891 
dend, profit, or other return on invest-
ment; or 
‘‘(IV) any other form (as defined 
by the Secretary). 
‘‘(C) With respect to a drug sample, the 
name, number, date, and dosage units of the 
sample. 
‘‘(2) 
AGGREGATE
REPORTING.—Information 
submitted by an applicable manufacturer or dis-
tributor under paragraph (1) shall include the ag-
gregate amount of all payments or other transfers of 
value provided by the manufacturer or distributor to 
covered recipients (and to entities or individuals at 
the request of or designated on behalf of a covered 
recipient) during the year involved, including all pay-
ments and transfers of value regardless of whether 
such payments or transfer of value were individually 
disclosed. 
‘‘(3) SPECIAL RULE FOR CERTAIN PAYMENTS 
OR
OTHER
TRANSFERS
OF
VALUE.—In the case 
where an applicable manufacturer or distributor pro-
vides a payment or other transfer of value to an en-
tity or individual at the request of or designated on 
behalf of a covered recipient, the manufacturer or 
distributor shall disclose that payment or other 
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transfer of value under the name of the covered re-
cipient. 
‘‘(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 recipient by an 
applicable manufacturer or distributor pursuant to a 
product development agreement for services fur-
nished in connection with the development of a new 
drug, device, biological, or medical supply, the appli-
cable manufacturer or distributor may report the 
value and recipient of such payment or other trans-
fer of value in the first reporting period under this 
subsection in the next reporting deadline after the 
earlier of the following: 
‘‘(A) The date of the approval or clearance 
of the covered drug, device, biological, or med-
ical supply by the Food and Drug Administra-
tion. 
‘‘(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 INVESTIGATIONS.—In 
the case of a payment or other transfer of value 
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made to a covered recipient by an applicable manu-
facturer or distributor in connection with a clinical 
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. 
‘‘(7) PHYSICIANS
IN
SELF-INSURED
HEALTH 
PLANS.—Nothing in this subsection shall be con-
strued to require the disclosure of a payment or 
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other transfer of value to a physician by a self-in-
sured health plan. 
‘‘(b) REPORTING OF OWNERSHIP INTEREST BY PHY-
SICIANS.— 
‘‘(1) 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 including a Medicare Advan-
tage organization) that bills the Secretary under 
part A or part B of title XVIII for services shall re-
port on the ownership shares (other than ownership 
shares described in section 1877(c)) of each physi-
cian who, directly or indirectly, owns an interest in 
the entity. 
‘‘(2) ADDITIONAL
PHYSICIAN
OWNERSHIP.— 
Not later than March 31 of each year (beginning 
with 2011), in addition to the requirement under 
subsection (a)(1), any applicable manufacturer, ap-
plicable group purchasing organization, or applicable 
distributor shall submit to the Secretary, in such 
electronic form as the Secretary shall require, the 
following information regarding any ownership or in-
vestment interest (other than an ownership or in-
vestment interest in a publicly traded security and 
mutual fund, as described in section 1877(c)) held 
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by a physician (or an immediate family member of 
such physician (as defined for purposes of section 
1877(a))) in the applicable manufacturer, applicable 
group purchasing organization or applicable dis-
tributor during the preceding year: 
‘‘(A) The dollar amount invested by each 
physician holding such an ownership or invest-
ment interest. 
‘‘(B) The value and terms of each such 
ownership or investment interest. 
‘‘(C) Any payment or other transfer of 
value provided to a physician holding such an 
ownership or investment interest (or to an enti-
ty or individual at the request of or designated 
on behalf of a physician holding such an owner-
ship or investment interest), including the infor-
mation described in clauses (i) through (iii) of 
paragraph (a)(1)(B), and information described 
in subsection (f)(8)(A) and (f)(8)(B). 
‘‘(D) Any other information regarding the 
ownership or investment interest the Secretary 
determines appropriate. 
‘‘(3) DEFINITIONS.—In this subsection: 
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‘‘(A) PHYSICIAN.—The term ‘physician’ in-
cludes a physician’s immediate family members 
(as defined for purposes of section 1877(a)). 
‘‘(B) APPLICABLE GROUP PURCHASING OR-
GANIZATION.—The term ‘applicable group pur-
chasing organization’ means any organization 
or other entity (as defined by the Secretary) 
that purchases, arranges for, or negotiates the 
purchase of a covered drug, device, biological, 
or medical supply. 
‘‘(4) STUDY OF PRACTICE PATTERNS IN AD-
VANCED DIAGNOSTIC IMAGING AND RADIATION ON-
COLOGY SERVICES.—The Comptroller General of the 
United States shall conduct a study to evaluate the 
extent of use of physician self-referral arrangements 
and the effects of such arrangements on the cost of 
providing advanced diagnostic imaging and radiation 
oncology services to Medicare beneficiaries under 
title XVIII. The study shall be completed and sub-
mitted to Congress not later than July 1, 2011. 
‘‘(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 
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‘‘(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; 
‘‘(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 reporting 
entity reporting under subsection (a) or (b), as ap-
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plicable. The Secretary shall establish procedures to 
ensure that the covered recipient is provided with an 
opportunity to submit corrections to the applicable 
reporting entity 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 
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.— 
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‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), except as provided in paragraph (2), 
any reporting entity that fails to submit infor-
mation required under subsection (a) or (b), as 
applicable, in a timely manner in accordance 
with regulations promulgated to carry out such 
applicable subsection shall be subject to a civil 
money penalty of not less than $1,000, but not 
more than $10,000, for each payment or other 
transfer of value or ownership or investment in-
terest not reported as required under such sub-
section. Such penalty shall be imposed and col-
lected in the same manner as civil money pen-
alties 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 a 
reporting entity, shall not exceed $150,000. 
‘‘(2) KNOWING FAILURE TO REPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), any reporting entity that knowingly 
fails to submit information required under sub-
section (a) or (b), as applicable, in a timely 
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manner in accordance with regulations promul-
gated to carry out such applicable 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 reporting entity shall not ex-
ceed $1,000,000, or, if greater, 0.1 percentage 
of the total annual revenues of the reporting en-
tity. 
‘‘(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, 
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after providing notice to the Secretary of an intent 
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 an applicable manufac-
turer or distributor 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 reporting entity that submitted such in-
formation 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
DISTRIBUTOR.—The term 
‘applicable distributor’ means— 
‘‘(A) any entity, other than an applicable 
group purchasing organization, that buys and 
resells, or receives a commission or other simi-
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lar form of payment, from another seller, for 
selling or arranging for the sale of a covered 
drug, device, biological, or medical supply; or 
‘‘(B) any entity under common ownership 
with such an entity described in subparagraph 
(A) and which provides assistance or support to 
such entity so described with respect to the pro-
duction, 
preparation, 
propagation, 
compounding, 
conversion, 
processing, 
mar-
keting, or distribution of a covered drug, device, 
biological, or medical supply. 
Such term does not include a wholesale pharma-
ceutical distributor. 
‘‘(2) APPLICABLE MANUFACTURER.—The term 
‘applicable manufacturer’ means any entity which is 
engaged in the production, preparation, propagation, 
compounding, conversion, processing, marketing, or 
manufacturer-direct distribution of a covered drug, 
device, biological, or medical supply (or any entity 
under common ownership with such entity and which 
provides assistance or support to such entity with re-
spect to the production, preparation, propagation, 
compounding, conversion, processing, marketing, or 
distribution or a covered drug, device, biological, or 
medical supply). For purposes of this section only, 
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such term does not include a retail pharmacy li-
censed under State law. 
‘‘(3) 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. 
‘‘(4) 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). 
‘‘(5) 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. 
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‘‘(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. 
‘‘(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. 
‘‘(8) 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. 
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‘‘(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-
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. 
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‘‘(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 
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 an appli-
cable manufacturer or distributor to a cov-
ered recipient who is directly employed by 
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908 
and works solely for such manufacturer or 
distributor. 
‘‘(viii) Payments made to a covered 
recipient by an applicable manufacturer or 
by a health plan affiliated with an applica-
ble manufacturer for medical care provided 
to employees of such manufacturer or their 
dependents. 
‘‘(ix) Any discount (including a re-
bate). 
‘‘(x) Any payment or other transfer of 
value that is made to a covered recipient 
indirectly through an entity other than the 
applicable manufacturer in connection with 
an activity or service— 
‘‘(I) in which the applicable man-
ufacturer is unaware of the identity of 
the covered recipient and is not using 
such activity or service to market its 
product to the covered recipient; and 
‘‘(II) that is not designed to mar-
ket or promote the product to the cov-
ered recipient. 
‘‘(xi) In the case of an applicable 
manufacturer who offers a self-insured 
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909 
plan, payments for the provision of health 
care to employees under the plan. 
‘‘(9) 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 
manufacturer that is required to submit information 
under subsection (a). 
‘‘(10) REPORTING ENTITY.—The term ‘report-
ing entity’ means— 
‘‘(A) with respect to the reporting require-
ment under subsection (a), an applicable manu-
facturer or distributor of a covered drug, device, 
biological, or medical supply required to report 
under such subsection; and 
‘‘(B) with respect to the reporting require-
ment under subsection (b), a hospital, other 
health care entity, applicable manufacturer, ap-
plicable distributor, or applicable group pur-
chasing organization required to report physi-
cian ownership under such subsection. 
‘‘(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), (b), 
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‘‘(C) The disclosure or reporting, in any 
format, of the type of information by any per-
son or entity other than an applicable manufac-
turer (as so defined) or a covered recipient (as 
defined in subsection (f)). 
‘‘(D) 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. 
Nothing in paragraph (1) shall be construed to limit 
the discovery or admissibility of information de-
scribed in this paragraph in a criminal, civil, or ad-
ministrative 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-
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licly available on an Internet website of the Department 
of Health and Human Services. 
(c) GAO REPORT.—Not later than December 31, 
2012, the Comptroller General of the United States shall 
submit to Congress a report on section 1128H of the So-
cial Security Act, as added by subsection (a). Such report 
shall address the extent to which important transfers of 
value are being adequately reported under such section 
(including unreported transfers required by such section 
as well as transfers not required to be reported by such 
section), the impact on States of the federal preemption 
provision under subsection (h) of such section, whether 
changes have occurred in the pattern of payments as a 
result of efforts to evade reporting requirements, a de-
scription of the financial relationships subject to delayed 
reporting under subsection (a) of such section, and any 
recommended improvements to the collection or the anal-
ysis of data reported under such section. 
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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 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 demo-
graphic information associated with such infections) 
as the Secretary specifies. 
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‘‘(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 
address failures to report as well as errors in report-
ing. 
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‘‘(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. 
‘‘(2) Factors that contribute to the occurrence 
of such infections, including health care worker im-
munization rates. 
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‘‘(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. 
