Public Comments
September 3rd, 2024: Blood-based Tests for Multiple Cancer Screening
December 20th, 2023: Docket No. FDA-2023-N-4720 Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee
December 4th, 2023: Docket No. FDA-2023-N-2177 Medical Devices; Laboratory Developed Tests
October 27th, 2023: 2024 CLFS Preliminary Determinations
September 8th, 2023: Genetic Testing for Oncology: DL39367 (First Coast) and DL39365 (Novitas)
October 24, 2022: 2023 CLFS Preliminary Determinations
September 1, 2022: Calendar Year (CY) 2023 Medicare Physician Fee Schedule Proposed Rule
July 22, 2022: Genetic Testing for Oncology – DL39367 (First Coast) and DL39365 (Novitas) Submitted electronically
November 11 2021: Public Comments for Proposed Local Coverage Determination, “Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (DL37810)” and Draft Article “Billing and Coding: Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (DA56867)”
Oct. 14, 2021: Proposed Rule to Repeal the Medicare Coverage of Innovative Technology (MCIT) implementation (CMS–3372–P2)
July 15, 2021: G0327 Colorectal cancer screening; blood-based biomarker
Apr. 16, 2021: Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘‘Reasonable and Necessary’’; Delay of Effective Date; Public Comment Period (CMS–3372–IFC)
Nov. 2, 2020: Medicare Coverage of Innovative Technology & Definition of “Reasonable & Necessary”
Nov. 20, 2019: Proposed Local Coverage Determination (LCD) - MolDX: Signatera™ and MinimalResidual Disease Testing for Colorectal Cancer (DL38290)
June 19, 2019: MolDX Local Coverage Determination (DL38043)
Sept. 10, 2017: CMS-1678-P — Hospital Outpatient Prospective Payment System, Proposed Rule – Potential Revisions to the Laboratory Date of Service Policy