---
kind: "range"
citation: "42 U.S.C. §§ 1320a–7–1320a–7e"
title: "42"
from: "1320a–7"
to: "1320a–7e"
count: 6
release: "119-102"
url: "https://uscodex.org/usc/42/1320a-7..1320a-7e"
---

# §1320a–7. Exclusion of certain individuals and entities from participation in Medicare and State health care programs

- (a) **Mandatory exclusion—** The [Secretary](/usc/42/1301.md?p=a-6) shall exclude the following individuals and entities from participation in any Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)):
  - (1) **Conviction of program-related crimes—** Any individual or entity that has been convicted of a criminal offense related to the delivery of an item or service under subchapter XVIII or under any [State health care program](#h).
  - (2) **Conviction relating to patient abuse—** Any individual or entity that has been convicted, under Federal or [State](/usc/42/1301.md?p=a-1) law, of a criminal offense relating to [neglect](/usc/42/1397j.md?p=16) or [abuse](/usc/42/1397j.md?p=1) of patients in connection with the delivery of a health care item or service.
  - (3) **Felony conviction relating to health care fraud—** Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or [State](/usc/42/1301.md?p=a-1) law, in connection with the delivery of a health care item or service or with respect to any act or omission in a health care [program](/usc/42/274l–1.md?p=4) (other than those specifically described in [paragraph (1)](#a-1)) operated by or financed in whole or in part by any Federal, [State](/usc/42/1301.md?p=a-1), or [local government](/usc/42/8401a.md) [agency](/usc/42/1397n–12.md?p=1), of a criminal offense consisting of a felony relating to fraud, theft, embezzlement, breach of [fiduciary](/usc/42/1397j.md?p=9) responsibility, or other financial misconduct.
  - (4) **Felony conviction relating to controlled substance—** Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or [State](/usc/42/1301.md?p=a-1) law, of a criminal offense consisting of a felony relating to the unlawful [manufacture](/usc/42/300aa–33.md?p=3), distribution, prescription, or dispensing of a [controlled substance](/usc/42/11851.md?p=2).
- (b) **Permissive exclusion—** The [Secretary](/usc/42/1301.md?p=a-6) may exclude the following individuals and entities from participation in any Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)):
  - (1) **Conviction relating to fraud—** Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or [State](/usc/42/1301.md?p=a-1) law—
    - (A) of a criminal offense consisting of a misdemeanor relating to fraud, theft, embezzlement, breach of [fiduciary](/usc/42/1397j.md?p=9) responsibility, or other financial misconduct—
      - (i) in connection with the delivery of a health care item or service, or
      - (ii) with respect to any act or omission in a health care [program](/usc/42/274l–1.md?p=4) (other than those specifically described in [subsection (a)(1)](#a-1)) operated by or financed in whole or in part by any Federal, [State](/usc/42/1301.md?p=a-1), or [local government](/usc/42/8401a.md) [agency](/usc/42/1397n–12.md?p=1); or
    - (B) of a criminal offense relating to fraud, theft, embezzlement, breach of [fiduciary](/usc/42/1397j.md?p=9) responsibility, or other financial misconduct with respect to any act or omission in a [program](/usc/42/274l–1.md?p=4) (other than a health care [program](/usc/42/274l–1.md?p=4)) operated by or financed in whole or in part by any Federal, [State](/usc/42/1301.md?p=a-1), or [local government](/usc/42/8401a.md) [agency](/usc/42/1397n–12.md?p=1).
  - (2) **Conviction relating to obstruction of an investigation or audit—** Any individual or entity that has been convicted, under Federal or [State](/usc/42/1301.md?p=a-1) law, in connection with the interference with or obstruction of any investigation or audit related to—
    - (i) any offense described in [paragraph (1)](#b-1) or in [subsection (a)](#a); or
    - (ii) the use of [funds](/usc/42/12854.md?p=3) received, directly or indirectly, from any Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)).
  - (3) **Misdemeanor conviction relating to controlled substance—** Any individual or entity that has been convicted, under Federal or [State](/usc/42/1301.md?p=a-1) law, of a criminal offense consisting of a misdemeanor relating to the unlawful [manufacture](/usc/42/300aa–33.md?p=3), distribution, prescription, or dispensing of a [controlled substance](/usc/42/11851.md?p=2).
  - (4) **License revocation or suspension—** Any individual or entity—
    - (A) whose license to provide health care has been revoked or suspended by any [State](/usc/42/1301.md?p=a-1) licensing authority, or who otherwise lost such a license or the right to apply for or renew such a license, for reasons bearing on the individual’s or entity’s professional competence, professional performance, or financial integrity, or
    - (B) who surrendered such a license while a formal disciplinary proceeding was pending before such an authority and the proceeding concerned the individual’s or entity’s professional competence, professional performance, or financial integrity.
  - (5) **Exclusion or suspension under Federal or State health care program—** Any individual or entity which has been suspended or excluded from participation, or otherwise sanctioned, under—
    - (A) any Federal [program](/usc/42/274l–1.md?p=4), [including](/usc/42/1301.md?p=b) [programs](/usc/42/274l–1.md?p=4) of the Department of Defense or the Department of Veterans Affairs, involving the provision of health care, or
    - (B) a [State health care program](#h),

    for reasons bearing on the individual’s or entity’s professional competence, professional performance, or financial integrity.

  - (6) **Claims for excessive charges or unnecessary services and failure of certain organizations to furnish medically necessary services—** Any individual or entity that the [Secretary](/usc/42/1301.md?p=a-6) determines—
    - (A) has submitted or caused to be submitted bills or requests for payment (where such bills or requests are based on charges or cost) under subchapter XVIII or a [State health care program](#h) containing charges (or, in applicable cases, requests for payment of costs) for items or services furnished substantially in excess of such individual’s or entity’s usual charges (or, in applicable cases, substantially in excess of such individual’s or entity’s costs) for such items or services, unless the [Secretary](/usc/42/1301.md?p=a-6) finds there is good [cause](/usc/42/9908.md?p=c-2) for such bills or requests containing such charges or costs;
    - (B) has furnished or caused to be furnished items or services to patients (whether or not eligible for benefits under subchapter XVIII or under a [State health care program](#h)) substantially in excess of the needs of such patients or of a quality which fails to meet professionally recognized [standards](/usc/42/1320d.md?p=7) of health care;
    - (C) is—
      - (i) a health maintenance organization (as defined in [section 1396b(m) of this title](/usc/42/1396b.md?p=m)) providing items and services under a [State](/usc/42/1301.md?p=a-1) plan approved under subchapter XIX, or
      - (ii) an entity furnishing services under a waiver approved under [section 1396n(b)(1) of this title](/usc/42/1396n.md?p=b-1),

      and has failed substantially to provide medically necessary items and services that are required (under law or the contract with the [State](/usc/42/1301.md?p=a-1) under subchapter XIX) to be provided to individuals covered under that plan or waiver, if the failure has adversely affected (or has a substantial likelihood of adversely affecting) these individuals; or

    - (D) is an entity providing items and services as an eligible organization under a risk-sharing contract under [section 1395mm of this title](/usc/42/1395mm.md) and has failed substantially to provide medically necessary items and services that are required (under law or such contract) to be provided to individuals covered under the risk-sharing contract, if the failure has adversely affected (or has a substantial likelihood of adversely affecting) these individuals.
  - (7) **Fraud, kickbacks, and other prohibited activities—** Any individual or entity that the [Secretary](/usc/42/1301.md?p=a-6) determines has committed an act which is described in section [1320a–7a](/usc/42/1320a–7a.md), [1320a–7b](/usc/42/1320a–7b.md), or [1320a–8](/usc/42/1320a–8.md) of this title.
  - (8) **Entities controlled by a sanctioned individual—** Any entity with respect to which the [Secretary](/usc/42/1301.md?p=a-6) determines that a [person](/usc/42/1301.md?p=a-3)—
    - (A)
      - (i) who has a direct or indirect ownership or control interest of 5 percent or more in the entity or with an ownership or control interest (as defined in [section 1320a–3(a)(3) of this title](/usc/42/1320a–3.md?p=a-3)) in that entity,
      - (ii) who is an officer, [director](/usc/42/5061.md?p=1), agent, or [managing employee](/usc/42/1320a–3a.md?p=d-2) (as defined in [section 1320a–5(b) of this title](/usc/42/1320a–5.md?p=b)) of that entity; or
      - (iii) who was described in [clause (i)](#b-8-A-i) but is no longer so described because of a transfer of ownership or control interest, in anticipation of (or following) a conviction, assessment, or exclusion described in [subparagraph (B)](#b-8-B) against the [person](/usc/42/1301.md?p=a-3), to an [immediate family member](#j-1) (as defined in [subsection (j)(1)](#j-1)) or a [member of the household](#j-2) of the [person](/usc/42/1301.md?p=a-3) (as defined in [subsection (j)(2)](#j-2)) who continues to maintain an interest described in such clause—

    is a [person](/usc/42/1301.md?p=a-3)—

    - (B)
      - (i) who has been convicted of any offense described in [subsection (a)](#a) or in paragraph (1), (2), or (3) of this subsection;
      - (ii) against whom a civil monetary penalty has been assessed under section [1320a–7a](/usc/42/1320a–7a.md) or [1320a–8](/usc/42/1320a–8.md) of this title; or
      - (iii) who has been excluded from participation under a [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or under a [State health care program](#h).
  - (9) **Failure to disclose required information—** Any entity that did not fully and accurately make any disclosure required by [section 1320a–3 of this title](/usc/42/1320a–3.md), [section 1320a–3a of this title](/usc/42/1320a–3a.md), or [section 1320a–5 of this title](/usc/42/1320a–5.md).
  - (10) **Failure to supply requested information on subcontractors and suppliers—** Any disclosing entity (as defined in [section 1320a–3(a)(2) of this title](/usc/42/1320a–3.md?p=a-2)) that fails to supply (within such period as may be specified by the [Secretary](/usc/42/1301.md?p=a-6) in regulations) upon request specifically addressed to the entity by the [Secretary](/usc/42/1301.md?p=a-6) or by the [State agency](/usc/42/1320a–7a.md?p=i-1) administering or supervising the [administration](/usc/42/1301.md?p=a-10) of a [State health care program](#h)—
    - (A) full and complete information as to the ownership of a subcontractor (as defined by the [Secretary](/usc/42/1301.md?p=a-6) in regulations) with whom the entity has had, during the previous 12 months, business transactions in an aggregate amount in excess of $25,000, or
    - (B) full and complete information as to any significant business transactions (as defined by the [Secretary](/usc/42/1301.md?p=a-6) in regulations), occurring during the five-year period ending on the date of such request, between the entity and any wholly owned [supplier](/usc/42/1395cc–4.md?p=a-2-I) or between the entity and any subcontractor.
  - (11) **Failure to supply payment information—** Any individual or entity furnishing, ordering, referring for furnishing, or certifying the need for items or services for which payment may be made under subchapter XVIII or a [State health care program](#h) that fails to provide such information as the [Secretary](/usc/42/1301.md?p=a-6) or the appropriate [State agency](/usc/42/1320a–7a.md?p=i-1) finds necessary to determine whether such payments are or were due and the amounts thereof, or has refused to permit such examination of its records by or on behalf of the [Secretary](/usc/42/1301.md?p=a-6) or that [agency](/usc/42/1397n–12.md?p=1) as may be necessary to verify such information.
  - (12) **Failure to grant immediate access—** Any individual or entity that fails to [grant](/usc/42/1397j.md?p=10) immediate access, upon reasonable request (as defined by the [Secretary](/usc/42/1301.md?p=a-6) in regulations) to any of the following:
    - (A) To the [Secretary](/usc/42/1301.md?p=a-6), or to the [agency](/usc/42/1397n–12.md?p=1) used by the [Secretary](/usc/42/1301.md?p=a-6), for the purpose specified in the first sentence of [section 1395aa(a) of this title](/usc/42/1395aa.md?p=a) (relating to compliance with conditions of participation or payment).
    - (B) To the [Secretary](/usc/42/1301.md?p=a-6) or the [State agency](/usc/42/1320a–7a.md?p=i-1), to perform the reviews and surveys required under [State](/usc/42/1301.md?p=a-1) plans under paragraphs (26), (31), and (33) of [section 1396a(a) of this title](/usc/42/1396a.md?p=a) and under [section 1396b(g) of this title](/usc/42/1396b.md?p=g).
    - (C) To the Inspector General of the Department of Health and Human Services, for the purpose of reviewing records, documents, and other data necessary to the performance of the statutory functions of the Inspector General.
    - (D) To a [State](/usc/42/1301.md?p=a-1) medicaid fraud control [unit](/usc/42/1395w–114b.md?p=g-2) (as defined in [section 1396b(q) of this title](/usc/42/1396b.md?p=q)), for the purpose of conducting activities described in that section.
  - (13) **Failure to take corrective action—** Any [hospital](/usc/42/1395dd.md?p=e-5) that fails to comply substantially with a corrective action required under [section 1395ww(f)(2)(B) of this title](/usc/42/1395ww.md?p=f-2-B).
  - (14) **Default on health education loan or scholarship obligations—** Any individual who the [Secretary](/usc/42/1301.md?p=a-6) determines is in default on repayments of scholarship obligations or loans in connection with health professions education made or secured, in whole or in part, by the [Secretary](/usc/42/1301.md?p=a-6) and with respect to whom the [Secretary](/usc/42/1301.md?p=a-6) has taken all reasonable steps available to the [Secretary](/usc/42/1301.md?p=a-6) to secure repayment of such obligations or loans, except that (A) the [Secretary](/usc/42/1301.md?p=a-6) shall not exclude pursuant to this paragraph a [physician](/usc/42/1301.md?p=a-7) who is the sole community [physician](/usc/42/1301.md?p=a-7) or sole source of essential specialized services in a community if a [State](/usc/42/1301.md?p=a-1) requests that the [physician](/usc/42/1301.md?p=a-7) not be excluded, and (B) the [Secretary](/usc/42/1301.md?p=a-6) shall take into account, in determining whether to exclude any other [physician](/usc/42/1301.md?p=a-7) pursuant to this paragraph, access of beneficiaries to [physician](/usc/42/1301.md?p=a-7) services for which payment may be made under subchapter XVIII or XIX.
  - (15) **Individuals controlling a sanctioned entity—**
    - (A) Any individual—
      - (i) who has a direct or indirect ownership or control interest in a [sanctioned entity](#b-15-B) and who knows or should know (as defined in [section 1320a–7a(i)(6)](/usc/42/1320a–7a.md?p=i-6)[^1] of this title) of the action constituting the basis for the conviction or exclusion described in [subparagraph (B)](#b-15-B); or
      - (ii) who is an officer or [managing employee](/usc/42/1320a–3a.md?p=d-2) (as defined in [section 1320a–5(b) of this title](/usc/42/1320a–5.md?p=b)) of such an entity.
    - (B) For purposes of [subparagraph (A)](#b-15-A), the term “sanctioned entity” means an entity—
      - (i) that has been convicted of any offense described in [subsection (a)](#a) or in paragraph (1), (2), or (3) of this subsection; or
      - (ii) that has been excluded from participation under a [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or under a [State health care program](#h).
  - (16) **Making false statements or misrepresentation of material facts—** Any individual or entity that knowingly makes or [causes](/usc/42/9908.md?p=c-2) to be made any false statement, omission, or misrepresentation of a material fact in any application, [agreement](/usc/42/1320b–8.md?p=a-3-A), bid, or contract to participate or enroll as a [provider of services](/usc/42/1395n.md?p=a-2) or [supplier](/usc/42/1395cc–4.md?p=a-2-I) under a Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)), [including](/usc/42/1301.md?p=b) Medicare Advantage organizations under part C of subchapter XVIII, [prescription drug plan](/usc/42/1395w–154.md?p=d-2) sponsors under part D of subchapter XVIII, [medicaid managed care organizations](/usc/42/1396b.md?p=m-1-A) under subchapter XIX, and entities that apply to participate as providers of services or [suppliers](/usc/42/1395cc–4.md?p=a-2-I) in such managed care organizations and such plans.
  - (17) **Knowingly misclassifying covered outpatient drugs—** Any [manufacturer](/usc/42/300aa–33.md?p=3) or officer, [director](/usc/42/5061.md?p=1), agent, or [managing employee](/usc/42/1320a–3a.md?p=d-2) of such [manufacturer](/usc/42/300aa–33.md?p=3) that knowingly misclassifies a covered outpatient [drug](/usc/42/282.md?p=j-1-A-vii) under an [agreement](/usc/42/1320b–8.md?p=a-3-A) under [section 1396r–8 of this title](/usc/42/1396r–8.md), knowingly fails to correct such misclassification, or knowingly provides false information related to [drug](/usc/42/282.md?p=j-1-A-vii) pricing, [drug](/usc/42/282.md?p=j-1-A-vii) product information, or data related to [drug](/usc/42/282.md?p=j-1-A-vii) pricing or [drug](/usc/42/282.md?p=j-1-A-vii) product information.
- (c) **Notice, effective date, and period of exclusion—**
  - (1) An exclusion under this section or under [section 1320a–7a of this title](/usc/42/1320a–7a.md) shall be 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 consistent with [paragraph (2)](#c-2).
  - (2)
    - (A) Except as provided in [subparagraph (B)](#c-2-B), such an exclusion shall be effective with respect to services furnished to an individual on or after the effective date of the exclusion.
    - (B) Unless the [Secretary](/usc/42/1301.md?p=a-6) determines that the health and safety of individuals receiving services warrants the exclusion taking effect earlier, an exclusion shall not apply to payments made under subchapter XVIII or under a [State health care program](#h) for—
      - (i) inpatient institutional services furnished to an individual who was admitted to such institution before the date of the exclusion, or
      - (ii) home health services and [hospice care](/usc/42/1396d.md?p=o-1-A) furnished to an individual under a plan of care established before the date of the exclusion,

