H. R. 3590—562 
and accompanied by such information as the Administrator may 
require, including a description of partnerships, or other arrange-
ments with local primary care providers, including community 
health centers, to provide services to special populations. 
‘‘(d) USE OF FUNDS.— 
‘‘(1) IN GENERAL.—For the benefit of special populations, 
an eligible entity shall use funds awarded under this section 
for— 
‘‘(A) the provision, by qualified primary care profes-
sionals, of on site primary care services; 
‘‘(B) reasonable costs associated with medically nec-
essary referrals to qualified specialty care professionals, 
other coordinators of care or, if permitted by the terms 
of the grant or cooperative agreement, by qualified specialty 
care professionals on a reasonable cost basis on site at 
the eligible entity; 
‘‘(C) information technology required to accommodate 
the clinical needs of primary and specialty care profes-
sionals; or 
‘‘(D) facility modifications needed to bring primary and 
specialty care professionals on site at the eligible entity. 
‘‘(2) LIMITATION.—Not to exceed 15 percent of grant or 
cooperative agreement funds may be used for activities 
described in subparagraphs (C) and (D) of paragraph (1). 
‘‘(e) EVALUATION.—Not later than 90 days after a grant or 
cooperative agreement awarded under this section expires, an 
eligible entity shall submit to the Secretary the results of an evalua-
tion to be conducted by the entity concerning the effectiveness 
of the activities carried out under the grant or agreement. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 
to be appropriated to carry out this section, $50,000,000 for fiscal 
year 2010 and such sums as may be necessary for each of fiscal 
years 2011 through 2014.’’. 
SEC. 5605. KEY NATIONAL INDICATORS. 
(a) DEFINITIONS.—In this section: 
(1) ACADEMY.—The term ‘‘Academy’’ means the National 
Academy of Sciences. 
(2) COMMISSION.—The term ‘‘Commission’’ means the 
Commission on Key National Indicators established under sub-
section (b). 
(3) INSTITUTE.—The term ‘‘Institute’’ means a Key National 
Indicators Institute as designated under subsection (c)(3). 
(b) COMMISSION ON KEY NATIONAL INDICATORS.— 
(1) ESTABLISHMENT.—There is established a ‘‘Commission 
on Key National Indicators’’. 
(2) MEMBERSHIP.— 
(A) NUMBER
AND
APPOINTMENT.—The Commission 
shall be composed of 8 members, to be appointed equally 
by the majority and minority leaders of the Senate and 
the Speaker and minority leader of the House of Represent-
atives. 
(B) PROHIBITED
APPOINTMENTS.—Members of the 
Commission shall not include Members of Congress or other 
elected Federal, State, or local government officials. 
(C) QUALIFICATIONS.—In making appointments under 
subparagraph (A), the majority and minority leaders of
H. R. 3590—563 
the Senate and the Speaker and minority leader of the 
House of Representatives shall appoint individuals who 
have shown a dedication to improving civic dialogue and 
decision-making through the wide use of scientific evidence 
and factual information. 
(D) PERIOD
OF
APPOINTMENT.—Each member of the 
Commission shall be appointed for a 2-year term, except 
that 1 initial appointment shall be for 3 years. Any vacan-
cies shall not affect the power and duties of the Commission 
but shall be filled in the same manner as the original 
appointment and shall last only for the remainder of that 
term. 
(E) DATE.—Members of the Commission shall be 
appointed by not later than 30 days after the date of 
enactment of this Act. 
(F) INITIAL ORGANIZING PERIOD.—–Not later than 60 
days after the date of enactment of this Act, the Commis-
sion shall develop and implement a schedule for completion 
of the review and reports required under subsection (d). 
(G) CO-CHAIRPERSONS.—The Commission shall select 
2 Co-Chairpersons from among its members. 
(c) DUTIES OF THE COMMISSION.— 
(1) IN GENERAL.—The Commission shall— 
(A) conduct comprehensive oversight of a newly estab-
lished key national indicators system consistent with the 
purpose described in this subsection; 
(B) make recommendations on how to improve the 
key national indicators system; 
(C) coordinate with Federal Government users and 
information providers to assure access to relevant and 
quality data; and 
(D) enter into contracts with the Academy. 
