Categories
Compliance Man Chooses the Target

Compliance Man Takes a EuroTrip – Andrea Cardoso on Healthcare

Compliance Man is back for a new season! Get ready for a EuroTrip with Tom Fox and Tim Khasanov-Batirov on their hit podcast, Compliance Man! Join Tom Tim as they chat with Andrea Cardoso, a compliance officer in the medical devices industry, about healthcare compliance in Europe. In their Euro trip series, they explore hot topics and share best practices, focusing on interactions with healthcare professionals and fair market value. With years of experience, Andrea highlights the importance of transparency and following certain principles to ensure compliance. Listen as they discuss the challenges of maintaining professionalism in the healthcare industry, understanding different rules and limitations in each country, and implementing effective compliance programs in multiple markets. Don’t miss out on the insightful tips and suggestions, and reach out to be part of the discussion. Tune in to the Compliance Man podcast for valuable insights and expert advice.

Key Highlights:

  • Healthcare Compliance in Europe
  • Compliance with event expenses and regulations in healthcare
  • Compliance with HCP rules in Europe
  • Video Calls and Challenges in Healthcare Industry
  • Empowering Teams for Informed Decision Making
  • What a difference 300 meters can make

 Resources

Andrea Cardoso on LinkedIn

Tim Khasanov-Batirov on LinkedIn

Tom Fox

Instagram

Facebook

YouTube

Twitter

LinkedIn

Categories
Innovation in Compliance

Exiger’s Fight to Secure Supply Chains: Spotlight on Healthcare


Welcome to a podcast series on the fight to secure Supply Chains, through cross-industry innovation. This series is sponsored by Exiger. In this series, we will explore the ongoing efforts of Exiger to lead the discussion and enhancement of Supply Chain Risk Management.
Over this series, I visit with Erika Peters, Senior Vice President and Global Head of Third Party & Supply Chain Risk Management;  Tim Stone, Senior Director, Supply Chain Risk Management for Exiger Federal Solutions; Kim Lee, Director who focuses on risk and compliance; Nick Wildgoose, a Consultant at Exiger; Skyler Chi, Director and Deputy Head of Supply Chain and Third-Party Risk Management;  Andrew Lehmann, Associate Director at Exiger; Jennifer Nestor, Vice President at Exiger, Americas and Public Sector; Theresa Campobasso, Senior Director for Defense Programs; Dan Banes President of Commercial Technology, and Mark Henderson, Director of Solution Design Lead.
In this episode 1, we discuss Supply Chain issues in the healthcare industry with Erika Peters and Tim Stone. Highlights of this podcast include:

  • Key challenges for Supply Chain Risk Management in healthcare;
  • Lessons learned from Covid-19 on Supply Chain in healthcare; and
  • The evolving areas for Supply Chain Risk Management in healthcare.

Resources
Erika Peters Profile
Tim Stone Profile
Exiger Website
Exiger’s Supply Chain Explorer

