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Secretary may require (which may include 
evidence of consultation with the State in 
which the eligible entity is located with re-
spect to carrying out activities funded 
under the grant). 
‘‘(iii) AUTHORITY TO LIMIT NUMBER 
OF APPLICANTS.—Nothing in this subpara-
graph shall be construed as prohibiting the 
Secretary from limiting the number of ap-
plicants for a grant under this subpara-
graph. 
‘‘(3) SPECIFIC PROGRAMS TO IMPROVE MANAGE-
MENT PRACTICES.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
make grants to eligible entities to enable the enti-
ties to provide training and technical assistance. 
‘‘(B) AUTHORIZED ACTIVITIES.—An eligible 
entity that receives a grant under subparagraph 
(A) shall use funds made available through the 
grant to provide training and technical assist-
ance regarding management practices using 
methods that are demonstrated to promote reten-
tion of individuals who provide direct care, such 
as— 
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‘‘(i) the establishment of standard 
human resource policies that reward high 
performance, including policies that provide 
for improved wages and benefits on the 
basis of job reviews; 
‘‘(ii) the establishment of motivational 
and thoughtful work organization practices; 
‘‘(iii) the creation of a workplace cul-
ture that respects and values caregivers and 
their needs; 
‘‘(iv) the promotion of a workplace cul-
ture that respects the rights of residents of 
an eligible entity or individuals receiving 
community-based long-term care from an el-
igible entity and results in improved care 
for the residents or the individuals; and 
‘‘(v) the establishment of other pro-
grams that promote the provision of high 
quality care, such as a continuing edu-
cation program that provides additional 
hours of training, including on-the-job 
training, for employees who are certified 
nurse aides. 
‘‘(C) APPLICATION.—To be eligible to re-
ceive a grant under this paragraph, an eligible 
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entity shall submit an application to the Sec-
retary at such time, in such manner, and con-
taining such information as the Secretary may 
require (which may include evidence of consulta-
tion with the State in which the eligible entity 
is located with respect to carrying out activities 
funded under the grant). 
‘‘(D) AUTHORITY TO LIMIT NUMBER OF AP-
PLICANTS.—Nothing in this paragraph shall be 
construed as prohibiting the Secretary from lim-
iting the number of applicants for a grant under 
this paragraph. 
‘‘(4) ACCOUNTABILITY
MEASURES.—The Sec-
retary shall develop accountability measures to ensure 
that the activities conducted using funds made avail-
able under this subsection benefit individuals who 
provide direct care and increase the stability of the 
long-term care workforce. 
‘‘(5) DEFINITIONS.—In this subsection: 
‘‘(A) 
COMMUNITY-BASED
LONG-TERM 
CARE.—The term ‘community-based long-term 
care’ has the meaning given such term by the 
Secretary. 
‘‘(B) ELIGIBLE ENTITY.—The term ‘eligible 
entity’ means the following: 
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‘‘(i) A long-term care facility. 
‘‘(ii) A community-based long-term 
care entity (as defined by the Secretary). 
‘‘(b) CERTIFIED EHR TECHNOLOGY GRANT PRO-
GRAM.— 
‘‘(1) GRANTS
AUTHORIZED.—The Secretary is 
authorized to make grants to long-term care facilities 
for the purpose of assisting such entities in offsetting 
the costs related to purchasing, leasing, developing, 
and implementing certified EHR technology (as de-
fined in section 1848(o)(4)) designed to improve pa-
tient safety and reduce adverse events and health care 
complications resulting from medication errors. 
‘‘(2) USE OF GRANT FUNDS.—Funds provided 
under grants under this subsection may be used for 
any of the following: 
‘‘(A) Purchasing, leasing, and installing 
computer software and hardware, including 
handheld computer technologies. 
‘‘(B) Making improvements to existing com-
puter software and hardware. 
‘‘(C) Making upgrades and other improve-
ments to existing computer software and hard-
ware to enable e-prescribing. 
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‘‘(D) Providing education and training to 
eligible long-term care facility staff on the use of 
such technology to implement the electronic 
transmission of prescription and patient infor-
mation. 
‘‘(3) APPLICATION.— 
‘‘(A) IN GENERAL.—To be eligible to receive 
a grant under this subsection, a long-term care 
facility shall submit an application to the Sec-
retary at such time, in such manner, and con-
taining such information as the Secretary may 
require (which may include evidence of consulta-
tion with the State in which the long-term care 
facility is located with respect to carrying out 
activities funded under the grant). 
‘‘(B) AUTHORITY TO LIMIT NUMBER OF AP-
PLICANTS.—Nothing in this subsection shall be 
construed as prohibiting the Secretary from lim-
iting the number of applicants for a grant under 
this subsection. 
‘‘(4) PARTICIPATION
IN
STATE
HEALTH
EX-
CHANGES.—A long-term care facility that receives a 
grant under this subsection shall, where available, 
participate in activities conducted by a State or a 
qualified State-designated entity (as defined in sec-
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tion 3013(f) of the Public Health Service Act) under 
a grant under section 3013 of the Public Health Serv-
ice Act to coordinate care and for other purposes de-
termined appropriate by the Secretary. 
‘‘(5) ACCOUNTABILITY
MEASURES.—The Sec-
retary shall develop accountability measures to ensure 
that the activities conducted using funds made avail-
able under this subsection help improve patient safety 
and reduce adverse events and health care complica-
tions resulting from medication errors. 
‘‘(c) ADOPTION OF STANDARDS FOR TRANSACTIONS IN-
VOLVING CLINICAL DATA BY LONG-TERM CARE FACILI-
TIES.— 
‘‘(1) STANDARDS AND COMPATIBILITY.—The Sec-
retary shall adopt electronic standards for the ex-
change of clinical data by long-term care facilities, 
including, where available, standards for messaging 
and nomenclature. Standards adopted by the Sec-
retary under the preceding sentence shall be compat-
ible with standards established under part C of title 
XI, 
standards 
established 
under 
subsections 
(b)(2)(B)(i) and (e)(4) of section 1860D–4, standards 
adopted under section 3004 of the Public Health Serv-
ice Act, and general health information technology 
standards. 
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‘‘(2) ELECTRONIC SUBMISSION OF DATA TO THE 
SECRETARY.— 
‘‘(A) IN GENERAL.—Not later than 10 years 
after the date of enactment of the Elder Justice 
Act of 2009, the Secretary shall have procedures 
in place to accept the optional electronic submis-
sion of clinical data by long-term care facilities 
pursuant to the standards adopted under para-
graph (1). 
‘‘(B) RULE OF CONSTRUCTION.—Nothing in 
this subsection shall be construed to require a 
long-term care facility to submit clinical data 
electronically to the Secretary. 
‘‘(3) REGULATIONS.—The Secretary shall pro-
mulgate regulations to carry out this subsection. Such 
regulations shall require a State, as a condition of the 
receipt of funds under this part, to conduct such data 
collection and reporting as the Secretary determines 
are necessary to satisfy the requirements of this sub-
section. 
‘‘(d) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this sec-
tion— 
‘‘(1) for fiscal year 2011, $20,000,000; 
‘‘(2) for fiscal year 2012, $17,500,000; and 
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‘‘(3) for each of fiscal years 2013 and 2014, 
$15,000,000. 
‘‘SEC. 2042. ADULT PROTECTIVE SERVICES FUNCTIONS AND 
GRANT PROGRAMS. 
