OIG Compliance Guidance for Pharmaceutical Manufacturers

The Office of Inspector General provides compliance program guidance to the health care community. Their guidance encourages the use of internal controls to monitor adherence to regulatory requirements so that fraud and abuse in federal health care programs are mitigated. The compliance program guidance for pharmaceutical manufacturers includes the following elements as they relate to the integrity of data used to establish accepted vs. illegal payments and compliance with laws regulating drug samples:

  • Implementing written policies and procedures
  • Designating a compliance officer and committee
  • Conducting effective training and education
  • Developing effective lines of communication
  • Monitoring and auditing compliance
  • Enforcing standards
  • Responding promptly to detected problems and undertaking corrective actions

 

The contents of the guidance is not mandatory, but following them, as demonstrated by an effective compliance program, exhibits a good faith effort by the company to comply with regulations and significantly reduces the risk of unlawful conduct and any penalties or lost business that could result from such behavior.

Compliance Made Easy

Hiperos 3PM helps pharmaceutical manufacturers manage potential risks under the anti-kickback statute arising from relationships with purchasers and their agents, persons and entities in a position to make or influence referrals and sales agents. Hiperos 3PM simplifies and streamlines the compliance management process by centralizing relationship information and workflows, automating and documenting due diligence, assessment and scoring of relationship risks, managing only relationships posing kickback risks and monitoring risk factors continuously with data from internal systems and data providers. All material kickback issues and actions taken are recorded in a central “book of record” with a verifiable audit trail.