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  • Michael Messino, MD, Receives Prestigious North Carolina Governor's Award

    On August 4, 2020, Messino Cancer Centers (MCC), a partner practice of American Oncology Network, LLC (AON), announced that medical oncologist and the 2011-2014 member of the North Carolina Oncology Association (NCOA) Board of Directors Michael Messino, MD, received North Carolina’s highest award for state service granted by the Office of the Governor. The Order of the Long Leaf Pine is an honor granted by the State of North Carolina to individuals who have shown extraordinary service to the state. Senator Terry Van Duyn presented the award to Dr. Messino on July 31, 2020.

    Read the press release.

    Posted 8/6/2020



  • 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




  • CMS Releases CY 2021 OPPS and PFS Proposed Rules

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

    Until this analysis is complete, read the proposed OPPS rule and the proposed PFS 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 8/6/2020



  • 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


  • HHS Report Reveals Dramatic Uptick in Telehealth During Pandemic

    The U.S. Department of Health and Human Services (HHS) this week released a report showing that traditional Medicare saw a dramatic increase in telehealth usage due to the COVID-19 pandemic, particularly in larger urban areas. While its use has leveled off, the report finds physicians still expect visits to be held via telehealth post-pandemic.

    The report by the HHS Assistant Secretary for Planning and Evaluation (APSE), which looked at telehealth visits from January through June 2020, found that virtual services made up 43.5 percent of Medicare primary care visits in April, a significant jump from February when telehealth accounted for less than 1 percent of visits. Usage dipped by May as in-person visits resumed but continued to remain significant compared to pre-pandemic.

    The report also finds that providers in both rural and urban counties saw increases in telehealth adoption and utilization; however, providers in rural counties saw a smaller growth in telehealth visits as a proportion of all primary care visits in March and April, with a decrease again in May. 

    A recent survey of practitioners suggests continued interest in telehealth among healthcare providers. In the IQVIA survey of about 300 practitioners (oncologists, specialists, and primary care) between April 17 and 22, 2020, only 9 percent of respondents reported that their patient interaction was via telehealth prior to the pandemic; however, during the pandemic period usage increased to 51 percent, and respondents expected it to remain at 21 percent after the pandemic ends. 

     Read the full HHS report here.

    Source: InsideHealthPolicy

    Posted 7/31/2020


  • Upcoming CMS COVID-19 Stakeholder Calls

    The Centers for Medicare & Medicaid Services (CMS) continues to host regularly scheduled COVID-19 stakeholder engagement calls. These include office hours calls, weekly site-specific calls for COVID-19 care, and lessons from the front lines. Calls are open to members of the healthcare community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.

    CMS COVID-19 Office Hours Call (Tuesdays at 5:00-6:00 pm ET)
    Tuesday, August 4, 2020
    Toll Free Attendee Dial In: 833-614-0820; Access Code: 3296947
    Audio Webcast Link 

    Tuesday, August 11, 2020
    Toll Free Attendee Dial In: 833-614-0820; Access Code: 3498643
    Audio Webcast Link

    Lessons from the Front Lines: COVID-19 (twice a month on Fridays at 12:30 - 2:00 pm ET)
    Friday, August 7, 2020
    Toll Free Attendee Dial In: 833-614-0820; Access Code: 4695240
    Audio Webcast Link

    See the CMS Coronavirus (COVID-19) Partner Toolkit for a full list of sessions and times. Audio webcast links and dial-in information is also available on this page. All previous session recordings and transcripts are posted to the CMS podcast page.

    Posted 7/29/2020



  • CMS Releases Updated Data on COVID-19's Impact on Medicare Population

    On July 28, 2020, the Centers for Medicare & Medicaid Services (CMS) released its first monthly update of data that provides a snapshot of the impact of COVID-19 on the Medicare population. 

    The updated data on COVID-19 cases and hospitalizations of Medicare beneficiaries covers the period from January 1 to June 20, 2020. It is based on Medicare claims and encounter data CMS received by July 17, 2020.

    For the first time, the snapshot includes data for American Indian/Alaskan Native Medicare beneficiaries. The new data indicate that American Indian/Alaskan Native beneficiaries have the second highest rate of hospitalization for COVID-19 among racial/ethnic groups after Blacks.

    The updated data confirm that the COVID-19 public health emergency is disproportionately affecting vulnerable populations, particularly racial and ethnic minorities. This is due, in part, to the higher rates of chronic health conditions in these populations and issues related to the social determinants of health.

