This presentation is meant to help you understand how you, as a pharmaceutical company, can protect yourself from risks of audit and fines even before you submit your final report to CMS.
Risks of Open Payments and Medicare Part D Dataqordata
This SlideShare is aimed at providing a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. Compiled by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, it will also present information about the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.
Next Generation Compliance: Using Analytics to Reduce Compliance Riskqordata
In this SlideShare, we will cover a compliance officer’s perspective on using analytics to enhance existing compliance and monitoring programs.You will also get a hands-on walk-through of top three methods that compliance officers can use to effectively monitor spend programs and reduce spend submission risks throughout the year.
This presentation discuss major applications of AI in Healthcare including medical diagnostics, personalized treatments and optimizing US healthcare system. This presentation also discuss some of the challenges of implementing AI in healthcare.
Ready or Not? Compliance in a World of New ModelsPYA, P.C.
PYA Consulting Manager Kristen Lilly recently co-presented “Ready or Not? Compliance in a World of New Models,” along with Fatema Zanzi, Esq., from Drinker Biddle & Reath.
In the presentation, they:
Discussed strategies for preventing, detecting, and enforcing basic compliance principles in a world of new models, such as accountable care organizations, bundled payments, and more.
Evaluated compliance considerations for new model drivers, such as quality and data analytics.
Explored incentive arrangements with patients.
Discussed how culture, quality, and human resources play a role in compliance.
FDA Cybersecurity Recommendations to Comply with NIST - Wearables Crash Cours...Epstein Becker Green
Epstein Becker Green Webinar with Attorney Kim Tyrrell-Knott - Wearables Crash Course Webinar Series - June 21, 2016.
Cybersecurity is a serious risk management issue for all technology and wearables and other wireless technologies, in particular. This session will address FDA's recommendations for a comprehensive cybersecurity program that manages risks throughout the product life cycle.
http://www.ebglaw.com/events/fda-cybersecurity-recommendations-to-comply-with-nist-a-best-practice-for-all-wearables-wearables-crash-course-webinar-series/
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
PYA Principal Barry Mathis presented “Hot Topics in Privacy and Security,” at the Florida Hospital Association's 14th Annual Health Care Corporate Compliance Education Retreat.
The presentation explored:
• Changes in the privacy and security ecosystem.
• Emerging technology risks and hot topics.
• What happens to hacked data.
• How to best protect data.
Risks of Open Payments and Medicare Part D Dataqordata
This SlideShare is aimed at providing a review of the cases against Insys Therapeutics Inc., and analyze the data that prosecutors used as part of the allegations against the manufacturer. Compiled by Brian A. Dahl, Principal, Dahl Compliance Consulting LLC, and Mohammad Ovais, Founder & CEO, it will also present information about the ways in which compliance teams can analyze publicly available Open Payments and Medicare Part D data to avoid risks of kickback violations.
Next Generation Compliance: Using Analytics to Reduce Compliance Riskqordata
In this SlideShare, we will cover a compliance officer’s perspective on using analytics to enhance existing compliance and monitoring programs.You will also get a hands-on walk-through of top three methods that compliance officers can use to effectively monitor spend programs and reduce spend submission risks throughout the year.
This presentation discuss major applications of AI in Healthcare including medical diagnostics, personalized treatments and optimizing US healthcare system. This presentation also discuss some of the challenges of implementing AI in healthcare.
Ready or Not? Compliance in a World of New ModelsPYA, P.C.
PYA Consulting Manager Kristen Lilly recently co-presented “Ready or Not? Compliance in a World of New Models,” along with Fatema Zanzi, Esq., from Drinker Biddle & Reath.
In the presentation, they:
Discussed strategies for preventing, detecting, and enforcing basic compliance principles in a world of new models, such as accountable care organizations, bundled payments, and more.
Evaluated compliance considerations for new model drivers, such as quality and data analytics.
Explored incentive arrangements with patients.
Discussed how culture, quality, and human resources play a role in compliance.
