42 U.S.C. § 1320a–7a — Civil monetary penalties
submitted 91 years ago by Pub. L. 97-35 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 6,002 words · no verdicts yet
This section authorizes civil money penalties, assessments, and exclusion from health-care programs for specified improper claims, payments, referrals, records, orders, applications, and overpayments. It also sets procedures, review rules, definitions, and specific exceptions and safe harbors.
(a) Improperly filed claims. Any person*, including an organization, agency, or other entity but not a "beneficiary" defined in subsection (i)(5), is subject to these penalties if the person does any of the following:
(1) The person knowingly presents, or causes to be presented, to an officer, employee, or agent of the United States* or one of its departments or agencies, or to a State* agency defined in subsection (i)(1), a "claim" defined in subsection (i)(2), and the Secretary* determines that the claim—(A) is for a medical or other "item or service" that the person knows or should know was not provided as claimed. This includes a pattern or practice of presenting claims based on a code that the person knows or should know will produce a greater payment than the code the person knows or should know applies to the item or service actually provided; (B) is for a medical or other item or service and the person knows or should know that the claim is false or fraudulent; (C) is for a physician's service, or an item or service related to a physician's service, presented by a person who knows or should know that the individual who furnished or supervised it—(i) was not licensed as a physician*; (ii) was licensed but obtained the license through a material misrepresentation, including cheating on a required licensing examination; or (iii) told the patient when the service was furnished that the physician was certified in a medical specialty by a specialty board when the individual was not certified; (D) is for an item or service furnished while the person was excluded under Federal law from the Federal health-care program under which the claim was made; or (E) is for a pattern of medical or other items or services that the person knows or should know are not medically necessary.
(2) The person knowingly presents, or causes to be presented to any person, a request for payment that violates the terms of (A) an assignment under section 1395u(b)(3)(B)(ii); (B) an agreement with a State agency, or another State-plan requirement, not to charge more than the permitted amount; (C) an agreement to be a participating physician or supplier under section 1395u(h)(1); or (D) an agreement under section 1395cc(a)(1)(G).
(3) The person knowingly gives, or causes to be given to any person, false or misleading information about inpatient hospital services covered under subchapter XVIII and subject to section 1395ww, when the information could reasonably be expected to influence when that person or another individual is discharged.
(4) The person is not an organization, agency, or other entity; is excluded from a program under subchapter XVIII or a State health-care program under this subsection or section 1320a–7; and, when violating this subsection, either (A) retains a direct or indirect ownership or control interest in an entity participating in such a program and knows or should know of the action that caused the exclusion, or (B) is an officer or managing employee of that entity. The knowledge condition in subparagraph (A) applies to the ownership-or-control branch; subparagraph (B) separately covers an officer or managing employee.
(5) The person offers or transfers "remuneration" to an individual eligible for benefits under subchapter XVIII or a State health-care program, knowing or having reason to know that it is likely to influence the individual to order or receive from a particular provider, practitioner, or supplier an item or service payable in whole or part under that program.
(6) The person arranges or contracts, through employment or otherwise, with an individual or entity the person knows or should know is excluded from a Federal health-care program, for items or services payable under that program.
(7) The person commits an act described in paragraph (1) or (2) of section 1320a–7b(b).
(8) The person knowingly makes, uses, or causes to be made or used a false record or statement material to a false or fraudulent claim for items or services furnished under a Federal health-care program.
(9) The person fails to give the Inspector General of the Department of Health and Human Services timely access, after a reasonable request defined by the Secretary in regulations, for audits, investigations, evaluations, or other statutory functions.
(10) The person orders or prescribes an item or service while excluded from a Federal health-care program, knowing or having reason to know that a claim for it will be made under that program.
(11) The person knowingly makes or causes to be made a false statement, omission, or material misrepresentation in an application, bid, or contract to participate or enroll as a provider or supplier under a Federal health-care program. This includes Medicare Advantage organizations, prescription drug* plan sponsors, Medicaid managed-care organizations, and entities applying to participate as providers or suppliers in those managed-care organizations and plans.
