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18 U.S.C. § 220 — Illegal remunerations for referrals to re-

Federal law — U.S. Code and appendices · legal_authorities

18 U.S.C. § 220 — Illegal remunerations for referrals to re-

Page 84 TITLE 18—CRIMES AND CRIMINAL PROCEDURE § 219 tion 218 of title 18 of the United States Code in relation to which there has been a final conviction for any vio- lation of chapter 11 of title 18. SEC. 2. The head of each Executive department and agency described in section 1 may exercise the author- ity hereby delegated by promulgating implementing regulations; provided that the Secretary of Defense, the Administrator of General Services and the Adminis- trator of the National Aeronautics and Space Adminis- tration jointly shall issue government-wide imple- menting regulations related to voiding or rescission of contracts. SEC. 3. Implementing regulations adopted pursuant to this Order shall, at a minimum, provide the following procedural protections: (a) Written notice of the proposed action shall be given in each case to the person or entity affected; (b) The person or entity affected shall be afforded an opportunity to submit pertinent information on its be- half before a final decision is made; (c) Upon the request of the person or entity affected, a hearing shall be held at which it shall have the oppor- tunity to call witnesses on its behalf and confront any witness the agency may present; and (d) The head of the agency or his designee shall issue a final written decision specifying the amount of res- titution or any other remedy authorized by section 218, provided that such remedy shall take into consider- ation the fair value of any tangible benefits received and retained by the agency. RONALD REAGAN. § 219. Officers and employees acting as agents of foreign principals (a) Whoever, being a public official, is or acts as an agent of a foreign principal required to register under the Foreign Agents Registration Act of 1938 or a lob

