Oncology Newsfeed

FDA Approves Calaspargase Pegol-mknl for Pediatric/AYA ALL

FDA Approves Olaparib for Ovarian, Fallopian, Peritoneal Cancers

On December 19, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer should be selected for therapy based on an FDA-approved companion diagnostic.

Read the FDA press release here.

Posted 12/19/2018

FDA Approves Pembrolizumab for Merkel Cell Carcinoma

On December 19, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co. Inc.) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Read the FDA press release here.

Posted 12/19/2018

ACCC Statement on Administration's MA & Part D Proposal to Tackle Drug Prices

The Centers for Medicare & Medicaid Services (CMS) announced the potential changes in a proposed rule that was released on November 26.

Read ACCC's Policy Statement.

Posted 12/17/2018

FDA Approves Trastuzumab-pkrb for Treatment of HER2-Positive Breast Cancer

PTAC Votes to Recommend MASON Model

On Dec. 10, 2018, the Physician-focused Payment Model Technical Advisory Committee (PTAC) voted (7-0, with 1 abstention) to recommend implementation of the Making Accountable Sustainable Oncology Networks (MASON) model. Innovative Oncology Business Solutions (IOBS) submitted the model. Medical oncologist Barbara McAneny, MD, is CEO and CMO for IOBS, and is currently serving as president of the American Medical Association.

MASON based on the earlier oncology medical home model COME HOME, which was developed with grant funding from the Center for Medicare and Medicaid Innovation.

This MedPage Today article explains how the proposed MASON model would work.

Unlike the Centers for Medicare & Medicaid Services (CMS) Oncology Care Model program, the MASON model excludes drug costs.

PTAC recommendations go to HHS and CMS for “potential” implementation.

Source: MedPage Today
Posted 12/12/18

ACCC Signs Letter Opposing Proposed Medicare Part B IPI Model

FDA Approves Atezolizumab for Metastatic NSq NSCLC

CMS Strengthens Federal Support to Alaska Following Earthquake

On December 6, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced that the agency has taken steps and is monitoring conditions in support of Alaska residents recovering from damage of the recent 7.0 earthquake that struck north of the city of Anchorage on Friday, November 30. On December 3, Health and Human Services Secretary Alex Azar declared a public health emergency (PHE) in areas of Alaska retroactive to Nov. 30, 2018. 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 Alaska and those residents impacted by the earthquake: 

• 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, 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 for Individuals Impacted by the Alaska Earthquake and Medicare Flexibilities: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries affected by the Alaska earthquake. This gives people impacted by the earthquake the opportunity to gain access to health coverage on the Exchange or to add, drop, or change their Medicare health and prescription drug plan if they are unable to make an election during the fall open enrollment period or another election period for which they are eligible. To request this SEP for Exchange coverage, individuals impacted by the earthquake must contact the Marketplace Call Center at 1-800-318-2596 or TTY at 1-855-889-4325 and indicate that they were unable to enroll during Open Enrollment due to the earthquake. To request the SEP for Medicare, individuals can contact the plan they wish to enroll, visit Medicare.gov, or call 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.

For more information on the special enrollment periods, visit:

• https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/8-9-natural-disaster-SEP.pdf
• 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 Northwest Renal Network (NW 16) Patient Hotline (800) 262-1514 for assistance. The following large dialysis organization hotline number is also available for patients: Fresenius Kidney Care Emergency Hotline: (800) 626-1297.
• Toolkit for Disaster Preparedness State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, visit: https://www.medicaid.gov/state-resource-center/disaster-response-toolkit/index.html.
• Provider Enrollment: CMS will temporarily waive and streamline provider enrollment requirements when enrolling providers to prevent a disruption in services to Medicaid.

ACCC Mourns the Loss of Lee E. Mortenson, DPA, MPA, MS

Lee E. Mortenson, DPA, MPA, MS

The Association of Community Cancer Centers (ACCC) and the Oncology State Society Network (OSSN) mourn the loss of founding Executive Director Lee E. Mortenson, DPA, MPA, MS. After a brief battle with non-small cell lung cancer, Dr. Mortenson passed away on December 3, 2018, at his home in Tucson, Arizona, surrounded by his family. He is survived by his wife Carol, daughter Leia, son Lars, and their families.

In 1974, Mortenson convened a small group of clinicians seeking to dispel the myth that community providers were uninterested in and incapable of participating in state-of-the-art cancer care. On the occasion of ACCC’s 30^th anniversary in 2004, Mortenson described the impetus behind the Association’s founding:

“In 1974, when we first came together, medical oncology was not yet a formalized medical specialty. Congress and President Nixon had declared a war on cancer in 1971 and provided funding for a group of university-based comprehensive cancer centers. Some graduates of those university-based programs went into research, and some went into private practice.

Many who went into private practice immediately realized that cancer care was on the verge of a radical shift, a whole new paradigm. . . .The Association’s initial purpose was to spread the gospel of multidisciplinary care and teach other hospitals how to establish an oncology unit.”   

ACCC would go on to become the mechanism through which clinical protocols and other oncology standards of care were developed and disseminated to community cancer programs across the nation. Led by ACCC, the community oncology care provider would emerge as an equal partner in the war against cancer.

“Lee was the right leader at the right time,” said ACCC Executive Director Christian G. Downs, JD, MHA.” He was tenacious in fighting to support ACCC’s commitment to patient access to quality cancer care close to home, while also contributing to advancing cancer care for the future. He brought ACCC to where we are today.”

Dr. Mortenson served as ACCC Executive Director from 1974 to 2004. He was a visionary leader for ACCC, supporting the creation of an association that involved the whole multidisciplinary cancer team: physicians, administrators, nurses, social workers, data managers, radiation therapists, pharmacists, and advocates. Under his guidance, the Association evolved as cancer care delivery evolved, continuing to meet the needs of its multidisciplinary membership through conferences and meetings, ACCC’s journal Oncology Issues, and innovative education programs. 

Over the course of his 45-year career, Dr. Mortenson provided personal facilitation, leadership, mentoring, project analysis, and corporate development and analysis projects. He published more than 165 articles and served as editor/author of 40 books and as a journal editor. He raised more than $100 million for causes and organizations, some through grant and contract writing, some through project development and corporate financing. Legislation on off-label drug availability for cancer treatment developed by Dr. Mortenson was adopted by over 38 states and the U.S. Congress.

Posted 12/4/2018