2029 
clude the rationale for continued 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 following: ‘‘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 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 subparagraph (B) the following: 
‘‘If the entity does not endorse a measure, 
such entity shall explain the reasons and 
provide suggestions about changes to 
such measure that might make it a poten-
tially endorsable measure.’’. 
(f) EFFECTIVE DATE.—Except as otherwise 
provided, the amendments made by this sec-
tion shall apply to quality measures applied 
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for payment years beginning with 2012 or fis-
cal 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’’ 
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 section 1631(a), is further amend-
ed by inserting after section 1128G the fol-
lowing new section: 
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‘‘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 
TRANSFERS OF VALUE.— 
‘‘(1) IN GENERAL.—Except as provided 
in this subsection, not later than March 
31, 2011 and annually thereafter, each ap-
plicable manufacturer or distributor that 
provides a payment or other transfer of 
value to a covered recipient, or to an en-
tity or individual at the request of or des-
ignated on behalf of a covered recipient, 
shall submit to the Secretary, in such 
electronic form as the Secretary shall re-
quire, the following information with re-
spect to the preceding calendar year: 
‘‘(A) With respect to the covered 
recipient, the recipient’s name, busi-
ness address, physician specialty, and 
national provider identifier. 
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‘‘(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, device, or supply, if avail-
able; and 
‘‘(iii) a description of its form, 
indicated (as appropriate for all 
that apply) as— 
‘‘(I) cash or a cash equiva-
lent; 
‘‘(II) in-kind items or serv-
ices; 
‘‘(III) stock, a stock option, 
or any other ownership inter-
est, dividend, profit, or other 
return on investment; or 
‘‘(IV) any other form (as 
defined by the Secretary). 
‘‘(C) With respect to a drug sam-
ple, the name, number, date, and dos-
age units of the sample. 
‘‘(2) AGGREGATE REPORTING.—Informa-
tion submitted by an applicable manufac-
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turer or distributor under paragraph (1) 
shall include the aggregate amount of all 
payments or other transfers of value pro-
vided by the manufacturer or distributor 
to covered recipients (and to entities or 
individuals at the request of or des-
ignated on behalf of a covered recipient) 
during the year involved, including all 
payments and transfers of value regard-
less of whether such payments or trans-
fer of value were individually disclosed. 
‘‘(3) SPECIAL
RULE
FOR
CERTAIN
PAY-
MENTS OR OTHER TRANSFERS OF VALUE.—In 
the case where an applicable manufac-
turer or distributor 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 man-
ufacturer or distributor shall disclose 
that payment or other transfer of value 
under the name of the covered recipient. 
‘‘(4) DELAYED REPORTING FOR PAYMENTS 
MADE PURSUANT TO PRODUCT DEVELOPMENT 
AGREEMENTS.—In the case of a payment or 
other transfer of value made to a covered 
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recipient by an applicable manufacturer 
or distributor pursuant to a product de-
velopment agreement for services fur-
nished in connection with the develop-
ment of a new drug, device, biological, or 
medical supply, the applicable manufac-
turer or distributor may report the value 
and recipient of such payment or other 
transfer of value in the first reporting pe-
riod under this subsection in the next re-
porting deadline after the earlier of the 
following: 
‘‘(A) The date of the approval or 
clearance of the covered drug, device, 
biological, or medical supply by the 
Food and Drug Administration. 
‘‘(B) Two calendar years after the 
date such payment or other transfer 
of value was made. 
‘‘(5) DELAYED REPORTING FOR PAYMENTS 
MADE
PURSUANT
TO
CLINICAL
INVESTIGA-
TIONS.—In the case of a payment or other 
transfer of value made to a covered re-
cipient by an applicable manufacturer or 
distributor in connection with a clinical 
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investigation regarding a new drug, de-
vice, biological, or medical supply, the 
applicable manufacturer or distributor 
may report as required under this section 
in the next reporting period under this 
subsection after the earlier of the fol-
lowing: 
‘‘(A) The date that the clinical in-
vestigation 
is 
registered 
on 
the 
website maintained by the National 
Institutes of Health pursuant to sec-
tion 671 of the Food and Drug Admin-
istration Amendments Act of 2007. 
‘‘(B) Two calendar years after the 
date such payment or other transfer 
of value was made. 
‘‘(6) 
CONFIDENTIALITY.—Information 
described 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 informa-
tion is made available to the public under 
such paragraph. 
