1487 
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There is authorized to be 
appropriated to carry out this section $12,000,000 
for each of fiscal years 2011 through 2015. 
‘‘(2) RESERVATION.—Of the amount appro-
priated to carry out this section for a fiscal year, the 
Secretary shall reserve 3 percent of such amount to 
carry out subsection (h) (relating to an independent 
evaluation).’’. 
SEC. 2554. ASSISTING VETERANS WITH MILITARY EMER-
GENCY 
MEDICAL 
TRAINING 
TO 
BECOME 
STATE-LICENSED OR CERTIFIED EMERGENCY 
MEDICAL TECHNICIANS (EMTS). 
(a) IN GENERAL.—Part B of title III (42 U.S.C. 243 
et seq.), as amended, is amended by inserting after section 
315 the following: 
‘‘SEC. 315A. ASSISTING VETERANS WITH MILITARY EMER-
GENCY 
MEDICAL 
TRAINING 
TO 
BECOME 
STATE-LICENSED OR CERTIFIED EMERGENCY 
MEDICAL TECHNICIANS (EMTS). 
‘‘(a) PROGRAM.—The Secretary shall establish a pro-
gram consisting of awarding grants to States to assist vet-
erans who received and completed military emergency 
medical training while serving in the Armed Forces of the 
United States to become, upon their discharge or release 
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from active duty service, State-licensed or certified emer-
gency medical technicians. 
‘‘(b) USE OF FUNDS.—Amounts received as a grant 
under this section may be used to assist veterans described 
in subsection (a) to become State-licensed or certified 
emergency medical technicians as follows: 
‘‘(1) Providing training. 
‘‘(2) Providing reimbursement for costs associ-
ated with— 
‘‘(A) training; or 
‘‘(B) applying for licensure or certification. 
‘‘(3) Expediting the licensing or certification 
process. 
‘‘(c) ELIGIBILITY.—To be eligible for a grant under 
this section, a State shall demonstrate to the Secretary’s 
satisfaction that the State has a shortage of emergency 
medical technicians. 
‘‘(d) REPORT.—The Secretary shall submit to the 
Congress an annual report on the program under this sec-
tion. 
‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for each of fiscal 
years 2011 through 2015.’’. 
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(b) GAO STUDY AND REPORT.—The Comptroller 
General of the United States shall— 
(1) conduct a study on the barriers experienced 
by veterans who received training as medical per-
sonnel while serving in the Armed Forces of the 
United States and, upon their discharge or release 
from active duty service, seek to become licensed or 
certified in a State as civilian health professionals; 
and 
(2) not later than 2 years after the date of the 
enactment of this Act, submit to the Congress a re-
port on the results of such study, including rec-
ommendations on whether the program established 
under section 315A of the Public Health Service 
Act, as added by subsection (a), should be expanded 
to assist veterans seeking to become licensed or cer-
tified in a State as health providers other than emer-
gency medical technicians. 
SEC. 2555. DENTAL EMERGENCY RESPONDERS: PUBLIC 
HEALTH AND MEDICAL RESPONSE. 
(a) NATIONAL HEALTH SECURITY STRATEGY.—Sec-
tion 2802(b)(3) (42 U.S.C. 300hh–1(b)(3)) is amended— 
(1) in the matter preceding subparagraph (A), 
by inserting ‘‘dental and’’ before ‘‘mental health fa-
cilities’’; and 
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(2) in subparagraph (D), by inserting ‘‘and 
dental’’ after ‘‘medical’’. 
(b) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL 
RESPONSE
CURRICULA
AND
TRAINING.—Section 
319F(a)(5)(B) (42 U.S.C. 247d–6(a)(5)(B)) is amended 
by striking ‘‘public health or medical’’ and inserting ‘‘pub-
lic health, medical, or dental’’. 
SEC. 2556. DENTAL EMERGENCY RESPONDERS: HOMELAND 
SECURITY. 
(a) NATIONAL RESPONSE FRAMEWORK.—Paragraph 
(6) of section 2 of the Homeland Security Act of 2002 
(6 U.S.C. 101) is amended by inserting ‘‘and dental’’ after 
‘‘emergency medical’’. 
(b) NATIONAL PREPAREDNESS SYSTEM.—Subpara-
graph (B) of section 653(b)(4) of the Post-Katrina Emer-
gency Management Reform Act of 2006 (6 U.S.C. 
753(b)(4)) is amended by striking ‘‘public health and med-
ical’’ and inserting ‘‘public health, medical, and dental’’. 
(c) CHIEF MEDICAL OFFICER.—Paragraph (5) of 
section 516(c) of the Homeland Security Act of 2002 (6 
U.S.C. 321e(c)) is amended by striking ‘‘medical commu-
nity’’ and inserting ‘‘medical and dental communities’’. 
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PART 4—PAIN CARE AND MANAGEMENT 
PROGRAMS 
SEC. 2561. INSTITUTE OF MEDICINE CONFERENCE ON PAIN. 
(a) CONVENING.—Not later than June 30, 2011, the 
Secretary of Health and Human Services shall seek to 
enter into an agreement with the Institute of Medicine of 
the National Academies to convene a Conference on Pain 
(in this section referred to as ‘‘the Conference’’). 
(b) PURPOSES.—The purposes of the Conference 
shall be to— 
(1) increase the recognition of pain as a signifi-
cant public health problem in the United States; 
(2) evaluate the adequacy of assessment, diag-
nosis, treatment, and management of acute and 
chronic pain in the general population, and in identi-
fied racial, ethnic, gender, age, and other demo-
graphic groups that may be disproportionately af-
fected by inadequacies in the assessment, diagnosis, 
treatment, and management of pain; 
(3) identify barriers to appropriate pain care, 
including— 
(A) lack of understanding and education 
among employers, patients, health care pro-
viders, regulators, and third-party payors; 
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(B) barriers to access to care at the pri-
mary, specialty, and tertiary care levels, includ-
ing barriers— 
(i) specific to those populations that 
are disproportionately undertreated for 
pain; 
(ii) related to physician concerns over 
regulatory and law enforcement policies 
applicable to some pain therapies; and 
(iii) attributable to benefit, coverage, 
and payment policies in both the public 
and private sectors; and 
(C) gaps in basic and clinical research on 
the symptoms and causes of pain, and potential 
assessment methods and new treatments to im-
prove pain care; and 
(4) establish an agenda for action in both the 
public and private sectors that will reduce such bar-
riers and significantly improve the state of pain care 
research, education, and clinical care in the United 
States. 
(c) OTHER APPROPRIATE ENTITY.—If the Institute 
of Medicine declines to enter into an agreement under sub-
section (a), the Secretary of Health and Human Services 
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may enter into such agreement with another appropriate 
entity. 
(d) REPORT.—A report summarizing the Con-
ference’s findings and recommendations shall be sub-
mitted to the Congress not later than June 30, 2012. 
(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there is authorized 
to be appropriated $500,000 for each of fiscal years 2011 
and 2012. 
SEC. 2562. PAIN RESEARCH AT NATIONAL INSTITUTES OF 
HEALTH. 
Part B of title IV (42 U.S.C. 284 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 409J. PAIN RESEARCH. 
‘‘(a) RESEARCH INITIATIVES.— 
‘‘(1) IN GENERAL.—The Director of NIH is en-
couraged to continue and expand, through the Pain 
Consortium, an aggressive program of basic and 
clinical research on the causes of and potential treat-
ments for pain. 
‘‘(2) ANNUAL
RECOMMENDATIONS.—Not less 
than annually, the Pain Consortium, in consultation 
with the Division of Program Coordination, Plan-
ning, and Strategic Initiatives, shall develop and 
submit to the Director of NIH recommendations on 
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appropriate pain research initiatives that could be 
undertaken with funds reserved under section 
402A(c)(1) for the Common Fund or otherwise 
available for such initiatives. 
‘‘(3) DEFINITION.—In this subsection, the term 
‘Pain Consortium’ means the Pain Consortium of 
the National Institutes of Health or a similar trans- 
National Institutes of Health coordinating entity 
designated by the Secretary for purposes of this sub-
section. 
‘‘(b) INTERAGENCY PAIN RESEARCH COORDINATING 
COMMITTEE.— 
‘‘(1) ESTABLISHMENT.—The Secretary shall es-
tablish not later than 1 year after the date of the 
enactment of this section and as necessary maintain 
a committee, to be known as the Interagency Pain 
Research Coordinating Committee (in this section 
referred to as the ‘Committee’), to coordinate all ef-
forts within the Department of Health and Human 
Services and other Federal agencies that relate to 
pain research. 
‘‘(2) MEMBERSHIP.— 
‘‘(A) IN GENERAL.—The Committee shall 
be composed of the following voting members: 
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‘‘(i) Not more than 7 voting Federal 
representatives as follows: 
‘‘(I) The Director of the Centers 
for Disease Control and Prevention. 
‘‘(II) The Director of the Na-
tional Institutes of Health and the di-
rectors of such national research insti-
tutes and national centers as the Sec-
retary determines appropriate. 
‘‘(III) The heads of such other 
agencies of the Department of Health 
and Human Services as the Secretary 
determines appropriate. 
‘‘(IV) Representatives of other 
Federal agencies that conduct or sup-
port pain care research and treat-
ment, including the Department of 
Defense and the Department of Vet-
erans Affairs. 
‘‘(ii) Twelve additional voting mem-
bers appointed under subparagraph (B). 
‘‘(B) ADDITIONAL MEMBERS.—The Com-
mittee shall include additional voting members 
appointed by the Secretary as follows: 
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‘‘(i) Six members shall be appointed 
from among scientists, physicians, and 
other health professionals, who— 
‘‘(I) are not officers or employees 
of the United States; 
‘‘(II) 
represent 
multiple 
dis-
ciplines, including clinical, basic, and 
public health sciences; 
‘‘(III) represent different geo-
graphical 
regions 
of 
the 
United 
States; and 
‘‘(IV) are from practice settings, 
academia, manufacturers, or other re-
search settings. 
‘‘(ii) Six members shall be appointed 
from members of the general public, who 
are representatives of leading research, ad-
vocacy, and service organizations for indi-
viduals with pain-related conditions. 
‘‘(C) NONVOTING
MEMBERS.—The Com-
mittee shall include such nonvoting members as 
the Secretary determines to be appropriate. 
‘‘(3) CHAIRPERSON.—The voting members of 
the Committee shall select a chairperson from 
among such members. The selection of a chairperson 
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shall be subject to the approval of the Director of 
NIH. 
‘‘(4) MEETINGS.—The Committee shall meet at 
the call of the chairperson of the Committee or upon 
the request of the Director of NIH, but in no case 
less often than once each year. 
‘‘(5) DUTIES.—The Committee shall— 
‘‘(A) develop a summary of advances in 
pain care research supported or conducted by 
the Federal agencies relevant to the diagnosis, 
prevention, and treatment of pain and diseases 
and disorders associated with pain; 
‘‘(B) identify critical gaps in basic and 
clinical research on the symptoms and causes of 
pain; 
‘‘(C) make recommendations to ensure that 
the activities of the National Institutes of 
Health and other Federal agencies, including 
the Department of Defense and the Department 
of Veteran Affairs, are free of unnecessary du-
plication of effort; 
‘‘(D) make recommendations on how best 
to disseminate information on pain care; and 
‘‘(E) make recommendations on how to ex-
pand partnerships between public entities, in-
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cluding Federal agencies, and private entities to 
expand collaborative, crosscutting research. 
‘‘(6) REVIEW.—The Secretary shall review the 
necessity of the Committee at least once every 2 
years.’’. 
SEC. 2563. PUBLIC AWARENESS CAMPAIGN ON PAIN MAN-
AGEMENT. 
Part B of title II (42 U.S.C. 238 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 249. NATIONAL EDUCATION OUTREACH AND AWARE-
NESS CAMPAIGN ON PAIN MANAGEMENT. 
‘‘(a) ESTABLISHMENT.—Not later than 12 months 
after the date of the enactment of this section, the Sec-
retary shall establish and implement a national pain care 
education outreach and awareness campaign described in 
subsection (b). 
‘‘(b) REQUIREMENTS.—The Secretary shall design 
the public awareness campaign under this section to edu-
cate consumers, patients, their families, and other care-
givers with respect to— 
‘‘(1) the incidence and importance of pain as a 
national public health problem; 
‘‘(2) the adverse physical, psychological, emo-
tional, societal, and financial consequences that can 
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result if pain is not appropriately assessed, diag-
nosed, treated, or managed; 
‘‘(3) the availability, benefits, and risks of all 
pain treatment and management options; 
‘‘(4) having pain promptly assessed, appro-
priately diagnosed, treated, and managed, and regu-
larly reassessed with treatment adjusted as needed; 
‘‘(5) the role of credentialed pain management 
specialists and subspecialists, and of comprehensive 
interdisciplinary centers of treatment expertise; 
‘‘(6) the availability in the public, nonprofit, 
and private sectors of pain management-related in-
formation, services, and resources for consumers, 
employers, third-party payors, patients, their fami-
lies, and caregivers, including information on— 
‘‘(A) appropriate assessment, diagnosis, 
treatment, and management options for all 
types of pain and pain-related symptoms; and 
‘‘(B) conditions for which no treatment op-
tions are yet recognized; and 
‘‘(7) other issues the Secretary deems appro-
priate. 
‘‘(c) CONSULTATION.—In designing and imple-
menting the public awareness campaign required by this 
section, the Secretary shall consult with organizations rep-
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resenting patients in pain and other consumers, employ-
ers, physicians including physicians specializing in pain 
care, other pain management professionals, medical device 
manufacturers, and pharmaceutical companies. 
‘‘(d) COORDINATION.— 
‘‘(1) LEAD OFFICIAL.—The Secretary shall des-
ignate one official in the Department of Health and 
Human Services to oversee the campaign established 
under this section. 
‘‘(2) AGENCY
COORDINATION.—The Secretary 
shall ensure the involvement in the public awareness 
campaign under this section of the Surgeon General 
of the Public Health Service, the Director of the 
Centers for Disease Control and Prevention, and 
such other representatives of offices and agencies of 
the Department of Health and Human Services as 
the Secretary determines appropriate. 
‘‘(e) UNDERSERVED AREAS AND POPULATIONS.—In 
designing the public awareness campaign under this sec-
tion, the Secretary shall— 
‘‘(1) take into account the special needs of geo-
graphic areas and racial, ethnic, gender, age, and 
other demographic groups that are currently under-
served; and 
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‘‘(2) provide resources that will reduce dispari-
ties in access to appropriate diagnosis, assessment, 
and treatment. 
‘‘(f) GRANTS AND CONTRACTS.—The Secretary may 
make awards of grants, cooperative agreements, and con-
tracts to public agencies and private nonprofit organiza-
tions to assist with the development and implementation 
of the public awareness campaign under this section. 
‘‘(g) EVALUATION AND REPORT.—Not later than the 
end of fiscal year 2012, the Secretary shall prepare and 
submit to the Congress a report evaluating the effective-
ness of the public awareness campaign under this section 
in educating the general public with respect to the matters 
described in subsection (b). 
‘‘(h) AUTHORIZATION
OF APPROPRIATIONS.—For 
purposes of carrying out this section, there are authorized 
to be appropriated $2,000,000 for fiscal year 2011 and 
$4,000,000 for each of fiscal years 2012 and 2015.’’. 