‘‘(e) HEALTH CARE-ASSOCIATED INFECTION.—For 
purposes of this section: 
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‘‘(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. 
(c) GAO REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
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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. 
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— 
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(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-
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.— 
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‘‘(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 
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 
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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 
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-
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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.— 
‘‘(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 
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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-
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 
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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 
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-
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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). 
‘‘(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. 
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‘‘(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-
ignated under section 332 of the Pub-
lic Health Service Act) or a health 
professional needs area (designated 
under section 2211 of such Act). 
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‘‘(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. 
‘‘(vii) DISTRIBUTION.—The Secretary 
shall distribute the increase in resident 
training positions to qualifying hospitals 
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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). 
‘‘(ii) The term ‘otherwise applicable 
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 para-
graph, the Secretary shall require hospitals that 
receive additional resident positions under sub-
paragraph (B)— 
‘‘(i) to maintain records, and periodi-
cally report to the Secretary, on the num-
ber of primary care residents in its resi-
dency training programs; and 
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‘‘(ii) as a condition of payment for a 
cost reporting period under this subsection 
for such positions, to maintain the level of 
such positions at not less than the sum 
of— 
‘‘(I) the base level of primary 
care resident positions (as determined 
under subparagraph (B)(ii)(I)) before 
receiving such additional positions; 
and 
‘‘(II) the number of such addi-
tional 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 in-
serting ‘‘subsections (h)(7) and (h)(8)’’; and 
(B) by striking ‘‘it applies’’ and inserting 
‘‘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 attributable to resident positions distrib-
uted to a hospital under subsection (h)(8)(B), the indirect 
teaching adjustment factor shall be computed in the same 
manner as provided under clause (ii) with respect to such 
resident positions.’’. 
(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 fol-
lows and inserting ‘‘paragraphs (7) and (8) of subsection 
(h) of section 1886 of the Social Security Act.’’. 
SEC. 1502. INCREASING TRAINING IN NONPROVIDER SET-
TINGS. 
(a) DIRECT GME.—Section 1886(h)(4)(E) of the So-
cial Security Act (42 U.S.C. 1395ww(h)) is amended— 
(1) by designating the first sentence as a clause 
(i) with the heading ‘‘IN GENERAL.—’’ and appro-
priate indentation; 
(2) by striking ‘‘shall be counted and that all 
the time’’ and inserting ‘‘shall be counted and 
that— 
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‘‘(I) effective for cost reporting 
periods beginning before 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 reporting 
periods beginning on or after July 1, 
2009, all the time so spent by a resi-
dent shall be counted towards the de-
termination of full-time equivalency, 
without regard to the setting in which 
the activities are performed, if the 
hospital incurs the costs of the sti-
pends and fringe benefits of the resi-
dent during the time the resident 
spends in that setting. 
Any hospital claiming under this subpara-
graph for time spent in a nonprovider set-
ting shall maintain and make available to 
the 
Secretary 
records 
regarding 
the 
amount of such time and such amount in 
comparison with amounts of such time in 
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such base year as the Secretary shall speci-
fy.’’. 
(b) IME.—Section 1886(d)(5)(B)(iv) of the Social 
Security Act (42 U.S.C. 1395ww(d)(5)(B)(iv)) is amend-
ed— 
(1) by striking ‘‘(iv) Effective for discharges oc-
curring 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 occurring on or 
after July 1, 2009, all the time spent by an intern 
or resident in patient care activities at an entity in 
a nonprovider setting shall be counted towards the 
determination of full-time equivalency if the hospital 
incurs the costs of the stipends and fringe benefits 
of the intern or resident during the time the intern 
or resident spends in that setting.’’. 
(c) OIG STUDY ON IMPACT ON TRAINING.—The In-
spector 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 
available to the Secretary under section 1886(h)(4)(E) of 
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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 nonpro-
vider settings as a result of the amendments made by this 
section. Not later than 4 years after the date of the enact-
ment of this Act, the Inspector General shall submit a re-
port to Congress on such analysis and assessment. 
(d) DEMONSTRATION
PROJECT
FOR
APPROVED 
TEACHING HEALTH CENTERS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall conduct a demonstration 
project under which an approved teaching health 
center (as defined in paragraph (3)) would be eligi-
ble 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 education activities for primary 
care residents, as well as for the direct costs of grad-
uate medical education activities of its contracting 
hospital for such residents, in a manner similar to 
the manner in which such payments would be made 
to a hospital if the hospital were to operate such a 
program. 
(2) CONDITIONS.—Under the demonstration 
project— 
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(A) an approved teaching health center 
shall contract with an accredited teaching hos-
pital to carry out the inpatient responsibilities 
of the primary care residency program of the 
hospital involved and is responsible 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 con-
tracting hospital’s resident limit; and 
(C) the contracting hospital shall agree not 
to diminish the number of residents in its pri-
mary care residency training program. 
(3) APPROVED TEACHING HEALTH CENTER DE-
FINED.—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 primary care residency program for which 
funding would be available if it were operated by a 
hospital. 
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SEC. 1503. RULES FOR COUNTING RESIDENT TIME FOR DI-
DACTIC AND SCHOLARLY ACTIVITIES AND 
OTHER ACTIVITIES. 
(a) DIRECT GME.—Section 1886(h) of the Social Se-
curity Act (42 U.S.C. 1395ww(h)) is amended— 
(1) in paragraph (4)(E), as amended by section 
1502(a)— 
(A) in clause (i), by striking ‘‘Such rules’’ 
and inserting ‘‘Subject to clause (ii), such 
rules’’; and 
(B) by adding at the end the following new 
clause: 
‘‘(ii) TREATMENT OF CERTAIN NON-
PROVIDER
AND
DIDACTIC
ACTIVITIES.— 
Such rules shall provide that all time spent 
by an intern or resident in an approved 
medical residency training program in a 
nonprovider setting that is primarily en-
gaged in furnishing patient care (as de-
fined in paragraph (5)(K)) in nonpatient 
care activities, such as didactic conferences 
and seminars, but not including research 
not associated with the treatment or diag-
nosis of a particular patient, as such time 
and activities are defined by the Secretary, 
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shall be counted toward the determination 
of full-time equivalency.’’; 
(2) in paragraph (4), by adding at the end the 
following new subparagraph: 
‘‘(I) TREATMENT OF CERTAIN TIME IN AP-
PROVED MEDICAL RESIDENCY TRAINING PRO-
GRAMING.—In determining the hospital’s num-
ber of full-time equivalent residents for pur-
poses of this subsection, all the time that is 
spent by an intern or resident in an approved 
medical residency training program on vacation, 
sick leave, or other approved leave, as such time 
is defined by the Secretary, and that does not 
prolong the total time the resident is partici-
pating in the approved program beyond the nor-
mal duration of the program shall be counted 
toward the determination of full-time equiva-
lency.’’; and 
(3) in paragraph (5), by adding at the end the 
following new subparagraph: 
‘‘(K) NONPROVIDER SETTING THAT IS PRI-
MARILY
ENGAGED
IN
FURNISHING
PATIENT 
CARE.—The term ‘nonprovider setting that is 
primarily engaged in furnishing patient care’ 
means a nonprovider setting in which the pri-
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mary activity is the care and treatment of pa-
tients, as defined by the Secretary.’’. 
(b) IME DETERMINATIONS.—Section 1886(d)(5)(B) 
of such Act (42 U.S.C. 1395ww(d)(5)(B)), as amended by 
section 1501(b), is amended by adding at the end the fol-
lowing new clause: 
‘‘(xi)(I) The provisions of subparagraph (I) of sub-
section (h)(4) shall apply under this subparagraph in the 
same manner as they apply under such subsection. 
‘‘(II) In determining the hospital’s number of full- 
time equivalent residents for purposes of this subpara-
graph, all the time spent by an intern or resident in an 
approved medical residency training program in non-
patient care activities, such as didactic conferences and 
seminars, as such time and activities are defined by the 
Secretary, that occurs in the hospital shall be counted to-
ward the determination of full-time equivalency if the hos-
pital— 
‘‘(aa) is recognized as a subsection (d) hospital; 
‘‘(bb) is recognized as a subsection (d) Puerto 
Rico hospital; 
‘‘(cc) is reimbursed under a reimbursement sys-
tem authorized under section 1814(b)(3); or 
‘‘(dd) is a provider-based hospital outpatient de-
partment. 
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‘‘(III) In determining the hospital’s number of full- 
time equivalent residents for purposes of this subpara-
graph, all the time spent by an intern or resident in an 
approved medical residency training program in research 
activities that are not associated with the treatment or di-
agnosis of a particular patient, as such time and activities 
are defined by the Secretary, shall not be counted toward 
the determination of full-time equivalency.’’. 
(c) EFFECTIVE DATES; APPLICATION.— 
(1) IN
GENERAL.—Except as otherwise pro-
vided, the Secretary of Health and Human Services 
shall implement the amendments made by this sec-
tion in a manner so as to apply to cost reporting pe-
riods beginning on or after January 1, 1983. 
(2) DIRECT GME.—Section 1886(h)(4)(E)(ii) of 
the Social Security Act, as added by subsection 
(a)(1)(B), shall apply to cost reporting periods be-
ginning on or after July 1, 2008. 
(3) IME.—Section 1886(d)(5)(B)(x)(III) of the 
Social Security Act, as added by subsection (b), shall 
apply to cost reporting periods beginning on or after 
October 1, 2001. Such section, as so added, shall 
not give rise to any inference on how the law in ef-
fect prior to such date should be interpreted. 
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(4) APPLICATION.—The amendments made by 
this section shall not be applied in a manner that re-
quires reopening of any settled hospital cost reports 
as to which there is not a jurisdictionally proper ap-
peal pending as of the date of the enactment of this 
Act on the issue of payment for indirect costs of 
medical education under section 1886(d)(5)(B) of 
the Social Security Act or for direct graduate med-
ical education costs under section 1886(h) of such 
Act. 
SEC. 1504. PRESERVATION OF RESIDENT CAP POSITIONS 
FROM CLOSED HOSPITALS. 
(a) DIRECT GME.—Section 1886(h)(4)(H) of the So-
cial Security Act (42 U.S.C. Section 1395ww(h)(4)(H)) 
is amended by adding at the end the following new clause: 
‘‘(vi) REDISTRIBUTION OF RESIDENCY 
SLOTS AFTER A HOSPITAL CLOSES.— 
‘‘(I) IN
GENERAL.—The Sec-
retary shall, by regulation, establish a 
process consistent with subclauses (II) 
and (III) under which, in the case 
where a hospital (other than a hos-
pital described in clause (v)) with an 
approved medical residency program 
in a State closes on or after the date 
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that is 2 years before the date of the 
enactment of this clause, the Sec-
retary shall increase the otherwise ap-
plicable resident limit under this para-
graph for other hospitals in the State 
in accordance with this clause. 
