In the month of April 2019, the FDA announced the following new or expanded drug approvals:
FDA approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 19, 2019
FDA granted accelerated approval to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. April 12, 2019
FDA approved pembrolizumab (KEYTRUDA, Merck Inc.) for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test. April 11, 2019
i-PARiHS (Promoting Action on Research Implementation) framework for the implementation of knowledge into practice
The Promoting Action on Research Implementation in Health Services, or PARIHS framework, was first published in 1998. A revised version of the framework, called the integrated or i-PARIHS framework, was proposed in 2016 by Harvey and Kitson.
The main reasons for re-visiting the original PARIHS framework included:
The authors propose adding a new construct termed ‘recipient’. The core constructs of the i-PARIHS framework are facilitation, innovation, recipients and context, with facilitation represented as the active element assessing, aligning and integrating the other three constructs.
Read more about the i-PARiHS framework here:
Harvey G, Kitson A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2016;11:33. Published 2016 Mar 10. doi:10.1186/s13012-016-0398-2
The Centers for Medicare & Medicaid Services (CMS) include accredited CME as an improvement activity in the Merit-Based Incentive Payment System (MIPS) of the Quality Payment Program (QPP). These improvement activities are included in the current (PY2018) Clinical Practice Improvement Activities and are listed as Completion of An Accredited Safety or Quality Improvement Program (Activity ID IA_PSPA_28) under the Patient Safety and Practice Assessment category on the QPP website.
CME activities that meet the criteria for improvement activities in the Merit-Based Incentive Payment System (MIPS) of QPP must:
More information about "CME for MIPS" is available from the ACCME website: https://www.accme.org/cme-for-mips
The ACCME has also provided a step-by-step guide around CME for MIPS
The following description is taken from the QPP website: https://qpp.cms.gov/mips/improvement-activities
Completion of an Accredited Safety or Quality Improvement Program
Completion of an accredited performance improvement continuing medical education program that addresses performance or quality improvement according to the following criteria: • The activity must address a quality or safety gap that is supported by a needs assessment or problem analysis, or must support the completion of such a needs assessment as part of the activity; • The activity must have specific, measurable aim(s) for improvement; • The activity must include interventions intended to result in improvement; • The activity must include data collection and analysis of performance data to assess the impact of the interventions; and The accredited program must define meaningful clinician participation in their activity, describe the mechanism for identifying clinicians who meet the requirements, and provide participant completion information.
Subcategory Name: Patient Safety And Practice Assessment
Activity ID: IA_PSPA_28
This free CME activity is available from ASCP.org
Implementing Immuno-Oncology Education in a Community Cancer Center
This CME panel discussion features faculty and members of the inter-professional team involved in an Implementation Science (IS) pilot program at a community cancer center. Panelists will discuss key findings related to the challenges and barriers they had to overcome in implementing immuno-oncology education, lessons learned, and plans for sustaining changes and improvements.
The following free CME activity is available on myCME.com:
Applying the Latest Evidence to Improve Care for Patients with HR+/HER2- Metastatic Breast Cancer
The care of patients with metastatic breast cancer is becoming increasingly complex and there is a growing need to ensure that members of the cancer care team are working together to provide the best possible care that driven by the latest evidence. Continuing education can ensure that clinicians are employing effective models of team-based care coordination and implementing systems-based processes that are designed to improve the management of patients with HR+/HER2- metastatic breast cancer.
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.
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