      until the passage of 30 days after the effective date of the exclusion.

  - (3)
    - (A) The [Secretary](/usc/42/1301.md?p=a-6) shall specify, in the notice of exclusion under [paragraph (1)](#c-1) and the written notice under [section 1320a–7a of this title](/usc/42/1320a–7a.md), the minimum period (or, in the case of an exclusion of an individual under [subsection (b)(12)](#b-12) or in the case described in [subparagraph (G)](#c-3-G), the period) of the exclusion.
    - (B) Subject to [subparagraph (G)](#c-3-G), in the case of an exclusion under [subsection (a)](#a), the minimum period of exclusion shall be not less than five years, except that, upon the request of the [administrator](/usc/42/4005.md?p=1) of a Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)) who determines that the exclusion would impose a hardship on beneficiaries (as defined in [section 1320a–7a(i)(5) of this title](/usc/42/1320a–7a.md?p=i-5)) of that [program](/usc/42/274l–1.md?p=4), the [Secretary](/usc/42/1301.md?p=a-6) may, after consulting with the Inspector General of the Department of Health and Human Services, waive the exclusion under subsection [(a)(1)](#a-1), [(a)(3)](#a-3), or [(a)(4)](#a-4) with respect to that [program](/usc/42/274l–1.md?p=4) in the case of an individual or entity that is the sole community [physician](/usc/42/1301.md?p=a-7) or sole source of essential specialized services in a community. The [Secretary](/usc/42/1301.md?p=a-6)’s decision whether to waive the exclusion shall not be reviewable.
    - (C) In the case of an exclusion of an individual under [subsection (b)(12)](#b-12), the period of the exclusion shall be equal to the sum of—
      - (i) the length of the period in which the individual failed to [grant](/usc/42/1397j.md?p=10) the immediate access described in that subsection, and
      - (ii) an additional period, not to exceed 90 days, set by the [Secretary](/usc/42/1301.md?p=a-6).
    - (D) Subject to [subparagraph (G)](#c-3-G), in the case of an exclusion of an individual or entity under paragraph [(1)](#b-1), [(2)](#b-2), or [(3)](#b-3) of subsection (b), the period of the exclusion shall be 3 years, unless the [Secretary](/usc/42/1301.md?p=a-6) determines in accordance with published regulations that a shorter period is appropriate because of mitigating circumstances or that a longer period is appropriate because of aggravating circumstances.
    - (E) In the case of an exclusion of an individual or entity under subsection [(b)(4)](#b-4) or [(b)(5)](#b-5), the period of the exclusion shall not be less than the period during which the individual’s or entity’s license to provide health care is revoked, suspended, or surrendered, or the individual or the entity is excluded or suspended from a Federal or [State health care program](#h).
    - (F) In the case of an exclusion of an individual or entity under [subsection (b)(6)(B)](#b-6-B), the period of the exclusion shall be not less than 1 year.
    - (G) In the case of an exclusion of an individual under [subsection (a)](#a) based on a conviction occurring on or after August 5, 1997, if the individual has (before, on, or after August 5, 1997) been convicted—
      - (i) on one previous occasion of one or more offenses for which an exclusion may be effected under such subsection, the period of the exclusion shall be not less than 10 years, or
      - (ii) on 2 or more previous occasions of one or more offenses for which an exclusion may be effected under such subsection, the period of the exclusion shall be permanent.
- (d) **Notice to State agencies and exclusion under State health care programs—**
  - (1) Subject to [paragraph (3)](#d-3), the [Secretary](/usc/42/1301.md?p=a-6) shall exercise the authority under this section and [section 1320a–7a of this title](/usc/42/1320a–7a.md) in a manner that results in an individual’s or entity’s exclusion from all the [programs](/usc/42/274l–1.md?p=4) under subchapter XVIII and all the [State health care programs](#h) in which the individual or entity may otherwise participate.
  - (2) The [Secretary](/usc/42/1301.md?p=a-6) shall promptly notify each appropriate [State agency](/usc/42/1320a–7a.md?p=i-1) administering or supervising the [administration](/usc/42/1301.md?p=a-10) of each [State health care program](#h) (and, in the case of an exclusion effected pursuant to [subsection (a)](#a) and to which [section 824(a)(5) of title 21](/usc/21/824.md?p=a-5) may apply, the [Attorney General](/usc/42/14902.md?p=6))—
    - (A) of the fact and circumstances of each exclusion effected against an individual or entity under this section or [section 1320a–7a of this title](/usc/42/1320a–7a.md), and
    - (B) of the period (described in [paragraph (3)](#d-3)) for which the [State agency](/usc/42/1320a–7a.md?p=i-1) is directed to exclude the individual or entity from participation in the [State health care program](#h).
  - (3)
    - (A) Except as provided in [subparagraph (B)](#d-3-B), the period of the exclusion under a [State health care program](#h) under [paragraph (2)](#d-2) shall be the same as any period of exclusion under subchapter XVIII.
    - (B)
      - (i) The [Secretary](/usc/42/1301.md?p=a-6) may waive an individual’s or entity’s exclusion under a [State health care program](#h) under [paragraph (2)](#d-2) if the [Secretary](/usc/42/1301.md?p=a-6) receives and approves a request for the waiver with respect to the individual or entity from the [State agency](/usc/42/1320a–7a.md?p=i-1) administering or supervising the [administration](/usc/42/1301.md?p=a-10) of the [program](/usc/42/274l–1.md?p=4).
      - (ii) A [State health care program](#h) may provide for a period of exclusion which is longer than the period of exclusion under subchapter XVIII.
- (e) **Notice to State licensing agencies—** The [Secretary](/usc/42/1301.md?p=a-6) shall—
  - (1) promptly notify the appropriate [State](/usc/42/1301.md?p=a-1) or local [agency](/usc/42/1397n–12.md?p=1) or authority having responsibility for the licensing or certification of an individual or entity excluded (or directed to be excluded) from participation under this section or [section 1320a–7a of this title](/usc/42/1320a–7a.md), of the fact and circumstances of the exclusion,
  - (2) request that appropriate investigations be made and sanctions invoked in accordance with applicable [State](/usc/42/1301.md?p=a-1) law and policy, and
  - (3) request that the [State](/usc/42/1301.md?p=a-1) or local [agency](/usc/42/1397n–12.md?p=1) or authority keep the [Secretary](/usc/42/1301.md?p=a-6) and the Inspector General of the Department of Health and Human Services fully and currently informed with respect to any actions taken in response to the request.
- (f) **Notice, hearing, and judicial review—**
  - (1) Subject to [paragraph (2)](#f-2), any individual or entity that is excluded (or directed to be excluded) from participation under this section is entitled to reasonable notice and opportunity for a hearing thereon by the [Secretary](/usc/42/1301.md?p=a-6) to the same extent as is provided in [section 405(b) of this title](/usc/42/405.md?p=b), and to judicial review of the [Secretary](/usc/42/1301.md?p=a-6)’s final decision after such hearing as is provided in [section 405(g) of this title](/usc/42/405.md?p=g), except that, in so applying such sections and [section 405(l)](/usc/42/405.md?p=l) of this title, any reference therein to the [Commissioner](/usc/42/12302.md?p=1) of [Social](/usc/42/1397j.md?p=20) Security or the [Social](/usc/42/1397j.md?p=20) Security [Administration](/usc/42/1301.md?p=a-10) shall be considered a reference to the [Secretary](/usc/42/1301.md?p=a-6) or the Department of Health and Human Services, respectively.
  - (2) Unless the [Secretary](/usc/42/1301.md?p=a-6) determines that the health or safety of individuals receiving services warrants the exclusion taking effect earlier, any individual or entity that is the subject of an adverse determination under [subsection (b)(7)](#b-7) shall be entitled to a hearing by an administrative law judge (as provided under [section 405(b) of this title](/usc/42/405.md?p=b)) on the determination under [subsection (b)(7)](#b-7) before any exclusion based upon the determination takes effect.
  - (3) The provisions of [section 405(h) of this title](/usc/42/405.md?p=h) shall apply with respect to this section and sections [1320a–7a](/usc/42/1320a–7a.md), [1320a–8](/usc/42/1320a–8.md), and [1320c–5](/usc/42/1320c–5.md) of this title to the same extent as it is applicable with respect to subchapter II, except that, in so applying such section and [section 405(l)](/usc/42/405.md?p=l) of this title, any reference therein to the [Commissioner](/usc/42/12302.md?p=1) of [Social](/usc/42/1397j.md?p=20) Security shall be considered a reference to the [Secretary](/usc/42/1301.md?p=a-6).
  - (4) The provisions of subsections (d) and (e) of [section 405 of this title](/usc/42/405.md) shall apply with respect to this section to the same extent as they are applicable with respect to subchapter II. The [Secretary](/usc/42/1301.md?p=a-6) may delegate the authority granted by [section 405(d) of this title](/usc/42/405.md?p=d) (as made applicable to this section) to the Inspector General of the Department of Health and Human Services for purposes of any investigation under this section.
- (g) **Application for termination of exclusion—**
  - (1) An individual or entity excluded (or directed to be excluded) from participation under this section or [section 1320a–7a of this title](/usc/42/1320a–7a.md) may apply to the [Secretary](/usc/42/1301.md?p=a-6), in the manner specified by the [Secretary](/usc/42/1301.md?p=a-6) in regulations and at the end of the minimum period of exclusion provided under [subsection (c)(3)](#c-3) and at such other times as the [Secretary](/usc/42/1301.md?p=a-6) may provide, for termination of the exclusion effected under this section or [section 1320a–7a of this title](/usc/42/1320a–7a.md).
  - (2) The [Secretary](/usc/42/1301.md?p=a-6) may terminate the exclusion if the [Secretary](/usc/42/1301.md?p=a-6) determines, on the basis of the conduct of the applicant which occurred after the date of the notice of exclusion or which was unknown to the [Secretary](/usc/42/1301.md?p=a-6) at the time of the exclusion, that—
    - (A) there is no basis under subsection [(a)](#a) or [(b)](#b) or [section 1320a–7a(a) of this title](/usc/42/1320a–7a.md?p=a) for a continuation of the exclusion, and
    - (B) there are reasonable assurances that the types of actions which formed the basis for the original exclusion have not recurred and will not recur.
  - (3) The [Secretary](/usc/42/1301.md?p=a-6) shall promptly notify each appropriate [State agency](/usc/42/1320a–7a.md?p=i-1) administering or supervising the [administration](/usc/42/1301.md?p=a-10) of each [State health care program](#h) (and, in the case of an exclusion effected pursuant to [subsection (a)](#a) and to which [section 824(a)(5) of title 21](/usc/21/824.md?p=a-5) may apply, the [Attorney General](/usc/42/14902.md?p=6)) of the fact and circumstances of each termination of exclusion made under this subsection.
- (h) **“State health care program” defined—** For purposes of this section and sections [1320a–7a](/usc/42/1320a–7a.md) and [1320a–7b](/usc/42/1320a–7b.md) of this title, the term “State health care program” means—
  - (1) a [State](/usc/42/1301.md?p=a-1) plan approved under subchapter XIX,
  - (2) any [program](/usc/42/274l–1.md?p=4) receiving [funds](/usc/42/12854.md?p=3) under subchapter V or from an allotment to a [State](/usc/42/1301.md?p=a-1) under such subchapter,
  - (3) any [program](/usc/42/274l–1.md?p=4) receiving [funds](/usc/42/12854.md?p=3) under division A[^2] of subchapter XX or from an allotment to a [State](/usc/42/1301.md?p=a-1) under such division, or
  - (4) a [State child health plan](/usc/42/1397jj.md?p=c-7) approved under subchapter XXI.
- (i) **“Convicted” defined—** For purposes of subsections [(a)](#a) and [(b)](#b), an individual or entity is considered to have been “convicted” of a criminal offense—
  - (1) when a judgment of conviction has been entered against the individual or entity by a Federal, [State](/usc/42/1301.md?p=a-1), or local court, regardless of whether there is an appeal pending or whether the judgment of conviction or other record relating to criminal conduct has been expunged;
  - (2) when there has been a finding of guilt against the individual or entity by a Federal, [State](/usc/42/1301.md?p=a-1), or local court;
  - (3) when a plea of guilty or nolo contendere by the individual or entity has been accepted by a Federal, [State](/usc/42/1301.md?p=a-1), or local court; or
  - (4) when the individual or entity has entered into participation in a first offender, deferred adjudication, or other arrangement or [program](/usc/42/274l–1.md?p=4) where judgment of conviction has been withheld.
- (j) **Definition of immediate family member and member of household—** For purposes of [subsection (b)(8)(A)(iii)](#b-8-A-iii):
  - (1) The term “immediate family member” means, with respect to a [person](/usc/42/1301.md?p=a-3)—
    - (A) the [husband](/usc/42/416.md?p=f) or [wife](/usc/42/416.md?p=b) of the [person](/usc/42/1301.md?p=a-3);
    - (B) the natural or adoptive [parent](/usc/42/1396a.md?p=k-3), [child](/usc/42/416.md?p=e), or sibling of the [person](/usc/42/1301.md?p=a-3);
    - (C) the stepparent, stepchild, stepbrother, or stepsister of the [person](/usc/42/1301.md?p=a-3);
    - (D) the father-, mother-, daughter-, son-, brother-, or sister-in-law of the [person](/usc/42/1301.md?p=a-3);
    - (E) the grandparent or grandchild of the [person](/usc/42/1301.md?p=a-3); and
    - (F) the spouse of a grandparent or grandchild of the [person](/usc/42/1301.md?p=a-3).
  - (2) The term “member of the household” means, with respect to any [person](/usc/42/1301.md?p=a-3), any individual sharing a common abode as part of a [single family](/usc/42/2304.md?p=m) [unit](/usc/42/1395w–114b.md?p=g-2) with the [person](/usc/42/1301.md?p=a-3), [including](/usc/42/1301.md?p=b) domestic [employees](/usc/42/1320a–7h.md?p=e-7) and others who live together as a [family](/usc/42/290ff–4.md?p=d-2) [unit](/usc/42/1395w–114b.md?p=g-2), but not [including](/usc/42/1301.md?p=b) a roomer or boarder.

