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Medicare Issues Draft Local Coverage Determination for Signatera™ in Immunotherapy Response Monitoring. Proposes expanded coverage of the Signatera minimal residual disease (MRD) test in a broad range of solid tumor types and indications including immunotherapy (IO) monitoring. Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the CMS Molecular Diagnostics […]

On September 2, the Centers for Medicare & Medicaid Services (CMS) released updates to the Inpatient Prospective Payment System (IPPS) final rule for fiscal year 2021, including updates to Medicare payment policies and payment rates for most acute care hospitals.CMS finalized its proposal to establish a Medicare Severity Diagnosis Related Group (MSDRG) for chimeric antigen […]

SAN CARLOS, Calif., Sept. 3, 2020 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced that the CMS Molecular Diagnostics Program (MOLDX) has finalized a local coverage determination (LCD) to provide Medicare benefits for serial use of the Signatera molecular residual disease (MRD) test in patients with stage II or III […]

On August 3, the Centers for Medicare and Medicaid Services (CMS) released the CY 2021 Physician Fee Schedule proposed rule.  CMS is not proposing any changes to the values of the outpatient evaluation and management (E/M) services finalized in the CY 2020 rulemaking. If this rule is finalized as proposed, hematology/oncology is projected to see […]

Merck announced that CMS has made a status indicator change regarding ONTRUZANT®(trastuzumab-dttb), for injection, for intravenous use 21 mg/mL, which has a Q-code of Q5112.  As of July 2020, Centers for Medicare & Medicaid Services (CMS) has issued a Corrected Addendum B to update the non-payable status for ONTRUZANT (Q5112) to Status Indicator “K”, which […]

ASTEX PHARMACEUTICALS, TAIHO ONCOLOGY, AND OTSUKA PHARMACEUTICAL ANNOUNCE FDA AND HEALTH CANADA APPROVAL OF INQOVI® (DECITABINE AND CEDAZURIDINE) TABLETS, ORAL HYPOMETHYLATING AGENT (HMA) THERAPY FOR INTERMEDIATE AND HIGH-RISK MDS AND CMML.  Additional information is available at:  https://www.taihooncology.com/us/news/2020-07-inqovi-approval/

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) injection 100 mg has been approved by the FDA for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. • PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients. PD-L1=programmed death ligand […]

Merck has informed OSCO that the Medicare Medically Unlikely Edit (MUE) value has been modified for KEYTRUDA® (pembrolizumab). The MUE for KEYTRUDA was modified effective July 1, 2020. A list of quarterly Procedure-to-Procedure and MUE version update changes from CMS can be found here. Payer coding and coverage requirements may vary or change over time, so it […]

Merck has announced that the FDA has approved KEYTRUDA® (pembrolizumab) for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC). MSI-H/dMMR testing is required prior to initiating treatment with KEYTRUDA in these patients. For the MSI-H/dMMR indication, select patients for treatment with KEYTRUDA as a single agent based on MSI-H/dMMR status in […]

Takeda Oncology has announced that the US Food and Drug Administration (FDA) has approved the label expansion for ALUNBRIG® (brigatinib) to include patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive. ALUNBRIG is indicated for the treatment of adult patients with ALK+ metastatic NSCLC as detected by an […]