Source: https://www.law.cornell.edu/uscode/text/42/1395nn?qt-us_code_tabs=2
Timestamp: 2016-02-11 19:32:34
Document Index: 41825888

Matched Legal Cases: ['§ 1395', '§ 1395', '§ 1395', '§\u202f1395', '§\u202f1877', '§\u202f6204', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f13562', '§\u202f152', '§\u202f4314', '§\u202f1000', '§\u202f524', '§\u202f101', '§\u202f507', '§\u202f143', '§\u202f6001', '§\u202f10601', '§\u202f1106', '§\u202f7', '§\u202f1877', '§\u202f242', '§\u202f4', '§\u202f917', '§\u202f2306', '§\u202f9321', '§\u202f4', '§\u202f4', '§\u202f6003', '§\u202f6001', '§\u202f6001', '§\u202f6001', '§\u202f1106', '§\u202f10601', '§\u202f1106', '§\u202f10601', '§\u202f10601', '§\u202f1106', '§\u202f1106', '§\u202f101', '§\u202f507', '§\u202f507', '§\u202f507', '§\u202f1000', '§\u202f524', '§\u202f1000', '§\u202f524', '§\u202f1000', '§\u202f524', '§\u202f524', '§\u202f152', '§\u202f152', '§\u202f152', '§\u202f13562', '§\u202f13562', '§\u202f13562', '§\u202f13562', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f6003', '§\u202f1000', '§\u202f524', '§\u202f152', '§\u202f13562', '§\u202f152', '§\u202f152', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f6204', '§\u202f6204', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f6001', '§\u202f10601', '§\u202f6409', '§\u202f507', '§\u202f507', '§\u202f6204', '§\u202f122', '§\u202f6204', '§\u202f4207', '§\u202f4027', '§\u202f160', '§\u202f122', 'art 411', 'art 1003']

42 U.S. Code § 1395nn - Limitation on certain physician referrals | US Law | LII / Legal Information Institute
U.S. Code › Title 42 › Chapter 7 › Subchapter XVIII › Part E › § 1395nn 42 U.S. Code § 1395nn - Limitation on certain physician referrals
§ 1395nn.
(1) In generalExcept as provided in subsection (b) of this section, if a physician (or an immediate family member of such physician) has a financial relationship with an entity specified in paragraph (2), then—
the physician may not make a referral to the entity for the furnishing of designated health services for which payment otherwise may be made under this subchapter, and
the entity may not present or cause to be presented a claim under this subchapter or bill to any individual, third party payor, or other entity for designated health services furnished pursuant to a referral prohibited under subparagraph (A).
(2) Financial relationship specifiedFor purposes of this section, a financial relationship of a physician (or an immediate family member of such physician) with an entity specified in this paragraph is—
except as provided in subsections (c) and (d) of this section, an ownership or investment interest in the entity, or
except as provided in subsection (e) of this section, a compensation arrangement (as defined in subsection (h)(1) of this section) between the physician (or an immediate family member of such physician) and the entity.
(b) General exceptions to both ownership and compensation arrangement prohibitionsSubsection (a)(1) of this section shall not apply in the following cases:
(1) Physicians’ services
In the case of physicians’ services (as defined in section 1395x(q) of this title) provided personally by (or under the personal supervision of) another physician in the same group practice (as defined in subsection (h)(4) of this section) as the referring physician.
(2) In-office ancillary servicesIn the case of services (other than durable medical equipment (excluding infusion pumps) and parenteral and enteral nutrients, equipment, and supplies)—
personally by the referring physician, personally by a physician who is a member of the same group practice as the referring physician, or personally by individuals who are directly supervised by the physician or by another physician in the group practice, and
in a building in which the referring physician (or another physician who is a member of the same group practice) furnishes physicians’ services unrelated to the furnishing of designated health services, or
for the provision of some or all of the group’s clinical laboratory services, or
for the centralized provision of the group’s designated health services (other than clinical laboratory services),
that are billed by the physician performing or supervising the services, by a group practice of which such physician is a member under a billing number assigned to the group practice, or by an entity that is wholly owned by such physician or such group practice,
(3) Prepaid plansIn the case of services furnished by an organization—
with a contract under section 1395mm of this title to an individual enrolled with the organization,
described in section 1395l(a)(1)(A) of this title to an individual enrolled with the organization,
receiving payments on a prepaid basis, under a demonstration project under section 1395b–1(a) of this title or under section 222(a) of the Social Security Amendments of 1972, to an individual enrolled with the organization,
that is a qualified health maintenance organization (within the meaning of section 300e–9(d) [1] of this title) to an individual enrolled with the organization, or
that is a Medicare Choice organization under part C of this subchapter that is offering a coordinated care plan described in section 1395w–21(a)(2)(A) of this title to an individual enrolled with the organization.
(c) General exception related only to ownership or investment prohibition for ownership in publicly traded securities and mutual fundsOwnership of the following shall not be considered to be an ownership or investment interest described in subsection (a)(2)(A) of this section:
securities listed on the New York Stock Exchange, the American Stock Exchange, or any regional exchange in which quotations are published on a daily basis, or foreign securities listed on a recognized foreign, national, or regional exchange in which quotations are published on a daily basis, or
traded under an automated interdealer quotation system operated by the National Association of Securities Dealers, and
in a corporation that had, at the end of the corporation’s most recent fiscal year, or on average during the previous 3 fiscal years, stockholder equity exceeding $75,000,000.
Ownership of shares in a regulated investment company as defined in section 851(a) of the Internal Revenue Code of 1986, if such company had, at the end of the company’s most recent fiscal year, or on average during the previous 3 fiscal years, total assets exceeding $75,000,000.
