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Oncology Newsfeed

  • 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).
    People with federal benefits and providers and suppliers of healthcare equipment and services that have been impacted by the California wildfires are encouraged to seek help by visiting CMS' emergency webpage: http://cms.gov/emergency.

    Posted 11/14/2018


  • 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:

    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:

    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

    On November 9, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

    Read the Merck press release here.

    Posted 11/12/2018


  • CMS to Unveil Mandatory Medicare Radiation Oncology Payment Model

    On November 8, Secretary of Health and Human Services (HHS) Alex Azar announced that the Centers for Medicare & Medicaid Services (CMS) plans to unveil a mandatory Medicare radiation oncology payment model for cancer patients in the coming weeks, as well as two new voluntary models for cardiac care. This announcement contradicts previous statements from the Trump Administration, which had previously promised it would not enforce payment models that would put them at risk of financial loss.

    Read news coverage from Modern Healthcare here.

    Posted 11/9/2018


  • FDA Approves Elotuzumab, Pomalidomide, Dexamethasone for Multiple Myeloma

    On November 6, Bristol-Myers Squibb Company announced that the Food and Drug Administration approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

    Read the Bristol-Myers Squibb press release here.

    Posted 11/7/2018


  • FDA Approves Lorlatinib for ALK+ Metastatic NSCLC

    On November 2, the FDA granted accelerated approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with ALK+ metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

    Read the full FDA press release here.

    Posted 11/5/2018




  • FDA Approves Second Biosimilar to Neulasta

    On November 2, the FDA approved pegfilgrastim-cbqv (Udenyca, Coherus BioSciences, Inc.) as a biosimilar to pegfilgrastim (Neulasta, Amgen, Inc.) for patients with cancer receiving myelosuppressive chemotherapy. Udenyca is the second pegfilgrastim biosimilar to be approved by the FDA following the approval of pegfilgrastim-jmdb (Fulphila, Mylan Inc.) in June.

    Read the Coherus press release here    .

    Posted 11/2/2018


  • CMS Releases CY 2019 OPPS Rule

    On November 2, the Centers for Medicare & Medicaid Services (CMS) released the final calendar year (CY) 2019 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule.

    Download the final 2019 OPPS rule from the Federal Register here.

    Highlights from the CMS fact sheet on the final rule include:

    • CMS is exercising its authority by applying a Physician Fee Schedule (PFS)-equivalent payment rate for the clinic visit service when provided at an off-campus provider-based department that is paid under the OPPS. The agency will phase this change in over two years.

       

    • In the 2019 OPPS final rule, CMS finalizes a policy to pay ASP minus 22.5 percent for 340B-acquired drugs furnished by non-excepted off-campus PBDs paid under the Physician Fee Schedule.

       

    • For 2019, CMS is not finalizing its proposed policy that off-campus PBDs excepted from Section 603 of the Bipartisan Budget Act of 2015 could continue to be paid at OPPS rates for items and services in each of 19 proposed “clinical families of services” if a PBD furnished and billed for a service in that clinical family of services prior to November 2, 2015. CMS notes the agency will continue to monitor the expansion of services in excepted off-campus PBDs.

    For more information, access the CMS fact sheet on the final CY 2019 OPPS rule here.

    ACCC is currently reviewing the final 2019 OPPS rule and will provide an in-depth analysis to membership shortly.

    Posted 11/2/18



  • CMS Releases 2019 PFS and QPP Final Rule

    On November 1, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2019 Physician Fee Schedule (PFS) and Quality Payment Program (QPP) final rule.

    The summary below is based on the CMS fact sheet on the 2019 PFS final rule.

    For CY 2019 and CY 2020, the agency is implementing several documentation policies "to provide immediate burden reduction" and would implement additional changes to documentation, coding, and payment in CY 2021. 

    Coding for E/M Office/Outpatient Visits
    The CMS fact sheet states:
    "For CY 2019 and CY 2020, CMS will continue the current coding and payment structure for E/M office/outpatient visits and practitioners should continue to use either the 1995 or 1997 E/M documentation guidelines to document E/M office/outpatient visits billed to Medicare."

    For CY 2021, CMS would move forward to reduce payment variation for E/M office/outpatient visit levels by paying a single rate for visit levels 2 through 4 for established and new patients, "while maintaining the payment rate for E/M office/outpatient visit level 5 to better account for the care and needs of complex patients."

    For 2019, CMS finalized its proposal to pay separately for two newly defined physicians’ services furnished using communication technology:

    • Brief communication technology-based service, e.g. virtual check-in (HCPCS code G2012) and
    • Remote evaluation of recorded video and/or images submitted by an established patient (HCPCS code G2010)
    And for 2019, CMS also finalizes policies to pay separately for new coding describing chronic care remote physiologic monitoring (CPT codes 99453, 99454, and 99457) and interprofessional internet consultation (CPT codes 99451, 99452, 99446, 99447, 99448, and 99449). 

    Payment Rates for Non-excepted Off-campus Provider-Based Hospital Departments Paid Under the PFS
    Since CY 2017, payment for certain items and services furnished in non-excepted off-campus provider-based departments has been made under the PFS using a PFS Relativity Adjuster based on a percentage of the OPPS payment rate. The PFS Relativity Adjuster in CY 2018 is 40 percent, i.e., non-excepted items and services are paid 40 percent of the amount that would have been paid for those services under the OPPS.

    For CY 2019 CMS is finalizing that the PFS Relativity Adjuster remain at 40 percent.

    Wholesale Acquisition Cost (WAC)-Based Payment for Part B Drugs: CMS Finalizes Reduction of Add-on Amount
    Effective Jan. 1, 2019, WAC-based payments for Part B drugs determined under section1847A of the Social Security Act, during the first quarter of sales when average sales price (ASP) is unavailable, will be subject to a 3 percent add-on in place of the current 6 percent add-on. The agency reiterated that these changes only apply to WAC-based payment for new Part B drugs.

    ACCC is analyzing the final rule and will provide in-depth analysis to the membership soon.

    View the CY 2019 Physician Fee Schedule and Quality Payment Program final rule here.

    Access the CMS fact sheet on the CY 2019 Physician Fee Schedule final rule.

    Access the CMS fact sheet on the CY 2019 Quality Payment Program final rule.
    Posted 11/1/18