Breaking Compliance News Blog

The U.S. Department of Justice, Criminal Division, publishes a guidance document: Evaluation of Corporate Compliance Programs (ECCP). The DOJ has updated the guidance multiple times, most recently in March 2023.

This guidance is used in two ways:

• Federal prosecutors conducting criminal fraud or misconduct investigations (including healthcare fraud) use it to evaluate the effectiveness of a corporation’s compliance program. An effective program has the potential to reduce financial penalties imposed.
• Corporations, including healthcare providers, use the ECCP as a resource when implementing or evaluating the effectiveness of their compliance programs.

The DOJ guidance focuses on three questions:

1. Is the corporation’s compliance program well designed?
2. Is the program being applied earnestly and in good faith? (Is the program adequately resourced and empowered to function effectively?)
3. Does the corporation’s compliance program work in practice?

June ECCP 2020 Updates

In June 2020, the DOJ updated the ECCP; a summary of updates follows.

In March, CMS announced that it was suspending routine surveys for nursing homes during the pandemic, in order to focus on infection control and Immediate Jeopardy issues. However, CMS announced on Monday that this suspension is coming to an end.

In its memo to State Survey Agency Directors, titled: Enforcement Cases Held during the Prioritization Period and Revised Survey Prioritization, CMS announced that it is resuming onsite revisits and other surveys, and expanding its desk review.

In addition to the expanded surveys previously authorized for states entering Phase 3 of the Nursing Homes Reopening guidance, CMS is authorizing further survey expansion. The guidance states (direct quote):

On November 22, 2019, CMS issued a memorandum with an update on the Phase 3 Requirements of Participation. In this memo, CMS advised:

• CMS will not release updated Interpretive Guidance and training addressing Phase 3 until the second quarter of 2020. CMS is somewhat limited in its ability to survey until then.
• But... nursing homes are still expected to comply with Phase 3 by November 28, 2019.

What does this mean??

It means that, right now, nursing homes are required by law to comply with Phase 3, including the Compliance and Ethics Program requirements - and CMS expects nursing homes to be in compliance.

The Department of Justice Criminal Division recently issued a Guidance Document for prosecutors: Evaluation of Corporate Compliance Programs. 

In this document, the DOJ outlines three questions prosecutors should ask when making an "individualized determination of a corporate compliance program's effectiveness:

1. "Is the corporation's compliance program well designed?"
2. "Is the program being applied earnestly and in good faith?" In other words, is the program being implemented effectively?
3. "Does the corporation's compliance program work" in practice?