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  • FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

    On March 27, 2020, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

    Read FDA announcement.

    Posted 3/30/2020


  • CMS Expands Accelerated & Advance Payment Program for Medicare Providers & Suppliers

    On March 28, the Centers for Medicare & Medicaid Services (CMS) announced it is expanding the Accelerated and Advance Payment Program for all Medicare providers throughout the country during the COVID-19 public health emergency. The payments can be requested by hospitals, doctors, durable medical equipment suppliers, and other Medicare Part A and Part B providers and suppliers.

    To qualify for accelerated or advance payments, the provider or supplier must:

    • Have billed Medicare for claims within 180 days immediately prior to the date of signature on the provider’s/ supplier’s request form,
    • Not be in bankruptcy,
    • Not be under active medical review or program integrity investigation, and
    • Not have any outstanding delinquent Medicare overpayments.

    Medicare will start accepting and processing the Accelerated/Advance Payment Requests immediately. CMS anticipates that the payments will be issued within seven days of the provider’s request. Access CMS fact sheet for more information.

    Posted 3/29/2020



  • President Trump Signs CARES Act

    On March 27, President Trump signed the $2 trillion coronavirus emergency aid bill, known as the CARES Act, into law.

    The legislation includes relief for state and local governments, businesses (large and small), hospitals, and individuals affected by the coronavirus emergency. This is the third coronavirus aid package from Congress this month.

    Posted 3/27/2020


  • ASCO Announces Virtual Annual Meeting

    The American Society of Clinical Oncology (ASCO) announced on March 24 that it will not be holding its 2020 Annual Meeting in person due to COVID-19. The scientific program will now be presented in a virtual format during the scheduled Annual Meeting timeframe. Please find more details from ASCO statement here.

    Posted 3/24/2020


  • FDA OCE Message to Oncology Providers & Patients on COVID-19

    The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued a message on March 23 that outlines how critical issues for patients with cancer and their healthcare providers are continuing to be addressed despite the national COVID-19 health emergency. The message highlights the following as among the OCE's current priorities:
    • Continuing to expedite oncology product development.
    •  Recognition that modifications may be required in clinical trials.
    •  Continuing Expanded Access requests for investigational products. Project Facilitate remains open at (240)402-0004 or ONCProjectFacilitate@fda.hhs.gov
      from 8:00 AM to 4:30 PM ET, M-F.
    • Working to anticipate and prevent drug shortages.
    • Keeping the cancer community informed.

      Posted 3/24/2020


  • CMS FAQs on Medicare Provider Enrollment Relief in Response to COVID-19

    In response to the COVID-19 national emergency, the Centers for Medicare & Medicaid Services (CMS) is using its authority under Section 1135 of the Social Security Act to offer flexibilities with Medicare provider enrollment.

    On March 23, CMS released Frequently Asked Questions (FAQs) on Medicare Provider Enrollment Relief related to COVID-19 including the toll-free hotlines available to provide expedited enrollment and answer questions related to COVID-19 enrollment requirements.

    Access the CMS FAQs.

    Posted 3/23/2020


  • CMS Announces Exceptions & Extensions for Quality Reporting Requirements

    In response to the COVID-19 health emergency, the Centers for Medicare & Medicaid Services (CMS) on March 22 announced exceptions from reporting requirements and extensions for clinicians and providers participating in Medicare quality reporting programs with respect to upcoming measure reporting and data submission for those programs.

    Read agency statement (includes extensions for upcoming measure reporting and submission deadlines).

    CMS states: "For those programs with data submission deadlines in April and May 2020, submission of those data will be optional, based on the facility’s choice to report. In addition, no data reflecting services provided January 1, 2020 through June 30, 2020 will be used in CMS’s calculations for the Medicare quality reporting and value-based purchasing programs."

    Posted 3/23/2020


  • CMS Provides FAQs on Essential Health Benefits Coverage for COVID-19

    On March 12, the Centers for Medicare & Medicaid Services (CMS) released COVID-19 FAQs for Essential Health Benefits (EHB). Read the FAQs here.

    Posted 3/12/2020


  • CMS Posts Fact Sheet on Coverage for COVID-19 Tests

    The Centers for Medicare & Medicaid Services (CMS) will be covering COVID-19 tests, and for those original Medicare there is generally no copay (deductible applies). CMS is also permitting Medicare Advantage plans to waive cost-sharing for these tests. 

    CMS has posted a fact sheet to the agency's website to aid Medicare providers with information relating to the pricing of both the CDC and non-CDC COVID-19 tests. Read the fact sheet

    Visit the CMS "Current Emergencies" webpage for updates on CMS' response to this COVID-19. 