(12) The person knows of an "overpayment" defined in section 1320a–7k(d)(4) and does not report and return it as that section requires.
The person is subject, in addition to other penalties allowed by law, to a civil money penalty of up to $20,000 for each item or service. The alternatives are up to $30,000 for each individual in paragraph (3), $20,000 for each day the prohibited relationship in paragraph (4) occurs, $100,000 for each act in paragraph (7), $100,000 for each false record or statement in paragraph (8), $15,000 for each day of the failure in paragraph (9), and $100,000 for each false statement or material misrepresentation in paragraph (11). The person is also subject to an assessment of up to three times the amount claimed for each item or service, instead of damages suffered by the United States or a State agency because of the claim. For paragraph (7), the alternative is damages of up to three times all remuneration offered, paid, solicited, or received, even if some of it was for a lawful purpose. For paragraph (11), the alternative assessment is up to three times the total amount claimed for each item or service paid on the basis of the application containing the false statement or misrepresentation. In the same proceeding, the Secretary may exclude the person from Federal health-care programs and direct the appropriate State agency to exclude the person from State health-care programs.
(b) Payments to induce reduction or limitation of services. (1) A hospital or critical access hospital that knowingly pays a physician, directly or indirectly, to induce the physician to reduce or limit medically necessary services for an individual under the physician's direct care is subject to a civil money penalty of up to $5,000 for that individual. The individual must be entitled to Medicare part A or B benefits or medical assistance under an approved Medicaid State plan. (2) A physician who knowingly accepts that payment is subject to a civil money penalty of up to $5,000 for each such individual. (3) A physician who knowingly signs a document certifying for Medicare that an individual meets the home-health requirements in section 1395f(a)(2)(C) or 1395n(a)(2)(A), when those requirements are not met, is subject to a penalty of up to the greater of $10,000 or three times the Medicare home-health payments made because of the certification. A qualifying document is one that makes that certification for home-health services.
(c) Initiation of proceeding; authorization, notice, estoppel, and sanctions. (1) The Secretary may begin a proceeding under (a) or (b) only with the Attorney General's authorization under procedures they agree on. The Secretary may not begin an action later than six years after the claim was presented, the payment request was made, or the other occurrence happened. Notice may be served in any manner authorized by Rule 4 of the Federal Rules of Civil Procedure. (2) Before an adverse determination, the person must receive written notice and an opportunity for a record hearing, with counsel, witnesses, and cross-examination of opposing witnesses. (3) In a proceeding against someone convicted by verdict, guilty plea, or nolo contendere plea of a Federal fraud or false-statement crime, when the proceeding concerns the same transaction, that person cannot deny the crime's essential elements. (4) The hearing official may sanction a person, party, or attorney for disobeying an order or procedure, failing to defend, or other misconduct interfering with a speedy, orderly, or fair hearing. The sanction must reasonably relate to the seriousness and nature of the failure or misconduct. It may include negative factual inferences or treating the matter or facts as established when discovery is refused; barring evidence or support for a claim or defense; striking pleadings in whole or part; staying the proceeding; dismissing the action; entering a default judgment; ordering the party or attorney to pay attorneys' fees and other costs caused by the failure or misconduct; and refusing to consider a motion or other action filed late.
(d) Amount or scope of penalty, assessment, or exclusion. When deciding the amount or scope of a penalty, assessment, or exclusion under (a) or (b), the Secretary must consider (1) the nature of the claims and the circumstances in which they were presented; (2) the person's degree of culpability, history of prior offenses, and financial condition; and (3) other matters that justice may require.
