971 
(4) OBSTETRICS.—Improving the provision of 
obstetrical and neonatal care, including the identi-
fication of interventions that are effective in reduc-
ing the risk of preterm and premature labor and the 
implementation of best practices for labor and deliv-
ery care. 
SEC. 2402. ASSISTANT SECRETARY FOR HEALTH INFORMA-
TION. 
(a) ESTABLISHMENT.—Title XVII (42 U.S.C. 300u 
et seq.) is amended— 
(1) by redesignating sections 1709 and 1710 as 
sections 1710 and 1711, respectively; and 
(2) by inserting after section 1708 the fol-
lowing: 
‘‘SEC. 1709. ASSISTANT SECRETARY FOR HEALTH INFORMA-
TION. 
‘‘(a) IN GENERAL.—There is established within the 
Department an Assistant Secretary for Health Informa-
tion (in this section referred to as the ‘Assistant Sec-
retary’), to be appointed by the Secretary. 
‘‘(b) RESPONSIBILITIES.—The Assistant Secretary 
shall— 
‘‘(1) ensure the collection, collation, reporting, 
and publishing of information (including full and 
complete statistics) on key health indicators regard-
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ing the Nation’s health and the performance of the 
Nation’s health care; 
‘‘(2) facilitate and coordinate the collection, col-
lation, reporting, and publishing of information re-
garding the Nation’s health and the performance of 
the Nation’s health care (other than information de-
scribed in paragraph (1)); 
‘‘(3)(A) develop standards for the collection of 
data regarding the Nation’s health and the perform-
ance of the Nation’s health care; and 
‘‘(B) in carrying out subparagraph (A)— 
‘‘(i) ensure appropriate specificity and 
standardization for data collection at the na-
tional, regional, State, and local levels; 
‘‘(ii) include standards, as appropriate, for 
the collection of accurate data on health and 
health care by race, ethnicity, primary lan-
guage, sex, sexual orientation, gender identity, 
disability, socioeconomic status, rural, urban, or 
other geographic setting, and any other popu-
lation or subpopulation determined appropriate 
by the Secretary; 
‘‘(iii) ensure, with respect to data on race 
and ethnicity, consistency with the 1997 Office 
of Management and Budget Standards for 
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Maintaining, Collecting and Presenting Federal 
Data on Race and Ethnicity (or any successor 
standards); and 
‘‘(iv) in consultation with the Director of 
the Office of Minority Health, and the Director 
of the Office of Civil Rights, of the Department, 
develop standards for the collection of data on 
health and health care with respect to data on 
primary language; 
‘‘(4) provide support to Federal departments 
and agencies whose programs have a significant im-
pact upon health (as determined by the Secretary) 
for the collection and collation of information de-
scribed in paragraphs (1) and (2); 
‘‘(5) ensure the sharing of information de-
scribed in paragraphs (1) and (2) among the agen-
cies of the Department; 
‘‘(6) facilitate the sharing of information de-
scribed in paragraphs (1) and (2) by Federal depart-
ments and agencies whose programs have a signifi-
cant impact upon health (as determined by the Sec-
retary); 
‘‘(7) identify gaps in information described in 
paragraphs (1) and (2) and the appropriate agency 
or entity to address such gaps; 
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‘‘(8) facilitate and coordinate identification and 
monitoring by the agencies of the Department of 
health disparities to inform program and policy ef-
forts to reduce such disparities, including facilitating 
and funding analyses conducted in cooperation with 
the Social Security Administration, the Bureau of 
the Census, and other appropriate agencies and enti-
ties; 
‘‘(9) consistent with privacy, proprietary, and 
other appropriate safeguards, facilitate public acces-
sibility of datasets (such as de-identified Medicare 
datasets or publicly available data on key health in-
dicators) by means of the Internet; and 
‘‘(10) award grants or contracts for the collec-
tion and collation of information described in para-
graphs (1) and (2) (including through statewide sur-
veys that provide standardized information). 
‘‘(c) KEY HEALTH INDICATORS.— 
‘‘(1) IN GENERAL.—In carrying out subsection 
(b)(1), the Assistant Secretary shall— 
‘‘(A) identify, and reassess at least once 
every 3 years, key health indicators described in 
such subsection; 
‘‘(B) publish statistics on such key health 
indicators for the public— 
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‘‘(i) not less than annually; and 
‘‘(ii) on a supplemental basis when-
ever warranted by— 
‘‘(I) the rate of change for a key 
health indicator; or 
‘‘(II) the need to inform policy 
regarding the Nation’s health and the 
performance of the Nation’s health 
care; and 
‘‘(C) ensure consistency with the national 
strategy developed by the Secretary under sec-
tion 3121 and consideration of the indicators 
specified in the reports under sections 308, 
903(a)(6), and 913(b)(2). 
‘‘(2) RELEASE OF KEY HEALTH INDICATORS.— 
The regulations, rules, processes, and procedures of 
the Office of Management and Budget governing the 
review, release, and dissemination of key health indi-
cators shall be the same as the regulations, rules, 
processes, and procedures of the Office of Manage-
ment and Budget governing the review, release, and 
dissemination of Principal Federal Economic Indica-
tors (or equivalent statistical data) by the Bureau of 
Labor Statistics. 
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‘‘(d) COORDINATION.—In carrying out this section, 
the Assistant Secretary shall coordinate with— 
‘‘(1) public and private entities that collect and 
disseminate information on health and health care, 
including foundations; and 
‘‘(2) the head of the Office of the National Co-
ordinator for Health Information Technology to en-
sure optimal use of health information technology. 
