By Brian S. Werfel, Esq.

On April 25, 2023, the HHS Office of the Inspector General (OIG) posted a notice in the Federal Register that it would be updating its publicly available resources, including its compliance program guidance documents.  The OIG’s Compliance Program Guidances (CPGs) were developed as voluntary, non-binding guidance documents that can assist healthcare providers in developing their own internal controls to ensure adherence to federal laws, regulations, and program requirements.

Specifically, the OIG announced that it will no longer publish updated or new CPGs in the Federal Register.  Instead, updates or new CPGs will now be made available on the OIG’s website.  The OIG will also revise the format for CGS.  The new format will consist of: (1) a General CPG (GCPG) that applies to all healthcare providers and (2) industry-specific CPGs (ICPGs) tailored to the fraud and abuse areas specific to that industry.  The OIG indicated that it anticipates issuing the GCPG by the end of calendar year 2023, with ICPGs being issued starting in calendar year 2024.  The OIG further indicated that it anticipates the first two ICPGs will address Medicare Advantage plans and nursing facilities.

Note: the OIG is not updating its 2003 guidance on compliance programs for ambulance suppliers.  The OIG frequently cites this document in enforcement actions it takes against ambulance providers and suppliers.  Thus, this guidance document remains relevant to this day.  For that reason, A.A.A. members are strongly encouraged to review this document to ensure that their existing compliance program incorporates the elements cited by the OIG.

Previous Compliance Program Guidance for Ambulance Suppliers

In March 2003, the OIG issued its “Compliance Program Guidance for Ambulance Suppliers.”  This document sets forth the basic elements that it believes should be included in any effective compliance program, and then discusses various fraud and abuse and compliance risks associated with the provision of ambulance services under the Medicare Program.

The 7 basic elements identified by the OIG are:

1. The development of compliance policies and procedures
2. The designation of a compliance officer or compliance committee
3. The implementation of education and training programs
4. The use of internal monitoring and reviews
5. Policies designed to respond appropriately to detected misconduct
6. Ensuring open lines of communication
7. The enforcement of disciplinary standards through well-publicized guidelines

The CPG then goes into greater detail on each of these elements, including specific recommendations on how to properly implement each of these elements.  For instance, the OIG suggests that the organization’s compliance office be a high-level individual who reports directly to the organization’s CEO or Board of Directors.

With respect to the specific fraud and abuse risks associated with ambulance, the OIG highlighted the issue of medical necessity.  The OIG also cited level of service issues (i.e., billing ALS vs. BLS), non-emergency transports, and coordination of benefit issues as particular areas of concern.