FDA Cybersecurity Recommendations to Comply with NIST - Wearables Crash Cours...Epstein Becker Green
Epstein Becker Green Webinar with Attorney Kim Tyrrell-Knott - Wearables Crash Course Webinar Series - June 21, 2016.
Cybersecurity is a serious risk management issue for all technology and wearables and other wireless technologies, in particular. This session will address FDA's recommendations for a comprehensive cybersecurity program that manages risks throughout the product life cycle.
http://www.ebglaw.com/events/fda-cybersecurity-recommendations-to-comply-with-nist-a-best-practice-for-all-wearables-wearables-crash-course-webinar-series/
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
PYA Principal Barry Mathis presented “Hot Topics in Privacy and Security,” at the Florida Hospital Association's 14th Annual Health Care Corporate Compliance Education Retreat.
The presentation explored:
• Changes in the privacy and security ecosystem.
• Emerging technology risks and hot topics.
• What happens to hacked data.
• How to best protect data.
Digital Health Devices and Clinical Trials – Wearables Crash Course Webinar S...Epstein Becker Green
Epstein Becker Green Webinar with Attorney Daniel G. Gottlieb - Wearables Crash Course Webinar Series - June 14, 2016.
Wearables can collect valuable data in clinical trials. However, there is not a lot of clarity on how wearables are regulated. This session will help you understand why this uncertainty exists and provide you with strategies for navigating these muddy regulatory waters.
See http://www.ebglaw.com/events/digital-health-devices-and-clinical-trials-wearables-crash-course-webinar-series/
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
Global AI seattle How AI will Reinvent HealthcareAlex Ermolaev
The latest AI advances have the potential to massively improve our health and well-being. However, most of the work is yet to be done. In this talk, we will explore the most important opportunities for AI in healthcare. For example, we will explore how AI can diagnose major life-threatening conditions even before those conditions emerge. We will talk about AI ability to recommend dramatically more effective and less harmful treatment plans based on AI understanding of patient's medical history and current conditions. Finally, we will talk about AI role in making our healthcare system effective and affordable for everyone. For each area, we will discuss the latest progress made as well as the challenges remaining.
The biggest opportunities in digital health for Turkey's Medical Sector Shahid Shah
This was presented at the Digital Health Summit Turkey 2014 in Istanbul. It is an American healthcare expert's viewpoint on what should matter to Turkey based on lessons from the USA. Designed for a mixed audience of providers, pharma, and bio entrepreneurs and executives.
Med Device Vendors Have Big Opportunities in Health IT Software, Services, an...Shahid Shah
If you’re in the medical device manufacturing or hardware sales business your revenue growth (CAGR) is under pressure like never before. You’re being asked to do more with less but you’re probably going to find that hard to accomplish because of one or more of the following challenges:
* Longer product development timelines caused by more FDA and other government regulations
* Increased demand by customers to have your devices deliver user experiences that are more like “consumer” devices such as cell phones and tablets
* Lower margins as a reaction to commodity competition (your sensor hardware business will be commoditized faster and faster over time)
* More complex and longer sales cycles because devices are now being approved for sale not by facilities and clinical executives alone but increasingly by CIOs and IT teams
* Increased cost of risk management and compliance caused by connectivity requirements
Any one of these challenges is difficult to meet but these days you’re probably being asked to meet more than one simultaneously. The solutions are not simple but the good news is that medical device manufacturers have many revenue generation opportunities today that can fund the new strategic imperatives you’ll need to put into place to meet the challenges listed above.
This briefing, presented by Netspective CEO Shahid Shah, describes some of the opportunities and how device vendors can take advantage of them.
Revenue opportunities in the management of healthcare data delugeShahid Shah
Healthcare data is hard to deal with and getting even harder and more expensive. In this presentation, Shahid Shah covers why:
* Healthcare data is going from hard to nearly impossible to manage.
* Applications come and go, data lives forever.
* Data integration is notoriously difficult, even in the best of circumstances, and requires sophisticated tools and attention to detail.
And, then talks about how new techniques are needed to store and manage healthcare data.