(d) Additional exceptions related only to ownership or investment prohibitionThe following, if not otherwise excepted under subsection (b) of this section, shall not be considered to be an ownership or investment interest described in subsection (a)(2)(A) of this section:
(2) Rural providersIn the case of designated health services furnished in a rural area (as defined in section 1395ww(d)(2)(D) of this title) by an entity, if—
substantially all of the designated health services furnished by the entity are furnished to individuals residing in such a rural area;
effective for the 18-month period beginning on December 8, 2003, the entity is not a specialty hospital (as defined in subsection (h)(7) of this section); and
(3) Hospital ownershipIn the case of designated health services provided by a hospital (other than a hospital described in paragraph (1)) if—
the referring physician is authorized to perform services at the hospital;
effective for the 18-month period beginning on December 8, 2003, the hospital is not a specialty hospital (as defined in subsection (h)(7) of this section);
the ownership or investment interest is in the hospital itself (and not merely in a subdivision of the hospital); and
the hospital meets the requirements described in subsection (i)(1) not later than 18 months after March 23, 2010.
(e) Exceptions relating to other compensation arrangementsThe following shall not be considered to be a compensation arrangement described in subsection (a)(2)(B) of this section:
(A) Office spacePayments made by a lessee to a lessor for the use of premises if—
the lease is set out in writing, signed by the parties, and specifies the premises covered by the lease,
the space rented or leased does not exceed that which is reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the lessee when being used by the lessee, except that the lessee may make payments for the use of space consisting of common areas if such payments do not exceed the lessee’s pro rata share of expenses for such space based upon the ratio of the space used exclusively by the lessee to the total amount of space (other than common areas) occupied by all persons using such common areas,
the lease provides for a term of rental or lease for at least 1 year,
the rental charges over the term of the lease are set in advance, are consistent with fair market value, and are not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
the lease would be commercially reasonable even if no referrals were made between the parties, and
the lease meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(B) EquipmentPayments made by a lessee of equipment to the lessor of the equipment for the use of the equipment if—
the lease is set out in writing, signed by the parties, and specifies the equipment covered by the lease,
the equipment rented or leased does not exceed that which is reasonable and necessary for the legitimate business purposes of the lease or rental and is used exclusively by the lessee when being used by the lessee,
the lease provides for a term of rental or lease of at least 1 year,
(2) Bona fide employment relationshipsAny amount paid by an employer to a physician (or an immediate family member of such physician) who has a bona fide employment relationship with the employer for the provision of services if—
the employment is for identifiable services,
is consistent with the fair market value of the services, and
is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician,
the remuneration is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the employer, and
the employment meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(A) In generalRemuneration from an entity under an arrangement (including remuneration for specific physicians’ services furnished to a nonprofit blood center) if—
the arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement,
the arrangement covers all of the services to be provided by the physician (or an immediate family member of such physician) to the entity,
the aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement,
the term of the arrangement is for at least 1 year,
the compensation to be paid over the term of the arrangement is set in advance, does not exceed fair market value, and except in the case of a physician incentive plan described in subparagraph (B), is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
the services to be performed under the arrangement do not involve the counseling or promotion or a business arrangement or other activity that violates any State or Federal law, and
the arrangement meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(i) In generalIn the case of a physician incentive plan (as defined in clause (ii)) between a physician and an entity, the compensation may be determined in a manner (through a withhold, capitation, bonus, or otherwise) that takes into account directly or indirectly the volume or value of any referrals or other business generated between the parties, if the plan meets the following requirements:
No specific payment is made directly or indirectly under the plan to a physician or a physician group as an inducement to reduce or limit medically necessary services provided with respect to a specific individual enrolled with the entity.
In the case of a plan that places a physician or a physician group at substantial financial risk as determined by the Secretary pursuant to section 1395mm(i)(8)(A)(ii) of this title, the plan complies with any requirements the Secretary may impose pursuant to such section.
Upon request by the Secretary, the entity provides the Secretary with access to descriptive information regarding the plan, in order to permit the Secretary to determine whether the plan is in compliance with the requirements of this clause.
(ii) “Physician incentive plan” defined
For purposes of this subparagraph, the term “physician incentive plan” means any compensation arrangement between an entity and a physician or physician group that may directly or indirectly have the effect of reducing or limiting services provided with respect to individuals enrolled with the entity.
(5) Physician recruitmentIn the case of remuneration which is provided by a hospital to a physician to induce the physician to relocate to the geographic area served by the hospital in order to be a member of the medical staff of the hospital, if—
the physician is not required to refer patients to the hospital,
the amount of the remuneration under the arrangement is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician, and
(6) Isolated transactionsIn the case of an isolated financial transaction, such as a one-time sale of property or practice, if—
the requirements described in subparagraphs (B) and (C) of paragraph (2) are met with respect to the entity in the same manner as they apply to an employer, and
the transaction meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(A) [2] In generalAn arrangement between a hospital and a group under which designated health services are provided by the group but are billed by the hospital if—
with respect to services provided to an inpatient of the hospital, the arrangement is pursuant to the provision of inpatient hospital services under section 1395x(b)(3) of this title,
the arrangement began before December 19, 1989, and has continued in effect without interruption since such date,
with respect to the designated health services covered under the arrangement, substantially all of such services furnished to patients of the hospital are furnished by the group under the arrangement,
the arrangement is pursuant to an agreement that is set out in writing and that specifies the services to be provided by the parties and the compensation for services provided under the agreement,
the compensation paid over the term of the agreement is consistent with fair market value and the compensation per unit of services is fixed in advance and is not determined in a manner that takes into account the volume or value of any referrals or other business generated between the parties,
the compensation is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the entity, and
the arrangement between the parties meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(8) Payments by a physician for items and servicesPayments made by a physician—
to a laboratory in exchange for the provision of clinical laboratory services, or
to an entity as compensation for other items or services if the items or services are furnished at a price that is consistent with fair market value.