    Other key data points:

    • Black beneficiaries continue to be hospitalized at higher rates than other racial and ethnic groups, with 670 hospitalizations per 100,000 beneficiaries.
    • Beneficiaries eligible for both Medicare and Medicaid – who often suffer from multiple chronic conditions and have low incomes – were hospitalized at a rate more than 5 times higher than beneficiaries with Medicare only (719 versus 153 per 100,000).
    • CMS paid $2.8 billion in Medicare fee-for-service claims for COVID-related hospitalizations, or an average of $25,255 per beneficiary.

    Access CMS' Medicare COVID-19 Data Snapshot and additional information here. 

    Posted 7/29/2020




  • FDA Approves CAR-T Cell Therapy Brexucabtagene Autoleucel for R/R MCL

    On July 24, 2020, Kite, a Gilead Company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

    Read FDA announcement.

    Read corporate press release.

    Posted 7/24/2020


  • ASCO & ACCC Join in Effort to Increase Diversity in Cancer Clinical Trials

    The American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC) announced on July 21 a new collaboration to foster participation in cancer treatment trials to more fully reflect the diversity of people at risk for or living with cancer. Read announcement.

    The joint ASCO-ACCC initiative is designed to identify and implement novel strategies and practical solutions to increase clinical trial participation of racial and ethnic minority populations that continue to be under-represented in cancer research when compared with their percentages in the overall population of patients with cancer. 

    ASCO-ACCC Request for Ideas (RFI)

    The ASCO-ACCC Request for Ideas (RFI) seeks novel strategies and practical solutions to increase participation of under-represented racial and ethnic populations in cancer treatment trials. The ASCO-ACCC Steering Group will review and select ideas that may be modified, combined, implemented, and evaluated by ASCO and ACCC. The ideas submitted may be implemented and evaluated through the ASCO Targeted Agent and Profiling Utilization Registry (TAPURTM) Study, for example.

    Criteria used to review and prioritize proposed ideas will include the potential to address racial and ethnic disparities in cancer treatment trials, replicability of the strategy, and indications that the submitter has demonstrated a commitment to equitable cancer care, among others. Individuals who submit ideas will be given an opportunity to work on the idea implementation, if interested.

    The RFI is open for participation now through August 24, 2020. Learn more.

    Posted 7/24/2020



  • HHS Secretary Azar Extends Public Health Emergency

    On Thursday, July 23, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar signed an extension of the COVID-19 public health emergency (PHE) designation for another 90 days. The PHE would have expired on July 25.

    Read Secretary Azar's tweet.

    Posted 7/24/2020



  • HHS Partners with ECHO Institute for Virtual Telemedicine Learning Community

    To support wide adoption of telemedicine, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response is partnering with the ECHO Institute at the University of New Mexico and the Public Health Foundation’s TRAIN Learning Network to deliver a 10-week, virtual peer-to-peer learning community for ambulatory providers called Telemedicine Hack.

    What: HHS Telemedicine Hack is a 10-week virtual, peer-to-peer learning community to accelerate telemedicine implementation for ambulatory providers. Components include: five teleECHO sessions; five virtual “office hour” discussion panels; and inter-session peer-to-peer learning facilitated via virtual discussion boards. CME/CEU credits are available at no cost to participants. 

    When: Telemedicine Hack sessions will take place on Wednesdays, from July 22–September 23, 2020, Noon–1 PM ET

    How to sign up: Click here to register.

    See the HHS Telemedicine Hack Flyer for more information.

    Posted 7/21/20



  • FDA Approves Inqovi Tablets for Adults with Intermediate and High-Risk Myelodysplastic Syndromes

    On July 7, 2020, the U.S. Food and Drug Administration (FDA) and Health Canada have approved decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.; Taiho Oncology, Inc.; and Otsuka Pharmaceutical Co., Ltd.) tablets for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

    Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies. The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral Inqovi® and intravenous decitabine. The safety and efficacy of Inqovi® was also assessed in the clinical studies.

    Read corporate announcement

    Posted 7/17/2020



  • FDA Approves Keytruda for Patients with Unresectable or Metastatic MSI-H or dMMR CRC

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) 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 tumor specimens. An FDA-approved test for the detection of MSI-H or dMMR is not currently available.

    Read prescribing information and medication guide

    Posted 7/17/2020



  • FDA Approves Pembrolizumab for Patients with Recurrent or Metastatic cSCC

    On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co.) injection 100 mg for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. 

    Read FDA announcement and prescribing information

     

    Posted 7/14/2020



  • FDA Approves Phesgo™ Injection for Subcutaneous Use

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo, Genentech) injection, for subcutaneous use.

    Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is indicated for use in combination with chemotherapy for:

      Phesgo™ is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

      Read corporate announcement.

      Billing and coding sheet.

      Prescribing information.

      Posted 7/14/2020