(e) Review by courts of appeals. A person adversely affected by the Secretary's determination may seek review in the United States Court of Appeals for the circuit where the person resides or where the claim or specified claim was presented. The person must file a written petition asking to modify or set aside the determination within 60 days after being notified of it. The court clerk must promptly send a copy to the Secretary, who must file the proceeding's record as section 2112 of title 28 provides. The court then has jurisdiction and may affirm, modify, remand for further consideration, or set aside all or part of the determination, and enforce it to the extent affirmed or modified. The court will not consider an objection not raised before the Secretary unless extraordinary circumstances excuse the failure. The Secretary's factual findings are conclusive if supported by substantial evidence on the whole record. If a party shows that additional evidence is material and that reasonable grounds prevented presenting it at the Secretary's hearing, the court may order the evidence taken before the Secretary and added to the record. The Secretary may change or make findings because of that evidence and must file the changed or new findings and any recommendation to modify or set aside the original order. The court's jurisdiction is exclusive after the record is filed, and its judgment is final subject to Supreme Court review under section 1254 of title 28.
(f) Compromise, recovery, and use of recovered funds. The Secretary may compromise penalties and assessments. They may be recovered in the United States' name in a civil action in the United States district court for the district where the claim or specified claim was presented or where the claimant resides, as the Secretary determines; for a person described in subsection (o), the action may be where that person resides. Recovered amounts are paid to the Secretary and disposed of as follows: (1)(A) For an amount arising from a Medicaid claim, the State agency receives the same proportion of the recovery as the State's share of the amount paid for the claim bears to the total amount paid. (B) For an amount arising from a State allotment under subchapter V, the State agency receives three-sevenths of the recovery. (2) The portion determined to have been paid from the trust funds under sections 1395i and 1395t is repaid to those trust funds. (3) For a recovery arising from a Federal health-care-program claim, the portion determined to have been paid by the program is repaid to the program, and the portion attributable, as estimated by the Secretary, to amendments made by the Health Insurance Portability and Accountability Act of 1996 is deposited in the Federal Hospital Insurance Trust Fund under section 1395i(k)(2)(C). (4) The remainder is deposited as miscellaneous receipts of the United States Treasury. A finally determined penalty or assessment, or an amount agreed in compromise, may be deducted from money then or later owed by the United States or a State agency to the person; for a penalty or assessment under (o), it may be deducted from money owed by a specified State agency.
(g) Finality. A Secretary's determination under (a) or (b) becomes final when the 60-day period in (e) expires. Matters raised or that could have been raised before the Secretary or on appeal cannot be used as a defense in the United States' civil collection action.
(h) Notification. When a determination becomes final, the Secretary must notify the appropriate State or local medical or professional organization; State agencies administering or supervising State health-care programs; the appropriate utilization and quality-control peer-review organization; and the appropriate State or local licensing agency or organization, including the agencies specified in sections 1395aa(a) and 1396a(a)(33), of the final penalty, assessment, or exclusion and its reasons.
(i) Definitions. For this section: (1) "State agency" means the agency established or designated to administer or supervise the State plan under subchapter XIX, or designated to administer the State's program under subchapter V or division A of subchapter XX. (2) "Claim" means an application for payment for items and services under a Federal health-care program. (3) "Item or service" includes a particular item, device, medical supply, or service claimed to have been provided to a patient and listed in an itemized payment claim, and, for a cost-based claim, each entry in the cost report, books of account, or other documents supporting the claim. (4) "Agency of the United States" includes a contractor acting as a fiscal intermediary, carrier, fiscal agent, or other claims-processing agent for a Federal health-care program. (5) "Beneficiary" means an individual eligible to receive items or services payable under a Federal health-care program, but not a provider, supplier, or practitioner. (6) "Remuneration" includes waiving coinsurance or deductibles, or transferring items or services for free or below fair market value. It does not include: (A) a waiver of coinsurance or deductibles that is not advertised or solicited, is not routine, and is made either after a good-faith determination of financial need or after reasonable collection efforts fail; (B) subject to (n), a permissible practice described in any paragraph of section 1320a–7b(b)(3) or in the Secretary's regulations; (C) disclosed coinsurance or deductible differences in a benefit-plan design that meet the Secretary's regulatory standards; (D) incentives the Secretary permits by regulation to promote preventive care; (E) a reduction in the copayment for covered outpatient department services under section 1395l(t)(5)(B); (F) other remuneration designated by the Secretary in regulations that promotes access to care and poses a low risk of harm to patients and Federal health-care programs; (G) free or below-market coupons, rebates, or other retailer rewards offered on equal terms to the general public regardless of insurance and not tied to program-reimbursed services; (H) free or below-market items or services not advertised or solicited, not tied to program-reimbursed services, reasonably connected to the individual's medical care*, and provided after a good-faith determination of financial need; (I) beginning on a date specified by the Secretary, but not before January 1, 2011, a qualifying first-fill generic-drug copayment waiver by a Part D plan sponsor or MA organization for an enrolled individual; or (J) on or after January 1, 2019, telehealth technologies defined by the Secretary provided by a provider or renal dialysis facility to an individual with end-stage renal disease receiving paid-for home dialysis, if not advertised or solicited, used to furnish related telehealth services, and provided under the Secretary's other regulatory requirements. (7) "Should know" means acting, about information, in deliberate ignorance of its truth or falsity or in reckless disregard of its truth or falsity. No specific intent to defraud must be proved.
