1334 
health care services (in this section referred to as 
‘best practices’). 
‘‘(2) CONSIDERATIONS.—In prioritizing areas 
under paragraph (1), the Director shall consider— 
‘‘(A) the priorities established under sec-
tion 1191 of the Social Security Act; and 
‘‘(B) the key health indicators identified by 
the Assistant Secretary for Health Information 
under section 1709. 
‘‘(3) LIMITATIONS.—In conducting its duties 
under this subsection, the Center for Quality Im-
provement shall not develop quality-adjusted life 
year measures or any other methodologies that can 
be used to deny benefits to a beneficiary against the 
beneficiary’s wishes on the basis of the beneficiary’s 
age, life expectancy, present or predicted disability, 
or expected quality of life. 
‘‘(c) OTHER RESPONSIBILITIES.—The Director, act-
ing directly or by awarding a grant or contract to an eligi-
ble entity, shall— 
‘‘(1) identify existing best practices under sub-
section (e); 
‘‘(2) develop new best practices under sub-
section (f);
1335 
‘‘(3) evaluate best practices under subsection 
(g); 
‘‘(4) implement best practices under subsection 
(h); 
‘‘(5) ensure that best practices are identified, 
developed, evaluated, and implemented under this 
section consistent with standards adopted by the 
Secretary under section 3004 for health information 
technology used in the collection and reporting of 
quality information (including for purposes of the 
demonstration of meaningful use of certified elec-
tronic health record (EHR) technology by physicians 
and hospitals under the Medicare program (under 
sections 1848(o)(2) and 1886(n)(3), respectively, of 
the Social Security Act)); and 
‘‘(6) provide for dissemination of information 
and reporting under subsections (i) and (j). 
‘‘(d) ELIGIBILITY.—To be eligible for a grant or con-
tract under subsection (c), an entity shall— 
‘‘(1) be a nonprofit entity; 
‘‘(2) agree to work with a variety of institu-
tional health care providers, physicians, nurses, and 
other health care practitioners; and 
‘‘(3) if the entity is not the organization holding 
a contract under section 1153 of the Social Security
1336 
Act for the area to be served, agree to cooperate 
with and avoid duplication of the activities of such 
organization. 
‘‘(e) IDENTIFYING EXISTING BEST PRACTICES.—The 
Director shall identify best practices that are— 
‘‘(1) currently utilized by health care providers 
(including hospitals, physician and other clinician 
practices, community cooperatives, and other health 
care entities) that deliver consistently high-quality, 
efficient health care services; and 
‘‘(2) easily adapted for use by other health care 
providers and for use across a variety of health care 
settings. 
‘‘(f) DEVELOPING NEW BEST PRACTICES.—The Di-
rector shall develop best practices that are— 
‘‘(1) based on a review of existing scientific evi-
dence; 
‘‘(2) sufficiently detailed for implementation 
and incorporation into the workflow of health care 
providers; and 
‘‘(3) designed to be easily adapted for use by 
health care providers across a variety of health care 
settings.
1337 
‘‘(g) EVALUATION OF BEST PRACTICES.—The Direc-
tor shall evaluate best practices identified or developed 
under this section. Such evaluation— 
‘‘(1) shall include determinations of which best 
practices— 
‘‘(A) most reliably and effectively achieve 
significant progress in improving the quality of 
patient care; and 
‘‘(B) are easily adapted for use by health 
care providers across a variety of health care 
settings; 
‘‘(2) shall include regular review, updating, and 
improvement of such best practices; and 
‘‘(3) may include in-depth case studies or em-
pirical assessments of health care providers (includ-
ing hospitals, physician and other clinician practices, 
community cooperatives, and other health care enti-
ties) and simulations of such best practices for de-
terminations under paragraph (1). 
