There is a great article on Medium.com titled, "Tools for Systems Thinkers: The 6 Fundamental Concepts of Systems Thinking." The author outlines six critical building blocks for developing a systems perspective:
Read more about complex adaptive systems thinking.
The original guidelines for HER2 testing in breast cancer were jointly published by ASCO and CAP over 10 years ago, updated in 2013, and updated again in 2018.
The Focused Update of the “Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer” clinical practice guideline has been developed by an expert panel of pathologists and oncologists and issued by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) to address new information made available since the guideline’s previous update in 2013.
The 2018 Focused Update addresses uncommon clinical scenarios and improves clarity, particularly for infrequent HER2 test results that are of uncertain biologic or clinical significance. Some of the highlights include:
Published May 30, 2018 as an early online release in Archives of Pathology & Laboratory Medicine.
At the American Association for Cancer Research (AACR) meeting, several major updates in lung cancer immunotherapy studies were announced and thee articles were concurrently published in the NEJM:
Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer
Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden
Neoadjuvant PD-1 Blockade in Resectable Lung Cancer
April 16, 2018
April 2-8 marks National Public Health Week (NPHW). Each day is marked with a specific public health theme:
Monday, April 2: Behavioral Health
Advocate for and promote well-being
Focus on and advocate for improved access to mental and behavioral health services. Use education and training to de-stigmatize mental health diagnoses and encourage people experiencing mental illness to seek treatment. Coverage for mental health services must be on par with physical health services in all health insurance coverage.
Tuesday, April 3: Communicable Diseases
Learn about ways to prevent disease transmission
Wash your hands. Know your HIV status. Call on employers to support and provide sick leave so sick workers can care for themselves and avoid spreading disease to others. Support comprehensive sexual health education in schools, which can reduce rates of sexually transmitted disease (as well as teen pregnancy). Keep yourself and your families immunized against vaccine-preventable diseases — and get your flu shot!
Wednesday, April 4: Environmental Health
Help to protect and maintain a healthy planet
Reduce our collective carbon emissions footprint. Transition to renewable energies. Protect our natural resources and use evidence-based policy to protect our air, water and food. Support environmental health efforts that monitor our communities for risks and develop health-promoting interventions. Call for transportation planning that promotes walking, biking and public transit — it not only reduces climate-related emissions, but helps us all stay physically active.
Thursday, April 5: Injury and Violence Prevention
Learn about the effects of injury and violence on health
Increase funding to programs that reduce and prevent community violence. Advocate for occupational health and safety standards that keep workers safe on the job. Support policies that save those struggling with addiction from a fatal drug overdose. Many injuries are preventable with the appropriate education, policy and safety measures.
Friday, April 6: Ensuring the Right to Health
Advocate for everyone's right to a healthy life
Everyone deserves an opportunity to live a life free from preventable disease and disability. The places where we live, learn, work, worship and play should promote our health, not threaten it. That’s why creating the healthiest nation requires a dogged focus on achieving health equity for all.
On March 16, 2018, Centers for Medicare & Medicaid Services (CMS) took action to advance innovative personalized medicine for Medicare patients with cancer. CMS announced their final National Coverage Determination of Next Generation Sequencing tests, ensuring enhanced access for cancer patients.
CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer). CMS believes when these tests are used as a companion diagnostic to identify patients with certain genetic mutations that may benefit from U.S. Food and Drug Administration (FDA)-approved treatments, these tests can assist patients and their oncologists in making more informed treatment decisions. Additionally, when a known cancer mutation cannot be matched to a treatment then results from the diagnostic lab test using NGS can help determine a patient’s candidacy for cancer clinical trials.
This decision was made following the parallel review with the FDA, which granted its approval of the FoundationOne CDx (F1CDx™) test on Nov. 30, 2017. At the same time, CMS issued a proposed NCD for NGS cancer diagnostics. F1CDx™ is the first breakthrough-designated, NGS-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies as well as can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor.
In addition to covering the FDA-approved F1CDx™, CMS is covering FDA-approved or cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer and results are provided to the treating physician for management of the patient using a report template to specify treatment options.
“These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial,” said Kate Goodrich, M.D., CMS chief medical officer and director of the Center for Clinical Standards and Quality (CCSQ). “The expanded coverage in this final NCD now includes additional tests for relapsed, refractory, and earlier stage III cancers to aid in the treatment of these cancer patients.”
This NCD recognizes the importance of analytical and clinical validation of the diagnostic laboratory test that is part of FDA approval or clearance and provides national coverage after demonstration that use of the diagnostic laboratory test guides the management and treatment of the patient improves health outcomes. Tests that gain FDA approval or clearance as an in vitro companion diagnostic will automatically receive full coverage under this final NCD, provided other coverage criteria are also met. Coverage determinations for other diagnostic laboratory tests using NGS for Medicare patients with advanced cancer will be made by local Medicare Administrative Contractors. In addition, after considering all public comments, this final decision expanded coverage to patients with relapsed, refractory or stage III cancers. The final decision also extends coverage to repeat testing when the patient has a new primary diagnosis of cancer.
Be sure to read the JAMA articled viewpoint title, "Ascent to the Summit of the CME Pyramid." The authors Robin Stevenson, MD and Donald E. Moore Jr, PhD write that CME activities that are more likely to lead to improved clinical competence (level 4) and performance (level 5) result in better patient health (level 6). Those types of effective CME activities share 5 characteristics: (1) active learning techniques; (2) multiple exposures to content; (3) a variety of instructional strategies; (4) more time for deeper penetration into what is being learned; and (5) a focus on outcomes important to physicians. The current landscape of CME includes many fragmented efforts that ought to be to coordinated and prioritized to collectively address gaps in community or population health.
Michele Rubin, Donna Bacchus, Joseph Feuerstein, Terry Ann Glauser, Joseph Kim; P184 IMPROVING PROCESS OF CARE MEASURES FOR PATIENTS WITH IBD: KEY FINDINGS FROM A QI PILOT , Inflammatory Bowel Diseases, Volume 24, Issue suppl_1, 18 January 2018, Pages S73, https://doi.org/10.1093/ibd/izy038.022
Don't miss this complimentary CME activity titled:
Improving Patient Access to Biologic Therapies for IBD: Effective Practices for Community GI Providers
This online CME activity is hosted on myCME.com and expires on March 21, 2018.
We recognize that physician burnout is a major problem and several major organizations are working on initiatives to reduce the administrative workload, to improve well-being, and to foster resilience in healthy ways. Here are a few of those key examples:
CMS: Meaningful Measures and Patients Over Paperwork
AMA Administrative Simplification
ACP Patients Over Paperwork
ACP Physician Well-being and Professional Satisfaction
National Academy of Medicine Action Collaborative on Clinician Well-Being and Resilience
Encourage your pathologists, your lab professionals, and your cancer clinicians to participate in these free online CME activities hosted on the American Society for Clinical Pathology (ASCP) e-learning website:
An Overview of Immuno-Oncology
Immune-Related Adverse Events Secondary to Checkpoint-Inhibitor Therapy
Immuno-Oncology: Next-Generation Sequencing and the New Biomarker Landscape
Stay tuned as ASCP releases more online education focused on immuno-oncology this year!
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