    Posted 3/13/2020



  • Report to the Nation Shows Overall Decline in Cancer Death Rates

    The Annual Report to the Nation on the Status of Cancer finds that from 2001 to 2017, deaths from cancer (all sites combined) continued to decline. The report was released on March 12 and is published in the journal, Cancer.

    The annual report, which represents the collaborative efforts of the Centers for Disease Control (CDC), the National Cancer Institute (NCI), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries NAACCR), found decreases in the overall cancer death rates in all major racial and ethnic groups and among men, women, adolescents, young adults, and children. From 2012 to 2016 incidence of new cancers (for all cancers combined) held steady for men and increased slightly for women.

    Over a four-year period (2013 to 2017), the report found:

    Cancer death rates for men declined in 11 of the 19 most prevalent cancers, remained stable in four cancers (including prostate), and increased in four cancers (oral cavity and pharynx; soft tissue including heart, brain, and other nervous system; and pancreas).

    Cancer death rates for women decreased in 14 of the 20 most common cancers, including (lung and bronchus, breast, and colorectal), but increased for cancers of the uterus; liver; brain and other nervous system; soft tissue including heart; and pancreas. Rates for cancers of the oral cavity and pharynx remained stable.

    A companion report assesses progress on the federal government’s Healthy People 2020 objectives for four leading cancers: lung, prostate, breast cancer in women, and colorectal cancer. The targets for reducing death rates were met for all cancers combined as well as for lung, prostate, female breast, and colorectal cancers overall. However, these decreases were not consistent across all sociodemographic groups. Despite some progress over the past decade, the report points to the continued need to address disparities in cancer screening and in certain risk behaviors.

    In addition, the report finds that Healthy People 2020 targets were not met for decreasing adult cigarette smoking; increasing success in smoking cessation; lowering excessive alcohol use; or reducing obesity—behaviors that have been associated with cancer risk.

    Posted 3/11/2020






  • CMS Issues Guidance to Help MA & Part D Plans Respond to COVID-19

    In a memorandum issued on March 10, the Centers for Medicare & Medicaid Services outlines the flexibilities Medicare Advantage (MA) and Part D plans have to waive certain requirements to help prevent the spread of COVID-19. These flexibilities include:

    • Waiving cost-sharing for COVID-19 tests
    • Waiving cost-sharing for COVID-19 treatments in doctor’s offices or emergency rooms and services delivered via telehealth
    • Removing prior authorizations requirements
    • Waiving prescription refill limits
    • Relaxing restrictions on home or mail delivery of prescription drugs
    • Expanding access to certain telehealth services
    On March 9, the agency issued guidance on the screening, treatment, and transfer procedures healthcare workers must follow when interacting with patients to prevent the spread of COVID-19 in a hospice setting. CMS also issued additional guidance specific to nursing homes to help control and prevent the spread of the virus.

    View additional information from CMS here.




  • Udenyca Well Prepared to Meet Market Demand

    Coherus BioSciences, Inc., has announced that its United States manufacturing and distribution is well positioned to
    ensure uninterrupted availability of Udenyca® (pegfilgrastim-cbqv) for patients. Coherus does not source active pharmaceutical ingredients for Udenyca® from China, or India, and its manufacturing site in Boulder, Colorado has not been impacted by coronavirus, the company said in a statement.

    Read the company statement.

    Posted 3/11/2020


  • FDA Approves Opdivo Plus Yervoy Combo For HCC Patients Previously Treated with Sorafenib

    On March 11, 2020, Bristol Myers-Squibb announced that the U.S. Food and Drug Adminstration (FDA) has approved Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo + Yervoy cohort of the Phase 1/2 CheckMate-040 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Read the corporate announcement

    Posted 3/11/2020


  • HHS Issues Final Interoperability and Patient Access Rule

    On Monday, March 9, the U.S. Department of Health and Human Services (HHS) issued The Interoperability and Patient Access final rule (CMS-9115-F) from CMS and the Office of the National Coordinator for Health IT (ONC). 

    The rule finalizes new policies aimed at giving patients access to their health information, using CMS's authority to regulate Medicare Advantage (MA), Medicaid, CHIP, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). Currently these data are held by health insurers, hospitals, and vendors of electronic health records (EHRs).

