Developing Compliance Healthcare Policies And Procedures Documents

Richard P. Kusserow | October 2014

Healthcare compliance policy and procedures are the foundation of any compliance program, both in terms of organization and management of the program. Writing policy and procedures provide guidance that facilitates compliance with applicable laws, regulations and standards. Healthcare compliance policy and procedures are not limited to the Compliance Office. They are also critical for ensuring compliance in high risk operational areas.

The U.S. Department of Health and Human Services Office of Inspector General (OIG) has issued a number of compliance program guidance documents, all of which stresses the importance of written healthcare compliance policies and procedures for employees. The OIG notes that “[a]t a minimum, comprehensive compliance programs should include…the development and distribution of written standards of conduct, as well as written policies and procedures that promote the [organization’s] commitment to compliance and that address specific areas of potential fraud, such as claims development and submission processes, code gaming, and financial relationships with physicians and other health care professionals.” Furthermore, the U.S. Sentencing Commission Federal Sentencing Guidelines notes “have an effective compliance and ethics program.., an organization shall…shall establish standards and procedures to prevent and detect criminal conduct.”

The failure to properly develop, disseminate and train covered persons on healthcare compliance policy and procedures can prove to be a huge mistake that can result in a variety of liabilities, loss of revenue and reputation. The fact is that scores, if not hundreds, of policy documents are needed to be in compliance with regulatory and care standards.

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Healthcare compliance policy and procedures are needed to establish the structure and operation of the compliance program and these alone number in the dozens. Many necessary healthcare compliance policy and procedures are identified in the OIG’s compliance program guidance documents, such as duty to report, non-retaliation and confidentiality in regards to confidential communication channels. Others policies topics specifically noted include the Anti-Kickback Statute, Emergency Medical Treatment and Active Labor Law, Health Insurance Portability and Accountability Act, Stark Law, claim processing system, clinical research, cost reports, laboratory services and physicians at teaching hospitals.

Developing and writing policy and procedures can average thousands of dollars for a single policy regardless of whether it is developed by an outside consultant or law firm or internally by a committee. If care is not taken, this can become a costly and time consuming endeavor. Therefore, it is not surprising that many seek shortcuts, such using policies prepared by another organization, when developing healthcare compliance policies and procedures.

However, care must be taken when using this approach. You may discover a significant difference between your organization and the organization that developed the policy that would affect the procedures of the policy. Furthermore, you may not know how the policy was developed, whether the laws and regulations that are cited are up-to-date and interpreted correctly for the policy.

There are legitimate and authoritative sources available to assist in writing policy and procedures that provide proper citation and referencing. This may prove to be an efficient, effective, and inexpensive solution to policy development. The Policy Resource Center is a major resource for healthcare compliance policies and procedures and can be a valuable resource to add up-to-date and customizable healthcare compliance policies and procedures to your compliance program.

The following are several tips and best practices for writing policy and procedures.

  • Standardize polices in form and format to avoid confusion.
  • Ensure all the policy statements are short, declarative, and specific to a single issue.
  • Write the document in the active voice.
  • Make documents user friendly to those that have to live by them.
  • Make sure the policy does not conflict with other policies.
  • Cross reference all policies to similar ones.
  • Define all key terms used in the document.
  • Anchor the document in cited authority.

About the Author

Richard P. Kusserow established Strategic Management Services, LLC, after retiring from being the DHHS Inspector General, and has assisted over 3,000 health care organizations and entities in developing, implementing and assessing compliance programs.