‘‘(e) REQUEST FOR INFORMATION FROM OTHER DE-
PARTMENTS AND AGENCIES.—Consistent with applicable 
law, the Assistant Secretary may secure directly from any 
Federal department or agency information necessary to 
enable the Assistant Secretary to carry out this section. 
‘‘(f) REPORT.— 
‘‘(1) SUBMISSION.—The Assistant Secretary 
shall submit to the Secretary and the Congress an 
annual report containing— 
‘‘(A) a description of national, regional, or 
State changes in health or health care, as re-
flected by the key health indicators identified 
under subsection (c)(1); 
‘‘(B) a description of gaps in the collection, 
collation, reporting, and publishing of informa-
tion regarding the Nation’s health and the per-
formance of the Nation’s health care; 
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‘‘(C) recommendations for addressing such 
gaps and identification of the appropriate agen-
cy within the Department or other entity to ad-
dress such gaps; 
‘‘(D) a description of analyses of health 
disparities, including the results of completed 
analyses, the status of ongoing longitudinal 
studies, and proposed or planned research; and 
‘‘(E) a plan for actions to be taken by the 
Assistant Secretary to address gaps described 
in subparagraph (B). 
‘‘(2) CONSIDERATION.—In preparing a report 
under paragraph (1), the Assistant Secretary shall 
take into consideration the findings and conclusions 
in the reports under sections 308, 903(a)(6), and 
913(b)(2). 
‘‘(g) PROPRIETARY AND PRIVACY PROTECTIONS.— 
Nothing in this section shall be construed to affect appli-
cable proprietary or privacy protections. 
‘‘(h) CONSULTATION.—In carrying out this section, 
the Assistant Secretary shall consult with— 
‘‘(1) the heads of appropriate health agencies 
and offices in the Department, including the Office 
of the Surgeon General of the Public Health Service, 
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the Office of Minority Health, and the Office on 
Women’s Health; and 
‘‘(2) as appropriate, the heads of other Federal 
departments and agencies whose programs have a 
significant impact upon health (as determined by the 
Secretary). 
‘‘(i) DEFINITION.—In this section: 
‘‘(1) The terms ‘agency’ and ‘agencies’ include 
an epidemiology center established under section 214 
of the Indian Health Care Improvement Act. 
‘‘(2) The term ‘Department’ means the Depart-
ment of Health and Human Services. 
‘‘(3) The term ‘health disparities’ has the 
meaning given to such term in section 3171.’’. 
(b) OTHER
COORDINATION
RESPONSIBILITIES.— 
Title III (42 U.S.C. 241 et seq.) is amended— 
(1) in paragraphs (1) and (2) of section 304(c) 
(42 U.S.C. 242b(c)), by inserting ‘‘, acting through 
the Assistant Secretary for Health Information,’’ 
after ‘‘The Secretary’’ each place it appears; and 
(2) in section 306(j) (42 U.S.C. 242k(j)), by in-
serting ‘‘, acting through the Assistant Secretary for 
Health Information,’’ after ‘‘of this section, the Sec-
retary’’. 
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SEC. 2403. AUTHORIZATION OF APPROPRIATIONS. 
Section 799C, as added and amended, is further 
amended by adding at the end the following: 
‘‘(e) QUALITY AND SURVEILLANCE.—For the pur-
pose of carrying out part D of title IX and section 1709, 
in addition to any other amounts authorized to be appro-
priated for such purpose, there is authorized to be appro-
priated, out of any monies in the Public Health Invest-
ment Fund, $300,000,000 for each of fiscal years 2010 
through 2014 and $330,000,000 for each of fiscal years 
2015 through 2019.’’. 
TITLE V—OTHER PROVISIONS 
Subtitle A—Drug Discount for 
Rural and Other Hospitals 
SEC. 2501. EXPANDED PARTICIPATION IN 340B PROGRAM. 
(a) EXPANSION OF COVERED ENTITIES RECEIVING 
DISCOUNTED PRICES.—Section 340B(a)(4) (42 U.S.C. 
256b(a)(4)) is amended by adding at the end the fol-
lowing: 
‘‘(M) A children’s hospital excluded from 
the Medicare prospective payment system pur-
suant to section 1886(d)(1)(B)(iii) of the Social 
Security Act which would meet the require-
ments of subparagraph (L), including the dis-
proportionate share adjustment percentage re-
quirement under subparagraph (L)(ii), if the 
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hospital were a subsection (d) hospital as de-
fined in section 1886(d)(1)(B) of the Social Se-
curity Act. 
‘‘(N) An entity that is a critical access hos-
pital (as determined under section 1820(c)(2) 
of the Social Security Act). 
‘‘(O) An entity receiving funds under title 
V of the Social Security Act (relating to mater-
nal and child health) for the provision of health 
services. 
‘‘(P) An entity receiving funds under sub-
part I of part B of title XIX of the Public 
Health Service Act (relating to comprehensive 
mental health services) for the provision of com-
munity mental health services. 
‘‘(Q) An entity receiving funds under sub-
part II of such part B (relating to the preven-
tion and treatment of substance abuse) for the 
provision of treatment services for substance 
abuse. 
‘‘(R) An entity that is a Medicare-depend-
ent, small rural hospital (as defined in section 
1886(d)(5)(G)(iv) of the Social Security Act). 
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‘‘(S) An entity that is a sole community 
hospital 
(as 
defined 
in 
section 
1886(d)(5)(D)(iii) of the Social Security Act). 