(2) REPORTS.— 
(A) ANNUAL REPORT TO CONGRESS.—Not later than 1 
year after the selection of the 2 Co-Chairpersons of the 
Commission, and each subsequent year thereafter, the 
Commission shall prepare and submit to the appropriate 
Committees of Congress and the President a report that 
contains a detailed statement of the recommendations, 
findings, and conclusions of the Commission on the activi-
ties of the Academy and a designated Institute related 
to the establishment of a Key National Indicator System. 
(B) ANNUAL REPORT TO THE ACADEMY.— 
(i) IN GENERAL.—Not later than 6 months after 
the selection of the 2 Co-Chairpersons of the Commis-
sion, and each subsequent year thereafter, the Commis-
sion shall prepare and submit to the Academy and 
a designated Institute a report making recommenda-
tions concerning potential issue areas and key indica-
tors to be included in the Key National Indicators. 
(ii) LIMITATION.—The Commission shall not have 
the authority to direct the Academy or, if established, 
the Institute, to adopt, modify, or delete any key indica-
tors. 
(3) CONTRACT WITH THE NATIONAL ACADEMY OF SCIENCES.— 
(A) IN GENERAL.—–As soon as practicable after the 
selection of the 2 Co-Chairpersons of the Commission, the
H. R. 3590—564 
Co-Chairpersons shall enter into an arrangement with the 
National Academy of Sciences under which the Academy 
shall— 
(i) review available public and private sector 
research on the selection of a set of key national indica-
tors; 
(ii) determine how best to establish a key national 
indicator system for the United States, by either cre-
ating its own institutional capability or designating 
an independent private nonprofit organization as an 
Institute to implement a key national indicator system; 
(iii) if the Academy designates an independent 
Institute under clause (ii), provide scientific and tech-
nical advice to the Institute and create an appropriate 
governance mechanism that balances Academy involve-
ment and the independence of the Institute; and 
(iv) provide an annual report to the Commission 
addressing scientific and technical issues related to 
the key national indicator system and, if established, 
the Institute, and governance of the Institute’s budget 
and operations. 
(B) PARTICIPATION.—In executing the arrangement 
under subparagraph (A), the National Academy of Sciences 
shall convene a multi-sector, multi-disciplinary process to 
define major scientific and technical issues associated with 
developing, maintaining, and evolving a Key National Indi-
cator System and, if an Institute is established, to provide 
it with scientific and technical advice. 
(C) ESTABLISHMENT
OF
A
KEY
NATIONAL
INDICATOR 
SYSTEM.— 
(i) IN
GENERAL.—In executing the arrangement 
under subparagraph (A), the National Academy of 
Sciences shall enable the establishment of a key 
national indicator system by— 
(I) creating its own institutional capability; 
or 
(II) partnering with an independent private 
nonprofit organization as an Institute to imple-
ment a key national indicator system. 
(ii) INSTITUTE.—If the Academy designates an 
Institute under clause (i)(II), such Institute shall be 
a non-profit entity (as defined for purposes of section 
501(c)(3) of the Internal Revenue Code of 1986) with 
an educational mission, a governance structure that 
emphasizes independence, and characteristics that 
make such entity appropriate for establishing a key 
national indicator system. 
(iii) RESPONSIBILITIES.—Either the Academy or the 
Institute designated under clause (i)(II) shall be 
responsible for the following: 
(I) Identifying and selecting issue areas to be 
represented by the key national indicators. 
(II) Identifying and selecting the measures 
used for key national indicators within the issue 
areas under subclause (I).
H. R. 3590—565 
(III) Identifying and selecting data to populate 
the key national indicators described under sub-
clause (II). 
(IV) Designing, publishing, and maintaining 
a public website that contains a freely accessible 
database allowing public access to the key national 
indicators. 
(V) Developing a quality assurance framework 
to ensure rigorous and independent processes and 
the selection of quality data. 