# §1320a–7a. Civil monetary penalties

- (a) **Improperly filed claims—** Any [person](/usc/42/1301.md?p=a-3) ([including](/usc/42/1301.md?p=b) an organization, [agency](/usc/42/1397n–12.md?p=1), or other entity, but excluding a [beneficiary](#i-5), as defined in [subsection (i)(5)](#i-5)) that—
  - (1) knowingly presents or [causes](/usc/42/9908.md?p=c-2) to be presented to an officer, [employee](/usc/42/1320a–7h.md?p=e-7), or agent of the [United States](/usc/42/1301.md?p=a-2), or of any department or [agency](/usc/42/1397n–12.md?p=1) thereof, or of any [State agency](#i-1) (as defined in [subsection (i)(1)](#i-1)), a [claim](#i-2) (as defined in [subsection (i)(2)](#i-2)) that the [Secretary](/usc/42/1301.md?p=a-6) determines—
    - (A) is for a medical or other [item or service](#i-3) that the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) was not provided as claimed, [including](/usc/42/1301.md?p=b) any [person](/usc/42/1301.md?p=a-3) who engages in a pattern or practice of presenting or causing to be presented a [claim](#i-2) for an [item or service](#i-3) that is based on a code that the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) will result in a greater payment to the [person](/usc/42/1301.md?p=a-3) than the code the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) is applicable to the [item or service](#i-3) actually provided,
    - (B) is for a medical or other [item or service](#i-3) and the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) the [claim](#i-2) is false or fraudulent,
    - (C) is presented for a [physician](/usc/42/1301.md?p=a-7)’s service (or an [item or service](#i-3) incident to a [physician](/usc/42/1301.md?p=a-7)’s service) by a [person](/usc/42/1301.md?p=a-3) who knows or [should know](#i-7) that the individual who furnished (or supervised the furnishing of) the service—
      - (i) was not licensed as a [physician](/usc/42/1301.md?p=a-7),
      - (ii) was licensed as a [physician](/usc/42/1301.md?p=a-7), but such license had been obtained through a misrepresentation of material fact ([including](/usc/42/1301.md?p=b) cheating on an examination required for licensing), or
      - (iii) represented to the patient at the time the service was furnished that the [physician](/usc/42/1301.md?p=a-7) was certified in a medical specialty by a medical specialty [board](/usc/42/10261.md?p=2) when the individual was not so certified,
    - (D) is for a medical or other [item or service](#i-3) furnished during a period in which the [person](/usc/42/1301.md?p=a-3) was excluded from the Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)) under which the [claim](#i-2) was made pursuant to Federal law.[^1]
    - (E) is for a pattern of medical or other items or services that a [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) are not medically necessary;
  - (2) knowingly presents or [causes](/usc/42/9908.md?p=c-2) to be presented to any [person](/usc/42/1301.md?p=a-3) a request for payment which is in [violation](/usc/42/2000e–16a.md?p=c) of the terms of (A) an assignment under [section 1395u(b)(3)(B)(ii) of this title](/usc/42/1395u.md?p=b-3-B-ii), or (B) an [agreement](/usc/42/1320b–8.md?p=a-3-A) with a [State agency](#i-1) (or other requirement of a [State](/usc/42/1301.md?p=a-1) plan under subchapter XIX) not to charge a [person](/usc/42/1301.md?p=a-3) for an [item or service](#i-3) in excess of the amount permitted to be charged, or (C) an [agreement](/usc/42/1320b–8.md?p=a-3-A) to be a participating [physician](/usc/42/1301.md?p=a-7) or [supplier](/usc/42/1395cc–4.md?p=a-2-I) under [section 1395u(h)(1) of this title](/usc/42/1395u.md?p=h-1), or (D) an [agreement](/usc/42/1320b–8.md?p=a-3-A) pursuant to [section 1395cc(a)(1)(G) of this title](/usc/42/1395cc.md?p=a-1-G);
  - (3) knowingly gives or [causes](/usc/42/9908.md?p=c-2) to be given to any [person](/usc/42/1301.md?p=a-3), with respect to coverage under subchapter XVIII of inpatient [hospital](/usc/42/1395dd.md?p=e-5) services subject to the provisions of [section 1395ww of this title](/usc/42/1395ww.md), information that he knows or [should know](#i-7) is false or misleading, and that could reasonably be expected to influence the decision when to discharge such [person](/usc/42/1301.md?p=a-3) or another individual from the [hospital](/usc/42/1395dd.md?p=e-5);
  - (4) in the case of a [person](/usc/42/1301.md?p=a-3) who is not an organization, [agency](/usc/42/1397n–12.md?p=1), or other entity, is excluded from participating in a [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4) in accordance with this subsection or under [section 1320a–7 of this title](/usc/42/1320a–7.md) and who, at the time of a [violation](/usc/42/2000e–16a.md?p=c) of this subsection—
    - (A) retains a direct or indirect ownership or control interest in an entity that is participating in a [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4), and who knows or [should know](#i-7) of the action constituting the basis for the exclusion; or
    - (B) is an officer or [managing employee](/usc/42/1320a–3a.md?p=d-2) (as defined in [section 1320a–5(b) of this title](/usc/42/1320a–5.md?p=b)) of such an entity;
  - (5) offers to or transfers [remuneration](#i-6) to any individual eligible for benefits under subchapter XVIII of this chapter, or under a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7(h) of this title](/usc/42/1320a–7.md?p=h)) that such [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) is likely to influence such individual to order or receive from a particular provider, [practitioner](/usc/42/1395a.md?p=b-6-C), or [supplier](/usc/42/1395cc–4.md?p=a-2-I) any [item or service](#i-3) for which payment may be made, in whole or in part, under subchapter XVIII, or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4) (as so defined);
  - (6) arranges or contracts (by employment or otherwise) with an individual or entity that the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) is excluded from participation in a Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)), for the provision of items or services for which payment may be made under such a [program](/usc/42/274l–1.md?p=4);
  - (7) commits an act described in paragraph (1) or (2) of [section 1320a–7b(b) of this title](/usc/42/1320a–7b.md?p=b);
  - (8) [^2] knowingly makes, uses, or [causes](/usc/42/9908.md?p=c-2) to be made or used, a false record or statement material to a false or fraudulent [claim](#i-2) for payment for items and services furnished under a Federal health care [program](/usc/42/274l–1.md?p=4); or[^3]
  - (9) [^4] fails to [grant](/usc/42/1397j.md?p=10) timely access, upon reasonable request (as defined by the [Secretary](/usc/42/1301.md?p=a-6) in regulations), to the Inspector General of the Department of Health and Human Services, for the purpose of audits, investigations, evaluations, or other statutory functions of the Inspector General of the Department of Health and Human Services;
  - (8) [^2] orders or prescribes a medical or other [item or service](#i-3) during a period in which the [person](/usc/42/1301.md?p=a-3) was excluded from a Federal health care [program](/usc/42/274l–1.md?p=4) (as so defined), in the case where the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) that a [claim](#i-2) for such medical or other [item or service](#i-3) will be made under such a [program](/usc/42/274l–1.md?p=4);
  - (9) [^4] knowingly makes or [causes](/usc/42/9908.md?p=c-2) to be made any false statement, omission, or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a [provider of services](/usc/42/1395n.md?p=a-2) or a [supplier](/usc/42/1395cc–4.md?p=a-2-I) under a Federal health care [program](/usc/42/274l–1.md?p=4) (as so defined), [including](/usc/42/1301.md?p=b) Medicare Advantage organizations under part C of subchapter XVIII, [prescription drug plan](/usc/42/1395w–154.md?p=d-2) sponsors under part D of subchapter XVIII, [medicaid managed care organizations](/usc/42/1396b.md?p=m-1-A) under subchapter XIX, and entities that apply to participate as providers of services or [suppliers](/usc/42/1395cc–4.md?p=a-2-I) in such managed care organizations and such plans;[^5]
  - (10) knows of an overpayment (as defined in paragraph (4) of [section 1320a–7k(d) of this title](/usc/42/1320a–7k.md?p=d)) and does not report and return the overpayment in accordance with such section;

  shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty of not more than $20,000 for each [item or service](#i-3) (or, in cases under [paragraph (3)](#a-3), $30,000 for each individual with respect to whom false or misleading information was given; in cases under [paragraph (4)](#a-4), $20,000 for each day the prohibited relationship occurs; in cases under [paragraph (7)](#a-7), $100,000 for each such act,[^6] in cases under [paragraph (8)](#a-8),[^7] $100,000 for each false record or statement,[^6] or[^3] in cases under [paragraph (9)](#a-9),[^8] $15,000 for each day of the failure described in such paragraph);[^9] or in cases under [paragraph (9)](#a-9),[^10] $100,000 for each false statement or misrepresentation of a material fact). In addition, such a [person](/usc/42/1301.md?p=a-3) shall be subject to an assessment of not more than 3 times the amount claimed for each such [item or service](#i-3) in lieu of [damages](/usc/42/9601.md?p=6) sustained by the [United States](/usc/42/1301.md?p=a-2) or a [State agency](#i-1) because of such [claim](#i-2) (or, in cases under [paragraph (7)](#a-7), [damages](/usc/42/9601.md?p=6) of not more than 3 times the total amount of [remuneration](#i-6) offered, paid, solicited, or received, without regard to whether a portion of such [remuneration](#i-6) was offered, paid, solicited, or received for a lawful purpose; or in cases under [paragraph (9)](#a-9), an assessment of not more than 3 times the total amount claimed for each [item or service](#i-3) for which payment was made based upon the application containing the false statement or misrepresentation of a material fact). In addition the [Secretary](/usc/42/1301.md?p=a-6) may make a determination in the same proceeding to exclude the [person](/usc/42/1301.md?p=a-3) from participation in the Federal health care [programs](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f)(1) of this title](/usc/42/1320a–7b.md?p=f-1)) and to direct the appropriate [State agency](#i-1) to exclude the [person](/usc/42/1301.md?p=a-3) from participation in any [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4).

- (b) **Payments to induce reduction or limitation of services—**
  - (1) If a [hospital](/usc/42/1395dd.md?p=e-5) or a [critical access hospital](/usc/42/1395x.md?p=mm-1) knowingly makes a payment, directly or indirectly, to a [physician](/usc/42/1301.md?p=a-7) as an inducement to reduce or limit medically necessary services provided with respect to individuals who—
    - (A) are entitled to benefits under part A or part B of subchapter XVIII or to medical assistance under a [State](/usc/42/1301.md?p=a-1) plan approved under subchapter XIX, and
    - (B) are under the [direct care](/usc/42/1397j.md?p=4) of the [physician](/usc/42/1301.md?p=a-7),

    the [hospital](/usc/42/1395dd.md?p=e-5) or a [critical access hospital](/usc/42/1395x.md?p=mm-1) shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty of not more than $5,000 for each such individual with respect to whom the payment is made.

  - (2) Any [physician](/usc/42/1301.md?p=a-7) who knowingly accepts receipt of a payment described in [paragraph (1)](#b-1) shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty of not more than $5,000 for each individual described in such paragraph with respect to whom the payment is made.
  - (3)
    - (A) Any [physician](/usc/42/1301.md?p=a-7) who executes a document described in [subparagraph (B)](#b-3-B) with respect to an individual knowing that all of the requirements referred to in such subparagraph are not met with respect to the individual shall be subject to a civil monetary penalty of not more than the greater of—
      - (i) $10,000, or
      - (ii) three times the amount of the payments under subchapter XVIII for home health services which are made pursuant to such certification.
    - (B) A document described in this subparagraph is any document that certifies, for purposes of subchapter XVIII, that an individual meets the requirements of section [1395f(a)(2)(C)](/usc/42/1395f.md?p=a-2-C) or [1395n(a)(2)(A)](/usc/42/1395n.md?p=a-2-A) of this title in the case of home health services furnished to the individual.
- (c) **Initiation of proceeding; authorization by Attorney General, notice, etc., estoppel, failure to comply with order or procedure—**
  - (1) The [Secretary](/usc/42/1301.md?p=a-6) may initiate a proceeding to determine whether to impose a civil money penalty, assessment, or exclusion under subsection [(a)](#a) or [(b)](#b) only as authorized by the [Attorney General](/usc/42/14902.md?p=6) pursuant to procedures agreed upon by them. The [Secretary](/usc/42/1301.md?p=a-6) may not initiate an action under this section with respect to any [claim](#i-2), request for payment, or other occurrence described in this section later than six years after the date the [claim](#i-2) was presented, the request for payment was made, or the occurrence took place. The [Secretary](/usc/42/1301.md?p=a-6) may initiate an action under this section by serving notice of the action in any manner authorized by [Rule 4](/usc/28a/civil-4.md) of the Federal Rules of Civil Procedure.
  - (2) The [Secretary](/usc/42/1301.md?p=a-6) shall not make a determination adverse to any [person](/usc/42/1301.md?p=a-3) under subsection [(a)](#a) or [(b)](#b) until the [person](/usc/42/1301.md?p=a-3) has been given written notice and an opportunity for the determination to be made on the record after a hearing at which the [person](/usc/42/1301.md?p=a-3) is entitled to be represented by counsel, to present witnesses, and to cross-examine witnesses against the [person](/usc/42/1301.md?p=a-3).
  - (3) In a proceeding under subsection [(a)](#a) or [(b)](#b) which—
    - (A) is against a [person](/usc/42/1301.md?p=a-3) who has been convicted (whether upon a verdict after trial or upon a plea of guilty or nolo contendere) of a Federal crime charging fraud or false statements, and
    - (B) involves the same transaction as in the criminal action,

    the [person](/usc/42/1301.md?p=a-3) is estopped from denying the essential elements of the criminal offense.

