Compliance Perspectives

By Adam Turteltaub Traditionally, explains, Tanya Ganguli (LinkedIn), Principal Associate, Law Offices of Panag & Babu, India’s criminal law framework revolved around the Indian Penal Code, The Code of Criminal Procedure and the Indian Evidence Act, two of which dated back to the 19th century. That changed with the passage of three new laws: the Bharatiya Nyaya (Second) Sanhita, 2023, the Bharatiya Nagarik Suraksha (Second) Sanhita, 2023 and the Bharatiya Sakshya (Second) Bill, 2023. Together they seek to bring criminal law into the 21st century and build off of long-established precedents. They are designed, she reports, to address loopholes, enhance efficiency and ensure justice. The laws are now more victim centric, but may not be too transformative, according to Tanya, for most compliance and ethics programs. Nonetheless, there are changes. New rules for searches and seizures will likely require updated training on dawn raids. Summons can now be delivered electronically. There is much greater need to d

By Adam Turteltaub As of January 2024, there’s a new Code of Conduct of the Volkswagen Group, replacing one developed in 2017. To understand what led to the latest iteration of the code and the vision behind it we spoke with Silke Becker and Sarah Specht (LinkedIn) of Volkswagen Group Integrity & Compliance. They are part of a team lead by Tina Landsmann, Head of Volkswagen Group Center of Competence Integrity & Compliance Awareness & Qualification and Dr. Kurt Michels, Volkswagen Group Chief Integrity & Compliance Officer. The code was updated to reflect changing times, including the draft European Supply Chain Act. This required a change in content, but the team also chose to update the tone and feel. The language of the document now focuses on “we” and “us”, and it is very proactive, making the document less about what the board or management calls for and is instead about what we as a group are committing to. Each section of the code has a headline that reinforces this message: “We take responsibility

By Adam Turteltaub On January 5, 2023 the EU Corporate Sustainability Reporting Directive went into force. The directive broadens the scope of companies report on sustainability issues, adds to the amount of information that needs to be reported, and even requires external assurance, reports Elena Sychenko (LinkedIn), Adjunct Professor at the Department of Management at the University of Bologna and currently a Fulbright Scholar at the Wharton School of Business. The directive now covers all listed companies with the exception of micro enterprises. Also falling under it are non-EU companies that have a significant presence in the EU. The reporting requirements, which are still being fully developed, closely follow the Global Reporting Initiative (GRI) standards and focus on ESG explicitly, with several areas of reporting under E, S, and G. These include: E: climate change, pollution, water, biodiversity S: the organization’s own workforce, the workforce in the value chain, affected communities, consum

By Adam Turteltaub The No Surprises Act is a significant change to how healthcare coverage is handled and billed. In general, it eliminates balance billing in three typical areas: A patient is brought to an emergency room in an out of network hospital A patient is transported by air ambulance A patient is being cared for at an in-network hospital but, unbeknownst to him or her, a physician or service that is out of network provides care. To understand the Act more fully, we spoke with Brian Stimson, Partner, Arnall Golden Gregory, who will be leading the session The All Surprises Act:  Avoiding Compliance Pitfalls and Responding to Administrative Enforcement Actions under the Surprise Billing Laws at the 2024 HCCA Compliance Institute. As he explains, there is a two-tiered enforcement structure to the law, with both individual states and the federal government involved. Compliance teams looking to ensure their organizations are complying need to pay close attention to patient complaints. These can

By Adam Turteltaub When it comes to risk assessments, the word “annual” comes up a lot. But, Kelly Alwin, Regional Compliance Officer North America for SAP America, believes that once a year may be more than a bit too long. To her, a risk assessment is more than a periodic assessment and an annual chore. It is critical to the program’s success and lends credibility and substance to the compliance program. She points out that from the Delaware Chancery Court to the US Department of Justice, the importance of a strong risk assessment is underscored. In this podcast she argues that, for the risk assessment to play the role it should, it can’t afford to sit on the shelf. It needs to be a dynamic document that both informs all the other elements of the program and evolves as risks evolve, whether due to a new go to market strategy, a merger or an entry into a new market. Bottom line: look at your risk assessment, she advises, not as a discrete activity but as a continuous analysis. Incorporate micro assessment