‘‘(a) SECRETARIAL RESPONSIBILITIES.— 
‘‘(1) IN GENERAL.—The Secretary shall ensure 
that the Department of Health and Human Serv-
ices— 
‘‘(A) provides funding authorized by this 
part to State and local adult protective services 
offices that investigate reports of the abuse, ne-
glect, and exploitation of elders; 
‘‘(B) collects and disseminates data annu-
ally relating to the abuse, exploitation, and ne-
glect of elders in coordination with the Depart-
ment of Justice; 
‘‘(C) develops and disseminates information 
on best practices regarding, and provides train-
ing on, carrying out adult protective services; 
‘‘(D) conducts research related to the provi-
sion of adult protective services; and 
‘‘(E) provides technical assistance to States 
and other entities that provide or fund the provi-
sion of adult protective services, including 
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through grants made under subsections (b) and 
(c). 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection, $3,000,000 for fiscal year 2011 and 
$4,000,000 for each of fiscal years 2012 through 2014. 
‘‘(b) GRANTS TO ENHANCE THE PROVISION OF ADULT 
PROTECTIVE SERVICES.— 
‘‘(1) ESTABLISHMENT.—There is established an 
adult protective services grant program under which 
the Secretary shall annually award grants to States 
in the amounts calculated under paragraph (2) for 
the purposes of enhancing adult protective services 
provided by States and local units of government. 
‘‘(2) AMOUNT OF PAYMENT.— 
‘‘(A) IN
GENERAL.—Subject to the avail-
ability of appropriations and subparagraphs (B) 
and (C), the amount paid to a State for a fiscal 
year under the program under this subsection 
shall equal the amount appropriated for that 
year to carry out this subsection multiplied by 
the percentage of the total number of elders who 
reside in the United States who reside in that 
State. 
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‘‘(B) 
GUARANTEED
MINIMUM
PAYMENT 
AMOUNT.— 
‘‘(i) 50 STATES.—Subject to clause (ii), 
if the amount determined under subpara-
graph (A) for a State for a fiscal year is 
less than 0.75 percent of the amount appro-
priated for such year, the Secretary shall 
increase such determined amount so that the 
total amount paid under this subsection to 
the State for the year is equal to 0.75 per-
cent of the amount so appropriated. 
‘‘(ii) TERRITORIES.—In the case of a 
State other than 1 of the 50 States, clause 
(i) shall be applied as if each reference to 
‘0.75’ were a reference to ‘0.1’. 
‘‘(C) PRO
RATA
REDUCTIONS.—The Sec-
retary shall make such pro rata reductions to the 
amounts described in subparagraph (A) as are 
necessary to comply with the requirements of 
subparagraph (B). 
‘‘(3) AUTHORIZED ACTIVITIES.— 
‘‘(A) 
ADULT
PROTECTIVE
SERVICES.— 
Funds made available pursuant to this sub-
section may only be used by States and local 
units of government to provide adult protective 
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services and may not be used for any other pur-
pose. 
‘‘(B) USE BY AGENCY.—Each State receiv-
ing funds pursuant to this subsection shall pro-
vide such funds to the agency or unit of State 
government having legal responsibility for pro-
viding adult protective services within the State. 
‘‘(C) SUPPLEMENT
NOT
SUPPLANT.—Each 
State or local unit of government shall use funds 
made available pursuant to this subsection to 
supplement and not supplant other Federal, 
State, and local public funds expended to provide 
adult protective services in the State. 
‘‘(4) STATE
REPORTS.—Each State receiving 
funds under this subsection shall submit to the Sec-
retary, at such time and in such manner as the Sec-
retary may require, a report on the number of elders 
served by the grants awarded under this subsection. 
‘‘(5) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection, $100,000,000 for each of fiscal years 
2011 through 2014. 
‘‘(c) STATE DEMONSTRATION PROGRAMS.— 
‘‘(1) 
ESTABLISHMENT.—The 
Secretary 
shall 
award grants to States for the purposes of conducting 
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demonstration programs in accordance with para-
graph (2). 
‘‘(2) DEMONSTRATION PROGRAMS.—Funds made 
available pursuant to this subsection may be used by 
States and local units of government to conduct dem-
onstration programs that test— 
‘‘(A) training modules developed for the 
purpose of detecting or preventing elder abuse; 
‘‘(B) methods to detect or prevent financial 
exploitation of elders; 
‘‘(C) methods to detect elder abuse; 
‘‘(D) whether training on elder abuse 
forensics enhances the detection of elder abuse by 
employees of the State or local unit of govern-
ment; or 
‘‘(E) other matters relating to the detection 
or prevention of elder abuse. 
‘‘(3) APPLICATION.—To be eligible to receive a 
grant under this subsection, a State shall submit an 
application to the Secretary at such time, in such 
manner, and containing such information as the Sec-
retary may require. 
‘‘(4) STATE REPORTS.—Each State that receives 
funds under this subsection shall submit to the Sec-
retary a report at such time, in such manner, and 
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containing such information as the Secretary may re-
quire on the results of the demonstration program 
conducted by the State using funds made available 
under this subsection. 
‘‘(5) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection, $25,000,000 for each of fiscal years 
2011 through 2014. 
‘‘SEC. 2043. LONG-TERM CARE OMBUDSMAN PROGRAM 
GRANTS AND TRAINING. 
‘‘(a) GRANTS TO SUPPORT THE LONG-TERM CARE 
OMBUDSMAN PROGRAM.— 
‘‘(1) IN
GENERAL.—The Secretary shall make 
grants to eligible entities with relevant expertise and 
experience in abuse and neglect in long-term care fa-
cilities or long-term care ombudsman programs and 
responsibilities, for the purpose of— 
‘‘(A) improving the capacity of State long- 
term care ombudsman programs to respond to 
and resolve complaints about abuse and neglect; 
‘‘(B) conducting pilot programs with State 
long-term care ombudsman offices or local om-
budsman entities; and 
‘‘(C) providing support for such State long- 
term care ombudsman programs and such pilot 
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programs (such as through the establishment of 
a national long-term care ombudsman resource 
center). 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection— 
‘‘(A) for fiscal year 2011, $5,000,000; 
‘‘(B) for fiscal year 2012, $7,500,000; and 
‘‘(C) for each of fiscal years 2013 and 2014, 
$10,000,000. 
‘‘(b) OMBUDSMAN TRAINING PROGRAMS.— 
‘‘(1) IN GENERAL.—The Secretary shall establish 
programs to provide and improve ombudsman train-
ing with respect to elder abuse, neglect, and exploi-
tation for national organizations and State long-term 
care ombudsman programs. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection, for each of fiscal years 2011 through 
2014, $10,000,000. 
‘‘SEC. 2044. PROVISION OF INFORMATION REGARDING, AND 
EVALUATIONS 
OF, 
ELDER 
JUSTICE 
PRO-
GRAMS. 
‘‘(a) PROVISION OF INFORMATION.—To be eligible to 
receive a grant under this part, an applicant shall agree— 
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‘‘(1) except as provided in paragraph (2), to pro-
vide the eligible entity conducting an evaluation 
under subsection (b) of the activities funded through 
the grant with such information as the eligible entity 
may require in order to conduct such evaluation; or 
‘‘(2) in the case of an applicant for a grant 
under section 2041(b), to provide the Secretary with 
such information as the Secretary may require to 
conduct an evaluation or audit under subsection (c). 
‘‘(b) USE OF ELIGIBLE ENTITIES TO CONDUCT EVAL-
UATIONS.— 
‘‘(1) EVALUATIONS REQUIRED.—Except as pro-
vided in paragraph (2), the Secretary shall— 
‘‘(A) reserve a portion (not less than 2 per-
cent) of the funds appropriated with respect to 
each program carried out under this part; and 
‘‘(B) use the funds reserved under subpara-
graph (A) to provide assistance to eligible enti-
ties to conduct evaluations of the activities fund-
ed under each program carried out under this 
part. 
