630 
‘‘(H) Public and private purchasers of 
health care items and services. 
‘‘(I) Labor organizations. 
‘‘(J) Relevant departments or agencies of 
the United States. 
‘‘(K) Biopharmaceutical companies and 
manufacturers of medical devices. 
‘‘(L) Licensing, credentialing, and accred-
iting bodies. 
‘‘(7) FUNDING.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
provide for the transfer, from the Federal Hos-
pital Insurance Trust Fund under section 1817 
and the Federal Supplementary Medical Insur-
ance Trust Fund under section 1841 (in such 
proportion as the Secretary determines appro-
priate), of $1,000,000, to the Secretary for pur-
poses of carrying out this subsection for each of 
the fiscal years 2010 through 2014. 
‘‘(B) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—For purposes of carrying out the provi-
sions of this subsection, in addition to funds 
otherwise available, out of any funds in the 
Treasury not otherwise appropriated, there are 
appropriated to the Secretary of Health and 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00630
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
631 
Human Services $1,000,000 for each of the fis-
cal years 2010 through 2014.’’. 
SEC. 1444. APPLICATION OF QUALITY MEASURES. 
(a) 
INPATIENT
HOSPITAL
SERVICES.—Section 
1886(b)(3)(B) of such Act (42 U.S.C. 1395ww(b)(3)(B)) 
is amended by adding at the end the following new clause: 
‘‘(x)(I) Subject to subclause (II), for purposes of re-
porting data on quality measures for inpatient hospital 
services furnished during fiscal year 2012 and each subse-
quent fiscal year, the quality measures specified under 
clause (viii) shall be measures selected by the Secretary 
from measures that have been endorsed by the entity with 
a contract with the Secretary under section 1890(a). 
‘‘(II) In the case of a specified area or medical topic 
determined appropriate by the Secretary for which a fea-
sible and practical quality measure has not been endorsed 
by the entity with a contract under section 1890(a), the 
Secretary may specify a measure that is not so endorsed 
as long as due consideration is given to measures that 
have been endorsed or adopted by a consensus organiza-
tion identified by the Secretary. The Secretary shall sub-
mit such a non-endorsed measure to the entity for consid-
eration for endorsement. If the entity considers but does 
not endorse such a measure and if the Secretary does not 
phase-out use of such measure, the Secretary shall include 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00631
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
632 
the rationale for continued use of such a measure in rule-
making.’’. 
(b) OUTPATIENT
HOSPITAL
SERVICES.—Section 
1833(t)(17) of such Act (42 U.S.C. 1395l(t)(17)) is 
amended by adding at the end the following new subpara-
graph: 
‘‘(F) USE OF ENDORSED QUALITY MEAS-
URES.—The provisions of clause (x) of section 
1886(b)(3)(C) shall apply to quality measures 
for covered OPD services under this paragraph 
in the same manner as such provisions apply to 
quality measures for inpatient hospital serv-
ices.’’. 
(c) 
PHYSICIANS’ 
SERVICES.—Section 
1848(k)(2)(C)(ii) of such Act (42 U.S.C. 1395w– 
4(k)(2)(C)(ii)) is amended by adding at the end the fol-
lowing: ‘‘The Secretary shall submit such a non-endorsed 
measure to the entity for consideration for endorsement. 
If the entity considers but does not endorse such a meas-
ure and if the Secretary does not phase-out use of such 
measure, the Secretary shall include the rationale for con-
tinued use of such a measure in rulemaking.’’. 
(d) 
RENAL
DIALYSIS
SERVICES.—Section 
1881(h)(2)(B)(ii) 
of 
such 
Act 
(42 
U.S.C. 
1395rr(h)(2)(B)(ii)) is amended by adding at the end the 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00632
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
633 
following: ‘‘The Secretary shall submit such a non-en-
dorsed measure to the entity for consideration for endorse-
ment. If the entity considers but does not endorse such 
a measure and if the Secretary does not phase-out use 
of such measure, the Secretary shall include the rationale 
for continued use of such a measure in rulemaking.’’. 
(e) 
ENDORSEMENT
OF
STANDARDS.—Section 
1890(b)(2) of the Social Security Act (42 U.S.C. 
1395aaa(b)(2)) is amended by adding after and below sub-
paragraph (B) the following: 
‘‘ ‘If the entity does not endorse a measure, such en-
tity shall explain the reasons and provide sugges-
tions about changes to such measure that might 
make it a potentially endorsable measure.’ ’’. 
