In early November, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released its General Compliance Program Guidance (the Guidance). This was HHS OIG’s first update since 2008.

What You Need to Know:

• This is the first compliance compendium released by HHS OIG since 2008.
• This new document is a precursor to industry-specific guidances that are scheduled to be posted in 2024.
• Health care compliance remains critically important for all participants in the health care delivery system.

The Guidance is available on-line here and provides a one-stop shop for an overview of important and relevant health care compliance issues. The non-binding Guidance applies to hospitals; home health agencies; clinical labs; third party clinical billing companies; the DME, orthotics, prosthetics and supply industry; hospices; Medicare advantage organizations; nursing facilities; physicians and physician groups; ambulance suppliers; and pharmaceutical manufacturers. The Guidance notes that beginning in 2024, the OIG will publish industry-specific guidance documents for different types of providers and suppliers participating in the health care delivery system. 

The Guidance provides an overview of the Federal Anti-Kickback Statute; the so-called Stark Law; the False Claims Act; the Civil Monetary Penalty Authorities; Exclusion Authorities; the Criminal Health Fraud Statute; and the HIPAA Privacy and Security Rules. The Civil Monetary Penalty section of the Guidance provides background for the beneficiary inducements CMP and information blocking. The Guidance is laid out in an easy-to-read format and includes discussions regarding problematic arrangements, key questions, tips, and steps to take if a problem is identified.    

The Guidance reiterates the seven elements of an effective compliance program: (i) written policies and procedures; (ii) compliance leadership and oversight; (iii) training and education; (iv) effective lines of communication; (v) enforcing standards; (vi) risk assessment, auditing and monitoring; and (vii) responding to offenses and developing corrective action initiatives. This section of the Guidance also includes helpful OIG tips and sidebar comments. 

Because the Guidance is voluntary and non-binding, the Guidance notes that compliance is not a one-size-fits-all endeavor. Large organizations and small entities will likely go about implementing their compliance programs in different ways. To help facilitate those compliance initiatives, the Guidance provides separate tips for small and large parties.

The Guidance appropriately notes the importance of incorporating quality and safety issues in a compliance program. Similarly, as the health care delivery system diversifies, new and new-ish participants, including those organizations providing non-traditional services, would be well-served to understand the importance of Federal fraud and abuse laws and understand and incorporate a compliance program to help prevent, address, and correct potential violations. Finally, the Guidance notes one of the best ways to identify potential fraud and abuse risks: follow the money. The Guidance describes the role of private equity in health care, the use of payment incentives, and the importance of tracking financial arrangements.

Health care compliance is not a new legal topic. The Guidance is an important and useful tool for every party involved in the health care delivery system to use as a checklist to ensure that their organization is doing the right things and, hopefully, to help parties understand and correct shortcomings in their compliance initiatives.