Categories
Blog

Exiger’s Fight to Secure Supply Chains: Spotlight on Healthcare

Welcome to a blog post series on Exiger’s fight to secure supply chains, sponsored by Exiger LLC. In this series, we will explore the ongoing efforts of Exiger to lead the discussion and enhancement of Supply Chain Risk Management. In Episode 1, I visit with Erika Peters, a Senior Vice President (SVP) with close to two decades of experience working across the financial, corporate, and government industry, and focus on the firm’s supply chain and third-party risk management practices, and Tim Stone, Senior Director, Supply Chain Risk Management, for Exiger Federal Solutions. We discuss supply chain issues in the healthcare industry, including hospitals, life sciences, pharmaceuticals, medical devices, and medical services.
We began with critical supply chain risk management challenges in the healthcare industry. Peters said the “way I think about the healthcare sector and how it differentiates from the other sectors is that the ultimate risk is trying to mitigate fatalities. This means thinking about the third parties that healthcare companies must work with and then their supply chain makes it one of the most extremely critical industries to be thinking about. In the current post-pandemic era, it is one of the timeliest topics. Equally important is that if you must switch out a key vendor, the entire process can take between 12-18 months, putting your organization in a bind. This means you need to put a rigorous process in place and then follow that process.”
Stone noted key lessons learned on healthcare industry supply chain issues from the pandemic. He stated that the federal government created a Joint Acquisition Task Force in the Department of Defense (DoD) during the pandemic. This was an interagency push to source products across various pandemic-related areas like therapies, vaccines, ingredients, testing, materials and equipment, personal equipment, and even items such as no-touch thermometers. The task force illuminated dozens of product areas across those different sectors, then used market intelligence tools to identify companies in each industry. Further, they used modeling to estimate production capacity and entered information into the Exiger software product DDIQ to risk-rank based upon these and other inputs.
This led to the finding of supply chain fragility. This is because many components in the healthcare supply chain come from state-owned enterprises, and many of these are from China. Even when the team began to focus on migrating to India, it turned out that many underlying components came from China. Another problem discovered was the concentration of raw goods and manufacturers. Stone noted, “we saw otherwise obscure examples of concentration risks arise during COVID that you had never thought about before. In Malaysia, for example, we realized it was a top producer of nitro gloves that owns about 65% of the market. This led to COVID-driven disruptions, which impacted our ability to get nitro gloves. This was the way the world turned and focused on supply chains and where goods are ultimately sourced.” Just-in-time supply chains saw similar if not more disruptions as well.
We then turned to how the healthcare industry supply chain can improve its approach to managing risk. Here Peters noted there were two key areas. The first is programmatic, and the second involves a technological solution. Companies need to create a genuinely risk-based program, for instance, looking at entities that will cause an operating room to shut down or prohibit a company from getting materials required for medicines. These critical entities need to have the most in-depth due diligence; taking that strategic risk appetite and having it trickled down to the tactical level is an important way of making sure that the people at the bottom who are doing the actual work that they are hitting the right risk lens that the company wants to take.
The other piece is to have technology in place to facilitate this and that “we need to improve on that technology.” She noted, “we get to this higher level of more of a predictive posture, which is the golden standard where we need to be. We need to have these teams looking at their risk and bringing it into one view of this entity, especially these critical ones.” It looks at a wide variety of risks, from legal/regulatory to geopolitical to operational. It is doing so quickly and efficiently so the front-line supply chain professionals can make decisions for their organizations’ long-term care and health.
Stone concluded that down the road, supply chain professionals in the healthcare sector “can improve the bottom line, through greater fluidity, greater understanding of their supply chains, greater ability to on the fly to gauge the credibility of vendors, and have that due diligence information at their fingertips through technology.” It will also help avoid a lot of fraud, waste, and abuse and create a more well-oiled machine from a supply chain perspective.
Join us tomorrow when we spotlight the manufacturing and consumer markets.
Resources
Erika Peters Profile
Tim Stone Profile
Exiger Website
Exiger’s Supply Chain Explorer

Categories
Innovation in Compliance

Not Your Father’s Monitor-Part 4: Jesse Caplan on the Intersection of Antitrust and Healthcare Monitors


In October, Deputy Attorney General (DAG) Lisa O. Monaco gave a Keynote Address at ABA’s 36th National Institute on White Collar Crime (Monaco Speech). Monaco’s remarks should be studied by every compliance professional as they portend a very large change in the way the DOJ will utilize monitors going forward. Over this podcast series, sponsored by AMI we will consider why DAG Monaco’s remarks herald a new era for monitorships.
Over this podcast series we have considered Monaco’s remarks from a variety of perspectives. Bethany Hengsbach considered this change in monitorships from the white-collar enforcement and defense perspective. Mikhail Reider Gordon looked at global aspects of the new DOJ monitor’s focus. Cristina Revelo discussed how E&C assessments help drive more compliant companies. Vin DiCianni looks at where monitors and monitorships are going in 2022 and beyond. In this Episode 4, Jesse Caplan brought his views on the intersection of the twin topics of antitrust and healthcare compliance.
Highlights of this podcast include

  1. What is the intersection of healthcare and antitrust compliance?
  2. Why compliance and ethical culture have become so important from a regulatory perspective, a commercial perspective and a talent acquisition and maintenance perspective?
  3. How and why are States’ Attorney Generals using monitorships with greater frequency and focus.