‘‘(2) CERTIFIED EHR TECHNOLOGY GRANT PRO-
GRAM NOT INCLUDED.—The provisions of this sub-
section shall not apply to the certified EHR tech-
nology grant program under section 2041(b). 
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‘‘(3) AUTHORIZED ACTIVITIES.—A recipient of 
assistance described in paragraph (1)(B) shall use the 
funds made available through the assistance to con-
duct a validated evaluation of the effectiveness of the 
activities funded under a program carried out under 
this part. 
‘‘(4) APPLICATIONS.—To be eligible to receive as-
sistance under paragraph (1)(B), an entity shall sub-
mit an application to the Secretary at such time, in 
such manner, and containing such information as the 
Secretary may require, including a proposal for the 
evaluation. 
‘‘(5) REPORTS.—Not later than a date specified 
by the Secretary, an eligible entity receiving assist-
ance under paragraph (1)(B) shall submit to the Sec-
retary, the Committee on Ways and Means and the 
Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Finance of the 
Senate a report containing the results of the evalua-
tion conducted using such assistance together with 
such recommendations as the entity determines to be 
appropriate. 
‘‘(c) EVALUATIONS AND AUDITS OF CERTIFIED EHR 
TECHNOLOGY GRANT PROGRAM BY THE SECRETARY.— 
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‘‘(1) EVALUATIONS.—The Secretary shall con-
duct an evaluation of the activities funded under the 
certified EHR technology grant program under sec-
tion 2041(b). Such evaluation shall include an eval-
uation of whether the funding provided under the 
grant is expended only for the purposes for which it 
is made. 
‘‘(2) AUDITS.—The Secretary shall conduct ap-
propriate audits of grants made under section 
2041(b). 
‘‘SEC. 2045. REPORT. 
‘‘Not later than October 1, 2014, the Secretary shall 
submit to the Elder Justice Coordinating Council estab-
lished under section 2021, the Committee on Ways and 
Means and the Committee on Energy and Commerce of the 
House of Representatives, and the Committee on Finance 
of the Senate a report— 
‘‘(1) compiling, summarizing, and analyzing the 
information contained in the State reports submitted 
under subsections (b)(4) and (c)(4) of section 2042; 
and 
‘‘(2) containing such recommendations for legis-
lative or administrative action as the Secretary deter-
mines to be appropriate. 
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‘‘SEC. 2046. RULE OF CONSTRUCTION. 
‘‘Nothing in this subtitle shall be construed as— 
‘‘(1) limiting any cause of action or other relief 
related to obligations under this subtitle that is avail-
able under the law of any State, or political subdivi-
sion thereof; or 
‘‘(2) creating a private cause of action for a vio-
lation of this subtitle.’’. 
(2) OPTION FOR STATE PLAN UNDER PROGRAM 
FOR
TEMPORARY
ASSISTANCE
FOR
NEEDY
FAMI-
LIES.— 
(A) IN GENERAL.—Section 402(a)(1)(B) of 
the Social Security Act (42 U.S.C. 602(a)(1)(B)) 
is amended by adding at the end the following 
new clause: 
‘‘(v) The document shall indicate 
whether the State intends to assist individ-
uals to train for, seek, and maintain em-
ployment— 
‘‘(I) providing direct care in a 
long-term care facility (as such terms 
are defined under section 2011); or 
‘‘(II) in other occupations related 
to elder care determined appropriate 
by the State for which the State identi-
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fies an unmet need for service per-
sonnel, 
and, if so, shall include an overview of such 
assistance.’’. 
(B) EFFECTIVE
DATE.—The amendment 
made by subparagraph (A) shall take effect on 
January 1, 2011. 
(b) PROTECTING RESIDENTS OF LONG-TERM CARE 
FACILITIES.— 
(1) NATIONAL
TRAINING
INSTITUTE
FOR
SUR-
VEYORS.— 
(A) IN GENERAL.—The Secretary of Health 
and Human Services shall enter into a contract 
with an entity for the purpose of establishing 
and operating a National Training Institute for 
Federal and State surveyors. Such Institute shall 
provide and improve the training of surveyors 
with respect to investigating allegations of abuse, 
neglect, and misappropriation of property in 
programs and long-term care facilities that re-
ceive payments under title XVIII or XIX of the 
Social Security Act. 
(B) ACTIVITIES CARRIED OUT BY THE IN-
STITUTE.—The contract entered into under sub-
paragraph (A) shall require the Institute estab-
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lished and operated under such contract to carry 
out the following activities: 
(i) Assess the extent to which State 
agencies use specialized surveyors for the in-
vestigation of reported allegations of abuse, 
neglect, and misappropriation of property 
in such programs and long-term care facili-
ties. 
(ii) Evaluate how the competencies of 
surveyors may be improved to more effec-
tively investigate reported allegations of 
such abuse, neglect, and misappropriation 
of property, and provide feedback to Federal 
and State agencies on the evaluations con-
ducted. 
(iii) Provide a national program of 
training, tools, and technical assistance to 
Federal and State surveyors on inves-
tigating reports of such abuse, neglect, and 
misappropriation of property. 
(iv) Develop and disseminate informa-
tion on best practices for the investigation 
of such abuse, neglect, and misappropria-
tion of property. 
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(v) Assess the performance of State 
complaint intake systems, in order to ensure 
that the intake of complaints occurs 24 
hours per day, 7 days a week (including 
holidays). 
(vi) To the extent approved by the Sec-
retary of Health and Human Services, pro-
vide a national 24 hours per day, 7 days a 
week (including holidays), back-up system 
to State complaint intake systems in order 
to ensure optimum national responsiveness 
to complaints of such abuse, neglect, and 
misappropriation of property. 
(vii) Analyze and report annually on 
the following: 
(I) The total number and sources 
of complaints of such abuse, neglect, 
and misappropriation of property. 
(II) The extent to which such com-
plaints are referred to law enforcement 
agencies. 
(III) General results of Federal 
and State investigations of such com-
plaints. 
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(viii) Conduct a national study of the 
cost to State agencies of conducting com-
plaint investigations of skilled nursing fa-
cilities and nursing facilities under sections 
1819 and 1919, respectively, of the Social 
Security Act (42 U.S.C. 1395i–3; 1396r), 
and making recommendations to the Sec-
retary of Health and Human Services with 
respect to options to increase the efficiency 
and cost-effectiveness of such investigations. 
(C) AUTHORIZATION.—There are authorized 
to be appropriated to carry out this paragraph, 
for the period of fiscal years 2011 through 2014, 
$12,000,000. 
(2) GRANTS TO STATE SURVEY AGENCIES.— 
(A) IN GENERAL.—The Secretary of Health 
and Human Services shall make grants to State 
agencies that perform surveys of skilled nursing 
facilities or nursing facilities under sections 
1819 or 1919, respectively, of the Social Security 
Act (42 U.S.C. 1395i–3; 1395r). 
(B) USE
OF
FUNDS.—A grant awarded 
under subparagraph (A) shall be used for the 
purpose of designing and implementing com-
plaint investigations systems that— 
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(i) promptly prioritize complaints in 
order to ensure a rapid response to the most 
serious and urgent complaints; 
(ii) respond to complaints with opti-
mum effectiveness and timeliness; and 
(iii) optimize the collaboration between 
local authorities, consumers, and providers, 
including— 
(I) such State agency; 
(II) the State Long-Term Care 
Ombudsman; 
(III) local law enforcement agen-
cies; 
(IV) advocacy and consumer orga-
nizations; 
(V) State aging units; 
(VI) Area Agencies on Aging; and 
(VII) other appropriate entities. 
