February 19, 2019
On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Read the FDA press release here .
Posted 2/19/2019
February 15, 2019
On February 14, the American Society of Breast Surgeons (ASBS) released a consensus guideline advising that genetic testing should be made available to all patients diagnosed with breast cancer, including patients who had previously been tested. ASBS developed this recommendation because it believes current guidelines regarding genetic testing for breast cancer to be too restrictive.
ASBS also recommended that genetic testing should be made available to patients without a history of breast cancer who meet NCCN guidelines. Read the ASBS consensus guideline here .
Posted 2/15/2019
February 15, 2019
On Friday, February 15, the Center for Medicare & Medicaid Services (CMS) released a proposed national coverage determination (NCD) to provide nationwide consistency in coverage of FDA-approved CAR T-cell therapy under “Coverage with Evidence Development” (CED). Currently, nationwide coverage policy is not available for approved CAR-T therapies, and it has been covered at the discretion of local Medicare Administration Contractors (MACs) until now.
With this proposed NCD, CMS would require Medicare to cover the therapy when offered to patients “in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.” Information generated from these registries would aid CMS in identification of future patients for CAR-T therapies and better inform future coverage determinations in which the therapy could be covered “with no registry or trial requirement.”
Read ACCC's summary of the proposed NCD for CAR-T therapies here [log in required].
Posted 2/15/2019
Updated 2/28/2019
February 4, 2019
The Association of Cancer Care Centers (ACCC) joined with more than 60 organizations in a January 31, 2019, letter to CMS Administrator Seema Verma expressing concern over recent developments in the agency's interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer .
An overarching concern is that, although the NCD was requested for a somatic-based test, the new interpretation will result in Medicare Administrative Contractors (MACs) applying the NCD's terms to both somatic and germline NGS-based testing for patients with cancer. As a result, patient access to medically necessary and relevant testing of germline mutations in patients with cancer would be restricted, as would NGS-based testing (both somatic and germline) for Medicare beneficiaries with early-stage cancer. Read the Letter . Posted 1/4/2019
February 1, 2019
On January 31, Health and Human Services Secretary Alex Azar proposed a rule to remove safe harbor protections for drug rebates paid by manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans, and Medicaid managed care organizations. Through the removal of these protections, HHS and the Trump Administration continue their attempts to lower prescription drug prices and out-of-pocket costs. The proposal would also create new safe harbor protection for fixed fee service arrangements between manufacturers and PBMs.
Read the proposed rule here . Read the HHS press release here and the HHS fact sheet here .
Posted 2/1/2019
January 31, 2019
On January 31, the U.S. Food and Drug Administration (FDA) approved pemetrexed for injection (Alimta, Eli Lilly and Company) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Read the Eli Lilly and Company press release here .
Posted 1/31/2019
January 29, 2019
The Center for Medicare & Medicaid Innovation (CMS Innovation Center) is hosting a webinar to provide a basic overview of the Part D Payment Modernization Model . CMS will host two sessions including the same content, which will take place on Thursday, January 31, 2019 at 1:00 p.m. EST , and on Wednesday, February 6, 2019 at 1:00 p.m. EST .
If you previously registered for the Part D Payment Modernization Model webinar originally scheduled for Tuesday, January 29, 2019 please re-register for one of the new dates.
During the webinar, CMS subject matter experts will provide information about The Part D Payment Modernization model, which tests the impact of modernized Part D program design and improved incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs. The model is open to eligible standalone Prescription Drug Plans and Medicare Advantage Prescription Drug Plans that are approved to participate, is voluntary, and will last 5 years, beginning with the 2020 plan year.
As part of the model, CMS will provide participants with additional programmatic tools, including Part D rewards and incentives programs, to increase engagement with enrollees, with the goal of promoting better enrollee understanding of: (1) their Part D benefit, including out-of-pocket and total drug costs; and (2) clinically equivalent therapeutic options.
Register for the Thursday, January 31, 2019 webinar here .
Register for the Wednesday, February 6, 2019 webinar here .
Posted 1/29/2019
January 28, 2019
On January 28, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Read the Janssen press release here .
Posted January 28, 2019
January 23, 2019
On January 17, Adaptive Biotechnologies announced that Palmetto GBA has established coverage of the clonoSEQ Assay for Medicare patients with multiple myeloma and B-cell acute lymphoblastic leukemia (ALL). clonoSEQ is the only test authorized by the U.S. Food and Drug Administration (FDA) to detect and monitor minimal residual disease (MRD) in myeloma and ALL using DNA from a patient’s bone marrow sample. The article is effective immediately and enables national coverage of Medicare patients undergoing testing. Read the Adaptive Biotechnologies press release here .
