March 23, 2018
On March 22, 2018, the U.S. Food and Drug Administration (FDA) approved nilotinib (Tasigna, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. Read FDA announcement .
Posted 3/23/2018
March 21, 2018
The United States Preventive Services Task Force (USPSTF) released its final recommendation statement on behavioral counseling to prevent skin cancer. The task force recommends counseling young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet (UV) radiation for persons aged 6 months to 24 years with fair skin types to reduce their risk of skin cancer. The USPSTF recommendation comes with B grade.
Read the recommendation here .
Read the full article published March 20, 2018, in the Journal of the American Medical Association .
Posted 3/21/18
March 20, 2018
The Centers for Medicare & Medicaid Services (CMS) has announced that the Oncology Care Model team will host a public forum for stakeholders on Thursday, May 3 from 1:00 PM – 4:00 PM EDT. All interested OCM stakeholders are invited to attend this public meeting, with the goal of hearing feedback about OCM. The meeting will include a brief introduction from the OCM team followed by discussion.
Registrants will be sent an agenda one week prior to the meeting that will include compiled topics submitted via the text field in the registration form.
Attendees may attend virtually or in-person at the Centers for Medicare & Medicaid Services Central Office located at 7500 Security Boulevard, Baltimore, Maryland 21244.
Registration for in-person attendance will close at 5:00 PM EDT on April 26, 2018 . Virtual registration will remain open until 1:00 PM EDT on Thursday May 3 . Virtual attendees will receive call-in information in the registration confirmation email.
Additional information, including access to the registration link, is available on the Oncology Care Model - Stakeholder Feedback Public Forum web page .
Posted 3/20/2018
March 20, 2018
On March 20, 2018, the U.S. Food and Drug Administration (FDA) approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Read the FDA announcement .
Posted 3/20/2018
March 13, 2018
A report from the President's Cancer Panel released March 13 calls on stakeholders from all segments of oncology to join together to "maximize the value and affordability of cancer drug treatment" while continuing to support investment in research to propel future innovations.
"Cancer patients should not have to choose between paying for their medications or paying their mortgages. For so many, it is truly a matter of life and death," said Barbara K. Rimer, DrPH, chair of the President's Cancer Panel, in a statement. "This is a national imperative that will not be solved by any one sector working alone."
The report, Promoting Value, Affordability, and Innovation in Cancer Drug Treatment , urges action informed by three guiding principles:
The President's Cancer Panel, established by the National Cancer Act of 1971, is an independent entity charged with monitoring the National Cancer Program and reporting to the President on any barriers to its execution. Learn more about the Panel's role and members .
Read the Executive Summary .
Read the Recommendations at a Glance .
Posted 3/13/18
March 13, 2018
The American Society for Radiation Oncology (ASTRO) today issued a new clinical guideline for the use of whole breast radiation therapy (WBRT) for breast cancer that expands the population of patients recommended to receive accelerated treatment known as hypofractionated therapy.
Reflecting current evidence from clinical trials and large cohort studies, the new guideline recommends hypofractionated WBI for breast cancer patients regardless of age, tumor stage, and whether they have received chemotherapy.
The guideline provides clinical guidance for dosing, planning and delivering whole breast irradiation (WBI) with or without an additional "boost" of radiation therapy to the tumor bed. Full recommendations and supporting evidence are provided in the guideline . Read the ASTRO press release .
Posted 3/13/18
March 7, 2018
Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma has announced the administration's new MyHealthEData, an initiative that aims to give Americans more complete access to their healthcare data. She made the announcement in an address on March 6, 2018, at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas. The government-wide initiative is being led by the White House Office of American Innovation with participation from the Department of Health and Human Services, including CMS; Office of the National Coordinator for Health Information Technology (ONC); the National Institutes of Health; and the Department of Veterans Affairs.
As part of MyHealthEData announcement, CMS also announced that the agency intends to "overhaul" the EHR Incentive Programs to "refocus the programs on interoperability and to reduce the time and cost required" for providers to meet requirements.
In her remarks, Administrator Verma also described Medicare's Blue Button 2.0 - a tool that would allow Medicare beneficiaries to access and their personal health data in a "universal digital format."
As part of this initiative, the administration is also calling on healthcare insurers to follow suit and give patients access to their claims data in a digital format.
The administration is still developing a timeline for the initiative, Verma said in an interview with Bloomberg BNA . Read the CMS press release . Read the CMS fact sheet .