(C) AUTHORIZATION.—There are authorized 
to be appropriated to carry out this paragraph, 
for each of fiscal years 2011 through 2014, 
$5,000,000. 
(3) REPORTING OF CRIMES IN FEDERALLY FUND-
ED LONG-TERM CARE FACILITIES.—Part A of title XI 
of the Social Security Act (42 U.S.C. 1301 et seq.), 
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as amended by section 6005, is amended by inserting 
after section 1150A the following new section: 
‘‘REPORTING TO LAW ENFORCEMENT OF CRIMES OCCUR-
RING IN FEDERALLY FUNDED LONG-TERM CARE FA-
CILITIES 
‘‘SEC. 1150B. (a) DETERMINATION
AND NOTIFICA-
TION.— 
‘‘(1) DETERMINATION.—The owner or operator of 
each long-term care facility that receives Federal 
funds under this Act shall annually determine wheth-
er the facility received at least $10,000 in such Fed-
eral funds during the preceding year. 
‘‘(2) NOTIFICATION.—If the owner or operator 
determines under paragraph (1) that the facility re-
ceived at least $10,000 in such Federal funds during 
the preceding year, such owner or operator shall an-
nually notify each covered individual (as defined in 
paragraph (3)) of that individual’s obligation to com-
ply with the reporting requirements described in sub-
section (b). 
‘‘(3) COVERED
INDIVIDUAL
DEFINED.—In this 
section, the term ‘covered individual’ means each in-
dividual who is an owner, operator, employee, man-
ager, agent, or contractor of a long-term care facility 
that is the subject of a determination described in 
paragraph (1). 
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‘‘(b) REPORTING REQUIREMENTS.— 
‘‘(1) IN
GENERAL.—Each covered individual 
shall report to the Secretary and 1 or more law en-
forcement entities for the political subdivision in 
which the facility is located any reasonable suspicion 
of a crime (as defined by the law of the applicable po-
litical subdivision) against any individual who is a 
resident of, or is receiving care from, the facility. 
‘‘(2) TIMING.—If the events that cause the sus-
picion— 
‘‘(A) result in serious bodily injury, the in-
dividual shall report the suspicion immediately, 
but not later than 2 hours after forming the sus-
picion; and 
‘‘(B) do not result in serious bodily injury, 
the individual shall report the suspicion not 
later than 24 hours after forming the suspicion. 
‘‘(c) PENALTIES.— 
‘‘(1) IN GENERAL.—If a covered individual vio-
lates subsection (b)— 
‘‘(A) the covered individual shall be subject 
to a civil money penalty of not more than 
$200,000; and 
‘‘(B) the Secretary may make a determina-
tion in the same proceeding to exclude the cov-
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ered individual from participation in any Fed-
eral health care program (as defined in section 
1128B(f)). 
‘‘(2) INCREASED HARM.—If a covered individual 
violates subsection (b) and the violation exacerbates 
the harm to the victim of the crime or results in harm 
to another individual— 
‘‘(A) the covered individual shall be subject 
to a civil money penalty of not more than 
$300,000; and 
‘‘(B) the Secretary may make a determina-
tion in the same proceeding to exclude the cov-
ered individual from participation in any Fed-
eral health care program (as defined in section 
1128B(f)). 
‘‘(3) EXCLUDED INDIVIDUAL.—During any pe-
riod for which a covered individual is classified as an 
excluded individual under paragraph (1)(B) or 
(2)(B), a long-term care facility that employs such 
individual shall be ineligible to receive Federal funds 
under this Act. 
‘‘(4) EXTENUATING CIRCUMSTANCES.— 
‘‘(A) IN GENERAL.—The Secretary may take 
into account the financial burden on providers 
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with underserved populations in determining 
any penalty to be imposed under this subsection. 
‘‘(B) 
UNDERSERVED
POPULATION
DE-
FINED.—In this paragraph, the term ‘under-
served population’ means the population of an 
area designated by the Secretary as an area with 
a shortage of elder justice programs or a popu-
lation group designated by the Secretary as hav-
ing a shortage of such programs. Such areas or 
groups designated by the Secretary may in-
clude— 
‘‘(i) areas or groups that are geo-
graphically isolated (such as isolated in a 
rural area); 
‘‘(ii) racial and ethnic minority popu-
lations; and 
‘‘(iii) populations underserved because 
of special needs (such as language barriers, 
disabilities, alien status, or age). 
‘‘(d) ADDITIONAL PENALTIES FOR RETALIATION.— 
‘‘(1) IN
GENERAL.—A long-term care facility 
may not— 
‘‘(A) discharge, demote, suspend, threaten, 
harass, or deny a promotion or other employ-
ment-related benefit to an employee, or in any 
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other manner discriminate against an employee 
in the terms and conditions of employment be-
cause of lawful acts done by the employee; or 
‘‘(B) file a complaint or a report against a 
nurse or other employee with the appropriate 
State professional disciplinary agency because of 
lawful acts done by the nurse or employee, 
for making a report, causing a report to be made, or 
for taking steps in furtherance of making a report 
pursuant to subsection (b)(1). 
‘‘(2) PENALTIES FOR RETALIATION.—If a long- 
term care facility violates subparagraph (A) or (B) of 
paragraph (1) the facility shall be subject to a civil 
money penalty of not more than $200,000 or the Sec-
retary may classify the entity as an excluded entity 
for a period of 2 years pursuant to section 1128(b), 
or both. 
‘‘(3) REQUIREMENT
TO
POST
NOTICE.—Each 
long-term care facility shall post conspicuously in an 
appropriate location a sign (in a form specified by 
the Secretary) specifying the rights of employees 
under this section. Such sign shall include a state-
ment that an employee may file a complaint with the 
Secretary against a long-term care facility that vio-
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lates the provisions of this subsection and information 
with respect to the manner of filing such a complaint. 
‘‘(e) PROCEDURE.—The provisions of section 1128A 
(other than subsections (a) and (b) and the second sentence 
of subsection (f)) shall apply to a civil money penalty or 
exclusion under this section in the same manner as such 
provisions apply to a penalty or proceeding under section 
1128A(a). 
‘‘(f) DEFINITIONS.—In this section, the terms ‘elder 
justice’, ‘long-term care facility’, and ‘law enforcement’ have 
the meanings given those terms in section 2011.’’. 
(c) NATIONAL NURSE AIDE REGISTRY.— 
(1) DEFINITION OF NURSE AIDE.—In this sub-
section, the term ‘‘nurse aide’’ has the meaning given 
that term in sections 1819(b)(5)(F) and 1919(b)(5)(F) 
of the Social Security Act (42 U.S.C. 1395i– 
3(b)(5)(F); 1396r(b)(5)(F)). 
(2) STUDY AND REPORT.— 
(A) IN GENERAL.—The Secretary, in con-
sultation with appropriate government agencies 
and private sector organizations, shall conduct a 
study on establishing a national nurse aide reg-
istry. 
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(B) AREAS
EVALUATED.—The study con-
ducted under this subsection shall include an 
evaluation of— 
(i) who should be included in the reg-
istry; 
(ii) how such a registry would comply 
with Federal and State privacy laws and 
regulations; 
(iii) how data would be collected for 
the registry; 
(iv) what entities and individuals 
would have access to the data collected; 
(v) how the registry would provide ap-
propriate information regarding violations 
of Federal and State law by individuals in-
cluded in the registry; 
(vi) how the functions of a national 
nurse aide registry would be coordinated 
with the nationwide program for national 
and State background checks on direct pa-
tient access employees of long-term care fa-
cilities and providers under section 4301; 
and 
(vii) how the information included in 
State nurse aide registries developed and 
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maintained under sections 1819(e)(2) and 
1919(e)(2) of the Social Security Act (42 
U.S.C. 1395i–3(e)(2); 1396r(e)(2)(2)) would 
be provided as part of a national nurse aide 
registry. 