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Page 84 TITLE 18—CRIMES AND CRIMINAL PROCEDURE § 219 tion 218 of title 18 of the United States Code in relation to which there has been a final conviction for any vio- lation of chapter 11 of title 18. SEC. 2. The head of each Executive department and agency described in section 1 may exercise the author- ity hereby delegated by promulgating implementing regulations; provided that the Secretary of Defense, the Administrator of General Services and the Adminis- trator of the National Aeronautics and Space Adminis- tration jointly shall issue government-wide imple- menting regulations related to voiding or rescission of contracts. SEC. 3. Implementing regulations adopted pursuant to this Order shall, at a minimum, provide the following procedural protections: (a) Written notice of the proposed action shall be given in each case to the person or entity affected; (b) The person or entity affected shall be afforded an opportunity to submit pertinent information on its be- half before a final decision is made; (c) Upon the request of the person or entity affected, a hearing shall be held at which it shall have the oppor- tunity to call witnesses on its behalf and confront any witness the agency may present; and (d) The head of the agency or his designee shall issue a final written decision specifying the amount of res- titution or any other remedy authorized by section 218, provided that such remedy shall take into consider- ation the fair value of any tangible benefits received and retained by the agency. RONALD REAGAN. § 219. Officers and employees acting as agents of foreign principals (a) Whoever, being a public official, is or acts as an agent of a foreign principal required to register under the Foreign Agents Registration Act of 1938 or a lobbyist required to register under the Lobbying Disclosure Act of 1995 in connection with the representation of a foreign entity, as defined in section 3(6) of that Act shall be fined under this title or imprisoned for not more than two years, or both. (b) Nothing in this section shall apply to the employment of any agent of a foreign principal as a special Government employee in any case in which the head of the employing agency cer- tifies that such employment is required in the national interest. A copy of any certification under this paragraph shall be forwarded by the head of such agency to the Attorney General who shall cause the same to be filed with the registration statement and other documents filed by such agent, and made available for pub- lic inspection in accordance with section 6 of the Foreign Agents Registration Act of 1938, as amended. (c) For the purpose of this section ‘‘public offi- cial’’ means Member of Congress, Delegate, or Resident Commissioner, either before or after he has qualified, or an officer or employee or per- son acting for or on behalf of the United States, or any department, agency, or branch of Govern- ment thereof, including the District of Colum- bia, in any official function, under or by author- ity of any such department, agency, or branch of Government. (Added Pub. L. 89–486, § 8(b), July 4, 1966, 80 Stat. 249; amended Pub. L. 98–473, title II, § 1116, Oct. 12, 1984, 98 Stat. 2149; Pub. L. 99–646, § 30, Nov. 10, 1986, 100 Stat. 3598; Pub. L. 101–647, title XXXV, § 3511, Nov. 29, 1990, 104 Stat. 4922; Pub. L. 104–65, § 12(b), Dec. 19, 1995, 109 Stat. 701.) Editorial Notes REFERENCES IN TEXT The Foreign Agents Registration Act of 1938, as amended, referred to in subsec. (a), is act June 8, 1938, ch. 327, 52 Stat. 631, which is classified generally to sub- chapter II (§ 611 et seq.) of chapter 11 of Title 22, For- eign Relations and Intercourse. Section 6 of the For- eign Agents Registration Act of 1938 is classified to sec- tion 616 of Title 22. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 611 of Title 22 and Tables. The Lobbying Disclosure Act of 1995, referred to in subsec. (a), is Pub. L. 104–65, Dec. 19, 1995, 109 Stat. 691, which is classified principally to chapter 26 (§ 1601 et seq.) of Title 2, The Congress. Section 3(6) of the Act is classified to section 1602(6) of Title 2. For complete classification of this Act to the Code, see Short Title note set out under section 1601 of Title 2 and Tables. PRIOR PROVISIONS A prior section 219 was renumbered section 214. AMENDMENTS 1995—Subsec. (a). Pub. L. 104–65 substituted ‘‘or a lob- byist required to register under the Lobbying Disclo- sure Act of 1995 in connection with the representation of a foreign entity, as defined in section 3(6) of that Act’’ for ‘‘, as amended,’’. 1990—Subsec. (c). Pub. L. 101–647 substituted ‘‘Govern- ment’’ for ‘‘Governments’’ before ‘‘thereof’’. 1986—Subsec. (a). Pub. L. 99–646, § 30(1), designated first par. as subsec. (a) and amended it generally, which prior to amendment read as follows: ‘‘Whoever, being a public official of the United States in the executive, legislative, or judicial branch of the Government or in any agency of the United States, including the District of Columbia, is or acts as an agent of a foreign prin- cipal required to register under the Foreign Agents Registration Act of 1938, as amended, shall be fined not more than $10,000 or imprisoned for not more than two years, or both.’’ Subsec. (b). Pub. L. 99–646, § 30(2), designated second par. as subsec. (b). Subsec. (c). Pub. L. 99–646, § 30(2), (3), designated third par. as subsec. (c) and substituted ‘‘Delegate’’ for ‘‘Del- egate from the District of Columbia’’ and ‘‘branch of Government’’ for ‘‘branch of Government, or a juror’’. 