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‘‘(b) REPORTING OF OWNERSHIP INTEREST BY 
PHYSICIANS IN HOSPITALS AND OTHER ENTITIES 
THAT BILL MEDICARE.—Not later than March 
31 of each year (beginning with 2011), each 
hospital or other health care entity (not in-
cluding a Medicare Advantage organization) 
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 
interest in the entity. In this subsection, the 
term ‘physician’ includes a physician’s imme-
diate family members (as defined for purposes 
of section 1877(a)). 
‘‘(c) PUBLIC AVAILABILITY.— 
‘‘(1) IN GENERAL.—The Secretary shall 
establish procedures to ensure that, not 
later than September 30, 2011, and on 
June 30 of each year beginning there-
after, the information submitted under 
subsections (a) and (b), other than infor-
mation regard drug samples, with respect 
to the preceding calendar year is made 
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available through an Internet website 
that— 
‘‘(A) is searchable and is in a for-
mat that is clear and understandable; 
‘‘(B) contains information that is 
presented by the name of the applica-
ble manufacturer or distributor, the 
name of the covered recipient, the 
business address of the covered re-
cipient, the specialty (if applicable) of 
the covered recipient, the value of the 
payment or other transfer of value, 
the date on which the payment or 
other transfer of value was provided 
to the covered recipient, the form of 
the payment or other transfer of 
value, 
indicated 
(as 
appropriate) 
under subsection (a)(1)(B)(ii), the na-
ture of the payment or other transfer 
of value, indicated (as appropriate) 
under subsection (a)(1)(B)(iii), and 
the name of the covered drug, device, 
biological, or medical supply, as ap-
plicable; 
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‘‘(C) contains information that is 
able to be easily aggregated and 
downloaded; 
‘‘(D) contains a description of any 
enforcement actions taken to carry 
out this section, including any pen-
alties imposed under subsection (d), 
during the preceding year; 
‘‘(E) contains background infor-
mation on industry-physician rela-
tionships; 
‘‘(F) in the case of information 
submitted with respect to a payment 
or other transfer of value described 
in subsection (a)(5), lists such infor-
mation separately from the other in-
formation 
submitted 
under 
sub-
section (a) and designates such sepa-
rately listed information as funding 
for clinical research; 
‘‘(G) contains any other informa-
tion the Secretary determines would 
be helpful to the average consumer; 
and 
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‘‘(H) provides the covered recipi-
ent an opportunity to submit correc-
tions to the information made avail-
able to the public with respect to the 
covered recipient. 
‘‘(2) ACCURACY OF REPORTING.—The ac-
curacy of the information that is sub-
mitted under subsections (a) and (b) and 
made available under paragraph (1) shall 
be the responsibility of the applicable 
manufacturer or distributor of a covered 
drug, device, biological, or medical sup-
ply reporting under subsection (a) or hos-
pital or other health care entity report-
ing 
physician 
ownership 
under 
sub-
section (b). The Secretary shall establish 
procedures to ensure that the covered re-
cipient is provided with an opportunity 
to submit corrections to the manufac-
turer, distributor, hospital, or other enti-
ty 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. 
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‘‘(3) SPECIAL
RULE
FOR
DRUG
SAM-
PLES.—Information relating to drug sam-
ples 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 re-
search or legitimate business purposes 
pursuant to data use agreements. 
‘‘(4) SPECIAL RULE FOR NATIONAL PRO-
VIDER
IDENTIFIERS.—Information relating 
to national provider 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 Serv-
ices by the Secretary for research or le-
gitimate business purposes pursuant to 
data use agreements. 
‘‘(d) PENALTIES FOR NONCOMPLIANCE.— 
‘‘(1) FAILURE TO REPORT.— 
‘‘(A) IN GENERAL.—Subject to sub-
paragraph (B), except as provided in 
paragraph (2), any applicable manu-
facturer or distributor that fails to 
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submit information required under 
subsection (a) in a timely manner in 
accordance with regulations promul-
gated to carry out such subsection, 
and any hospital or other entity that 
fails to submit information required 
under subsection (b) in a timely man-
ner in accordance with regulations 
promulgated to carry out such sub-
section 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 sub-
section. Such penalty shall be im-
posed and collected in the same man-
ner as civil money penalties under 
subsection (a) of section 1128A are 
imposed and collected under that sec-
tion. 