(VI) Developing a budget for the construction 
and management of a sustainable, adaptable, and 
evolving key national indicator system that reflects 
all Commission funding of Academy and, if an 
Institute is established, Institute activities. 
(VII) Reporting annually to the Commission 
regarding its selection of issue areas, key indica-
tors, data, and progress toward establishing a web- 
accessible database. 
(VIII) Responding directly to the Commission 
in response to any Commission recommendations 
and to the Academy regarding any inquiries by 
the Academy. 
(iv) GOVERNANCE.—Upon the establishment of a 
key national indicator system, the Academy shall 
create an appropriate governance mechanism that 
incorporates advisory and control functions. If an 
Institute is designated under clause (i)(II), the govern-
ance mechanism shall balance appropriate Academy 
involvement and the independence of the Institute. 
(v) MODIFICATION
AND
CHANGES.—The Academy 
shall retain the sole discretion, at any time, to alter 
its approach to the establishment of a key national 
indicator system or, if an Institute is designated under 
clause (i)(II), to alter any aspect of its relationship 
with the Institute or to designate a different non- 
profit entity to serve as the Institute. 
(vi) CONSTRUCTION.—Nothing in this section shall 
be construed to limit the ability of the Academy or 
the Institute designated under clause (i)(II) to receive 
private funding for activities related to the establish-
ment of a key national indicator system. 
(D) ANNUAL
REPORT.—As part of the arrangement 
under subparagraph (A), the National Academy of Sciences 
shall, not later than 270 days after the date of enactment 
of this Act, and annually thereafter, submit to the Co- 
Chairpersons of the Commission a report that contains 
the findings and recommendations of the Academy. 
(d) 
GOVERNMENT
ACCOUNTABILITY
OFFICE
STUDY
AND 
REPORT.— 
(1) GAO STUDY.—The Comptroller General of the United 
States shall conduct a study of previous work conducted by 
all public agencies, private organizations, or foreign countries 
with respect to best practices for a key national indicator 
system. The study shall be submitted to the appropriate author-
izing committees of Congress.
H. R. 3590—566 
(2) GAO FINANCIAL AUDIT.—If an Institute is established 
under this section, the Comptroller General shall conduct an 
annual audit of the financial statements of the Institute, in 
accordance with generally accepted government auditing stand-
ards and submit a report on such audit to the Commission 
and the appropriate authorizing committees of Congress. 
(3) GAO PROGRAMMATIC REVIEW.—The Comptroller General 
of the United States shall conduct programmatic assessments 
of the Institute established under this section as determined 
necessary by the Comptroller General and report the findings 
to the Commission and to the appropriate authorizing commit-
tees of Congress. 
(e) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN GENERAL.—–There are authorized to be appropriated 
to carry out the purposes of this section, $10,000,000 for fiscal 
year 2010, and $7,500,000 for each of fiscal year 2011 through 
2018. 
(2) AVAILABILITY.—–Amounts appropriated under para-
graph (1) shall remain available until expended. 
Subtitle H—General Provisions 
SEC. 5701. REPORTS. 
(a) REPORTS BY SECRETARY OF HEALTH AND HUMAN SERVICES.— 
On an annual basis, the Secretary of Health and Human Services 
shall submit to the appropriate Committees of Congress a report 
on the activities carried out under the amendments made by this 
title, and the effectiveness of such activities. 
(b) REPORTS BY RECIPIENTS OF FUNDS.—The Secretary of Health 
and Human Services may require, as a condition of receiving funds 
under the amendments made by this title, that the entity receiving 
such award submit to such Secretary such reports as the such 
Secretary may require on activities carried out with such award, 
and the effectiveness of such activities. 
TITLE VI—TRANSPARENCY AND 
PROGRAM INTEGRITY 
Subtitle A—Physician Ownership and 
Other Transparency 
SEC. 6001. LIMITATION ON MEDICARE EXCEPTION TO THE PROHIBI-
TION ON CERTAIN PHYSICIAN REFERRALS FOR HOS-
PITALS. 
