The Secretary shall exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1320a-7b(f) of this title):
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.
Any individual or entity that has been convicted, under Federal or State law, of a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service.
Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or State 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 (other than those specifically described in paragraph (1)) operated by or financed in whole or in part by any Federal, State, or local government agency, of a criminal offense consisting of a felony relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct.
Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or State law, of a criminal offense consisting of a felony relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.
The Secretary may exclude the following individuals and entities from participation in any Federal health care program (as defined in section 1320a-7b(f) of this title):
Any individual or entity that has been convicted for an offense which occurred after August 21, 1996, under Federal or State law-
Any individual or entity that has been convicted, under Federal or State law, in connection with the interference with or obstruction of any investigation or audit related to-
Any individual or entity that has been convicted, under Federal or State law, of a criminal offense consisting of a misdemeanor relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.
Any individual or entity-
Any individual or entity which has been suspended or excluded from participation, or otherwise sanctioned, under-
for reasons bearing on the individual's or entity's professional competence, professional performance, or financial integrity.
Any individual or entity that the Secretary determines-
and has failed substantially to provide medically necessary items and services that are required (under law or the contract with the State 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
Any individual or entity that the Secretary determines has committed an act which is described in section 1320a-7a, 1320a-7b, or 1320a-8 of this title.
Any entity with respect to which the Secretary determines that a person-
is a person-
Any entity that did not fully and accurately make any disclosure required by section 1320a-3 of this title, section 1320a-3a of this title, or section 1320a-5 of this title.
Any disclosing entity (as defined in section 1320a-3(a)(2) of this title) that fails to supply (within such period as may be specified by the Secretary in regulations) upon request specifically addressed to the entity by the Secretary or by the State agency administering or supervising the administration of a State health care program-
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 that fails to provide such information as the Secretary or the appropriate State agency 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 or that agency as may be necessary to verify such information.
Any individual or entity that fails to grant immediate access, upon reasonable request (as defined by the Secretary in regulations) to any of the following:
Any hospital that fails to comply substantially with a corrective action required under section 1395ww(f)(2)(B) of this title.
Any individual who the Secretary 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 and with respect to whom the Secretary has taken all reasonable steps available to the Secretary to secure repayment of such obligations or loans, except that (A) the Secretary shall not exclude pursuant to this paragraph a physician who is the sole community physician or sole source of essential specialized services in a community if a State requests that the physician not be excluded, and (B) the Secretary shall take into account, in determining whether to exclude any other physician pursuant to this paragraph, access of beneficiaries to physician services for which payment may be made under subchapter XVIII or XIX.
Any individual or entity that knowingly makes or causes to be made any false statement, omission, or misrepresentation of a material fact in any application, agreement, bid, or contract to participate or enroll as a provider of services or supplier under a Federal health care program (as defined in section 1320a-7b(f) of this title), including Medicare Advantage organizations under part C of subchapter XVIII, prescription drug plan sponsors under part D of subchapter XVIII, medicaid managed care organizations under subchapter XIX, and entities that apply to participate as providers of services or suppliers in such managed care organizations and such plans.
Any manufacturer or officer, director, agent, or managing employee of such manufacturer that knowingly misclassifies a covered outpatient drug under an agreement under section 1396r-8 of this title, knowingly fails to correct such misclassification, or knowingly provides false information related to drug pricing, drug product information, or data related to drug pricing or drug product information.
until the passage of 30 days after the effective date of the exclusion.
The Secretary shall-
For purposes of this section and sections 1320a-7a and 1320a-7b of this title, the term "State health care program" means-
For purposes of subsections (a) and (b), an individual or entity is considered to have been "convicted" of a criminal offense-
For purposes of subsection (b)(8)(A)(iii):
1 So in original. Probably should be section "1320a-7a(i)(7)".
2 See References in Text note below.
42 U.S.C. § 1320a-7
EDITORIAL NOTES
REFERENCES IN TEXTDivision A of subchapter XX, referred to in subsec. (h)(3), was in the original a reference to subtitle 1 of title XX, which was translated as if referring to subtitle A of title XX of the Social Security Act, to reflect the probable intent of Congress. Title XX of the Act, enacting subchapter XX of this chapter, does not contain a subtitle 1.