  - (4) The official conducting a hearing under this section may sanction a [person](/usc/42/1301.md?p=a-3), [including](/usc/42/1301.md?p=b) any party or attorney, for failing to comply with an order or procedure, failing to defend an action, or other misconduct as would interfere with the speedy, orderly, or fair conduct of the hearing. Such sanction shall reasonably relate to the severity and nature of the failure or misconduct. Such sanction may include—
    - (A) in the case of refusal to provide or permit discovery, drawing negative factual inferences or treating such refusal as an admission by deeming the matter, or certain facts, to be established,
    - (B) prohibiting a party from introducing certain evidence or otherwise supporting a particular [claim](#i-2) or defense,
    - (C) striking pleadings, in whole or in part,
    - (D) staying the proceedings,
    - (E) dismissal of the action,
    - (F) entering a default judgment,
    - (G) ordering the party or attorney to pay attorneys’ fees and other costs caused by the failure or misconduct, and
    - (H) refusing to consider any motion or other action which is not filed in a timely manner.
- (d) **Amount or scope of penalty, assessment, or exclusion—** In determining the amount or scope of any penalty, assessment, or exclusion imposed pursuant to subsection [(a)](#a) or [(b)](#b), the [Secretary](/usc/42/1301.md?p=a-6) shall take into account—
  - (1) the nature of [claims](#i-2) and the circumstances under which they were presented,
  - (2) the degree of culpability, history of prior offenses, and financial condition of the [person](/usc/42/1301.md?p=a-3) presenting the [claims](#i-2), and
  - (3) such other matters as justice may require.
- (e) **Review by courts of appeals—** Any [person](/usc/42/1301.md?p=a-3) adversely affected by a determination of the [Secretary](/usc/42/1301.md?p=a-6) under this section may obtain a review of such determination in the [United States](/usc/42/1301.md?p=a-2) Court of Appeals for the circuit in which the [person](/usc/42/1301.md?p=a-3) resides, or in which the [claim](#i-2) or specified claim was presented, by filing in such court (within sixty days following the date the [person](/usc/42/1301.md?p=a-3) is notified of the [Secretary](/usc/42/1301.md?p=a-6)’s determination) a written petition requesting that the determination be [modified](/usc/42/7501.md?p=4) or set aside. A copy of the petition shall be forthwith transmitted by the clerk of the court to the [Secretary](/usc/42/1301.md?p=a-6), and thereupon the [Secretary](/usc/42/1301.md?p=a-6) shall file in the Court[^11] the record in the proceeding as provided in [section 2112 of title 28](/usc/28/2112.md). Upon such filing, the court shall have jurisdiction of the proceeding and of the question determined therein, and shall have the power to make and enter upon the pleadings, testimony, and proceedings set forth in such record a decree affirming, modifying, remanding for further consideration, or setting aside, in whole or in part, the determination of the [Secretary](/usc/42/1301.md?p=a-6) and enforcing the same to the extent that such order is affirmed or [modified](/usc/42/7501.md?p=4). No objection that has not been urged before the [Secretary](/usc/42/1301.md?p=a-6) shall be considered by the court, unless the failure or [neglect](/usc/42/1397j.md?p=16) to urge such objection shall be excused because of extraordinary circumstances. The findings of the [Secretary](/usc/42/1301.md?p=a-6) with respect to questions of fact, if supported by substantial evidence on the record considered as a whole, shall be conclusive. If any party shall apply to the court for leave to adduce additional evidence and shall show to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the hearing before the [Secretary](/usc/42/1301.md?p=a-6), the court may order such additional evidence to be taken before the [Secretary](/usc/42/1301.md?p=a-6) and to be made a part of the record. The [Secretary](/usc/42/1301.md?p=a-6) may modify his findings as to the facts, or make new findings, by reason of additional evidence so taken and filed, and he shall file with the court such [modified](/usc/42/7501.md?p=4) or new findings, which findings with respect to questions of fact, if supported by substantial evidence on the record considered as a whole, shall be conclusive, and his recommendations, if any, for the [modification](/usc/42/7501.md?p=4) or setting aside of his original order. Upon the filing of the record with it, the jurisdiction of the court shall be exclusive and its judgment and decree shall be final, except that the same shall be subject to review by the Supreme Court of the [United States](/usc/42/1301.md?p=a-2), as provided in [section 1254 of title 28](/usc/28/1254.md).
- (f) **Compromise of penalties and assessments; recovery; use of funds recovered—** Civil money penalties and assessments imposed under this section may be compromised by the [Secretary](/usc/42/1301.md?p=a-6) and may be recovered in a civil action in the name of the [United States](/usc/42/1301.md?p=a-2) brought in [United States](/usc/42/1301.md?p=a-2) district court for the district where the [claim](#i-2) or specified claim (as defined in [subsection (r)](#r)) was presented, or where the claimant (or, with respect to a [person](/usc/42/1301.md?p=a-3) described in [subsection (o)](#o), the [person](/usc/42/1301.md?p=a-3)) resides, as determined by the [Secretary](/usc/42/1301.md?p=a-6). Amounts recovered under this section shall be paid to the [Secretary](/usc/42/1301.md?p=a-6) and disposed of as follows:
  - (1)
    - (A) In the case of amounts recovered arising out of a [claim](#i-2) under subchapter XIX, there shall be paid to the [State agency](#i-1) an amount bearing the same proportion to the total amount recovered as the [State](/usc/42/1301.md?p=a-1)’s share of the amount paid by the [State agency](#i-1) for such [claim](#i-2) bears to the total amount paid for such [claim](#i-2).
    - (B) In the case of amounts recovered arising out of a [claim](#i-2) under an allotment to a [State](/usc/42/1301.md?p=a-1) under subchapter V, there shall be paid to the [State agency](#i-1) an amount equal to three-sevenths of the amount recovered.
  - (2) Such portion of the amounts recovered as is determined to have been paid out of the [trust](/usc/42/12854.md?p=6) [funds](/usc/42/12854.md?p=3) under sections [1395i](/usc/42/1395i.md) and [1395t](/usc/42/1395t.md) of this title shall be repaid to such [trust](/usc/42/12854.md?p=6) [funds](/usc/42/12854.md?p=3).
  - (3) With respect to amounts recovered arising out of a [claim](#i-2) under a Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)), the portion of such amounts as is determined to have been paid by the [program](/usc/42/274l–1.md?p=4) shall be repaid to the [program](/usc/42/274l–1.md?p=4), and the portion of such amounts attributable to the amounts recovered under this section by reason of the amendments made by the Health Insurance Portability and Accountability Act of 1996 (as estimated by the [Secretary](/usc/42/1301.md?p=a-6)) shall be deposited into the Federal [Hospital](/usc/42/1395dd.md?p=e-5) Insurance [Trust](/usc/42/12854.md?p=6) [Fund](/usc/42/12854.md?p=3) pursuant to [section 1395i(k)(2)(C) of this title](/usc/42/1395i.md?p=k-2-C).
  - (4) The remainder of the amounts recovered shall be deposited as miscellaneous receipts of the Treasury of the [United States](/usc/42/1301.md?p=a-2).

  The amount of such penalty or assessment, when finally determined, or the amount agreed upon in compromise, may be deducted from any sum then or later owing by the [United States](/usc/42/1301.md?p=a-2) or a [State agency](#i-1) (or, in the case of a penalty or assessment under [subsection (o)](#o), by a specified State agency (as defined in [subsection (q)(6)](#q-6)), to the [person](/usc/42/1301.md?p=a-3) against whom the penalty or assessment has been assessed.

- (g) **Finality of determination respecting penalty, assessment, or exclusion—** A determination by the [Secretary](/usc/42/1301.md?p=a-6) to impose a penalty, assessment, or exclusion under subsection [(a)](#a) or [(b)](#b) shall be final upon the expiration of the sixty-day period referred to in [subsection (e)](#e). Matters that were raised or that could have been raised in a hearing before the [Secretary](/usc/42/1301.md?p=a-6) or in an appeal pursuant to [subsection (e)](#e) may not be raised as a defense to a civil action by the [United States](/usc/42/1301.md?p=a-2) to collect a penalty, assessment, or exclusion assessed under this section.
- (h) **Notification of appropriate entities of finality of determination—** Whenever the [Secretary](/usc/42/1301.md?p=a-6)’s determination to impose a penalty, assessment, or exclusion under subsection [(a)](#a) or [(b)](#b) becomes final, he shall notify the appropriate [State](/usc/42/1301.md?p=a-1) or local medical or professional organization, the appropriate [State agency](#i-1) or [agencies](/usc/42/1397n–12.md?p=1) administering or supervising the [administration](/usc/42/1301.md?p=a-10) of [State](/usc/42/1301.md?p=a-1) health care [programs](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7(h) of this title](/usc/42/1320a–7.md?p=h)), and the appropriate utilization and quality control peer review organization, and the appropriate [State](/usc/42/1301.md?p=a-1) or local licensing [agency](/usc/42/1397n–12.md?p=1) or organization ([including](/usc/42/1301.md?p=b) the [agency](/usc/42/1397n–12.md?p=1) specified in section [1395aa(a)](/usc/42/1395aa.md?p=a) and [1396a(a)(33)](/usc/42/1396a.md?p=a-33) of this title) that such a penalty, assessment, or exclusion has become final and the reasons therefor.
- (i) **Definitions—** For the purposes of this section:
  - (1) The term “State agency” means the [agency](/usc/42/1397n–12.md?p=1) established or designated to administer or supervise the [administration](/usc/42/1301.md?p=a-10) of the [State](/usc/42/1301.md?p=a-1) plan under subchapter XIX of this chapter or designated to administer the [State](/usc/42/1301.md?p=a-1)’s [program](/usc/42/274l–1.md?p=4) under subchapter V or division A[^12] of subchapter XX of this chapter.
  - (2) The term “claim” means an application for payments for items and services under a Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)).
  - (3) The term “item or service” [includes](/usc/42/1301.md?p=b) (A) any particular item, device, medical supply, or service claimed to have been provided to a patient and listed in an itemized [claim](#i-2) for payment, and (B) in the case of a [claim](#i-2) based on costs, any entry in the cost report, books of account or other documents supporting such [claim](#i-2).
  - (4) The term “agency of the United States” [includes](/usc/42/1301.md?p=b) any contractor acting as a fiscal intermediary, carrier, or fiscal agent or any other [claims](#i-2) processing agent for a Federal health care [program](/usc/42/274l–1.md?p=4) (as so defined).
  - (5) The term “beneficiary” means an individual who is eligible to receive items or services for which payment may be made under a Federal health care [program](/usc/42/274l–1.md?p=4) (as so defined) but does not include a provider, [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](/usc/42/1395a.md?p=b-6-C).
  - (6) The term “remuneration” [includes](/usc/42/1301.md?p=b) the waiver of coinsurance and deductible amounts (or any part thereof), and transfers of items or services for free or for other than fair market value. The term “remuneration” does not include—
    - (A) the waiver of coinsurance and deductible amounts by a [person](/usc/42/1301.md?p=a-3), if—
      - (i) the waiver is not offered as part of any advertisement or solicitation;
      - (ii) the [person](/usc/42/1301.md?p=a-3) does not routinely waive coinsurance or deductible amounts; and
      - (iii) the [person](/usc/42/1301.md?p=a-3)—
        - (I) waives the coinsurance and deductible amounts after determining in good faith that the individual is in financial need; or
        - (II) fails to collect coinsurance or deductible amounts after making reasonable collection efforts;
    - (B) subject to [subsection (n)](#n), any permissible practice described in any subparagraph of [section 1320a–7b(b)(3) of this title](/usc/42/1320a–7b.md?p=b-3) or in regulations issued by the [Secretary](/usc/42/1301.md?p=a-6);
    - (C) differentials in coinsurance and deductible amounts as part of a benefit plan design as long as the differentials have been disclosed in writing to all [beneficiaries](#i-5), third party payers, and providers, to whom [claims](#i-2) are presented and as long as the differentials meet the [standards](/usc/42/1320d.md?p=7) as defined in regulations promulgated by the [Secretary](/usc/42/1301.md?p=a-6) not later than 180 days after August 21, 1996;
    - (D) incentives given to individuals to promote the delivery of preventive care as determined by the [Secretary](/usc/42/1301.md?p=a-6) in regulations so promulgated;
    - (E) a reduction in the copayment amount for covered OPD services under [section 1395l(t)(5)(B)](/usc/42/1395l.md?p=t-5-B)[^12] of this title; or[^3]
    - (F) any other [remuneration](#i-6) which promotes access to care and poses a low risk of harm to patients and Federal health care [programs](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f) and designated by the [Secretary](/usc/42/1301.md?p=a-6) under regulations);
    - (G) the offer or transfer of items or services for free or less than fair market value by a [person](/usc/42/1301.md?p=a-3), if—
      - (i) the items or services consist of coupons, rebates, or other rewards from a retailer;
      - (ii) the items or services are offered or transferred on equal terms available to the general public, regardless of health insurance status; and
      - (iii) the offer or transfer of the items or services is not tied to the provision of other items or services reimbursed in whole or in part by the [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7(h) of this title](/usc/42/1320a–7.md?p=h));
    - (H) the offer or transfer of items or services for free or less than fair market value by a [person](/usc/42/1301.md?p=a-3), if—
      - (i) the items or services are not offered as part of any advertisement or solicitation;
      - (ii) the items or services are not tied to the provision of other services reimbursed in whole or in part by the [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4) (as so defined);
      - (iii) there is a reasonable connection between the items or services and the [medical care](/usc/42/1301.md?p=a-7) of the individual; and
      - (iv) the [person](/usc/42/1301.md?p=a-3) provides the items or services after determining in good faith that the individual is in financial need;
    - (I) effective on a date specified by the [Secretary](/usc/42/1301.md?p=a-6) (but not earlier than January 1, 2011), the waiver by a PDP sponsor of a [prescription drug plan](/usc/42/1395w–154.md?p=d-2) under part D of subchapter XVIII or an MA organization offering an [MA–PD plan](/usc/42/1395w–151.md?p=a-9) under part C of such subchapter of any copayment for the first fill of a [covered part D drug](/usc/42/1395w–141.md?p=a-4-A) (as defined in [section 1395w–102(e) of this title](/usc/42/1395w–102.md?p=e)) that is a generic [drug](/usc/42/282.md?p=j-1-A-vii) for individuals enrolled in the [prescription drug plan](/usc/42/1395w–154.md?p=d-2) or [MA–PD plan](/usc/42/1395w–151.md?p=a-9), respectively; or
    - (J) the provision of telehealth technologies (as defined by the [Secretary](/usc/42/1301.md?p=a-6)) on or after January 1, 2019, by a [provider of services](/usc/42/1395n.md?p=a-2) or a renal dialysis [facility](/usc/42/11049.md?p=4) (as such terms are defined for purposes of subchapter XVIII) to an individual with end stage renal disease who is receiving home dialysis for which payment is being made under part B of such subchapter, if—
      - (i) the telehealth technologies are not offered as part of any advertisement or solicitation;
      - (ii) the telehealth technologies are provided for the purpose of furnishing telehealth services related to the individual’s end stage renal disease; and
      - (iii) the provision of the telehealth technologies meets any other requirements set forth in regulations promulgated by the [Secretary](/usc/42/1301.md?p=a-6).
  - (7) The term “should know” means that a [person](/usc/42/1301.md?p=a-3), with respect to information—
    - (A) acts in deliberate ignorance of the truth or falsity of the information; or
    - (B) acts in reckless disregard of the truth or falsity of the information,

    and no proof of specific intent to defraud is required.