(a) IN GENERAL.—Section 1877 of the Social Security Act (42 
U.S.C. 1395nn) is amended— 
(1) in subsection (d)(2)— 
(A) in subparagraph (A), by striking ‘‘and’’ at the end; 
(B) in subparagraph (B), by striking the period at 
the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new subpara-
graph: 
‘‘(C) in the case where the entity is a hospital, the 
hospital meets the requirements of paragraph (3)(D).’’;
H. R. 3590—570 
rooms, and beds’ means the number of operating rooms, 
procedure rooms, and beds for which the applicable 
hospital is licensed as of the date of enactment of 
this subsection. 
‘‘(D) INCREASE
LIMITED
TO
FACILITIES
ON
THE
MAIN 
CAMPUS OF THE HOSPITAL.—Any increase in the number 
of operating rooms, procedure rooms, and beds for which 
an applicable hospital is licensed pursuant to this para-
graph may only occur in facilities on the main campus 
of the applicable hospital. 
‘‘(E) APPLICABLE
HOSPITAL.—In this paragraph, the 
term ‘applicable hospital’ means a hospital— 
‘‘(i) that is located in a county in which the percent-
age 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; 
‘‘(ii) whose annual percent of total inpatient admis-
sions that represent inpatient admissions under the 
program under title 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; 
‘‘(iii) that does not discriminate against bene-
ficiaries of Federal health care programs and does 
not permit physicians practicing at the hospital to 
discriminate against such beneficiaries; 
‘‘(iv) that is located in a State in which the average 
bed capacity in the State is less than the national 
average bed capacity; and 
‘‘(v) 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) PROCEDURE ROOMS.—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 per-
formed). 
‘‘(G) PUBLICATION OF FINAL DECISIONS.—Not later than 
60 days after receiving a complete application under this 
paragraph, the Secretary shall publish in the Federal Reg-
ister the final decision with respect to such application. 
‘‘(H) LIMITATION
ON
REVIEW.—There shall be no 
administrative or judicial review under section 1869, sec-
tion 1878, or otherwise of the process under this paragraph 
(including the establishment of such process). 
‘‘(4) COLLECTION OF OWNERSHIP AND INVESTMENT INFORMA-
TION.—For purposes of subparagraphs (A)(i) and (D)(i) of para-
graph (1), the Secretary shall collect physician ownership and 
investment information for each hospital. 
‘‘(5) PHYSICIAN
OWNER
OR
INVESTOR
DEFINED.—For pur-
poses of this subsection, the term ‘physician owner or investor’ 
means a physician (or an immediate family member of such
H. R. 3590—571 
physician) with a direct or an indirect ownership or investment 
interest in the hospital. 
‘‘(6) CLARIFICATION.—Nothing in this subsection shall be 
construed as preventing the Secretary from revoking a hos-
pital’s provider agreement if not in compliance with regulations 
implementing section 1866.’’. 
(b) ENFORCEMENT.— 
(1) ENSURING COMPLIANCE.—The Secretary of Health and 
Human Services shall establish policies and procedures to 
ensure compliance with the requirements described in sub-
section (i)(1) of section 1877 of the Social Security Act, as 
added by subsection (a)(3), beginning on the date such require-
ments first apply. Such policies and procedures may include 
unannounced site reviews of hospitals. 
(2) AUDITS.—Beginning not later than November 1, 2011, 
the Secretary of Health and Human Services shall conduct 
audits to determine if hospitals violate the requirements 
referred to in paragraph (1). 
SEC. 6002. TRANSPARENCY REPORTS AND REPORTING OF PHYSICIAN 
OWNERSHIP OR INVESTMENT INTERESTS. 
Part A of title XI of the Social Security Act (42 U.S.C. 1301 
et seq.) is amended by inserting after section 1128F the following 
new section: 
‘‘SEC. 1128G. TRANSPARENCY REPORTS AND REPORTING OF PHYSI-
CIAN 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 cal-
endar 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 physi-
cian, 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 owner-
ship 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).
