Douglas Dew, MD, MBA, FAAOS’ Post

Do you need to better understand #commercial #benefits? Just updated & expanded, Integrated Pharmacy Benefits for Specialty #Pharmaceuticals covers medical or #pharmacy coverage issues that are important today. Included is a glossary of terms & acronyms to better understand the coverage landscape impacting access. LINK bELow #medical #cellandgenetherapy #insurance #employeebenefits https://lnkd.in/e9dnUJd #biotech #manufacturers #employers #epcouncil.org

Need Help with Your Plan of Correction? We’ve Got You Covered! Ensure compliance and streamline your improvement process with our Directed Plan of Correction Support. Our expert team offers tailored guidance to help you address deficiencies, meet regulatory requirements, and implement effective solutions. Get the support you need to stay on track and achieve lasting results. Davis Clinical has a 100% success rate for passing revisits! Let us help you turn challenges into opportunities. Contact us today to get started!

Thanks to Professor Alison Ritter, AO for her informative and generous review of my book on #DrugPolicyConstellations. Highlight for me: "There is a richness and a depth to this book; it can be read and re-read with new ideas emerging each time." https://lnkd.in/eGuYUGJZ

Edwards Lifesciences files en banc Petition re 271(e)(1) safe harbor  . Edwards Lifesciences has filed a Petition for rehearing en banc in the Federal Circuit case No. 22-1877 following a panel split 2-1 decision that held the 271(e)(1)’s safe harbor applies whenever any use reasonably related to obtaining FDA approval is found even if the accused infringing party also engages in so-called “alternative uses” (which Plaintiffs-Appellants argue is often commercial in nature).  The Edwards’ Petition notes that SCOTUS has twice granted review to consider the scope of the safe-harbor provision, and that SCOTUS has also prohibited courts from attempting to judicially “redline” a statute (citing Badgerow v. Walters, 596 U.S. 1, 11 (2022)).  Edwards also cites to Judge Lourie’s dissent urging the CAFC to consider en banc review to “fix [the Court’s] errors”, including recognizing the plain meaning of the word “solely” in the statute.  The Petition notes that Congress enumerated “a single basis for a safe harbor because it intended to exclude all others” (Petition at p. 15, citing Jennings v. Rodriguez, 583 U.S. 281, 300 (2018) for the principle of expressio unius).  The Petition concludes (pp. 18-21) noting the Supreme Court’s broad interpretation of the “reasonable relation” requirement in Merck KGaA v. Integra, 545 U.S. 193 (2005) and the close attention of industry stakeholders. The Petition is attached for your review (Document No. 64 filed May 24, 2024).

Creating a strong #MarketAccess strategy for your medical benefit drug can be tricky. MMIT's free ebook offers tips on ensuring a favorable status, keeping payer policies and clinical pathways aligned, and determining when contracting is needed. Download the ebook now to discover the five crucial steps your organization should take to establish a firm foundation for your commercialization journey: https://ow.ly/2n4450RIgnI. #MedicalBenefitTherapy #MedicalBenefitTherapies #CommercializationStrategy #HCPs

𝐬𝐩𝐫𝐞𝐚𝐝 𝐩𝐫𝐢𝐜𝐢𝐧𝐠 (𝐧): A common PBM practice of charging a health plan one price for a drug, paying the pharmacy less, and pocketing the difference. It happens. In fact, it happens so much it costs health plans and pharmacies an estimated $𝟕 𝐛𝐢𝐥𝐥𝐢𝐨𝐧 each year. But the fallout reaches much farther than that, if we're considering the financial impacts on pharmacies (which have closed at a rapid pace in recent years) and the artificially inflated drug prices that hurt uninsured and underinsured patients. https://lnkd.in/e4xwkWYv #PBMs #pharmacy #healthcare #PBMreform #spreadpricing #pharmacyreimbursement #pharmacybenefitmanagers #patientsfirst

Hey everyone! Want to be informed about what you're putting in your body? This FREE digital book, "Drugs: Know the risk before you do this sh*t", is your guide to understanding the effects of substances on your health and mind. Download your FREE copy by June 12th! Spread the Knowledge! We're aiming for 1,000 downloads to help everyone make informed decisions, we need about 600 more downloads. Share this with your friends so they can get their free copy too! Together, let's be informed on what we get high on! (Disclaimer: This book is for informational purposes only and does not replace professional medical advice.) https://lnkd.in/gSR3CsaQ

🌟 𝗙𝗿𝗲𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁: 𝗗𝗲𝗰𝗹𝗮𝗿𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁 (𝗗𝗼𝗜) 🌟 Simplify your Clinical Evaluation Report (CER) with our free Declaration of Interest (DoI) template! ⚠️ 𝗜𝗳 𝘆𝗼𝘂 𝗹𝗶𝗸𝗲 𝘁𝗵𝗶𝘀 𝗽𝗼𝘀𝘁, 𝗽𝗹𝗲𝗮𝘀𝗲 𝘀𝗵𝗮𝗿𝗲 𝗶𝘁 𝗶𝗻 𝘆𝗼𝘂𝗿 𝗻𝗲𝘁𝘄𝗼𝗿𝗸! 🔍 Why is it important? 🛡️ Ensures impartiality by addressing potential conflicts of interest. 🕵️♀️ Avoids Notified Body Non-Conformity. A ready-to-use, comprehensive document to 𝗺𝗮𝗸𝗲 𝘆𝗼𝘂𝗿 𝗟𝗶𝗳𝗲𝗘𝗮𝘀𝗶𝗲𝗿. 👉 Download now: https://lnkd.in/eK2xtrfF

Defining, Describing, and Defending Against Crisis in the Medical Product Industry The medical product industry faces unique challenges that can evolve rapidly into crises, often without warning. From regulatory disputes to safety concerns, companies must be prepared to handle potentially destabilizing events that threaten finances, reputation, and operations. Our book on regulatory crisis management offers crucial insights into managing these crises effectively, helping companies protect their interests and safeguard public health. Read More: https://lnkd.in/gJTijkpN Author: Dr. Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #book #regulatorycrisismanagement #medicalproductindustry #fdaregulations #fdacompliance

A few years ago, I stumbled upon a book by Dan Ariely #PredictablyIrrational and was captivated by its exploration of human behavior and decision-making. Little did I know that one concept from the book would profoundly influence my approach to procurement. As I delved into the pages, one concept stood out #TheAnchoringEffect - a psychological phenomenon that shapes our perception of value based on arbitrary reference points. Fast forward to a pivotal moment in my career: I was tasked with selecting a clinical trials service provider for my organization. While reviewing proposals from various providers, I couldn't ignore the subtle influence of anchoring. The high-priced options came adorned with bells and whistles, presenting themselves as the gold standard. Yet, I couldn't shake the realization that these features weren't necessarily what we needed. Recalling the lessons from #PredictablyIrrational I resisted the temptation to anchor our perception of value solely on price and prestige. Instead, I focused on identifying the essential services that aligned with the organization's goals and patient needs. By breaking free from the anchor's grip, I made a decision that prioritized #value and #efficacy over flashy extras. And as we partnered with a provider that offered tailored solutions at a reasonable cost, I couldn't help but reflect on how Ariely's teachings had guided me to a rational and informed choice.