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Oncology Newsfeed

  • CMS Issues RFI on Reducing Administrative Burden

    On June 6, the Centers for Medicare & Medicaid Services (CMS) issued a Request for Information (RFI) seeking new ideas from the public to continue the administration's Patients over Paperwork initiative. The RFI will be published in the Federal Register on June 11. 

    The RFI invites patients and their families, the medical community, and other healthcare stakeholders to recommend further changes to rules, policies, and procedures that would shift more of clinicians’ time and healthcare system’s resources from paperwork to high-quality care that improves patient health.

    According to the agency's press release, CMS is seeking innovative ideas to relieve burden and improve:

    • Reporting and documentation requirements
    • Coding and documentation requirements for Medicare or Medicaid payment
    • Prior authorization procedures
    • Policies and requirements for rural providers, clinicians, and beneficiaries
    • Policies and requirements for dually enrolled (i.e., Medicare and Medicaid) beneficiaries
    • Beneficiary enrollment and eligibility determination
    • CMS processes for issuing regulations and policies

    Comments must be submitted by August 12, 2019.

    Posted 6/6/2019

     


  • Annual Cancer Report to the Nation: Overall Cancer Mortality Decline Continues

    The Annual Report to the Nation on the Status of Cancer released on May 30, finds that for all cancer sites combined the overall cancer death rate continued to decrease in U.S. men, women, and children from 1999 to 2016. In men, the overall cancer incidence rates decreased from 2008 to 2015, after increasing from 1999 to 2008. Cancer incidence rates were stable in women from 1999 to 2015.

    This year's report includes a special section on cancer rates and trends in adults ages 20 to 49.  Among adults 20-49 years, researchers report that incidence and death rates were lower among men than women. The most common cancers in this age group were:
    • Breast, thyroid, and melanoma of the skin for women, with breast cancer far exceeding any of the other cancers; and
    • Colorectal, testicular, and melanoma of the skin for men.
    The report is jointly issued by the Centers for Disease Control and Prevention (CDC), the North American Association of Central Cancer Registries (NAACCR), the American Cancer Society (ACS), and the National Cancer Institute (NCI).

    Access highlights and the full report on the CDC website here.

    Read NCI press release here.

    Posted 5/30/2019


  • FDA Approves Lenalidomide in Combination for Follicular and Marginal Zone Lymphoma

    On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

    Read FDA announcement.

    Posted 5/28/2019


  • FDA Approves Alpelisib for Metastatic Breast Cancer

    On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

    Read FDA announcement    .

    Posted 5/28/2019


  • FDA Approves Ruxolitinib for Acute Graft-Versus-Host Disease

    On May 24, Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) for adults and pediatric patients ≥12 years of age. It is the first and only FDA-approved treatment for this indication.

    Read the Incyte press release here.

    Posted 5/24/2019


  • Radiation Oncology APM: Sooner or Later?

    Since April 19, a proposed rule titled "Potential Model Updates" has been under Office of Management and Budget review. Healthcare stakeholders and members of the oncology community are speculating that this proposed rule could offer the public a more finalized look into a radiation oncology specific alternative payment model (APM) that Administration healthcare leadership has been hinting at since last year.

    Stakeholders anticipate that more information about the RO-APM will come either in this proposed rule or in the larger Medicare outpatient prospective payment system proposed rule later this summer.

    Posted 5/23/2019


  • Administration Slows Timeline for IPI, Rebate Regulatory Action

    The Trump Administration's spring regulatory agenda, released on May 22, shows a slow down of next steps for regulatory action on two pivotal drug-pricing reform measures: the International Pricing Index (IPI) model and the revamping of the rebate system.

    The IPI model was outlined last fall in an advance notice of proposed rulemaking from the Department of Health and Human Services (HHS). The rule, originally expected this spring, is now slated to be proposed in August.

    The regulatory agenda also indicates that Administration's proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system are now scheduled to be released later than originally anticipated.

    Source: Inside Health Policy
    Posted 5/23/2019


  • Verma: CAR-T NCD "New Ground" for CMS, Agency Needs More Time

    On May 17, the Centers for Medicare & Medicaid Services (CMS) abruptly announced a delay in its release of a Medicare National Coverage Determination (NCD) for CAR T-cell therapy, which was due to be published that same day. The agency statement did not provide an explanation for the delay.

    In a meeting with reporters on Wednesday, May 22, CMS Administrator Seema Verma said that the agency is taking care with the NCD because not only is the technology "new ground" for CMS, but also application of CAR-T therapy is expected to expand to other types of cancer beyond lymphoma. “So we want to make sure that we’re doing this appropriately, dotting our i’s and crossing our t’s. It’s just taking a little bit more time because it’s not a routine type of decision,” Verma said.

    Source: Inside Health Policy
    Posted 5/23/2019



  • CMS Releases Finalized Medicare Advantage & Part D Rule

    On May 16, the Centers for Medicare & Medicaid Services (CMS) released their final rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.” Highlights from this final rule include:

    • Reversal from the outlined proposed rule that would have allowed for significant change to the Medicare Part D six protected classes and coverage of these important therapies.
    • Part D plan sponsors will be required to implement an electronic real-time benefit tool (RTBT) with the goal of increasing price transparency. This tool seeks to be capable of integrating with at least one prescriber's electronic prescribing system or electronic health record.

    The ACCC policy team will continue to analyze this rule and provide a more detailed analysis at a later date.

    Read the CMS final rule here.

    Posted 5/17/2019



  • FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

    On May 15, AbbVie Inc. and Genentech Inc. announced that the U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA had previously granted Breakthrough Therapy designation to this chemotherapy-free combination.

    Read the Genentech press release    .

    Posted 5/15/2019