Compliance Perspectives SCCE

By Adam Turteltaub



Best known as The FCPA Professor, Mike Koehler argues that that many people have it all wrong when it comes to enforcement of the Foreign Corrupt Practices Act (FCPA). Citing historical data he argues that there is not, contrary to popular opinion, a slow down in enforcement of the FCPA. The pace of roughly 12-13 resolutions per year has continued.



In fact, the three resolutions in the first quarter of 2024, he notes, puts it on track to continue the trend.



How do compliance teams get management attention to FCPA enforcement? He recommends against just focusing on the likely price of the settlement. Instead, outline all the costs. Those start with the multiple years before the resolution when the costs of legal, accounting and other fees may be as much as twice the resolution. Then, point to the eighteen months or so after the settlement when the organization will be under ongoing scrutiny, likely at a substantial cost.



All of this, of course, is in addition to the diminished productivity and potential business losses.



Listen in to learn more about how he sees anticorruption enforcement shaping out both by US and international prosecutors.



 

By Adam Turteltaub



Jessica Zeff (LinkedIn) loves government audits. I know, it’s hard to believe, given the dread they inspire. But, the founder and lead consultant of Simply Compliance makes a very good case in this podcast that audits can be much better than people expect and actually helpful for the compliance program.



How is this possible?  She argues strongly that, given the inevitability of an eventual audit, compliance teams should prepare for them on an ongoing basis rather than just when the audit notification arrives in the mail. By assessing what data an auditor might need, what gaps they may find, and what concerns they may have, compliance teams can complement their risk assessment process and have a better handle on where they should be focusing their efforts.



As importantly, having this information handy can be helpful during the audit. Not only does it reduce last minute rushing to prepare, it enables the team to tell auditors their story in a way that shows the organization is doing the right thing and that compliance is on the ball.



When the auditors arrive, she advises being prepared logistically as well. This includes having relevant (and not irrelevant) data ready for the auditors. In addition, she recommends thinking through what they will need -- from space to meals -- and ensuring that the staff they need to interview is available.



Listen in to learn more about how a government audit may not just be better than you think but also a positive experience.

By Adam Turteltaub



Integrity is like peace, love and brotherhood.  We’re all for it, but when it comes to practicing it, that’s when the challenges start.



Paul Fiorelli hopes to change that. The Director, Cintas Institute for Business Ethics at Xavier University has just written a new book: Establishing Workplace Integrity. In it, Paul addresses six lessons in values-based leadership.



To benefit from some of his long-established and well-recognized expertise we asked him to join us for this podcast. He discusses the importance, of values-based leadership. He also cites six factors that lead people into unethical or non-compliant behavior:



* Pressure to perform

* Going down a slippery slope

* Rationalization

* Groupthink

* Altruism (violating the law to help the company)

* Greed



One or several of them are at play when wrongdoing occurs.



So what makes for success and helps to prevent wrongdoing? He makes an argument for SMART goals: specific, measurable, attainable, relevant and time-based.



Listen in to learn more about values-based leadership and promoting a workplace of integrity.

By Adam Turteltaub



What makes for an effective compliance program, not just from a legal perspective but from a practical one? Getting that answer, and sharing it is the focus of the LRN 2024 Ethics & Compliance Program Effectiveness Report



To learn what it contains we sat down with Meredith Hunt (LinkedIn), Ethics and Compliance Specialist at LRN. In this podcast she shared that more effective programs are focused on values rather than rules, and underscore the importance of ethical culture. They are also taking a risk-based approach.



Their research also revealed the importance of adapting to the current business environment. With employees working remotely has come a change in how they gather information. The code of conduct, policies and procedures have to be accessible wherever workers are.



Within the compliance program’s internal operations, effective programs, they report, are focusing more on data and metrics, looking for the data that show where the program is and isn’t working, and enabling continuous improvement.



Listen in to learn more about how to create a more effective compliance program in your organization.

