OnConferences’ Post

Last week the HHS-OIG released their much anticipated General Compliance Program Guidance, timing the release with Corporate Compliance and Ethics Week - super cute! I found the section on Compliance Officer characteristics to be the most interesting to ruminate on. I understood the guidance to recommend: ✅ Compliance should not not report into or lead Legal or Finance therefore; ✅ The General Counsel ought not hold the Chief Compliance Officer mantle ✅ Compliance Officers should be focused on and dedicated to Compliance and not other business functions also as part of their role. They especially should not be lawyering or giving financial advice. Following these considerations, I believe companies in health care and life sciences are now challenged to: 🤔Consider whether they ought to adjust organizational structure and reporting lines that are not already wholly independent 🤔Document rationale for significant factors in the guidance that they don’t adhere to 🤔 Consider whether requiring a JD and admission to a bar in good standing as well as making Compliance roles “Counsel” or “Attorney” roles is difficult to reconcile with the indication we ought not be acting as lawyers or giving Legal advice (spoiler alert: I think they’re difficult to reconcile and it’s unnecessary to make compliance roles counsel roles, so will we see a drop in this trend? I hope so). I note that the separation of Legal and Compliance has long been a requirement in Corporate Integrity Agreements, but this is the first time I’ve seen it in guidance. Donna Boehme, thought leader in Compliance, has been campaigning for the separation of Legal and Compliance for years and I’m glad to see the recommendation by the OIG support her hard work. If you’re interested in reading more, I take a deep dive in this article released today on Corporate Compliance Insights and include my views on what this means for companies outside of the healthcare and life sciences fields also.

Last week the HHS-OIG released their much anticipated General Compliance Program Guidance, timing the release with Corporate Compliance and Ethics Week - super cute! I found the section on Compliance Officer characteristics to be the most interesting to ruminate on. I understood the guidance to recommend: ✅ Compliance should not not report into or lead Legal or Finance therefore; ✅ The General Counsel ought not hold the Chief Compliance Officer mantle ✅ Compliance Officers should be focused on and dedicated to Compliance and not other business functions also as part of their role. They especially should not be lawyering or giving financial advice. Following these considerations, I believe companies in health care and life sciences are now challenged to: 🤔Consider whether they ought to adjust organizational structure and reporting lines that are not already wholly independent 🤔Document rationale for significant factors in the guidance that they don’t adhere to 🤔 Consider whether requiring a JD and admission to a bar in good standing as well as making Compliance roles “Counsel” or “Attorney” roles is difficult to reconcile with the indication we ought not be acting as lawyers or giving Legal advice (spoiler alert: I think they’re difficult to reconcile and it’s unnecessary to make compliance roles counsel roles, so will we see a drop in this trend? I hope so). I note that the separation of Legal and Compliance has long been a requirement in Corporate Integrity Agreements, but this is the first time I’ve seen it in guidance. Donna Boehme, thought leader in Compliance, has been campaigning for the separation of Legal and Compliance for years and I’m glad to see the recommendation by the OIG support her hard work. If you’re interested in reading more, I take a deep dive in this article released today on Corporate Compliance Insights and include my views on what this means for companies outside of the healthcare and life sciences fields also.

