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Compliance Training

42 CFR § 411.357(o) makes an exception for compensation arrangements involving compliance training provided by a designated health service entity to a physician (or the physician's immediate family member or members of the physician's office staff) who practices in the entity's local community or service area. The exception requires that the training must be held in the designated health service entity's local community or service area.

Compliance training means, for purposes of this exception, training on the basic elements of a compliance program, such as establishing policies and procedures, educating staff, internal monitoring and reporting.  It may include training on the requirements of federal and state health care programs, such as billing, coding, reasonable and necessary services, documentation and unlawful referral arrangements. Compliance training may also cover other federal, state or local laws, regulations or rules governing the conduct of the party for whom the training is provided. 

This exception builds on comments that were made regarding the de minimus compensation exception in the proposed rule. CMS noted that many hospitals provide compliance training as part of medical staff benefits, and such training is therefore excepted under the rule. CMS refined and broadened the exception in the phase II rule to apply to compliance training by any designated health service entity -- not just hospitals. This exception is hardly surprising, given the overall emphasis on compliance by CMS and the OIG. 

The phase III final rule expanded the compliance training exception to include programs that involve CME credit -- so long as compliance training is the predominate focus of the program. 
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