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
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Top Takeaways | 2023 Physician Practice Management & ASC Symposium 2023 | Fraud & Abuse Risk Mitigation and Enforcement Trends

In this session, McDermott Will & Emery Partners Denise Burke, Tony Maida and Monica Wallace discussed top issues and enforcement trends that physician practice management companies (PPMs) and ambulatory surgery centers (ASCs) should watch to mitigate their fraud and abuse risk. The panel also discussed the potential impact of recent regulatory changes on future enforcement priorities.

Session panelists included:

  • Denise Burke, Partner, McDermott Will & Emery
  • Tony Maida, Partner, McDermott Will & Emery
  • Monica Wallace, Partner, McDermott Will & Emery

Top takeaways included:

  1. The federal government recently released False Claims Act recovery data for 2022. While the recovery amounts went down, the number of reported cases actually went up. We anticipate seeing more COVID-19-related enforcement actions. We are also seeing continued government focus on financial arrangements with physicians, including transactions involving physicians receiving preferential investment terms, such as below-fair-market-value purchase prices.
  2. In the most recent revision to the Stark rules, there is a new ability to cure compensation errors. Specifically, if a designated health services (DHS) entity has a compliant written compensation arrangement with a physician and discovers a payment error during the term of the arrangement or within 90 days of termination, the entity can correct or reconcile the compensation error and there is no need to submit a self-disclosure. The US Centers for Medicare & Medicaid Services (CMS) recently said that errors could even be fixed after 90 days from termination, but this requires a close analysis of the facts.
  3. The federal government has started [...]

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Top Takeaways: New Steps for Compliance: A Closer Look at the DOJ’s Revised Corporate Compliance Program

The US Department of Justice’s (DOJ) revised compliance program document “The Evaluation of Corporate Compliance Programs,” released June 1, 2020, helps organizations understand how DOJ evaluates compliance programs for effectiveness. Below are the the top takeaways from this revision that you should be aware of. For a deeper dive into this revision, listen to our webinar recording.

  1. Three questions the DOJ looks to answer are:
    • Is the corporation’s program well designed?
    • Is the program being applied earnestly and in good faith? (In other words, is the program adequately resourced and empowered to function effectively?)
    • Does the corporation’s program work in practice?
  2. Under the June 2020 updates, the DOJ will increase its focus on evaluating how effectively compliance programs are tailored to the organization’s risk profile, including the company’s size, industry, geographic footprint, regulatory landscape and other factors.
  3. Compliance programs should continuously evolve to pass muster under the DOJ’s updated guidance. Programs are expected to adapt based on review of new data, as well as lessons learned from the company’s own experiences and the experiences of similar companies.
  4. The design of compliance programs will be even more closely scrutinized. The DOJ has added more detailed questions on program design, including, among others, have the policies and procedures been published in a searchable format?; how do employees ask questions during on-line trainings; and does the company take measures to test whether employees are aware of the compliance hotline and feel comfortable using it?
  5. The importance [...]

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