December 19, 2018
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
December 19, 2018
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
December 17, 2018
On Friday, December 14, the Association of Cancer Care Centers (ACCC) issued a policy statement expressing deep concern regarding the broad impact of the Trump Administration's proposed changes to Medicare Advantage and Part D on the nation's cancer care delivery infrastructure and, in particular, on those cancer programs and practices that see a high percentage of Medicare, Medicare only, and dual eligible patients.
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
December 17, 2018
On December 14, Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. announced that the FDA has approved trastuzumab-pkrb (Herzuma), a biosimilar to Herceptin, for the treatment of HER2-positive breast cancer. Read the Celltrion press release here .
Posted 12/17/2018
December 12, 2018
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
December 11, 2018
On Monday, December 10, ACCC and 338 patient, provider, and caregiver groups that are part of the Part B Access for Seniors and Physicians Coalition have sent a letter to Congressional leaders asking them to block the Trump Administration's Medicare Part B international price referencing demo. Chief among concerns are the creation of a "middleman" role to negotiate drug pricing; the demo's international price indexing (IPI) mechanism, and its proposed changes to provider reimbursement. Read the full letter here . Read coverage of the letter here .
Posted 12/11/2018
December 7, 2018
On December 6, 2018, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. Read FDA announcement .
Posted 12/7/2018
December 6, 2018
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:
For more information on the special enrollment periods, visit:
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.
CMS encourages people with federal benefits and providers and suppliers of healthcare equipment and services that have been impacted by the Alaska earthquake to seek help by visiting CMS’ emergency webpage at www.cms.gov/emergency .
Posted 12/6/2018
December 5, 2018
Lee E. Mortenson, DPA, MPA, MS
The Association of Cancer Care 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
November 29, 2018
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. ACCC has expressed 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.
As ACCC urges policymakers to be aware the effect this demonstration has on the oncology community, we invite you to hear from ACCC and our legal experts at Hogan Lovells to learn more about this proposed mode and what it could mean for your cancer program and your patients.
Webinar: Health Policy to Watch: Medicare Part B Drug Pricing Reform - The International Pricing Index (IPI) ModelWednesday, December 5, 20183:30 PM - 4:30 PM ESTRegister here (login required) .
Posted 11/29/2018
November 28, 2018
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
November 27, 2018
On November 26, the FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. Read the full FDA press release here .
Posted 11/27/2018
November 26, 2018
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:
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.
Posted 11/26/2018
November 26, 2018
On November 26, the Association of Community Cancer Centers (ACCC) joined dozens of cancer care organizations and associations in signing a letter of support for H.R. 6836 , the CLINICAL TREATMENT Act. This legislation would ensure that states cover routine care costs of participation in approved clinical trials for Medicaid enrollees with life-threatening conditions. Medicaid is currently the only major payer that is not required by federal law to cover these costs. Read the full letter of support for H.R. 6836 here .
Posted 11/26/2018
November 26, 2018
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
November 26, 2018
On November 21, the Food and Drug Administration approved glasdegib (Daurismo, Pfizer Inc.) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. Read the full FDA press release here .
Posted 11/26/2018
November 19, 2018
On November 19, the American Cancer Society (ACS) published a report in CA: A Cancer Journal for Clinicians discussing the status of cancer screening and proposing key areas where further attention is needed. ACS highlighted five key focus areas to help cancer screening realize its full potential:
Read the full report here . Read the ACS press release on the report here .
Posted 11/19/2018
November 19, 2018
On November 19, Walgreens announced the launch of its "Feel More Like You" program designed to assist people living with cancer manage the physical changes associated with treatment. Formed in collaboration with Look Good, Feel Better and Cancer Support Community, the program will feature trained beauty consultants and pharmacists working together to provide personalized support to individuals with cancers at more than 400 stores across the country. Read the full Walgreens press release here .
Posted 11/19/18
November 16, 2018
On November 16, the U.S. Food and Drug Administration expanded the approved use of brentuximab vedotin (Adcetris, Seattle Genetics) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnoses PTCL, and the agency used a new review program to complete the approval more quickly. Read the full FDA press release here .
Posted 11/16/2018
November 14, 2018
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:
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
November 14, 2018
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:
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
November 13, 2018
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
November 12, 2018
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
November 9, 2018
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