Accountability requirements for facilities

42 U.S. Code § 1320a-7j. Accountability requirements for facilities

(a) Definition of facilityIn this section, the term “facility” means—
(1)
a skilled nursing facility (as defined in section 1395i–3(a) of this title); or
(2)
a nursing facility (as defined in section 1396r(a) of this title).
(b) Effective compliance and ethics programs
(1) Requirement
On or after the date that is 36 months after March 23, 2010, a facility shall, with respect to the entity that operates the facility (in this subparagraph [1] referred to as the “operating organization” or “organization”), have in operation a compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations under this chapter and in promoting quality of care consistent with regulations developed under paragraph (2).
(2) Development of regulations
(A) In general
Not later than the date that is 2 years after March 23, 2010, the Secretary, working jointly with the Inspector General of the Department 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 standards 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 paragraph, 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 programsIn 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 chapter and in promoting quality of care; and
(B)
includes at least the required components specified in paragraph (4).
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