(f) EFFECTIVE DATE.—Except as otherwise pro-
vided, the amendments made by this section shall apply 
to quality measures applied for payment years beginning 
with 2012 or fiscal year 2012, as the case may be. 
SEC. 1445. CONSENSUS-BASED ENTITY FUNDING. 
Section 1890(d) of the Social Security Act (42 U.S.C. 
1395aaa(d)) is amended by striking ‘‘for each of fiscal 
years 2009 through 2012’’ and inserting ‘‘for fiscal year 
2009, and $12,000,000 for each of the fiscal years 2010 
through 2012.’’ 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00633
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
634 
Subtitle D—Physician Payments 
Sunshine Provision 
SEC. 1451. REPORTS ON FINANCIAL RELATIONSHIPS BE-
TWEEN 
MANUFACTURERS 
AND 
DISTRIBU-
TORS 
OF 
COVERED 
DRUGS, 
DEVICES, 
BIOLOGICALS, 
OR 
MEDICAL 
SUPPLIES 
UNDER MEDICARE, MEDICAID, OR CHIP AND 
PHYSICIANS AND OTHER HEALTH CARE ENTI-
TIES AND BETWEEN PHYSICIANS AND OTHER 
HEALTH CARE ENTITIES. 
(a) IN GENERAL.—Part A of title XI of the Social 
Security Act (42 U.S.C. 1301 et seq.), as amended by sec-
tion 1631(a), is further amended by inserting after section 
1128G the following new section: 
‘‘SEC. 1128H. FINANCIAL REPORTS ON PHYSICIANS’ FINAN-
CIAL RELATIONSHIPS WITH MANUFACTUR-
ERS 
AND 
DISTRIBUTORS 
OF 
COVERED 
DRUGS, DEVICES, BIOLOGICALS, OR MEDICAL 
SUPPLIES UNDER MEDICARE, MEDICAID, OR 
CHIP AND WITH ENTITIES THAT BILL FOR 
SERVICES UNDER MEDICARE. 
‘‘(a) REPORTING OF PAYMENTS OR OTHER TRANS-
FERS OF VALUE.— 
‘‘(1) IN GENERAL.—Except as provided in this 
subsection, not later than March 31, 2011, and an-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00634
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
635 
nually thereafter, each applicable manufacturer or 
distributor that provides a payment or other transfer 
of value to a covered recipient, or to an entity or in-
dividual 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 pre-
ceding calendar year: 
‘‘(A) With respect to the covered recipient, 
the recipient’s name, business address, physi-
cian specialty, and national provider identifier. 
‘‘(B) With respect to the payment or other 
transfer of value, other than a drug sample— 
‘‘(i) its value and date; 
‘‘(ii) the name of the related drug, de-
vice, or supply, if available; and 
‘‘(iii) a description of its form, indi-
cated (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, divi-
dend, profit, or other return on invest-
ment; or 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00635
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
638 
investigation regarding a new drug, device, biologi-
cal, or medical supply, the applicable manufacturer 
or distributor may report as required under this sec-
tion in the next reporting period under this sub-
section after the earlier of the following: 
‘‘(A) The date that the clinical investiga-
tion is registered on the website maintained by 
the National Institutes of Health pursuant to 
section 671 of the Food and Drug Administra-
tion Amendments Act of 2007. 
‘‘(B) Two calendar years after the date 
such payment or other transfer of value was 
made. 
‘‘(6) 
CONFIDENTIALITY.—Information 
de-
scribed in paragraph (4) or (5) 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 
or after the date on which the information is made 
available to the public under such paragraph. 
