I 
112TH CONGRESS 
1ST SESSION H. R. 2954 
To improve the health of minority individuals, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 15, 2011 
Ms. LEE of California (for herself, Mrs. CHRISTENSEN, Ms. ROYBAL-ALLARD, 
Ms. BASS of California, Mr. BISHOP of Georgia, Ms. BORDALLO, Mr. 
BROOKS, Ms. BROWN of Florida, Mr. BUTTERFIELD, Mr. CARSON of In-
diana, Ms. CHU, Mr. CLARKE of Michigan, Ms. CLARKE of New York, 
Mr. CLAY, Mr. CLEAVER, Mr. COHEN, Mr. CONYERS, Mr. CUMMINGS, 
Mr. DAVIS of Illinois, Ms. DEGETTE, Ms. DELAURO, Ms. EDWARDS, Mr. 
ELLISON, Mr. FALEOMAVAEGA, Mr. FATTAH, Ms. FUDGE, Mr. GON-
ZALEZ, Mr. AL GREEN of Texas, Mr. GRIJALVA, Mr. GUTIERREZ, Ms. 
HAHN, Ms. HANABUSA, Mr. HASTINGS of Florida, Ms. HIRONO, Mr. 
HONDA, Mr. JACKSON of Illinois, Ms. JACKSON LEE of Texas, Mr. JOHN-
SON of Georgia, Ms. EDDIE BERNICE JOHNSON of Texas, Mr. LEWIS of 
Georgia, Mr. KUCINICH, Ms. MATSUI, Mr. MCGOVERN, Mr. MEEKS, Ms. 
MOORE, Mrs. NAPOLITANO, Ms. NORTON, Mr. OLVER, Mr. PAYNE, Mr. 
PIERLUISI, Mr. RANGEL, Mr. REYES, Ms. RICHARDSON, Mr. RICHMOND, 
Mr. RUSH, Mr. SABLAN, Ms. LINDA T. SA´NCHEZ of California, Ms. 
SCHAKOWSKY, Mr. SCOTT of Virginia, Mr. DAVID SCOTT of Georgia, Mr. 
SERRANO, Mr. SIRES, Ms. SLAUGHTER, Mr. THOMPSON of Mississippi, 
Mr. TOWNS, Ms. WATERS, Mr. WATT, Ms. WILSON of Florida, and Ms. 
WOOLSEY) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committees on 
Ways and Means, Education and the Workforce, the Budget, Veterans’ 
Affairs, Armed Services, Agriculture, the Judiciary, and Natural Re-
sources, for a period to be subsequently determined by the Speaker, in 
each case for consideration of such provisions as fall within the jurisdic-
tion of the committee concerned 
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A BILL 
To improve the health of minority individuals, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Health Equity and 
Accountability Act of 2011’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Findings. 
TITLE I—DATA COLLECTION AND REPORTING 
Sec. 101. Amendment to the Public Health Service Act. 
Sec. 102. Elimination of prerequisite of direct appropriations for data collection 
and analysis. 
Sec. 103. Collection of race and ethnicity data by the Social Security Adminis-
tration. 
Sec. 104. Revision of HIPAA claims standards. 
Sec. 105. National Center for Health Statistics. 
Sec. 106. Oversampling of Asian-Americans, Native Hawaiians, or Pacific Is-
landers and other underrepresented groups in Federal health 
surveys. 
Sec. 107. Geo-access study. 
Sec. 108. Racial, ethnic, and linguistic data collected by the Federal Govern-
ment. 
Sec. 109. Data collection and analysis grants to minority-serving institutions. 
Sec. 110. Standards for measuring sexual orientation and gender identity in 
collection of health data. 
Sec. 111. Optional collection of health data on immigrants and individuals in 
their households. 
Sec. 112. Standards for measuring socioeconomic status in collection of health 
data. 
Sec. 113. Safety and effectiveness of drugs with respect to racial and ethnic 
background. 
Sec. 114. GAO study on compliance with existing FDA requirements to present 
drug and device safety and effectiveness data by sex, age, and 
racial and ethnic subgroups. 