- (j) **Subpoenas—**
  - (1) The provisions of subsections (d) and (e) of [section 405 of this title](/usc/42/405.md) shall apply with respect to this section to the same extent as they are applicable with respect to subchapter II. The [Secretary](/usc/42/1301.md?p=a-6) may delegate the authority granted by [section 405(d) of this title](/usc/42/405.md?p=d) (as made applicable to this section) to the Inspector General of the Department of Health and Human Services for purposes of any investigation under this section.
  - (2) The [Secretary](/usc/42/1301.md?p=a-6) may delegate authority granted under this section and under [section 1320a–7 of this title](/usc/42/1320a–7.md) to the Inspector General of the Department of Health and Human Services.
- (k) **Injunctions—** Whenever the [Secretary](/usc/42/1301.md?p=a-6) has reason to believe that any [person](/usc/42/1301.md?p=a-3) has engaged, is engaging, or is about to engage in any activity which makes the [person](/usc/42/1301.md?p=a-3) subject to a civil monetary penalty under this section, the [Secretary](/usc/42/1301.md?p=a-6) may bring an action in an appropriate district court of the [United States](/usc/42/1301.md?p=a-2) (or, if applicable, a [United States](/usc/42/1301.md?p=a-2) court of any territory) to enjoin such activity, or to enjoin the [person](/usc/42/1301.md?p=a-3) from concealing, removing, encumbering, or disposing of assets which may be required in order to pay a civil monetary penalty if any such penalty were to be imposed or to seek other appropriate relief.
- (l) **Liability of principal for acts of agent—** A principal is liable for penalties, assessments, and an exclusion under this section for the actions of the principal’s agent acting within the scope of the [agency](/usc/42/1397n–12.md?p=1).
- (m) **Claims within jurisdiction of other departments or agencies—**
  - (1) For purposes of this section, with respect to a Federal health care [program](/usc/42/274l–1.md?p=4) not contained in this chapter, references to the [Secretary](/usc/42/1301.md?p=a-6) in this section shall be deemed to be references to the [Secretary](/usc/42/1301.md?p=a-6) or [Administrator](/usc/42/4005.md?p=1) of the department or [agency](/usc/42/1397n–12.md?p=1) with jurisdiction over such [program](/usc/42/274l–1.md?p=4) and references to the Inspector General of the Department of Health and Human Services in this section shall be deemed to be references to the Inspector General of the applicable department or [agency](/usc/42/1397n–12.md?p=1).
  - (2)
    - (A) The [Secretary](/usc/42/1301.md?p=a-6) and [Administrator](/usc/42/4005.md?p=1) of the departments and [agencies](/usc/42/1397n–12.md?p=1) referred to in [paragraph (1)](#m-1) may include in any action pursuant to this section, [claims](#i-2) within the jurisdiction of other Federal departments or [agencies](/usc/42/1397n–12.md?p=1) as long as the following conditions are satisfied:
      - (i) The case involves primarily [claims](#i-2) submitted to the Federal health care [programs](/usc/42/274l–1.md?p=4) of the department or [agency](/usc/42/1397n–12.md?p=1) initiating the action.
      - (ii) The [Secretary](/usc/42/1301.md?p=a-6) or [Administrator](/usc/42/4005.md?p=1) of the department or [agency](/usc/42/1397n–12.md?p=1) initiating the action gives notice and an opportunity to participate in the investigation to the Inspector General of the department or [agency](/usc/42/1397n–12.md?p=1) with primary jurisdiction over the Federal health care [programs](/usc/42/274l–1.md?p=4) to which the [claims](#i-2) were submitted.
    - (B) If the conditions specified in [subparagraph (A)](#m-2-A) are fulfilled, the Inspector General of the department or [agency](/usc/42/1397n–12.md?p=1) initiating the action is authorized to exercise all powers granted under [chapter 4](/usc/5/chptI-ch4.md) of title 5 with respect to the [claims](#i-2) submitted to the other departments or [agencies](/usc/42/1397n–12.md?p=1) to the same manner and extent as provided in that Act with respect to [claims](#i-2) submitted to such departments or [agencies](/usc/42/1397n–12.md?p=1).
- (n) **Safe harbor for payment of medigap premiums—**
  - (1) [Subparagraph (B)](#i-6-B) of subsection (i)(6) shall not apply to a practice described in [paragraph (2)](#n-2) unless—
    - (A) the [Secretary](/usc/42/1301.md?p=a-6), through the Inspector General of the Department of Health and Human Services, promulgates a rule authorizing such a practice as an exception to [remuneration](#i-6); and
    - (B) the [remuneration](#i-6) is offered or transferred by a [person](/usc/42/1301.md?p=a-3) under such rule during the 2-year period beginning on the date the rule is first promulgated.
  - (2) A practice described in this paragraph is a practice under which a [health care provider](/usc/42/300jj.md?p=3) or [facility](/usc/42/11049.md?p=4) pays, in whole or in part, premiums for [medicare supplemental policies](/usc/42/1320d–9.md?p=b-2) for individuals entitled to benefits under part A of subchapter XVIII pursuant to [section 426–1 of this title](/usc/42/426–1.md).
- (o) **Penalties for violations of grants, contracts, and other agreements—** Any [person](/usc/42/1301.md?p=a-3) ([including](/usc/42/1301.md?p=b) an organization, [agency](/usc/42/1397n–12.md?p=1), or other entity, but excluding a [program beneficiary](#q-4), as defined in [subsection (q)(4)](#q-4)) that, with respect to a [grant](/usc/42/1397j.md?p=10), contract, or [other agreement](#q-3) for which the [Secretary](/usc/42/1301.md?p=a-6) provides funding—
  - (1) knowingly presents or [causes](/usc/42/9908.md?p=c-2) to be presented a specified claim (as defined in [subsection (r)](#r)) under such [grant](/usc/42/1397j.md?p=10), contract, or [other agreement](#q-3) that the [person](/usc/42/1301.md?p=a-3) knows or [should know](#i-7) is false or fraudulent;
  - (2) knowingly makes, uses, or [causes](/usc/42/9908.md?p=c-2) to be made or used any false statement, omission, or misrepresentation of a [material](#q-2) fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain [funds](/usc/42/12854.md?p=3) provided in whole or in part by such [Secretary](/usc/42/1301.md?p=a-6) pursuant to such [grant](/usc/42/1397j.md?p=10), contract, or [other agreement](#q-3);
  - (3) knowingly makes, uses, or [causes](/usc/42/9908.md?p=c-2) to be made or used, a false record or statement [material](#q-2) to a false or fraudulent specified claim under such [grant](/usc/42/1397j.md?p=10), contract, or [other agreement](#q-3);
  - (4) knowingly makes, uses, or [causes](/usc/42/9908.md?p=c-2) to be made or used, a false record or statement [material](#q-2) to an [obligation](#s) (as defined in [subsection (s)](#s)) to pay or transmit [funds](/usc/42/12854.md?p=3) or property to such [Secretary](/usc/42/1301.md?p=a-6) with respect to such [grant](/usc/42/1397j.md?p=10), contract, or [other agreement](#q-3), or knowingly conceals or knowingly and improperly avoids or decreases an [obligation](#s) to pay or transmit [funds](/usc/42/12854.md?p=3) or property to such [Secretary](/usc/42/1301.md?p=a-6) with respect to such [grant](/usc/42/1397j.md?p=10), contract, or [other agreement](#q-3); or
  - (5) fails to [grant](/usc/42/1397j.md?p=10) timely access, upon reasonable request (as defined by such [Secretary](/usc/42/1301.md?p=a-6) in regulations), to the Inspector General of the [Department](#q-1), for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such [grants](/usc/42/1397j.md?p=10), contracts, or [other agreements](#q-3);

  shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty in cases under [paragraph (1)](#o-1), of not more than $10,000 for each specified claim; in cases under [paragraph (2)](#o-2), not more than $50,000 for each false statement, omission, or misrepresentation of a [material](#q-2) fact; in cases under [paragraph (3)](#o-3), not more than $50,000 for each false record or statement; in cases under [paragraph (4)](#o-4), not more than $50,000 for each false record or statement or $10,000 for each day that the [person](/usc/42/1301.md?p=a-3) knowingly conceals or knowingly and improperly avoids or decreases an [obligation](#s) to pay; or in cases under [paragraph (5)](#o-5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs [(1)](#o-1) and [(3)](#o-3), such a [person](/usc/42/1301.md?p=a-3) shall be subject to an assessment of not more than 3 times the amount claimed in the specified claim described in such paragraph in lieu of [damages](/usc/42/9601.md?p=6) sustained by the [United States](/usc/42/1301.md?p=a-2) or a [specified State agency](#q-6) because of such specified claim, and in cases under paragraphs [(2)](#o-2) and [(4)](#o-4), such a [person](/usc/42/1301.md?p=a-3) shall be subject to an assessment of not more than 3 times the total amount of the [funds](/usc/42/12854.md?p=3) described in paragraph [(2)](#o-2) or [(4)](#o-4), respectively (or, in the case of an [obligation](#s) to transmit property to the [Secretary](/usc/42/1301.md?p=a-6) described in [paragraph (4)](#o-4), of the value of the property described in such paragraph) in lieu of [damages](/usc/42/9601.md?p=6) sustained by the [United States](/usc/42/1301.md?p=a-2) or a [specified State agency](#q-6) because of such case. In addition, the [Secretary](/usc/42/1301.md?p=a-6) may make a determination in the same proceeding to exclude the [person](/usc/42/1301.md?p=a-3) from participation in the Federal health care [programs](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f)(1) of this title](/usc/42/1320a–7b.md?p=f-1)) and to direct the appropriate [State agency](#i-1) to exclude the [person](/usc/42/1301.md?p=a-3) from participation in any [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4).

- (p) **Applicability of rules to penalties or assessments for violations of grants, contracts, and other agreements—** The provisions of subsections [(c)](#c), [(d)](#d), [(g)](#g), and [(h)](#h) shall apply to a civil money penalty or assessment under [subsection (o)](#o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under [subsection (a)](#a). In applying [subsection (d)](#d), each reference to a [claim](#i-2) under such subsection shall be treated as [including](/usc/42/1301.md?p=b) a reference to a specified claim (as defined in [subsection (r)](#r)).
- (q) **Definitions of terms used in subsections (o) and (p)—** For purposes of this subsection and subsections [(o)](#o) and [(p)](#p):
  - (1) The term “Department” means the Department of Health and Human Services.
  - (2) The term “material” means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.
  - (3) The term “other agreement” [includes](/usc/42/1301.md?p=b) a cooperative [agreement](/usc/42/1320b–8.md?p=a-3-A), scholarship, [fellowship](/usc/42/1862n–1.md?p=i-3), loan, subsidy, payment for a specified use, donation [agreement](/usc/42/1320b–8.md?p=a-3-A), award, or subaward (regardless of whether one or more of the [persons](/usc/42/1301.md?p=a-3) entering into the [agreement](/usc/42/1320b–8.md?p=a-3-A) is a contractor or subcontractor).
  - (4) The term “program beneficiary” means, in the case of a [grant](/usc/42/1397j.md?p=10), contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the [Secretary](/usc/42/1301.md?p=a-6) provides funding, an individual who applies for, or who receives, such benefits or assistance from such [grant](/usc/42/1397j.md?p=10), contract, or other agreement. Such term does not include, with respect to such [grant](/usc/42/1397j.md?p=10), contract, or other agreement, an officer, [employee](/usc/42/1320a–7h.md?p=e-7), or agent of a [person](/usc/42/1301.md?p=a-3) or entity that receives such [grant](/usc/42/1397j.md?p=10) or that enters into such contract or other agreement.
  - (5) The term “[recipient](/usc/42/2996a.md?p=6)” [includes](/usc/42/1301.md?p=b) a subrecipient or subcontractor.
  - (6) The term “specified State agency” means an [agency](/usc/42/1397n–12.md?p=1) of a [State](/usc/42/1301.md?p=a-1) government established or designated to administer or supervise the [administration](/usc/42/1301.md?p=a-10) of a [grant](/usc/42/1397j.md?p=10), contract, or other agreement funded in whole or in part by the [Secretary](/usc/42/1301.md?p=a-6).
- (r) **Definition of “specified claim”—** For purposes of this section, the term “specified claim” means any application, request, or demand under a [grant](/usc/42/1397j.md?p=10), contract, or other agreement for money or property, whether or not the [United States](/usc/42/1301.md?p=a-2) or a specified State agency has title to the money or property, that is not a [claim](#i-2) (as defined in [subsection (i)(2)](#i-2)) and that—
  - (1) is presented or caused to be presented to an officer, [employee](/usc/42/1320a–7h.md?p=e-7), or agent of the Department or [agency](/usc/42/1397n–12.md?p=1) thereof, or of any specified State agency; or
  - (2) is made to a contractor, grantee, or any other [recipient](/usc/42/2996a.md?p=6) if the money or property is to be spent or used on the Department’s behalf or to advance a Department [program](/usc/42/274l–1.md?p=4) or interest, and if the Department—
    - (A) provides or has provided any portion of the money or property requested or demanded; or
    - (B) will reimburse such contractor, grantee, or other [recipient](/usc/42/2996a.md?p=6) for any portion of the money or property which is requested or demanded.
- (s) **Definition of “obligation”—** For purposes of [subsection (o)](#o), the term “obligation” means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment.

# §1320a–7b. Criminal penalties for acts involving Federal health care programs

- (a) **Making or causing to be made false statements or representations—** Whoever—
  - (1) knowingly and willfully makes or [causes](/usc/42/9908.md?p=c-2) to be made any false statement or representation of a material fact in any application for any benefit or payment under a [Federal health care program](#f) (as defined in [subsection (f)](#f)),
  - (2) at any time knowingly and willfully makes or [causes](/usc/42/9908.md?p=c-2) to be made any false statement or representation of a material fact for use in determining rights to such benefit or payment,
  - (3) having knowledge of the occurrence of any event affecting (A) his initial or continued right to any such benefit or payment, or (B) the initial or continued right to any such benefit or payment of any other individual in whose behalf he has applied for or is receiving such benefit or payment, conceals or fails to disclose such event with an intent fraudulently to secure such benefit or payment either in a greater amount or quantity than is due or when no such benefit or payment is authorized,
  - (4) having made application to receive any such benefit or payment for the use and benefit of another and having received it, knowingly and willfully converts such benefit or payment or any part thereof to a use other than for the use and benefit of such other [person](/usc/42/1301.md?p=a-3),
  - (5) presents or [causes](/usc/42/9908.md?p=c-2) to be presented a [claim](/usc/42/1320a–7a.md?p=i-2) for a [physician](/usc/42/1301.md?p=a-7)’s service for which payment may be made under a [Federal health care program](#f) and knows that the individual who furnished the service was not licensed as a [physician](/usc/42/1301.md?p=a-7), or
  - (6) for a fee knowingly and willfully counsels or assists an individual to dispose of assets ([including](/usc/42/1301.md?p=b) by any transfer in [trust](/usc/42/12854.md?p=6)) in order for the individual to become eligible for medical assistance under a [State](/usc/42/1301.md?p=a-1) plan under subchapter XIX, if disposing of the assets results in the imposition of a period of ineligibility for such assistance under [section 1396p(c) of this title](/usc/42/1396p.md?p=c),

  shall (i) in the case of such a statement, representation, concealment, failure, or conversion by any [person](/usc/42/1301.md?p=a-3) in connection with the furnishing (by that [person](/usc/42/1301.md?p=a-3)) of items or services for which payment is or may be made under the [program](/usc/42/274l–1.md?p=4), be guilty of a felony and upon conviction thereof fined not more than $100,000 or imprisoned for not more than 10 years or both, or (ii) in the case of such a statement, representation, concealment, failure, conversion, or provision of counsel or assistance by any other [person](/usc/42/1301.md?p=a-3), be guilty of a misdemeanor and upon conviction thereof fined not more than $20,000 or imprisoned for not more than one year, or both. In addition, in any case where an individual who is otherwise eligible for assistance under a [Federal health care program](#f) is convicted of an offense under the preceding provisions of this subsection, the [administrator](/usc/42/4005.md?p=1) of such [program](/usc/42/274l–1.md?p=4) may at its option (notwithstanding any other provision of such [program](/usc/42/274l–1.md?p=4)) limit, restrict, or suspend the eligibility of that individual for such period (not exceeding one year) as it deems appropriate; but the imposition of a limitation, restriction, or suspension with respect to the eligibility of any individual under this sentence shall not affect the eligibility of any other [person](/usc/42/1301.md?p=a-3) for assistance under the plan, regardless of the relationship between that individual and such other [person](/usc/42/1301.md?p=a-3).