1984—Pub. L. 98–473 substituted ‘‘a public official’’ for ‘‘an officer or employee’’ in first par., and inserted par. defining ‘‘public official’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1995 AMENDMENT Amendment by Pub. L. 104–65 effective Jan. 1, 1996, except as otherwise provided, see section 24 of Pub. L. 104–65, set out as an Effective Date note under section 1601 of Title 2, The Congress. EFFECTIVE DATE Section effective ninety days after July 4, 1966, see section 9 of Pub. L. 89–486, set out as an Effective Date of 1966 Amendment note under section 611 of Title 22, Foreign Relations and Intercourse. § 220. Illegal remunerations for referrals to re- covery homes, clinical treatment facilities, and laboratories (a) OFFENSE.—Except as provided in subsection (b), whoever, with respect to services covered by a health care benefit program, in or affecting interstate or foreign commerce, knowingly and willfully— (1) solicits or receives any remuneration (in- cluding any kickback, bribe, or rebate) di- rectly or indirectly, overtly or covertly, in Page 85 TITLE 18—CRIMES AND CRIMINAL PROCEDURE [§ 223 cash or in kind, in return for referring a pa- tient or patronage to a recovery home, clinical treatment facility, or laboratory; or (2) pays or offers any remuneration (includ- ing any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or (B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory, shall be fined not more than $200,000, imprisoned not more than 10 years, or both, for each occur- rence. (b) APPLICABILITY.—Subsection (a) shall not apply to— (1) a discount or other reduction in price ob- tained by a provider of services or other entity under a health care benefit program if the re- duction in price is properly disclosed and ap- propriately reflected in the costs claimed or charges made by the provider or entity; (2) a payment made by an employer to an employee or independent contractor (who has a bona fide employment or contractual rela- tionship with such employer) for employment, if the employee’s payment is not determined by or does not vary by— (A) the number of individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (B) the number of tests or procedures per- formed; or (C) the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (3) a discount in the price of an applicable drug of a manufacturer that is furnished to an applicable beneficiary under the Medicare cov- erage gap discount program under section 1860D–14A(g) of the Social Security Act (42 U.S.C. 1395w–114a(g)); (4) a payment made by a principal to an agent as compensation for the services of the agent under a personal services and manage- ment contract that meets the requirements of section 1001.952(d) of title 42, Code of Federal Regulations, as in effect on the date of enact- ment of this section; (5) a waiver or discount (as defined in sec- tion 1001.952(h)(5) of title 42, Code of Federal Regulations, or any successor regulation) of any coinsurance or copayment by a health care benefit program if— (A) the waiver or discount is not routinely provided; and (B) the waiver or discount is provided in good faith; (6) a remuneration described in section 1128B(b)(3)(I) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)(I)); (7) a remuneration made pursuant to an al- ternative payment model (as defined in sec- tion 1833(z)(3)(C) of the Social Security Act) or pursuant to a payment arrangement used by a State, health insurance issuer, or group health plan if the Secretary of Health and Human Services has determined that such arrange- ment is necessary for care coordination or value-based care; or (8) any other payment, remuneration, dis- count, or reduction as determined by the At- torney General, in consultation with the Sec- retary of Health and Human Services, by regu- lation. (c) REGULATIONS.—The Attorney General, in consultation with the Secretary of Health and Human Services, may promulgate regulations to clarify the exceptions described in subsection (b). (d) PREEMPTION.— (1) FEDERAL LAW.—This section shall not apply to conduct that is prohibited under sec- tion 1128B of the Social Security Act (42 U.S.C. 1320a–7b). (2) STATE LAW.—Nothing in this section shall be construed to occupy the field in which any provisions of this section operate to the exclu- sion of State laws on the same subject matter. (e) DEFINITIONS.—In this section— (1) the terms ‘‘applicable beneficiary’’ and ‘‘applicable drug’’ have the meanings given those terms in section 1860D–14A(g) of the So- cial Security Act (42 U.S.C. 1395w–114a(g)); (2) the term ‘‘clinical treatment facility’’ means a medical setting, other than a hos- pital, that provides detoxification, risk reduc- tion, outpatient treatment and care, residen- tial treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law; (3) the term ‘‘health care benefit program’’ has the meaning given the term in section 24(b); (4) the term ‘‘laboratory’’ has the meaning given the term in section 353 of the Public Health Service Act (42 U.S.C. 263a); and (5) the term ‘‘recovery home’’ means a shared living environment that is, or purports to be, free from alcohol and illicit drug use and centered on peer support and connection to services that promote sustained recovery from substance use disorders. (Added Pub. L. 115–271, title VIII, § 8122(a), Oct. 24, 2018, 132 Stat. 4108.) Editorial Notes REFERENCES IN TEXT The date of enactment of this section, referred to in subsec. (b)(4), is the date of enactment of Pub. L. 115–271, which was approved Oct. 24, 2018. Section 1833(z)(3)(C) of the Social Security Act, re- ferred to in subsec. (b)(7), is classified to section 1395l(z)(3)(C) of Title 42, The Public Health and Welfare. PRIOR PROVISIONS A prior section 220 was renumbered section 215. [§§ 221, 222. Renumbered §§ 216, 217] [§ 223. Repealed. Pub. L. 87–849, § 1(c), Oct. 23, 1962, 76 Stat. 1125] Section, act June 25, 1948, ch. 645, 62 Stat. 696, related to transactions of the Home Owners’ Loan Corporation.