AMENDMENTS2019-Subsec. (b)(17). Pub. L. 116-16 added par. (17).2010-Subsec. (b)(2). Pub. L. 111-148, §6408(c), inserted "or audit" after "investigation" in the heading, substituted "investigation or audit related to-" for "investigation into any criminal offense described in paragraph (1) or in subsection (a) of this section.", and added cls. (i) and (ii).Subsec. (b)(11). Pub. L. 111-148, §6406(c), inserted ", ordering, referring for furnishing, or certifying the need for" after "furnishing". Subsec. (b)(16). Pub. L. 111-148, §6402(d)(1), added par. (16).Subsec. (c)(3)(B). Pub. L. 111-148, §6402(k), substituted "beneficiaries (as defined in section 1320a-7a(i)(5) of this title) of that program" for "individuals entitled to benefits under part A of subchapter XVIII or enrolled under part B of such subchapter, or both".Subsec. (f)(4). Pub. L. 111-148, §6402(e), added par. (4).Subsec. (h)(3). Pub. L. 111-148, §6703(d)(3)(A), inserted "division A of" before "subchapter XX" and substituted "such division" for "such subchapter". 2003-Subsec. (c)(3)(B). Pub. L. 108-173 amended first sentence generally. Prior to amendment, first sentence read as follows: "Subject to subparagraph (G), in the case of an exclusion under subsection (a) of this section, the minimum period of exclusion shall be not less than five years, except that, upon the request of a State, the Secretary may waive the exclusion under subsection (a)(1) of this section in the case of an individual or entity that is the sole community physician or sole source of essential specialized services in a community." 1997-Subsec. (a). Pub. L. 105-33, §4331(c)(1), substituted "any Federal health care program (as defined in section 1320a-7b(f) of this title)" for "any program under subchapter XVIII and shall direct that the following individuals and entities be excluded from participation in any State health care program (as defined in subsection (h) of this section)" in introductory provisions.Subsec. (b). Pub. L. 105-33, §4331(c)(2), substituted "any Federal health care program (as defined in section 1320a-7b(f) of this title)" for "any program under subchapter XVIII and may direct that the following individuals and entities be excluded from participation in any State health care program" in introductory provisions.Subsec. (b)(8)(A)(iii). Pub. L. 105-33, §4303(a)(1), added cl. (iii).Subsec. (c)(3)(A). Pub. L. 105-33, §4301(1), inserted "or in the case described in subparagraph (G)" after "subsection (b)(12)".Subsec. (c)(3)(B), (D). Pub. L. 105-33, §4301(2), substituted "Subject to subparagraph (G), in the case" for "In the case".Subsec. (c)(3)(G). Pub. L. 105-33, §4301(3), added subpar. (G).Subsec. (h)(4). Pub. L. 105-33, §4901(b)(2), added par. (4).Subsec. (j). Pub. L. 105-33, §4303(a)(2), added subsec. (j). 1996-Subsec. (a)(3). Pub. L. 104-191, §211(a)(1), added par. (3).Subsec. (a)(4). Pub. L. 104-191, §211(b)(1), added par. (4).Subsec. (b)(1). Pub. L. 104-191, §211(a)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Any individual or entity that has been convicted, under Federal or State law, in connection with the delivery of a health care item or service or with respect to any act or omission in a program operated by or financed in whole or in part by any Federal, State, or local government agency, of a criminal offense relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct."Subsec. (b)(3). Pub. L. 104-191, §211(b)(2), substituted "Misdemeanor conviction" for "conviction" in heading and "criminal offense consisting of a misdemeanor" for "criminal offense" in text.Subsec. (b)(15). Pub. L. 104-191, §213, added par. (15).Subsec. (c)(3)(D) to (F). Pub. L. 104-191, §212, added subpars. (D) to (F). 