Shirley Reynolds, Senior Product Manager with United Health Group, shared testing results and lessons learned for ICD-10 on our November 21 Open Line Friday call. Be sure to visit www.floridablue.com/icd-10 for a comprehensive list of ICD-10 resources and archived content.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price.
Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price.
Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Accelerating Post-approval Change Management with ICH Q12Veeva Systems
Adopting ICH Q12 and modern technologies can reduce the number of changes that require regulatory approval as well as accelerate evaluation, implementation, and global approval of a change. In a 2017 PDA survey, almost 40% of respondents said that 50% or more of their post-approval changes required submission to a health authority. With increasing complexity in the manufacturing of new therapies and growing number of changes that require filing review and updates in multiple markets, the global post-approval change management (PACM) process is becoming unmanageable.
Modern technologies are reducing complexity in pharma by bringing together systems and people to seamlessly support global, end-to-end processes. With greater visibility and collaboration, change management processes are more efficient and less risky. In this webinar, learn:
What is ICH Q12 and potential benefits
Best practices and approaches to key PACM challenges
Approaches to manage ‘established conditions’
How technology can support ICH Q12 and simplify change management
Innovative ways leading pharma companies are addressing PACM
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Preparing and Implementing a Comprehensive ICD-10 Testing StrategyCognizant
This paper describes a testing strategy that, if healthcare organizations begin now, can help ensure compliance without endangering critical business operations.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
FDA Third Party Review Specialists
It takes one-third of the time to reach a 510K approval with TPRG - 55 days via 160 days. 510(k) in Calendar Days
You are welcome to call their epesenttive to the region
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
In this presentation from IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Chris Wubbolt and John Patterson focus on current trends in cloud computing environments, including aspects of cloud computing and Software-as-a-Service (SaaS) providers that may be of interest to US Food and Drug Administration investigators during an FDA inspection. Important compliance related points to consider for software vendors as they shift to becoming SaaS providers are discussed. The presentation also reviews the pros and cons of cloud computing from a business and compliance perspective, including differences between traditional computing environments and private/public clouds. Examples of issues to consider when using cloud computing environments and SaaS providers are also discussed.
Icd 10 remediation for provider practices – key challenges and mitigation str...Apoorv S
On October 1, 2014, the U.S. healthcare system will transition from the Ninth Edition of the International Classification of Diseases (ICD-9) set of diagnosis and inpatient procedure codes to the Tenth Edition of those code sets (ICD-10). Provider systems are impacted across the value chain due to ICD-10 remediation and significant changes are required across the value chain and provider business functions. This article focuses on the key challenges being faced by providers in their ICD-10 remediation journey and the mitigation approaches that providers can adopt to address them.
Computer System Validation - The Validation Master PlanWolfgang Kuchinke
Computer System Validation (CSV) is the process used to ensure and document that a computerbased system is operating according to predefined requirements. CSV is necessary when replacing paper records, like
Case Report Forms for clinical trials, with an electronic system within the highly regulated data zone that impacts public health and safety. Necessary validation documents are for example the Standard Operating Procedures (SOPs), which outline how the computer system should be used. Here, we describe in detail the System Validation Master Plan, the most important document in Computer System Validation. In contains topics, like: Validation Policy, Definition of Validation, Rules and Regulations in CSV, Legal basis, FDA 21 CFR Part 11, FDA Guidance for industry, ICH Guideline GCP, Annex 11 EU-GMP, Validation Philosophy, Organisation validation document, Audit Reports, Organisation guidelines, Organisation quality management handbook, etc.
The steps of the Validation Life Cycle are: 1. System Specification, 2. System Classification, 3. Validation Planning, 4. Establishing of the validated state, 5. Maintaining the validated state, 6. System Retirement.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
FDA Regulations and Medical Device Pathways to MarketMethodSense, Inc.
Bringing your medical device to market requires in-depth attention to its safety, reliability and compliance. In addition to designing a quality medical device, it’s critical that you anticipate and address the requirements that allow you to introduce it to the market successfully.
Life Science consulting firm, MethodSense, discusses important FDA regulations as they relate to bringing a medical device to market, including 21 CFR Part 821, 510(k) approval and 21 CFR Part 11.
