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Industry News Archive

  • FDA Approves Olaparib for Ovarian, Fallopian, Peritoneal Cancers

    On December 19, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.

    Read the FDA press release here
    .

    Posted 12/19/2018



  • FDA Approves Pembrolizumab for Merkel Cell Carcinoma

    On December 19, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

    Read the FDA press release here.

    Posted 12/19/2018



  • CMS Assigns Unique HCPCS Code for Imfinzi

    Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System and Quality Reporting Program:

    • J9173: Injection, durvalumab, 10 mg (APC 9492, SI G, Payment Rate $73.971*)
    * The payment rate is the average sales price (ASP) per 10mg of Imfinzi as documented by the CMS Hospital Outpatient PPS Addendum A. Effective from January 1, 2019 through March 31, 2019.

    Each provider is responsible for ensuring all coding is accurate and documented in the medical record based on the condition of the patient. The use of this information does not guarantee reimbursement.  Healthcare providers are encouraged to contact payers to confirm code adoption and approved usage prior to submitting claims.

    Posted 12/19/2018



  • CMS Assigns New J-Codes for Rituxan and Rituxan Hycela

    Effective January 1, 2019, the Centers for Medicare & Medicaid Services (CMS) has assigned new J-codes for Rituxan and Rituxan Hycela (Genentech, Inc.):
    • J9312: Injection, rituximab, 10 mg (replaces J-code J9310)
    • J9311: Injection, rituximab 10 mg and hyaluronidase
    These codes are not all-inclusive; appropriate codes can vary by patient, setting of care and payer. Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements.

    Read more about the new J-codes for Rituxan and Rituxan Hycela here.

    Posted 12/7/2018


  • FDA Approves Atezolizumab for Metastatic NSq NSCLC

    On December 6, 2018, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations.

    Read FDA announcement.

    Posted 12/7/2018


  • FDA Approves Larotrectinib for Solid Tumors with NTRK Gene Fusion

    On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment.

    Read the full FDA press release here.

    Posted 11/27/2018


  • FDA Approves Venetoclax for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/18



  • FDA Approves Glasdegib for Acute Myeloid Leukemia

    On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.

    Read the full FDA press release here.

    Posted 11/26/2018


  • Imfinzi Assigned Unique HCPCS Code for Reimbursement by CMS

    Effective for dates of services on or after January 1, 2019, the following code can be used to identify Imfinzi (durvalumab, AstraZeneca) when billing across settings of care as noted in the Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs:

    • J9173: Injection, durvalumab, 10 m
    Read the full CY 2019 OPPS Final Rule here.

    Posted 11/20/2018


  • FDA Approves Pembrolizumab for Hepatocellular Carcinoma

    On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

    Read the Merck press release here.

    Posted 11/12/2018



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