42 CFR §1001.1401

1. (a)Circumstance for exclusion. The OIG may exclude any hospital that CMS determines has failed substantially to comply with a corrective action plan required by CMS under section 1886(f)(2)(B) of the Act.
2. (b)Length of exclusion. The following factors will be considered in determining the length of exclusion under this section—
   1. (1)The impact of the hospital's failure to comply on Medicare, Medicaid or any of the other Federal health care programs, program beneficiaries or other individuals;
   2. (2)The circumstances under which the failure occurred;
   3. (3)The nature of the failure to comply;
   4. (4)The impact of the exclusion on Medicare, Medicaid or any of the other Federal health care programs, beneficiaries or the public; and
   5. (5)Whether the individual or entity has a documented history of criminal, civil or administrative wrongdoing (The lack of any prior record is to be considered neutral).