Subtitle C—Food and Drug 
Administration 
PART 1—IN GENERAL 
SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY. 
(a) REGISTRY.— 
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(1) IN GENERAL.—Section 519 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is 
amended— 
(A) by redesignating subsection (g) as sub-
section (h); and 
(B) by inserting after subsection (f) the 
following: 
‘‘National Medical Device Registry 
‘‘(g)(1)(A) The Secretary shall establish a national 
medical device registry (in this subsection referred to as 
the ‘registry’) to facilitate analysis of postmarket safety 
and outcomes data on each covered device. 
‘‘(B) In this subsection, the term ‘covered device’— 
‘‘(i) shall include each class III device; and 
‘‘(ii) may include, as the Secretary determines 
appropriate and specifies in regulation, a class II de-
vice that is life-supporting or life-sustaining. 
‘‘(C) Notwithstanding subparagraph (B)(i), the Sec-
retary may by order exempt a class III device from the 
provisions of this subsection if the Secretary concludes 
that inclusion of information on the device in the registry 
will not provide useful information on safety or effective-
ness. 
‘‘(2) In developing the registry, the Secretary shall, 
in consultation with the Commissioner of Food and Drugs, 
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the Administrator of the Centers for Medicare & Medicaid 
Services, the Administrator of the Agency for Healthcare 
Research and Quality, the head of the Office of the Na-
tional Coordinator for Health Information Technology, 
and the Secretary of Veterans Affairs, determine the best 
methods for— 
‘‘(A) including in the registry, in a manner con-
sistent with subsection (f), appropriate information 
to identify each covered device by type, model, and 
serial number or other unique identifier; 
‘‘(B) validating methods for analyzing patient 
safety and outcomes data from multiple sources and 
for linking such data with the information included 
in the registry as described in subparagraph (A), in-
cluding, to the extent feasible, use of— 
‘‘(i) data provided to the Secretary under 
other provisions of this chapter; and 
‘‘(ii) information from public and private 
sources identified under paragraph (3); 
‘‘(C) integrating the activities described in this 
subsection (so as to avoid duplication) with— 
‘‘(i) activities under paragraph (3) of sec-
tion 505(k) (relating to active postmarket risk 
identification); 
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‘‘(ii) activities under paragraph (4) of sec-
tion 505(k) (relating to advanced analysis of 
drug safety data); 
‘‘(iii) other postmarket device surveillance 
activities of the Secretary authorized by this 
chapter; and 
‘‘(iv) registries carried out by or for the 
Agency for Healthcare Research and Quality; 
and 
‘‘(D) providing public access to the data and 
analysis collected or developed through the registry 
in a manner and form that protects patient privacy 
and proprietary information and is comprehensive, 
useful, and not misleading to patients, physicians, 
and scientists. 
‘‘(3)(A) To facilitate analyses of postmarket safety 
and patient outcomes for covered devices, the Secretary 
shall, in collaboration with public, academic, and private 
entities, develop methods to— 
‘‘(i) obtain access to disparate sources of 
patient safety and outcomes data, including— 
‘‘(I) Federal health-related electronic 
data (such as data from the Medicare pro-
gram under title XVIII of the Social Secu-
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rity Act or from the health systems of the 
Department of Veterans Affairs); 
‘‘(II) private sector health-related 
electronic data (such as pharmaceutical 
purchase data and health insurance claims 
data); and 
‘‘(III) other data as the Secretary 
deems necessary to permit postmarket as-
sessment of device safety and effectiveness; 
and 
‘‘(ii) link data obtained under clause (i) 
with information in the registry. 
‘‘(B) In this paragraph, the term ‘data’ refers to in-
formation respecting a covered device, including claims 
data, patient survey data, standardized analytic files that 
allow for the pooling and analysis of data from disparate 
data environments, electronic health records, and any 
other data deemed appropriate by the Secretary. 
‘‘(4) The Secretary shall promulgate regulations for 
establishment and operation of the registry under para-
graph (1). Such regulations— 
‘‘(A)(i) in the case of covered devices that are 
sold on or after the date of the enactment of this 
subsection, shall require manufacturers of such de-
vices to submit information to the registry, includ-
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ing, for each such device, the type, model, and serial 
number or, if required under subsection (f), other 
unique device identifier; and 
‘‘(ii) in the case of covered devices that are sold 
before such date, may require manufacturers of such 
devices to submit such information to the registry, 
if deemed necessary by the Secretary to protect the 
public health; 
‘‘(B) shall establish procedures— 
‘‘(i) to permit linkage of information sub-
mitted pursuant to subparagraph (A) with pa-
tient safety and outcomes data obtained under 
paragraph (3); and 
‘‘(ii) to permit analyses of linked data; 
‘‘(C) may require covered device manufacturers 
to submit such other information as is necessary to 
facilitate postmarket assessments of device safety 
and effectiveness and notification of device risks; 
‘‘(D) shall establish requirements for regular 
and timely reports to the Secretary, which shall be 
included in the registry, concerning adverse event 
trends, adverse event patterns, incidence and preva-
lence of adverse events, and other information the 
Secretary determines appropriate, which may include 
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data on comparative safety and outcomes trends; 
and 
‘‘(E) shall establish procedures to permit public 
access to the information in the registry in a manner 
and form that protects patient privacy and propri-
etary information and is comprehensive, useful, and 
not misleading to patients, physicians, and sci-
entists. 
‘‘(5)(A) The Secretary shall promulgate final regula-
tions under paragraph (4) not later than 36 months after 
the date of the enactment of this subsection. 
‘‘(B) Before issuing the notice of proposed rule-
making preceding the final regulations described in sub-
paragraph (A), the Secretary shall hold a public hearing 
before an advisory committee on the issue of which class 
II devices to include in the definition of covered devices. 
‘‘(C) The Secretary shall include in any regulation 
under this subsection an explanation demonstrating that 
the requirements of such regulation— 
‘‘(i) do not duplicate other Federal require-
ments; and 
‘‘(ii) do not impose an undue burden on device 
manufacturers. 
‘‘(6) With respect to any entity that submits or is 
required to submit a safety report or other information 
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in connection with the safety of a device under this section 
(and any release by the Secretary of that report or infor-
mation), such report or information shall not be construed 
to reflect necessarily a conclusion by the entity or the Sec-
retary that the report or information constitutes an admis-
sion that the product involved malfunctioned, caused or 
contributed to an adverse experience, or otherwise caused 
or contributed to a death, serious injury, or serious illness. 
Such an entity need not admit, and may deny, that the 
report or information submitted by the entity constitutes 
an admission that the product involved malfunctioned, 
caused or contributed to an adverse experience, or caused 
or contributed to a death, serious injury, or serious illness. 
‘‘(7) To carry out this subsection, there are author-
ized to be appropriated such sums as may be necessary 
for each of fiscal years 2011 and 2012.’’. 
(2) 
EFFECTIVE
DATE.—The 
Secretary 
of 
Health and Human Services shall establish and 
begin implementation of the registry under section 
519(g) of the Federal Food, Drug, and Cosmetic 
Act, as added by paragraph (1), by not later than 
the date that is 36 months after the date of the en-
actment of this Act, without regard to whether or 
not final regulations to establish and operate the 
registry have been promulgated by such date. 
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(3) 
CONFORMING
AMENDMENT.—Section 
303(f)(1)(B)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amend-
ed by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’. 
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED 
ELECTRONIC HEALTH RECORDS
OF UNIQUE DEVICE 
IDENTIFIERS.— 
(1) 
RECOMMENDATIONS.—The 
HIT 
Policy 
Committee established under section 3002 of the 
Public Health Service Act (42 U.S.C. 300jj–12) 
shall recommend to the head of the Office of the Na-
tional Coordinator for Health Information Tech-
nology standards, implementation specifications, and 
certification criteria for the electronic exchange and 
use in certified electronic health records of a unique 
device identifier for each covered device (as defined 
under section 519(g)(1)(B) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection 
(a)). 
(2) STANDARDS, IMPLEMENTATION
CRITERIA, 
AND
CERTIFICATION
CRITERIA.—The Secretary of 
Health and Human Services, acting through the 
head of the Office of the National Coordinator for 
Health Information Technology, shall adopt stand-
ards, implementation specifications, and certification 
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criteria for the electronic exchange and use in cer-
tified electronic health records of a unique device 
identifier for each covered device referred to in para-
graph (1), if such an identifier is required by section 
519(f) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360i(f)) for the device. 
(c) UNIQUE DEVICE IDENTIFICATION SYSTEM.—The 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall issue proposed 
regulations to implement section 519(f) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not 
later than 6 months after the date of the enactment of 
this Act. 
SEC. 2572. NUTRITION LABELING OF STANDARD MENU 
ITEMS AT CHAIN RESTAURANTS AND OF AR-
TICLES OF FOOD SOLD FROM VENDING MA-
CHINES. 
(a) 
TECHNICAL
AMENDMENTS.—Section 
403(q)(5)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 343(q)(5)(A)) is amended— 
(1) in subclause (i), by inserting ‘‘except as pro-
vided in clause (H)(ii)(III),’’ after ‘‘(i)’’ ; and 
(2) in subclause (ii), by inserting ‘‘except as 
provided in clause (H)(ii)(III),’’ after ‘‘(ii)’’. 
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(b) LABELING REQUIREMENTS.—Section 403(q)(5) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(5)) is amended by adding at the end the following: 
‘‘(H) RESTAURANTS, RETAIL FOOD ESTABLISH-
MENTS, AND VENDING MACHINES.— 
‘‘(i) 
GENERAL
REQUIREMENTS
FOR
RES-
TAURANTS AND SIMILAR RETAIL FOOD ESTABLISH-
MENTS.—Except for food described in subclause 
(vii), in the case of food that is a standard menu 
item that is offered for sale in a restaurant or simi-
lar retail food establishment that is part of a chain 
with 20 or more locations doing business under the 
same name (regardless of the type of ownership of 
the locations) and offering for sale substantially the 
same menu items, the restaurant or similar retail 
food establishment shall disclose the information de-
scribed in subclauses (ii) and (iii). 
‘‘(ii) INFORMATION
REQUIRED
TO
BE
DIS-
CLOSED BY RESTAURANTS AND RETAIL FOOD ES-
TABLISHMENTS.—Except as provided in subclause 
(vii), the restaurant or similar retail food establish-
ment shall disclose in a clear and conspicuous man-
ner— 
‘‘(I)(aa) in a nutrient content disclosure 
statement adjacent to the name of the standard 
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menu item, so as to be clearly associated with 
the standard menu item, on the menu listing 
the item for sale, the number of calories con-
tained in the standard menu item, as usually 
prepared and offered for sale; and 
‘‘(bb) a succinct statement concerning sug-
gested daily caloric intake, as specified by the 
Secretary by regulation and posted prominently 
on the menu and designed to enable the public 
to understand, in the context of a total daily 
diet, the significance of the caloric information 
that is provided on the menu; 
‘‘(II)(aa) in a nutrient content disclosure 
statement adjacent to the name of the standard 
menu item, so as to be clearly associated with 
the standard menu item, on the menu board, 
including a drive-through menu board, the 
number of calories contained in the standard 
menu item, as usually prepared and offered for 
sale; and 
‘‘(bb) a succinct statement concerning sug-
gested daily caloric intake, as specified by the 
Secretary by regulation and posted prominently 
on the menu board, designed to enable the pub-
lic to understand, in the context of a total daily 
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diet, the significance of the nutrition informa-
tion that is provided on the menu board; 
‘‘(III) in a written form, available on the 
premises of the restaurant or similar retail es-
tablishment and to the consumer upon request, 
the 
nutrition 
information 
required 
under 
clauses (C) and (D) of subparagraph (1); and 
‘‘(IV) on the menu or menu board, a 
prominent, clear, and conspicuous statement re-
garding the availability of the information de-
scribed in item (III). 
‘‘(iii) SELF-SERVICE FOOD AND FOOD ON DIS-
PLAY.—Except as provided in subclause (vii), in the 
case of food sold at a salad bar, buffet line, cafeteria 
line, or similar self-service facility, and for self-serv-
ice beverages or food that is on display and that is 
visible to customers, a restaurant or similar retail 
food establishment shall place adjacent to each food 
offered a sign that lists calories per displayed food 
item or per serving. 
‘‘(iv) REASONABLE BASIS.—For the purposes of 
this clause, a restaurant or similar retail food estab-
lishment shall have a reasonable basis for its nutri-
ent content disclosures, including nutrient databases, 
cookbooks, laboratory analyses, and other reasonable 
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means, as described in section 101.10 of title 21, 
Code of Federal Regulations (or any successor regu-
lation) or in a related guidance of the Food and 
Drug Administration. 
‘‘(v) MENU
VARIABILITY
AND
COMBINATION 
MEALS.—The Secretary shall establish by regulation 
standards for determining and disclosing the nutri-
ent content for standard menu items that come in 
different flavors, varieties, or combinations, but 
which are listed as a single menu item, such as soft 
drinks, ice cream, pizza, doughnuts, or children’s 
combination meals, through means determined by 
the Secretary, including ranges, averages, or other 
methods. 
‘‘(vi) ADDITIONAL INFORMATION.—If the Sec-
retary determines that a nutrient, other than a nu-
trient required under subclause (ii)(III), should be 
disclosed for the purpose of providing information to 
assist consumers in maintaining healthy dietary 
practices, the Secretary may require, by regulation, 
disclosure of such nutrient in the written form re-
quired under subclause (ii)(III). 
‘‘(vii) NONAPPLICABILITY TO CERTAIN FOOD.— 
‘‘(I) IN GENERAL.—Subclauses (i) through 
(vi) do not apply to— 
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‘‘(aa) items that are not listed on a 
menu or menu board (such as condiments 
and other items placed on the table or 
counter for general use); 
‘‘(bb) daily specials, temporary menu 
items appearing on the menu for less than 
60 days per calendar year, or custom or-
ders; or 
‘‘(cc) such other food that is part of 
a customary market test appearing on the 
menu for less than 90 days, under terms 
and conditions established by the Sec-
retary. 
‘‘(II) WRITTEN FORMS.—Clause (C) shall 
apply to any regulations promulgated under 
subclauses (ii)(III) and (vi). 
‘‘(viii) VENDING MACHINES.—In the case of an 
article of food sold from a vending machine that— 
‘‘(I) does not permit a prospective pur-
chaser to examine the Nutrition Facts Panel 
before purchasing the article or does not other-
wise provide visible nutrition information at the 
point of purchase; and 
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‘‘(II) is operated by a person who is en-
gaged in the business of owning or operating 20 
or more vending machines, 
the vending machine operator shall provide a sign in 
close proximity to each article of food or the selec-
tion button that includes a clear and conspicuous 
statement disclosing the number of calories con-
tained in the article. 
‘‘(ix) VOLUNTARY PROVISION OF NUTRITION IN-
FORMATION.— 
‘‘(I) IN GENERAL.—An authorized official 
of any restaurant or similar retail food estab-
lishment or vending machine operator not sub-
ject to the requirements of this clause may elect 
to be subject to the requirements of such 
clause, by registering biannually the name and 
address of such restaurant or similar retail food 
establishment or vending machine operator with 
the Secretary, as specified by the Secretary by 
regulation. 