(f) Reporting requirementsEach entity providing covered items or services for which payment may be made under this subchapter shall provide the Secretary with the information concerning the entity’s ownership, investment, and compensation arrangements, including—
the covered items and services provided by the entity, and
the names and unique physician identification numbers of all physicians with an ownership or investment interest (as described in subsection (a)(2)(A) of this section), or with a compensation arrangement (as described in subsection (a)(2)(B) of this section), in the entity, or whose immediate relatives have such an ownership or investment interest or who have such a compensation relationship with the entity.
Such information shall be provided in such form, manner, and at such times as the Secretary shall specify. The requirement of this subsection shall not apply to designated health services provided outside the United States or to entities which the Secretary determines provides [3] services for which payment may be made under this subchapter very infrequently.
Any person who is required, but fails, to meet a reporting requirement of subsection (f) of this section is subject to a civil money penalty of not more than $10,000 for each day for which reporting is required to have been made. The provisions of section 1320a–7a of this title (other than the first sentence of subsection (a) and other than subsection (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title.
The Secretary shall, to the extent practicable, apply the rules under subsections (b)(3) and (b)(4) of this section and take into account the regulations promulgated under subsection (b)(5) of section 1320a–7d of this title in the issuance of advisory opinions under this paragraph.
(h) Definitions and special rulesFor purposes of this section:
The term “compensation arrangement” means any arrangement involving any remuneration between a physician (or an immediate family member of such physician) and an entity other than an arrangement involving only remuneration described in subparagraph (C).
The term “remuneration” includes any remuneration, directly or indirectly, overtly or covertly, in cash or in kind.
The forgiveness of amounts owed for inaccurate tests or procedures, mistakenly performed tests or procedures, or the correction of minor billing errors.
collect, transport, process, or store specimens for the entity providing the item, device, or supply, or
order or communicate the results of tests or procedures for such entity.
the health services are not furnished, and the payment is not made, pursuant to a contract or other arrangement between the insurer or the plan and the physician,
the payment is made to the physician on behalf of the covered individual and would otherwise be made directly to such individual,
the amount of the payment is set in advance, does not exceed fair market value, and is not determined in a manner that takes into account directly or indirectly the volume or value of any referrals, and
the payment meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
An individual is considered to be “employed by” or an “employee” of an entity if the individual would be considered to be an employee of the entity under the usual common law rules applicable in determining the employer-employee relationship (as applied for purposes of section 3121(d)(2) of the Internal Revenue Code of 1986).
The term “fair market value” means the value in arms length transactions, consistent with the general market value, and, with respect to rentals or leases, the value of rental property for general commercial purposes (not taking into account its intended use) and, in the case of a lease of space, not adjusted to reflect the additional value the prospective lessee or lessor would attribute to the proximity or convenience to the lessor where the lessor is a potential source of patient referrals to the lessee.
(A) Definition of group practiceThe term “group practice” means a group of 2 or more physicians legally organized as a partnership, professional corporation, foundation, not-for-profit corporation, faculty practice plan, or similar association—
in which each physician who is a member of the group provides substantially the full range of services which the physician routinely provides, including medical care, consultation, diagnosis, or treatment, through the joint use of shared office space, facilities, equipment and personnel,
for which substantially all of the services of the physicians who are members of the group are provided through the group and are billed under a billing number assigned to the group and amounts so received are treated as receipts of the group,
in which the overhead expenses of and the income from the practice are distributed in accordance with methods previously determined,
except as provided in subparagraph (B)(i), in which no physician who is a member of the group directly or indirectly receives compensation based on the volume or value of referrals by the physician,
in which members of the group personally conduct no less than 75 percent of the physician-patient encounters of the group practice, and
which meets such other standards as the Secretary may impose by regulation.
(A) Physicians’ services
Except as provided in subparagraph (C), in the case of an item or service for which payment may be made under part B of this subchapter, the request by a physician for the item or service, including the request by a physician for a consultation with another physician (and any test or procedure ordered by, or to be performed by (or under the supervision of) that other physician), constitutes a “referral” by a “referring physician”.
Except as provided in subparagraph (C), the request or establishment of a plan of care by a physician which includes the provision of the designated health service constitutes a “referral” by a “referring physician”.
A request by a pathologist for clinical diagnostic laboratory tests and pathological examination services, a request by a radiologist for diagnostic radiology services, and a request by a radiation oncologist for radiation therapy, if such services are furnished by (or under the supervision of) such pathologist, radiologist, or radiation oncologist pursuant to a consultation requested by another physician does not constitute a “referral” by a “referring physician”.
(6) Designated health servicesThe term “designated health services” means any of the following items or services:
Radiology services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services.
(A) In generalFor purposes of this section, except as provided in subparagraph (B), the term “specialty hospital” means a subsection (d) hospital (as defined in section 1395ww(d)(1)(B) of this title) that is primarily or exclusively engaged in the care and treatment of one of the following categories:
Patients with a cardiac condition.
Patients with an orthopedic condition.
Patients receiving a surgical procedure.
Any other specialized category of services that the Secretary designates as inconsistent with the purpose of permitting physician ownership and investment interests in a hospital under this section.
(B) ExceptionFor purposes of this section, the term “specialty hospital” does not include any hospital—
to be in operation before November 18, 2003; or
under development as of such date;
for which the number of physician investors at any time on or after such date is no greater than the number of such investors as of such date;
for which the type of categories described in subparagraph (A) at any time on or after such date is no different than the type of such categories as of such date;
for which any increase in the number of beds occurs only in the facilities on the main campus of the hospital and does not exceed 50 percent of the number of beds in the hospital as of November 18, 2003, or 5 beds, whichever is greater; and
that meets such other requirements as the Secretary may specify.
