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Oncology Newsfeed

  • Senate Confirms Dr. Stephen Hahn as U.S. FDA Commissioner

    On Dec. 12, 2019, the U.S. Senate voted to confirm radiation oncology Stephen Hahn, MD, FASTRO, as the next Commissioner of the U.S. Food and Drug Administration (FDA).

    Posted 12/12/2019  



  • Inside Health Policy Reports: CMS to Repay Hospitals for 2019 Site-Neutral Pay Cut

    On Dec. 11, 2019, Inside Health Policy reported that the Centers for Medicare & Medicaid Services (CMS) "plans to repay hospitals that sued over 2019 pay cuts from the agency’s so-called site-neutral policy. The agency has also updated the 2019 pay rates for clinic visits at certain off-campus hospital facilities to remove the cut in light of a federal court decision that said the agency didn’t have the authority to implement it."

    In September 2019, a Federal Washington, D.C., District Court judge found that CMS exceeded its authority in introducing these cuts in the 2019 Hospital Outpatient Prospective Payment System (HOPPS) rule. Several stakeholder organizations filed suit against CMS in response to the final 2019 (HOPPS) rule's provision that established a new reimbursement rate for off-campus hospital outpatient department clinic visits that aligned the payment rate with that under Medicare's Physician Fee Schedule. The 2019 HOPPS rule extended these payment cuts to providers that were specifically exempted from these site-neutrality reimbursement reductions by the Bipartisan Budget Act of 2015.

    Inside Health Policy reports that the "American Hospital Association, Association of American Medical Colleges and others that sued CMS over the cuts say in a Dec. 9 court notice that some hospitals 'recently received payments for claims processed over the past few weeks at the pre-2019 OPPS Rule payment rates for challenged services.' "

    Inside Health Policy further reports that: "the [court] notice says that hospitals haven’t been reimbursed for claims from previous months in 2019 and the government has not 'receded from its stated intention to continue to implement in 2020 the same plan this court already vacated.' "

    CMS told Inside Health Policy that it began paying hospitals the higher reimbursement rate as of Nov. 4, and that Medicare Administrative Contractors will reprocess claims previously subject to the cut during the first few months of 2019.

    ACCC's policy team will provide more information when it becomes available.

    Posted 12/12/2019






  • ASTRO Issues New Clinical Guideline for Radiation Therapy for BCC and cSCC

    On Dec. 10, 2019, the American Society for Radiation Oncology (ASTRO) issued a new clinical guideline on the use of radiation therapy to treat patients diagnosed with basal cell and cutaneous squamous cell carcinomas (BCC, cSCC). The guideline suggests dosing and fractionation for these treatments.

    An executive summary and full-text version of ASTRO's first guideline for skin cancer are published online in Practical Radiation Oncology.

    Read ASTRO press release.

    Posted 12/10/2019


  • NCCN Updates Genetic Testing Guidelines for Assessing Breast, Ovarian, and Pancreatic Cancer Risk

    On Dec. 4, 2019, the National Comprehensive Cancer Network (NCCN) announced publication of updated genetic risk assessment recommendations for breast, ovarian and pancreatic cancers. Updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic Version 1.2020 include new and expanded sections on risk assessment and management related to these cancer types, but retains a conservative approach toward testing practices where evidence is still lacking. 

    Read NCCN press release.

    Posted 12/6/2019


  • FDA Approves Atezolizumab + Chemotherapy for Metastatic Non-Squamous NSCLC

    On Dec. 3, 2019, the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

    Read the corporate announcement.

    Read FDA announcement.

    Posted 12/04/2019; updated 12/06/2019


  • ACCC Dec. 5 Webinar on CY2020 Medicare Final Payment Rules

    On Thursday, Dec. 5 the Association of Community Cancer Centers (ACCC) will host a members-only webinar on the Centers for Medicare & Medicaid Services (CMS) CY2020 Hospital Outpatient Prospective Payment System (OPPS) and Medicare Physician Fee Schedule (MPFS) final rules.

    ACCC's summaries of the CY 2020 OPPS final rule  MPFS final rule are available here [login required].

