9/28/22 Steering Committee Meeting
Please find the slides from the meeting here.
Please find the topics, all resources and content, along with a video recording of the meeting below.
We look forward to hearing from you.
Watch the recording of the meeting above.
0:00-2:39 Introduction
2:40-9:35 FDA Updates
9:36-14:03 Legislation
14:04-21:30 Payor Strategies
21:31-24:20 MDIC Updates
24:21-25:52 ctDNA
25:53-28:19 Diversity and Inclusion
28:20-36:34 Resources
36:35-46:23 Publications
46:24-53:14 Events & closing remarks
Meeting Summary & Content Links
FDA Updates
Advancing Regulatory Science at FDA (download)
Clinical Decision Support Software (download)
FDA Evaluation of Infant Formula Response (download)
Legislative Updates
ACLA Launches “Stop Lab Cuts” Campaign Urging Congress to Protect Patient Access to Laboratory Services (link)
StopLabCuts.org (link)
Prior Authorization: House passes bill to install electronic prior authorization in Medicare Advantage plans (link)
Huge operational budget
Cost still non-transparent
Discoveries in Health Policy (link)
VALID ACT = FDA oversight
SALSA = guardrails around PAMA
Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 (when FDA approved) Rep. Sewell
Medicare: Reducing Hereditary Cancer Act
Medicaid, prenatal genetic screening “Expanded Screening Access Act”
Precision Medicine Answers for Kids Today Act (Peds ICU genomics)
Right Drug Dose Now Act (Pharmacogenetics)
Patent Eligibility Restoration Act of 2022 (diagnostic test patents)
Find Act: Medicare Bundling in (Imaging) Diagnostics
State Law: Biomarkers => several states passed biomarker legislation
21 Century Cures Act 2.0 => ARPA-H = translational medicine institute
Letter to The Honorable Chiquita Brooks-LaSure, MPP Administrator, Centers for Medicare & Medicaid Services | Re: Notice of Proposed Rulemaking: Clinical Laboratory Improvement Amendments Fees: Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; CMS-3326-P (download)
VALID Act
Congress to Pass FDA User Fee Bill Without VALID Act, Again Putting Aside LDT Regulation (link)
Lawmakers attach user fees to CR, plan to revisit riders after mid-terms (link)
ARPA-H will:
Speed application and implementation of health breakthroughs to serve all patients
Foster breakthroughs across various levels — from the molecular to the societal
Build capabilities and platforms to revolutionize prevention, treatment, and cures in a range of diseases
Support “use-driven” ideas focused on solving practical problems that advance equity and rapidly transform breakthroughs into tangible solutions for all patients.
Focus on multiple time-limited projects with different approaches to achieve a quantifiable goal.
Use a stage-gate process, with defined metrics, and inject accountability through meeting these metrics.
Overcome market failures through critical solutions or incentives
Use the Defense Advanced Research Projects Agency (DARPA) as a model to establish a culture of championing innovative ideas in health and medicine.
Advanced Research Projects Agency for Health (ARPA-H) (link)
Payor Strategies
Medicare Coverage for Innovative Technology: What's the Scorecard? v2 (link)
Jiang et al., Comparison of US Hospital Cash Prices and Commercial Negotiated Prices for 70 Services (download)
Current Activities- Payor Strategy Workgroup
We need to educate community how to use these recently approved add-on codes:
Proposal and working on PODcast with DPA and CAP
Recording taking place at Pathology Visions
PIcc webinar to create awareness and understanding:
What is current landscape?
What is going on in Digital Health (e.g., HalioDx and Veracyt with crosswalk)?
How to develop more codes for DP?
How YOU, and webinar attendees can get involved:
e.g. set up clinical evidence study, work with DPA-Foundation to execute,…A meeting invitation will be sent soon.