‘‘(b) REPORTING OF OWNERSHIP INTEREST BY PHY-
SICIANS IN HOSPITALS AND OTHER ENTITIES THAT BILL 
MEDICARE.—Not later than March 31 of each year (be-
ginning with 2011), each hospital or other health care en-
tity (not including a Medicare Advantage organization) 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00638
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
639 
that bills the Secretary under part A or part B of title 
XVIII for services shall report on the ownership shares 
(other than ownership shares described in section 1877(c)) 
of each physician who, directly or indirectly, owns an in-
terest in the entity. In this subsection, the term ‘physician’ 
includes a physician’s immediate family members (as de-
fined for purposes of section 1877(a)). 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish procedures to ensure that, not later than Sep-
tember 30, 2011, and on June 30 of each year be-
ginning thereafter, the information submitted under 
subsections (a) and (b), other than information re-
gard drug samples, with respect to the preceding 
calendar year is made available through an Internet 
website that— 
‘‘(A) is searchable and is in a format that 
is clear and understandable; 
‘‘(B) contains information that is pre-
sented by the name of the applicable manufac-
turer or distributor, the name of the covered re-
cipient, the business address of the covered re-
cipient, the specialty (if applicable) of the cov-
ered recipient, the value of the payment or 
other transfer of value, the date on which the 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00639
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
640 
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 
appropriate) under subsection (a)(1)(B)(ii), the 
nature of the payment or other transfer of 
value, indicated (as appropriate) under sub-
section (a)(1)(B)(iii), and the name of the cov-
ered drug, device, biological, or medical supply, 
as applicable; 
‘‘(C) contains information that is able to 
be easily aggregated and downloaded; 
‘‘(D) contains a description of any enforce-
ment actions taken to carry out this section, in-
cluding any penalties imposed under subsection 
(d), during the preceding year; 
‘‘(E) contains background information on 
industry-physician relationships; 
‘‘(F) in the case of information submitted 
with respect to a payment or other transfer of 
value described in subsection (a)(5), lists such 
information separately from the other informa-
tion submitted under subsection (a) and des-
ignates such separately listed information as 
funding for clinical research; 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00640
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
641 
‘‘(G) contains any other information the 
Secretary determines would be helpful to the 
average consumer; and 
‘‘(H) provides the covered recipient an op-
portunity to submit corrections to the informa-
tion made available to the public with respect to 
the covered recipient. 
‘‘(2) ACCURACY OF REPORTING.—The accuracy 
of the information that is submitted under sub-
sections (a) and (b) and made available under para-
graph (1) shall be the responsibility of the applicable 
manufacturer or distributor of a covered drug, de-
vice, biological, or medical supply reporting under 
subsection (a) or hospital or other health care entity 
reporting physician ownership under subsection (b). 
The Secretary shall establish procedures to ensure 
that the covered recipient is provided with an oppor-
tunity to submit corrections to the manufacturer, 
distributor, hospital, or other entity reporting under 
subsection (a) or (b) with regard to information 
made public with respect to the covered recipient 
and, under such procedures, the corrections shall be 
transmitted to the Secretary. 
‘‘(3) SPECIAL RULE FOR DRUG SAMPLES.—In-
formation relating to drug samples provided under 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00641
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
642 
subsection (a) shall not be made available to the 
public by the Secretary but may be made available 
outside the Department of Health and Human Serv-
ices by the Secretary for research or legitimate busi-
ness purposes pursuant to data use agreements. 
‘‘(4) SPECIAL RULE FOR NATIONAL PROVIDER 
IDENTIFIERS.—Information relating to national pro-
vider identifiers provided under subsection (a) shall 
not be made available to the public by the Secretary 
but may be made available outside the Department 
of Health and Human Services by the Secretary for 
research or legitimate business purposes pursuant to 
data use agreements. 
‘‘(d) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), except as provided in paragraph (2), 
any applicable manufacturer or distributor that 
fails to submit information required under sub-
section (a) in a timely manner in accordance 
with regulations promulgated to carry out such 
subsection, and any hospital or other entity that 
fails to submit information required under sub-
section (b) in a timely manner in accordance 
with regulations promulgated to carry out such 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00642
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
643 
subsection shall be subject to a civil money pen-
alty 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 penalties imposed under subpara-
graph (A) with respect to each annual submis-
sion of information under subsection (a) by an 
applicable manufacturer or distributor or other 
entity shall not exceed $150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), any applicable manufacturer or dis-
tributor that knowingly fails to submit informa-
tion required under subsection (a) in a timely 
manner in accordance with regulations promul-
gated to carry out such subsection and any hos-
pital or other entity that fails to submit infor-
mation required under subsection (b) in a time-
ly manner in accordance with regulations pro-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00643
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
644 
mulgated 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 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) or (b) 
by an applicable manufacturer, distributor, or 
entity shall not exceed $1,000,000, or, if great-
er, 0.1 percentage of the total annual revenues 
of the manufacturer, distributor, or entity. 
‘‘(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. 
‘‘(4) ENFORCEMENT THROUGH STATE ATTOR-
NEYS GENERAL.—The attorney general of a State, 
after providing notice to the Secretary of an intent 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00644
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
645 
to proceed under this paragraph in a specific case 
and providing the Secretary with an opportunity to 
bring an action under this subsection and the Sec-
retary declining such opportunity, may proceed 
under this subsection against a manufacturer or dis-
tributor in the State. 