By Adam Turteltaub Behavioral health shares many of the same compliance challenges as the rest of healthcare, but it also has several of its own. To understand the risks, we sat down with Community Counseling Solutions’ Executive Director Kimberly Lindsay and Compliance & Privacy Officer Tim Timmons. They will be leading the session “Developing an Ethics and Compliance Program in Behavioral Health” at the HCCA 28th Annual Compliance Institute, which will be in Nashville, April 14-17 and also offered in a virtual format. In this podcast they identify several typical compliance challenges in the behavioral health setting: Managers and supervisors who are well intentioned but busy, not holding staff accountable and not reporting in a timely manner. Incidents after hours when a patient is in crisis. This is a very difficult situation.  The team is eager to help the patient get better, but with lots of adrenaline flowing in a difficult situation, they may find themselves sharing more information about the

By Adam Turteltaub While Ericsson is best known for its mobile phones, the company’s reach in wireless is far greater. It is the creator of Bluetooth technology, owns patents on much of the critical IP that wireless systems depend on, and is active in more than 180 countries providing much of the hardware, and even cellphone towers, that enables all of us to talk, text, and surf the web wherever we are in the world. Jan Sprafke, Chief Compliance Officer at Ericsson, explains in this podcast that with that global reach – including operations in approximately 100 high risk countries – also comes a large network of suppliers. To manage the potential compliance challenges that go along with it, the company uses a risk-based approach to supplier management They assess the country risk, go to market approach and whether the supplier will be using subcontractors. Then they work closely with sourcing and other assurance functions on an ongoing basis. The company’s supplier code of conduct is shared with their ven

By Adam Turteltaub Julie Janeway (LinkedIn), General Counsel and principal owner, Principled  Healthcare Consulting will be speaking about internal and parallel investigations at the 2024 HCCA Compliance Institute. In this podcast she slices off a bit of that expertise. A thorough investigation is needed, she advises whenever there is an issue that could require arbitration, a court case, administrative hearing, contractual dispute or reputational issues, whether by an employee, contractor or the organization itself. The same is true if there is a policy breach or alleged violation of the code of conduct. So how best to do it? Have both an investigation plan and a preplan which designates who will be responsible for the investigation depending on what the issue is. For example, a privacy officer would likely play the lead role in a HIPAA breach allegation. As for the plan itself, it should be thorough. The team executing it should include individuals with a wide range of skills and, she highly recommends

By Adam Turteltaub In 1984 I went to my friend Chris’s wedding, and one of the other groomsmen, Drew Neisser (LinkedIn), his then boss, talked me into pursuing a career in advertising. Just a few months shy of 40 years later, I caught a video on LinkedIn of him with chief marketing officers discussing the struggles of managing remote workers. It didn’t matter that these were marketing people, the problems sounded just like we in compliance face. So, I asked Drew, who is the founder of CMO Huddles and the author of the book Renegade Marketing:  12 Steps to Building Unbeatable B2B Brands, to sit down and do a podcast on the topic. Drew points out that, despite workers being required to come into the office more often, there is still a cost to remote work. Churn is higher than before. Partners at law firms complain that their associates are years behind in their development, likely due to the inability to learn by osmosis. So what do we do? He recommends that we recognize the present reality and look to hire

By Adam Turteltaub Some people have a gift for invisibly attending a conference, and no one knows that they were even there. That’s great for a conference of spies, but most people at compliance conferences like to meet at least some of the other attendees. For many, though, connecting with strangers is difficult, whether they know no one or they are shy about going beyond their usual circle of contacts. So what do you do if you are one of them? To find out we spoke with Richard Bistrong (LinkedIn), newsletter author and CEO Of Frontline Antibribery, who will be moderating a general session at the 2024 SCCE European Compliance & Ethics Institute in Amsterdam. If you spot someone standing alone and looking a bit lost, he recommends you think like a host and invite them to join you. Even if you’re already talking with friends, he advises being a croissant and not a bagel: be sure there is an opening for others. Make the effort to catch them up with the conversation – “we were just discussing helplines”—and