Open Source is a great opportunity for EHR, Digital Health, and Health IT Int...Shahid Shah
Presented at the OSEHRA Summit 2014, this talk focused on:
* OSEHRA is major business opportunity for ISVs and systems integrators
* Open source software and associated business models can satisfy most needs.
* There’s nothing special about health IT data that justifies complex, expensive, or special technology.
This group paper, written as a graduate student at CMU, attempts to define and summarize the huge challenge ahead of North American healthcare providers by illuminating current and future trends of healthcare business intelligence (BI); ramifications of EMR; the pros and cons of BI and analytics; the myriad ethical and privacy issues of big data’s role (normally associated with market share and profits); and lastly provide an industry overview of BI and analytics solutions specific to healthcare.
To view the 30+ page paper for which this presentation summarizes, please contact James Young via LinkedIn: https://www.linkedin.com/in/jamesyoung007
CHC Briefing: OSEHRA is a great business opportunity for healthcare IT ISVs a...Shahid Shah
An opinionated look at why current health IT systems integrate poorly and how it’s a big opportunity for the OSEHRA Community
Topics Covered:
* An overview of VA, VHA, VistA, and OSEHRA
* The macro healthcare environment and why OSEHRA is am important participant
* What’s needed by the industry that OSEHRA can provide
Key takeaways:
* OSEHRA is major business opportunity for ISVs and systems integrators
* There’s nothing special about health IT data that justifies complex, expensive, or special technology
Modernizing Architecture for a Complete Data StrategyCloudera, Inc.
Data is the future of business. Either take advantage of it, or get surpassed by those who do.
In this webinar, Ovum's Tony Baer discusses the importance of building a modern data strategy that ensures your journey with Apache Hadoop and big data is a successful one. Together, we'll walk through how to build a plan for long-term success while realizing short-term gains, including:
How to pinpoint the business goals that matter most
How to assess your strengths and weaknesses to meet those goals
How to build a thoughtful approach that ensures your initiatives succeed
FDA News Webinar - Inspection IntelligenceArmin Torres
Developing a Digital Data-Driven Approach to preparing for FDA Inspections. Using Data Analytics to proactively monitor internal and external Quality & Compliance data sources.
Digital Health Devices and Clinical Trials – Wearables Crash Course Webinar S...Epstein Becker Green
Epstein Becker Green Webinar with Attorney Daniel G. Gottlieb - Wearables Crash Course Webinar Series - June 14, 2016.
Wearables can collect valuable data in clinical trials. However, there is not a lot of clarity on how wearables are regulated. This session will help you understand why this uncertainty exists and provide you with strategies for navigating these muddy regulatory waters.
See http://www.ebglaw.com/events/digital-health-devices-and-clinical-trials-wearables-crash-course-webinar-series/
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
Global AI seattle How AI will Reinvent HealthcareAlex Ermolaev
The latest AI advances have the potential to massively improve our health and well-being. However, most of the work is yet to be done. In this talk, we will explore the most important opportunities for AI in healthcare. For example, we will explore how AI can diagnose major life-threatening conditions even before those conditions emerge. We will talk about AI ability to recommend dramatically more effective and less harmful treatment plans based on AI understanding of patient's medical history and current conditions. Finally, we will talk about AI role in making our healthcare system effective and affordable for everyone. For each area, we will discuss the latest progress made as well as the challenges remaining.
The biggest opportunities in digital health for Turkey's Medical Sector Shahid Shah
This was presented at the Digital Health Summit Turkey 2014 in Istanbul. It is an American healthcare expert's viewpoint on what should matter to Turkey based on lessons from the USA. Designed for a mixed audience of providers, pharma, and bio entrepreneurs and executives.
