1466 
Medicare, a private health insurer, or any other ap-
propriate entity to provide care under Medicare, 
under health insurance coverage offered by the in-
surer, or otherwise. 
‘‘(e) EVALUATIONS.— 
‘‘(1) GRANTEE
REPORTS.—Beginning in the 
third year following an initial grant, each commu-
nity-based collaborative care network shall submit to 
the Secretary, with respect to each year the grantee 
has received a grant, an evaluation on the activities 
carried out by the community-based collaborative 
care network under the community-based collabo-
rative care network program and shall include— 
‘‘(A) the number of people served; 
‘‘(B) the most common health problems 
treated; 
‘‘(C) any reductions in emergency depart-
ment use; 
‘‘(D) any improvements in access to pri-
mary care; 
‘‘(E) an accounting of how amounts re-
ceived were used, including identification of 
amounts used for patient care services as may 
be required for HRSA grantees; and
1467 
‘‘(F) to the extent requested by the Sec-
retary, any quality measures or any other meas-
ures specified by the Secretary. 
‘‘(2) PROGRAM REPORTS.—The Secretary shall 
submit to Congress an annual evaluation (beginning 
not later than 6 months after the first reports under 
paragraph (1) are submitted) on the extent to which 
emergency department use was reduced as a result 
of the activities carried out by the community-based 
collaborative care network under the program. Each 
such evaluation shall also include information on— 
‘‘(A) the prevalence of certain chronic con-
ditions in various populations, including a com-
parison of such prevalence in the general popu-
lation versus in the population of individuals 
with inadequate health insurance coverage; 
‘‘(B) demographic characteristics of the 
population of uninsured and underinsured indi-
viduals served by the community-based collabo-
rative care network involved; and 
‘‘(C) the conditions of such individuals for 
whom services were requested at such emer-
gency departments of participating hospitals. 
‘‘(3) AUDIT AUTHORITY.—The Secretary may 
conduct periodic audits and request periodic spend-
1468 
ing reports of community-based collaborative care 
networks under the community-based collaborative 
care network program. 
‘‘(f) CLARIFICATION.—Nothing in this section re-
quires a provider to report individually identifiable infor-
mation of an individual to government agencies, unless the 
individual consents, consistent with HIPAA privacy and 
security law, as defined in section 3009(a)(2). 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary for each of fiscal years 
2011 through 2015.’’. 
SEC. 2535. COMMUNITY-BASED OVERWEIGHT AND OBESITY 
PREVENTION PROGRAM. 
Part Q of title III (42 U.S.C. 280h et seq.) is amend-
ed by inserting after section 399W the following: 
‘‘SEC. 399W–1. COMMUNITY-BASED OVERWEIGHT AND OBE-
SITY PREVENTION PROGRAM. 
‘‘(a) PROGRAM.—The Secretary shall establish a 
community-based overweight and obesity prevention pro-
gram consisting of awarding grants and contracts under 
subsection (b). 
‘‘(b) GRANTS.—The Secretary shall award grants to, 
or enter into contracts with, eligible entities—
1469 
‘‘(1) to plan evidence-based programs for the 
prevention of overweight and obesity among children 
and their families through improved nutrition and 
increased physical activity; or 
‘‘(2) to implement such programs. 
‘‘(c) ELIGIBILITY.—To be eligible for a grant or con-
tract under subsection (b), an entity shall be a community 
partnership that demonstrates community support and in-
cludes— 
‘‘(1) a broad cross section of stakeholders, such 
as— 
‘‘(A) hospitals, health care systems, com-
munity health centers, or other health care pro-
viders; 
‘‘(B) universities, local educational agen-
cies, or childcare providers; 
‘‘(C) State, local, and tribal health depart-
ments; 
‘‘(D) State, local, and tribal park and 
recreation departments; 
‘‘(E) employers; and 
‘‘(F) health insurance companies; 
‘‘(2) residents of the community; and
1470 
‘‘(3) representatives of public and private enti-
ties that have a history of working within and serv-
ing the community. 
‘‘(d) PERIOD OF AWARDS.— 
‘‘(1) IN GENERAL.—The period of a grant or 
contract under this section shall be 5 years, subject 
to renewal under paragraph (2). 
‘‘(2) RENEWAL.—At the end of each fiscal year, 
the Secretary may renew a grant or contract award 
under this section only if the grant or contract re-
cipient demonstrates to the Secretary’s satisfaction 
that the recipient has made appropriate, measurable 
progress in preventing overweight and obesity. 
‘‘(e) REQUIREMENTS.— 
‘‘(1) IN GENERAL.—The Secretary may award 
a grant or contract under this section to an entity 
only if the entity demonstrates to the Secretary’s 
satisfaction that— 
‘‘(A) not later than 90 days after receiving 
the grant or contract, the entity will establish 
a steering committee to provide input on the as-
sessment of, and recommendations on improve-
ments to, the entity’s program funded through 
the grant or contract; and
1471 
‘‘(B) the entity has conducted or will con-
duct an assessment of the overweight and obe-
sity problem in its community, including the ex-
tent of the problem and factors contributing to 
the problem. 
‘‘(2) MATCHING
REQUIREMENT.—The Sec-
retary may award a grant or contract to an eligible 
entity under this section only if the entity agrees to 
provide, from non-Federal sources, an amount equal 
to $1 (in cash or in kind) for each $9 provided 
through the grant or contract to carry out the activi-
ties supported by the grant or contract. 
‘‘(3) PAYOR OF LAST RESORT.—The Secretary 
may award a grant or contract under this section to 
an entity only if the entity demonstrates to the satis-
faction of the Secretary that funds received through 
the grant or contract will not be expended for any 
activity to the extent that payment has been made, 
or can reasonably be expected to be made— 
‘‘(A) under any insurance policy; 
‘‘(B) under any Federal or State health 
benefits program (including titles XIX and XXI 
of the Social Security Act); or 
‘‘(C) by an entity which provides health 
services on a prepaid basis.
1472 
‘‘(4) MAINTENANCE
OF
EFFORT.—The Sec-
retary may award a grant or contract under this sec-
tion to an entity only if the entity demonstrates to 
the satisfaction of the Secretary that— 
‘‘(A) funds received through the grant or 
contract will be expended only to supplement, 
and not supplant, non-Federal and Federal 
funds otherwise available to the entity for the 
activities to be funded through the grant or 
contract; and 
‘‘(B) with respect to such activities, the en-
tity will maintain expenditures of non-Federal 
amounts for such activities at a level not less 
than the lesser of such expenditures maintained 
by the entity for the fiscal year preceding the 
fiscal year for which the entity receives the 
grant or contract. 
‘‘(f) PREFERENCES.—In awarding grants and con-
tracts under this section, the Secretary shall give pref-
erence to eligible entities that— 
‘‘(1) will serve communities with high levels of 
overweight and obesity and related chronic diseases; 
or
1473 
‘‘(2) will plan or implement activities for the 
prevention of overweight and obesity in school or 
workplace settings. 
‘‘(g) REPORT.—The Secretary shall submit to the 
Congress an annual report on the program of grants and 
contracts awarded under this section. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) The term ‘evidence-based’ means that 
methodologically sound research has demonstrated a 
beneficial health effect in the judgment of the Sec-
retary and includes the Ways to Enhance Children’s 
Activity and Nutrition (We Can) program and cur-
riculum of the National Institutes of Health. 
‘‘(2) The term ‘local educational agency’ has 
the meaning given to the term in section 9101 of the 
Elementary and Secondary Education Act of 1965. 
‘‘(i) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $10,000,000 for fiscal year 2011 and such sums 
as may be necessary for each of fiscal years 2012 through 
2015.’’. 
SEC. 2536. REDUCING STUDENT-TO-SCHOOL NURSE RATIOS. 
(a) DEMONSTRATION GRANTS.— 
(1) IN GENERAL.—The Secretary of Education, 
in consultation with the Secretary of Health and
1474 
Human Services and the Director of the Centers for 
Disease Control and Prevention, may make dem-
onstration grants to eligible local educational agen-
cies for the purpose of reducing the student-to- 
school nurse ratio in public elementary and sec-
ondary schools. 
(2) SPECIAL
CONSIDERATION.—In awarding 
grants under this section, the Secretary of Edu-
cation shall give special consideration to applications 
submitted by high-need local educational agencies 
that demonstrate the greatest need for new or addi-
tional nursing services among children in the public 
elementary and secondary schools served by the 
agency, in part by providing information on current 
ratios of students to school nurses. 
(3) MATCHING FUNDS.—The Secretary of Edu-
cation may require recipients of grants under this 
subsection to provide matching funds from non-Fed-
eral sources, and shall permit the recipients to 
match funds in whole or in part with in-kind con-
tributions. 
(b) REPORT.—Not later than 24 months after the 
date on which assistance is first made available to local 
educational agencies under this section, the Secretary of 
Education shall submit to the Congress a report on the
1475 
results of the demonstration grant program carried out 
under this section, including an evaluation of the effective-
ness of the program in improving the student-to-school 
nurse ratios described in subsection (a) and an evaluation 
of the impact of any resulting enhanced health of students 
on learning. 