By Adam Turteltaub Compliance programs have come far over the last few decades, but there is still more that they could do to elevate their performance. In this podcast, Alison Taylor, Clinical Associate Professor at NYU Stern School of Business and author of the book Higher Ground shares some intriguing and provocative ideas for improvement. She is a strong believer in what she calls “firm foundations”. These foundations avoid having too many rules which can, inadvertently, have a negative impact, causing employees to abdicate responsibility for their action and grow overly reliant on following rules. Instead, she argues for simplifying and being attuned to human behavior and the role of incentives. Be wary too, she advises, of mixed messages and potentially pernicious effects when it appears, whether true or not, that the rules for the rank and file do not apply to leadership. It degrades trust and the culture. To get more employees to speak up when they see wrongdoing, she advises investing the time in

By Adam Turteltaub Clara Becerra Campos, Senior Compliance Analyst-Europe for TD SYNNEX, and Dr. Tobias Kruis, Head of Corporate Compliance, Giesecke+Devrient, will be addressing the new EU whistleblowing requirements at the 2024 SCCE European Compliance & Ethics Institute, which takes place in Amsterdam March 18-20. In this podcast, they delve into the challenges posed by the directive, which significantly expands the number of EU-based and non-EU-based companies that must comply. The directive not only provides protections for whistleblowers, they explain. It also establishes procedures and deadlines for handling reports. As significantly, it leaves the door open to variations among EU member states, which complicates the picture considerably. So what should you do? If your organization does not have a whistleblower line already in place they recommend you: Implement an internal reporting channel Be sure it’s aligned with legal and data privacy Consider who will manage the system and conduct the

By Adam Turteltaub At the 2024 SCCE European Compliance & Ethics Institute, Segev Shani, Chief Compliance & Regulatory Officer at Neopharm Group will be leading the session “Corporate Use of Third-Party Artificial Intelligence (AI) Tools.” In this podcast he shares that a great deal of risk comes from the headlong pursuit of AI technology. Businesses believe that if they are not using Ai that they will be left behind, but the adoption rate is not being matched with a complete understanding of what AI is. To manage this issue, he recommends creating an AI governance model that balances the risks and rewards. It can help employees and managers understand the risks, including inaccuracy, bias and both misuse and improper use of intellectual property. And, of course, there can be substantial privacy risks as well. Listen in as he discusses proper governance, the need for training and the importance of integrating AI governance into business processes. Then plan on joining us in Amsterdam, 18-20 March, at the

By Adam Turteltaub A good employee survey on compliance and ethics can yield a wealth of data on how your program is and isn’t working, where the risks are, and how to move forward. The challenge is getting the survey right and getting employees to respond. Klaus Moosmayer, Member of the Executive Committee and Chief Ethics, Risk and Compliance Officer at Novartis, shares in this podcast that the compliance team has just completed the second round of their survey. The goal was to get first-hand data from as many employees globally as they could about any unethical behavior they perceive around them and how it is acted on. The survey was developed with substantial help from behavioral scientists, who created a questionnaire that captured where the company is now but also enabled them to dig deeper into key issues. For example, in the first round of the survey the Novartis team discovered that approximately 80% of employees go first to their leaders and managers when seeing unethical behavior. In the second

By Adam Turteltaub When it comes to AI, there is little agreement. Some see great potential, while others see great nightmares. Some see opportunities, and many see nothing but risks. In the EU, though, there is agreement on one thing, a new EU AI Law. In December 2023 the EU Parliament and Council agreed to  a bill “…to ensure AI in Europe is safe, respects fundamental rights and democracy, while businesses can thrive and expand.” Longtime compliance professional Letitia Adu-Ampoma (LinkedIn) explains that while the law won’t fully come into force for two years or more, it’s time for compliance teams to start paying attention and preparing. The act is a part of the EU digital strategy, which is very focused on human-centric legislation. Its goal is to keep positive the impact of AI on people and society. The approach it takes is risk-based, categorizing AI systems based on the level of risk: unacceptable (and prohibited), high risk, minimal risk and no risk. The act is very specific in how it defines whi