Addressing above also to global DPA taskforce (Japan and Europe) to identify mutual pains and how to overcome
ESMO Scale for Clinical Actionability of Molecular Targets (ESCAT) (link)
Feinberg et al., Is There a Mathematical Resolution to the Cost-Versus-Value Debate? (download)
MDIC Updates
MDIC Cybersecurity Maturity Benchmarking report: To be released, October 2022
Please contact nfalah@mdic.org or jveetil@mdic.org with any questions about MDIC initiatives
Rincon-Gonzalez et al., Leveraging Patient Preference Information in Medical Device Clinical Trial Design (download)
MDIC MedTech Cybersecurity Summit (link)
MDIC 2022 Threat Modeling Bootcamps (link)
ctDNA
Merino Vega et al., Changes in Circulating Tumor DNA Reflect Clinical Benefit Across Multiple Studies of Patients With Non-Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors (download)
Draft Guidance: Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development (download)
Diversity and Inclusion
Frones et al., Equity, Equality, and Diversity in the Nordic Model of Education (download)
Shafi et al., Quantifying Individual-Level Inaccuracy in Glomerular Filtration Rate Estimation (download)
Certain Medicare Beneficiaries, Such as Urban and Hispanic Beneficiaries, Were More Likely Thank Others To Use Telehealth During the First Year of the COVID-19 Pandemic (download)
Resources
Lungevity
Reading a Biomarker Test Report (download)
Breakthrough Therapies (link)
Diagnostic Error Resources
Measure Dx: A Resources To Identify, Analyze, and Learn From Diagnostic Safety Events (download)
57 page .pdf
Safer Dx Framework
Excellent “quality management” resource
Which organizations recognize the value of Health Care Quality and Management (HCQM) Certification? (link)
Choosing Wisely for oncology in Brazil: 10 recommendations to deliver evidence-based cancer care (download)
Provides 10 high-yield recommendations
Focus “Brazil” - but applicable beyond
Oncology Task Force
Le Tourneau et al., An Approach to Solving the Complex Landscape in Precision Oncology: Learning from the Design of WAYFIND-R, a Global Precision Oncology Registry (download)
“Data Model”
Callahan et al., Ontologizing Health Systems Data at Scale: Making Translational Discovery a Reality (download)
Ontologizing Health System Data is a challenge
Pre-print (Callahan et al.,)
Translation Discover Focus
May-Newman and Cornwall, Teaching Medical Device Design Using Design Control (download)
Pei-Ying Lin et al., Analysis of Cancer Survival Associated with Immune Checkpoint Inhibitors After Statistical Adjustment (download)
Bonaguro et al., A guide to systems-level immunomics (download)
Publications
Baez-Navarro et al., Selecting patients with HER2-low breast cancer: Getting out of the tangle (download)
Wymann and Borsari, Two-drug trick to block systemic toxicity (download)
Acha-Sagredo et al., Somatic variation in normal tissues: friend or for of cancer early detection? (download)
Peled et al., Image-Based Detection of FGFR3-Mutations & Fusion in Urothelial Bladder Cancer (download)
Chen et al., Decoding Artificial Intelligence to Achieve Diagnostic Excellence Learning From Experts, Examples, and Experience (download)
Reyna et al., Rethinking Algorithm Performance Metrics for Artificial Intelligence in Diagnostic Medicine (download)
Ching-Roa et al., Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy (download)
Nazarian et al., Real-Time Tracking and Classification of Tumor and Nontumor Tissue in Upper Gastrointestinal Cancers Using Diffuse Reflectance Spectroscopy for Resection Margin Assessment (download)
Acosta et al., Multimodal biomedical Ai (download)
Havas et al., The role of aging in cancer (download)
Esplin et al., Universal Germline Genetic Testing for Hereditary Cancer Syndrome in Patients With Solid Tumor Cancer (download)
Mayer et al., Direct identification of ALK and ROS1 fusions in non-small cell lung cancer from hematoxylin and eosin-stained slides using deep learning algorithms (download)
Fernandez-Torras et al., Integrating and formatting biomedical data as pre-calculated knowledge graph embeddings in the Bioteque (download) (link)
Tiu et al., Expert-level detection of pathologies from unannotated chest X-ray images via self-supervised learning (download)
Rao et al., Exploring tissue architecture using spatial transcriptions (download)
Sinha et al., Beginner’s Guide for Systematic Reviews (download)
Downey, Think Python: How to Think Like a Computer Scientist (download)
Making Data Meaningful (download)
Moitra, Algorithmic Aspects of Machine Learning (download)
Perez, The Optimal Multi-Isotopic Atomic Code of Life: Perspectives in Astrobiology (download)
Lea et al., Who do you look like? Evidence of facial stereotypes for male names (download)
Berneburg et al., Changes in esthetic standards since 1940 (download)
Sekeres and Taylor, Diagnosis and Treatment of Myelodysplastic Syndromes (download)
Silver and Warner, ESCAT: a step in the right direction (download)
Karras et al., A cellular hierarchy in melanoma uncouples growth and metastasis (link)
Upcoming Events of Interest
October 12th, 2022 at 10:00 AM EST National Academies - Roundtable on Genomics and Precision Health - Realizing the Potential of Genomics across the Continuum of Precision Health Care: A Workshop (link)
October 16th-18th, 2022 in Las Vegas, Nevada DPA Association- The Lens of Innovation