42 U.S.C. §§ 1320a–7–1320a–7e

6 sections in range

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

42 U.S.C. § 1320a–7

(a)

Mandatory exclusion— 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):

(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.

(2)

Conviction relating to patient abuse— 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.

(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 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.

(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 law, of a criminal offense consisting of a felony relating to the unlawful manufacture, distribution, prescription, or dispensing of a controlled substance.

(b)

Permissive exclusion— 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):

(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 law—

(A)

of a criminal offense consisting of a misdemeanor relating to fraud, theft, embezzlement, breach of fiduciary 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 (other than those specifically described in subsection (a)(1)) operated by or financed in whole or in part by any Federal, State, or local government agency; or

(B)

of a criminal offense relating to fraud, theft, embezzlement, breach of fiduciary responsibility, or other financial misconduct with respect to any act or omission in a program (other than a health care program) operated by or financed in whole or in part by any Federal, State, or local government agency.

(2)

Conviction relating to obstruction of an investigation or audit— 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—

(i)

any offense described in paragraph (1) or in subsection (a); or

(ii)

the use of funds received, directly or indirectly, from any Federal health care program (as defined in section 1320a–7b(f) of this title).

(3)

Misdemeanor conviction relating to controlled substance— 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.

(4)

License revocation or suspension— Any individual or entity—

(A)

whose license to provide health care has been revoked or suspended by any State 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, including programs of the Department of Defense or the Department of Veterans Affairs, involving the provision of health care, or

(B)

a State health care program,

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 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 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 finds there is good cause 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) substantially in excess of the needs of such patients or of a quality which fails to meet professionally recognized standards of health care;

(C)

is—

(i)

a health maintenance organization (as defined in section 1396b(m) of this title) providing items and services under a State plan approved under subchapter XIX, or

(ii)

an entity furnishing services under a waiver approved under section 1396n(b)(1) of this title,

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

(D)

is an entity providing items and services as an eligible organization under a risk-sharing contract under section 1395mm of this title 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 determines has committed an act which is described in section 1320a–7a, 1320a–7b, or 1320a–8 of this title.

(8)

Entities controlled by a sanctioned individual— Any entity with respect to which the Secretary determines that a person—

(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) in that entity,

(ii)

who is an officer, director, agent, or managing employee (as defined in section 1320a–5(b) of this title) of that entity; or

(iii)

who was described in clause (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) against the person, to an immediate family member (as defined in subsection (j)(1)) or a member of the household of the person (as defined in subsection (j)(2)) who continues to maintain an interest described in such clause—

is a person—

(B)

(i)

who has been convicted of any offense described in subsection (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 or 1320a–8 of this title; or

(iii)

who has been excluded from participation under a program under subchapter XVIII or under a State health care program.

(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, section 1320a–3a of this title, or section 1320a–5 of this title.

(10)

Failure to supply requested information on subcontractors and suppliers— 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—

(A)

full and complete information as to the ownership of a subcontractor (as defined by the Secretary 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 in regulations), occurring during the five-year period ending on the date of such request, between the entity and any wholly owned supplier 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 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.

(12)

Failure to grant immediate access— 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:

(A)

To the Secretary, or to the agency used by the Secretary, for the purpose specified in the first sentence of section 1395aa(a) of this title (relating to compliance with conditions of participation or payment).

(B)

To the Secretary or the State agency, to perform the reviews and surveys required under State plans under paragraphs (26), (31), and (33) of section 1396a(a) of this title and under section 1396b(g) of this title.

(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 medicaid fraud control unit (as defined in section 1396b(q) of this title), for the purpose of conducting activities described in that section.

(13)

Failure to take corrective action— Any hospital that fails to comply substantially with a corrective action required under section 1395ww(f)(2)(B) of this title.

(14)

Default on health education loan or scholarship obligations— 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.

(15)

Individuals controlling a sanctioned entity—

(A)

Any individual—

(i)

who has a direct or indirect ownership or control interest in a sanctioned entity and who knows or should know (as defined in section 1320a–7a(i)(6)¹ of this title) of the action constituting the basis for the conviction or exclusion described in subparagraph (B); or

(ii)

who is an officer or managing employee (as defined in section 1320a–5(b) of this title) of such an entity.

(B)

For purposes of subparagraph (A), the term “sanctioned entity” means an entity—

(i)

that has been convicted of any offense described in subsection (a) or in paragraph (1), (2), or (3) of this subsection; or

(ii)

that has been excluded from participation under a program under subchapter XVIII or under a State health care program.

(16)

Making false statements or misrepresentation of material facts— 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.

(17)

Knowingly misclassifying covered outpatient drugs— 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.

(c)

Notice, effective date, and period of exclusion—

(1)

An exclusion under this section or under section 1320a–7a of this title 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).

(2)

(A)

Except as provided in subparagraph (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 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 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 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 shall specify, in the notice of exclusion under paragraph (1) and the written notice under section 1320a–7a of this title, the minimum period (or, in the case of an exclusion of an individual under subsection (b)(12) or in the case described in subparagraph (G), the period) of the exclusion.

(B)

Subject to subparagraph (G), in the case of an exclusion under subsection (a), the minimum period of exclusion shall be not less than five years, except that, upon the request of the administrator of a Federal health care program (as defined in section 1320a–7b(f) of this title) who determines that the exclusion would impose a hardship on beneficiaries (as defined in section 1320a–7a(i)(5) of this title) of that program, the Secretary may, after consulting with the Inspector General of the Department of Health and Human Services, waive the exclusion under subsection (a)(1), (a)(3), or (a)(4) with respect to that program in the case of an individual or entity that is the sole community physician or sole source of essential specialized services in a community. The Secretary’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), 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 the immediate access described in that subsection, and

(ii)

an additional period, not to exceed 90 days, set by the Secretary.

(D)

Subject to subparagraph (G), in the case of an exclusion of an individual or entity under paragraph (1), (2), or (3) of subsection (b), the period of the exclusion shall be 3 years, unless the Secretary 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) or (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.

(F)

In the case of an exclusion of an individual or entity under subsection (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) 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), the Secretary shall exercise the authority under this section and section 1320a–7a of this title in a manner that results in an individual’s or entity’s exclusion from all the programs under subchapter XVIII and all the State health care programs in which the individual or entity may otherwise participate.

(2)

The Secretary shall promptly notify each appropriate State agency administering or supervising the administration of each State health care program (and, in the case of an exclusion effected pursuant to subsection (a) and to which section 824(a)(5) of title 21 may apply, the Attorney General)—

(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, and

(B)

of the period (described in paragraph (3)) for which the State agency is directed to exclude the individual or entity from participation in the State health care program.

(3)

(A)

Except as provided in subparagraph (B), the period of the exclusion under a State health care program under paragraph (2) shall be the same as any period of exclusion under subchapter XVIII.

(B)

(i)

The Secretary may waive an individual’s or entity’s exclusion under a State health care program under paragraph (2) if the Secretary receives and approves a request for the waiver with respect to the individual or entity from the State agency administering or supervising the administration of the program.

(ii)

A State health care program 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 shall—

(1)

promptly notify the appropriate State or local agency 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, of the fact and circumstances of the exclusion,

(2)

request that appropriate investigations be made and sanctions invoked in accordance with applicable State law and policy, and

(3)

request that the State or local agency or authority keep the Secretary 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), 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 to the same extent as is provided in section 405(b) of this title, and to judicial review of the Secretary’s final decision after such hearing as is provided in section 405(g) of this title, 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.

(2)

Unless the Secretary 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) shall be entitled to a hearing by an administrative law judge (as provided under section 405(b) of this title) on the determination under subsection (b)(7) before any exclusion based upon the determination takes effect.

(3)

The provisions of section 405(h) of this title shall apply with respect to this section and sections 1320a–7a, 1320a–8, and 1320c–5 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) of this title, any reference therein to the Commissioner of Social Security shall be considered a reference to the Secretary.

(4)

The provisions of subsections (d) and (e) of section 405 of this title shall apply with respect to this section to the same extent as they are applicable with respect to subchapter II. The Secretary may delegate the authority granted by section 405(d) of this title (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 may apply to the Secretary, in the manner specified by the Secretary in regulations and at the end of the minimum period of exclusion provided under subsection (c)(3) and at such other times as the Secretary may provide, for termination of the exclusion effected under this section or section 1320a–7a of this title.

(2)

The Secretary may terminate the exclusion if the Secretary 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 at the time of the exclusion, that—

(A)

there is no basis under subsection (a) or (b) or section 1320a–7a(a) of this title 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)

(h)

“State health care program” defined— For purposes of this section and sections 1320a–7a and 1320a–7b of this title, the term “State health care program” means—

(1)

a State plan approved under subchapter XIX,

(2)

any program receiving funds under subchapter V or from an allotment to a State under such subchapter,

(3)

any program receiving funds under division A² of subchapter XX or from an allotment to a State under such division, or

(4)

a State child health plan approved under subchapter XXI.

(i)

“Convicted” defined— For purposes of subsections (a) and (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, 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, or local court;

(3)

when a plea of guilty or nolo contendere by the individual or entity has been accepted by a Federal, State, 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 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):

(1)

The term “immediate family member” means, with respect to a person—

(A)

the husband or wife of the person;

(B)

the natural or adoptive parent, child, or sibling of the person;

(C)

the stepparent, stepchild, stepbrother, or stepsister of the person;

(D)

the father-, mother-, daughter-, son-, brother-, or sister-in-law of the person;

(E)

the grandparent or grandchild of the person; and

(F)

the spouse of a grandparent or grandchild of the person.

(2)

The term “member of the household” means, with respect to any person, any individual sharing a common abode as part of a single family unit with the person, including domestic employees and others who live together as a family unit, but not including a roomer or boarder.

Footnotes

1 So in original. Probably should be section “1320a–7a(i)(7)”.
2 See References in Text note below.

Notes, amendments, and revision history

(Aug. 14, 1935, ch. 531, title XI, § 1128, as added Pub. L. 96–499, title IX, § 913(a), Dec. 5, 1980, 94 Stat. 2619; amended Pub. L. 97–35, title XXI, § 2105(b), title XXIII, § 2353(k), Aug. 13, 1981, 95 Stat. 791, 873; Pub. L. 98–369, div. B, title III, § 2333(a), (b), July 18, 1984, 98 Stat. 1089; Pub. L. 99–509, title IX, § 9317(c), Oct. 21, 1986, 100 Stat. 2008; Pub. L. 100–93, § 2, Aug. 18, 1987, 101 Stat. 680; Pub. L. 100–203, title IV, § 4118(e)(2)–(5), Dec. 22, 1987, 101 Stat. 1330–155, as amended Pub. L. 100–360, title IV, § 411(k)(10)(D), July 1, 1988, 102 Stat. 795; Pub. L. 100–360, title IV, § 411(k)(10)(C), July 1, 1988, 102 Stat. 795; Pub. L. 101–239, title VI, § 6411(d)(1), Dec. 19, 1989, 103 Stat. 2270; Pub. L. 101–508, title IV, § 4164(b)(3), Nov. 5, 1990, 104 Stat. 1388–102; Pub. L. 102–54, § 13(q)(3)(A)(ii), June 13, 1991, 105 Stat. 279; Pub. L. 103–296, title I, § 108(b)(9), title II, § 206(b)(2), Aug. 15, 1994, 108 Stat. 1483, 1513; Pub. L. 104–191, title II, §§ 211–213, Aug. 21, 1996, 110 Stat. 2003–2005; Pub. L. 105–33, title IV, §§ 4301, 4303(a), 4331(c), 4901(b)(2), Aug. 5, 1997, 111 Stat. 382, 396, 570; Pub. L. 108–173, title IX, § 949, Dec. 8, 2003, 117 Stat. 2426; Pub. L. 111–148, title VI, §§ 6402(d)(1), (e), (k), 6406(c), 6408(c), 6703(d)(3)(A), Mar. 23, 2010, 124 Stat. 757, 759, 763, 769, 772, 804; Pub. L. 116–16, § 6(d), Apr. 18, 2019, 133 Stat. 864.)

Editorial Notes

References in Text

Division 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.

Amendments

2019—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, title VI, § 6406(d), Mar. 23, 2010, 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, title VI, § 6408(d), Mar. 23, 2010, 124 Stat. 772, provided that: 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. 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, title IV, § 4303(b), Aug. 5, 1997, 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, title II, § 218, Aug. 21, 1996, 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, title II, § 206(b)(3), Aug. 15, 1994, 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, title VI, § 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: 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. 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]. Effective Date for Changes in Medicaid Law.— 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. 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. 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. 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. 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]. 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— 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 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.

§1320a–7a. Civil monetary penalties

42 U.S.C. § 1320a–7a

(a)

Improperly filed claims— Any person (including an organization, agency, or other entity, but excluding a beneficiary, as defined in subsection (i)(5)) that—

(1)

knowingly presents or causes to be presented to an officer, employee, or agent of the United States, or of any department or agency thereof, or of any State agency (as defined in subsection (i)(1)), a claim (as defined in subsection (i)(2)) that the Secretary determines—

(A)

is for a medical or other item or service that the person knows or should know was not provided as claimed, including any person who engages in a pattern or practice of presenting or causing to be presented a claim for an item or service that is based on a code that the person knows or should know will result in a greater payment to the person than the code the person knows or should know is applicable to the item or service actually provided,

(B)

is for a medical or other item or service and the person knows or should know the claim is false or fraudulent,

(C)

is presented for a physician’s service (or an item or service incident to a physician’s service) by a person who knows or should know that the individual who furnished (or supervised the furnishing of) the service—

(i)

was not licensed as a physician,

(ii)

was licensed as a physician, but such license had been obtained through a misrepresentation of material fact (including cheating on an examination required for licensing), or

(iii)

represented to the patient at the time the service was furnished that the physician was certified in a medical specialty by a medical specialty board when the individual was not so certified,

(D)

is for a medical or other item or service furnished during a period in which the person was excluded from the Federal health care program (as defined in section 1320a–7b(f) of this title) under which the claim was made pursuant to Federal law.¹

(E)

is for a pattern of medical or other items or services that a person knows or should know are not medically necessary;

(2)

knowingly presents or causes to be presented to any person a request for payment which is in violation of the terms of (A) an assignment under section 1395u(b)(3)(B)(ii) of this title, or (B) an agreement with a State agency (or other requirement of a State plan under subchapter XIX) not to charge a person for an item or service in excess of the amount permitted to be charged, or (C) an agreement to be a participating physician or supplier under section 1395u(h)(1) of this title, or (D) an agreement pursuant to section 1395cc(a)(1)(G) of this title;

(3)

knowingly gives or causes to be given to any person, with respect to coverage under subchapter XVIII of inpatient hospital services subject to the provisions of section 1395ww of this title, information that he knows or should know is false or misleading, and that could reasonably be expected to influence the decision when to discharge such person or another individual from the hospital;

(4)

in the case of a person who is not an organization, agency, or other entity, is excluded from participating in a program under subchapter XVIII or a State health care program in accordance with this subsection or under section 1320a–7 of this title and who, at the time of a violation of this subsection—

(A)

retains a direct or indirect ownership or control interest in an entity that is participating in a program under subchapter XVIII or a State health care program, and who knows or should know of the action constituting the basis for the exclusion; or

(B)

is an officer or managing employee (as defined in section 1320a–5(b) of this title) of such an entity;