(C) CONSIDERATIONS.—In conducting the 
study and preparing the report required under 
this subsection, the Secretary shall take into con-
sideration the findings and conclusions of rel-
evant reports and other relevant resources, in-
cluding the following: 
(i) The Department of Health and 
Human Services Office of Inspector General 
Report, Nurse Aide Registries: State Com-
pliance and Practices (February 2005). 
(ii) The General Accounting Office 
(now known as the Government Account-
ability Office) Report, Nursing Homes: 
More Can Be Done to Protect Residents 
from Abuse (March 2002). 
(iii) The Department of Health and 
Human Services Office of the Inspector 
General Report, Nurse Aide Registries: 
Long-Term Care Facility Compliance and 
Practices (July 2005). 
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(iv) The Department of Health and 
Human Services Health Resources and 
Services Administration Report, Nursing 
Aides, Home Health Aides, and Related 
Health Care Occupations—National and 
Local Workforce Shortages and Associated 
Data Needs (2004) (in particular with re-
spect to chapter 7 and appendix F). 
(v) The 2001 Report to CMS from the 
School of Rural Public Health, Texas A&M 
University, Preventing Abuse and Neglect 
in Nursing Homes: The Role of Nurse Aide 
Registries. 
(vi) Information included in State 
nurse aide registries developed and main-
tained 
under 
sections 
1819(e)(2) 
and 
1919(e)(2) of the Social Security Act (42 
U.S.C. 1395i–3(e)(2); 1396r(e)(2)(2)). 
(D) REPORT.—Not later than 18 months 
after the date of enactment of this Act, the Sec-
retary shall submit to the Elder Justice Coordi-
nating Council established under section 2021 of 
the Social Security Act, as added by section 
1805(a), the Committee on Finance of the Sen-
ate, and the Committee on Ways and Means and 
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the Committee on Energy and Commerce of the 
House of Representatives a report containing the 
findings and recommendations of the study con-
ducted under this paragraph. 
(E) FUNDING LIMITATION.—Funding for the 
study conducted under this subsection shall not 
exceed $500,000. 
(3) CONGRESSIONAL ACTION.—After receiving the 
report submitted by the Secretary under paragraph 
(2)(D), the Committee on Finance of the Senate and 
the Committee on Ways and Means and the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives shall, as they deem appropriate, take ac-
tion based on the recommendations contained in the 
report. 
(4) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated such sums as 
are necessary for the purpose of carrying out this sub-
section. 
(d) CONFORMING AMENDMENTS.— 
(1) TITLE XX.—Title XX of the Social Security 
Act (42 U.S.C. 1397 et seq.), as amended by section 
6703(a), is amended— 
(A) in the heading of section 2001, by strik-
ing ‘‘TITLE’’ and inserting ‘‘SUBTITLE’’; and 
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(B) in subtitle 1, by striking ‘‘this title’’ 
each place it appears and inserting ‘‘this sub-
title’’. 
(2) TITLE IV.—Title IV of the Social Security 
Act (42 U.S.C. 601 et seq.) is amended— 
(A) in section 404(d)— 
(i) in paragraphs (1)(A), (2)(A), and 
(3)(B), by inserting ‘‘subtitle 1 of’’ before 
‘‘title XX’’ each place it appears; 
(ii) in the heading of paragraph (2), 
by inserting ‘‘SUBTITLE
OF’’ before 
‘‘TITLE XX’’; and 
(iii) in the heading of paragraph 
(3)(B), by inserting ‘‘SUBTITLE 1 OF’’ before 
‘‘TITLE XX’’; and 
(B) in sections 422(b), 471(a)(4), 472(h)(1), 
and 473(b)(2), by inserting ‘‘subtitle 1 of’’ before 
‘‘title XX’’ each place it appears. 
(3) TITLE XI.—Title XI of the Social Security 
Act (42 U.S.C. 1301 et seq.) is amended— 
(A) in section 1128(h)(3)— 
(i) by inserting ‘‘subtitle 1 of’’ before 
‘‘title XX’’; and 
(ii) by striking ‘‘such title’’ and insert-
ing ‘‘such subtitle’’; and 
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(B) in section 1128A(i)(1), by inserting 
‘‘subtitle 1 of’’ before ‘‘title XX’’. 
Subtitle I—Sense of the Senate 
Regarding Medical Malpractice 
SEC. 6801. SENSE OF THE SENATE REGARDING MEDICAL 
MALPRACTICE. 
It is the sense of the Senate that— 
(1) health care reform presents an opportunity to 
address issues related to medical malpractice and 
medical liability insurance; 
(2) States should be encouraged to develop and 
test alternatives to the existing civil litigation system 
as a way of improving patient safety, reducing med-
ical errors, encouraging the efficient resolution of dis-
putes, increasing the availability of prompt and fair 
resolution of disputes, and improving access to liabil-
ity insurance, while preserving an individual’s right 
to seek redress in court; and 
(3) Congress should consider establishing a State 
demonstration program to evaluate alternatives to the 
existing civil litigation system with respect to the res-
olution of medical malpractice claims. 
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TITLE VII—IMPROVING ACCESS 
TO 
INNOVATIVE 
MEDICAL 
THERAPIES 
Subtitle A—Biologics Price 
Competition and Innovation 
SEC. 7001. SHORT TITLE. 
(a) IN GENERAL.—This subtitle may be cited as the 
‘‘Biologics Price Competition and Innovation Act of 2009’’. 
(b) SENSE OF THE SENATE.—It is the sense of the Sen-
ate that a biosimilars pathway balancing innovation and 
consumer interests should be established. 
SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGI-
CAL PRODUCTS. 
(a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO-
SIMILAR OR INTERCHANGEABLE.—Section 351 of the Public 
Health Service Act (42 U.S.C. 262) is amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘under 
this subsection or subsection (k)’’ after ‘‘biologics li-
cense’’; and 
(2) by adding at the end the following: 
‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO-
SIMILAR OR INTERCHANGEABLE.— 
‘‘(1) IN GENERAL.—Any person may submit an 
application for licensure of a biological product under 
this subsection. 
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‘‘(2) CONTENT.— 
‘‘(A) IN GENERAL.— 
‘‘(i) REQUIRED INFORMATION.—An ap-
plication submitted under this subsection 
shall include information demonstrating 
that— 
‘‘(I) the biological product is bio-
similar to a reference product based 
upon data derived from— 
‘‘(aa) analytical studies that 
demonstrate that the biological 
product is highly similar to the 
reference product notwithstanding 
minor differences in clinically in-
active components; 
‘‘(bb) animal studies (includ-
ing the assessment of toxicity); 
and 
‘‘(cc) a clinical study or 
studies (including the assessment 
of immunogenicity and phar-
macokinetics 
or 
pharmacodynamics) that are suf-
ficient to demonstrate safety, pu-
rity, and potency in 1 or more 
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appropriate conditions of use for 
which the reference product is li-
censed and intended to be used 
and for which licensure is sought 
for the biological product; 
‘‘(II) the biological product and 
reference product utilize the same 
mechanism or mechanisms of action 
for the condition or conditions of use 
prescribed, recommended, or suggested 
in the proposed labeling, but only to 
the extent the mechanism or mecha-
nisms of action are known for the ref-
erence product; 
‘‘(III) the condition or conditions 
of use prescribed, recommended, or sug-
gested in the labeling proposed for the 
biological product have been previously 
approved for the reference product; 
‘‘(IV) the route of administration, 
the dosage form, and the strength of the 
biological product are the same as 
those of the reference product; and 
‘‘(V) the facility in which the bio-
logical product is manufactured, proc-
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essed, packed, or held meets standards 
designed to assure that the biological 
product continues to be safe, pure, and 
potent. 