- (b) **Illegal remunerations—**
  - (1) Whoever knowingly and willfully solicits or receives any remuneration ([including](/usc/42/1301.md?p=b) any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind—
    - (A) in return for referring an individual to a [person](/usc/42/1301.md?p=a-3) for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a [Federal health care program](#f), or
    - (B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, [facility](/usc/42/11049.md?p=4), service, or item for which payment may be made in whole or in part under a [Federal health care program](#f),

    shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

  - (2) Whoever knowingly and willfully offers or pays any remuneration ([including](/usc/42/1301.md?p=b) any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any [person](/usc/42/1301.md?p=a-3) to induce such [person](/usc/42/1301.md?p=a-3)—
    - (A) to refer an individual to a [person](/usc/42/1301.md?p=a-3) for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a [Federal health care program](#f), or
    - (B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, [facility](/usc/42/11049.md?p=4), service, or item for which payment may be made in whole or in part under a [Federal health care program](#f),

    shall be guilty of a felony and upon conviction thereof, shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

  - (3) Paragraphs [(1)](#b-1) and [(2)](#b-2) shall not apply to—
    - (A) a discount or other reduction in price obtained by a [provider of services](/usc/42/1395n.md?p=a-2) or other entity under a [Federal health care program](#f) if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity under a [Federal health care program](#f);
    - (B) any amount paid by an employer to an [employee](/usc/42/1320a–7h.md?p=e-7) (who has a bona fide employment relationship with such employer) for employment in the provision of covered items or services;
    - (C) any amount paid by a vendor of goods or services to a [person](/usc/42/1301.md?p=a-3) authorized to act as a purchasing agent for a group of individuals or entities who are furnishing services reimbursed under a [Federal health care program](#f) if—
      - (i) the [person](/usc/42/1301.md?p=a-3) has a written contract, with each such individual or entity, which specifies the amount to be paid the [person](/usc/42/1301.md?p=a-3), which amount may be a fixed amount or a fixed percentage of the value of the purchases made by each such individual or entity under the contract, and
      - (ii) in the case of an entity that is a [provider of services](/usc/42/1395n.md?p=a-2) (as defined in [section 1395x(u) of this title](/usc/42/1395x.md?p=u)), the [person](/usc/42/1301.md?p=a-3) discloses (in such form and manner as the [Secretary](/usc/42/1301.md?p=a-6) requires) to the entity and, upon request, to the [Secretary](/usc/42/1301.md?p=a-6) the amount received from each such vendor with respect to purchases made by or on behalf of the entity;
    - (D) a waiver of any coinsurance under part B of subchapter XVIII by a Federally qualified health care center with respect to an individual who qualifies for subsidized services under a provision of the Public Health Service Act [[42 U.S.C. 201](/usc/42/201.md) et seq.];
    - (E) any payment practice specified by the [Secretary](/usc/42/1301.md?p=a-6) in regulations promulgated pursuant to section 14(a) of the Medicare and Medicaid Patient and [Program](/usc/42/274l–1.md?p=4) Protection Act of 1987 or in regulations under [section 1395w–104(e)(6)](/usc/42/1395w–104.md?p=e-6)[^1] of this title;
    - (F) any remuneration between an organization and an individual or entity providing items or services, or a combination thereof, pursuant to a written [agreement](/usc/42/1320b–8.md?p=a-3-A) between the organization and the individual or entity if the organization is an eligible organization under [section 1395mm of this title](/usc/42/1395mm.md) or if the written [agreement](/usc/42/1320b–8.md?p=a-3-A), through a risk-sharing arrangement, places the individual or entity at substantial financial risk for the cost or utilization of the items or services, or a combination thereof, which the individual or entity is obligated to provide;
    - (G) the waiver or reduction by pharmacies ([including](/usc/42/1301.md?p=b) pharmacies of the [Indian](/usc/42/6862.md?p=6) Health Service, [Indian tribes](/usc/42/1397j.md?p=12-A), [tribal organizations](/usc/42/629a.md?p=a-6), and urban [Indian](/usc/42/6862.md?p=6) organizations) of any [cost-sharing](/usc/42/18022.md?p=c-3-A) imposed under part D of subchapter XVIII, if the conditions described in clauses (i) through (iii) of [section 1320a–7a(i)(6)(A) of this title](/usc/42/1320a–7a.md?p=i-6-A) are met with respect to the waiver or reduction (except that, in the case of such a waiver or reduction on behalf of a [subsidy eligible individual](/usc/42/1395w–151.md?p=a-18) (as defined in [section 1395w–114(a)(3) of this title](/usc/42/1395w–114.md?p=a-3)), [section 1320a–7a(i)(6)(A) of this title](/usc/42/1320a–7a.md?p=i-6-A) shall be applied without regard to clauses [(ii)](/usc/42/1320a–7a.md?p=i-6-A-ii) and [(iii)](/usc/42/1320a–7a.md?p=i-6-A-iii) of that section);
    - (H) any remuneration between a [federally qualified health center](/usc/42/254c.md?p=b-2) (or an entity controlled by such a health center) and an MA organization pursuant to a written [agreement](/usc/42/1320b–8.md?p=a-3-A) described in [section 1395w–23(a)(4) of this title](/usc/42/1395w–23.md?p=a-4);
    - (I) any remuneration between a health center entity described under clause [(i)](/usc/42/1396d.md?p=l-2-B-i) or [(ii)](/usc/42/1396d.md?p=l-2-B-ii) of section 1396d(l)(2)(B) of this title and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to such health center entity pursuant to a contract, lease, [grant](/usc/42/1397j.md?p=10), loan, or other [agreement](/usc/42/1320b–8.md?p=a-3-A), if such [agreement](/usc/42/1320b–8.md?p=a-3-A) contributes to the ability of the health center entity to maintain or increase the availability, or enhance the quality, of services provided to a [medically underserved population](/usc/42/254c.md?p=b-5) served by the health center entity;
    - (J) a discount in the price of an applicable [drug](/usc/42/282.md?p=j-1-A-vii) (as defined in paragraph (2) of [section 1395w–114a(g) of this title](/usc/42/1395w–114a.md?p=g)) of a [manufacturer](/usc/42/300aa–33.md?p=3) that is furnished to an applicable beneficiary (as defined in [paragraph (1)](/usc/42/1395w–114a.md?p=g-1) of such section) under the Medicare coverage gap discount [program](/usc/42/274l–1.md?p=4) under [section 1395w–114a of this title](/usc/42/1395w–114a.md);
    - (K) an incentive payment made to a [Medicare fee-for-service beneficiary](/usc/42/1395jjj.md?p=h-3) by an ACO under an ACO Beneficiary Incentive [Program](/usc/42/274l–1.md?p=4) established under subsection (m) of [section 1395jjj of this title](/usc/42/1395jjj.md), if the payment is made in accordance with the requirements of such subsection and meets such other conditions as the [Secretary](/usc/42/1301.md?p=a-6) may establish; and
    - (L) a bona fide mental health or behavioral health improvement or maintenance [program](/usc/42/274l–1.md?p=4), if—
      - (i) such [program](/usc/42/274l–1.md?p=4)—
        - (I) consists of counseling, mental health services, a suicide prevention [program](/usc/42/274l–1.md?p=4), or a substance use disorder prevention and [treatment](/usc/42/11851.md?p=11) [program](/usc/42/274l–1.md?p=4);
        - (II) is made available to a [physician](/usc/42/1301.md?p=a-7) or other clinician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing [training](/usc/42/285e–2.md?p=b-2) in appropriate strategies to promote the mental health and resiliency of such [physician](/usc/42/1301.md?p=a-7) or other clinician;
        - (III) is set out in a written policy, approved in advance of the operation of the [program](/usc/42/274l–1.md?p=4) by the governing body of the entity providing such [program](/usc/42/274l–1.md?p=4) (and which shall be updated accordingly in advance to substantial changes to the operation of such [program](/usc/42/274l–1.md?p=4)), that [includes](/usc/42/1301.md?p=b)—
          - (aa) a description of the content and duration of the [program](/usc/42/274l–1.md?p=4);
          - (bb) a description of the evidence-based support for the design of the [program](/usc/42/274l–1.md?p=4);
          - (cc) the estimated cost of the [program](/usc/42/274l–1.md?p=4);
          - (dd) the personnel ([including](/usc/42/1301.md?p=b) the qualifications of such personnel) implementing the [program](/usc/42/274l–1.md?p=4); and
          - (ee) the method by which such entity will evaluate the use and success of the [program](/usc/42/274l–1.md?p=4);
        - (IV) is offered by an entity described in [clause (ii)](#b-3-L-ii) with a formal medical staff to all [physicians](/usc/42/1395cc–4.md?p=a-2-E) and other clinicians who practice in the [geographic area](/usc/42/11360.md?p=9) served by such entity, [including](/usc/42/1301.md?p=b) [physicians](/usc/42/1395cc–4.md?p=a-2-E) who hold bona fide appointments to the medical staff of such entity or otherwise have clinical privileges at such entity;
        - (V) is offered to all such [physicians](/usc/42/1395cc–4.md?p=a-2-E) and clinicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a [physician](/usc/42/1301.md?p=a-7) or clinician for such entity;
        - (VI) is evidence-based and conducted by a qualified health professional; and
        - (VII) meets such other requirements the [Secretary](/usc/42/1301.md?p=a-6) may impose by regulation as needed to protect against [program](/usc/42/274l–1.md?p=4) or patient [abuse](/usc/42/1397j.md?p=1);
      - (ii) such entity is—
        - (I) a [hospital](/usc/42/1395dd.md?p=e-5);
        - (II) an ambulatory surgical center;
        - (III) a [community health center](/usc/42/1786.md?p=j-4-A);
        - (IV) a rural emergency [hospital](/usc/42/1395dd.md?p=e-5);
        - (V) a [skilled nursing facility](/usc/42/1395x.md?p=j); or
        - (VI) any similar entity, as determined by the [Secretary](/usc/42/1301.md?p=a-6); and
      - (iii) neither the provision of such [program](/usc/42/274l–1.md?p=4), nor the value of such [program](/usc/42/274l–1.md?p=4), are contingent upon the number or value of referrals made by a [physician](/usc/42/1301.md?p=a-7) or other clinician to such entity or the amount or value of other business generated by such [physician](/usc/42/1301.md?p=a-7) for the entity.
  - (4) Whoever without lawful authority knowingly and willfully purchases, sells or distributes, or arranges for the purchase, sale, or distribution of a beneficiary identification number or unique health identifier for a [health care provider](/usc/42/300jj.md?p=3) under subchapter XVIII, subchapter XIX, or subchapter XXI shall be imprisoned for not more than 10 years or fined not more than $500,000 ($1,000,000 in the case of a [corporation](/usc/42/1301.md?p=a-4)), or both.
- (c) **False statements or representations with respect to condition or operation of institutions—** Whoever knowingly and willfully makes or [causes](/usc/42/9908.md?p=c-2) to be made, or induces or seeks to induce the making of, any false statement or representation of a material fact with respect to the conditions or operation of any institution, [facility](/usc/42/11049.md?p=4), or entity in order that such institution, [facility](/usc/42/11049.md?p=4), or entity may qualify (either upon initial certification or upon recertification) as a [hospital](/usc/42/1395dd.md?p=e-5), [critical access hospital](/usc/42/1395x.md?p=mm-1), [skilled nursing facility](/usc/42/1395x.md?p=j), [nursing facility](/usc/42/1396d.md?p=c), intermediate care [facility](/usc/42/11049.md?p=4) for the mentally retarded, home health [agency](/usc/42/1397n–12.md?p=1), or other entity ([including](/usc/42/1301.md?p=b) an eligible organization under [section 1395mm(b) of this title](/usc/42/1395mm.md?p=b)) for which certification is required under subchapter XVIII or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7(h) of this title](/usc/42/1320a–7.md?p=h)), or with respect to information required to be provided under [section 1320a–3a of this title](/usc/42/1320a–3a.md), shall be guilty of a felony and upon conviction thereof shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.
- (d) **Illegal patient admittance and retention practices—** Whoever knowingly and willfully—
  - (1) charges, for any service provided to a patient under a [State](/usc/42/1301.md?p=a-1) plan approved under subchapter XIX, money or other consideration at a rate in excess of the rates established by the [State](/usc/42/1301.md?p=a-1) (or, in the case of services provided to an individual enrolled with a [medicaid managed care organization](/usc/42/1396b.md?p=m-1-A) under subchapter XIX under a contract under [section 1396b(m) of this title](/usc/42/1396b.md?p=m) or under a contractual, referral, or other arrangement under such contract, at a rate in excess of the rate permitted under such contract), or
  - (2) charges, solicits, accepts, or receives, in addition to any amount otherwise required to be paid under a [State](/usc/42/1301.md?p=a-1) plan approved under subchapter XIX, any gift, money, donation, or other consideration (other than a charitable, religious, or philanthropic contribution from an organization or from a [person](/usc/42/1301.md?p=a-3) unrelated to the patient)—
    - (A) as a precondition of admitting a patient to a [hospital](/usc/42/1395dd.md?p=e-5), [nursing facility](/usc/42/1396d.md?p=c), or intermediate care [facility](/usc/42/11049.md?p=4) for the mentally retarded, or
    - (B) as a requirement for the patient’s continued stay in such a [facility](/usc/42/11049.md?p=4),

    when the cost of the services provided therein to the patient is paid for (in whole or in part) under the [State](/usc/42/1301.md?p=a-1) plan,

  shall be guilty of a felony and upon conviction thereof shall be fined not more than $100,000 or imprisoned for not more than 10 years, or both.

- (e) **Violation of assignment terms—** Whoever accepts assignments described in [section 1395u(b)(3)(B)(ii) of this title](/usc/42/1395u.md?p=b-3-B-ii) or agrees to be a participating [physician](/usc/42/1301.md?p=a-7) or [supplier](/usc/42/1395cc–4.md?p=a-2-I) under [section 1395u(h)(1) of this title](/usc/42/1395u.md?p=h-1) and knowingly, willfully, and repeatedly violates the term of such assignments or [agreement](/usc/42/1320b–8.md?p=a-3-A), shall be guilty of a misdemeanor and upon conviction thereof shall be fined not more than $4,000 or imprisoned for not more than six months, or both.
- (f) **“Federal health care program” defined—** For purposes of this section, the term “Federal health care program” means—
  - (1) any plan or [program](/usc/42/274l–1.md?p=4) that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the [United States](/usc/42/1301.md?p=a-2) Government (other than the health insurance [program](/usc/42/274l–1.md?p=4) under [chapter 89](/usc/5/chptIII-sptG-ch89.md) of title 5); or
  - (2) any [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4), as defined in [section 1320a–7(h) of this title](/usc/42/1320a–7.md?p=h).
- (g) **Liability under subchapter III of chapter 37 of title 31—** In addition to the penalties provided for in this section or [section 1320a–7a of this title](/usc/42/1320a–7a.md), a [claim](/usc/42/1320a–7a.md?p=i-2) that [includes](/usc/42/1301.md?p=b) items or services resulting from a [violation](/usc/42/2000e–16a.md?p=c) of this section constitutes a false or fraudulent [claim](/usc/42/1320a–7a.md?p=i-2) for purposes of subchapter III of [chapter 37](/usc/31/chstIII-ch37.md) of title 31.
- (h) **Actual knowledge or specific intent not required—** With respect to [violations](/usc/42/2000e–16a.md?p=c) of this section, a [person](/usc/42/1301.md?p=a-3) need not have actual knowledge of this section or specific intent to commit a [violation](/usc/42/2000e–16a.md?p=c) of this section.

