Steve Cagle, MBA, HCISPP, CHISL, CDH-E

The Medicaid Drug Rebate Program (MDRP) Final Rule introduces significant updates that manufacturers must navigate to remain compliant. To help you address these changes effectively, Riparian, part of Two Labs (an Envision Pharma Group), has developed the Medicaid Final Rule Reference Guide. This guide provides: ✅ Key insights into the Final Rule’s provisions. ✅ Actionable recommendations for compliance and risk management. ✅ Practical tools for evaluating operational and financial impacts. Download your copy now to stay informed and ahead of the curve: https://lnkd.in/gSeC5nDf Riparian combines regulatory expertise and innovative solutions to support your compliance needs. Let us help you meet these new challenges with confidence. #MedicaidFinalRule #GovernmentPricing #PharmaCompliance

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Check out this special presentation on Safeguarding Clinical Trial Data in the Age of Artificial Intelligence from RIC's Strategic Partner, Buchanan Ingersoll & Rooney PC.

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In today's Expert Contributor, Sandra Sanchez-Oldenhage, President & CEO of PharmaAdvice/BizAdvice, explains how the sanctity of patient data, once safely secured in medical offices, now faces an onslaught of digital predators. #MexicoBusinessNews #MexicoBusiness #ExpertOpinion

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Are your #SpecialtyPharmacies meeting program expectations? Management of external partners is an essential aspect of any program. In a NEW, must-watch webinar, Archbow Consulting pharmacy experts Gabrielle Brennan and Michael Poland reveal four critical best practices for Specialty Pharmacy performance assessments. Link to the webinar in comments. #pharma #biotech

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The recent Change Healthcare cyberattack is a wake-up call. APhA urges Congress and the administration to step up and protect our healthcare data. Read more in APhA CEO's latest blog post: https://ow.ly/nByh50Riwas #forpharmacy

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Understanding the vital role of a #HIPAA Privacy Officer is crucial for healthcare compliance. Explore how this position safeguards patient data. https://loom.ly/P-cRUnQ #IsItDrummondValidated #HealthcareCompliance

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ICYMI: Updated map of vertical integration helps you tell lawmakers what’s at stake #pharmacy #independentpharmacy #drugprices #PBm #PBMReform Read more https://lnkd.in/eitVcxEA

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From tracking gains and losses to managing unprofitable products, take a deep dive into pharmacy analytics on this week’s episode of the Beyond the Scripts Podcast. Watch the full episode here: https://redsail.us/4cfJuUY

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𝗔𝘂𝗱𝗶𝗼 𝗣𝗼𝗱𝗰𝗮𝘀𝘁: 𝗔𝗣𝟬𝟬3: What is cDI? The NextGen IT Stack for Life Sciences. https://lnkd.in/eFvRYXq9 This audio podcast discusses xLM's cDI solution. Continuous Data Integrity (cDI) is a suite of managed services built on data integrity principles that are crucial for life science companies. This podcast discusses the eight use cases of cDI, highlighting its benefits in various domains such as: - Application Lifecycle Management (ALM) - Document Management (DM) - Service Management (SM) - Risk Management (RM) - IT Operations Management (ITOM) - Email Security (MP) - Managed Treat Response (MTR) -Remote Monitoring & Management (RMM) The role of cDI in ensuring data integrity, regulatory compliance, and operational efficiency within the life sciences sector is discussed. This podcast is designed to provide you with insightful discussions on this important and cutting edge topic in healthcare.

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Digital #pharmacies occupy a unique space in the #healthcare landscape -- and they come with some unique #regulatory hurdles. Heidi McKinnon, PharmD, CHC (Head of Compliance) discussed some of those challenges, including licensing requirements, on our most recent episode of #AstonishingHealthcare. 🎧 Listen to the full episode here: https://okt.to/zG3F1L

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The Health Department empowers pharmacists to manage estradiol patch shortages with new substitution guidelines, ensuring uninterrupted patient care. Stay informed on the latest updates via the PBS Medicine Shortages page. #PricingandReimbursement #Pharmacy #RegulatoryAgencies #Healthcare #PatientCare #MarketAccessToday #MarketAccess