(1) Requirements describedFor purposes of subsection (d)(3)(D), the requirements described in this paragraph for a hospital are as follows:
(A) Provider agreementThe hospital had—
physician ownership or investment on December 31, 2010; and
a provider agreement under section 1395cc of this title in effect on such date.
the identity of each physician owner or investor and any other owners or investors of the hospital; and
the nature and extent of all ownership and investment interests in the hospital.
the ownership or investment interest, as applicable, of such referring physician in the hospital; and
if applicable, any such ownership or investment interest of the treating physician.
The hospital does not condition any physician ownership or investment interests either directly or indirectly on the physician owner or investor making or influencing referrals to the hospital or otherwise generating business for the hospital.
The percentage of the total value of the ownership or investment interests held in the hospital, or in an entity whose assets include the hospital, by physician owners or investors in the aggregate does not exceed such percentage as of March 23, 2010.
Any ownership or investment interests that the hospital offers to a physician owner or investor are not offered on more favorable terms than the terms offered to a person who is not a physician owner or investor.
The hospital (or any owner or investor in the hospital) does not directly or indirectly provide loans or financing for any investment in the hospital by a physician owner or investor.
The hospital (or any owner or investor in the hospital) does not directly or indirectly guarantee a loan, make a payment toward a loan, or otherwise subsidize a loan, for any individual physician owner or investor or group of physician owners or investors that is related to acquiring any ownership or investment interest in the hospital.
Ownership or investment returns are distributed to each owner or investor in the hospital in an amount that is directly proportional to the ownership or investment interest of such owner or investor in the hospital.
Physician owners and investors do not receive, directly or indirectly, any guaranteed receipt of or right to purchase other business interests related to the hospital, including the purchase or lease of any property under the control of other owners or investors in the hospital or located near the premises of the hospital.
The hospital does not offer a physician owner or investor the opportunity to purchase or lease any property under the control of the hospital or any other owner or investor in the hospital on more favorable terms than the terms offered to an individual who is not a physician owner or investor.
In this paragraph, the term “baseline number of operating rooms, procedure rooms, and beds” means the number of operating rooms, procedure rooms, and beds for which the applicable hospital is licensed as of March 23, 2010 (or, in the case of a hospital that did not have a provider agreement in effect as of such date but does have such an agreement in effect on December 31, 2010, the effective date of such provider agreement).
(E) Applicable hospitalIn this paragraph, the term “applicable hospital” means a hospital—
that is located in a county in which the percentage increase in the population during the most recent 5-year period (as of the date of the application under subparagraph (A)) is at least 150 percent of the percentage increase in the population growth of the State in which the hospital is located during that period, as estimated by Bureau of the Census;
whose annual percent of total inpatient admissions that represent inpatient admissions under the program under subchapter XIX is equal to or greater than the average percent with respect to such admissions for all hospitals located in the county in which the hospital is located;
that has an average bed occupancy rate that is greater than the average bed occupancy rate in the State in which the hospital is located.
(F) High Medicaid facility describedA high Medicaid facility described in this subparagraph is a hospital that—
is not the sole hospital in a county;
with respect to each of the 3 most recent years for which data are available, has an annual percent of total inpatient admissions that represent inpatient admissions under subchapter XIX that is estimated to be greater than such percent with respect to such admissions for any other hospital located in the county in which the hospital is located; and
meets the conditions described in subparagraph (E)(iii).
In this subsection, the term “procedure rooms” includes rooms in which catheterizations, angiographies, angiograms, and endoscopies are performed, except such term shall not include emergency rooms or departments (exclusive of rooms in which catheterizations, angiographies, angiograms, and endoscopies are performed).
For purposes of this subsection, the term “physician owner or investor” means a physician (or an immediate family member of such physician) with a direct or an indirect ownership or investment interest in the hospital.
Nothing in this subsection shall be construed as preventing the Secretary from revoking a hospital’s provider agreement if not in compliance with regulations implementing section 1395cc of this title.
(Aug. 14, 1935, ch. 531, title XVIII, § 1877, as added Pub. L. 101–239, title VI, § 6204(a), Dec. 19, 1989, 103 Stat. 2236; amended Pub. L. 101–508, title IV, § 4207(e)(1)–(3), (k)(2), formerly § 4027(e)(1)–(3), (k)(2), Nov. 5, 1990, 104 Stat. 1388–121, 1388–122, 1388–124, renumbered Pub. L. 103–432, title I, § 160(d)(4), Oct. 31, 1994, 108 Stat. 4444; Pub. L. 103–66, title XIII, § 13562(a), Aug. 10, 1993, 107 Stat. 596; Pub. L. 103–432, title I, § 152(a), (b), Oct. 31, 1994, 108 Stat. 4436; Pub. L. 105–33, title IV, § 4314, Aug. 5, 1997, 111 Stat. 389; Pub. L. 106–113, div. B, § 1000(a)(6) [title V, § 524(a)], Nov. 29, 1999, 113 Stat. 1536, 1501A–387; Pub. L. 108–173, title I, § 101(e)(8)(B), title V, § 507(a), Dec. 8, 2003, 117 Stat. 2152, 2295; Pub. L. 110–275, title I, § 143(b)(9), July 15, 2008, 122 Stat. 2543; Pub. L. 111–148, title VI, §§ 6001(a), 6003(a), title X, § 10601(a), Mar. 23, 2010, 124 Stat. 684, 697, 1005; Pub. L. 111–152, title I, § 1106, Mar. 30, 2010, 124 Stat. 1049.)