    Webinar 
    CMS CY2020 OPPS & PFS Final Rules: What You Need to Know
    Thursday, December 5, 2019
    2:00 – 3:00 PM EST

    REGISTER HERE. [Login required]

    Posted 11/27/2019



  • FDA Approves Reblozyl for Anemia in Adults with Beta Thalassemia

    On Nov. 8, 2019, the U.S. Food and Drug Administration (FDA) granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

    REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

    Beta thalassemia, also called “Cooley’s anemia,” is an inherited blood disorder that reduces the production of hemoglobin, an iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body and anemia, which can cause pale skin, weakness, fatigue and more serious complications. Supportive treatment for people with beta thalassemia often consists of lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. People with beta thalassemia are also at an increased risk of developing abnormal blood clots.

    Read the FDA announcement.

    Posted 11/25/2019



  • FDA Approves New Treatment Option for CLL Under International Collaboration

    Nov. 21, 2019, the U.S. Food and Drug Administration (FDA) -  as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada - granted supplemental approval to acalabrutinib (Calquence ) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.

    Read FDA announcement.

    Read AstraZeneca corporate press release.

    Posted 11/21/2019
    Re-posted 11/26/2019


  • CMS Plans Dec. 3 Call on Hospital Price Transparency Final Rule

    The Centers for Medicare & Medicaid Services (CMS) Medicare Learning Network is holding a call on the final Hospital Price Transparency Final Rule on Dec. 3, from 1:30 - 3:30 PM EST.

    Register here.

    During this call, learn about provisions in the final rule effective Jan.1, 2021, including:

    • Requirements for making public all standard charges for all items and services in a machine-readable format
    • Requirements for displaying shoppable services in a consumer-friendly manner
    • Monitoring and enforcement

    A question and answer session follows the presentation. CMS encourages participants  to review the fact sheet and final rule prior to the call.

    Posted: 11/21/2019



  • CMS Issues Rules on Price Transparency for Hospitals and Health Insurance Issuers

    On Nov. 15, the Centers for Medicare & Medicaid Services (CMS) issued two rules that aim to increase price transparency and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The agency finalized the calendar year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Charges Public rule, and issued the Transparency in Coverage Proposed Rule. Both rules (final and proposed) require that pricing information be made publicly available.

    The final "Price Transparency Requirements for Hospitals to Make Standard Charges Public" rule will require hospitals to make their standard charges public in two ways starting in January 1, 2021:

    • Comprehensive Machine-Readable File: Hospitals will be required to make public all hospital standard charges (including the gross charges, payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient, and the minimum and maximum negotiated charges) for all items and services on the Internet in a single data file that can be read by other computer systems. The file must include additional information such as common billing or accounting codes used by the hospital (such as Healthcare Common Procedure Coding System (HCPCS) codes) and a description of the item or service to provide common elements for consumers to compare standard charges from hospital to hospital.
    • Display of Shoppable Services in a Consumer-Friendly Manner: Hospitals will be required to make public payer-specific negotiated charges, the amount the hospital is willing to accept in cash from a patient for an item or service, and the minimum and maximum negotiated charges for 300 common "shoppable services" in a consumer-friendly way and update the information at least annually.

    CMS fact sheet on final rule.
    Access final rule.

    CMS states that the proposed "Transparency in Coverage" rule is issued in response to an Executive Order dated June 24, 2019. The Department of Health and Human Services, the Department of Labor, and the Department of the Treasury are collectively issuing the proposed rule. As written, the rule would require that most employer-based group health plan and health insurance issuers provide up-front disclosure of price and cost-sharing information to participants, beneficiaries, and enrollees. 

    If finalized, the "Transparency in Coverage" proposed rule would require health plans to:

    • Provide consumers with real-time, personalized access to cost-sharing information, including an estimate of their cost-sharing liability for all covered healthcare items and services, through an online tool that most group health plans and health insurance issuers would be required to make available to all of their members, and in paper form, at the consumer’s request. This would allow consumers to shop and compare costs between specific providers before receiving care.

    Disclose on a public website their negotiated rates for in-network providers and allowed amounts paid for out-of-network providers. Making this information available to the public is intended to drive innovation, support informed, price-conscious decision-making, and promote competition in the healthcare industry.  

    Access a CMS fact sheet on the proposed rule.
    Access the proposed rule.

    More details are available in the HHS press release.

    Posted 11/15/2019