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Oncology Newsfeed

  • 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

  • FDA Approves Pembrolizumab for First-Line Treatment of Metastatic Squamous NSCLC

    On October 30, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

    Read the full FDA press release here.

    Posted 10/31/2018

  • ACCC Statement in Response to Administration’s Part B Drug Pricing ANPRM

    On Thursday, October 25, the Trump Administration released of a three-pronged proposal to overhaul Medicare Part B and tackle rising drug costs. ACCC looks forward to commenting on this proposal, but the Administration's actions are still in the nascent stages of development. An Advance Notice of Proposed Rulemaking (ANPRM) was released on October 25, with expectation that a formal proposed rule would be released in Spring 2019. Many questions are yet to be addressed regarding the intricacies in implementation of this model.

    Under the proposal the Medicare Part B landscape would change significantly through the use of a mandatory demonstration through the Center for Medicare and Medicaid Innovation (CMMI) with an International Pricing Index (IPI) model.

    In a policy statement, the Association of Community Cancer Centers (ACCC) expresses overarching concerns about the impact of the proposal on the entire cancer care delivery infrastructure and, in particular, those programs and practices that see a high percentage of Medicare, Medicare only, and dual-eligible patients. ACCC urges policymakers to be aware that this policy has the potential to drastically hamper access to vital patient care and harm innovation for cancer care treatment.

    ACCC looks forward to working with the Centers for Medicare & Medicaid Services (CMS) to ensure that any model put forth to the public is voluntary, maintains appropriate safeguards for access to patient care, and drives increased value-based propositions for the oncology community.

    Posted 10/26/2018

  • President Trump to Make Announcement on Expected Medicare Part B Changes

    President Trump is expected to make an announcement this afternoon, October 25, detailing continued reform efforts in lowering drug prices. The proposal to be released this afternoon would use the Center for Medicare & Medicaid Innovation center to test three ways of lowering the cost of drugs in Medicare Part B. A report released from the Department of Health & Human Services, Office of the Assistant Secretary for Planning and Evaluation (ASPE) advocates for the reform of Medicare Part B to align more with the negotiation and utilization management tactics currently utilized in Medicare Part D.

    Stay tuned for more updates from the ACCC Policy Team.

    Posted 10/25/18

  • FDA Approves Levoleucovorin for Injection for mCRC, Osteosarcoma

    On October 23, the FDA approved levoleucovorin for injection (Khapzory, Spectrum Pharmaceuticals, Inc.) for three indications:
    • Rescue after high-dose methotrexate therapy in patients with osteosarcoma
    • Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination
    • The treatment of patients with metastatic colorectal cancer (mCRC) in combination with fluorouracil.
    Read the Spectrum Pharmaceuticals press release here.

  • HHS Secretary Azar Provides Updates to Drug Pricing Blueprint

    Health and Human Services Secretary Alex Azar yesterday outlined updates to HHS’s “four strategies” for addressing prescription drug pricing in remarks delivered during the National Academy of Medicine’s President’s Forum on Affordable Medicines: Access, Innovation, and the Public Interest.

    In his address, Secretary Azar called attention to the proposed rule issued yesterday by the Centers for Medicare & Medicaid Services (CMS) that would require manufacturers to include in their direct-to-consumer TV advertising the list price of drugs paid for by Medicare & Medicaid. While acknowledging a pharmaceutical industry announcement yesterday of an initiative to improve price transparency, Secretary Azar stated that HHS “will not rely on voluntary action to accomplish our goals.” 

    Secretary Azar’s speech centered on HHS’ four areas of drug-pricing focus under the Administration's blueprint for lowering drug prices released last May: negotiation, reducing consumer out-of-pocket costs, improving competition, and creating incentives for lower list prices. In his remarks, Secretary Azar highlighted specific actions the administration has taken to date and outlined possible future steps in each of the four areas.

    The full text of Secretary Azar's address is available here.

    ACCC policy staff will provide a more in-depth look at Secretary Azar's remarks shortly. 

    Posted 11/16/18