(c) DEFINITIONS.—For purposes of this section: 
(1) The terms ‘‘elementary school’’, ‘‘local edu-
cational agency’’, and ‘‘secondary school’’ have the 
meanings given to those terms in section 9101 of the 
Elementary and Secondary Education Act of 1965 
(20 U.S.C. 7801). 
(2) The term ‘‘eligible local educational agency’’ 
means a local educational agency in which the stu-
dent-to-school nurse ratio in the public elementary 
and secondary schools served by the agency is 750 
or more students to every school nurse. 
(3) The term ‘‘high-need local educational agen-
cy’’ means a local educational agency— 
(A) that serves not fewer than 10,000 chil-
dren from families with incomes below the pov-
erty line; or 
(B) for which not less than 20 percent of 
the children served by the agency are from fam-
ilies with incomes below the poverty line.
1476 
(4) The term ‘‘nurse’’ means a licensed nurse, 
as defined under State law. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for each of fiscal years 
2011 through 2015. 
SEC. 2537. MEDICAL-LEGAL PARTNERSHIPS. 
(a) IN GENERAL.—The Secretary shall establish a 
nationwide demonstration project consisting of— 
(1) awarding grants to, and entering into con-
tracts with, medical-legal partnerships to assist pa-
tients and their families to navigate health-related 
programs and activities; and 
(2) evaluating the effectiveness of such partner-
ships. 
(b) USE OF FUNDS.—Amounts received as a grant 
or contract under this section shall be used to assist pa-
tients and their families to navigate health care-related 
programs and activities and thereby achieve one or more 
of the following goals: 
(1) Enhancing access to health care services. 
(2) Improving health outcomes for low-income 
individuals. 
(3) Reducing health disparities.
1477 
(4) Enhancing wellness and prevention of 
chronic conditions. 
(c) PROHIBITION.—No funds under this section may 
be used— 
(1) for any medical malpractice or other civil 
action or proceeding; or 
(2) to assist individuals who are not lawfully 
present in the United States. 
(d) REPORT.—Not later than 5 years after the date 
of the enactment of this Act, the Secretary shall submit 
a report to the Congress on the results of the demonstra-
tion project under this section. Such report shall include 
the following: 
(1) A description of the extent to which med-
ical-legal partnerships funded through this section 
achieved the goals described in subsection (b). 
(2) Recommendations on the possibility of ex-
tending or expanding the demonstration project. 
(e) DEFINITIONS.—In this section: 
(1) The term ‘‘health disparities’’ has the 
meaning given to the term in section 3171 of the 
Public Health Service Act, as added by section 
2301. 
(2) The term ‘‘medical-legal partnership’’ 
means an entity—
1479 
‘‘SEC. 544. SCREENING, BRIEF INTERVENTION, REFERRAL, 
AND TREATMENT FOR MENTAL HEALTH AND 
SUBSTANCE ABUSE DISORDERS. 
‘‘(a) PROGRAM.—The Secretary, acting through the 
Administrator, shall establish a program (consisting of 
awarding grants, contracts, and cooperative agreements 
under subsection (b)) on mental health and substance 
abuse screening, brief intervention, referral, and recovery 
services for individuals in primary health care settings. 
‘‘(b) USE OF FUNDS.—The Secretary may award 
grants to, or enter into contracts or cooperative agree-
ments with, entities— 
‘‘(1) to provide mental health and substance 
abuse screening, brief interventions, referral, and re-
covery services; 
‘‘(2) to coordinate these services with primary 
health care services in the same program and set-
ting; 
‘‘(3) to develop a network of facilities to which 
patients may be referred if needed; 
‘‘(4) to purchase needed screening and other 
tools that are— 
‘‘(A) necessary for providing these services; 
and 
‘‘(B) supported by evidence-based research; 
and
1480 
‘‘(5) to maintain communication with appro-
priate State mental health and substance abuse 
agencies. 
‘‘(c) ELIGIBILITY.—To be eligible for a grant, con-
tract, or cooperative agreement under this section, an enti-
ty shall be a public or private nonprofit entity that— 
‘‘(1) provides primary health services; 
‘‘(2) seeks to integrate mental health and sub-
stance abuse services into its service system; 
‘‘(3) has developed a working relationship with 
providers of mental health and substance abuse serv-
ices; 
‘‘(4) demonstrates a need for the inclusion of 
mental health and substance abuse services in its 
service system; and 
‘‘(5) agrees— 
‘‘(A) to prepare and submit to the Sec-
retary at the end of the grant, contract, or co-
operative agreement period an evaluation of all 
activities funded through the grant, contract, or 
cooperative agreement; and 
‘‘(B) to use such performance measures as 
may be stipulated by the Secretary for purposes 
of such evaluation.
1481 
‘‘(d) PREFERENCE.—In awarding grants, contracts, 
and cooperative agreements under this section, the Sec-
retary shall give preference to entities that— 
‘‘(1) provide services in rural or frontier areas 
of the Nation; 
‘‘(2) provide services to special needs popu-
lations, including American Indian or Alaska Native 
populations; or 
‘‘(3) provide services in school-based health 
clinics or on university and college campuses. 
‘‘(e) DURATION.—The period of a grant, contract, or 
cooperative agreement under this section may not exceed 
5 years. 
‘‘(f) REPORT.—Not later than 4 years after the first 
appropriation of funds to carry out this section, the Sec-
retary shall submit a report to the Congress on the pro-
gram under this section— 
‘‘(1) including an evaluation of the benefits of 
integrating mental health and substance abuse care 
within primary health care; and 
‘‘(2) focusing on the performance measures 
stipulated by the Secretary under subsection (c)(5). 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.— 
‘‘(1) IN GENERAL.—To carry out this section, 
there are authorized to be appropriated $30,000,000
1482 
for fiscal year 2011 and such sums as may be nec-
essary for each of fiscal years 2012 through 2015. 
‘‘(2) PROGRAM
MANAGEMENT.—Of the funds 
appropriated to carry out this section for a fiscal 
year, the Secretary may use not more than 5 percent 
to manage the program under this section.’’. 
SEC. 2539. GRANTS TO ASSIST IN DEVELOPING MEDICAL 
SCHOOLS 
IN 
FEDERALLY-DESIGNATED 
HEALTH PROFESSIONAL SHORTAGE AREAS. 
(a) GRANTS AUTHORIZED.—The Secretary of Health 
and Human Services may make grants to nonprofit orga-
nizations or institutions of higher education for the pur-
pose of assisting the organization or institution involved 
to develop a medical school if— 
(1) the medical school will be located in an area 
that is designated (under section 332 of the Public 
Health Service Act (42 U.S.C. 254e)) as a health 
professional shortage area; 
(2) the organization or institution provides as-
surances satisfactory to the Secretary of substantial 
private or public funding from non-Federal sources 
for the development of the medical school; and 
(3) the organization or institution provides as-
surances satisfactory to the Secretary that accredita-
tion will be achieved for the medical school.
1483 
(b) USE OF GRANT FUNDS.—Grants awarded under 
this section may be used for the acquisition and building 
of the medical school campus in a health professional 
shortage area and the purchase of equipment, curriculum 
and faculty development, and general operations related 
to the development and establishment of the medical 
school. 
(c) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there is authorized 
to be appropriated $100,000,000 for each of fiscal years 
2011 through 2015. 
PART 3—EMERGENCY CARE-RELATED 
PROGRAMS 
SEC. 2551. TRAUMA CARE CENTERS. 
(a) GRANTS FOR TRAUMA CARE CENTERS.—Section 
1241 (42 U.S.C. 300d–41) is amended to read as follows: 
‘‘SEC. 1241. GRANTS FOR CERTAIN TRAUMA CENTERS. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
trauma center program consisting of awarding grants 
under section (b). 
‘‘(b) GRANTS.—The Secretary shall award grants as 
follows: 
‘‘(1) EXISTING
CENTERS.—Grants to public, 
private nonprofit, Indian Health Service, Indian 
tribal, and urban Indian trauma centers—
1484 
‘‘(A) to further the core missions of such 
centers; or 
‘‘(B) to provide emergency relief to ensure 
the continued and future availability of trauma 
services by trauma centers— 
‘‘(i) at risk of closing or operating in 
an area where a closing has occurred with-
in their primary service area; or 
‘‘(ii) in need of financial assistance 
following a natural disaster or other cata-
strophic event, such as a terrorist attack. 
‘‘(2) NEW CENTERS.—Grants to local govern-
ments and public or private nonprofit entities to es-
tablish new trauma centers in urban areas with a 
substantial degree of trauma resulting from violent 
crimes. 
‘‘(c) MINIMUM QUALIFICATIONS OF TRAUMA CEN-
TERS.— 
‘‘(1) PARTICIPATION IN TRAUMA CARE SYSTEM 
OPERATING UNDER CERTAIN PROFESSIONAL GUIDE-
LINES.— 
‘‘(A) LIMITATION.—Subject to subpara-
graph (B), the Secretary may not award a 
grant to an existing trauma center under this 
section unless the center is a participant in a
1485 
trauma care system that substantially complies 
with section 1213. 