Preparing and Implementing a Comprehensive ICD-10 Testing StrategyCognizant
This paper describes a testing strategy that, if healthcare organizations begin now, can help ensure compliance without endangering critical business operations.
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development life cycle to be scrutinized.
Prepare your medical device for market with this Action List that walks you through the complexities of IEC 62304
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Presentation describes the importance of IT validation from the perspectives of the FDA and our company. It explains GAMP 5, the Validation Life Cycle, good documentation practices, document naming conventions, Change Control, Problem Management, Periodic Evaluation, FDA 483 Warning Letters and 21 CFR Part 11 and a unique Validation Life Cycle.
CODEX Validation Group is a consulting company with broad experience in the cGMP, compliance, automation, and validation for the Pharmaceutical, Biotechnology and Medical Device industries committed to follow the highest ethical standards as we work with our customers.
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
FDA Third Party Review Specialists
It takes one-third of the time to reach a 510K approval with TPRG - 55 days via 160 days. 510(k) in Calendar Days
You are welcome to call their epesenttive to the region
Computer System Validation (CSV) is a core requirement for several industries. The aim of Computer System Validation is to ensure, through documentation, that the computer systems function the way they are intended to, consistently, repeatedly and reproducibly, somewhat in the manner expected of scientific experiments. So, the validation, meaning authentication or corroboration, is something that has to be done right from the start, that is, defining the computer system, to their use and going all the way right up to the time the computer system is retired.
In this presentation from IVT's Qualifying and Validating Cloud and Virtualized IT Infrastructures, Chris Wubbolt and John Patterson focus on current trends in cloud computing environments, including aspects of cloud computing and Software-as-a-Service (SaaS) providers that may be of interest to US Food and Drug Administration investigators during an FDA inspection. Important compliance related points to consider for software vendors as they shift to becoming SaaS providers are discussed. The presentation also reviews the pros and cons of cloud computing from a business and compliance perspective, including differences between traditional computing environments and private/public clouds. Examples of issues to consider when using cloud computing environments and SaaS providers are also discussed.
Icd 10 remediation for provider practices – key challenges and mitigation str...Apoorv S
On October 1, 2014, the U.S. healthcare system will transition from the Ninth Edition of the International Classification of Diseases (ICD-9) set of diagnosis and inpatient procedure codes to the Tenth Edition of those code sets (ICD-10). Provider systems are impacted across the value chain due to ICD-10 remediation and significant changes are required across the value chain and provider business functions. This article focuses on the key challenges being faced by providers in their ICD-10 remediation journey and the mitigation approaches that providers can adopt to address them.
Aetna icd 10 collaborative testing Nov 2014Florida Blue
Mr. Brian Parkany, Senior Director of Strategic Initiatives at Aetna, shared their testing results for ICD-10 on our November 21, 2014 Open Line Friday call. For a complete list of ICD-10 resources, visit www.floridablue.com/icd-10
Ben Quirk spoke to the South Florida medical group community about the impact of ICD-10 on the healthcare industry. It was a very informative talk that covered a lot of need-to-know details, including how ICD-10 relates to Meaningful Use and SNOMED.
We feature experts Stanley Nachimsom of Nachimsom Associates and Michael Palatoni of Athena Health to review WEDI survey results and share small practice/physician update on ICD-10 implementation. Visit floridablue.com/icd-10, your complete ICD-10 resource.
ICD-10-CM is the United States’ clinical modification of the World Health Organization’s (WHO) International Classification of Diseases (ICD) Tenth Revision. It is used to classify diseases and causes of illness recorded on health records, claims, and other vital information.
The U.S. Department of Health and Human Services (HHS) will require covered entities (i.e., health plans, health care providers, and health care clearinghouses) that conduct electronic HIPAA standard transactions to move from ICD-9 to the next generation ICD-10 code sets by October 1, 2015.
ICD-10 Implementation for Physicians WhitepaperMarie Bunch
Many providers are operating with blinders on, completely unaware of the magnitude of the conversion and potential train wreck ahead for their reimbursement. Support your physicians through the difficult change ahead by helping them take the right steps forward to make their transition as efficient and painless as possible.
