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Why the Money in Healthcare is SO Important... Behind the Scenes with Healthcare Uncovered
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Apr 26, 2023
This video provides an in-depth exploration of the critical lack of financial understanding among physicians and the systemic issues contributing to the opacity and complexity of the U.S. healthcare system. Dr. Eric Bricker, an internist and healthcare finance expert, partners with Nomi Health to launch the "Healthcare Uncovered" series, aiming to democratize information on healthcare finance for medical professionals. He emphasizes that while doctors are highly educated in medicine, they receive virtually no training in the economics of healthcare, leaving them vulnerable to financial exploitation and hindering their ability to advocate effectively for their patients and practices. Dr. Bricker draws on his extensive experience, including founding Compass Professional Health Services, a company that helped 1.8 million people navigate the U.S. healthcare system, from doctors' visits to hospital stays and insurance complexities. He asserts that healthcare, despite its perceived intricacy, becomes "incredibly easy to understand" once one grasps the underlying incentives driving the behavior of various stakeholders—insurance companies, hospitals, doctors, and the government. He posits that money is a major, though not sole, incentive, and understanding its flow is key to comprehending the system's current state and identifying pathways for improvement by altering incentive structures. He even frames misaligned incentives within healthcare as a "public health threat," akin to environmental hazards. The discussion delves into the root causes of this financial illiteracy and systemic dysfunction. Dr. Bricker highlights the "complete vacuum of non-information" in medical education regarding how doctors get paid, how patients pay, and how hospitals are compensated. Furthermore, he points to a significant "lack of transparency" and "lack of competition" across the healthcare industry. He explains that consolidation among hospitals, health insurance companies (decreasing from dozens to just three or four major players), and Pharmacy Benefits Managers (PBMs) has been fueled by historically low interest rates and cheap debt, enabling mergers that subsequently lead to increased prices and reduced accountability. This absence of competitive pressure allows organizations to cut corners and avoid providing full, transparent answers. Ultimately, Dr. Bricker aims to empower physicians by helping them understand these dynamics. He acknowledges the widespread disheartening experiences among doctors but believes that by comprehending the "why" behind systemic issues and recognizing their inherent power, physicians can take "small, concrete steps" to improve patient care and their professional lives. The "Healthcare Uncovered" series is designed to provide these initial "training wheels," enabling doctors to begin their journey toward financial literacy and systemic change, fostering a more transparent and patient-centric healthcare environment. Key Takeaways: * **Critical Gap in Physician Financial Literacy:** Doctors receive virtually no formal training in healthcare finance during medical school or residency, leading to a profound lack of understanding regarding how they are paid, how patients pay for care, and how hospitals are compensated. This "vacuum of non-information" leaves them unprepared for the economic realities of their profession. * **The "Incentives" Framework for Understanding Healthcare:** The U.S. healthcare system, though complex, can be demystified by understanding the financial incentives that drive the behavior of key players, including insurance companies, hospitals, doctors, and the government. Comprehending these money flows is crucial for identifying systemic issues and pathways for change. * **Misaligned Incentives as a Public Health Threat:** Dr. Bricker views the current incentive structures within healthcare as detrimental to patient care and professional well-being, likening them to a public health hazard that needs to be addressed by physicians. * **Lack of Transparency and Competition:** A significant problem in healthcare is the pervasive lack of transparency and robust competition among providers, insurers, and other entities. This absence of competitive pressure allows organizations to operate with less accountability, leading to higher costs and less clear information. * **Impact of Industry Consolidation:** The healthcare sector has experienced extensive consolidation among hospitals, health insurance companies (reducing from dozens to a few major players), and Pharmacy Benefits Managers (PBMs). This consolidation, ironically fueled by cheap debt and low interest rates, leads to reduced competition, increased prices, and a further erosion of transparency. * **Physician Empowerment Through Knowledge:** Despite feeling disheartened by the system, physicians possess tremendous power. By understanding the underlying financial and structural dynamics, they can identify actionable, small steps to improve patient outcomes, enhance their professional careers, and advocate for systemic change. * **Simplifying Complex Healthcare Information:** The "Healthcare Uncovered" series aims to break down complex healthcare finance topics into understandable language, avoiding jargon, to make this critical information accessible to busy physicians who may not know where to start. * **Historical Context of Consolidation:** The video highlights a historical trend where the number of major health insurance companies has drastically decreased over the past 20-30 years, illustrating the long-term impact of consolidation on market dynamics. * **The Role of Debt in Consolidation:** Low interest rates and readily available cheap debt have inadvertently fueled consolidation across healthcare sectors, enabling mergers and acquisitions that subsequently allow consolidated entities to raise prices due to reduced competition. * **Actionable Steps for Physicians:** The initiative encourages physicians to take "baby steps" in learning about healthcare finance, asserting that even small increases in understanding can open up a world of possibilities for positive change in their practices and for their patients. Tools/Resources Mentioned: * **Nomi Health:** A partner in creating the "Healthcare Uncovered" series, focused on bringing transparency to healthcare finance. * **Healthcare Uncovered:** A video series designed to educate physicians and others about healthcare finance. * **Compass Professional Health Services:** Dr. Bricker's former company, which provided healthcare navigation services to employers and individuals. Key Concepts: * **Healthcare Finance:** The economic aspects of healthcare, including how services are paid for, how providers are compensated, and the financial flows within the system. * **Incentives:** The financial or non-financial motivators that influence the decisions and behaviors of individuals and organizations within the healthcare system. * **Transparency:** The degree to which information about healthcare costs, quality, and financial dealings is openly available and understandable to the public and stakeholders. * **Competition:** The presence of multiple providers or payers vying for business, which typically drives down prices and improves quality and transparency. * **Consolidation:** The process by which smaller companies merge or are acquired by larger ones, leading to fewer, larger entities dominating a market. * **Pharmacy Benefits Manager (PBM):** An intermediary between pharmaceutical manufacturers, pharmacies, and health insurance plans that manages prescription drug benefits. Examples/Case Studies: * **Compass Professional Health Services:** Dr. Bricker's company that grew to serve over 2,000 employer clients and 1.8 million people, demonstrating the need for and impact of healthcare navigation services. * **Consolidation of Health Insurance Companies:** The reduction from "dozens" of major health insurance companies 20-30 years ago to only "three or four" today, illustrating the dramatic impact of market consolidation. * **Consolidation of PBMs:** Mentioned as another sector where consolidation has reduced choices and competition.
Health Insurance Denials and Prior Authorizations--Impact on Patients, Doctors and Wall Street.
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Apr 23, 2023
This video provides an in-depth exploration of the true financial implications of health insurance prior authorizations and denials, challenging the perceived impact of announced reductions by major insurers like UnitedHealthcare. The speaker, Dr. Bricker, leverages the Pareto Principle (the 80/20 rule) to demonstrate how a seemingly significant decrease in the *number* of prior authorizations may have a minimal effect on the *total dollar amount* of claims requiring authorization, thereby maintaining tight control over medical loss ratios for insurance companies. The presentation progresses from an initial debunking of insurer claims to a detailed analysis of high-cost medical areas, the strategic motivations of health insurers, and the ultimate financial burden placed on patients and healthcare providers. Dr. Bricker meticulously explains the Pareto Principle, illustrating that approximately 80% of the total claim spend requiring prior authorization is concentrated within only 20% of the actual prior authorization requests. This stratification is further detailed, showing that the top 4% of prior authorizations account for 50% of the money, while the bottom 20% accounts for merely 1%. This principle is then applied to UnitedHealthcare's pledge to reduce prior authorizations from 13 million to 10 million annually (a 23% reduction). The video argues that this reduction, if applied to the low-dollar, high-volume prior authorizations, would result in barely more than a 1% decrease in overall payments to providers, rendering the reduction largely financially insignificant from the insurer's perspective. The discussion then shifts to identifying the specific high-dollar medical procedures that drive the majority of prior authorization costs. These include orthopedic and neurosurgeries (e.g., joint replacements, spine surgeries, scoliosis), organ transplants (predominantly kidney transplants), and oncology treatments (surgery, chemotherapy, radiation for common cancers like breast, colon, prostate, lung), as well as certain cardiac procedures (pacemakers, ICDs, stress tests, echocardiograms). These procedures often cost hundreds of thousands of dollars, making their prior authorization crucial for insurers. The video concludes by revealing that insurance companies intentionally maintain prior authorizations and denials as a "thermostat" to tightly control their Medical Loss Ratio (MLR), ensuring it stays within the Affordable Care Act's mandated 80-85% range. This control is so precise that even during periods of significant healthcare utilization shifts, such as the COVID-19 pandemic, major insurers like UnitedHealthcare maintained remarkably consistent MLRs, demonstrating their ability to adjust claim payments through these mechanisms. Key Takeaways: * **The Pareto Principle in Healthcare Finance:** The 80/20 rule is critical for understanding healthcare costs; 80% of the financial impact of prior authorizations comes from only 20% of the total number of authorizations. Similarly, 80% of a health plan's costs are driven by 20% of its members. * **Deceptive Prior Authorization Reductions:** A reduction in the *number* of prior authorizations (e.g., UnitedHealthcare's 23% decrease) does not equate to a proportional reduction in the *dollar amount* of claims impacted. Such reductions often target low-cost, high-volume procedures, leading to a minimal financial impact (potentially just over 1% of total payments). * **High-Dollar Prior Authorization Categories:** The vast majority of claim spend requiring prior authorization is concentrated in expensive clinical areas such as orthopedic and neurosurgeries (joint replacements, spine surgeries), organ transplants (especially kidney), oncology treatments (cancer surgeries, chemo, radiation), and complex cardiac procedures (pacemakers, ICDs). * **Strategic Use of Denials and Prior Authorizations:** Health insurance companies intentionally keep denials and prior authorizations in contracts to serve as a "thermostat" for tightly controlling their Medical Loss Ratio (MLR), which is the percentage of premium revenue spent on claims. This control is crucial for meeting regulatory requirements (ACA) and satisfying Wall Street analysts. * **Consistent Medical Loss Ratios:** Despite natural variability in medical care and claims submissions (e.g., higher claims in Q4 due to met deductibles, or shifts during a pandemic), major insurers demonstrate remarkably consistent MLRs quarter-over-quarter. This consistency is achieved by actively adjusting claim payments through denials and prior authorizations. * **Impact on Provider Revenue:** Prior authorizations and denials impose a significant financial burden on doctors and hospitals, costing them 16-25% of their revenue to manage these processes and fight for payment. This constricts their cash flow and operational efficiency. * **Patient Financial Responsibility:** Patients are ultimately financially responsible for care if their insurance company denies payment. The term "medical policy" used by insurers is often deceptive, masking what is effectively a document outlining non-coverage, leading to delayed or denied access to care. * **Quality of Engagement Over Quantity:** When engaging a patient population to control costs, it's crucial to focus on the "quality" (who is being engaged) rather than just the "quantity." Engaging the bottom 60% of plan members, who only drive 8% of total spend, will have almost zero impact on overall plan costs. * **Implications for Pharma and Med Device:** Pharmaceutical and medical device companies need to understand the PA landscape for their products. The prevalence and financial impact of PAs directly affect market access, patient adherence, and commercial strategies for high-cost drugs and devices, especially in areas like oncology, specialty drugs, and complex surgical implants. * **Data-Driven Market Access:** Leveraging data engineering and business intelligence to analyze PA trends, denial rates, and their correlation with specific products or clinical areas can provide critical insights for pharma companies to optimize market access strategies and patient support programs. Key Concepts: * **Pareto Principle (80/20 Rule):** An observation that roughly 80% of effects come from 20% of causes. In healthcare, this means a small percentage of prior authorizations or plan members account for a large percentage of costs. * **Prior Authorization (PA):** A requirement by some health insurance plans for a healthcare provider to obtain approval from the plan before performing a service or prescribing a medication. * **Denials:** When an insurance company refuses to pay for a medical service or prescription. * **Medical Loss Ratio (MLR):** The percentage of premium revenue that health insurers spend on medical care and quality improvement activities. The Affordable Care Act (ACA) mandates that insurers spend 80-85% of premiums on claims. * **Elective Surgeries:** Non-emergency surgical procedures that can be scheduled in advance, often subject to prior authorization. Examples/Case Studies: * **UnitedHealthcare's PA Reduction:** The video analyzes UnitedHealthcare's promise to decrease prior authorizations from 13 million to 10 million per year, demonstrating how this 23% reduction in count would likely result in a minimal (barely >1%) financial impact due to the Pareto Principle. * **High-Cost Procedures:** Specific examples include hip/knee replacements, spine surgeries, scoliosis surgeries, kidney transplants, and treatments for breast, colon, prostate, and lung cancers, as well as cardiac devices like pacemakers and ICDs. * **COVID-19 Impact on MLR:** The video highlights how UnitedHealthcare maintained remarkably consistent MLRs during Q3 and Q4 of 2021 and Q1 of 2022, despite the pandemic causing a decrease in elective surgeries and subsequent rebound, illustrating the insurer's tight control through PAs and denials. Tools/Resources Mentioned: * **Becker's ASC:** A source cited for news on UnitedHealthcare's prior authorization cuts. * **QIMacros.com:** A resource mentioned for understanding the Pareto Principle and Pareto charts. * **Dr. Bricker’s Book:** "16 Lessons in the Business of Healing," available at ahealthcarez.com.
End to End Regulatory Information Management Case Study of a Veeva RIM Implementation
Astrix On Demand Webinars for Life Sciences
/@astrixlifescience
Apr 19, 2023
This. The discussion covers critical aspects like harmonizing global regulatory processes, managing data migration and integration from legacy systems, ensuring compliance, and navigating large-scale enterprise software adoption within the life sciences industry. This video explores an end-to-end Veeva Regulatory Information Management (RIM) system implementation for a top 10 pharmaceutical company, transitioning from disparate legacy systems to a globally consistent solution. The speakers discuss the complexities of harmonizing processes and terminology across global teams managing regulatory, CMC, and safety submissions. The case study highlights a multi-year journey involving current state assessment, future state design, detailed requirements gathering, configuration, and phased rollout strategies. A key theme is the collaborative approach between the client, Astrix (the consulting firm), and Veeva, emphasizing strong program management, communication, and meticulous planning for process and data readiness, as well as user adoption in a highly regulated environment. Key Takeaways: * **Complex Global Harmonization:** Large pharmaceutical companies face significant challenges in harmonizing regulatory processes and terminology across global teams due to reliance on disparate legacy tools (spreadsheets, SharePoint, bespoke systems). * **Structured Multi-Workstream Approach:** Successful large-scale implementations require a highly structured approach with dedicated workstreams for different functional areas (e.g., CMC, Safety, Regulatory, Authoring, Archive, Labeling), ensuring focused effort and expertise. * **Criticality of Process & Data Readiness:** Meticulous assessment of current processes, definition of harmonized future states, alignment on terminology, and comprehensive data mapping, migration, and integration planning are fundamental to a successful RIM system rollout. * **Vendor Collaboration is Key:** Direct and continuous collaboration with the software vendor (Veeva) is crucial for understanding system capabilities, best practices, configuration options, and leveraging product roadmaps for future enhancements. * **Comprehensive Change Management & Adoption:** Effective user adoption plans, including stakeholder analysis, continuous communication (newsletters, intranet), and tailored training, are essential to manage the learning curve and ensure business continuity during phased rollouts. * **Navigating Implementation Hurdles:** Common challenges include managing team member bandwidth, coordinating global time zones, addressing workstream dependencies, and adapting to system changes while maintaining ongoing critical operations and submission deadlines. * **Phased Rollout Strategy:** An iterative, phased rollout, starting with core capabilities and gradually expanding scope based on system readiness, legacy constraints, and business continuity, is an effective strategy for managing large-scale enterprise software implementations.