‘‘(B) 
EXEMPTION.—Subparagraph 
(A) 
shall not apply to trauma centers that are lo-
cated in States with no existing trauma care 
system. 
‘‘(2) DESIGNATION.—The Secretary may not 
award a grant under this section to an existing trau-
ma center unless the center is— 
‘‘(A) verified as a trauma center by the 
American College of Surgeons; or 
‘‘(B) designated as a trauma center by the 
applicable State health or emergency medical 
services authority.’’. 
(b) CONSIDERATIONS IN MAKING GRANTS.—Section 
1242 (42 U.S.C. 300d–42) is amended to read as follows: 
‘‘SEC. 1242. CONSIDERATIONS IN MAKING GRANTS. 
‘‘(a) CORE MISSION AWARDS.— 
‘‘(1) IN GENERAL.—In awarding grants under 
section 1241(b)(1)(A), the Secretary shall— 
‘‘(A) reserve a minimum of 25 percent of 
the amount allocated for such grants for level 
III and level IV trauma centers in rural or un-
derserved areas;
1486 
‘‘(B) reserve a minimum of 25 percent of 
the amount allocated for such grants for level 
I and level II trauma centers in urban areas; 
and 
‘‘(C) give preference to any application 
made by a trauma center— 
‘‘(i) in a geographic area where 
growth in demand for trauma services ex-
ceeds capacity; 
‘‘(ii) that demonstrates the financial 
support of the State or political subdivision 
involved; 
‘‘(iii) that has at least 1 graduate 
medical education fellowship in trauma or 
trauma-related specialties, including neuro-
logical surgery, surgical critical care, vas-
cular surgery, and spinal cord injury, for 
which demand is exceeding supply; or 
‘‘(iv) that demonstrates a substantial 
commitment to serving vulnerable popu-
lations. 
‘‘(2) FINANCIAL
SUPPORT.—For purposes of 
paragraph (1)(C)(ii), financial support may be dem-
onstrated by State or political subdivision funding 
for the trauma center’s capital or operating expenses
1487 
(including through State trauma regional advisory 
coordination activities, Medicaid funding designated 
for trauma services, or other governmental funding). 
State funding derived from Federal support shall 
not constitute State or local financial support for 
purposes of preferential treatment under this sub-
section. 
‘‘(3) USE OF FUNDS.—The recipient of a grant 
under section 1241(b)(1)(A) shall carry out, con-
sistent with furthering the core missions of the cen-
ter, one or more of the following activities: 
‘‘(A) Providing 24-hour-a-day, 7-day-a- 
week trauma care availability. 
‘‘(B) Reducing overcrowding related to 
throughput of trauma patients. 
‘‘(C) Enhancing trauma surge capacity. 
‘‘(D) Ensuring physician and essential per-
sonnel availability. 
‘‘(E) Trauma education and outreach. 
‘‘(F) Coordination with local and regional 
trauma care systems. 
‘‘(G) Such other activities as the Secretary 
may deem appropriate.
1488 
‘‘(b) EMERGENCY
AWARDS; NEW
CENTERS.—In 
awarding grants under paragraphs (1)(B) and (2) of sec-
tion 1241(b), the Secretary shall— 
‘‘(1) give preference to any application sub-
mitted by an applicant that demonstrates the finan-
cial support (in accordance with subsection (a)(2)) 
of the State or political subdivision involved for the 
activities to be funded through the grant for each 
fiscal year during which payments are made to the 
center under the grant; and 
‘‘(2) give preference to any application sub-
mitted for a trauma center that— 
‘‘(A) is providing or will provide trauma 
care in a geographic area in which the avail-
ability of trauma care has either significantly 
decreased as a result of a trauma center in the 
area permanently ceasing participation in a sys-
tem described in section 1241(c)(1) as of a date 
occurring during the 2-year period preceding 
the fiscal year for which the trauma center is 
applying to receive a grant, or in geographic 
areas where growth in demand for trauma serv-
ices exceeds capacity; 
‘‘(B) will, in providing trauma care during 
the 1-year period beginning on the date on
1489 
which the application for the grant is sub-
mitted, incur substantial uncompensated care 
costs in an amount that renders the center un-
able to continue participation in such system 
and results in a significant decrease in the 
availability of trauma care in the geographic 
area; 
‘‘(C) operates or will operate in rural areas 
where trauma care availability will significantly 
decrease if the center is forced to close or down-
grade service and substantial costs are contrib-
uting to a likelihood of such closure or 
downgradation; 
‘‘(D) is in a geographic location substan-
tially affected by a natural disaster or other 
catastrophic event such as a terrorist attack; or 
‘‘(E) will establish a new trauma service in 
an urban area with a substantial degree of 
trauma resulting from violent crimes. 
‘‘(c) DESIGNATIONS OF LEVELS OF TRAUMA CEN-
TERS IN CERTAIN STATES.—In the case of a State which 
has not designated 4 levels of trauma centers, any ref-
erence in this section to— 
‘‘(1) a level I or level II trauma center is 
deemed to be a reference to a trauma center within
1490 
the highest 2 levels of trauma centers designated 
under State guidelines; and 
‘‘(2) a level III or IV trauma center is deemed 
to be a reference to a trauma center not within such 
highest 2 levels.’’. 
(c) CERTAIN
AGREEMENTS.—Section 1243 (42 
U.S.C. 300d–43) is amended to read as follows: 
‘‘SEC. 1243. CERTAIN AGREEMENTS. 
‘‘(a) COMMITMENT REGARDING CONTINUED PAR-
TICIPATION IN TRAUMA CARE SYSTEM.—The Secretary 
may not award a grant to an applicant under section 
1241(b) unless the applicant agrees that— 
‘‘(1) the trauma center involved will continue 
participation, or in the case of a new center will par-
ticipate, 
in 
the 
system 
described 
in 
section 
1241(c)(1), 
except 
as 
provided 
in 
section 
1241(c)(1)(B), throughout the grant period begin-
ning on the date that the center first receives pay-
ments under the grant; and 
‘‘(2) if the agreement made pursuant to para-
graph (1) is violated by the center, the center will 
be liable to the United States for an amount equal 
to the sum of— 
‘‘(A) the amount of assistance provided to 
the center under section 1241; and
1491 
‘‘(B) an amount representing interest on 
the amount specified in subparagraph (A). 
‘‘(b) MAINTENANCE OF FINANCIAL SUPPORT.—With 
respect to activities for which funds awarded through a 
grant under section 1241 are authorized to be expended, 
the Secretary may not award such a grant unless the ap-
plicant agrees that, during the period in which the trauma 
center involved is receiving payments under the grant, the 
center will maintain access to trauma services at levels not 
less than the levels for the prior year, taking into ac-
count— 
‘‘(1) reasonable volume fluctuation that is not 
caused by intentional trauma boundary reduction; 
‘‘(2) downgrading of the level of services; and 
‘‘(3) whether such center diverts its incoming 
patients away from such center 5 percent or more 
of the time during which the center is in operation 
over the course of the year. 
‘‘(c) TRAUMA CARE REGISTRY.—The Secretary may 
not award a grant to a trauma center under section 
1241(b)(1) unless the center agrees that— 
‘‘(1) not later than 6 months after the date on 
which the center submits a grant application to the 
Secretary, the center will establish and operate a 
registry of trauma cases in accordance with guide-
1492 
lines developed by the American College of Surgeons; 
and 
‘‘(2) in carrying out paragraph (1), the center 
will maintain information on the number of trauma 
cases treated by the center and, for each such case, 
the extent to which the center incurs uncompensated 
costs in providing trauma care.’’. 
(d) GENERAL
PROVISIONS.—Section 1244 (42 
U.S.C. 300d–44) is amended to read as follows: 
‘‘SEC. 1244. GENERAL PROVISIONS. 
‘‘(a) LIMITATION ON DURATION OF SUPPORT.—The 
period during which a trauma center receives payments 
under a grant under section 1241(b)(1) shall be for 3 fis-
cal years, except that the Secretary may waive such re-
quirement for the center and authorize the center to re-
ceive such payments for 1 additional fiscal year. 
‘‘(b) ELIGIBILITY.—The acquisition of, or eligibility 
for, a grant under section 1241(b) shall not preclude a 
trauma center’s eligibility for another grant described in 
such section. 
‘‘(c) FUNDING DISTRIBUTION.—Of the total amount 
appropriated for a fiscal year under section 1245— 
‘‘(1) 90 percent shall be used for grants under 
paragraph (1)(A) of section 1241(b); and
1493 
‘‘(2) 10 percent shall be used for grants under 
paragraphs (1)(B) and (2) of section 1241(b). 