1994-Subsec. (b)(7). Pub. L. 103-296, §206(b)(2)(A), substituted "section 1320a-7a, 1320a-7b, or 1230a-8 of this title" for "section 1320a-7a of this title or section 1320a-7b of this title". Subsec. (b)(8)(B)(ii). Pub. L. 103-296, §206(b)(2)(B), inserted "or 1320a-8" after "section 1320a-7a". Subsec. (f)(1). Pub. L. 103-296, §108(b)(9)(A), inserted before period at end ", except that, in so applying such sections and section 405(l) of this title, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively". Subsec. (f)(3). Pub. L. 103-296, §206(b)(2)(C), inserted ", 1320a-8," after "sections 1320a-7a". Pub. L. 103-296, §108(b)(9)(B), inserted before period at end ", except that, in so applying such section and section 405(l) of this title, any reference therein to the Commissioner of Social Security shall be considered a reference to the Secretary". 1991-Subsec. (b)(5)(A). Pub. L. 102-54 substituted "Department of Veterans Affairs" for "Veterans' Administration". 1990-Subsec. (b)(9). Pub. L. 101-508 substituted "section 1320a-3 of this title, section 1320a-3a of this title," for "section 1320a-3 of this title". 1989-Subsec. (b)(4)(A). Pub. L. 101-239 inserted "or the right to apply for or renew such a license" after "lost such a license".1988-Pub. L. 100-360, §411(k)(10)(D), added Pub. L. 100-203, §4118(e)(3)-(5), which amended subsec. (b)(8)(A)(i), (d)(1), (3)(A), and (i). See 1987 Amendment notes below.Subsec. (d)(3)(B)(ii). Pub. L. 100-360, §411(k)(10)(C), struck out "under a program" after "longer than the period of exclusion".1987-Pub. L. 100-93 amended section generally, substituting subsecs. (a) to (i) for former subsecs. (a) to (f).Subsec. (b)(8)(A)(i). Pub. L. 100-203, §4118(e)(3), as added by Pub. L. 100-360, §411(k)(10)(D), inserted at beginning "who has a direct or indirect ownership or control interest of 5 percent or more in the entity or".Subsec. (d)(1). Pub. L. 100-203, §4118(e)(4)(A), as added by Pub. L. 100-360, §411(k)(10)(D), substituted "this section and section 1320a-7a of this title" for "subsection (b) of this section". Subsec. (d)(3)(A). Pub. L. 100-203, §4118(e)(4)(B), as added by Pub. L. 100-360, §411(k)(10)(D), struck out "under a program" after "any period of exclusion". Subsec. (d)(3)(B). Pub. L. 100-203, §4118(e)(2), designated existing provisions as cl. (i) and added cl. (ii). Subsec. (i). Pub. L. 100-203, §4118(e)(5)(A), as added by Pub. L. 100-360, §411(k)(10)(D), substituted "an individual or entity" for "a physician or other individual" in introductory provisions.Pub. L. 100-203, §4118(e)(5)(B), as added by Pub. L. 100-360, §411(k)(10)(D), which directed amendment of pars. (1) to (4) by substituting "individual or entity" for "physician or other individual" each place it appears, was executed by substituting "individual or entity" for "physician or individual" in pars. (1) to (4) as the probable intent of Congress.Subsec. (i)(4). Pub. L. 100-203, §4118(e)(5)(C), as added by Pub. L. 100-360, §411(k)(10)(D), substituted "first offender, deferred adjudication, or other arrangement or program" for "first offender or other program". 1986-Subsec. (f). Pub. L. 99-509 added subsec. (f).1984-Subsecs. (b) to (e). Pub. L. 98-369 added subsec. (b), redesignated former subsecs. (b) to (d) as (c) to (e), respectively, and in subsec. (e) substituted "Any person or entity" for "Any person" and "(a), (b), or (c)" for "(a) or (b)". 1981-Subsec. (a)(1). Pub. L. 97-35, §2105(b)(1), struck out ", for such period as he may deem appropriate," after "subchapter XVIII of this chapter".Subsec. (a)(2). Pub. L. 97-35, §2353(k), substituted in subpar. (A) "subchapter XIX of this chapter" for "subchapter XIX or subchapter XX of this chapter," and in subpar. (B) "subchapter XIX of this chapter" for "subchapter XIX or subchapter XX of this chapter". Subsecs. (b) to (d). Pub. L. 97-35, §2105(b)(2)-(4), added subsec. (b), redesignated former subsecs. (b) and (c) as (c) and (d), respectively, and in subsec. (d) as so redesignated substituted "subsection (a) or (b)" for "subsection (a)".
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2019 AMENDMENT Pub. L. 116-16, §6(e), Apr. 18, 2019, 133 Stat. 864, provided that: "The amendments made by this section [amending this section and sections 1396b and 1396r-8 of this title] shall take effect on the date of the enactment of this Act [Apr. 18, 2019], and shall apply to covered outpatient drugs supplied by manufacturers under agreements under section 1927 of the Social Security Act (42 U.S.C. 1396r-8) on or after such date."
