42 C.F.R. § 1001.2

Definitions

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For purposes of this part:

Agent means any person who has express or implied authority to obligate or act on behalf of an entity.

Controlled substance means a drug or other substance, or immediate precursor:

(a) Included in schedules I, II, III, IV or V of part B of subchapter I in 21 U.S.C. chapter 13, or

(b) That is deemed a controlled substance by the law of any State.

Convicted means that—

(a) A judgment of conviction has been entered against an individual or entity by a Federal, State or local court, regardless of whether:

(1) There is a post-trial motion or an appeal pending, or

(2) The judgment of conviction or other record relating to the criminal conduct has been expunged or otherwise removed;

(b) A Federal, State or local court has made a finding of guilt against an individual or entity;

(d) An individual or entity has entered into participation in a first offender, deferred adjudication or other program or arrangement where judgment of conviction has been withheld.

HHS means Department of Health and Human Services.

Immediate family member means a person's husband or wife; natural or adoptive parent; child or sibling; stepparent, stepchild, stepbrother, or stepsister; father-, mother-, daughter-, son-, brother- or sister-in-law; grandparent or grandchild; or spouse of a grandparent or grandchild.

Incarceration means imprisonment or any type of confinement with or without supervised release, including, but not limited to, community confinement, house arrest and home detention.

Indirect ownership interest includes an ownership interest through any other entities that ultimately have an ownership interest in the entity in issue. (For example, an individual has a 10-percent ownership interest in the entity at issue if he or she has a 20-percent ownership interest in a corporation that wholly owns a subsidiary that is a 50-percent owner of the entity in issue.)

Managing employee means an individual (including a general manager, business manager, administrator, or director) who exercises operational or managerial control over the entity or part thereof or directly or indirectly conducts the day-to-day operations of the entity or part thereof.

Member of household means, with respect to a person, any individual with whom the person is sharing a common abode as part of a single-family unit, including domestic employees and others who live together as a family unit. A roomer or boarder is not considered a member of household.

Ownership interest means an interest in:

(1) The capital, the stock, or the profits of the entity, or

(2) Any mortgage, deed, trust or note, or other obligation secured in whole or in part by the property or assets of the entity.

Ownership or control interest means, with respect to an entity, a person who

(1) Has a direct or an indirect ownership interest (or any combination thereof) of 5 percent or more in the entity;

(2) Is the owner of a whole or part interest in any mortgage, deed of trust, note, or other obligation secured (in whole or in part) by the entity or any of the property assets thereof, if such interest is equal to or exceeds 5 percent of the total property and assets of the entity;

(3) Is an officer or a director of the entity;

(4) Is a partner in the entity if the entity is organized as a partnership;

(5) Is an agent of the entity; or

(6) Is a managing employee of the entity.

Patient means any individual who is receiving health care items or services, including any item or service provided to meet his or her physical, mental or emotional needs or well-being (including a resident receiving care in a facility as described in part 483 of this chapter), whether or not reimbursed under Medicare, Medicaid and any other Federal health care program and regardless of the location in which such item or service is provided.

Professionally recognized standards of health care are Statewide or national standards of care, whether in writing or not, that professional peers of the individual or entity whose provision of care is an issue, recognize as applying to those peers practicing or providing care within a State. When the Department has declared a treatment modality not to be safe and effective, practitioners who employ such a treatment modality will be deemed not to meet professionally recognized standards of health care. This definition will not be construed to mean that all other treatments meet professionally recognized standards.

Sole community physician means a physician who is the only physician who provides primary care services to Federal or State health care program beneficiaries within a defined service area.

Sole source of essential specialized services in the community means that an individual or entity—

(1) Is the only practitioner, supplier or provider furnishing specialized services in an area designated by the Health Resources Services Administration as a health professional shortage area for that medical specialty, as listed in 42 part 5, appendices B-F;

(2) Is a sole community hospital, as defined in § 412.92 of this title; or

(3) Is the only source of specialized services in a reasonably defined service area where services by a non-specialist could not be substituted for the source without jeopardizing the health or safety of beneficiaries.

State Medicaid Fraud Control Unit means a unit certified by the Secretary as meeting the criteria of 42 U.S.C. 1396b(q) and § 1002.305 of this chapter.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46686, Sept. 2, 1998; 64 FR 39426, July 22, 1999; 82 FR 4111, Jan. 12, 2017]

Notes of Decisions

Cited in 9 cases (4 in the last 5 years), 2003–2025 · leading case: Michael Friedman v. Kathleen Sebelius, 686 F.3d 813 (D.C. Cir. 2012).

Sort: Relevance Newest Treatment

Michael Friedman v. Kathleen Sebelius, 686 F.3d 813 (D.C. Cir. 2012). · cites it 2× “42 C.F.R. § 1001.2 provides “items and services furnished, ordered, or prescribed by [an excluded person] will not be reimbursed under Medicare, Medicaid and all other Federal health care programs until [that person] is reinstated by the OIG.”

Ahmed v. Sebelius, 710 F. Supp. 2d 167 (D. Mass. 2010). “” 42 C.F.R. § 1001.2 . 3. Detrimental to the Best Interests of Medicare In the final analysis, even if Ahmed’s felony conviction is somehow conceived as not expressly financial in nature, I am persuaded that his admitted obstruction of a criminal investigation of a health care…”

United States v. Divyesh Patel, 577 F. App'x 568 (6th Cir. 2014). · cites it 2× “Office of Inspector General – Health Care, Department of Health and Human Services, Program Integrity – Medicare and State Health Care Programs, 42 CFR § 1001.2 . 2 This equates to an increase in revenue from approximately $35,543 to $62,546 a month.”

Pennington v. Thompson, 249 F. Supp. 2d 931 (W.D. Tenn. 2003). “§§ 1320a—7(i)(l) and (3); 42 C.F.R. § 1001.2 . Exclusions imposed under § 1128(a) of the Act are for a minimum period of five years.”

Basem Abdulla Attum v. Xavier Becerra (C.D. Cal. 2023). · cites it 2× “) Among other things, the ALJ concluded that, “regardless 14 of the state court’s disposition of [Attum’s] criminal case, the record shows that 15 [Attum] was convicted within the meaning of 42 C.”

White v. Becerra (E.D. Wash. 2024). · cites it 2× “The provider, supplier, or any owner, managing 24 employee, managing organization, officer, or director of the provider or supplier was, within the preceding 10 years, convicted (as that term is 25 defined in 42 CFR 1001.2) of a Federal or State felony offense that CMS 26…”

Figueroa v. Dep't of Health & Human Servs. (M.D. Fla. 2025). · cites it 2× “§ 1320a-7(i)(1), (3); 42 C.F.R. § 1001.2 . An exclusion becomes effective “at such time and upon such reasonable notice to the public and to the individual or entity excluded as may be specified in regulations.”

Sunsites-Pearce Fire Dist. v. Azar (D. Ariz. 2020). “AR 659-60; 42 C.F.R. § 1001.2 . Because the 2015 version included pretrial 8 diversions and deferred adjudications, CMS found that Chief Steinberg’s participation in 9 2 In 2013, when the revised Application was first submitted, the regulations permitted revocation 10 of a…”

Ali v. U.S. Dep't of Health & Human Servs. (E.D. Mich. 2022). “§ 1320a-7(i)(1), (3); 42 C.F.R. § 1001.2 . The regulations provide that an exclusion takes effect twenty days after the date of the Inspector General’s notice of exclusion.”

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