‘‘(h) IMPLEMENTATION OF BEST PRACTICES.— 
‘‘(1) IN
GENERAL.—The Director shall enter 
into arrangements with entities in a State or region 
to implement best practices identified or developed 
under this section. Such implementation—
1338 
‘‘(A) may include forming collaborative 
multi-institutional teams; and 
‘‘(B) shall include an evaluation of the best 
practices being implemented, including the 
measurement of patient outcomes before, dur-
ing, and after implementation of such best 
practices. 
‘‘(2) PREFERENCES.—In carrying out this sub-
section, the Director shall give priority to health 
care providers implementing best practices that— 
‘‘(A) have the greatest impact on patient 
outcomes and satisfaction; 
‘‘(B) are the most easily adapted for use 
by health care providers across a variety of 
health care settings; 
‘‘(C) promote coordination of health care 
practitioners across the continuum of care; and 
‘‘(D) engage patients and their families in 
improving patient care and outcomes. 
‘‘(i) PUBLIC DISSEMINATION
OF INFORMATION.— 
The Director shall provide for the public dissemination of 
information with respect to best practices and activities 
under this section. Such information shall be made avail-
able in appropriate formats and languages to reflect the
1339 
varying needs of consumers and diverse levels of health 
literacy. 
‘‘(j) REPORT.— 
‘‘(1) IN GENERAL.—The Director shall submit 
an annual report to the Congress and the Secretary 
on activities under this section. 
‘‘(2) CONTENT.—Each report under paragraph 
(1) shall include— 
‘‘(A) information on activities conducted 
pursuant to grants and contracts awarded; 
‘‘(B) summary data on patient outcomes 
before, during, and after implementation of best 
practices; and 
‘‘(C) recommendations on the adaptability 
of best practices for use by health providers.’’. 
(b) INITIAL QUALITY IMPROVEMENT ACTIVITIES AND 
INITIATIVES TO BE IMPLEMENTED.—Until the Director 
of the Agency for Healthcare Research and Quality has 
established initial priorities under section 931(b) of the 
Public Health Service Act, as added by subsection (a), the 
Director shall, for purposes of such section, prioritize the 
following: 
(1) HEALTH CARE-ASSOCIATED INFECTIONS.— 
Reducing health care-associated infections, including 
infections in nursing homes and outpatient settings.
1340 
(2) SURGERY.—Increasing hospital and out-
patient perioperative patient safety, including reduc-
ing surgical-site infections and surgical errors (such 
as wrong-site surgery and retained foreign bodies). 
(3) EMERGENCY
ROOM.—Improving care in 
hospital emergency rooms, including through the use 
of principles of efficiency of design and delivery to 
improve patient flow. 
(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. 
(5) PEDIATRICS.—Improving the provision of 
preventive and developmental child health services, 
including interventions that can reduce child health 
disparities (as defined in section 3171 of the Public 
Health Service Act, as added by section 2301) and 
reduce the risk of developing chronic health-threat-
ening conditions that affect an individual’s life 
course development. 
(c) REPORT.—Not later than 18 months after the 
date of the enactment of this Act, the Director of the 
Agency for Healthcare Research and Quality shall submit
1341 
a report to the Congress on the impact of the nurse-to- 
patient ratio on the quality of care and patient outcomes, 
including recommendations for further integration into 
quality measurement and quality improvement activities. 
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-
ing the Nation’s health and the performance of the 
Nation’s health care;
1342 
‘‘(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 dis-
parities; 
‘‘(iii) ensure, with respect to data on race 
and ethnicity, consistency with the 1997 Office 
of Management and Budget Standards for 
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
1343 
health and health care with respect to 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; 
‘‘(8) facilitate and coordinate identification and 
monitoring of health disparities by the agencies of 
the Department 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
1344 
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— 
‘‘(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
1345 
‘‘(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. 
‘‘(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
1346 
‘‘(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 DEPART-
MENTS AND AGENCIES.—Consistent with applicable law, 
the Assistant Secretary may secure directly from any Fed-
eral 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; 
‘‘(C) recommendations for addressing such 
gaps and identification of the appropriate agen-
cy within the Department or other entity to ad-
dress such gaps;
1347 
‘‘(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, 
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
1348 
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’’. 
