August 3, 2018
On August 3, the Food and Drug Administration issued a warning against the long-term use of the antibiotic azithromycin (Zithromax, Pfizer Inc.) to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional data and will communicate its conclusions and recommendations when its review is complete.
The serious lung condition for which long-term azithromycin was being studied, called bronchiolitis obliterans syndrome, is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Cancer patients who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome.
Azithromycin is not approved for preventing bronchiolitis obliterans syndrome; there are no known effective antibiotic treatments for prophylaxis of bronchiolitis obliterans syndrome. Health care professionals should not prescribe long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome to patients who undergo donor stem cell transplants because of the increased potential for cancer relapse and death. Read the full FDA warning here.
Posted 8/3/2018
August 2, 2018
On August 22, join the Centers for Medicare & Medicaid Services (CMS) for a listening session on the CY 2019 Physician Fee Schedule (PFS) proposed rule.
During this listening session, CMS experts will briefly cover three provisions from the proposed rule and address clarifying questions to help formulate written comments for formal submission:
Participants are encouraged to review the proposed rule prior to the call, as well as the following materials on the provisions to be covered:
This listening session will take place from 1:30 - 3:00 PM ET . Click here to register for this listening session as well as other Medicare Learning Network events.
Posted 8/2/2018
August 1, 2018
On July 31, the Food and Drug Administration approved lusutrombopag(Mulpleta, Shionogi Inc.) for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 10 9 /L. Read the full FDA announcement here.
Posted 8/1/2018
July 31, 2018
On July 30, 2018, the U.S. Food and Drug Administration (FDA) approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site, and require systemic anticancer therapy. This is the first FDA-approved drug for this use.
Pheochromocytomas are rare tumors of the adrenal glands. These glands are located right above the kidneys and make hormones including stress hormones called epinephrines and norepinephrines. Pheochromocytomas increase the production of these hormones, leading to hypertension (high blood pressure) and symptoms such as headaches, irritability, sweating, rapid heart rate, nausea, vomiting, weight loss, weakness, chest pain or anxiety. When this type of tumor occurs outside the adrenal gland, it is called a paraganglioma. Read the FDA announcement .
Posted 7/31/2018
July 25, 2018
On July 25, 2018, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule for calendar year 2019. The deadline for submitting comments on the proposed rule is September 24, 2018.
ACCC is currently analyzing the rule and will provide an update to members soon.
Read the CMS fact sheet .
View the proposed CY 2019 OPPS rule .
Posted 7/25/2018
July 25, 2018
On July 18, the Government Accountability Office (GAO) issued a report that compares characteristics of hospitals participating in the 340 Drug Pricing Program with those not participating in the 340B Program. The report focuses on three types of hospitals that made up more than 95 percent of 340B participants in 2016.
The report examines the effects of Medicaid expansion on 340B participation and other characteristics such as rates of charity care provided.
Because for certain types of hospitals 340B eligibility is partially based on the number of Medicaid patients served, the report finds that 340B participation increased for those particular hospitals in states that expanded Medicaid. Read the report summary . View the full report .
Posted 07/25/18
July 24, 2018
On July 23, the House of Representatives passed four Energy and Commerce Committee bills to authorize critical health workforce programs:
Posted 7/24/2018
July 23, 2018
On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015. Read the Pfizer corporate press release here.
Posted 7/23/2018
July 20, 2018
The Centers for Medicare & Medicaid Services (CMS) will be hosting two "Office Hours" sessions over the next few weeks to provide a brief overview of the Merit-based Incentive Payment System (MIPS 2017) performance feedback and targeted review, answer frequently asked questions, and highlight available resources on performance feedback and targeted review. The two webinars will be held at the following times:
If you are interested in submitting a question to be considered, please email CMSQualityTeam@ketchum.com . This email address is only for office hours questions; do not use this to submit a targeted review request. Space for these sessions is limited; register now to reserve your spot. The audio portion of the sessions will be broadcast through the web. Questions? Contact the Quality Payment Payment program at qpp@cms.hhs.gov .
CMS is also hosting a series of webinars on the MIPS Performance Categories for Year 2 (2018) of the Quality Payment Program. The webinars will provide an overview on the Cost, Improvement Activities, and Quality performance categories for Year 2. CMS subject matter experts will cover topics including category requirements, scoring details, and data submission mechanisms. Below are details for these webinars:
MIPS Cost Performance Category for Year 2 (2018) Overview Webinar
MIPS Improvement Activities Performance Category for Year 2 (2018) Overview Webinar
MIPS Quality Performance Category for Year 2 (2018) Overview Webinar
The audio portion of these webinars will be broadcast through the web; you can listen to the presentation through your computer speakers. CMS will open the phone line for the Q&A portion, but if you are unable to hear audio through your computer speakers, please contact CMSQualityTeam@ketchum.com .
Posted 7/20/2018
July 20, 2018
On July 20, the Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. It is the first FDA-approved therapy for patients with R/R AML and an IDH1 mutation. Read the Agios corporate press release here.
Posted 7/20/18
July 18, 2018
On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy. Read the full FDA press release here.
Posted 7/18/18
July 16, 2018
On July 16, the Association of Community Cancer Centers (ACCC) submitted comments to the Request for Information (RFI) included in the administration's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs . The plan was released in May.
In its comments , ACCC expresses support for the overarching goal to "bend the cost curve by improving care, providing the right care at the right time, reducing over-treatment and under-treatment, and reducing hospital admissions and readmissions." However, ACCC cautions that "any policy solution to rein in drug costs must preserve patients' access to—and ability to afford—quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer providers."