H. R. 3590—572 
‘‘(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 con-
sulting; 
‘‘(III) honoraria; 
‘‘(IV) gift; 
‘‘(V) entertainment; 
‘‘(VI) food; 
‘‘(VII) travel (including the specified destina-
tions); 
‘‘(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 fac-
ulty or as a speaker for a medical education pro-
gram; 
‘‘(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.—In the case where an applicable 
manufacturer provides a payment or other transfer of value 
to an entity or individual at the request of or designated 
on behalf of a covered recipient, the applicable manufac-
turer shall disclose that payment or other transfer of value 
under the name of the covered recipient. 
‘‘(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 owner-
ship or investment interest (other than an ownership or invest-
ment interest in a publicly traded security and mutual fund, 
as described in section 1877(c)) held by a physician (or an 
immediate family member of such physician (as defined for 
purposes of section 1877(a))) in the applicable manufacturer 
or applicable group purchasing organization during the pre-
ceding 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.
H. R. 3590—573 
‘‘(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 informa-
tion 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 appro-
priate. 
‘‘(b) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) FAILURE TO REPORT.— 
‘‘(A) IN GENERAL.—Subject to subparagraph (B) except 
as provided in paragraph (2), any applicable manufacturer 
or applicable group purchasing organization that fails to 
submit information required under subsection (a) in a 
timely manner in accordance with rules or regulations 
promulgated to carry out such subsection, shall be subject 
to a civil money penalty of not less than $1,000, but not 
more than $10,000, for each 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 pen-
alties imposed under subparagraph (A) with respect to 
each annual submission of information under subsection 
(a) by an applicable manufacturer or applicable group pur-
chasing organization shall not exceed $150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN GENERAL.—Subject to subparagraph (B), any 
applicable manufacturer or applicable group purchasing 
organization that knowingly fails to submit information 
required under subsection (a) in a timely manner in accord-
ance with rules or regulations promulgated to carry out 
such subsection, 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 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 sub-
section (a) of section 1128A are imposed and collected under 
that section. 
‘‘(B) LIMITATION.—The total amount of civil money pen-
alties imposed under subparagraph (A) with respect to 
each annual submission of information under subsection 
(a) by an applicable manufacturer or applicable group pur-
chasing organization 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 INFORMATION AND PUBLIC 
AVAILABILITY.— 
‘‘(1) IN GENERAL.—
H. R. 3590—574 
‘‘(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.—The procedures estab-
lished under subparagraph (A) shall provide for the defini-
tion of terms (other than those terms defined in subsection 
(e)), as appropriate, for purposes of this section. 
‘‘(C) PUBLIC
AVAILABILITY.—Except as provided in 
subparagraph (E), the procedures established under 
subparagraph (A)(ii) shall ensure that, not later than Sep-
tember 30, 2013, and on June 30 of each calendar year 
beginning thereafter, the information submitted under sub-
section (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 pay-
ment 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 appro-
priate) 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 pre-
ceding 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) 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 sub-
mitted with respect to the applicable manufacturer,
H. R. 3590—575 
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.—In no case may the 45-day period for review 
and submission of corrections to information under 
subparagraph (C)(ix) prevent such information from being 
made available to the public in accordance with the dates 
described in the matter preceding clause (i) in subpara-
graph (C). 
‘‘(E) DELAYED PUBLICATION FOR PAYMENTS MADE PURSU-
ANT TO PRODUCT RESEARCH OR DEVELOPMENT AGREEMENTS 
AND CLINICAL INVESTIGATIONS.— 
‘‘(i) IN GENERAL.—In the case of information sub-
mitted 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 fur-
nished 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 investiga-
tion 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.—Information described in clause (i) shall 
be considered confidential and shall not be subject 
to disclosure under section 552 of title 5, United States 
Code, or any other similar Federal, State, or local 
law, until on or after the date on which the information 
is made available to the public under such clause. 