Resources
Jesse Caplan
Affiliated Monitors Inc.

Categories
Blog

Not Your Father’s Monitor – Jesse Caplan on Antitrust and Healthcare Compliance

In October, Deputy Attorney General (DAG) Lisa O. Monaco gave a Keynote Address at ABA’s 36th National Institute on White Collar Crime (Monaco Speech). Her remarks reframed a discussion about the uses of, reasons for and perceptions on independent monitors and monitorships. I asked Affiliated Monitors Inc. (AMI) founder Vin DiCianni for his thoughts around the remarks on monitors. He said, “For Affiliated Monitors this refreshed approach by DAG Monaco highlights the seriousness which businesses must place on the investment in their programs and in addressing what has for some been a negative experience with a monitor. For those who might be the subject of a monitorship, DAG Monaco recognized that the negativity that has sometimes surrounded monitorships as being punitive, should be seen in a different light bringing value, pointing a way forward and as a solution which has had great success in resolving matters.”
Monaco’s remarks should be studied by every compliance professional as they portend a very large change in the way the Department of Justice (DOJ) will utilize monitors going forward. Over this podcast series, sponsored by AMI, we will consider why DAG Monaco’s remarks herald a new era for monitorships. We will consider Monaco’s remarks from a variety of perspectives. Bethany Hengsbach discussed this change in monitorships from the white-collar enforcement and defense perspective. Mikhail Reider-Gordon looked at global aspects of the new DOJ monitor’s focus. Cristina Revelo discussed how ethics and compliance (E&C) assessments help drive more compliant companies. We will conclude the series with Vin DiCianni who will look at where monitorships are going in 2022 and beyond. In Part 4, Jesse Caplan, Managing Director of Corporate Oversight, brings his views on the twin topics of antitrust and healthcare compliance.
Both antitrust and healthcare have significant needs for monitorships. Antitrust concerns raised by the government can be handled through a monitorship of specific issues so that a merger can often go through and satisfy the regulators. This is a prime example of the DOJ or Federal Trade Commission (FTC) extending their reach so that anti-competitive issues do not arise or are properly remediated. Healthcare regulators are most interested in the continued delivery of healthcare services, particularly on the state and local level. It is not in anyone’s interest to stop the delivery of healthcare services which puts a hospital, healthcare practice group or doctor out of business, absent grievous circumstances. By using a monitor, a state regulator can help assure an appropriate level of compliance from a healthcare provider.
There were three key components from the Monaco Speech around monitors. Number one, that monitors are not viewed by the DOJ as punitive and should not be viewed as such by the compliance community or wider corporate community. Here Caplan observed, it is not the job of a monitor “to be punitive, but rather to facilitate a successful compliance program and a successful settlement agreement, works with both the government and for the company.” Number two is a monitor can act as an early tripwire to prevent companies from sliding into a recidivous situation. Number three, monitors bring a level of skill and talent around compliance programs and corporate culture that can help companies create a best practices program so the monitor actually works with the companies under an enforcement action to help them create a program that will be sustainable far down the road. Caplan said, a monitor can bring an “appreciation for what government enforcers are looking for, what the goals of government regulators are, as well as some of the challenges and goals of companies, who want to be successful and to do so in a compliant and fair manner.”
We then turned to the evolution of thinking of state regulators around monitors. Caplan noted, “some of these state Attorney General’s (AG) offices have realized for a long-time monitors can really be a resource extend for government agencies and particularly enforcement agencies.” He pointed to the example of the “Massachusetts Attorney General’s office, particularly with their Medicaid fraud control.” He went on to say, “more and more state AGs are using monitors when they enter in settlement agreement with conditions.” Using an independent allows an extension of their resources, to “verify that the company is compliant with those settlement conditions.”
Perhaps most powerfully, independent monitors can be seen as “an honest broker, bridging between the company and the regulator. Moreover, monitors can actually facilitate, a successful transition and then termination of a monitorship.” Caplan said, “we can do that because we can have candid conversations with both the company and then separately with the government, so that we can better understand where there might be disconnect between the two, and then we can help connect compliance up so that there’s not misunderstandings. There may be different expectations that end up sometimes torpedoing a settlement agreement and by having those conversations, by serving as that bridge, we can help prevent problems address so that ultimately the monitorship is successful.”
Affiliated Monitors
Jesse Caplan