‘‘(T) An entity that is classified as a rural 
referral center under section 1886(d)(5)(C) of 
the Social Security Act.’’. 
(b) PROHIBITION ON GROUP PURCHASING ARRANGE-
MENTS.—Section 340B(a) (42 U.S.C. 256b(a)) is amend-
ed— 
(1) in paragraph (4)(L)— 
(A) by adding ‘‘and’’ at the end of clause 
(i); 
(B) by striking ‘‘; and’’ at the end of 
clause (ii) and inserting a period; and 
(C) by striking clause (iii); 
(2) in paragraph (5), by redesignating subpara-
graphs (C) and (D) as subparagraphs (D) and (E), 
respectively, and by inserting after subparagraph 
(B) the following: 
‘‘(C) PROHIBITING
USE
OF
GROUP
PUR-
CHASING ARRANGEMENTS.— 
‘‘(i) A hospital described in subpara-
graph (L), (M), (N), (R), (S), or (T) of 
paragraph (4) shall not obtain covered out-
patient drugs through a group purchasing 
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organization or other group purchasing ar-
rangement, except as permitted or pro-
vided pursuant to clause (ii). 
‘‘(ii) The Secretary shall establish rea-
sonable exceptions to the requirement of 
clause (i)— 
‘‘(I) with respect to a covered 
outpatient drug that is unavailable to 
be purchased through the program 
under this section due to a drug 
shortage problem, manufacturer non-
compliance, or any other reason be-
yond the hospital’s control; 
‘‘(II) to facilitate generic substi-
tution when a generic covered out-
patient drug is available at a lower 
price; and 
‘‘(III) to reduce in other ways 
the administrative burdens of man-
aging both inventories of drugs ob-
tained under this section and not 
under this section, if such exception 
does not create a duplicate discount 
problem in violation of subparagraph 
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(A) or a diversion problem in violation 
of subparagraph (B).’’. 
SEC. 2502. EXTENSION OF DISCOUNTS TO INPATIENT 
DRUGS. 
(a) IN GENERAL.—Section 340B (42 U.S.C. 256b) 
is amended— 
(1) in subsection (b)— 
(A) by striking ‘‘In this section, the terms’’ 
and inserting the following: ‘‘In this section: 
‘‘(1) IN GENERAL.—The terms’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(2) COVERED
DRUG.—The term ‘covered 
drug’— 
‘‘(A) means a covered outpatient drug (as 
defined in section 1927(k)(2) of the Social Se-
curity Act); and 
‘‘(B) includes, notwithstanding the section 
1927(k)(3)(A) of such Act, a drug used in con-
nection with an inpatient or outpatient service 
provided by a hospital described in subpara-
graph (L), (M), (N), (R), (S), or (T) of sub-
section (a)(4) that is enrolled to participate in 
the drug discount program under this section.’’; 
and 
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(2) in paragraphs (5), (7), and (9) of sub-
section (a), by striking ‘‘outpatient’’ each place it 
appears. 
(b) MEDICAID CREDITS ON INPATIENT DRUGS.— 
Subsection (c) of section 340B (42 U.S.C. 256b(c)) is 
amended to read as follows: 
‘‘(c) MEDICAID CREDITS ON INPATIENT DRUGS.— 
‘‘(1) IN GENERAL.—For the cost reporting pe-
riod covered by the most recently filed Medicare cost 
report under title XVIII of the Social Security Act, 
a hospital described in subparagraph (L), (M), (N), 
(R), (S), or (T) of subsection (a)(4) and enrolled to 
participate in the drug discount program under this 
section shall provide to each State under its plan 
under title XIX of such Act— 
‘‘(A) a credit on the estimated annual 
costs to such hospital of single source and inno-
vator multiple source drugs provided to Med-
icaid beneficiaries for inpatient use; and 
‘‘(B) a credit on the estimated annual 
costs to such hospital of noninnovator multiple 
source drugs provided to Medicaid beneficiaries 
for inpatient use. 
‘‘(2) AMOUNT OF CREDITS.— 
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‘‘(A) SINGLE
SOURCE
AND
INNOVATOR 
MULTIPLE
SOURCE
DRUGS.—For purposes of 
paragraph (1)(A)— 
‘‘(i) the credit under such paragraph 
shall be equal to the product of— 
‘‘(I) the annual value of single 
source and innovator multiple source 
drugs purchased under this section by 
the hospital based on the drugs’ aver-
age manufacturer price; 
‘‘(II) the estimated percentage of 
the hospital’s drug purchases attrib-
utable to Medicaid beneficiaries for in-
patient use; and 
‘‘(III) the minimum rebate per-
centage 
described 
in 
section 
1927(c)(1)(B) of the Social Security 
Act; 
‘‘(ii) the reference in clause (i)(I) to 
the annual value of single source and inno-
vator multiple source drugs purchased 
under this section by the hospital based on 
the drugs’ average manufacturer price 
shall be equal to the sum of— 
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‘‘(I) the annual quantity of each 
single source and innovator multiple 
source drug purchased during the cost 
reporting period, multiplied by 
‘‘(II) the average manufacturer 
price for that drug; 
‘‘(iii) the reference in clause (i)(II) to 
the estimated percentage of the hospital’s 
drug purchases attributable to Medicaid 
beneficiaries for inpatient use; shall be 
equal to— 
‘‘(I) the Medicaid inpatient drug 
charges as reported on the hospital’s 
most recently filed Medicare cost re-
port, divided by 
‘‘(II) total drug charges reported 
on the cost report; and 
‘‘(iv) the terms ‘single source drug’ 
and ‘innovator multiple source drug’ have 
the meanings given such terms in section 
1927(k)(7) of the Social Security Act. 
‘‘(B) NONINNOVATOR
MULTIPLE
SOURCE 
DRUGS.—For purposes of paragraph (1)(B)— 
‘‘(i) the credit under such paragraph 
shall be equal to the product of— 
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987 
‘‘(I) the annual value of noninno-
vator multiple source drugs purchased 
under this section by the hospital 
based on the drugs’ average manufac-
turer price; 
‘‘(II) the estimated percentage of 
the hospital’s drug purchases attrib-
utable to Medicaid beneficiaries for in-
patient use; and 
‘‘(III) the applicable percentage 
as defined in section 1927(c)(3)(B) of 
the Social Security Act; 
‘‘(ii) the reference in clause (i)(I) to 
the annual value of noninnovator multiple 
source drugs purchased under this section 
by the hospital based on the drugs’ average 
manufacturer price shall be equal to the 
sum of— 
‘‘(I) the annual quantity of each 
noninnovator multiple source drug 
purchased during the cost reporting 
period, multiplied by 
‘‘(II) the average manufacturer 
price for that drug; 
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‘‘(iii) the reference in clause (i)(II) to 
the estimated percentage of the hospital’s 
drug purchases attributable to Medicaid 
beneficiaries for inpatient use shall be 
equal to— 
‘‘(I) the Medicaid inpatient drug 
charges as reported on the hospital’s 
most recently filed Medicare cost re-
port, divided by 
‘‘(II) total drug charges reported 
on the cost report; and 
‘‘(iv) the term ‘noninnovator multiple 
source drug’ has the meaning given such 
term in section 1927(k)(7) of the Social 
Security Act. 
‘‘(3) CALCULATION OF CREDITS.— 
‘‘(A) IN GENERAL.—Each State calculates 
credits under paragraph (1) and informs hos-
pitals of amount under section 1927(a)(5)(D) 
of the Social Security Act. 
‘‘(B) HOSPITAL PROVISION OF INFORMA-
TION.—Not later than 30 days after the date of 
the filing of the hospital’s most recently filed 
Medicare cost report, the hospital shall provide 
the State with the information described in 
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989 
paragraphs (2)(A)(ii) and (2)(B)(ii). With re-
spect to each drug purchased during the cost 
reporting period, the hospital shall provide the 
dosage form, strength, package size, date of 
purchase and the number of units purchased. 
‘‘(4) PAYMENT
DEADLINE.—The credits pro-
vided by a hospital under paragraph (1) shall be 
paid within 60 days after receiving the information 
specified in paragraph (3)(A). 
‘‘(5) OPT
OUT.—A hospital shall not be re-
quired to provide the Medicaid credit required under 
paragraph (1) if it can demonstrate to the State 
that it will lose reimbursement under the State plan 
resulting from the extension of discounts to inpa-
tient drugs under subsection (b)(2) and that the loss 
of reimbursement will exceed the amount of the 
credit otherwise owed by the hospital. 
‘‘(6) OFFSET AGAINST MEDICAL ASSISTANCE.— 
Amounts received by a State under this subsection 
in any quarter shall be considered to be a reduction 
in the amount expended under the State plan in the 
quarter for medical assistance for purposes of sec-
tion 1903(a)(1) of the Social Security Act.’’. 
(c) CONFORMING AMENDMENTS.—Section 1927 of 
the Social Security Act (42 U.S.C. 1396r–8) is amended— 
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(1) in subsection (a)(5)(A), by striking ‘‘covered 
outpatient drugs’’ and inserting ‘‘covered drugs (as 
defined in section 340B(b)(2) of the Public Health 
Service Act)’’; 
(2) in subsection (a)(5), by striking subpara-
graph (D) and inserting the following: 
‘‘(D) STATE RESPONSIBILITY FOR CALCU-
LATING HOSPITAL CREDITS.—The State shall 
calculate the credits owed by the hospital under 
paragraph (1) of section 340B(c) of the Public 
Health Service Act and provide the hospital 
with both the amounts and an explanation of 
how it calculated the credits. In performing the 
calculations specified in paragraphs (2)(A)(ii) 
and (2)(B)(ii) of such section, the State shall 
use the average manufacturer price applicable 
to the calendar quarter in which the drug was 
purchased by the hospital.’’; and 
(3) in subsection (k)(1)— 
(A) in subparagraph (A), by striking ‘‘sub-
paragraph (B)’’ and inserting ‘‘subparagraphs 
(B) and (D)’’; and 
(B) by adding at the end the following: 
‘‘(D) 
CALCULATION
FOR
COVERED 
DRUGS.—With respect to a covered drug (as de-
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991 
fined in section 340B(b)(2) of the Public 
Health Service Act), the average manufacturer 
price shall be determined in accordance with 
subparagraph (A) except that, in the event a 
covered drug is not distributed to the retail 
pharmacy class of trade, it shall mean the aver-
age price paid to the manufacturer for the drug 
in the United States by wholesalers for drugs 
distributed to the acute care class of trade, 
after deducting customary prompt pay dis-
counts.’’. 
SEC. 2503. EFFECTIVE DATE. 
(a) IN GENERAL.—The amendments made by this 
subtitle shall take effect on July 1, 2010, and shall apply 
to drugs dispensed on or after such date. 
(b) EFFECTIVENESS.—The amendments made by 
this subtitle shall be effective, and shall be taken into ac-
count in determining whether a manufacturer is deemed 
to meet the requirements of section 340B(a) of the Public 
Health Service Act (42 U.S.C. 256b(a)) and of section 
1927(a)(5) of the Social Security Act (42 U.S.C. 1396r– 
8(a)(5)), notwithstanding any other provision of law. 
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Subtitle B—School-Based Health 
Clinics 
SEC. 2511. SCHOOL-BASED HEALTH CLINICS. 
(a) IN GENERAL.—Part Q of title III (42 U.S.C. 
280h et seq.) is amended by adding at the end the fol-
lowing: 
‘‘SEC. 399Z–1. SCHOOL-BASED HEALTH CLINICS. 
‘‘(a) PROGRAM.—The Secretary shall establish a 
school-based health clinic program consisting of awarding 
grants to eligible entities to support the operation of 
school-based health clinics (referred to in this section as 
‘SBHCs’). 
‘‘(b) ELIGIBILITY.—To be eligible for a grant under 
this section, an entity shall— 
‘‘(1) be an SBHC (as defined in subsection 
(l)(4)); and 
‘‘(2) submit an application at such time, in 
such manner, and containing such information as 
the Secretary may require, including at a min-
imum— 
‘‘(A) evidence that the applicant meets all 
criteria necessary to be designated as an 
SBHC; 
‘‘(B) evidence of local need for the services 
to be provided by the SBHC; 
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‘‘(C) an assurance that— 
‘‘(i) SBHC services will be provided in 
accordance with Federal, State, and local 
laws governing— 
‘‘(I) obtaining parental or guard-
ian consent; and 
‘‘(II) patient privacy and student 
records, including section 264 of the 
Health Insurance Portability and Ac-
countability Act of 1996 and section 
444 of the General Education Provi-
sions Act; 
‘‘(ii) the SBHC has established and 
maintains collaborative relationships with 
other 
health 
care 
providers 
in 
the 
catchment area of the SBHC; 
‘‘(iii) the SBHC will provide on-site 
access during the academic day when 
school is in session and has an established 
network of support and access to services 
with backup health providers when the 
school or SBHC is closed; 
‘‘(iv) the SBHC will be integrated into 
the school environment and will coordinate 
health services with appropriate school per-
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sonnel and other community providers co- 
located at the school; and 
‘‘(v) the SBHC sponsoring facility as-
sumes all responsibility for the SBHC ad-
ministration, operations, and oversight; 
and 
‘‘(D) such other information as the Sec-
retary may require. 
‘‘(c) USE OF FUNDS.—Funds awarded under a grant 
under this section may be used for— 
‘‘(1) providing training related to the provision 
of comprehensive primary health services and addi-
tional health services; 
‘‘(2) the management and operation of SBHC 
programs; and 
‘‘(3) the payment of salaries for health profes-
sionals and other appropriate SBHC personnel. 
‘‘(d) CONSIDERATION OF NEED.—In determining the 
amount of a grant under this section, the Secretary shall 
take into consideration— 
‘‘(1) the financial need of the SBHC; 
‘‘(2) State, local, or other sources of funding 
provided to the SBHC; and 
‘‘(3) other factors as determined appropriate by 
the Secretary. 
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‘‘(e) PREFERENCES.—In awarding grants under this 
section, the Secretary shall give preference to SBHCs that 
have a demonstrated record of service to the following: 
‘‘(1) A high percentage of medically under-
served children and adolescents. 
‘‘(2) Communities or populations in which chil-
dren and adolescents have difficulty accessing health 
and mental health services. 
‘‘(3) Communities with high percentages of chil-
dren and adolescents who are uninsured, under-
insured, or eligible for medical assistance under Fed-
eral or State health benefits programs (including ti-
tles XIX and XXI of the Social Security Act). 
‘‘(f) MATCHING REQUIREMENT.—The Secretary may 
award a grant to an SBHC only if the SBHC agrees to 
provide, from non-Federal sources, an amount equal to 20 
percent of the amount of the grant (which may be pro-
vided in cash or in kind) to carry out the activities sup-
ported by the grant. 
‘‘(g) SUPPLEMENT, NOT SUPPLANT.—The Secretary 
may award a grant to an SBHC under this section only 
if the SBHC demonstrates to the satisfaction of the Sec-
retary that funds received through the grant will be ex-
pended only to supplement, and not supplant, non-Federal 
and Federal funds otherwise available to the SBHC for 
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operation of the SBHC (including each activity described 
in paragraph (1) or (2) of subsection (c)). 
‘‘(h) PAYOR OF LAST RESORT.—The Secretary may 
award a grant to an SBHC under this section only if the 
SBHC demonstrates to the satisfaction of the Secretary 
that funds received through the grant will not be expended 
for any activity to the extent that payment has been made, 
or can reasonably be expected to be made— 
‘‘(1) under any insurance policy; 
‘‘(2) under any Federal or State health benefits 
program (including titles XIX and XXI of the Social 
Security Act); or 
‘‘(3) by an entity which provides health services 
on a prepaid basis. 
‘‘(i) REGULATIONS REGARDING REIMBURSEMENT 
FOR HEALTH SERVICES.—The Secretary shall issue regu-
lations regarding the reimbursement for health services 
provided by SBHCs to individuals eligible to receive such 
services through the program under this section, including 
reimbursement under any insurance policy or any Federal 
or State health benefits program (including titles XIX and 
XXI of the Social Security Act). 
‘‘(j) TECHNICAL ASSISTANCE.—The Secretary shall 
provide (either directly or by grant or contract) technical 
and other assistance to SBHCs to assist such SBHCs to 
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meet the requirements of this section. Such assistance 
may include fiscal and program management assistance, 
training in fiscal and program management, operational 
and administrative support, and the provision of informa-
tion to the SBHCs of the variety of resources available 
under this title and how those resources can be best used 
to meet the health needs of the communities served by 
the SBHCs. 
‘‘(k) EVALUATION; REPORT.—The Secretary shall— 
‘‘(1) develop and implement a plan for evalu-
ating SBHCs and monitoring quality performances 
under the awards made under this section; and 
‘‘(2) submit to the Congress on an annual basis 
a report on the program under this section. 
‘‘(l) DEFINITIONS.—In this section: 
‘‘(1) COMPREHENSIVE PRIMARY HEALTH SERV-
ICES.—The term ‘comprehensive primary health 
services’ means the core services offered by SBHCs, 
which shall include the following: 
‘‘(A) PHYSICAL.—Comprehensive health 
assessments, diagnosis, and treatment of minor, 
acute, and chronic medical conditions and refer-
rals to, and follow-up for, specialty care. 
‘‘(B) MENTAL
HEALTH.—Mental health 
assessments, crisis intervention, counseling, 
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treatment, and referral to a continuum of serv-
ices including emergency psychiatric care, com-
munity support programs, inpatient care, and 
outpatient programs. 
‘‘(C) 
OPTIONAL
SERVICES.—Additional 
services, which may include oral health, social, 
and age-appropriate health education services, 
including nutritional counseling. 
‘‘(2) MEDICALLY
UNDERSERVED
CHILDREN 
AND
ADOLESCENTS.—The term ‘medically under-
served children and adolescents’ means a population 
of children and adolescents who are residents of an 
area designated by the Secretary as an area with a 
shortage of personal health services and health in-
frastructure for such children and adolescents. 
‘‘(3) SCHOOL-BASED
HEALTH
CLINIC.—The 
term ‘school-based health clinic’ means a health clin-
ic that— 
‘‘(A) is located in, or is adjacent to, a 
school facility of a local educational agency; 
‘‘(B) is organized through school, commu-
nity, and health provider relationships; 
‘‘(C) is administered by a sponsoring facil-
ity; and 
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999 
‘‘(D) provides, at a minimum, comprehen-
sive primary health services during school hours 
to children and adolescents by health profes-
sionals in accordance with State and local laws 
and regulations, established standards, and 
community practice. 
‘‘(4) SPONSORING FACILITY.—The term ‘spon-
soring facility’ is— 
‘‘(A) a hospital; 
‘‘(B) a public health department; 
‘‘(C) a community health center; 
‘‘(D) a nonprofit health care agency; 
‘‘(E) a local educational agency; or 
‘‘(F) a program administered by the In-
dian Health Service or the Bureau of Indian 
Affairs or operated by an Indian tribe or a trib-
al organization under the Indian Self-Deter-
mination and Education Assistance Act, a Na-
tive Hawaiian entity, or an urban Indian pro-
gram under title V of the Indian Health Care 
Improvement Act. 
‘‘(m) AUTHORIZATION
OF APPROPRIATIONS.—For 
purposes of carrying out this section, there are authorized 
to be appropriated $50,000,000 for fiscal year 2010 and 
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such sums as may be necessary for each of the fiscal years 
2011 through 2014.’’. 
(b) EFFECTIVE DATE.—The Secretary of Health and 
Human Services shall begin awarding grants under section 
399Z–1 of the Public Health Service Act, as added by sub-
section (b), not later than July 1, 2010, without regard 
to whether or not final regulations have been issued under 
section 399Z–1(h) of such Act. 
Subtitle C—National Medical 
Device Registry 
SEC. 2521. 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) The Secretary shall establish a national med-
ical device registry (in this subsection referred to as the 
‘registry’) to facilitate analysis of postmarket safety and 
outcomes data on each device that— 
‘‘(A) is or has been used in or on a patient; and 
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‘‘(B) is— 
‘‘(i) a class III device; or 
‘‘(ii) a class II device that is implantable, 
life-supporting, or life-sustaining. 
‘‘(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 head of the Office of the National Coordi-
nator for Health Information Technology, and the Sec-
retary 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 device described in paragraph (1) by 
type, model, and serial number or other unique iden-
tifier; 
‘‘(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); 
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‘‘(C) integrating the activities described in this 
subsection 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); and 
‘‘(iii) other postmarket device surveillance 
activities of the Secretary authorized by this 
chapter; 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 devices described in paragraph 
(1), the Secretary shall, in collaboration with public, aca-
demic, and private entities, develop methods to— 
‘‘(i) obtain access to disparate sources of 
patient safety and outcomes data, including— 
‘‘(I) Federal health-related electronic 
data (such as data from the Medicare pro-
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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 device described in paragraph (1), 
including claims data, patient survey data, standardized 
analytic files that allow for the pooling and analysis of 
data from disparate data environments, electronic health 
records, and any other data deemed appropriate by the 
Secretary. 
‘‘(4) Not later than 36 months after the date of the 
enactment of this subsection, the Secretary shall promul-
gate regulations for establishment and operation of the 
registry under paragraph (1). Such regulations— 
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‘‘(A)(i) in the case of devices that are described 
in paragraph (1) and sold on or after the date of the 
enactment of this subsection, shall require manufac-
turers of such devices to submit information to the 
registry, including, for each such device, the type, 
model, and serial number or, if required under sub-
section (f), other unique device identifier; and 
‘‘(ii) in the case of devices that are described in 
paragraph (1) and sold before such date, may re-
quire 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 device manufacturers to sub-
mit such other information as is necessary to facili-
tate postmarket assessments of device safety and ef-
fectiveness and notification of device risks; 
‘‘(D) shall establish requirements for regular 
and timely reports to the Secretary, which shall be 
included in the registry, concerning adverse event 
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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) To carry out this subsection, there are author-
ized to be appropriated such sums as may be necessary 
for fiscal years 2010 and 2011.’’. 
(2) 
EFFECTIVE
DATE.—The 
Secretary 
of 
Health and Human Services shall establish and 
begin implementation of the registry under section 
519(g) of the Federal Food, Drug, and Cosmetic 
Act, as added by paragraph (1), by not later than 
the date that is 36 months after the date of the en-
actment of this Act, without regard to whether or 
not final regulations to establish and operate the 
registry have been promulgated by such date. 
(3) 
CONFORMING
AMENDMENT.—Section 
303(f)(1)(B)(ii) of the Federal Food, Drug, and 
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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 device described in section 
519(g)(1) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a). 
(2) STANDARDS, IMPLEMENTATION
CRITERIA, 
AND
CERTIFICATION
CRITERIA.—The Secretary of 
the Health 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 device described in paragraph (1), 
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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. 
Subtitle D—Grants for Comprehen-
sive Programs To Provide Edu-
cation to Nurses and Create a 
Pipeline to Nursing 
SEC. 2531. ESTABLISHMENT OF GRANT PROGRAM. 
(a) PURPOSES.—It is the purpose of this section to 
authorize grants to— 
(1) address the projected shortage of nurses by 
funding comprehensive programs to create a career 
ladder to nursing (including Certified Nurse Assist-
ants, Licensed Practical Nurses, Licensed Vocational 
Nurses, and Registered Nurses) for incumbent ancil-
lary health care workers; 
(2) increase the capacity for educating nurses 
by increasing both nurse faculty and clinical oppor-
tunities through collaborative programs between 
staff nurse organizations, health care providers, and 
accredited schools of nursing; and 
(3) provide training programs through edu-
cation and training organizations jointly adminis-
tered by health care providers and health care labor 
organizations or other organizations representing 
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staff nurses and frontline health care workers, work-
ing in collaboration with accredited schools of nurs-
ing and academic institutions. 
(b) GRANTS.—Not later than 6 months after the date 
of the enactment of this Act, the Secretary of Labor (re-
ferred to in this section as the ‘‘Secretary’’) shall establish 
a partnership grant program to award grants to eligible 
entities to carry out comprehensive programs to provide 
education to nurses and create a pipeline to nursing for 
incumbent ancillary health care workers who wish to ad-
vance their careers, and to otherwise carry out the pur-
poses of this section. 
(c) ELIGIBILITY.—To be eligible for a grant under 
this section, an entity shall be— 
(1) a health care entity that is jointly adminis-
tered by a health care employer and a labor union 
representing the health care employees of the em-
ployer and that carries out activities using labor 
management training funds as provided for under 
section 302(c)(6) of the Labor Management Rela-
tions Act, 1947 (29 U.S.C. 186(c)(6)); 
(2) an entity that operates a training program 
that is jointly administered by— 
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(A) one or more health care providers or 
facilities, or a trade association of health care 
providers; and 
(B) one or more organizations which rep-
resent the interests of direct care health care 
workers or staff nurses and in which the direct 
care health care workers or staff nurses have 
direct input as to the leadership of the organi-
zation; 
(3) a State training partnership program that 
consists of nonprofit organizations that include equal 
participation from industry, including public or pri-
vate employers, and labor organizations including 
joint labor-management training programs, and 
which may include representatives from local govern-
ments, worker investment agency one-stop career 
centers, community-based organizations, community 
colleges, and accredited schools of nursing; or 
(4) a school of nursing (as defined in section 
801 of the Public Health Service Act (42 U.S.C. 
296)). 
(d) ADDITIONAL REQUIREMENTS FOR HEALTH CARE 
EMPLOYER DESCRIBED IN SUBSECTION (c).—To be eligi-
ble for a grant under this section, a health care employer 
described in subsection (c) shall demonstrate that it— 
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(1) has an established program within their fa-
cility to encourage the retention of existing nurses; 
(2) provides wages and benefits to its nurses 
that are competitive for its market or that have been 
collectively bargained with a labor organization; and 
(3) supports programs funded under this sec-
tion through 1 or more of the following: 
(A) The provision of paid leave time and 
continued health coverage to incumbent health 
care workers to allow their participation in 
nursing career ladder programs, including cer-
tified nurse assistants, licensed practical nurses, 
licensed 
vocational 
nurses, 
and 
registered 
nurses. 
(B) Contributions to a joint labor-manage-
ment training fund which administers the pro-
gram involved. 
(C) The provision of paid release time, in-
centive compensation, or continued health cov-
erage to staff nurses who desire to work full- or 
part-time in a faculty position. 
(D) The provision of paid release time for 
staff nurses to enable them to obtain a bachelor 
of science in nursing degree, other advanced 
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nursing degrees, specialty training, or certifi-
cation program. 
(E) The payment of tuition assistance 
which is managed by a joint labor-management 
training fund or other jointly administered pro-
gram. 
(e) OTHER REQUIREMENTS.— 
(1) MATCHING REQUIREMENT.— 
(A) IN GENERAL.—The Secretary may not 
make a grant under this section unless the ap-
plicant involved agrees, with respect to the costs 
to be incurred by the applicant in carrying out 
the program under the grant, to make available 
non-Federal contributions (in cash or in kind 
under subparagraph (B)) toward such costs in 
an amount equal to not less than $1 for each 
$1 of Federal funds provided in the grant. Such 
contributions may be made directly or through 
donations from public or private entities, or 
may be provided through the cash equivalent of 
paid release time provided to incumbent worker 
students. 
(B) DETERMINATION OF AMOUNT OF NON- 
FEDERAL
CONTRIBUTION.—Non-Federal con-
tributions required in subparagraph (A) may be 
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in cash or in kind (including paid release time), 
fairly evaluated, including equipment or services 
(and excluding indirect or overhead costs). 
Amounts provided by the Federal Government, 
or services assisted or subsidized to any signifi-
cant extent by the Federal Government, may 
not be included in determining the amount of 
such non-Federal contributions. 
(2) REQUIRED COLLABORATION.—Entities car-
rying out or overseeing programs carried out with 
assistance provided under this section shall dem-
onstrate collaboration with accredited schools of 
nursing which may include community colleges and 
other academic institutions providing associate, 
bachelor’s, or advanced nursing degree programs or 
specialty training or certification programs. 
(f) USE OF FUNDS.—Amounts awarded to an entity 
under a grant under this section shall be used for the fol-
lowing: 
(1) To carry out programs that provide edu-
cation and training to establish nursing career lad-
ders to educate incumbent health care workers to be-
come nurses (including certified nurse assistants, li-
censed practical nurses, licensed vocational nurses, 
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and registered nurses). Such programs shall include 
one or more of the following: 
(A) Preparing incumbent workers to return 
to the classroom through English -as-a-second 
language education, GED education, pre-college 
counseling, college preparation classes, and sup-
port with entry level college classes that are a 
prerequisite to nursing. 
(B) Providing tuition assistance with pref-
erence for dedicated cohort classes in commu-
nity colleges, universities, accredited schools of 
nursing with supportive services including tu-
toring and counseling. 
(C) Providing assistance in preparing for 
and meeting all nursing licensure tests and re-
quirements. 
(D) 
Carrying 
out 
orientation 
and 
mentorship programs that assist newly grad-
uated nurses in adjusting to working at the 
bedside 
to 
ensure 
their 
retention 
postgraduation, and ongoing programs to sup-
port nurse retention. 
(E) Providing stipends for release time and 
continued health care coverage to enable incum-
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bent health care workers to participate in these 
programs. 
(2) To carry out programs that assist nurses in 
obtaining advanced degrees and completing specialty 
training or certification programs and to establish 
incentives for nurses to assume nurse faculty posi-
tions on a part-time or full-time basis. Such pro-
grams shall include one or more of the following: 
(A) Increasing the pool of nurses with ad-
vanced degrees who are interested in teaching 
by funding programs that enable incumbent 
nurses to return to school. 
(B) Establishing incentives for advanced 
degree bedside nurses who wish to teach in 
nursing programs so they can obtain a leave 
from their bedside position to assume a full- or 
part-time position as adjunct or full-time fac-
ulty without the loss of salary or benefits. 
(C) Collaboration with accredited schools 
of nursing which may include community col-
leges and other academic institutions providing 
associate, bachelor’s, or advanced nursing de-
gree programs, or specialty training or certifi-
cation programs, for nurses to carry out innova-
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tive nursing programs which meet the needs of 
bedside nursing and health care providers. 
(g) PREFERENCE.—In awarding grants under this 
section the Secretary shall give preference to programs 
that— 
(1) provide for improving nurse retention; 
(2) provide for improving the diversity of the 
new nurse graduates to reflect changes in the demo-
graphics of the patient population; 
(3) provide for improving the quality of nursing 
education to improve patient care and safety; 
(4) have demonstrated success in upgrading in-
cumbent health care workers to become nurses or 
which have established effective programs or pilots 
to increase nurse faculty; or 
(5) are modeled after or affiliated with such 
programs described in paragraph (4). 
(h) EVALUATION.— 
(1) PROGRAM
EVALUATIONS.—An entity that 
receives a grant under this section shall annually 
evaluate, and submit to the Secretary a report on, 
the activities carried out under the grant and the 
outcomes of such activities. Such outcomes may in-
clude— 
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(A) an increased number of incumbent 
workers entering an accredited school of nurs-
ing and in the pipeline for nursing programs; 
(B) an increasing number of graduating 
nurses and improved nurse graduation and li-
censure rates; 
(C) improved nurse retention; 
(D) an increase in the number of staff 
nurses at the health care facility involved; 
(E) an increase in the number of nurses 
with advanced degrees in nursing; 
(F) an increase in the number of nurse 
faculty; 
(G) improved measures of patient quality 
(which may include staffing ratios of nurses, 
patient satisfaction rates, patient safety meas-
ures); and 
(H) an increase in the diversity of new 
nurse graduates relative to the patient popu-
lation. 
(2) GENERAL REPORT.—Not later than 2 years 
after the date of the enactment of this Act, and an-
nually thereafter, the Secretary of Labor shall, using 
data and information from the reports received 
under paragraph (1), submit to the Congress a re-
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port concerning the overall effectiveness of the grant 
program carried out under this section. 
(i) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
such sums as may be necessary. 
Subtitle E—States Failing To Ad-
here to Certain Employment Ob-
ligations 
SEC. 2541. LIMITATION ON FEDERAL FUNDS. 
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. 
Æ 
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