‘‘(e) ANNUAL REPORT
TO CONGRESS.—Not later 
than April 1 of each year beginning with 2011, the Sec-
retary shall submit to Congress a report that includes the 
following: 
‘‘(1) The information submitted under this sec-
tion during the preceding year, aggregated for each 
applicable manufacturer or distributor of a covered 
drug, device, biological, or medical supply that sub-
mitted such information during such year. 
‘‘(2) A description of any enforcement actions 
taken to carry out this section, including any pen-
alties imposed under subsection (d), during the pre-
ceding year. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE
MANUFACTURER; APPLICA-
BLE DISTRIBUTOR.—The term ‘applicable manufac-
turer’ means a manufacturer of a covered drug, de-
vice, biological, or medical supply, and the term ‘ap-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00645
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
646 
plicable distributor’ means a distributor of a covered 
drug, device, or medical supply. 
‘‘(2) CLINICAL
INVESTIGATION.—The term 
‘clinical investigation’ means any experiment involv-
ing one or more human subjects, or materials de-
rived from human subjects, in which a drug or de-
vice is administered, dispensed, or used. 
‘‘(3) COVERED DRUG, DEVICE, BIOLOGICAL, OR 
MEDICAL SUPPLY.—The term ‘covered’ means, with 
respect to a drug, device, biological, or medical sup-
ply, such a drug, device, biological, 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). 
‘‘(4) COVERED RECIPIENT.—The term ‘covered 
recipient’ means the following: 
‘‘(A) A physician. 
‘‘(B) A physician group practice. 
‘‘(C) Any other prescriber of a covered 
drug, device, biological, or medical supply. 
‘‘(D) A pharmacy or pharmacist. 
‘‘(E) A health insurance issuer, group 
health plan, or other entity offering a health 
benefits plan, including any employee of such 
an issuer, plan, or entity. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00646
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
647 
‘‘(F) A pharmacy benefit manager, includ-
ing any employee of such a manager. 
‘‘(G) A hospital. 
‘‘(H) A medical school. 
‘‘(I) A sponsor of a continuing medical 
education program. 
‘‘(J) A patient advocacy or disease specific 
group. 
‘‘(K) A organization of health care profes-
sionals. 
‘‘(L) A biomedical researcher. 
‘‘(M) A group purchasing organization. 
‘‘(5) DISTRIBUTOR OF A COVERED DRUG, DE-
VICE, OR MEDICAL SUPPLY.—The term ‘distributor 
of a covered drug, device, or medical supply’ means 
any entity which is engaged in the marketing or dis-
tribution of a covered drug, device, or medical sup-
ply (or any subsidiary of or entity affiliated with 
such entity), but does not include a wholesale phar-
maceutical distributor. 
‘‘(6) EMPLOYEE.—The term ‘employee’ has the 
meaning given such term in section 1877(h)(2). 
‘‘(7) KNOWINGLY.—The term ‘knowingly’ has 
the meaning given such term in section 3729(b) of 
title 31, United States Code. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00647
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
648 
‘‘(8) 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 affili-
ated with such entity). 
‘‘(9) PAYMENT
OR
OTHER
TRANSFER
OF 
VALUE.— 
‘‘(A) IN GENERAL.—The term ‘payment or 
other transfer of value’ means a transfer of 
anything of value for or of any of the following: 
‘‘(i) Gift, food, or entertainment. 
‘‘(ii) Travel or trip. 
‘‘(iii) Honoraria. 
‘‘(iv) Research funding or grant. 
‘‘(v) Education or conference funding. 
‘‘(vi) Consulting fees. 
‘‘(vii) Ownership or investment inter-
est and royalties or license fee. 
‘‘(B) INCLUSIONS.—Subject to subpara-
graph (C), the term ‘payment or other transfer 
of value’ includes any compensation, gift, hono-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00648
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
649 
rarium, speaking fee, consulting fee, travel, 
services, dividend, profit distribution, stock or 
stock option grant, or any ownership or invest-
ment interest held by a physician in a manufac-
turer (excluding a dividend or other profit dis-
tribution from, or ownership or investment in-
terest in, a publicly traded security or mutual 
fund (as described in section 1877(c))). 
‘‘(C) EXCLUSIONS.—The term ‘payment or 
other transfer of value’ does not include the fol-
lowing: 
‘‘(i) Any payment or other transfer of 
value provided by an applicable manufac-
turer or distributor to a covered recipient 
where the amount transferred to, requested 
by, or designated on behalf of the covered 
recipient does not exceed $5. 
‘‘(ii) 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. 
‘‘(iii) Items or services provided under 
a contractual warranty, including the re-
placement of a covered device, where the 
terms of the warranty are set forth in the 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00649
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
650 
purchase or lease agreement for the cov-
ered device. 