Regardless of the size of the practice, training for any implementation – especially for one as complex and far reaching as ICD-10 – can be costly and difficult to deliver. With only a year remaining to complete the transition, providers and their staff must step up to planning, training, software/system upgrades/replacements, as well as other necessary investments. ICD-10 will require a significant education investment in order to ensure accurate coding and minimize productivity loss. While large organizations may have the resources to purchase training materials or send staff to training sessions, smaller organizations may have to depend on special societies or share resources to provide the needed training.
Start the conversation with your physicians now. Help them through the transition with resources designed to get them on board with the transition now. Practice Management Institute® (PMI) is already helping practices adapt to the change with classes especially focused on the transition steps for medical offices, hosted by leading hospitals across the country. PMI’s Professional Services Department and Faculty Team is committed to providing the most up-to-date information on implementation guidelines, coding conversion steps and staff training fulfillment.
About PMI
PMI is the nation’s leading provider of continuing education for medical office professionals, with a broad curriculum of educational workshops that address the office training needs for private practice physicians. Classes are presented in leading hospitals, health care systems, and medical societies. For more than 30 years, physicians have relied on PMI to provide the latest information on managing an efficient and compliant practice.
The benefits of revenue cycle and compliance collaborationBESLER
This presentation highlights the importance of the working relationship between hospital Revenue Cycle and Compliance teams. This complimentary partnership can become seamless by utilizing the data analytics obtained from 835 and 837 data sets, Return to Provider (RTP), CERTs, Readmissions, ZPICs, HACs, RACs and Transfer DRGs. The combination of this data can assist in quickly identifying and resolving issues prior to provider submission, reducing days in AR and improving cash in the door.
QualiTest offers a holistic testing approach which provides an end-to-end test at a fraction of the cost compared to current market approaches.
QualiTest understands the challenges and risks involved in ICD-10 transformation across the healthcare spectrum: providers, payers, clearinghouses, and vendors. As the world’s second-largest independent pure play QA and testing solution partner, QualiTest provides comprehensive end-to-end services for ICD-10 testing to all entities in the healthcare industry.
http://www.qualitestgroup.com
A Dell Healthcare Services POV on payment integrity, utilization management and provider management. Browse the slides and discover more at Dell.com/healthplans
The recent extension of the ICD-10 deadline was greeted with mixed reactions throughout the healthcare industry. Some favored an extension, while others preferred to move ahead with the change. In this webinar, we look at the pros and cons of the delay and how it will affect providers and patients. Reactions from other vendors are also presented.
Experience guide to or implementation and compliance 2015Edifecs Inc
Ready to kick-off a compliance project? Don’t miss this webinar; leverage our experience to accelerate your compliance programs. Understand the certification options. Gain insight to assist your organization maintain compliance after project completion. Understand how certification and partner communication can protect your organization.
March 2015 ICD10: Preparation for Physicians and Small PracticesFlorida Blue
March: ICD-10 Preparation for Physicians and Small Practices. Covers survey findings from WEDI and PAHCOM and points out the ICD-10 training costs were much lower than previously though.
This month we tackle the issue of the real cost to implement ICD-10 at the physician practice level. We are pleased to feature two testimonials from Harbor Oaks Eye Associates and Advance Medical of Naples, LLC. Stanley Nachimson also shares his expertise. Visit floridablue.com/icd-10 for your comprehensive list of resources.
ICD-10 Open Line Friday Meeting December 2014Florida Blue
Open Line Friday goes social as we invite two esteemed guests to our panel of experts: Joe Lavelle and Steve Sisko. They'll share how social media can help engage more providers in being educated on the issues surrounding ICD-10 implementation. Visit floridablue.com/icd-10 for a complete directory of resources.
ICD-10: A Payer Update with Aetna & United Health GroupFlorida Blue
Our November 2014 Open Line Friday call brings you updates from three major payers on their ICD-10 testing: Aetna, United, and Florida Blue. Follow our live tweeting of the call @FLBlue, or go to www.floridablue.com/icd-10 for a comprehensive list of resources.
Our Open Line Friday panelists discussed how medical practices can use the official ICD-10 compliance date as a target for their preparedness. Remember to visit floridablue.com/icd-10 for a complete list of resources.