‘‘(B) 
LIMITATION.—The 
total 
amount of civil money penalties im-
posed under subparagraph (A) with 
respect to each annual submission of 
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information under subsection (a) by 
an applicable manufacturer or dis-
tributor or other entity shall not ex-
ceed $150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN GENERAL.—Subject to sub-
paragraph (B), any applicable manu-
facturer or distributor that know-
ingly fails to submit information re-
quired under subsection (a) in a time-
ly manner in accordance with regula-
tions promulgated to carry out such 
subsection and any hospital or other 
entity that fails to submit information 
required under subsection (b) in a 
timely manner in accordance with 
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 in-
terest not reported as required under 
such subsection. Such penalty shall 
be imposed and collected in the same 
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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 im-
posed under subparagraph (A) with 
respect to each annual submission of 
information under subsection (a) or 
(b) by an applicable manufacturer, 
distributor, or entity shall not exceed 
$1,000,000, or, if greater, 0.1 percent-
age of the total annual revenues of 
the manufacturer, distributor, or en-
tity. 
‘‘(3) USE
OF
FUNDS.—Funds collected 
by the Secretary as a result of the imposi-
tion of a civil money penalty under this 
subsection shall be used to carry out this 
section. 
‘‘(4) ENFORCEMENT THROUGH STATE AT-
TORNEYS GENERAL.—The attorney general 
of a State, after providing notice to the 
Secretary of an intent to proceed under 
this paragraph in a specific case and pro-
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viding the Secretary with an opportunity 
to bring an action under this subsection 
and the Secretary declining such oppor-
tunity, may proceed under this sub-
section 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 Secretary shall submit to Congress 
a report that includes the following: 
‘‘(1) The information submitted under 
this section during the preceding year, 
aggregated for each applicable manufac-
turer or distributor of a covered drug, de-
vice, biological, or medical supply that 
submitted such information during such 
year. 
‘‘(2) A description of any enforcement 
actions taken to carry out this section, in-
cluding any penalties imposed under sub-
section (d), during the preceding year. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE MANUFACTURER; APPLI-
CABLE DISTRIBUTOR.—The term ‘applicable 
manufacturer’ means a manufacturer of a 
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covered drug, device, biological, or med-
ical supply, and the term ‘applicable dis-
tributor’ means a distributor of a covered 
drug, device, or medical supply. 
‘‘(2) 
CLINICAL
INVESTIGATION.—The 
term ‘clinical investigation’ means any 
experiment involving one or more human 
subjects, 
or 
materials 
derived 
from 
human subjects, in which a drug or de-
vice is administered, dispensed, or used. 
‘‘(3) COVERED
DRUG, DEVICE, BIOLOGI-
CAL, OR MEDICAL SUPPLY.—The term ‘cov-
ered’ means, with respect to a drug, de-
vice, biological, or medical supply, such a 
drug, device, biological, or medical sup-
ply 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. 
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‘‘(D) A pharmacy or pharmacist. 
‘‘(E) A health insurance issuer, 
group health plan, or other entity of-
fering a health benefits plan, includ-
ing any employee of such an issuer, 
plan, or entity. 
‘‘(F) A pharmacy benefit manager, 
including 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 
professionals. 
‘‘(L) A biomedical researcher. 
‘‘(M) A group purchasing organi-
zation. 
‘‘(5) DISTRIBUTOR OF A COVERED DRUG, 
DEVICE, OR
MEDICAL
SUPPLY.—The term 
‘distributor of a covered drug, device, or 
medical supply’ means any entity which 
is engaged in the marketing or distribu-
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tion of a covered drug, device, or medical 
supply (or any subsidiary of or entity af-
filiated with such entity), but does not in-
clude a wholesale pharmaceutical dis-
tributor. 
‘‘(6) EMPLOYEE.—The term ‘employee’ 
has the meaning given such term in sec-
tion 1877(h)(2). 
‘‘(7) KNOWINGLY.—The term ‘know-
ingly’ has the meaning given such term in 
section 3729(b) of title 31, United States 
Code. 
‘‘(8) MANUFACTURER
OF
A
COVERED 
DRUG, DEVICE, BIOLOGICAL, OR MEDICAL SUP-
PLY.—The term ‘manufacturer of a cov-
ered drug, device, biological, or medical 
supply’ means any entity which is en-
gaged 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 affiliated with such entity). 
‘‘(9) PAYMENT OR OTHER TRANSFER OF 
VALUE.— 
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‘‘(A) IN GENERAL.—The term ‘pay-
ment or other transfer of value’ 
means a transfer of anything of value 
for or of any of the following: 
‘‘(i) Gift, food, or entertain-
ment. 
‘‘(ii) Travel or trip. 
‘‘(iii) Honoraria. 
‘‘(iv) 
Research 
funding 
or 
grant. 
‘‘(v) Education or conference 
funding. 
‘‘(vi) Consulting fees. 
‘‘(vii) Ownership or invest-
ment interest and royalties or li-
cense fee. 
