§ 1395nn.
(c)
General exception related only to ownership or investment prohibition for ownership in publicly traded securities and mutual funds
Ownership of the following shall not be considered to be an ownership or investment interest described in subsection (a)(2)(A):
(1)
Ownership of investment securities (including shares or bonds, debentures, notes, or other debt instruments) which may be purchased on terms generally available to the public and which are—
(A)
(i)
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
(ii)
traded under an automated interdealer quotation system operated by the National Association of Securities Dealers, and
(B)
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.
(2)
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.
(e)
Exceptions relating to other compensation arrangements
The following shall not be considered to be a compensation arrangement described in subsection (a)(2)(B):
(1)
Rental of office space; rental of equipment
(A)
Office space
Payments made by a lessee to a lessor for the use of premises if—
(i)
the lease is set out in writing, signed by the parties, and specifies the premises covered by the lease,
(ii)
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,
(iii)
the lease provides for a term of rental or lease for at least 1 year,
(iv)
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,
(v)
the lease would be commercially reasonable even if no referrals were made between the parties, and
(vi)
the lease meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(B)
Equipment
Payments made by a lessee of equipment to the lessor of the equipment for the use of the equipment if—
(i)
the lease is set out in writing, signed by the parties, and specifies the equipment covered by the lease,
(ii)
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,
(iii)
the lease provides for a term of rental or lease of at least 1 year,
(iv)
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,
(v)
the lease would be commercially reasonable even if no referrals were made between the parties, and
(vi)
the lease meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(C)
Holdover lease arrangements
In the case of a holdover lease arrangement for the lease of office space or equipment, which immediately follows a lease arrangement described in subparagraph (A) for the use of such office space or subparagraph (B) for the use of such equipment and that expired after a term of at least 1 year, payments made by the lessee to the lessor pursuant to such holdover lease arrangement, if—
(i)
the lease arrangement met the conditions of subparagraph (A) for the lease of office space or subparagraph (B) for the use of equipment when the arrangement expired;
(ii)
the holdover lease arrangement is on the same terms and conditions as the immediately preceding arrangement; and
(iii)
the holdover arrangement continues to satisfy the conditions of subparagraph (A) for the lease of office space or subparagraph (B) for the use of equipment.
(2)
Bona fide employment relationships
Any 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—
(A)
the employment is for identifiable services,
(B)
the amount of the remuneration under the employment—
(i)
is consistent with the fair market value of the services, and
(ii)
is not determined in a manner that takes into account (directly or indirectly) the volume or value of any referrals by the referring physician,
(C)
the remuneration is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the employer, and
(D)
the employment meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
Subparagraph (B)(ii) shall not prohibit the payment of remuneration in the form of a productivity bonus based on services performed personally by the physician (or an immediate family member of such physician).
(3)
Personal service arrangements
(A)
In general
Remuneration from an entity under an arrangement (including remuneration for specific physicians’ services furnished to a nonprofit blood center) if—
(i)
the arrangement is set out in writing, signed by the parties, and specifies the services covered by the arrangement,
(ii)
the arrangement covers all of the services to be provided by the physician (or an immediate family member of such physician) to the entity,
(iii)
the aggregate services contracted for do not exceed those that are reasonable and necessary for the legitimate business purposes of the arrangement,
(iv)
the term of the arrangement is for at least 1 year,
(v)
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,
(vi)
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
(vii)
the arrangement meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(B)
Physician incentive plan exception
(i)
In general
In 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:
(I)
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.
(II)
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.
(III)
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
(C)
Holdover personal service arrangement
In the case of a holdover personal service arrangement, which immediately follows an arrangement described in subparagraph (A) that expired after a term of at least 1 year, remuneration from an entity pursuant to such holdover personal service arrangement, if—
(i)
the personal service arrangement met the conditions of subparagraph (A) when the arrangement expired;
(ii)
the holdover personal service arrangement is on the same terms and conditions as the immediately preceding arrangement; and
(iii)
the holdover arrangement continues to satisfy the conditions of subparagraph (A).
(4)
Remuneration unrelated to the provision of designated health services
(5)
Physician recruitment
In 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—
(A)
the physician is not required to refer patients to the hospital,
(B)
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
(C)
the arrangement meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(6)
Isolated transactions
In the case of an isolated financial transaction, such as a one-time sale of property or practice, if—
(A)
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
(B)
the transaction meets such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.
(7)
Certain group practice arrangements with a hospital
(A)
2
So in original. No subpar. (B) has been enacted.
In general
An arrangement between a hospital and a group under which designated health services are provided by the group but are billed by the hospital if—
(i)
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,
(ii)
the arrangement began before December 19, 1989, and has continued in effect without interruption since such date,
(iii)
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,
(iv)
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,
(v)
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,
(vi)
the compensation is provided pursuant to an agreement which would be commercially reasonable even if no referrals were made to the entity, and
(vii)
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 services
Payments made by a physician—
(A)
to a laboratory in exchange for the provision of clinical laboratory services, or
(B)
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.
(9)
Physician wellness programs
A bona fide mental health or behavioral health improvement or maintenance program offered to a physician by an entity, if—
(A)
such program—
(i)
consists of counseling, mental health services, a suicide prevention program, or a substance use disorder prevention and treatment program;
(ii)
is made available to a physician for the primary purpose of preventing suicide, improving mental health and resiliency, or providing training in appropriate strategies to promote the mental health and resiliency of such physician;
(iii)
is set out in a written policy, approved in advance of the operation of the program by the governing body of the entity providing such program (and which shall be updated accordingly in advance to substantial changes to the operation of such program), that includes—
(I)
a description of the content and duration of the program;
(II)
a description of the evidence-based support for the design of the program;
(III)
the estimated cost of the program;
(IV)
the personnel (including the qualifications of such personnel) conducting the program; and
(V)
the method by which such entity will evaluate the use and success of the program;
(iv)
is offered by an entity described in subparagraph (B) with a formal medical staff to all physicians who practice in the geographic area served by such entity, including physicians who hold bona fide appointments to the medical staff of such entity or otherwise have clinical privileges at such entity;
(v)
is offered to all such physicians on the same terms and conditions and without regard to the volume or value of referrals or other business generated by a physician for such entity;
(vi)
is evidence-based and conducted by a qualified health professional; and
(vii)
meets such other requirements the Secretary may impose by regulation as needed to protect against program or patient abuse;
(B)
such entity is—
(ii)
an ambulatory surgical center;
(iii)
a community health center;
(iv)
a rural emergency hospital;
(v)
a rural health clinic;
(vi)
a skilled nursing facility; or
(vii)
a similar entity, as determined by the Secretary; and
(C)
neither the provision of such program, nor the value of such program, are contingent upon the number or value of referrals made by a physician to such entity or the amount or value of other business generated by such physician for the entity.
([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]; [Pub. L. 115–123, div. E, title IV, § 50404], Feb. 9, 2018, [132 Stat. 218]; [Pub. L. 117–328, div. FF, title IV, § 4126(a)], Dec. 29, 2022, [136 Stat. 5913].)