ICD-10 Readiness: Another Practice Testimonial Florida Blue
Join us as we hear from guest Lori Ann Martell with Advance Medical of Naples, LLC on how their practice is working towards ICD-10 implementation. Our regular panel of experts from Availity, Secure EDI, Mayo Clinic, Florida Blue and others will provide the latest information in this, our monthly Open Line Friday teleconference. How can Florida Blue help you with ICD-10? Visit us at http://floridablue.com/icd-10.
Rhonda Buckholtz, VP with the American Association of Professional Coders, shares the results of a survey they conducted on the state of provider readiness for a 2014 ICD-10 implementation. She participated in our June Open Line Friday call. Find more here: www.
We're pleased to present Rhonda Buckholtz, VP of ICD-10 Education and Training for the American Association of Professional Coders (AAPC), as our June Open Line Friday guest. Rhonda will explain the approach the AAPC has taken with the delay of ICD-10 to 2015. Visit http://www.bcbsfl.com/wps/portal/bcbsfl/w/providers/providerdetails/SA_ToolsResources/SA_ICD10 for your comprehensive list of ICD-10 resources.
A Provider View on ICD-10 and the 2015 DelayFlorida Blue
How are providers coping with the delay of the ICD-10 implementation to 2015, when many had established budgets and training for being live 2014? Guests from Prime Health Physicians LLC and Harbor Oaks Eye join our Open Line Friday panel to share their experience. Visit floridablue.com/icd10 for a complete repository of tools and information.
5 Real World Non-Profit Challenges Solved through Social MediaFlorida Blue
Social media can solve non-profits' five most common challenges, including:
Ensuring your mission and brand is accurately depicted.
Creating advocates.
Fundraising.
Keeping volunteers engaged.
Doing more with less money and less time.
This presentation was shared during the Florida Blue Foundation's 2014 Sapphire Awards and Symposium at the World Golf Village Renaissance Resort by Annie Erstling and Kate Warnock.
With the vote to delay ICD-10 implementation to 2015, many in the industry are left to wonder whether to continue with plans to implement in 2014 or not. Our Open Line Friday call with panelists from Mayo Clinic, Secure EDI, Availity and more will explore the implications of the recent decision to delay the implementation of ICD-10, and to rethink YOUR options most effectively.
ICD-10 Open Line Friday Presentation March 21, 2014Florida Blue
Today's ICD-10 Open Line Friday presentation provides the latest regulatory updates, testing schedules and more. Hear from experts at The Mayo Clinic, Secure EDI, Availity and more. Visit floridablue.com for a complete repository of ICD-10 tools and resources to help with your conversion.
Seven Months to ICD-10: Useful Guidance for the CountdownFlorida Blue
Twelve months ago, it may have been too early to engage individual physicians and small medical practices in ICD-10 preparations. However, six months from today, it may be too late! Today's session will focus on practical tips for getting your organization ready for the ICD-10 conversion.
Focus on 2014: A Tampa Bay Economic ForecastFlorida Blue
Carl Patten, director of the Florida Blue Center for Health Policy, presented a forecast of the health policy environment in Florida, and how it impacts Pinellas businesses in particular. His presentation included the current state of the Affordable Care Act, and its ongoing implications for employers. For more information, visit http://ow.ly/sNeN7.
ICD-10 Presentation to Bays Medical Society January 2014Florida Blue
Collaboration between physicians, payers and others across the health care industry is critical to a successful ICD10 implementation. Florida Blue is here with resources and expertise as you begin your ICD-10 journey, but the time to act is now! Visit our site to get started: http://ow.ly/sGVfF
Latest ICD-10 Readiness Surveys and Testing ResultsFlorida Blue
On this Open Line Friday call with experts from Mayo Clinic, Baptist Health South Florida, Tampa General Hospital and others, we share the results of a survey Florida Blue conducted on the state of readiness for ICD-10 implementation.
Open Line Friday: The Importance of Data for ICD-10 SuccessFlorida Blue
ICD-10 is an enormous change for healthcare providers, particularly with all of the mandates we’re now facing. This may be why so many physicians consider the ICD-10 mandate burdensome. In this session of Open Line Friday, Florida Blue meets with our panel of experts and gets insights from special guests, Dr. Joseph Nichols, orthopedic surgeon and WEDI co-chair. With preparation and collaboration, we can overcome the burden. Want to join us for our next Open Line Friday? Details here: http://ow.ly/sEZRe
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
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United Health Care ICD-10 Testing Results November 2014
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Proprietary Information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.
