Medicare National Coverage Determination (NCD) for Next Generation Sequencing (NGS) in Cancer3/19/2018
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! Joint Accreditation for Interprofessional Continuing Education (Joint Accreditation) offers organizations the opportunity to be simultaneously accredited to provide medical, nursing, pharmacy, and optometry continuing education activities through a single, unified application process, fee structure, and set of accreditation standards.
Joint Accreditation originally began by focusing on CME, CNE, and CPE. This meant collaboration across these groups:
The American Academy of PAs (AAPA) and the Association of Regulatory Boards of Optometry's Council on Optometric Practitioner Education (ARBO/COPE) have recently joined the Joint Accreditation collaboration. This growing collaboration will help to advance the vision of interprofessional continuing education (IPCE). Interprofessional continuing education (IPCE) is when members from two or more professions learn with, from, and about each other to enable effective collaboration and improve health outcomes. Question for the week: What is the difference between implicit vs. explicit learning?
Implicit learning involves a process where people acquire knowledge of new information through exposure (a passive process) Explicit learning involves a process where people seek out information, find it, and receive instruction (either actively or passively) Implicit learning is acquisition of knowledge about the underlying structure of a complex stimulus environment by a process which takes place naturally, simply and without conscious operations. Explicit learning is a more conscious operation where the individual makes and tests hypotheses in a search for structure. Knowledge attainment can thus take place implicitly (a nonconscious and automatic abstraction of the structural nature of the material arrived at from experience of instances), explicitly through selective learning (Nick C. Ellis) Don't miss the MIT paper written by Emile Bruneau titled, "Implicit vs. Explicit Learning Activity." For 2017, the Quality Payment Program (QPP) will calculate 2017 MIPS Performance accordingly:
Let's take a look at some of the "high" weighted improvement activities: Engagement of new Medicaid patients and follow-up Subcategory: Achieving Health Equity Participation in CAHPS or other supplemental questionnaire Subcategory: Patient Safety And Practice Assessment Provide 24/7 access to eligible clinicians or groups who have real-time access to patient's medical record Subcategory: Expanded Practice Access Use of QCDR for feedback reports that incorporate population health Subcategory: Population Management Oncology groups participating in the Oncology Care Model (OCM) are scored based on the requirements of participating in the APM. Before diving into government health policy documents around Medicare or Medicaid, be sure to familiarize yourself with some of these acronyms (this is a short, basic list):
ACA: Affordable Care Act AHIP: America’s Health Insurance Plans APM: Alternative Payment Model CMS: Centers for Medicare and Medicaid Services EHR: Electronic Health Record FFS: Fee-for-Service GAO: Government Accountability Office HCC: Hierarchical Condition Category HCP LAN: Health Care Payment Learning and Action Network Health IT: Health Information Technology HMO: Health Maintenance Organization HMOPOS: Health Maintenance Organization Point of Service ICD-10: International Classification of Diseases MA: Medicare Advantage MACRA: Medicare Access and CHIP Reauthorization Act of 2015 MAO: Medicare Advantage Organization MedPAC: Medicare Payment and Advisory Committee MIPS: Merit-based Incentive Payment System MLR: Medical Loss Ratio MMA: Medicare Prescription Drug, Improvement and Modernization Act of 2003 MSA: Medical Savings Account OIG: Office of Inspector General PFFS: Private Fee-for-Service PFS: Physician Fee Schedule PPO: Preferred Provider Organization QPP: Quality Payment Program SNP: Special Needs Plans |
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