‘‘(II) REGISTRATION.—Within 120 days of 
the enactment of this clause, the Secretary shall 
publish a notice in the Federal Register speci-
fying the terms and conditions for implementa-
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tion of item (I), pending promulgation of regu-
lations. 
‘‘(III) RULE OF CONSTRUCTION.—Nothing 
in this subclause shall be construed to authorize 
the Secretary to require an application, review, 
or licensing process for any entity to register 
with the Secretary, as described in such item. 
‘‘(x) REGULATIONS.— 
‘‘(I) PROPOSED
REGULATION.—Not later 
than 1 year after the date of the enactment of 
this clause, the Secretary shall promulgate pro-
posed regulations to carry out this clause. 
‘‘(II) CONTENTS.—In promulgating regula-
tions, the Secretary shall— 
‘‘(aa) consider standardization of rec-
ipes and methods of preparation, reason-
able variation in serving size and formula-
tion of menu items, space on menus and 
menu boards, inadvertent human error, 
training of food service workers, variations 
in ingredients, and other factors, as the 
Secretary determines; and 
‘‘(bb) specify the format and manner 
of the nutrient content disclosure require-
ments under this subclause. 
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‘‘(III) REPORTING.—The Secretary shall 
submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the 
House of Representatives a quarterly report 
that describes the Secretary’s progress toward 
promulgating final regulations under this sub-
paragraph. 
‘‘(xi) DEFINITION.—In this clause, the term 
‘menu’ or ‘menu board’ means the primary writing 
of the restaurant or other similar retail food estab-
lishment from which a consumer makes an order se-
lection.’’. 
(c) NATIONAL UNIFORMITY.—Section 403A(a)(4) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343–1(a)(4)) is amended by striking ‘‘except a require-
ment for nutrition labeling of food which is exempt under 
subclause (i) or (ii) of section 403(q)(5)(A)’’ and inserting 
‘‘except that this paragraph does not apply to food that 
is offered for sale in a restaurant or similar retail food 
establishment that is not part of a chain with 20 or more 
locations doing business under the same name (regardless 
of the type of ownership of the locations) and offering for 
sale substantially the same menu items unless such res-
taurant or similar retail food establishment complies with 
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the voluntary provision of nutrition information require-
ments under section 403(q)(5)(H)(ix)’’. 
(d) RULE
OF
CONSTRUCTION.—Nothing in the 
amendments made by this section shall be construed— 
(1) to preempt any provision of State or local 
law, unless such provision establishes or continues 
into effect nutrient content disclosures of the type 
required under section 403(q)(5)(H) of the Federal 
Food, Drug, and Cosmetic Act (as added by sub-
section (b)) and is expressly preempted under sec-
tion 403A(a)(4) of such Act; 
(2) to apply to any State or local requirement 
respecting a statement in the labeling of food that 
provides for a warning concerning the safety of the 
food or component of the food; or 
(3) 
except 
as 
provided 
in 
section 
403(q)(5)(H)(ix) of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (b)), to apply 
to any restaurant or similar retail food establish-
ment other than a restaurant or similar retail food 
establishment described in section 403(q)(5)(H)(i) of 
such Act. 
SEC. 2573. PROTECTING CONSUMER ACCESS TO GENERIC 
DRUGS. 
(a) FINDINGS; PURPOSE.— 
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(1) FINDINGS.—The Congress finds the fol-
lowing: 
(A) In 1984, the Drug Price Competition 
and Patent Term Restoration Act (Pub. L. 98– 
417; in this subsection referred to as the ‘‘1984 
Act’’) was enacted with the intent of facilitating 
the early entry of generic drugs while pre-
serving incentives for innovation. 
(B) Prescription drugs make up 10 percent 
of national health care spending, but for the 
past decade have been one of the fastest grow-
ing segments of health care expenditures. 
(C) Until recently, the 1984 Act was suc-
cessful in facilitating generic competition to the 
benefit of consumers and health care payers— 
although 67 percent of all prescriptions dis-
pensed in the United States are generic drugs, 
they account for only 20 percent of all expendi-
tures. 
(D) In recent years, the intent of the 1984 
Act has been subverted by certain settlement 
agreements between brand companies and their 
potential generic competitors that make reverse 
payments, i.e., payments by the brand company 
to the generic company. 
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(E) These settlement agreements have un-
duly delayed the marketing of low-cost generic 
drugs contrary to free competition and the in-
terests of consumers. 
(F) The state of antitrust law relating to 
such settlement agreements is unsettled. 
(2) PURPOSE.—The purpose of this section is 
to provide an additional means to effectuate the in-
tent of the 1984 Act by enhancing competition in 
the pharmaceutical market by stopping agreements 
between brand name and generic drug manufactur-
ers that limit, delay, or otherwise prevent competi-
tion from generic drugs. 
(b) IN GENERAL.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following: 
‘‘(w) PROTECTING CONSUMER ACCESS TO GENERIC 
DRUGS.— 
‘‘(1) UNFAIR AND DECEPTIVE ACTS AND PRAC-
TICES RELATED TO NEW DRUG APPLICATIONS.— 
‘‘(A) CONDUCT PROHIBITED.—It shall be 
unlawful for any person to directly or indirectly 
be a party to any agreement resolving or set-
tling a patent infringement claim in which— 
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‘‘(i) an ANDA filer receives anything 
of value; and 
‘‘(ii) the ANDA filer agrees to limit or 
forego research, development, manufac-
turing, marketing, or sales, for any period 
of time, of the drug that is to be manufac-
tured under the ANDA involved and is the 
subject of the patent infringement claim. 
‘‘(B) EXCEPTIONS.—Notwithstanding sub-
paragraph (A)(i), subparagraph (A) does not 
prohibit a resolution or settlement of a patent 
infringement claim in which the value received 
by the ANDA filer includes no more than— 
‘‘(i) the right to market the drug that 
is to be manufactured under the ANDA in-
volved and is the subject of the patent in-
fringement claim, before the expiration 
of— 
‘‘(I) the patent that is the basis 
for the patent infringement claim; or 
‘‘(II) any other statutory exclu-
sivity that would prevent the mar-
keting of such drug; and 
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‘‘(ii) the waiver of a patent infringe-
ment claim for damages based on prior 
marketing of such drug. 
‘‘(C) ENFORCEMENT.— 
‘‘(i) IN GENERAL.—A violation of sub-
paragraph (A) shall be treated as an un-
fair and deceptive act or practice and an 
unfair method of competition in or affect-
ing interstate commerce prohibited under 
section 5 of the Federal Trade Commission 
Act and shall be enforced by the Federal 
Trade Commission in the same manner, by 
the same means, and with the same juris-
diction as though all applicable terms and 
provisions of the Federal Trade Commis-
sion Act were incorporated into and made 
a part of this subsection. 
‘‘(ii) 
INAPPLICABILITY.—Subchapter 
A of chapter VII shall not apply with re-
spect to this subsection. 
‘‘(D) DEFINITIONS.—In this subsection: 
‘‘(i) AGREEMENT.—The term ‘agree-
ment’ means anything that would con-
stitute an agreement under section 5 of the 
Federal Trade Commission Act. 
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‘‘(ii) AGREEMENT RESOLVING OR SET-
TLING.—The term ‘agreement resolving or 
settling’, in reference to a patent infringe-
ment claim, includes any agreement that is 
contingent upon, provides a contingent 
condition for, or is otherwise related to the 
resolution or settlement of the claim. 
‘‘(iii) ANDA.—The term ‘ANDA’ 
means an abbreviated new drug application 
for the approval of a new drug under sec-
tion (j). 
‘‘(iv) 
ANDA 
FILER.—The 
term 
‘ANDA filer’ means a party that has filed 
an ANDA with the Food and Drug Admin-
istration. 
‘‘(v) PATENT
INFRINGEMENT.—The 
term ‘patent infringement’ means infringe-
ment of any patent or of any filed patent 
application, extension, reissuance, renewal, 
division, continuation, continuation in part, 
reexamination, patent term restoration, 
patent of addition, or extension thereof. 
‘‘(vi) 
PATENT
INFRINGEMENT 
CLAIM.—The term ‘patent infringement 
claim’ means any allegation made to an 
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ANDA filer, whether or not included in a 
complaint filed with a court of law, that its 
ANDA or drug to be manufactured under 
such ANDA may infringe any patent. 
‘‘(2) FTC RULEMAKING.—The Federal Trade 
Commission may, by rule promulgated under section 
553 of title 5, United States Code, exempt certain 
agreements described in paragraph (1) from the re-
quirements of this subsection if the Commission 
finds such agreements to be in furtherance of mar-
ket competition and for the benefit of consumers. 
Consistent with the authority of the Commission, 
such rules may include interpretive rules and general 
statements of policy with respect to the practices 
prohibited under paragraph (1).’’. 
(c) NOTICE AND CERTIFICATION OF AGREEMENTS.— 
(1) NOTICE
OF
ALL
AGREEMENTS.—Section 
1112(c)(2) of the Medicare Prescription Drug, Im-
provement, and Modernization Act of 2003 (21 
U.S.C. 3155 note) is amended by— 
(A) striking ‘‘the Commission the’’ and in-
serting the following: ‘‘the Commission— 
‘‘(A) the’’; 
(B) striking the period at the end and in-
serting ‘‘; and’’; and 
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(C) adding at the end the following: 
‘‘(B) any other agreement the parties enter 
into within 30 days of entering into an agree-
ment covered by subsection (a) or (b).’’. 
(2) CERTIFICATION OF AGREEMENTS.—Section 
1112 of such Act is amended by adding at the end 
the following: 
‘‘(d) CERTIFICATION.—The chief executive officer or 
the company official responsible for negotiating any agree-
ment required to be filed under subsection (a), (b), or (c) 
shall execute and file with the Assistant Attorney General 
and the Commission a certification as follows: ‘I declare 
under penalty of perjury that the following is true and 
correct: The materials filed with the Federal Trade Com-
mission and the Department of Justice under section 1112 
of subtitle B of title XI of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003, with re-
spect to the agreement referenced in this certification: (1) 
represent the complete, final, and exclusive agreement be-
tween the parties; (2) include any ancillary agreements 
that are contingent upon, provide a contingent condition 
for, or are otherwise related to, the referenced agreement; 
and (3) include written descriptions of any oral agree-
ments, representations, commitments, or promises be-
tween the parties that are responsive to subsection (a) or 
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(b) of such section 1112 and have not been reduced to 
writing.’.’’. 
(d) GAO STUDY.— 
(1) STUDY.—Beginning 2 years after the date 
of enactment of this Act, and each year for a period 
of 4 years thereafter, the Comptroller General shall 
conduct a study on the litigation in United States 
courts during the period beginning 5 years prior to 
the date of enactment of this Act relating to patent 
infringement claims involving generic drugs, the 
number of patent challenges initiated by manufac-
turers of generic drugs, and the number of settle-
ments of such litigation. The Comptroller General 
shall transmit to Congress a report of the findings 
of such a study and an analysis of the effect of the 
amendments made by subsections (b) and (c) on 
such litigation, whether such amendments have had 
an effect on the number and frequency of claims set-
tled, and whether such amendments resulted in ear-
lier or delayed entry of generic drugs to market, in-
cluding whether any harm or benefit to consumers 
has resulted. 
(2) DISCLOSURE
OF
AGREEMENTS.—Notwith-
standing any other law, agreements filed under sec-
tion 1112 of the Medicare Prescription Drug, Im-
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provement, and Modernization Act of 2003 (21 
U.S.C. 355 note), or unaggregated information from 
such agreements, shall be disclosed to the Comp-
troller General for purposes of the study under para-
graph (1) within 30 days of a request by the Comp-
troller General. 
PART 2—BIOSIMILARS 
SEC. 2575. LICENSURE PATHWAY FOR BIOSIMILAR BIO-
LOGICAL 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. 
‘‘(2) CONTENT.— 
‘‘(A) IN GENERAL.— 
‘‘(i) REQUIRED
INFORMATION.—An 
application submitted under this subsection 
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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 
notwith-
standing minor differences in 
clinically inactive 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 
appropriate conditions of use for 
which the reference product is li-
censed and intended to be used 
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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 sug-
gested in the proposed labeling, but 
only to the extent the mechanism or 
mechanisms of action are known for 
the reference product; 
‘‘(III) the condition or conditions 
of use prescribed, recommended, or 
suggested in the labeling proposed for 
the biological product have been pre-
viously approved for the reference 
product; 
‘‘(IV) the route of administra-
tion, 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-
essed, packed, or held meets stand-
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ards designed to assure that the bio-
logical product continues to be safe, 
pure, and potent. 
‘‘(ii) 
DETERMINATION
BY
SEC-
RETARY.—The Secretary may determine, 
in the Secretary’s discretion, that an ele-
ment described in clause (i)(I) is unneces-
sary in an application submitted under this 
subsection. 
‘‘(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 infor-
mation with respect to the reference 
product or another biological product. 
‘‘(B) INTERCHANGEABILITY.—An applica-
tion (or a supplement to an application) sub-
mitted under this subsection may include infor-
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mation demonstrating that the biological prod-
uct meets the standards described in paragraph 
(4). 
‘‘(3) EVALUATION BY SECRETARY.—Upon re-
view of an application (or a supplement to an appli-
cation) submitted under this subsection, the Sec-
retary 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 bio-
logical product— 
‘‘(i) is biosimilar to the reference 
product; or 
‘‘(ii) meets the standards described in 
paragraph (4), and therefore is inter-
changeable 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 deter-
mines that the information submitted in the applica-
tion (or a supplement to such application) is suffi-
cient to show that— 
‘‘(A) the biological product— 
‘‘(i) is biosimilar to the reference 
product; and 
‘‘(ii) can be expected to produce the 
same clinical result as the reference prod-
uct in any given patient; and 
‘‘(B) for a biological product that is ad-
ministered more than once to an individual, the 
risk in terms of safety or diminished efficacy of 
alternating or switching between use of the bio-
logical product and the reference product is not 
greater than the risk of using the reference 
product without such alternation or switch. 
‘‘(5) GENERAL RULES.— 
‘‘(A) ONE REFERENCE PRODUCT PER AP-
PLICATION.—A biological product, in an appli-
cation submitted under this subsection, may not 
be evaluated against more than 1 reference 
product. 
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‘‘(B) REVIEW.—An application submitted 
under this subsection shall be reviewed by the 
division 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). 
‘‘(D) RESTRICTIONS ON BIOLOGICAL PROD-
UCTS
CONTAINING
DANGEROUS
INGREDI-
ENTS.—If information in an application sub-
mitted under this subsection, in a supplement 
to such an application, or otherwise available to 
the Secretary shows that a biological product— 
‘‘(i) is, bears, or contains a select 
agent or toxin listed in section 73.3 or 
73.4 of title 42, section 121.3 or 121.4 of 
title 9, or section 331.3 of title 7, Code of 
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Federal Regulations (or any successor reg-
ulations); or 
‘‘(ii) is, bears, or contains a controlled 
substance in schedule I or II of section 
202 of the Controlled Substances Act, as 
listed in part 1308 of title 21, Code of 
Federal Regulations (or any successor reg-
ulations); 
the Secretary shall not license the biological 
product under this subsection unless the Sec-
retary determines, after consultation with ap-
propriate national security and drug enforce-
ment agencies, that there would be no increased 
risk to the security or health of the public from 
licensing such biological product under this sub-
section. 
‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE-
ABLE
BIOLOGICAL
PRODUCT.—Upon review of an 
application submitted under this subsection relying 
on the same reference product for which a prior bio-
logical product has received a determination of inter-
changeability for any condition of use, the Secretary 
shall not make a determination under paragraph (4) 
that the second or subsequent biological product is 
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interchangeable for any condition of use until the 
earlier of— 
‘‘(A) 1 year after the first commercial 
marketing of the first interchangeable bio-
similar biological product to be approved as 
interchangeable for that reference product; 
‘‘(B) 18 months after— 
‘‘(i) a final court decision on all pat-
ents in suit in an action instituted under 
subsection (l)(5) against the applicant that 
submitted the application for the first ap-
proved interchangeable biosimilar biological 
product; or 
‘‘(ii) the dismissal with or without 
prejudice of an action instituted under sub-
section (l)(5) against the applicant that 
submitted the application for the first ap-
proved interchangeable biosimilar biological 
product; or 
‘‘(C)(i) 42 months after approval of the 
first interchangeable biosimilar biological prod-
uct if the applicant that submitted such appli-
cation has been sued under subsection (l)(5) 
and such litigation is still ongoing within such 
42-month period; or 
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‘‘(ii) 18 months after approval of the first 
interchangeable biosimilar biological product if 
the applicant that submitted such application 
has not been sued under subsection (l)(5). 
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
PROD-
UCT.— 
‘‘(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 
product 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— 
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‘‘(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 
biological product that is the reference 
product (or a licensor, predecessor in inter-
est, or other related entity) for— 
‘‘(I) a change (not including a 
modification to the structure of the bi-
ological 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, 
purity, or potency. 
‘‘(8) PEDIATRIC STUDIES.— 
‘‘(A) EXCLUSIVITY.—If, before or after li-
censure of the reference product under sub-
section (a) of this section, the Secretary deter-
mines that information relating to the use of 
such product in the pediatric population may 
produce health benefits in that population, the 
Secretary makes a written request for pediatric 
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studies (which shall include a timeframe for 
completing such studies), the applicant or hold-
er of the approved application agrees to the re-
quest, such studies are completed using appro-
priate formulations for each age group for 
which the study is requested within any such 
timeframe, and the reports thereof are sub-
mitted and accepted in accordance with section 
505A(d)(3) of the Federal Food, Drug, and 
Cosmetic Act the period referred to in para-
graph (7)(A) of this subsection is deemed to be 
12 years and 6 months rather than 12 years. 
‘‘(B) EXCEPTION.—The Secretary shall 
not extend the period referred to in subpara-
graph (A) of this paragraph if the determina-
tion under section 505A(d)(3) of the Federal 
Food, Drug, and Cosmetic Act is made later 
than 9 months prior to the expiration of such 
period. 
‘‘(C) APPLICATION
OF
CERTAIN
PROVI-
SIONS.—The provisions of subsections (a), (d), 
(e), (f), (h), (j), (k), and (l) of section 505A of 
the Federal Food, Drug, and Cosmetic Act 
shall apply with respect to the extension of a 
period under subparagraph (A) of this para-
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graph to the same extent and in the same man-
ner as such provisions apply with respect to the 
extension of a period under subsection (b) or 
(c) of section 505A of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(9) 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 
comment on any proposed guidance issued 
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. 
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‘‘(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 de-
scription 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). 
‘‘(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 
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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 
guidance document under subparagraph 
(A) to modify or reverse a guidance docu-
ment under clause (i). 
‘‘(iii) NO
EFFECT
ON
ABILITY
TO 
DENY
LICENSE.—Clause (i) shall not be 
construed to require the Secretary to ap-
prove a product 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. 
‘‘(10) NAMING.—The Secretary shall ensure 
that the labeling and packaging of each biological 
product licensed under this subsection bears a name 
that uniquely identifies the biological product and 
distinguishes it from the reference product and any 
other biological products licensed under this sub-
section following evaluation against such reference 
product. 
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‘‘(l) PATENT NOTICES; RELATIONSHIP TO FINAL AP-
PROVAL.— 
‘‘(1) DEFINITIONS.—For the purposes of this 
subsection, the term— 
‘‘(A) ‘biosimilar product’ means the bio-
logical product that is the subject of the appli-
cation under subsection (k); 
‘‘(B) ‘relevant patent’ means a patent 
that— 
‘‘(i) expires after the date specified in 
subsection (k)(7)(A) that applies to the 
reference product; and 
‘‘(ii) could reasonably be asserted 
against the applicant due to the unauthor-
ized making, use, sale, or offer for sale 
within the United States, or the importa-
tion into the United States of the bio-
similar product, or materials used in the 
manufacture of the biosimilar product, or 
due to a use of the biosimilar product in 
a method of treatment that is indicated in 
the application; 
‘‘(C) ‘reference product sponsor’ means the 
holder of an approved application or license for 
the reference product; and 
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‘‘(D) ‘interested third party’ means a per-
son other than the reference product sponsor 
that owns a relevant patent, or has the right to 
commence or participate in an action for in-
fringement of a relevant patent. 
‘‘(2) HANDLING OF CONFIDENTIAL INFORMA-
TION.—Any entity receiving confidential information 
pursuant to this subsection shall designate one or 
more individuals to receive such information. Each 
individual so designated shall execute an agreement 
in accordance with regulations promulgated by the 
Secretary. The regulations shall require each such 
individual to take reasonable steps to maintain the 
confidentiality of information received pursuant to 
this subsection and use the information solely for 
purposes authorized by this subsection. The obliga-
tions imposed on an individual who has received con-
fidential information pursuant to this subsection 
shall continue until the individual returns or de-
stroys the confidential information, a court imposes 
a protective order that governs the use or handling 
of the confidential information, or the party pro-
viding the confidential information agrees to other 
terms or conditions regarding the handling or use of 
the confidential information. 
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‘‘(3) PUBLIC NOTICE BY SECRETARY.—Within 
30 days of acceptance by the Secretary of an appli-
cation filed under subsection (k), the Secretary shall 
publish a notice identifying— 
‘‘(A) the reference product identified in the 
application; and 
‘‘(B) the name and address of an agent 
designated by the applicant to receive notices 
pursuant to paragraph (4)(B). 
‘‘(4) EXCHANGES CONCERNING PATENTS.— 
‘‘(A) 
EXCHANGES
WITH
REFERENCE 
PRODUCT SPONSOR.— 
‘‘(i) Within 30 days of the date of ac-
ceptance of the application by the Sec-
retary, the applicant shall provide the ref-
erence product sponsor with a copy of the 
application and information concerning the 
biosimilar product and its production. This 
information shall include a detailed de-
scription of the biosimilar product, its 
method of manufacture, and the materials 
used in the manufacture of the product. 
‘‘(ii) Within 60 days of the date of re-
ceipt of the information required to be pro-
vided under clause (i), the reference prod-
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uct sponsor shall provide to the applicant 
a list of relevant patents owned by the ref-
erence product sponsor, or in respect of 
which the reference product sponsor has 
the right to commence an action of in-
fringement or otherwise has an interest in 
the patent as such patent concerns the bio-
similar product. 
‘‘(iii) If the reference product sponsor 
is issued or acquires an interest in a rel-
evant patent after the date on which the 
reference product sponsor provides the list 
required by clause (ii) to the applicant, the 
reference product sponsor shall identify 
that patent to the applicant within 30 days 
of the date of issue of the patent, or the 
date of acquisition of the interest in the 
patent, as applicable. 
‘‘(B) 
EXCHANGES
WITH
INTERESTED 
THIRD PARTIES.— 
‘‘(i) At any time after the date on 
which the Secretary publishes a notice for 
an application under paragraph (3), any 
interested third party may provide notice 
to the designated agent of the applicant 
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that the interested third party owns or has 
rights under 1 or more patents that may 
be relevant patents. The notice shall iden-
tify at least 1 patent and shall designate 
an individual who has executed an agree-
ment in accordance with paragraph (2) to 
receive confidential information from the 
applicant. 
‘‘(ii) Within 30 days of the date of re-
ceiving notice pursuant to clause (i), the 
applicant shall send to the individual des-
ignated by the interested third party the 
information 
specified 
in 
subparagraph 
(A)(i), unless the applicant and interested 
third party otherwise agree. 
‘‘(iii) Within 90 days of the date of 
receiving information pursuant to clause 
(ii), the interested third party shall provide 
to the applicant a list of relevant patents 
which the interested third party owns, or 
in respect of which the interested third 
party has the right to commence or partici-
pate in an action for infringement. 
‘‘(iv) If the interested third party is 
issued or acquires an interest in a relevant 
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patent after the date on which the inter-
ested third party provides the list required 
by clause (iii), the interested third party 
shall identify that patent within 30 days of 
the date of issue of the patent, or the date 
of acquisition of the interest in the patent, 
as applicable. 
‘‘(C) IDENTIFICATION OF BASIS FOR IN-
FRINGEMENT.—For any patent identified under 
clause (ii) or (iii) of subparagraph (A) or under 
clause (iii) or (iv) of subparagraph (B), the ref-
erence product sponsor or the interested third 
party, as applicable— 
‘‘(i) shall explain in writing why the 
sponsor or the interested third party be-
lieves the relevant patent would be in-
fringed by the making, use, sale, or offer 
for sale within the United States, or im-
portation into the United States, of the 
biosimilar product or by a use of the bio-
similar product in treatment that is indi-
cated in the application; 
‘‘(ii) may specify whether the relevant 
patent is available for licensing; and 
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‘‘(iii) shall specify the number and 
date of expiration of the relevant patent. 
‘‘(D) CERTIFICATION BY APPLICANT CON-
CERNING
IDENTIFIED
RELEVANT
PATENTS.— 
Not later than 45 days after the date on which 
a patent is identified under clause (ii) or (iii) of 
subparagraph (A) or under clause (iii) or (iv) of 
subparagraph (B), the applicant shall send a 
written statement regarding each identified pat-
ent to the party that identified the patent. Such 
statement shall either— 
‘‘(i) state that the applicant will not 
commence marketing of the biosimilar 
product and has requested the Secretary to 
not grant final approval of the application 
before the date of expiration of the noticed 
patent; or 
‘‘(ii) provide a detailed written expla-
nation setting forth the reasons why the 
applicant believes— 
‘‘(I) the making, use, sale, or 
offer for sale within the United 
States, or the importation into the 
United States, of the biosimilar prod-
uct, or the use of the biosimilar prod-
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uct in a treatment indicated in the ap-
plication, would not infringe the pat-
ent; or 
‘‘(II) the patent is invalid or un-
enforceable. 
‘‘(5) ACTION
FOR
INFRINGEMENT
INVOLVING 
REFERENCE PRODUCT SPONSOR.—If an action for 
infringement concerning a relevant patent identified 
by the reference product sponsor under clause (ii) or 
(iii) of paragraph (4)(A), or by an interested third 
party under clause (iii) or (iv) of paragraph (4)(B), 
is brought within 60 days of the date of receipt of 
a statement under paragraph (4)(D)(ii), and the 
court in which such action has been commenced de-
termines the patent is infringed prior to the date ap-
plicable under subsection (k)(7)(A) or (k)(8), the 
Secretary shall make approval of the application ef-
fective on the day after the date of expiration of the 
patent that has been found to be infringed. If more 
than one such patent is found to be infringed by the 
court, the approval of the application shall be made 
effective on the day after the date that the last such 
patent expires. 
‘‘(6) NOTIFICATION OF AGREEMENTS.— 
‘‘(A) REQUIREMENTS.— 
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‘‘(i) 
AGREEMENT
BETWEEN
BIO-
SIMILAR
PRODUCT
APPLICANT
AND
REF-
ERENCE
PRODUCT
SPONSOR.—If a bio-
similar product applicant under subsection 
(k) and the reference product sponsor 
enter into an agreement described in sub-
paragraph (B), the applicant and sponsor 
shall each file the agreement in accordance 
with subparagraph (C). 
‘‘(ii) 
AGREEMENT
BETWEEN
BIO-
SIMILAR PRODUCT APPLICANTS.—If 2 or 
more biosimilar product applicants submit 
an application under subsection (k) for bio-
similar products with the same reference 
product and enter into an agreement de-
scribed in subparagraph (B), the appli-
cants shall each file the agreement in ac-
cordance with subparagraph (C). 
‘‘(B) SUBJECT MATTER OF AGREEMENT.— 
An agreement described in this subparagraph— 
‘‘(i) is an agreement between the bio-
similar product applicant under subsection 
(k) and the reference product sponsor or 
between 2 or more biosimilar product ap-
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plicants under subsection (k) regarding the 
manufacture, marketing, or sale of— 
‘‘(I) the biosimilar product (or 
biosimilar products) for which an ap-
plication was submitted; or 
‘‘(II) the reference product; 
‘‘(ii) includes any agreement between 
the biosimilar product applicant under sub-
section (k) and the reference product spon-
sor or between 2 or more biosimilar prod-
uct applicants under subsection (k) that is 
contingent upon, provides a contingent 
condition for, or otherwise relates to an 
agreement described in clause (i); and 
‘‘(iii) excludes any agreement that 
solely concerns— 
‘‘(I) purchase orders for raw ma-
terial supplies; 
‘‘(II) equipment and facility con-
tracts; 
‘‘(III) employment or consulting 
contracts; or 
‘‘(IV) packaging and labeling 
contracts. 
‘‘(C) FILING.— 
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‘‘(i) IN
GENERAL.—The text of an 
agreement required to be filed by subpara-
graph (A) shall be filed with the Assistant 
Attorney General and the Federal Trade 
Commission not later than— 
‘‘(I) 10 business days after the 
date on which the agreement is exe-
cuted; and 
‘‘(II) prior to the date of the first 
commercial marketing of, for agree-
ments 
described 
in 
subparagraph 
(A)(i), the biosimilar product that is 
the subject of the application or, for 
agreements described in subparagraph 
(A)(ii), any biosimilar product that is 
the subject of an application described 
in such subparagraph. 
‘‘(ii) IF
AGREEMENT
NOT
REDUCED 
TO TEXT.—If an agreement required to be 
filed by subparagraph (A) has not been re-
duced to text, the persons required to file 
the agreement shall each file written de-
scriptions of the agreement that are suffi-
cient to disclose all the terms and condi-
tions of the agreement. 
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‘‘(iii) CERTIFICATION.—The chief ex-
ecutive officer or the company official re-
sponsible for negotiating any agreement re-
quired to be filed by subparagraph (A) 
shall include in any filing under this para-
graph a certification as follows: ‘I declare 
under penalty of perjury that the following 
is true and correct: The materials filed 
with the Federal Trade Commission and 
the Department of Justice under section 
351(l)(6) of the Public Health Service Act, 
with respect to the agreement referenced in 
this certification: (1) represent the com-
plete, final, and exclusive agreement be-
tween the parties; (2) include any ancillary 
agreements that are contingent upon, pro-
vide a contingent condition for, or are oth-
erwise related to, the referenced agree-
ment; and (3) include written descriptions 
of any oral agreements, representations, 
commitments, or promises between the 
parties that are responsive to such section 
and have not been reduced to writing.’. 