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,
1349 
in addition to any other amounts authorized to be appro-
priated for such purpose, there are authorized to be appro-
priated, out of any monies in the Public Health Invest-
ment Fund, $300,000,000 for each of fiscal years 2011 
through 2015.’’. 
TITLE V—OTHER PROVISIONS 
Subtitle 
A—Drug 
Discount 
for 
Rural and Other Hospitals; 340B 
Program Integrity 
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, or a free-standing cancer hospital 
excluded from the Medicare prospective pay-
ment 
system 
pursuant 
to 
section 
1886(d)(1)(B)(v) of the Social Security Act 
that would meet the requirements of subpara-
graph (L), including the disproportionate share 
adjustment 
percentage 
requirement 
under 
clause (ii) of such subparagraph, if the hospital
1350 
were a subsection (d) hospital as defined by sec-
tion 1886(d)(1)(B) of the Social Security 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). 
‘‘(S) An entity that is a sole community 
hospital 
(as 
defined 
in 
section 
1886(d)(5)(D)(iii) of the Social Security Act).
1351 
‘‘(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); and 
(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.—A 
hospital 
de-
scribed in subparagraph (L), (M), (N), (R), 
(S), or (T) of paragraph (4) shall not obtain 
covered outpatient drugs through a group pur-
chasing organization or other group purchasing 
arrangement.’’.
1352 
SEC. 2502. IMPROVEMENTS TO 340B PROGRAM INTEGRITY. 
(a) INTEGRITY IMPROVEMENTS.—Section 340B (42 
U.S.C. 256b) is amended— 
(1) by striking subsections (c) and (d); and 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) IMPROVEMENTS IN PROGRAM INTEGRITY.— 
‘‘(1) MANUFACTURER COMPLIANCE.— 
‘‘(A) IN GENERAL.—From amounts appro-
priated under paragraph (4), the Secretary 
shall provide for improvements in compliance by 
manufacturers with the requirements of this 
section in order to prevent overcharges and 
other violations of the discounted pricing re-
quirements specified in this section. 
‘‘(B) IMPROVEMENTS.—The improvements 
described in subparagraph (A) shall include the 
following: 
‘‘(i) The establishment of a process to 
enable the Secretary to verify the accuracy 
of ceiling prices calculated by manufactur-
ers under subsection (a)(1) and charged to 
covered entities, which shall include the 
following: 
‘‘(I) Developing and publishing, 
through an appropriate policy or regu-
1353 
latory issuance, standards and meth-
odology for the calculation of ceiling 
prices under such subsection. 
‘‘(II) Comparing regularly the 
ceiling prices calculated by the Sec-
retary with the quarterly pricing data 
that is reported by manufacturers to 
the Secretary. 
‘‘(III) Conducting periodic moni-
toring of sales transactions to covered 
entities. 
‘‘(IV) Inquiring into any discrep-
ancies between ceiling prices and 
manufacturer pricing data that may 
be identified and taking, or requiring 
manufacturers to take, corrective ac-
tion in response to such discrepancies, 
including the issuance of refunds pur-
suant to the procedures set forth in 
clause (ii). 
‘‘(ii) The establishment of procedures 
for the issuance of refunds to covered enti-
ties by manufacturers in the event that the 
Secretary finds there has been an over-
charge, including the following:
1354 
‘‘(I) Submission to the Secretary 
by manufacturers of an explanation of 
why and how the overcharge occurred, 
how the refunds will be calculated, 
and to whom the refunds will be 
issued. 
‘‘(II) Oversight by the Secretary 
to ensure that the refunds are issued 
accurately and within a reasonable pe-
riod of time. 
‘‘(iii) Notwithstanding any other pro-
vision of law prohibiting the disclosure of 
ceiling prices or data used to calculate the 
ceiling price, the provision of access to cov-
ered entities and State Medicaid agencies 
through an Internet website of the Depart-
ment of Health and Human Services or 
contractor to the applicable ceiling prices 
for covered drugs as calculated and verified 
by the Secretary in a manner that ensures 
protection of privileged pricing data from 
unauthorized disclosure. 