EFFECTIVE DATE OF 2010 AMENDMENT Pub. L. 111-148, §6406, 124 Stat. 769, provided that: "The amendments made by this section [amending this section and sections 1395u and 1395cc of this title] shall apply to orders, certifications, and referrals made on or after January 1, 2010." Pub. L. 111-148, §6408, 124 Stat. 772, provided that:"(1) IN GENERAL.-Except as provided in paragraph (2), the amendments made by this section [amending this section and sections 1320a-7a and 1395w-27 of this title] shall apply to acts committed on or after January 1, 2010."(2) EXCEPTION.-The amendments made by subsection (b)(1) [amending section 1395w-27 of this title] take effect on the date of enactment of this Act [Mar. 23, 2010]."
EFFECTIVE DATE OF 1997 AMENDMENT Pub. L. 105-33, §4303, 111 Stat. 383, provided that: "The amendments made by this section [amending this section] shall take effect on the date that is 45 days after the date of the enactment of this Act [Aug. 5, 1997]."Amendments by section 4331(c) of Pub. L. 105-33 effective Aug. 5, 1997, see section 4331(f)(2) of Pub. L. 105-33, set out as a note under section 1320a-7e of this title.
EFFECTIVE DATE OF 1996 AMENDMENT Pub. L. 104-191, §218, 110 Stat. 2009, provided that: "Except as otherwise provided, the amendments made by this subtitle [subtitle B, §§211-218, of title II of Pub. L. 104-191, amending this section and sections 1320a-7b, 1320c-5, and 1395mm of this title] shall take effect January 1, 1997."
EFFECTIVE DATE OF 1994 AMENDMENT Amendment by section 108(b)(9) of Pub. L. 103-296 effective Mar. 31, 1995, see section 110(a) of Pub. L. 103-296, set out as a note under section 401 of this title. Pub. L. 103-296, §206, 108 Stat. 1513, provided that: "The amendments made by this subsection [enacting section 1320a-8 of this title and amending this section] shall apply to conduct occurring on or after October 1, 1994."
EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101-508 applicable with respect to items or services furnished on or after Jan. 1, 1993, in the case of items or services furnished by a provider who, on or before Nov. 5, 1990, has furnished items or services for which payment may be made under part B of subchapter XVIII of this chapter, or Jan. 1, 1992, in the case of items or services furnished by any other provider, see section 4164(b)(4) of Pub. L. 101-508, set out as an Effective Date note under section 1320a-3a of this title.
EFFECTIVE DATE OF 1989 AMENDMENT Pub. L. 101-239, §6411(d)(4) [(A)], Dec. 19, 1989, 103 Stat. 2271, provided that: "The amendments made by paragraphs (1) and (2) [amending this section and sections 1395y and 1396b of this title] shall take effect on the date of the enactment of this Act [Dec. 19, 1989]."
EFFECTIVE DATE OF 1988 AMENDMENT Except as specifically provided in section 411 of Pub. L. 100-360, amendment by Pub. L. 100-360, as it relates to a provision in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203, effective as if included in the enactment of that provision in Pub. L. 100-203, see section 411(a) of Pub. L. 100-360 set out as a Reference to OBRA; Effective Date note under section 106 of Title 1, General Provisions.