‘‘(B) INCLUSIONS.—Subject to sub-
paragraph (C), the term ‘payment or 
other transfer of value’ includes any 
compensation, 
gift, 
honorarium, 
speaking fee, consulting fee, travel, 
services, dividend, profit distribution, 
stock or stock option grant, or any 
ownership 
or 
investment 
interest 
held by a physician in a manufac-
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turer (excluding a dividend or other 
profit distribution from, or ownership 
or investment interest in, a publicly 
traded security or mutual fund (as 
described in section 1877(c))). 
‘‘(C) EXCLUSIONS.—The term ‘pay-
ment or other transfer of value’ does 
not include the following: 
‘‘(i) Any payment or other 
transfer of value provided by an 
applicable manufacturer or dis-
tributor 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 de-
vice 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 pro-
vided under a contractual war-
ranty, including the replacement 
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 covered device. 
‘‘(iv) 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. 
‘‘(v) In-kind items used for the 
provision of charity care. 
‘‘(vi) A dividend or other prof-
it distribution from, or ownership 
or investment interest in, a pub-
licly traded security and mutual 
fund (as described in section 
1877(c)). 
‘‘(vii) Compensation paid by a 
manufacturer or distributor of a 
covered drug, device, biological, 
or medical supply to a covered re-
cipient who is directly employed 
by and works solely for such man-
ufacturer or distributor. 
‘‘(viii) Any discount or cash 
rebate. 
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‘‘(10) PHYSICIAN.—The term ‘physician’ 
has the meaning given that term in sec-
tion 1861(r). For purposes of this section, 
such term does not include a physician 
who is an employee of the applicable 
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 re-
port that includes a summary of the informa-
tion submitted under subsections (a) and (d) 
during the preceding year with respect to 
covered recipients or other hospitals and en-
tities in the State. 
‘‘(h) RELATION TO STATE LAWS.— 
‘‘(1) IN GENERAL.—Effective on Janu-
ary 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 re-
quires an applicable manufacturer and 
applicable distributor (as such terms are 
defined in subsection (f)) to disclose or 
report, in any format, the type of infor-
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mation (described in subsection (a)) re-
garding 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 pre-
empt any law or regulation of a State or 
of a political subdivision of a State that 
requires any of the following: 
‘‘(A) The disclosure or reporting 
of information not of the type re-
quired to be disclosed or reported 
under this section. 
‘‘(B) The disclosure or reporting, 
in any format, of the type of informa-
tion required to be disclosed or re-
ported under this section to a Fed-
eral, State, or local governmental 
agency for public health surveillance, 
investigation, or other public health 
purposes or health oversight pur-
poses. 
‘‘(C) The discovery or admissi-
bility of information described in this 
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section in a criminal, civil, or admin-
istrative proceeding.’’. 
(b) AVAILABILITY OF INFORMATION FROM THE 
DISCLOSURE
OF FINANCIAL RELATIONSHIP RE-
PORT (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 surveys re-
quired pursuant to section 5006 of the Deficit 
Reduction 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 publicly avail-
able on an Internet website of the Department 
of Health and Human Services. 
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 Se-
curity Act is amended by inserting after sec-
tion 1138 the following section: 
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‘‘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 sub-
section (g)) or ambulatory surgical center 
meeting the requirements of titles XVIII 
or XIX may participate in the programs 
established under such titles (pursuant to 
the applicable provisions of law, includ-
ing 
sections 
1866(a)(1) 
and 
1832(a)(1)(F)(i)) only if, in accordance 
with this section, the hospital or center 
reports such information on health care- 
associated infections that develop in the 
hospital or center (and such demographic 
information associated with such infec-
tions) as the Secretary specifies. 
‘‘(2) REPORTING PROTOCOLS.—Such in-
formation shall be reported in accord-
ance 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 
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‘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 Office of the National Coordi-
nator for Health Information Technology, 
shall ensure that the transmission of in-
formation under this subsection is co-
ordinated with systems established under 
the HITECH Act, where appropriate. 
‘‘(4) PROCEDURES TO ENSURE THE VALID-
ITY OF INFORMATION.—The Secretary shall 
establish procedures regarding the valid-
ity of the information submitted under 
this subsection in order to ensure that 
such information is appropriately com-
pared across hospitals and centers. Such 
procedures shall address failures to re-
port as well as errors in reporting. 
‘‘(5) IMPLEMENTATION.—Not later than 
1 year after the date of enactment of this 
section, the Secretary, through the Direc-
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tor of CDC, shall promulgate regulations 
to carry out this section. 