United Healthcare’s
ICD-10 Provider Test Approach, Results & Lessons Learned
Shirley Reynolds, UnitedHealthcare
Director, Regulatory Implementation Office
icd10testing@uhc.com
Florida Blue’s ICD-10 Open-Line Friday
November 21, 2014
2. 2
Proprietary Information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.
ICD-10 Impact
ICD-10 implementation across all UnitedHealth Group business segments:
•Impacted over 450 internal systems and applications
•Required execution of over 140,000 internal test cases to verify system and business rule accuracy and neutrality.
3. ICD-10 - Guiding Principles
UnitedHealthcare is committed to:
•Full regulatory compliance.
•Systems will accept new ICD-10 transactions (while continuing to accommodate ICD-9 coded claims for service dates prior to the regulatory compliance date) without data mapping or transformation.
•Perform extensive internal testing to verify predictable processing outcomes:
•Clinical Integrity: Ensure alignment with industry code mapping and consistent clinical review decisions.
•Benefit Neutrality: Ensure transparent benefit administration for members and providers across both code sets .
•Revenue Predictability: Perform internal analysis and collaborate with selected external providers to assess the impact of ICD-10 code selection on DRGs.
•Collaborate and perform external testing with facilities, physician groups and other business partners, including:
•Testing with selected facilities to identify areas at risk for unpredictable results and define strategies to improve the accuracy and predictability of production transaction outcomes.
•End-to-end testing to verify transaction compliance, accuracy and predictable payment results..
•Support health care providers in their readiness efforts.
•United Healthcare has a dedicated communication effort to advise providers on ICD-10 preparation steps and to provide resource materials.
•Communicate testing lessons learned, mitigation strategies and readiness recommendations to our providers via portals and other communication channels
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Proprietary Information of UnitedHealth Group. Do not distribute or reproduce without express permission of UnitedHealth Group.
4. Payer-Provider Collaborative Testing
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“Manual” Facility-Payer test effort to practice ICD-10 coding of key Dx categories to evaluate code assignments that may generate an ICD-9 to ICD-10 DRG shift.
•12 Regional Facility Providers, multiple locations
•Sample of 100-300 ICD-9 adjudicated claims for each provider (covering all DRG categories)
•Analysis included over 4,000 claims
•Facility staff assigned ICD-10 codes using original medical records
•Compared DRGs assigned to the paid ICD-9 claim against the ICD-10 coded test claim.
•Claims with DRG shifts were jointly analyzed by Facility and UHC/OptumInsight certified coders.
2013-2014
Phase 1: ICD-10 Coding &
DRG Shift Analysis
Obtained ICD-10 coded claims from providers and processed through production-like business flows (in test environments) to:
•Confirm system readiness and transaction processing through provider, claim intermediaries and payer;
•Validate processing accuracy;
•Identify potential payment variations between ICD-9 and ICD- 10 coded claims.
•Test partners included Facilities, Professional, Lab, Behavioral service providers and CMS.
•Providers coded claims in ICD-10 and submitted 837 files through clearinghouse(s).
•Claims were processed and 835s returned to providers.
•DRG and payment variances were collaboratively reviewed.
Complete End-to-End testing with remaining provider test partners to validate transaction accuracy through:
•Provider 837 generation
•Clearinghouse edits
•Application of ICD-10 codes in payer claim processing rules, business and clinical edits, including:
•Member benefit plans
•Provider contracts
•Authorization processing Testing will identify payment neutrality variances.
• ICD-10 coded claim results are compared to original paid ICD-9 claims.
•Claim report and 835s are returned to provider.
•DRG and payment variances are collaboratively reviewed.
Phase 2: End-to-End Transaction Pilots
Phase 3: “End-to-End” Claim Processing & Payment Test
2014
2015
5. Phase 1: ICD-10 Coding and DRG Shift Results
•Analysis included over 4,000 claims
•Compared previously paid ICD-9 Facility claims to newly coded ICD-10 claims to identify potential DRG Shifts.
•MS-DRG grouper v31 was used to assess both claim sets.
•Valid shifts were measured after coding issues were reviewed with providers and any agreed upon coding or test submission errors were resolved.