    New policies include:

    • Patient Access API (applicable Jan.1, 2021)
    • Provider Directory API (applicable Jan.1, 2021)
    • Payer-to-Payer Data Exchange (applicable Jan.1, 2022)
    • Improving the Dually Eligible Experience by Increasing the Frequency of Federal-State Data Exchanges (applicable April 1, 2022)
    • Public Reporting and Information Blocking (applicable late 2020)
    • Digital Contact Information (applicable late 2020)
    • Admission, Discharge, and Transfer Event Notifications (applicable fall 2020)
    Read CMS fact sheet.

    Posted 3/10/2020


  • USPSTF New Guideline Calls for HCV Screening for Adults Aged 18 to 79

    The U.S. Preventive Services Task Force (USPSTF) has published new screening recommends for hepatitis C virus (HCV) infection. The recommendation statement calls for HCV screening in adults 18 to 79 years of age. The new screening guidance was published March 2 in the Journal of the American Medical Association (JAMA).

    Access the full JAMA article.
    View USPSTF recommendtion statement.

    Posted 3/3/2020


  • FDA Approves Sarclisa® for Relapsed Refractory Multiple Myeloma

    On March, 2, 2020, the U.S. Food and Drug Administration (FDA) approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly.

    Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.

    Sarclisa has Orphan Drug Designation status from the FDA.

    Read corporate press release.

    Posted 3/2/2020



  • Lung Cancer Screening Rates Still Low, CDC Reports

    A report published by the Centers for Disease Control and Prevention (CDC) on Feb. 28, examines the prevalence of lung cancer screening by state for 10 states using Behavioral Risk Factor Surveillance System (BRFSS) data. The study found that overall for the 10 states,12.7% adults aged 55–80 years met the U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening.* Of adults meeting USPSTF criteria, 12.5% reported they had received a CT scan to check for lung cancer in the last 12 months. 

    The study is published in the February 28, Morbidity and Mortality Weekly Report. 2020;69(8);201.

    Access the report here.

    *The USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery.



  • CAP Opens Comment Period for MMR/MSI Testing Draft Recommendations

    The College of American Pathologists (CAP), the American Society of Clinical Oncology (ASCO), the Association for Molecular Pathology, and Fight Colorectal Cancer are collaborating to develop clinical guidelines for testing DNA mismatch repair (MMR) and microsatellite instability (MSI) status in patients with a range of cancers.

    The groups have opened the public comment period for the guideline “MMR and MSI Testing in Patients Being Considered for Checkpoint Inhibitor Therapy.” Find details, including background information, recommended resources to review before providing comments, and overarching questions for consideration here

    All stakeholders—including pathologists who refer and perform molecular testing, oncologists, laboratory personnel, and allied health professionals—are encouraged to provide feedback on the draft recommendations to ensure the final recommendations are clinically practical. The comment period runs from February 19 to March 13, 2020.

    Posted 2/24/2020
     



  • HHS Issues Final Report on Reducing Administrative & Regulatory Burden of HIT & EHRs

    The U.S. Department of Health and Human Services (HHS) on Feb. 21, 2020, issued its Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.

    The report outlines examples of electronic health record (EHR) related burden, as well as strategies and recommendations that HHS and other stakeholders can use to help clinicians focus their attention on patients rather administrative tasks when using health information technology (health IT).

    The 21st Century Cures Act required development of the report, which was led by the HHS Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services. An initial draft was issued in November 2018.

    In developing the report, ONC and CMS looked at four key areas and offered strategies to address each area:

    • Clinical documentation
    • Health IT usability (or ease of use of health IT tools and systems)
    • Federal health IT and EHR reporting requirements
    • Public health reporting (including coordination with prescription drug reporting programs and electronic prescribing of controlled substances).
    Download a copy of the report here.

    Read ACCC's 2017 report, "Optimizing Your EHR: Real-World Experiences with Electronic Health Records, here.

    Posted 2/21/2020


  • ACCC Joins Coalition Letter Urging Inclusion of H.R. 913 in Healthcare Extenders Package

    The Association of Community Cancer Centers (ACCC) joined in a wide coalition letter to congressional leadership urging that Congress include the bipartisan Clinical Treatment Act (H.R. 913) in the Healthcare Extenders Package that is likely to pass this spring.  

    Passage of the Clinical Treatment Act would guarantee that routine care costs of clinical trial participation would be covered for Medicaid beneficiaries with a life-threatening condition. Currently, Medicaid is not federally required to cover these clinical trial associated costs. 

    Because these costs only encompass non-experimental costs of treating patients (e.g., doctor's visits and lab work) on clinical trials, the Clinical Treatment Act would not significantly affect overall cost to Medicaid programs.

    Read coalition letter.

    Posted 2/19/20