Last week the HHS-OIG released their much anticipated General Compliance Program Guidance, timing the release with Corporate Compliance and Ethics Week - super cute! I found the section on Compliance Officer characteristics to be the most interesting to ruminate on. I understood the guidance to recommend: ✅ Compliance should not not report into or lead Legal or Finance therefore; ✅ The General Counsel ought not hold the Chief Compliance Officer mantle ✅ Compliance Officers should be focused on and dedicated to Compliance and not other business functions also as part of their role. They especially should not be lawyering or giving financial advice. Following these considerations, I believe companies in health care and life sciences are now challenged to: 🤔Consider whether they ought to adjust organizational structure and reporting lines that are not already wholly independent 🤔Document rationale for significant factors in the guidance that they don’t adhere to 🤔 Consider whether requiring a JD and admission to a bar in good standing as well as making Compliance roles “Counsel” or “Attorney” roles is difficult to reconcile with the indication we ought not be acting as lawyers or giving Legal advice (spoiler alert: I think they’re difficult to reconcile and it’s unnecessary to make compliance roles counsel roles, so will we see a drop in this trend? I hope so). I note that the separation of Legal and Compliance has long been a requirement in Corporate Integrity Agreements, but this is the first time I’ve seen it in guidance. Donna Boehme, thought leader in Compliance, has been campaigning for the separation of Legal and Compliance for years and I’m glad to see the recommendation by the OIG support her hard work. If you’re interested in reading more, I take a deep dive in this article released today on Corporate Compliance Insights and include my views on what this means for companies outside of the healthcare and life sciences fields also.

OIG Guidance: Let Compliance Officers Stay in Their Lane 😤 (I'm going to be talking about this alllllllll year btw so get ready) The OIG has made it crystal clear: Compliance should report directly to the CEO or the board. . I've listed a few takeaways from this article I stumbled upon, but you'll want to read the full article for more insights! AND in case you missed it: today's #Ethicsverse webinar "CCOs & CEOs: Forging an Effective C-Suite Bond" is happening at 12p EST (link to register in comments) My Key Takeaways from this CCI Article: 🌟 Compliance Officers Doing Their Thing: The guide is saying that compliance officers should do their job independently and with power. They should have their own roles and stay away from the legal or financial stuff. 🌟 Legal and Compliance: The guide is saying it's a good idea to keep legal and compliance separate. Don't mix them up like we used to. 🌟 Qualifications: The guide says it's fine for compliance officers to not be lawyers. You don't need a law degree for the job! 🌟 More Than Just Healthcare: Even though it's talking mostly about healthcare, the guide is telling everyone else to pay attention too. 🤔 What challenges or benefits do you foresee in implementing these distinctions in your company? Thank you Mary Shirley for such a well written and enlightening piece! #OIGguidance #ethicsandcompliance #CCI #growthmindset #complianceprogram https://lnkd.in/eX-4WcSk

In my view, one of the greatest areas of opportunity for many Compliance functions, is building a department full of Ethics and Compliance practitioners with diverse, holistic experience and skillsets, rather than mini-me staff of the team's leader, creating more vulnerability for multi-way echo chambers. In this month's Living Your Best Compliance Life Column, I invited my friend and colleague, also Chief Compliance Officer #GOAT Andrew McBride to discuss building an epic and effective Compliance function. The former CCO of Albermarle and I talk about his experience building fabulous teams (his last team had 13 members consisting of 11 different nationalities!), as well as a thought for recruiters and how other leaders can play a part in encouraging the creation of stronger teams in the Compliance space more broadly, particularly in regards to background and academic diversity. Check out the piece here and be sure to follow Andrew as one of the field's most recognized at being able to constructively deploy data analytics: https://lnkd.in/gdtEHE7g

In my view, one of the greatest areas of opportunity for many Compliance functions, is building a department full of Ethics and Compliance practitioners with diverse, holistic experience and skillsets, rather than mini-me staff of the team's leader, creating more vulnerability for multi-way echo chambers. In this month's Living Your Best Compliance Life Column, I invited my friend and colleague, also Chief Compliance Officer #GOAT Andrew McBride to discuss building an epic and effective Compliance function. The former CCO of Albermarle and I talk about his experience building fabulous teams (his last team had 13 members consisting of 11 different nationalities!), as well as a thought for recruiters and how other leaders can play a part in encouraging the creation of stronger teams in the Compliance space more broadly, particularly in regards to background and academic diversity. Check out the piece here and be sure to follow Andrew as one of the field's most recognized at being able to constructively deploy data analytics: https://lnkd.in/gdtEHE7g