‘‘(D) DISCLOSURE
EXEMPTION.—Any in-
formation or documentary material filed with 
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the Assistant Attorney General or the Federal 
Trade Commission pursuant to this paragraph 
shall be exempt from disclosure under section 
552 of title 5, United States Code, and no such 
information or documentary material may be 
made public, except as may be relevant to any 
administrative or judicial action or proceeding. 
Nothing in this subparagraph prevents disclo-
sure of information or documentary material to 
either body of the Congress or to any duly au-
thorized committee or subcommittee of the Con-
gress. 
‘‘(E) ENFORCEMENT.— 
‘‘(i) CIVIL
PENALTY.—Any person 
that violates a provision of this paragraph 
shall be liable for a civil penalty of not 
more than $11,000 for each day on which 
the violation occurs. Such penalty may be 
recovered in a civil action— 
‘‘(I) brought by the United 
States; or 
‘‘(II) brought by the Federal 
Trade Commission in accordance with 
the procedures established in section 
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16(a)(1) of the Federal Trade Com-
mission Act. 
‘‘(ii) COMPLIANCE
AND
EQUITABLE 
RELIEF.—If any person violates any provi-
sion of this paragraph, the United States 
district court may order compliance, and 
may grant such other equitable relief as 
the court in its discretion determines nec-
essary or appropriate, upon application of 
the Assistant Attorney General or the Fed-
eral Trade Commission. 
‘‘(F) RULEMAKING.—The Federal Trade 
Commission, with the concurrence of the Assist-
ant Attorney General and by rule in accordance 
with section 553 of title 5, United States Code, 
consistent with the purposes of this para-
graph— 
‘‘(i) may define the terms used in this 
paragraph; 
‘‘(ii) may exempt classes of persons or 
agreements from the requirements of this 
paragraph; and 
‘‘(iii) may prescribe such other rules 
as may be necessary and appropriate to 
carry out the purposes of this paragraph. 
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‘‘(G) SAVINGS CLAUSE.—Any action taken 
by the Assistant Attorney General or the Fed-
eral Trade Commission, or any failure of the 
Assistant Attorney General or the Commission 
to take action, under this paragraph shall not 
at any time bar any proceeding or any action 
with respect to any agreement between a bio-
similar product applicant under subsection (k) 
and the reference product sponsor, or any 
agreement between biosimilar product appli-
cants under subsection (k), under any other 
provision of law, nor shall any filing under this 
paragraph constitute or create a presumption of 
any violation of any competition laws.’’. 
(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 ‘bio-
logical product’ means’’ and inserting the following: 
‘‘In this section: 
‘‘(1) The term ‘biological product’ means’’; 
(2) in paragraph (1), as so designated, by in-
serting ‘‘protein (except any chemically synthesized 
polypeptide),’’ after ‘‘allergenic product,’’; and 
(3) by adding at the end the following: 
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‘‘(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 notwith-
standing minor differences in clinically inactive 
components; 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 ‘inter-
changeability’, 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 substituted for the reference product without 
the intervention of the health care provider who pre-
scribed the reference product. 
‘‘(4) The term ‘reference product’ means the 
single biological product licensed under subsection 
(a) against which a biological product is evaluated in 
an application submitted under subsection (k).’’. 
(c) PRODUCTS PREVIOUSLY APPROVED UNDER SEC-
TION 505.— 
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(1) REQUIREMENT TO FOLLOW SECTION 351.— 
Except as provided in paragraph (2), an application 
for a biological product shall be submitted under 
section 351 of the Public Health Service Act (42 
U.S.C. 262) (as amended by this Act). 
(2) EXCEPTION.—An application for a biologi-
cal product may be submitted under section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) if— 
(A) such biological product is in a product 
class for which a biological product in such 
product class is the subject of an application 
approved under such section 505 not later than 
the date of enactment of this Act; and 
(B) such application— 
(i) has been submitted to the Sec-
retary of Health and Human Services (re-
ferred to in this Act as the ‘‘Secretary’’) 
before the date of enactment of this Act; 
or 
(ii) is submitted to the Secretary not 
later than the date that is 10 years after 
the date of enactment of this Act. 
(3) LIMITATION.—Notwithstanding paragraph 
(2), an application for a biological product may not 
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be submitted under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) if there is 
another biological product approved under sub-
section (a) of section 351 of the Public Health Serv-
ice Act that could be a reference product with re-
spect to such application (within the meaning of 
such section 351) if such application were submitted 
under subsection (k) of such section 351. 
(4) DEEMED APPROVED UNDER SECTION 351.— 
An approved application for a biological product 
under section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) shall be deemed to be 
a license for the biological product under such sec-
tion 351 on the date that is 10 years after the date 
of enactment of this Act. 
(5) DEFINITIONS.—For purposes of this sub-
section, the term ‘‘biological product’’ has the mean-
ing given such term under section 351 of the Public 
Health Service Act (42 U.S.C. 262) (as amended by 
this Act). 
SEC. 2576. FEES RELATING TO BIOSIMILAR BIOLOGICAL 
PRODUCTS. 
Subparagraph (B) of section 735(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is 
amended by inserting ‘‘, including licensure of a biological 
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product under section 351(k) of such Act’’ before the pe-
riod at the end. 
SEC. 2577. AMENDMENTS TO CERTAIN PATENT PROVI-
SIONS. 
(a) Section 271(e)(2) of title 35, United States Code 
is amended— 
(1) in subparagraph (A), by striking ‘‘or’’ after 
‘‘patent,’’; 
(2) in subparagraph (B), by adding ‘‘or’’ after 
the comma at the end; 
(3) by inserting the following after subpara-
graph (B): 
‘‘(C) 
a 
statement 
under 
section 
351(l)(4)(D)(ii) of the Public Health Service 
Act,’’; and 
(4) in the matter following subparagraph (C) 
(as added by paragraph (3)), by inserting before the 
period the following: ‘‘, or if the statement described 
in subparagraph (C) is provided in connection with 
an application to obtain a license to engage in the 
commercial manufacture, use, or sale of a biological 
product claimed in a patent or the use of which is 
claimed in a patent before the expiration of such 
patent’’. 
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(b) Section 271(e)(4) of title 35, United States Code, 
is amended by striking ‘‘in paragraph (2)’’ in both places 
it appears and inserting ‘‘in paragraph (2)(A) or (2)(B)’’. 
Subtitle D—Community Living 
Assistance Services and Supports 
SEC. 2581. ESTABLISHMENT OF NATIONAL VOLUNTARY IN-
SURANCE PROGRAM FOR PURCHASING COM-
MUNITY LIVING ASSISTANCE SERVICES AND 
SUPPORT (CLASS PROGRAM). 
(a) ESTABLISHMENT
OF CLASS PROGRAM.—The 
Public Health Service Act (42 U.S.C. 201 et seq.), as 
amended by section 2301, is amended by adding at the 
end the following: 
‘‘TITLE XXXII—COMMUNITY LIV-
ING 
ASSISTANCE 
SERVICES 
AND SUPPORTS 
‘‘SEC. 3201. PURPOSE. 
‘‘The purpose of this title is to establish a national 
voluntary insurance program for purchasing community 
living assistance services and supports in order to— 
‘‘(1) provide individuals with functional limita-
tions with tools that will allow them to maintain 
their personal and financial independence and live in 
the community through a new financing strategy for 
community living assistance services and supports; 
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‘‘(2) establish an infrastructure that will help 
address the Nation’s community living assistance 
services and supports needs; 
‘‘(3) alleviate burdens on family caregivers; and 
‘‘(4) address institutional bias by providing a fi-
nancing mechanism that supports personal choice 
and independence to live in the community. 
‘‘SEC. 3202. DEFINITIONS. 
‘‘In this title: 
‘‘(1) ACTIVE ENROLLEE.—The term ‘active en-
rollee’ means an individual who is enrolled in the 
CLASS program in accordance with section 3204 
and who has paid any premiums due to maintain 
such enrollment. 
‘‘(2) ACTIVELY EMPLOYED.—The term ‘actively 
employed’ means an individual who— 
‘‘(A) is reporting for work at the individ-
ual’s usual place of employment or at another 
location to which the individual is required to 
travel because of the individual’s employment 
(or in the case of an individual who is a mem-
ber of the uniformed services, is on active duty 
and is physically able to perform the duties of 
the individual’s position); and 
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‘‘(B) is able to perform all the usual and 
customary duties of the individual’s employment 
on the individual’s regular work schedule. 
‘‘(3) ACTIVITIES OF DAILY LIVING.—The term 
‘activities of daily living’ has the meaning given the 
term in section 7702B(c)(2)(B) of the Internal Rev-
enue Code of 1986. 
‘‘(4) CLASS PROGRAM.—The term ‘CLASS 
program’ means the program established under this 
title. 
‘‘(5) ELIGIBILITY ASSESSMENT SYSTEM.—The 
term ‘Eligibility Assessment System’ means the enti-
ty designated by the Secretary under section 
3205(a)(2)(A)(i). 
‘‘(6) ELIGIBLE BENEFICIARY.— 
‘‘(A) IN
GENERAL.—The term ‘eligible 
beneficiary’ means any individual who is an ac-
tive enrollee in the CLASS program and, as of 
the date described in subparagraph (B)— 
‘‘(i) has paid premiums for enrollment 
in such program for at least 60 months; 
‘‘(ii) has earned, for each calendar 
year that occurs during the first 60 
months for which the individual has paid 
premiums for enrollment in the program, 
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at least an amount equal to the amount of 
wages and self-employment income which 
an individual must have in order to be 
credited with a quarter of coverage under 
section 213(d) of the Social Security Act 
for that year; and 
‘‘(iii) has paid premiums for enroll-
ment in such program for at least 24 con-
secutive months, if a lapse in premium 
payments of more than 3 months has oc-
curred during the period that begins on the 
date of the individual’s enrollment and 
ends on the date of such determination. 
‘‘(B) DATE DESCRIBED.—For purposes of 
subparagraph (A), the date described in this 
subparagraph is the date on which the indi-
vidual is determined to have a functional limita-
tion described in section 3203(a)(1)(C) that is 
expected to last for a continuous period of more 
than 90 days. 
‘‘(C) REGULATIONS.—The Secretary shall 
promulgate regulations specifying exceptions to 
the minimum earnings requirements under sub-
paragraph (A)(ii) for purposes of being consid-
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ered an eligible beneficiary for certain popu-
lations. 
‘‘(7) HOSPITAL; NURSING
FACILITY; INTER-
MEDIATE CARE FACILITY FOR THE MENTALLY RE-
TARDED; INSTITUTION
FOR
MENTAL
DISEASES.— 
The terms ‘hospital’, ‘nursing facility’, ‘intermediate 
care facility for the mentally retarded’, and ‘institu-
tion for mental diseases’ have the meanings given 
such terms for purposes of Medicaid. 
‘‘(8) CLASS INDEPENDENCE ADVISORY COUN-
CIL.—The term ‘CLASS Independence Advisory 
Council’ or ‘Council’ means the Advisory Council es-
tablished under section 3207 to advise the Secretary. 
‘‘(9) CLASS INDEPENDENCE BENEFIT PLAN.— 
The term ‘CLASS Independence Benefit Plan’ 
means the benefit plan developed and designated by 
the Secretary in accordance with section 3203. 
‘‘(10) CLASS 
INDEPENDENCE
FUND.—The 
term ‘CLASS Independence Fund’ or ‘Fund’ means 
the fund established under section 3206. 
‘‘(11) MEDICAID.—The term ‘Medicaid’ means 
the program established under title XIX of the So-
cial Security Act. 
‘‘(12) PROTECTION AND ADVOCACY SYSTEM.— 
The term ‘Protection and Advocacy System’ means 
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the system for each State established under section 
143 of the Developmental Disabilities Assistance 
and Bill of Rights Act of 2000. 
‘‘SEC. 3203. CLASS INDEPENDENCE BENEFIT PLAN. 
‘‘(a) PROCESS FOR DEVELOPMENT.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with appropriate actuaries and other experts, 
shall develop at least 3 actuarially sound benefit 
plans as alternatives for consideration for designa-
tion by the Secretary as the CLASS Independence 
Benefit Plan under which eligible beneficiaries shall 
receive benefits under this title. Each of the plan al-
ternatives developed shall be designed to provide eli-
gible beneficiaries with the benefits described in sec-
tion 3205 consistent with the following require-
ments: 
‘‘(A) PREMIUMS.—Beginning with the first 
year of the CLASS program, and for each year 
thereafter, the Secretary shall establish all pre-
miums to be paid by enrollees for the year 
based on an actuarial analysis of the 75-year 
costs of the program that ensures solvency 
throughout such 75-year period. 
‘‘(B) VESTING PERIOD.—A 5-year vesting 
period for eligibility for benefits. 
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‘‘(C) BENEFIT TRIGGERS.—A benefit trig-
ger for provision of benefits that requires a de-
termination that an individual has a functional 
limitation, as certified by a licensed health care 
practitioner, described in any of the following 
clauses that is expected to last for a continuous 
period of more than 90 days: 
‘‘(i) The individual is determined to 
be unable to perform at least the minimum 
number (which may be 2 or 3) of activities 
of daily living as are required under the 
plan for the provision of benefits without 
substantial assistance (as defined by the 
Secretary) from another individual. 
‘‘(ii) The individual requires substan-
tial supervision to protect the individual 
from threats to health and safety due to 
substantial cognitive impairment. 
‘‘(iii) The individual has a level of 
functional limitation similar (as determined 
under regulations prescribed by the Sec-
retary) to the level of functional limitation 
described in clause (i) or (ii). 
‘‘(D) CASH BENEFIT.—Payment of a cash 
benefit that satisfies the following requirements: 
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‘‘(i) MINIMUM REQUIRED AMOUNT.— 
The benefit amount provides an eligible 
beneficiary with not less than an average 
of $50 per day (as determined based on 
the reasonably expected distribution of 
beneficiaries receiving benefits at various 
benefit levels). 
‘‘(ii) AMOUNT
SCALED
TO
FUNC-
TIONAL ABILITY.—The benefit amount is 
varied based on a scale of functional abil-
ity, with not less than 2, and not more 
than 6, benefit level amounts. 
‘‘(iii) DAILY OR WEEKLY.—The ben-
efit is paid on a daily or weekly basis. 
‘‘(iv) NO
LIFETIME
OR
AGGREGATE 
LIMIT.—The benefit is not subject to any 
lifetime or aggregate limit. 
‘‘(2) REVIEW AND RECOMMENDATION BY THE 
CLASS
INDEPENDENCE
ADVISORY
COUNCIL.—The 
CLASS Independence Advisory Council shall— 
‘‘(A) evaluate the alternative benefit plans 
developed under paragraph (1); and 
‘‘(B) recommend for designation as the 
CLASS Independence Benefit Plan for offering 
to the public the plan that the Council deter-
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mines best balances price and benefits to meet 
enrollees’ needs in an actuarially sound manner, 
while optimizing the probability of the long- 
term sustainability of the CLASS program. 