(5)

offers to or transfers remuneration to any individual eligible for benefits under subchapter XVIII of this chapter, or under a State health care program (as defined in section 1320a–7(h) of this title) that such person knows or should know is likely to influence such individual to order or receive from a particular provider, practitioner, or supplier any item or service for which payment may be made, in whole or in part, under subchapter XVIII, or a State health care program (as so defined);

(6)

arranges or contracts (by employment or otherwise) with an individual or entity that the person knows or should know is excluded from participation in a Federal health care program (as defined in section 1320a–7b(f) of this title), for the provision of items or services for which payment may be made under such a program;

(7)

commits an act described in paragraph (1) or (2) of section 1320a–7b(b) of this title;

(8)

² knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim for payment for items and services furnished under a Federal health care program; or³

(9)

⁴ fails to grant timely access, upon reasonable request (as defined by the Secretary 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 during a period in which the person was excluded from a Federal health care program (as so defined), in the case where the person knows or should know that a claim for such medical or other item or service will be made under such a program;

(9)

⁴ knowingly makes or causes 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 or a supplier under a Federal health care program (as so defined), 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;⁵

(10)

knows of an overpayment (as defined in paragraph (4) of section 1320a–7k(d) of this title) 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 (or, in cases under paragraph (3), $30,000 for each individual with respect to whom false or misleading information was given; in cases under paragraph (4), $20,000 for each day the prohibited relationship occurs; in cases under paragraph (7), $100,000 for each such act,⁶ in cases under paragraph (8),⁷ $100,000 for each false record or statement,⁶ or³ in cases under paragraph (9),⁸ $15,000 for each day of the failure described in such paragraph);⁹ or in cases under paragraph (9),¹⁰ $100,000 for each false statement or misrepresentation of a material fact). In addition, such a person shall be subject to an assessment of not more than 3 times the amount claimed for each such item or service in lieu of damages sustained by the United States or a State agency because of such claim (or, in cases under paragraph (7), damages of not more than 3 times the total amount of remuneration offered, paid, solicited, or received, without regard to whether a portion of such remuneration was offered, paid, solicited, or received for a lawful purpose; or in cases under paragraph (9), an assessment of not more than 3 times the total amount claimed for each item or service for which payment was made based upon the application containing the false statement or misrepresentation of a material fact). In addition the Secretary may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1320a–7b(f)(1) of this title) and to direct the appropriate State agency to exclude the person from participation in any State health care program.

(b)

Payments to induce reduction or limitation of services—

(1)

If a hospital or a critical access hospital knowingly makes a payment, directly or indirectly, to a physician 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 plan approved under subchapter XIX, and

(B)

are under the direct care of the physician,

the hospital or a critical access hospital 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 who knowingly accepts receipt of a payment described in paragraph (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 who executes a document described in subparagraph (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) or 1395n(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 may initiate a proceeding to determine whether to impose a civil money penalty, assessment, or exclusion under subsection (a) or (b) only as authorized by the Attorney General pursuant to procedures agreed upon by them. The Secretary may not initiate an action under this section with respect to any claim, request for payment, or other occurrence described in this section later than six years after the date the claim was presented, the request for payment was made, or the occurrence took place. The Secretary may initiate an action under this section by serving notice of the action in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure.

(2)

The Secretary shall not make a determination adverse to any person under subsection (a) or (b) until the person has been given written notice and an opportunity for the determination to be made on the record after a hearing at which the person is entitled to be represented by counsel, to present witnesses, and to cross-examine witnesses against the person.

(3)

In a proceeding under subsection (a) or (b) which—

(A)

is against a person 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 is estopped from denying the essential elements of the criminal offense.

(4)

The official conducting a hearing under this section may sanction a person, including 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 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) or (b), the Secretary shall take into account—

(1)

the nature of claims and the circumstances under which they were presented,

(2)

the degree of culpability, history of prior offenses, and financial condition of the person presenting the claims, and

(3)

such other matters as justice may require.

(e)

Review by courts of appeals— Any person adversely affected by a determination of the Secretary under this section may obtain a review of such determination in the United States Court of Appeals for the circuit in which the person resides, or in which the claim or specified claim was presented, by filing in such court (within sixty days following the date the person is notified of the Secretary’s determination) a written petition requesting that the determination be modified or set aside. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary, and thereupon the Secretary shall file in the Court¹¹ the record in the proceeding as provided in section 2112 of title 28. 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 and enforcing the same to the extent that such order is affirmed or modified. No objection that has not been urged before the Secretary shall be considered by the court, unless the failure or neglect to urge such objection shall be excused because of extraordinary circumstances. The findings of the Secretary 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, the court may order such additional evidence to be taken before the Secretary and to be made a part of the record. The Secretary 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 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 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, as provided in section 1254 of title 28.

(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 and may be recovered in a civil action in the name of the United States brought in United States district court for the district where the claim or specified claim (as defined in subsection (r)) was presented, or where the claimant (or, with respect to a person described in subsection (o), the person) resides, as determined by the Secretary. Amounts recovered under this section shall be paid to the Secretary and disposed of as follows:

(1)

(A)

In the case of amounts recovered arising out of a claim under subchapter XIX, there shall be paid to the State agency an amount bearing the same proportion to the total amount recovered as the State’s share of the amount paid by the State agency for such claim bears to the total amount paid for such claim.

(B)

In the case of amounts recovered arising out of a claim under an allotment to a State under subchapter V, there shall be paid to the State agency 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 funds under sections 1395i and 1395t of this title shall be repaid to such trust funds.

(3)

With respect to amounts recovered arising out of a claim under a Federal health care program (as defined in section 1320a–7b(f) of this title), the portion of such amounts as is determined to have been paid by the program shall be repaid to the program, 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) shall be deposited into the Federal Hospital Insurance Trust Fund pursuant to section 1395i(k)(2)(C) of this title.

(4)

The remainder of the amounts recovered shall be deposited as miscellaneous receipts of the Treasury of the United States.

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 or a State agency (or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (q)(6)), to the person against whom the penalty or assessment has been assessed.

(g)

Finality of determination respecting penalty, assessment, or exclusion— A determination by the Secretary to impose a penalty, assessment, or exclusion under subsection (a) or (b) shall be final upon the expiration of the sixty-day period referred to in subsection (e). Matters that were raised or that could have been raised in a hearing before the Secretary or in an appeal pursuant to subsection (e) may not be raised as a defense to a civil action by the United States to collect a penalty, assessment, or exclusion assessed under this section.

(h)

Notification of appropriate entities of finality of determination— Whenever the Secretary’s determination to impose a penalty, assessment, or exclusion under subsection (a) or (b) becomes final, he shall notify the appropriate State or local medical or professional organization, the appropriate State agency or agencies administering or supervising the administration of State health care programs (as defined in section 1320a–7(h) of this title), and the appropriate utilization and quality control peer review organization, and the appropriate State or local licensing agency or organization (including the agency specified in section 1395aa(a) and 1396a(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 established or designated to administer or supervise the administration of the State plan under subchapter XIX of this chapter or designated to administer the State’s program under subchapter V or division A¹² 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 (as defined in section 1320a–7b(f) of this title).

(3)

The term “item or service” includes (A) any particular item, device, medical supply, or service claimed to have been provided to a patient and listed in an itemized claim for payment, and (B) in the case of a claim based on costs, any entry in the cost report, books of account or other documents supporting such claim.

(4)

The term “agency of the United States” includes any contractor acting as a fiscal intermediary, carrier, or fiscal agent or any other claims processing agent for a Federal health care program (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 (as so defined) but does not include a provider, supplier, or practitioner.

(6)

The term “remuneration” includes 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, if—

(i)

the waiver is not offered as part of any advertisement or solicitation;

(ii)

the person does not routinely waive coinsurance or deductible amounts; and

(iii)

the person—

(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), any permissible practice described in any subparagraph of section 1320a–7b(b)(3) of this title or in regulations issued by the Secretary;

(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, third party payers, and providers, to whom claims are presented and as long as the differentials meet the standards as defined in regulations promulgated by the Secretary 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 in regulations so promulgated;

(E)

a reduction in the copayment amount for covered OPD services under section 1395l(t)(5)(B)¹² of this title; or³

(F)

any other remuneration which promotes access to care and poses a low risk of harm to patients and Federal health care programs (as defined in section 1320a–7b(f) of this title and designated by the Secretary under regulations);

(G)

the offer or transfer of items or services for free or less than fair market value by a person, 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 under subchapter XVIII or a State health care program (as defined in section 1320a–7(h) of this title);

(H)

the offer or transfer of items or services for free or less than fair market value by a person, 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 under subchapter XVIII or a State health care program (as so defined);

(iii)

there is a reasonable connection between the items or services and the medical care of the individual; and

(iv)

the person 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 (but not earlier than January 1, 2011), the waiver by a PDP sponsor of a prescription drug plan under part D of subchapter XVIII or an MA organization offering an MA–PD plan under part C of such subchapter of any copayment for the first fill of a covered part D drug (as defined in section 1395w–102(e) of this title) that is a generic drug for individuals enrolled in the prescription drug plan or MA–PD plan, respectively; or

(J)

the provision of telehealth technologies (as defined by the Secretary) on or after January 1, 2019, by a provider of services or a renal dialysis facility (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.

(7)

The term “should know” means that a person, 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)

(2)

The Secretary may delegate authority granted under this section and under section 1320a–7 of this title to the Inspector General of the Department of Health and Human Services.

(k)

Injunctions— Whenever the Secretary has reason to believe that any person has engaged, is engaging, or is about to engage in any activity which makes the person subject to a civil monetary penalty under this section, the Secretary may bring an action in an appropriate district court of the United States (or, if applicable, a United States court of any territory) to enjoin such activity, or to enjoin the person 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.

(m)

Claims within jurisdiction of other departments or agencies—

(1)

For purposes of this section, with respect to a Federal health care program not contained in this chapter, references to the Secretary in this section shall be deemed to be references to the Secretary or Administrator of the department or agency with jurisdiction over such program 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.

(2)

(A)

The Secretary and Administrator of the departments and agencies referred to in paragraph (1) may include in any action pursuant to this section, claims within the jurisdiction of other Federal departments or agencies as long as the following conditions are satisfied:

(i)

The case involves primarily claims submitted to the Federal health care programs of the department or agency initiating the action.

(ii)

The Secretary or Administrator of the department or agency initiating the action gives notice and an opportunity to participate in the investigation to the Inspector General of the department or agency with primary jurisdiction over the Federal health care programs to which the claims were submitted.

(B)

If the conditions specified in subparagraph (A) are fulfilled, the Inspector General of the department or agency initiating the action is authorized to exercise all powers granted under chapter 4 of title 5 with respect to the claims submitted to the other departments or agencies to the same manner and extent as provided in that Act with respect to claims submitted to such departments or agencies.

(n)

Safe harbor for payment of medigap premiums—

(1)

Subparagraph (B) of subsection (i)(6) shall not apply to a practice described in paragraph (2) unless—

(A)

the Secretary, through the Inspector General of the Department of Health and Human Services, promulgates a rule authorizing such a practice as an exception to remuneration; and

(B)

the remuneration is offered or transferred by a person 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 or facility pays, in whole or in part, premiums for medicare supplemental policies for individuals entitled to benefits under part A of subchapter XVIII pursuant to section 426–1 of this title.

(o)

Penalties for violations of grants, contracts, and other agreements— Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (q)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary provides funding—

(1)

knowingly presents or causes to be presented a specified claim (as defined in subsection (r)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent;

(2)

knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material 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 provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement;

(3)

knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement;

(4)

knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation (as defined in subsection (s)) to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or

(5)

fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements;

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), of not more than $10,000 for each specified claim; in cases under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases under paragraph (3), not more than $50,000 for each false record or statement; in cases under paragraph (4), not more than $50,000 for each false record or statement or $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay; or in cases under paragraph (5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs (1) and (3), such a person 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 sustained by the United States or a specified State agency because of such specified claim, and in cases under paragraphs (2) and (4), such a person shall be subject to an assessment of not more than 3 times the total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to the Secretary described in paragraph (4), of the value of the property described in such paragraph) in lieu of damages sustained by the United States or a specified State agency because of such case. In addition, the Secretary may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1320a–7b(f)(1) of this title) and to direct the appropriate State agency to exclude the person from participation in any State health care program.

(p)

Applicability of rules to penalties or assessments for violations of grants, contracts, and other agreements— The provisions of subsections (c), (d), (g), and (h) shall apply to a civil money penalty or assessment under subsection (o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a). In applying subsection (d), each reference to a claim under such subsection shall be treated as including a reference to a specified claim (as defined in subsection (r)).

(q)

Definitions of terms used in subsections (o) and (p)— For purposes of this subsection and subsections (o) and (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 a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or subaward (regardless of whether one or more of the persons entering into the agreement is a contractor or subcontractor).

(4)

The term “program beneficiary” means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.

(5)

The term “recipient” includes a subrecipient or subcontractor.

(6)

The term “specified State agency” means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary.

(r)

Definition of “specified claim”— For purposes of this section, the term “specified claim” means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that—

(1)

is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or

(2)

is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department’s behalf or to advance a Department program 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 for any portion of the money or property which is requested or demanded.

(s)

Definition of “obligation”— For purposes of subsection (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.

Footnotes

1 So in original. Probably should be “law, or”.
2 So in original. Two pars. (8) have been enacted.
3 So in original. The word “or” probably should not appear.
4 So in original. Two pars. (9) have been enacted.
5 So in original. Probably should be followed by “or”.
6 So in original. The comma probably should be a semicolon.
7 So in original. Probably is a reference to the first paragraph (8).
8 So in original. Probably is a reference to the first paragraph (9).
9 So in original. Probably should be “paragraph;”.
10 So in original. Probably is a reference to the second paragraph (9).
11 So in original. Probably should not be capitalized.
12 See References in Text note below.