‘‘(d) REPORT.—Beginning 2 years after the date of 
the enactment of the Affordable Health Care for America 
Act, and every 2 years thereafter, the Secretary shall bien-
nially— 
‘‘(1) report to Congress on the status of the 
grants made pursuant to section 1241; 
‘‘(2) evaluate and report to Congress on the 
overall financial stability of trauma centers in the 
United States; 
‘‘(3) report on the populations using trauma 
care centers and include aggregate patient data on 
income, race, ethnicity, and geography; and 
‘‘(4) evaluate the effectiveness and efficiency of 
trauma care center activities using standard public 
health measures and evaluation methodologies.’’. 
(e) AUTHORIZATION OF APPROPRIATIONS.—Section 
1245 (42 U.S.C. 300d–45) is amended to read as follows: 
‘‘SEC. 1245. AUTHORIZATION OF APPROPRIATIONS. 
‘‘(a) IN GENERAL.—For the purpose of carrying out 
this part, there are authorized to be appropriated 
$100,000,000 for fiscal year 2011, and such sums as may 
be necessary for each of fiscal years 2012 through 2015. 
Such authorization of appropriations is in addition to any
1494 
other authorization of appropriations or amounts that are 
available for such purpose. 
‘‘(b) REALLOCATION.—The Secretary shall reallocate 
for grants under section 1241(b)(1)(A) any funds appro-
priated for grants under paragraph (1)(B) or (2) of sec-
tion 1241(b), but not obligated due to insufficient applica-
tions eligible for funding.’’. 
SEC. 2552. EMERGENCY CARE COORDINATION. 
(a) IN GENERAL.—Subtitle B of title XXVIII (42 
U.S.C. 300hh–10 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 2816. EMERGENCY CARE COORDINATION. 
‘‘(a) EMERGENCY CARE COORDINATION CENTER.— 
‘‘(1) ESTABLISHMENT.—The Secretary shall es-
tablish, within the Office of the Assistant Secretary 
for Preparedness and Response, an Emergency Care 
Coordination Center (in this section referred to as 
the ‘Center’), to be headed by a director. 
‘‘(2) DUTIES.—The Secretary, acting through 
the Director of the Center, in coordination with the 
Federal Interagency Committee on Emergency Med-
ical Services, shall— 
‘‘(A) promote and fund research in emer-
gency medicine and trauma health care;
1495 
‘‘(B) promote regional partnerships and 
more effective emergency medical systems in 
order to enhance appropriate triage, distribu-
tion, and care of routine community patients; 
and 
‘‘(C) promote local, regional, and State 
emergency medical systems’ preparedness for 
and response to public health events. 
‘‘(b) COUNCIL OF EMERGENCY CARE.— 
‘‘(1) ESTABLISHMENT.—The Secretary, acting 
through the Director of the Center, shall establish a 
Council of Emergency Care to provide advice and 
recommendations to the Director on carrying out 
this section. 
‘‘(2) COMPOSITION.—The Council shall be com-
prised of employees of the departments and agencies 
of the Federal Government who are experts in emer-
gency care and management. 
‘‘(c) REPORT.— 
‘‘(1) SUBMISSION.—Not later than 12 months 
after the date of the enactment of the Affordable 
Health Care for America Act, the Secretary shall 
submit to the Congress an annual report on the ac-
tivities carried out under this section.
1496 
‘‘(2) CONSIDERATIONS.—In preparing a report 
under paragraph (1), the Secretary shall consider 
factors including— 
‘‘(A) emergency department crowding and 
boarding; and 
‘‘(B) delays in care following presentation. 
‘‘(d) 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.’’. 
(b) FUNCTIONS, PERSONNEL, ASSETS, LIABILITIES, 
AND
ADMINISTRATIVE
ACTIONS.—All functions, per-
sonnel, assets, and liabilities of, and administrative actions 
applicable to, the Emergency Care Coordination Center, 
as in existence on the day before the date of the enactment 
of this Act, shall be transferred to the Emergency Care 
Coordination Center established under section 2816(a) of 
the Public Health Service Act, as added by subsection (a). 
SEC. 2553. PILOT PROGRAMS TO IMPROVE EMERGENCY 
MEDICAL CARE. 
Part B of title III (42 U.S.C. 243 et seq.) is amended 
by inserting after section 314 the following:
1497 
‘‘SEC. 315. REGIONALIZED COMMUNICATION SYSTEMS FOR 
EMERGENCY CARE RESPONSE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Assistant Secretary for Preparedness and Response, 
shall award not fewer than 4 multiyear contracts or com-
petitive grants to eligible entities to support demonstration 
programs that design, implement, and evaluate innovative 
models of regionalized, comprehensive, and accountable 
emergency care systems. 
‘‘(b) ELIGIBLE ENTITY; REGION.— 
‘‘(1) ELIGIBLE
ENTITY.—In this section, the 
term ‘eligible entity’ means a State or a partnership 
of 1 or more States and 1 or more local govern-
ments. 
‘‘(2) REGION.—In this section, the term ‘re-
gion’ means an area within a State, an area that lies 
within multiple States, or a similar area (such as a 
multicounty area), as determined by the Secretary. 
‘‘(c) DEMONSTRATION PROGRAM.—The Secretary 
shall award a contract or grant under subsection (a) to 
an eligible entity that proposes a demonstration program 
to design, implement, and evaluate an emergency medical 
system that— 
‘‘(1) coordinates with public safety services, 
public health services, emergency medical services, 
medical facilities, and other entities within a region;
1498 
‘‘(2) coordinates an approach to emergency 
medical system access throughout the region, includ-
ing 9–1–1 public safety answering points and emer-
gency medical dispatch; 
‘‘(3) includes a mechanism, such as a regional 
medical direction or transport communications sys-
tem, that operates throughout the region to ensure 
that the correct patient is taken to the medically ap-
propriate facility (whether an initial facility or a 
higher level facility) in a timely fashion; 
‘‘(4) allows for the tracking of prehospital and 
hospital resources, including inpatient bed capacity, 
emergency department capacity, on-call specialist 
coverage, ambulance diversion status, and the co-
ordination of such tracking with regional commu-
nications and hospital destination decisions; and 
‘‘(5) 
includes 
a 
consistent 
regionwide 
prehospital, hospital, and interfacility data manage-
ment system that— 
‘‘(A) complies with the National EMS In-
formation System, the National Trauma Data 
Bank, and others; 
‘‘(B) reports data to appropriate Federal 
and State databanks and registries; and
1499 
‘‘(C) contains information sufficient to 
evaluate key elements of prehospital care, hos-
pital destination decisions, including initial hos-
pital and interfacility decisions, and relevant 
outcomes of hospital care. 
‘‘(d) APPLICATION.— 
‘‘(1) IN
GENERAL.—An eligible entity that 
seeks a contract or grant described in subsection (a) 
shall submit to the Secretary an application at such 
time and in such manner as the Secretary may re-
quire. 
‘‘(2) APPLICATION INFORMATION.—Each appli-
cation shall include— 
‘‘(A) an assurance from the eligible entity 
that the proposed system— 
‘‘(i) has been coordinated with the ap-
plicable State office of emergency medical 
services (or equivalent State office); 
‘‘(ii) is compatible with the applicable 
State emergency medical services system; 
‘‘(iii) includes consistent indirect and 
direct medical oversight of prehospital, 
hospital, 
and 
interfacility 
transport 
throughout the region;
1500 
‘‘(iv) coordinates prehospital treat-
ment and triage, hospital destination, and 
interfacility transport throughout the re-
gion; 
‘‘(v) includes a categorization or des-
ignation system for special medical facili-
ties throughout the region that is— 
‘‘(I) consistent with State laws 
and regulations; and 
‘‘(II) integrated with the proto-
cols for transport and destination 
throughout the region; and 
‘‘(vi) includes a regional medical di-
rection system, a patient tracking system, 
and a resource allocation system that— 
‘‘(I) support day-to-day emer-
gency care system operation; 
‘‘(II) can manage surge capacity 
during a major event or disaster; and 
‘‘(III) are integrated with other 
components of the national and State 
emergency preparedness system; 
‘‘(B) an agreement to make available non- 
Federal contributions in accordance with sub-
section (e); and
1501 
‘‘(C) such other information as the Sec-
retary may require. 
‘‘(e) MATCHING FUNDS.— 
‘‘(1) IN GENERAL.—With respect to the costs of 
the activities to be carried out each year with a con-
tract or grant under subsection (a), a condition for 
the receipt of the contract or grant is that the eligi-
ble entity involved agrees to make available (directly 
or through donations from public or private entities) 
non-Federal contributions toward such costs in an 
amount that is not less than 25 percent of such 
costs. 
‘‘(2) DETERMINATION
OF
AMOUNT
CONTRIB-
UTED.—Non-Federal contributions required in para-
graph (1) may be in cash or in kind, fairly evalu-
ated, including plant, equipment, or services. 
Amounts provided by the Federal Government, or 
services assisted or subsidized to any significant ex-
tent by the Federal Government, may not be in-
cluded in determining the amount of such non-Fed-
eral contributions. 