‘‘(iv) 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. 
‘‘(v) In-kind items used for the provi-
sion of charity care. 
‘‘(vi) 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)). 
‘‘(vii) Compensation paid by a manu-
facturer or distributor of a covered drug, 
device, biological, or medical supply to a 
covered recipient who is directly employed 
by and works solely for such manufacturer 
or distributor. 
‘‘(viii) Any discount or cash rebate. 
‘‘(10) 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 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00650
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
651 
manufacturer that is required to submit information 
under subsection (a). 
‘‘(g) ANNUAL REPORTS TO STATES.—Not later than 
April 1 of each year beginning with 2011, the Secretary 
shall submit to States a report that includes a summary 
of the information submitted under subsections (a) and 
(d) during the preceding year with respect to covered re-
cipients or other hospitals and entities in the State. 
‘‘(h) RELATION TO STATE LAWS.— 
‘‘(1) IN
GENERAL.—Effective on January 1, 
2011, subject to paragraph (2), the provisions of 
this section shall preempt any law or regulation of 
a State or of a political subdivision of a State that 
requires an applicable manufacturer and applicable 
distributor (as such terms are defined in subsection 
(f)) to disclose or report, in any format, the type of 
information (described in subsection (a)) regarding a 
payment or other transfer of value provided by the 
manufacturer to a covered recipient (as so defined). 
‘‘(2) NO
PREEMPTION
OF
ADDITIONAL
RE-
QUIREMENTS.—Paragraph (1) shall not preempt any 
law or regulation of a State or of a political subdivi-
sion of a State that requires any of the following: 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00651
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
652 
‘‘(A) The disclosure or reporting of infor-
mation not of the type required to be disclosed 
or reported under this section. 
‘‘(B) The disclosure or reporting, in any 
format, of the type of information required to 
be disclosed or reported under this section to a 
Federal, State, or local governmental agency for 
public health surveillance, investigation, or 
other public health purposes or health oversight 
purposes. 
‘‘(C) The discovery or admissibility of in-
formation described in this section in a crimi-
nal, civil, or administrative proceeding.’’. 
(b) AVAILABILITY OF INFORMATION FROM THE DIS-
CLOSURE
OF
FINANCIAL
RELATIONSHIP
REPORT 
(DFRR).—The Secretary of Health and Human Services 
shall submit to Congress a report on the full results of 
the Disclosure of Physician Financial Relationships sur-
veys required pursuant to section 5006 of the Deficit Re-
duction Act of 2005. Such report shall be submitted to 
Congress not later than the date that is 6 months after 
the date such surveys are collected and shall be made pub-
licly available on an Internet website of the Department 
of Health and Human Services. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00652
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
653 
Subtitle E—Public Reporting on 
Health Care-Associated Infections 
SEC. 1461. REQUIREMENT FOR PUBLIC REPORTING BY 
HOSPITALS 
AND 
AMBULATORY 
SURGICAL 
CENTERS ON HEALTH CARE-ASSOCIATED IN-
FECTIONS. 
(a) IN GENERAL.—Title XI of the Social Security Act 
is amended by inserting after section 1138 the following 
section: 
‘‘SEC. 1138A. REQUIREMENT FOR PUBLIC REPORTING BY 
HOSPITALS 
AND 
AMBULATORY 
SURGICAL 
CENTERS ON HEALTH CARE-ASSOCIATED IN-
FECTIONS. 
‘‘(a) REPORTING REQUIREMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
that a hospital (as defined in subsection (g)) or am-
bulatory surgical center meeting the requirements of 
titles XVIII or XIX may participate in the programs 
established under such titles (pursuant to the appli-
cable 
provisions 
of 
law, 
including 
sections 
1866(a)(1) and 1832(a)(1)(F)(i)) only if, in accord-
ance with this section, the hospital or center reports 
such information on health care-associated infections 
that develop in the hospital or center (and such de-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00653
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
654 
mographic information associated with such infec-
tions) as the Secretary specifies. 
‘‘(2) REPORTING PROTOCOLS.—Such informa-
tion shall be reported in accordance with reporting 
protocols established by the Secretary through the 
Director of the Centers for Disease Control and Pre-
vention (in this section referred to as the ‘CDC’) 
and to the National Healthcare Safety Network of 
the CDC or under such another reporting system of 
such Centers as determined appropriate by the Sec-
retary in consultation with such Director. 
