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.
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
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”.
Pub. L. 111–148, title III, § 3301(d)(3),
Pub. L. 108–173, title II, § 237(e),
Amendment by section 4201(c)(1) of Pub. L. 105–33 applicable to services furnished on or after
Amendment by section 4704(b) of Pub. L. 105–33 effective
Pub. L. 104–191, title II, § 204(b),
Pub. L. 104–191, title II, § 216(c),
Amendment by section 217 of Pub. L. 104–191 effective
Amendment by section 133(a)(2) of Pub. L. 103–432 applicable to items or services furnished on or after
Amendment by section 4161(a)(4) of Pub. L. 101–508 applicable to services furnished on or after
Amendment by section 4164(b)(2) of Pub. L. 101–508 applicable with respect to items or services furnished on or after
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.
Amendment by section 4211(h)(7) of Pub. L. 100–203 applicable to nursing facility services furnished on or after
Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning
Pub. L. 95–142, § 4(d),
Pub. L. 92–603, title II, § 242(d),
Pub. L. 117–169, title I, § 11301,
Similar provisions were contained in the following prior act:
Pub. L. 117–58, div. I, § 90006,
Pub. L. 108–173, title IV, § 431(b), “(1) “(A) 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.“(B) The Secretary shall consider the following factors, among others, in establishing standards relating to the exception for health center entity arrangements under subparagraph (A):“(i) 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.“(ii) Whether the arrangement between the health center entity and the other party restricts or limits an individual’s freedom of choice.“(iii) 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.“(2) Not later than 1 year after the date of the enactment of this Act [
Pub. L. 104–191, title II, § 216(b), “(1) “(A) 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).“(B) In establishing standards relating to the exception for risk-sharing arrangements to the anti-kickback penalties under subparagraph (A), the Secretary—“(i) shall consult with the Attorney General and representatives of the hospital, physician, other health practitioner, and health plan communities, and other interested parties; and“(ii) shall take into account—“(I) the level of risk appropriate to the size and type of arrangement;“(II) the frequency of assessment and distribution of incentives;“(III) the level of capital contribution; and“(IV) the extent to which the risk-sharing arrangement provides incentives to control the cost and quality of health care services.“(2) 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 [“(3) 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 “(4) In applying section 564(c) of such title under this subsection, ‘15 days’ shall be substituted for ‘30 days’.“(5) The Secretary shall provide for—“(A) 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“(B) 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.“(6) The negotiated rulemaking committee appointed under paragraph (5) shall report to the Secretary, by not later than “(7) 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.“(8) 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.“(9) 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.”
Pub. L. 100–93, § 14(a),
Ex. Ord. No. 13939,
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:
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.
(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.
(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.