‘‘(f) PRIORITY.—The Secretary shall give priority for 
the award of the contracts or grants described in sub-
section (a) to any eligible entity that serves a medically 
underserved population (as defined in section 330(b)(3)).
1502 
‘‘(g) REPORT.—Not later than 90 days after the com-
pletion of a demonstration program under subsection (a), 
the recipient of such contract or grant described in such 
subsection shall submit to the Secretary a report con-
taining the results of an evaluation of the program, includ-
ing an identification of— 
‘‘(1) the impact of the regional, accountable 
emergency care system on patient outcomes for var-
ious critical care categories, such as trauma, stroke, 
cardiac emergencies, and pediatric emergencies; 
‘‘(2) the system characteristics that contribute 
to the effectiveness and efficiency of the program (or 
lack thereof); 
‘‘(3) methods of assuring the long-term finan-
cial sustainability of the emergency care system; 
‘‘(4) the State and local legislation necessary to 
implement and to maintain the system; and 
‘‘(5) the barriers to developing regionalized, ac-
countable emergency care systems, as well as the 
methods to overcome such barriers. 
‘‘(h) EVALUATION.—The Secretary, acting through 
the Assistant Secretary for Preparedness and Response, 
shall enter into a contract with an academic institution 
or other entity to conduct an independent evaluation of
1503 
the demonstration programs funded under subsection (a), 
including an evaluation of— 
‘‘(1) the performance of the eligible entities re-
ceiving the funds; and 
‘‘(2) the impact of the demonstration programs. 
‘‘(i) DISSEMINATION OF FINDINGS.—The Secretary 
shall, as appropriate, disseminate to the public and to the 
appropriate committees of the Congress, the information 
contained in a report made under subsection (h). 
‘‘(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:
1504 
‘‘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 
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.
1505 
‘‘(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.’’. 
(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.
1506 
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 
(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’’.
1507 
(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’’. 
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—
1508 
(A) lack of understanding and education 
among employers, patients, health care pro-
viders, regulators, and third-party payors; 
(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.
1509 
(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 
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
1510 
with the Division of Program Coordination, Plan-
ning, and Strategic Initiatives, shall develop and 
submit to the Director of NIH recommendations on 
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.—
1511 
‘‘(A) IN GENERAL.—The Committee shall 
be composed of the following voting members: 
‘‘(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).
1512 
‘‘(B) ADDITIONAL MEMBERS.—The Com-
mittee shall include additional voting members 
appointed by the Secretary as follows: 
‘‘(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.
1513 
‘‘(3) CHAIRPERSON.—The voting members of 
the Committee shall select a chairperson from 
among such members. The selection of a chairperson 
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;
1514 
‘‘(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-
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—
1515 
‘‘(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 
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
1517 
‘‘(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 
‘‘(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.’’.
1518 
Subtitle C—Food and Drug 
Administration 
PART 1—IN GENERAL 
SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY. 
(a) REGISTRY.— 
(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
1519 
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, 
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);
1520 
‘‘(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); 
‘‘(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—
1521 
‘‘(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-
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.
1522 
‘‘(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-
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;
1523 
‘‘(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 
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—
1524 
‘‘(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 
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
1525 
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. 
(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)).
1526 
(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 
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.
1527 
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)’’. 
(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
1528 
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 
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
1529 
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 
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-
1530 
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 
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.
1531 
‘‘(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— 
‘‘(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.
1532 
‘‘(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 
‘‘(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
1533 
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-
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-
1534 
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. 
‘‘(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-
1535 
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 
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
1536 
(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.— 
(1) FINDINGS.—The Congress finds the fol-
lowing: 
(A) In 1984, the Drug Price Competition 
and Patent Term Restoration Act (Public Law 
98–417; in this subsection referred to as the 
‘‘1984 Act’’) was enacted with the intent of fa-
cilitating the early entry of generic drugs while 
preserving 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—
1537 
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. 
(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.
1538 
(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— 
‘‘(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—
1539 
‘‘(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 
‘‘(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 subject to enforce-
ment by the Federal Trade Commission in 
the same manner, by the same means, and 
with the same jurisdiction as would an un-
fair and deceptive act or practice in or af-
fecting interstate commerce or an unfair 
method of competition in or affecting inter-
state commerce prohibited under section 5 
of the Federal Trade Commission Act, as 
though all applicable terms and provisions
1540 
of the Federal Trade Commission 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. 
‘‘(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
1541 
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 
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 for the benefit of con-
sumers. Consistent with the authority of the Com-
mission, such rules may include interpretive rules
1542 
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 
(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
1543 
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 
(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
1544 
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-
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—
1545 
(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 
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;
1546 
‘‘(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 
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;
1547 
‘‘(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-
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.
1548 
‘‘(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-
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—
1549 
‘‘(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-
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
1550 
‘‘(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. 
‘‘(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
1551 
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 
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-
1552 
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 
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-
1553 
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 
‘‘(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.—
1554 
‘‘(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— 
‘‘(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,
1555 
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 
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-
1556 
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-
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
1557 
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. 
‘‘(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—
1558 
‘‘(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 
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
1559 
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. 
‘‘(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—
1560 
‘‘(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 
‘‘(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
1561 
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. 
‘‘(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).
1562 
‘‘(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-
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.
1563 
‘‘(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 
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.
1564 
‘‘(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 
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.
1565 
‘‘(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 
‘‘(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
1566 
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-
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
1567 
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.— 
‘‘(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
1568 
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-
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-
1569 
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.— 
‘‘(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
1570 
‘‘(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. 
‘‘(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
1571 
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 
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-
1572 
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 
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
1573 
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. 
‘‘(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
1574 
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: 
‘‘(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
1575 
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.— 
(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—
1576 
(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 
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.
1577 
(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 
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,’’;
1578 
(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’’. 
(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)’’.
1579 
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; 
‘‘(2) establish an infrastructure that will help 
address the Nation’s community living assistance 
services and supports needs;
1580 
‘‘(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 
‘‘(B) is able to perform all the usual and 
customary duties of the individual’s employment 
on the individual’s regular work schedule.
1581 
‘‘(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, 
at least an amount equal to the amount of 
wages and self-employment income which 
an individual must have in order to be
1582 
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-
ered an eligible beneficiary for certain popu-
lations. 
‘‘(7) HOSPITAL; NURSING
FACILITY; INTER-
MEDIATE CARE FACILITY FOR THE MENTALLY RE-
1583 
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 
the system for each State established under section 
143 of the Developmental Disabilities Assistance 
and Bill of Rights Act of 2000.
1584 
‘‘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. 
‘‘(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
1585 
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: 
‘‘(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
1586 
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-
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.
1587 
‘‘(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.— 
‘‘(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
1588 
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; 
‘‘(II) has paid premiums for en-
rollment in the program for at least 
20 years; and 
‘‘(III) is not actively employed.
1589 
‘‘(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— 
‘‘(I) credited with any months of 
paid premiums that accrued prior to 
the individual’s lapse in enrollment; 
and
1590 
‘‘(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 
enrollment in the CLASS program and 
ends with the month preceding the month 
in which the reenrollment is effective; or
1591 
‘‘(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. 
‘‘SEC. 3204. ENROLLMENT AND DISENROLLMENT REQUIRE-
MENTS. 
‘‘(a) AUTOMATIC ENROLLMENT.—
1592 
‘‘(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—
1593 
‘‘(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—
1594 
‘‘(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
1595 
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
1596 
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
1597 
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
1598 
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
1599 
‘‘(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-
sumer price index for all urban consumers
1600 
(United States 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
1601 
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—
1602 
‘‘(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
1603 
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
1604 
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
1605 
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
1606 
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
1607 
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.—
1608 
‘‘(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
1609 
‘‘(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
1610 
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-
1611 
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-
1612 
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.
1613 
‘‘(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.
1614 
‘‘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
1615 
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
1616 
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-
1617 
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
1618 
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
1619 
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,
1620 
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
1621 
‘‘(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:
1622 
‘‘(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.’’.
1623 
(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
1624 
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
1625 
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).’’.
1626 
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
1627 
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-
1628 
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-
1629 
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. 
‘‘(e) REFERENCES.—Except as otherwise specified, 
any reference in Federal law to an Office on Women’s 
Health (in the Department of Health and Human Serv-
1630 
ices) is deemed to be a reference to the Office on Women’s 
Health in the Office of the Secretary.’’. 
(2) TRANSFER
OF
FUNCTIONS.—There are 
transferred to the Office on Women’s Health (estab-
lished under section 229 of the Public Health Serv-
ice Act, as added by this section), all functions exer-
cised by the Office on Women’s Health of the Public 
Health Service prior to the date of enactment of this 
section, including all personnel and compensation 
authority, all delegation and assignment authority, 
and all remaining appropriations. All orders, deter-
minations, rules, regulations, permits, agreements, 
grants, contracts, certificates, licenses, registrations, 
privileges, and other administrative actions that— 
(A) have been issued, made, granted, or al-
lowed to become effective by the President, any 
Federal agency or official thereof, or by a court 
of competent jurisdiction, in the performance of 
functions transferred under this paragraph; and 
(B) are in effect at the time this section 
takes effect, or were final before the date of en-
actment of this section and are to become effec-
tive on or after such date; 
shall continue in effect according to their terms until 
modified, terminated, superseded, set aside, or re-
1631 
voked in accordance with law by the President, the 
Secretary, or other authorized official, a court of 
competent jurisdiction, or by operation of law. 