[1]  See References in Text note below.[2]  So in original. No subpar. (B) has been enacted.[3]  So in original. Probably should be “provide”.
Section 222(a) of the Social Security Amendments of 1972, referred to in subsec. (b)(3)(C), is section 222(a) of Pub. L. 92–603, Oct. 30, 1972, 86 Stat. 1329, which is set out as a note under section 1395b–1 of this title.
Section 300e–9(d) of this title, referred to in subsec. (b)(3)(D), was redesignated section 300e–9(c) of this title by Pub. L. 100–517, § 7(b), Oct. 24, 1988, 102 Stat. 2580.
Section 1395w–104(e)(6) of this title, referred to in subsec. (b)(5), was in the original “section 1860D–3(e)(6)”, and was translated as reading “section 1860D–4(e)(6)”, meaning section 1860D–4(e)(6) of the Social Security Act, 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 1860D–4(e)(6) relates to electronic prescription program regulations.
A prior section 1395nn, act Aug. 14, 1935, ch. 531, title XVIII, § 1877, as added and amended Oct. 30, 1972, Pub. L. 92–603, title II, §§ 242(b), 278(b)(8), 86 Stat. 1419, 1454; Oct. 25, 1977, Pub. L. 95–142, § 4(a), 91 Stat. 1179; Dec. 5, 1980, Pub. L. 96–499, title IX, § 917, 94 Stat. 2625; July 18, 1984, Pub. L. 98–369, div. B, title III, § 2306(f)(2), 98 Stat. 1073; Oct. 21, 1986, Pub. L. 99–509, title IX, § 9321(a)(1), 100 Stat. 2016; Aug. 18, 1987, Pub. L. 100–93, § 4(c), 101 Stat. 689, enumerated offenses relating to the Medicare program and penalties for such offenses, prior to repeal by Pub. L. 100–93, §§ 4(e), 15(a), Aug. 18, 1987, 101 Stat. 689, 698, effective at end of fourteen-day period beginning Aug. 18, 1987, and inapplicable to administrative proceedings commenced before end of such period.
2010—Subsec. (b)(2). Pub. L. 111–148, § 6003(a), inserted at end of concluding provisions “Such requirements shall, with respect to magnetic resonance imaging, computed tomography, positron emission tomography, and any other designated health services specified under subsection (h)(6)(D) that the Secretary determines appropriate, include a requirement that the referring physician inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred from a person other than a person described in subparagraph (A)(i) and provide such individual with a written list of suppliers (as defined in section 1395x(d) of this title) who furnish such services in the area in which such individual resides.”
Subsec. (d)(2)(C). Pub. L. 111–148, § 6001(a)(1), added subpar. (C).
Subsec. (d)(3)(D). Pub. L. 111–148, § 6001(a)(2), added subpar. (D).
Subsec. (i). Pub. L. 111–148, § 6001(a)(3), added subsec. (i).
Subsec. (i)(1)(A)(i). Pub. L. 111–152, § 1106(1), substituted “December 31, 2010” for “August 1, 2010”.
Pub. L. 111–148, § 10601(a)(1), substituted “August 1, 2010” for “February 1, 2010”.
Subsec. (i)(3)(A)(i). Pub. L. 111–152, § 1106(2)(A), substituted “a hospital that is an applicable hospital (as defined in subparagraph (E)) or is a high Medicaid facility described in subparagraph (F)” for “an applicable hospital (as defined in subparagraph (E))”.
Subsec. (i)(3)(A)(iii). Pub. L. 111–148, § 10601(a)(2)(A), substituted “February 1, 2012” for “August 1, 2011”.
Subsec. (i)(3)(A)(iv). Pub. L. 111–148, § 10601(a)(2)(B), substituted “January 1, 2012” for “July 1, 2011”.
Subsec. (i)(3)(C)(iii). Pub. L. 111–152, § 1106(2)(B), inserted “(or, in the case of a hospital that did not have a provider agreement in effect as of such date but does have such an agreement in effect on December 31, 2010, the effective date of such provider agreement)” after “March 23, 2010”.
Subsec. (i)(3)(F) to (I). Pub. L. 111–152, § 1106(2)(C), (D), added subpar. (F) and redesignated former subpars. (F) to (H) as (G) to (I), respectively.
2008—Subsec. (h)(6)(L). Pub. L. 110–275 added subpar. (L).
2003—Subsec. (b)(5). Pub. L. 108–173, § 101(e)(8)(B), added par. (5).
Subsec. (d)(2). Pub. L. 108–173, § 507(a)(2), amended heading and text of par. (2) generally. Prior to amendment, text read as follows: “In the case of designated health services furnished in a rural area (as defined in section 1395ww(d)(2)(D) of this title) by an entity, if substantially all of the designated health services furnished by such entity are furnished to individuals residing in such a rural area.”
Subsec. (d)(3)(B), (C). Pub. L. 108–173, § 507(a)(1)(A), added subpar. (B) and redesignated former subpar. (B) as (C).
Subsec. (h)(7). Pub. L. 108–173, § 507(a)(1)(B), added par. (7).
1999—Subsec. (b)(3)(C). Pub. L. 106–113, § 1000(a)(6) [title V, § 524(a)(1)], struck out “or” at the end.
Subsec. (b)(3)(D). Pub. L. 106–113, § 1000(a)(6) [title V, § 524(a)(2)], substituted “, or” for period at end.
Subsec. (b)(3)(E). Pub. L. 106–113, § 1000(a)(6) [title V, § 524(a)(3)], which directed addition of provisions at end of par. (3) but which separated directory language from language to be added because of the apparent placement out of sequence of pars. (2) and (3) of § 524(a), was executed by adding subpar. (E) at end of par. (3) to reflect the probable intent of Congress.