Notes, amendments, and revision history

(Aug. 14, 1935, ch. 531, title XI, § 1128A, as added Pub. L. 97–35, title XXI, § 2105(a), Aug. 13, 1981, 95 Stat. 789; amended Pub. L. 97–248, title I, § 137(b)(26), Sept. 3, 1982, 96 Stat. 380; Pub. L. 98–369, div. B, title III, §§ 2306(f)(1), 2354(a)(3), July 18, 1984, 98 Stat. 1073, 1100; Pub. L. 99–509, title IX, §§ 9313(c)(1), 9317(a), (b), Oct. 21, 1986, 100 Stat. 2003, 2008; Pub. L. 100–93, § 3, Aug. 18, 1987, 101 Stat. 686; Pub. L. 100–203, title IV, §§ 4039(h)(1), 4118(e)(1), (6)–(10), Dec. 22, 1987, 101 Stat. 1330–155, as amended Pub. L. 100–360, title IV, § 411(e)(3), (k)(10)(B)(ii), (D), July 1, 1988, 102 Stat. 775, 794, 795; Pub. L. 100–360, title II, § 202(c)(2), July 1, 1988, 102 Stat. 715; Pub. L. 100–485, title VI, § 608(d)(26)(H)–(K)(i), Oct. 13, 1988, 102 Stat. 2422; Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981; Pub. L. 101–239, title VI, § 6003(g)(3)(D)(i), Dec. 19, 1989, 103 Stat. 2153; Pub. L. 101–508, title IV, §§ 4204(a)(3), 4207(h), formerly 4027(h), 4731(b)(1), 4753, Nov. 5, 1990, 104 Stat. 1388–109, 1388–123, 1388–195, 1388–208, renumbered § 4207(h), Pub. L. 103–432, title I, § 160(d)(4), Oct. 31, 1994, 108 Stat. 4444; Pub. L. 104–191, title II, §§ 231(a)–(e), (h), 232(a), Aug. 21, 1996, 110 Stat. 2012–2015; Pub. L. 105–33, title IV, §§ 4201(c)(1), 4304(a), (b), 4331(e), 4523(c), Aug. 5, 1997, 111 Stat. 373, 383, 396, 449; Pub. L. 105–277, div. J, title V, § 5201(a), (b)(1), Oct. 21, 1998, 112 Stat. 2681–916; Pub. L. 111–148, title VI, §§ 6402(d)(2), 6408(a), 6703(d)(3)(B), Mar. 23, 2010, 124 Stat. 757, 770, 804; Pub. L. 114–10, title V, § 512(a)(1), Apr. 16, 2015, 129 Stat. 170; Pub. L. 114–255, div. A, title V, § 5003, Dec. 13, 2016, 130 Stat. 1188; Pub. L. 115–123, div. E, title III, § 50302(c), title IV, § 50412(a)(1), Feb. 9, 2018, 132 Stat. 191, 220; Pub. L. 117–286, § 4(b)(77), Dec. 27, 2022, 136 Stat. 4351.)

Editorial Notes

References in Text

The Federal Rules of Civil Procedure, referred to in subsec. (c)(1), are set out in the Appendix to Title 28, Judiciary and Judicial Procedure.

The Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (f)(3), is Pub. L. 104–191, Aug. 21, 1996, 110 Stat. 1936. For complete classification of this Act to the Code, see Short Title of 1996 Amendments note set out under section 201 of this title and Tables.

Division A of subchapter XX, referred to in subsec. (i)(1), 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.

Section 1395l(t)(5)(B) of this title, referred to in subsec. (i)(6)(E), was redesignated section 1395l(t)(8)(B) of this title by Pub. L. 106–113, div. B, § 1000(a)(6) [title II, §§ 201(a)(1), 202(a)(2)], Nov. 29, 1999, 113 Stat. 1536, 1501A–336, 1501A–342.

Amendments

2022—Subsec. (m)(2)(B). Pub. L. 117–286 substituted “chapter 4 of title 5” for “the Inspector General Act of 1978 (5 U.S.C. App.)”.

2018—Subsec. (a). Pub. L. 115–123, § 50412(a)(1)(A)(i), (iii), in concluding provisions, substituted “$20,000” for “$10,000” in two places and “$100,000” for “$50,000” wherever appearing.

Pub. L. 115–123, § 50412(a)(1)(A)(ii), which directed substitution of “$30,000” for “$15,000” in concluding provisions, was executed by making the substitution for “$15,000” the first time appearing to reflect the probable intent of Congress.

Subsec. (b)(1). Pub. L. 115–123, § 50412(a)(1)(B)(i), substituted “$5,000” for “$2,000” in concluding provisions.

Subsec. (b)(2). Pub. L. 115–123, § 50412(a)(1)(B)(ii), substituted “$5,000” for “$2,000”.

Subsec. (b)(3)(A)(i). Pub. L. 115–123, § 50412(a)(1)(B)(iii), substituted “$10,000” for “$5,000”.

Subsec. (i)(6)(J). Pub. L. 115–123, § 50302(c), added subpar. (J).

2016—Subsec. (e). Pub. L. 114–255, § 5003(b)(1), inserted “or specified claim” after “claim”.

Subsec. (f). Pub. L. 114–255, § 5003(b)(2), inserted “or specified claim (as defined in subsection (r))” after “district where the claim” and “(or, with respect to a person described in subsection (o), the person)” after “claimant” in introductory provisions and “(or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (q)(6)),” after “or a State agency” in concluding provisions.

Subsecs. (o) to (s). Pub. L. 114–255, § 5003(a), added subsecs. (o) to (s).

2015—Subsec. (b)(1). Pub. L. 114–10 inserted “medically necessary” after “reduce or limit”.

2010—Subsec. (a). Pub. L. 111–148, § 6408(a)(3)(B), which directed substitution of “act, in cases under paragraph (8), $50,000 for each false record or statement, or in cases under paragraph (9), $15,000 for each day of the failure described in such paragraph)” for “act)” in first sentence, was executed by making the substitution for “act” to reflect the probable intent of Congress. See amendment by Pub. L. 111–148, § 6402(d)(2)(A)(iv) below.

Pub. L. 111–148, § 6408(a)(3)(A), which directed substitution of “in cases under paragraph (7)” for “or in cases under paragraph (7)” in first sentence, was executed by making the substitution for “in cases under paragraph (7)” resulting in no change in text and to reflect the probable intent of Congress. See amendment by Pub. L. 111–148, § 6402(d)(2)(A)(iv) below.

Pub. L. 111–148, § 6402(d)(2)(A)(iv), (v), in concluding provisions, struck out “or” after “prohibited relationship occurs;” and substituted “act; or in cases under paragraph (9), $50,000 for each false statement or misrepresentation of a material fact)” for “act)” and “purpose; or in cases under paragraph (9), an assessment of not more than 3 times the total amount claimed for each item or service for which payment was made based upon the application containing the false statement or misrepresentation of a material fact)” for “purpose)”.

Subsec. (a)(1)(D). Pub. L. 111–148, § 6402(d)(2)(A)(i), which directed substitution of “was excluded from the Federal health care program (as defined in section 1320a–7b(f) of this title) under which the claim was made pursuant to Federal law.” for “ ‘was excluded’ and all that follows through the period at the end”, was executed by making the substitution for “was excluded from the program under which the claim was made pursuant to a determination by the Secretary under this section or under section 1320a–7, 1320c–5, 1320c–9(b) (as in effect on September 2, 1982), 1395y(d) (as in effect on August 18, 1987), or 1395cc(b) of this title or as a result of the application of the provisions of section 1395u(j)(2) of this title, or”, to reflect the probable intent of Congress, because there was no period at the end.

Subsec. (a)(6). Pub. L. 111–148, §§ 6402(d)(2)(A)(ii), 6408(a)(1), amended par. (6) identically, striking out “or” at the end.

Subsec. (a)(8), (9). Pub. L. 111–148, § 6408(a)(2), added pars. (8) and (9) relating to false or fraudulent claims for payment for items and services furnished under a Federal health care program and failure to grant timely access to the Inspector General of the Department of Health and Human Services, respectively.

Pub. L. 111–148, § 6402(d)(2)(A)(iii), added pars. (8) and (9) relating to orders or prescriptions for persons excluded from a Federal health care program; and false statements, omissions, or misrepresentations in applications, bids, or contracts to participate or enroll as a provider of services or a supplier under a Federal health care program, respectively.

Subsec. (a)(10). Pub. L. 111–148, § 6402(d)(2)(A)(iii), added par. (10).

Subsec. (i)(1). Pub. L. 111–148, § 6703(d)(3)(B), inserted “division A of” after “subchapter V or”.

Subsec. (i)(6)(C). Pub. L. 111–148, § 6402(d)(2)(B)(i), struck out “or” at the end.

Subsec. (i)(6)(D). Pub. L. 111–148, § 6402(d)(2)(B)(ii), in subpar. (D) relating to incentives given to individuals to promote delivery, substituted a semicolon for the period.

Subsec. (i)(6)(E). Pub. L. 111–148, § 6402(d)(2)(B)(iii), redesignated subpar. (D) relating to a reduction in copayment amount for covered OPD services as (E) and substituted “; or” for the period.

Subsec. (i)(6)(F) to (I). Pub. L. 111–148, § 6402(d)(2)(B)(iv), added pars. (F) to (I).

1998—Subsec. (i)(6)(B). Pub. L. 105–277, § 5201(a), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “any permissible waiver as specified in section 1320a–7b(b)(3) of this title or in regulations issued by the Secretary;”.

Subsec. (n). Pub. L. 105–277, § 5201(b)(1), added subsec. (n).

1997—Subsec. (a). Pub. L. 105–33, § 4304(b)(2), in concluding provisions, substituted “occurs; or in cases under paragraph (7), $50,000 for each such act).” for “occurs).” and inserted “(or, in cases under paragraph (7), damages of not more than 3 times the total amount of remuneration offered, paid, solicited, or received, without regard to whether a portion of such remuneration was offered, paid, solicited, or received for a lawful purpose)” after “of such claim”.

Subsec. (a)(6). Pub. L. 105–33, § 4304(a), added par. (6).

Subsec. (a)(7). Pub. L. 105–33, § 4304(b)(1), added par. (7).

Subsec. (b)(1). Pub. L. 105–33, § 4201(c)(1), substituted “critical access” for “rural primary care” in introductory and concluding provisions.

Subsec. (i)(6)(A)(iii). Pub. L. 105–33, § 4331(e)(1), inserted “or” at end of subcl. (I), struck out “or” at end of subcl. (II), and struck out subcl. (III) which read as follows: “provides for any permissible waiver as specified in section 1320a–7b(b)(3) of this title or in regulations issued by the Secretary;”.

Subsec. (i)(6)(B). Pub. L. 105–33, § 4523(c)(1), which directed amendment of par. (6) by striking “or” at end of subpar. (B), could not be executed because the word “or” did not appear at end of subpar. (B) subsequent to amendment by Pub. L. 105–33, § 4331(e)(2), (3). See below.

Pub. L. 105–33, § 4331(e)(3), added subpar. (B). Former subpar. (B) redesignated (C).

Subsec. (i)(6)(C). Pub. L. 105–33, § 4523(c)(2), which directed amendment of par. (6) by substituting “; or” for the period at end of subpar. (C), could not be executed because there was not a period at the end of subpar. (C) subsequent to amendment by Pub. L. 105–33, § 4331(e)(2). See below.

Pub. L. 105–33, § 4331(e)(2), redesignated subpar. (B) as (C). Former subpar. (C) redesignated (D).

Subsec. (i)(6)(D). Pub. L. 105–33, § 4523(c), added subpar. (D) relating to a reduction in copayment amount for covered OPD services.

Pub. L. 105–33, § 4331(e)(2), redesignated subpar. (C), relating to incentives given to individuals to promote delivery, as (D).

1996—Subsec. (a). Pub. L. 104–191, § 231(c), in concluding provisions, substituted “$10,000” for “$2,000”, inserted “; in cases under paragraph (4), $10,000 for each day the prohibited relationship occurs” after “false or misleading information was given”, and substituted “3 times the amount” for “twice the amount”.

Pub. L. 104–191, § 231(a)(1), in concluding provisions, substituted “Federal health care programs (as defined in section 1320a–7b(f)(1) of this title)” for “programs under subchapter XVIII of this chapter”.

Subsec. (a)(1). Pub. L. 104–191, § 231(d)(1)(A), inserted “knowingly” before “presents” in introductory provisions.

Subsec. (a)(1)(A). Pub. L. 104–191, § 231(e)(1), substituted “claimed, including any person who engages in a pattern or practice of presenting or causing to be presented a claim for an item or service that is based on a code that the person knows or should know will result in a greater payment to the person than the code the person knows or should know is applicable to the item or service actually provided,” for “claimed,”.

Subsec. (a)(1)(E). Pub. L. 104–191, § 231(e)(2)–(4), added subpar. (E).

Subsec. (a)(2). Pub. L. 104–191, § 231(d)(1)(A), inserted “knowingly” before “presents”.

Subsec. (a)(3). Pub. L. 104–191, § 231(d)(1)(B), substituted “knowingly gives or causes to be given” for “gives”.

Subsec. (a)(4). Pub. L. 104–191, § 231(b), added par. (4).

Subsec. (a)(5). Pub. L. 104–191, § 231(h)(1), added par. (5).

Subsec. (b)(3). Pub. L. 104–191, § 232(a), added par. (3).

Subsec. (f)(3), (4). Pub. L. 104–191, § 231(a)(2), added par. (3) and redesignated former par. (3) as (4).

Subsec. (i)(2). Pub. L. 104–191, § 231(a)(3)(A), substituted “a Federal health care program (as defined in section 1320a–7b(f) of this title)” for “subchapter V, XVIII, XIX, or XX of this chapter”.

Subsec. (i)(4). Pub. L. 104–191, § 231(a)(3)(B), substituted “a Federal health care program (as so defined)” for “a health insurance or medical services program under subchapter XVIII or XIX of this chapter”.

Subsec. (i)(5). Pub. L. 104–191, § 231(a)(3)(C), substituted “a Federal health care program (as so defined)” for “subchapter V, XVIII, XIX, or XX of this chapter”.

Subsec. (i)(6). Pub. L. 104–191, § 231(h)(2), added par. (6).

Subsec. (i)(7). Pub. L. 104–191, § 231(d)(2), added par. (7).

Subsec. (m). Pub. L. 104–191, § 231(a)(4), added subsec. (m).

1990—Subsec. (b)(1). Pub. L. 101–508, § 4731(b)(1), struck out “or an entity with a contract under section 1396b(m) of this title” before “knowingly makes a payment” in introductory provisions.

Pub. L. 101–508, § 4204(a)(3), struck out “, an eligible organization with a risk-sharing contract under section 1395mm of this title,” after “primary care hospital” in introductory provisions, struck out “or organization” after “primary care hospital” in concluding provisions, redesignated subpar. (C) as (B), and struck out former subpar. (B) which read as follows: “in the case of an eligible organization or an entity, are enrolled with the organization or entity, and”.

Subsec. (j). Pub. L. 101–508, § 4753, made an amendment to subsec. (j) identically to that of Pub. L. 101–508, § 4207(h). See below.

Pub. L. 101–508, § 4207(h), formerly § 4027(h), as renumbered by Pub. L. 103–432, designated existing provisions as par. (1) and added par. (2).

1989—Subsec. (a)(1)(D), (2)(C), (4). Pub. L. 101–234 repealed Pub. L. 100–360, § 202(c), and provided that the provisions of law amended or repealed by such section are restored or revived as if such section had not been enacted, see 1988 Amendment note below.

Subsec. (b)(1). Pub. L. 101–239 substituted “hospital or a rural primary care hospital” for “hospital” in introductory and concluding provisions.

1988—Subsec. (a). Pub. L. 100–360, § 411(k)(10)(D), added Pub. L. 100–203, § 4118(e)(10)(A), see 1987 Amendment note below.

Subsec. (a)(1). Pub. L. 100–360, § 411(k)(10)(B)(ii)(I), (II), as amended by Pub. L. 100–485, § 608(d)(26)(H), amended directory language of Pub. L. 100–203, § 4118(e)(1), see 1987 Amendment note below.

Subsec. (a)(1)(D). Pub. L. 100–360, § 411(k)(10)(D), as amended by Pub. L. 100–485, § 608(d)(26)(K)(i), added Pub. L. 100–203, § 4118(e)(6), see 1987 Amendment note below.

Pub. L. 100–360, § 202(c)(2)(A), struck out “or” after semicolon.

Subsec. (a)(2)(C). Pub. L. 100–360, § 202(c)(2)(B), inserted “or to be a participating pharmacy under section 1395u(o) of this title” after “section 1395u(h)(1) of this title”.

