42 USC 1320a-7h - Transparency reports and reporting of physician ownership or investment interests

U.S Code last checked for updates: Nov 22, 2024

§ 1320a–7h.

Transparency reports and reporting of physician ownership or investment interests

(a)

Transparency reports

(1)

Payments or other transfers of value

(A)

In general

On March 31, 2013, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient), shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information with respect to the preceding calendar year:

(i)

The name of the covered recipient.

(ii)

The business address of the covered recipient and, in the case of a covered recipient who is a physician, the specialty and National Provider Identifier of the covered recipient.

(iii)

The amount of the payment or other transfer of value.

(iv)

The dates on which the payment or other transfer of value was provided to the covered recipient.

(v)

A description of the form of the payment or other transfer of value, indicated (as appropriate for all that apply) as—

(I)

cash or a cash equivalent;

(II)

in-kind items or services;

(III)

stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment; or

(IV)

any other form of payment or other transfer of value (as defined by the Secretary).

(vi)

A description of the nature of the payment or other transfer of value, indicated (as appropriate for all that apply) as—

(I)

consulting fees;

(II)

compensation for services other than consulting;

(III)

honoraria;

(IV)

gift;

(V)

entertainment;

(VI)

food;

(VII)

travel (including the specified destinations);

(VIII)

education;

(IX)

research;

(X)

charitable contribution;

(XI)

royalty or license;

(XII)

current or prospective ownership or investment interest;

(XIII)

direct compensation for serving as faculty or as a speaker for a medical education program;

(XIV)

grant; or

(XV)

any other nature of the payment or other transfer of value (as defined by the Secretary).

(vii)

If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of that covered drug, device, biological, or medical supply.

(viii)

Any other categories of information regarding the payment or other transfer of value the Secretary determines appropriate.

(B)

Special rule for certain payments or other transfers of value

(2)

Physician ownership

In addition to the requirement under paragraph (1)(A), on March 31, 2013, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer or applicable group purchasing organization shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information regarding any ownership or investment interest (other than an ownership or investment interest in a publicly traded security and mutual fund, as described in section 1395nn(c) of this title) held by a physician (or an immediate family member of such physician (as defined for purposes of section 1395nn(a) of this title)) in the applicable manufacturer or applicable group purchasing organization during the preceding year:

(A)

The dollar amount invested by each physician holding such an ownership or investment interest.

(B)

The value and terms of each such ownership or investment interest.

(C)

Any payment or other transfer of value provided to a physician holding such an ownership or investment interest (or to an entity or individual at the request of or designated on behalf of a physician holding such an ownership or investment interest), including the information described in clauses (i) through (viii) of paragraph (1)(A), except that in applying such clauses, “physician” shall be substituted for “covered recipient” each place it appears.

(D)

Any other information regarding the ownership or investment interest the Secretary determines appropriate.

(b)

Penalties for noncompliance

(1)

Failure to report

(A)

In general

(B)

Limitation

(2)

Knowing failure to report

(A)

In general

(B)

Limitation

(3)

Use of funds

(c)

Procedures for submission of information and public availability

(1)

In general

(A)

Establishment

Not later than October 1, 2011, the Secretary shall establish procedures—

(i)

for applicable manufacturers and applicable group purchasing organizations to submit information to the Secretary under subsection (a); and

(ii)

for the Secretary to make such information submitted available to the public.

(B)

Definition of terms

(C)

Public availability

Except as provided in subparagraph (E), the procedures established under subparagraph (A)(ii) shall ensure that, not later than September 30, 2013, and on June 30 of each calendar year beginning thereafter, the information submitted under subsection (a) with respect to the preceding calendar year is made available through an Internet website that—

(i)

is searchable and is in a format that is clear and understandable;

(ii)

contains information that is presented by the name of the applicable manufacturer or applicable group purchasing organization, the name of the covered recipient, the business address of the covered recipient, the specialty of the covered recipient, the value of the payment or other transfer of value, the date on which the payment or other transfer of value was provided to the covered recipient, the form of the payment or other transfer of value, indicated (as appropriate) under subsection (a)(1)(A)(v), the nature of the payment or other transfer of value, indicated (as appropriate) under subsection (a)(1)(A)(vi), and the name of the covered drug, device, biological, or medical supply, as applicable;

(iii)

contains information that is able to be easily aggregated and downloaded;

(iv)

contains a description of any enforcement actions taken to carry out this section, including any penalties imposed under subsection (b), during the preceding year;

(v)

contains background information on industry-physician relationships;

(vi)

in the case of information submitted with respect to a payment or other transfer of value described in subparagraph (E)(i), lists such information separately from the other information submitted under subsection (a) and designates such separately listed information as funding for clinical research;

(vii)

contains any other information the Secretary determines would be helpful to the average consumer;

(viii)

in the case of information made available under this subparagraph prior to January 1, 2022, does not contain the National Provider Identifier of the covered recipient, and

(ix)

subject to subparagraph (D), provides the applicable manufacturer, applicable group purchasing organization, or covered recipient an opportunity to review and submit corrections to the information submitted with respect to the applicable manufacturer, applicable group purchasing organization, or covered recipient, respectively, for a period of not less than 45 days prior to such information being made available to the public.