1997—Subsec. (g)(6). Pub. L. 105–33 added par. (6).
1994—Subsec. (f). Pub. L. 103–432, § 152(a)(1), (4), (5), in introductory provisions, substituted “ownership, investment, and compensation arrangements” for “ownership arrangements”, and in closing provisions, substituted “designated health services” for “covered items and services” and struck out “Such information shall first be provided not later than October 1, 1991.” after “shall specify.” and “The Secretary may waive the requirements of this subsection (and the requirements of chapter 35 of title 44 with respect to information provided under this subsection) with respect to reporting by entities in a State (except for entities providing designated health services) so long as such reporting occurs in at least 10 States, and the Secretary may waive such requirements with respect to the providers in a State required to report so long as such requirements are not waived with respect to parenteral and enteral suppliers, end stage renal disease facilities, suppliers of ambulance services, hospitals, entities providing physical therapy services, and entities providing diagnostic imaging services of any type.” at end.
Subsec. (f)(2). Pub. L. 103–432, § 152(a)(2), (3), inserted “, or with a compensation arrangement (as described in subsection (a)(2)(B) of this section),” after “investment interest (as described in subsection (a)(2)(A) of this section)” and “interest or who have such a compensation relationship with the entity” before period at end.
Subsec. (h)(6). Pub. L. 103–432, § 152(b), in subpar. (D), substituted “services, including magnetic resonance imaging, computerized axial tomography scans, and ultrasound services” for “or other diagnostic services”, and in subpars. (E), (F), and (H), inserted “and supplies” before period at end.
1993—Subsecs. (a) to (e). Pub. L. 103–66, § 13562(a)(1), amended headings and text of subsecs. (a) to (e) generally, substituting present provisions for provisions which related to: prohibition of certain referrals in subsec. (a), general exceptions to both ownership and compensation arrangement prohibitions in subsec. (b), general exception related only to ownership or investment prohibition for ownership in publicly-traded securities in subsec. (c), additional exceptions related only to ownership or investment prohibition in subsec. (d), and exceptions relating to other compensation arrangements in subsec. (e).
Subsec. (f). Pub. L. 103–66, § 13562(a)(3), substituted “designated health services” for “clinical laboratory services” in concluding provisions.
Subsec. (g)(1). Pub. L. 103–66, § 13562(a)(4), substituted “designated health service” for “clinical laboratory service”.
Subsec. (h). Pub. L. 103–66, § 13562(a)(2), amended heading and text of subsec. (h) generally, substituting pars. (1) to (6) for former pars. (1) to (7) which defined “compensation arrangement”, “remuneration”, “employee”, “fair market value”, “group practice”, “investor”, “interested investor”, “disinterested investor”, “referral”, and “referring physician”.
1990—Subsec. (b)(4), (5). Pub. L. 101–508, § 4207(e)(2), formerly § 4027(e)(2), as renumbered by Pub. L. 103–432, § 160(d)(4), added par. (4) and redesignated former par. (4) as (5).
Subsec. (f). Pub. L. 101–508, § 4207(e)(3)(B), (C), formerly § 4027(e)(3)(B), (C), as renumbered by Pub. L. 103–432, § 160(d)(4), substituted “October 1, 1991” for “1 year after December 19, 1989” in second sentence and inserted at end “The requirement of this subsection shall not apply to covered items and services provided outside the United States or to entities which the Secretary determines provides services for which payment may be made under this subchapter very infrequently. The Secretary may waive the requirements of this subsection (and the requirements of chapter 35 of title 44 with respect to information provided under this subsection) with respect to reporting by entities in a State (except for entities providing clinical laboratory services) so long as such reporting occurs in at least 10 States, and the Secretary may waive such requirements with respect to the providers in a State required to report so long as such requirements are not waived with respect to parenteral and enteral suppliers, end stage renal disease facilities, suppliers of ambulance services, hospitals, entities providing physical therapy services, and entities providing diagnostic imaging services of any type.”
Subsec. (f)(2). Pub. L. 101–508, § 4207(e)(3)(A), formerly § 4027(e)(3)(A), as renumbered by Pub. L. 103–432, § 160(d)(4), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “the names and all of the medicare provider numbers of the physicians who are interested investors or who are immediate relatives of interested investors.”
Subsec. (g)(5). Pub. L. 101–508, § 4207(k)(2), formerly § 4027(k)(2), as renumbered by Pub. L. 103–432, § 160(d)(4), inserted at end “The provisions of section 1320a–7a of this title (other than the first sentence of subsection (a) and other than subsection (b)) shall apply to a civil money penalty under the previous sentence in the same manner as such provisions apply to a penalty or proceeding under section 1320a–7a(a) of this title.”
Subsec. (h)(6). Pub. L. 101–508, § 4207(e)(1)(C), formerly § 4027(e)(1)(C), as renumbered by Pub. L. 103–432, § 160(d)(4), added par. (6). Former par. (6) redesignated (7).
Pub. L. 101–508, § 4207(e)(1)(A), (B), formerly § 4027(e)(1)(A), (B), as renumbered by Pub. L. 103–432, § 160(d)(4), substituted “in the case of an item or service for which payment may be made under part B of this subchapter, the request by a physician for the item or service,” for “in the case of a clinical laboratory service which under law is required to be provided by (or under the supervision of) a physician, the request by a physician for the service,” in subpar. (A) and struck out “in the case of another clinical laboratory service,” after “subparagraph (C),” in subpar. (B).
Subsec. (h)(7). Pub. L. 101–508, § 4207(e)(1)(C), formerly § 4027(e)(1)(C), as renumbered by Pub. L. 103–432, § 160(d)(4), redesignated par. (6) as (7).