Categories
Integrity Through Compliance

From Business Opportunities to Compliance Risks: Healthcare Expectations in 2021

 
 

In this weeks installment, Jesse CaplanDionne Lomax, and Jim Anliot team up to discuss wide ranging risks and opportunities for healthcare practitioners and entrepreneurs. Dionne Lomax reflects on the unprecedented collaboration that was necessary to provide quality care in the height of the COVID-19 crisis. But antitrust and fraud concerns come with the territory, and the panel provides anecdotes and advice for dealing with this collaboration. Additionally, Jim Anliot’s main advice for anyone looking to innovate in the healthcare space with a new idea or service needs the guidance of experts to navigate the extremely complicated regulatory landscape.
 

 
Email podcast@affiliatedmonitors.com with comments or questions, and be sure to subscribe and/or leave a review if you enjoy this show!
 

Categories
Sunday Book Review

Sunday Book Review: May 23, 2021, the Summer Non-Fiction edition


In today’s edition of Sunday Book Review:

Categories
The Ethics Experts

Episode 040–Karen Pendergraft


On this episode of The Ethics Experts, Nick welcomes Karen Pendergraft to discuss compliance in US and global healthcare clinical trials.

Check out more episodes, and don’t forget to subscribe on your favorite podcast platform!

Categories
The Affiliated Monitors Expert Podcast

3rd-party independents in the health care industry


In this episode, I am joined by AMI Managing Director Stern. We consider how defense counsel can work proactively with independent monitors to help clients who may have sustained an ethical or compliance violation or are under government scrutiny for allegations of illegal misconduct in a wide variety of industries, disciplines and corporate settings. We look at a third-party independent in the health care industry.
In many ways the health care arena can be similar to other business, with their need to work with third-party independents. Stern said, “the cost of getting it wrong these days is very high. It’s not just the cost of hiring lawyers to defend you with a government agency or the Department of Justice. It is even more than the reputational risk. If you are a public company, your stock price is probably going to take a nosedive.” This makes bringing in a third-party independent a “cost effective step to try to get ahead of the situation.” All of this means that bringing in a third-party independent, on a proactive basis to assess a compliance program to bring it up to a best in class standard can really work as a business advantage. Stern believes that to be correct and added, “we work with the company at benchmarking and coming up with best practices. I think most companies want a kind of a state of the art,  best practice compliance program rather than simply rely upon what worked five years or 10 years ago.”
Find out more about Affiliated Monitors Inc. by checking out their website here.

Categories
FCPA Compliance Report

The Current State of Compliance – Issues and Challenges: Part 5 – New Compliance Concerns in Healthcare

Over this five-part podcast series, I have visited with Terry L Orr, a Managing Director at Kroll, a division of Duff & Phelps, and the sponsor of this podcast series. We have taken a comprehensive look at state of compliance at the half-year mark of 2019. In the concluding episode, Part V, we consider some of the latest challenges for healthcare compliance, including legislative changes and a recent corruption trial which Orr believes will be seen as a landmark event.
There are some safe harbor exceptions but outside of those exceptions a broad interpretation of value is used. For more information on Kroll, a division of Duff & Phelps, click here. For more information on Terry Orr, click here.