42 CFR 1001.951 - Fraud and kickbacks and other prohibited activities.
(a) Circumstance for exclusion.
(i) May exclude any individual or entity that it determines has knowingly and willfully solicited, received, offered or paid any remuneration in the manner and for the purposes described therein, irrespective of whether the individual or entity may be able to prove that the remuneration was also intended for some other purpose; and
(ii) Will not exclude any individual or entity if that individual or entity can prove that the remuneration that is the subject of the exclusion is exempted from serving as the basis for an exclusion.
(b) Length of exclusion.
(1) The following factors will be considered in determining the length of exclusion in accordance with this section -
(ii) The nature and extent of any adverse physical, mental, financial or other impact the conduct had on program beneficiaries or other individuals or the Medicare, Medicaid and all other Federal health care programs;
(iii) 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);
(iv) The individual or entity has been the subject of any other adverse action by any Federal, State or local government agency or board, if the adverse action is based on the same set of circumstances that serves as the basis for the imposition of the exclusion; or
(v) Any other facts bearing on the nature and seriousness of the individual's or entity's misconduct.
(2) It will be considered a mitigating factor if -
(i) The individual had a documented mental, emotional, or physical condition before or during the commission of the prohibited act(s) that reduced the individual's culpability for the acts in question;
(ii) The individual's or entity's cooperation with Federal or State officials resulted in the -
(A) Sanctioning of other individuals or entities, or
(B) Imposition of a civil money penalty against others; or
(iii) Alternative sources of the type of health care items or services provided by the individual or entity are not available.