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Oncology Newsfeed

  • CMS Extends AUC Program Educational + Operational Testing Period to 2021

    On Monday August 10, 2020, the Centers for Medicare & Medicaid Services updated the Appropriate Use Criteria (AUC) Program website to announce that the Educational and Operations Testing Period, during which there are not payment penalties, has been extended through 2021. You can view this update at the top of the AUC web page in a green boarder.

    CMS does not have further information to share, but as new information becomes available it will be accessible via the outreach and education page of the AUC website.

    Posted 8/19/20



  • NCCN Adds Tafasitamab-cxix to Guidelines for B-Cell Lymphomas

    On August 18, 2020, MorphoSys and Incyte announced that the National Comprehensive Cancer Network (NCCN) has included Monjuvi® (tafasitamab-cxix) in its latest Clinical Practice Guidelines update in oncology for B-cell Lymphomas. Specifically, the NCCN Guidelines in the United States now include Monjuvi in combination with lenalidomide with a Category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant.

    Read the corporate press release.

    The U.S. Food and Drug Administration granted accelerated approved to Monjuvi in combination with lenalidomide in July 2020. Read the FDA approval announcement.

    Posted 8/19/2020


  • CMS Opens CHART Model Webinar Registration

    The Centers for Medicare & Medicaid Services (CMS) will host a webinar on August 18, 2020 to provide an overview of the Community Health Access and Rural Transformation (CHART) Model.

    The CHART Model will test whether upfront investments, predictable capitated payments, and operational and regulatory flexibilities will enable rural health care providers to improve access to high quality care while reducing health care costs.

    During the session, the CHART Model team will present on key aspects of the Model, including its objectives, eligible participants and their roles, payment options, and timeline. The forum will also provide an opportunity for potential applicants to ask the CHART team questions regarding these topics.

    When: Tuesday, August 18, 2020, 1:00 pm to 2:30 pm ET.

    Click here to register.

    To learn more about the model visit the CMS CHART Model web page. Following the event, presentation materials will also be available on its web page.



  • CMS Opens PFS Listening Session Registration

    Registration is now open for the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) listening session. Please note that the PFS proposed rules include expanding telehealth and licensing flexibilities beyond the current public health emergency.

    Physician Fee Schedule Proposed Rule: Understanding 4 Key Topics Listening Session

    Proposed changes to the CY 2021 Physician Fee Schedule are aimed at reducing burden, recognizing clinicians for the time they spend taking care of patients, removing unnecessary measures, and making it easier for clinicians to be on the path towards value-based care. During this listening session, CMS experts briefly cover provisions from the proposed rule and address your clarifying questions to help you formulate your written comments for formal submission: 

    1. Extending telehealth and licensing flexibilities beyond the public health emergency
    2. Updating Evaluation and Management (E/M) coding guidance
    3. Updating the Quality Payment Program/MIPS Value Pathways
    4. Updating opioid use disorder/substance use disorder provisions.

    When: Thursday, August 13, 2020, 1:30-3:00 pm ET.

    Who: Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent health care providers; and other stakeholders.

    Click here to register

    CMS encourages you to review the following materials prior to the call:

    Visit the CMS event page for more information.

    Posted 8/6/2020




  • FDA Approves Belantamab Mafodotin-blmf for R/R Multiple Myeloma

    On August 6, 2020, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.

    Read the corporate press release.

    Read the FDA announcement.

    Posted 8/6/2020


  • CMS Releases CY 2021 OPPS Proposed Rule

    On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment Proposed Rule (CMS-1736-P). ACCC and counsel are reviewing these proposed rules and will be providing comments.

    Until this analysis is complete, read the proposed rule. Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your cancer program.

    Posted 8/4/2020



  • CMS Releases CY 2021 PFS Proposed Rule

    On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Physician Fee Schedule (PFS) Proposed Rule. ACCC and counsel are reviewing these proposed rules and will be providing comments.

    Until this analysis is complete, read the proposed rule. Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your practice.

    Posted 8/4/2020


  • FDA Approves Tafasitamab-cxix + Lenalidomide for R/R DLBCL

    On July 31, 2020 MorphoSys and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

    Read corporate press release.

    Read FDA announcement.

    Posted 8/3/20



  • ASCO Statement on Home Infusions Raises Safety Concerns

    The American Society of Clinical Oncology (ASCO) has released a position statement on Home Infusion of Anticancer Therapy that raises safety and oversight concerns related to home infusion of anticancer therapy and the Centers for Medicare & Medicaid Services (CMS) regulations regarding the practice. 

    In response to the COVID-19 public health emergency, CMS has enabled temporary flexibility related to home infusion for Part B cancer drugs. 

    “We understand that COVID-19 has resulted in treatment challenges in some cases, and that home infusion services have been utilized as an alternative to treatment in outpatient facilities, but it is still unclear if the benefits outweigh the risks of this approach,”ASCO President Lori J. Pierce, MD, FASTRO, FASCO, said in a statement. “During and beyond this pandemic, patient safety must continue to be the first priority, and the decision to administer anticancer therapy in a home setting should be made only if both the treating physician and patient agree it’s in the patient’s best interest.”

    ASCO states that the decision to administer anticancer therapy in a home setting should be made by the treating physician in consultation with the patient, and only after consideration of the availability of necessary precautions to protect medical staff, patients, and caregivers during infusion and disposal. The position statement makes the following six recommendations: 
    • Publicly funded independent research should be conducted to evaluate the safety and effectiveness of home infusion of anticancer therapy. 
    • CMS should not extend the temporary flexibility related to home infusion for Part B cancer drugs that was approved as part of the agency's response to the public health emergency. 
    • CMS should consult closely with oncology experts prior to implementation of its home infusion benefit in 2021, to ensure that it is only used when the treating physician and patient determine that home infusion is the most appropriate setting based on the patient’s need and treatment plan. Quality reporting for home infusion therapy services should require collection of oncology-specific measures to enable the evaluation of safety in anticancer therapy administration. 
    • With anticancer therapy, home infusion benefit policies from public and commercial insurance providers should be strictly limited to exceptional circumstances where the benefits of home infusion outweigh the potential risks to patients. 
    • Any insurance provider designing a system to deliver pre-prepared antineoplastic drugs to clinical staff should consult with treating oncologists prior to implementation. 
    • Home infusion benefit policies from public and commercial insurance providers should require verification that necessary safety protocols and precautions are in place to protect health care personnel, patients, and caregivers.
    Read ASCO's news release and position statement.

    Posted 7/31/2020


  • FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib in BRAF+ Advanced Melanoma

    On July 31, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.

    Read corporate press release.

    Read FDA announcement.

    Posted 7/31/2020