Financial Implications of Ozempic, Wegovy and Mounjaro... Training Session Highlights
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Apr 16, 2023
This video provides an in-depth exploration of the financial implications of GLP-1 agonist medications, specifically Ozempic, Wegovy, and Mounjaro, for employer-sponsored health plans. The speaker, Dr. Bricker, begins by detailing each drug's profile, including its active ingredient (Semaglutide for Ozempic/Wegovy, Tirzepatide for Mounjaro), mechanism of action (primarily appetite suppression via GLP-1 agonism), FDA approval status (diabetes vs. weight loss), and typical dosages and administration. He highlights the significant weight loss potential of these drugs, while emphasizing that studies were conducted in conjunction with caloric deficits and exercise, not as standalone solutions. The presentation then transitions to the substantial costs associated with these medications and their rapid market adoption. Dr. Bricker provides specific sales figures for each drug in 2022, demonstrating their explosive growth and market impact. He calculates the annual cost of treatment for each medication, noting the pricing strategies employed by manufacturers. A core segment of the video is a detailed cost projection model for a hypothetical employer group, illustrating how quickly these drug costs can escalate from thousands to millions of dollars annually as adoption rates increase among eligible employees. Finally, the video delves into various cost containment strategies for employers. Dr. Bricker frames these options using the healthcare cost equation (cost per unit x number of units). He critically analyzes the role of Pharmacy Benefit Managers (PBMs), advocating for a shift from traditional PBM models, which he argues are incentivized by higher drug spend, to transparent pass-through PBMs. Other strategies discussed include prior authorization requirements, specialty carve-out programs (which are noted as controversial), and practical advice like optimizing Ozempic prescribing to utilize the most cost-effective 8mg pens for maintenance doses. Key Takeaways: * **GLP-1 Agonists are a Major Market Force:** Ozempic (Semaglutide), Wegovy (Semaglutide), and Mounjaro (Tirzepatide) are rapidly growing pharmaceutical products with significant sales (e.g., Ozempic at $9 billion in 2022, Wegovy up 400% year-over-year), indicating a substantial and expanding market. * **Distinct FDA Approvals and Mechanisms:** While all three are GLP-1 agonists causing appetite suppression and weight loss, Ozempic and Mounjaro are currently FDA-approved for Type 2 Diabetes, with weight loss as a significant side effect. Wegovy, a higher dose of Semaglutide, is specifically FDA-approved for weight loss in adults with obesity and comorbidities, and recently for adolescents aged 12 and over. * **Significant Weight Loss Potential with Lifestyle Integration:** These medications can lead to substantial weight loss (e.g., 10-13 lbs for Ozempic, 35 lbs for Wegovy, 25-52 lbs for Mounjaro). However, studies were conducted in conjunction with a 500-calorie daily deficit and 150 minutes of weekly exercise, emphasizing that they are not standalone "magic pills." * **High Annual Treatment Costs:** The annual cost for these medications is substantial, with Ozempic costing approximately $6,478 per year (when optimized), Mounjaro around $13,044 per year, and Wegovy exceeding $17,184 per year, posing a significant financial burden. * **Escalating Employer Health Plan Costs:** A model for a 1,000-life employer plan projects a potential $1.9 million annual increase in pharmacy costs if 50% of eligible obese members adopt these medications, representing a 19% increase in total health plan spend. This cost can scale to tens of millions for larger employers. * **Traditional PBMs May Exacerbate Costs:** The traditional PBM model, which profits from rebates and administrative fees tied to drug spend, is financially incentivized to increase the utilization of high-cost medications like GLP-1s, potentially working against employer cost containment efforts. * **Transparent PBMs as a Cost Mitigation Strategy:** Moving from a traditional PBM to a transparent or pass-through PBM model is recommended to align incentives and potentially lower the unit cost of medications by eliminating hidden profits and rebate structures. * **Prior Authorization Limitations:** While prior authorization is a common strategy to limit the number of units, the speaker suggests that PBMs may not be genuinely motivated to restrict access due to their financial models, making its effectiveness questionable. * **Controversial Specialty Rx Carve-Outs:** Some self-funded plans are implementing specialty carve-out vendors to exclude these medications from coverage, directing patients to pharmaceutical company patient assistance programs. This is a highly controversial but potentially significant cost-saving measure. * **Optimize Ozempic Dosing for Cost Efficiency:** Employers can reduce costs by ensuring that plan members on a maintenance dose of 1mg Ozempic are prescribed the 8mg pen, which provides more medication for the same cost as smaller pens, maximizing the "unit" for the "cost per unit." * **Understanding the "Healthy Obese" Population:** The video notes that up to a third of people classified as obese may not experience adverse health consequences, a concept known as "healthy obese," which could influence eligibility criteria for weight-loss medications. Key Concepts: * **GLP-1 Agonists (Glucagon-like peptide-1 receptor agonists):** A class of drugs that mimic the effects of the natural hormone GLP-1, stimulating insulin secretion, suppressing glucagon, and slowing gastric emptying, leading to improved glycemic control and appetite suppression. * **Semaglutide:** The active ingredient in Ozempic (for diabetes) and Wegovy (for weight loss). * **Tirzepatide:** The active ingredient in Mounjaro, a dual GLP-1 and GIP (glucose-dependent insulinotropic polypeptide) receptor agonist, offering a potentially more powerful effect. * **Traditional PBM vs. Pass-through PBM:** Traditional PBMs profit from spread pricing and rebates, often incentivizing higher drug spend. Pass-through PBMs charge a transparent administrative fee and pass all discounts and rebates directly to the client. * **Prior Authorization:** A process requiring healthcare providers to obtain approval from a health plan before prescribing certain medications or services. * **Specialty Rx Carve-Out:** A strategy where an employer's health plan excludes coverage for specific high-cost specialty medications, often directing patients to manufacturer-sponsored patient assistance programs. Examples/Case Studies: * **Ozempic Sales:** $9 billion in 2022, representing 77% year-over-year growth. * **Wegovy Sales:** $913 million in 2022, with a 400% year-over-year growth rate. * **Mounjaro Sales:** $280 million in Q4 2022, rapidly ramping up due to its recent approval. * **Employer Group Cost Projection:** A self-funded company with 500 employees (1,000 covered lives) and an average $10 million annual health spend could see an increase of $95,000 (2.5% adoption), $603,000 (16% adoption), or $1.9 million (50% adoption) in annual pharmacy costs due to GLP-1 medications.
Why We Need to Expand Patient Choice in Clinical Trials
Veeva Systems Inc
@VeevaSystems
Apr 13, 2023
This video provides an in-depth exploration of the evolution and future of clinical trials, emphasizing the critical need to expand patient choice and streamline site operations through technology. Featuring Tim Davis, VP of Strategy for MyVeeva for Patients, and Richard Young, the discussion aims to cut through the industry buzzwords like "decentralized clinical trials," "patient centricity," and "site centricity" to focus on practical, impactful strategies. The conversation traces the journey from archaic paper-based data collection to the promise of integrated digital platforms, highlighting the challenges and opportunities in managing clinical data, engaging patients, and navigating regulatory landscapes. The speakers delve into their early experiences in clinical data management, recalling the days of red and green pens, paper CRFs, and the initial skepticism surrounding electronic patient-reported outcomes (e-PRO) on devices like Palm Pilots. This historical context sets the stage for understanding the persistent challenges in data integration, where e-PRO data was often an "afterthought" and disconnected from the main clinical data management systems. Tim Davis argues that while regulators have become more supportive of digital solutions and patient-owned devices, the industry's own hesitancy and legacy practices often hinder innovation. He redefines patient centricity as simply "choice" and site centricity as "convenience," advocating for flexible, mixed-model approaches to trials rather than rigid adherence to the "decentralized" label. The discussion progresses to envisioning the future of "digital trials," emphasizing the necessity of a consistent, underlying platform that can flex to accommodate diverse patient needs and participation models, regardless of location. The COVID-19 pandemic is cited as a catalyst that exposed the shortcomings of disparate technology "islands" but also demonstrated the industry's capacity for rapid digital adoption. The podcast concludes with a "magic wand" thought experiment, where Tim Davis expresses a desire to overcome the historical baggage of e-PRO/e-COA, enhance patient recognition and transparency by sharing study outcomes, and eliminate the costly and often unnecessary practice of provisioning devices to every patient. The overarching message is to embrace the learnings from recent years and bravely move forward with integrated, patient-focused technological solutions. Key Takeaways: * **Evolution of Clinical Data Management:** Early clinical trials were heavily reliant on manual, paper-based data collection, leading to significant delays (often 8-14 weeks) between data recording and its availability for analysis, hindering timely insights. * **E-PRO Data as an Afterthought:** Historically, e-PRO/e-COA data was frequently treated as secondary to EDC data, often falling outside the primary purview of clinical data management teams, leading to integration challenges and being perceived as an additional burden. * **Bridging Real-time Data Gaps:** While early electronic methods (e.g., pain scales on rudimentary touchscreens) offered real-time patient data, the critical challenge lay in seamlessly integrating this data into the broader study database for comprehensive analysis and regulatory submission. * **Regulators are More Supportive:** Regulators are generally open to and supportive of digital solutions and the use of patient-owned devices in clinical trials, provided fundamental requirements like audit trails and data security are met. Industry hesitancy often stems from internal regulatory interpretations and a reluctance to be "first." * **Patient Centricity is Choice:** True patient centricity should be understood as providing patients with genuine "choice" in their participation, including flexibility in how and where they engage (e.g., remote visits, local pharmacies) and access to digestible educational information about their disease and trial. * **Site Centricity is Convenience:** Site centricity focuses on offering convenience to clinical sites through integrated technology solutions that operate "under one roof" with a single login, intuitive interfaces, and reduced administrative burden, especially when balancing multiple stakeholder demands. * **Rethinking "Decentralized Clinical Trials":** The term "decentralized clinical trials" is viewed as potentially restrictive, advocating instead for "digital trials" that offer inherent flexibility—a mix of remote, in-person, and hybrid approaches—tailored to patient needs and study design, rather than a rigid, all-or-nothing model. * **Integrated Data Strategy:** Data managers should adopt an "end-to-beginning" approach, considering how e-PRO data will integrate into the final data warehouse and statistical tables from the initial design phase. Consistent patient identification across all systems (EDC, RTSM, e-PRO) is paramount to avoid transcription errors and ensure data integrity. * **Overcoming E-PRO Legacy:** The industry must move past outdated e-PRO/e-COA practices, such as the historical necessity of providing every patient with a company-issued device (e.g., Palm Pilots), which is now an expensive and often unnecessary barrier to innovation. * **Enhancing Patient Recognition:** A significant improvement would be to "switch on" greater patient recognition and transparency by providing participants with high-level summaries of study outcomes, information on drug publication, and ongoing engagement, fostering trust and encouraging future participation. * **Eliminate Mandatory Device Provisioning:** The practice of mandatorily provisioning devices to all patients is costly, logistically complex, often disliked by sites, and frequently unnecessary, as most patients possess their own, often superior, mobile devices. A choice-based model is preferred. * **Leveraging COVID-19 Learnings:** The pandemic demonstrated the industry's ability to rapidly adopt digital technologies and maintain trial continuity under extreme pressure. These learnings about technology's potential and the need for adaptable operating models should inform future trial design and not be abandoned. * **Platform-Based Approach:** Moving away from disparate "islands" of technology vendors towards a unified, integrated platform approach (like Veeva's ecosystem) can significantly reduce timelines, improve data flow, and streamline the management of diverse data sources. **Tools/Resources Mentioned:** * **Palm Pilots:** Mentioned as an early, rudimentary device used for e-PRO data collection. * **EDC (Electronic Data Capture):** A standard system for collecting clinical trial data. * **e-PRO (Electronic Patient-Reported Outcomes):** Electronic methods for patients to report their own health status. * **e-COA (Electronic Clinical Outcome Assessment):** A broader term encompassing e-PRO and other electronic assessments. * **MyVeeva for Patients:** A patient-facing technology platform from Veeva Systems. **Key Concepts:** * **Patient Centricity:** Redefined as providing patients with "choice" and options in their clinical trial participation, focusing on convenience and accessibility. * **Site Centricity:** Defined as providing "convenience" to clinical sites through integrated and intuitive technology solutions that simplify workflows and reduce burden. * **Digital Trials:** A preferred term over "decentralized clinical trials," emphasizing the use of technology to enable flexible, mixed-model patient participation (remote, in-person, hybrid) based on individual needs and study requirements. * **Data Islands:** Refers to the common problem of disparate, unintegrated technology systems used across different aspects of clinical trials, leading to inefficiencies and data management challenges. **Examples/Case Studies:** * **Early Osteoarthritis Studies:** Use of rudimentary touchscreen devices in the early 2000s to collect pain scales from osteoarthritis patients, highlighting early efforts in e-PRO. * **Photocopied CRF Pages:** An anecdote about monitors photocopying paper CRF pages for visual analog scales, which resulted in incorrect measurements (e.g., 9.7cm instead of 10cm), underscoring the critical importance of data integrity and the flaws of paper-based methods for primary endpoints. * **COVID-19 Pandemic Impact:** The pandemic forced clinical trials to rapidly adopt layered technologies and adapt operating models, exposing both the challenges of disparate systems and the potential for technology to maintain trial continuity and accelerate drug development.