(j) Subpoenas. Subsections (d) and (e) of section 405 of title 5 apply to this section to the same extent they apply to subchapter II. The Secretary may delegate the authority under section 405(d), as applied here, to the HHS Inspector General for an investigation under this section. The Secretary may also delegate authority under this section and section 1320a–7 to that Inspector General.
(k) Injunctions. If the Secretary has reason to believe a person has engaged, is engaging, or is about to engage in conduct covered by this section, the Secretary may ask the proper United States district court to enjoin that conduct. The injunction may also prevent the person from concealing, removing, encumbering, or disposing of assets, and may seek other appropriate relief.
(l) Principal's liability for an agent. A principal is liable under this section for penalties, assessments, and exclusion based on an agent's actions within the scope of the agency.
(m) Claims within another department or agency's jurisdiction. (1) For a Federal health-care program outside this chapter, a reference here to the Secretary means the Secretary or Administrator* of the department or agency with jurisdiction over that program, and a reference to the HHS Inspector General means the applicable department or agency's Inspector General. (2)(A) Those Secretaries or Administrators may include claims within another Federal department's or agency's jurisdiction if the case primarily involves claims submitted to the initiating department's or agency's programs and the initiating official gives notice and an opportunity to participate in the investigation to the Inspector General with primary jurisdiction over the programs receiving the claims. (B) If those conditions are met, the initiating department's or agency's Inspector General may exercise all powers granted under chapter 4 of title 5 for the other departments' or agencies' claims, to the same extent and in the same manner provided by that chapter.
(n) Safe harbor for payment of Medigap premiums. The remuneration exception in subsection (i)(6)(B) does not apply to the described Medigap-premium practice unless the Secretary, through the HHS Inspector General, authorizes it by rule and the person offers or transfers the remuneration under that rule during the two years beginning when the rule is first issued. The practice is a health-care provider or facility paying all or part of Medicare supplemental-policy premiums for a person entitled to Part A benefits under section 426–1.
