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Industry News Archive

  • 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



  • FDA Approves Pembrolizumab for Treatment of Subset of Bladder Cancer Patients

    On Jan. 8, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

    Read the FDA announcement.

    Posted 1/8/2020


  • FDA Approves Olaparib for Pancreatic Cancer

    On Dec. 30, 2019, AstraZeneca and Merck announced U.S. Food and Drug Administration (FDA) approval of olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

    Read the corporate press release.

    Myriad Genetics, Inc., announced Dec. 30, 2019, FDA has approved the company's BRACAnalysis CDx® for use as a companion diagnostic test by healthcare professionals to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with PARP inhibitor Lynparza® (olaparib). 

    Read the corporate press release.

    Posted 12/30/2019



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