(b) CENTERS FOR DISEASE CONTROL AND PREVEN-
TION OFFICE OF WOMEN’S HEALTH.—Part A of title III 
(42 U.S.C. 241 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 310A. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION OFFICE OF WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—There is established within 
the Office of the Director of the Centers for Disease Con-
trol and Prevention, an office to be known as the Office 
of Women’s Health (referred to in this section as the ‘Of-
fice’). The Office shall be headed by a director who shall 
be appointed by the Director of such Centers. 
‘‘(b) PURPOSE.—The Director of the Office shall— 
‘‘(1) report to the Director of the Centers for 
Disease Control and Prevention on the current level 
of the Centers’ activity regarding women’s health 
conditions across, where appropriate, age, biological, 
and sociocultural contexts, in all aspects of the Cen-
ters’ work, including prevention programs, public 
and professional education, services, and treatment; 
‘‘(2) establish short-range and long-range goals 
and objectives within the Centers for women’s health
1632 
and, as relevant and appropriate, coordinate with 
other appropriate offices on activities within the 
Centers that relate to prevention, research, edu-
cation and training, service delivery, and policy de-
velopment, for issues of particular concern to 
women; 
‘‘(3) identify projects in women’s health that 
should be conducted or supported by the Centers; 
‘‘(4) consult with health professionals, non-
governmental organizations, consumer organizations, 
women’s health professionals, and other individuals 
and groups, as appropriate, on the policy of the Cen-
ters with regard to women; and 
‘‘(5) serve as a member of the Department of 
Health and Human Services Coordinating Com-
mittee on Women’s Health (established under sec-
tion 229(b)(4)). 
‘‘(c) DEFINITION.—As used in this section, the term 
‘women’s health conditions’, with respect to women of all 
age, ethnic, and racial groups, means diseases, disorders, 
and conditions— 
‘‘(1) unique to, significantly more serious for, 
or significantly more prevalent in women; and 
‘‘(2) for which the factors of medical risk or 
type of medical intervention are different for women,
1633 
or for which there is reasonable evidence that indi-
cates that such factors or types may be different for 
women.’’. 
(c) OFFICE OF WOMEN’S HEALTH RESEARCH.—Sec-
tion 486(a) (42 U.S.C. 287d(a)) is amended by inserting 
‘‘and who shall report directly to the Director’’ before the 
period at the end thereof. 
(d) SUBSTANCE
ABUSE
AND
MENTAL
HEALTH 
SERVICES ADMINISTRATION.—Section 501(f) (42 U.S.C. 
290aa(f)) is amended— 
(1) in paragraph (1), by inserting ‘‘who shall 
report directly to the Administrator’’ before the pe-
riod; 
(2) by redesignating paragraph (4) as para-
graph (5); and 
(3) by inserting after paragraph (3), the fol-
lowing: 
‘‘(4) OFFICE.—Nothing in this subsection shall 
be construed to preclude the Secretary from estab-
lishing within the Substance Abuse and Mental 
Health Administration an Office of Women’s 
Health.’’. 
(e) AGENCY
FOR HEALTHCARE RESEARCH
AND 
QUALITY ACTIVITIES REGARDING WOMEN’S HEALTH.— 
Part C of title IX (42 U.S.C. 299c et seq.) is amended—
1634 
(1) by redesignating sections 927 and 928 as 
sections 928 and 929, respectively; 
(2) by inserting after section 926 the following: 
‘‘SEC. 927. ACTIVITIES REGARDING WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—There is established within 
the Office of the Director, an Office of Women’s Health 
and Gender-Based Research (referred to in this section 
as the ‘Office’). The Office shall be headed by a director 
who shall be appointed by the Director of Healthcare and 
Research Quality. 
‘‘(b) PURPOSE.—The official designated under sub-
section (a) shall— 
‘‘(1) report to the Director on the current 
Agency level of activity regarding women’s health, 
across, where appropriate, age, biological, and 
sociocultural contexts, in all aspects of Agency work, 
including the development of evidence reports and 
clinical practice protocols and the conduct of re-
search into patient outcomes, delivery of health care 
services, quality of care, and access to health care; 
‘‘(2) establish short-range and long-range goals 
and objectives within the Agency for research impor-
tant to women’s health and, as relevant and appro-
priate, coordinate with other appropriate offices on 
activities within the Agency that relate to health
1635 
services and medical effectiveness research, for 
issues of particular concern to women; 
‘‘(3) identify projects in women’s health that 
should be conducted or supported by the Agency; 
‘‘(4) consult with health professionals, non-
governmental organizations, consumer organizations, 
women’s health professionals, and other individuals 
and groups, as appropriate, on Agency policy with 
regard to women; and 
‘‘(5) serve as a member of the Department of 
Health and Human Services Coordinating Com-
mittee on Women’s Health (established under sec-
tion 229(b)(4)).’’; and 
(3) by adding at the end of section 928 (as re-
designated by paragraph (1)) the following: 
‘‘(e) WOMEN’S HEALTH.—For the purpose of car-
rying out section 927 regarding women’s health, there are 
authorized to be appropriated such sums as may be nec-
essary for each of fiscal years 2011 through 2015.’’. 
(f) HEALTH RESOURCES AND SERVICES ADMINIS-
TRATION OFFICE OF WOMEN’S HEALTH.—Title VII of 
the Social Security Act (42 U.S.C. 901 et seq.) is amended 
by adding at the end the following:
1636 
‘‘SEC. 713. OFFICE OF WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish within the Office of the Administrator of the Health 
Resources and Services Administration, an office to be 
known as the Office of Women’s Health. The Office shall 
be headed by a director who shall be appointed by the Ad-
ministrator. 
‘‘(b) PURPOSE.—The Director of the Office shall— 
‘‘(1) report to the Administrator on the current 
Administration level of activity regarding women’s 
health across, where appropriate, age, biological, and 
sociocultural contexts; 
‘‘(2) establish short-range and long-range goals 
and objectives within the Health Resources and 
Services Administration for women’s health and, as 
relevant and appropriate, coordinate with other ap-
propriate offices on activities within the Administra-
tion that relate to health care provider training, 
health service delivery, research, and demonstration 
projects, for issues of particular concern to women; 
‘‘(3) identify projects in women’s health that 
should be conducted or supported by the bureaus of 
the Administration; 
‘‘(4) consult with health professionals, non-
governmental organizations, consumer organizations, 
women’s health professionals, and other individuals
1638 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 911. OFFICE OF WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—There is established within 
the Office of the Commissioner, an office to be known as 
the Office of Women’s Health (referred to in this section 
as the ‘Office’). The Office shall be headed by a director 
who shall be appointed by the Commissioner of Food and 
Drugs. 
‘‘(b) PURPOSE.—The Director of the Office shall— 
‘‘(1) report to the Commissioner of Food and 
Drugs on current Food and Drug Administration 
(referred to in this section as the ‘Administration’) 
levels of activity regarding women’s participation in 
clinical trials and the analysis of data by sex in the 
testing of drugs, medical devices, and biological 
products across, where appropriate, age, biological, 
and sociocultural contexts; 
‘‘(2) establish short-range and long-range goals 
and objectives within the Administration for issues 
of particular concern to women’s health within the 
jurisdiction of the Administration, including, where 
relevant and appropriate, adequate inclusion of 
women and analysis of data by sex in Administration 
protocols and policies;
1639 
‘‘(3) provide information to women and health 
care providers on those areas in which differences 
between men and women exist; 
‘‘(4) consult with pharmaceutical, biologics, and 
device manufacturers, health professionals with ex-
pertise in women’s issues, consumer organizations, 
and women’s health professionals on Administration 
policy with regard to women; 
‘‘(5) make annual estimates of funds needed to 
monitor clinical trials and analysis of data by sex in 
accordance with needs that are identified; and 
‘‘(6) serve as a member of the Department of 
Health and Human Services Coordinating Com-
mittee on Women’s Health (established under sec-
tion 229(b)(4) of the Public Health Service Act).’’. 
(h) NO NEW REGULATORY AUTHORITY.—Nothing in 
this section and the amendments made by this section may 
be construed as establishing regulatory authority or modi-
fying any existing regulatory authority. 
(i) LIMITATION ON TERMINATION.—Notwithstanding 
any other provision of law, a Federal office of women’s 
health (including the Office of Research on Women’s 
Health of the National Institutes of Health) or Federal 
appointive position with primary responsibility over wom-
en’s health issues (including the Associate Administrator
1640 
for Women’s Services under the Substance Abuse and 
Mental Health Services Administration) that is in exist-
ence on the date of enactment of this section shall not 
be terminated, reorganized, or have any of its powers or 
duties transferred unless such termination, reorganization, 
or transfer is approved by an Act of Congress. 
(j) RULE OF CONSTRUCTION.—Nothing in this sec-
tion (or the amendments made by this section) shall be 
construed to limit the authority of the Secretary of Health 
and Human Services with respect to women’s health, or 
with respect to activities carried out through the Depart-
ment of Health and Human Services on the date of enact-
ment of this section. 
SEC. 2588A. OFFICES OF MINORITY HEALTH. 
(a) EXISTING OFFICE.—Section 1707(a) (42 U.S.C. 
300u–6(a)) is amended by striking ‘‘within the Office of 
Public Health and Science’’ and inserting ‘‘within the Of-
fice of the Secretary’’. 
(b) ADDITIONAL OFFICES.—Title XVII (42 U.S.C. 
300u et seq.) is amended by inserting after section 1707 
the following: 
‘‘SEC. 1707A. ADDITIONAL OFFICES OF MINORITY HEALTH. 
‘‘(a) ESTABLISHMENT.—In addition to the Office of 
Minority Health established within the Office of the Sec-
retary under section 1707, the Secretary shall establish
1641 
an Office of Minority Health in each of the following agen-
cies: 
‘‘(1) The Centers for Disease Control and Pre-
vention. 
‘‘(2) The Substance Abuse and Mental Health 
Services Administration. 
‘‘(3) The Agency for Healthcare Research and 
Quality. 
‘‘(4) The Health Resources and Services Ad-
ministration. 
‘‘(5) The Food and Drug Administration. 
‘‘(b) DIRECTOR; APPOINTMENT.—Each Office of Mi-
nority Health established in an agency listed in subsection 
(a) shall be headed by a director, who shall be appointed 
by and report directly to the head of such agency. 
‘‘(c) REFERENCES.—Except as otherwise specified, 
any reference in Federal law to an Office of Minority 
Health (in the Department of Health and Human Serv-
ices) is deemed to be a reference to the Office of Minority 
Health in the Office of the Secretary.’’. 
(c) NO NEW REGULATORY AUTHORITY.—Nothing in 
this section and the amendments made by this section may 
be construed as establishing regulatory authority or modi-
fying any existing regulatory authority.
1642 
(d) 
LIMITATION
ON
TERMINATION.—Notwith-
standing any other provision of law, a Federal office of 
minority health or Federal appointive position with pri-
mary responsibility over minority health issues that is in 
existence in an office or agency of the Department of 
Health and Human Services on the date of enactment of 
this section shall not be terminated, reorganized, or have 
any of its powers or duties transferred unless such termi-
nation, reorganization, or transfer is approved by an Act 
of Congress. 
SEC. 2589. LONG-TERM CARE AND FAMILY CAREGIVER SUP-
PORT. 
(a) AMENDMENTS TO THE OLDER AMERICANS ACT 
OF 1965.— 
(1) PROMOTION
OF
DIRECT
CARE
WORK-
FORCE.—Section 202(b)(1) of the Older Americans 
Act of 1965 (42 U.S.C. 3012(b)(1)) is amended by 
inserting before the semicolon the following: ‘‘, and, 
in carrying out the purposes of this paragraph, shall 
make recommendations to other Federal entities re-
garding appropriate and effective means of identi-
fying, promoting, and implementing investments in 
the direct care workforce necessary to meet the 
growing demand for long-term health services and 
supports and of assisting States in developing a
1643 
comprehensive State workforce development plan 
with respect to such workforce, including assisting 
efforts to systematically assess, track, and report on 
workforce adequacy and capacity’’. 
(2) PERSONAL CARE ATTENDANT WORKFORCE 
ADVISORY
PANEL.—Section 202 of such Act (42 
U.S.C. 3012) is amended by adding at the end the 
following: 
‘‘(g)(1) Not later than 90 days after the date of the 
enactment of this subsection, the Assistant Secretary shall 
establish a Personal Care Attendant Workforce Advisory 
Panel to examine and formulate recommendations on— 
‘‘(A) working conditions and training for work-
ers providing long-term services and supports, in-
cluding home health aides, certified nurse aides, and 
personal care attendants; and 
‘‘(B) other workforce issues related to such 
workers, including with respect to the adequacy of 
the number of such workers; the salaries, wages, and 
benefits of such workers; and access to the services 
provided by such workers. 
‘‘(2) The Panel shall include representatives of— 
‘‘(A) relevant home- and community-based serv-
ice providers, health care agencies, and facilities (in-
cluding personal or home care agencies, home health
1644 
care agencies, nursing homes, assisted living facili-
ties, and residential care facilities); 
‘‘(B) the disability community, including indi-
viduals with disabilities and family caregivers; 
‘‘(C) the nursing community; 
‘‘(D) direct care workers (which may include 
unions and national organizations); 
‘‘(E) older individuals, including senior individ-
uals and family caregivers; 
‘‘(F) State and Federal health care entities; 
and 
‘‘(G) experts in workforce development and 
adult learning. 
‘‘(3) Within one year after the establishment of the 
Panel, the Panel shall submit a report to the Assistant 
Secretary and the Congress on workforce issues related 
to providing long-term services and supports, including in-
formation on core competencies for eligible personal or 
home care aides necessary to successfully provide long- 
term services and supports to eligible consumers, as well 
as recommended training curricula and resources. 
‘‘(4) Within 180 days after receipt by the Assistant 
Secretary of the report under paragraph (3), the Assistant 
Secretary shall establish a 3-year demonstration program 
in 4 States to pilot and evaluate the effectiveness of the
1645 
competencies articulated by the Panel and the training 
curricula and training methods recommended by the 
Panel. 
‘‘(5) Not later than 1 year after the completion of 
the demonstration program under paragraph (4), the As-
sistant Secretary shall submit to the Congress a report 
containing the results of the evaluations by the Assistant 
Secretary pursuant to paragraph (4), together with such 
recommendations for legislation or administrative action 
as the Assistant Secretary determines appropriate.’’. 
(b) AUTHORIZATION
OF ADDITIONAL APPROPRIA-
TIONS FOR THE FAMILY CAREGIVER SUPPORT PROGRAM 
UNDER THE OLDER AMERICANS ACT OF 1965.—Section 
303(e)(2) of the Older Americans Act of 1965 (42 U.S.C. 
3023(e)(2)) is amended by striking ‘‘, $173,000,000’’ and 
all that follows through ‘‘2011’’, and inserting ‘‘and 
$250,000,000 for each of fiscal years 2011, 2012, and 
2013’’. 
SEC. 2590. WEB SITE ON HEALTH CARE LABOR MARKET 
AND RELATED EDUCATIONAL AND TRAINING 
OPPORTUNITIES. 
(a) IN GENERAL.—The Secretary of Labor, in con-
sultation with the National Center for Health Workforce 
Analysis, shall establish and maintain a Web site to serve 
as a comprehensive source of information, searchable by
1646 
workforce region, on the health care labor market and re-
lated educational and training opportunities. 
(b) CONTENTS.—The Web site maintained under this 
section shall include the following: 
(1) Information on the types of jobs that are 
currently or are projected to be in high demand in 
the health care field, including— 
(A) salary information; and 
(B) training requirements, such as require-
ments for educational credentials, licensure, or 
certification. 
(2) Information on training and educational op-
portunities within each region for the type of jobs 
described in paragraph (1), including by— 
(A) type of provider or program (such as 
public, private nonprofit, or private for-profit); 
(B) duration; 
(C) cost (such as tuition, fees, books, lab-
oratory expenses, and other mandatory costs); 
(D) performance outcomes (such as grad-
uation rates, job placement, average salary, job 
retention, and wage progression); 
(E) Federal financial aid participation; 
(F) average graduate loan debt; 
(G) student loan default rates;
1647 
(H) average institutional grant aid pro-
vided; 
(I) Federal and State accreditation infor-
mation; and 
(J) other information determined by the 
Secretary. 
(3) A mechanism for searching and comparing 
training and educational options for specific health 
care occupations to facilitate informed career and 
education choices. 
(4) Financial aid information, including with 
respect to loan forgiveness, loan cancellation, loan 
repayment, stipends, scholarships, and grants or 
other assistance authorized by this Act or other Fed-
eral or State programs. 
(c) PUBLIC ACCESSIBILITY.—The Web site main-
tained under this section shall— 
(1) be publicly accessible; 
(2) be user friendly and convey information in 
a manner that is easily understandable; and 
(3) be in English and the second most prevalent 
language spoken based on the latest Census informa-
tion.
1648 
SEC. 2591. ONLINE HEALTH WORKFORCE TRAINING PRO-
GRAMS. 