‘‘(II) PROCESS
FOR
HOSPITALS 
IN CERTAIN AREAS.—In determining 
for which hospitals the increase in the 
otherwise applicable resident limit de-
scribed in subclause (I) is provided, 
the Secretary shall establish a process 
to provide for such increase to one or 
more hospitals located in the State. 
Such process shall take into consider-
ation the recommendations submitted 
to the Secretary by the senior health 
official (as designated by the chief ex-
ecutive officer of such State) if such 
recommendations are submitted not 
later than 180 days after the date of 
the hospital closure involved (or, in 
the case of a hospital that closed after 
the date that is 2 years before the 
date of the enactment of this clause, 
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180 days after such date of enact-
ment). 
‘‘(III) LIMITATION.—The esti-
mated aggregate number of increases 
in the otherwise applicable resident 
limits for hospitals under this clause 
shall be equal to the estimated num-
ber of resident positions in the ap-
proved medical residency programs 
that closed on or after the date de-
scribed in subclause (I).’’. 
(b) NO EFFECT ON TEMPORARY FTE CAP ADJUST-
MENTS.—The amendments made by this section shall not 
effect any temporary adjustment to a hospital’s FTE cap 
under section 413.79(h) of title 42, Code of Federal Regu-
lations (as in effect on the date of enactment of this Act) 
and 
shall 
not 
affect 
the 
application 
of 
section 
1886(h)(4)(H)(v) of the Social Security Act. 
(c) CONFORMING AMENDMENTS.— 
(1) Section 422(b)(2) of the Medicare Prescrip-
tion Drug, Improvement, and Modernization Act of 
2003 (Public Law 108–173), as amended by section 
1501(c), is amended by striking ‘‘(7) and’’ and in-
serting ‘‘(4)(H)(vi), (7), and’’. 
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(2) Section 1886(h)(7)(E) of the Social Secu-
rity Act (42 U.S.C. 1395ww(h)(7)(E)) is amended 
by inserting ‘‘or under paragraph (4)(H)(vi)’’ after 
‘‘under this paragraph’’. 
SEC. 1505. IMPROVING ACCOUNTABILITY FOR APPROVED 
MEDICAL RESIDENCY TRAINING. 
(a) SPECIFICATION OF GOALS FOR APPROVED MED-
ICAL
RESIDENCY
TRAINING
PROGRAMS.—Section 
1886(h)(1) of the Social Security Act (42 U.S.C. 
1395ww(h)(1)) is amended— 
(1) by designating the matter beginning with 
‘‘Notwithstanding’’ as a subparagraph (A) with the 
heading ‘‘IN GENERAL.—’’ and with appropriate in-
dentation; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(B) GOALS
AND
ACCOUNTABILITY
FOR 
APPROVED MEDICAL RESIDENCY TRAINING PRO-
GRAMS.—The goals of medical residency train-
ing programs are to foster a physician work-
force so that physicians are trained to be able 
to do the following: 
‘‘(i) Work effectively in various health 
care delivery settings, such as nonprovider 
settings. 
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‘‘(ii) Coordinate patient care within 
and across settings relevant to their spe-
cialties. 
‘‘(iii) Understand the relevant cost 
and value of various diagnostic and treat-
ment options. 
‘‘(iv) Work in inter-professional teams 
and multi-disciplinary team-based models 
in provider and nonprovider settings to en-
hance safety and improve quality of patient 
care. 
‘‘(v) Be knowledgeable in methods of 
identifying systematic errors in health care 
delivery and in implementing systematic 
solutions in case of such errors, including 
experience and participation in continuous 
quality improvement projects to improve 
health outcomes of the population the phy-
sicians serve. 
‘‘(vi) Be meaningful EHR users (as 
determined under section 1848(o)(2)) in 
the delivery of care and in improving the 
quality of the health of the community and 
the individuals that the hospital serves.’’ 
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(b) GAO STUDY ON EVALUATION OF TRAINING PRO-
GRAMS.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study to evaluate 
the extent to which medical residency training pro-
grams— 
(A) are meeting the goals described in sec-
tion 1886(h)(1)(B) of the Social Security Act, 
as added by subsection (a), in a range of resi-
dency programs, including primary care and 
other specialties; and 
(B) have the appropriate faculty expertise 
to teach the topics required to achieve such 
goals. 
(2) REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comp-
troller General shall submit to Congress a report on 
such study and shall include in such report rec-
ommendations as to how medical residency training 
programs could be further encouraged to meet such 
goals through means such as— 
(A) development of curriculum require-
ments; and 
(B) assessment of the accreditation proc-
esses of the Accreditation Council for Graduate 
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Medical Education and the American Osteo-
pathic Association and effectiveness of those 
processes in accrediting medical residency pro-
grams that meet the goals referred to in para-
graph (1)(A). 
TITLE VI—PROGRAM INTEGRITY 
Subtitle A—Increased Funding to 
Fight Waste, Fraud, and Abuse 
SEC. 1601. INCREASED FUNDING AND FLEXIBILITY TO 
FIGHT FRAUD AND ABUSE. 
(a) IN GENERAL.—Section 1817(k) of the Social Se-
curity Act (42 U.S.C. 1395i(k)) is amended— 
(1) by adding at the end the following new 
paragraph: 
‘‘(7) ADDITIONAL FUNDING.—In addition to the 
funds otherwise appropriated to the Account from 
the Trust Fund under paragraphs (3) and (4) and 
for purposes described in paragraphs (3)(C) and 
(4)(A), there are hereby appropriated an additional 
$100,000,000 to such Account from such Trust 
Fund for each fiscal year beginning with 2011. The 
funds appropriated under this paragraph shall be al-
located in the same proportion as the total funding 
appropriated with respect to paragraphs (3)(A) and 
(4)(A) was allocated with respect to fiscal year 
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2010, and shall be available without further appro-
priation until expended.’’. 
(2) in paragraph (4)(A)— 
(A) by inserting ‘‘for activities described in 
paragraph (3)(C) and’’ after ‘‘necessary’’; and 
(B) by inserting ‘‘until expended’’ after 
‘‘appropriation’’. 
(b) 
FLEXIBILITY
IN
PURSUING
FRAUD
AND 
ABUSE.—Section 1893(a) of the Social Security Act (42 
U.S.C. 1395ddd(a)) is amended by inserting ‘‘, or other-
wise,’’ after ‘‘entities’’. 
Subtitle B—Enhanced Penalties for 
Fraud and Abuse 
SEC. 1611. ENHANCED PENALTIES FOR FALSE STATEMENTS 
ON PROVIDER OR SUPPLIER ENROLLMENT 
APPLICATIONS. 
(a) IN GENERAL.—Section 1128A(a) of the Social 
Security Act (42 U.S.C. 1320a–7a(a)) is amended— 
(1) in paragraph (1)(D), by striking all that fol-
lows ‘‘in which the person was excluded’’ and insert-
ing ‘‘under Federal law from the Federal health care 
program under which the claim was made, or’’; 
(2) by striking ‘‘or’’ at the end of paragraph 
(6); 
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(3) in paragraph (7), by inserting at the end 
‘‘or’’; 
(4) by inserting after paragraph (7) the fol-
lowing new paragraph: 
‘‘(8) knowingly makes or causes to be made any 
false statement, omission, or misrepresentation of a 
material fact in any application, agreement, bid, or 
contract to participate or enroll as a provider of 
services or supplier under a Federal health care pro-
gram, including managed care organizations under 
title XIX, Medicare Advantage organizations under 
part C of title XVIII, prescription drug plan spon-
sors under part D of title XVIII, and entities that 
apply to participate as providers of services or sup-
pliers in such managed care organizations and such 
plans;’’; 
(5) in the matter following paragraph (8), as 
inserted by paragraph (4), by striking ‘‘or in cases 
under paragraph (7), $50,000 for each such act)’’ 
and inserting ‘‘in cases under paragraph (7), 
$50,000 for each such act, or in cases under para-
graph (8), $50,000 for each false statement, omis-
sion, or misrepresentation of a material fact)’’; and 
(6) in the second sentence, by striking ‘‘for a 
lawful purpose)’’ and inserting ‘‘for a lawful pur-
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pose, or in cases under paragraph (8), an assess-
ment of not more than 3 times the amount claimed 
as the result of the false statement, omission, or 
misrepresentation of material fact claimed by a pro-
vider of services or supplier whose application to 
participate contained such false statement, omission, 
or misrepresentation)’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to acts committed on or after 
January 1, 2010. 
SEC. 1612. ENHANCED PENALTIES FOR SUBMISSION OF 
FALSE STATEMENTS MATERIAL TO A FALSE 
CLAIM. 
(a) IN GENERAL.—Section 1128A(a) of the Social 
Security Act (42 U.S.C. 1320a–7a(a)), as amended by sec-
tion 1611, is further amended— 
(1) in paragraph (7), by striking ‘‘or’’ at the 
end; 
(2) in paragraph (8), by inserting ‘‘or’’ at the 
end; and 
(3) by inserting after paragraph (8), the fol-
lowing new paragraph: 
‘‘(9) knowingly makes, uses, or causes to be 
made or used, a false record or statement material 
to a false or fraudulent claim for payment for items 
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and services furnished under a Federal health care 
program;’’; and 
(4) in the matter following paragraph (9), as 
inserted by paragraph (3)— 
(A) by striking ‘‘or in cases under para-
graph (8)’’ and inserting ‘‘in cases under para-
graph (8)’’; and 
(B) by striking ‘‘a material fact)’’ and in-
serting ‘‘a material fact, in cases under para-
graph (9), $50,000 for each false record or 
statement)’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to acts committed on or after 
January 1, 2010. 
SEC. 1613. ENHANCED PENALTIES FOR DELAYING INSPEC-
TIONS. 
(a) IN GENERAL.—Section 1128A(a) of the Social 
Security Act (42 U.S.C. 1320a–7a(a)), as amended by sec-
tions 1611 and 1612, is further amended— 
(1) in paragraph (8), by striking ‘‘or’’ at the 
end; 
(2) in paragraph (9), by inserting ‘‘or’’ at the 
end; 
(3) by inserting after paragraph (9) the fol-
lowing new paragraph: 
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‘‘(10) fails to grant timely access, upon reason-
able request (as defined by the Secretary in regula-
tions), to the Inspector General of the Department 
of Health and Human Services, for the purpose of 
audits, investigations, evaluations, or other statutory 
functions of the Inspector General of the Depart-
ment of Health and Human Services;’’; and 
(4) in the matter following paragraph (10), as 
inserted by paragraph (3), by inserting ‘‘, or in cases 
under paragraph (10), $15,000 for each day of the 
failure described in such paragraph’’ after ‘‘false 
record or statement’’. 