(o) Penalties for violations of grants, contracts, and other agreements. A person, including an organization, agency, or other entity but not a "program beneficiary" defined in (q)(4), is covered when, regarding a Secretary-funded grant, contract, or other agreement, the person: (1) knowingly presents or causes a specified claim that the person knows or should know is false or fraudulent; (2) knowingly makes, uses, or causes a materially false statement, omission, or misrepresentation in an application, proposal, bid, progress report, or other document required to receive or retain the funds; (3) knowingly makes, uses, or causes a false record or statement material to a false or fraudulent specified claim; (4) knowingly makes, uses, or causes a false record or statement material to an obligation to pay or transmit funds or property to the Secretary, or knowingly conceals or knowingly and improperly avoids or decreases that obligation; or (5) fails to give the Department's Inspector General timely access, after a reasonable request defined in regulations, for audits, investigations, evaluations, or other statutory functions involving the grant, contract, or agreement. The civil penalty is up to $10,000 for each specified claim under (1); $50,000 for each false statement, omission, or misrepresentation under (2); $50,000 for each false record or statement under (3); $50,000 for each false record or statement under (4), or $10,000 for each day of knowingly concealing or knowingly and improperly avoiding or decreasing the obligation; and $15,000 for each day of the failure under (5). For (1) and (3), the assessment may be up to three times the amount claimed in the specified claim, instead of damages suffered by the United States or a specified State agency. For (2) and (4), it may be up to three times the total funds described in that paragraph, or, for property to be transmitted under (4), three times the property's value. The Secretary may also exclude the person from Federal health-care programs and direct the appropriate State agency to exclude the person from State health-care programs.
(p) Rules for violations of grants, contracts, and other agreements. Subsections (c), (d), (g), and (h) apply to a penalty or assessment under (o) as they apply to a penalty, assessment, or proceeding under (a). In applying (d), a reference to a claim includes a "specified claim" under (r).
(q) Definitions for (o) and (p). "Department" means HHS. "Material" means having a natural tendency to influence, or being capable of influencing, payment or receipt of money or property. "Other agreement" includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or subaward, whether or not a party is a contractor or subcontractor. "Program beneficiary" means, for a funded grant, contract, or other agreement designed to furnish benefits or assistance to individuals, an individual who applies for or receives those benefits or assistance; it does not include an officer, employee, or agent of a recipient or contracting person or entity. "Recipient" includes a subrecipient or subcontractor. "Specified State agency" means a State-government agency designated to administer or supervise a Secretary-funded grant, contract, or other agreement.
(r) Definition of "specified claim". A "specified claim" is an 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 it, that is not a claim under (i)(2) and that—(1) is presented or caused to be presented to a Department officer, employee, or agent, or to a specified State agency; or (2) is made to a contractor, grantee, or other recipient when the money or property will be spent or used for the Department or to advance a Department program or interest, and the Department (A) provides or provided any portion requested or demanded, or (B) will reimburse the recipient for any portion requested or demanded.
(s) Definition of "obligation". For subsection (o), "obligation" means an established duty, whether fixed or not, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship; a fee-based or similar relationship; a statute or regulation; or retaining an overpayment. This section does not define terms it merely uses.
Any person* (including an organization, agency, or other entity, but excluding a beneficiary, as defined in subsection (i)(5)) that—
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—
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,
is for a medical or other item or service and the person knows or should know the claim is false or fraudulent,
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—
was not licensed as a physician*,
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
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,
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
is for a pattern of medical or other items or services that a person knows or should know are not medically necessary;
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;
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;
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—
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
is an officer or managing employee (as defined in section 1320a–5(b) of this title) of such an entity;
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);
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;
commits an act described in paragraph (1) or (2) of section 1320a–7b(b) of this title;
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; or 3
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;
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;
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
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 or 3 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.
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—
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
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.
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.
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—
$10,000, or
three times the amount of the payments under subchapter XVIII for home health services which are made pursuant to such certification.
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.
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.
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.
In a proceeding under subsection (a) or (b) which—
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
involves the same transaction as in the criminal action,
the person is estopped from denying the essential elements of the criminal offense.
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—
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,
prohibiting a party from introducing certain evidence or otherwise supporting a particular claim or defense,
striking pleadings, in whole or in part,
staying the proceedings,
dismissal of the action,
entering a default judgment,
ordering the party or attorney to pay attorneys’ fees and other costs caused by the failure or misconduct, and
refusing to consider any motion or other action which is not filed in a timely manner.
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—
the nature of claims and the circumstances under which they were presented,
the degree of culpability, history of prior offenses, and financial condition of the person presenting the claims, and
such other matters as justice may require.
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 Court 11 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.
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:
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.
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.
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.
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.
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.
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.
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.
