1001.1101—Failure to disclose certain information.

The OIG will exclude any individual or entity that—
(a) Has been convicted of a criminal offense related to the delivery of an item or service under Medicare or a State health care program, including the performance of management or administrative services relating to the delivery of items or services under any such program;
(b) Has been convicted, under Federal or State law, of a criminal offense related to the neglect or abuse of a patient, in connection with the delivery of a health care item or service, including any offense that the OIG concludes entailed, or resulted in, neglect or abuse of patients (the delivery of a health care item or service includes the provision of any item or service to an individual to meet his or her physical, mental or emotional needs or well-being, whether or not reimbursed under Medicare, Medicaid or any Federal health care program);
(c) Has been convicted, under Federal or State law, of a felony that occurred after August 21, 1996, relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct—
(1) In connection with the delivery of a health care item or service, including the performance of management or administrative services relating to the delivery of such items or services, or
(2) With respect to any act or omission in a health care program (other than Medicare and a State health care program) operated by, or financed in whole or in part, by any Federal, State or local government agency; or
(d) Has been convicted, under Federal or State law, of a felony that occurred after August 21, 1996 relating to the unlawful manufacture, distribution, prescription or dispensing of a controlled substance, as defined under Federal or State law. This applies to any individual or entity that—
(1) Is, or has ever been, a health care practitioner, provider or supplier;
(2) Holds, or has held, a direct or indirect ownership or control interest (as defined in section 1124(a)(3) of the Act) in an entity that is a health care provider or supplier, or is, or has ever been, an officer, director, agent or managing employee (as defined in section 1126(b) of the Act) of such an entity; or
(3) Is, or has ever been, employed in any capacity in the health care industry.
[63 FR 46686, Sept. 2, 1998, as amended at 67 FR 11932, Mar. 18, 2002]
(a) Circumstance for exclusion. The OIG may exclude any entity that did not fully and accurately, or completely, make disclosures as required by section 1124, 1124A or 1126 of the Act, and by part 455, subpart B and part 420, subpart C of this title.
(b) Length of exclusion. The following factors will be considered in determining the length of an exclusion under this section—
(1) The number of instances where full and accurate, or complete, disclosure was not made;
(2) The significance of the undisclosed information;
(3) 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);
(4) Any other facts that bear on the nature or seriousness of the conduct;
(5) The availability of alternative sources of the type of health care services provided by the entity; and
(6) The extent to which the entity knew that the disclosures made were not full or accurate.
[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46689, Sept. 2, 1998]