Compliance Program (7 Elements) Policy and Procedure Templates

Compliance Program Guidance (“CPG”) from the Office of Inspector General (“OIG”) has always stressed the importance of drafting written policies and procedures that support your Compliance Program. The most recent “General Compliance Program Guidance,” released late in 2023, made it crystal clear that not only is your organization required to have policies and procedures that address specific areas of regulatory risk, but that you must also have implemented policies and procedures that address the 7 Elements of a Compliance Program. As the Guidance states:

“Compliance policies and procedures should encompass...the implementation and operation of the entity’s compliance program, including the seven elements.”

 Compliance Program policies and procedures help to protect your organization from the significant financial and reputational risks of non-compliance.

Moreover, the AFFORDABLE CARE ACT OF 2010 mandated the implementation of Compliance Programs as a condition of enrollment in Medicare, Medicaid, and other federally funded health care programs. CMS has yet to finalize precise requirements but once they do, enforcement is not far behind with the expectation that your policies and procedures must be in place and fully implemented.

The Compliance Program Policy and Procedure Templates offered by Wild Consulting, Inc., have been drafted and revised over my more than 20-year career in health care compliance and have been continually revised as the industry has evolved. Based on the many guidances offered by the OIG, they are grounded in detailed expertise in compliance program development and careful scrutiny of not only OIG recommendations but on direction offered by other governmental and professional entities such as the Department of Justice, the US Federal Sentencing Guidelines, the Health Care Compliance Association references, etc.

The intent of offering this compilation of Compliance Program Policy and Procedure Templates is to provide assistance in the development of your Compliance Program. They can serve as a type of roadmap giving definition to what needs to be done, and direction on how to get it done. They can be extremely helpful and save your organization a tremendous amount of time, money, and resources if you were to develop them on your own.

For those new to Health Care Compliance, or with a fledgling Program, wondering where to start the Templates can kick start your Program and help you learn and understand what the 7 Elements are all about, and what is required of you and your organization. Instead of spending countless hours and resources developing them independently, this may be a shortcut to accomplishing organizational objectives and getting your compliance house in order before the government finalizes requirements and sets a deadline!

For those with an existing Compliance Program the Templates can help to energize and improve your Compliance Program by ensuring your organization has the requisite written policies and procedures completed. If your Compliance Program has been established for some time, and you still have not had the opportunity to write and implement Compliance Program policies and procedures, it’s time to get that done!

All of the Templates are comprehensive (not the bare minimum), detailed, and provide the regulatory references behind each policy and procedure. They are developed in a formal and professional standard format, with a clear policy statement and an organized, easy to follow procedure. See example of a Template Policy and Procedure.  

The 13 Compliance Program Policy and Procedure Templates offered in this compilation address each of the 7 Elements of a Compliance Program as recommended and organized by the OIG in the 2023 “General Compliance Program Guidance” and include:

  •   Compliance Program Policies and Procedures Development [Element 1]

  •   Implementation and Maintenance of the Code of Conduct [Element 1]

  •   Compliance Program Oversight Obligations of the Board of Directors [Element 2]

  •   Board of Directors Resolution for the Compliance Program

  •   Compliance Program Oversight and Responsibilities [Element 2]

  •   Compliance Committee Charter

  •   Compliance Education and Training [Element 3]

  •   Reporting and Open Communications (Compliance Hotline) [Element 4]

  •   Enforcing Standards (Incentives and Consequences) [Element 5]

  •   Risk Assessment, Auditing, and Monitoring [Element 6]

  •   Internal Investigations and Corrective Action [Element 7]

  •   Exclusion Background Screening [Element 7]

  •   Exclusion Background Screening Form

Each document should be carefully considered to help ensure they are reflective of your organizational operations. The Templates are not, unto themselves, a Compliance Program, and are not final as they are written – they must be customized. The Templates are provided in Microsoft Word making them easy to customize to fit the needs of your organization.

The 13 documents that address and support implementation of the 7 Elements of a Compliance Program are available for $2,900.

In addition, if you or your organization just don’t have the time or are unclear about what needs to be done to review and implement your Compliance Program Policies and Procedures, and would like additional consulting services, hourly consulting fees will be offered at a discounted rate with the purchase of the Compliance Program Policy and Procedure Templates. Regular remote meetings can be scheduled to review each policy and procedure so further background and regulatory information can be provided to assist your organization in decision-making and to allow time to ask in-depth questions.

 

For more information contact

Kirsten Ruzic Wild, RN, BSN, MBA, CHC

Wild Consulting, Inc.

kirsten@wildconsultinginc.net

262.993.4747

 https://www.wildconsultinginc.net

linkedin.com/in/kirstenruzicwild