‘‘(b) PUBLIC POSTING OF INFORMATION.—The 
Secretary shall promptly post, on the official 
public Internet site of the Department of 
Health and Human Services, the information 
reported under subsection (a). Such informa-
tion shall be set forth in a manner that allows 
for the comparison of information on health 
care-associated infections— 
‘‘(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-associated infections reported under 
subsection (a) in hospitals and ambula-
tory surgical centers during such year. 
‘‘(2) Factors that contribute to the oc-
currence of such infections, including 
health care worker immunization rates. 
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‘‘(3) Based on the most recent infor-
mation available to the Secretary on the 
composition of the professional staff of 
hospitals and ambulatory surgical cen-
ters, the number of certified infection 
control professionals on the staff of hos-
pitals and ambulatory surgical centers. 
‘‘(4) The total increases or decreases 
in health care costs that resulted from in-
creases or decreases in the rates of occur-
rence of each such type of infection dur-
ing such year. 
‘‘(5) Recommendations, in coordina-
tion with the Center for Quality Improve-
ment established under section 931 of the 
Public Health Service Act, for best prac-
tices to eliminate the rates of occurrence 
of each such type of infection in hospitals 
and ambulatory surgical centers. 
‘‘(d) NON-PREEMPTION
OF
STATE
LAWS.— 
Nothing in this section shall be construed as 
preempting or otherwise affecting any provi-
sion of State law relating to the disclosure of 
information on health care-associated infec-
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tions or patient safety procedures for a hos-
pital or ambulatory surgical center. 
‘‘(e) HEALTH CARE-ASSOCIATED INFECTION.— 
For purposes of this section: 
‘‘(1) IN
GENERAL.—The term ‘health 
care-associated infection’ means an infec-
tion that develops in a patient who has 
received care in any institutional setting 
where health care is delivered and is re-
lated to receiving health care. 
‘‘(2) RELATED
TO
RECEIVING
HEALTH 
CARE.—The term ‘related to receiving 
health care’, with respect to an infection, 
means that the infection was not incu-
bating 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 sec-
tion 1138A of the Social Security Act (as in-
serted by subsection (a) of this section), the 
requirement under such section that hos-
pitals and ambulatory surgical centers submit 
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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. 
(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 sub-
section (a). Such report shall include an anal-
ysis of the appropriateness of the types of in-
formation required for submission, compli-
ance with reporting requirements, the suc-
cess of the validity procedures established, 
and any conflict or overlap between the re-
porting 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 en-
actment of this Act, the Secretary of Health 
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and Human Services shall submit to the Con-
gress a report on the appropriateness of ex-
panding the requirements under such section 
to include additional information (such as 
health care worker immunization rates), in 
order to improve health care quality and pa-
tient safety. 
TITLE V—MEDICARE GRADUATE 
MEDICAL EDUCATION 
SEC. 1501. DISTRIBUTION OF UNUSED RESIDENCY POSI-
TIONS. 
(a) IN GENERAL.—Section 1886(h) of the So-
cial Security Act (42 U.S.C. 1395ww(h)) is 
amended— 
(1) in paragraph (4)(F)(i), by striking 
‘‘paragraph (7)’’ and inserting ‘‘para-
graphs (7) and (8)’’; 
(2) in paragraph (4)(H)(i), by striking 
‘‘paragraph (7)’’ and inserting ‘‘para-
graphs (7) and (8)’’; 
(3) in paragraph (7)(E), by inserting 
‘‘and paragraph (8)’’ after ‘‘this para-
graph’’; and 
(4) by adding at the end the following 
new paragraph: 
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‘‘(8) ADDITIONAL REDISTRIBUTION OF UN-
USED RESIDENCY POSITIONS.— 
‘‘(A) REDUCTIONS IN LIMIT BASED ON 
UNUSED POSITIONS.— 
‘‘(i) PROGRAMS SUBJECT TO RE-
DUCTION.—If a hospital’s reference 
resident level (specified in clause 
(ii)) is less than the otherwise ap-
plicable resident limit (as defined 
in subparagraph (C)(ii)), effective 
for portions of cost reporting pe-
riods occurring on or after July 1, 
2011, the otherwise applicable 
resident limit shall be reduced 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 ref-
erence resident level specified 
in this clause for a hospital is 
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the highest resident level for 
any of the 3 most recent cost 
reporting periods (ending be-
fore the date of the enactment 
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 
ACCOUNTING PERIOD TO RECOG-
NIZE
EXPANSION
OF
EXISTING 
PROGRAMS.—If a hospital sub-
mits a timely request to in-
crease its resident level due 
to an expansion, or planned 
expansion, of an existing resi-
dency training program that 
is not reflected on the most 
recent settled or submitted 
cost report, after audit and 
subject to the discretion of 
the Secretary, subject to sub-
clause (IV), the reference resi-
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dent level for such hospital is 
the resident level that in-
cludes 
the 
additional 
resi-
dents attributable to such ex-
pansion or establishment, as 
determined by the Secretary. 