Subsec. (a)(3). Pub. L. 100–360, § 411(k)(10)(B)(ii)(I), (II), as amended by Pub. L. 100–485, § 608(d)(26)(H), made technical amendment to directory language of Pub. L. 100–203, § 4118(e)(1)(A), see 1987 Amendment note below.

Subsec. (a)(4). Pub. L. 100–360, § 202(c)(2)(C)–(E), added par. (4) relating to participating or nonparticipating pharmacies.

Subsec. (b)(1)(A). Pub. L. 100–360, § 411(e)(3), added Pub. L. 100–203, § 4039(h)(1)(A), see 1987 Amendment note below.

Subsec. (b)(2). Pub. L. 100–360, § 411(e)(3), added Pub. L. 100–203, § 4039(h)(1)(B), see 1987 Amendment note below.

Subsec. (c)(1). Pub. L. 100–360, § 411(k)(10)(D), added Pub. L. 100–203, § 4118(e)(7), see 1987 Amendment note below.

Subsec. (i). Pub. L. 100–360, § 411(k)(10)(D), added Pub. L. 100–203, § 4118(e)(8), see 1987 Amendment note below.

Subsec. (i)(1). Pub. L. 100–360, § 411(k)(10)(D), added Pub. L. 100–203, § 4118(e)(9), see 1987 Amendment note below.

Subsec. (i)(2). Pub. L. 100–360, § 411(k)(10)(D), added Pub. L. 100–203, § 4118(e)(10)(B), see 1987 Amendment note below.

Subsec. (i)(5). Pub. L. 100–485, § 608(d)(26)(J), amended directory language of Pub. L. 100–203, § 4118(e)(10)(C), see 1987 Amendment note below.

Pub. L. 100–360, § 411(k)(10)(D), added Pub. L. 100–203, § 4118(e)(10)(C), see 1987 Amendment note below.

Subsec. (l). Pub. L. 100–485, § 608(d)(26)(I), inserted “for penalties, assessments, and an exclusion” after “liable”.

Pub. L. 100–360, § 411(k)(10)(B)(ii)(III), added Pub. L. 100–203, § 4118(e)(1)(B), see 1987 Amendment note below.

1987—Subsec. (a). Pub. L. 100–203, § 4118(e)(10)(A), as added by Pub. L. 100–360, § 411(k)(10)(D), inserted “, but excluding a beneficiary, as defined in subsection (i)(5)” in introductory provisions.

Pub. L. 100–93, § 3(a)(3)(B), in concluding provisions, inserted “(or, in cases under paragraph (3), $15,000 for each individual with respect to whom false or misleading information was given)” before period at end of first sentence, and inserted at end “In addition the Secretary may make a determination in the same proceeding to exclude the person from participation in the programs under subchapter XVIII of this chapter and to direct the appropriate State agency to exclude the person from participation in any State health care program.”

Subsec. (a)(1). Pub. L. 100–203, § 4118(e)(1)(A), formerly § 4118(e)(1), as amended by Pub. L. 100–360, § 411(k)(10)(B)(ii)(I), (II), as amended by Pub. L. 100–485, § 608(d)(26)(H), substituted “or should know” for “or has reason to know” in subpars. (A) to (C).

Pub. L. 100–93, § 3(a)(1), substituted “the Secretary determines” for “the Secretary determines is for a medical or other item or service” in introductory provisions and substituted subpars. (A) to (D) for former subpars. (A) and (B) which read as follows:

“(A) that the person knows or has reason to know was not provided as claimed, or

“(B) payment for which may not be made under the program under which such claim was made, pursuant to a determination by the Secretary under section 1320a–7, 1320c–9(b), or 1395y(d) of this title, or pursuant to a determination by the Secretary under section 1395cc(b)(2) of this title with respect to which the Secretary has initiated termination proceedings; or”.

Subsec. (a)(1)(D). Pub. L. 100–203, § 4118(e)(6), as added by Pub. L. 100–360, § 411(k)(10)(D), as amended by Pub. L. 100–485, § 608(d)(26)(K)(i), substituted “excluded from” for “excluded under” and inserted “or as a result of the application of the provisions of section 1395u(j)(2) of this title”.

Subsec. (a)(2). Pub. L. 100–93, § 3(a)(2), inserted “(or other requirement of a State plan under subchapter XIX)” after “State agency” in subpar. (B) and added subpar. (D).

Subsec. (a)(3). Pub. L. 100–203, § 4118(e)(1)(A), as amended by Pub. L. 100–360, § 411(k)(10)(B)(ii)(I), (II), as amended by Pub. L. 100–485, § 608(d)(26)(H), substituted “or should know” for “or has reason to know”.

Pub. L. 100–93, § 3(a)(3)(A), added par. (3).

Subsec. (b)(1)(A). Pub. L. 100–203, § 4039(h)(1)(A), as added by Pub. L. 100–360, § 411(e)(3), substituted “subchapter XVIII” for “subchapter XVII”.

Subsec. (b)(2). Pub. L. 100–203, § 4039(h)(1)(B), as added by Pub. L. 100–360, § 411(e)(3), substituted “$2,000 for each” for “$2,000 for”.

Subsec. (c)(1). Pub. L. 100–203, § 4118(e)(7), as added by Pub. L. 100–360, § 411(k)(10)(D), inserted “, request for payment, or other occurrence described in this section” and “, the request for payment was made, or the occurrence took place”.

Pub. L. 100–93, § 3(b), (c), substituted “penalty, assessment, or exclusion” for “penalty or assessment” and inserted provision that the Secretary not initiate an action under this section with respect to a claim later than six years after the claim was presented and that the Secretary initiate an action in the manner authorized by Rule 4 of the Federal Rules of Civil Procedure.

Subsec. (d). Pub. L. 100–93, § 3(c), substituted “penalty, assessment, or exclusion” for “penalty or assessment” in introductory provisions.

Subsec. (f)(1)(A). Pub. L. 100–93, § 3(d), substituted “bearing the same proportion to the total amount recovered as the State’s share of the amount paid by the State agency for such claim bears to the total amount paid” for “equal to the State’s share of the amount paid by the State agency”.

Subsec. (g). Pub. L. 100–93, § 3(c), substituted “penalty, assessment, or exclusion” for “penalty or assessment” in two places.

Subsec. (h). Pub. L. 100–93, § 3(c), (e), substituted “penalty, assessment, or exclusion” for “penalty or assessment” in two places and inserted “the appropriate State agency or agencies administering or supervising the administration of State health care programs (as defined in section 1320a–7(h) of this title),” after “professional organization,”.

Subsec. (i). Pub. L. 100–203, § 4118(e)(8), as added by Pub. L. 100–360, § 411(k)(10)(D), substituted “this section” for “this subsection” in introductory provisions.

Subsec. (i)(1). Pub. L. 100–203, § 4118(e)(9), as added by Pub. L. 100–360, § 411(k)(10)(D), inserted “or subchapter XX”.

Subsec. (i)(2). Pub. L. 100–203, § 4118(e)(10)(B), as added by Pub. L. 100–360, § 411(k)(10)(D), substituted “for payments for items and services under subchapter V, XVIII, XIX, or XX of this chapter” for “submitted by—

“(A) a provider of services or other person, agency, or organization that furnishes an item or service under subchapter XVIII of this chapter, or

“(B) a person, agency, or organization that furnishes an item or service for which medical assistance is provided under subchapter XIX of this chapter, or

“(C) a person, agency, or organization that provides an item or service for which payment is made under subchapter V of this chapter or from an allotment to a State under such subchapter,

to the United States or a State agency, or agent thereof, for payment for health care services under subchapter XVIII or XIX of this chapter or for any item or service under subchapter V of this chapter”.

Subsec. (i)(5). Pub. L. 100–203, § 4118(e)(10)(C), as added by Pub. L. 100–360, § 411(k)(10)(D), and amended by Pub. L. 100–485, § 608(d)(26)(J), added par. (5).

Subsecs. (j), (k). Pub. L. 100–93, § 3(f), added subsecs. (j) and (k).

Subsec. (l). Pub. L. 100–203, § 4118(e)(1)(B), as added by Pub. L. 100–360, § 411(k)(10)(B)(ii)(III), added subsec. (l).

1986—Subsec. (a)(1). Pub. L. 99–509, § 9313(c)(1)(B), substituted “(i)(1)” and “(i)(2)” for “(h)(1)” and “(h)(2)”, respectively.

Subsec. (b). Pub. L. 99–509, § 9313(c)(1)(D), (E), added subsec. (b). Former subsec. (b) redesignated (c).

Subsec. (c). Pub. L. 99–509, § 9313(c)(1)(A), (D), redesignated subsec. (b) as (c) and substituted “subsection (a) or (b)” for “subsection (a)” in pars. (1) and (2). Former subsec. (c) redesignated (d).

Subsec. (c)(3). Pub. L. 99–509, § 9317(a), added par. (3).

Subsec. (c)(4). Pub. L. 99–509, § 9317(b), added par. (4).

Subsec. (d). Pub. L. 99–509, § 9313(c)(1)(A), (D), redesignated subsec. (c) as (d) and substituted “subsection (a) or (b)” for “subsection (a)” in introductory provisions. Former subsec. (d) redesignated (e).

Subsecs. (e), (f). Pub. L. 99–509, § 9313(c)(1)(D), redesignated subsecs. (d) and (e) as (e) and (f), respectively. Former subsec. (f) redesignated (g).

Subsec. (g). Pub. L. 99–509, § 9313(c)(1)(A), (C), (D), redesignated subsec. (f) as (g) and substituted “subsection (a) or (b)” for “subsection (a)” and “subsection (e)” for “subsection (d)”. Former subsec. (g) redesignated (h).

Subsec. (h). Pub. L. 99–509, § 9313(c)(1)(A), (D), redesignated subsec. (g) as (h) and substituted “subsection (a) or (b)” for “subsection (a)”. Former subsec. (h) redesignated (i).

Subsec. (i). Pub. L. 99–509, § 9313(c)(1)(D), redesignated subsec. (h) as (i).

1984—Subsec. (a)(2)(C). Pub. L. 98–369, § 2306(f)(1), added cl. (C).

Subsec. (g). Pub. L. 98–369, § 2354(a)(3), substituted “utilization and quality control peer review organization” for “Professional Standards Review Organization”.

1982—Subsec. (a). Pub. L. 97–248 redesignated as part of par. (1) preceding subpar. (A) provisions formerly preceding par. (1), in subpar. (B) substituted “or pursuant to a determination by the Secretary under section 1395cc(b)(2) of this title with respect to which the Secretary has initiated termination proceedings;” for “or 1395cc(b)(2) of this title,”, and in par. (2) substituted “presents or causes to be presented to any person a request for payment which is in violation of the terms of (A) an assignment under section 1842(b)(3)(B)(ii), or (B) an agreement with a State agency not to charge a person for an item or service in excess of the amount permitted to be charged” for “is submitted in violation of an agreement between the person and the United States or a State agency”.

Statutory Notes and Related Subsidiaries

Effective Date of 2018 Amendment

Pub. L. 115–123, div. E, title IV, § 50412(c), Feb. 9, 2018, 132 Stat. 221, provided that: “The amendments made by this section [amending this section and section 1320a–7b of this title] shall apply to acts committed after the date of the enactment of this Act.”

Effective Date of 2015 Amendment

Pub. L. 114–10, title V, § 512(a)(2), Apr. 16, 2015, 129 Stat. 170, provided that: “The amendment made by paragraph (1) [amending this section] shall apply to payments made on or after the date of the enactment of this Act [Apr. 16, 2015].”

Effective Date of 2010 Amendment

Amendment by section 6408(a) of Pub. L. 111–148 applicable to acts committed on or after Jan. 1, 2010, see section 6408(d)(1) of Pub. L. 111–148, set out as a note under section 1320a–7 of this title.

Effective Date of 1998 Amendment

Pub. L. 105–277, div. J, title V, § 5201(d), Oct. 21, 1998, 112 Stat. 2681–917, provided that: “The amendments made by this section [amending this section and section 1320a–7d of this title] shall take effect on the date of the enactment of this Act [Oct. 21, 1998].”

Effective Date of 1997 Amendment

Amendment by section 4201(c)(1) of Pub. L. 105–33 applicable to services furnished on or after Oct. 1, 1997, see section 4201(d) of Pub. L. 105–33, set out as a note under section 1395f of this title.

Pub. L. 105–33, title IV, § 4304(c), Aug. 5, 1997, 111 Stat. 384, provided that: Contracts with excluded persons.—The amendments made by subsection (a) [amending this section] shall apply to arrangements and contracts entered into after the date of the enactment of this Act [Aug. 5, 1997]. Kickbacks.—The amendments made by subsection (b) [amending this section] shall apply to acts committed after the date of the enactment of this Act.”

Amendment by section 4331(e) of Pub. L. 105–33 effective as if included in the enactment of the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104–191, see section 4331(f) 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, title II, § 231(i), Aug. 21, 1996, 110 Stat. 2015, provided that: “The amendments made by this section [amending this section and sections 1320c–5 and 1395mm of this title] shall apply to acts or omissions occurring on or after January 1, 1997.”

Pub. L. 104–191, title II, § 232(b), Aug. 21, 1996, 110 Stat. 2015, provided that: “The amendment made by subsection (a) [amending this section] shall apply to certifications made on or after the date of the enactment of this Act [Aug. 21, 1996].”

Effective Date of 1989 Amendment

Pub. L. 101–234, title II, § 201(c), Dec. 13, 1989, 103 Stat. 1981, provided that: “The provisions of this section [amending this section and sections 1320c–3, 1395h, 1395k, 1395l, 1395m, 1395n, 1395u, 1395w–2, 1395x, 1395y, 1395z, 1395aa, 1395bb, 1395cc, 1395mm, 1396a, 1396b, 1396d, and 1396n of this title, repealing section 1395w–3 of this title, and amending or repealing provisions set out as notes under sections 1320c–3, 1395b–1, 1395k, 1395m, 1395u, 1395x, 1395ll, and 1395ww of this title] shall take effect January 1, 1990.”

Effective Date of 1988 Amendment

Amendment by Pub. L. 100–485 effective as if included in the enactment of the Medicare Catastrophic Coverage Act of 1988, Pub. L. 100–360, see section 608(g)(1) of Pub. L. 100–485, set out as a note under section 704 of this title.

Amendment by section 202(c)(2) of Pub. L. 100–360 applicable to items dispensed on or after Jan. 1, 1990, see section 202(m)(1) of Pub. L. 100–360, set out as a note under section 1395u of this title.

Except as specifically provided in section 411 of Pub. L. 100–360, amendment by section 411(e)(3), (k)(10)(B)(ii), (D) of 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. 100–203, title IV, § 4118(e)(14), formerly § 4118(e)(3), Dec. 22, 1987, 101 Stat. 1330–155, as renumbered and amended by Pub. L. 100–360, title IV, § 411(k)(10)(B)(i), (D), July 1, 1988, 102 Stat. 794, 795, provided that: “The amendments made by paragraph (1) [amending this section] shall apply to activities occurring before, on, or after the date of the enactment of this Act [Dec. 22, 1987].”

Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning Aug. 18, 1987, and inapplicable to administrative proceedings commenced before end of such period, except that amendment by section 3(a)(1) of Pub. L. 100–93 applicable to claims presented for services performed on or after date at end of fourteen-day period beginning Aug. 18, 1987, without regard to the date the physician’s misrepresentation of fact was made, and amendment by section 3(f) of Pub. L. 100–93 effective Aug. 18, 1987, see section 15(a), (c)(3), and (d) of Pub. L. 100–93, set out as a note under section 1320a–7 of this title.

Effective Date of 1986 Amendment

Pub. L. 99–509, title IX, § 9313(c)(2), Oct. 21, 1986, 100 Stat. 2003, as amended by Pub. L. 100–203, title IV, § 4016, Dec. 22, 1987, 101 Stat. 1330–64; Pub. L. 101–239, title VI, § 6207(a), Dec. 19, 1989, 103 Stat. 2245, provided that: “The amendments made by paragraph (1) [amending this section] shall apply to— payments by hospitals occurring more than 6 months after the date of the enactment of this Act [Oct. 21, 1986], and payments by eligible organizations or entities occurring on or after April 1, 1991.”

Pub. L. 99–509, title IX, § 9317(d)(1), (2), Oct. 21, 1986, 100 Stat. 2009, provided that: The amendment made by subsection (a) [amending this section] shall take effect on the date of the enactment of this Act [Oct. 21, 1986], without regard to when the criminal conviction was obtained, but shall only apply to a conviction upon a plea of nolo contendere tendered after the date of the enactment of this Act. The amendment made by subsection (b) [amending this section] shall apply to failures or misconduct occurring on or after the date of the enactment of this Act.”

Effective Date of 1984 Amendment

Amendment by section 2354(a)(3) of Pub. L. 98–369 effective July 18, 1984, but not to be construed as changing or affecting any right, liability, status, or interpretation which existed (under the provisions of law involved) before that date, see section 2354(e)(1) of Pub. L. 98–369, set out as a note under section 1320a–1 of this title.

Effective Date of 1982 Amendment

Amendment by Pub. L. 97–248 effective as if originally included as part of this section as this section was amended by the Omnibus Budget Reconciliation Act of 1981, Pub. L. 97–35, see section 137(d)(2) of Pub. L. 97–248, set out as a note under section 1396a of this title.

Regulations

Pub. L. 105–277, div. J, title V, § 5201(e), Oct. 21, 1998, 112 Stat. 2681–917, provided that: “The Secretary of Health and Human Services may promulgate regulations that take effect on an interim basis, after notice and pending opportunity for public comment, in order to implement the amendments made by this section [amending this section and section 1320a–7d of this title] in a timely manner.”

GAO Study and Report on Impact of Safe Harbor on Medigap Policies

Pub. L. 105–277, div. J, title V, § 5201(b)(2), Oct. 21, 1998, 112 Stat. 2681–917, which provided that, if a permissible practice was promulgated under subsec. (n)(1)(A) of this section, the Comptroller General was to conduct a study comparing any disproportionate impact on specific issuers of medicare supplemental policies due to adverse selection in enrolling medicare ESRD beneficiaries before Aug. 21, 1996, and 1 year after the date of promulgation of such permissible practice under subsec. (n)(1)(A) of this section and was to submit a report to Congress on such study with recommendations concerning extension of the time limitation under subsec. (n)(1)(B), was repealed by Pub. L. 111–8, div. G, title I, § 1301(c), Mar. 11, 2009, 123 Stat. 829.

Repeal of 1988 Expansion of Medicare Part B Benefits

Pub. L. 101–234, title II, § 201(a), Dec. 13, 1989, 103 Stat. 1981, provided that: General rule.—Except as provided in paragraph (2), sections 201 through 208 of MCCA [sections 201 to 208 of Pub. L. 100–360, enacting section 1395w–3 of this title, amending this section and sections 1320c–3, 1395h, 1395k, 1395l, 1395m, 1395n, 1395u, 1395w–2, 1395x, 1395y, 1395z, 1395aa, 1395bb, 1395cc, 1395mm, 1396a, 1396b, and 1396n of this title, and enacting provisions set out as notes under sections 1320c–3, 1395b–1, 1395k, 1395m, 1395u, 1395x, 1395ll, and 1395ww of this title] are repealed and the provisions of law amended or repealed by such sections are restored or revived as if such sections had not been enacted. Exception.—Paragraph (1) shall not apply to subsections (g) and (m)(4) of section 202 of MCCA [amending section 1395u of this title and enacting provisions set out as a note under section 1395u of this title.]”

Study and Report on Incentive Arrangements Offered to Physicians

Pub. L. 99–509, title IX, § 9313(c)(3), Oct. 21, 1986, 100 Stat. 2003, directed Secretary of Health and Human Services to report to Congress, not later than Jan. 1, 1988, concerning incentive arrangements offered by health maintenance organizations and competitive medical plans to physicians.

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

42 U.S.C. § 1320a–7b

(a)

Making or causing to be made false statements or representations— Whoever—

(1)

knowingly and willfully makes or causes 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 (as defined in subsection (f)),

(2)

at any time knowingly and willfully makes or causes 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,

(5)

presents or causes to be presented a claim for a physician’s service for which payment may be made under a Federal health care program and knows that the individual who furnished the service was not licensed as a physician, or

(6)

for a fee knowingly and willfully counsels or assists an individual to dispose of assets (including by any transfer in trust) in order for the individual to become eligible for medical assistance under a State 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,

shall (i) in the case of such a statement, representation, concealment, failure, or conversion by any person in connection with the furnishing (by that person) of items or services for which payment is or may be made under the program, 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, 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 is convicted of an offense under the preceding provisions of this subsection, the administrator of such program may at its option (notwithstanding any other provision of such program) 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 for assistance under the plan, regardless of the relationship between that individual and such other person.

(b)

Illegal remunerations—

(1)

Whoever knowingly and willfully solicits or receives any remuneration (including 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 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, or

(B)

in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,

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 any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any person to induce such person—

(A)

to refer an individual to a person 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, or

(B)

to purchase, lease, order, or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program,

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) and (2) shall not apply to—

(A)

a discount or other reduction in price obtained by a provider of services or other entity under a Federal health care program 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;

(B)

any amount paid by an employer to an employee (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 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 if—

(i)

the person has a written contract, with each such individual or entity, which specifies the amount to be paid the person, 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 (as defined in section 1395x(u) of this title), the person discloses (in such form and manner as the Secretary requires) to the entity and, upon request, to the Secretary 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 et seq.];

(E)

any payment practice specified by the Secretary in regulations promulgated pursuant to section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987 or in regulations under section 1395w–104(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 between the organization and the individual or entity if the organization is an eligible organization under section 1395mm of this title or if the written agreement, 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 pharmacies of the Indian Health Service, Indian tribes, tribal organizations, and urban Indian organizations) of any cost-sharing 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 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 (as defined in section 1395w–114(a)(3) of this title), section 1320a–7a(i)(6)(A) of this title shall be applied without regard to clauses (ii) and (iii) of that section);

(H)

any remuneration between a federally qualified health center (or an entity controlled by such a health center) and an MA organization pursuant to a written agreement described in section 1395w–23(a)(4) of this title;

(I)

any remuneration between a health center entity described under clause (i) or (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, loan, or other agreement, if such agreement 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 served by the health center entity;

(J)

a discount in the price of an applicable drug (as defined in paragraph (2) of section 1395w–114a(g) of this title) of a manufacturer that is furnished to an applicable beneficiary (as defined in paragraph (1) of such section) under the Medicare coverage gap discount program under section 1395w–114a of this title;

(K)

an incentive payment made to a Medicare fee-for-service beneficiary by an ACO under an ACO Beneficiary Incentive Program established under subsection (m) of section 1395jjj of this title, if the payment is made in accordance with the requirements of such subsection and meets such other conditions as the Secretary may establish; and

(L)

a bona fide mental health or behavioral health improvement or maintenance program, if—

(i)

such program—

(I)

consists of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program;

(II)

is made available to a physician or other clinician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in appropriate strategies to promote the mental health and resiliency of such physician or other clinician;

(III)

is set out in a written policy, approved in advance of the operation of the program by the governing body of the entity providing such program (and which shall be updated accordingly in advance to substantial changes to the operation of such program), that includes—

(aa)

a description of the content and duration of the program;

(bb)

a description of the evidence-based support for the design of the program;

(cc)

the estimated cost of the program;

(dd)

the personnel (including the qualifications of such personnel) implementing the program; and

(ee)

the method by which such entity will evaluate the use and success of the program;

(IV)

is offered by an entity described in clause (ii) with a formal medical staff to all physicians and other clinicians who practice in the geographic area served by such entity, including physicians 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 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 or clinician for such entity;

(VI)

is evidence-based and conducted by a qualified health professional; and

(VII)

meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient abuse;

(ii)

such entity is—

(I)

a hospital;

(II)

an ambulatory surgical center;

(III)

a community health center;

(IV)

a rural emergency hospital;

(V)

a skilled nursing facility; or

(VI)

any similar entity, as determined by the Secretary; and

(iii)

neither the provision of such program, nor the value of such program, are contingent upon the number or value of referrals made by a physician or other clinician to such entity or the amount or value of other business generated by such physician 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 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), or both.

(c)

False statements or representations with respect to condition or operation of institutions— Whoever knowingly and willfully makes or causes 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, or entity in order that such institution, facility, or entity may qualify (either upon initial certification or upon recertification) as a hospital, critical access hospital, skilled nursing facility, nursing facility, intermediate care facility for the mentally retarded, home health agency, or other entity (including an eligible organization under section 1395mm(b) of this title) for which certification is required under subchapter XVIII or a State health care program (as defined in section 1320a–7(h) of this title), or with respect to information required to be provided under section 1320a–3a of this title, 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 plan approved under subchapter XIX, money or other consideration at a rate in excess of the rates established by the State (or, in the case of services provided to an individual enrolled with a medicaid managed care organization under subchapter XIX under a contract under section 1396b(m) of this title 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 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 unrelated to the patient)—

(A)

as a precondition of admitting a patient to a hospital, nursing facility, or intermediate care facility for the mentally retarded, or

(B)

as a requirement for the patient’s continued stay in such a facility,

when the cost of the services provided therein to the patient is paid for (in whole or in part) under the State 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 or agrees to be a participating physician or supplier under section 1395u(h)(1) of this title and knowingly, willfully, and repeatedly violates the term of such assignments or agreement, 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 that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government (other than the health insurance program under chapter 89 of title 5); or

(2)

any State health care program, as defined in section 1320a–7(h) of this title.

(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, a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim for purposes of subchapter III of chapter 37 of title 31.

(h)

Actual knowledge or specific intent not required— With respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.

Footnotes

1 See References in Text note below.

Notes, amendments, and revision history

(Aug. 14, 1935, ch. 531, title XI, § 1128B, formerly title XVIII, § 1877(d), and title XIX, § 1909, as added and amended Pub. L. 92–603, title II, §§ 242(c), 278(b)(9), Oct. 30, 1972, 86 Stat. 1419, 1454; Pub. L. 95–142, § 4(a), (b), Oct. 25, 1977, 91 Stat. 1179, 1181; Pub. L. 96–499, title IX, § 917, Dec. 5, 1980, 94 Stat. 2625; Pub. L. 98–369, div. B, title III, § 2306(f)(2), July 18, 1984, 98 Stat. 1073; renumbered title XI, § 1128B, and amended Pub. L. 100–93, §§ 4(a)–(d), 14(b), Aug. 18, 1987, 101 Stat. 688, 689, 697; Pub. L. 100–203, title IV, §§ 4039(a), 4211(h)(7), Dec. 22, 1987, 101 Stat. 1330–81, 1330–206; Pub. L. 100–360, title IV, § 411(a)(3)(A), (B)(i), July 1, 1988, 102 Stat. 768; Pub. L. 101–239, title VI, § 6003(g)(3)(D)(ii), Dec. 19, 1989, 103 Stat. 2153; Pub. L. 101–508, title IV, §§ 4161(a)(4), 4164(b)(2), Nov. 5, 1990, 104 Stat. 1388–94, 1388–102; Pub. L. 103–432, title I, § 133(a)(2), Oct. 31, 1994, 108 Stat. 4421; Pub. L. 104–191, title II, §§ 204(a), 216(a), 217, Aug. 21, 1996, 110 Stat. 1999, 2007, 2008; Pub. L. 105–33, title IV, §§ 4201(c)(1), 4704(b), 4734, Aug. 5, 1997, 111 Stat. 373, 498, 522; Pub. L. 108–173, title I, § 101(e)(2), (8)(A), title II, § 237(d), title IV, § 431(a), Dec. 8, 2003, 117 Stat. 2150, 2152, 2213, 2287; Pub. L. 111–148, title III, § 3301(d)(1), title VI, § 6402(f), Mar. 23, 2010, 124 Stat. 468, 759; Pub. L. 114–115, § 8, Dec. 28, 2015, 129 Stat. 3134; Pub. L. 115–123, div. E, title III, § 50341(b), title IV, § 50412(a)(2), (b), Feb. 9, 2018, 132 Stat. 208, 220; Pub. L. 117–328, div. FF, title IV, § 4126(b), Dec. 29, 2022, 136 Stat. 5914.)

Editorial Notes

References in Text

The Public Health Service Act, referred to in subsec. (b)(3)(D), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 201 of this title and Tables.

Section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987, referred to in subsec. (b)(3)(E), is section 14(a) of Pub. L. 100–93, which is set out below.

Section 1395w–104(e)(6) of this title, referred to in subsec. (b)(3)(E), was in the original “section 1860D–3(e)(6)”, and was translated as reading “section 1860D–4(e)(6)” to reflect the probable intent of Congress, because section 1860D–3, which is classified to section 1395w–103 of this title, does not contain a subsec. (e), and section 1395w–104(e)(6) relates to regulations.

Codification

Prior to redesignation by Pub. L. 100–93, subsecs. (a) to (d) of this section were subsecs. (a) to (d) of section 1909 of act Aug. 14, 1935, which was classified to section 1396h of this title, and subsec. (e) of this section was subsec. (d) of section 1877 of act Aug. 14, 1935, which was classified to section 1395nn of this title.

Amendments

2022—Subsec. (b)(3)(L). Pub. L. 117–328 added subpar. (L).

2018—Subsec. (a). Pub. L. 115–123, § 50412(a)(2)(A), (b)(1), in concluding provisions, substituted “$100,000” for “$25,000”, “not more than 10 years or both, or (ii)” for “not more than five years or both, or (ii)”, and “$20,000” for “$10,000”.

Subsec. (b)(1). Pub. L. 115–123, § 50412(a)(2)(B)(i), (b)(2)(A), in concluding provisions, substituted “$100,000” for “$25,000” and “not more than 10 years” for “not more than five years”.

Subsec. (b)(2). Pub. L. 115–123, § 50412(a)(2)(B)(ii), (b)(2)(B), in concluding provisions, substituted “$100,000” for “$25,000” and “not more than 10 years” for “not more than five years”.

Subsec. (b)(3)(K). Pub. L. 115–123, § 50341(b), added subpar. (K).

Subsec. (c). Pub. L. 115–123, § 50412(a)(2)(C), (b)(3), substituted “$100,000” for “$25,000” and “not more than 10 years” for “not more than five years”.

Subsec. (d). Pub. L. 115–123, § 50412(a)(2)(D), (b)(4), in concluding provisions, substituted “$100,000” for “$25,000” and “not more than 10 years” for “not more than five years”.