![Smpc/SPC [summary product characteristics ]](https://i.ytimg.com/vi_webp/NuaEf4sCMx0/maxresdefault.webp)
Smpc/SPC [summary product characteristics ]
PHARMACOPEDIA
/@PHARMACOPEDIA-rt2cu
Apr 10, 2023
This video provides a foundational explanation of the Summary of Product Characteristics (SmPC), often abbreviated as SPC. The speaker begins by defining SmPC as a document exclusively intended for healthcare professionals, emphasizing its crucial role in ensuring the safe and effective use of medications. The core purpose of the SmPC is to provide comprehensive and accurate information about a medicinal product, serving as a vital resource for informed decision-making in prescribing and dispensing. The content of an SmPC document is detailed, encompassing essential information such as a medication's ingredients, recommended dosage, and potential side effects. The video highlights that this critical information is derived from robust data, primarily clinical trials, and other validated sources. A key characteristic of the SmPC, as explained, is its dynamic nature; it is not a static document but is continuously updated to incorporate new scientific information and reflect changes in regulatory requirements, ensuring its ongoing accuracy and relevance. Throughout the explanation, the speaker reiterates the importance of the SmPC in empowering healthcare professionals. By providing up-to-date and reliable data, the SmPC enables these professionals to confidently prescribe medications and make well-informed decisions that prioritize patient safety and treatment efficacy. The consistent availability of accurate product information through the SmPC is presented as a cornerstone for maintaining trust in prescribed medications and upholding high standards of patient care within the healthcare system. Key Takeaways: * **Definition and Audience:** The Summary of Product Characteristics (SmPC), also known as SPC, is a critical regulatory document specifically designed for healthcare professionals. Its primary function is to serve as a definitive source of information regarding medicinal products. * **Essential Information Provided:** SmPC documents contain vital details about a medication, including its active ingredients, recommended dosages, administration routes, indications, contraindications, warnings, precautions, and potential side effects. This comprehensive data is crucial for safe and effective use. * **Role in Medication Safety:** A core function of the SmPC is to ensure the safe and effective use of medications. By standardizing and centralizing essential product information, it helps healthcare professionals understand the full profile of a drug before prescribing or dispensing. * **Evidence-Based Foundation:** The information contained within an SmPC is rigorously based on data derived from clinical trials and other scientific sources. This ensures that the guidance provided is evidence-based and reflects the most current understanding of the medication's profile. * **Dynamic and Regulatory Nature:** SmPC documents are not static; they are continuously updated to reflect new scientific findings, post-market surveillance data, and changes in regulatory requirements. This dynamic aspect underscores the importance of robust version control and dissemination mechanisms within the pharmaceutical industry. * **Informed Decision-Making for HCPs:** The SmPC empowers healthcare professionals to make informed decisions regarding prescribing and dispensing medications. Access to accurate and up-to-date information is fundamental for tailoring treatments to individual patient needs and minimizing risks. * **Impact on Patient Confidence:** By providing healthcare professionals with reliable information, the SmPC indirectly contributes to patient confidence in the medications they are prescribed. This transparency and accuracy are vital for therapeutic adherence and positive health outcomes. * **Regulatory Compliance Cornerstone:** For pharmaceutical companies, the creation, maintenance, and dissemination of an accurate SmPC are fundamental aspects of regulatory compliance. It represents a commitment to providing complete product information as mandated by regulatory bodies like the FDA and EMA. * **Implications for Medical Affairs and Commercial Operations:** The SmPC is a cornerstone for medical affairs teams in responding to inquiries from healthcare professionals and for commercial teams in ensuring promotional materials align with approved product information. Any AI solutions for these departments would heavily rely on SmPC data. * **Data Management Challenge:** The constant updates and the sheer volume of information within SmPCs present a significant data management challenge for pharmaceutical companies, requiring sophisticated systems for data integration, version control, and accessibility. Key Concepts: * **SmPC (Summary of Product Characteristics) / SPC:** A comprehensive regulatory document outlining the essential information about a medicinal product, intended for healthcare professionals to ensure its safe and effective use. It includes details on ingredients, dosage, side effects, and is regularly updated based on clinical data and regulatory changes.
How Power Works in Healthcare
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Apr 9, 2023
This video provides an in-depth exploration of how power structures operate within healthcare organizations, drawing parallels to political systems. The speaker, Dr. Bricker, leverages insights from Bruce Bueno De Mesquita's work, particularly "The Dictator's Handbook," to illustrate that all organizations, including hospitals, health insurance companies, physician groups, and pharmaceutical companies, are inherently political. He establishes that power distribution within these entities follows a predictable pattern, not just at the top leadership level but fractally throughout the entire hierarchy. The core of the discussion revolves around four fundamental rules leaders must follow to attain and maintain power. First, a leader cannot rule alone and must form a coalition of followers. Second, the leader must control the organization's financial resources and use this budgetary power to buy loyalty from their coalition. Third, it is crucial to keep the size of this inner circle or coalition relatively small to prevent internal squabbling and maintain control, as larger groups are harder to manage and require more resources to satisfy. Finally, leaders must ensure a large pool of potential candidates for the inner circle, making any current member easily replaceable if they become non-compliant, thereby removing their leverage and ensuring obedience. Dr. Bricker then extends this framework by explaining that these power relationships are fractal, meaning they repeat in smaller, self-similar patterns down the organizational chart. A department head, for instance, receives a budget from their superior and then, in turn, distributes portions of that budget to their own loyal supporters, forming their own mini-coalition and inner circle. This creates a pyramid of power where each layer replicates the dynamics of the layer above it. The video concludes by providing specific, real-world examples from healthcare to illustrate these abstract principles, offering concrete evidence of how these power dynamics play out in practice. Key Takeaways: * **Universal Political Dynamics:** All organizations, including those in healthcare (hospitals, pharmaceutical companies, health insurance carriers, medical schools), operate with inherent political power structures, not just formal hierarchies. * **The Four Rules of Power:** Leaders must (1) form a coalition of followers, (2) control financial resources to buy loyalty, (3) keep the inner circle/coalition small to minimize dissent, and (4) maintain a large pool of potential replacements to ensure compliance and leverage. * **Budgetary Control as a Loyalty Tool:** Access to and control over budgets (e.g., "slush funds" or discretionary spending) is a primary mechanism for leaders to secure and maintain loyalty from key personnel within their coalition. * **Fractal Nature of Power:** Power dynamics are not confined to the top; they are fractal, repeating at every level of an organization. Department heads, for example, manage their own budgets and form sub-coalitions among their teams. * **Siloed Information in Large Organizations:** Large healthcare organizations, particularly health insurance carriers, are often intentionally siloed and top-down. Information about strategic direction or overall operations is limited to a small leadership coalition, preventing broader understanding among employees. * **Intentional "Dumbing Down" of Workforce:** Some healthcare organizations may intentionally limit comprehensive training (e.g., the elimination of "group school" for health insurance sales reps) to reduce internal squabbling and ensure employees simply follow directives without questioning the broader strategy. * **Impact of Limited Employee Understanding:** This lack of holistic understanding among employees can lead to inefficiencies, misaligned efforts (e.g., sales reps unaware of utilization management practices), and a reliance on external resources for basic operational knowledge. * **Replaceability and Compliance:** The existence of a large pool of potential replacements for inner circle positions ensures that current members remain compliant and do not "rock the boat," as their leverage is minimal. This is exemplified by pre-tenured medical school faculty who must adhere to publishing goals to achieve tenure. * **Challenges for External Partners:** For consulting firms like IntuitionLabs.ai, understanding these internal political landscapes, budgetary controls, and information silos is crucial for successful engagement, identifying true decision-makers, and navigating resistance to change or new solutions. * **Opportunity for Value Proposition:** The observed lack of internal understanding within client organizations (e.g., health insurance employees watching external videos to understand their own industry) highlights an opportunity for external experts to provide clarity and strategic insights. Key Concepts: * **Political Power in Organizations:** The informal influence and control dynamics that exist within formal organizational structures. * **Coalition:** A group of followers or key individuals that a leader relies on to maintain power. * **Inner Circle:** The small, trusted group within a coalition that directly supports the leader and wields significant influence. * **Replaceability:** The ease with which a member of a coalition or inner circle can be substituted, which reduces their leverage and ensures compliance. * **Fractal Power:** The concept that power dynamics and structures repeat in similar patterns at different scales throughout an organization. * **Budgetary Power:** The control over financial resources used by leaders to reward loyalty and influence behavior. * **Siloed Organizations:** Organizational structures where different departments or teams operate in isolation, with limited information sharing or understanding of each other's functions. Examples/Case Studies: * **Hospital CEO Discretionary Budget:** A new hospital CEO provided a medical director with a special "slush fund" or discretionary budget outside the normal process to buy loyalty and encourage the pursuit of specific improvements in outpatient clinics. * **Health Insurance Carrier Siloing and "Group School" Elimination:** Major health insurance carriers are characterized by top-down, siloed structures where employees (e.g., sales reps) lack comprehensive training (e.g., the discontinued "group school") on overall operations like utilization management, leading to a disconnect between sales promises and actual member experience. * **Medical School Pre-Tenured Faculty:** Associate and assistant professors at medical schools are highly replaceable and must diligently pursue research and publishing goals to avoid being "gone" and to progress towards the scarce tenured full professor positions, demonstrating the principle of replaceability and compliance.
ISO 9001 - 2015 | QMS | Quality Management System | Global QMS | Summarized Video | DNG Academy
DNG Academy
/@dng-academy
Apr 8, 2023
This video provides a comprehensive overview of ISO 9001:2015, the international standard for Quality Management Systems (QMS). It delves into the definition of quality and QMS, outlining the standard's history, key revisions, and its 10 core clauses. The speaker highlights the numerous advantages of implementing ISO 9001, such as improved customer satisfaction, enhanced process efficiency, better risk management, and increased stakeholder confidence. Furthermore, the video offers practical guidance through 10 smart techniques for successful ISO 9001 implementation, alongside a discussion of common challenges organizations face during this process. Key Takeaways: * **Foundational QMS Framework:** ISO 9001:2015 provides a globally recognized, systematic approach to quality management, emphasizing continuous improvement, customer satisfaction, and the effective management of processes, which is critical for regulated industries. * **Strategic Focus Areas:** The standard places a strong emphasis on risk-based thinking, leadership commitment from top management, and understanding the organizational context, all of which are vital for robust quality and compliance strategies. * **Tangible Business Benefits:** Implementing ISO 9001 can lead to significant operational and reputational advantages, including streamlined processes, reduced waste, improved decision-making, enhanced supplier relationships, and a stronger market reputation. * **Structured Implementation Approach:** Successful adoption requires a structured approach involving top management buy-in, detailed project planning, gap analysis, comprehensive employee training, robust document control, and regular internal audits. * **Anticipating and Mitigating Challenges:** Organizations should be prepared for common implementation hurdles such as resistance to change, resource limitations, the complexity of the standard, and the need for effective communication and employee involvement to ensure sustained compliance and improvement.
Health Insurance Self-Funding Across America
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Apr 2, 2023
This video provides an in-depth exploration of health insurance self-funding trends across the United States, highlighting significant geographic and employer-size variations. The speaker, Dr. Bricker from AHealthcareZ, begins by presenting a visual map illustrating areas with higher (dark green) and lower (light orange) concentrations of self-funded employers. He identifies a "self-funding alley" in the Midwest and South (e.g., North Carolina, Virginia, Kentucky, West Virginia, Ohio, Indiana) where self-funding rates are notably high, contrasting with lower rates in populous states like California, Arizona, Nevada, and the Northeast (e.g., Massachusetts, New York, New Jersey, Maryland). The analysis then delves into specific data, breaking down self-funding rates by employer size: companies with 100-1,000 employees (mid-market) and those with over 1,000 employees. While large employers consistently show high self-funding rates (around 77% nationally), the mid-market segment exhibits considerable variability across states, with a national average of 42%. This mid-market segment is identified as the key area where employers' cost-consciousness regarding health benefits is most evident. The speaker posits that states with higher mid-market self-funding rates are more focused on the financial performance and efficiency of their employee health plans, as self-funded plans are generally less expensive without compromising quality. A core theme explored is the "push and pull" dynamic influencing self-funding decisions, primarily driven by business margins and health insurance carriers. Low-margin businesses, such as grocery stores or manufacturing (e.g., auto parts in Ohio and Indiana, general manufacturing in Pennsylvania, Iowa, Georgia, Carolinas), are "pushed" towards self-funding due to their intense focus on cost-cutting. Conversely, high-margin businesses like software, technology, finance, and biotech (prevalent in California, New York, Massachusetts) are less likely to self-fund because their substantial profits reduce the urgency for aggressive cost-cutting in health benefits. The "pull" factor comes from health insurance carriers, who actively discourage self-funding, especially in the mid-market, as they generate more profit from fully insured plans. The video concludes by noting a "social proof" or "herd mentality" among employers, where local CFOs and HR heads influence each other's decisions regarding self-funding. Key Takeaways: * **Geographic Disparity in Self-Funding:** There are significant regional differences in health insurance self-funding rates across the U.S., with a "self-funding alley" in the Midwest/South showing high rates and populous coastal states often exhibiting lower rates. * **Mid-Market as a Key Indicator:** The self-funding rate for mid-market employers (100-1,000 employees) is the most variable and indicative of a state's overall focus on cost-effective health benefits, averaging 42% nationally but ranging widely. * **Large Employers Consistently Self-Fund:** Employers with over 1,000 employees show a consistently high rate of self-funding (around 77% nationally), indicating that for larger organizations, self-funding is a standard practice regardless of location. * **Business Margins Drive Self-Funding Decisions:** Low-margin industries (e.g., manufacturing, grocery) are strongly incentivized to self-fund to cut costs, while high-margin industries (e.g., software, finance, biotech) are less focused on health benefit cost-cutting and thus less likely to self-fund. * **Health Insurance Carriers Discourage Self-Funding:** Insurance carriers actively work to keep employers, particularly in the mid-market, on fully insured plans because these generate higher profits for them compared to self-funded arrangements. * **High-Margin States Have Lower Self-Funding:** States with a high concentration of high-margin businesses like California (tech, entertainment), New York (finance), and Massachusetts (software, biotech) exhibit significantly lower mid-market self-funding rates (e.g., CA 31%, NY 29%, MA 35% vs. national average 42%). * **Low-Margin States Have Higher Self-Funding:** Conversely, states with a strong manufacturing base and other lower-margin industries, such as Pennsylvania (55%), Indiana (67%), Ohio (56%), Iowa (58%), Georgia (59%), and the Carolinas (61%), show much higher mid-market self-funding rates. * **Self-Funding Offers Cost Savings:** Self-funded health plans are generally presented as a less expensive option for employers without necessarily compromising the quality of care provided to employees. * **Social Proof and Herd Mentality:** Employer decisions regarding self-funding are influenced by local peer groups; CFOs and HR heads often adopt practices common among similar companies in their geographic area. * **Specific State Examples:** The video provides concrete data points, such as Nebraska having a very high self-funding rate (79%) for mid-market employers, potentially due to its concentrated employer base and social proof dynamics. Key Concepts: * **Self-funding (health insurance):** An arrangement where an employer directly assumes the financial risk for providing healthcare benefits to its employees, paying claims out of its own assets rather than paying fixed premiums to an insurance carrier. * **Fully insured (health insurance):** An arrangement where an employer pays a fixed premium to an insurance carrier, and the carrier assumes the financial risk for paying employee healthcare claims. * **Mid-market employers:** Companies typically defined as having between 100 and 1,000 employees. * **Low-margin vs. High-margin businesses:** Refers to businesses with different profit margins, influencing their sensitivity to cost-cutting measures, including health benefits. * **Social proof/Herd mentality:** A psychological phenomenon where people assume the actions of others in an attempt to reflect correct behavior in a given situation, often seen in business decision-making.