The Secretary is authorized to 
determine an alternative ref-
erence 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 resi-
dent level due to a planned 
expansion. 
‘‘(III) 
SPECIAL
PROVIDER 
AGREEMENT.—In the case of a 
hospital described in para-
graph (4)(H)(v), the reference 
resident level specified in this 
clause is the limitation appli-
cable under subclause (I) of 
such paragraph. 
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‘‘(IV) PREVIOUS REDISTRIBU-
TION.—The reference resident 
level specified in this clause 
for a hospital shall be in-
creased to the extent required 
to take into account an in-
crease in resident positions 
made available to the hospital 
under paragraph (7)(B) that 
are not otherwise taken into 
account under a previous sub-
clause. 
‘‘(iii) AFFILIATION.—The provi-
sions 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 dem-
onstrate that they are filling any 
additional
resident 
slots 
allo-
cated to other hospitals through 
an affiliation agreement, the Sec-
retary shall adjust the determina-
tion of available slots accordingly, 
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or which the Secretary otherwise 
has permitted the resident posi-
tions (under section 402 of the So-
cial 
Security 
Amendments 
of 
1967) to be aggregated for pur-
poses of applying the resident po-
sition limitations under this sub-
section. 
‘‘(B) REDISTRIBUTION.— 
‘‘(i) 
IN
GENERAL.—The 
Sec-
retary shall increase the other-
wise applicable resident limit for 
each qualifying hospital that sub-
mits an application under this 
subparagraph 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 increases in the otherwise ap-
plicable resident limit under this 
subparagraph may not exceed the 
Secretary’s estimate of the aggre-
gate reduction in such limits at-
tributable to subparagraph (A). 
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‘‘(ii) REQUIREMENTS FOR QUALI-
FYING
HOSPITALS.—A hospital is 
not a qualifying hospital for pur-
poses of this paragraph unless the 
following requirements are met: 
‘‘(I) MAINTENANCE
OF
PRI-
MARY
CARE
RESIDENT
LEVEL.— 
The hospital maintains the 
number of primary care resi-
dents at a level that is not less 
than the base level of primary 
care residents increased by 
the number of additional pri-
mary care resident positions 
provided 
to 
the 
hospital 
under this subparagraph. For 
purposes 
of 
this 
subpara-
graph, the ‘base level of pri-
mary care residents’ for a hos-
pital is the level of such resi-
dents as of a base period 
(specified by the Secretary), 
determined without regard to 
whether such positions were 
in excess of the otherwise ap-
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plicable 
resident 
limit 
for 
such period but taking into 
account 
the 
application 
of 
subclauses (II) and (III) of 
subparagraph (A)(ii). 
‘‘(II) 
DEDICATED
ASSIGN-
MENT OF ADDITIONAL RESIDENT 
POSITIONS TO PRIMARY CARE.— 
The hospital assigns all such 
additional resident positions 
for primary care residents. 
‘‘(III) ACCREDITATION.—The 
hospital’s residency programs 
in primary care are fully ac-
credited or, in the case of a 
residency training program 
not in operation as of the base 
year, the hospital is actively 
applying for such accredita-
tion for the program for such 
additional resident positions 
(as determined by the Sec-
retary). 
‘‘(iii) CONSIDERATIONS IN REDIS-
TRIBUTION.—In 
determining 
for 
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which qualifying hospitals the in-
crease in the otherwise applicable 
resident limit is provided under 
this subparagraph, the Secretary 
shall take into account the dem-
onstrated likelihood of the hos-
pital filling the positions within 
the first 3 cost reporting periods 
beginning on or after July 1, 2011, 
made available under this sub-
paragraph, as determined by the 
Secretary. 
‘‘(iv) PRIORITY
FOR
CERTAIN 
HOSPITALS.—In 
determining 
for 
which qualifying hospitals the in-
crease in the otherwise 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 reduction in resi-
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dent training positions under 
subparagraph (A). 
‘‘(II) The Secretary shall 
give preference to hospitals 
with 3-year primary care resi-
dency 
training 
programs, 
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 de-
termined by the Secretary) 
that place greater emphasis 
upon training in Federally 
qualified health centers, rural 
health clinics, and other non-
provider settings, and to hos-
pitals that receive additional 
payments 
under 
subsection 
(d)(5)(F) and emphasize train-
ing in an outpatient depart-
ment. 
