Wednesday, January 8, 2020
Hospitals, health systems, physician groups and other healthcare industry face an enormous regulatory and compliance burden unlike any other sector. Below, Womble Bond Dickinson Healthcare Consultant Carrie Tuttle gives her Seven Elements of an Effective Compliance Program. These elements can serve as general guideposts to help healthcare providers and employers create a culture of compliance and proactively address compliance shortcomings that may lead to problems down the road.
Also, watch below to see a comprehensive webinar presentation with Tuttle discussing the elements of an effective compliance program in the healthcare industry.
Implementing Policies, Procedures, and Standards of Conduct
Policies, procedures, and standards of conduct should be written in such a way that is easily understood in order to maintain compliance while performing job functions. Policies and procedures should be clearly written, they should be relevant and current, specific to job functions, reviewed on a regular basis (e.g. monthly or quarterly), and readily available.
Designating a Compliance Officer and Compliance Committee
Designating a Compliance Officer and Compliance Committee will at minimum prevent, detect, and correct non-compliance, supports the organization’s unique structure and compliance program with sufficient resources, promotes standards of conduct, and establishes a clear means of communication for reporting non-compliance.
Training and Education
Effective training and education can be achieved by offering compliance training frequently (at minimum annually), making training and education part of the job requirements, and staying current on compliance issues and trends by attending conferences, reading articles and/or publications, and professional networking.
Effective Communication
Developing effective lines of communication is essential and is a great mechanism for reporting instances of potential non-compliance. Effective communication can be developed by being visible and approachable, ensuring confidentiality, communicating the compliance message, encouraging feedback, and providing methods for anonymous and good-faith reporting (e.g. anonymous hotline, survey, etc.).
Monitoring and Auditing
Conduct internal monitoring and auditing by establishing an annual work plan, determine any areas of risk, proactively audit, and review the compliance program. This ensures the compliance program addresses any areas of concern while sustaining compliance program effectiveness.
Disciplinary Guidelines
Well-published disciplinary guidelines ensure standards are followed continuously and consistently throughout the organization. Standards should be followed by all personnel regardless of position, title, or rank. Never assume the standards are being followed, check in often to inspect for the standards set forth.
Detecting Offenses and Corrective Action
Developing a method for tracking and responding to compliance issues, thoroughly documenting and investigating, enforcing corrective action, and tracking the resolution of complaints are effective ways to address offenses. Acting promptly to detected offenses and undertaking the appropriate corrective action is pertinent to maintaining an effective compliance program.
Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.National Law Review, Volume X, Number 8
We operate in a highly regulated industry and an increasingly challenging business environment. In 2003, the Office of Inspector General (OIG), Department of Health and Human Services, developed the OIG Compliance Program Guidance for Pharmaceutical Manufacturers. According to the OIG, "it is imperative for pharmaceutical manufacturers to establish and maintain effective compliance programs. These programs should foster a culture of compliance that begins at the executive level and permeates throughout the organization." The OIG's guidance includes seven widely recognized and fundamental elements to an effective compliance program. We have gone a step further by identifying an additional three tenets to complete Amgen's Elements of an Effective Compliance Program. The OIG's seven elements, combined with the additional three tenets identified by Amgen, are the foundation for our Worldwide Compliance & Business Ethics Program.
Core Elements of an Effective Compliance Program
- Written policies and procedures
- Designated compliance officer and compliance committee
- Effective training and education
- Effective lines of communication
- Internal monitoring and auditing
- Enforcement of standards through well-publicized disciplinary guidelines
- Prompt response to detected problems through corrective actions
Additional Tenets Identified by Amgen
- Compliance metrics reviewed by Compliance Committee to assess program effectiveness
- Compliance leadership is part of executive performance reviews
- Prompt, balanced and effective decisions regarding compliance activities may require Compliance Committee involvement