Pub. L. 111–148, title VI, § 6003(b), Mar. 23, 2010, 124 Stat. 697, provided that: “The amendment made by this section [amending this section] shall apply to services furnished on or after January 1, 2010.”
Pub. L. 106–113, div. B, § 1000(a)(6) [title V, § 524(b)], Nov. 29, 1999, 113 Stat. 1536, 1501A–388, provided that: “The amendment made by this section [amending this section] shall apply to services furnished on or after the date of the enactment of this Act [Nov. 29, 1999].”
Pub. L. 103–432, title I, § 152(d)(1), Oct. 31, 1994, 108 Stat. 4437, provided that: “The amendments made by subsections (a) and (b) [amending this section] shall apply to referrals made on or after January 1, 1995.”
Pub. L. 103–66, title XIII, § 13562(b), Aug. 10, 1993, 107 Stat. 604, as amended by Pub. L. 103–432, title I, § 152(c), Oct. 31, 1994, 108 Stat. 4437, provided that:
“(1)In general.—Except as provided in paragraph (2), the amendments made by this section [amending this section] shall apply to referrals—
made on or after January 1, 1992, in the case of clinical laboratory services, and
made after December 31, 1994, in the case of other designated health services.
“(2)Exceptions.—With respect to referrals made for clinical laboratory services on or before December 31, 1994—
the second sentence of subsection (a)(2), and subsections (b)(2)(B) and (d)(2), of section 1877 of the Social Security Act [42 U.S.C. 1395nn(a)(2), (b)(2)(B), (d)(2)] (as in effect on the day before the date of the enactment of this Act [Aug. 10, 1993]) shall apply instead of the corresponding provisions in section 1877 (as amended by this Act);
section 1877(b)(4) of the Social Security Act [42 U.S.C. 1395nn(b)(4)] (as in effect on the day before the date of the enactment of this Act) shall apply;
the requirements of section 1877(c)(2) of the Social Security Act [42 U.S.C. 1395nn(c)(2)] (as amended by this Act) shall not apply to any securities of a corporation that meets the requirements of section 1877(c)(2) of the Social Security Act (as in effect on the day before the date of the enactment of this Act);
section 1877(e)(3) of the Social Security Act [42 U.S.C. 1395nn(e)(3)] (as amended by this Act) shall apply, except that it shall not apply to any arrangement that meets the requirements of subsection (e)(2) or subsection (e)(3) of section 1877 of the Social Security Act (as in effect on the day before the date of the enactment of this Act);
the requirements of clauses (iv) and (v) of section 1877(h)(4)(A), and of clause (i) of section 1877(h)(4)(B), of the Social Security Act [42 U.S.C. 1395nn(h)(4)(A)(iv), (v), (B)(i)] (as amended by this Act) shall not apply; and
section 1877(h)(4)(B) of the Social Security Act [42 U.S.C. 1395nn(h)(4)(B)] (as in effect on the day before the date of the enactment of this Act) shall apply instead of section 1877(h)(4)(A)(ii) of such Act (as amended by this Act).”
[Pub. L. 103–432, title I, § 152(d)(2), Oct. 31, 1994, 108 Stat. 4437, provided that: “The amendment made by subsection (c) [amending section 13562(b) of Pub. L. 103–66, set out above] shall apply as if included in the enactment of OBRA–1993 [Pub. L. 103–66].”
Pub. L. 101–508, title IV, § 4207(e)(5), formerly § 4027(e)(5), Nov. 5, 1990, 104 Stat. 1388–123, as renumbered by Pub. L. 103–432, title I, § 160(d)(4), Oct. 31, 1994, 108 Stat. 4444, provided that: “The amendments made by this subsection [amending this section and provisions set out below] shall be effective as if included in the enactment of section 6204 of the Omnibus Budget Reconciliation Act of 1989 [Pub. L. 101–239].”
Pub. L. 101–239, title VI, § 6204(c), Dec. 19, 1989, 103 Stat. 2242, provided that:
Except as provided in paragraph (2), the amendments made by this section [enacting this section and amending section 1395l of this title] shall become effective with respect to referrals made on or after January 1, 1992.
The reporting requirement of section 1877(f) of the Social Security Act [42 U.S.C. 1395nn(f)] shall take effect on October 1, 1990.”
Pub. L. 101–239, title VI, § 6204(d), Dec. 19, 1989, 103 Stat. 2242, as amended by Pub. L. 101–508, title IV, § 4207(e)(4)(B), formerly § 4027(e)(4)(B), Nov. 5, 1990, 104 Stat. 1388–122, renumbered Pub. L. 103–432, title I, § 160(d)(4), Oct. 31, 1994, 108 Stat. 4444, provided that: “The Secretary of Health and Human Services shall publish final regulations to carry out section 1877 of the Social Security Act [42 U.S.C. 1395nn] by not later than October 1, 1991.”
Pub. L. 111–148, title VI, § 6001(b), Mar. 23, 2010, 124 Stat. 689, as amended by Pub. L. 111–148, title X, § 10601(b), Mar. 23, 2010, 124 Stat. 1005, provided that:
“(1)Ensuring compliance.—
The Secretary of Health and Human Services shall establish policies and procedures to ensure compliance with the requirements described in subsection (i)(1) of section 1877 of the Social Security Act [42 U.S.C. 1395nn(i)(1)], as added by subsection (a)(3), beginning on the date such requirements first apply. Such policies and procedures may include unannounced site reviews of hospitals.
Beginning not later than May 1, 2012, the Secretary of Health and Human Services shall conduct audits to determine if hospitals violate the requirements referred to in paragraph (1).”