Veeva 22R3 Release Questions and Answers || Veeva 22R3 New Features || Veeva Vault Certification
The Corporate Guys
/@TheCorporateGuys
Mar 28, 2023
This video provides an in-depth exploration of the new features introduced in the Veeva Vault 22R3 release, specifically tailored for individuals preparing for the Veeva Vault certification exam. The speaker, Vaibhav Agrawal, begins by outlining critical information regarding the certification process, including deadlines, the number of attempts allowed, and passing score requirements. He then systematically delves into several key new features, explaining their functionality, configuration steps, and practical implications for administrators and users within the Veeva Vault ecosystem. The presentation emphasizes how these updates address common challenges and enhance the platform's capabilities in areas such as data management, workflow automation, and reporting. The core of the video focuses on practical enhancements that improve user experience and administrative control within Veeva Vault. Each new feature is presented with a clear explanation of its purpose and how it can be configured or utilized. For instance, the discussion on "Person Object Duplicate Detection" highlights a solution to prevent redundant user accounts, detailing the configuration settings for matching rules based on various parameters like email or name. Similarly, the "Notification Email Notification Status" feature is presented as a crucial tool for troubleshooting email delivery issues, providing administrators with visibility into the success or failure of notifications. The speaker's approach is highly practical, often relating the features back to real-world scenarios and potential exam questions. Further into the presentation, the video covers more technical and administrative improvements. The "Object Reference Field Formula" feature is explained as an advancement that allows for more complex formula configurations by enabling the use of object reference fields within text or ID functions, thereby enriching reporting and automation possibilities. The introduction of "Output Package Support for Migrating Group Data" addresses a significant pain point for administrators, allowing for the automated migration of user groups between Veeva Vault environments, which previously required manual effort. The discussion culminates with features like "Limit Workflow Participants" and "Document with Object Report Type," which offer enhanced control over workflow assignments and more flexible reporting capabilities by linking documents with related business objects. The speaker concludes by reiterating key points that are likely to appear on the certification exam, reinforcing the practical and exam-oriented nature of the content. Key Takeaways: * **Veeva Vault 22R3 Certification Details:** The certification exam for the 22R3 release must be completed by April 14, 2023. Candidates are allowed two attempts; a score of 80% or higher on the first attempt qualifies, while a score above 50% but below 80% allows for a second attempt. Scoring below 50% on the first attempt disqualifies the candidate. * **Person Object Duplicate Detection:** This new feature helps prevent the creation of duplicate person records (e.g., user accounts) in Veeva Vault. Administrators can configure detection settings to check for duplicates based on parameters like first name, last name, email address, or username, with options for exact or fuzzy matching. * **Notification Email Notification Status:** A highly valuable feature for troubleshooting, it allows administrators to check the delivery status of email notifications sent to specific users or roles. This can be accessed via the "Operations" tab, providing clarity on whether a notification was successfully sent or if there were delivery issues. * **Object Reference Field Formula:** Veeva Vault 22R3 enhances formula capabilities by allowing the use of object reference fields within formulas. This means administrators can now reference related objects directly within text functions (to retrieve names) or ID functions (to retrieve IDs), enabling more dynamic and powerful calculations and data displays. * **Output Package Support for Migrating Group Data:** Previously, migrating user groups between Veeva Vault environments required manual recreation. With 22R3, administrators can now include user groups in outbound packages, streamlining the migration process and reducing manual effort when moving configurations between sandboxes and production environments. * **Limit Workflow Participants:** This feature allows administrators to set a maximum number of participants for a specific role within a workflow start step. This prevents scenarios where a workflow task is assigned to an excessively large group (e.g., thousands of users), which could lead to operational inefficiencies. The default maximum is 5000, but it can be configured to a lower limit (e.g., 100). * **Workflow Participant Limit Error Handling:** If a workflow is initiated with a group that exceeds the configured maximum number of participants for a specific role, the system will now throw an error, preventing the workflow from starting. This ensures adherence to the defined participant limits and avoids unintended mass assignments. * **Document with Object Report Type:** This new report type enables users to create reports that use a document as the primary object and any related business object (e.g., Product, Country) as the secondary object. This allows for more comprehensive reporting that links document-centric data with other critical business information. * **Standard Report Type Object Limit:** When creating a standard report type in Veeva Vault, a maximum of 10 objects can be selected for inclusion. This is an important limitation to be aware of for report design and certification exam questions. * **Permissions for Glossary and Glossary Definition:** To view Glossary and Glossary Definition records in Veeva Vault, users require the "Content View Content" permission. This ensures controlled access to critical terminology and definitions within the system. Key Concepts: * **Veeva Vault 22R3 Release:** The latest major update to the Veeva Vault platform, introducing new features and enhancements. * **Veeva Vault Certification:** An examination validating an individual's knowledge and proficiency in configuring and managing Veeva Vault. * **Person Object:** A standard object in Veeva Vault representing individuals (e.g., users, external collaborators). * **Outbound Package:** A mechanism in Veeva Vault to package and migrate configurations, data, and components from one environment to another. * **Workflow:** An automated sequence of tasks and approvals within Veeva Vault, often used for document review, approval, or process management. * **Report Type:** A predefined structure in Veeva Vault that specifies which objects and fields are available for reporting, serving as the basis for creating reports. Examples/Case Studies: * **Duplicate Person Records:** The speaker provides an example of a user, Vaibhav Agrawal, having two accounts created due to lack of duplicate detection, leading to wasted licenses and administrative issues. The new feature resolves this by flagging potential duplicates during record creation. * **Email Notification Troubleshooting:** The speaker recounts personal experiences where he was unsure if a configured email notification was sent due to Outlook settings. The "Notification Email Notification Status" feature provides a direct way to verify delivery within Veeva Vault. * **Workflow Participant Overload:** An example is given where a workflow task might be assigned to a group of 1000 users, causing inefficiency. The "Limit Workflow Participants" feature allows setting a maximum (e.g., 100) to prevent such scenarios and ensure tasks are assigned to manageable groups.
Veeva Systems Stock | Cheap or Expensive ???
KNTV
/@kncashtv
Mar 27, 2023
This video explores a financial analysis of Veeva Systems (VEEV stock), discussing whether its current valuation makes it a cheap or expensive investment. The speaker delves into Veeva's business model, highlighting its dominant position within the pharmaceutical, biotech, and medtech industries, serving these sectors with cloud-based solutions across Development, Commercial, and Data Clouds. A significant portion of the discussion focuses on Veeva's impressive revenue growth, market capitalization, and the strategic importance of its flagship Vault platform, which accounts for 60% of its revenue. The analysis also touches upon customer stickiness due to deep product integration, Veeva's substantial total addressable market (TAM), consistent execution on long-term revenue goals, and the role of R&D in maintaining its competitive edge.ai offers its AI, CRM consulting, and data engineering services. * **High Customer Stickiness:** Veeva benefits from significant customer lock-in due to deep product integration and the complexity of switching systems, indicating a stable and entrenched market for related consulting and integration services. * **Strong Growth and Market Potential:** Veeva's consistent revenue growth, large total addressable market, and ambitious long-term targets confirm the robust and expanding demand for specialized cloud solutions in the life sciences sector.
Separate VIP Customer Service for Heath Insurance
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Mar 26, 2023
This video provides an in-depth exploration of the distinct and often preferential customer service experience afforded to corporate executives within the U.S. health insurance system, contrasting it sharply with the standard process for general employees. Dr. Eric Bricker, the speaker, argues that the personal health insurance experiences of C-suite executives are a significant, yet often overlooked, impetus for companies to change their health insurance carriers. He posits that this "special treatment" for a small segment of the workforce ultimately hinders broader, positive changes in employer-sponsored health plans. The core of Dr. Bricker's argument revolves around the existence of what he terms "Rapid Resolutions Teams" within health insurance carriers. These are described as highly specialized, "Green Berets and Seals" of customer service, dedicated to swiftly resolving health insurance claim issues for executives. Unlike regular employees who navigate standard, often frustrating, customer service channels, executives (or their family members) typically escalate issues directly to HR. HR then contacts the company's insurance broker/consultant, who in turn reaches out to the carrier's account executive. It is this account executive who possesses the exclusive access to the Rapid Resolutions Team, ensuring that executive claims are often paid without dispute, mitigating the risk of the company switching carriers. Dr. Bricker quantifies this disparity, noting that there are approximately 1 million C-suite executives in America, compared to 78 million workers with employer-sponsored insurance. This means roughly 1.3% of the insured workforce receives this expedited, high-priority service. He further estimates that about 200,000 executives annually experience significant health issues (like cancer, cardiovascular disease, or musculoskeletal problems) that require substantial health insurance use. For insurance carriers, retaining the business of a company whose executive is experiencing a claim issue can represent billions of dollars in annual healthcare spending. This immense financial stake motivates carriers to maintain these specialized resolution teams, effectively insulating executives from the common frustrations of health insurance, and thus removing a key driver for them to advocate for systemic change. Key Takeaways: * **Executive Claims Drive Corporate Change:** Personal health insurance claim denials or negative experiences for C-suite executives (CEO, CFO, CTO, etc.) are a primary catalyst for companies to switch health insurance carriers, often more so than high renewal rates or widespread employee dissatisfaction. * **"Rapid Resolutions Teams" for Executives:** Health insurance carriers maintain specialized, hidden customer service units, dubbed "Rapid Resolutions Teams," designed to quickly and favorably resolve claim issues for corporate executives and their families. * **Bypassing Standard Customer Service:** Executives do not typically engage with standard health insurance customer service. Instead, their claim issues are escalated through a specific chain: Executive -> HR -> Broker/Consultant -> Carrier Account Executive -> Rapid Resolutions Team. * **Disparity in Service:** This executive-level process stands in stark contrast to the experience of the vast majority of employees, who must navigate often inefficient and unhelpful standard customer service channels, frequently without resolution. * **Quantified Privilege:** Approximately 1 million C-suite executives exist among 78 million workers with employer-sponsored insurance, meaning only about 1.3% of the insured workforce benefits from this "special treatment." * **Significant Financial Stakes:** For insurance carriers, each "sick" executive represents potentially billions of dollars in healthcare spending for their company. This financial incentive drives carriers to prioritize executive satisfaction to prevent losing large corporate accounts. * **"Rules for Thee, But Not for Me":** The system perpetuates a two-tiered approach to health insurance, where executives are largely shielded from the frustrations that plague the general workforce, leading to a lack of personal impetus for systemic change. * **Executive Health Profile:** The average age of an executive is 51, compared to 44 for the average worker, making them more likely to experience significant health issues such as cancer, cardiovascular problems, or musculoskeletal conditions. * **Access to Care Beyond Insurance:** Beyond insurance claims, executives often have better access to specialized doctors and hospitals due to their connections, further differentiating their healthcare experience from that of typical employees. * **Impact on Broader Healthcare Reform:** The speaker argues that this insulated executive experience prevents the "pain" necessary to drive significant, positive changes in employer-sponsored health plans across America, as those with the power to enact change are often not personally affected by the system's flaws. Key Concepts: * **C-suite:** Refers to the highest-ranking executive positions within a company, typically including CEO, CFO, COO, CTO, CIO, CHRO, and Chief Revenue Officer. * **Rapid Resolutions Team:** A specialized, internal department within health insurance carriers dedicated to quickly resolving complex or denied claims for high-value corporate clients' executives, often by simply paying the claim. * **Employer-sponsored insurance:** Health insurance plans provided by employers to their employees and their dependents, a dominant form of health coverage in the U.S. Examples/Case Studies: * The speaker recounts an instance where a major high-tech/biomedical manufacturer with over 10,000 employees completely re-evaluated and changed its health insurance plan priorities due to a high-level executive's negative experience with cancer treatment, both clinically and in terms of their insurance.
Episode 9: How Can We Prepare for the Future of Clinical Trials?
Veeva Systems Inc
/@VeevaSystems
Mar 22, 2023
This podcast episode, hosted by Richard Young of Veeva Vault CDMS and featuring Rhona O’Donnell, VP of Data Management Systems and Standards at Novo Nordisk, delves into the evolving landscape of clinical trial data management and how the industry can prepare for its future. The discussion traces the journey of data management from its early, paper-based days to the complex, technology-driven environment of today, highlighting the significant increase in data volume and the expanded responsibilities of data managers. A central theme is the urgent need for the pharmaceutical industry to embrace risk-based approaches in data management to enhance efficiency, ensure data quality, and address talent shortages. The conversation begins by contrasting the past, where data management involved manual tracking of paper CRFs and double data entry into systems like OC, with the present challenges. Rhona O’Donnell shares anecdotes from her early career, illustrating a slower pace and more centralized teams, which offered a longer grounding for new data managers. Today, data managers are expected to quickly become functional leads, involved in all project meetings, and manage risks and issues—a far cry from the "back-end services" role of the past. This evolution, coupled with a persistent talent shortage, underscores the necessity for innovative training programs, such as industry-wide academies, to equip the next generation with the skills to navigate increasingly complex technological landscapes. A significant portion of the discussion focuses on the industry's slow adoption of risk-based data management (RBDM), despite the successful implementation of risk-based quality management (RBQM) in clinical monitoring. The speakers argue that the pursuit of "perfection" for every data point is unsustainable and inefficient, especially given the exponential increase in data volume (from 10 data points per page to potentially millions per patient per day). They advocate for a shift in mindset to accept a certain tolerance for errors in less critical data, allowing technology to surface true signals for investigation. This strategic change is presented as crucial for making trials more sustainable, improving data quality where it matters most, and alleviating pressure on overstretched teams. The episode also highlights Novo Nordisk's "Study Builder" project as a forward-thinking initiative. This system aims to create a metadata repository that defines standards from the protocol all the way through data collection to Tables, Figures, and Listings (TFLs). The goal is to solidify standardization, enable end-to-end efficiency, and provide a framework for automation opportunities across the entire study lifecycle, from CRF build in EDC to data cleaning. This project exemplifies how a major pharmaceutical company is proactively addressing the challenges discussed, emphasizing that significant time and cost savings can be achieved by optimizing processes at the study's outset, rather than solely focusing on accelerating the end-of-study submission. The speakers conclude by stressing the importance of greater collaboration among CROs, sponsors, regulators, and technology companies to develop shared roadmaps and standards, leveraging collective intelligence to drive the industry forward. Key Takeaways: * **Elevated Role of Data Management:** Data managers have transitioned from a "back-end services" role to critical "functional leads" involved in all project phases, including risk and issue management, demanding a broader skill set and earlier engagement in trial design. * **Talent Shortage and Training Imperative:** The industry faces a significant talent shortage in data management, necessitating investment in academies and graduate programs to prepare the next generation, who possess innate technological savviness, for the speed and complexity of modern clinical trials. * **Urgency for Risk-Based Data Management (RBDM):** While risk-based quality management (RBQM) is adopted in monitoring, RBDM is lagging. The industry must move away from the unsustainable pursuit of "perfection" for all data points, tolerating minor errors in less critical data to focus resources on key efficacy and safety data. * **Leveraging Technology for Data Flow Oversight:** With the proliferation of external data sources, decentralized clinical trials (DCTs), and hybrid models, there's a critical need for integrated technology solutions and dashboards to oversee complex data flows and identify issues proactively. * **Standardization through Metadata Repositories:** Novo Nordisk's "Study Builder" project demonstrates the power of a metadata repository to enforce end-to-end standardization from protocol definition to TFLs, enabling greater efficiency and automation across the entire study lifecycle. * **Significant Automation Opportunities:** Defining standards within a system like "Study Builder" creates numerous opportunities for automation, such as automated CRF building in EDC, streamlining processes, and reducing manual effort. * **Focus on Upfront Efficiency:** The greatest opportunities for time and cost savings lie in optimizing the initial phases of a study, specifically from protocol finalization to first patient in, rather than solely pushing for faster database lock or submission. * **Industry-Wide Collaboration is Key:** Progress requires enhanced collaboration among sponsors, Contract Research Organizations (CROs), regulators, and technology companies to develop shared roadmaps, standards, and resources, avoiding duplicated efforts. * **Learning from Other Industries:** The pharmaceutical industry can benefit from studying risk-based approaches and large data set management strategies employed by other conservative sectors, such as the finance industry, to accelerate its own evolution. * **Critique of Current Inefficiencies:** Practices like programming numerous EDC edit checks that never fire and painful, often unnecessary, data reconciliation processes are highlighted as wasteful and ripe for elimination through risk-based approaches. * **Regulator's Role in Modernization:** Regulators are encouraged to provide clearer guidance on digital transactions and local/regional differences to facilitate the adoption of modern, efficient processes in clinical trials. * **Embrace Next-Generation Problem Solving:** The inherent ability of younger generations to quickly adapt to and leverage technology should be harnessed to bring fresh ideas and innovative solutions to clinical data management challenges. **Tools/Resources Mentioned:** * Veeva Vault CDMS (Clinical Data Management System) * MS Access (Microsoft Access) * OC (Oracle Clinical) * EDC (Electronic Data Capture) * Study Builder (Novo Nordisk internal project for metadata repository and standardization) **Key Concepts:** * **Risk-Based Data Management (RBDM):** An approach to data management that prioritizes data cleaning and quality control efforts based on the criticality of the data, moving away from the traditional "perfect data" expectation for all data points. * **Risk-Based Quality Management (RBQM):** A broader quality management approach in clinical trials that focuses resources on preventing and detecting errors that are most critical to patient safety and data integrity, often applied to monitoring. * **Metadata Repository:** A centralized database that stores metadata (data about data), used in the "Study Builder" project to define and manage standards from protocol to TFLs. * **Decentralized Clinical Trials (DCTs) / Hybrid Trials:** Clinical trial models that incorporate virtual elements and remote data collection, leading to more diverse and complex data sources. * **CRF (Case Report Form):** A document (paper or electronic) used in clinical trials to record patient data. * **TFLs (Tables, Figures, Listings):** The final outputs of statistical analysis in clinical trials, used for regulatory submissions. * **STDM (Study Data Tabulation Model):** A standard for organizing and formatting clinical trial data for submission to regulatory authorities. **Examples/Case Studies:** * **Novo Nordisk's "Study Builder" Project:** An initiative to create a system with a metadata repository to define and link standards from the clinical trial protocol through data collection to TFLs, aiming for end-to-end efficiency and automation. * **Historical Cardiovascular Trial:** An anecdote from the guest's early career involving a large cardiovascular trial that used paper CRFs, MS Access for tracking, and double data entry into OC, highlighting the manual and centralized nature of data management in the early 2000s.