Med Device Vendors Have Big Opportunities in Health IT Software, Services, an...Shahid Shah
If you’re in the medical device manufacturing or hardware sales business your revenue growth (CAGR) is under pressure like never before. You’re being asked to do more with less but you’re probably going to find that hard to accomplish because of one or more of the following challenges:
* Longer product development timelines caused by more FDA and other government regulations
* Increased demand by customers to have your devices deliver user experiences that are more like “consumer” devices such as cell phones and tablets
* Lower margins as a reaction to commodity competition (your sensor hardware business will be commoditized faster and faster over time)
* More complex and longer sales cycles because devices are now being approved for sale not by facilities and clinical executives alone but increasingly by CIOs and IT teams
* Increased cost of risk management and compliance caused by connectivity requirements
Any one of these challenges is difficult to meet but these days you’re probably being asked to meet more than one simultaneously. The solutions are not simple but the good news is that medical device manufacturers have many revenue generation opportunities today that can fund the new strategic imperatives you’ll need to put into place to meet the challenges listed above.
This briefing, presented by Netspective CEO Shahid Shah, describes some of the opportunities and how device vendors can take advantage of them.
Revenue opportunities in the management of healthcare data delugeShahid Shah
Healthcare data is hard to deal with and getting even harder and more expensive. In this presentation, Shahid Shah covers why:
* Healthcare data is going from hard to nearly impossible to manage.
* Applications come and go, data lives forever.
* Data integration is notoriously difficult, even in the best of circumstances, and requires sophisticated tools and attention to detail.
And, then talks about how new techniques are needed to store and manage healthcare data.
Open Source is a great opportunity for EHR, Digital Health, and Health IT Int...Shahid Shah
Presented at the OSEHRA Summit 2014, this talk focused on:
* OSEHRA is major business opportunity for ISVs and systems integrators
* Open source software and associated business models can satisfy most needs.
* There’s nothing special about health IT data that justifies complex, expensive, or special technology.
This group paper, written as a graduate student at CMU, attempts to define and summarize the huge challenge ahead of North American healthcare providers by illuminating current and future trends of healthcare business intelligence (BI); ramifications of EMR; the pros and cons of BI and analytics; the myriad ethical and privacy issues of big data’s role (normally associated with market share and profits); and lastly provide an industry overview of BI and analytics solutions specific to healthcare.
To view the 30+ page paper for which this presentation summarizes, please contact James Young via LinkedIn: https://www.linkedin.com/in/jamesyoung007
CHC Briefing: OSEHRA is a great business opportunity for healthcare IT ISVs a...Shahid Shah
An opinionated look at why current health IT systems integrate poorly and how it’s a big opportunity for the OSEHRA Community
Topics Covered:
* An overview of VA, VHA, VistA, and OSEHRA
* The macro healthcare environment and why OSEHRA is am important participant
* What’s needed by the industry that OSEHRA can provide
Key takeaways:
* OSEHRA is major business opportunity for ISVs and systems integrators
* There’s nothing special about health IT data that justifies complex, expensive, or special technology
Modernizing Architecture for a Complete Data StrategyCloudera, Inc.
Data is the future of business. Either take advantage of it, or get surpassed by those who do.
In this webinar, Ovum's Tony Baer discusses the importance of building a modern data strategy that ensures your journey with Apache Hadoop and big data is a successful one. Together, we'll walk through how to build a plan for long-term success while realizing short-term gains, including:
How to pinpoint the business goals that matter most
How to assess your strengths and weaknesses to meet those goals
How to build a thoughtful approach that ensures your initiatives succeed
FDA News Webinar - Inspection IntelligenceArmin Torres
Developing a Digital Data-Driven Approach to preparing for FDA Inspections. Using Data Analytics to proactively monitor internal and external Quality & Compliance data sources.
BIG Data & Hadoop Applications in HealthcareSkillspeed
Explore the applications of BIG Data & Hadoop in Healthcare via Skillspeed.
BIG Data & Hadoop in Healthcare is a key differentiator, especially in terms of providing superior patient care. They are used for optimizing clinical trials, disease detection & boosting healthcare profitability.
To get more details regarding BIG Data & Hadoop, please visit - www.SkillSpeed.com
AlgoAnalytics is the “one stop AI shop”. We are the best organization in India as far as applied machine learning expertise is considered. We aim to be the one of the best in the world.