‘‘(3) COORDINATION
WITH
HIT.—The Sec-
retary, through the Director of the CDC and the Of-
fice of the National Coordinator for Health Informa-
tion Technology, shall ensure that the transmission 
of information under this subsection is coordinated 
with systems established under the HITECH Act, 
where appropriate. 
‘‘(4) PROCEDURES TO ENSURE THE VALIDITY 
OF
INFORMATION.—The Secretary shall establish 
procedures regarding the validity of the information 
submitted under this subsection in order to ensure 
that such information is appropriately compared 
across hospitals and centers. Such procedures shall 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00654
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
655 
address failures to report as well as errors in report-
ing. 
‘‘(5) IMPLEMENTATION.—Not later than 1 year 
after the date of enactment of this section, the Sec-
retary, through the Director of CDC, shall promul-
gate regulations to carry out this section. 
‘‘(b) PUBLIC POSTING OF INFORMATION.—The Sec-
retary shall promptly post, on the official public Internet 
site of the Department of Health and Human Services, 
the information reported under subsection (a). Such infor-
mation shall be set forth in a manner that allows for the 
comparison of information on health care-associated infec-
tions— 
‘‘(1) among hospitals and ambulatory surgical 
centers; and 
‘‘(2) by demographic information. 
‘‘(c) ANNUAL REPORT TO CONGRESS.—On an annual 
basis the Secretary shall submit to the Congress a report 
that summarizes each of the following: 
‘‘(1) The number and types of health care-asso-
ciated infections reported under subsection (a) in 
hospitals and ambulatory surgical centers during 
such year. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00655
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
656 
‘‘(2) Factors that contribute to the occurrence 
of such infections, including health care worker im-
munization rates. 
‘‘(3) Based on the most recent information 
available to the Secretary on the composition of the 
professional staff of hospitals and ambulatory sur-
gical centers, the number of certified infection con-
trol professionals on the staff of hospitals and ambu-
latory surgical centers. 
‘‘(4) The total increases or decreases in health 
care costs that resulted from increases or decreases 
in the rates of occurrence of each such type of infec-
tion during such year. 
‘‘(5) Recommendations, in coordination with the 
Center for Quality Improvement established under 
section 931 of the Public Health Service Act, for 
best practices to eliminate the rates of occurrence of 
each such type of infection in hospitals and ambula-
tory surgical centers. 
‘‘(d) NON-PREEMPTION OF STATE LAWS.—Nothing 
in this section shall be construed as preempting or other-
wise affecting any provision of State law relating to the 
disclosure of information on health care-associated infec-
tions or patient safety procedures for a hospital or ambu-
latory surgical center. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00656
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
657 
‘‘(e) HEALTH CARE-ASSOCIATED INFECTION.—For 
purposes of this section: 
‘‘(1) IN GENERAL.—The term ‘health care-asso-
ciated infection’ means an infection that develops in 
a patient who has received care in any institutional 
setting where health care is delivered and is related 
to receiving health care. 
‘‘(2) RELATED TO RECEIVING HEALTH CARE.— 
The term ‘related to receiving health care’, with re-
spect to an infection, means that the infection was 
not incubating or present at the time health care 
was provided. 
‘‘(f) APPLICATION
TO
CRITICAL
ACCESS
HOS-
PITALS.—For purposes of this section, the term ‘hospital’ 
includes a critical access hospital, as defined in section 
1861(mm)(1).’’. 
(b) EFFECTIVE DATE.—With respect to section 
1138A of the Social Security Act (as inserted by sub-
section (a) of this section), the requirement under such 
section that hospitals and ambulatory surgical centers 
submit reports takes effect on such date (not later than 
2 years after the date of the enactment of this Act) as 
the Secretary of Health and Human Services shall specify. 
In order to meet such deadline, the Secretary may imple-
ment such section through guidance or other instructions. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00657
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
658 
(c) GAO REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
General of the United States shall submit to Congress a 
report on the program established under section 1138A 
of the Social Security Act, as inserted by subsection (a). 
Such report shall include an analysis of the appropriate-
ness of the types of information required for submission, 
compliance with reporting requirements, the success of the 
validity procedures established, and any conflict or overlap 
between the reporting required under such section and any 
other reporting systems mandated by either the States or 
the Federal Government. 
(d) REPORT ON ADDITIONAL DATA.—Not later than 
18 months after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall submit 
to the Congress a report on the appropriateness of expand-
ing the requirements under such section to include addi-
tional information (such as health care worker immuniza-
tion rates), in order to improve health care quality and 
patient safety. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00658
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
659 
TITLE V—MEDICARE GRADUATE 
MEDICAL EDUCATION 
SEC. 1501. DISTRIBUTION OF UNUSED RESIDENCY POSI-
TIONS. 