QMS-4-SME - Customer Complaint & CAPA
GxpManager
/@gxpmanager_app
Mar 13, 2023
This video provides an in-depth exploration of managing customer complaints and Corrective and Preventive Actions (CAPAs) using the QMS-4-SME application, part of the GxpManager platform. The presentation guides viewers through the entire lifecycle of a customer complaint, from its initial creation and workflow initiation to its analysis, CAPA implementation, customer acceptance, and final closure, including subsequent efficiency monitoring. The speaker emphasizes the application's design for regulated environments, highlighting features crucial for quality assurance and compliance. The demonstration begins with connecting to the GxpManager platform and selecting the QMS-4-SME application. It showcases the customizable analytics, such as charts for sorting customer complaints by criticality, and a pending list for quick information processing. The video details the application's structure, including sections for Quality Management System (with customer complaints), Action Management (immediate actions and CAPAs), and Resource Management (customer contacts). A significant portion is dedicated to the practical aspects of record management, covering user rights for creating, editing, deleting, and duplicating records, as well as publishing to PDF or Microsoft Word formats, which are essential for regulated bodies. The core of the presentation meticulously walks through the customer complaint process. It illustrates how to create a new complaint record, explaining automated features like unique ID generation and theoretical response date calculation (customizable, e.g., 15 days). The workflow, comprising initiation, analysis, customer acceptance, and closure, is central, with fields dynamically activating or locking based on the current stage, and email notifications sent to relevant personnel like the QA group. The video then covers the treatment phase, including creating and linking immediate actions, documenting customer communication, and approving the treatment. Following this, the analysis phase is demonstrated, where criticality, risk/impact, and root cause types (e.g., manpower) are identified, with a mention of using methods like 5M or WH questions for Root Cause Analysis (RCA). Finally, the creation and workflow of a CAPA are shown, linking it to the customer complaint, assigning an owner, and tracking its execution and eventual closure, culminating in a crucial step of efficiency monitoring to assess the CAPA's long-term effectiveness. Key Takeaways: * The QMS-4-SME application offers a comprehensive, structured approach to managing customer complaints and CAPAs, specifically designed to meet the stringent requirements of regulated industries. * Workflows are central to the system, guiding users through distinct stages (Initiation, Analysis, Customer Acceptance, Closure) for customer complaints and their associated CAPAs, ensuring consistency and accountability. * Extensive customization options are available, allowing organizations to tailor analytics, response timelines, workflow steps, mandatory fields, and data lists to align precisely with their internal processes and regulatory obligations. * The application facilitates meticulous record-keeping, automatically generating unique IDs, tracking declaration and response dates, and enabling the linking of customer contacts and investigation files for a complete audit trail. * Immediate actions can be swiftly created and directly linked to customer complaints, enabling prompt responses to issues and demonstrating proactive problem-solving. * Integrated Root Cause Analysis (RCA) capabilities allow for the classification of complaint criticality, assessment of risks and impacts, and identification of underlying causes using methodologies like the 5M or WH questions. * CAPAs are seamlessly linked to customer complaints, ensuring that corrective and preventive measures directly address identified issues. Each CAPA has its own workflow, target dates, and assigned owner for clear responsibility. * The system supports the attachment of various documents, such as investigation files and CAPA plans, which is vital for comprehensive documentation and regulatory compliance. * Automated email notifications keep relevant personnel (e.g., QA, CAPA owners) informed at each stage of the workflow, promoting timely action and collaboration. * Electronic signatures and approval processes are embedded throughout the system, fulfilling regulatory requirements for accountability and data integrity. * A critical feature is the post-CAPA efficiency monitoring, which allows organizations to track the long-term effectiveness of implemented CAPAs, ensuring that issues are not only resolved but also prevented from recurring. * Robust data management features include user-based access rights, publishing to regulated formats (PDF/Word), exporting to Excel, advanced filtering, global search, and customizable column layouts, enhancing data accessibility and reporting. * The QMS-4-SME application, as part of GxpManager, is positioned as a tool to help organizations maintain regulatory compliance by providing structured processes for quality events, audit trails, and required documentation. Tools/Resources Mentioned: * QMS-4-SME application * GxpManager platform Key Concepts: * **QMS (Quality Management System):** A system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, particularly in regulated industries. * **CAPA (Corrective and Preventive Action):** A process to investigate and eliminate the causes of nonconformities (corrective) and prevent their recurrence or occurrence (preventive). * **Customer Complaint:** Any expression of dissatisfaction with a product or service, requiring formal tracking and resolution within a QMS. * **Workflow:** A predefined sequence of tasks or steps that a process follows from initiation to completion, often involving multiple stakeholders and approvals. * **Root Cause Analysis (RCA):** A systematic process for identifying the fundamental reasons for a problem or incident, rather than just addressing its symptoms. * **5M Method:** A root cause analysis technique that categorizes potential causes into Manpower, Machine, Material, Method, and Measurement. * **WH Questions Method:** A root cause analysis technique that uses a series of "Why," "What," "Where," "When," "How," and "Who" questions to uncover deeper causes. * **Efficiency Monitoring:** The process of evaluating the effectiveness of implemented actions, particularly CAPAs, to ensure they have achieved their intended outcome and prevented recurrence. * **Regulated Body / Quality Assurance / Management:** Refers to the external authorities (e.g., FDA, EMA) and internal departments responsible for overseeing and ensuring compliance with industry standards and regulations. Examples/Case Studies: * **Customer Complaint Scenario:** A customer complaint stating "the support team is not responsive enough" is used as the primary example throughout the demonstration. * **Immediate Action:** Notifying the support team about the customer complaint is given as an example of an immediate action. * **Root Cause Type:** "Manpower" is chosen as a potential root cause for the support team's unresponsiveness. * **CAPA Description:** A preventive action is described as "increase support budget to hire additional help-desk engineers" to address the manpower issue. * **Efficiency Monitoring Criterion:** The "hiring plan assessment" is set as a criterion for monitoring the effectiveness of the CAPA. * **Efficiency Monitoring Result:** The successful hiring and training of new engineers is provided as a positive outcome of the efficiency monitoring.
Veeva’s Analytics Development Program
WayUp
/@WayUp
Mar 13, 2023
This video provides an in-depth exploration of Veeva's Analytics Development Program (ADP), offering insights into the company's structure, values, and career opportunities for early-career professionals in data analytics within the pharmaceutical and life sciences sectors. The presentation, led by a Veeva University Recruiter and two current program participants, details the two main roles within the ADP—Analytics Services Associate (ASA) and Marketing Data Analyst—and outlines the skills developed, training structure, mentorship opportunities, and career progression within the two-year program. It highlights Veeva's commitment to employee development and a supportive, collaborative work culture. The discussion delves into Veeva's broader business, segmenting its "industry Cloud" into the Development Cloud (clinical data management, operations, quality, regulatory, drug safety) and the Commercial Cloud (medical affairs, commercial operations). It also touches upon Veeva's acquisition of Crossix in 2019, which underpins its data solutions. A significant portion of the video is dedicated to explaining the day-to-day responsibilities and project types for both the client-facing ASA role, which focuses on extracting insights and making media optimization recommendations to pharmaceutical brand marketing teams, and the more technical Marketing Data Analyst role, which involves building business rules, slicing data, and measuring campaign performance on Veeva's proprietary "FIFA" (Digital Impact for Advertisers) platform. Speakers emphasize the practical, hands-on learning approach, where new associates are quickly staffed on projects after an initial training period. They share personal anecdotes about learning curves, collaborative team environments, and the satisfaction derived from seeing data-driven recommendations positively impact client campaigns, particularly for unbranded campaigns aimed at increasing disease awareness or new medication launches. The video also covers the interview process, offering advice on resume tailoring and demonstrating practical application of skills, and touches upon the company culture, highlighting flexibility, social events, and a strong emphasis on internal growth and mobility within Veeva. Key Takeaways: * **Veeva's Industry Focus and Solutions:** Veeva operates an "industry Cloud" serving the pharmaceutical and life sciences sectors, with distinct Development (clinical, regulatory, drug safety) and Commercial (medical affairs, commercial) Clouds, along with data software, implementation, and business consulting services. * **Crossix Data Integration:** Veeva's data solutions are significantly supported by its 2019 acquisition of Crossix, which provides the underlying data for its analytics programs. * **Analytics Development Program (ADP) Structure:** The ADP is a two-year early talent program under the "Generation Veeva" umbrella, designed for new graduates, focusing on both personal and professional development through a "learning by doing" approach. * **Dual Roles within ADP:** The program offers two distinct paths: Analytics Services Associate (ASA), a client-facing role focused on data storytelling and media optimization recommendations, and Marketing Data Analyst, a more technical, back-end role involving data manipulation and building measurement rules. * **Proprietary Platform Expertise:** Participants become experts in Veeva's proprietary "FIFA" (Digital Impact for Advertisers) platform, which delivers anonymized data insights to brand marketing teams within pharmaceutical companies. * **Technical Skills Development:** The Marketing Data Analyst role specifically involves working with SQL and advanced Excel techniques for data analysis and measurement, while both roles require a deep understanding of healthcare data and its application in marketing. * **Comprehensive Training and Mentorship:** The program includes a 3-4 week training (Veeva 101 boot camp followed by analytics-specific training), a dedicated "Crossix companion" (buddy), and a structured mentor relationship to support growth and career planning. * **Hands-on Project Experience:** Associates are quickly placed on client projects after training, allowing them to apply learned skills immediately and gain practical experience, often working on diverse campaigns like new medication launches or unbranded disease awareness initiatives. * **Client-Centric Approach:** ASAs regularly communicate with media agencies, creating reports and making recommendations to optimize media plans and improve campaign performance based on audience quality and healthcare data. * **Collaborative and Supportive Culture:** Veeva fosters a highly collaborative environment where team members, including senior analysts, actively support junior colleagues. The company emphasizes a culture of open communication, making it comfortable for new hires to ask questions and learn. * **Work-Life Flexibility:** Veeva promotes a "work anywhere" model, offering significant flexibility for employees to work from home, the office, or other locations, while also providing incentives like free lunches, social events, and happy hours to encourage in-person connection and team bonding. * **Strong Internal Mobility and Growth:** The company prides itself on internal transfers and a steep growth trajectory within the development programs, with associates typically promoted to a lead position in their second year and multiple career paths available upon graduation from the program. * **Application Tips for Candidates:** Applicants should tailor their resumes to highlight relevant projects (even personal ones) that demonstrate practical application of analytics skills, rather than just listing coursework. Utilizing the STAR method for interview questions is also recommended. Tools/Resources Mentioned: * **Veeva CRM:** A leading platform in the pharmaceutical industry. * **Crossix:** A data solution acquired by Veeva in 2019, supporting its data offerings. * **FIFA (Digital Impact for Advertisers):** Veeva's proprietary platform for delivering anonymized data insights to brand marketing teams. * **SQL:** A technical skill used by Marketing Data Analysts. * **Advanced Excel Techniques:** A technical skill used by Marketing Data Analysts. * **WayUp:** A platform where job seekers can find information and apply for positions at Veeva. * **Coursera/Google Analytics Courses:** Examples of external learning resources mentioned for skill development. Key Concepts: * **Development Cloud:** Veeva's suite of solutions for clinical data management, operations, quality processes, regulatory affairs, and drug safety within the life sciences. * **Commercial Cloud:** Veeva's suite of solutions for medical affairs and commercial operations, including sales and marketing. * **Anonymized Data Insights:** Data that has been processed to remove personally identifiable information, used to understand trends and campaign performance without compromising patient privacy. * **Audience Quality:** A metric used in marketing analytics to assess the relevance and effectiveness of an advertising campaign in reaching its target demographic, often involving a combination of marketing and healthcare data. * **Unbranded Campaigns:** Marketing campaigns that focus on raising awareness about a disease or condition rather than promoting a specific pharmaceutical product, often used to educate the public or healthcare professionals. * **Public Benefit Corporation (PBC):** A type of for-profit corporate entity, authorized by a majority of U.S. states, that includes positive impact on society, workers, the community, and the environment as a material part of its mission in addition to maximizing shareholder value. Veeva became a PBC in 2022.