Subsec. (e). Pub. L. 115–123, § 50412(a)(2)(E), substituted “$4,000” for “$2,000”.

2015—Subsec. (b)(4). Pub. L. 114–115 added par. (4).

2010—Subsec. (b)(3)(G). Pub. L. 111–148, § 3301(d)(1)(A), struck out “and” at the end.

Subsec. (b)(3)(H). Pub. L. 111–148, § 3301(d)(1)(B), amended subpar. (H) relating to remuneration between a federally qualified health center and an MA organization by substituting a semicolon for the period at the end and realigning margins.

Subsec. (b)(3)(I). Pub. L. 111–148, § 3301(d)(1)(C)(i), (ii), redesignated subpar. (H) relating to remuneration between a health center entity and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to such health center entity as (I) and realigned margins.

Subsec. (b)(3)(J). Pub. L. 111–148, § 3301(d)(1)(C)(iii), (D), added subpar. (J).

Subsecs. (g), (h). Pub. L. 111–148, § 6402(f), added subsecs. (g) and (h).

2003—Subsec. (b)(3)(E). Pub. L. 108–173, § 101(e)(8)(A), which directed the amendment of subpar. (C) by inserting “or in regulations under section 1395w–104(e)(6) of this title” after “1987”, was executed by making the insertion in subpar. (E) to reflect the probable intent of Congress because “1987” does not appear in subpar. (C).

Subsec. (b)(3)(G). Pub. L. 108–173, § 101(e)(2), added subpar. (G).

Subsec. (b)(3)(H). Pub. L. 108–173, § 431(a), added subpar. (H) relating to remuneration between a health center entity and any individual or entity providing goods, items, services, donations, loans, or a combination thereof, to such health center entity.

Pub. L. 108–173, § 237(d), added subpar. (H) relating to remuneration between a federally qualified health center and an MA organization.

1997—Subsec. (a). Pub. L. 105–33, § 4734(2), in cl. (ii) of concluding provisions, substituted “failure, conversion, or provision of counsel or assistance by any other person” for “failure, or conversion by any other person”.

Subsec. (a)(6). Pub. L. 105–33, § 4734(1), added par. (6) and struck out former par. (6) which read as follows: “knowingly and willfully disposes of assets (including by any transfer in trust) in order for an individual to become eligible for medical assistance under a State plan under subchapter XIX of this chapter, if disposing of the assets results in the imposition of a period of ineligibility for such assistance under section 1396p(c) of this title,”.

Subsec. (c). Pub. L. 105–33, § 4201(c)(1), substituted “critical access” for “rural primary care”.

Subsec. (d)(1). Pub. L. 105–33, § 4704(b), inserted “(or, in the case of services provided to an individual enrolled with a medicaid managed care organization under subchapter XIX under a contract under section 1396b(m) of this title or under a contractual, referral, or other arrangement under such contract, at a rate in excess of the rate permitted under such contract)” after “by the State”.

1996—Pub. L. 104–191, § 204(a)(1), substituted “Federal” for “Medicare or State” in section catchline.

Subsec. (a). Pub. L. 104–191, § 204(a)(4), in concluding provisions, substituted “a Federal health care program” for “a State plan approved under subchapter XIX of this chapter” and “the administrator of such program may at its option (notwithstanding any other provision of such program)” for “the State may at its option (notwithstanding any other provision of that subchapter or of such plan)”.

Subsec. (a)(1). Pub. L. 104–191, § 204(a)(2), substituted “a Federal health care program (as defined in subsection (f))” for “a program under subchapter XVIII of this chapter or a State health care program (as defined in section 1320a–7(h) of this title)”.

Subsec. (a)(5). Pub. L. 104–191, § 204(a)(3), substituted “a Federal” for “a program under subchapter XVIII of this chapter or a State”.

Subsec. (a)(6). Pub. L. 104–191, § 217, added par. (6).

Subsec. (b). Pub. L. 104–191, § 204(a)(5), substituted “a Federal health care program” for “subchapter XVIII of this chapter or a State health care program” wherever appearing.

Subsec. (b)(3)(F). Pub. L. 104–191, § 216(a), added subpar. (F).

Subsec. (c). Pub. L. 104–191, § 204(a)(6), inserted “(as defined in section 1320a–7(h) of this title)” after “a State health care program”.

Subsec. (f). Pub. L. 104–191, § 204(a)(7), added subsec. (f).

1994—Subsec. (b)(3)(B). Pub. L. 103–432, which directed substitution of “1395m(j)(5)” for “1395m(j)(4)” in subpar. (B) as amended by section 134(a) of Pub. L. 103–432, could not be executed because “1395m(j)(4)” does not appear in subpar. (B) and section 134(a) of Pub. L. 103–432 did not amend this section.

1990—Subsec. (b)(3)(D), (E). Pub. L. 101–508, § 4161(a)(4), added subpar. (D) and redesignated former subpar. (D) as (E).

Subsec. (c). Pub. L. 101–508, § 4164(b)(2), substituted “health care program, or with respect to information required to be provided under section 1320a–3a of this title,” for “health care program”.

1989—Subsec. (c). Pub. L. 101–239 inserted “rural primary care hospital,” after “hospital,”.

1988—Subsec. (c). Pub. L. 100–360 made technical correction to directory language of Pub. L. 100–203, § 4039(a), see 1987 Amendment note below.

Pub. L. 100–203, § 4211(h)(7)(A), substituted “nursing facility, intermediate care facility for the mentally retarded” for “intermediate care facility”.

Subsec. (d)(2)(A). Pub. L. 100–203, § 4211(h)(7)(B), substituted “nursing facility, or intermediate care facility for the mentally retarded” for “skilled nursing facility, or intermediate care facility”.

1987—Pub. L. 100–93, § 4(a)(1), substituted “Criminal penalties for acts involving Medicare or State health care programs” for “Offenses and penalties” in section catchline.

Subsec. (a). Pub. L. 100–93, § 4(a)(3), (4), in concluding provisions, substituted “made under the program” for “made under this subchapter”, “approved under subchapter XIX of this chapter” for “approved under this subchapter”, and “provision of that subchapter” for “provision of this subchapter”.

Subsec. (a)(1). Pub. L. 100–93, § 4(a)(2), substituted “a program under subchapter XVIII of this chapter or a State health care program (as defined in section 1320a–7(h) of this title)” for “a State plan approved under this subchapter”.

Subsec. (a)(5). Pub. L. 100–93, § 4(b), added par. (5).

Subsec. (b)(1)(A), (B), (2)(A), (B). Pub. L. 100–93, § 4(a)(5), substituted “subchapter XVIII of this chapter or a State health care program” for “this subchapter”.

Subsec. (b)(3). Pub. L. 100–93, §§ 4(a)(5), (6), 14(b), substituted “subchapter XVIII of this chapter or a State health care program” for “this subchapter” in two places in subpar. (A) and added subpars. (C) and (D).

Subsec. (c). Pub. L. 100–203, § 4039(a), as amended by Pub. L. 100–360, substituted “institution, facility, or entity” for “institution or facility” wherever appearing and inserted “(including an eligible organization under section 1395mm(b) of this title)” after “other entity”.

Pub. L. 100–93, § 4(a)(7), substituted “home health agency, or other entity for which certification is required under subchapter XVIII or a State health care program” for “or home health agency (as those terms are employed in this subchapter)”.

Subsec. (d)(1), (2). Pub. L. 100–93, § 4(a)(8), substituted “subchapter XIX” for “this subchapter”.

Subsec. (e). Pub. L. 100–93, § 4(c), redesignated subsec. (d) of section 1395nn of this title as subsec. (e) of this section.

1984—Subsec. (e). Pub. L. 98–369 inserted “or agrees to be a participating physician or supplier under section 1395u(h)(1) of this title” after “section 1395u(b)(3)(B)(ii) of this title”, and substituted “or agreement” for “specified in subclause (I) of such section”.

1980—Subsec. (b)(1), (2). Pub. L. 96–499 inserted “knowingly and willfully” after “Whoever”.

1977—Subsec. (a). Pub. L. 95–142, § 4(b), designated existing provisions following par. (4) as cl. (ii) and, as so designated, inserted provisions relating to activities of other persons, and inserted provisions authorizing the State to limit, restrict, or suspend, the eligibility of any convicted persons for benefits, and added cl. (i). See Codification note above.

Subsec. (b). Pub. L. 95–142, § 4(b), redesignated existing provisions as par. (1), substituted provisions relating to solicitation or receiving of any remuneration in return for referring an individual to a person for the furnishing or arranging the furnishing of any item or service, or in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, etc., as constituting a felony punishable by a fine of not more than $25,000 and/or imprisonment for not more than five years, for provisions relating to furnishing items or services and soliciting, offering or receiving any kickback, bribe, or rebate in connection with furnishing, etc. items or services as constituting a misdemeanor punishable by a fine of not more than $10,000 and/or imprisonment for not more than one year, and added pars. (2) and (3). See Codification note above.

Subsec. (c). Pub. L. 95–142, § 4(b), substituted provisions setting forth felony nature of criminal activities with a fine of not more than $25,000, or imprisonment for not more than five years, or both, for provisions setting forth misdemeanor nature of criminal activities with a fine of not more than $2,000, or imprisonment for not more than six months, or both. See Codification note above.

Subsec. (d). Pub. L. 95–142, § 4(b), added subsec. (d). See Codification note above.

Subsec. (e). Pub. L. 95–142, § 4(a), added subsec. (e). See Codification note above.

1972—Subsec. (c). Pub. L. 92–603, § 278(b)(9), substituted “skilled nursing facility” for “skilled nursing home”.

Statutory Notes and Related Subsidiaries

Effective Date of 2010 Amendment

Pub. L. 111–148, title III, § 3301(d)(3), Mar. 23, 2010, 124 Stat. 468, provided that: “The amendments made by this subsection [amending this section and 1396r–8 of this title] shall apply to drugs dispensed on or after July 1, 2010.”

Effective Date of 2003 Amendment

Pub. L. 108–173, title II, § 237(e), Dec. 8, 2003, 117 Stat. 2213, provided that: “The amendments made by this section [amending this section and sections 1395l, 1395w–21, 1395w–23, and 1395w–27 of this title] shall apply to services provided on or after January 1, 2006, and contract years beginning on or after such date.”

Effective Date of 1997 Amendment

Amendment by section 4704(b) of Pub. L. 105–33 effective Aug. 5, 1997, and applicable to contracts entered into or renewed on or after Oct. 1, 1997, see section 4710 of Pub. L. 105–33, set out as a note under section 1396b of this title.

Effective Date of 1996 Amendment

Pub. L. 104–191, title II, § 204(b), Aug. 21, 1996, 110 Stat. 2000, provided that: “The amendments made by this section [amending this section] shall take effect on January 1, 1997.”

Pub. L. 104–191, title II, § 216(c), Aug. 21, 1996, 110 Stat. 2008, provided that: “The amendments made by subsection (a) [amending this section] shall apply to written agreements entered into on or after January 1, 1997, without regard to whether regulations have been issued to implement such amendments.”

Amendment by section 217 of Pub. L. 104–191 effective Jan. 1, 1997, except as otherwise provided, see section 218 of Pub. L. 104–191, set out as a note under section 1320a–7 of this title.

Effective Date of 1994 Amendment

Amendment by section 133(a)(2) of Pub. L. 103–432 applicable to items or services furnished on or after Jan. 1, 1995, see section 133(c) of Pub. L. 103–432, set out as a note under section 1395m of this title.

Effective Date of 1990 Amendment

Amendment by section 4161(a)(4) of Pub. L. 101–508 applicable to services furnished on or after Oct. 1, 1991, see section 4161(a)(8) of Pub. L. 101–508, set out as a note under section 1395k of this title.

Amendment by section 4164(b)(2) of 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 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 Amendments

Amendment by section 4211(h)(7) of Pub. L. 100–203 applicable to nursing facility services furnished on or after Oct. 1, 1990, without regard to whether regulations implementing such amendment are promulgated by such date, except as otherwise specifically provided in section 1396r of this title, with transitional rule, see section 4214(a), (b)(2) of Pub. L. 100–203, as amended, set out as an Effective Date note under section 1396r of this title.

Effective Date of 1977 Amendment

Pub. L. 95–142, § 4(d), Oct. 25, 1977, 91 Stat. 1183, provided that: “The amendments made by subsections (a) and (b) [amending this section] shall apply with respect to acts occurring and statements or representations made on or after the date of the enactment of this Act [Oct. 25, 1977].”

Effective Date

Pub. L. 92–603, title II, § 242(d), Oct. 30, 1972, 86 Stat. 1420, provided that: “The provisions of amendments made by this section [enacting this section and section 1396h of this title and amending section 1395ii of this title] shall not be applicable to any acts, statements, or representations made or committed prior to the enactment of this Act [Oct. 30, 1972].”

Moratorium on Implementation of Rule Relating to Eliminating the Anti-Kickback Statute Safe Harbor Protection for Prescription Drug Rebates

Pub. L. 117–169, title I, § 11301, Aug. 16, 2022, 136 Stat. 1896, provided that: “The Secretary of Health and Human Services shall not, prior to January 1, 2032, implement, administer, or enforce the provisions of the final rule published by the Office of the Inspector General of the Department of Health and Human Services on November 30, 2020, and titled ‘Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees’ (85 Fed. Reg. 76666).”

Similar provisions were contained in the following prior act:

Pub. L. 117–58, div. I, § 90006, Nov. 15, 2021, 135 Stat. 1346, as amended by Pub. L. 117–159, div. A, title III, § 13101, June 25, 2022, 136 Stat. 1333.

Rulemaking for Exception for Health Center Entity Arrangements

Pub. L. 108–173, title IV, § 431(b), Dec. 8, 2003, 117 Stat. 2287, provided that:Establishment.— In general.—The Secretary [of Health and Human Services] shall establish, on an expedited basis, standards relating to the exception described in section 1128B(b)(3)(H) [now section 1128B(b)(3)(I)] of the Social Security Act [42 U.S.C. 1320a–7b(b)(3)(I)], as added by subsection (a), for health center entity arrangements to the antikickback penalties. Factors to consider.—The Secretary shall consider the following factors, among others, in establishing standards relating to the exception for health center entity arrangements under subparagraph (A): Whether the arrangement between the health center entity and the other party results in savings of Federal grant funds or increased revenues to the health center entity. Whether the arrangement between the health center entity and the other party restricts or limits an individual’s freedom of choice. Whether the arrangement between the health center entity and the other party protects a health care professional’s independent medical judgment regarding medically appropriate treatment.The Secretary may also include other standards and criteria that are consistent with the intent of Congress in enacting the exception established under this section. Deadline.—Not later than 1 year after the date of the enactment of this Act [Dec. 8, 2003] the Secretary shall publish final regulations establishing the standards described in paragraph (1).”