‘‘(3) DESIGNATION BY THE SECRETARY.—Not 
later than October 1, 2012, the Secretary, taking 
into consideration the recommendation of the 
CLASS Independence Advisory Council under para-
graph (2)(B), shall designate a benefit plan as the 
CLASS Independence Benefit Plan. The Secretary 
shall publish such designation, along with details of 
the plan and the reasons for the selection by the 
Secretary, in a final rule that allows for a period of 
public comment. 
‘‘(b) ADDITIONAL PREMIUM REQUIREMENTS.— 
‘‘(1) ADJUSTMENT OF PREMIUMS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraphs (B), (C), (D), and (E), the 
amount of the monthly premium determined for 
an individual upon such individual’s enrollment 
in the CLASS program shall remain the same 
for as long as the individual is an active en-
rollee in the program. 
‘‘(B) RECALCULATED
PREMIUM
IF
RE-
QUIRED FOR PROGRAM SOLVENCY.— 
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‘‘(i) IN GENERAL.—Subject to clause 
(ii), if the Secretary determines, based on 
the most recent report of the Board of 
Trustees of the CLASS Independence 
Fund, the advice of the CLASS Independ-
ence Advisory Council, and the annual re-
port of the Inspector General of the De-
partment of Health and Human Services, 
and waste, fraud, and abuse, or such other 
information as the Secretary determines 
appropriate, that the monthly premiums 
and income to the CLASS Independence 
Fund for a year are projected to be insuffi-
cient with respect to the 20-year period 
that begins with that year, the Secretary 
shall adjust the monthly premiums for in-
dividuals enrolled in the CLASS program 
as necessary. 
‘‘(ii) EXEMPTION FROM INCREASE.— 
Any increase in a monthly premium im-
posed as result of a determination de-
scribed in clause (i) shall not apply with 
respect to the monthly premium of any ac-
tive enrollee who— 
‘‘(I) has attained age 65; 
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‘‘(II) has paid premiums for en-
rollment in the program for at least 
20 years; and 
‘‘(III) is not actively employed. 
‘‘(C) RECALCULATED
PREMIUM
IF
RE-
ENROLLMENT AFTER MORE THAN A 3-MONTH 
LAPSE.— 
‘‘(i) IN GENERAL.—The reenrollment 
of an individual after a 90-day period dur-
ing which the individual failed to pay the 
monthly premium required to maintain the 
individual’s enrollment in the CLASS pro-
gram shall be treated as an initial enroll-
ment for purposes of age-adjusting the 
premium for enrollment in the program. 
‘‘(ii) CREDIT FOR PRIOR MONTHS IF 
REENROLLED WITHIN 5 YEARS.—An indi-
vidual who reenrolls in the CLASS pro-
gram after such a 90-day period and be-
fore the end of the 5-year period that be-
gins with the first month for which the in-
dividual failed to pay the monthly premium 
required to maintain the individual’s en-
rollment in the program shall be— 
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‘‘(I) credited with any months of 
paid premiums that accrued prior to 
the individual’s lapse in enrollment; 
and 
‘‘(II) notwithstanding the total 
amount of any such credited months, 
required 
to 
satisfy 
section 
3202(6)(A)(ii) before being eligible to 
receive benefits. 
‘‘(D) 
PENALTY
FOR
REENROLLMENT 
AFTER 5-YEAR LAPSE.—In the case of an indi-
vidual who reenrolls in the CLASS program 
after the end of the 5-year period described in 
subparagraph (C)(ii), the monthly premium re-
quired for the individual shall be the age-ad-
justed premium that would be applicable to an 
initially enrolling individual who is the same age 
as the reenrolling individual, increased by the 
greater of— 
‘‘(i) an amount that the Secretary de-
termines is actuarially sound for each 
month that occurs during the period that 
begins with the first month for which the 
individual failed to pay the monthly pre-
mium required to maintain the individual’s 
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enrollment in the CLASS program and 
ends with the month preceding the month 
in which the reenrollment is effective; or 
‘‘(ii) 1 percent of the applicable age- 
adjusted premium for each such month oc-
curring in such period. 
‘‘(2) ADMINISTRATIVE
EXPENSES.—In deter-
mining the monthly premiums for the CLASS pro-
gram, the Secretary may factor in costs for admin-
istering the program, not to exceed— 
‘‘(A) in the case of the first 5 years in 
which the program is in effect under this title, 
an amount equal to 3 percent of all premiums 
paid during each such year; and 
‘‘(B) in the case of subsequent years, an 
amount equal to 5 percent of the total amount 
of all expenditures (including benefits paid) 
under this title with respect to that year. 
‘‘(3) NO UNDERWRITING REQUIREMENTS.—No 
underwriting (other than on the basis of age in ac-
cordance with paragraph (2)) shall be used to— 
‘‘(A) determine the monthly premium for 
enrollment in the CLASS program; or 
‘‘(B) prevent an individual from enrolling 
in the program. 
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‘‘SEC. 3204. ENROLLMENT AND DISENROLLMENT REQUIRE-
MENTS. 
‘‘(a) AUTOMATIC ENROLLMENT.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall establish procedures under which 
each individual described in subsection (c) shall be 
automatically enrolled in the CLASS program by an 
employer of such individual under rules similar to 
the rules of sections 401(k)(13) and 414(w) of the 
Internal Revenue Code of 1986. 
‘‘(2) 
ALTERNATIVE
ENROLLMENT
PROCE-
DURES.—The procedures established under para-
graph (1) shall provide for an alternative enrollment 
process for an individual described in subsection (c) 
in the case of such an individual— 
‘‘(A) who is self-employed; 
‘‘(B) who has more than 1 employer; 
‘‘(C) whose employer does not elect to par-
ticipate in the automatic enrollment process es-
tablished by the Secretary; or 
‘‘(D) who is a spouse described in sub-
section (c)(2) of who is not subject to automatic 
enrollment. 
‘‘(3) ADMINISTRATION.— 
‘‘(A) IN GENERAL.—The Secretary shall, 
by regulation, establish procedures to— 
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‘‘(i) ensure that an individual is not 
automatically enrolled in the CLASS pro-
gram by more than 1 employer; and 
‘‘(ii) allow for an individual’s em-
ployer to deduct a premium for a spouse 
described in subsection (c)(1)(B) who is 
not subject to automatic enrollment. 
‘‘(B) FORM.—Enrollment in the CLASS 
program shall be made in such manner as the 
Secretary may prescribe in order to ensure ease 
of administration. 
‘‘(b) ELECTION TO OPT-OUT.—An individual de-
scribed in subsection (c) may elect to waive enrollment in 
the CLASS program at any time in such form and manner 
as the Secretary shall prescribe. 
‘‘(c) INDIVIDUAL DESCRIBED.—For purposes of en-
rolling in the CLASS program, an individual described in 
this paragraph is— 
‘‘(1) an individual— 
‘‘(A) who has attained age 18; 
‘‘(B) who receives wages on which there is 
imposed a tax under section 3101(a) or 3201(a) 
of the Internal Revenue Code of 1986; 
‘‘(C) who is actively employed; and 
‘‘(D) who is not— 
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‘‘(i) a patient in a hospital or nursing 
facility, an intermediate care facility for 
the mentally retarded, or an institution for 
mental diseases and receiving medical as-
sistance under Medicaid; or 
‘‘(ii) confined in a jail, prison, other 
penal institution or correctional facility, or 
by court order pursuant to conviction of a 
criminal offense or in connection with a 
verdict or finding described in section 
202(x)(1)(A)(ii) of the Social Security Act; 
or 
‘‘(2) the spouse of an individual described in 
paragraph (1) and who would be an individual so de-
scribed but for subparagraph (B) or (C) of that 
paragraph. 
‘‘(d) RULE OF CONSTRUCTION.—Nothing in this title 
shall be construed as requiring an active enrollee to con-
tinue to satisfy subparagraph (B) or (C) of subsection 
(c)(1) in order to maintain enrollment in the CLASS pro-
gram. 
‘‘(e) PAYMENT.— 
‘‘(1) PAYROLL DEDUCTION.—An amount equal 
to the monthly premium for the enrollment in the 
CLASS program of an individual shall be deducted 
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from the wages of such individual in accordance with 
such procedures as the Secretary shall establish for 
employers who elect to deduct and withhold such 
premiums on behalf of enrolled employees. 
‘‘(2) ALTERNATIVE
PAYMENT
MECHANISM.— 
The Secretary shall establish alternative procedures 
for the payment of monthly premiums by an indi-
vidual enrolled in the CLASS program who does not 
have an employer who elects to deduct and withhold 
premiums in accordance with subparagraph (A). 
‘‘(f) TRANSFER OF PREMIUMS COLLECTED.— 
‘‘(1) IN GENERAL.—During each calendar year 
the Secretary of the Treasury shall deposit into the 
CLASS Independence Fund a total amount equal, in 
the aggregate, to 100 percent of the premiums col-
lected during that year. 
‘‘(2) TRANSFERS BASED ON ESTIMATES.—The 
amount deposited pursuant to paragraph (1) shall be 
transferred in at least monthly payments to the 
CLASS Independence Fund on the basis of esti-
mates by the Secretary and certified to the Sec-
retary of the Treasury of the amounts collected in 
accordance with this section. Proper adjustments 
shall be made in amounts subsequently transferred 
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to the Fund to the extent prior estimates were in ex-
cess of, or were less than, actual amounts collected. 
‘‘(g) OTHER ENROLLMENT
AND DISENROLLMENT 
OPPORTUNITIES.—The Secretary shall establish proce-
dures under which— 
‘‘(1) an individual who, in the year of the indi-
vidual’s initial eligibility to enroll in the CLASS pro-
gram, has elected to waive enrollment in the pro-
gram, is eligible to elect to enroll in the program, in 
such form and manner as the Secretary shall estab-
lish, only during an open enrollment period estab-
lished by the Secretary that is specific to the indi-
vidual and that may not occur more frequently than 
biennially after the date on which the individual first 
elected to waive enrollment in the program; and 
‘‘(2) an individual shall only be permitted to 
disenroll from the program during an annual 
disenrollment period established by the Secretary 
and in such form and manner as the Secretary shall 
establish. 
‘‘SEC. 3205. BENEFITS. 
‘‘(a) DETERMINATION OF ELIGIBILITY.— 
‘‘(1) APPLICATION
FOR
RECEIPT
OF
BENE-
FITS.—The Secretary shall establish procedures 
under which an active enrollee shall apply for receipt 
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of benefits under the CLASS Independence Benefit 
Plan. 
‘‘(2) ELIGIBILITY ASSESSMENTS.— 
‘‘(A) IN GENERAL.—Not later than Janu-
ary 1, 2012, the Secretary shall— 
‘‘(i) designate an entity (other than a 
service with which the Commissioner of So-
cial Security has entered into an agree-
ment, with respect to any State, to make 
disability determinations for purposes of 
title II or XVI of the Social Security Act) 
to serve as an Eligibility Assessment Sys-
tem by providing for eligibility assessments 
of active enrollees who apply for receipt of 
benefits; 
‘‘(ii) enter into an agreement with the 
Protection and Advocacy System for each 
State to provide advocacy services in ac-
cordance with subsection (d); and 
‘‘(iii) enter into an agreement with 
public and private entities to provide ad-
vice and assistance counseling in accord-
ance with subsection (e). 
‘‘(B) REGULATIONS.—The Secretary shall 
promulgate regulations to develop an expedited 
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nationally equitable eligibility determination 
process, as certified by a licensed health care 
practitioner, an appeals process, and a redeter-
mination process, as certified by a licensed 
health care practitioner, including whether an 
applicant is eligible for a cash benefit under the 
program and if so, the amount of the cash ben-
efit (in accordance the sliding scale established 
under the plan). 
‘‘(C) PRESUMPTIVE ELIGIBILITY FOR CER-
TAIN
INSTITUTIONALIZED
ENROLLEES
PLAN-
NING TO DISCHARGE.—An active enrollee shall 
be deemed presumptively eligible if the en-
rollee— 
‘‘(i) has applied for, and attests is eli-
gible for, the maximum cash benefit avail-
able under the sliding scale established 
under the CLASS Independence Benefit 
Plan; 
‘‘(ii) is a patient in a hospital (but 
only if the hospitalization is for long-term 
care), nursing facility, intermediate care 
facility for the mentally retarded, or an in-
stitution for mental diseases; and 
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‘‘(iii) is in the process of, or about to 
being the process of, planning to discharge 
from the hospital, facility, or institution, or 
within 60 days from the date of discharge 
from the hospital, facility, or institution. 
‘‘(D) APPEALS.—The Secretary shall es-
tablish procedures under which an applicant for 
benefits under the CLASS Independence Ben-
efit Plan shall be guaranteed the right to ap-
peal an adverse determination. 
‘‘(b) BENEFITS.—An eligible beneficiary shall receive 
the following benefits under the CLASS Independence 
Benefit Plan: 
‘‘(1) CASH
BENEFIT.—A cash benefit estab-
lished by the Secretary in accordance with the re-
quirements of section 3203(a)(1)(D) that— 
‘‘(A) the first year in which beneficiaries 
receive the benefits under the plan, is not less 
than the average dollar amount specified in 
clause (i) of such section; and 
‘‘(B) for any subsequent year, is not less 
than the average per day dollar limit applicable 
under this subparagraph for the preceding year, 
increased by the percentage increase in the con-
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sumer price index for all urban consumers 
(U.S. city average) over the previous year. 
‘‘(2) ADVOCACY SERVICES.—Advocacy services 
in accordance with subsection (d). 
‘‘(3) ADVICE AND ASSISTANCE COUNSELING.— 
Advice and assistance counseling in accordance with 
subsection (e). 
‘‘(4) ADMINISTRATIVE
EXPENSES.—Advocacy 
services and advise and assistance counseling serv-
ices under paragraphs (2) and (3) of this subsection 
shall be included as administrative expenses under 
section 3203(b)(2). 
‘‘(c) PAYMENT OF BENEFITS.— 
‘‘(1) LIFE INDEPENDENCE ACCOUNT.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish procedures for administering the pro-
vision of benefits to eligible beneficiaries under 
the CLASS Independence Benefit Plan, includ-
ing the payment of the cash benefit for the ben-
eficiary into a Life Independence Account es-
tablished by the Secretary on behalf of each eli-
gible beneficiary. 
‘‘(B) USE OF CASH BENEFITS.—Cash ben-
efits paid into a Life Independence Account of 
an eligible beneficiary shall be used to purchase 
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nonmedical services and supports that the bene-
ficiary needs to maintain his or her independ-
ence at home or in another residential setting 
of their choice in the community, including (but 
not limited to) home modifications, assistive 
technology, accessible transportation, home-
maker services, respite care, personal assistance 
services, home care aides, and nursing support. 
Nothing in the preceding sentence shall prevent 
an eligible beneficiary from using cash benefits 
paid into a Life Independence Account for ob-
taining assistance with decisionmaking con-
cerning medical care, including the right to ac-
cept or refuse medical or surgical treatment 
and the right to formulate advance directives or 
other written instructions recognized under 
State law, such as a living will or durable power 
of attorney for health care, in the case that an 
injury or illness causes the individual to be un-
able to make health care decisions. 