Full-Risk Primary Care Described in 'The Calling' by Drs. Chris and Gordon Chen
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Mar 12, 2023
This video provides an in-depth exploration of the "full-risk primary care" model, as detailed in the book "The Calling" by Drs. Chris and Gordon Chen, the founders of ChenMed. Dr. Eric Bricker reviews the book, highlighting ChenMed's unique approach to healthcare delivery for Medicare Advantage patients. The core premise is that ChenMed, operating over 100 clinics in 12 states, assumes full financial risk for each patient's total cost of care, encompassing not just primary care visits but also medications, procedures, and hospitalizations. This model incentivizes keeping patients healthy and out of expensive acute care settings. The video delves into ChenMed's "secret sauce" for achieving remarkable health outcomes and cost reductions. Central to their success is a significantly smaller patient panel size, with each primary care physician managing approximately 450 patients, in stark contrast to the typical 3,000 or more. This allows for monthly patient visits, ensuring frequent interactions. Beyond the frequency, ChenMed emphasizes direct access, with doctors providing their personal cell phone numbers to patients. These frequent, accessible interactions are critical for developing two essential elements: trust between the patient and doctor, and patient accountability for their health behaviors and medication adherence. Dr. Bricker elaborates on how trust is paramount, enabling patients to call their ChenMed doctor before resorting to emergency room visits, a key strategy for cost control. The frequent check-ins also foster accountability, allowing physicians to consistently reinforce positive behavior changes, such as dietary modifications, and ensure medication adherence. The video cites impressive results: ChenMed has reduced overall ER visits and hospitalizations by 30-50%, CHF hospitalizations by 70%, and strokes by 22%. The speaker concludes by applying these lessons to the burgeoning "retailization of primary care" by entities like Walmart, Amazon, and CVS, asserting that these new models will fail to achieve similar outcomes unless they adopt ChenMed's fundamental principles of small patient panels, frequent visits, trust, and accountability. Key Takeaways: * **Full-Risk Primary Care Model:** ChenMed operates on a full-risk model for Medicare Advantage patients, where the primary care practice is responsible for all healthcare costs (primary care, medications, hospitalizations, surgeries) for a set per-patient amount. This financial structure heavily incentivizes proactive health management and prevention. * **Exceptional Outcomes:** ChenMed has demonstrated significant success in improving patient health and reducing costs, including a 30-50% reduction in ER visits and hospitalizations, a 70% reduction in congestive heart failure hospitalizations, and a 22% reduction in strokes. * **Small Patient Panel Size:** The cornerstone of ChenMed's success is a dramatically smaller patient panel, with one primary care doctor caring for approximately 450 patients, compared to the industry average of 3,000 or more. This allows for a high-touch, personalized approach to care. * **Frequent Patient Interactions:** The small panel size enables doctors to see patients approximately once a month, regardless of their health status. Some patients may be seen daily or weekly depending on their needs, ensuring continuous engagement and monitoring. * **Direct Physician Access:** All 450 patients have the personal cell phone number of their doctor, providing unparalleled access and fostering a strong sense of support and availability, which is crucial for urgent needs and preventing unnecessary ER visits. * **Building Patient Trust:** Frequent interactions and direct access are essential for establishing deep trust between the patient and their doctor. This trust is critical because it encourages patients to contact their primary care physician first before seeking emergency care, thereby controlling costs and ensuring appropriate treatment. * **Fostering Patient Accountability:** Regular check-ins allow doctors to hold patients accountable for their health behaviors (e.g., diet, exercise) and medication adherence. This consistent reinforcement is vital for managing chronic diseases effectively, as simply providing instructions once is often insufficient for lasting change. * **Importance of Behavior Change and Medication Adherence:** The video emphasizes that chronic disease management relies heavily on patients changing their behavior and consistently taking prescribed medications. The ChenMed model provides the necessary framework (frequent contact, trust, accountability) to facilitate these crucial aspects. * **Economic Impact of Prevention:** Preventing hospitalizations is a significant cost-saving measure, with each hospitalization estimated to cost around $15,000. ChenMed's model actively works to keep patients out of the hospital through proactive care and engagement. * **Lessons for "Retailization of Primary Care":** The speaker warns that the growing trend of "retailization" in primary care (e.g., Walmart, Amazon, CVS acquiring clinics) will fail to achieve similar positive outcomes unless they adopt ChenMed's core principles of small patient panels, frequent visits, trust, and accountability. * **Beyond Physician-Only Care:** While the model emphasizes the doctor-patient relationship, the speaker acknowledges that scaling such a model nationwide would require the involvement of physician assistants (PAs) and nurse practitioners (NPs) to augment the physician workforce. **Tools/Resources Mentioned:** * **"The Calling" by Drs. Chris and Gordon Chen:** The book reviewed in the video, which details the story and operational model of ChenMed. * **ChenMed:** A full-risk primary care practice serving Medicare Advantage patients, highlighted as a successful case study for its innovative healthcare delivery model. **Key Concepts:** * **Full-Risk Primary Care:** A healthcare delivery model where the primary care provider receives a fixed payment per patient and is responsible for all of that patient's healthcare costs, including specialist care, hospitalizations, and medications. * **Patient Panel Size:** The number of patients assigned to a single primary care physician. ChenMed's model significantly reduces this number to enable more personalized and frequent care. * **Retailization of Primary Care:** The trend of large retail corporations and tech companies (e.g., Walmart, Amazon, CVS, Optum) entering and acquiring primary care clinics, often with a focus on convenience and accessibility. * **Patient Trust:** The confidence and reliance a patient places in their healthcare provider, which is crucial for effective communication, adherence to treatment plans, and seeking appropriate care. * **Patient Accountability:** The patient's responsibility for actively participating in their own healthcare, including adhering to medical advice, making lifestyle changes, and taking medications as prescribed. **Examples/Case Studies:** * **ChenMed's Outcome Data:** Specific reductions in ER visits (30-50%), hospitalizations (30-50%), CHF hospitalizations (70%), and strokes (22%) serve as concrete evidence of the model's effectiveness. * **FDR's Blood Pressure:** The example of President Franklin D. Roosevelt's extremely high blood pressure (240/140) and subsequent death from a stroke is used to illustrate the historical lack of effective chronic disease management and the life-saving potential of modern medication and adherence.
How to Manage Complex Design Systems
Zeplin
/@ZeplinIo
Mar 7, 2023
This video provides an in-depth exploration of how Veeva, a major player in the life sciences technology space, successfully overhauled and scaled its complex design system. Louis Dorman, Lead Product Designer, and Robert Burton, Design Operations Manager at Veeva, share practical tips and lessons learned from their journey to achieve widespread adoption and efficiency in a collaborative design environment. The discussion highlights the evolution from a UX-department-owned system with scattered efforts to a formalized, transparent, and highly integrated design system that supports 1200 customers across 165 countries, including 47 out of the top 50 pharmaceutical companies. The presentation details the critical steps Veeva took to transform its design system. Initially, the company faced challenges such as duplication of effort, lack of transparency, and inconsistent adoption across product squads. The turning point involved embracing atomic design principles, which helped standardize the language used across design, build, and QA phases. This standardization was further supported by tools like Zeplin for documenting component definitions and fostering cross-team collaboration. A key innovation was the introduction of "design system previews," which opened communication channels between UX and engineering, streamlining the build process by providing early visibility into design decisions. Further enhancements included formalizing the handoff process by clearly defining roles and responsibilities and documenting communications within Zeplin to ensure accountability and facilitate revisiting decisions. Veeva also tackled the complex issue of regressions and explicit changes by involving QA resources early in "dev discoveries" to identify all impacted areas of a component before changes were implemented. This proactive approach significantly reduced downstream work and prevented breaking existing functionalities. The speakers also emphasized standardizing the design workflow, choosing the right tools (e.g., migrating from Sketch to Figma), and establishing comprehensive guidelines and templates, including a detailed checklist for designers to ensure consistency and completeness. The success of these efforts culminated in 100% adoption of the design system for Android development and the integration of over 450 iOS components across hundreds of thousands of locations, alongside large-scale audits to replace legacy assets like PNG icons with vector SVGs and inconsistent hex colors with a defined palette of semantic colors. Key Takeaways: * **Dedicated Design Operations (DesignOps) Role is Crucial:** Hiring a dedicated DesignOps manager significantly improves design system management, prioritization, and execution by acting as a bridge between UX, engineering, QA, product squads, and leadership. This role brings structure and accountability that a purely UX-owned system often lacks. * **Embrace Atomic Design Principles Across the Entire Workflow:** Adopting atomic design not just for UX but for the entire design-to-build-to-QA process helps standardize language, define component scope (atoms, molecules), and improve collaboration and communication across all teams. * **Implement Design System Previews for Enhanced Transparency:** Regular previews of design system updates or new components for engineering and QA teams foster early engagement, provide a "bigger picture" understanding, and streamline the build process by aligning expectations upstream. * **Formalize the Handoff Process with Clear Roles and Documentation:** Establishing clear roles, responsibilities, and a documented handoff process (e.g., using Zeplin to record communications and component definitions) minimizes miscommunication, allows for revisiting decisions, and ensures consistent implementation. * **Involve QA Early in "Dev Discoveries" for Regression Management:** Proactively engaging QA and dev teams in "dev discoveries" for legacy or complex components helps identify all potential impacted areas before design changes are made, preventing regressions and significant rework later in the development cycle. * **Standardize Design Workflow and Tooling:** Defining a clear design workflow and choosing intuitive tools (e.g., migrating from Sketch to Figma with organized files) is essential for efficiency, consistency, and future scalability. Proper naming conventions and folder structures are vital for smooth transitions between tools. * **Establish Comprehensive Guidelines and Templates:** Creating and continuously updating guidelines, templates, and checklists for designers (e.g., for interactive layers, light/dark mode properties) ensures consistency, serves as a reminder for best practices, and empowers designers to contribute effectively. * **Achieve High Adoption Rates for Significant Impact:** Veeva's success in achieving 100% design system adoption for Android and integrating hundreds of iOS components demonstrates the profound impact of a well-managed system on consistency, efficiency, and scalability across multiple applications and organizations. * **Conduct Large-Scale Audits for Technical Debt Reduction:** Proactive audits, such as replacing hundreds of PNG icons with vector SVGs and standardizing hex colors into a semantic palette, significantly reduce technical debt, improve performance, and provide engineers with clear, consistent resources. * **Build Trust Through Transparency in the Design Workflow:** Communicating the status of design work (e.g., "waiting on peer review") to product managers and other stakeholders builds trust in the design process and provides clarity on project progression. * **Document Everything:** Maintaining a Design System Manager (DSM) or CMS for components, along with documenting decisions and properties within design tools like Zeplin, ensures that all definitions, guidelines, and historical context are easily accessible to all teams. * **Prioritize Peer Review:** Implementing a peer review process for design system components ensures quality, consistency, and adherence to established guidelines before components are finalized and adopted. Tools/Resources Mentioned: * **Zeplin:** Used for documenting component definitions, fostering collaboration, and recording handoff communications. * **Sketch:** Previous primary design tool for Veeva's design system. * **Figma:** Current primary design tool, Veeva migrated from Sketch to Figma. * **DSM (Design System Manager):** Described as a CMS (Content Management System) for defining and documenting components. Key Concepts: * **Design System:** A comprehensive set of standards, components, and guidelines used to manage design at scale, ensuring consistency and efficiency across products. * **DesignOps (Design Operations):** The practice of optimizing and streamlining design processes, workflows, and tools to enable design teams to work more effectively and deliver higher quality outcomes. * **Atomic Design:** A methodology for creating design systems by breaking interfaces down into their fundamental building blocks (atoms) and progressively combining them into molecules, organisms, templates, and pages. * **Regressions (Explicit Changes):** Unintended negative impacts or broken functionalities that occur in existing software when new changes or updates are introduced, particularly within a design system. * **Dev Discovery:** A collaborative process involving design, development, and QA teams to thoroughly investigate existing components or features, outline their states, labels, and definitions, to inform new design system component builds and prevent issues. * **Handoff Process:** The formal transfer of design specifications, assets, and documentation from the design team to the development team for implementation. * **Semantic Colors:** A system of naming colors based on their purpose or meaning within the UI (e.g., "primary-button-background," "error-text") rather than their literal hue (e.g., "blue-500"), improving consistency and maintainability. * **Vector SVG Icons:** Scalable Vector Graphics (SVG) are XML-based vector image formats for two-dimensional graphics, offering scalability without loss of quality, preferred over raster images like PNGs for icons in design systems. Examples/Case Studies: * **Veeva's Design System Overhaul:** The core case study of the video, detailing the company's journey from a fragmented design approach to a highly integrated and adopted design system. * **100% Android Adoption:** Veeva achieved complete adoption of its design system for all new Android development, demonstrating the effectiveness of their processes. * **450+ iOS Components Integration:** Over 450 iOS components were integrated across hundreds of thousands of different locations within Veeva's applications. * **PNG to SVG Icon Audit:** A large-scale audit replaced hundreds of legacy PNG icons with modern, scalable vector SVG icons. * **Hex to Semantic Color Audit:** Hundreds of inconsistent hex colors were replaced with a defined palette of about 60 primary, secondary, and alert semantic colors, improving consistency and maintainability.
QMS-4-SME - Quality Management System / Non-Compliance & CAPA Management
GxpManager
/@gxpmanager_app
Mar 7, 2023
This video provides an in-depth exploration of GxpManager's QMS-4-SME application, a software-as-a-service (SaaS) low-code platform designed for quality management in regulated companies. The primary focus is on demonstrating the platform's capabilities for handling non-compliance (deviations) and corrective and preventive actions (CAPA) workflows. The presenter meticulously walks through the entire lifecycle of a non-compliance event, from its initial declaration and analysis to the implementation of immediate actions, the creation and approval of CAPA plans, their execution, and ultimate closure, emphasizing the system's auditability and customization features. The presentation highlights the GxpManager platform's user interface, which supports multi-factor authentication, single sign-on, and multiple languages, allowing users to select their environment and application. A key aspect is the customizable dashboard, featuring analytics and a pending list for assigned workflows and actions. The core of the demonstration revolves around the structured workflow for non-compliance, illustrating how different roles (initiator, Quality Assurance, action owner) interact with the system. This includes defining criticality, conducting root cause analysis using methods like 5M or QQOQCP (Who, What, Where, When, How, Why), and linking related actions. Throughout the video, the speaker emphasizes the system's adherence to regulatory requirements, such as the ability to generate auditable reports in PDF or Microsoft Word, export data to Excel, and maintain electronic signatures for all approvals. The platform's flexibility is repeatedly stressed, with features like customizable forms, workflows, mandatory fields, and data display options. The comprehensive demonstration of linking immediate actions and CAPAs directly to the non-compliance record showcases an integrated approach to quality event management, ensuring traceability and accountability from discovery to resolution. Key Takeaways: * **Integrated QMS Platform:** GxpManager's QMS-4-SME is presented as a comprehensive, auditable, and customizable SaaS low-code application platform for managing quality events in regulated environments, accessible via any modern browser. * **Non-Compliance and CAPA Management:** The core functionality demonstrated is the end-to-end management of non-compliance records and associated corrective and preventive actions (CAPA), crucial for maintaining quality and regulatory adherence. * **Customizable Workflows and Roles:** The system supports fully customizable workflows with defined steps and roles (e.g., initiator, Quality Assurance, action owner), ensuring that only authorized personnel can perform specific actions at each stage. * **Data Integrity and Auditability:** Features like mandatory fields, electronic signatures, version control, and the ability to publish records to PDF or Microsoft Word formats ensure data integrity and facilitate regulatory audits. * **Advanced Data Management:** Users can leverage advanced search, filtering, and column customization options to personalize their view of data sets, making it easier to navigate and analyze quality records. Data can also be exported to Excel for further analysis. * **Integrated Analytics:** The platform includes built-in analytics features, allowing users to create customizable graphs and dashboards from any data within the system, providing quick insights into quality trends and performance. * **Root Cause Analysis Tools:** The system integrates tools for conducting root cause analysis, offering methods such as the 5M (Man, Machine, Material, Method, Measurement, Environment) or QQOQCP (Quoi, Qui, Où, Quand, Comment, Pourquoi - What, Who, Where, When, How, Why) to identify underlying issues. * **Action Linking and Traceability:** Immediate actions and CAPA plans can be directly created and linked to specific non-compliance records, ensuring a clear audit trail and comprehensive management of all follow-up activities. * **Notification System:** Assigned persons receive email notifications to review and act on pending workflows or records, streamlining communication and ensuring timely action within the quality process. * **Regulatory Compliance Focus:** The platform is designed with regulated companies in mind, emphasizing features that support GxP requirements, audit trails, and the management of quality processes critical for industries like pharmaceutical and life sciences. * **Efficiency Monitoring:** The system allows for efficiency monitoring of CAPAs, enabling organizations to track the effectiveness of their corrective and preventive measures post-implementation. Tools/Resources Mentioned: * **GxpManager (QMS-4-SME application):** The primary software platform demonstrated. * **Microsoft Word:** For publishing records. * **Microsoft Excel:** For exporting data. * **PDF:** For publishing records. Key Concepts: * **Quality Management System (QMS):** A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. * **Non-Compliance (NC) / Deviation:** A failure to meet a specified requirement, procedure, or standard, often an incident or deviation from an expected outcome. * **Corrective and Preventive Action (CAPA):** A system for investigating and correcting non-conformances (corrective actions) and preventing potential non-conformances (preventive actions). * **GxP:** A general term for "Good x Practice" quality guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) applicable to life sciences industries. * **5M Method:** A root cause analysis technique that categorizes potential causes into five main categories: Manpower, Methods, Machines, Materials, and Measurement (sometimes including Environment). * **QQOQCP (Quoi, Qui, Où, Quand, Comment, Pourquoi):** A French acronym for a systematic questioning method, equivalent to the 5W1H (What, Who, Where, When, How, Why) used for problem-solving and root cause analysis. * **Electronic Signature:** A method of signing a document or record digitally, often with cryptographic security, to ensure authenticity and integrity, particularly important in regulated industries (e.g., 21 CFR Part 11). Examples/Case Studies: * **Non-Compliance Scenario:** A "procedure not respected" is used as a specific example of a non-compliance event. * **Criticality Justification:** An example of justifying a "major criticality" due to an "ISO 27001 issue." * **Immediate Action:** "Best practices were reminded to the operator" is cited as an immediate action taken to address a non-compliance. * **Root Cause Specification:** A non-compliance stemming from a "method" root cause, specifically "non-respect of the procedure because it is too complex for the operations."