‘‘(IV) The Secretary shall 
give preference to hospitals 
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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 pro-
fessional shortage area (des-
ignated under section 332 of 
the Public Health Service Act) 
or a health professional needs 
area (designated under sec-
tion 2211 of such Act). 
‘‘(VI) The Secretary shall 
give preference to hospitals in 
States that have low resident- 
to-population ratios (includ-
ing a greater preference for 
those States with lower resi-
dent-to-population ratios). 
‘‘(v) LIMITATION.—In no case 
shall 
more 
than 
full-time 
equivalent additional residency 
positions be made available under 
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this subparagraph with respect to 
any hospital. 
‘‘(vi) APPLICATION OF PER RESI-
DENT
AMOUNTS
FOR
PRIMARY 
CARE.—With respect to additional 
residency positions in a hospital 
attributable to the increase pro-
vided under this subparagraph, 
the 
approved 
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. 
‘‘(vii) DISTRIBUTION.—The Sec-
retary shall distribute the in-
crease in resident training posi-
tions 
to 
qualifying 
hospitals 
under this subparagraph not later 
than July 1, 2011. 
‘‘(C) RESIDENT LEVEL AND LIMIT DE-
FINED.—In this paragraph: 
‘‘(i) The term ‘resident level’ 
has the meaning given such term 
in paragraph (7)(C)(i). 
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‘‘(ii) The term ‘otherwise ap-
plicable resident limit’ means, 
with respect to a hospital, the 
limit otherwise applicable under 
subparagraphs (F)(i) and (H) of 
paragraph (4) on the resident 
level for the hospital determined 
without regard to this paragraph 
but taking into account para-
graph (7)(A). 
‘‘(D) 
MAINTENANCE
OF
PRIMARY 
CARE
RESIDENT
LEVEL.—In carrying 
out this paragraph, the Secretary 
shall require hospitals that receive 
additional resident positions under 
subparagraph (B)— 
‘‘(i) to maintain records, and 
periodically report to the Sec-
retary, on the number of primary 
care residents in its residency 
training programs; and 
‘‘(ii) as a condition of payment 
for a cost reporting period under 
this subsection for such positions, 
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to maintain the level of such posi-
tions at not less than the sum of— 
‘‘(I) the base level of pri-
mary care resident positions 
(as determined under sub-
paragraph (B)(ii)(I)) before re-
ceiving such additional posi-
tions; and 
‘‘(II) the number of such 
additional positions.’’. 
(b) IME.— 
(1) 
IN
GENERAL.—Section 
1886(d)(5)(B)(v) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(B)(v)), in the 
third sentence, is amended— 
(A) by striking ‘‘subsection (h)(7)’’ 
and inserting ‘‘subsections (h)(7) and 
(h)(8)’’; and 
(B) by striking ‘‘it applies’’ and in-
serting ‘‘they apply’’. 
(2) CONFORMING
PROVISION.—Section 
1886(d)(5)(B) of the Social Security Act 
(42 U.S.C. 1395ww(d)(5)(B)) is amended by 
adding at the end the following clause: 
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‘‘(x) For discharges occurring on or after 
July 1, 2011, insofar as an additional payment 
amount under this subparagraph is attrib-
utable to resident positions distributed to a 
hospital under subsection (h)(8)(B), the indi-
rect teaching adjustment factor shall be com-
puted in the same manner as provided under 
clause (ii) with respect to such resident posi-
tions.’’. 
(c) 
CONFORMING
AMENDMENT.—Section 
422(b)(2) of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 
(Public Law 108–173) is amended by striking 
‘‘section 1886(h)(7)’’ and all that follows and 
inserting ‘‘paragraphs (7) and (8) of sub-
section (h) of section 1886 of the Social Secu-
rity Act.’’. 
SEC. 1502. INCREASING TRAINING IN NONPROVIDER SET-
TINGS. 
(a) DIRECT GME.—Section 1886(h)(4)(E) of 
the Social Security Act (42 U.S.C. 1395ww(h)) 
is amended— 
(1) by designating the first sentence 
as a clause (i) with the heading ‘‘IN GEN-
ERAL.—’’ and appropriate indentation; 
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(2) by striking ‘‘shall be counted and 
that all the time’’ and inserting ‘‘shall be 
counted and that— 
‘‘(I) effective for cost re-
porting periods beginning be-
fore July 1, 2009, all the time’’; 
(3) in subclause (I), as inserted by 
paragraph (1), by striking the period at 
the end and inserting ‘‘; and’’; and 
(A) by inserting after subclause 
(I), as so inserted, the following: 
‘‘(II) effective for cost re-
porting periods beginning on 
or after July 1, 2009, all the 
time so spent by a resident 
shall be counted towards the 
determination 
of 
full-time 
equivalency, without regard 
to the setting in which the ac-
tivities are performed, if the 
hospital incurs the costs of 
the stipends and fringe bene-
fits of the resident during the 
time the resident spends in 
that setting. 
