent cut on its hereditary breast cancer panel (81432);
  • CardioDx, which instead of a 28 percent cut had its rate almost completely restored on its coronary artery disease risk test Corus CAD (81493); and
  • Veracyte,which instead of a 22 percent cut got its rate restored on its thyroid nodule assessment assay Affirma (81545).

2017 Medicare Rate for New Molecular Diagnostic Tests
(Boldface tests are those for which discounts were proposed but not adopted)

CPT Code Test Proposed National Limitation Rate Final National Limitation Rate
81412 9-Gene Ashkenazi Jewish Screen $602.10 $602.10
81432 Hereditary Breast Cancer Panel, 14 Genes $622.53 $931.48
81433 Hereditary Breast Cancer, Duplications/ Deletions Panel $602.10 $602.10
81434 Hereditary Retinal Disorder Screen $602.10 $602.10
81437 Hereditary Neuroendocrine Tumor $602.10 $602.10
81438 Hereditary Neuroendocrine Tumor, Duplications/ Deletions $602.10 $602.10
81442 Noonan Gene Screen $602.10 $602.10
81490 Vectra Screen $590.61 $590.61
81493 Corus CAD $741.01 $1,042.35
81525 Oncotype DX $848.86 $3,125.73
81538 Veristrat $283.00 $2,126.78
81540 bioTheranostics $1,522.17 $2,920.30
81545 Affirma $2,240.16 $3,222.40
81595 AlloMap $732.00 $2,840.75
0009M VisibiliT $602.10 $602.10

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