Disease Management VS. Case Management VS. Utilization Management
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Mar 5, 2023
This video provides an in-depth exploration of the critical distinctions among three core healthcare management functions: Utilization Management (UM), Case Management (CM), and Disease Management (DM). Dr. Eric Bricker, the speaker, aims to clarify these often-confused terms and, more importantly, detail how the value of each program should be uniquely measured from a financial perspective. He establishes the context by highlighting that while all three involve nurses from insurance carriers or third-party administrators (TPAs), their scope, patient interaction, and ultimate goals differ significantly. The presentation systematically breaks down each management type. Utilization Management is defined as the process where an insurance carrier's nurse approves "bed days" for hospitalized health plan members, focusing on the appropriateness and length of hospital stays. The nurse interacts with hospital staff, not the patient, and can deny payment for unapproved days. Case Management, in contrast, involves an insurance carrier nurse working with patients who have been discharged from a hospital but are not yet home, instead residing in facilities like acute rehab, skilled nursing facilities (SNFs), or long-term acute care facilities (LTACs). The primary goal here is to prevent readmissions back to the hospital, again with no direct patient interaction. Finally, Disease Management involves a nurse, dietitian, or health coach, potentially from the insurance carrier or a separate vendor, working directly with patients suffering from chronic conditions such as diabetes, COPD, congestive heart failure (CHF), or chronic kidney disease (CKD). This is the only one of the three with direct patient interaction, focusing on care coordination, medication adherence, and lifestyle counseling, though it often faces a low patient reach rate. A significant portion of the video is dedicated to explaining the distinct methodologies for measuring the financial value of each program. For Utilization Management, value is quantified by calculating the total cost of denied length-of-stay days versus what would have been paid without those denials, then comparing this saving to the program's cost. Case Management's value is measured by analyzing 30-day readmission rates for patients who received case management compared to those who did not, attributing the cost savings from prevented readmissions to the program. Disease Management's value is assessed by comparing the total healthcare spend over a 12-month period for patients involved in the program versus those with similar chronic conditions who were not, then multiplying the per-patient savings by the number of engaged patients. Dr. Bricker emphasizes that combining the per-employee-per-month (PEPPM) costs for these distinct programs is a mistake, as their value propositions and measurement metrics are fundamentally different. Key Takeaways: * **Distinct Management Functions:** Utilization Management (UM), Case Management (CM), and Disease Management (DM) are separate healthcare management functions, each with unique objectives and operational models, often confused but critical to differentiate. * **Utilization Management (UM) Focus:** UM primarily involves an insurance carrier's nurse approving hospital "bed days" to ensure appropriate length of stay, with the goal of reducing costs associated with unnecessary or prolonged hospitalization through length-of-stay denials. * **Case Management (CM) Focus:** CM is centered on preventing hospital readmissions for patients discharged to post-acute care settings like acute rehab, Skilled Nursing Facilities (SNFs), or Long-Term Acute Care Facilities (LTACs), with nurses working with facility staff rather than directly with patients. * **Disease Management (DM) Focus:** DM targets patients with chronic conditions (e.g., diabetes, COPD, CHF, CKD) through direct interaction by nurses, dietitians, or coaches (from carriers or vendors) to coordinate care, promote adherence, and provide counseling, despite often having a low patient engagement rate (e.g., 4%). * **Absence of Patient Interaction in UM/CM:** A key differentiator is that UM and CM nurses do not typically interact directly with patients; their communication is with hospital or facility staff, whereas DM explicitly involves patient interaction. * **Unique Value Measurement for Each Program:** It is crucial to measure the financial value of UM, CM, and DM programs separately, as their mechanisms for generating savings are entirely different and cannot be conflated. * **UM Value Calculation:** The value of Utilization Management is quantified by the difference between the potential cost of hospitalizations (if all days were approved) and the actual paid amount after length-of-stay denials, compared against the program's cost. * **CM Value Calculation:** Case Management's value is determined by comparing 30-day readmission rates for patients who received case management versus those who did not, then calculating the cost savings from the readmissions prevented. * **DM Value Calculation:** Disease Management's value is assessed by comparing the total healthcare spend over a 12-month period for patients engaged in the program against a similar group not involved, identifying per-patient savings. * **Separate Cost Tracking:** Carriers often combine Per Employee Per Month (PEPPM) costs for UM and CM; however, for accurate value assessment, these costs should be tracked and reported separately. * **Data Reporting Challenges:** Self-funded employers may need to specifically request detailed reports from their carriers to obtain the necessary data for accurately measuring the value of these individual programs, as such reports are not always standard. Key Concepts: * **Utilization Management (UM):** The process of reviewing the appropriateness and necessity of medical services, particularly hospital stays, to ensure efficient resource allocation. * **Case Management (CM):** A collaborative process that assesses, plans, implements, coordinates, monitors, and evaluates the options and services required to meet an individual's health needs, especially post-hospitalization to prevent readmissions. * **Disease Management (DM):** A system of coordinated healthcare interventions and communications for populations with conditions in which patient self-care efforts are significant, focusing on chronic disease management and patient education. * **Bed Days:** The number of days a patient occupies a bed in a healthcare facility, often used as a metric for utilization. * **Acute Rehab:** Intensive rehabilitation services for patients recovering from severe injuries or illnesses. * **Skilled Nursing Facility (SNF):** A facility that provides skilled nursing care and rehabilitation services for patients who need medical care or therapy that cannot be provided at home. * **Long-Term Acute Care Facility (LTAC):** A specialized hospital that provides extended medical and rehabilitative care for patients with complex medical conditions who require longer hospital stays. * **Length of Stay Denials:** When an insurance carrier refuses to pay for a portion of a patient's hospital stay deemed medically unnecessary or exceeding approved limits. * **Readmission Rates:** The percentage of patients who are readmitted to a hospital within a specific timeframe (e.g., 30 days) after an initial discharge, often used as a quality and cost-effectiveness metric. * **Per Employee Per Month (PEPPM):** A common pricing model in healthcare benefits, representing the cost per employee per month for a particular service or program.
![[Recording] How to automate submission content prep. & report generation for content stored in Veeva](https://i.ytimg.com/vi/Aee2dyK2uIo/hqdefault.jpg?sqp=-oaymwEcCNACELwBSFXyq4qpAw4IARUAAIhCGAFwAcABBg==&rs=AOn4CLCLwKUiSxs9GAYf1aVLERUE63wcBQ)
[Recording] How to automate submission content prep. & report generation for content stored in Veeva
DocShifter
/@docshifter
Mar 3, 2023
This video provides an in-depth exploration of automating content preparation and report generation for regulatory submissions, specifically focusing on content stored within Veeva Vault. The presenter, representing DocShifter, outlines how their platform integrates with Veeva to streamline traditionally manual, slow, and error-prone processes in the pharmaceutical and life sciences industries. The session highlights common challenges such as resource-intensive manual steps, the risk of human error, and the use of overly complex tools for simple tasks, proposing automation as a solution to enhance efficiency and compliance. The core of the presentation details DocShifter's capabilities as a software solution designed to automate content conversion and enrichment. It emphasizes the platform's ability to integrate with various repositories, including Veeva Vault, SharePoint, and legacy systems, to repurpose and transform content for different use cases. Beyond simple PDF conversion, DocShifter offers advanced functionalities like OCR, applying headers/footers, watermarks, pagination, merging/splitting documents to meet file size limitations, generating detailed bookmarks and tables of contents, managing security, and ensuring compliance with diverse health authority requirements. The discussion also touches upon non-PDF conversions, such as XML, HTML, and refreshing legacy document formats, underscoring the platform's versatility. A significant portion of the webinar is dedicated to demonstrating specific use cases through workflow automation. These include automatically preparing Microsoft Word content by validating and fixing issues before conversion, rendering submission-ready PDFs simultaneously for multiple global health authorities (e.g., FDA, PMDA, European specs) from a single source, and generating complex reports by leveraging Veeva binders. The platform automates the merging of documents, creation of cover pages, tables of contents, and pagination, all while ensuring full health authority compliance. Furthermore, the video showcases automated PDF validation, which checks generated PDFs against predefined requirements for bookmarks, hyperlinks, fonts, and other technical specifications, with the capability to report issues or automatically fix them. Additional use cases like content migration, archival preparation (PDF/A), and automated email processing are also briefly covered, illustrating the broad applicability of the platform in a regulated environment. Key Takeaways: * **Addressing Manual Inefficiencies in Regulatory Operations:** The video highlights that traditional content preparation and report generation for regulatory submissions are often slow, resource-intensive, and prone to human error due to manual steps. Automation, particularly when integrated with platforms like Veeva, can significantly mitigate these challenges. * **DocShifter as a Comprehensive Automation Platform:** DocShifter is presented as a versatile software solution that automates not only content conversion (e.g., to PDF) but also its enrichment and preparation for various use cases across the enterprise, integrating with major content repositories like Veeva Vault and SharePoint. * **Automated Word Content Preparation (Doc Validator):** The platform includes a "Doc Validator" feature that can automatically check Microsoft Word documents for errors, report identified issues, or even fix them directly. This pre-processing step helps ensure source document quality before conversion, reducing manual QA/QC efforts. * **Simultaneous Multi-Region PDF Rendition:** A key benefit is the ability to generate multiple, health authority-compliant PDF renditions (e.g., for FDA, PMDA, EMA, Swissmedic, Health Canada) simultaneously from a single source document. This is crucial for global submissions, allowing for region-specific nuances in PDF specifications based on metadata. * **Automated Report Generation from Veeva Binders:** The platform can leverage Veeva binders (or similar structures) to automatically compile complex reports. Users only need to define the content within the binder, and the system handles merging documents, adding cover pages, tables of contents, pagination, and ensuring compliance, eliminating the need for complex publishing tools. * **Comprehensive PDF Validation:** Post-conversion, PDFs can be automatically validated against specific health authority requirements for elements like bookmarks, hyperlinks, font embedding, security settings, and file size. The system can report non-compliance or automatically apply fixes where possible. * **Metadata-Driven Workflows:** Automation is driven by configurable workflows that leverage metadata from Veeva Vault. This allows for conditional processing, routing content based on document type, status, or regional requirements, ensuring tailored and compliant output without manual intervention. * **Beyond PDF Conversion:** While heavily focused on PDF, the platform also supports conversions to other formats like XML, HTML, and modernizing legacy document types (e.g., DOC to DOCX). It can also handle image, audio, and video format conversions, expanding its utility. * **Support for Content Migration and Archival:** DocShifter workflows can facilitate content migration between different repositories (e.g., SharePoint to Veeva) and prepare documents for long-term archival by converting them to formats like PDF/A. * **Automated Email Processing:** The platform can connect to email repositories to capture correspondences and attachments, convert them into readable formats, and store them in Veeva or other designated locations, streamlining the management of critical communications. * **Reduced Training Burden and Risk:** By automating complex and repetitive tasks, the solution aims to reduce the need for extensive training on multiple complex tools and minimizes the risk of human error inherent in manual processes. Tools/Resources Mentioned: * **DocShifter:** The primary software platform for content automation and rendering. * **Veeva Vault:** The main content repository and management system that DocShifter integrates with. * **Microsoft Word:** Source document format for content preparation and validation. * **PDF:** The primary output format, with a focus on health authority compliance. * **SharePoint, Documentum, Cara:** Other content repositories mentioned as being compatible with DocShifter. * **Acrobat:** Mentioned as a tool for viewing PDF reports. Key Concepts: * **Rendition:** A converted version of a document, typically a PDF, prepared for a specific purpose like regulatory submission. * **Health Authority Compliance:** Adherence to the specific technical and content requirements set by regulatory bodies (e.g., FDA, EMA, PMDA) for submission documents. * **Veeva Binders:** A feature within Veeva Vault that allows users to group multiple documents together, often used for compiling reports or submissions. * **Metadata-driven Workflows:** Automated processes that use document attributes and properties (metadata) to make decisions about how content should be processed, converted, or routed. * **PDF/A:** An ISO-standardized version of the Portable Document Format (PDF) for archiving and long-term preservation of electronic documents. * **OCR (Optical Character Recognition):** Technology that enables conversion of different types of documents, such as scanned paper documents, into editable and searchable data.
Episode 8: Are We Any Closer to Patient-Centric Trials?