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#ICYMI: Consultants Corner is where Market Pathways checks in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access. Standards promote consensus and efficiency, but small companies face barriers in identifying, leveraging, and helping shape standards that can benefit their business. In this edition of Consultants Corner, Elisabeth George offers advice from her years of experience putting standards to use in medtech: https://bit.ly/4e3PkL6 #marketresearch #policyresearch #marketaccess #medtech

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InStockRx Collaborates with GS1 to Enhance Pharmacy Supply Chain Transparency Written by: Laisha Daley – InStockRx InStockRx, a centralized inventory hub for surplus medications, has announced a partnership with GS1, a global standards organization, as a Standard Solutions Partner. This collaboration aims to address key challenges in the pharmaceutical sector, including drug shortages and medication waste, while enhancing transparency and efficiency across the supply chain. Leveraging GS1’s globally recognized standards, InStockRx’s platform enables precise tracking and tracing of surplus medications, ensuring these resources are distributed to locations and individuals in need. The partnership aligns with broader efforts to create more sustainable healthcare systems and improve access to medications globally. Addressing Supply Chain Challenges The pharmaceutical industry faces significant challenges with billions of dollars’ worth of medications going unused annually while many patients encounter shortages of essential drugs. InStockRx’s data-driven platform and pharmacy-to-pharmacy marketplace aim to tackle these issues by redistributing surplus medications, reducing waste, and improving supply chain efficiency. Mac Dougherty, Co-Founder and CEO of InStockRx, highlighted the importance of the partnership: “Our collaboration with GS1 represents a critical milestone in creating a more sustainable and equitable pharmaceutical supply chain. By utilizing GS1’s standards alongside the Drug Supply Chain Security Act (DSCSA), we are enhancing supply chain integrity, preventing waste, and ensuring medications are available where they are needed most.” Recognized for Innovation The announcement follows InStockRx’s recognition at the 1871 Supply Chain Innovation Summit in Chicago, where the company was honored for its innovative solutions in addressing pharmaceutical waste and drug shortages. InStockRx was also selected as a Showcase Company at Venture Atlanta earlier this year. About InStockRx InStockRx provides a platform to optimize pharmacy supply chains by aggregating medication data, identifying surplus, and facilitating redistribution in compliance with DSCSA regulations. By employing artificial intelligence and data analytics, the platform supports pharmacy operations while addressing broader industry issues such as sustainability and accessibility. Contact Information: InStockRx Laisha Daley – Chief Marketing Officer Phone: +1 813-213-4945 Email: [email protected] Website: www.instockrx.com Stay on top of supply chain logistics news updates at The Supply Chain Report. Visit ADAMftd.com for free international trade tools. #PharmaceuticalSupplyChain #HealthcareInnovation #MedicationRedistribution #SustainablePharmacy #GlobalHealthcareAccess

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In this week's episode of The Biotech Bytes Podcast, Steve welcomes Julianne Averill, MS/CPA, SHRM-CP, NACD.DC, a Managing Director and CFO at Danforth Advisors, to the show. Julianne is at the forefront of biotech and digital health finance, providing vital guidance on corporate development strategies for companies navigating complex markets. We touch on the critical challenges of obtaining clean data, especially in healthcare tech, and how AI can help convert unstructured data into usable formats. Julianne discusses the importance of human supervision in AI tasks, ensuring accuracy and continuous improvement. Listen in to gain a deeper understanding of these critical topics. 👉 https://lnkd.in/e6mP4yg5 #podcast #biotech #IT #AI #CFO #DigitalHealth #finance #data #healthcare #tech