‘‘(iv) The development of a mecha-
nism by which—
1355 
‘‘(I) rebates, discounts, or other 
price concessions provided by manu-
facturers to other purchasers subse-
quent to the sale of covered drugs to 
covered entities are reported to the 
Secretary; and 
‘‘(II) appropriate credits and re-
funds are issued to covered entities if 
such rebates, discounts, or other price 
concessions have the effect of lowering 
the applicable ceiling price for the rel-
evant quarter for the drugs involved. 
‘‘(v) In addition to authorities under 
section 1927(b)(3) of the Social Security 
Act, the Secretary may conduct audits of 
manufacturers and wholesalers to ensure 
the integrity of the program under this 
section, including audits on the market 
price of covered drugs. 
‘‘(vi) The establishment of a require-
ment that manufacturers and wholesalers 
use the identification system developed by 
the Secretary for purposes of facilitating 
the ordering, purchasing, and delivery of 
covered drugs under this section, including
1356 
the processing of chargebacks for such 
drugs. 
‘‘(vii) The imposition of sanctions in 
the form of civil monetary penalties, 
which— 
‘‘(I) shall be assessed according 
to standards and procedures estab-
lished in regulations to be promul-
gated by the Secretary within one 
year of the date of the enactment of 
the Affordable Health Care for Amer-
ica Act; and 
‘‘(II) shall apply to any manufac-
turer with an agreement under this 
section and shall not exceed $100,000 
for each instance where a manufac-
turer knowingly charges a covered en-
tity a price for purchase of a drug 
that exceeds the maximum applicable 
price under subsection (a)(1) or that 
knowingly violates any other provision 
of this section, or withholds or pro-
vides false information to the Sec-
retary or to covered entities under 
this section.
1357 
‘‘(2) COVERED ENTITY COMPLIANCE.— 
‘‘(A) IN GENERAL.—From amounts appro-
priated under paragraph (4), the Secretary 
shall provide for improvements in compliance by 
covered entities with the requirements of this 
section in order to prevent diversion and viola-
tions of the duplicate discount provision and 
other requirements under subsection (a)(5). 
‘‘(B) IMPROVEMENTS.—The improvements 
described in subparagraph (A) shall include the 
following: 
‘‘(i) The development of procedures to 
enable and require covered entities to up-
date at least annually the information on 
the Internet Web site of the Department of 
Health and Human Services relating to 
this section. 
‘‘(ii) The development of procedures 
for the Secretary to verify the accuracy of 
information regarding covered entities that 
is listed on the Web site described in 
clause (i). 
‘‘(iii) The development of more de-
tailed guidance describing methodologies 
and options available to covered entities for
1358 
billing covered drugs to State Medicaid 
agencies in a manner that avoids duplicate 
discounts pursuant to subsection (a)(5)(A). 
‘‘(iv) The establishment of a single, 
universal, and standardized identification 
system by which each covered entity site 
can be identified by manufacturers, dis-
tributors, covered entities, and the Sec-
retary for purposes of facilitating the or-
dering, purchasing, and delivery of covered 
drugs under this section, including the 
processing of chargebacks for such drugs. 
‘‘(v) The imposition of sanctions in 
the form of civil monetary penalties, 
which— 
‘‘(I) shall be assessed according 
to standards and procedures estab-
lished in regulations promulgated by 
the Secretary; 
‘‘(II) shall not exceed $5,000 for 
each violation; and 
‘‘(III) shall apply to any covered 
entity that knowingly violates sub-
paragraph (a)(5)(B) or knowingly vio-
1359 
lates any other provision of this sec-
tion. 