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Any hospital claiming under this 
subparagraph for time spent in a 
nonprovider setting shall main-
tain and make available to the 
Secretary records regarding the 
amount of such time and such 
amount 
in 
comparison 
with 
amounts of such time in such 
base year as the Secretary shall 
specify.’’. 
(b) IME.—Section 1886(d)(5)(B)(iv) of the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(d)(5)(B)(iv)) is amended— 
(1) by striking ‘‘(iv) Effective for dis-
charges occurring on or after October 1, 
1997’’ and inserting ‘‘(iv)(I) Effective for 
discharges occurring on or after October 
1, 1997, and before July 1, 2009’’; and 
(2) by inserting after subclause (I), as 
inserted by paragraph (1), the following 
new subclause: 
‘‘(II) Effective for discharges occur-
ring on or after July 1, 2009, all the time 
spent by an intern or resident in patient 
care activities at an entity in a nonpro-
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vider setting shall be counted towards 
the determination of full-time equiva-
lency if the hospital incurs the costs of 
the stipends and fringe benefits of the in-
tern or resident during the time the in-
tern or resident spends in that setting.’’. 
(c) OIG STUDY ON IMPACT ON TRAINING.— 
The Inspector General of the Department of 
Health and Human Services shall analyze the 
data collected by the Secretary of Health and 
Human Services from the records made avail-
able 
to 
the 
Secretary 
under 
section 
1886(h)(4)(E) of the Social Security Act, as 
amended by subsection (a), in order to assess 
the extent to which there is an increase in 
time spent by medical residents in training in 
nonprovider settings as a result of the amend-
ments made by this section. Not later than 4 
years after the date of the enactment of this 
Act, the Inspector General shall submit a re-
port to Congress on such analysis and assess-
ment. 
(d) 
DEMONSTRATION
PROJECT
FOR
AP-
PROVED TEACHING HEALTH CENTERS.— 
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(1) IN
GENERAL.—The Secretary of 
Health and Human Services shall conduct 
a demonstration project under which an 
approved teaching health center (as de-
fined in paragraph (3)) would be eligible 
for payment under subsections (h) and 
(k) of section 1886 of the Social Security 
Act (42 U.S.C. 1395ww) of amounts for its 
own direct costs of graduate medical edu-
cation activities for primary care resi-
dents, as well as for the direct costs of 
graduate medical education activities of 
its contracting hospital for such resi-
dents, in a manner similar to the manner 
in which such payments would be made 
to a hospital if the hospital were to oper-
ate such a program. 
(2) 
CONDITIONS.—Under 
the 
dem-
onstration project— 
(A) an approved teaching health 
center shall contract with an accred-
ited teaching hospital to carry out 
the inpatient responsibilities of the 
primary care residency program of 
the hospital involved and is respon-
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bajohnson on DSK2BSOYB1PROD with BILLS
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sible for payment to the hospital for 
the hospital’s costs of the salary and 
fringe benefits for residents in the 
program; 
(B) the number of primary care 
residents of the center shall not count 
against 
the 
contracting 
hospital’s 
resident limit; and 
(C) the contracting hospital shall 
agree not to diminish the number of 
residents in its primary care resi-
dency training program. 
(3) APPROVED
TEACHING
HEALTH
CEN-
TER
DEFINED.—In this subsection, the 
term ‘‘approved teaching health center’’ 
means a nonprovider setting, such as a 
Federally qualified health center or rural 
health 
clinic 
(as 
defined 
in 
section 
1861(aa) of the Social Security Act), that 
develops and operates an accredited pri-
mary care residency program for which 
funding would be available if it were op-
erated by a hospital. 
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‘‘(I) knowledge of age-ap-
propriate child development 
in cognitive, language, social, 
emotional, and motor domains 
(including knowledge of sec-
ond language acquisition, in 
the case of English language 
learners); 
‘‘(II) knowledge of real-
istic expectations of age-ap-
propriate child behaviors; 
‘‘(III) knowledge of health 
and wellness issues for chil-
dren and parents; 
‘‘(IV) modeling, consulting, 
and coaching on parenting 
practices; 
‘‘(V) skills to interact with 
their child to enhance age-ap-
propriate development; 
‘‘(VI) skills to recognize 
and seek help for issues re-
lated to health, developmental 
delays, and social, emotional, 
and behavioral skills; and 
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