(b) ENSURING TIMELY INSPECTIONS RELATING TO 
CONTRACTS
WITH
MA 
ORGANIZATIONS.—Section 
1857(d)(2) of such Act (42 U.S.C. 1395w–27(d)(2)) is 
amended— 
(1) in subparagraph (A), by inserting ‘‘timely’’ 
before ‘‘inspect’’; and 
(2) in subparagraph (B), by inserting ‘‘timely’’ 
before ‘‘audit and inspect’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to violations committed on or 
after January 1, 2010. 
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SEC. 1614. ENHANCED HOSPICE PROGRAM SAFEGUARDS. 
(a) MEDICARE.—Part A of title XVIII of the Social 
Security Act is amended by inserting after section 1819 
the following new section: 
‘‘SEC. 1819A. ASSURING QUALITY OF CARE IN HOSPICE 
CARE. 
‘‘(a) IN GENERAL.—If the Secretary determines on 
the basis of a survey or otherwise, that a hospice program 
that is certified for participation under this title has dem-
onstrated a substandard quality of care and failed to meet 
such other requirements as the Secretary may find nec-
essary in the interest of the health and safety of the indi-
viduals who are provided care and services by the agency 
or organization involved and determines— 
‘‘(1) that the deficiencies involved immediately 
jeopardize the health and safety of the individuals to 
whom the program furnishes items and services, the 
Secretary shall take immediate action to remove the 
jeopardy and correct the deficiencies through the 
remedy specified in subsection (b)(2)(A)(iii) or ter-
minate the certification of the program, and may 
provide, in addition, for 1 or more of the other rem-
edies described in subsection (b)(2)(A); or 
‘‘(2) that the deficiencies involved do not imme-
diately jeopardize the health and safety of the indi-
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viduals to whom the program furnishes items and 
services, the Secretary may— 
‘‘(A) impose intermediate sanctions devel-
oped pursuant to subsection (b), in lieu of ter-
minating the certification of the program; and 
‘‘(B) if, after such a period of intermediate 
sanctions, the program is still not in compliance 
with such requirements, the Secretary shall ter-
minate the certification of the program. 
If the Secretary determines that a hospice program 
that is certified for participation under this title is 
in compliance with such requirements but, as of a 
previous period, was not in compliance with such re-
quirements, the Secretary may provide for a civil 
money penalty under subsection (b)(2)(A)(i) for the 
days in which it finds that the program was not in 
compliance with such requirements. 
‘‘(b) INTERMEDIATE SANCTIONS.— 
‘‘(1) DEVELOPMENT AND IMPLEMENTATION.— 
The Secretary shall develop and implement, by not 
later than July 1, 2012— 
‘‘(A) a range of intermediate sanctions to 
apply to hospice programs under the conditions 
described in subsection (a), and 
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‘‘(B) appropriate procedures for appealing 
determinations relating to the imposition of 
such sanctions. 
‘‘(2) SPECIFIED SANCTIONS.— 
‘‘(A) 
IN
GENERAL.—The 
intermediate 
sanctions developed under paragraph (1) may 
include— 
‘‘(i) civil money penalties in an 
amount not to exceed $10,000 for each day 
of noncompliance or, in the case of a per 
instance penalty applied by the Secretary, 
not to exceed $25,000, 
‘‘(ii) denial of all or part of the pay-
ments to which a hospice program would 
otherwise be entitled under this title with 
respect to items and services furnished by 
a hospice program on or after the date on 
which the Secretary determines that inter-
mediate sanctions should be imposed pur-
suant to subsection (a)(2), 
‘‘(iii) the appointment of temporary 
management to oversee the operation of 
the hospice program and to protect and as-
sure the health and safety of the individ-
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uals under the care of the program while 
improvements are made, 
‘‘(iv) corrective action plans, and 
‘‘(v) in-service training for staff. 
The provisions of section 1128A (other than 
subsections (a) and (b)) shall apply to a civil 
money penalty under clause (i) in the same 
manner as such provisions apply to a penalty or 
proceeding under section 1128A(a). The tem-
porary management under clause (iii) shall not 
be terminated until the Secretary has deter-
mined that the program has the management 
capability to ensure continued compliance with 
all requirements referred to in that clause. 
‘‘(B) 
CLARIFICATION.—The 
sanctions 
specified in subparagraph (A) are in addition to 
sanctions otherwise available under State or 
Federal law and shall not be construed as lim-
iting other remedies, including any remedy 
available to an individual at common law. 
‘‘(C) COMMENCEMENT
OF
PAYMENT.—A 
denial of payment under subparagraph (A)(ii) 
shall terminate when the Secretary determines 
that the hospice program no longer dem-
onstrates a substandard quality of care and 
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meets such other requirements as the Secretary 
may find necessary in the interest of the health 
and safety of the individuals who are provided 
care and services by the agency or organization 
involved. 
‘‘(3) SECRETARIAL AUTHORITY.—The Secretary 
shall develop and implement, by not later than July 
1, 2011, specific procedures with respect to the con-
ditions under which each of the intermediate sanc-
tions developed under paragraph (1) is to be applied, 
including the amount of any fines and the severity 
of each of these sanctions. Such procedures shall be 
designed so as to minimize the time between identi-
fication of deficiencies and imposition of these sanc-
tions and shall provide for the imposition of incre-
mentally more severe fines for repeated or uncor-
rected deficiencies.’’. 
(b) APPLICATION TO MEDICAID.—Section 1905(o) of 
the Social Security Act (42 U.S.C. 1396d(o)) is amended 
by adding at the end the following new paragraph: 
‘‘(4) The provisions of section 1819A shall apply to 
a hospice program providing hospice care under this title 
in the same manner as such provisions apply to a hospice 
program providing hospice care under title XVIII.’’. 
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(c) APPLICATION TO CHIP.—Title XXI of the Social 
Security Act is amended by adding at the end the fol-
lowing new section: 
‘‘SEC. 2114. ASSURING QUALITY OF CARE IN HOSPICE CARE. 
‘‘The provisions of section 1819A shall apply to a 
hospice program providing hospice care under this title in 
the same manner such provisions apply to a hospice pro-
gram providing hospice care under title XVIII.’’. 
SEC. 1615. ENHANCED PENALTIES FOR INDIVIDUALS EX-
CLUDED FROM PROGRAM PARTICIPATION. 
(a) IN GENERAL.—Section 1128A(a) of the Social 
Security Act (42 U.S.C. 1320a–7a(a)), as amended by the 
previous sections, is further amended— 
(1) by striking ‘‘or’’ at the end of paragraph 
(9); 
(2) by inserting ‘‘or’’ at the end of paragraph 
(10); 
(3) by inserting after paragraph (10) the fol-
lowing new paragraph: 
‘‘(11) orders or prescribes an item or service, 
including without limitation home health care, diag-
nostic and clinical lab tests, prescription drugs, du-
rable medical equipment, ambulance services, phys-
ical or occupational therapy, or any other item or 
service, during a period when the person has been 
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excluded from participation in a Federal health care 
program, and the person knows or should know that 
a claim for such item or service will be presented to 
such a program;’’; and 
(4) in the matter following paragraph (11), as 
inserted by paragraph (2), by striking ‘‘$15,000 for 
each day of the failure described in such paragraph’’ 
and inserting ‘‘$15,000 for each day of the failure 
described in such paragraph, or in cases under para-
graph (11), $50,000 for each order or prescription 
for an item or service by an excluded individual’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to violations committed on or 
after January 1, 2010. 
SEC. 1616. ENHANCED PENALTIES FOR PROVISION OF 
FALSE INFORMATION BY MEDICARE ADVAN-
TAGE AND PART D PLANS. 
(a) IN GENERAL.—Section 1857(g)(2)(A) of the So-
cial Security Act (42 U.S.C. 1395w—27(g)(2)(A)) is 
amended by inserting ‘‘except with respect to a determina-
tion under subparagraph (E), an assessment of not more 
than 3 times the amount claimed by such plan or plan 
sponsor based upon the misrepresentation or falsified in-
formation involved,’’ after ‘‘for each such determination,’’. 
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(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to violations committed on or 
after January 1, 2010. 
SEC. 1617. ENHANCED PENALTIES FOR MEDICARE ADVAN-
TAGE AND PART D MARKETING VIOLATIONS. 
(a) IN GENERAL.—Section 1857(g)(1) of the Social 
Security Act (42 U.S.C. 1395w—27(g)(1)), as amended 
by section 1221(b), is amended— 
(1) in subparagraph (G), by striking ‘‘or’’ at 
the end; 
(2) by inserting after subparagraph (H) the fol-
lowing new subparagraphs: 
‘‘(I) except as provided under subpara-
graph (C) or (D) of section 1860D–1(b)(1), en-
rolls an individual in any plan under this part 
without the prior consent of the individual or 
the designee of the individual; 
‘‘(J) transfers an individual enrolled under 
this part from one plan to another without the 
prior consent of the individual or the designee 
of the individual or solely for the purpose of 
earning a commission; 
‘‘(K) fails to comply with marketing re-
strictions described in subsections (h) and (j) of 
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section 1851 or applicable implementing regula-
tions or guidance; or 
‘‘(L) employs or contracts with any indi-
vidual or entity who engages in the conduct de-
scribed in subparagraphs (A) through (K) of 
this paragraph;’’; and 
(3) by adding at the end the following new sen-
tence: ‘‘The Secretary may provide, in addition to 
any other remedies authorized by law, for any of the 
remedies described in paragraph (2), if the Secretary 
determines that any employee or agent of such orga-
nization, or any provider or supplier who contracts 
with such organization, has engaged in any conduct 
described in subparagraphs (A) through (L) of this 
paragraph.’’ 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to violations committed on or 
after January 1, 2010. 
SEC. 1618. ENHANCED PENALTIES FOR OBSTRUCTION OF 
PROGRAM AUDITS. 
(a) IN GENERAL.—Section 1128(b)(2) of the Social 
Security Act (42 U.S.C. 1320a–7(b)(2)) is amended— 
(1) in the heading, by inserting ‘‘OR AUDIT’’ 
after ‘‘INVESTIGATION’’; and 
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(2) by striking ‘‘investigation into’’ and all that 
follows through the period and inserting ‘‘investiga-
tion or audit related to—’’ 
‘‘(i) any offense described in para-
graph (1) or in subsection (a); or 
‘‘(ii) the use of funds received, directly 
or indirectly, from any Federal health care 
program 
(as 
defined 
in 
section 
1128B(f)).’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to violations committed on or 
after January 1, 2010. 
SEC. 1619. EXCLUSION OF CERTAIN INDIVIDUALS AND EN-
TITIES FROM PARTICIPATION IN MEDICARE 
AND STATE HEALTH CARE PROGRAMS. 