‘‘(vi) The exclusion of a covered entity 
from participation in the program under 
this section, for a period of time to be de-
termined by the Secretary, in cases in 
which the Secretary determines, in accord-
ance with standards and procedures estab-
lished in regulations, that— 
‘‘(I) a violation of a requirement 
of this section was repeated and 
knowing; and 
‘‘(II) imposition of a monetary 
penalty would be insufficient to rea-
sonably ensure compliance. 
‘‘(vii) The referral of matters as ap-
propriate to the Food and Drug Adminis-
tration, the Office of Inspector General of 
Department of Health and Human Serv-
ices, or other Federal agencies. 
‘‘(3) ADMINISTRATIVE
DISPUTE
RESOLUTION 
PROCESS.—From amounts appropriated under para-
graph (4), the Secretary may establish and imple-
ment an administrative process for the resolution of 
the following:
1360 
‘‘(A) Claims by covered entities that manu-
facturers have violated the terms of their agree-
ment with the Secretary under subsection 
(a)(1). 
‘‘(B) Claims by manufacturers that cov-
ered entities have violated subsection (a)(5)(A) 
or (a)(5)(B). 
‘‘(4) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
this subsection, such sums as may be necessary for 
fiscal year 2011 and each succeeding fiscal year.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 340B(a) (42 U.S.C. 256b(a)) is 
amended— 
(A) by adding at the end of paragraph (1) 
the following: ‘‘Such agreement shall require 
that the manufacturer offer each covered entity 
covered drugs for purchase at or below the ap-
plicable ceiling price if such drug is made avail-
able to any other purchaser at any price. Such 
agreement shall require that, if the supply of a 
covered drug is insufficient to meet demand, 
then the manufacturer may utilize an allocation 
method that is reported in writing to the Sec-
retary and does not discriminate on the basis of
1361 
the price paid by covered entities or on any 
other basis related to an entity’s participation 
in the program under this section. Notwith-
standing any other provision of law, if the Sec-
retary requests a manufacturer to enter into a 
new or amended agreement under this section 
that complies with current law and if the manu-
facturer opts not to sign the new or amended 
agreement, then any existing agreement be-
tween the manufacturer and the Secretary 
under this section is deemed to no longer meet 
the requirements of this section for purposes of 
this section and section 1927 of the Social Se-
curity Act.’’; and 
(B) by adding at the end the following 
paragraph: 
‘‘(11) QUARTERLY
REPORTS.—An agreement 
described in paragraph (1) shall require that the 
manufacturer furnish the Secretary with reports on 
a quarterly basis that include the following informa-
tion: 
‘‘(A) The price for each covered drug sub-
ject to the agreement that, according to the 
manufacturer, represents the maximum price 
that covered entities may permissibly be re-
1362 
quired to pay for the drug (referred to in this 
section as the ‘ceiling price’). 
‘‘(B) The component information used to 
calculate the ceiling price as determined nec-
essary to administer the requirements of the 
program under this section. 
‘‘(C) Rebates, discounts, and other price 
concessions provided by manufacturers to other 
purchasers subsequent to the sale of covered 
drugs to covered entities.’’. 
(2) Section 1927(a)(5) of the Social Security 
Act (42 U.S.C. 1396r–8(a)(5)) is amended by strik-
ing subparagraph (D). 
SEC. 2503. EFFECTIVE DATE. 
(a) IN GENERAL.—The amendments made by this 
subtitle shall take effect on the date of the enactment of 
this Act, and sections 2501, 2502(a)(1), and 2502(b)(2) 
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.
1363 
Subtitle B—Programs 
PART 1—GRANTS FOR CLINICS AND CENTERS 
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)(3)); 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;
1364 
‘‘(C) an assurance that— 
‘‘(i) SBHC services will be provided in 
accordance with Federal, State, and local 
laws; 
‘‘(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 onsite ac-
cess during the academic day when school 
is in session and has an established net-
work 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-
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.