‘‘(ii) 
DETERMINATION
BY
SEC-
RETARY.—The Secretary may determine, in 
the Secretary’s discretion, that an element 
described in clause (i)(I) is unnecessary in 
an application submitted under this sub-
section. 
‘‘(iii) ADDITIONAL INFORMATION.—An 
application submitted under this sub-
section— 
‘‘(I) shall include publicly-avail-
able information regarding the Sec-
retary’s previous determination that 
the reference product is safe, pure, and 
potent; and 
‘‘(II) may include any additional 
information in support of the applica-
tion, including publicly-available in-
formation with respect to the reference 
product or another biological product. 
‘‘(B) INTERCHANGEABILITY.—An applica-
tion (or a supplement to an application) sub-
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mitted under this subsection may include infor-
mation demonstrating that the biological product 
meets the standards described in paragraph (4). 
‘‘(3) EVALUATION BY SECRETARY.—Upon review 
of an application (or a supplement to an application) 
submitted under this subsection, the Secretary shall 
license the biological product under this subsection 
if— 
‘‘(A) the Secretary determines that the in-
formation submitted in the application (or the 
supplement) is sufficient to show that the biologi-
cal product— 
‘‘(i) is biosimilar to the reference prod-
uct; or 
‘‘(ii) meets the standards described in 
paragraph (4), and therefore is interchange-
able with the reference product; and 
‘‘(B) the applicant (or other appropriate 
person) consents to the inspection of the facility 
that is the subject of the application, in accord-
ance with subsection (c). 
‘‘(4) SAFETY
STANDARDS
FOR
DETERMINING 
INTERCHANGEABILITY.—Upon review of an applica-
tion submitted under this subsection or any supple-
ment to such application, the Secretary shall deter-
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mine the biological product to be interchangeable with 
the reference product if the Secretary determines that 
the information submitted in the application (or a 
supplement to such application) is sufficient to show 
that— 
‘‘(A) the biological product— 
‘‘(i) is biosimilar to the reference prod-
uct; and 
‘‘(ii) can be expected to produce the 
same clinical result as the reference product 
in any given patient; and 
‘‘(B) for a biological product that is admin-
istered more than once to an individual, the risk 
in terms of safety or diminished efficacy of alter-
nating or switching between use of the biological 
product and the reference product is not greater 
than the risk of using the reference product with-
out such alternation or switch. 
‘‘(5) GENERAL RULES.— 
‘‘(A) ONE REFERENCE PRODUCT PER APPLI-
CATION.—A biological product, in an applica-
tion submitted under this subsection, may not be 
evaluated against more than 1 reference product. 
‘‘(B) REVIEW.—An application submitted 
under this subsection shall be reviewed by the di-
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vision within the Food and Drug Administra-
tion that is responsible for the review and ap-
proval of the application under which the ref-
erence product is licensed. 
‘‘(C) RISK
EVALUATION
AND
MITIGATION 
STRATEGIES.—The authority of the Secretary 
with respect to risk evaluation and mitigation 
strategies under the Federal Food, Drug, and 
Cosmetic Act shall apply to biological products 
licensed under this subsection in the same man-
ner as such authority applies to biological prod-
ucts licensed under subsection (a). 
‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE 
BIOLOGICAL PRODUCT.—Upon review of an applica-
tion submitted under this subsection relying on the 
same reference product for which a prior biological 
product has received a determination of interchange-
ability for any condition of use, the Secretary shall 
not make a determination under paragraph (4) that 
the second or subsequent biological product is inter-
changeable for any condition of use until the earlier 
of— 
‘‘(A) 1 year after the first commercial mar-
keting of the first interchangeable biosimilar bio-
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For purposes of this paragraph, the term ‘final court 
decision’ means a final decision of a court from which 
no appeal (other than a petition to the United States 
Supreme Court for a writ of certiorari) has been or 
can be taken. 
‘‘(7) EXCLUSIVITY FOR REFERENCE PRODUCT.— 
‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP-
PLICATION APPROVAL.—Approval of an applica-
tion under this subsection may not be made ef-
fective by the Secretary until the date that is 12 
years after the date on which the reference prod-
uct was first licensed under subsection (a). 
‘‘(B) 
FILING
PERIOD.—An 
application 
under this subsection may not be submitted to 
the Secretary until the date that is 4 years after 
the date on which the reference product was first 
licensed under subsection (a). 
‘‘(C) FIRST
LICENSURE.—Subparagraphs 
(A) and (B) shall not apply to a license for or 
approval of— 
‘‘(i) a supplement for the biological 
product that is the reference product; or 
‘‘(ii) a subsequent application filed by 
the same sponsor or manufacturer of the bi-
ological product that is the reference prod-
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uct (or a licensor, predecessor in interest, or 
other related entity) for— 
‘‘(I) a change (not including a 
modification to the structure of the bio-
logical product) that results in a new 
indication, route of administration, 
dosing schedule, dosage form, delivery 
system, delivery device, or strength; or 
‘‘(II) a modification to the struc-
ture of the biological product that does 
not result in a change in safety, pu-
rity, or potency. 
‘‘(8) GUIDANCE DOCUMENTS.— 
‘‘(A) IN
GENERAL.—The Secretary may, 
after opportunity for public comment, issue 
guidance in accordance, except as provided in 
subparagraph (B)(i), with section 701(h) of the 
Federal Food, Drug, and Cosmetic Act with re-
spect to the licensure of a biological product 
under this subsection. Any such guidance may be 
general or specific. 
‘‘(B) PUBLIC COMMENT.— 
‘‘(i) IN GENERAL.—The Secretary shall 
provide the public an opportunity to com-
ment on any proposed guidance issued 
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under subparagraph (A) before issuing final 
guidance. 
‘‘(ii) INPUT
REGARDING
MOST
VALU-
ABLE GUIDANCE.—The Secretary shall es-
tablish a process through which the public 
may provide the Secretary with input re-
garding priorities for issuing guidance. 
‘‘(C) NO REQUIREMENT FOR APPLICATION 
CONSIDERATION.—The 
issuance 
(or 
non- 
issuance) of guidance under subparagraph (A) 
shall not preclude the review of, or action on, an 
application submitted under this subsection. 
‘‘(D) REQUIREMENT FOR PRODUCT CLASS- 
SPECIFIC
GUIDANCE.—If the Secretary issues 
product class-specific guidance under subpara-
graph (A), such guidance shall include a descrip-
tion of— 
‘‘(i) the criteria that the Secretary will 
use to determine whether a biological prod-
uct is highly similar to a reference product 
in such product class; and 
‘‘(ii) the criteria, if available, that the 
Secretary will use to determine whether a 
biological product meets the standards de-
scribed in paragraph (4). 
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‘‘(E) CERTAIN PRODUCT CLASSES.— 
‘‘(i) GUIDANCE.—The Secretary may 
indicate in a guidance document that the 
science and experience, as of the date of 
such guidance, with respect to a product or 
product class (not including any recom-
binant protein) does not allow approval of 
an application for a license as provided 
under this subsection for such product or 
product class. 
‘‘(ii) MODIFICATION OR REVERSAL.— 
The Secretary may issue a subsequent guid-
ance document under subparagraph (A) to 
modify or reverse a guidance document 
under clause (i). 
