Corporate Compliance Plans and Investigations

The Basis for Action

Federal

• RICO (18 USC § 1961)

• The False Claims Act and the qui tam provisions (31 USC)

• Anti-kickback Statute, (42 USC)

• Program Fraud Civil Remedies Act (5 USC SBREFA)

• Stark I and Stark II  Acts

State

Many states have similar provisions and will pursue actions in lieu of or in addition to federal action.

Compliance Programs

• Internal compliance review/audit

• Identification of practices which are improper, illegal, or potentially abusive

• Draft of a code of conduct

• Implementation of a reporting hot line

• Training program

XG Consultants Group, Inc. can also assist with recommendations for:

• Compliance officer and compliance oversight committee

• Appropriate disciplinary sanctions for violations

• Continued compliance through dissemination of new regulations & statutes

• Regular audits of practices and procedures to ensure continued compliance.

• Investigator and Coordinator Training for individuals involved in Clinical Research

• IRB and Site audit teams

Go to Compliance