‘‘(C) 
ELECTRONIC
MANAGEMENT
OF 
FUNDS.—The Secretary shall establish proce-
dures for— 
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‘‘(i) crediting an account established 
on behalf of a beneficiary with the bene-
ficiary’s cash daily benefit; 
‘‘(ii) allowing the beneficiary to access 
such account through debit cards; and 
‘‘(iii) accounting for withdrawals by 
the beneficiary from such account. 
‘‘(D) PRIMARY PAYOR RULES FOR BENE-
FICIARIES WHO ARE ENROLLED IN MEDICAID.— 
In the case of an eligible beneficiary who is en-
rolled in Medicaid, the following payment rules 
shall apply: 
‘‘(i) 
INSTITUTIONALIZED
BENE-
FICIARY.—If the beneficiary is a patient in 
a hospital, nursing facility, intermediate 
care facility for the mentally retarded, or 
an institution for mental diseases, the ben-
eficiary shall retain an amount equal to 5 
percent of the beneficiary’s daily or weekly 
cash benefit (as applicable) (which shall be 
in addition to the amount of the bene-
ficiary’s personal needs allowance provided 
under Medicaid), and the remainder of 
such benefit shall be applied toward the fa-
cility’s cost of providing the beneficiary’s 
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care, and Medicaid shall provide secondary 
coverage for such care. 
‘‘(ii) 
BENEFICIARIES
RECEIVING 
HOME
AND
COMMUNITY-BASED
SERV-
ICES.— 
‘‘(I) 50 PERCENT
OF
BENEFIT 
RETAINED BY BENEFICIARY.—Subject 
to subclause (II), if a beneficiary is 
receiving medical assistance under 
Medicaid for home and community- 
based services, the beneficiary shall 
retain an amount equal to 50 percent 
of the beneficiary’s daily or weekly 
cash benefit (as applicable), and the 
remainder of the daily or weekly cash 
benefit shall be applied toward the 
cost to the State of providing such as-
sistance (and shall not be used to 
claim Federal matching funds under 
Medicaid), and Medicaid shall provide 
secondary coverage for the remainder 
of any costs incurred in providing 
such assistance. 
‘‘(II) REQUIREMENT FOR STATE 
OFFSET.—A State shall be paid the 
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remainder of a beneficiary’s daily or 
weekly cash benefit under subclause 
(I) only if the State home and com-
munity-based waiver under section 
1115 of the Social Security Act or 
subsection (c) or (d) of section 1915 
of such Act, or the State plan amend-
ment under subsection (i) of such sec-
tion does not include a waiver of the 
requirements of section 1902(a)(1) of 
the Social Security Act (relating to 
statewideness) 
or 
of 
section 
1902(a)(10)(B) of such Act (relating 
to comparability) and the State offers 
at a minimum case management serv-
ices, personal care services, habili-
tation services, and respite care under 
such a waiver or State plan amend-
ment. 
‘‘(III) DEFINITION OF HOME AND 
COMMUNITY-BASED
SERVICES.—In 
this clause, the term ‘home and com-
munity-based services’ means any 
services which may be offered under a 
home and community-based waiver 
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authorized for a State under section 
1115 of the Social Security Act or 
subsection (c) or (d) of section 1915 
of such Act or under a State plan 
amendment under subsection (i) of 
such section. 
‘‘(iii) BENEFICIARIES
ENROLLED
IN 
PROGRAMS OF ALL-INCLUSIVE CARE FOR 
THE ELDERLY (PACE).— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), if a beneficiary is re-
ceiving medical assistance under Med-
icaid for PACE program services 
under section 1934 of the Social Secu-
rity Act, the beneficiary shall retain 
an amount equal to 50 percent of the 
beneficiary’s daily or weekly cash ben-
efit (as applicable), and the remainder 
of the daily or weekly cash benefit 
shall be applied toward the cost to the 
State of providing such assistance 
(and shall not be used to claim Fed-
eral matching funds under Medicaid), 
and Medicaid shall provide secondary 
coverage for the remainder of any 
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costs incurred in providing such as-
sistance. 
‘‘(II) 
INSTITUTIONALIZED
RE-
CIPIENTS
OF
PACE
PROGRAM
SERV-
ICES.—If a beneficiary receiving as-
sistance under Medicaid for PACE 
program services is a patient in a hos-
pital, nursing facility, intermediate 
care facility for the mentally retarded, 
or an institution for mental diseases, 
the beneficiary shall be treated as in 
institutionalized 
beneficiary 
under 
clause (i). 
‘‘(2) AUTHORIZED REPRESENTATIVES.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish procedures to allow access to a bene-
ficiary’s cash benefits by an authorized rep-
resentative of the eligible beneficiary on whose 
behalf such benefits are paid. 
‘‘(B) QUALITY ASSURANCE AND PROTEC-
TION AGAINST FRAUD AND ABUSE.—The proce-
dures established under subparagraph (A) shall 
ensure that authorized representatives of eligi-
ble beneficiaries comply with standards of con-
duct established by the Secretary, including 
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standards requiring that such representatives 
provide quality services on behalf of such bene-
ficiaries, do not have conflicts of interest, and 
do not misuse benefits paid on behalf of such 
beneficiaries or otherwise engage in fraud or 
abuse. 
‘‘(3) COMMENCEMENT OF BENEFITS.—Benefits 
shall be paid to, or on behalf of, an eligible bene-
ficiary beginning with the first month in which an 
application for such benefits is approved. 
‘‘(4) ROLLOVER OPTION FOR LUMP-SUM PAY-
MENT.—An eligible beneficiary may elect to— 
‘‘(A) defer payment of their daily or weekly 
benefit and to rollover any such deferred bene-
fits from month-to-month, but not from year-to- 
year; and 
‘‘(B) receive a lump-sum payment of such 
deferred benefits in an amount that may not 
exceed the lesser of— 
‘‘(i) the total amount of the accrued 
deferred benefits; or 
‘‘(ii) the applicable annual benefit. 
‘‘(5) PERIOD FOR DETERMINATION OF ANNUAL 
BENEFITS.— 
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‘‘(A) IN GENERAL.—The applicable period 
for determining with respect to an eligible bene-
ficiary the applicable annual benefit and the 
amount of any accrued deferred benefits is the 
12-month period that commences with the first 
month in which the beneficiary began to receive 
such benefits, and each 12-month period there-
after. 
‘‘(B) INCLUSION
OF
INCREASED
BENE-
FITS.—The Secretary shall establish procedures 
under which cash benefits paid to an eligible 
beneficiary that increase or decrease as a result 
of a change in the functional status of the bene-
ficiary before the end of a 12-month benefit pe-
riod shall be included in the determination of 
the applicable annual benefit paid to the eligible 
beneficiary. 
‘‘(C) RECOUPMENT OF UNPAID, ACCRUED 
BENEFITS.— 
‘‘(i) IN GENERAL.—The Secretary, in 
coordination with the Secretary of the 
Treasury, shall recoup any accrued bene-
fits in the event of— 
‘‘(I) the death of a beneficiary; or 
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‘‘(II) the failure of a beneficiary 
to elect under paragraph (4)(B) to re-
ceive such benefits as a lump-sum 
payment before the end of the 12- 
month period in which such benefits 
accrued. 
‘‘(ii) PAYMENT
INTO
CLASS
INDE-
PENDENCE FUND.—Any benefits recouped 
in accordance with clause (i) shall be paid 
into the CLASS Independence Fund and 
used in accordance with section 3206. 
‘‘(6) REQUIREMENT TO RECERTIFY ELIGIBILITY 
FOR RECEIPT OF BENEFITS.—An eligible beneficiary 
shall periodically, as determined by the Secretary— 
‘‘(A) recertify by submission of medical 
evidence the beneficiary’s continued eligibility 
for receipt of benefits; and 
‘‘(B) submit records of expenditures attrib-
utable to the aggregate cash benefit received by 
the beneficiary during the preceding year. 
‘‘(7) SUPPLEMENT, 
NOT
SUPPLANT
OTHER 
HEALTH CARE BENEFITS.—Subject to the Medicaid 
payment rules under paragraph (1)(D), benefits re-
ceived by an eligible beneficiary shall supplement, 
but not supplant, other health care benefits for 
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which the beneficiary is eligible under Medicaid or 
any other Federally funded program that provides 
health care benefits or assistance. 
‘‘(d) ADVOCACY SERVICES.—An agreement entered 
into under subsection (a)(2)(A)(ii) shall require the Pro-
tection and Advocacy System for the State to— 
‘‘(1) assign, as needed, an advocacy counselor 
to each eligible beneficiary that is covered by such 
agreement and who shall provide an eligible bene-
ficiary with— 
‘‘(A) information regarding how to access 
the appeals process established for the program; 
‘‘(B) assistance with respect to the annual 
recertification and notification required under 
subsection (c)(6); and 
‘‘(C) such other assistance with obtaining 
services as the Secretary, by regulation, shall 
require; and 
‘‘(2) ensure that the System and such coun-
selors comply with the requirements of subsection 
(h). 
‘‘(e) ADVICE
AND ASSISTANCE COUNSELING.—An 
agreement entered into under subsection (a)(2)(A)(iii) 
shall require the entity to assign, as requested by an eligi-
ble beneficiary that is covered by such agreement, an ad-
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vice and assistance counselor who shall provide an eligible 
beneficiary with information regarding— 
‘‘(1) accessing and coordinating long-term serv-
ices and supports in the most integrated setting; 
‘‘(2) possible eligibility for other benefits and 
services; 
‘‘(3) development of a service and support plan; 
‘‘(4) information about programs established 
under the Assistive Technology Act of 1998 and the 
services offered under such programs; 
‘‘(5) available assistance with decisionmaking 
concerning medical care, including the right to ac-
cept or refuse medical or surgical treatment and the 
right to formulate advance directives or other writ-
ten instructions recognized under State law, such as 
a living will or durable power of attorney for health 
care, in the case that an injury or illness causes the 
individual to be unable to make health care deci-
sions; and 
‘‘(6) such other services as the Secretary, by 
regulation, may require. 
‘‘(f) NO EFFECT ON ELIGIBILITY FOR OTHER BENE-
FITS.—Benefits paid to an eligible beneficiary under the 
CLASS program shall be disregarded for purposes of de-
termining or continuing the beneficiary’s eligibility for re-
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ceipt of benefits under any other Federal, State, or locally 
funded assistance program, including benefits paid under 
titles II, XVI, XVIII, XIX, or XXI of the Social Security 
Act, under the laws administered by the Secretary of Vet-
erans Affairs, under low-income housing assistance pro-
grams, or under the supplemental nutrition assistance 
program established under the Food and Nutrition Act of 
2008. 
‘‘(g) RULE OF CONSTRUCTION.—Nothing in this title 
shall be construed as prohibiting benefits paid under the 
CLASS Independence Benefit Plan from being used to 
compensate a family caregiver for providing community 
living assistance services and supports to an eligible bene-
ficiary. 
‘‘(h) PROTECTION AGAINST CONFLICTS OF INTER-
EST.—The Secretary shall establish procedures to ensure 
that the Eligibility Assessment System, the Protection and 
Advocacy System for a State, advocacy counselors for eli-
gible beneficiaries, and any other entities that provide 
services to active enrollees and eligible beneficiaries under 
the CLASS program comply with the following: 
‘‘(1) If the entity provides counseling or plan-
ning services, such services are provided in a manner 
that fosters the best interests of the active enrollee 
or beneficiary. 
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‘‘(2) The entity has established operating proce-
dures that are designed to avoid or minimize con-
flicts of interest between the entity and an active en-
rollee or beneficiary. 
‘‘(3) The entity provides information about all 
services and options available to the active enrollee 
or beneficiary, to the best of its knowledge, including 
services available through other entities or providers. 
‘‘(4) The entity assists the active enrollee or 
beneficiary to access desired services, regardless of 
the provider. 
‘‘(5) The entity reports the number of active 
enrollees and beneficiaries provided with assistance 
by age, disability, and whether such enrollees and 
beneficiaries received services from the entity or an-
other entity. 
‘‘(6) If the entity provides counseling or plan-
ning services, the entity ensures that an active en-
rollee or beneficiary is informed of any financial in-
terest that the entity has in a service provider. 
‘‘(7) The entity provides an active enrollee or 
beneficiary with a list of available service providers 
that can meet the needs of the active enrollee or 
beneficiary. 
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‘‘SEC. 3206. CLASS INDEPENDENCE FUND. 
‘‘(a) ESTABLISHMENT OF CLASS INDEPENDENCE 
FUND.—There is established in the Treasury of the 
United States a trust fund to be known as the ‘CLASS 
Independence Fund’. The Secretary of the Treasury shall 
serve as Managing Trustee of such Fund. The Fund shall 
consist of all amounts derived from payments into the 
Fund under sections 3204(f) and 3205(c)(5)(C)(ii), and 
remaining after investment of such amounts under sub-
section (b), including additional amounts derived as in-
come from such investments. The amounts held in the 
Fund are appropriated and shall remain available without 
fiscal year limitation— 
‘‘(1) to be held for investment on behalf of indi-
viduals enrolled in the CLASS program; 
‘‘(2) to pay the administrative expenses related 
to the Fund and to investment under subsection (b); 
and 
‘‘(3) to pay cash benefits to eligible bene-
ficiaries under the CLASS Independence Benefit 
Plan. 
‘‘(b) INVESTMENT OF FUND BALANCE.—The Sec-
retary of the Treasury shall invest and manage the 
CLASS Independence Fund in the same manner, and to 
the same extent, as the Federal Supplementary Medical 
Insurance Trust Fund may be invested and managed 
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under subsections (c), (d), and (e) of section 1841(d) of 
the Social Security Act. 
‘‘(c) BOARD OF TRUSTEES.— 
‘‘(1) IN GENERAL.—With respect to the CLASS 
Independence Fund, there is hereby created a body 
to be known as the Board of Trustees of the CLASS 
Independence Fund (hereinafter in this section re-
ferred to as the ‘Board of Trustees’) composed of 
the Secretary of the Treasury, the Secretary of 
Labor, and the Secretary of Health and Human 
Services, all ex officio, and of two members of the 
public (both of whom may not be from the same po-
litical party), who shall be nominated by the Presi-
dent for a term of 4 years and subject to confirma-
tion by the Senate. A member of the Board of 
Trustees serving as a member of the public and 
nominated and confirmed to fill a vacancy occurring 
during a term shall be nominated and confirmed 
only for the remainder of such term. An individual 
nominated and confirmed as a member of the public 
may serve in such position after the expiration of 
such member’s term until the earlier of the time at 
which the member’s successor takes office or the 
time at which a report of the Board is first issued 
under paragraph (2) after the expiration of the 
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member’s term. The Secretary of the Treasury shall 
be the Managing Trustee of the Board of Trustees. 
The Board of Trustees shall meet not less frequently 
than once each calendar year. A person serving on 
the Board of Trustees shall not be considered to be 
a fiduciary and shall not be personally liable for ac-
tions taken in such capacity with respect to the 
Trust Fund. 
‘‘(2) DUTIES.— 
‘‘(A) IN GENERAL.—It shall be the duty of 
the Board of Trustees to do the following: 
‘‘(i) Hold the CLASS Independence 
Fund. 