‘‘(iii) NO EFFECT ON ABILITY TO DENY 
LICENSE.—Clause (i) shall not be construed 
to require the Secretary to approve a prod-
uct with respect to which the Secretary has 
not indicated in a guidance document that 
the science and experience, as described in 
clause (i), does not allow approval of such 
an application. 
‘‘(l) PATENTS.— 
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‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION (k) 
APPLICATION.— 
‘‘(A) APPLICATION OF PARAGRAPH.—Unless 
otherwise agreed to by a person that submits an 
application under subsection (k) (referred to in 
this subsection as the ‘subsection (k) applicant’) 
and the sponsor of the application for the ref-
erence product (referred to in this subsection as 
the ‘reference product sponsor’), the provisions of 
this paragraph shall apply to the exchange of in-
formation described in this subsection. 
‘‘(B) IN GENERAL.— 
‘‘(i) PROVISION OF CONFIDENTIAL IN-
FORMATION.—When a subsection (k) appli-
cant submits an application under sub-
section (k), such applicant shall provide to 
the persons described in clause (ii), subject 
to the terms of this paragraph, confidential 
access to the information required to be pro-
duced pursuant to paragraph (2) and any 
other information that the subsection (k) 
applicant determines, in its sole discretion, 
to be appropriate (referred to in this sub-
section as the ‘confidential information’). 
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‘‘(ii) RECIPIENTS OF INFORMATION.— 
The persons described in this clause are the 
following: 
‘‘(I) OUTSIDE COUNSEL.—One or 
more attorneys designated by the ref-
erence product sponsor who are em-
ployees of an entity other than the ref-
erence product sponsor (referred to in 
this paragraph as the ‘outside coun-
sel’), provided that such attorneys do 
not engage, formally or informally, in 
patent prosecution relevant or related 
to the reference product. 
‘‘(II) IN-HOUSE
COUNSEL.—One 
attorney that represents the reference 
product sponsor who is an employee of 
the reference product sponsor, provided 
that such attorney does not engage, for-
mally or informally, in patent prosecu-
tion relevant or related to the reference 
product. 
‘‘(iii) PATENT OWNER ACCESS.—A rep-
resentative of the owner of a patent exclu-
sively licensed to a reference product spon-
sor with respect to the reference product and 
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who has retained a right to assert the pat-
ent or participate in litigation concerning 
the patent may be provided the confidential 
information, provided that the representa-
tive informs the reference product sponsor 
and the subsection (k) applicant of his or 
her agreement to be subject to the confiden-
tiality provisions set forth in this para-
graph, including those under clause (ii). 
‘‘(C) LIMITATION ON DISCLOSURE.—No per-
son that receives confidential information pursu-
ant to subparagraph (B) shall disclose any con-
fidential information to any other person or en-
tity, including the reference product sponsor em-
ployees, outside scientific consultants, or other 
outside counsel retained by the reference product 
sponsor, without the prior written consent of the 
subsection (k) applicant, which shall not be un-
reasonably withheld. 
‘‘(D) USE
OF
CONFIDENTIAL
INFORMA-
TION.—Confidential information shall be used 
for the sole and exclusive purpose of determining, 
with respect to each patent assigned to or exclu-
sively licensed by the reference product sponsor, 
whether a claim of patent infringement could 
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reasonably be asserted if the subsection (k) appli-
cant engaged in the manufacture, use, offering 
for sale, sale, or importation into the United 
States of the biological product that is the subject 
of the application under subsection (k). 
‘‘(E) OWNERSHIP OF CONFIDENTIAL INFOR-
MATION.—The confidential information disclosed 
under this paragraph is, and shall remain, the 
property of the subsection (k) applicant. By pro-
viding the confidential information pursuant to 
this paragraph, the subsection (k) applicant does 
not provide the reference product sponsor or the 
outside counsel any interest in or license to use 
the confidential information, for purposes other 
than those specified in subparagraph (D). 
‘‘(F) EFFECT OF INFRINGEMENT ACTION.— 
In the event that the reference product sponsor 
files a patent infringement suit, the use of con-
fidential information shall continue to be gov-
erned by the terms of this paragraph until such 
time as a court enters a protective order regard-
ing the information. Upon entry of such order, 
the subsection (k) applicant may redesignate 
confidential information in accordance with the 
terms of that order. No confidential information 
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shall be included in any publicly-available com-
plaint or other pleading. In the event that the 
reference product sponsor does not file an in-
fringement action by the date specified in para-
graph (6), the reference product sponsor shall re-
turn or destroy all confidential information re-
ceived under this paragraph, provided that if the 
reference product sponsor opts to destroy such in-
formation, it will confirm destruction in writing 
to the subsection (k) applicant. 
‘‘(G) RULE OF CONSTRUCTION.—Nothing in 
this paragraph shall be construed— 
‘‘(i) as an admission by the subsection 
(k) applicant regarding the validity, en-
forceability, or infringement of any patent; 
or 
‘‘(ii) as an agreement or admission by 
the subsection (k) applicant with respect to 
the competency, relevance, or materiality of 
any confidential information. 
‘‘(H) EFFECT OF VIOLATION.—The disclo-
sure of any confidential information in violation 
of this paragraph shall be deemed to cause the 
subsection (k) applicant to suffer irreparable 
harm for which there is no adequate legal rem-
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edy and the court shall consider immediate in-
junctive relief to be an appropriate and nec-
essary remedy for any violation or threatened 
violation of this paragraph. 
‘‘(2) SUBSECTION (k) APPLICATION
INFORMA-
TION.—Not later than 20 days after the Secretary no-
tifies the subsection (k) applicant that the application 
has been accepted for review, the subsection (k) appli-
cant— 
‘‘(A) shall provide to the reference product 
sponsor a copy of the application submitted to 
the Secretary under subsection (k), and such 
other information that describes the process or 
processes used to manufacture the biological 
product that is the subject of such application; 
and 
‘‘(B) may provide to the reference product 
sponsor additional information requested by or 
on behalf of the reference product sponsor. 
‘‘(3) LIST AND DESCRIPTION OF PATENTS.— 
‘‘(A) LIST BY REFERENCE PRODUCT SPON-
SOR.—Not later than 60 days after the receipt of 
the application and information under para-
graph (2), the reference product sponsor shall 
provide to the subsection (k) applicant— 
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‘‘(i) a list of patents for which the ref-
erence product sponsor believes a claim of 
patent infringement could reasonably be as-
serted by the reference product sponsor, or 
by a patent owner that has granted an ex-
clusive license to the reference product spon-
sor with respect to the reference product, if 
a person not licensed by the reference prod-
uct sponsor engaged in the making, using, 
offering to sell, selling, or importing into 
the United States of the biological product 
that is the subject of the subsection (k) ap-
plication; and 
‘‘(ii) an identification of the patents 
on such list that the reference product spon-
sor would be prepared to license to the sub-
section (k) applicant. 
‘‘(B) LIST
AND
DESCRIPTION
BY
SUB-
SECTION (k) APPLICANT.—Not later than 60 days 
after receipt of the list under subparagraph (A), 
the subsection (k) applicant— 
‘‘(i) may provide to the reference prod-
uct sponsor a list of patents to which the 
subsection (k) applicant believes a claim of 
patent infringement could reasonably be as-
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serted by the reference product sponsor if a 
person not licensed by the reference product 
sponsor engaged in the making, using, offer-
ing to sell, selling, or importing into the 
United States of the biological product that 
is the subject of the subsection (k) applica-
tion; 
‘‘(ii) shall provide to the reference 
product sponsor, with respect to each patent 
listed by the reference product sponsor 
under subparagraph (A) or listed by the 
subsection (k) applicant under clause (i)— 
‘‘(I) a detailed statement that de-
scribes, on a claim by claim basis, the 
factual and legal basis of the opinion 
of the subsection (k) applicant that 
such patent is invalid, unenforceable, 
or will not be infringed by the commer-
cial marketing of the biological product 
that is the subject of the subsection (k) 
application; or 
‘‘(II) a statement that the sub-
section (k) applicant does not intend to 
begin commercial marketing of the bio-
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logical product before the date that 
such patent expires; and 
‘‘(iii) shall provide to the reference 
product sponsor a response regarding each 
patent identified by the reference product 
sponsor under subparagraph (A)(ii). 
