Oncology Newsfeed

FDA Approves Venetoclax for Acute Myeloid Leukemia

On November 21, the Food and Drug Administration granted accelerated approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Read the full FDA press release here.

Posted 11/26/18

FDA Approves Glasdegib for Acute Myeloid Leukemia

ACS Releases Report on Current State of Cancer Screening

• Improving the implementation of existing screening modalities
• Improving the quality and performance of currently available screening tests
• Developing entirely new screening strategies to screen for cancers currently amenable to screening
• Developing increasingly refined, risk-based screening strategies
• Developing effective ways to screen for cancers for which screening tests do not exist.
  

"Feel More Like You" Program to Help Cancer Patients with Physical Changes

FDA Approves Brentuximab Vedotin for Peripheral T-Cell Lymphoma

CMS Strengthens Federal Support to Californians Affected by Wildfires

On November 14, the Centers for Medicare & Medicaid Services (CMS) announced that the agency has taken steps to support California residents displaced and recovering from the wildfires destroying portions of the state.On November 13, Health and Human Services Secretary Alex Azar declared a public health emergency (PHE) in areas of California retroactive to November 8. The PHE allows CMS to waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements if necessary to provide health services.

The agency will take the following steps to support the state of California and those residents impacted by wildfires: 

• Waivers for Skilled Nursing Facilities and Assistance for Hospitals and other Healthcare Facilities: CMS will issue a blanket Skilled Nursing Facility waiver, described on the website below; and the Regional Office will provide numerous technical assistance responses to the state, California Hospital Association and providers on specific types of CMS and other HHS program flexibilities that are available with and without waivers. These program flexibilities and waivers work to provide continued access to care for beneficiaries. For more information on the waivers CMS will grant, visit https://www.cms.gov/Emergency.
• Special Enrollment Opportunities and Medicare Flexibilities: CMS will be providing beneficiaries affected by the California wildfires an Special Enrollment Period (SEP) that gives them an additional opportunity to add, drop, or change their Medicare health and prescription drug plan in the event they are eligible for an SEP and unable to make an election during the fall open enrollment period or another election period for which they were eligible. For more information on special enrollment periods, visit: https://www.cms.gov/Medicare/Eligibility-and-Enrollment/MedicareMangCareEligEnrol/index.html. When a public health emergency is in effect, Medicare Advantage Organizations in affected areas are required to waive prior authorization and other gatekeeper requirements and to allow care to be provided by non-contracted providers and facilities. In addition, Part D plan sponsors are expected to lift certain limits for drug benefits.
• Dialysis Care: Dialysis patients who are unable to receive dialysis services at their usual facility and who need assistance to locate a facility where they can be dialyzed, should call the NW 17 (Northern California) Patient Hotline (800.232,3773) or NW 18 (Southern California) Patient Hotline (800.637.4767) for assistance. The following large dialysis organization hotline numbers are also available for patients: DaVita Emergency Dialysis Services (800.400-8331); Fresenius Kidney Care Emergency Hotline (800.626.1297); Dialysis Clinic Inc. (DCI) Emergency Command Center (866.424.1990); and U.S. Renal Care Emergency Hotline (866.671.8772).

CMS to Host November 19 PFS Final Rule Open Call

On Monday, November 19, from 2:00 to 3:30 PM ET, the Centers for Medicare & Medicaid Services (CMS) will host a call to address three key topics stemming from the finalization of the CY 2019 Physician Fee Schedule (PFS) Final Rule. During this call, CMS experts will briefly cover three provisions and address questions related to:

• Streamlining Evaluation and Management (E/M) payment and reducing clinician burden
• Advancing virtual care
• Continuing to improve the Quality Payment Program to reduce burden and offer flexibilities to help clinicians successfully participate.
  

Participants are encouraged to review the final rule prior to the call and the following materials:

• Physician Fee Schedule: Press release, fact sheet, and E/M payment chart
• Quality Payment Program: Year 3 overview fact sheet and quick start guide for MIPS 2019 participation.
  

The target audiences for this call are Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent healthcare providers; and other stakeholders.

Click here to register for this call and other Medicare Learning Network events.

Posted 11/14/2018

ACCC Releases CY 2019 MPFS and OPPS Final Rule Summaries

On November 1 and 2, the Centers for Medicare & Medicaid Services (CMS) finalized its CY 2019 Physician Fee Schedule (PFS)/Quality Payment Program (QPP) and Hospital Outpatient Prospective Payment System (OPPS) rules. ACCC has released summaries on these final rules, available for ACCC members here:

• CY 2019 Physician Fee Schedule (PFS) Final Rule Summary (login required)
  
• CY 2019 Hospital Outpatient Prospective Payment System (OPPS) Final Rule Summary (login required)
  

On Wednesday, November 28, join legal experts from Hogan Lovells for a one-hour overview and discussion about the Centers for Medicare & Medicaid Services (CMS) Final CY 2019 OPPS and PFS rules. The agency finalized several significant proposals this year and beyond that will impact payments to Evaluation & Management (E/M) visits, 340B hospitals and outpatient facilities, as well as access for biosimilars and telehealth, and much more.

Webinar: CMS Final CY 2019 Outpatient Prospective Payment System (OPPS) & Physician Fee Schedule (PFS) Rules: What You Need to Know
Wednesday, November 28, 2018
3:30 – 4:30 PM EST
Register Here (login required)

Posted 11/13/2018

FDA Approves Pembrolizumab for Hepatocellular Carcinoma

CMS to Unveil Mandatory Medicare Radiation Oncology Payment Model