Veeva Systems Inc
/@VeevaSystems
Mar 1, 2023
This video provides an in-depth exploration of the current state of patient-centric clinical trials, viewed through the lens of a mid-sized Contract Research Organization (CRO). Host Richard Young, VP of Strategy at Veeva Vault CDMS, speaks with Alan Morgan, CEO Advisor at Excelya, about the persistent challenges and emerging opportunities in making trials more patient-focused. The discussion highlights the disconnect between significant industry investment in "big data" tools for site selection and the actual improvements in patient recruitment, emphasizing that traditional methods and strong site relationships remain crucial. Alan Morgan details Excelya's strategy as a mid-sized CRO, focusing on quality, speed, and a "centers of excellence" approach. These centers include specialized services in statistics and programming, data management, pharmacovigilance, electronic Trial Master File (eTMF) – notably in partnership with Veeva – and medical writing. He stresses the importance of technology as an enabler for cost and speed, while acknowledging that smaller CROs often need to partner with larger technology providers rather than developing proprietary solutions. The conversation also delves into the critical role of patient advocacy groups in achieving a truly diverse and global patient voice, especially given the varying standards of care across different regions. A significant portion of the discussion centers on the evolution of data management and the persistent issues that hinder clinical trial efficiency. Morgan laments the lack of dramatic improvement in patient accrual metrics over 25 years, despite extensive investment in data mining and big data for site identification. He argues that the role of the data manager has transformed from a "poor relation" to a dynamic, proactive integrator and custodian of complex, multi-source data. The speakers also identify protocol changes as a major source of cost, waste, and inefficiency in the drug development process, advocating for more rigorous upfront planning and higher hurdles for amendments. The episode concludes with a call for greater industry collaboration and interoperability, referencing initiatives like TransCelerate, to collectively advance clinical research for the benefit of patients. Key Takeaways: * **Mid-sized CROs have a distinct market opportunity:** Excelya's strategy emphasizes quality, speed, and specialized "centers of excellence" in areas like data management, pharmacovigilance, and eTMF, catering to clients seeking focused expertise. * **Technology partnerships are crucial for CROs:** Smaller CROs cannot sustain the investment for state-of-the-art proprietary technologies and must partner with larger providers (e.g., Veeva for eTMF) to leverage advanced solutions and drive efficiency. * **Big data's impact on site selection and patient recruitment is underwhelming:** Despite significant investment in "big data" tools for site identification, overall patient accrual metrics have not dramatically improved over the last 25 years, indicating a gap between technology promise and real-world results. * **Traditional site relationships remain vital:** Professional sites and established relationships, often requiring in-person engagement, are still fundamental for effective patient recruitment, highlighting the limitations of purely data-driven approaches. * **Patient advocacy groups are essential for patient-centricity:** To truly incorporate a diverse global patient voice into trial protocols and address varying standards of care, strong, professional, and sustainable connections with patient advocacy groups are indispensable. * **The role of data management has significantly evolved:** Data managers are no longer merely transactional but have become critical integrators and custodians of increasingly complex, multi-source data, requiring smarter management and critical thinking skills. * **Offshore data management teams are becoming client-facing:** There's a dramatic shift in offshore teams (e.g., in India) from simple task execution to direct client engagement, managing data and interacting with US and Western European customers. * **Protocol changes are a major industry inefficiency:** Frequent protocol amendments are costly, wasteful, and risk compromising trial integrity. The industry needs to prioritize getting protocols right upfront and introduce higher hurdles for changes. * **Critical thinking is a vital skill across clinical trial teams:** The industry needs to invest more in training and developing team members (from CRAs to data managers) to foster critical thinking, beyond mere SOP compliance, to navigate complex processes. * **Data integration complexity hinders FDA approvals:** The proliferation of diverse data sources (e.g., e-pro, mobile data) makes data integration and database lock challenging, contributing to basic errors and missing data that can lead to FDA non-approvals on first submission. * **Industry collaboration and interoperability are key to progress:** Organizations like TransCelerate are crucial for driving coordinated action and addressing interoperability challenges across the industry, particularly in data-focused activities. * **The line between competitors and partners is blurring:** In the complex landscape of clinical trials, organizations often find themselves partnering on one project and competing on another, necessitating strong trust and quality alignment. Tools/Resources Mentioned: * **Veeva (Vault CDMS, eTMF platform):** A key technology partner for Excelya, particularly for electronic Trial Master File solutions. * **Excelya:** A mid-sized full-service CRO based in Europe and India, with emerging US presence. * **TransCelerate:** An industry initiative focused on improving clinical trial efficiency and interoperability. * **Panthera:** An example of a Site Management Organization (SMO) in the UK. * **Cystic Fibrosis Foundation:** Cited as a highly professional patient advocacy group with its own IP and domain knowledge. Key Concepts: * **Patient-Centric Trials:** The core theme, discussing efforts and challenges in designing and executing clinical trials with the patient's perspective and needs at the forefront. * **Site-less Trials/Hybrid Models:** Discussions around decentralized trial approaches, noting that while there's investment, the market hasn't fully shifted away from traditional site-based recruitment. * **Centers of Excellence:** A strategic approach by Excelya to build standalone strength and expertise in specific non-clinical monitoring and project management activities (e.g., data management, eTMF, pharmacovigilance). * **Electronic Trial Master File (eTMF):** A digital system for managing essential clinical trial documents, highlighted as a key area of focus and partnership with Veeva. * **Protocol Amendments:** Changes made to a clinical trial protocol after it has been initiated, identified as a significant source of cost, delay, and operational complexity. * **Data Management Evolution:** The shift in the data manager's role from a low-status, transactional position to a high-value, proactive, client-facing role as an integrator and custodian of diverse data sources.
Healthcare Ecosystem Power Structure Explained
AHealthcareZ - Healthcare Finance Explained
@ahealthcarez
Feb 26, 2023
This video provides an in-depth exploration of the power structure within the employee healthcare ecosystem, specifically focusing on employer-sponsored health plans. Dr. Eric Bricker begins by establishing the critical importance of understanding industry power dynamics for both incumbents and potential disruptors. He illustrates a recurring pattern of "disruptors" – such as disease management companies, wellness programs, and modern point solutions – that experience a surge in popularity only to fade due to a fundamental flaw: consistently low utilization rates among employees and plan members. The core of Dr. Bricker's analysis introduces the "Table of Power," identifying three permanent and influential entities in the employee healthcare ecosystem: the Plan Sponsor (the employer, typically represented by HR, benefits, and CFO teams), the Healthcare Consultant/Broker (who aggregates and integrates plan components), and the Health Insurance Carrier (the platform on which the plan operates). He further elaborates on a hierarchical structure within each of these power players, drawing on Jeffrey Moore's framework of "gorillas," "chimpanzees," and "monkeys" to describe large national accounts, mid-market players, and small local entities, respectively. Examples are provided for each category, from Aon and United Healthcare as "gorillas" to smaller regional brokerages and Third-Party Administrators (TPAs) as "monkeys." Dr. Bricker then draws a powerful analogy between this healthcare power structure and the enterprise software industry, likening carriers to large platforms like SAP or Oracle, and consultants/brokers to integration services like Accenture or Cognizant. He explains that venture capital and private equity typically invest in scalable platforms rather than services. For true, lasting disruption in healthcare, he argues, one must aim to unseat the incumbent carriers by offering a "better, faster, cheaper" platform solution, citing Salesforce.com and AWS as prime examples of companies that successfully disrupted established enterprise platforms. He warns that "fourth parties" (the temporary disruptors) are often either acquired or replicated by the powerful carriers, making their independent existence precarious. Key Takeaways: * **The "Table of Power" is Permanent:** The employee healthcare ecosystem is dominated by three enduring entities: the Plan Sponsor (employer), the Healthcare Consultant/Broker, and the Health Insurance Carrier. Any solution aiming for lasting impact must engage with or become one of these. * **"Fourth Party" Disruptors are Temporary:** Historically, solutions like disease management, wellness programs, and current point solutions (e.g., for diabetes, mental health, MSK) are temporary "fourth parties" that rise and fall. * **Low Utilization is the Death Knell:** The primary reason for the failure and eventual waning of these "fourth party" disruptors is consistently low utilization rates by employees and plan members, despite their initial appeal. * **Hierarchical Structure Exists Everywhere:** Within each of the three power seats (Plan Sponsor, Consultant/Broker, Carrier), there's a hierarchy (Gorillas, Chimpanzees, Monkeys) based on market size and influence, which dictates who serves whom. * **Platforms vs. Integrators:** The healthcare ecosystem mirrors enterprise software, with carriers acting as scalable platforms (like SAP/Oracle) and consultants/brokers as integrators/customization services (like Accenture/Cognizant). * **VC/PE Favor Scalable Platforms:** Venture Capital and Private Equity firms primarily invest in scalable platform businesses, not typically in services, due to differences in profit margins and growth potential. * **Carriers Absorb or Replicate Disruptors:** Incumbent carriers often neutralize "fourth party" disruptors by either acquiring them (e.g., Aetna buying Active Health Matters) or building their own competing solutions. * **True Disruption Requires Unseating the Platform:** For a startup to create lasting change and achieve high utilization, it must aim to replace an existing platform (the carrier) with a "better, faster, cheaper" alternative, rather than operating as a temporary "fourth party." * **Salesforce.com and AWS as Disruption Models:** These companies serve as prime examples of successfully disrupting entrenched enterprise platforms by offering superior value propositions, providing a blueprint for potential healthcare disruptors. * **Broker/Consultant Loyalty is Transactional:** Brokers and consultants are often open to alternatives to carriers, as their loyalty is frequently maintained through override payments, indicating a potential opening for truly innovative platform solutions. * **Strategic Attachment for "Fourth Parties":** If a company operates as a "fourth party," its best strategy for survival and impact is to tightly integrate or attach itself to one of the permanent players at the "Table of Power." Key Concepts: * **Employee Healthcare Ecosystem Power Structure:** The established hierarchy and influence of various entities within employer-sponsored health plans. * **Table of Power:** The three core, permanent entities: Plan Sponsor, Healthcare Consultant/Broker, and Health Insurance Carrier. * **Fourth Parties / Disruptors:** Temporary solutions that aim to improve cost containment or specific health outcomes but lack a permanent seat at the power table (e.g., Disease Management, Wellness Programs, Point Solutions). * **Low Utilization:** The critical failure point for many "fourth party" solutions, where employees and plan members do not sufficiently engage with the programs. * **Jeffrey Moore's Hierarchy:** A framework categorizing market players into "Gorillas" (large national accounts/dominant players), "Chimpanzees" (mid-market/super-regional), and "Monkeys" (small market/local). * **Platform vs. Integrator Model:** An analogy drawn from enterprise software where large, scalable systems (platforms) are distinct from the services that customize and integrate them (integrators). * **Better, Faster, Cheaper:** The fundamental value proposition often required to successfully disrupt and replace incumbent platforms. Examples/Case Studies: * **Disease Management Companies:** Active Health Matters, Health Dialog (early 2000s disruptors). * **Wellness Programs:** RedBrick Health, Virgin Pulse (2010-2015 disruptors). * **Point Solutions:** Livongo (diabetes), Hinge Health (musculoskeletal), Ovia (maternity) (current disruptors). * **Consultants/Brokers (Gorillas):** Aon, Willis Towers Watson, Mercer. * **Consultants/Brokers (Chimpanzees):** Lockton, Gallagher, USI. * **Consultants/Brokers (Monkeys):** McGohan Brabender (regional example). * **Health Insurance Carriers (Gorillas):** United Healthcare, Blue Cross plans. * **Health Insurance Carriers (Chimpanzees):** Aetna, Cigna. * **Health Insurance Carriers (Monkeys):** Various Third-Party Administrators (TPAs). * **Enterprise Software Platforms:** SAP, Oracle. * **Enterprise Software Integrators:** Accenture, Cognizant. * **Successful Platform Disruptors:** Salesforce.com, Amazon Web Services (AWS).
Introduction to Deviation Handling and Root Cause Analysis
Scilife
/@ScilifePlatform
Feb 24, 2023
This video provides a comprehensive introduction to deviation handling and root cause analysis within the context of manufacturing medicinal products and medical devices. It emphasizes the critical role of a robust Quality Management System (QMS) that incorporates GxP and quality risk management to ensure product quality, patient safety, and adherence to regulatory expectations, including references to 21 CFR. The speaker details the systematic process for managing non-conformities and deviations, from identification and reporting through investigation, risk assessment, corrective and preventive actions (CAPA), effectiveness checks, and periodic reviews. The discussion highlights the importance of thorough investigation to determine root causes, classifying deviations based on criticality using risk assessment tools like FMEA, and addressing various types of errors including human, documentation, equipment, and process-related issues. The video also touches upon the benefits of electronic quality management systems (eQMS) for streamlining these processes and maintaining an agile, compliant environment. Key Takeaways: * **Structured Deviation Management:** An effective QMS requires a clearly defined, multi-phase process for handling deviations and non-conformities, encompassing identification, investigation, risk assessment, CAPA implementation, effectiveness verification, and periodic review to ensure continuous quality and compliance in life sciences. * **Risk-Based Classification:** Deviations should be classified (critical, major, minor, incident) using quality risk management principles and tools like Failure Modes and Effects Analysis (FMEA), which considers severity, probability of occurrence, and detectability, to prioritize investigation efforts and resource allocation. * **Thorough Root Cause Analysis (RCA):** Investigations must employ systematic RCA methodologies (e.g., 5 Whys, Fishbone diagrams, FMEA) by cross-functional teams to identify the true underlying causes of non-conformities, rather than just superficial symptoms, to prevent reoccurrence. * **Comprehensive Error Categorization:** Root causes often stem from human errors (emission or commission, intentional or unintentional), documentation deficiencies (e.g., obsolete SOPs, lack of training), equipment malfunctions, or process deviations from established parameters, all of which require specific attention during investigation. * **Importance of CAPA Effectiveness:** Corrective and Preventive Actions (CAPAs) must be identified, implemented, and rigorously monitored for their effectiveness in line with quality risk management principles, demonstrating to auditors and inspectors that the quality system is actively preventing issues and maintaining a validated state. * **Leveraging Electronic Systems:** Electronic Quality Management Systems (eQMS) are crucial for streamlining the deviation management process, integrating event data with other quality processes like change controls and calibrations, and facilitating agile, documented, and compliant operations, which aligns with the need for regulated enterprise software.
![The Good, the Bad, and the Ugliness of Regulation [No. 86 LECTURE]](https://i.ytimg.com/vi/FgTRVi23LGo/maxresdefault.jpg)
The Good, the Bad, and the Ugliness of Regulation [No. 86 LECTURE]
The Federalist Society
/@TheFederalistSociety
Feb 23, 2023
This video, "The Good, the Bad, and the Ugliness of Regulation," features Professor Susan Dudley discussing the origins, functions, and impact of administrative agencies and regulations in the U.S. It delves into the historical context of administrative law, tracing the evolution from early economic regulations to the modern prevalence of social regulations concerning environment, health, and safety. Professor Dudley explains the constitutional debates surrounding agency powers, the significance of the Administrative Procedure Act, and various methods for measuring the vast scope and economic impact of regulations. She highlights that while regulations are often perceived as burdensome, they are fundamentally justified by market failures such as externalities and asymmetric information, which are particularly relevant in complex industries like pharmaceuticals and life sciences. Key Takeaways: * **Foundational Role of Agencies:** Administrative agencies emerged to address the increasing complexity of society, operating under legislative delegation (e.g., Administrative Procedure Act of 1946) to create detailed regulations that Congress lacks the expertise or capacity to write. * **Shift to Social Regulation:** While early regulation focused on economic aspects, there has been a dramatic and continuing increase in "social regulation" since the 1970s, covering areas like environment, health, safety, and workplace conditions. This category directly encompasses the regulations critical to the pharmaceutical and life sciences industries. * **Market Failures as Justification:** The primary rationale for regulation stems from market failures, including externalities (costs borne by third parties, like pollution) and asymmetric information (where one party lacks crucial information, such as product safety or efficacy). * **Vast and Growing Regulatory Landscape:** There are at least 100 federal agencies issuing thousands of regulations annually, with 50-100 "economically significant" regulations (>$100 million impact) each year.ai helps its clients manage through AI and consulting services. * **Challenges in Measuring Regulatory Impact:** Unlike fiscal budgets, there's no single, comprehensive measure for the total impact of regulations, making it difficult for businesses to fully grasp and comply with the "stock" of existing rules (Code of Federal Regulations) and the "flow" of new ones (Federal Register). This complexity highlights the value of specialized consulting and AI solutions for compliance tracking.