‘‘(2) CONSULTATION.—In establishing the procedures under 
paragraph (1), the Secretary shall consult with the Inspector 
General of the Department of Health and Human Services, 
affected industry, consumers, consumer advocates, and other 
interested 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 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 organiza-
tion that submitted such information during such year
H. R. 3590—576 
(except, in the case of information submitted with respect 
to a payment or other transfer of value described in sub-
section (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.—Not later than Sep-
tember 30, 2013 and on June 30 of each calendar year there-
after, the Secretary shall submit to States a report that includes 
a summary of the information submitted under subsection (a) 
during the preceding year with respect to covered recipients 
in the State (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 States after the date on which 
such information is made available to the public under such 
subsection). 
‘‘(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 sub-
section (e)) on or after January 1, 2012, subject to subpara-
graph (B), the provisions of this section shall preempt 
any statute or regulation of a State or of a political subdivi-
sion 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 regula-
tion 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 pur-
poses. 
‘‘(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.—The Secretary shall consult with the 
Inspector General of the Department of Health and Human 
Services on the implementation of this section. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE GROUP PURCHASING ORGANIZATION.—The 
term ‘applicable group purchasing organization’ means a group
H. R. 3590—577 
purchasing organization (as defined by the Secretary) that pur-
chases, arranges for, or negotiates the purchase of a covered 
drug, device, biological, or medical supply which is operating 
in the United States, or in a territory, possession, or common-
wealth of the United States. 
‘‘(2) APPLICABLE
MANUFACTURER.—The term ‘applicable 
manufacturer’ means a manufacturer of a covered drug, device, 
biological, or medical supply which is operating in the United 
States, or in a territory, possession, or commonwealth of the 
United States. 
‘‘(3) CLINICAL INVESTIGATION.—The term ‘clinical investiga-
tion’ means any experiment involving 1 or more human sub-
jects, or materials derived from human subjects, in which a 
drug or device is administered, dispensed, or used. 
‘‘(4) COVERED DEVICE.—The term ‘covered device’ means 
any device for which payment is available under title XVIII 
or a State plan under title XIX or XXI (or a waiver of such 
a plan). 
‘‘(5) COVERED
DRUG, DEVICE, BIOLOGICAL, OR
MEDICAL 
SUPPLY.—The term ‘covered drug, device, biological, or medical 
supply’ means any drug, biological 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). 
‘‘(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. 
‘‘(B) EXCLUSION.—Such term does not include a physi-
cian who is an employee of the applicable manufacturer 
that is required to submit information under subsection 
(a). 
‘‘(7) EMPLOYEE.—The term ‘employee’ has the meaning 
given such term in section 1877(h)(2). 
‘‘(8) KNOWINGLY.—The term ‘knowingly’ has the meaning 
given such term in section 3729(b) of title 31, United States 
Code. 
‘‘(9) 
MANUFACTURER
OF
A
COVERED
DRUG, 
DEVICE, 
BIOLOGICAL, OR MEDICAL SUPPLY.—The term ‘manufacturer of 
a covered drug, device, biological, or medical supply’ means 
any entity which is engaged in the production, preparation, 
propagation, compounding, or conversion of a covered drug, 
device, biological, or medical supply (or any entity under 
common ownership with such entity which provides assistance 
or support to such entity with respect to the production, 
preparation, propagation, compounding, conversion, marketing, 
promotion, sale, or distribution of a covered drug, device, 
biological, or medical supply). 
‘‘(10) PAYMENT OR OTHER TRANSFER OF VALUE.— 
‘‘(A) IN GENERAL.—The term ‘payment or other transfer 
of value’ means a transfer of anything of value. Such term 
does not include a transfer of anything of value that is 
made indirectly to a covered recipient through a third 
party in connection with an activity or service in the case 
where the applicable manufacturer is unaware of the 
identity of the covered recipient.
H. R. 3590—578 
‘‘(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 pre-
vious 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 sec-
tion 1877(c)). 
‘‘(x) In the case of an applicable manufacturer 
who offers a self-insured plan, payments for the provi-
sion 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 any-
thing of value to the covered recipient if the transfer 
is payment solely for the non-medical professional serv-
ices 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 pro-
ceeding. 
‘‘(11) PHYSICIAN.—The term ‘physician’ has the meaning 
given that term in section 1861(r).’’.