Pub. L. 111–148, title VI, § 6409, Mar. 23, 2010, 124 Stat. 772, provided that:
“(a) Development of Self-Referral Disclosure Protocol.—
“(1)In general.—The Secretary of Health and Human Services, in cooperation with the Inspector General of the Department of Health and Human Services, shall establish, not later than 6 months after the date of the enactment of this Act [Mar. 23, 2010], a protocol to enable health care providers of services and suppliers to disclose an actual or potential violation of section 1877 of the Social Security Act (42 U.S.C. 1395nn) pursuant to a self-referral disclosure protocol (in this section referred to as an ‘SRDP’). The SRDP shall include direction to health care providers of services and suppliers on—
a specific person, official, or office to whom such disclosures shall be made; and
instruction on the implication of the SRDP on corporate integrity agreements and corporate compliance agreements.
“(2)Publication on internet website of srdp information.—
The Secretary of Health and Human Services shall post information on the public Internet website of the Centers for Medicare & Medicaid Services to inform relevant stakeholders of how to disclose actual or potential violations pursuant to an SRDP.
“(3)Relation to advisory opinions.—
The SRDP shall be separate from the advisory opinion process set forth in regulations implementing section 1877(g) of the Social Security Act [42 U.S.C. 1395nn(g)].
“(b)Reduction in Amounts Owed.—The Secretary of Health and Human Services is authorized to reduce the amount due and owing for all violations under section 1877 of the Social Security Act [42 U.S.C. 1395nn] to an amount less than that specified in subsection (g) of such section. In establishing such amount for a violation, the Secretary may consider the following factors:
The nature and extent of the improper or illegal practice.
The timeliness of such self-disclosure.
The cooperation in providing additional information related to the disclosure.
“(c)Report.—Not later than 18 months after the date on which the SRDP protocol is established under subsection (a)(1), the Secretary shall submit to Congress a report on the implementation of this section. Such report shall include—
the number of health care providers of services and suppliers making disclosures pursuant to the SRDP;
the amounts collected pursuant to the SRDP;
the types of violations reported under the SRDP; and
such other information as may be necessary to evaluate the impact of this section.”
Pub. L. 108–173, title V, § 507(b), Dec. 8, 2003, 117 Stat. 2296, provided that: “For purposes of section 1877(h)(7)(B)(i)(II) of the Social Security Act [42 U.S.C. 1395nn(h)(7)(B)(i)(II)], as added by subsection (a)(1)(B), in determining whether a hospital is under development as of November 18, 2003, the Secretary [of Health and Human Services] shall consider—
whether architectural plans have been completed, funding has been received, zoning requirements have been met, and necessary approvals from appropriate State agencies have been received; and
any other evidence the Secretary determines would indicate whether a hospital is under development as of such date.”
Pub. L. 108–173, title V, § 507(c), Dec. 8, 2003, 117 Stat. 2296, provided that:
“(1)MedPAC study.—The Medicare Payment Advisory Commission, in consultation with the Comptroller General of the United States, shall conduct a study to determine—
any differences in the costs of health care services furnished to patients by physician-owned specialty hospitals and the costs of such services furnished by local full-service community hospitals within specific diagnosis-related groups;
the extent to which specialty hospitals, relative to local full-service community hospitals, treat patients in certain diagnosis-related groups within a category, such as cardiology, and an analysis of the selection;
the financial impact of physician-owned specialty hospitals on local full-service community hospitals;
how the current diagnosis-related group system should be updated to better reflect the cost of delivering care in a hospital setting; and
the proportions of payments received, by type of payer, between the specialty hospitals and local full-service community hospitals.
“(2) HHS study.—The Secretary [of Health and Human Services] shall conduct a study of a representative sample of specialty hospitals—
to determine the percentage of patients admitted to physician-owned specialty hospitals who are referred by physicians with an ownership interest;
to determine the referral patterns of physician owners, including the percentage of patients they referred to physician-owned specialty hospitals and the percentage of patients they referred to local full-service community hospitals for the same condition;
to compare the quality of care furnished in physician-owned specialty hospitals and in local full-service community hospitals for similar conditions and patient satisfaction with such care; and
to assess the differences in uncompensated care, as defined by the Secretary, between the specialty hospital and local full-service community hospitals, and the relative value of any tax exemption available to such hospitals.
Not later than 15 months after the date of the enactment of this Act [Dec. 8, 2003], the Commission and the Secretary, respectively, shall each submit to Congress a report on the studies conducted under paragraphs (1) and (2), respectively, and shall include any recommendations for legislation or administrative changes.”
Pub. L. 101–239, title VI, § 6204(e), Dec. 19, 1989, 103 Stat. 2242, directed Comptroller General to conduct a study of ownership of hospitals and other providers of medicare services by referring physicians and, by not later than Feb. 1, 1991, report to Congress on results of such study, prior to repeal by Pub. L. 104–316, title I, § 122(h)(1), Oct. 19, 1996, 110 Stat. 3837.
Pub. L. 101–239, title VI, § 6204(f), Dec. 19, 1989, 103 Stat. 2243, as amended by Pub. L. 101–508, title IV, § 4207(e)(4)(A), formerly § 4027(e)(4)(A), Nov. 5, 1990, 104 Stat. 1388–122, renumbered Pub. L. 103–432, title I, § 160(d)(4), Oct. 31, 1994, 108 Stat. 4444; Pub. L. 104–316, title I, § 122(h)(2), Oct. 19, 1996, 110 Stat. 3837, directed Secretary of Health and Human Services, not later than June 30, 1992, to submit to Congress a statistical profile comparing utilization of items and services by medicare beneficiaries served by entities in which the referring physician has a direct or indirect financial interest and by medicare beneficiaries served by other entities, for the States and entities specified in subsec. (f) of this section (other than entities providing clinical laboratory services).
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.42 CFR - Public Health42 CFR Part 411 - EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT42 CFR Part 1003 - CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS