1474 
•AMDT. NO. 2786 
Investment Act of 1998, a sponsor of an ap-
prenticeship program registered under the Na-
tional Apprenticeship Act or a community-based 
organization. 
‘‘(B) ELIGIBLE INDIVIDUAL.— 
‘‘(i) IN GENERAL.—The term ‘eligible 
individual’ means a individual receiving as-
sistance under the State TANF program. 
‘‘(ii) OTHER
LOW-INCOME
INDIVID-
UALS.—Such term may include other low- 
income individuals described by the eligible 
entity in its application for a grant under 
this section. 
‘‘(C) INDIAN
TRIBE; TRIBAL
ORGANIZA-
TION.—The terms ‘Indian tribe’ and ‘tribal or-
ganization’ have the meaning given such terms 
in section 4 of the Indian Self-Determination 
and Education Assistance Act (25 U.S.C. 
450b). 
‘‘(D) INSTITUTION
OF
HIGHER
EDU-
CATION.—The term ‘institution of higher edu-
cation’ has the meaning given that term in sec-
tion 101 of the Higher Education Act of 1965 
(20 U.S.C. 1001). 
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•AMDT. NO. 2786 
‘‘(E) STATE.—The term ‘State’ means 
each of the 50 States, the District of Columbia, 
the Commonwealth of Puerto Rico, the United 
States Virgin Islands, Guam, and American 
Samoa. 
‘‘(F) STATE TANF PROGRAM.—The term 
‘State TANF program’ means the temporary 
assistance for needy families program funded 
under part A of title IV. 
‘‘(G) TRIBAL COLLEGE OR UNIVERSITY.— 
The term ‘Tribal College or University’ has the 
meaning given that term in section 316(b) of 
the Higher Education Act of 1965 (20 U.S.C. 
1059c(b)). 
‘‘(b) DEMONSTRATION
PROJECT
TO
DEVELOP 
TRAINING
AND CERTIFICATION PROGRAMS
FOR PER-
SONAL OR HOME CARE AIDES.— 
‘‘(1) AUTHORITY
TO
AWARD
GRANTS.—Not 
later than 18 months after the date of enactment of 
this section, the Secretary shall award grants to eli-
gible entities that are States to conduct demonstra-
tion projects for purposes of developing core training 
competencies and certification programs for personal 
or home care aides. The Secretary shall— 
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•AMDT. NO. 2786 
‘‘(A) evaluate the efficacy of the core train-
ing competencies described in paragraph (3)(A) 
for newly hired personal or home care aides and 
the methods used by States to implement such 
core training competencies in accordance with 
the issues specified in paragraph (3)(B); and 
‘‘(B) ensure that the number of hours of 
training provided by States under the dem-
onstration project with respect to such core 
training competencies are not less than the 
number of hours of training required under any 
applicable State or Federal law or regulation. 
‘‘(2) DURATION.—A demonstration project shall 
be conducted under this subsection for not less than 
3 years. 
‘‘(3) CORE TRAINING COMPETENCIES FOR PER-
SONAL OR HOME CARE AIDES.— 
‘‘(A) IN
GENERAL.—The core training 
competencies for personal or home care aides 
described in this subparagraph include com-
petencies with respect to the following areas: 
‘‘(i) The role of the personal or home 
care aide (including differences between a 
personal or home care aide employed by an 
agency and a personal or home care aide 
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•AMDT. NO. 2786 
employed directly by the health care con-
sumer or an independent provider). 
‘‘(ii) Consumer rights, ethics, and 
confidentiality (including the role of proxy 
decision-makers in the case where a health 
care consumer has impaired decision-mak-
ing capacity). 
‘‘(iii) Communication, cultural and 
linguistic competence and sensitivity, prob-
lem solving, behavior management, and re-
lationship skills. 
‘‘(iv) Personal care skills. 
‘‘(v) Health care support. 
‘‘(vi) Nutritional support. 
‘‘(vii) Infection control. 
‘‘(viii) Safety and emergency training. 
‘‘(ix) Training specific to an indi-
vidual consumer’s needs (including older 
individuals, younger individuals with dis-
abilities, individuals with developmental 
disabilities, individuals with dementia, and 
individuals with mental and behavioral 
health needs). 
‘‘(x) Self-Care. 
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•AMDT. NO. 2786 
‘‘(B) IMPLEMENTATION.—The implemen-
tation issues specified in this subparagraph in-
clude the following: 
‘‘(i) The length of the training. 
‘‘(ii) The appropriate trainer to stu-
dent ratio. 
‘‘(iii) The amount of instruction time 
spent in the classroom as compared to on- 
site in the home or a facility. 
‘‘(iv) Trainer qualifications. 
‘‘(v) Content for a ‘hands-on’ and 
written certification exam. 
‘‘(vi) Continuing education require-
ments. 
‘‘(4) 
APPLICATION
AND
SELECTION
CRI-
TERIA.— 
‘‘(A) IN GENERAL.— 
‘‘(i) NUMBER OF STATES.—The Sec-
retary shall enter into agreements with not 
more than 6 States to conduct demonstra-
tion projects under this subsection. 
‘‘(ii) REQUIREMENTS FOR STATES.— 
An agreement entered into under clause (i) 
shall require that a participating State— 
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•AMDT. NO. 2786 
‘‘(I) implement the core training 
competencies described in paragraph 
(3)(A); and 
‘‘(II) develop written materials 
and protocols for such core training 
competencies, including the develop-
ment of a certification test for per-
sonal or home care aides who have 
completed such training competencies. 
‘‘(iii) CONSULTATION AND COLLABO-
RATION
WITH
COMMUNITY
AND
VOCA-
TIONAL
COLLEGES.—The Secretary shall 
encourage participating States to consult 
with community and vocational colleges re-
garding the development of curricula to 
implement the project with respect to ac-
tivities, as applicable, which may include 
consideration of such colleges as partners 
in such implementation. 
‘‘(B) APPLICATION
AND
ELIGIBILITY.—A 
State seeking to participate in the project 
shall— 
‘‘(i) submit an application to the Sec-
retary containing such information and at 
such time as the Secretary may specify; 
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•AMDT. NO. 2786 
‘‘(ii) meet the selection criteria estab-
lished under subparagraph (C); and 
‘‘(iii) meet such additional criteria as 
the Secretary may specify. 
‘‘(C) SELECTION
CRITERIA.—In selecting 
States to participate in the program, the Sec-
retary shall establish criteria to ensure (if appli-
cable with respect to the activities involved)— 
‘‘(i) geographic and demographic di-
versity; 
‘‘(ii) that participating States offer 
medical assistance for personal care serv-
ices under the State Medicaid plan; 
‘‘(iii) that the existing training stand-
ards for personal or home care aides in 
each participating State— 
‘‘(I) are different from such 
standards in the other participating 
States; and 
‘‘(II) are different from the core 
training competencies described in 
paragraph (3)(A); 
‘‘(iv) that participating States do not 
reduce the number of hours of training re-
quired under applicable State law or regu-
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•AMDT. NO. 2786 
lation after being selected to participate in 
the project; and 
‘‘(v) that participating States recruit 
a minimum number of eligible health and 
long-term care providers to participate in 
the project. 
‘‘(D) TECHNICAL ASSISTANCE.—The Sec-
retary shall provide technical assistance to 
States in developing written materials and pro-
tocols for such core training competencies. 
‘‘(5) EVALUATION AND REPORT.— 
‘‘(A) EVALUATION.—The Secretary shall 
develop an experimental or control group test-
ing protocol in consultation with an inde-
pendent evaluation contractor selected by the 
Secretary. Such contractor shall evaluate— 
‘‘(i) the impact of core training com-
petencies described in paragraph (3)(A), 
including curricula developed to implement 
such core training competencies, for per-
sonal or home care aides within each par-
ticipating State on job satisfaction, mas-
tery of job skills, beneficiary and family 
caregiver satisfaction with services, and ad-
ditional measures determined by the Sec-
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•AMDT. NO. 2786 
retary in consultation with the expert 
panel; 
‘‘(ii) the impact of providing such core 
training competencies on the existing 
training infrastructure and resources of 
States; and 
‘‘(iii) whether a minimum number of 
hours of initial training should be required 
for personal or home care aides and, if so, 
what minimum number of hours should be 
required. 
‘‘(B) REPORTS.— 
‘‘(i) REPORT ON INITIAL IMPLEMEN-
TATION.—Not later than 2 years after the 
date of enactment of this section, the Sec-
retary shall submit to Congress a report on 
the initial implementation of activities con-
ducted under the demonstration project, 
including any available results of the eval-
uation conducted under subparagraph (A) 
with respect to such activities, together 
with such recommendations for legislation 
or administrative action as the Secretary 
determines appropriate. 
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•AMDT. NO. 2786 
‘‘(ii) FINAL REPORT.—Not later than 
1 year after the completion of the dem-
onstration project, the Secretary shall sub-
mit to Congress a report containing the re-
sults of the evaluation conducted under 
subparagraph (A), together with such rec-
ommendations for legislation or adminis-
trative action as the Secretary determines 
appropriate. 
‘‘(6) DEFINITIONS.—In this subsection: 
‘‘(A) ELIGIBLE HEALTH AND LONG-TERM 
CARE PROVIDER.—The term ‘eligible health and 
long-term care provider’ means a personal or 
home care agency (including personal or home 
care public authorities), a nursing home, a 
home health agency (as defined in section 
1861(o)), or any other health care provider the 
Secretary determines appropriate which— 
‘‘(i) is licensed or authorized to pro-
vide services in a participating State; and 
‘‘(ii) receives payment for services 
under title XIX. 
‘‘(B) PERSONAL
CARE
SERVICES.—The 
term ‘personal care services’ has the meaning 
given such term for purposes of title XIX. 
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•AMDT. NO. 2786 
‘‘(C) PERSONAL OR HOME CARE AIDE.— 
The term ‘personal or home care aide’ means 
an individual who helps individuals who are el-
derly, disabled, ill, or mentally disabled (includ-
ing an individual with Alzheimer’s disease or 
other dementia) to live in their own home or a 
residential care facility (such as a nursing 
home, assisted living facility, or any other facil-
ity the Secretary determines appropriate) by 
providing routine personal care services and 
other appropriate services to the individual. 
‘‘(D) STATE.—The term ‘State’ has the 
meaning given that term for purposes of title 
XIX. 
‘‘(c) FUNDING.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
out of any funds in the Treasury not otherwise ap-
propriated, there are appropriated to the Secretary 
to carry out subsections (a) and (b), $85,000,000 
for each of fiscal years 2010 through 2014. 
‘‘(2) TRAINING AND CERTIFICATION PROGRAMS 
FOR PERSONAL AND HOME CARE AIDES.—With re-
spect to the demonstration projects under subsection 
(b), the Secretary shall use $5,000,000 of the 
amount appropriated under paragraph (1) for each 
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•AMDT. NO. 2786 
of fiscal years 2010 through 2012 to carry out such 
projects. No funds appropriated under paragraph 
(1) shall be used to carry out demonstration projects 
under subsection (b) after fiscal year 2012. 
‘‘(d) NONAPPLICATION.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the preceding sections of this title shall 
not apply to grant awarded under this section. 
‘‘(2) LIMITATIONS ON USE OF GRANTS.—Sec-
tion 2005(a) (other than paragraph (6)) shall apply 
to a grant awarded under this section to the same 
extent and in the same manner as such section ap-
plies to payments to States under this title.’’. 
(b) EXTENSION OF FAMILY-TO-FAMILY HEALTH IN-
FORMATION CENTERS.—Section 501(c)(1)(A)(iii) of the 
Social Security Act (42 U.S.C. 701(c)(1)(A)(iii)) is 
amended by striking ‘‘fiscal year 2009’’ and inserting 
‘‘each of fiscal years 2009 through 2012’’. 
SEC. 5508. INCREASING TEACHING CAPACITY. 
(a) TEACHING HEALTH CENTERS TRAINING
AND 
ENHANCEMENT.—Part C of title VII of the Public Health 
Service Act (42 U.S.C. 293k et. seq.), as amended by sec-
tion 5303, is further amended by inserting after section 
749 the following: 
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•AMDT. NO. 2786 
‘‘SEC. 749A. TEACHING HEALTH CENTERS DEVELOPMENT 
GRANTS. 
‘‘(a) PROGRAM AUTHORIZED.—The Secretary may 
award grants under this section to teaching health centers 
for the purpose of establishing new accredited or expanded 
primary care residency programs. 
‘‘(b) AMOUNT
AND DURATION.—Grants awarded 
under this section shall be for a term of not more than 
3 years and the maximum award may not be more than 
$500,000. 
‘‘(c) USE OF FUNDS.—Amounts provided under a 
grant under this section shall be used to cover the costs 
of— 
‘‘(1) establishing or expanding a primary care 
residency training program described in subsection 
(a), including costs associated with— 
‘‘(A) curriculum development; 
‘‘(B) recruitment, training and retention of 
residents and faculty: 
‘‘(C) accreditation by the Accreditation 
Council 
for 
Graduate 
Medical 
Education 
(ACGME), the American Dental Association 
(ADA), or the American Osteopathic Associa-
tion (AOA); and 
‘‘(D) faculty salaries during the develop-
ment phase; and 
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•AMDT. NO. 2786 
‘‘(2) technical assistance provided by an eligible 
entity. 
‘‘(d) APPLICATION.—A teaching health center seek-
ing a grant under this section shall submit an application 
to the Secretary at such time, in such manner, and con-
taining such information as the Secretary may require. 
‘‘(e) PREFERENCE FOR CERTAIN APPLICATIONS.—In 
selecting recipients for grants under this section, the Sec-
retary shall give preference to any such application that 
documents an existing affiliation agreement with an area 
health education center program as defined in sections 
751 and 799B. 
‘‘(f) DEFINITIONS.—In this section: 
‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en-
tity’ means an organization capable of providing 
technical assistance including an area health edu-
cation center program as defined in sections 751 
and 799B. 
‘‘(2) PRIMARY
CARE
RESIDENCY
PROGRAM.— 
The term ‘primary care residency program’ means 
an approved graduate medical residency training 
program (as defined in section 340H) in family med-
icine, internal medicine, pediatrics, internal medi-
cine-pediatrics, obstetrics and gynecology, psychi-
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•AMDT. NO. 2786 
atry, general dentistry, pediatric dentistry, and geri-
atrics. 
‘‘(3) TEACHING HEALTH CENTER.— 
‘‘(A) IN
GENERAL.—The term ‘teaching 
health center’ means an entity that— 
‘‘(i) is a community based, ambula-
tory patient care center; and 
‘‘(ii) operates a primary care resi-
dency program. 
‘‘(B) INCLUSION OF CERTAIN ENTITIES.— 
Such term includes the following: 
‘‘(i) A Federally qualified health cen-
ter (as defined in section 1905(l)(2)(B), of 
the Social Security Act). 
‘‘(ii) A community mental health cen-
ter (as defined in section 1861(ff)(3)(B) of 
the Social Security Act). 
‘‘(iii) A rural health clinic, as defined 
in section 1861(aa) of the Social Security 
Act. 
‘‘(iv) A health center operated by the 
Indian Health Service, an Indian tribe or 
tribal organization, or an urban Indian or-
ganization (as defined in section 4 of the 
Indian Health Care Improvement Act). 
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•AMDT. NO. 2786 
‘‘(v) An entity receiving funds under 
title X of the Public Health Service Act. 
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated, $25,000,000 for fiscal 
year 2010, $50,000,000 for fiscal year 2011, $50,000,000 
for fiscal year 2012, and such sums as may be necessary 
for each fiscal year thereafter to carry out this section. 
Not to exceed $5,000,000 annually may be used for tech-
nical assistance program grants.’’. 
(b) NATIONAL HEALTH SERVICE CORPS TEACHING 
CAPACITY.—Section 338C(a) of the Public Health Service 
Act (42 U.S.C. 254m(a)) is amended to read as follows: 
‘‘(a) SERVICE IN FULL-TIME CLINICAL PRACTICE.— 
Except as provided in section 338D, each individual who 
has entered into a written contract with the Secretary 
under section 338A or 338B shall provide service in the 
full-time clinical practice of such individual’s profession as 
a member of the Corps for the period of obligated service 
provided in such contract. For the purpose of calculating 
time spent in full-time clinical practice under this sub-
section, up to 50 percent of time spent teaching by a mem-
ber of the Corps may be counted toward his or her service 
obligation.’’. 
(c) PAYMENTS TO QUALIFIED TEACHING HEALTH 
CENTERS.—Part D of title III of the Public Health Serv-
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•AMDT. NO. 2786 
ice Act (42 U.S.C. 254b et seq.) is amended by adding 
at the end the following: 
‘‘Subpart XI—Support of Graduate Medical 
Education in Qualified Teaching Health Centers 
‘‘SEC. 
340H. 
PROGRAM 
OF 
PAYMENTS 
TO 
TEACHING 
HEALTH CENTERS THAT OPERATE GRAD-
UATE MEDICAL EDUCATION PROGRAMS. 
‘‘(a) PAYMENTS.—Subject to subsection (h)(2), the 
Secretary shall make payments under this section for di-
rect expenses and for indirect expenses to qualified teach-
ing health centers that are listed as sponsoring institutions 
by the relevant accrediting body for expansion of existing 
or establishment of new approved graduate medical resi-
dency training programs. 
‘‘(b) AMOUNT OF PAYMENTS.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the amounts payable under this section to qualified 
teaching health centers for an approved graduate 
medical residency training program for a fiscal year 
are each of the following amounts: 
‘‘(A) DIRECT
EXPENSE
AMOUNT.—The 
amount determined under subsection (c) for di-
rect expenses associated with sponsoring ap-
proved graduate medical residency training pro-
grams. 
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•AMDT. NO. 2786 
‘‘(B) INDIRECT
EXPENSE
AMOUNT.—The 
amount determined under subsection (d) for in-
direct expenses associated with the additional 
costs relating to teaching residents in such pro-
grams. 
‘‘(2) CAPPED AMOUNT.— 
‘‘(A) IN GENERAL.—The total of the pay-
ments made to qualified teaching health centers 
under paragraph (1)(A) or paragraph (1)(B) in 
a fiscal year shall not exceed the amount of 
funds appropriated under subsection (g) for 
such payments for that fiscal year. 
‘‘(B) LIMITATION.—The Secretary shall 
limit the funding of full-time equivalent resi-
dents in order to ensure the direct and indirect 
payments as determined under subsection (c) 
and (d) do not exceed the total amount of funds 
appropriated in a fiscal year under subsection 
(g). 
‘‘(c) AMOUNT OF PAYMENT FOR DIRECT GRADUATE 
MEDICAL EDUCATION.— 
‘‘(1) IN
GENERAL.—The amount determined 
under this subsection for payments to qualified 
teaching health centers for direct graduate expenses 
relating to approved graduate medical residency 
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•AMDT. NO. 2786 
training programs for a fiscal year is equal to the 
product of— 
‘‘(A) the updated national per resident 
amount for direct graduate medical education, 
as determined under paragraph (2); and 
‘‘(B) the average number of full-time 
equivalent residents in the teaching health cen-
ter’s graduate approved medical residency train-
ing programs as determined under section 
1886(h)(4) of the Social Security Act (without 
regard to the limitation under subparagraph 
(F) of such section) during the fiscal year. 
‘‘(2) UPDATED
NATIONAL
PER
RESIDENT 
AMOUNT
FOR
DIRECT
GRADUATE
MEDICAL
EDU-
CATION.—The updated per resident amount for di-
rect graduate medical education for a qualified 
teaching health center for a fiscal year is an amount 
determined as follows: 
‘‘(A) 
DETERMINATION
OF
QUALIFIED 
TEACHING
HEALTH
CENTER
PER
RESIDENT 
AMOUNT.—The Secretary shall compute for 
each individual qualified teaching health center 
a per resident amount— 
‘‘(i) by dividing the national average 
per resident amount computed under sec-
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•AMDT. NO. 2786 
tion 340E(c)(2)(D) into a wage-related 
portion and a non-wage related portion by 
applying the proportion determined under 
subparagraph (B); 
‘‘(ii) by multiplying the wage-related 
portion by the factor applied under section 
1886(d)(3)(E) of the Social Security Act 
(but without application of section 4410 of 
the Balanced Budget Act of 1997 (42 
U.S.C. 1395ww note)) during the pre-
ceding fiscal year for the teaching health 
center’s area; and 
‘‘(iii) by adding the non-wage-related 
portion to the amount computed under 
clause (ii). 
‘‘(B) UPDATING
RATE.—The Secretary 
shall update such per resident amount for each 
such qualified teaching health center as deter-
mined appropriate by the Secretary. 
‘‘(d) AMOUNT OF PAYMENT FOR INDIRECT MEDICAL 
EDUCATION.— 
‘‘(1) IN
GENERAL.—The amount determined 
under this subsection for payments to qualified 
teaching health centers for indirect expenses associ-
ated with the additional costs of teaching residents 
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•AMDT. NO. 2786 
for a fiscal year is equal to an amount determined 
appropriate by the Secretary. 
‘‘(2) FACTORS.—In determining the amount 
under paragraph (1), the Secretary shall— 
‘‘(A) evaluate indirect training costs rel-
ative to supporting a primary care residency 
program in qualified teaching health centers; 
and 
‘‘(B) based on this evaluation, assure that 
the aggregate of the payments for indirect ex-
penses under this section and the payments for 
direct graduate medical education as deter-
mined under subsection (c) in a fiscal year do 
not exceed the amount appropriated for such 
expenses as determined in subsection (g). 
‘‘(3) INTERIM PAYMENT.—Before the Secretary 
makes a payment under this subsection pursuant to 
a determination of indirect expenses under para-
graph (1), the Secretary may provide to qualified 
teaching health centers a payment, in addition to 
any payment made under subsection (c), for ex-
pected indirect expenses associated with the addi-
tional costs of teaching residents for a fiscal year, 
based on an estimate by the Secretary. 
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•AMDT. NO. 2786 
‘‘(e) CLARIFICATION REGARDING RELATIONSHIP TO 
OTHER
PAYMENTS
FOR
GRADUATE
MEDICAL
EDU-
CATION.—Payments under this section— 
‘‘(1) shall be in addition to any payments— 
‘‘(A) for the indirect costs of medical edu-
cation under section 1886(d)(5)(B) of the So-
cial Security Act; 
‘‘(B) for direct graduate medical education 
costs under section 1886(h) of such Act; and 
‘‘(C) for direct costs of medical education 
under section 1886(k) of such Act; 
‘‘(2) shall not be taken into account in applying 
the limitation on the number of total full-time equiv-
alent residents under subparagraphs (F) and (G) of 
section 1886(h)(4) of such Act and clauses (v), 
(vi)(I), and (vi)(II) of section 1886(d)(5)(B) of such 
Act for the portion of time that a resident rotates 
to a hospital; and 
‘‘(3) shall not include the time in which a resi-
dent is counted toward full-time equivalency by a 
hospital under paragraph (2) or under section 
1886(d)(5)(B)(iv) of the Social Security Act, section 
1886(h)(4)(E) of such Act, or section 340E of this 
Act. 
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•AMDT. NO. 2786 
‘‘(f) RECONCILIATION.—The Secretary shall deter-
mine any changes to the number of residents reported by 
a hospital in the application of the hospital for the current 
fiscal year to determine the final amount payable to the 
hospital for the current fiscal year for both direct expense 
and indirect expense amounts. Based on such determina-
tion, the Secretary shall recoup any overpayments made 
to pay any balance due to the extent possible. The final 
amount so determined shall be considered a final inter-
mediary determination for the purposes of section 1878 
of the Social Security Act and shall be subject to adminis-
trative and judicial review under that section in the same 
manner as the amount of payment under section 1186(d) 
of such Act is subject to review under such section. 
‘‘(g) FUNDING.—To carry out this section, there are 
appropriated such sums as may be necessary, not to ex-
ceed $230,000,000, for the period of fiscal years 2011 
through 2015. 
‘‘(h) ANNUAL REPORTING REQUIRED.— 
‘‘(1) ANNUAL
REPORT.—The report required 
under this paragraph for a qualified teaching health 
center for a fiscal year is a report that includes (in 
a form and manner specified by the Secretary) the 
following information for the residency academic 
year completed immediately prior to such fiscal year: 
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•AMDT. NO. 2786 
‘‘(A) The types of primary care resident 
approved training programs that the qualified 
teaching health center provided for residents. 
‘‘(B) The number of approved training po-
sitions for residents described in paragraph (4). 
‘‘(C) The number of residents described in 
paragraph (4) who completed their residency 
training at the end of such residency academic 
year and care for vulnerable populations living 
in underserved areas. 
‘‘(D) Other information as deemed appro-
priate by the Secretary. 
‘‘(2) AUDIT AUTHORITY; LIMITATION ON PAY-
MENT.— 
‘‘(A) AUDIT
AUTHORITY.—The Secretary 
may audit a qualified teaching health center to 
ensure the accuracy and completeness of the in-
formation submitted in a report under para-
graph (1). 
‘‘(B) LIMITATION ON PAYMENT.—A teach-
ing health center may only receive payment in 
a cost reporting period for a number of such 
resident positions that is greater than the base 
level of primary care resident positions, as de-
termined by the Secretary. For purposes of this 
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•AMDT. NO. 2786 
subparagraph, the ‘base level of primary care 
residents’ for a teaching health center is the 
level of such residents as of a base period. 
‘‘(3) REDUCTION IN PAYMENT FOR FAILURE TO 
REPORT.— 
‘‘(A) IN GENERAL.—The amount payable 
under this section to a qualified teaching health 
center for a fiscal year shall be reduced by at 
least 25 percent if the Secretary determines 
that— 
‘‘(i) the qualified teaching health cen-
ter has failed to provide the Secretary, as 
an addendum to the qualified teaching 
health center’s application under this sec-
tion for such fiscal year, the report re-
quired under paragraph (1) for the pre-
vious fiscal year; or 
‘‘(ii) such report fails to provide com-
plete and accurate information required 
under any subparagraph of such para-
graph. 
‘‘(B) NOTICE AND OPPORTUNITY TO PRO-
VIDE ACCURATE AND MISSING INFORMATION.— 
Before imposing a reduction under subpara-
graph (A) on the basis of a qualified teaching 
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•AMDT. NO. 2786 
health center’s failure to provide complete and 
accurate information described in subparagraph 
(A)(ii), the Secretary shall provide notice to the 
teaching health center of such failure and the 
Secretary’s intention to impose such reduction 
and shall provide the teaching health center 
with the opportunity to provide the required in-
formation within the period of 30 days begin-
ning on the date of such notice. If the teaching 
health center provides such information within 
such period, no reduction shall be made under 
subparagraph (A) on the basis of the previous 
failure to provide such information. 
‘‘(4) RESIDENTS.—The residents described in 
this paragraph are those who are in part-time or 
full-time equivalent resident training positions at a 
qualified teaching health center in any approved 
graduate medical residency training program. 
‘‘(i) REGULATIONS.—The Secretary shall promulgate 
regulations to carry out this section. 
‘‘(j) DEFINITIONS.—In this section: 
‘‘(1) APPROVED
GRADUATE
MEDICAL
RESI-
DENCY
TRAINING
PROGRAM.—The term ‘approved 
graduate medical residency training program’ means 
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•AMDT. NO. 2786 
a residency or other postgraduate medical training 
program— 
‘‘(A) participation in which may be count-
ed toward certification in a specialty or sub-
specialty and includes formal postgraduate 
training programs in geriatric medicine ap-
proved by the Secretary; and 
‘‘(B) that meets criteria for accreditation 
(as established by the Accreditation Council for 
Graduate Medical Education, the American Os-
teopathic Association, or the American Dental 
Association). 
‘‘(2) PRIMARY
CARE
RESIDENCY
PROGRAM.— 
The term ‘primary care residency program’ has the 
meaning given that term in section 749A. 
‘‘(3) QUALIFIED TEACHING HEALTH CENTER.— 
The term ‘qualified teaching health center’ has the 
meaning given the term ‘teaching health center’ in 
section 749A.’’. 
SEC. 5509. GRADUATE NURSE EDUCATION DEMONSTRA-
TION. 
(a) IN GENERAL.— 
(1) ESTABLISHMENT.— 
(A) IN GENERAL.—The Secretary shall es-
tablish a graduate nurse education demonstra-
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•AMDT. NO. 2786 
tion under title XVIII of the Social Security 
Act (42 U.S.C. 1395 et seq.) under which an el-
igible hospital may receive payment for the hos-
pital’s reasonable costs (described in paragraph 
(2)) for the provision of qualified clinical train-
ing to advance practice nurses. 
(B) NUMBER.—The demonstration shall 
include up to 5 eligible hospitals. 
(C) WRITTEN AGREEMENTS.—Eligible hos-
pitals selected to participate in the demonstra-
tion shall enter into written agreements pursu-
ant to subsection (b) in order to reimburse the 
eligible partners of the hospital the share of the 
costs attributable to each partner. 
(2) COSTS DESCRIBED.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B) and subsection (d), the costs de-
scribed in this paragraph are the reasonable 
costs (as described in section 1861(v) of the So-
cial Security Act (42 U.S.C. 1395x(v))) of each 
eligible hospital for the clinical training costs 
(as determined by the Secretary) that are at-
tributable to providing advanced practice reg-
istered nurses with qualified training. 
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•AMDT. NO. 2786 
(B) LIMITATION.—With respect to a year, 
the amount reimbursed under subparagraph (A) 
may not exceed the amount of costs described 
in subparagraph (A) that are attributable to an 
increase in the number of advanced practice 
registered nurses enrolled in a program that 
provides qualified training during the year and 
for which the hospital is being reimbursed 
under the demonstration, as compared to the 
average number of advanced practice registered 
nurses who graduated in each year during the 
period beginning on January 1, 2006, and end-
ing on December 31, 2010 (as determined by 
the Secretary) from the graduate nursing edu-
cation program operated by the applicable 
school of nursing that is an eligible partner of 
the hospital for purposes of the demonstration. 
(3) WAIVER AUTHORITY.—The Secretary may 
waive such requirements of titles XI and XVIII of 
the Social Security Act as may be necessary to carry 
out the demonstration. 
(4) ADMINISTRATION.—Chapter 35 of title 44, 
United States Code, shall not apply to the imple-
mentation of this section. 
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•AMDT. NO. 2786 
(b) WRITTEN AGREEMENTS WITH ELIGIBLE PART-
NERS.—No payment shall be made under this section to 
an eligible hospital unless such hospital has in effect a 
written agreement with the eligible partners of the hos-
pital. Such written agreement shall describe, at a min-
imum— 
(1) the obligations of the eligible partners with 
respect to the provision of qualified training; and 
(2) the obligation of the eligible hospital to re-
imburse such eligible partners applicable (in a timely 
manner) for the costs of such qualified training at-
tributable to partner. 
(c) EVALUATION.—Not later than October 17, 2017, 
the Secretary shall submit to Congress a report on the 
demonstration. Such report shall include an analysis of the 
following: 
(1) The growth in the number of advanced 
practice registered nurses with respect to a specific 
base year as a result of the demonstration. 
(2) The growth for each of the specialties de-
scribed in subparagraphs (A) through (D) of sub-
section (e)(1). 
(3) The costs to the Medicare program under 
title XVIII of the Social Security Act as a result of 
the demonstration. 
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•AMDT. NO. 2786 
(4) Other items the Secretary determines ap-
propriate and relevant. 
(d) FUNDING.— 
(1) IN
GENERAL.—There is hereby appro-
priated to the Secretary, out of any funds in the 
Treasury not otherwise appropriated, $50,000,000 
for each of fiscal years 2012 through 2015 to carry 
out this section, including the design, implementa-
tion, monitoring, and evaluation of the demonstra-
tion. 
(2) PRORATION.—If the aggregate payments to 
eligible hospitals under the demonstration exceed 
$50,000,000 for a fiscal year described in paragraph 
(1), the Secretary shall prorate the payment 
amounts to each eligible hospital in order to ensure 
that the aggregate payments do not exceed such 
amount. 
(3) WITHOUT
FISCAL
YEAR
LIMITATION.— 
Amounts appropriated under this subsection shall 
remain available without fiscal year limitation. 
(e) DEFINITIONS.—In this section: 
(1) 
ADVANCED
PRACTICE
REGISTERED 
NURSE.—The term ‘‘advanced practice registered 
nurse’’ includes the following: 
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•AMDT. NO. 2786 
(A) A clinical nurse specialist (as defined 
in subsection (aa)(5) of section 1861 of the So-
cial Security Act (42 U.S.C. 1395x)). 
(B) A nurse practitioner (as defined in 
such subsection). 
(C) A certified registered nurse anesthetist 
(as defined in subsection (bb)(2) of such sec-
tion). 
(D) A certified nurse-midwife (as defined 
in subsection (gg)(2) of such section). 
(2) APPLICABLE
NON-HOSPITAL
COMMUNITY- 
BASED CARE SETTING.—The term ‘‘applicable non- 
hospital community-based care setting’’ means a 
non-hospital community-based care setting which 
has entered into a written agreement (as described 
in subsection (b)) with the eligible hospital partici-
pating in the demonstration. Such settings include 
Federally qualified health centers, rural health clin-
ics, and other non-hospital settings as determined 
appropriate by the Secretary. 
(3) APPLICABLE
SCHOOL
OF
NURSING.—The 
term ‘‘applicable school of nursing’’ means an ac-
credited school of nursing (as defined in section 801 
of the Public Health Service Act) which has entered 
into a written agreement (as described in subsection 
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•AMDT. NO. 2786 
(b)) with the eligible hospital participating in the 
demonstration. 
(4) DEMONSTRATION.—The term ‘‘demonstra-
tion’’ means the graduate nurse education dem-
onstration established under subsection (a). 
(5) ELIGIBLE
HOSPITAL.—The term ‘‘eligible 
hospital’’ means a hospital (as defined in subsection 
(e) of section 1861 of the Social Security Act (42 
U.S.C. 1395x)) or a critical access hospital (as de-
fined in subsection (mm)(1) of such section) that 
has a written agreement in place with— 
(A) 1 or more applicable schools of nurs-
ing; and 
(B) 2 or more applicable non-hospital com-
munity-based care settings. 
(6) ELIGIBLE PARTNERS.—The term ‘‘eligible 
partners’’ includes the following: 
(A) An applicable non-hospital community- 
based care setting. 
(B) An applicable school of nursing. 
(7) QUALIFIED TRAINING.— 
(A) IN
GENERAL.—The term ‘‘qualified 
training’’ means training— 
(i) that provides an advanced practice 
registered nurse with the clinical skills nec-
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•AMDT. NO. 2786 
essary to provide primary care, preventive 
care, transitional care, chronic care man-
agement, and other services appropriate 
for individuals entitled to, or enrolled for, 
benefits under part A of title XVIII of the 
Social Security Act, or enrolled under part 
B of such title; and 
(ii) subject to subparagraph (B), at 
least half of which is provided in a non- 
hospital community-based care setting. 
(B) WAIVER OF REQUIREMENT HALF OF 
TRAINING
BE
PROVIDED
IN
NON-HOSPITAL 
COMMUNITY-BASED CARE SETTING IN CERTAIN 
AREAS.—The Secretary may waive the require-
ment under subparagraph (A)(ii) with respect 
to eligible hospitals located in rural or medically 
underserved areas. 
(8) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
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•AMDT. NO. 2786 
Subtitle G—Improving Access to 
Health Care Services 
SEC. 5601. SPENDING FOR FEDERALLY QUALIFIED HEALTH 
CENTERS (FQHCS). 
(a) IN GENERAL.—Section 330(r) of the Public 
Health Service Act (42 U.S.C. 254b(r)) is amended by 
striking paragraph (1) and inserting the following: 
‘‘(1) GENERAL
AMOUNTS
FOR
GRANTS.—For 
the purpose of carrying out this section, in addition 
to the amounts authorized to be appropriated under 
subsection (d), there is authorized to be appro-
priated the following: 
‘‘(A) 
For 
fiscal 
year 
2010, 
$2,988,821,592. 
‘‘(B) 
For 
fiscal 
year 
2011, 
$3,862,107,440. 
‘‘(C) For fiscal year 2012, $4,990,553,440. 
‘‘(D) 
For 
fiscal 
year 
2013, 
$6,448,713,307. 
‘‘(E) 
For 
fiscal 
year 
2014, 
$7,332,924,155. 
‘‘(F) 
For 
fiscal 
year 
2015, 
$8,332,924,155. 
‘‘(G) For fiscal year 2016, and each subse-
quent fiscal year, the amount appropriated for 
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•AMDT. NO. 2786 
the preceding fiscal year adjusted by the prod-
uct of— 
‘‘(i) one plus the average percentage 
increase in costs incurred per patient 
served; and 
‘‘(ii) one plus the average percentage 
increase in the total number of patients 
served.’’. 
(b) RULE OF CONSTRUCTION.—Section 330(r) of the 
Public Health Service Act (42 U.S.C. 254b(r)) is amended 
by adding at the end the following: 
‘‘(4) RULE OF CONSTRUCTION WITH RESPECT 
TO RURAL HEALTH CLINICS.— 
‘‘(A) IN GENERAL.—Nothing in this sec-
tion shall be construed to prevent a community 
health center from contracting with a Federally 
certified rural health clinic (as defined in sec-
tion 1861(aa)(2) of the Social Security Act), a 
low-volume hospital (as defined for purposes of 
section 1886 of such Act), a critical access hos-
pital, a sole community hospital (as defined for 
purposes of section 1886(d)(5)(D)(iii) of such 
Act), or a medicare-dependent share hospital 
(as 
defined 
for 
purposes 
of 
section 
1886(d)(5)(G)(iv) of such Act) for the delivery 
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•AMDT. NO. 2786 
of primary health care services that are avail-
able at the clinic or hospital to individuals who 
would otherwise be eligible for free or reduced 
cost care if that individual were able to obtain 
that care at the community health center. Such 
services may be limited in scope to those pri-
mary health care services available in that clinic 
or hospitals. 
‘‘(B) ASSURANCES.—In order for a clinic 
or hospital to receive funds under this section 
through a contract with a community health 
center under subparagraph (A), such clinic or 
hospital shall establish policies to ensure— 
‘‘(i) nondiscrimination based on the 
ability of a patient to pay; and 
‘‘(ii) the establishment of a sliding fee 
scale for low-income patients.’’. 
SEC. 5602. NEGOTIATED RULEMAKING FOR DEVELOPMENT 
OF METHODOLOGY AND CRITERIA FOR DES-
IGNATING MEDICALLY UNDERSERVED POPU-
LATIONS AND HEALTH PROFESSIONS SHORT-
AGE AREAS. 
(a) ESTABLISHMENT.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the 
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•AMDT. NO. 2786 
‘‘Secretary’’) shall establish, through a negotiated 
rulemaking process under subchapter 3 of chapter 5 
of title 5, United States Code, a comprehensive 
methodology and criteria for designation of— 
(A) medically underserved populations in 
accordance with section 330(b)(3) of the Public 
Health Service Act (42 U.S.C. 254b(b)(3)); 
(B) health professions shortage areas 
under section 332 of the Public Health Service 
Act (42 U.S.C. 254e). 
(2) FACTORS
TO
CONSIDER.—In establishing 
the methodology and criteria under paragraph (1), 
the Secretary— 
(A) shall consult with relevant stakeholders 
who will be significantly affected by a rule 
(such as national, State and regional organiza-
tions representing affected entities), State 
health offices, community organizations, health 
centers and other affected entities, and other 
interested parties; and 
(B) shall take into account— 
(i) the timely availability and appro-
priateness of data used to determine a des-
ignation to potential applicants for such 
designations; 
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•AMDT. NO. 2786 
(ii) the impact of the methodology and 
criteria on communities of various types 
and on health centers and other safety net 
providers; 
(iii) the degree of ease or difficulty 
that will face potential applicants for such 
designations in securing the necessary 
data; and 
(iv) the extent to which the method-
ology accurately measures various barriers 
that confront individuals and population 
groups in seeking health care services. 
(b) PUBLICATION OF NOTICE.—In carrying out the 
rulemaking process under this subsection, the Secretary 
shall publish the notice provided for under section 564(a) 
of title 5, United States Code, by not later than 45 days 
after the date of the enactment of this Act. 
(c) TARGET DATE FOR PUBLICATION OF RULE.—As 
part of the notice under subsection (b), and for purposes 
of this subsection, the ‘‘target date for publication’’, as 
referred to in section 564(a)(5) of title 5, United Sates 
Code, shall be July 1, 2010. 
(d) APPOINTMENT
OF NEGOTIATED RULEMAKING 
COMMITTEE AND FACILITATOR.—The Secretary shall pro-
vide for— 
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•AMDT. NO. 2786 
(1) the appointment of a negotiated rulemaking 
committee under section 565(a) of title 5, United 
States Code, by not later than 30 days after the end 
of the comment period provided for under section 
564(c) of such title; and 
(2) the nomination of a facilitator under section 
566(c) of such title 5 by not later than 10 days after 
the date of appointment of the committee. 
(e) PRELIMINARY COMMITTEE REPORT.—The nego-
tiated rulemaking committee appointed under subsection 
(d) shall report to the Secretary, by not later than April 
1, 2010, regarding the committee’s progress on achieving 
a consensus with regard to the rulemaking proceeding and 
whether such consensus is likely to occur before one month 
before the target date for publication of the rule. If the 
committee reports that the committee has failed to make 
significant progress toward such consensus or is unlikely 
to reach such consensus by the target date, the Secretary 
may terminate such process and provide for the publica-
tion of a rule under this section through such other meth-
ods as the Secretary may provide. 
(f) FINAL COMMITTEE REPORT.—If the committee 
is not terminated under subsection (e), the rulemaking 
committee shall submit a report containing a proposed 
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•AMDT. NO. 2786 
rule by not later than one month before the target publica-
tion date. 
(g) INTERIM FINAL EFFECT.—The Secretary shall 
publish a rule under this section in the Federal Register 
by not later than the target publication date. Such rule 
shall be effective and final immediately on an interim 
basis, but is subject to change and revision after public 
notice and opportunity for a period (of not less than 90 
days) for public comment. In connection with such rule, 
the Secretary shall specify the process for the timely re-
view and approval of applications for such designations 
pursuant to such rules and consistent with this section. 
(h) PUBLICATION OF RULE AFTER PUBLIC COM-
MENT.—The Secretary shall provide for consideration of 
such comments and republication of such rule by not later 
than 1 year after the target publication date. 
SEC. 5603. REAUTHORIZATION OF THE WAKEFIELD EMER-
GENCY MEDICAL SERVICES FOR CHILDREN 
PROGRAM. 
Section 1910 of the Public Health Service Act (42 
U.S.C. 300w–9) is amended— 
(1) in subsection (a), by striking ‘‘3-year period 
(with an optional 4th year’’ and inserting ‘‘4-year 
period (with an optional 5th year’’; and 
(2) in subsection (d)— 
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•AMDT. NO. 2786 
(A) by striking ‘‘and such sums’’ and in-
serting ‘‘such sums’’; and 
(B) by inserting before the period the fol-
lowing: ‘‘, $25,000,000 for fiscal year 2010, 
$26,250,000 for fiscal year 2011, $27,562,500 
for fiscal year 2012, $28,940,625 for fiscal year 
2013, and $30,387,656 for fiscal year 2014’’. 
SEC. 5604. CO-LOCATING PRIMARY AND SPECIALTY CARE 
IN COMMUNITY-BASED MENTAL HEALTH SET-
TINGS. 
Subpart 3 of part B of title V of the Public Health 
Service Act (42 U.S.C. 290bb–31 et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 520K. AWARDS FOR CO-LOCATING PRIMARY AND SPE-
CIALTY CARE IN COMMUNITY-BASED MENTAL 
HEALTH SETTINGS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ELIGIBLE ENTITY.—The term ‘eligible en-
tity’ means a qualified community mental health 
program defined under section 1913(b)(1). 
‘‘(2) SPECIAL POPULATIONS.—The term ‘spe-
cial populations’ means adults with mental illnesses 
who have co-occurring primary care conditions and 
chronic diseases. 
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•AMDT. NO. 2786 
‘‘(b) PROGRAM AUTHORIZED.—The Secretary, acting 
through the Administrator shall award grants and cooper-
ative agreements to eligible entities to establish dem-
onstration projects for the provision of coordinated and 
integrated services to special populations through the co- 
location of primary and specialty care services in commu-
nity-based mental and behavioral health settings. 
‘‘(c) APPLICATION.—To be eligible to receive a grant 
or cooperative agreement under this section, an eligible en-
tity shall submit an application to the Administrator at 
such time, in such manner, and accompanied by such in-
formation as the Administrator may require, including a 
description of partnerships, or other arrangements with 
local primary care providers, including community health 
centers, to provide services to special populations. 
‘‘(d) USE OF FUNDS.— 
‘‘(1) IN GENERAL.—For the benefit of special 
populations, an eligible entity shall use funds award-
ed under this section for— 
‘‘(A) the provision, by qualified primary 
care professionals, of on site primary care serv-
ices; 
‘‘(B) reasonable costs associated with 
medically necessary referrals to qualified spe-
cialty care professionals, other coordinators of 
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•AMDT. NO. 2786 
care or, if permitted by the terms of the grant 
or cooperative agreement, by qualified specialty 
care professionals on a reasonable cost basis on 
site at the eligible entity; 
‘‘(C) information technology required to 
accommodate the clinical needs of primary and 
specialty care professionals; or 
‘‘(D) facility modifications needed to bring 
primary and specialty care professionals on site 
at the eligible entity. 
‘‘(2) LIMITATION.—Not to exceed 15 percent of 
grant or cooperative agreement funds may be used 
for activities described in subparagraphs (C) and 
(D) of paragraph (1). 
‘‘(e) EVALUATION.—Not later than 90 days after a 
grant or cooperative agreement awarded under this section 
expires, an eligible entity shall submit to the Secretary the 
results of an evaluation to be conducted by the entity con-
cerning the effectiveness of the activities carried out under 
the grant or agreement. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section, 
$50,000,000 for fiscal year 2010 and such sums as may 
be necessary for each of fiscal years 2011 through 2014.’’. 
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•AMDT. NO. 2786 
SEC. 5605. KEY NATIONAL INDICATORS. 
(a) DEFINITIONS.—In this section: 
(1) ACADEMY.—The term ‘‘Academy’’ means 
the National Academy of Sciences. 
(2) COMMISSION.—The term ‘‘Commission’’ 
means the Commission on Key National Indicators 
established under subsection (b). 
(3) INSTITUTE.—The term ‘‘Institute’’ means a 
Key National Indicators Institute as designated 
under subsection (c)(3). 
(b) COMMISSION ON KEY NATIONAL INDICATORS.— 
(1) ESTABLISHMENT.—There is established a 
‘‘Commission on Key National Indicators’’. 
(2) MEMBERSHIP.— 
(A) NUMBER
AND
APPOINTMENT.—The 
Commission shall be composed of 8 members, to 
be appointed equally by the majority and mi-
nority leaders of the Senate and the Speaker 
and minority leader of the House of Represent-
atives. 
(B) PROHIBITED
APPOINTMENTS.—Mem-
bers of the Commission shall not include Mem-
bers of Congress or other elected Federal, 
State, or local government officials. 
(C) QUALIFICATIONS.—In making appoint-
ments under subparagraph (A), the majority 
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•AMDT. NO. 2786 
and minority leaders of the Senate and the 
Speaker and minority leader of the House of 
Representatives shall appoint individuals who 
have shown a dedication to improving civic dia-
logue and decision-making through the wide use 
of scientific evidence and factual information. 
(D) PERIOD
OF
APPOINTMENT.—Each 
member of the Commission shall be appointed 
for a 2-year term, except that 1 initial appoint-
ment shall be for 3 years. Any vacancies shall 
not affect the power and duties of the Commis-
sion but shall be filled in the same manner as 
the original appointment and shall last only for 
the remainder of that term. 
(E) DATE.—Members of the Commission 
shall be appointed by not later than 30 days 
after the date of enactment of this Act. 
(F) INITIAL
ORGANIZING
PERIOD.—–Not 
later than 60 days after the date of enactment 
of this Act, the Commission shall develop and 
implement a schedule for completion of the re-
view and reports required under subsection (d). 
(G) CO-CHAIRPERSONS.—The Commission 
shall select 2 Co-Chairpersons from among its 
members. 
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•AMDT. NO. 2786 
(c) DUTIES OF THE COMMISSION.— 
(1) IN GENERAL.—The Commission shall— 
(A) conduct comprehensive oversight of a 
newly established key national indicators system 
consistent with the purpose described in this 
subsection; 
(B) make recommendations on how to im-
prove the key national indicators system; 
(C) coordinate with Federal Government 
users and information providers to assure ac-
cess to relevant and quality data; and 
(D) enter into contracts with the Academy. 
(2) REPORTS.— 
(A) ANNUAL REPORT TO CONGRESS.—Not 
later than 1 year after the selection of the 2 
Co-Chairpersons of the Commission, and each 
subsequent year thereafter, the Commission 
shall prepare and submit to the appropriate 
Committees of Congress and the President a re-
port that contains a detailed statement of the 
recommendations, findings, and conclusions of 
the Commission on the activities of the Acad-
emy and a designated Institute related to the 
establishment of a Key National Indicator Sys-
tem. 
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•AMDT. NO. 2786 
(B) ANNUAL REPORT TO THE ACADEMY.— 
(i) IN GENERAL.—Not later than 6 
months after the selection of the 2 Co- 
Chairpersons of the Commission, and each 
subsequent year thereafter, the Commis-
sion shall prepare and submit to the Acad-
emy and a designated Institute a report 
making recommendations concerning po-
tential issue areas and key indicators to be 
included in the Key National Indicators. 
(ii) LIMITATION.—The Commission 
shall not have the authority to direct the 
Academy or, if established, the Institute, 
to adopt, modify, or delete any key indica-
tors. 
(3) CONTRACT WITH THE NATIONAL ACADEMY 
OF SCIENCES.— 
(A) IN GENERAL.—–As soon as practicable 
after the selection of the 2 Co-Chairpersons of 
the Commission, the Co-Chairpersons shall 
enter into an arrangement with the National 
Academy of Sciences under which the Academy 
shall— 
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•AMDT. NO. 2786 
(i) review available public and private 
sector research on the selection of a set of 
key national indicators; 
(ii) determine how best to establish a 
key national indicator system for the 
United States, by either creating its own 
institutional capability or designating an 
independent private nonprofit organization 
as an Institute to implement a key national 
indicator system; 
(iii) if the Academy designates an 
independent Institute under clause (ii), 
provide scientific and technical advice to 
the Institute and create an appropriate 
governance mechanism that balances Acad-
emy involvement and the independence of 
the Institute; and 
(iv) provide an annual report to the 
Commission addressing scientific and tech-
nical issues related to the key national in-
dicator system and, if established, the In-
stitute, and governance of the Institute’s 
budget and operations. 
(B) PARTICIPATION.—In executing the ar-
rangement under subparagraph (A), the Na-
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•AMDT. NO. 2786 
tional Academy of Sciences shall convene a 
multi-sector, multi-disciplinary process to define 
major scientific and technical issues associated 
with developing, maintaining, and evolving a 
Key National Indicator System and, if an Insti-
tute is established, to provide it with scientific 
and technical advice. 
(C) ESTABLISHMENT OF A KEY NATIONAL 
INDICATOR SYSTEM.— 
(i) IN GENERAL.—In executing the ar-
rangement under subparagraph (A), the 
National Academy of Sciences shall enable 
the establishment of a key national indi-
cator system by— 
(I) creating its own institutional 
capability; or 
(II) partnering with an inde-
pendent private nonprofit organization 
as an Institute to implement a key na-
tional indicator system. 
(ii) INSTITUTE.—If the Academy des-
ignates an Institute under clause (i)(II), 
such Institute shall be a non-profit entity 
(as 
defined 
for 
purposes 
of 
section 
501(c)(3) of the Internal Revenue Code of 
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•AMDT. NO. 2786 
1986) with an educational mission, a gov-
ernance structure that emphasizes inde-
pendence, and characteristics that make 
such entity appropriate for establishing a 
key national indicator system. 
(iii) RESPONSIBILITIES.—Either the 
Academy or the Institute designated under 
clause (i)(II) shall be responsible for the 
following: 
(I) Identifying and selecting issue 
areas to be represented by the key na-
tional indicators. 
(II) Identifying and selecting the 
measures used for key national indica-
tors within the issue areas under sub-
clause (I). 
(III) Identifying and selecting 
data to populate the key national indi-
cators described under subclause (II). 
(IV) Designing, publishing, and 
maintaining a public website that con-
tains a freely accessible database al-
lowing public access to the key na-
tional indicators. 
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•AMDT. NO. 2786 
(V) Developing a quality assur-
ance framework to ensure rigorous 
and independent processes and the se-
lection of quality data. 
(VI) Developing a budget for the 
construction and management of a 
sustainable, adaptable, and evolving 
key national indicator system that re-
flects all Commission funding of 
Academy and, if an Institute is estab-
lished, Institute activities. 
(VII) Reporting annually to the 
Commission regarding its selection of 
issue areas, key indicators, data, and 
progress toward establishing a web-ac-
cessible database. 
(VIII) Responding directly to the 
Commission in response to any Com-
mission recommendations and to the 
Academy regarding any inquiries by 
the Academy. 
(iv) GOVERNANCE.—Upon the estab-
lishment of a key national indicator sys-
tem, the Academy shall create an appro-
priate governance mechanism that incor-
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•AMDT. NO. 2786 
porates advisory and control functions. If 
an Institute is designated under clause 
(i)(II), the governance mechanism shall 
balance appropriate Academy involvement 
and the independence of the Institute. 
(v) MODIFICATION AND CHANGES.— 
The Academy shall retain the sole discre-
tion, at any time, to alter its approach to 
the establishment of a key national indi-
cator system or, if an Institute is des-
ignated under clause (i)(II), to alter any 
aspect of its relationship with the Institute 
or to designate a different non-profit entity 
to serve as the Institute. 
(vi) CONSTRUCTION.—Nothing in this 
section shall be construed to limit the abil-
ity of the Academy or the Institute des-
ignated under clause (i)(II) to receive pri-
vate funding for activities related to the es-
tablishment of a key national indicator sys-
tem. 
(D) ANNUAL REPORT.—As part of the ar-
rangement under subparagraph (A), the Na-
tional Academy of Sciences shall, not later than 
270 days after the date of enactment of this 
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•AMDT. NO. 2786 
Act, and annually thereafter, submit to the Co- 
Chairpersons of the Commission a report that 
contains the findings and recommendations of 
the Academy. 
(d) GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
AND REPORT.— 
(1) GAO STUDY.—The Comptroller General of 
the United States shall conduct a study of previous 
work conducted by all public agencies, private orga-
nizations, or foreign countries with respect to best 
practices for a key national indicator system. The 
study shall be submitted to the appropriate author-
izing committees of Congress. 
(2) GAO FINANCIAL AUDIT.—If an Institute is 
established under this section, the Comptroller Gen-
eral shall conduct an annual audit of the financial 
statements of the Institute, in accordance with gen-
erally accepted government auditing standards and 
submit a report on such audit to the Commission 
and the appropriate authorizing committees of Con-
gress. 
(3) GAO PROGRAMMATIC REVIEW.—The Comp-
troller General of the United States shall conduct 
programmatic assessments of the Institute estab-
lished under this section as determined necessary by 
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•AMDT. NO. 2786 
the Comptroller General and report the findings to 
the Commission and to the appropriate authorizing 
committees of Congress. 
(e) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN GENERAL.—–There are authorized to be 
appropriated to carry out the purposes of this sec-
tion, $10,000,000 for fiscal year 2010, and 
$7,500,000 for each of fiscal year 2011 through 
2018. 
(2) 
AVAILABILITY.—–Amounts 
appropriated 
under paragraph (1) shall remain available until ex-
pended. 
Subtitle H—General Provisions 
SEC. 5701. REPORTS. 
(a) REPORTS
BY SECRETARY
OF HEALTH
AND 
HUMAN SERVICES.—On an annual basis, the Secretary of 
Health and Human Services shall submit to the appro-
priate Committees of Congress a report on the activities 
carried out under the amendments made by this title, and 
the effectiveness of such activities. 
(b) REPORTS BY RECIPIENTS OF FUNDS.—The Sec-
retary of Health and Human Services may require, as a 
condition of receiving funds under the amendments made 
by this title, that the entity receiving such award submit 
to such Secretary such reports as the such Secretary may 
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•AMDT. NO. 2786 
require on activities carried out with such award, and the 
effectiveness of such activities. 
TITLE VI—TRANSPARENCY AND 
PROGRAM INTEGRITY 
Subtitle A—Physician Ownership 
and Other Transparency 
SEC. 6001. LIMITATION ON MEDICARE EXCEPTION TO THE 
PROHIBITION ON CERTAIN PHYSICIAN RE-
FERRALS FOR HOSPITALS. 
(a) IN GENERAL.—Section 1877 of the Social Secu-
rity Act (42 U.S.C. 1395nn) is amended— 
(1) in subsection (d)(2)— 
(A) in subparagraph (A), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (B), by striking the 
period at the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(C) in the case where the entity is a hos-
pital, the hospital meets the requirements of 
paragraph (3)(D).’’; 
(2) in subsection (d)(3)— 
(A) in subparagraph (B), by striking 
‘‘and’’ at the end; 
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•AMDT. NO. 2786 
(B) in subparagraph (C), by striking the 
period at the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subparagraph: 
‘‘(D) the hospital meets the requirements 
described in subsection (i)(1) not later than 18 
months after the date of the enactment of this 
subparagraph.’’; and 
(3) by adding at the end the following new sub-
section: 
‘‘(i) REQUIREMENTS FOR HOSPITALS TO QUALIFY 
FOR RURAL PROVIDER AND HOSPITAL EXCEPTION TO 
OWNERSHIP OR INVESTMENT PROHIBITION.— 
‘‘(1) REQUIREMENTS
DESCRIBED.—For pur-
poses of subsection (d)(3)(D), the requirements de-
scribed in this paragraph for a hospital are as fol-
lows: 
‘‘(A) PROVIDER
AGREEMENT.—The hos-
pital had— 
‘‘(i) physician ownership or invest-
ment on February 1, 2010; and 
‘‘(ii) a provider agreement under sec-
tion 1866 in effect on such date. 
‘‘(B) LIMITATION ON EXPANSION OF FA-
CILITY CAPACITY.—Except as provided in para-
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•AMDT. NO. 2786 
graph (3), the number of operating rooms, pro-
cedure rooms, and beds for which the hospital 
is licensed at any time on or after the date of 
the enactment of this subsection is no greater 
than the number of operating rooms, procedure 
rooms, and beds for which the hospital is li-
censed as of such date. 
‘‘(C) PREVENTING CONFLICTS OF INTER-
EST.— 
‘‘(i) The hospital submits to the Sec-
retary an annual report containing a de-
tailed description of— 
‘‘(I) the identity of each physi-
cian owner or investor and any other 
owners or investors of the hospital; 
and 
‘‘(II) the nature and extent of all 
ownership and investment interests in 
the hospital. 
‘‘(ii) The hospital has procedures in 
place to require that any referring physi-
cian owner or investor discloses to the pa-
tient being referred, by a time that permits 
the patient to make a meaningful decision 
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•AMDT. NO. 2786 
regarding the receipt of care, as deter-
mined by the Secretary— 
‘‘(I) the ownership or investment 
interest, as applicable, of such refer-
ring physician in the hospital; and 
‘‘(II) if applicable, any such own-
ership or investment interest of the 
treating physician. 
‘‘(iii) The hospital does not condition 
any physician ownership or investment in-
terests either directly or indirectly on the 
physician owner or investor making or in-
fluencing referrals to the hospital or other-
wise generating business for the hospital. 
‘‘(iv) The hospital discloses the fact 
that the hospital is partially owned or in-
vested in by physicians— 
‘‘(I) on any public website for the 
hospital; and 
‘‘(II) in any public advertising 
for the hospital. 
‘‘(D) ENSURING
BONA
FIDE
INVEST-
MENT.— 
‘‘(i) The percentage of the total value 
of the ownership or investment interests 
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•AMDT. NO. 2786 
available on the premises to provide serv-
ices during all hours in which the hospital 
is providing services to such patient, before 
admitting the patient— 
‘‘(I) the hospital discloses such 
fact to a patient; and 
‘‘(II) following such disclosure, 
the hospital receives from the patient 
a signed acknowledgment that the pa-
tient understands such fact. 
‘‘(ii) The hospital has the capacity 
to— 
‘‘(I) provide assessment and ini-
tial treatment for patients; and 
‘‘(II) refer and transfer patients 
to hospitals with the capability to 
treat the needs of the patient in-
volved. 
‘‘(F) LIMITATION
ON
APPLICATION
TO 
CERTAIN
CONVERTED
FACILITIES.—The hos-
pital was not converted from an ambulatory 
surgical center to a hospital on or after the date 
of enactment of this subsection. 
‘‘(2) 
PUBLICATION
OF
INFORMATION
RE-
PORTED.—The Secretary shall publish, and update 
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•AMDT. NO. 2786 
on an annual basis, the information submitted by 
hospitals under paragraph (1)(C)(i) on the public 
Internet website of the Centers for Medicare & Med-
icaid Services. 
‘‘(3) EXCEPTION TO PROHIBITION ON EXPAN-
SION OF FACILITY CAPACITY.— 
‘‘(A) PROCESS.— 
‘‘(i) ESTABLISHMENT.—The Secretary 
shall establish and implement a process 
under which an applicable hospital (as de-
fined in subparagraph (E)) may apply for 
an exception from the requirement under 
paragraph (1)(B). 
‘‘(ii) OPPORTUNITY FOR COMMUNITY 
INPUT.—The process under clause (i) shall 
provide individuals and entities in the com-
munity in which the applicable hospital ap-
plying for an exception is located with the 
opportunity to provide input with respect 
to the application. 
‘‘(iii) 
TIMING
FOR
IMPLEMENTA-
TION.—The Secretary shall implement the 
process under clause (i) on August 1, 
2011. 
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•AMDT. NO. 2786 
‘‘(iv) REGULATIONS.—Not later than 
July 1, 2011, the Secretary shall promul-
gate regulations to carry out the process 
under clause (i). 
‘‘(B) FREQUENCY.—The process described 
in subparagraph (A) shall permit an applicable 
hospital to apply for an exception up to once 
every 2 years. 
‘‘(C) PERMITTED INCREASE.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii) and subparagraph (D), an applicable 
hospital granted an exception under the 
process described in subparagraph (A) may 
increase the number of operating rooms, 
procedure rooms, and beds for which the 
applicable hospital is licensed above the 
baseline number of operating rooms, proce-
dure rooms, and beds of the applicable 
hospital (or, if the applicable hospital has 
been granted a previous exception under 
this paragraph, above the number of oper-
ating rooms, procedure rooms, and beds 
for which the hospital is licensed after the 
application of the most recent increase 
under such an exception). 
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•AMDT. NO. 2786 
‘‘(ii) 100 PERCENT INCREASE LIMITA-
TION.—The Secretary shall not permit an 
increase in the number of operating rooms, 
procedure rooms, and beds for which an 
applicable hospital is licensed under clause 
(i) to the extent such increase would result 
in the number of operating rooms, proce-
dure rooms, and beds for which the appli-
cable hospital is licensed exceeding 200 
percent of the baseline number of oper-
ating rooms, procedure rooms, and beds of 
the applicable hospital. 
‘‘(iii) BASELINE
NUMBER
OF
OPER-
ATING
ROOMS, PROCEDURE
ROOMS, AND 
BEDS.—In this paragraph, the term ‘base-
line number of operating rooms, procedure 
rooms, and beds’ means the number of op-
erating rooms, procedure rooms, and beds 
for which the applicable hospital is licensed 
as of the date of enactment of this sub-
section. 
‘‘(D) INCREASE
LIMITED
TO
FACILITIES 
ON THE MAIN CAMPUS OF THE HOSPITAL.— 
Any increase in the number of operating rooms, 
procedure rooms, and beds for which an appli-
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cable hospital is licensed pursuant to this para-
graph may only occur in facilities on the main 
campus of the applicable hospital. 
‘‘(E) APPLICABLE
HOSPITAL.—In this 
paragraph, the term ‘applicable hospital’ means 
a hospital— 
‘‘(i) that is located in a county in 
which the percentage increase in the popu-
lation during the most recent 5-year period 
(as of the date of the application under 
subparagraph (A)) is at least 150 percent 
of the percentage increase in the popu-
lation growth of the State in which the 
hospital is located during that period, as 
estimated by Bureau of the Census; 
‘‘(ii) whose annual percent of total in-
patient admissions that represent inpatient 
admissions under the program under title 
XIX is equal to or greater than the aver-
age percent with respect to such admis-
sions for all hospitals located in the county 
in which the hospital is located; 
‘‘(iii) that does not discriminate 
against beneficiaries of Federal health care 
programs and does not permit physicians 
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•AMDT. NO. 2786 
practicing at the hospital to discriminate 
against such beneficiaries; 
‘‘(iv) that is located in a State in 
which the average bed capacity in the 
State is less than the national average bed 
capacity; and 
‘‘(v) that has an average bed occu-
pancy rate that is greater than the average 
bed occupancy rate in the State in which 
the hospital is located. 
‘‘(F) PROCEDURE
ROOMS.—In this sub-
section, the term ‘procedure rooms’ includes 
rooms in which catheterizations, angiographies, 
angiograms, and endoscopies are performed, ex-
cept such term shall not include emergency 
rooms or departments (exclusive of rooms in 
which 
catheterizations, 
angiographies, 
angiograms, and endoscopies are performed). 
‘‘(G) 
PUBLICATION
OF
FINAL
DECI-
SIONS.—Not later than 60 days after receiving 
a complete application under this paragraph, 
the Secretary shall publish in the Federal Reg-
ister the final decision with respect to such ap-
plication. 
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•AMDT. NO. 2786 
‘‘(H) LIMITATION
ON
REVIEW.—There 
shall be no administrative or judicial review 
under section 1869, section 1878, or otherwise 
of the process under this paragraph (including 
the establishment of such process). 
‘‘(4) COLLECTION OF OWNERSHIP AND INVEST-
MENT
INFORMATION.—For purposes of subpara-
graphs (A)(i) and (D)(i) of paragraph (1), the Sec-
retary shall collect physician ownership and invest-
ment information for each hospital. 
‘‘(5) PHYSICIAN
OWNER
OR
INVESTOR
DE-
FINED.—For purposes of this subsection, the term 
‘physician owner or investor’ means a physician (or 
an immediate family member of such physician) with 
a direct or an indirect ownership or investment in-
terest in the hospital. 
‘‘(6) CLARIFICATION.—Nothing in this sub-
section shall be construed as preventing the Sec-
retary from revoking a hospital’s provider agreement 
if not in compliance with regulations implementing 
section 1866.’’. 
(b) ENFORCEMENT.— 
(1) ENSURING COMPLIANCE.—The Secretary of 
Health and Human Services shall establish policies 
and procedures to ensure compliance with the re-
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•AMDT. NO. 2786 
quirements described in subsection (i)(1) of section 
1877 of the Social Security Act, as added by sub-
section (a)(3), beginning on the date such require-
ments first apply. Such policies and procedures may 
include unannounced site reviews of hospitals. 
(2) AUDITS.—Beginning not later than Novem-
ber 1, 2011, the Secretary of Health and Human 
Services shall conduct audits to determine if hos-
pitals violate the requirements referred to in para-
graph (1). 
SEC. 6002. TRANSPARENCY REPORTS AND REPORTING OF 
PHYSICIAN OWNERSHIP OR INVESTMENT IN-
TERESTS. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.) is amended by inserting after section 
1128F the following new section: 
‘‘SEC. 1128G. TRANSPARENCY REPORTS AND REPORTING 
OF PHYSICIAN OWNERSHIP OR INVESTMENT 
INTERESTS. 
‘‘(a) TRANSPARENCY REPORTS.— 
‘‘(1) PAYMENTS
OR
OTHER
TRANSFERS
OF 
VALUE.— 
‘‘(A) IN GENERAL.—On March 31, 2013, 
and on the 90th day of each calendar year be-
ginning thereafter, any applicable manufacturer 
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•AMDT. NO. 2786 
that provides a payment or other transfer of 
value to a covered recipient (or to an entity or 
individual at the request of or designated on be-
half of a covered recipient), shall submit to the 
Secretary, in such electronic form as the Sec-
retary shall require, the following information 
with respect to the preceding calendar year: 
‘‘(i) The name of the covered recipi-
ent. 
‘‘(ii) The business address of the cov-
ered recipient and, in the case of a covered 
recipient who is a physician, the specialty 
and National Provider Identifier of the 
covered recipient. 
‘‘(iii) The amount of the payment or 
other transfer of value. 
‘‘(iv) The dates on which the payment 
or other transfer of value was provided to 
the covered recipient. 
‘‘(v) A description of the form of the 
payment or other transfer of value, indi-
cated (as appropriate for all that apply) 
as— 
‘‘(I) cash or a cash equivalent; 
‘‘(II) in-kind items or services; 
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•AMDT. NO. 2786 
‘‘(III) stock, a stock option, or 
any other ownership interest, divi-
dend, profit, or other return on invest-
ment; or 
‘‘(IV) any other form of payment 
or other transfer of value (as defined 
by the Secretary). 
‘‘(vi) A description of the nature of 
the payment or other transfer of value, in-
dicated (as appropriate for all that apply) 
as— 
‘‘(I) consulting fees; 
‘‘(II) compensation for services 
other than consulting; 
‘‘(III) honoraria; 
‘‘(IV) gift; 
‘‘(V) entertainment; 
‘‘(VI) food; 
‘‘(VII) travel (including the speci-
fied destinations); 
‘‘(VIII) education; 
‘‘(IX) research; 
‘‘(X) charitable contribution; 
‘‘(XI) royalty or license; 
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•AMDT. NO. 2786 
‘‘(XII) current or prospective 
ownership or investment interest; 
‘‘(XIII) direct compensation for 
serving as faculty or as a speaker for 
a medical education program; 
‘‘(XIV) grant; or 
‘‘(XV) any other nature of the 
payment or other transfer of value (as 
defined by the Secretary). 
‘‘(vii) If the payment or other transfer 
of value is related to marketing, education, 
or research specific to a covered drug, de-
vice, biological, or medical supply, the 
name of that covered drug, device, biologi-
cal, or medical supply. 
‘‘(viii) Any other categories of infor-
mation regarding the payment or other 
transfer of value the Secretary determines 
appropriate. 
‘‘(B) SPECIAL
RULE
FOR
CERTAIN
PAY-
MENTS OR OTHER TRANSFERS OF VALUE.—In 
the case where an applicable manufacturer pro-
vides a payment or other transfer of value to an 
entity or individual at the request of or des-
ignated on behalf of a covered recipient, the ap-
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•AMDT. NO. 2786 
plicable manufacturer shall disclose that pay-
ment or other transfer of value under the name 
of the covered recipient. 
‘‘(2) PHYSICIAN
OWNERSHIP.—In addition to 
the requirement under paragraph (1)(A), on March 
31, 2013, and on the 90th day of each calendar year 
beginning thereafter, any applicable manufacturer or 
applicable group purchasing organization shall sub-
mit to the Secretary, in such electronic form as the 
Secretary shall require, the following information re-
garding any ownership or investment interest (other 
than an ownership or investment interest in a pub-
licly traded security and mutual fund, as described 
in section 1877(c)) held by a physician (or an imme-
diate family member of such physician (as defined 
for purposes of section 1877(a))) in the applicable 
manufacturer or applicable group purchasing organi-
zation during the preceding year: 
‘‘(A) The dollar amount invested by each 
physician holding such an ownership or invest-
ment interest. 
‘‘(B) The value and terms of each such 
ownership or investment interest. 
‘‘(C) Any payment or other transfer of 
value provided to a physician holding such an 
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•AMDT. NO. 2786 
(voluntarily or involuntarily) or is 
decertified (including offsetting 
costs of relocating residents to 
home and community-based set-
tings or another facility), projects 
that support resident and family 
councils and other consumer in-
volvement in assuring quality 
care in facilities, and facility im-
provement initiatives approved by 
the Secretary (including joint 
training of facility staff and sur-
veyors, technical assistance for 
facilities implementing quality as-
surance programs, the appoint-
ment of temporary management 
firms, and other activities ap-
proved by the Secretary).’’. 
(2) CONFORMING
AMENDMENT.—The second 
sentence of section 1819(h)(5) of the Social Security 
Act (42 U.S.C. 1395i–3(h)(5)) is amended by insert-
ing ‘‘(ii)(IV),’’ after ‘‘(i),’’. 
(b) NURSING FACILITIES.— 
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•AMDT. NO. 2786 
alty under subclause (II) if the 
Secretary had reduced a penalty 
imposed on the facility in the 
preceding year under such sub-
clause with respect to a repeat 
deficiency. 
‘‘(bb) CERTAIN OTHER DE-
FICIENCIES.—The Secretary may 
not reduce the amount of a pen-
alty under subclause (II) if the 
penalty is imposed on the facility 
for a deficiency that is found to 
result in a pattern of harm or 
widespread harm, immediately 
jeopardizes the health or safety 
of a resident or residents of the 
facility, or results in the death of 
a resident of the facility. 
‘‘(IV) COLLECTION
OF
CIVIL 
MONEY PENALTIES.—In the case of a 
civil money penalty imposed under 
this clause, the Secretary shall issue 
regulations that— 
‘‘(aa) subject to item (cc), 
not later than 30 days after the 
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•AMDT. NO. 2786 
tailed statement that describes, with respect to 
each 
patent 
described 
in 
subparagraph 
(B)(ii)(I), on a claim by claim basis, the factual 
and legal basis of the opinion of the reference 
product sponsor that such patent will be in-
fringed by the commercial marketing of the bio-
logical product that is the subject of the sub-
section (k) application and a response to the 
statement concerning validity and enforceability 
provided under subparagraph (B)(ii)(I). 
‘‘(4) PATENT RESOLUTION NEGOTIATIONS.— 
‘‘(A) IN GENERAL.—After receipt by the 
subsection (k) applicant of the statement under 
paragraph (3)(C), the reference product spon-
sor and the subsection (k) applicant shall en-
gage in good faith negotiations to agree on 
which, if any, patents listed under paragraph 
(3) by the subsection (k) applicant or the ref-
erence product sponsor shall be the subject of 
an action for patent infringement under para-
graph (6). 
‘‘(B) FAILURE TO REACH AGREEMENT.— 
If, within 15 days of beginning negotiations 
under subparagraph (A), the subsection (k) ap-
plicant and the reference product sponsor fail to 
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