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Guidance on Compliance Plans

The U.S. Department of Justice (DOJ) frequently launches criminal as well as civil investigations of the billing practices of health care providers. Often, the eventual remedies sought by the DOJ depend in part on the quality and past implementation of the provider’s billing compliance program. 

More specifically, United States Attorneys consider several factors when deciding whether to bring claims, and when deciding what remedies to seek, including: (1) the adequacy and effectiveness of the company’s compliance program at the time of the offense, as well as at the time of a charging decision; and (2) the company’s remedial efforts to put an effective corporate compliance program in place or improve an existing one. 

On April 30, 2019, an updated version of the DOJ’s “Guidance Document on Evaluation of Corporate Compliance Programs” (Revised Guidance) was released, and health care providers are well advised to review their compliance plans in light of the Revised Guidance.

A.  The Revised Guidance

The Revised Guidance proposes three questions that prosecutors are expected to ask when evaluating compliance programs:

1.  Is the compliance program well designed?

Prosecutors will assess whether the company’s compliance program includes appropriate policies and procedures, effective compliance training, and a confidential reporting structure and investigative mechanism. 

2. Is the compliance program effectively implemented?

Prosecutors will assess the extent to which senior management has clearly articulated the company’s ethical standards, and demonstrated adherence to such standards by example. Prosecutors will also assess how middle management has reinforced those standards, and encouraged employees to abide by them.

Prosecutors will also assess whether those charged with oversight of the compliance program have adequate authority and stature. In other words, prosecutors will assess the sufficiency of the personnel and resources associated with the compliance program.

Part of effective implementation is the development of incentives for compliance and disciplinary measures for noncompliance, so prosecutors are instructed to assess such measures when determining whether a compliance program is effectively implemented.

3. Does the compliance program actually work in practice?

Prosecutors will assess how the company reviews and improves its compliance program, especially in light of lessons learned. Prosecutors will also assess the effectiveness of, and the adequacy of the resources assigned to, the investigative function of the program, as well as the timeliness and adequacy of any remediation efforts.

B. Takeaway

Companies without compliance programs should take this opportunity to design an effective compliance program, and companies with existing compliance programs should take this opportunity to review their programs to assess whether they comply with the Revised Guidance, and whether the plans have evolved as the companies have evolved.

Leslie M. Cumber
410-576-4248 • lcumber@gfrlaw.com

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Date

09.23.19

Type

Publications

Authors

Cumber, Leslie M.

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