(a) IN GENERAL.—Section 1128(c) of the Social Se-
curity Act, as previously amended by this division, is fur-
ther amended— 
(1) in the heading, by striking ‘‘AND PERIOD’’ 
and inserting ‘‘PERIOD, AND EFFECT’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(4)(A) For purposes of this Act, subject to subpara-
graph (C), the effect of exclusion is that no payment may 
be made by any Federal health care program (as defined 
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in section 1128B(f)) with respect to any item or service 
furnished— 
‘‘(i) by an excluded individual or entity; or 
‘‘(ii) at the medical direction or on the prescrip-
tion of a physician or other authorized individual 
when the person submitting a claim for such item or 
service knew or had reason to know of the exclusion 
of such individual. 
‘‘(B) For purposes of this section and sections 1128A 
and 1128B, subject to subparagraph (C), an item or serv-
ice has been furnished by an individual or entity if the 
individual or entity directly or indirectly provided, ordered, 
manufactured, distributed, prescribed, or otherwise sup-
plied the item or service regardless of how the item or 
service was paid for by a Federal health care program or 
to whom such payment was made. 
‘‘(C)(i) Payment may be made under a Federal 
health care program for emergency items or services (not 
including items or services furnished in an emergency 
room of a hospital) furnished by an excluded individual 
or entity, or at the medical direction or on the prescription 
of an excluded physician or other authorized individual 
during the period of such individual’s exclusion. 
‘‘(ii) In the case that an individual eligible for bene-
fits under title XVIII or XIX submits a claim for payment 
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for items or services furnished by an excluded individual 
or entity, and such individual eligible for such benefits did 
not know or have reason to know that such excluded indi-
vidual or entity was so excluded, then, notwithstanding 
such exclusion, payment shall be made for such items or 
services. In such case the Secretary shall notify such indi-
vidual eligible for such benefits of the exclusion of the indi-
vidual or entity furnishing the items or services. Payment 
shall not be made for items or services furnished by an 
excluded individual or entity to an individual eligible for 
such benefits after a reasonable time (as determined by 
the Secretary in regulations) after the Secretary has noti-
fied the individual eligible for such benefits of the exclu-
sion of the individual or entity furnishing the items or 
services. 
‘‘(iii) In the case that a claim for payment for items 
or services furnished by an excluded individual or entity 
is submitted by an individual or entity other than an indi-
vidual eligible for benefits under title XVIII or XIX or 
the excluded individual or entity, and the Secretary deter-
mines that the individual or entity that submitted the 
claim took reasonable steps to learn of the exclusion and 
reasonably relied upon inaccurate or misleading informa-
tion from the relevant Federal health care program or its 
contractor, the Secretary may waive repayment of the 
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amount paid in violation of the exclusion to the individual 
or entity that submitted the claim for the items or services 
furnished by the excluded individual or entity. If a Federal 
health care program contractor provided inaccurate or 
misleading information that resulted in the waiver of an 
overpayment under this clause, the Secretary shall take 
appropriate action to recover the improperly paid amount 
from the contractor.’’. 
SEC. 1620. OIG AUTHORITY TO EXCLUDE FROM FEDERAL 
HEALTH CARE PROGRAMS OFFICERS AND 
OWNERS OF ENTITIES CONVICTED OF FRAUD. 
Section 1128(b)(15)(A) of the Social Security Act 
(42 U.S.C. 1320a–7(b)(15)(A)) is amended— 
(1) in clause (i)— 
(A) by striking ‘‘has’’ and inserting ‘‘had’’; 
and 
(B) by striking ‘‘sanctioned entity and who 
knows or should know (as defined in section 
1128A(i)(6)) of’’ and inserting ‘‘sanctioned en-
tity at the time of, and who knew or should 
have known (as defined in section 1128A(i)(6)) 
of,’’ ; and 
(2) in clause (ii)— 
(A) by striking ‘‘is an officer’’ and insert-
ing ‘‘was an officer’’; and 
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(B) by inserting before the period the fol-
lowing: ‘‘at the time of the action constituting 
the basis for the conviction or exclusion de-
scribed in subparagraph (B)’’. 
SEC. 1621. SELF-REFERRAL DISCLOSURE PROTOCOL. 
(a) DEVELOPMENT OF SELF-REFERRAL DISCLOSURE 
PROTOCOL.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services, in cooperation with the Inspector 
General of the Department of Health and Human 
Services, shall establish, not later than 6 months 
after the date of the enactment of this Act, a pro-
tocol to enable health care providers of services and 
suppliers to disclose an actual or potential violation 
of section 1877 of the Social Security Act (42 
U.S.C. 1395nn) pursuant to a self-referral disclosure 
protocol (in this section referred to as an ‘‘SRDP’’). 
The SRDP shall include direction to health care pro-
viders of services and suppliers on— 
(A) a specific person, official, or office to 
whom such disclosures shall be made; and 
(B) instruction on the implication of the 
SRDP on corporate integrity agreements and 
corporate compliance agreements. 
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(2) PUBLICATION ON INTERNET WEBSITE OF 
SRDP INFORMATION.—The Secretary shall post in-
formation on the public Internet website of the Cen-
ters for Medicare & Medicaid Services to inform rel-
evant stakeholders of how to disclose actual or po-
tential violations pursuant to an SRDP. 
(3) RELATION
TO
ADVISORY
OPINIONS.—The 
SRDP shall be separate from the advisory opinion 
process set forth in regulations implementing section 
1877(g) of the Social Security Act. 
(b) REDUCTION IN AMOUNTS OWED.—The Secretary 
is authorized to reduce the amount due and owing for all 
violations under section 1877 of the Social Security Act 
to an amount less than that specified in subsection (g) 
of such section. In establishing such amount for a viola-
tion, the Secretary may consider the following factors: 
(1) The nature and extent of the improper or 
illegal practice. 
(2) The timeliness of such self-disclosure. 
(3) The cooperation in providing additional in-
formation related to the disclosure. 
(4) Such other factors as the Secretary con-
siders appropriate. 
(c) REPORT.—Not later than 18 months after the 
date on which the SRDP protocol is established under sub-
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section (a)(1), the Secretary shall submit to Congress a 
report on the implementation of this section. Such report 
shall include— 
(1) the number of health care providers of serv-
ices and suppliers making disclosures pursuant to an 
SRDP; 
(2) the amounts collected pursuant to the 
SRDP; 
(3) the types of violations reported under the 
SRDP; and 
(4) such other information as may be necessary 
to evaluate the impact of this section. 
(d) RELATION TO OTHER LAW AND REGULATION.— 
Nothing in this section shall affect the application of sec-
tion 1128G(c) of the Social Security Act, as added by sec-
tion 1641, except, in the case of a health care provider 
of services or supplier who is a person (as defined in para-
graph (4) of such section 1128G(c)) who discloses an over-
payment (as defined in such paragraph) to the Secretary 
of Health and Human Services pursuant to a SRDP es-
tablished under this section, the 60-day period described 
in paragraph (2) of such section 1128G(c) shall be ex-
tended with respect to the return of an overpayment to 
the extent necessary for the Secretary to determine pursu-
ant to the SRDP the amount due and owing. 
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Subtitle C—Enhanced Program 
and Provider Protections 
SEC. 1631. ENHANCED CMS PROGRAM PROTECTION AU-
THORITY. 
(a) IN GENERAL.—Title XI of the Social Security Act 
(42 U.S.C. 1301 et seq.) is amended by inserting after 
section 1128F the following new section: 
‘‘SEC. 1128G. ENHANCED PROGRAM AND PROVIDER PRO-
TECTIONS IN THE MEDICARE, MEDICAID, AND 
CHIP PROGRAMS. 
‘‘(a) CERTAIN AUTHORIZED SCREENING, ENHANCED 
OVERSIGHT PERIODS, AND ENROLLMENT MORATORIA.— 
‘‘(1) IN GENERAL.—For periods beginning after 
January 1, 2011, in the case that the Secretary de-
termines there is a significant risk of fraudulent ac-
tivity (as determined by the Secretary based on rel-
evant complaints, reports, referrals by law enforce-
ment or other sources, data analysis, trending infor-
mation, or claims submissions by providers of serv-
ices and suppliers) with respect to a category of pro-
vider of services or supplier of items or services, in-
cluding a category within a geographic area, under 
title XVIII, XIX, or XXI, the Secretary may impose 
any of the following requirements with respect to a 
provider of services or a supplier (whether such pro-
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vider or supplier is initially enrolling in the program 
or is renewing such enrollment): 
‘‘(A) Screening under paragraph (2). 
‘‘(B) Enhanced oversight periods under 
paragraph (3). 
‘‘(C) Enrollment moratoria under para-
graph (4). 
In applying this subsection for purposes of title XIX 
and XXI the Secretary may require a State to carry 
out the provisions of this subsection as a require-
ment of the State plan under title XIX or the child 
health plan under title XXI. Actions taken and de-
terminations made under this subsection shall not be 
subject to review by a judicial tribunal. 
‘‘(2) SCREENING.—For purposes of paragraph 
(1), the Secretary shall establish procedures under 
which screening is conducted with respect to pro-
viders of services and suppliers described in such 
paragraph. Such screening may include— 
‘‘(A) licensing board checks; 
‘‘(B) screening against the list of individ-
uals and entities excluded from the program 
under title XVIII, XIX, or XXI; 
‘‘(C) the excluded provider list system; 
‘‘(D) background checks; and 
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‘‘(E) unannounced pre-enrollment or other 
site visits. 
‘‘(3) ENHANCED
OVERSIGHT
PERIOD.—For 
purposes of paragraph (1), the Secretary shall estab-
lish procedures to provide for a period of not less 
than 30 days and not more than 365 days during 
which providers of services and suppliers described 
in such paragraph, as the Secretary determines ap-
propriate, would be subject to enhanced oversight, 
such as required or unannounced (or required and 
unannounced) site visits or inspections, prepayment 
review, enhanced review of claims, and such other 
actions as specified by the Secretary, under the pro-
grams under titles XVIII, XIX, and XXI. Under 
such procedures, the Secretary may extend such pe-
riod for more than 365 days if the Secretary deter-
mines that after the initial period such additional 
period of oversight is necessary. 
‘‘(4) MORATORIUM ON ENROLLMENT OF PRO-
VIDERS
AND
SUPPLIERS.—For purposes of para-
graph (1), the Secretary, based upon a finding of a 
risk of serious ongoing fraud within a program 
under title XVIII, XIX, or XXI, may impose a mor-
atorium on the enrollment of providers of services 
and suppliers within a category of providers of serv-
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ices and suppliers (including a category within a spe-
cific geographic area) under such title. Such a mora-
torium may only be imposed if the Secretary makes 
a determination that the moratorium would not ad-
versely impact access of individuals to care under 
such program. 