We work at the intersection of mathematics, computer science and specific domain knowledge like finance, retail, healthcare, manufacturing and others. We have developed expertise in handling structured/numerical, image and text data and integrating the intelligence gathered from heterogeneous data which is combination of structured and un-structured.
We integrate the cutting edge tools and technologies with our strong domain expertise to design predictive analytics solutions for businesses.We are proficient in classical as well as deep learning methodologies. In AlgoAnalytics we extensively use tools like R-Caret, Scikit-learn, Tensorflow, Theano and Microsoft Cognitive toolkit (CNTK).
Understanding New Technology and Security Risks as you respond to COVID-19Emma Kelly
As world economies reopen, businesses must adjust their risk management posture for the “new normal”, while continuing to drive digital transformation initiatives. The “new normal” has brought change to key risk vectors across people, process, and technology. To enable effective financial and operational controls, business teams must adapt to these changes and fully understand these new technology and security risks.
A key change has been a move to a work from home workforce. Organizations must rethink their approach to approach to enabling employee access to key enterprise systems and sensitive data.
In this session, we will share our thoughts on where new risks have emerged and traditional risks have changed. In addition, we will provide a point of view on the latest technologies and techniques to help you assess and control risks in enterprise systems that enable business finance and operations management.
Join SafePaaS CEO Adil Khan and Director Dan Miller at Altum Strategy Group.
Solving the Data Management Challenge for HealthcareDelphix
Need a proven blueprint to fast-track application development in your healthcare organization? With triple-digit growth, 3,000+ databases and over a petabyte of data, Molina Healthcare needed a way to accelerate application development and drive digital transformation.
Success meant slashing time to provision new dev and test environments in half, putting self-service data access in the hands of application teams―and doing it all without taking an eye off data security and HIPAA compliance.
How Data and AI is transforming Pharma.
Value of Data
How Data and AI can transform each and every functions
How organizations should approach the data and AI
What should be the data strategy
What is the future post Covid19
The Power of your Data Achieved - Next Gen ModernizationHortonworks
Fueled by ever-changing customer behaviors and an increasing number of industry disruptions, the modern enterprise requires analytics to stay ahead of the game. Today’s data warehouse needs continuous enhancements to address new requirements for advanced analytics, real-time streaming data, Big Data, and unstructured data. The focus should be on developing a forward-looking, future-proof view and holistically addressing the combination of forces that are impacting the existing operational model.
Delivering high quality patient care, ensuring business resiliency, and protecting reputation: these form the pillars of a high-performing healthcare enterprise. The question then becomes: how firm is the technology foundation underneath these pillars? Here are the four critical risks you should be aware of. For more info, visit our site: http://ow.ly/FQjW301iD1A
NATURE, ORIGIN AND DEVELOPMENT OF INTERNATIONAL LAW.pptxanvithaav
These slides helps the student of international law to understand what is the nature of international law? and how international law was originated and developed?.
The slides was well structured along with the highlighted points for better understanding .
ALL EYES ON RAFAH BUT WHY Explain more.pdf46adnanshahzad
All eyes on Rafah: But why?. The Rafah border crossing, a crucial point between Egypt and the Gaza Strip, often finds itself at the center of global attention. As we explore the significance of Rafah, we’ll uncover why all eyes are on Rafah and the complexities surrounding this pivotal region.
INTRODUCTION
What makes Rafah so significant that it captures global attention? The phrase ‘All eyes are on Rafah’ resonates not just with those in the region but with people worldwide who recognize its strategic, humanitarian, and political importance. In this guide, we will delve into the factors that make Rafah a focal point for international interest, examining its historical context, humanitarian challenges, and political dimensions.
A "File Trademark" is a legal term referring to the registration of a unique symbol, logo, or name used to identify and distinguish products or services. This process provides legal protection, granting exclusive rights to the trademark owner, and helps prevent unauthorized use by competitors.
