C.F.R. » Title 42 » CHAPTER V—OFFICE OF INSPECTOR GENERAL-HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—OIG AUTHORITIES › PART 1001—PROGRAM INTEGRITY—MEDICARE AND STATE HEALTH CARE PROGRAMS › Subpart B—Mandatory Exclusions

42 C.F.R. § 1001.101

Basis for liability

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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 or furnished or furnishes items or services;

(2) Holds, or has held, a direct or an indirect ownership or control interest in an entity that furnished or furnishes items or services or is, or has ever been, an officer, director, agent, or managing employee 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; 82 FR 4112, Jan. 12, 2017]
Notes of Decisions
Cited in 8 cases (2 in the last 5 years), 1988–2025 · leading case: Stephen Doane v. Dep't of Health & Human Servs., 2017 ME 193 (Me. 2017).
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Stephen Doane v. Dep't of Health & Human Servs., 2017 ME 193 (Me. 2017). · cites it 2× “See 42 C.F.R. §§ 1001.101 , 1001.201-1001.951 (2016).”
Anderson v. Thompson, 311 F. Supp. 2d 1121 (D. Kan. 2004). “See 42 C.F.R. § 1001.101 (a) (program-related offenses for purposes of mandatory exclusion under section 1320a-7(a)(l) include "the performance of management or administrative services relating to the delivery of health care items or services”); see also Travers v.”
Integrated Generics, Inc. v. Bowen, 678 F. Supp. 1004 (E.D.N.Y 1988). “See 42 C.F.R. § 1001.101 (a); 42 C.F.R. § 1001.”
Lasher v. Dep't of Health & Human Servs., 369 F. Supp. 3d 243 (D.C. Cir. 2019). “§ 1320a-7(a)(3) ; see 42 C.F.R. § 1001.101 . An individual is deemed "convicted of a criminal offense .”
Lasher v. Dep't of Health & Human Servs. (D.D.C. 2019). “§ 1320a-7(a)(3); see 42 C.F.R. § 1001.101 . An individual is deemed “convicted of a criminal offense .”
Baxter v. Becerra (E.D. Va. 2024). “§ 1320a-7(a)(1); see also 42 C.F.R. § 1001.101 . For such mandatory exclusions, the statutory minimum exclusion period is five years.”
Figueroa v. Dep't of Health & Human Servs. (M.D. Fla. 2025). “§ 1320a- 7(a)(3) and 42 C.F.R. § 1001.101 (c) (Tr. 165). Plaintiff’s exclusion began 20 days after the notice on September 20, 2022 (Id.”
United States v. Shipley, 286 F. Supp. 2d 499 (W.D. Pa. 2003). “77(c)(2) & 42 C.F.R. § 1001.101 ). We offer no opinion on this issue, but note that it undercuts the primary motivation of petitioner’s motion to modify his sentence.”
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