For the purposes of this section:
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 A 12 of subchapter XX of this chapter.
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).
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.
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).
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.
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—
the waiver of coinsurance and deductible amounts by a person, if—
the waiver is not offered as part of any advertisement or solicitation;
the person does not routinely waive coinsurance or deductible amounts; and
the person—
waives the coinsurance and deductible amounts after determining in good faith that the individual is in financial need; or
fails to collect coinsurance or deductible amounts after making reasonable collection efforts;
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;
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;
incentives given to individuals to promote the delivery of preventive care as determined by the Secretary in regulations so promulgated;
a reduction in the copayment amount for covered OPD services under section 1395l(t)(5)(B) 12 of this title; or 3
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);
the offer or transfer of items or services for free or less than fair market value by a person, if—
the items or services consist of coupons, rebates, or other rewards from a retailer;
the items or services are offered or transferred on equal terms available to the general public, regardless of health insurance status; and
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);
the offer or transfer of items or services for free or less than fair market value by a person, if—
the items or services are not offered as part of any advertisement or solicitation;
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);
there is a reasonable connection between the items or services and the medical care* of the individual; and
the person provides the items or services after determining in good faith that the individual is in financial need;
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
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—
the telehealth technologies are not offered as part of any advertisement or solicitation;
the telehealth technologies are provided for the purpose of furnishing telehealth services related to the individual’s end stage renal disease; and
the provision of the telehealth technologies meets any other requirements set forth in regulations promulgated by the Secretary.
The term “should know” means that a person, with respect to information—
acts in deliberate ignorance of the truth or falsity of the information; or
acts in reckless disregard of the truth or falsity of the information,
and no proof of specific intent to defraud is required.
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.
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.
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.
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.
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.
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:
The case involves primarily claims submitted to the Federal health care programs of the department or agency initiating the action.
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.
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.
Subparagraph (B) of subsection (i)(6) shall not apply to a practice described in paragraph (2) unless—
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
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.
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.
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—
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;
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;
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;
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
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.
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)).
For purposes of this subsection and subsections (o) and (p):
The term “Department” means the Department of Health and Human Services.
The term “material” means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property.
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).
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.
The term “recipient” includes a subrecipient or subcontractor.
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.
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—
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
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—
provides or has provided any portion of the money or property requested or demanded; or
will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded.
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.
Source credit: (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.)
- 1935Enacted · Pub. L. 97-35 · 95 Stat. 789
- 1982Amended · Pub. L. 97-248 · 96 Stat. 380
- 1984Amended · Pub. L. 98-369 · 98 Stat. 1073, 1100
- 1986Amended · Pub. L. 99-509 · 100 Stat. 2003, 2008
- 1987Amended · Pub. L. 100-93 · 101 Stat. 686
- 1987Amended · Pub. L. 100-203 · 101 Stat. 1330
- 1988Amended · Pub. L. 100-360 · 102 Stat. 715
- 1988Amended · Pub. L. 100-485 · 102 Stat. 2422
- 1989Amended · Pub. L. 101-234 · 103 Stat. 1981
- 1989Amended · Pub. L. 101-239 · 103 Stat. 2153
- 1990Amended · Pub. L. 101-508 · 104 Stat. 1388
- 1996Amended · Pub. L. 104-191 · 110 Stat. 2012
- 1997Amended · Pub. L. 105-33 · 111 Stat. 373, 383, 396, 449
- 1998Amended · Pub. L. 105-277 · 112 Stat. 2681
- 2010Amended · Pub. L. 111-148 · 124 Stat. 757, 770, 804
- 2015Amended · Pub. L. 114-10 · 129 Stat. 170
- 2016Amended · Pub. L. 114-255 · 130 Stat. 1188
- 2018Amended · Pub. L. 115-123 · 132 Stat. 191, 220
- 2022Amended · Pub. L. 117-286 · 136 Stat. 4351
A history note hasn’t been published yet. The record shows enactment by Pub. L. 97-35 on 1935-08-14.
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