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USA: Health and Human Services Inspector General publishes General Compliance Program Guidance

On November 28, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published its General Compliance Program Guidance. In particular, the Guidance details voluntary, nonbinding guidance for healthcare industry stakeholders to help identify risk areas for consideration when developing or updating compliance programs. To this end, the Guidance highlights relevant Federal laws, compliance program infrastructure, and OIG resources useful to understanding healthcare compliance.

What federal laws are relevant to healthcare compliance?

The Guidance provides an overview of federal laws critical to understanding compliance risks in the healthcare industry including:

  • the Federal Anti-Kickback Statute;
  • the Physician Self-Referral Law;
  • the False Claims Act; 
  • the Criminal Health Care Fraud Statute; and

  • the Health Insurance Portability and Accountability Act (HIPAA).

Notably, the Guidance recommends that covered entities should prioritize compliance with the HIPAA rules related to the privacy and security of health information.

What are the elements of an effective compliance program?

According to the Guidance for a compliance program to be effective, it should:

  • contain written policies and procedures;
  • have officials responsible for compliance leadership and oversight such as compliance officers;
  • provide appropriate education and training specific to the needs of and risks presented by the entity;

  • have effective lines of communication with the compliance officer and disclosure programs;

  • establish consequences for noncompliance, as well as incentives for compliance; 

  • contain a formal process for compliance risk assessment, auditing, and monitoring; and

  • include processes to detect compliance concerns and remedy any violations.

What are other compliance considerations?

The Guidance emphasizes the importance of incorporating quality and patient safety oversight into compliance processes. For new entrants in the healthcare sector, the Guidance recommends that they familiarize themselves with the relevant healthcare compliance laws and regulations. To identify potential compliance issues the Guidance encourages entities to review the varying incentives created by different types of healthcare funding structures.

Lastly, the Guidance cites several OIG resources and processes including among other things compliance toolkits, advisory opinions, and Frequently Asked Questions.

You can read the press release here and the Guidance here.