Page:United States Statutes at Large Volume 124.djvu/729

 124 STAT. 703 PUBLIC LAW 111–148—MAR. 23, 2010 working jointly with the Inspector General of the Depart- ment of Health and Human Services, shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program. ‘‘(B) DESIGN OF REGULATIONS.—Such regulations with respect to specific elements or formality of a program shall, in the case of an organization that operates 5 or more facilities, vary with the size of the organization, such that larger organizations should have a more formal program and include established written policies defining the stand- ards and procedures to be followed by its employees. Such requirements may specifically apply to the corporate level management of multi unit nursing home chains. ‘‘(C) EVALUATION.—Not later than 3 years after the date of the promulgation of regulations under this para- graph, the Secretary shall complete an evaluation of the compliance and ethics programs required to be established under this subsection. Such evaluation shall determine if such programs led to changes in deficiency citations, changes in quality performance, or changes in other metrics of patient quality of care. The Secretary shall submit to Congress a report on such evaluation and shall include in such report such recommendations regarding changes in the requirements for such programs as the Secretary determines appropriate. ‘‘(3) REQUIREMENTS FOR COMPLIANCE AND ETHICS PRO- GRAMS.—In this subsection, the term ‘compliance and ethics program’ means, with respect to a facility, a program of the operating organization that— ‘‘(A) has been reasonably designed, implemented, and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations under this Act and in promoting quality of care; and ‘‘(B) includes at least the required components specified in paragraph (4). ‘‘(4) REQUIRED COMPONENTS OF PROGRAM.—The required components of a compliance and ethics program of an operating organization are the following: ‘‘(A) The organization must have established compli- ance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administra- tive violations under this Act. ‘‘(B) Specific individuals within high-level personnel of the organization must have been assigned overall respon- sibility to oversee compliance with such standards and procedures and have sufficient resources and authority to assure such compliance. ‘‘(C) The organization must have used due care not to delegate substantial discretionary authority to individ- uals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, and administrative violations under this Act. ‘‘(D) The organization must have taken steps to commu- nicate effectively its standards and procedures to all Definition. Reports.