By Adam Turteltaub Having a compliance champions or ambassadors program can be a great boon for the compliance program, if you keep the champions engaged. Unfortunately, that doesn’t always happen. If not managed properly your champions may end up sleep walking through the job. In this podcast, Matt Silverman, author of the book The Champions Network and Global Trade Director and Senior Counsel at Viavi lays out several strategies for maintaining the involvement and commitment of your champions network. To ensure engagement, he recommends remembering that the people who decided to be champions did so for a reason. It may be for a wage stipend or for altruistic reasons.  Tapping into that motivation is essential. On an ongoing basis it’s important that they see the impact of their work on the organization and their own career. That means sharing outcomes, as best you can, and providing them with access to development opportunities. These could be specific to deepening compliance expertise or as broad as de

By Adam Turteltaub Mergers and acquisitions create stress, opportunity and risk both for the organization and the compliance team. In this podcast, Sergio Leal, who until recently was head of M&A compliance at Ericsson along with Jan Sprafke, the company’s chief compliance officer, share their advice for compliance professionals in the midst of a transaction. They stress that the compliance team needs to be involved during the entire lifecycle, from target identification to due diligence to post-acquisition integration. This will help the organization avoid unanticipated liabilities and risks. To ensure success the compliance team needs to be embedded in the M&A team. Meet with the stakeholders regularly to ensure you are aligned with their processes. When you do, remember that compliance is just one piece of a very complex puzzle. Be prepared to move quickly. The DOJ amnesty program for issues discovered in an acquisition has a rapidly ticking clock. At the start of an acquisition or merger, they recomm

By Adam Turteltaub To quote CMS, “The Open Payments program is a national disclosure program that promotes a more transparent and accountable health care system. Open Payments houses a publicly accessible database of payments that reporting entities, including drug and medical device companies, make to covered recipients like physicians.” For this transparency to work, though, it’s important for the data to actually be used. Kelly Cooper (LinkedIn), Compliance Specialist at UF Health Shands Compliance Services, reports that too often it isn’t. There is a downward trend of providers reviewing the data collected, she reports, due to lack of awareness of the program and why it matters. That needs to change. Physicians and the hospitals that employ them are now required to post a notice for patients about the Open Payment system and how to access it. This will likely lead to more questions from patients and the need for providers to monitor the data more closely. So what should compliance teams do? She recomm

By Adam Turteltaub The 2024 CMS Medicare Physician Fee Schedule extends no less than ten different pandemic flexibilities related to telehealth. In this podcast, Randi Seigel, partner and Jared Augenstein, managing director, at Manatt take us through all of them, including in-person visit requirements, audio-only services, physician supervision and opioid treatment. They also address: Changes in the structure of the telehealth services list Changes to payment by place of services Remote psychological and therapeutic monitoring Enrollment and revocation A new opportunity for payments for social needs of Medicare beneficiaries Listen in to learn more about what’s new, what’s the same, and what will sunset at the end of 2024.

By Adam Turteltaub Effective investigative interviews are both important and sensitive. To get some pointers about how to conduct them properly, we turn in this podcast to Wendy Evans, Senior Corporate Ethics Investigator at Lockheed Martin. Wendy is also an instructor for the SCCE Fundamentals of Compliance Investigations workshops. She recommends starting by doing your homework. Before you talk with anyone, whether a possible witness or the subject, get all the information you can from the reporter. Then, review it to see if it includes the what, where, when, why and who. If you don’t have all that information, take the time to find it since it can identify what the potential motivation behind the incident was. With that information in hand, check your case management system to see if any of the parties were involved in previous reports. Follow that by notifying HR and the subject’s manager that you will be conducting an interview. They may have important insight. Think through what other evidence you m