Visit Now: https://www.tumblr.com/trademark-quick/751620857551634432/ensure-legal-protection-file-your-trademark-with?source=share
Military Commissions details LtCol Thomas Jasper as Detailed Defense CounselThomas (Tom) Jasper
Military Commissions Trial Judiciary, Guantanamo Bay, Cuba. Notice of the Chief Defense Counsel's detailing of LtCol Thomas F. Jasper, Jr. USMC, as Detailed Defense Counsel for Abd Al Hadi Al-Iraqi on 6 August 2014 in the case of United States v. Hadi al Iraqi (10026)
In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
WINDING UP of COMPANY, Modes of DissolutionKHURRAMWALI
Winding up, also known as liquidation, refers to the legal and financial process of dissolving a company. It involves ceasing operations, selling assets, settling debts, and ultimately removing the company from the official business registry.
Here's a breakdown of the key aspects of winding up:
Reasons for Winding Up:
Insolvency: This is the most common reason, where the company cannot pay its debts. Creditors may initiate a compulsory winding up to recover their dues.
Voluntary Closure: The owners may decide to close the company due to reasons like reaching business goals, facing losses, or merging with another company.
Deadlock: If shareholders or directors cannot agree on how to run the company, a court may order a winding up.
Types of Winding Up:
Voluntary Winding Up: This is initiated by the company's shareholders through a resolution passed by a majority vote. There are two main types:
Members' Voluntary Winding Up: The company is solvent (has enough assets to pay off its debts) and shareholders will receive any remaining assets after debts are settled.
Creditors' Voluntary Winding Up: The company is insolvent and creditors will be prioritized in receiving payment from the sale of assets.
Compulsory Winding Up: This is initiated by a court order, typically at the request of creditors, government agencies, or even by the company itself if it's insolvent.
Process of Winding Up:
Appointment of Liquidator: A qualified professional is appointed to oversee the winding-up process. They are responsible for selling assets, paying off debts, and distributing any remaining funds.
Cease Trading: The company stops its regular business operations.
Notification of Creditors: Creditors are informed about the winding up and invited to submit their claims.
Sale of Assets: The company's assets are sold to generate cash to pay off creditors.
Payment of Debts: Creditors are paid according to a set order of priority, with secured creditors receiving payment before unsecured creditors.
Distribution to Shareholders: If there are any remaining funds after all debts are settled, they are distributed to shareholders according to their ownership stake.
Dissolution: Once all claims are settled and distributions made, the company is officially dissolved and removed from the business register.
Impact of Winding Up:
Employees: Employees will likely lose their jobs during the winding-up process.
Creditors: Creditors may not recover their debts in full, especially if the company is insolvent.
Shareholders: Shareholders may not receive any payout if the company's debts exceed its assets.
Winding up is a complex legal and financial process that can have significant consequences for all parties involved. It's important to seek professional legal and financial advice when considering winding up a company.
RIGHTS OF VICTIM EDITED PRESENTATION(SAIF JAVED).pptxOmGod1
Victims of crime have a range of rights designed to ensure their protection, support, and participation in the justice system. These rights include the right to be treated with dignity and respect, the right to be informed about the progress of their case, and the right to be heard during legal proceedings. Victims are entitled to protection from intimidation and harm, access to support services such as counseling and medical care, and the right to restitution from the offender. Additionally, many jurisdictions provide victims with the right to participate in parole hearings and the right to privacy to protect their personal information from public disclosure. These rights aim to acknowledge the impact of crime on victims and to provide them with the necessary resources and involvement in the judicial process.
ASHWINI KUMAR UPADHYAY v/s Union of India.pptxshweeta209
transfer of the P.I.L filed by lawyer Ashwini Kumar Upadhyay in Delhi High Court to Supreme Court.
on the issue of UNIFORM MARRIAGE AGE of men and women.