(a) IN GENERAL.—Section 1886(h) of the Social Se-
curity Act (42 U.S.C. 1395ww(h)) is amended— 
(1) in paragraph (4)(F)(i), by striking ‘‘para-
graph (7)’’ and inserting ‘‘paragraphs (7) and (8)’’; 
(2) in paragraph (4)(H)(i), by striking ‘‘para-
graph (7)’’ and inserting ‘‘paragraphs (7) and (8)’’; 
(3) in paragraph (7)(E), by inserting ‘‘and 
paragraph (8)’’ after ‘‘this paragraph’’; and 
(4) by adding at the end the following new 
paragraph: 
‘‘(8) ADDITIONAL REDISTRIBUTION OF UNUSED 
RESIDENCY POSITIONS.— 
‘‘(A) REDUCTIONS IN LIMIT BASED ON UN-
USED POSITIONS.— 
‘‘(i) PROGRAMS SUBJECT TO REDUC-
TION.—If a hospital’s reference resident 
level (specified in clause (ii)) is less than 
the otherwise applicable resident limit (as 
defined in subparagraph (C)(ii)), effective 
for portions of cost reporting periods oc-
curring on or after July 1, 2011, the oth-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00659
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
660 
erwise applicable resident limit shall be re-
duced by 90 percent of the difference be-
tween such otherwise applicable resident 
limit and such reference resident level. 
‘‘(ii) REFERENCE RESIDENT LEVEL.— 
‘‘(I) IN
GENERAL.—Except as 
otherwise provided in a subsequent 
subclause, the reference resident level 
specified in this clause for a hospital 
is the highest resident level for any of 
the 3 most recent cost reporting peri-
ods (ending before the date of the en-
actment of this paragraph) of the hos-
pital for which a cost report has been 
settled (or, if not, submitted (subject 
to audit)), as determined by the Sec-
retary. 
‘‘(II) USE OF MOST RECENT AC-
COUNTING PERIOD TO RECOGNIZE EX-
PANSION OF EXISTING PROGRAMS.—If 
a hospital submits a timely request to 
increase its resident level due to an 
expansion, or planned expansion, of 
an existing residency training pro-
gram that is not reflected on the most 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00660
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
661 
recent settled or submitted cost re-
port, after audit and subject to the 
discretion of the Secretary, subject to 
subclause (IV), the reference resident 
level for such hospital is the resident 
level that includes the additional resi-
dents attributable to such expansion 
or establishment, as determined by 
the Secretary. The Secretary is au-
thorized to determine an alternative 
reference resident level for a hospital 
that submitted to the Secretary a 
timely request, before the start of the 
2009–2010 academic year, for an in-
crease in its reference resident level 
due to a planned expansion. 
‘‘(III) 
SPECIAL
PROVIDER 
AGREEMENT.—In the case of a hos-
pital 
described 
in 
paragraph 
(4)(H)(v), the reference resident level 
specified in this clause is the limita-
tion applicable under subclause (I) of 
such paragraph. 
‘‘(IV) 
PREVIOUS
REDISTRIBU-
TION.—The reference resident level 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00661
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
662 
specified in this clause for a hospital 
shall be increased to the extent re-
quired to take into account an in-
crease in resident positions made 
available to the hospital under para-
graph (7)(B) that are not otherwise 
taken into account under a previous 
subclause. 
‘‘(iii) AFFILIATION.—The provisions 
of clause (i) shall be applied to hospitals 
which are members of the same affiliated 
group (as defined by the Secretary under 
paragraph (4)(H)(ii)) and to the extent the 
hospitals can demonstrate that they are 
filling any additional
resident slots allo-
cated to other hospitals through an affili-
ation agreement, the Secretary shall adjust 
the determination of available slots accord-
ingly, or which the Secretary otherwise has 
permitted the resident positions (under 
section 402 of the Social Security Amend-
ments of 1967) to be aggregated for pur-
poses of applying the resident position lim-
itations under this subsection. 
‘‘(B) REDISTRIBUTION.— 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00662
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
663 
‘‘(i) IN
GENERAL.—The Secretary 
shall increase the otherwise applicable resi-
dent limit for each qualifying hospital that 
submits an application under this subpara-
graph by such number as the Secretary 
may approve for portions of cost reporting 
periods occurring on or after July 1, 2011. 