Posted 3/7/18
March 6, 2018
On March 6, 2018, the U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.
The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.
The FDA press release states:
"Consumers and healthcare professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. Such decisions require confirmatory testing and genetic counseling. The test also does not provide information on a person’s overall risk of developing any type of cancer. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor." Read the FDA announcement .
Posted 3/6/2018
February 27, 2018
On February 26, 2018, the U.S. Food and Drug Administration FDA) approved abemaciclib (Verzenio™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Read FDA announcement .
Posted 2/27/2018
February 20, 2018
On September 16, 2018, the U.S. Food and Drug Administration (FDA) approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).
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February 14, 2018
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.
The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program , an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page . Read FDA press release .
Posted 2/14/2018
February 14, 2018
On February 14, 2018, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) jointly announced release of guidance on managing side effects of immunotherapy with immune checkpoint inhibitors. The organizations note that these guidelines pertain only to immune checkpoint inhibitors, not to other types of immunotherapy.
To date, several checkpoint inhibitor immunotherapies have been approved by the U.S. Food and Drug Administration (FDA) for treatment of a number of cancer types, including melanoma, Hodgkin lymphoma, and lung, liver, kidney, and bladder cancer. In the rapidly evolving cancer immunotherapy landscape, the number of agents, new indications, and combination therapies continues to grow.
In a joint news release, ASCO and NCCN briefly outline the guideline development process, which included convening multidisciplinary panels with representation from medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, and nursing, as well as patient advocacy experts. The clinical recommendations were based on a systematic literature review and an informal consensus process.
"The Management of Immune-related Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline," was published online February 14, 2018, in the Journal of Clinical Oncology. Read the article .
NCCN Guidelines® for Management of Immunotherapy-Related Toxicities were published online at NCCN.org on February 14, 2018.
ASCO and NCCN welcome feedback on their guidelines from oncologists, practitioners, and patients through the ASCO Guidelines Wiki or via the NCCN submission form at NCCN.org .
February 12, 2018
The National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine (NASEM) has announced that the final Proceedings from its public workshop , Incorporating Weight Management and Physical Activity Throughout the Cancer Care Continuum are now available.
The workshop, held February 13-14, 2017, in Washington, D.C., highlighted the current evidence base, gaps in knowledge, and research needs on the associations among obesity, physical activity, weight management, and health outcomes for cancer survivors. Presentations and discussions also examined the effectiveness of interventions for promoting physical activity and weight management among people living with or beyond cancer, as well as opportunities and challenges for providing weight management and physical activity interventions to cancer survivors. Download proceedings .
Posted 2/12/18
February 12, 2018
A report from the White House Council of Economic Advisors released on February 9 asserts the need for major policy changes at the federal level in order to lower drug prices, including reforms impacting the FDA and changes to Medicare and Medicaid.
Read " Reforming Biopharmaceutical Pricing at Home and Abroad ."
Posted 2/12/2018
February 9, 2018
The Centers for Medicare & Medicaid Services (CMS) is hosting three “Office Hours” sessions on Merit-based Incentive Payment Systems (MIPS) submission over the next several weeks. CMS subject matter experts will answer commonly asked questions about the submission feature on qpp.cms.gov , and answer attendees’ questions live. Registrants will also be able to submit questions by email prior to the sessions.
View “Office Hours” topics and register below. Please note that Qualified Registries, Qualified Clinical Data Registries and Web Interface Reporters should use their support calls for data submission support.
February 14, 3:30-4:30 pm ET
Quality Payment Program Data Submission Office Hours: Individual Eligible Clinician and Group Submission
February 28, 3-4 pm ET
Quality Payment Program Data Submission Office Hours: MIPS Quality Data Submission
March 14, 3-4 pm ET
Quality Payment Program Data Submission Office Hours: MIPS Attestation for Advancing Care Information and Improvement Activities
Space for these sessions is limited. Register now to secure your spot. The audio portion of the sessions will be broadcast through the web. You can listen to the presentation through your computer speakers.
For More Information
For step-by-step instructions on how to submit MIPS data, check out this video and fact sheet . Questions about your participation status or MIPS data submission? Contact the Quality Payment Program Service Center by
email: qpp@cms.hhs.gov .
February 8, 2018
Planning to submit data for the 2017 Merit-based Incentive Payment System (MIPS) Merit-based Incentive Payment System (MIPS) performance period? Deadlines are coming in March, and the Centers for Medicare & Medicaid Services (CMS) urges providers not to wait until the last minute to submit data.