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Federal law — U.S. Code and appendices · legal_authorities

18 U.S.C. § 220 — Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories

**(a) Offense.—** Except as provided in subsection (b), whoever, with respect to services covered by a health care benefit program, in or affecting interstate or foreign commerce, knowingly and willfully— (1) solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind, in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or (2) pays or offers any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind— (A) to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory; or (B) in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory, shall be fined not more than $200,000, imprisoned not more than 10 years, or both, for each occurrence. **(b) Applicability.—** Subsection (a) shall not apply to— (1) a discount or other reduction in price obtained by a provider of services or other entity under a health care benefit program if the reduction in price is properly disclosed and appropriately reflected in the costs claimed or charges made by the provider or entity; (2) a payment made by an employer to an employee or independent contractor (who has a bona fide employment or contractual relationship with such employer) for employment, if the employee’s payment is not determined by or does not vary by— (A) the number of individuals referred to a particular recovery home, clinical treatment facility, or laboratory; (B) the number of tests or procedures performed; or (C) the amount billed to or received from, in part or in whole, the health care benefit program from

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1320a — Uniform reporting systems for health services facilities and organizations

**(a) Establishment; criteria for regulations; requirements for hospitals** For the purposes of reporting the cost of services provided by, of planning, and of measuring and comparing the efficiency of and effective use of services in, hospitals, skilled nursing facilities, intermediate care facilities, home health agencies, health maintenance organizations, and other types of health services facilities and organizations to which payment may be made under this chapter, the Secretary shall establish by regulation, for each such type of health services facility or organization, a uniform system for the reporting by a facility or organization of that type of the following information: (1) The aggregate cost of operation and the aggregate volume of services. (2) The costs and volume of services for various functional accounts and subaccounts. (3) Rates, by category of patient and class of purchaser. (4) Capital assets, as defined by the Secretary, including (as appropriate) capital funds, debt service, lease agreements used in lieu of capital funds, and the value of land, facilities, and equipment. (5) Discharge and bill data. The uniform reporting system for a type of health services facility or organization shall provide for appropriate variation in the application of the system to different classes of facilities or organizations within that type and shall be established, to the extent practicable, consistent with the cooperative system for producing comparable and uniform health information and statistics described in [section 242k(e)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section242k/e/1&num=0&edition=prelim). In reporting under such a system, hospitals shall employ such chart of accounts, definitions, principles, and

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1320a — Uniform reporting systems for health

Page 2598 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320 chapter has made a finding (prior to making such expenditure) that (A) such home is so de- fective that continued occupancy is unwar- ranted, (B) unless repairs are made to such home, rental quarters will be necessary for such individual, and (C) the cost of rental quarters to take care of the needs of such indi- vidual (including his spouse living with him in such home and any other individual whose needs were taken into account in determining the need of such individual) would exceed (over such time as the Secretary may specify) the cost of repairs needed to make such home habitable together with other costs attrib- utable to continued occupancy of such home, and (2) no such expenditures were made for re- pairing such home pursuant to any prior find- ing under this section, the amount paid to any such State for any quar- ter under section 303(a), 1203(a), 1353(a), or 1383(a) of this title shall be increased by 50 per centum of such expenditures, except that the ex- cess above $500 expended with respect to any one home shall not be included in determining such expenditures. (Aug. 14, 1935, ch. 531, title XI, § 1119, as added Pub. L. 90–248, title II, § 209(a), Jan. 2, 1968, 81 Stat. 894; amended Pub. L. 104–193, title I, § 108(g)(5), Aug. 22, 1996, 110 Stat. 2168.) Editorial Notes REFERENCES IN TEXT Section 1383(a) of this title, referred to in text, is a reference to section 1383(a) of this title as it existed prior to the general revision of this subchapter by Pub. L. 92–603, title III, § 301, Oct. 30, 1972, 86 Stat. 1465, eff. Jan. 1, 1974. The prior section (which is set out as a note under section 1383 of this title) continues in effect for Puerto Rico, Guam, and the Virgin Islands