‘‘(5) CLARIFICATION.—Nothing in this sub-
section shall be interpreted to preclude or limit the 
ability of a State to engage in provider screening or 
enhanced provider oversight activities beyond those 
required by the Secretary.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) MEDICAID.—Section 1902(a) of the Social 
Security Act (42 U.S.C. 42 U.S.C. 1396a(a)) is 
amended— 
(A) in paragraph (23), by inserting before 
the semicolon at the end the following: ‘‘or by 
a person to whom or entity to which a morato-
rium under section 1128G(a)(4) is applied dur-
ing the period of such moratorium’’; 
(B) in paragraph (72); by striking at the 
end ‘‘and’’; 
(C) in paragraph (73), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
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(D) by adding after paragraph (73) the 
following new paragraph: 
‘‘(74) provide that the State will enforce any 
determination made by the Secretary under sub-
section (a) of section 1128G (relating to a signifi-
cant risk of fraudulent activity with respect to a cat-
egory of provider or supplier described in such sub-
section (a) through use of the appropriate proce-
dures described in such subsection (a)), and that the 
State will carry out any activities as required by the 
Secretary for purposes of such subsection (a).’’. 
(2) CHIP.—Section 2102 of such Act (42 
U.S.C. 1397bb) is amended by adding at the end the 
following new subsection: 
‘‘(d) PROGRAM INTEGRITY.—A State child health 
plan shall include a description of the procedures to be 
used by the State— 
‘‘(1) to enforce any determination made by the 
Secretary under subsection (a) of section 1128G (re-
lating to a significant risk of fraudulent activity with 
respect to a category of provider or supplier de-
scribed in such subsection through use of the appro-
priate procedures described in such subsection); and 
‘‘(2) to carry out any activities as required by 
the Secretary for purposes of such subsection.’’. 
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(3) MEDICARE.—Section 1866(j) of such Act 
(42 U.S.C. 1395cc(j)) is amended by adding at the 
end the following new paragraph: 
‘‘(3) PROGRAM INTEGRITY.—The provisions of 
section 1128G(a) apply to enrollments and renewals 
of enrollments of providers of services and suppliers 
under this title.’’. 
SEC. 1632. ENHANCED MEDICARE, MEDICAID, AND CHIP 
PROGRAM DISCLOSURE REQUIREMENTS RE-
LATING TO PREVIOUS AFFILIATIONS. 
(a) IN GENERAL.—Section 1128G of the Social Secu-
rity Act, as inserted by section 1631, is amended by add-
ing at the end the following new subsection: 
‘‘(b) ENHANCED PROGRAM DISCLOSURE REQUIRE-
MENTS.— 
‘‘(1) DISCLOSURE.—A provider of services or 
supplier who submits on or after July 1, 2011, an 
application for enrollment and renewing enrollment 
in a program under title XVIII, XIX, or XXI shall 
disclose (in a form and manner determined by the 
Secretary) any current affiliation or affiliation with-
in the previous 10-year period with a provider of 
services or supplier that has uncollected debt or with 
a person or entity that has been suspended or ex-
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cluded under such program, subject to a payment 
suspension, or has had its billing privileges revoked. 
‘‘(2) ENHANCED
SAFEGUARDS.—If the Sec-
retary determines that such previous affiliation of 
such provider or supplier poses a risk of fraud, 
waste, or abuse, the Secretary may apply such en-
hanced safeguards as the Secretary determines nec-
essary to reduce such risk associated with such pro-
vider or supplier enrolling or participating in the 
program under title XVIII, XIX, or XXI. Such safe-
guards may include enhanced oversight, such as en-
hanced screening of claims, required or unannounced 
(or required and unannounced) site visits or inspec-
tions, additional information reporting requirements, 
and conditioning such enrollment on the provision of 
a surety bond. 
‘‘(3) AUTHORITY TO DENY PARTICIPATION.—If 
the Secretary determines that there has been at 
least one such affiliation and that such affiliation or 
affiliations, as applicable, of such provider or sup-
plier poses a serious risk of fraud, waste, or abuse, 
the Secretary may deny the application of such pro-
vider or supplier.’’. 
(b) CONFORMING AMENDMENTS.— 
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(1) MEDICAID.—Paragraph (74) of section 
1902(a) of such Act (42 U.S.C. 1396a(a)), as added 
by section 1631(b)(1), is amended— 
(A) by inserting ‘‘or subsection (b) of such 
section (relating to disclosure requirements)’’ 
before ‘‘, and that the State’’; and 
(B) by inserting before the period the fol-
lowing: ‘‘and apply any enhanced safeguards, 
with respect to a provider or supplier described 
in such subsection (b), as the Secretary deter-
mines necessary under such subsection (b)’’. 
(2) CHIP.—Subsection (d) of section 2102 of 
such Act (42 U.S.C. 1397bb), as added by section 
1631(b)(2), is amended— 
(A) in paragraph (1), by striking at the 
end ‘‘and’’; 
(B) in paragraph (2) by striking the period 
at the end and inserting ‘‘; and’ ’’ and 
(C) by adding at the end the following new 
paragraph: 
‘‘(3) to enforce any determination made by the 
Secretary under subsection (b) of section 1128G (re-
lating to disclosure requirements) and to apply any 
enhanced safeguards, with respect to a provider or 
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supplier described in such subsection, as the Sec-
retary determines necessary under such subsection.’’. 
SEC. 1633. REQUIRED INCLUSION OF PAYMENT MODIFIER 
FOR CERTAIN EVALUATION AND MANAGE-
MENT SERVICES. 
Section 1848 of the Social Security Act (42 U.S.C. 
1395w–4), as amended by section 4101 of the HITECH 
Act (Public Law 111–5), is amended by adding at the end 
the following new subsection: 
‘‘(p) PAYMENT MODIFIER FOR CERTAIN EVALUA-
TION AND MANAGEMENT SERVICES.—The Secretary shall 
establish a payment modifier under the fee schedule under 
this section for evaluation and management services (as 
specified in section 1842(b)(16)(B)(ii)) that result in the 
ordering of additional services (such as lab tests), the pre-
scription of drugs, the furnishing or ordering of durable 
medical equipment in order to enable better monitoring 
of claims for payment for such additional services under 
this title, or the ordering, furnishing, or prescribing of 
other items and services determined by the Secretary to 
pose a high risk of waste, fraud, and abuse. The Secretary 
may require providers of services or suppliers to report 
such modifier in claims submitted for payment.’’. 
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SEC. 1634. EVALUATIONS AND REPORTS REQUIRED UNDER 
MEDICARE INTEGRITY PROGRAM. 
(a) IN GENERAL.—Section 1893(c) of the Social Se-
curity Act (42 U.S.C. 1395ddd(c)) is amended— 
(1) in paragraph (3), by striking at the end 
‘‘and’’; 
(2) by redesignating paragraph (4) as para-
graph (5); and 
(3) by inserting after paragraph (3) the fol-
lowing new paragraph: 
‘‘(4) for the contract year beginning in 2011 
and each subsequent contract year, the entity pro-
vides assurances to the satisfaction of the Secretary 
that the entity will conduct periodic evaluations of 
the effectiveness of the activities carried out by such 
entity under the Program and will submit to the 
Secretary an annual report on such activities; and’’. 
(b) REFERENCE
TO MEDICAID INTEGRITY PRO-
GRAM.—For a similar provision with respect to the Med-
icaid Integrity Program, see section 1752. 
SEC. 1635. REQUIRE PROVIDERS AND SUPPLIERS TO 
ADOPT 
PROGRAMS 
TO 
REDUCE 
WASTE, 
FRAUD, AND ABUSE. 
(a) IN GENERAL.—Section 1866(j) of the Social Se-
curity Act (42 U.S.C. 42 U.S.C. 1395cc(j)), as amended 
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by section 1631(d)(3), is further amended by adding at 
the end the following new paragraph: 
‘‘(4) COMPLIANCE PROGRAMS FOR PROVIDERS 
OF SERVICES AND SUPPLIERS.— 
‘‘(A) IN
GENERAL.—The Secretary may 
not enroll (or renew the enrollment of) a pro-
vider of services or a supplier (other than a 
physician or a skilled nursing facility) under 
this title if such provider of services or supplier 
fails to, subject to subparagraph (E), establish 
a compliance program that contains the core 
elements established under subparagraph (B) 
and certify in a manner determined by the Sec-
retary, that the provider or suppler has estab-
lished such a program. 
‘‘(B) ESTABLISHMENT
OF
CORE
ELE-
MENTS.—The Secretary, in consultation with 
the Inspector General of the Department of 
Health and Human Services, shall establish 
core elements for a compliance program under 
subparagraph (A). Such elements may include 
written policies, procedures, and standards of 
conduct, a designated compliance officer and a 
compliance committee; effective training and 
education pertaining to fraud, waste, and abuse 
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for the organization’s employees, and contrac-
tors; a confidential or anonymous mechanism, 
such as a hotline, to receive compliance ques-
tions and reports of fraud, waste, or abuse; dis-
ciplinary guidelines for enforcement of stand-
ards; internal monitoring and auditing proce-
dures, including monitoring and auditing of 
contractors; procedures for ensuring prompt re-
sponses to detected offenses and development of 
corrective action initiatives, including responses 
to potential offenses; and procedures to return 
all identified overpayments to the programs 
under this title, title XIX, and title XXI. 
‘‘(C) TIMELINE FOR IMPLEMENTATION.— 
The Secretary shall determine a timeline for the 
establishment of the core elements under sub-
paragraph (B) and the date on which a pro-
vider of services and suppliers (other than phy-
sicians and skilled nursing facilities) shall be re-
quired to have established such a program for 
purposes of this subsection. 
‘‘(D) PILOT
PROGRAM.—The Secretary 
may conduct a pilot program on the application 
of this subsection with respect to a category of 
providers of services or suppliers (other than 
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physicians and skilled nursing facilities) that 
the Secretary determines to be a category which 
is at high risk for waste, fraud, and abuse be-
fore implementing the requirements of this sub-
section to all providers of services and suppliers 
described in subparagraph (C). 
‘‘(E) TREATMENT
OF
SKILLED
NURSING 
FACILITIES.—For the requirement for skilled 
nursing facilities to establish compliance and 
ethics programs see section 1819(d)(1)(C). 
‘‘(F) CONSTRUCTION.—Nothing in this 
subsection exempts a physician from partici-
pating in a compliance program established by 
a health care provider or other entity with 
which the physician is employed, under con-
tract, or affiliated if such compliance is re-
quired by such provider or entity.’’. 