Section 171 of the Workforce Investment Act of 1998 
(29 U.S.C. 2916) is amended by adding at the end the 
following: 
‘‘(f) ONLINE HEALTH WORKFORCE TRAINING PRO-
GRAM.— 
‘‘(1) GRANT PROGRAM.— 
‘‘(A) IN GENERAL.—The Secretary in con-
sultation with the Secretary of Health and 
Human Services, shall award National Health 
Workforce Online Training Grants on a com-
petitive basis to eligible entities to enable such 
entities to carry out training for individuals to 
attain or advance in health care occupations. 
An entity may leverage such grant with other 
Federal, State, local, and private resources, in 
order to expand the participation of businesses, 
employees, and individuals in such training pro-
grams. 
‘‘(B) ELIGIBILITY.—In order to receive a 
grant under the program established under this 
paragraph— 
‘‘(i) an entity shall be an educational 
institution, community-based organization, 
nonprofit organization, workforce invest-
1649 
ment board, or local or county government; 
and 
‘‘(ii) an entity shall provide online 
workforce training for individuals seeking 
to attain or advance in health care occupa-
tions, including nursing, nursing assist-
ants, dentistry, pharmacy, health care 
management and administration, public 
health, health information systems anal-
ysis, medical assistants, and other health 
care practitioner and support occupations. 
‘‘(C) PRIORITY.—Priority in awarding 
grants under this paragraph shall be given to 
entities that— 
‘‘(i) have demonstrated experience in 
implementing and operating online worker 
skills training and education programs; 
‘‘(ii) have demonstrated experience co-
ordinating activities, where appropriate, 
with the workforce investment system; and 
‘‘(iii) conduct training for occupations 
with national or local shortages. 
‘‘(D) DATA COLLECTION.—Grantees under 
this paragraph shall collect and report informa-
tion on—
1650 
‘‘(i) the number of participants; 
‘‘(ii) the services received by the par-
ticipants; 
‘‘(iii) program completion rates; 
‘‘(iv) factors determined as signifi-
cantly interfering with program participa-
tion or completion; 
‘‘(v) the rate of job placement; and 
‘‘(vi) other information as determined 
as needed by the Secretary. 
‘‘(E) OUTREACH.—Grantees under this 
paragraph shall conduct outreach activities to 
disseminate information about their program 
and results to workforce investment boards, 
local governments, educational institutions, and 
other workforce training organizations. 
‘‘(F) PERFORMANCE
LEVELS.—The Sec-
retary shall establish indicators of performance 
that will be used to evaluate the performance of 
grantees under this paragraph in carrying out 
the activities described in this paragraph. The 
Secretary shall negotiate and reach agreement 
with each grantee regarding the levels of per-
formance expected to be achieved by the grant-
ee on the indicators of performance.
1651 
‘‘(G) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—There are authorized to be appro-
priated to the Secretary to carry out this sub-
section $50,000,000 for fiscal years 2011 
through 2020. 
‘‘(2) ONLINE HEALTH PROFESSIONS TRAINING 
PROGRAM CLEARINGHOUSE.— 
‘‘(A) DESCRIPTION OF GRANT.—The Sec-
retary may award one or more grants to eligible 
postsecondary educational institutions to pro-
vide the services described in this paragraph. 
‘‘(B) ELIGIBILITY.—To be eligible to re-
ceive a grant under this paragraph, a postsec-
ondary educational institution shall— 
‘‘(i) have demonstrated the ability to 
disseminate research on best practices for 
implementing workforce investment pro-
grams; and 
‘‘(ii) be a national leader in producing 
cutting-edge research on technology related 
to workforce investment systems under 
subtitle B. 
‘‘(C) SERVICES.—The postsecondary edu-
cational institution that receives a grant under 
this paragraph shall use such grant—
1652 
‘‘(i) to provide technical assistance to 
entities that receive grants under para-
graph (1); 
‘‘(ii) to collect and nationally dissemi-
nate the data gathered by entities that re-
ceive grants under paragraph (1); and 
‘‘(iii) to disseminate the best practices 
identified by the National Health Work-
force Online Training Grant Program to 
other workforce training organizations. 
‘‘(D) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—There are authorized to be appro-
priated to the Secretary to carry out this sub-
section $1,000,000 for fiscal years 2011 
through 2020.’’. 
SEC. 2592. ACCESS FOR INDIVIDUALS WITH DISABILITIES. 
Title V of the Rehabilitation Act of 1973 (29 U.S.C. 
791 et seq.) is amended by adding at the end of the fol-
lowing: 
‘‘SEC. 510. STANDARDS FOR ACCESSIBILITY OF MEDICAL 
DIAGNOSTIC EQUIPMENT. 
‘‘(a) STANDARDS.—Not later than 9 months after the 
date of enactment of the Affordable Health Care for 
America Act, the Architectural and Transportation Bar-
riers Compliance Board (Access Board) shall issue guide-
1653 
lines setting forth the minimum technical criteria for new 
medical diagnostic equipment to be purchased for use in 
(or in conjunction with) physician’s offices, clinics, emer-
gency rooms, hospitals, and other medical settings. The 
guidelines shall ensure that such equipment is accessible 
to, and usable by, individuals with disabilities, including 
provisions to ensure independent entry to, use of, and exit 
from the equipment by such individuals to the maximum 
extent possible. 
‘‘(b) 
MEDICAL
DIAGNOSTIC
EQUIPMENT
COV-
ERED.—The guidelines issued under subsection (a) for 
medical diagnostic equipment shall apply to new purchases 
of equipment that includes examination tables, examina-
tion chairs (including chairs used for eye examinations or 
procedures, and dental examinations or procedures), 
weight scales, mammography equipment, x-ray machines, 
and other equipment commonly used for diagnostic or ex-
amination purposes by health professionals. 
‘‘(c) REGULATIONS.—Not later than 6 months after 
the date of the issuance of the guidelines under subsection 
(a), each appropriate Federal agency authorized to pro-
mulgate regulations under this Act or under the Ameri-
cans with Disabilities Act shall— 
‘‘(1) prescribe regulations in an accessible for-
mat as necessary to carry out the provisions of such
1654 
Act and section 504 of this Act that include accessi-
bility standards that are consistent with the guide-
lines issued under subsection (a); and 
‘‘(2) ensure that health care providers and 
health care plans covered by the Affordable Health 
Care for America Act meet the requirements of the 
Americans with Disabilities Act and section 504, in-
cluding provisions ensuring that individuals with dis-
abilities receive equal access to all aspects of the 
health care delivery system. 
‘‘(d) REVIEW AND AMEND.—The Architectural and 
Transportation Barriers Compliance Board (Access 
Board) shall periodically review and, as appropriate, 
amend the guidelines as prescribed under subsection (a). 
Not later than 6 months after the date of the issuance 
of such revised guidelines, revised regulations consistent 
with such guidelines shall be promulgated in an accessible 
format by the appropriate Federal agencies described in 
subsection (c).’’. 
SEC. 2593. DUPLICATIVE GRANT PROGRAMS. 
(a) STUDY.—The Secretary of Health and Human 
Services (in this section referred to as the ‘‘Secretary’’) 
shall conduct a study to determine if any new division C 
grant program is duplicative of one or more other grant
1655 
programs of the Department of Health and Human Serv-
ices that— 
(1) are specifically authorized in the Public 
Health Service Act (42 U.S.C. 201 et seq.); or 
(2) are receiving appropriations. 
(b) DUPLICATIVE PROGRAMS.—If the Secretary de-
termines under subsection (a) that a new division C grant 
program is duplicative of one or more other grant pro-
grams described in such subsection, the Secretary shall— 
(1) attempt to integrate the new division C 
grant program with the duplicative programs; and 
(2) if the Secretary determines that such inte-
gration is not appropriate or has not been success-
ful, promulgate a rule eliminating the duplication, 
including, if appropriate, by terminating one or more 
programs. 
(c) CONTINUED AVAILABILITY
OF FUNDS.—Any 
funds appropriated to carry out a program that is termi-
nated under subsection (b)(2) shall remain available for 
obligation for the one or more programs that— 
(1) were determined under subsection (a) to be 
duplicative of such program; and 
(2) remain in effect. 
(d) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Secretary shall submit
1656 
to the Congress and make available to the public a report 
that contains the results of the study required under sub-
section (a). 
(e) CONGRESSIONAL REVIEW.—Any rule under sub-
section (b)(2) terminating a program is deemed to be a 
major rule for purposes of chapter 8 of title 5, United 
States Code. 
(f) DEFINITION.—In this section, the term ‘‘new divi-
sion C grant program’’— 
(1) means a grant program first established by 
this division; and 
(2) excludes any program whose statutory au-
thorization was in existence before the enactment of 
this division. 
SEC. 2594. DIABETES SCREENING COLLABORATION AND 
OUTREACH PROGRAM. 
(a) ESTABLISHMENT.—With respect to diabetes 
screening tests and for the purposes of reducing the num-
ber of undiagnosed seniors with diabetes or prediabetes, 
the Secretary of Health and Human Services (referred to 
in this section as the ‘‘Secretary’’), in collaboration with 
the Director of the Centers for Disease Control and Pre-
vention (referred to in this section as the ‘‘Director’’), 
shall—