42 C.F.R. § 1001.601

Exclusion or suspension under a Federal or State health care program

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(a) Circumstance for exclusion. (1) The OIG may exclude an individual or entity suspended or excluded from participation, or otherwise sanctioned, under—

(i) Any Federal program involving the provision of health care, or

(ii) A State health care program, for reasons bearing on the individual's or entity's professional competence, professional performance or financial integrity.

(2) The term “or otherwise sanctioned” in paragraph (a)(1) of this section is intended to cover all actions that limit the ability of a person to participate in the program at issue regardless of what such an action is called, and includes situations where an individual or entity voluntarily withdraws from a program to avoid a formal sanction.

(b) Length of exclusion. (1) An exclusion imposed in accordance with this section will not be for a period of time less than the period during which the individual or entity is excluded or suspended from a Federal or State health care program.

(2) Any of the following factors may be considered aggravating and a basis for lengthening the period of exclusion—

(i) The acts that resulted in the exclusion, suspension or other sanction under Medicare, Medicaid and all other Federal health care programs had, or could have had, a significant adverse impact on Federal or State health care programs or the beneficiaries of those programs or other individuals;

(ii) Whether the individual or entity has a documented history of criminal, civil or administrative wrongdoing; or

(iii) 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.

(3) Only if any of the aggravating factors listed in paragraph (b)(2) of this section justifies a longer exclusion may a mitigating factor be considered as a basis for reducing the period of exclusion to a period not less than that set forth in paragraph (b)(1) of this section. Only the following factor may be considered mitigating: The individual's or entity's cooperation with Federal or State officials resulted in—

(i) The sanctioning of other individuals or entities, or

(ii) Additional cases being investigated or reports being issued by the appropriate law enforcement agency identifying program vulnerabilities or weaknesses.

(4) If the individual or entity is eligible to apply for reinstatement in accordance with § 1001.3001 and the sole reason why the State or Federal health care program denied reinstatement to that program is the existing exclusion imposed by the OIG as a result of the original State or Federal health care program action, the OIG will consider a request for reinstatement.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46688, Sept. 2, 1998; 82 FR 4114, Jan. 12, 2017]

Notes of Decisions

Cited in 2 cases, 1997–2018 · leading case: Nomo-Ongolo v. Sec'y of the U.S. Dep't of Health & Human Servs. (D. Minnesota 2018).

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Nomo-Ongolo v. Sec'y of the U.S. Dep't of Health & Human Servs. (D. Minnesota 2018). · cites it 3× “On November 30, 2016, the United States Department of Health and Human Services, Office of Inspector General (OIG) notified Nomo-Ongolo that she was being excluded from participation in all federal health programs under Section 1128(b)(5)(B) of the Social Security Act and 42…”

Ramanadhan v. Wing, 174 Misc. 2d 11 (N.Y. Sup. Ct. 1997). “(42 USC § 1320a-7 [b] [5]; 42 CFR 1001.601.) The petitioner has submitted evidence demonstrating that the MetLife Empire Plan automatically terminates contracts with physicians who have been excluded by Medicaid.”

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