Managing The Risk of Open Payments - Validate Spend Report Before CMS Submission
1. By Ned Mumtaz, Brian A. Dahl & Mohammad Ovais
Session Moderator: Thomas Sullivan
Webinar: Managing the Risks of Open Payments – Validate Spend
Report Before CMS Submission
www.qordata.com
2. qordata is a data analytics and integration company
specializing in pharmaceutical, biotech and medical
device industries. With a DNA in data integration and
analytics, qordata provides software and tools to
extract insights for decision making from a variety of
publicly available data sets. Our consulting services
enable pharma, biotech and device companies to
operationalize the use of data based decision making
across business functions such as compliance and
marketing.
About qordata
www.qordata.com
3. • This webinar is being recorded. Recording will be provided after today’s presentation.
• This is an hour long webinar. Plug in headsets or turn up your speakers.
• You can connect via VoIP and Phone.
• Your lines are muted.
• Please ask your Questions via Panel on GoToWebinar.
• We will address questions at the end of the webinar.
• A copy of the presentation slide will be sent to you.
• Please note all slides are copyrighted and maybe used with attribution to the copyright
holder.
• For anything related to webinar support, please call 832 772 6000 x 501
Webinar Housekeeping Rules
www.qordata.com
5. • Introduction
• Implications of Transparency – Case Study
• Evaluation of Spend Before CMS Submission
• Platform Demonstration
• Q&A
Agenda
www.qordata.com
6. Thomas Sullivan
Editor-in-Chief – Policy and Medicine
Editor/author of popular website Policy and Medicine, ranked #1 by Google for five years, which
covers important compliance and regulatory issues effecting the pharmaceutical and device industry.
Brian A. Dahl
Principal - Dahl Compliance Consulting LLC
Architect of the Corporate Compliance Programs at two top tier pharmaceutical companies.
Independent compliance consultant, author and a frequent speaker on compliance-related topics.
Ned Mumtaz
Practice Lead, Life sciences – qordata
Leads the qordata transparency directive program in the US & EU and has over 15 years of
pharmaceutical industry experience as IT Director for several manufacturers.
Mohammad Ovais
CEO – qordata
Leads the Information Management Practice at qordata (formarly a division of Streebo). He is an
expert in data management and analytics. Prior to launching Streebo in 2008 he held various
positions at Kalido Inc., IBM, and Bowstreet.
Speakers Profile
7. Data Mining and Transparency
Gold Mining the FCA and the Emergence of the
Data Driven Whistle Blower (LSCU 1/16)
Using Open Payments Data to Support Corporate
Liability (LSCU 1/16)
Using the Open Payments System as Compliance
Tool (P&M 11/11/15)
• “Pharmaceutical and device companies can
expect federal agencies to begin pursuing
enforcement actions against companies that fail
to comply with Open Payment reporting
requirements within the next year.”
www.qordata.com
8. Objective:
To give Compliance Teams analytical tools and techniques to utilize for
evaluating spend before CMS submission
Expected Result / Key Take-away:
At least one analytical tool or method to utilize to reduce compliance
program risks for 2015 spend submission
www.qordata.com
11. • Penalties for What is Not Reported
– $1,000-$10,000/transaction up to $150,000
– $10,000-$100,000/transaction up to $1 million
• Penalties for What Is Reported
– Kickbacks
– False Claims
Implications of Transparency
www.qordata.com
12. • Launched Subsys in March 2012
• Sublingual Fentanyl Spray for Breakthrough Cancer Pain
– Sudden, temporary flares of severe pain
• Blackbox Warning and Subject to Risk Evaluation and
Mitigation Strategy (REMS)
Case Study: Insys Therapeutics
www.qordata.com
28. Dr. Awerbuch Criminal Complaint
• $46,600.00 in compensation from Insys
for speaking/consulting
www.qordata.com
29. Case Study: Insys Therapeutics
• Company Announced Subpoenas
• December 2013 from OIG requesting documents relating to
commercialization of Subsys
• September 2014 U.S. Attorney District of MA requesting
documents relating to sales and marketing practices for
Subsys
www.qordata.com
33. Challenges in Monitoring Spend Data for Completeness and Accuracy:
Aggregated transactions require context and ease of use.
Too many individual spend transactions to monitor.