The estimated aggregate number of in-
creases in the otherwise applicable resident 
limit under this subparagraph may not ex-
ceed the Secretary’s estimate of the aggre-
gate reduction in such limits attributable 
to subparagraph (A). 
‘‘(ii) REQUIREMENTS
FOR
QUALI-
FYING
HOSPITALS.—A hospital is not a 
qualifying hospital for purposes of this 
paragraph unless the following require-
ments are met: 
‘‘(I) MAINTENANCE OF PRIMARY 
CARE
RESIDENT
LEVEL.—The hos-
pital maintains the number of primary 
care residents at a level that is not 
less than the base level of primary 
care residents increased by the num-
ber of additional primary care resi-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00663
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
664 
dent positions provided to the hospital 
under this subparagraph. For pur-
poses of this subparagraph, the ‘base 
level of primary care residents’ for a 
hospital is the level of such residents 
as of a base period (specified by the 
Secretary), determined without regard 
to whether such positions were in ex-
cess of the otherwise applicable resi-
dent limit for such period but taking 
into account the application of sub-
clauses (II) and (III) of subparagraph 
(A)(ii). 
‘‘(II) DEDICATED
ASSIGNMENT 
OF ADDITIONAL RESIDENT POSITIONS 
TO PRIMARY CARE.—The hospital as-
signs all such additional resident posi-
tions for primary care residents. 
‘‘(III) 
ACCREDITATION.—The 
hospital’s residency programs in pri-
mary care are fully accredited or, in 
the case of a residency training pro-
gram not in operation as of the base 
year, the hospital is actively applying 
for such accreditation for the program 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00664
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
665 
for such additional resident positions 
(as determined by the Secretary). 
‘‘(iii) CONSIDERATIONS
IN
REDIS-
TRIBUTION.—In determining for which 
qualifying hospitals the increase in the oth-
erwise applicable resident limit is provided 
under this subparagraph, the Secretary 
shall take into account the demonstrated 
likelihood of the hospital filling the posi-
tions within the first 3 cost reporting peri-
ods beginning on or after July 1, 2011, 
made available under this subparagraph, 
as determined by the Secretary. 
‘‘(iv) PRIORITY
FOR
CERTAIN
HOS-
PITALS.—In determining for which quali-
fying hospitals the increase in the other-
wise applicable resident limit is provided 
under this subparagraph, the Secretary 
shall distribute the increase to qualifying 
hospitals based on the following criteria: 
‘‘(I) The Secretary shall give 
preference to hospitals that had a re-
duction in resident training positions 
under subparagraph (A). 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00665
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
666 
‘‘(II) The Secretary shall give 
preference to hospitals with 3-year 
primary care residency training pro-
grams, such as family practice and 
general internal medicine. 
‘‘(III) The Secretary shall give 
preference to hospitals insofar as they 
have in effect formal arrangements 
(as determined by the Secretary) that 
place greater emphasis upon training 
in Federally qualified health centers, 
rural health clinics, and other nonpro-
vider settings, and to hospitals that 
receive additional payments under 
subsection (d)(5)(F) and emphasize 
training in an outpatient department. 
‘‘(IV) The Secretary shall give 
preference to hospitals with a number 
of positions (as of July 1, 2009) in 
excess of the otherwise applicable resi-
dent limit for such period. 
‘‘(V) The Secretary shall give 
preference to hospitals that place 
greater emphasis upon training in a 
health professional shortage area (des-
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00666
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS
667 
ignated under section 332 of the Pub-
lic Health Service Act) or a health 
professional needs area (designated 
under section 2211 of such Act). 
‘‘(VI) The Secretary shall give 
preference to hospitals in States that 
have low resident-to-population ratios 
(including a greater preference for 
those States with lower resident-to- 
population ratios). 
‘‘(v) LIMITATION.—In no case shall 
more than 20 full-time equivalent addi-
tional residency positions be made available 
under this subparagraph with respect to 
any hospital. 
‘‘(vi) APPLICATION OF PER RESIDENT 
AMOUNTS FOR PRIMARY CARE.—With re-
spect to additional residency positions in a 
hospital attributable to the increase pro-
vided under this subparagraph, the ap-
proved FTE resident amounts are deemed 
to be equal to the hospital per resident 
amounts for primary care and nonprimary 
care computed under paragraph (2)(D) for 
that hospital. 
VerDate Nov 24 2008 
00:36 Jul 15, 2009
Jkt 079200
PO 00000
Frm 00667
Fmt 6652
Sfmt 6201
E:\BILLS\H3200.IH
H3200
jlentini on DSKJ8SOYB1PROD with BILLS