(D)

Clarification of time period for review and corrections

(E)

Delayed publication for payments made pursuant to product research or development agreements and clinical investigations

(i)

In general

In the case of information submitted under subsection (a) with respect to a payment or other transfer of value made to a covered recipient by an applicable manufacturer pursuant to a product research or development agreement for services furnished in connection with research on a potential new medical technology or a new application of an existing medical technology or the development of a new drug, device, biological, or medical supply, or by an applicable manufacturer in connection with a clinical investigation regarding a new drug, device, biological, or medical supply, the procedures established under subparagraph (A)(ii) shall provide that such information is made available to the public on the first date described in the matter preceding clause (i) in subparagraph (C) after the earlier of the following:

(I)

The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration.

(II)

Four calendar years after the date such payment or other transfer of value was made.

(ii)

Confidentiality of information prior to publication

(2)

Consultation

(d)

Annual reports and relation to State laws

(1)

Annual report to Congress

Not later than April 1 of each year beginning with 2013, the Secretary shall submit to Congress a report that includes the following:

(A)

The information submitted under subsection (a) during the preceding year, aggregated for each applicable manufacturer and applicable group purchasing organization that submitted such information during such year (except, in the case of information submitted with respect to a payment or other transfer of value described in subsection (c)(1)(E)(i), such information shall be included in the first report submitted to Congress after the date on which such information is made available to the public under such subsection).

(B)

A description of any enforcement actions taken to carry out this section, including any penalties imposed under subsection (b), during the preceding year.

(2)

Annual reports to States

(3)

Relation to State laws

(A)

In general.—

In the case of a payment or other transfer of value provided by an applicable manufacturer that is received by a covered recipient (as defined in subsection (e)) on or after January 1, 2012, subject to subparagraph (B), the provisions of this section shall preempt any statute or regulation of a State or of a political subdivision of a State that requires an applicable manufacturer (as so defined) to disclose or report, in any format, the type of information (as described in subsection (a)) regarding such payment or other transfer of value.

(B)

No preemption of additional requirements.—

Subparagraph (A) shall not preempt any statute or regulation of a State or of a political subdivision of a State that requires the disclosure or reporting of information—

(i)

not of the type required to be disclosed or reported under this section;

(ii)

described in subsection (e)(10)(B), except in the case of information described in clause (i) of such subsection;

(iii)

by any person or entity other than an applicable manufacturer (as so defined) or a covered recipient (as defined in subsection (e)); or

(iv)

to a Federal, State, or local governmental agency for public health surveillance, investigation, or other public health purposes or health oversight purposes.

(C)

Nothing in subparagraph (A) shall be construed to limit the discovery or admissibility of information described in such subparagraph in a criminal, civil, or administrative proceeding.

(4)

Consultation

(e)

Definitions

In this section:

(1)

Applicable group purchasing organization

(2)

Applicable manufacturer

(3)

Clinical investigation

(4)

Covered device

(5)

Covered drug, device, biological, or medical supply

(6)

Covered recipient

(A)

In general

Except as provided in subparagraph (B), the term “covered recipient” means the following:

(i)

A physician.

(ii)

A teaching hospital.

(iii)

A physician assistant, nurse practitioner, or clinical nurse specialist (as such terms are defined in section 1395x(aa)(5) of this title).

(iv)

A certified registered nurse anesthetist (as defined in section 1395x(bb)(2) of this title).

(v)

A certified nurse-midwife (as defined in section 1395x(gg)(2) of this title).

(B)

Exclusion

(7)

Employee

(8)

Knowingly

(9)

Manufacturer of a covered drug, device, biological, or medical supply

(10)

Payment or other transfer of value

(A)

In general

(B)

Exclusions

An applicable manufacturer shall not be required to submit information under subsection (a) with respect to the following:

(i)

A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100. For calendar years after 2012, the dollar amounts specified in the preceding sentence shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers (all items; U.S. city average) for the 12-month period ending with June of the previous year.

(ii)

Product samples that are not intended to be sold and are intended for patient use.

(iii)

Educational materials that directly benefit patients or are intended for patient use.

(iv)

The loan of a covered device for a short-term trial period, not to exceed 90 days, to permit evaluation of the covered device by the covered recipient.

(v)

Items or services provided under a contractual warranty, including the replacement of a covered device, where the terms of the warranty are set forth in the purchase or lease agreement for the covered device.

(vi)

A transfer of anything of value to a covered recipient when the covered recipient is a patient and not acting in the professional capacity of a covered recipient.

(vii)

Discounts (including rebates).

(viii)

In-kind items used for the provision of charity care.

(ix)

A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security and mutual fund (as described in section 1395nn(c) of this title).

(x)

In the case of an applicable manufacturer who offers a self-insured plan, payments for the provision of health care to employees under the plan.

(xi)

In the case of a covered recipient who is a licensed non-medical professional, a transfer of anything of value to the covered recipient if the transfer is payment solely for the non-medical professional services of such licensed non-medical professional.

(xii)

In the case of a covered recipient who is a physician, a transfer of anything of value to the covered recipient if the transfer is payment solely for the services of the covered recipient with respect to a civil or criminal action or an administrative proceeding.

(11)

Physician

(Aug. 14, 1935, ch. 531, title XI, § 1128G, as added Pub. L. 111–148, title VI, § 6002, Mar. 23, 2010, 124 Stat. 689; amended Pub. L. 115–271, title VI, § 6111(a)(1), (b), Oct. 24, 2018, 132 Stat. 4006, 4007.)

cite as: 42 USC 1320a-7h