Negotiated Rulemaking for Risk-Sharing Exception

Pub. L. 104–191, title II, § 216(b), Aug. 21, 1996, 110 Stat. 2007, provided that:Establishment.— In general.—The Secretary of Health and Human Services (in this subsection referred to as the ‘Secretary’) shall establish, on an expedited basis and using a negotiated rulemaking process under subchapter 3 [III] of chapter 5 of title 5, United States Code, standards relating to the exception for risk-sharing arrangements to the anti-kickback penalties described in section 1128B(b)(3)(F) of the Social Security Act [42 U.S.C. 1320a–7b(b)(3)(F)], as added by subsection (a). Factors to consider.—In establishing standards relating to the exception for risk-sharing arrangements to the anti-kickback penalties under subparagraph (A), the Secretary— shall consult with the Attorney General and representatives of the hospital, physician, other health practitioner, and health plan communities, and other interested parties; and shall take into account— the level of risk appropriate to the size and type of arrangement; the frequency of assessment and distribution of incentives; the level of capital contribution; and the extent to which the risk-sharing arrangement provides incentives to control the cost and quality of health care services. Publication of notice.—In carrying out the rulemaking process under this subsection, the Secretary shall publish the notice provided for under section 564(a) of title 5, United States Code, by not later than 45 days after the date of the enactment of this Act [Aug. 21, 1996]. Target date for publication of rule.—As part of the notice under paragraph (2), and for purposes of this subsection, the ‘target date for publication’ (referred to in section 564(a)(5) of such title) shall be January 1, 1997. Abbreviated period for submission of comments.—In applying section 564(c) of such title under this subsection, ‘15 days’ shall be substituted for ‘30 days’. Appointment of negotiated rulemaking committee and facilitator.—The Secretary shall provide for— the appointment of a negotiated rulemaking committee under section 565(a) of such title by not later than 30 days after the end of the comment period provided for under section 564(c) of such title (as shortened under paragraph (4)), and the nomination of a facilitator under section 566(c) of such title by not later than 10 days after the date of appointment of the committee. Preliminary committee report.—The negotiated rulemaking committee appointed under paragraph (5) shall report to the Secretary, by not later than October 1, 1996, regarding the committee’s progress on achieving a consensus with regard to the rulemaking proceeding and whether such consensus is likely to occur before one month before the target date for publication of the rule. If the committee reports that the committee has failed to make significant progress toward such consensus or is unlikely to reach such consensus by the target date, the Secretary may terminate such process and provide for the publication of a rule under this subsection through such other methods as the Secretary may provide. Final committee report.—If the committee is not terminated under paragraph (6), the rulemaking committee shall submit a report containing a proposed rule by not later than one month before the target publication date. Interim, final effect.—The Secretary shall publish a rule under this subsection in the Federal Register by not later than the target publication date. Such rule shall be effective and final immediately on an interim basis, but is subject to change and revision after public notice and opportunity for a period (of not less than 60 days) for public comment. In connection with such rule, the Secretary shall specify the process for the timely review and approval of applications of entities to be certified as provider-sponsored organizations pursuant to such rules and consistent with this subsection. Publication of rule after public comment.—The Secretary shall provide for consideration of such comments and republication of such rule by not later than 1 year after the target publication date.”

Anti-Kickback Regulations

Pub. L. 100–93, § 14(a), Aug. 18, 1987, 101 Stat. 697, provided that: “The Secretary of Health and Human Services, in consultation with the Attorney General, not later than 1 year after the date of the enactment of this Act [Aug. 18, 1987] shall publish proposed regulations, and not later than 2 years after the date of the enactment of this Act shall promulgate final regulations, specifying payment practices that shall not be treated as a criminal offense under section 1128B(b) of the Social Security Act [42 U.S.C. 1320a–7b(b)] and shall not serve as the basis for an exclusion under section 1128(b)(7) of such Act. Any practices specified in regulations pursuant to the preceding sentence shall be in addition to the practices described in subparagraphs (A) through (C) of section 1128B(b)(3).”

Executive Documents

Ex. Ord. No. 13939. Lowering Prices for Patients by Eliminating Kickbacks to Middlemen

Ex. Ord. No. 13939, July 24, 2020, 85 F.R. 45759, provided:

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows:

Section 1. Purpose. One of the reasons pharmaceutical drug prices in the United States are so high is because of the complex mix of payers and negotiators that often separates the consumer from the manufacturer in the drug-purchasing process. The result is that the prices patients see at the point-of-sale do not reflect the prices that the patient’s insurance companies, and middlemen hired by the insurance companies, actually pay for drugs. Instead, these middlemen—health plan sponsors and pharmacy benefit managers (PBMs)—negotiate significant discounts off of the list prices, sometimes up to 50 percent of the cost of the drug. Medicare patients, whose cost sharing is typically based on list prices, pay more than they should for drugs while the middlemen collect large “rebate” checks. These rebates are the functional equivalent of kickbacks, and erode savings that could otherwise go to the Medicare patients taking those drugs. Yet currently, Federal regulations create a safe harbor for such discounts and preclude treating them as kickbacks under the law.

Fixing this problem could save Medicare patients billions of dollars. The Office of the Inspector General at the Department of Health and Human Services has found that patients in the catastrophic phase of the Medicare Part D program saw their out-of-pocket costs for high-price drugs increase by 47 percent from 2010 to 2015, from $175 per month to $257 per month. Narrowing the safe harbor for these discounts under the anti-kickback statute will allow tens of billions in dollars of rebates on prescription drugs in the Medicare Part D program to go directly to patients, saving many patients hundreds or thousands of dollars per year at the pharmacy counter.

Sec. 2. Policy. It is the policy of the United States that discounts offered on prescription drugs should be passed on to patients.

Sec. 3. Directing Drug Rebates to Patients Instead of Middlemen. The Secretary of Health and Human Services shall complete the rulemaking process he commenced seeking to:

(a) exclude from safe harbor protections under the anti-kickback statute, section 1128B(b) of the Social Security Act, 42 U.S.C. 1320a–7b[(b)], certain retrospective reductions in price that are not applied at the point-of-sale or other remuneration that drug manufacturers provide to health plan sponsors, pharmacies, or PBMs in operating the Medicare Part D program; and

(b) establish new safe harbors that would permit health plan sponsors, pharmacies, and PBMs to apply discounts at the patient’s point-of-sale in order to lower the patient’s out-of-pocket costs, and that would permit the use of certain bona fide PBM service fees.

Sec. 4. Protecting Low Premiums. Prior to taking action under section 3 of this order, the Secretary of Health and Human Services shall confirm—and make public such confirmation—that the action is not projected to increase Federal spending, Medicare beneficiary premiums, or patients’ total out-of-pocket costs.

Sec. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.

(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

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

42 U.S.C. § 1320a–7c

(a)

Establishment of program—

(1)

In general— Not later than January 1, 1997, the Secretary, acting through the Office of the Inspector General of the Department of Health and Human Services, and the Attorney General shall establish a program—

(A)

to coordinate Federal, State, and local law enforcement programs to control fraud and abuse with respect to health plans,

(B)

to conduct investigations, audits, evaluations, and inspections relating to the delivery of and payment for health care in the United States,

(C)

to facilitate the enforcement of the provisions of sections 1320a–7, 1320a–7a, and 1320a–7b of this title and other statutes applicable to health care fraud and abuse, and

(D)

to provide for the modification and establishment of safe harbors and to issue advisory opinions and special fraud alerts pursuant to section 1320a–7d of this title.

(2)

Coordination with health plans— In carrying out the program established under paragraph (1), the Secretary and the Attorney General shall consult with, and arrange for the sharing of data with representatives of health plans.

(3)

Guidelines—

(A)

In general— The Secretary and the Attorney General shall issue guidelines to carry out the program under paragraph (1). The provisions of sections 553, 556, and 557 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, providers, and others to enable the Secretary and the Attorney General to carry out the program (including coordination with health plans under paragraph (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 (relating to limitation on liability) shall apply to a person providing information to the Secretary or the Attorney General 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 as necessary with respect to the activities under the fraud and abuse control program 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 such authority as provided in chapter 4 of title 5.

(6)

Public-private partnership for waste, fraud, and abuse detection—

(A)

In general— Under the program described in paragraph (1), there is established a public-private partnership (in this paragraph referred to as the “partnership”) of health plans, Federal and State agencies, law enforcement agencies, health care anti-fraud organizations, and any other entity determined appropriate by the Secretary (in this paragraph referred to as “partners”) for purposes of detecting and preventing health care waste, fraud, and abuse.

(B)

Contract with trusted third party— In carrying out the partnership, the Secretary shall enter into a contract with a trusted third party for purposes of carrying out the duties of the partnership described in subparagraph (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, and private health plans for purposes of detecting fraud, waste, and abuse 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 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 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) may enter the partnership and requirements such entities must meet to enter the partnership;

(x)

provide appropriate training, outreach, and education to partners based on the results of data analyses described in clauses (ii) and (iii); and

(xi)

perform such other duties as the Secretary determines appropriate.

(D)

Substance use disorder treatment analysis— Not later than 2 years after December 27, 2020, the trusted third party with a contract in effect under subparagraph (B) shall perform an analysis of aberrant or fraudulent billing patterns and trends with respect to providers and suppliers of substance use disorder treatments from data shared with the partnership.

(E)

Executive board—

(i)

Executive board composition—

(I)

In general— There shall be an executive board of the partnership comprised of representatives of the Federal Government and representatives of the private sector selected by the Secretary.

(II)

Chairs— The executive board shall be co-chaired by one Federal Government official and one representative from the private sector.

(ii)

Meetings— The executive board of the partnership shall meet at least once per year.

(iii)

Executive board duties— The duties of the executive board shall include the following:

(I)

Providing strategic direction for the partnership, including 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 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 any progress to any objectives established by the partnership;

(ii)

any savings voluntarily reported by health plans 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, 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 a description of any emerging fraud and abuse schemes, trends, or practices that the partnership intends to study during such period.

(G)

Funding— The partnership shall be funded by amounts otherwise made available to the Secretary for carrying out the program described in paragraph (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 shall be transferred to the partnership established under subparagraph (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).

(J)

Implementation— Notwithstanding any other provision of law, the Secretary may implement the partnership established by subparagraph (A) by program 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);

(ii)

complies with such conflict of interest standards determined appropriate by the Secretary; and

(iii)

meets such other requirements as the Secretary 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 received by the Inspector General under paragraph (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.

(c)

“Health plan” defined— For purposes of this section, the term “health plan” means a plan or program that provides health benefits, whether directly, through insurance, or otherwise, and includes—

(1)

a policy of health insurance;

(2)

a contract of a service benefit organization; and

(3)

a membership agreement with a health maintenance organization or other prepaid health plan.

Notes, amendments, and revision history

(Aug. 14, 1935, ch. 531, title XI, § 1128C, as added Pub. L. 104–191, title II, § 201(a), Aug. 21, 1996, 110 Stat. 1992; amended Pub. L. 111–148, title VI, § 6403(c), Mar. 23, 2010, 124 Stat. 766; Pub. L. 116–260, div. CC, title I, § 124(a), Dec. 27, 2020, 134 Stat. 2957; Pub. L. 117–286, § 4(b)(78), Dec. 27, 2022, 136 Stat. 4351.)

Editorial Notes

References in Text

The Federal Advisory Committee Act, referred to in subsec. (a)(6)(I), is Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 770, which was set out in the Appendix to Title 5, Government Organization and Employees, and was substantially repealed and restated in chapter 10 (§ 1001 et seq.) of Title 5 by Pub. L. 117–286, §§ 3(a), 7, Dec. 27, 2022, 136 Stat. 4197, 4361. For disposition of sections of the Act into chapter 10 of Title 5, see Disposition Table preceding section 101 of Title 5.

Amendments

2022—Subsec. (a)(4). Pub. L. 117–286, § 4(b)(78)(A), substituted “paragraphs (3) through (9) of section 406(a) of title 5” for “paragraphs (3) through (9) of section 6 of the Inspector General Act of 1978 (5 U.S.C. App.)”.

Subsec. (a)(5). Pub. L. 117–286, § 4(b)(78)(B), substituted “chapter 4 of title 5.” for “the Inspector General Act of 1978 (5 U.S.C. App.).”

2020—Subsec. (a)(6). Pub. L. 116–260 added par. (6).

2010—Subsec. (a)(1)(C) to (E). Pub. L. 111–148 inserted “and” at end of subpar. (C), substituted period for “, and” at end of subpar. (D), and struck out subpar. (E) which read as follows: “to provide for the reporting and disclosure of certain final adverse actions against health care providers, suppliers, or practitioners pursuant to the data collection system established under section 1320a–7e of this title.”

Statutory Notes and Related Subsidiaries

Effective Date of 2010 Amendment

Amendment by Pub. L. 111–148 effective on the first day after the final day of the transition period defined in section 6403(d)(5) of Pub. L. 111–148, see section 6403(d)(6) of Pub. L. 111–148, set out as a Transition Process; Regulations; Effective Date of 2010 Amendment note under section 1320a–7e of this title.

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

42 U.S.C. § 1320a–7d

(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 shall publish a notice in the Federal Register soliciting proposals, which will be accepted during a 60-day period, for—

(i)

modifications to existing safe harbors issued pursuant to section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987 (42 U.S.C. 1320a–7b note);

(ii)

additional safe harbors specifying payment practices that shall not be treated as a criminal offense under section 1320a–7b(b) of this title and shall not serve as the basis for an exclusion under section 1320a–7(b)(7) of this title;

(iii)

advisory opinions to be issued pursuant to subsection (b); and

(iv)

special fraud alerts to be issued pursuant to subsection (c).

(B)

Publication of proposed modifications and proposed additional safe harbors— After considering the proposals described in clauses (i) and (ii) of subparagraph (A), the Secretary, in consultation with the Attorney General, shall publish in the Federal Register proposed modifications 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 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, describe the proposals received under clauses (i) and (ii) of subparagraph (A) and explain which proposals were included in the publication described in subparagraph (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), the Secretary 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.

(D)

An increase or decrease in competition among health care providers.

(E)

An increase or decrease in the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations.

(F)

An increase or decrease in the cost to Federal health care programs (as defined in section 1320a–7b(f) of this title).

(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 or provider.

(I)

Any other factors the Secretary deems appropriate in the interest of preventing fraud and abuse in Federal health care programs (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) 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).

(B)

Report— Not later than two years after December 29, 2022, the Secretary and the Inspector General shall submit to Congress recommendations, including based on the review conducted under subparagraph (A), for improving access to evidence-based contingency management interventions while ensuring quality of care, ensuring fidelity to evidence-based practices, and including strong program integrity safeguards that prevent increased waste, fraud, and abuse and prevent medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care program.

(b)

Advisory opinions—

(1)

Issuance of advisory opinions— The Secretary, in consultation with the Attorney General, shall issue written advisory opinions as provided in this subsection.

(2)

Matters subject to advisory opinions— The Secretary 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 or section 1320a–7a(i)(6) of this title.

(B)

Whether an arrangement or proposed arrangement satisfies the criteria set forth in section 1320a–7b(b)(3) of this title for activities which do not result in prohibited remuneration.

(C)

Whether an arrangement or proposed arrangement satisfies the criteria which the Secretary 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.

(E)

Whether any activity or proposed activity constitutes grounds for the imposition of a sanction under section 1320a–7, 1320a–7a, or 1320a–7b 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 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 shall be binding as to the Secretary 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 sections¹ 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 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 in responding to a request for an advisory opinion;

(iii)

the interval in which the Secretary 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)—

(i)

the Secretary 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 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 may present, at any time, a request to the Inspector General for a notice which informs the public of practices which the Inspector General considers to be suspect or of particular concern under the Medicare program under subchapter XVIII or a State health care program, as defined in section 1320a–7(h) of this title (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), 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), the Inspector General may consider—

(A)

whether and to what extent the practices that would be identified in the special fraud alert may result in any of the consequences described in subsection (a)(2); and

(B)

the volume and frequency of the conduct that would be identified in the special fraud alert.

