‘‘(C) Any payment or other transfer of 
value provided to a physician holding such an 
ownership or investment interest (or to an enti-
ty or individual at the request of or designated 
on behalf of a physician holding such an owner-
ship or investment interest), including the infor-
mation described in clauses (i) through (viii) of 
paragraph (1)(A), except that in applying such 
clauses, ‘physician’ shall be substituted for ‘cov-
ered 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.—Subject to subpara-
graph (B), except as provided in paragraph (2), 
any applicable manufacturer, applicable group 
purchasing organization, or applicable dis-
tributor that fails to submit information re-
quired under subsection (a) in a timely manner 
in accordance with rules or regulations promul-
gated to carry out such subsection, shall be sub-
ject to a civil money penalty of not less than 
$1,000, but not more than $10,000, for each 
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payment or other transfer of value or ownership 
or investment interest not reported as required 
under such subsection. Such penalty shall be 
imposed and collected in the same manner as 
civil money penalties under subsection (a) of 
section 1128A are imposed and collected under 
that section. 
‘‘(B) LIMITATION.—The total amount of 
civil money penalties imposed under subpara-
graph (A) with respect to each annual submis-
sion of information under subsection (a) by an 
applicable manufacturer, applicable group pur-
chasing organization, or applicable distributor 
shall not exceed $150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), any applicable manufacturer, appli-
cable group purchasing organization, or applica-
ble distributor that knowingly fails to submit 
information required under subsection (a) in a 
timely manner in accordance with rules or regu-
lations promulgated to carry out such sub-
section, shall be subject to a civil money penalty 
of not less than $10,000, but not more than 
$100,000, for each payment or other transfer of 
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value or ownership or investment interest not 
reported as required under such subsection. 
Such penalty shall be imposed and collected in 
the same manner as civil money penalties under 
subsection (a) of section 1128A are imposed 
and collected under that section. 
‘‘(B) LIMITATION.—The total amount of 
civil money penalties imposed under subpara-
graph (A) with respect to each annual submis-
sion of information under subsection (a) by an 
applicable manufacturer, applicable group pur-
chasing organization, or applicable distributor 
shall not exceed $1,000,000. 
‘‘(3) USE OF FUNDS.—Funds collected by the 
Secretary as a result of the imposition of a civil 
money penalty under this subsection shall be used to 
carry out this section. 
‘‘(c) PROCEDURES FOR SUBMISSION OF INFORMA-
TION AND PUBLIC AVAILABILITY.— 
‘‘(1) IN GENERAL.— 
‘‘(A) ESTABLISHMENT.—Not later than 
June 1, 2011, the Secretary shall establish pro-
cedures— 
‘‘(i) for applicable manufacturers, ap-
plicable group purchasing organizations, 
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and applicable distributors to submit infor-
mation to the Secretary under subsection 
(a); and 
‘‘(ii) for the Secretary to make such 
information submitted available to the pub-
lic. 
‘‘(B) DEFINITION OF TERMS.—The proce-
dures established under subparagraph (A) shall 
provide for the definition of terms (other than 
those terms defined in subsection (g)), as ap-
propriate, for purposes of this section. 
‘‘(C) PUBLIC
AVAILABILITY.—The proce-
dures established under subparagraph (A)(ii) 
shall ensure that, not later than September 30, 
2012, and on June 30 of each succeeding cal-
endar year, the information submitted under 
subsection (a) with respect to the preceding cal-
endar year is made available through an Inter-
net website that— 
‘‘(i) is searchable and is in a format 
that is clear and understandable; 
‘‘(ii) contains information that is pre-
sented by the name of the applicable man-
ufacturer, applicable group purchasing or-
ganization, or applicable distributor, the 
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name of the covered recipient, the business 
address of the covered recipient, the spe-
cialty of the covered recipient, the value of 
the payment or other transfer of value, the 
date on which the payment or other trans-
fer of value was provided to the covered re-
cipient, the form of the payment or other 
transfer of value, indicated (as appro-
priate) 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 en-
forcement 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 sub-
mitted with respect to a payment or other 
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transfer of value described in subsection 
(e), lists such information separately from 
the other information submitted under 
subsection (a) and designates such sepa-
rately listed information as funding for 
clinical research; 
‘‘(vii) contains any other information 
the Secretary determines would be helpful 
to the average consumer; and 
‘‘(viii) provides the covered recipient 
an opportunity to submit corrections to the 
information made available to the public 
with respect to the covered recipient. 