Posted 1/23/2019
January 18, 2019
On January 18, the Centers for Medicare & Medicaid Services (CMS) announced that its Center for Medicare and Medicaid Innovation (CMMI) will test a new model for Part D plans and an update to the Medicare Advantage Value-Based Insurance Design (VBID) model that the agency launched in 2017.
The Part D model, titled the Part D Payment Modernization model, is voluntary as is the MA VBID update model, meaning that certain Medicare Advantage and Part D plans can choose to participate, and patients can choose to enroll in participating plans.
The Part D Payment Modernization model will begin in January 2020. The model is intended to test the impact of a revised Part D program design and incentive alignment on overall Part D prescription drug spending and beneficiary out-of-pocket costs.
The voluntary, five-year Part D Modernization model will be open to eligible standalone Prescription Drug Plans (PDPs) and Medicare Advantage-Prescription Drug Plans (MA-PDs) that are approved to participate.
The CMS fact sheet on the Part D Modernization model states: "Through this model, CMS is testing the impact of a modernized Part D payment structure that increases and better aligns Part D plan sponsor liability with the costs paid for by CMS and Medicare beneficiaries. Ultimately, this model will allow CMS to address the high list price of drugs covered by Medicare Part D and evaluate the impact on cost and quality for Medicare beneficiaries."
Read CMS fact sheet on Part D Modernization Model here .
More information is available on the CMMI website here .
The CMS press release is available here .
Posted 1/18/19
January 15, 2019
On January 14, Exelixis, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved cabozantinib (Cabometyx) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Read the full Exelixis, Inc. press release here .
Posted 1/15/2019
January 8, 2019
Over the past 25 years, the U.S. has seen a steady decline in the death rate from cancer, according to " Cancer Statistics, 2019 ," the annual report from the American Cancer Society (ACS) published online January 8, in CA: A Cancer Journal for Clinicians.
Between 1991 and 2016, the U.S. saw an overall 27 percent decrease in cancer deaths. The decrease is attributed to reduction in smoking and advances in early detection and treatment of cancer. However, the ACS report finds that not all of the U.S. population is benefiting equally. While the historic racial disparities in cancer death rates are lessening, socioeconomic gaps are widening.
A companion version of the report, " Cancer Facts & Figures 2019 ," includes a special section on the oldest old population in the U.S., which includes incidence, mortality rates, trends, survival, treatment, and challenges affecting this growing segment of the population.
Posted 1/8/19
January 3, 2019
The Centers for Medicare & Medicaid Services (CMS) has officially opened the data submission period for Merit-based Incentive Payment System (MIPS)-eligible clinicians who participated in Year 2 (2018) of the Quality Payment Program. With the exceptions noted in the paragraph below, data can be submitted and updated any time from January 2, 2019 to April 2, 2019 .
CMS Web Interface users need to report their Quality performance category data between January 22 and March 22, 2019. Also, for clinicians who reported Quality measures via Medicare Part B claims throughout the 2018 performance year, we’ll receive your quality data from claims processed by your Medicare Administrative Contractor, and claims for services furnished during 2018 must be processed within 60 days after the end of the 2018 performance period.
Clinicians will follow the steps outlined below to submit their data:
To log in and submit data, clinicians will need to use the new HCQIS Authorization Roles and Profile (HARP) system. Previously, clinicians received their credentials through the Enterprise Identity Management (EIDM) system. Clinicians are encouraged to log in early to familiarize themselves with the system.
Clinicians who are not sure if they are eligible to participate in the Quality Payment Program can check their eligibility status using the QPP Participation Status Tool .
To learn more about how to submit data, please review the 2018 MIPS Data Submission FAQs and other resources available in the QPP Resource Library .
If you have questions about how to submit your 2018 MIPS data, contact the Quality Payment Program by phone: (1-866-288-8292 / TTY: 1-877-715-6222) or email QPP@cms.hhs.gov.
Posted 1/2/2019
December 26, 2018
On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) approved tagraxofusp-erzs (Elzonris, Stemline Therapeutics), a CD123-directed cytotoxin, for blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
Read the FDA announcement here . Read the Stemline Therapeutics press release here .
Posted 12/26/18
December 20, 2018
On December 20, 2018, the Food and Drug Administration approved calaspargase pegol-mknl (Asparlas, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years. Read the full FDA press release here .
Posted 12/20/2018
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