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Industry News Archive

  • IMFINZI® ES-SCLC National Broadcast

    Tuesday, April 21
    7:30 PM ET or 9:30 PM ET

    This national broadcast program includes a 45-minute presentation followed by a Q & A session. Preregistration is required. Click here for details. 

    4/14/2020


  • CMS Issues Guidance on Payer COVID-19 Coverage

    On April 11, the Centers for Medicare & Medicaid Services (CMS) released guidance for implementation of the requirement for group health plans and group and individual health insurance to cover both COVID-19 diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test. Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.

    The guidance also ensures that COVID-19 antibody testing will be covered. When a COVID-19 antibody test becomes widely available, it could become a key element in fighting the pandemic.

    Access the guidance

    4/13/2020



  • ASCO Launches COVID-19 Registry

    The American Society of Clinical Oncology (ASCO) has announced the launch of the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry) to help the cancer community learn about the pattern of symptoms and severity of COVID-19 among patients with cancer. The registry will also aim to gain insight into how COVID-19 infections impact the delivery of cancer care and patient outcomes. The registry will collect both baseline and follow-up data throughout the pandemic and into 2021.

    Learn more.

    Posted 4/13/2020


  • HHS Starts Distribution of $30 Billion in Provider Relief Funds

    The bipartisan CARES Act, signed into law March 27, provides for $100 billion in relief funds to hospitals and other healthcare providers on the front lines of the coronavirus response. On April 10, the U.S. Department of Health and Human Services (HHS) announced the immediate start to distribution of $30 billion in relief funds to providers. HHS states that eligible providers will begin receiving payment via direct deposit starting April 10, 2020. 

    Full details including who is eligible, how payment distributions are determined, what to do if you are an eligible provider, and 
    more here.

    Posted 4/10/2020

     
     


  • CMS Adds New COVID-19 Workforce Flexibility Waivers

    On April 9, the Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules so that hospitals, clinics, and other healthcare facilities can boost their frontline medical staffs during the novel Coronavirus (COVID-19) pandemic.

    These changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30.

    Access CMS fact sheet on detailing Blanket Waivers for Healthcare Providers (includes information on the new waivers and those announced previously).

    Posted 4/10/2020



  • FDA Approves Braftovi in Combo with Cetuximab for mCRC with BRAF V600E Mutation

    On April 8, 2020, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy.

    Read FDA announcements.

    Posted 4/9/2020


  • HHS Announces Upcoming Funding to Provide $186 Million for COVID-19 Response

    On Monday, April 6, the U.S. Department of Health and Human Services (HHS) announced upcoming action by the Centers for Disease Control and Prevention (CDC) to provide $186,000,000 in funding for additional resources to state and local jurisdictions in support of the nation’s response to the 2019 novel coronavirus (COVID-19). An HHS press release states that the CDC will use the funding to: 
    • Supplement an existing cooperative agreement to a number of states and local  identified as having the highest number of reported COVID-19 cases (“hot zones”) and jurisdictions with accelerating or rapidly accelerating COVID-19 cases.
    • Supplement an existing cooperative agreement to state jurisdictions through the Emerging Infections Program (EIP) to enhance surveillance capabilities.

    CDC will use existing networks to reach out to state and local jurisdictions to access this initial funding.

    To view the list of CDC funding actions to jurisdictions, click here.

    Read HHS press release here.

    Posted 4/6/2020



  • Novartis Announces New C-Code for Adakveo®, Effective April 1

    Novartis has announced that, effective April 1, 2020, the Centers for Medicare & Medicaid Services (CMS) has issued a product-specific C-code, C9053 for 100 mg/10 mL (10 mg/mL) solution in a single-dose vial of ADAKVEO® (crizanlizumab-tmca) for IV infusion. The code can be reported in box 44 on the CMS-1450 (UB-04) claim form for the hospital outpatient department.

    C-codes are used primarily to report services under the Outpatient Prospective Payment System (OPPS), but may also be recognized by other private and public payer types. Please check with each payer for specific requirements.

    Important billing and coding information:

    ADAKVEO is supplied as a 100 mg/10 mL (10 mg/mL) single dose vial. See below for coding details:

    Unique C-Code for ADAKVEO

    Description

    Units per 10 mL (10 mg/mL) single-dose vial

    C9053

    Injection, ADAKVEO, 1 mg

    100


    Please make sure to include C9053 on appropriate claims submission forms for ADAKVEO administered April 1 and later. If you have questions or need further clarification, please contact your Reimbursement Manager or ADAKVEO Support at PANO at 1-800-282-7630.

    Posted 3/24/2020



  • 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



  • 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


  • 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 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






  • 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 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



  • CMS Issues Proposed Changes to Medicare Advantage & Part D

    On Feb. 5, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule and Advance Notice Part II.  

    The CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P) would:

    • require Part D plans to offer real-time drug price comparison tools to beneficiaries starting Jan. 1, 2022, to allow consumers to shop for lower-cost alternative therapies under their prescription drug benefit plan. 

    • allow a second, “preferred” specialty tier in Part D with a lower cost sharing amount.

    • require Part D plans to disclose the measures they use to evaluate pharmacy performance in their network agreements. This would allow CMS to track and report publicly how plans are measuring and applying pharmacy performance measures.
    In the Advance Notice, the agency asks for comments on potentially developing measures of generic and biosimilar utilization in Medicare Part D as part of a plan’s star rating.

    Access a fact sheet on the CY 2021/2022 Medicare Advantage and Part D Proposed Rule (CMS- 4190-P).
    Download the proposed rule.

    Access a fact sheet on the 2021 Medicare Advantage and Part D Advance Notice Part II.

    Download Medicare Advantage and Part D Advance Notice Part II.

    Posted 2/6/2020



  • FDA Approves Avapritinib for GIST Subset

    On Jan. 9, 2020, the U.S. Food and Drug Administration (FDA) announced approval of avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keep the cancer cells from growing.

    Read the FDA approval announcement.

    Posted 1/9/2020.


  • ACS Report Finds Largest One-Year Drop in Cancer Deaths

    The American Cancer Society’s annual report on U.S. cancer statistics, released Jan. 8, announced the greatest one-year decline in deaths from cancer since 1930. From 2016 to 2017, overall deaths from cancer dropped 2.2 percent. Between 1991 and 2017, the U.S. has seen the overall cancer death rate drop 29 percent.  

    In a statement, lead study author Rebecca Siegel, MPH, attributed the record drop to improved statistics related to lung cancer. While a decrease in smoking rates has contributed to the decline, Siegel also credited recent advances in lung cancer treatment for this year's record drop. These include surgical advances, improved diagnostic screening, as well as advances in radiation therapy and anticancer therapeutics.

    The U.S. continues to see increases in new cases of certain cancers including cancers of the kidney, pancreas, liver, and oral cavity and pharynx (among non-Hispanic whites), and melanoma skin cancer.

    The American Cancer Society estimates for 2019, the U.S. saw approximately 1,762,450 cancers diagnosed.


    Read the full report.
    Read Facts & Figures 2020.

    Posted 1/9/2019




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