The two key dates are:
If you’re not sure if you are required to report for MIPS, enter your National Provider Identifier (NPI) in the MIPS Lookup Tool to find out whether you need to report. Additionally, if you know you are in a MIPS APM or Advanced APM, you can use the APM Lookup Tool .
Questions about your participation status or MIPS data submission? Contact the Quality Payment Program Service Center by:
For more information and a quality reporting timeline, visit the Quality Payment Program website
Posted 2/8/18
February 8, 2018
The Janssen Pharmaceutical Companies of Johnson & Johnson on February 8, 2018, announced U.S. Food and Drug Administration (FDA) approval of a new indication for Zytiga (abiraterone acetate) in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer (CSPC).
Read Corporate Press Release
Posted 2/8/18
February 8, 2018
The American Society of Clinical Oncology (ASCO) reviews six leading commercial oncology pathway vendors in "Oncology Clinical Pathways: Charting the Landscape of Pathway Providers." The article, published online February 7, 2018, in the Journal of Oncology Practice, " assesses six commercial clinical pathway vendors using ASCO's criteria for high-quality clinical pathways.
Read ASCO Press Release Access Article and Learn More
Posted 2/8/18
January 26, 2018
On Jan. 26, 2018, the U.S. Food and Drug Administration (FDA) approved Lutathera (lutetium Lu 177 dotatate) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), a type of cancer that affects the pancreas or gastrointestinal tract. This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.
GEP-NETs can be present in the pancreas and in different parts of the gastrointestinal tract such as the stomach, intestines, colon and rectum. It is estimated that approximately one out of 27,000 people are diagnosed with GEP-NETs per year.
Posted 1/26/2018
January 25, 2018
On January 24, the U.S. Senate confirmed Alex Azar, as Secretary of the Department of Health and Human Services (HHS) by a 55-43 vote. Azar, a former Eli Lilly executive, is anticipated to align closely with Trump administration policies on the Affordable Care Act, Medicare spending, and other issues, reports Bloomberg BNA.
Posted 1/25/2018
January 25, 2018
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced the much-anticipated release of their updated guideline for molecular testing and targeted therapies in lung cancer. The work of these three leading medical societies, updates their 2013 evidence-based guidelines.
Published first online on January 23, the “ Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors ,” makes revisions to standards for the molecular analysis of lung cancers for test results that reflect advances in understanding of lung cancer and the increase in available molecularly-targeted therapies.
“Several factors influenced this update, which builds on the guidance we set forth in 2013,” said Neal Lindeman, MD, director of Molecular Diagnostics at Brigham and Women’s Hospital and Associate Professor of Pathology at Harvard Medical School in Boston, and AMP member. “Clinical practice guidelines must continually assess new evidence as it accumulates and consider new testing technologies as they emerge,” he said in a statement.
According to the IASLC press release , the updated guideline "strengthens or reaffirms" the majority of recommendations included in the 2013 guideline and recommends testing for some new genes.
View resources from CAP , IASLC , and AMP to help pathologists and oncologists review and implement the guidelines (includes a summary of recommendations, teaching presention, and FAQs).
Posted 1/25/2018
January 22, 2018
The Centers for Medicare & Medicaid Services (CMS) has stated that "During the time that the partial government shutdown is in effect, Medicare Administrative Contractors will continue to perform all functions related to Medicare fee-for-service claims processing and payment." This announcement was made through a special edition of CMS's MLN Connects dated Monday, January 22, 2018.
Posted 1/22/2018
January 19, 2018
The Medicare Payment Advisory Commission (MedPAC) voted on Jan. 11, to recommend to Congress that the Merit-based Incentive Payment System (MIPS) be scrapped. The federal advisory panel suggested replacing the quality reporting program with a Voluntary Value Program. MedPAC is an independent congressional agency established by the Balanced Budget Act of 1997 to advise the U.S. Congress on issues affecting the Medicare program.
Whether Congress will accept MedPAC's recommendation to eliminate MIPS is unknown. However, Bloomberg BNA reports that a House Energy and Commerce Committee spokesperson has indicated that the committee plans to continue work to ensure the success of MIPS.
Posted 1/19/2018
January 12, 2018
On Jan. 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.
This is the first FDA-approved treatment for patients with gBRCAm HER2-negative metastatic breast cancer. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib .
Posted 1/12/2018