In brief, ACCC comments on the following concerns:
Read the ACCC Comment letter for a full discussion of these issues.
Posted 7/16/2018
July 16, 2018
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC. Read FDA announcement .
Posted 7/16/2018
July 12, 2018
On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) released the CY 2019 Medicare Physician Fee Schedule (PFS) proposed rule . Included are proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare PFS on or after January 1, 2019.
The agency's proposals for Year 3 of the Quality Payment Program (QPP) are incorporated under the CY2019 PFS proposed rule .
Comments on the proposed rule are due by September 10, 2018.
ACCC is currently analyzing the proposed rule and will provide an in-depth analysis for membership.
Read the CMS fact sheet on the 2019 PFS proposed rule .
Read the CMS fact sheet on proposed QPP changes .
On Tuesday, July 17 from 1:00 - 2:30 PM ET, CMS will host a webinar on the proposed rule for Year 3 (2019) of the Quality Payment Program. CMS subject matter experts will:
Register here .
Posted 7/12/2018
July 10, 2018
In an effort to refocus nationwide efforts in oncology care, the American Cancer Society (ACS) has begun to outline its vision for cancer control in the 21st century through a series of articles. The first article in this series , published July 1, addresses trends in cancer mortality and disparities in cancer outcomes. ACS found that one area of critical disparity in cancer outcomes was socioeconomic status, indicated by educational attainment. Future articles in the series will focus on areas such as prevention, screening and early detection, cancer care and treatment, and research. Read the full ACS press release here.
Posted 7/10/2018
July 10, 2018
On July 10, the National Cancer Institute (NCI) and the Department of Veterans Affairs (VA) announced the launch of the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). NAVIGATE will be launching at 12 VA facilities across the country. As part of the agreement, NCI will provide infrastructure funding support needed for VA facilities to participate in NCI-sponsored clinical trials, and VA will manage organizational and operational activities within its national healthcare system to establish a network to focus on NCI trial goals. Read the full NIH press release here.
Posted 7/10/2018
July 3, 2018
In a report released on June 28, the Government Accountability Office (GAO) calls for improvement in federal oversight of compliance at 340B contract pharmacies. From 2010 to 2017, the number of pharmacies with which 340B covered entities have contracted increased from about 1,300 to almost 20,000. The 340B Drug Pricing Program is administered by the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS).
The GAO report describes:
1) financial arrangements selected covered entities have with contract pharmacies;
2) the extent that selected covered entities provide discounts on 340B drugs dispensed by contract pharmacies to low-income, uninsured patients; and
3) HRSA's efforts to ensure compliance with 340B Program requirements at contract pharmacies.
Among the report's seven recommendations for improving oversight are that HRSA audits assess for duplicate discounts in Medicaid managed care, and that HRSA require information on how entities determined the scope of noncompliance and evidence of corrective action before closing audits.
Read GAO recommendations .
Read full report .
Posted July 3, 2018
July 2, 2018
On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website . The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.
MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review.
If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018 . The following are examples of circumstances in which you may wish to request a targeted review:
You can access your MIPS final score and performance feedback and request a targeted review by:
CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:
For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).
Posted 7/2/2018
June 29, 2018
On June 29, the Centers for Medicare & Medicaid Services (CMS) announced that they would be advancing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, which would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who participate sufficiently in certain Medicare Advantage plans that involve taking on risk. CMS seeks public comment on the information collection burdens associated with the demonstration, which is under consideration for formal approval. Read the full CMS press release here.
Posted 6/29/2018
June 27, 2018
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Read FDA announcement .
Posted June 27, 2018
June 20, 2018
On June 15, 2018, the Association of Cancer Care Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's opening of a National Coverage Analysis (NCA) for CAR T therapies for cancer. Currently, two CAR T-cell therapies are approved the U.S. Food and Drug Administration, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel). In comments its to the agency , ACCC urged that CMS:
Additionally, ACCC expressed concern that the outcome of the NCA process may be stifling to innovation of CAR T therapies in the pipeline. Read ACCC Comment Letter
Posted 6/20/2018
June 13, 2018
On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.
Read the full FDA announcement here.
Posted 6/13/18
June 13, 2018
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Read the full FDA press release here.
Posted 6/13/2018
June 13, 2018
At the 2018 ASCO Annual Meeting, we had the opportunity to connect with many ACCC members and engage a wide audience! Oncology Business Review, OncLive, and ASCO Post sat down with a number of ACCC advocates and leaders to discuss pressing issues in cancer care.
ACCC Treasurer Randall A. Oyer, MD , with an update on the ACCC Immuno-Oncology Institute:
ACCC Immuno-Oncology Institute Executive Committee Member Ivo Abraham, PhD, RN , speaks about value in cancer care:
ACCC Past President Jennie R. Crews, MD, MMM, FAC P , describes how care coordination in immunotherapy is engaging new providers with the cancer care team:
Dr. Abraham shares his perspective on hurdles to adoption of biosimilars in oncology:
Watch more from Dr. Abraham on:
Key features of a biosimilar- via OBR
Biosimilars approved and nearing approval for oncology- via OBR
Biosimilar pricing and reimbursement- via OBR
Dr. McBride Discusses financial toxicity in oncology with OncLive :
Lee S. Schwartzberg, MD, FACP, discusses how the ACCC Immuno-Oncology Institute is evolving to support integration of IO in the community through new working groups, resources for cross-specialty care coordination, and team education for this rapidly expanding field. - ASCO Post
Dr. Zibelman discusses managing immune-related adverse events with OncLive :
Posted 6/13/2018