(b) REFERENCE
TO
SIMILAR
MEDICAID
PROVI-
SION.—For a similar provision with respect to the Med-
icaid program under title XIX of the Social Security Act, 
see section 1753. 
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SEC. 1636. MAXIMUM PERIOD FOR SUBMISSION OF MEDI-
CARE CLAIMS REDUCED TO NOT MORE THAN 
12 MONTHS. 
(a) PURPOSE.—In general, the 36-month period cur-
rently allowed for claims filing under parts A, B, C, and, 
D of title XVIII of the Social Security Act presents oppor-
tunities for fraud schemes in which processing patterns 
of the Centers for Medicare & Medicaid Services can be 
observed and exploited. Narrowing the window for claims 
processing will not overburden providers and will reduce 
fraud and abuse. 
(b) REDUCING MAXIMUM PERIOD
FOR SUBMIS-
SION.— 
(1) PART A.—Section 1814(a) of the Social Se-
curity Act (42 U.S.C. 1395f(a)) is amended— 
(A) in paragraph (1), by striking ‘‘period 
of 3 calendar years’’ and all that follows and in-
serting ‘‘period of 1 calendar year from which 
such services are furnished; and’’; and 
(B) by adding at the end the following new 
sentence: ‘‘In applying paragraph (1), the Sec-
retary may specify exceptions to the 1 calendar 
year period specified in such paragraph.’’. 
(2) PART B.—Section 1835(a) of such Act (42 
U.S.C. 1395n(a)) is amended— 
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(A) in paragraph (1), by striking ‘‘period 
of 3 calendar years’’ and all that follows and in-
serting ‘‘period of 1 calendar year from which 
such services are furnished; and’’; and 
(B) by adding at the end the following new 
sentence: ‘‘In applying paragraph (1), the Sec-
retary may specify exceptions to the 1 calendar 
year period specified in such paragraph.’’. 
(3) PARTS C AND D.—Section 1857(d) of such 
Act is amended by adding at the end the following 
new paragraph: 
‘‘(7) PERIOD FOR SUBMISSION OF CLAIMS.— 
The contract shall require an MA organization or 
PDP sponsor to require any provider of services 
under contract with, in partnership with, or affili-
ated with such organization or sponsor to ensure 
that, with respect to items and services furnished by 
such provider to an enrollee of such organization, 
written request, signed by such enrollee, except in 
cases in which the Secretary finds it impracticable 
for the enrollee to do so, is filed for payment for 
such items and services in such form, in such man-
ner, and by such person or persons as the Secretary 
may by regulation prescribe, no later than the close 
of the 1 calendar year period after such items and 
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services are furnished. In applying the previous sen-
tence, the Secretary may specify exceptions to the 1 
calendar year period specified.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsection (b) shall be effective for items and services fur-
nished on or after January 1, 2011. 
SEC. 1637. PHYSICIANS WHO ORDER DURABLE MEDICAL 
EQUIPMENT OR HOME HEALTH SERVICES RE-
QUIRED TO BE MEDICARE ENROLLED PHYSI-
CIANS OR ELIGIBLE PROFESSIONALS. 
(a) DME.—Section 1834(a)(11)(B) of the Social Se-
curity Act (42 U.S.C. 1395m(a)(11)(B)) is amended by 
striking ‘‘physician’’ and inserting ‘‘physician enrolled 
under section 1866(j) or other professional, as determined 
by the Secretary’’. 
(b) HOME HEALTH SERVICES.— 
(1) PART A.—Section 1814(a)(2) of such Act 
(42 U.S.C. 1395(a)(2)) is amended in the matter 
preceding subparagraph (A) by inserting ‘‘in the 
case of services described in subparagraph (C), a 
physician enrolled under section 1866(j) or other 
professional, as determined by the Secretary,’’ before 
‘‘or, in the case of services’’. 
(2) PART B.—Section 1835(a)(2) of such Act 
(42 U.S.C. 1395n(a)(2)) is amended in the matter 
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preceding subparagraph (A) by inserting ‘‘, or in the 
case of services described in subparagraph (A), a 
physician enrolled under section 1866(j) or other 
professional, as determined by the Secretary,’’ after 
‘‘a physician’’. 
(c) DISCRETION
TO EXPAND APPLICATION.—The 
Secretary may extend the requirement applied by the 
amendments made by subsections (a) and (b) to durable 
medical equipment and home health services (relating to 
requiring certifications and written orders to be made by 
enrolled physicians and health professions) to other cat-
egories of items or services under this title, including cov-
ered part D drugs as defined in section 1860D–2(e), if 
the Secretary determines that such application would help 
to reduce the risk of waste, fraud, and abuse with respect 
to such other categories under title XVIII of the Social 
Security Act. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply to written orders and certifications 
made on or after July 1, 2010. 
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SEC. 1638. REQUIREMENT FOR PHYSICIANS TO PROVIDE 
DOCUMENTATION ON REFERRALS TO PRO-
GRAMS AT HIGH RISK OF WASTE AND ABUSE. 
(a) PHYSICIANS AND OTHER SUPPLIERS.—Section 
1842(h) of the Social Security Act is further amended by 
adding at the end the following new paragraph 
‘‘(9) The Secretary may disenroll, for a period of not 
more than one year for each act, a physician or supplier 
under section 1866(j) if such physician or supplier fails 
to maintain and, upon request of the Secretary, provide 
access to documentation relating to written orders or re-
quests for payment for durable medical equipment, certifi-
cations for home health services, or referrals for other 
items or services written or ordered by such physician or 
supplier under this title, as specified by the Secretary.’’. 
(b) PROVIDERS OF SERVICES.—Section 1866(a)(1) 
of such Act (42 U.S.C. 1395cc), is amended— 
(1) in subparagraph (U), by striking at the end 
‘‘and’’; 
(2) in subparagraph (V), by striking the period 
at the end and adding ‘‘; and’’; and 
(3) by adding at the end the following new sub-
paragraph: 
‘‘(W) maintain and, upon request of the 
Secretary, provide access to documentation re-
lating to written orders or requests for payment 
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for durable medical equipment, certifications for 
home health services, or referrals for other 
items or services written or ordered by the pro-
vider under this title, as specified by the Sec-
retary.’’. 
(c) OIG PERMISSIVE EXCLUSION AUTHORITY.—Sec-
tion 1128(b)(11) of the Social Security Act (42 U.S.C. 
1320a–7(b)(11)) is amended by inserting ‘‘, ordering, re-
ferring for furnishing, or certifying the need for’’ after 
‘‘furnishing’’. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply to orders, certifications, and refer-
rals made on or after January 1, 2010. 
SEC. 1639. FACE-TO-FACE ENCOUNTER WITH PATIENT RE-
QUIRED 
BEFORE 
ELIGIBILITY 
CERTIFI-
CATIONS FOR HOME HEALTH SERVICES OR 
DURABLE MEDICAL EQUIPMENT. 
(a) CONDITION OF PAYMENT FOR HOME HEALTH 
SERVICES.— 
(1) PART
A.—Section 1814(a)(2)(C) of such 
Act is amended— 
(A) by striking ‘‘and such services’’ and in-
serting ‘‘such services’’; and 
(B) by inserting after ‘‘care of a physi-
cian’’ the following: ‘‘, and, in the case of a cer-
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tification or recertification made by a physician 
after January 1, 2010, prior to making such 
certification the physician must document that 
the physician has had a face-to-face encounter 
(including through use of telehealth and other 
than with respect to encounters that are inci-
dent to services involved) with the individual 
during the 6-month period preceding such cer-
tification, or other reasonable timeframe as de-
termined by the Secretary’’. 
(2) PART B.—Section 1835(a)(2)(A) of the So-
cial Security Act is amended— 
(A) by striking ‘‘and’’ before ‘‘(iii)’’; and 
(B) by inserting after ‘‘care of a physi-
cian’’ the following: ‘‘, and (iv) in the case of 
a certification or recertification after January 
1, 2010, prior to making such certification the 
physician must document that the physician has 
had a face-to-face encounter (including through 
use of telehealth and other than with respect to 
encounters that are incident to services in-
volved) with the individual during the 6-month 
period preceding such certification or recertifi-
cation, or other reasonable timeframe as deter-
mined by the Secretary’’. 
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(b) CONDITION OF PAYMENT FOR DURABLE MED-
ICAL EQUIPMENT.—Section 1834(a)(11)(B) of the Social 
Security Act (42 U.S.C. 1395m(a)(11)(B)) is amended by 
adding before the period at the end the following: ‘‘and 
shall require that any written order required for payment 
under this subsection be written only pursuant to the eligi-
ble health care professional authorized to make such writ-
ten order documenting that such professional has had a 
face-to-face encounter (including through use of telehealth 
and other than with respect to encounters that are inci-
dent to services involved) with the individual involved dur-
ing the 6-month period preceding such written order, or 
other reasonable timeframe as determined by the Sec-
retary’’. 
(c) APPLICATION TO OTHER AREAS UNDER MEDI-
CARE.—The Secretary may apply a face-to-face encounter 
requirement similar to the requirement described in the 
amendments made by subsections (a) and (b) to other 
items and services for which payment is provided under 
title XVIII of the Social Security Act based upon a finding 
that such a decision would reduce the risk of waste, fraud, 
or abuse. 
(d) APPLICATION TO MEDICAID AND CHIP.—The 
face-to-face encounter requirements described in the 
amendments made by subsections (a) and (b) and any ex-
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panded application of similar requirements pursuant to 
subsection (c) shall apply with respect to a certification 
or recertification for home health services under title XIX 
or XXI of the Social Security Act, a written order for du-
rable medical equipment under such title, and any other 
applicable item or service identified pursuant to subsection 
(c) for which payment is made under such title, respec-
tively, in the same manner and to the same extent as such 
requirements apply in the case of such a certification or 
recertification, written order, or other applicable item or 
service so identified, respectively, under title XVIII of such 
Act. 
SEC. 1640. EXTENSION OF TESTIMONIAL SUBPOENA AU-
THORITY TO PROGRAM EXCLUSION INVES-
TIGATIONS. 
(a) IN GENERAL.—Section 1128(f) of the Social Se-
curity Act (42 U.S.C. 1320a-7(f)) is amended by adding 
at the end the following new paragraph: 
‘‘(4) The provisions of subsections (d) and (e) of sec-
tion 205 shall apply with respect to this section to the 
same extent as they are applicable with respect to title 
II. The Secretary may delegate the authority granted by 
section 205(d) (as made applicable to this section) to the 
Inspector General of the Department of Health and 
Human Services or the Administrator of the Centers for 
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Medicare & Medicaid Services for purposes of any inves-
tigation under this section.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to investigations beginning on 
or after January 1, 2010. 
SEC. 1641. REQUIRED REPAYMENTS OF MEDICARE AND 
MEDICAID OVERPAYMENTS. 