1365 
‘‘(c) USE OF FUNDS.—Funds awarded under a grant 
under this section— 
‘‘(1) may be used for— 
‘‘(A) providing training related to the pro-
vision of comprehensive primary health services 
and additional health services; 
‘‘(B) the management and operation of 
SBHC 
programs, 
including 
through 
sub-
contracts; and 
‘‘(C) the payment of salaries for health 
professionals and other appropriate SBHC per-
sonnel; and 
‘‘(2) may not be used to provide abortions. 
‘‘(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. 
‘‘(e) PREFERENCES.—In awarding grants under this 
section, the Secretary shall give preference to SBHCs that 
have a demonstrated record of service to at least one of 
the following:
1366 
‘‘(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 under this section 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 provided in cash or in kind) to carry out 
the activities supported 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 
operation of the SBHC (including each activity described 
in paragraph (1) or (2) of subsection (c)).
1367 
‘‘(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 
meet the requirements of this section. Such assistance 
may include fiscal and program management assistance,
1368 
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— 
‘‘(A) shall include— 
‘‘(i) 
comprehensive 
health 
assess-
ments, diagnosis, and treatment of minor, 
acute, and chronic medical conditions and 
referrals to, and followup for, specialty 
care; and 
‘‘(ii) mental health assessments, crisis 
intervention, counseling, treatment, and re-
1369 
ferral to a continuum of services including 
emergency psychiatric care, community 
support programs, inpatient care, and out-
patient programs; and 
‘‘(B) may include additional services, such 
as 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;
1370 
‘‘(D) 
provides 
comprehensive 
primary 
health services during school hours to children 
and adolescents by health professionals in ac-
cordance with State and local laws and regula-
tions, established standards, and community 
practice; and 
‘‘(E) does not perform abortion services. 
‘‘(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 entity whose 
mission is to provide access to comprehensive 
primary health care services; 
‘‘(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.
1371 
‘‘(m) AUTHORIZATION
OF APPROPRIATIONS.—For 
purposes of carrying out this section, there are authorized 
to be appropriated $50,000,000 for fiscal year 2011 and 
such sums as may be necessary for each of fiscal years 
2012 through 2015.’’. 
(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 (a), not later than July 1, 2010, without regard 
to whether or not final regulations have been issued under 
section 399Z–1(i) of such Act. 
(c) TERMINATION OF STUDY.—Section 2(b) of the 
Health Care Safety Net Act of 2008 (42 U.S.C. 254b 
note) is amended by striking paragraph (2) (relating to 
a school-based health center study). 
SEC. 2512. NURSE-MANAGED HEALTH CENTERS. 
Title III (42 U.S.C. 241 et seq.) is amended by add-
ing at the end the following: 
‘‘PART S—NURSE-MANAGED HEALTH CENTERS 
‘‘SEC. 399FF. NURSE-MANAGED HEALTH CENTERS. 
‘‘(a) PROGRAM.—The Secretary, acting through the 
Administrator of the Health Resources and Services Ad-
ministration, shall establish a nurse-managed health cen-
ter program consisting of awarding grants to entities 
under subsection (b).
1372 
‘‘(b) GRANT.—The Secretary shall award grants to 
entities— 
‘‘(1) to plan and develop a nurse-managed 
health center; or 
‘‘(2) to operate a nurse-managed health center. 
‘‘(c) USE OF FUNDS.—Amounts received as a grant 
under subsection (b) may be used for activities including 
the following: 
‘‘(1) Purchasing or leasing equipment. 
‘‘(2) Training and technical assistance related 
to the provision of comprehensive primary care serv-
ices and wellness services. 
‘‘(3) Other activities for planning, developing, 
or operating, as applicable, a nurse-managed health 
center. 
‘‘(d) ASSURANCES APPLICABLE TO BOTH PLANNING 
AND OPERATION GRANTS.— 
‘‘(1) IN GENERAL.—The Secretary may award 
a grant under this section to an entity only if the 
entity demonstrates to the Secretary’s satisfaction 
that— 
‘‘(A) nurses, in addition to managing the 
center, will be adequately represented as pro-
viders at the center; and