EFFECTIVE DATE OF 1987 AMENDMENT Pub. L. 100-93, §15, Aug. 18, 1987, 101 Stat. 698, provided that:"(a) IN GENERAL.-Except as provided in subsections (b), (c), (d), and (e), the amendments made by this Act [enacting sections 1395aaa and 1396r-2 of this title, amending this section, sections 704, 1320a-3, 1320a-5, 1320a-7a, 1320a-7b, 1320c-5, 1395u, 1395y, 1395cc, 1395ff, 1395nn, 1395rr, 1395ss, 1395ww, 1396a, 1396b, 1396h, 1396n, 1396s, and 1397d of this title, and section 824 of Title 21, Food and Drugs, transferring section 1396h of this title to section 1320a-7b of this title, repealing section 1395nn of this title, enacting provisions set out as a note under section 1320a-7b of this title, and amending provisions set out as a note under section 1396a of this title] shall become effective at the end of the fourteen-day period beginning on the date of the enactment of this Act [Aug. 18, 1987] and shall not apply to administrative proceedings commenced before the end of such period."(b) MANDATORY MINIMUM EXCLUSIONS APPLY PROSPECTIVELY.-Section 1128(c)(3)(B) of the Social Security Act [42 U.S.C. 1320a-7(c)(3)(B)] (as amended by this Act), which requires an exclusion of not less than five years in the case of certain exclusions, shall not apply to exclusions based on convictions occurring before the date of the enactment of this Act [Aug. 18, 1987]."(c) EFFECTIVE DATE FOR CHANGES IN MEDICAID LAW.-(1) The amendments made by sections 5 and 8(f) [enacting section 1396r-2 of this title and amending sections 1396a and 1396s of this title] apply (except as provided under paragraph (2)) to payments under title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for calendar quarters beginning more than thirty days after the date of the enactment of this Act [Aug. 18, 1987], without regard to whether or not final regulations to carry out such amendment have been published by such date."(2) In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirements imposed by the amendments made by this Act, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act."(3) Subsection (j) of section 1128A of the Social Security Act [42 U.S.C. 1320a-7a(j)] (as added by section 3(f) of this Act) takes effect on the date of the enactment of this Act."(d) PHYSICIAN MISREPRESENTATIONS.-Clauses (ii) and (iii) of section 1128A(a)(1)(C) of the Social Security Act [42 U.S.C. 1320a-7a(a)(1)(C)(ii), (iii)], as amended by section 3(a)(1) of this Act, apply to claims presented for services performed on or after the effective date specified in subsection (a), without regard to the date the misrepresentation of fact was made. "(e) CLARIFICATION OF MEDICAID MORATORIUM.-The amendments made by section 9 of this Act [amending provisions set out as a note under section 1396a of this title] shall apply as though they were originally included in the enactment of section 2373(c) of the Deficit Reduction Act of 1984 [set out as a note under section 1396a of this title]."(f) TREATMENT OF CERTAIN DENIALS OF PAYMENT.-For purposes of section 1128(b)(8)(B)(iii) of the Social Security Act [42 U.S.C. 1320a-7(b)(8)(B)(iii)] (as amended by section 2 of this Act), a person shall be considered to have been excluded from participation under a program under title XVIII [42 U.S.C. 1395 et seq.] if payment to the person has been denied under section 1862(d) of the Social Security Act [42 U.S.C. 1395y(d)], as in effect before the effective date specified in subsection (a)."
EFFECTIVE DATE OF 1986 AMENDMENT Pub. L. 99-509, title IX, §9317(d)(3), Oct. 21, 1986, 100 Stat. 2009, provided that: "The provisions-"(A) of paragraphs (1), (2), and (3) of section 1128(f) of the Social Security Act [42 U.S.C. 1320a-7(f)(1)-(3)] (as added by the amendment made by subsection (c)) shall apply to judgments entered, findings made, and pleas entered, before, on, or after the date of the enactment of this Act [Oct. 21, 1986], and "(B) of paragraph (4) of such section [42 U.S.C. 1320a-7(f)(4)] shall apply to participation in a program entered into on or after the date of the enactment of this Act."
EFFECTIVE DATE OF 1984 AMENDMENT Pub. L. 98-369, div. B, title III, §2333(c), July 18, 1984, 98 Stat. 1089, provided that: "The amendments made by this section [amending this section] become effective on the date of the enactment of this Act [July 18, 1984] and shall apply to convictions of persons occurring after such date."
EFFECTIVE DATE OF 1981 AMENDMENT Amendment by section 2353(k) of Pub. L. 97-35 effective Oct. 1, 1981, except as otherwise explicitly provided, see section 2354 of Pub. L. 97-35, set out as an Effective Date note under section 1397 of this title.
- Administrator
- The term "Administrator" means the Administrator of General Services.
- Secretary
- The term "Secretary" means the Secretary of Housing and Urban Development.1 See References in Text note below.
- person
- The term "person" means an individual, a trust or estate, a partnership, or a corporation.
- Director
- the term "Director" means the Chief Executive Officer of the Corporation for National and Community Service,
- drug
- the term "drug" means-(A) a beverage containing alcohol,(B) a controlled substance, or(C) a controlled substance analogue,