Engage multiple stakeholders to verify spend.Accuracy:
www.qordata.com
Too many individual spend transactions to monitor.
Aggregated transactions require context and ease of use.Volume:
Method:
Too much effort to chase individual exceptions.
Need systematic plan to regularly monitor.
34. Method:
Challenges in Monitoring Spend Data for Completeness and Accuracy:
Aggregated transactions require context and ease of use.
Too many individual spend transactions to monitor.
Too much effort to chase individual exceptions.
Need systematic plan to regularly monitor.
Volume:
Engage multiple stakeholders to verify spend.Accuracy:
www.qordata.com
36. Challenges in Monitoring Spend Data for Completeness and Accuracy:
Too many individual spend transactions to monitor.
Aggregated transactions require context and ease of use.
Too much effort to chase individual exceptions.
Need systematic plan to regularly monitor.
Volume:
Method:
Engage multiple stakeholders to verify spend.Accuracy:
www.qordata.com
39. Ready platform to manage risk before submission40
Pharma/Device
Companies
Utilizing the Platform
Ready built SaaS solution
(SaaS: Software as a Service)
2013/2014 CMS data pre-loaded
Readily add 2015 company data
Prebuilt monitoring dashboards
Easy to use and track
Enterprise wide access to
Shared reports and notifications
+ Manufacturers current year spend.
- History, Industry, Competitors, etc.
www.qordata.com
40. Published Data
2013
2014
2015 (when available)
Internal Data
Current Year
From Agg Spend
System
2015
Other Data
(Medicare Part D,
EFPIA when
available)
Overview
Trends
Comparisons
Management Reports
Compliance Dashboards
Outliers
New Physicians
Peer comparison
Ad-Hoc Analysis
For Analysts
Access to all
Data
Compliance Data Flow
www.qordata.com
41. “Open Payments Analytics provides new
insight into the reams of physician
payment data that, due to the shear file
size, has so far been near impossible to
achieve.” –
Policy and Medicine
“qordata comes in with a portal that
organizes the data by physician,
specialty, originating payer, geography
and time…. qordata offers customized
analytics solutions on top of the data”–
Pharmaceutical Commerce
Recognition – In the media
“Pioneering Business Intelligence for the
Pharma Sector”
CIO Review
www.qordata.com
42. Next Steps …
Utilize Open Payments Analytics Vital to audit your 2015 spend before submission
• Get up and running in a week (cloud software requires no installation)
• One year subscription will provide two year spend review (2015 and 2016)
• Risk-Free 100% refund policy
• Compatible with all leading aggregate spend tools
• Webinar specific special pricing –
if it saves you one penalty, it will pay for itself for a decade!
Compatible
with all
Aggregate
Spend tools
Risk Free
Subscripti
on Cancel
Anytime
100%
Money Back
Guarantee
www.qordata.com
43. Q&A
Come meet us next week at
13th Annual Pharmaceutical Compliance Congress
Venue: THE RITZ-CARLTON - Washington, DC
Date: January 26-27, 2016
For more information and scheduling, contact:
Ned Mumtaz
Life Sciences Practice Leader
Ned.mumtaz@qordata.com
Tel: 201-753-1734
www.qordata.com
44. Takeaways
• Prosecutors and Qui Tam Attorneys Will Utilize Sophisticated Data
Analytics
• Monitoring and Reviewing your Ag Spend Data During the Year Is
Important
• There are Tools Available To Review Your Data
• Important to Look for Outliers and Perhaps Merge/Compare with
Other Data Sources for Analytics
www.qordata.com
45. Thank You
Thomas Sullivan
Editor-in-Chief – Policy and Medicine
tsullivan@rockpointe.com
Brian A. Dahl
Principal - Dahl Compliance Consulting LLC
dahlcomplianceconsulting@gmail.com
Ned Mumtaz
Practice Lead, Life sciences – qordata
ned.mumtaz@qordata.com
Mohammad Ovais
CEO – qordata
mohammad.ovais@qordata.com
www.qordata.com