# §1320a–7c. Fraud and abuse control program

- (a) **Establishment of program—**
  - (1) **In general—** Not later than January 1, 1997, the [Secretary](/usc/42/1301.md?p=a-6), acting through the [Office](/usc/42/3058f.md?p=1) of the Inspector General of the Department of Health and Human Services, and the [Attorney General](/usc/42/14902.md?p=6) shall establish a [program](/usc/42/274l–1.md?p=4)—
    - (A) to coordinate Federal, [State](/usc/42/1301.md?p=a-1), and local [law enforcement](/usc/42/1397j.md?p=13) [programs](/usc/42/274l–1.md?p=4) to control fraud and [abuse](/usc/42/1397j.md?p=1) with respect to [health plans](#c),
    - (B) to conduct investigations, audits, evaluations, and [inspections](/usc/42/4851b.md?p=12) relating to the delivery of and payment for health care in the [United States](/usc/42/1301.md?p=a-2),
    - (C) to facilitate the enforcement of the provisions of sections [1320a–7](/usc/42/1320a–7.md), [1320a–7a](/usc/42/1320a–7a.md), and [1320a–7b](/usc/42/1320a–7b.md) of this title and other statutes applicable to health care fraud and [abuse](/usc/42/1397j.md?p=1), and
    - (D) to provide for the [modification](/usc/42/7501.md?p=4) and establishment of safe harbors and to issue advisory opinions and special fraud alerts pursuant to [section 1320a–7d of this title](/usc/42/1320a–7d.md).
  - (2) **Coordination with health plans—** In carrying out the [program](/usc/42/274l–1.md?p=4) established under [paragraph (1)](#a-1), the [Secretary](/usc/42/1301.md?p=a-6) and the [Attorney General](/usc/42/14902.md?p=6) shall consult with, and arrange for the sharing of data with [representatives](/usc/42/3058f.md?p=5) of [health plans](#c).
  - (3) **Guidelines—**
    - (A) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) and the [Attorney General](/usc/42/14902.md?p=6) shall issue guidelines to carry out the [program](/usc/42/274l–1.md?p=4) under [paragraph (1)](#a-1). The provisions of sections [553](/usc/5/553.md), [556](/usc/5/556.md), and [557](/usc/5/557.md) of title 5 shall not apply in the issuance of such guidelines.
    - (B) **Information guidelines—**
      - (i) **In general—** Such guidelines shall include guidelines relating to the furnishing of information by [health plans](#c), providers, and others to enable the [Secretary](/usc/42/1301.md?p=a-6) and the [Attorney General](/usc/42/14902.md?p=6) to carry out the [program](/usc/42/274l–1.md?p=4) ([including](/usc/42/1301.md?p=b) coordination with [health plans](#c) under [paragraph (2)](#a-2)).
      - (ii) **Confidentiality—** Such guidelines shall include procedures to assure that such information is provided and utilized in a manner that appropriately protects the confidentiality of the information and the privacy of individuals receiving health care services and items.
      - (iii) **Qualified immunity for providing information—** The provisions of [section 1320c–6(a) of this title](/usc/42/1320c–6.md?p=a) (relating to limitation on liability) shall apply to a [person](/usc/42/1301.md?p=a-3) providing information to the [Secretary](/usc/42/1301.md?p=a-6) or the [Attorney General](/usc/42/14902.md?p=6) in conjunction with their performance of duties under this section.
  - (4) **Ensuring access to documentation—** The Inspector General of the Department of Health and Human Services is authorized to exercise such authority described in paragraphs (3) through (9) of [section 406(a) of title 5](/usc/5/406.md?p=a) as necessary with respect to the activities under the fraud and [abuse](/usc/42/1397j.md?p=1) control [program](/usc/42/274l–1.md?p=4) established under this subsection.
  - (5) **Authority of Inspector General—** Nothing in this chapter shall be construed to diminish the authority of any Inspector General, [including](/usc/42/1301.md?p=b) such authority as provided in [chapter 4](/usc/5/chptI-ch4.md) of title 5.
  - (6) **Public-private partnership for waste, fraud, and abuse detection—**
    - (A) **In general—** Under the [program](/usc/42/274l–1.md?p=4) described in [paragraph (1)](#a-1), there is established a public-private partnership (in this paragraph referred to as the “partnership”) of [health plans](#c), Federal and [State agencies](/usc/42/1320a–7a.md?p=i-1), [law enforcement](/usc/42/1397j.md?p=13) [agencies](/usc/42/1397n–12.md?p=1), health care anti-fraud organizations, and any other entity determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6) (in this paragraph referred to as “partners”) for purposes of detecting and preventing health care waste, fraud, and [abuse](/usc/42/1397j.md?p=1).
    - (B) **Contract with trusted third party—** In carrying out the partnership, the [Secretary](/usc/42/1301.md?p=a-6) shall enter into a contract with a [trusted third party](#a-6-K) for purposes of carrying out the duties of the partnership described in [subparagraph (C)](#a-6-C).
    - (C) **Duties of partnership—** The partnership shall—
      - (i) provide technical and operational support to facilitate data sharing between partners in the partnership;
      - (ii) analyze data so shared to identify fraudulent and aberrant billing patterns;
      - (iii) conduct aggregate analyses of health care data so shared across Federal, [State](/usc/42/1301.md?p=a-1), and private [health plans](#c) for purposes of detecting fraud, waste, and [abuse](/usc/42/1397j.md?p=1) schemes;
      - (iv) identify outlier trends and potential vulnerabilities of partners in the partnership with respect to such schemes;
      - (v) refer specific cases of potential unlawful conduct to appropriate governmental entities;
      - (vi) convene, not less than annually, meetings with partners in the partnership for purposes of providing updates on the partnership’s work and facilitating information sharing between the partners;
      - (vii) enter into data sharing and data use [agreements](/usc/42/1320b–8.md?p=a-3-A) with partners in the partnership in such a manner so as to ensure the partnership has access to data necessary to identify waste, fraud, and [abuse](/usc/42/1397j.md?p=1) while maintaining the confidentiality and integrity of such data;
      - (viii) provide partners in the partnership with plan-specific, confidential feedback on any aberrant billing patterns or potential fraud identified by the partnership with respect to such partner;
      - (ix) establish a process by which entities described in [subparagraph (A)](#a-6-A) may enter the partnership and requirements such entities must meet to enter the partnership;
      - (x) provide appropriate [training](/usc/42/285e–2.md?p=b-2), outreach, and education to partners based on the results of data analyses described in clauses [(ii)](#a-6-C-ii) and [(iii)](#a-6-C-iii); and
      - (xi) perform such other duties as the [Secretary](/usc/42/1301.md?p=a-6) determines appropriate.
    - (D) **Substance use disorder treatment analysis—** Not later than 2 years after December 27, 2020, the [trusted third party](#a-6-K) with a contract in effect under [subparagraph (B)](#a-6-B) shall perform an analysis of aberrant or fraudulent billing patterns and trends with respect to providers and [suppliers](/usc/42/1395cc–4.md?p=a-2-I) of substance use disorder [treatments](/usc/42/11851.md?p=11) from data shared with the partnership.
    - (E) **Executive board—**
      - (i) **Executive board composition—**
        - (I) **In general—** There shall be an executive [board](/usc/42/10261.md?p=2) of the partnership comprised of [representatives](/usc/42/3058f.md?p=5) of the Federal Government and [representatives](/usc/42/3058f.md?p=5) of the private sector selected by the [Secretary](/usc/42/1301.md?p=a-6).
        - (II) **Chairs—** The executive [board](/usc/42/10261.md?p=2) shall be co-chaired by one Federal Government official and one [representative](/usc/42/3058f.md?p=5) from the private sector.
      - (ii) **Meetings—** The executive [board](/usc/42/10261.md?p=2) of the partnership shall meet at least once per year.
      - (iii) **Executive board duties—** The duties of the executive [board](/usc/42/10261.md?p=2) shall include the following:
        - (I) Providing strategic direction for the partnership, [including](/usc/42/1301.md?p=b) membership criteria and a mission statement.
        - (II) Communicating with the leadership of the Department of Health and Human Services and the Department of Justice and the various private health sector associations.
    - (F) **Reports—** Not later than January 1, 2023, and every 2 years thereafter, the [Secretary](/usc/42/1301.md?p=a-6) shall submit to Congress and make available on the public website of the Centers for Medicare & Medicaid Services a report containing—
      - (i) a review of activities conducted by the partnership over the 2-year period ending on the date of the submission of such report, [including](/usc/42/1301.md?p=b) any progress to any objectives established by the partnership;
      - (ii) any savings voluntarily reported by [health plans](#c) participating in the partnership attributable to the partnership during such period;
      - (iii) any savings to the Federal Government attributable to the partnership during such period;
      - (iv) any other outcomes attributable to the partnership, as determined by the [Secretary](/usc/42/1301.md?p=a-6), during such period; and
      - (v) a strategic plan for the 2-year period beginning on the day after the date of the submission of such report, [including](/usc/42/1301.md?p=b) a description of any emerging fraud and [abuse](/usc/42/1397j.md?p=1) schemes, trends, or [practices](/usc/42/17061.md?p=19) that the partnership intends to study during such period.
    - (G) **Funding—** The partnership shall be funded by amounts otherwise made available to the [Secretary](/usc/42/1301.md?p=a-6) for carrying out the [program](/usc/42/274l–1.md?p=4) described in [paragraph (1)](#a-1).
    - (H) **Transitional provisions—** To the extent consistent with this subsection, all functions, personnel, assets, liabilities, and administrative actions applicable on the date before December 27, 2020, to the National Fraud Prevention Partnership established on September 17, 2012, by charter of the [Secretary](/usc/42/1301.md?p=a-6) shall be transferred to the partnership established under [subparagraph (A)](#a-6-A) as of December 27, 2020.
    - (I) **Nonapplicability of FACA—** The provisions of the Federal Advisory Committee Act shall not apply to the partnership established by [subparagraph (A)](#a-6-A).
    - (J) **Implementation—** Notwithstanding any other provision of law, the [Secretary](/usc/42/1301.md?p=a-6) may implement the partnership established by [subparagraph (A)](#a-6-A) by [program](/usc/42/274l–1.md?p=4) instruction or otherwise.
    - (K) **Definition—** For purposes of this paragraph, the term “trusted third party” means an entity that—
      - (i) demonstrates the capability to carry out the duties of the partnership described in [subparagraph (C)](#a-6-C);
      - (ii) complies with such conflict of interest [standards](/usc/42/1320d.md?p=7) determined appropriate by the [Secretary](/usc/42/1301.md?p=a-6); and
      - (iii) meets such other requirements as the [Secretary](/usc/42/1301.md?p=a-6) may prescribe.
- (b) **Additional use of funds by Inspector General—**
  - (1) **Reimbursements for investigations—** The Inspector General of the Department of Health and Human Services is authorized to receive and retain for current use reimbursement for the costs of conducting investigations and audits and for monitoring compliance plans when such costs are ordered by a court, voluntarily agreed to by the payor, or otherwise.
  - (2) **Crediting—** [Funds](/usc/42/12854.md?p=3) received by the Inspector General under [paragraph (1)](#b-1) as reimbursement for costs of conducting investigations shall be deposited to the credit of the appropriation from which initially paid, or to appropriations for similar purposes currently available at the time of deposit, and shall remain available for obligation for 1 year from the date of the deposit of such [funds](/usc/42/12854.md?p=3).
- (c) **“Health plan” defined—** For purposes of this section, the term “health plan” means a plan or [program](/usc/42/274l–1.md?p=4) that provides health benefits, whether directly, through insurance, or otherwise, and [includes](/usc/42/1301.md?p=b)—
  - (1) a policy of health insurance;
  - (2) a contract of a service benefit organization; and
  - (3) a membership [agreement](/usc/42/1320b–8.md?p=a-3-A) with a health maintenance organization or other prepaid [health plan](#c).

