Oncology Newsfeed

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

ACCC to Host 12/5 Webinar on Part B Proposed Changes

Webinar: Health Policy to Watch: Medicare Part B Drug Pricing Reform - The International Pricing Index (IPI) Model
Wednesday, December 5, 2018
3:30 PM - 4:30 PM EST
Register here (login required).

Posted 11/29/2018

FDA Approves First Biosimilar to Rituxan

FDA Approves Gilteritinib for Acute Myeloid Leukemia

On November 28, the Food and Drug Administration approved gilteritinib (Xospata, Astellas Pharma US Inc.) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

The FDA also approved an expanded indication for a companion diagnostic, to include use with gilteritinib. The LeukoStrat CDx FLT3 Mutation Assay, (Invivoscribe Technologies, Inc.) is used to detect the FLT3 mutation in patients with AML.

Read the full FDA press release here.

Posted 11/28/2018

FDA Approves Larotrectinib for Solid Tumors with NTRK Gene Fusion

CMS Releases Medicare Part C and Part D Proposed Rule

On November 26, the Centers for Medicare & Medicaid Services (CMS) announced proposed policies that continue to tackle drug pricing reform. Top-line takeaways from today’s proposals include:

• Proposed reform to Medicare Part D’s “protected” therapeutic classes.
• A new requirement in Medicare Part D to allow for increased transparency between patient and provider with provision of out-of-pocket cost obligations for prescription drugs whenever a prescription is written.
• A continued push to allow for and implement “step therapy” in Medicare Advantage plans for Part B drugs. The proposed rule also states the potential to infuse prior authorizations within this pool as well.
• Proposed implementation of a “statutory requirement” that would prohibit pharmacy gag clauses in Part D.

Read the CMS fact sheet on the proposed rule here.
Read the full proposed rule here.

The ACCC policy team is continuing to analyze this proposal. Stay tuned for more updates.

ACCC Signs Letter of Support for CLINICAL TREATMENT Act

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