‘‘(C) DESCRIPTION BY REFERENCE PROD-
UCT SPONSOR.—Not later than 60 days after re-
ceipt of the list and statement under subpara-
graph (B), the reference product sponsor shall 
provide to the subsection (k) applicant a detailed 
statement that describes, with respect to each 
patent described in subparagraph (B)(ii)(I), on 
a claim by claim basis, the factual and legal 
basis of the opinion of the reference product 
sponsor that such patent will be infringed by the 
commercial marketing of the biological product 
that is the subject of the subsection (k) applica-
tion and a response to the statement concerning 
validity and enforceability provided under sub-
paragraph (B)(ii)(I). 
‘‘(4) PATENT RESOLUTION NEGOTIATIONS.— 
‘‘(A) IN
GENERAL.—After receipt by the 
subsection (k) applicant of the statement under 
paragraph (3)(C), the reference product sponsor 
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tion prohibiting the subsection (k) applicant 
from engaging in the commercial manufacture or 
sale of such biological product until the court de-
cides the issue of patent validity, enforcement, 
and infringement with respect to any patent that 
is— 
‘‘(i) included in the list provided by 
the reference product sponsor under para-
graph (3)(A) or in the list provided by the 
subsection (k) applicant under paragraph 
(3)(B); and 
‘‘(ii) not included, as applicable, on— 
‘‘(I) the list of patents described 
in paragraph (4); or 
‘‘(II) the lists of patents described 
in paragraph (5)(B). 
‘‘(C) REASONABLE
COOPERATION.—If the 
reference product sponsor has sought a prelimi-
nary injunction under subparagraph (B), the 
reference product sponsor and the subsection (k) 
applicant shall reasonably cooperate to expedite 
such further discovery as is needed in connection 
with the preliminary injunction motion. 
‘‘(9) LIMITATION ON DECLARATORY JUDGMENT 
ACTION.— 
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‘‘(A) SUBSECTION (k) APPLICATION
PRO-
VIDED.—If a subsection (k) applicant provides 
the application and information required under 
paragraph (2)(A), neither the reference product 
sponsor nor the subsection (k) applicant may, 
prior to the date notice is received under para-
graph (8)(A), bring any action under section 
2201 of title 28, United States Code, for a dec-
laration of infringement, validity, or enforce-
ability of any patent that is described in clauses 
(i) and (ii) of paragraph (8)(B). 
‘‘(B) SUBSEQUENT
FAILURE
TO
ACT
BY 
SUBSECTION (k) APPLICANT.—If a subsection (k) 
applicant fails to complete an action required of 
the subsection (k) applicant under paragraph 
(3)(B)(ii), paragraph (5), paragraph (6)(C)(i), 
paragraph (7), or paragraph (8)(A), the ref-
erence product sponsor, but not the subsection (k) 
applicant, may bring an action under section 
2201 of title 28, United States Code, for a dec-
laration of infringement, validity, or enforce-
ability of any patent included in the list de-
scribed in paragraph (3)(A), including as pro-
vided under paragraph (7). 
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‘‘(C) SUBSECTION
(k) APPLICATION
NOT 
PROVIDED.—If a subsection (k) applicant fails to 
provide the application and information re-
quired under paragraph (2)(A), the reference 
product sponsor, but not the subsection (k) appli-
cant, may bring an action under section 2201 of 
title 28, United States Code, for a declaration of 
infringement, validity, or enforceability of any 
patent that claims the biological product or a use 
of the biological product.’’. 
(b) DEFINITIONS.—Section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i)) is amended— 
(1) by striking ‘‘In this section, the term ‘biologi-
cal product’ means’’ and inserting the following: ‘‘In 
this section: 
‘‘(1) The term ‘biological product’ means’’; 
(2) in paragraph (1), as so designated, by insert-
ing ‘‘protein (except any chemically synthesized 
polypeptide),’’ after ‘‘allergenic product,’’; and 
(3) by adding at the end the following: 
‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in 
reference to a biological product that is the subject of 
an application under subsection (k), means— 
‘‘(A) that the biological product is highly 
similar to the reference product notwithstanding 
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minor differences in clinically inactive compo-
nents; and 
‘‘(B) there are no clinically meaningful dif-
ferences between the biological product and the 
reference product in terms of the safety, purity, 
and potency of the product. 
‘‘(3) The term ‘interchangeable’ or ‘interchange-
ability’, in reference to a biological product that is 
shown to meet the standards described in subsection 
(k)(4), means that the biological product may be sub-
stituted for the reference product without the interven-
tion of the health care provider who prescribed the 
reference product. 
‘‘(4) The term ‘reference product’ means the sin-
gle biological product licensed under subsection (a) 
against which a biological product is evaluated in an 
application submitted under subsection (k).’’. 
(c) CONFORMING AMENDMENTS RELATING TO PAT-
ENTS.— 
(1) PATENTS.—Section 271(e) of title 35, United 
States Code, is amended— 
(A) in paragraph (2)— 
(i) in subparagraph (A), by striking 
‘‘or’’ at the end; 
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(ii) in subparagraph (B), by adding 
‘‘or’’ at the end; and 
(iii) by inserting after subparagraph 
(B) the following: 
‘‘(C)(i) with respect to a patent that is identified 
in the list of patents described in section 351(l)(3) of 
the Public Health Service Act (including as provided 
under section 351(l)(7) of such Act), an application 
seeking approval of a biological product, or 
‘‘(ii) if the applicant for the application fails to 
provide the application and information required 
under section 351(l)(2)(A) of such Act, an application 
seeking approval of a biological product for a patent 
that 
could 
be 
identified 
pursuant 
to 
section 
351(l)(3)(A)(i) of such Act,’’; and 
(iv) in the matter following subpara-
graph (C) (as added by clause (iii)), by 
striking ‘‘or veterinary biological product’’ 
and inserting ‘‘, veterinary biological prod-
uct, or biological product’’; 
(B) in paragraph (4)— 
(i) in subparagraph (B), by— 
(I) striking ‘‘or veterinary biologi-
cal product’’ and inserting ‘‘, veteri-
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nary biological product, or biological 
product’’; and 
(II) striking ‘‘and’’ at the end; 
(ii) in subparagraph (C), by— 
(I) striking ‘‘or veterinary biologi-
cal product’’ and inserting ‘‘, veteri-
nary biological product, or biological 
product’’; and 
(II) striking the period and in-
serting ‘‘, and’’; 
(iii) by inserting after subparagraph 
(C) the following: 
‘‘(D) the court shall order a permanent injunc-
tion prohibiting any infringement of the patent by 
the biological product involved in the infringement 
until a date which is not earlier than the date of the 
expiration of the patent that has been infringed under 
paragraph (2)(C), provided the patent is the subject 
of a final court decision, as defined in section 
351(k)(6) of the Public Health Service Act, in an ac-
tion for infringement of the patent under section 
351(l)(6) of such Act, and the biological product has 
not yet been approved because of section 351(k)(7) of 
such Act.’’; and 
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