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395w — Payment of benefits

**(a) Amounts** Except as provided in [section 1395mm of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395mm&num=0&edition=prelim), and subject to the succeeding provisions of this section, there shall be paid from the Federal Supplementary Medical Insurance Trust Fund, in the case of each individual who is covered under the insurance program established by this part and incurs expenses for services with respect to which benefits are payable under this part, amounts equal to— (1) in the case of services described in [section 1395k(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395k/a/1&num=0&edition=prelim)—80 percent of the reasonable charges for the services; except that (A) an organization which provides medical and other health services (or arranges for their availability) on a prepayment basis (and either is sponsored by a union or employer, or does not provide, or arrange for the provision of, any inpatient hospital services) may elect to be paid 80 percent of the reasonable cost of services for which payment may be made under this part on behalf of individuals enrolled in such organization in lieu of 80 percent of the reasonable charges for such services if the organization undertakes to charge such individuals no more than 20 percent of such reasonable cost plus any amounts payable by them as a result of subsection (b), (B) with respect to items and services described in [section 1395x(s)(10)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395x/s/10/A&num=0&edition=prelim), the amounts paid shall be 100 percent of the reasonable charges for such items and services, (C) with respect to expenses incurred for those physicians

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395w — Appropriations to cover Government

Page 3243 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395w 1 See References in Text note below. mentary medical insurance program established under part B of title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.], and (2) provisions will be made for payment of the monthly premiums of such individuals for such program.’’ § 1395w. Appropriations to cover Government contributions and contingency reserve (a) In general There are authorized to be appropriated from time to time, out of any moneys in the Treasury not otherwise appropriated, to the Federal Sup- plementary Medical Insurance Trust Fund— (1)(A) a Government contribution equal to the aggregate premiums payable for a month for enrollees age 65 and over under this part and deposited in the Trust Fund, multiplied by the ratio of— (i) twice the dollar amount of the actuari- ally adequate rate per enrollee age 65 and over as determined under section 1395r(a)(1) of this title for such month minus the dollar amount of the premium per enrollee for such month, as determined under section 1395r(a)(3) of this title, to (ii) the dollar amount of the premium per enrollee for such month, plus (B) a Government contribution equal to the aggregate premiums payable for a month for enrollees under age 65 under this part and de- posited in the Trust Fund, multiplied by the ratio of— (i) twice the dollar amount of the actuari- ally adequate rate per enrollee under age 65 as determined under section 1395r(a)(4) of this title for such month minus the dollar amount of the premium per enrollee for such month, as determined under section 1395r(a)(3) of this title, to (ii) the dollar amount of the premium per enrollee for such month; minus (C) the aggregate amount of additional pre- mium payment

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 263a — Certification of laboratories

**(a) “Laboratory” or “clinical laboratory” defined** As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. **(b) Certificate requirement** No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure. **(c) Issuance and renewal of certificates** (1) **In general** — The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d). (2) **Term** — A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish. **(d) Requirements for certificates** (1) **In general** — A laboratory may be issued a certificate or have its certificate renewed if— (A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application— (i) in such form and manner as the Secretary shall prescribe, (ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including— (I) the number and types of laboratory examinations and other procedures

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 263a — Certification of laboratories

Page 477 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 263a (B) information related to development programs for biological products, including biosimilar biological products and inter- changeable biosimilar biological products and relevant clinical considerations for pre- scribers, which may include, as appropriate and applicable, information related to the comparability of such biological products; (C) an explanation of the process for re- porting adverse events for biological prod- ucts, including biosimilar biological prod- ucts and interchangeable biosimilar biologi- cal products; and (D) an explanation of the relationship be- tween biosimilar biological products and interchangeable biosimilar biological prod- ucts licensed under section 262(k) of this title and reference products (as defined in section 262(i) of this title), including the standards for review and licensing of each such type of biological product. (3) Format The educational materials provided under paragraph (1) may be— (A) in formats such as webinars, con- tinuing education modules, videos, fact sheets, infographics, stakeholder toolkits, or other formats as appropriate and applicable; and (B) tailored for the unique needs of health care providers, patients, caregivers, and other audiences, as the Secretary deter- mines appropriate. (4) Other information In addition to the information described in paragraph (2), the Secretary shall continue to publish— (A) the action package of each biological product licensed under subsection (a) or (k) of section 262 of this title; or (B) the summary review of each biological product licensed under subsection (a) or (k) of section 262 of this title. (5) Confidential and trade secret information This subsection does not authorize the di

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 263a

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