By Adam Turteltaub



The 340B Drug Pricing Program was created to protect safety net hospitals from rising drug prices. It allows them to purchase outpatient drugs, and pharma companies to sell those drugs, at a discount.



In this podcast, Jason Reddish (LinkedIn), Principal and Mark Ogunsusi (LinkedIn), Associate, at Powers Pyles Sutter & Verville provide an overview of the program and the compliance requirements. They are also two of the authors of the chapter “Pharmacy:  340B Drug Pricing Program” in the Complete Healthcare Compliance Manual.



The 340B program helps hospitals that are the last line of defense for underserved communities, including those with a large percentage of Medicaid patients. Often, they are the only hospital around in rural areas. Also helped by the program are federal grantees such as Ryan White clinics and those providing treatment for STDs.



The program dictates which entities can buy discounted drugs and have very specific requirements including two very important ones. First, the drugs cannot be resold or transferred to anyone who is not a patient of the covered entity. Second, double billing of Medicaid is prohibited and must be monitored for.



There are a number of typical compliance problem areas, but the good news is that there has been a decline in non-compliance.



Listen in to learn more about what covered entities are doing right, and what you should be on the lookout for.

By Adam Turteltaub



Currently on hold due to pending court challenges, the SEC’s rules to standardize climate-related disclosures created a fire storm of controversy and comments when first proposed.



The final rules (assuming the courts sides with the SEC), explains Laura Ann Smith and Judy Mayo of the communications firm Labrador (LinkedIn), reflected strong industry pushback, easing the burden on some 4000 filers.



Nonetheless, there are serious demands on industry. To quote from the SEC press release, registrants will be required to disclose:



* Climate-related risks that have had or are reasonably likely to have a material impact on the registrant’s business strategy, results of operations, or financial condition;

* The actual and potential material impacts of any identified climate-related risks on the registrant’s strategy, business model, and outlook;

* If, as part of its strategy, a registrant has undertaken activities to mitigate or adapt to a material climate-related risk, a quantitative and qualitative description of material expenditures incurred and material impacts on financial estimates and assumptions that directly result from such mitigation or adaptation activities;

* Specified disclosures regarding a registrant’s activities, if any, to mitigate or adapt to a material climate-related risk including the use, if any, of transition plans, scenario analysis, or internal carbon prices;

* Any oversight by the board of directors of climate-related risks and any role by management in assessing and managing the registrant’s material climate-related risks;

* Any processes the registrant has for identifying, assessing, and managing material climate-related risks and, if the registrant is managing those risks, whether and how any such processes are integrated into the registrant’s overall risk management system or processes;

* Information about a registrant’s climate-related targets or goals, if any, that have materially affected or are reasonably likely to materially affect the registrant’s business, results of operations, or financial condition. Disclosures would include material expenditures and material impacts on financial estimates and assumptions as a direct result of the target or goal or actions taken to make progress toward meeting such target or goal;

* For large accelerated filers (LAFs) and accelerated filers (AFs) that are not otherwise exempted, information about material Scope 1 emissions and/or Scope 2 emissions;

* For those required to disclose Scope 1 and/or Scope 2 emissions, an assurance report at the limited assurance level, which, for an LAF, following an additional transition period, will be at the reasonable assurance level;

* The capitalized costs, expenditures expensed, charges, and losses incurred as a result of severe weather events and other natural conditions, such as hurricanes, tornadoes, flooding, drought, wildfires, extreme temperatures, and sea level rise, subject to applicable one percent and de minimis disclosure thresholds, disclosed in a note to the financial statements;

* The capitalized costs, expenditures expensed, and losses related to carbon offsets and renewable energy credits or certificates (RECs) if used as a material component of a registrant’s plans to achieve its disclosed climate-related targets or goals, disclosed in a note to the financial statements; and

* If the estimates and assumptions a registrant uses to produce the financial statements were materially impacted by risks and ...