‘‘(2) CONSULTATION.—In establishing the pro-
cedures under paragraph (1), the Secretary shall 
consult with the Inspector General of the Depart-
ment of Health and Human Services, affected indus-
try, consumers, consumer advocates, and other inter-
ested parties in order to ensure that the information 
made available to the public under such paragraph 
is presented in the appropriate overall context. 
‘‘(d) ANNUAL REPORTS AND RELATION TO STATE 
LAWS.— 
‘‘(1) ANNUAL
REPORT
TO
CONGRESS.—Not 
later than April 1 of each year beginning with 2012, 
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the Secretary shall submit to Congress a report that 
includes the following: 
‘‘(A) The information submitted under 
subsection (a) during the preceding year, aggre-
gated for each applicable manufacturer and ap-
plicable group purchasing organization that 
submitted such information during such year. 
‘‘(B) A description of any enforcement ac-
tions taken to carry out this section, including 
any penalties imposed under subsection (b), 
during the preceding year. 
‘‘(2) ANNUAL REPORTS TO STATES.—Not later 
than April 1 of each year beginning with 2012, the 
Secretary shall submit to States a report that in-
cludes a summary of the information submitted 
under subsection (a) during the preceding year with 
respect to covered recipients in the State. 
‘‘(3) RELATION TO STATE LAWS.— 
‘‘(A) IN GENERAL.—Effective on January 
1, 2010, subject to subparagraph (B), the pro-
visions of this section shall preempt any law or 
regulation of a State or of a political subdivi-
sion of a State that requires an applicable man-
ufacturer (as defined in subsection (g)) to dis-
close or report information in the categories (as 
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described in subsection (a)) and the exclusions 
in (g)(11)(B) regarding a payment or other 
transfer of value provided by the applicable 
manufacturer to a covered recipient (as so de-
scribed), including such laws or regulations that 
impose different schedules or frequency of re-
porting (including the timing of reporting of 
payments made pursuant to product develop-
ment agreements and clinical investigations as 
provided 
under 
subsection 
(e)), 
threshold 
amounts for reporting of such payments or 
transfers of value, reporting formats, or defini-
tions of covered recipients. 
‘‘(B) NO PREEMPTION OF ADDITIONAL RE-
QUIREMENTS.—Subparagraph (A) shall not 
preempt any law or regulation of a State or of 
a political subdivision of a State that requires 
the disclosure or reporting of information not 
required to be disclosed or reported under this 
section to the extent such information is not 
specifically excluded from the reporting require-
ments under subsection (g)(11)(B). 
‘‘(e) DELAYED REPORTING FOR PAYMENTS MADE 
PURSUANT TO PRODUCT RESEARCH AND DEVELOPMENT 
AGREEMENTS, CLINICAL INVESTIGATIONS, AND PRE-DE-
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VELOPMENT RESEARCH.—In the case of a payment or 
other transfer of value made to a covered recipient by an 
applicable manufacturer pursuant to a product research 
and development agreement for services furnished in con-
nection with research of a potential new medical tech-
nology or application, the development of a new drug, de-
vice, biological, or medical supply, or by an applicable 
manufacturer in connection with a clinical investigation, 
the applicable manufacturer may report the value of such 
payment or other transfer of value in the first reporting 
period under subsection (a) after the earlier of the fol-
lowing: 
‘‘(1) The date of the approval or clearance of 
the covered drug, device, biological, or medical sup-
ply by the Food and Drug Administration. 
‘‘(2) Four calendar years after the date such 
payment or other transfer of value was made. 
‘‘(f) IMPLEMENTATION.—The Secretary shall consult 
with the Inspector General of the Department of Health 
and Human Services on the implementation of this sec-
tion. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE
DISTRIBUTOR.—The term 
‘applicable distributor’ means an entity, other than 
an applicable group purchasing organization, that 
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buys and resells, or receives a commission or other 
similar form of payment, from another seller, for 
selling or arranging for the sale of a covered drug, 
device, biological, or medical supply. 