Footnotes

1 So in original. Probably should be “section”.

Notes, amendments, and revision history

(Aug. 14, 1935, ch. 531, title XI, § 1128D, as added Pub. L. 104–191, title II, § 205, Aug. 21, 1996, 110 Stat. 2000; amended Pub. L. 105–33, title IV, § 4331(a)(1), Aug. 5, 1997, 111 Stat. 395; Pub. L. 105–277, div. J, title V, § 5201(c), Oct. 21, 1998, 112 Stat. 2681–917; Pub. L. 106–554, § 1(a)(6) [title V, § 543], Dec. 21, 2000, 114 Stat. 2763, 2763A–551; Pub. L. 117–286, § 4(b)(79), Dec. 27, 2022, 136 Stat. 4351; Pub. L. 117–328, div. FF, title IV, § 4127, Dec. 29, 2022, 136 Stat. 5915.)

Editorial Notes

References in Text

Section 14(a) of the Medicare and Medicaid Patient and Program Protection Act of 1987, referred to in subsec. (a)(1)(A)(i), is section 14(a) of Pub. L. 100–93, which is set out as a note under section 1320a–7b of this title.

The Internal Revenue Code of 1986, referred to in subsec. (b)(3)(B), is classified generally to Title 26, Internal Revenue Code.

Amendments

2022—Subsec. (a)(1)(C). Pub. L. 117–286 substituted “section 405 of title 5,” for “section 5 of the Inspector General Act of 1978 (5 U.S.C. App.),”.

Subsec. (a)(3). Pub. L. 117–328 added par. (3).

2000—Subsec. (b)(6). Pub. L. 106–554 struck out “, and before the date which is 4 years after August 21, 1996” before period at end.

1998—Subsec. (b)(2)(A). Pub. L. 105–277 inserted “or section 1320a–7a(i)(6) of this title” before period at end.

1997—Subsec. (b)(2)(D). Pub. L. 105–33 substituted “section 1320a–7a(b)” for “section 1320a–7b(b)”.

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–33 effective as if included in the enactment of the Health Insurance Portability and Accountability Act of 1996, Pub. L. 104–191, see section 4331(f) of Pub. L. 105–33, set out as a note under section 1320a–7e of this title.

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

42 U.S.C. § 1320a–7e

(a)

In general— The Secretary shall maintain a national health care fraud and abuse data collection program under this section for the reporting of certain final adverse actions (not including settlements in which no findings of liability have been made) against health care providers, suppliers, or practitioners as required by subsection (b), with access as set forth in subsection (d), and shall furnish the information collected under this section to the National Practitioner Data Bank established pursuant to the Health Care Quality Improvement Act of 1986 (42 U.S.C. 11101 et seq.).

(b)

Reporting of information—

(1)

In general— Each Government agency and health plan shall report any final adverse action (not including settlements in which no findings of liability have been made) taken against a health care provider, supplier, or practitioner.

(2)

Information to be reported— The information to be reported under paragraph (1) includes:

(A)

The name and TIN (as defined in section 7701(a)(41) of the Internal Revenue Code of 1986) of any health care provider, supplier, or practitioner who is the subject of a final adverse action.

(B)

The name (if known) of any health care entity with which a health care provider, supplier, or practitioner, who is the subject of a final adverse action, is affiliated or associated.

(C)

The nature of the final adverse action and whether such action is on appeal.

(D)

A description of the acts or omissions and injuries upon which the final adverse action was based, and such other information as the Secretary determines by regulation is required for appropriate interpretation of information reported under this section.

(3)

Confidentiality— In determining what information is required, the Secretary 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 prescribes. Such information shall first be required to be reported on a date specified by the Secretary.

(5)

To whom reported— The information required to be reported under this subsection shall be reported to the Secretary.

(6)

Sanctions for failure to report—

(A)

Health plans— Any health plan 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 are imposed and collected under that section.

(B)

Governmental agencies— The Secretary shall provide for a publication of a public report that identifies those Government agencies 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 (not including settlements in which no findings of liability have been made) reported to the Secretary under this section with respect to a health care provider, supplier, or practitioner, the Secretary shall, by regulation, provide for—

(A)

disclosure of the information, upon request, to the health care provider, supplier, or licensed practitioner, and

(B)

procedures in the case of disputed accuracy of the information.

(2)

Corrections— Each Government agency and health plan shall report corrections of information already reported about any final adverse action taken against a health care provider, supplier, or practitioner, in such form and manner that the Secretary prescribes by regulation.

(d)

Access to reported information—

(1)

Availability— The information collected under this section shall be available from the National Practitioner Data Bank to the agencies, authorities, and officials which are provided under section 1396r–2(b) of this title information reported under section 1396r–2(a) of this title.

(2)

Fees for disclosure— The Secretary 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 to cover such costs.

(e)

Protection from liability for reporting— No person or entity, including the agency designated by the Secretary in subsection (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 shall provide for the maximum appropriate coordination with part B of the Health Care Quality Improvement Act of 1986 (42 U.S.C. 11131 et seq.) and section 1396r–2 of this title.

(g)

Definitions and special rules— For purposes of this section:

(1)

Final adverse action—

(A)

In general— The term “final adverse action” includes:

(i)

Civil judgments against a health care provider, supplier, or practitioner in Federal or State court related to the delivery of a health care item or service.

(ii)

Federal or State criminal convictions related to the delivery of a health care item or service.

(iii)

Actions by Federal agencies responsible for the licensing and certification of health care providers, suppliers, and licensed health care practitioners, including—

(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, or practitioner surrendering their license or leaving the State or jurisdiction¹

(III)

any other loss of license or the right to apply for, or renew, a license of the provider, supplier, or practitioner, whether by operation of law, voluntary surrender, non-renewability, or otherwise, or

(IV)

any other negative action or finding by such Federal agency that is publicly available information.

(iv)

Exclusion from participation in a Federal health care program (as defined in section 1320a–7b(f) of this title).

(v)

Any other adjudicated actions or decisions that the Secretary shall establish by regulation.

(B)

Exception— The term does not include any action with respect to a malpractice claim.

(2)

Practitioner— The terms “licensed health care practitioner”, “licensed practitioner”, and “practitioner” mean, with respect to a State, an individual who is licensed or otherwise authorized by the State 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 that either administers or provides payment for the delivery of health care services, including, but not limited to the Department of Defense and the Department of Veterans Affairs.

(D)

Federal agencies responsible for the licensing and certification of health care providers and licensed health care practitioners.

(4)

Health plan— The term “health plan” has the meaning given such term by section 1320a–7c(c) of this title.

(5)

Determination of conviction— For purposes of paragraph (1), the existence of a conviction shall be determined under paragraphs (1) through (4) of section 1320a–7(i) of this title.

Footnotes

1 So in original. Probably should be followed by a comma.

Notes, amendments, and revision history

(Aug. 14, 1935, ch. 531, title XI, § 1128E, as added Pub. L. 104–191, title II, § 221(a), Aug. 21, 1996, 110 Stat. 2009; amended Pub. L. 105–33, title IV, § 4331(a)(2), (b), (d), Aug. 5, 1997, 111 Stat. 395, 396; Pub. L. 111–148, title VI, § 6403(a), Mar. 23, 2010, 124 Stat. 763.)

Editorial Notes

References in Text

The Health Care Quality Improvement Act of 1986, referred to in subsecs. (a) and (f), is title IV of Pub. L. 99–660, Nov. 14, 1986, 100 Stat. 3784, which is classified generally to chapter 117 (§ 11101 et seq.) of this title. Part B of the Act is classified generally to subchapter II (§ 11131 et seq.) of chapter 117 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 11101 of this title and Tables.

The Internal Revenue Code of 1986, referred to in subsec. (b)(2)(A), is classified generally to Title 26, Internal Revenue Code.

Amendments

2010—Subsec. (a). Pub. L. 111–148, § 6403(a)(1), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: “Not later than January 1, 1997, the Secretary shall establish a national health care fraud and abuse data collection program for the reporting of final adverse actions (not including settlements in which no findings of liability have been made) against health care providers, suppliers, or practitioners as required by subsection (b) of this section, with access as set forth in subsection (c) of this section, and shall maintain a database of the information collected under this section.”

Subsec. (d). Pub. L. 111–148, § 6403(a)(2), added subsec. (d) and struck out former subsec. (d). Prior to amendment, text read as follows:

“(1) Availability.—The information in the database maintained under this section shall be available to Federal and State government agencies and health plans pursuant to procedures that the Secretary shall provide by regulation.

“(2) Fees for disclosure.—The Secretary may establish or approve reasonable fees for the disclosure of information in such database (other than with respect to requests by Federal agencies). The amount of such a fee shall be sufficient to recover the full costs of operating the database. Such fees shall be available to the Secretary or, in the Secretary’s discretion to the agency designated under this section to cover such costs.”

Subsec. (f). Pub. L. 111–148, § 6403(a)(3), added subsec. (f) and struck out former subsec. (f). Prior to amendment, text read as follows: “The Secretary shall implement this section in such a manner as to avoid duplication with the reporting requirements established for the National Practitioner Data Bank under the Health Care Quality Improvement Act of 1986 (42 U.S.C. 11101 et seq.).”

Subsec. (g)(1)(A)(iii). Pub. L. 111–148, § 6403(a)(4)(A)(i)(I), struck out “or State” after “Federal” in introductory provisions.

Subsec. (g)(1)(A)(iii)(II). Pub. L. 111–148, § 6403(a)(4)(A)(i)(III), added subcl. (II).

Subsec. (g)(1)(A)(iii)(III). Pub. L. 111–148, § 6403(a)(4)(A)(i)(II), redesignated subcl. (II) as (III). Former subcl. (III) redesignated (IV).

Pub. L. 111–148, § 6403(a)(4)(A)(i)(I), struck out “or State” after “Federal”.

Subsec. (g)(1)(A)(iii)(IV). Pub. L. 111–148, § 6403(a)(4)(A)(i)(II), redesignated subcl. (III) as (IV).

Subsec. (g)(1)(A)(iv). Pub. L. 111–148, § 6403(a)(4)(A)(ii), added cl. (iv) and struck out former cl. (iv) which read as follows: “Exclusion from participation in Federal or State health care programs (as defined in sections 1320a–7b(f) and 1320a–7(h) of this title, respectively).”

Subsec. (g)(3)(D). Pub. L. 111–148, § 6403(a)(4)(C), which directed amendment of subpar. (D) of subsec. (g) by striking out “or State”, was executed by striking out “or State” after “Federal” in subpar. (D) of subsec. (g)(3) to reflect the probable intent of Congress.

Pub. L. 111–148, § 6403(a)(4)(B), redesignated subpar. (F) as (D) and struck out former subpar. (D) which read as follows: “State law enforcement agencies.”

Subsec. (g)(3)(E). Pub. L. 111–148, § 6403(a)(4)(B)(i), struck out subpar. (E) which read as follows: “State medicaid fraud control units.”

Subsec. (g)(3)(F). Pub. L. 111–148, § 6403(a)(4)(B)(ii), redesignated subpar. (F) as (D).

1997—Subsec. (b)(6). Pub. L. 105–33, § 4331(d), added par. (6).

Subsec. (g)(3)(C). Pub. L. 105–33, § 4331(a)(2), substituted “Department of Veterans Affairs” for “Veterans’ Administration”.

Subsec. (g)(5). Pub. L. 105–33, § 4331(b), substituted “paragraphs (1) through (4)” for “paragraph (4)”.

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Pub. L. 105–33, title IV, § 4331(f), Aug. 5, 1997, 111 Stat. 396, provided that: In general.—Except as provided in this subsection, the amendments made by this section [amending this section and sections 1320a–7, 1320a–7a, and 1320a–7d of this title] shall be effective as if included in the enactment of the Health Insurance Portability and Accountability Act of 1996 [Pub. L. 104–191]. Federal health program.—The amendments made by subsection (c) [amending section 1320a–7 of this title] shall take effect on the date of the enactment of this Act [Aug. 5, 1997]. Sanction for failure to report.—The amendment made by subsection (d) [amending this section] shall apply to failures occurring on or after the date of the enactment of this Act.”

Transition Process; Regulations; Effective Date of 2010 Amendment

Pub. L. 111–148, title VI, § 6403(d), Mar. 23, 2010, 124 Stat. 766, provided that: In general.—Effective on the date of enactment of this Act [Mar. 23, 2010], the Secretary of Health and Human Services (in this section referred to as the ‘Secretary’) shall implement a transition process under which, by not later than the end of the transition period described in paragraph (5), the Secretary shall cease operating the Healthcare Integrity and Protection Data Bank established under section 1128E of the Social Security Act [42 U.S.C. 1320a–7e] (as in effect before the effective date specified in paragraph (6)) and shall transfer all data collected in the Healthcare Integrity and Protection Data Bank to the National Practitioner Data Bank established pursuant to the Health Care Quality Improvement Act of 1986 (42 U.S.C. 11101 et seq.). During such transition process, the Secretary shall have in effect appropriate procedures to ensure that data collection and access to the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank are not disrupted. Regulations.—The Secretary shall promulgate regulations to carry out the amendments made by subsections (a) and (b) [amending this section and section 1396r–2 of this title].Funding.— Availability of fees.—Fees collected pursuant to section 1128E(d)(2) of the Social Security Act [42 U.S.C. 1320a–7e(d)(2)] prior to the effective date specified in paragraph (6) for the disclosure of information in the Healthcare Integrity and Protection Data Bank shall be available to the Secretary, without fiscal year limitation, for payment of costs related to the transition process described in paragraph (1). Any such fees remaining after the transition period is complete shall be available to the Secretary, without fiscal year limitation, for payment of the costs of operating the National Practitioner Data Bank. Availability of additional funds.—In addition to the fees described in subparagraph (A), any funds available to the Secretary or to the Inspector General of the Department of Health and Human Services for a purpose related to combating health care fraud, waste, or abuse shall be available to the extent necessary for operating the Healthcare Integrity and Protection Data Bank during the transition period, including systems testing and other activities necessary to ensure that information formerly reported to the Healthcare Integrity and Protection Data Bank will be accessible through the National Practitioner Data Bank after the end of such transition period.Special provision for access to the national practitioner data bank by the department of veterans affairs.— In general.—Notwithstanding any other provision of law, during the 1-year period that begins on the effective date specified in paragraph (6), the information described in subparagraph (B) shall be available from the National Practitioner Data Bank to the Secretary of Veterans Affairs without charge. Information described.—For purposes of subparagraph (A), the information described in this subparagraph is the information that would, but for the amendments made by this section [amending this section and sections 1320a–7c and 1396r–2 of this title], have been available to the Secretary of Veterans Affairs from the Healthcare Integrity and Protection Data Bank. Transition period defined.—For purposes of this subsection, the term ‘transition period’ means the period that begins on the date of enactment of this Act [Mar. 23, 2010] and ends on the later of— the date that is 1 year after such date of enactment; or the effective date of the regulations promulgated under paragraph (2). Effective date.—The amendments made by subsections (a), (b), and (c) [amending this section and sections 1320a–7c and 1396r–2 of this title] shall take effect on the first day after the final day of the transition period.”