•4.2% of claims generated a valid DRG shift.
•Slightly more than half (2.3%) shifted to higher paying DRGs
•1.9% shifted to lower DRGs.
•Some claims that generated a valid shift indicated possible issues with the draft MS-DRG grouper. UnitedHealthcare escalated to CMS to address in future DRG releases.
Phase 1 - DRG Shift Results
% of Total
Claims with DRG Shift (pre-review)
16%
Variance between v28 and v31 grouper
6.5%
Coding Errors
5.3%
Valid DRG Shift
4.2%
Claim Results – After Joint Coding Review
Claims with no Valid DRG Shift
95.8%
Claims with Valid DRG Shifts
4.2%
Shift to higher DRG
2.3%
Shift to lower DRG
1.9%
6. Conclusions
•Most DRG variances (6.5%) were due to explainable differences between the MS- DRG v28 grouper (applied to ICD-9 base claims) vs. the later v31 version (applied to ICD-10 test claims).
•5.3% of claims varied due to inaccurate provider coding. Examples include:
• Invalid codes
• Improperly sequenced codes
• Improper usage of codes
• Coding that did not follow industry-standard guidelines
•Root causes for provider coding issues included:
•Errors due to manual claim coding/submission (“spreadsheet”) process
•Contract coders used by some providers (facility coding staff not yet trained in 2013- early 2014).
•Coders inexperience with ICD-10 code set.
•Insufficient data in historical medical records to support ICD-10 code specificity
Phase 1: ICD-10 Coding and DRG Shift Results
7. Phase 2: 2014 End-to-End Pilot Test Results
ICD-9 vs. ICD-10 Claim Comparison Results
% of total
DRG & Payment Matched
93.3%
Claims with DRG Shifts
3.2%
Shift to different MDC (Major Diagnostic Category)
0%
DRG Family (within same MDC)
3.2%
Claims with Same DRG – Payment Differs
0.6%
Test Environment Issues (prevents valid comparison)
2.9%
ICD-9 to ICD-10
Claim Variations
93.3% - DRG & Payment
Matches
3.2% - DRGs Differ
0.6% - DRGs Match;
Payments Differ
2.9% - Test Environment
Issues
•93.3% of ICD-10 test claims (adjudicated through full end-to-end processing) generated the same DRG and payment as the ICD-9 paid claim.
•3.2% of test claims that generated a different DRG were primarily due to procedure code differences, including:
•Variations in the number of procedure codes on the ICD-9 paid vs. ICD-10 test claim, or
•Assignment of ICD-10 procedure codes that did not match ICD-9 procedures (such as a diagnostic code on one claim and a surgical code on the other).
•“Test environment issues” refers to constraints that prevented generation of an accurate ICD-10 claim result. These issues will not affect production claims.
Inpatient Test Claim Results
8. Phase 2: 2014 End-to-End Pilot Test Results
Professional and Laboratory Claim Results
•2014 testing included some Professional and Laboratory claims to:
•Verify capability to accept and process claims through an end-to-end, production-like process involving all claim transaction parties (provider, claim intermediaries, payer)
•Assess impact of medical policies and other claim edits
•Verify benefit plan neutrality
•Services are not reimbursed based on ICD diagnosis codes.
•However, approximately 2% of test claims generated different payment results due to variations in the CPT/procedure codes assigned to original ICD-9 vs. ICD-10 test claims. As with inpatient claims, procedure code variations included:
•Additional or fewer CPT codes entered on ICD-10 vs. ICD-9 claim;
•ICD-9 codes were not accurately translated to ICD-10’s by coders.
9. •UnitedHealth Group verified the capability to successfully perform end-to-end exchange and processing of ICD-10 coded claims with multiple providers and claim intermediary partners.
•DRG variances for facility test claims dropped significantly between 2013 and 2014 test phases, potentially due to improved coder training and provider “practice” with other ICD-10 test initiatives.
•Most DRG variances identified in recent inpatient claim testing were due to inconsistent or incorrect assignment of new ICD-10 PCS codes.
•As expected, results from Professional and Lab testing confirmed a low risk of payment variation between ICD-9 paid and ICD-10 test claims. Payment differences were due to variations in assignment of CPT codes.
Lessons Learned