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🚀 Pharmacy Decision Support for Transitions of Care at adherent360 🚀 In the evolving landscape of #healthcare, effective transitions of care are critical to ensuring patient safety and optimal health outcomes. At adherent360, we are dedicated to enhancing #pharmacy operations that support these transitions with our innovative solutions. 📦 Our Key Solutions: 1. Meds-to-Beds -Deliver prepackaged, high-volume inventory 24/7. -Extend existing hospital pharmacy operations for seamless access to medications at discharge. 2. Automated Transitions of Care  -Utilize AI-driven workflows integrated with dispensing and patient discharge processes. -Reduce manual workflows and save valuable time for pharmacy staff, ensuring a streamlined discharge experience. 3. Delivery Coordination  -Integrated storage lockers to enhance efficiency. -Implement automated coordination between hospital pharmacies and couriers for timely home delivery of medications. -By leveraging these solutions, adherent360 aims to improve medication adherence, minimize readmission rates, and ultimately enhance the overall patient experience during transitions of care. Together, let’s create a smoother journey for patients as they navigate the healthcare continuum! #PharmacyDecisionSupport #TransitionsOfCare #adherent360 #MedicationManagement #HealthcareInnovation #MedstoBeds #AIinHealthcare

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The CMS 2025 Proposed Physician Fee Schedule (PFS) was released and, for the first time, includes codes specifically for DTx products. Three proposed new codes were created to cover the supply and management of FDA cleared "digital mental health treatment (DMHT) devices" as a physician service. Last year, DTA responded to the request for information on digital therapies from CMS in the proposed PFS. DTA strongly encouraged CMS to classify these products under the durable medical equipment (DME) and incident-to physician services benefit categories. Read DTA's 2023 Comment Here: https://lnkd.in/ehJYD24v While we asked for coverage of all federally regulated DTx under multiple benefit categories, and did not get everything we requested, CMS has responded favorably by introducing incremental updates. ❓ What is the PFS The PFS is the primary method of payment for enrolled health care providers. Medicare uses the PFS when paying:  🔹 Professional services of physicians and other health care providers in private practice. 🔹 Services covered incident to physicians' services (other than certain drugs covered as incident to services) 🔹 The PFS is updated annually with the proposal for the following year released mid-year and the final rule released at the end of the year. ❓ How does the proposed rule apply to me Coding, coverage, and reimbursement are critical to access in the US. CMS is a trend setter and has historically not covered DTx products in any streamlined capacity. This is the first time CMS has provided Medicare reimbursable codes for DTx products. These codes are furnished through physician services. If you haven’t looked at your product as a physician service, consider if this applies to you. ❓ Is this good news Yes! This is the first acknowledgement of a reimbursement pathway for a certain sector of DTx interventions. This sets a precedent for Medicare coding, coverage, and reimbursement that can be applied to additional therapeutic categories. This allows for fewer payment workarounds to gain traction for your product. This also signals to the investment community that there is a viable reimbursement pathway for DTx. If you are not FDA cleared, then this does not directly apply to you. However, you should keep working with DTA to ensure that you are up to date with the evolving landscape. ❓ What will happen next DTA will submit a response. DTA is seeking Members to work as a temporary sub-committee to develop an draft that we will share with the US Policy Task Group in mid-August for feedback. If you have interest in Sub-Committee, please reach out to [email protected] DTA will not lose sight of the additional reimbursement pathways necessary to complete the picture. #DTA #CMS #Medicare #DTx #DigitalTherapeutics #MedTech #HealthTech

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Long Island Plastic Surgical Group Faces Major Data Breach Investigation Federman & Sherwood has initiated an investigation into Long Island Plastic Surgical Group, P.C., following a data breach affecting sensitive patient information. The breach, reported on October 11, 2024, may have compromised personal, medical, and financial details of thousands of individuals. This incident has raised significant concerns regarding patient privacy and data protection standards. As investigations continue, those affected are urged to monitor their accounts for suspicious activity and consider enrolling in identity theft protection services. Read the full story here: https://lnkd.in/g4fQhKZM #DataBreach #Cybersecurity #PrivacyBreach #MedicalData #PlasticSurgery #LongIsland #FedermanSherwood #Investigation #PersonalData #PatientPrivacy #IdentityTheft #FinancialSecurity #HIPAACompliance #DataProtection #CyberAttacks #BreachNotification #HealthcareSecurity #RiskManagement #SecurityBreach #HealthcareData #LongIslandPlasticSurgicalGroup #LIPSG #PatientDataSecurity #MedicalPrivacy #DataSecurity #CyberAwareness #LegalAction #DataBreachResponse #SecurityIncident #CyberResilience

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