Industry News Archive

  • FDA Restricts Use of Keytruda and Tecentriq for Urothelial Cancer

    On June 20, 2018, the FDA announced that it was restricting the use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

    This restriction results from decreased survival associated with the use of Keytruda or Tecentriq as monotherapy compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

    Read the full FDA announcement here.

    Posted 6/21/2018

  • Pfizer’s Biosimilar Retacrit® Receives Q-Codes

    On May 15, 2018 the U.S. Food and Drug Administration approved Retacrit (epoetin alfa-epbx), a biosimilar to Epogen®/Procrit® (epoetin alfa). Retacrit is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) in the United States and is approved for the same indications as Epogen/Procrit.

    CMS has granted two Q-codes for Retacrit effective July 1, 2018:

    Q5105: Injection, epoetin alfa, biosimilar, (Retacrit) (for esrd on dialysis), 100 units

    Q5106: Injection, epoetin alfa, biosimilar, (Retacrit) (for non-esrd use), 1000 units

    View Codes on CMS Website

  • FDA Approves Pembrolizumab for Treatment of PMBCL

    On June 13, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy.

    Read the FDA press release here.

    Posted 6/19/2018

  • FDA Approves Pembrolizumab for Advanced Cervical Cancer

    On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.

    Read the full FDA press release here.

    Posted 6/13/2018

  • FDA Approves Venetoclax for CLL, Small Lymphocytic Lymphoma

    On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.

    Read the full FDA announcement here.

    Posted 6/11/2018

  • Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

    Read Press Release

  • CMS Begins Mailing Out New Medicare Cards

    The Centers for Medicare & Medicaid Services (CMS) has begun mailing its newly-designed Medicare cards with new Medicare Beneficiary Identifiers to newly eligible and current Medicare beneficiaries. Cards will be sent out on a rolling basis throughout 2018 to fulfill the CMS requirement to remove Social Security Numbers from all Medicare cards by April 2019.

    CMS will host a special Open Door Forum on April 5, 12:30 – 1:30 PM EST, to share updates about the new Medicare card mailing, information on how people with Medicare can look up their new Medicare card number or print a replacement card, and updates on resources for partners. To participate, visit and use the following information:

    • Dial-In Number: 1-800-837-1935
    • Conference ID #: 7065199

    Check often for the most up-to-date information.

    Posted 4/4/2018

  • Trump Administration Announces MyHealthEData Initiative

    Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma has announced the administration's new MyHealthEData, an initiative that aims to give Americans more complete access to their healthcare data. She made the announcement in an address on March 6, 2018, at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas. The government-wide initiative is being led by the White House Office of American Innovation with participation from the Department of Health and Human Services, including CMS; Office of the National Coordinator for Health Information Technology (ONC); the National Institutes of Health; and the Department of Veterans Affairs. 

    As part of MyHealthEData announcement, CMS also announced that the agency intends to "overhaul" the EHR Incentive Programs to "refocus the programs on interoperability and to reduce the time and cost required" for providers to meet requirements. 

    In her remarks, Administrator Verma also described Medicare's Blue Button 2.0 - a tool that would allow Medicare beneficiaries to access and their personal health data in a "universal digital format."  

    As part of this initiative, the administration is also calling on healthcare insurers to follow suit and give patients access to their claims data in a digital format. 

    The administration is still developing a timeline for the initiative, Verma said in an interview with Bloomberg BNA

    Read the CMS press release.
    Read the CMS fact sheet

    Posted 3/7/18

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