Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries
Exploring Critical Business and Legal Issues across the Healthcare and Life Sciences Industries

Best of McDermott’s 2018 Health Care Litigation, Compliance & Investigations Forum

By on October 26, 2018
Posted In Uncategorized

At a time when health care organizations are facing greater financial and reputational costs than ever before, more than 150 health care industry leaders, legal and compliance executives, and investors gathered for McDermott’s Health Care Litigation, Compliance & Investigations Forum at the Ritz-Carlton in Chicago to discuss strategies for proactively managing and effectively responding to compliance risks, investigations and litigation.

Sylvia Mathews Burwell, Secretary of Health and Human Services from 2014 to 2017, delivers the keynote presentation.

The event covered a wide range of issues, including fraud and abuse (such as False Claims Act and Stark Law matters), governance, cybersecurity, antitrust, white-collar, intellectual property, products liability and tax-exemption disputes. The event also featured a keynote address by Sylvia Mathews Burwell, Secretary of Health and Human Services from 2014 to 2017, on the foundations of the Affordable Care Act (ACA), the ramifications of the elimination of the individual mandate and the ACA’s prospects going forward.

If your organization needs support in current litigation or wants to ensure best practices to help avoid one, we’re here to help.

Below are key insights from the sessions:

Every Day’s Adventure: How Leading GCs Are Thinking about Compliance and Enforcement

  • Collaboration between the general counsel and the compliance officer provides a proactive and team-oriented approach to substantive legal and policy issues.
  • Keys to effective collaboration include communication, coordination and a culture of sharing, coupled with respect for the independence of the compliance/audit function.
  • Transparency is key; bad news is OK, but surprises are not. Stay closely engaged with the board and internal audit team. Of audience members surveyed, 40 percent brief their board on legal or compliance matters about once a quarter, and 47 percent do so every board meeting.
  • Preventative compliance measures involve a formal enterprise risk management plan and proactive two-way communication with line teams regarding trends and solutions.

Attendees share their thoughts on the biggest practical takeaway that has emerged from Escobar.

Trendspotting: Government Enforcement 2020

  • Cooperation and individual accountability will remain government priorities in enforcement efforts and settlements with companies.
  • Government investment will continue to center on the opioid crisis and Anti-Kickback Statute/False Claims Act enforcement. The Granston and Brand Memoranda are unlikely to curtail the latter.
  • For an in-depth discussion of these issues and other recent developments, see McDermott’s Health Care Enforcement Quarterly Roundup Q3.

Avoiding Dante’s Inferno: Dealing with Physician Disputes

  • During a physician practice management organization acquisition, transparency and education regarding the transaction and integration process help prevent physician disputes down the road. Be clear regarding the goals of, and rationale for, the transaction. Effective integration is the most important factor for success in a transaction with physicians, according to 56 percent of audience respondents.
  • Internal physician champions foster cooperation; seek buy-in by demonstrating how the integration will advance quality of care.
  • Align incentives and economics to keep physician and company goals consistent.

    Attendees share what they consider to be their biggest digital health compliance threat.

Managing Compliance and Data Privacy in 2018: From Human Error to Artificial Intelligence

  • Creating a culture of compliance is critical for managing risk, but doing so is increasingly challenging for organizations seeking to innovate within health care and apply expertise and ideas from other fields.
  • Compliance and legal, while serving separate purposes, are inextricably intertwined. Align these functions thoughtfully to ensure optimal performance and clarify the relationship between the compliance officer and the general counsel.
  • Artificial intelligence (AI) offers powerful tools not only for health care delivery but also for managing an organization’s compliance risks. Currently, 20 percent of audience respondents use AI to identify or investigate compliance issues. Like any tool, AI must be thoughtfully leveraged. Establish rigorous processes to prevent human error and ensure data security.

Expecting the Unexpected in a Government Investigation: From Ambush Interviews to Unbudgeted Legal Fees

  • In responding to investigations and promoting business concerns, care must be taken to avoid even the appearance of obstructing the investigation. Be accurate and observe ethical boundaries.
  • Early credibility and candor with the government can promote collaboration on narrowing the scope and burden of response, especially regarding digital data.
  • Discourage employee speculation about the identity of the whistleblower in order to reduce the risk of retaliation claims.

Attendees share their highest communication priorities during a crisis.

Crisis Management: Weathering the Storm and Protecting Your Reputation

  • When mapping out a crisis management strategy, think “when,” not “if.” Twelve percent of audience respondents reported that their organization has no crisis response plan in place and 33 percent were unsure.
  • Even if a crisis event does not reflect on an organization’s performance, the organization’s response to the crisis often shapes public perception of its standards and quality.
  • Tone is key, as is demonstrating core values such as integrity, competence, transparency and empathy. An effective crisis response shows care for victims, promises a thorough investigation and implements speedy corrective actions.

McDermott lawyers who presented at this event included David S. Rosenbloom, Laura McLane, Stephen W. Bernstein, Monica Wallace, Tony Maida, Amy Hooper Kearbey, Amandeep S. Sidhu, and Paul M. Thompson.





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