# §1320a–7d. Guidance regarding application of health care fraud and abuse sanctions

- (a) **Solicitation and publication of modifications to existing safe harbors and new safe harbors—**
  - (1) **In general—**
    - (A) **Solicitation of proposals for safe harbors—** Not later than January 1, 1997, and not less than annually thereafter, the [Secretary](/usc/42/1301.md?p=a-6) shall publish a notice in the Federal Register soliciting proposals, which will be accepted during a 60-day period, for—
      - (i) [modifications](/usc/42/7501.md?p=4) to existing safe harbors issued pursuant to section 14(a) of the Medicare and Medicaid Patient and [Program](/usc/42/274l–1.md?p=4) Protection Act of 1987 ([42 U.S.C. 1320a–7b](/usc/42/1320a–7b.md) note);
      - (ii) additional safe harbors specifying payment [practices](/usc/42/17061.md?p=19) that shall not be treated as a criminal offense under [section 1320a–7b(b) of this title](/usc/42/1320a–7b.md?p=b) and shall not serve as the basis for an exclusion under [section 1320a–7(b)(7) of this title](/usc/42/1320a–7.md?p=b-7);
      - (iii) advisory opinions to be issued pursuant to [subsection (b)](#b); and
      - (iv) special fraud alerts to be issued pursuant to [subsection (c)](#c).
    - (B) **Publication of proposed modifications and proposed additional safe harbors—** After considering the proposals described in clauses [(i)](#a-1-A-i) and [(ii)](#a-1-A-ii) of subparagraph (A), the [Secretary](/usc/42/1301.md?p=a-6), in consultation with the [Attorney General](/usc/42/14902.md?p=6), shall publish in the Federal Register proposed [modifications](/usc/42/7501.md?p=4) to existing safe harbors and proposed additional safe harbors, if appropriate, with a 60-day comment period. After considering any public comments received during this period, the [Secretary](/usc/42/1301.md?p=a-6) shall issue final rules modifying the existing safe harbors and establishing new safe harbors, as appropriate.
    - (C) **Report—** The Inspector General of the Department of Health and Human Services (in this section referred to as the “Inspector General”) shall, in an annual report to Congress or as part of the year-end semiannual report required by [section 405 of title 5](/usc/5/405.md), describe the proposals received under clauses [(i)](#a-1-A-i) and [(ii)](#a-1-A-ii) of subparagraph (A) and explain which proposals were included in the publication described in [subparagraph (B)](#a-1-B), which proposals were not included in that publication, and the reasons for the rejection of the proposals that were not included.
  - (2) **Criteria for modifying and establishing safe harbors—** In modifying and establishing safe harbors under [paragraph (1)(B)](#a-1-B), the [Secretary](/usc/42/1301.md?p=a-6) may consider the extent to which providing a safe harbor for the specified payment practice may result in any of the following:
    - (A) An increase or decrease in access to health care services.
    - (B) An increase or decrease in the quality of health care services.
    - (C) An increase or decrease in patient freedom of choice among [health care providers](/usc/42/300jj.md?p=3).
    - (D) An increase or decrease in competition among [health care providers](/usc/42/300jj.md?p=3).
    - (E) An increase or decrease in the ability of health care [facilities](/usc/42/11049.md?p=4) to provide services in [medically underserved areas](/usc/42/254c–14.md?p=a-4) or to [medically underserved populations](/usc/42/254c.md?p=b-5).
    - (F) An increase or decrease in the cost to Federal health care [programs](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)).
    - (G) An increase or decrease in the potential overutilization of health care services.
    - (H) The existence or nonexistence of any potential financial benefit to a health care professional or provider which may vary based on their decisions of—
      - (i) whether to order a health care item or service; or
      - (ii) whether to arrange for a referral of health care items or services to a particular [practitioner](/usc/42/1395a.md?p=b-6-C) or provider.
    - (I) Any other factors the [Secretary](/usc/42/1301.md?p=a-6) deems appropriate in the interest of preventing fraud and [abuse](/usc/42/1397j.md?p=1) in Federal health care [programs](/usc/42/274l–1.md?p=4) (as so defined).
  - (3) **Consideration of safe harbor for certain contingency management interventions—**
    - (A) **In general—** Not later than one year after December 29, 2022, the Inspector General shall conduct a review on whether to establish a safe harbor described in [paragraph (1)(A)(ii)](#a-1-A-ii) for evidence-based contingency management incentives and the parameters for such a safe harbor. In conducting the review under the previous sentence, the Inspector General shall consider the extent to which providing such a safe harbor for evidence-based contingency management incentives may result in any of the factors described in [paragraph (2)](#a-2).
    - (B) **Report—** Not later than two years after December 29, 2022, the [Secretary](/usc/42/1301.md?p=a-6) and the Inspector General shall submit to Congress recommendations, [including](/usc/42/1301.md?p=b) based on the review conducted under [subparagraph (A)](#a-3-A), for improving access to evidence-based contingency management [interventions](/usc/42/1397n–12.md?p=2) while ensuring quality of care, ensuring fidelity to evidence-based [practices](/usc/42/17061.md?p=19), and [including](/usc/42/1301.md?p=b) strong [program](/usc/42/274l–1.md?p=4) integrity safeguards that prevent increased waste, fraud, and [abuse](/usc/42/1397j.md?p=1) and prevent medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care [program](/usc/42/274l–1.md?p=4).
- (b) **Advisory opinions—**
  - (1) **Issuance of advisory opinions—** The [Secretary](/usc/42/1301.md?p=a-6), in consultation with the [Attorney General](/usc/42/14902.md?p=6), shall issue written advisory opinions as provided in this subsection.
  - (2) **Matters subject to advisory opinions—** The [Secretary](/usc/42/1301.md?p=a-6) shall issue advisory opinions as to the following matters:
    - (A) What constitutes prohibited remuneration within the meaning of [section 1320a–7b(b) of this title](/usc/42/1320a–7b.md?p=b) or [section 1320a–7a(i)(6) of this title](/usc/42/1320a–7a.md?p=i-6).
    - (B) Whether an arrangement or proposed arrangement satisfies the criteria set forth in [section 1320a–7b(b)(3) of this title](/usc/42/1320a–7b.md?p=b-3) for activities which do not result in prohibited remuneration.
    - (C) Whether an arrangement or proposed arrangement satisfies the criteria which the [Secretary](/usc/42/1301.md?p=a-6) has established, or shall establish by regulation for activities which do not result in prohibited remuneration.
    - (D) What constitutes an inducement to reduce or limit services to individuals entitled to benefits under subchapter XVIII or subchapter XIX within the meaning of [section 1320a–7a(b) of this title](/usc/42/1320a–7a.md?p=b).
    - (E) Whether any activity or proposed activity constitutes grounds for the imposition of a sanction under section [1320a–7](/usc/42/1320a–7.md), [1320a–7a](/usc/42/1320a–7a.md), or [1320a–7b](/usc/42/1320a–7b.md) of this title.
  - (3) **Matters not subject to advisory opinions—** Such advisory opinions shall not address the following matters:
    - (A) Whether the fair market value shall be, or was paid or received for any goods, services or property.
    - (B) Whether an individual is a bona fide [employee](/usc/42/1320a–7h.md?p=e-7) within the requirements of section 3121(d)(2) of the Internal Revenue Code of 1986.
  - (4) **Effect of advisory opinions—**
    - (A) **Binding as to Secretary and parties involved—** Each advisory opinion issued by the [Secretary](/usc/42/1301.md?p=a-6) shall be binding as to the [Secretary](/usc/42/1301.md?p=a-6) and the party or parties requesting the opinion.
    - (B) **Failure to seek opinion—** The failure of a party to seek an advisory opinion may not be introduced into evidence to prove that the party intended to violate the provisions of sections[^1] 1320a–7, 1320a–7a, or 1320a–7b of this title.
  - (5) **Regulations—**
    - (A) **In general—** Not later than 180 days after August 21, 1996, the [Secretary](/usc/42/1301.md?p=a-6) shall issue regulations to carry out this section. Such regulations shall provide for—
      - (i) the procedure to be followed by a party applying for an advisory opinion;
      - (ii) the procedure to be followed by the [Secretary](/usc/42/1301.md?p=a-6) in responding to a request for an advisory opinion;
      - (iii) the interval in which the [Secretary](/usc/42/1301.md?p=a-6) shall respond;
      - (iv) the reasonable fee to be charged to the party requesting an advisory opinion; and
      - (v) the manner in which advisory opinions will be made available to the public.
    - (B) **Specific contents—** Under the regulations promulgated pursuant to [subparagraph (A)](#b-5-A)—
      - (i) the [Secretary](/usc/42/1301.md?p=a-6) shall be required to issue to a party requesting an advisory opinion by not later than 60 days after the request is received; and
      - (ii) the fee charged to the party requesting an advisory opinion shall be equal to the costs incurred by the [Secretary](/usc/42/1301.md?p=a-6) in responding to the request.
  - (6) **Application of subsection—** This subsection shall apply to requests for advisory opinions made on or after the date which is 6 months after August 21, 1996.
- (c) **Special fraud alerts—**
  - (1) **In general—**
    - (A) **Request for special fraud alerts—** Any [person](/usc/42/1301.md?p=a-3) may present, at any time, a request to the Inspector General for a notice which informs the public of [practices](/usc/42/17061.md?p=19) which the Inspector General considers to be suspect or of particular concern under the Medicare [program](/usc/42/274l–1.md?p=4) under subchapter XVIII or a [State](/usc/42/1301.md?p=a-1) health care [program](/usc/42/274l–1.md?p=4), as defined in [section 1320a–7(h) of this title](/usc/42/1320a–7.md?p=h) (in this subsection referred to as a “special fraud alert”).
    - (B) **Issuance and publication of special fraud alerts—** Upon receipt of a request described in [subparagraph (A)](#c-1-A), the Inspector General shall investigate the subject matter of the request to determine whether a special fraud alert should be issued. If appropriate, the Inspector General shall issue a special fraud alert in response to the request. All special fraud alerts issued pursuant to this subparagraph shall be published in the Federal Register.
  - (2) **Criteria for special fraud alerts—** In determining whether to issue a special fraud alert upon a request described in [paragraph (1)](#c-1), the Inspector General may consider—
    - (A) whether and to what extent the [practices](/usc/42/17061.md?p=19) that would be identified in the special fraud alert may result in any of the consequences described in [subsection (a)(2)](#a-2); and
    - (B) the volume and frequency of the conduct that would be identified in the special fraud alert.

# §1320a–7e. Health care fraud and abuse data collection program

- (a) **In general—** The [Secretary](/usc/42/1301.md?p=a-6) shall maintain a national health care fraud and [abuse](/usc/42/1397j.md?p=1) data collection [program](/usc/42/274l–1.md?p=4) under this section for the reporting of certain [final adverse actions](#g-1-A) (not [including](/usc/42/1301.md?p=b) settlements in which no findings of liability have been made) against [health care providers](/usc/42/300jj.md?p=3), [suppliers](/usc/42/1395cc–4.md?p=a-2-I), or [practitioners](#g-2) as required by [subsection (b)](#b), with access as set forth in [subsection (d)](#d), and shall furnish the information collected under this section to the National [Practitioner](#g-2) Data Bank established pursuant to the Health Care Quality Improvement Act of 1986 ([42 U.S.C. 11101](/usc/42/11101.md) et seq.).
- (b) **Reporting of information—**
  - (1) **In general—** Each [Government agency](#g-3) and [health plan](/usc/42/300jj.md?p=6) shall report any [final adverse action](#g-1-A) (not [including](/usc/42/1301.md?p=b) settlements in which no findings of liability have been made) taken against a [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2).
  - (2) **Information to be reported—** The information to be reported under [paragraph (1)](#b-1) [includes](/usc/42/1301.md?p=b):
    - (A) The name and TIN (as defined in section 7701(a)(41) of the Internal Revenue Code of 1986) of any [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2) who is the subject of a [final adverse action](#g-1-A).
    - (B) The name (if known) of any health care entity with which a [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2), who is the subject of a [final adverse action](#g-1-A), is affiliated or associated.
    - (C) The nature of the [final adverse action](#g-1-A) and whether such action is on appeal.
    - (D) A description of the acts or omissions and injuries upon which the [final adverse action](#g-1-A) was based, and such other information as the [Secretary](/usc/42/1301.md?p=a-6) determines by regulation is required for appropriate interpretation of information reported under this section.
  - (3) **Confidentiality—** In determining what information is required, the [Secretary](/usc/42/1301.md?p=a-6) shall include procedures to assure that the privacy of individuals receiving health care services is appropriately protected.
  - (4) **Timing and form of reporting—** The information required to be reported under this subsection shall be reported regularly (but not less often than monthly) and in such form and manner as the [Secretary](/usc/42/1301.md?p=a-6) prescribes. Such information shall first be required to be reported on a date specified by the [Secretary](/usc/42/1301.md?p=a-6).
  - (5) **To whom reported—** The information required to be reported under this subsection shall be reported to the [Secretary](/usc/42/1301.md?p=a-6).
  - (6) **Sanctions for failure to report—**
    - (A) **Health plans—** Any [health plan](/usc/42/300jj.md?p=6) that fails to report information on an adverse action required to be reported under this subsection shall be subject to a civil money penalty of not more than $25,000 for each such adverse action not reported. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of [section 1320a–7a of this title](/usc/42/1320a–7a.md) are imposed and collected under that section.
    - (B) **Governmental agencies—** The [Secretary](/usc/42/1301.md?p=a-6) shall provide for a publication of a public report that identifies those [Government agencies](#g-3) that have failed to report information on adverse actions as required to be reported under this subsection.
- (c) **Disclosure and correction of information—**
  - (1) **Disclosure—** With respect to the information about [final adverse actions](#g-1-A) (not [including](/usc/42/1301.md?p=b) settlements in which no findings of liability have been made) reported to the [Secretary](/usc/42/1301.md?p=a-6) under this section with respect to a [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2), the [Secretary](/usc/42/1301.md?p=a-6) shall, by regulation, provide for—
    - (A) disclosure of the information, upon request, to the [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [licensed practitioner](#g-2), and
    - (B) procedures in the case of disputed accuracy of the information.
  - (2) **Corrections—** Each [Government agency](#g-3) and [health plan](/usc/42/300jj.md?p=6) shall report corrections of information already reported about any [final adverse action](#g-1-A) taken against a [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2), in such form and manner that the [Secretary](/usc/42/1301.md?p=a-6) prescribes by regulation.
- (d) **Access to reported information—**
  - (1) **Availability—** The information collected under this section shall be available from the National [Practitioner](#g-2) Data Bank to the [agencies](/usc/42/1397n–12.md?p=1), authorities, and officials which are provided under [section 1396r–2(b) of this title](/usc/42/1396r–2.md?p=b) information reported under [section 1396r–2(a) of this title](/usc/42/1396r–2.md?p=a).
  - (2) **Fees for disclosure—** The [Secretary](/usc/42/1301.md?p=a-6) may establish or approve reasonable fees for the disclosure of information under this section. The amount of such a fee may not exceed the costs of processing the requests for disclosure and of providing such information. Such fees shall be available to the [Secretary](/usc/42/1301.md?p=a-6) to cover such costs.
- (e) **Protection from liability for reporting—** No [person](/usc/42/1301.md?p=a-3) or entity, [including](/usc/42/1301.md?p=b) the [agency](/usc/42/1397n–12.md?p=1) designated by the [Secretary](/usc/42/1301.md?p=a-6) in [subsection (b)(5)](#b-5) shall be held liable in any civil action with respect to any report made as required by this section, without knowledge of the falsity of the information contained in the report.
- (f) **Appropriate coordination—** In implementing this section, the [Secretary](/usc/42/1301.md?p=a-6) shall provide for the maximum appropriate coordination with part B of the Health Care Quality Improvement Act of 1986 ([42 U.S.C. 11131](/usc/42/11131.md) et seq.) and [section 1396r–2 of this title](/usc/42/1396r–2.md).
- (g) **Definitions and special rules—** For purposes of this section:
  - (1) **Final adverse action—**
    - (A) **In general—** The term “final adverse action” [includes](/usc/42/1301.md?p=b):
      - (i) Civil judgments against a [health care provider](/usc/42/300jj.md?p=3), [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2) in Federal or [State](/usc/42/1301.md?p=a-1) court related to the delivery of a health care item or service.
      - (ii) Federal or [State](/usc/42/1301.md?p=a-1) criminal convictions related to the delivery of a health care item or service.
      - (iii) Actions by Federal [agencies](/usc/42/1397n–12.md?p=1) responsible for the licensing and certification of [health care providers](/usc/42/300jj.md?p=3), [suppliers](/usc/42/1395cc–4.md?p=a-2-I), and [licensed health care practitioners](#g-2), [including](/usc/42/1301.md?p=b)—
        - (I) formal or official actions, such as revocation or suspension of a license (and the length of any such suspension), reprimand, censure or probation,
        - (II) any dismissal or closure of the proceedings by reason of the provider, [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2) surrendering their license or leaving the [State](/usc/42/1301.md?p=a-1) or jurisdiction[^1]
        - (III) any other loss of license or the right to apply for, or renew, a license of the provider, [supplier](/usc/42/1395cc–4.md?p=a-2-I), or [practitioner](#g-2), whether by operation of law, voluntary surrender, non-renewability, or otherwise, or
        - (IV) any other negative action or finding by such Federal [agency](/usc/42/1397n–12.md?p=1) that is publicly available information.
      - (iv) Exclusion from participation in a Federal health care [program](/usc/42/274l–1.md?p=4) (as defined in [section 1320a–7b(f) of this title](/usc/42/1320a–7b.md?p=f)).
      - (v) Any other adjudicated actions or decisions that the [Secretary](/usc/42/1301.md?p=a-6) shall establish by regulation.
    - (B) **Exception—** The term does not include any action with respect to a malpractice [claim](/usc/42/1320a–7a.md?p=i-2).
  - (2) **Practitioner—** The terms “licensed health care practitioner”, “licensed practitioner”, and “practitioner” mean, with respect to a [State](/usc/42/1301.md?p=a-1), an individual who is licensed or otherwise authorized by the [State](/usc/42/1301.md?p=a-1) to provide health care services (or any individual who, without authority holds himself or herself out to be so licensed or authorized).
  - (3) **Government agency—** The term “Government agency” shall include:
    - (A) The Department of Justice.
    - (B) The Department of Health and Human Services.
    - (C) Any other Federal [agency](/usc/42/1397n–12.md?p=1) that either administers or provides payment for the delivery of health care services, [including](/usc/42/1301.md?p=b), but not limited to the Department of Defense and the Department of Veterans Affairs.
    - (D) Federal [agencies](/usc/42/1397n–12.md?p=1) responsible for the licensing and certification of [health care providers](/usc/42/300jj.md?p=3) and [licensed health care practitioners](#g-2).
  - (4) **Health plan—** The term “[health plan](/usc/42/300jj.md?p=6)” has the meaning given such term by [section 1320a–7c(c) of this title](/usc/42/1320a–7c.md?p=c).
  - (5) **Determination of conviction—** For purposes of [paragraph (1)](#g-1), the existence of a conviction shall be determined under paragraphs (1) through (4) of [section 1320a–7(i) of this title](/usc/42/1320a–7.md?p=i).