‘‘(2) APPLICABLE GROUP PURCHASING ORGANI-
ZATION.—The term ‘applicable group purchasing or-
ganization’ means a group purchasing organization 
(as defined by the Secretary) that purchases, ar-
ranges for, or negotiates the purchase of a covered 
drug, device, biological, or medical supply. 
‘‘(3) APPLICABLE MANUFACTURER.—The term 
‘applicable manufacturer’ means a manufacturer of 
a covered drug, device, biological, or medical supply. 
‘‘(4) CLINICAL
INVESTIGATION.—The term 
‘clinical investigation’ means any experiment involv-
ing 1 or more human subjects, or materials derived 
from human subjects, in which a drug or device is 
administered, dispensed, or used. 
‘‘(5) COVERED DEVICE.—The term ‘covered de-
vice’ means any device for which payment is avail-
able under title XVIII or a State plan under title 
XIX or XXI (or a waiver of such a plan). 
‘‘(6) COVERED DRUG, DEVICE, BIOLOGICAL, OR 
MEDICAL SUPPLY.—The term ‘covered drug, device, 
biological, or medical supply’ means any drug, bio-
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logical product, device, or medical supply for which 
payment is available under title XVIII or a State 
plan under title XIX or XXI (or a waiver of such 
a plan). 
‘‘(7) COVERED RECIPIENT.—The term ‘covered 
recipient’ means the following: 
‘‘(A) A physician. 
‘‘(B) A physician medical practice. 
‘‘(C) A physician group practice. 
‘‘(8) EMPLOYEE.—The term ‘employee’ has the 
meaning given such term in section 1877(h)(2). 
‘‘(9) KNOWINGLY.—The term ‘knowingly’ has 
the meaning given such term in section 3729(b) of 
title 31, United States Code. 
‘‘(10) MANUFACTURER OF A COVERED DRUG, 
DEVICE, BIOLOGICAL, OR
MEDICAL
SUPPLY.—The 
term ‘manufacturer of a covered drug, device, bio-
logical, or medical supply’ means any entity which is 
engaged in the production, preparation, propagation, 
compounding, conversion, processing, marketing, or 
distribution of a covered drug, device, biological, or 
medical supply (or any subsidiary of or entity under 
common ownership with such entity). 
‘‘(11) PAYMENT
OR
OTHER
TRANSFER
OF 
VALUE.— 
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‘‘(A) IN GENERAL.—The term ‘payment or 
other transfer of value’ means a transfer of 
anything of value that exceeds $25 and in-
cludes, subject to subparagraph (B), without 
limitation, any compensation, gift, honorarium, 
speaking fee, consulting fee, travel, services, 
dividend, profit distribution, stock or stock op-
tion grant, or ownership or investment interest. 
‘‘(B) EXCLUSIONS.—An applicable manu-
facturer shall not be required to submit infor-
mation under subsection (a) with respect to the 
following: 
‘‘(i) Product samples that are not in-
tended to be sold and are intended for pa-
tient use. 
‘‘(ii) Educational materials that di-
rectly benefit patients or are intended for 
patient use. 
‘‘(iii) 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. 
‘‘(iv) Items or services provided under 
a contractual warranty, including the re-
placement of a covered device, where the 
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terms of the warranty are set forth in the 
purchase or lease agreement for the cov-
ered device. 
‘‘(v) A transfer of anything of value to 
a covered recipient when the covered re-
cipient is a patient and not acting in the 
professional capacity of a covered recipient. 
‘‘(vi) Discounts (including rebates). 
‘‘(vii) In-kind items used for the pro-
vision of charity care. 
‘‘(viii) A dividend or other profit dis-
tribution from, or ownership or investment 
interest in, a publicly traded security and 
mutual fund (as described in section 
1877(c)). 
‘‘(ix) Payments made to a covered re-
cipient by an applicable manufacturer or 
by a health plan affiliated with an applica-
ble manufacturer for medical care provided 
to employees of such manufacturer and 
their dependents. 
‘‘(12) PHYSICIAN.—The term ‘physician’ has 
the meaning given that term in section 1861(r). For 
purposes of this section, such term does not include 
a physician who is an employee of the applicable 
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manufacturer that is required to submit information 
under subsection (a).’’. 
Æ 
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