‘‘(ii) Report to the Congress not later 
than the first day of April of each year on 
the operation and status of the CLASS 
Independence Fund during the preceding 
fiscal year and on its expected operation 
and status during the current fiscal year 
and the next 2 fiscal years. 
‘‘(iii) Report immediately to the Con-
gress whenever the Board is of the opinion 
that the amount of the CLASS Independ-
ence Fund is not actuarially sound in re-
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gards to the projections under section 
3203(b)(1)(B)(i). 
‘‘(iv) Review the general policies fol-
lowed in managing the CLASS Independ-
ence Fund, and recommend changes in 
such policies, including necessary changes 
in the provisions of law which govern the 
way in which the CLASS Independence 
Fund is to be managed. 
‘‘(B) REPORT.—The report provided for in 
subparagraph (A)(ii) shall— 
‘‘(i) include— 
‘‘(I) a statement of the assets of, 
and the disbursements made from, the 
CLASS Independence Fund during 
the preceding fiscal year; 
‘‘(II) an estimate of the expected 
income to, and disbursements to be 
made from, the CLASS Independence 
Fund during the current fiscal year 
and each of the next 2 fiscal years; 
‘‘(III) a statement of the actu-
arial status of the CLASS Independ-
ence Fund for the current fiscal year, 
each of the next 2 fiscal years, and as 
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projected over the 75-year period be-
ginning with the current fiscal year; 
and 
‘‘(IV) an actuarial opinion certi-
fying that the techniques and meth-
odologies used are generally accepted 
within the actuarial profession and 
that the assumptions and cost esti-
mates used are reasonable; and 
‘‘(ii) be printed as a House document 
of the session of the Congress to which the 
report is made. 
‘‘(C) RECOMMENDATIONS.—If the Board 
of Trustees determines that enrollment trends 
and expected future benefit claims on the 
CLASS Independence Fund are not actuarially 
sound in regards to the projections under sec-
tion 3203(b)(1)(B)(i) and are unlikely to be re-
solved with reasonable premium increases or 
through other means, the Board of Trustees 
shall include in the report provided for in sub-
paragraph (A)(ii) recommendations for such 
legislative action as the Board of Trustees de-
termine to be appropriate, including whether to 
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adjust monthly premiums or impose a tem-
porary moratorium on new enrollments. 
‘‘SEC. 3207. CLASS INDEPENDENCE ADVISORY COUNCIL. 
‘‘(a) ESTABLISHMENT.—There is hereby created an 
Advisory Committee to be known as the ‘CLASS Inde-
pendence Advisory Council’. 
‘‘(b) MEMBERSHIP.— 
‘‘(1) IN GENERAL.—The CLASS Independence 
Advisory Council shall be composed of not more 
than 15 individuals, not otherwise in the employ of 
the United States— 
‘‘(A) who shall be appointed by the Presi-
dent without regard to the civil service laws and 
regulations; and 
‘‘(B) a majority of whom shall be rep-
resentatives of individuals who participate or 
are likely to participate in the CLASS program, 
and shall include representatives of older and 
younger workers, individuals with disabilities, 
family caregivers of individuals who require 
services and supports to maintain their inde-
pendence at home or in another residential set-
ting of their choice in the community, individ-
uals with expertise in long-term care or dis-
ability insurance, actuarial science, economics, 
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and other relevant disciplines, as determined by 
the Secretary. 
‘‘(2) TERMS.— 
‘‘(A) IN GENERAL.—The members of the 
CLASS Independence Advisory Council shall 
serve overlapping terms of 3 years (unless ap-
pointed to fill a vacancy occurring prior to the 
expiration of a term, in which case the indi-
vidual shall serve for the remainder of the 
term). 
‘‘(B) LIMITATION.—A member shall not be 
eligible to serve for more than 2 consecutive 
terms. 
‘‘(3) CHAIR.—The President shall, from time to 
time, appoint one of the members of the CLASS 
Independence Advisory Council to serve as the 
Chair. 
‘‘(c) DUTIES.—The CLASS Independence Advisory 
Council shall advise the Secretary on matters of general 
policy in the administration of the CLASS program estab-
lished under this title and in the formulation of regula-
tions under this title including with respect to— 
‘‘(1) the development of the CLASS Independ-
ence Benefit Plan under section 3203; and 
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‘‘(2) the determination of monthly premiums 
under such plan. 
‘‘(d) APPLICATION OF FACA.—The Federal Advisory 
Committee Act, other than section 14 of that Act, shall 
apply to the CLASS Independence Advisory Council. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—There are authorized to be 
appropriated to the CLASS Independence Advisory 
Council to carry out its duties under this section, 
such sums as may be necessary for fiscal year 2011 
and for each fiscal year thereafter. 
‘‘(2) AVAILABILITY.—Any sums appropriated 
under the authorization contained in this section 
shall remain available, without fiscal year limitation, 
until expended. 
‘‘SEC. 3208. REGULATIONS; ANNUAL REPORT. 
‘‘(a) REGULATIONS.—The Secretary shall promulgate 
such regulations as are necessary to carry out the CLASS 
program in accordance with this title. Such regulations 
shall include provisions to prevent fraud and abuse under 
the program. 
‘‘(b) ANNUAL REPORT.—Beginning January 1, 2014, 
the Secretary shall submit an annual report to Congress 
on the CLASS program. Each report shall include the fol-
lowing: 
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‘‘(1) The total number of enrollees in the pro-
gram. 
‘‘(2) The total number of eligible beneficiaries 
during the fiscal year. 
‘‘(3) The total amount of cash benefits provided 
during the fiscal year. 
‘‘(4) A description of instances of fraud or 
abuse identified during the fiscal year. 
‘‘(5) Recommendations for such administrative 
or legislative action as the Secretary determines is 
necessary to improve the program or to prevent the 
occurrence of fraud or abuse. 
‘‘SEC. 3209. INSPECTOR GENERAL’S REPORT. 
‘‘The Inspector General of the Department of Health 
and Human Services shall submit an annual report to the 
Secretary and Congress relating to the overall progress of 
the CLASS program and of the existence of waste, fraud, 
and abuse in the CLASS program. Each such report shall 
include findings in the following areas: 
‘‘(1) The eligibility determination process. 
‘‘(2) The provision of cash benefits. 
‘‘(3) Quality assurance and protection against 
waste, fraud, and abuse. 
‘‘(4) Recouping of unpaid and accrued bene-
fits.’’. 
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(b) CONFORMING AMENDMENTS TO MEDICAID.—For 
conforming provisions amending the Medicaid program, 
see section 1739. 
Subtitle E—Miscellaneous 
SEC. 2585. STATES FAILING TO ADHERE TO CERTAIN EM-
PLOYMENT OBLIGATIONS. 
A State is eligible for Federal funds under the provi-
sions of the Public Health Service Act (42 U.S.C. 201 et 
seq.) only if the State— 
(1) agrees to be subject in its capacity as an 
employer to each obligation under division A of this 
Act and the amendments made by such division ap-
plicable to persons in their capacity as an employer; 
and 
(2) assures that all political subdivisions in the 
State will do the same. 
SEC. 2586. HEALTH CENTERS UNDER PUBLIC HEALTH 
SERVICE ACT; LIABILITY PROTECTIONS FOR 
VOLUNTEER PRACTITIONERS. 
(a) IN GENERAL.—Section 224 (42 U.S.C. 233) is 
amended— 
(1) in subsection (g)(1)(A)— 
(A) in the first sentence, by striking ‘‘or 
employee’’ and inserting ‘‘employee, or (subject 
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to subsection (k)(4)) volunteer practitioner’’; 
and 
(B) in the second sentence, by inserting 
‘‘and subsection (k)(4)’’ after ‘‘subject to para-
graph (5)’’; and 
(2) in each of subsections (g), (i), (j), (l), and 
(m), by striking the term ‘‘employee, or contractor’’ 
each place such term appears and inserting ‘‘em-
ployee, volunteer practitioner, or contractor’’; 
(3) in subsection (g)(1)(H), by striking the 
term ‘‘employee, and contractor’’ each place such 
term appears and inserting ‘‘employee, volunteer 
practitioner, and contractor’’; 
(4) in subsection (l), by striking the term ‘‘em-
ployee, or any contractor’’ and inserting ‘‘employee, 
volunteer practitioner, or contractor’’; and 
(5) in subsections (h)(3) and (k), by striking 
the term ‘‘employees, or contractors’’ each place 
such term appears and inserting ‘‘employees, volun-
teer practitioners, or contractors’’. 
(b) APPLICABILITY; DEFINITION.—Section 224(k) 
(42 U.S.C. 233(k)) is amended by adding at the end the 
following paragraph: 
‘‘(4)(A) Subsections (g) through (m) apply with re-
spect to volunteer practitioners beginning with the first 
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fiscal year for which an appropriations Act provides that 
amounts in the fund under paragraph (2) are available 
with respect to such practitioners. 
‘‘(B) For purposes of subsections (g) through (m), 
the term ‘volunteer practitioner’ means a practitioner who, 
with respect to an entity described in subsection (g)(4), 
meets the following conditions: 
‘‘(i) The practitioner is a licensed physician, a 
licensed clinical psychologist, or other licensed or 
certified health care practitioner. 
‘‘(ii) At the request of such entity, the practi-
tioner provides services to patients of the entity, at 
a site at which the entity operates or at a site des-
ignated by the entity. The weekly number of hours 
of services provided to the patients by the practi-
tioner is not a factor with respect to meeting condi-
tions under this subparagraph. 
‘‘(iii) The practitioner does not for the provision 
of such services receive any compensation from such 
patients, from the entity, or from third-party payors 
(including reimbursement under any insurance pol-
icy or health plan, or under any Federal or State 
health benefits program).’’. 
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SEC. 2587. REPORT TO CONGRESS ON THE CURRENT STATE 
OF PARASITIC DISEASES THAT HAVE BEEN 
OVERLOOKED AMONG THE POOREST AMERI-
CANS. 
Not later than 12 months after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall report to Congress on the epidemiology of, 
impact of, and appropriate funding required to address ne-
glected diseases of poverty, including neglected parasitic 
diseases identified as Chagas disease, cysticercosis, 
toxocariasis, toxoplasmosis, trichomoniasis, the soil-trans-
mitted helminths, and others. The report should provide 
the information necessary to enhance health policy to ac-
curately evaluate and address the threat of these diseases. 
SEC. 2588. OFFICE OF WOMEN’S HEALTH. 
(a) HEALTH
AND HUMAN SERVICES OFFICE
ON 
WOMEN’S HEALTH.— 
(1) ESTABLISHMENT.—Part A of title II (42 
U.S.C. 202 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON 
WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT OF OFFICE.—There is estab-
lished within the Office of the Secretary, an Office on 
Women’s Health (referred to in this section as the ‘Of-
fice’). The Office shall be headed by a Deputy Assistant 
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Secretary for Women’s Health who may report to the Sec-
retary. 
‘‘(b) DUTIES.—The Secretary, acting through the Of-
fice, with respect to the health concerns of women, shall— 
‘‘(1) establish short-range and long-range goals 
and objectives within the Department of Health and 
Human Services and, as relevant and appropriate, 
coordinate with other appropriate offices on activi-
ties within the Department that relate to disease 
prevention, health promotion, service delivery, re-
search, and public and health care professional edu-
cation, for issues of particular concern to women 
throughout their lifespan; 
‘‘(2) provide expert advice and consultation to 
the Secretary concerning scientific, legal, ethical, 
and policy issues relating to women’s health; 
‘‘(3) monitor the Department of Health and 
Human Services’ offices, agencies, and regional ac-
tivities regarding women’s health and identify needs 
regarding the coordination of activities, including in-
tramural and extramural multidisciplinary activities; 
‘‘(4) establish a Department of Health and 
Human Services Coordinating Committee on Wom-
en’s Health, which shall be chaired by the Deputy 
Assistant Secretary for Women’s Health and com-
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posed of senior level representatives from each of the 
agencies and offices of the Department of Health 
and Human Services; 
‘‘(5) establish a National Women’s Health In-
formation Center to— 
‘‘(A) facilitate the exchange of information 
regarding matters relating to health informa-
tion, health promotion, preventive health serv-
ices, research advances, and education in the 
appropriate use of health care; 
‘‘(B) facilitate access to such information; 
‘‘(C) assist in the analysis of issues and 
problems relating to the matters described in 
this paragraph; and 
‘‘(D) provide technical assistance with re-
spect to the exchange of information (including 
facilitating the development of materials for 
such technical assistance); 
‘‘(6) coordinate efforts to promote women’s 
health programs and policies with the private sector; 
and 
‘‘(7) through publications and any other means 
appropriate, provide for the exchange of information 
between the Office and recipients of grants, con-
tracts, and agreements under subsection (c), and be-
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tween the Office and health professionals and the 
general public. 
‘‘(c) GRANTS
AND CONTRACTS REGARDING DU-
TIES.— 
‘‘(1) AUTHORITY.—In carrying out subsection 
(b), the Secretary may make grants to, and enter 
into cooperative agreements, contracts, and inter-
agency agreements with, public and private entities, 
agencies, and organizations. 
‘‘(2) EVALUATION AND DISSEMINATION.—The 
Secretary shall directly or through contracts with 
public and private entities, agencies, and organiza-
tions, provide for evaluations of projects carried out 
with financial assistance provided under paragraph 
(1) and for the dissemination of information devel-
oped as a result of such projects. 
‘‘(d) REPORTS.—Not later than 1 year after the date 
of enactment of this section, and every second year there-
after, the Secretary shall prepare and submit to the appro-
priate committees of Congress a report describing the ac-
tivities carried out under this section during the period 
for which the report is being prepared.’’. 
(2) TRANSFER
OF
FUNCTIONS.—There are 
transferred to the Office on Women’s Health (estab-
lished under section 229 of the Public Health Serv-
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‘‘(23) The term ‘tribal college or university’ has 
the meaning given the term in section 316(b)(3) of 
the Higher Education Act (20 U.S.C. 1059c(b)(3)). 
‘‘(24) The term ‘Tribal Health Program’ means 
an Indian Tribe or Tribal Organization that oper-
ates any health program, service, function, activity, 
or facility funded, in whole or part, by the Service 
through, or provided for in, a contract or compact 
with the Service under the Indian Self-Determina-
tion and Education Assistance Act (25 U.S.C. 450 
et seq.). 
‘‘(25) The term ‘Tribal Organization’ has the 
meaning given the term in the Indian Self-Deter-
mination and Education Assistance Act (25 U.S.C. 
450 et seq.). 
‘‘(26) The term ‘Urban Center’ means any com-
munity which has a sufficient Urban Indian popu-
lation with unmet health needs to warrant assistance 
under title V of this Act, as determined by the Sec-
retary. 
‘‘(27) The term ‘Urban Indian’ means any indi-
vidual who resides in an Urban Center and who 
meets 1 or more of the following criteria: 
‘‘(A) Irrespective of whether the individual 
lives on or near a reservation, the individual is 
VerDate Nov 24 2008 
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Jkt 089200
PO 00000
Frm 01651
Fmt 6652
Sfmt 6201
E:\BILLS\H3962.IH
H3962
rmajette on DSK29S0YB1PROD with BILLS