Section 1128G of the Social Security Act, as inserted 
by section 1631 and amended by section 1632, is further 
amended by adding at the end the following new sub-
section: 
‘‘(c) REPORTS ON AND REPAYMENT OF OVERPAY-
MENTS IDENTIFIED THROUGH INTERNAL AUDITS AND 
REVIEWS.— 
‘‘(1) REPORTING
AND
RETURNING
OVERPAY-
MENTS.—If a person knows of an overpayment, the 
person must— 
‘‘(A) report and return the overpayment to 
the Secretary, the State, an intermediary, a 
carrier, or a contractor, as appropriate, at the 
correct address, and 
‘‘(B) notify the Secretary, the State, inter-
mediary, carrier, or contractor to whom the 
overpayment was returned in writing of the rea-
son for the overpayment. 
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‘‘(2) TIMING.—Subject to section 1620(d) of 
the Affordable Health Care for America Act, an 
overpayment must be reported and returned under 
paragraph (1)(A) by not later than the date that is 
60 days after the date the person knows of the over-
payment. 
Any known overpayment retained later than the ap-
plicable date specified in this paragraph creates an 
obligation as defined in section 3729(b)(3) of title 
31 of the United States Code. 
‘‘(3) CLARIFICATION.—Repayment of any over-
payments (or refunding by withholding of future 
payments) by a provider of services or supplier does 
not otherwise limit the provider or supplier’s poten-
tial liability for administrative obligations such as 
applicable interests, fines, and penalties or civil or 
criminal sanctions involving the same claim if it is 
determined later that the reason for the overpay-
ment was related to fraud or other intentional con-
duct by the provider or supplier or the employees or 
agents of such provider or supplier. 
‘‘(4) DEFINITIONS.—In this subsection: 
‘‘(A) KNOWS.—The term ‘knows’ has the 
meaning given the terms ‘knowing’ and ‘know-
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ingly’ in section 3729(b) of title 31 of the 
United States Code. 
‘‘(B) OVERPAYMENT.—The term ‘‘overpay-
ment’’ means any funds that a person receives 
or retains under title XVIII, XIX, or XXI to 
which the person, after applicable reconciliation 
(pursuant to the applicable existing process 
under the respective title), is not entitled under 
such title. 
‘‘(C) PERSON.—The term ‘person’ means a 
provider of services, supplier, Medicaid man-
aged care organization (as defined in section 
1903(m)(1)(A)), Medicare Advantage organiza-
tion (as defined in section 1859(a)(1)), or PDP 
sponsor 
(as 
defined 
in 
section 
1860D– 
41(a)(13)), but excluding a beneficiary.’’. 
SEC. 1642. EXPANDED APPLICATION OF HARDSHIP WAIV-
ERS 
FOR 
OIG 
EXCLUSIONS 
TO 
BENE-
FICIARIES OF ANY FEDERAL HEALTH CARE 
PROGRAM. 
Section 1128(c)(3)(B) of the Social Security Act (42 
U.S.C. 1320a–7(c)(3)(B)) is amended by striking ‘‘indi-
viduals entitled to benefits under part A of title XVIII 
or enrolled under part B of such title, or both’’ and insert-
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ing ‘‘beneficiaries (as defined in section 1128A(i)(5)) of 
that program’’. 
SEC. 1643. ACCESS TO CERTAIN INFORMATION ON RENAL 
DIALYSIS FACILITIES. 
Section 1881(b) of the Social Security Act (42 U.S.C. 
1395rr(b)) is amended by adding at the end the following 
new paragraph: 
‘‘(15) For purposes of evaluating or auditing pay-
ments made to renal dialysis facilities for items and serv-
ices under this section under paragraph (1), each such 
renal dialysis facility, upon the request of the Secretary, 
shall provide to the Secretary access to information relat-
ing to any ownership or compensation arrangement be-
tween such facility and the medical director of such facility 
or between such facility and any physician.’’. 
SEC. 1644. BILLING AGENTS, CLEARINGHOUSES, OR OTHER 
ALTERNATE PAYEES REQUIRED TO REG-
ISTER UNDER MEDICARE. 
(a) MEDICARE.—Section 1866(j)(1) of the Social Se-
curity Act (42 U.S.C. 1395cc(j)(1)) is amended by adding 
at the end the following new subparagraph: 
‘‘(D) BILLING
AGENTS
AND
CLEARING-
HOUSES REQUIRED TO BE REGISTERED UNDER 
MEDICARE.—Any agent, clearinghouse, or other 
alternate payee that submits claims on behalf of 
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a health care provider must be registered with 
the Secretary in a form and manner specified 
by the Secretary.’’. 
(b) MEDICAID.—For a similar provision with respect 
to the Medicaid program under title XIX of the Social Se-
curity Act, see section 1759. 
(c) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to claims submitted on or after 
January 1, 2012. 
SEC. 1645. CONFORMING CIVIL MONETARY PENALTIES TO 
FALSE CLAIMS ACT AMENDMENTS. 
Section 1128A of the Social Security Act, as amended 
by sections 1611, 1612, 1613, and 1615, is further 
amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by striking ‘‘to an 
officer, employee, or agent of the United States, 
or of any department or agency thereof, or of 
any State agency (as defined in subsection 
(i)(1))’’; 
(B) in paragraph (4)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘participating in a 
program under title XVIII or a State 
health care program’’ and inserting ‘‘par-
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ticipating in a Federal health care program 
(as defined in section 1128B(f))’’; and 
(ii) in subparagraph (A), by striking 
‘‘title XVIII or a State health care pro-
gram’’ and inserting ‘‘a Federal health 
care program (as defined in section 
1128B(f))’’; 
(C) by striking ‘‘or’’ at the end of para-
graph (10); 
(D) by inserting after paragraph (11) the 
following new paragraphs: 
‘‘(12) conspires to commit a violation of this 
section; or 
‘‘(13) knowingly makes, uses, or causes to be 
made or used, a false record or statement material 
to an obligation to pay or transmit money or prop-
erty to a Federal health care program, or knowingly 
conceals or knowingly and improperly avoids or de-
creases an obligation to pay or transmit money or 
property to a Federal health care program;’’; and 
(E) in the matter following paragraph 
(13), as inserted by subparagraph (D)— 
(i) by striking ‘‘or’’ before ‘‘in cases 
under paragraph (11)’’; and 
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(ii) by inserting ‘‘, in cases under 
paragraph (12), $50,000 for any violation 
described in this section committed in fur-
therance of the conspiracy involved; or in 
cases under paragraph (13), $50,000 for 
each false record or statement, or conceal-
ment, avoidance, or decrease’’ after ‘‘by an 
excluded individual’’; and 
(F) in the second sentence, by striking 
‘‘such false statement, omission, or misrepre-
sentation)’’ and inserting ‘‘such false statement 
or misrepresentation, in cases under paragraph 
(12), an assessment of not more than 3 times 
the total amount that would otherwise apply for 
any violation described in this section com-
mitted in furtherance of the conspiracy in-
volved, or in cases under paragraph (13), an as-
sessment of not more than 3 times the total 
amount of the obligation to which the false 
record or statement was material or that was 
avoided or decreased)’’. 
(2) in subsection (c)(1), by striking ‘‘six years’’ 
and inserting ‘‘10 years’’; and 
(3) in subsection (i)— 
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996 
(A) by amending paragraph (2) to read as 
follows: 
‘‘(2) The term ‘claim’ means any application, 
request, or demand, whether under contract, or oth-
erwise, for money or property for items and services 
under a Federal health care program (as defined in 
section 1128B(f)), whether or not the United States 
or a State agency has title to the money or property, 
that— 
‘‘(A) is presented or caused to be pre-
sented to an officer, employee, or agent of the 
United States, or of any department or agency 
thereof, or of any State agency (as defined in 
subsection (i)(1)); or 
‘‘(B) is made to a contractor, grantee, or 
other recipient if the money or property is to be 
spent or used on the Federal health care pro-
gram’s behalf or to advance a Federal health 
care program interest, and if the Federal health 
care program— 
‘‘(i) provides or has provided any por-
tion of the money or property requested or 
demanded; or 
‘‘(ii) will reimburse such contractor, 
grantee, or other recipient for any portion 
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997 
of the money or property which is re-
quested or demanded.’’; 
(B) by amending paragraph (3) to read as 
follows: 
‘‘(3) The term ‘item or service’ means, without 
limitation, any medical, social, management, admin-
istrative, or other item or service used in connection 
with or directly or indirectly related to a Federal 
health care program.’’; 
(C) in paragraph (6)— 
(i) in subparagraph (C), by striking at 
the end ‘‘or’’; 
(ii) in the first subparagraph (D), by 
striking at the end the period and inserting 
‘‘; or’’; and 
(iii) by redesignating the second sub-
paragraph (D) as a subparagraph (E); 
(D) by amending paragraph (7) to read as 
follows: 
‘‘(7) The terms ‘knowing’, ‘knowingly’, and 
‘should know’ mean that a person, with respect to 
information— 
‘‘(A) has actual knowledge of the informa-
tion; 
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998 
‘‘(B) acts in deliberate ignorance of the 
truth or falsity of the information; or 
‘‘(C) acts in reckless disregard of the truth 
or falsity of the information; 
and require no proof of specific intent to defraud.’’; 
and 
(E) by adding at the end the following new 
paragraphs: 
‘‘(8) The term ‘obligation’ means an established 
duty, whether or not fixed, arising from an express 
or implied contractual, grantor-grantee, or licensor- 
licensee relationship, from a fee-based or similar re-
lationship, from statute or regulation, or from the 
retention of any overpayment. 
‘‘(9) The term ‘material’ means having a nat-
ural tendency to influence, or be capable of influ-
encing, the payment or receipt of money or prop-
erty.’’. 
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ister a notice specifying the DSH allotment to 
each State under 1923(f) of the Social Security 
Act for the respective fiscal year specified in 
such subparagraph, consistent with the applica-
tion of the DSH Health Reform methodology 
described in paragraph (2). 
(B) PUBLICATION DEADLINE.—The publi-
cation deadline specified in this subparagraph 
is— 
(i) January 1, 2016, with respect to 
DSH allotments described in subparagraph 
(A) for fiscal year 2017; 
(ii) January 1, 2017, with respect to 
DSH allotments described in subparagraph 
(A) for fiscal year 2018; and 
(iii) January 1, 2018, with respect to 
DSH allotments described in subparagraph 
(A) for fiscal year 2019. 
(c) CONFORMING AMENDMENTS.— 
(1) Section 1923(f) of the Social Security Act 
(42 U.S.C. 1396r–4(f)) is amended— 
(A) by redesignating paragraph (7) as 
paragraph (8); and 
(B) by inserting after paragraph (6) the 
following new paragraph: 
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