Sec. 115. Improving health data regarding Native Hawaiians and other Pacific 
Islanders. 
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TITLE II—CULTURALLY AND LINGUISTICALLY APPROPRIATE 
HEALTH CARE 
Sec. 201. Definitions. 
Sec. 202. Amendment to the Public Health Service Act. 
Sec. 203. Federal reimbursement for culturally and linguistically appropriate 
services under the Medicare, Medicaid, and State Children’s 
Health Insurance Programs. 
Sec. 204. Increasing understanding of and improving health literacy. 
Sec. 205. Assurances for receiving Federal funds. 
Sec. 206. Report on Federal efforts to provide culturally and linguistically ap-
propriate health care services. 
Sec. 207. English for speakers of other languages. 
Sec. 208. Implementation. 
Sec. 209. Language access services. 
TITLE III—HEALTH WORKFORCE DIVERSITY 
Sec. 301. Amendment to the Public Health Service Act. 
Sec. 302. Hispanic-serving health professions schools. 
Sec. 303. Loan repayment program of Centers for Disease Control and Preven-
tion. 
Sec. 304. Cooperative agreements for online degree programs at schools of pub-
lic health and schools of allied health. 
Sec. 305. National report on the preparedness of health professionals to care 
for diverse populations. 
Sec. 306. Scholarship and fellowship programs. 
Sec. 307. Advisory Committee on Health Professions Training for Diversity. 
Sec. 308. McNair Postbaccalaureate Achievement Program. 
Sec. 309. Rules for determination of full-time equivalent residents for cost re-
porting periods. 
Sec. 310. Developing and implementing strategies for local health equity. 
Sec. 311. Loan forgiveness for mental and behavioral health social workers. 
TITLE IV—IMPROVEMENT OF HEALTH CARE SERVICES 
Subtitle A—Health Empowerment Zones 
Sec. 401. Short title. 
Sec. 402. Findings. 
Sec. 403. Designation of health empowerment zones. 
Sec. 404. Assistance to those seeking designation. 
Sec. 405. Benefits of designation. 
Sec. 406. Definition. 
Sec. 407. Authorization of appropriations. 
Subtitle B—Other Improvements of Health Care Services 
CHAPTER 1—EXPANSION OF COVERAGE 
Sec. 411. Amendment to the Public Health Service Act. 
Sec. 412. Removing barriers to unsubsidized purchase of private insurance in 
American Health Benefit Exchanges. 
Sec. 413. Study on the uninsured. 
Sec. 414. Medicaid payment parity for the territories. 
Sec. 415. Clarification of Medicaid coverage for citizens of Freely Associated 
States. 
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Sec. 416. Extension of Medicare secondary payer. 
Sec. 417. Border health grants. 
Sec. 418. Removing Medicare barrier to health care. 
Sec. 419. 100 percent FMAP for medical assistance provided by urban Indian 
health centers. 
Sec. 420. 100 percent FMAP for medical assistance provided to a Native Ha-
waiian through a federally qualified health center or a Native 
Hawaiian health care system under the Medicaid program. 
CHAPTER 2—EXPANSION OF ACCESS 
Sec. 421. Grants for racial and ethnic approaches to community health. 
Sec. 422. Critical access hospital improvements. 
Sec. 423. Establishment of Rural Community Hospital (RCH) Program. 
Sec. 424. Medicare remote monitoring pilot projects. 
Sec. 425. Rural health quality advisory commission and demonstration projects. 
Sec. 426. Rural health care services. 
Sec. 427. Community health center collaborative access expansion. 
Sec. 428. Facilitating the provision of telehealth services across State lines. 
Sec. 429. Scoring of preventive health savings. 
Sec. 430. Sense of Congress. 
Sec. 431. Repeal of requirement for documentation evidencing citizenship or 
nationality under the Medicaid program. 
Sec. 432. Office of Minority Health in Veterans Health Administration of De-
partment of Veterans Affairs. 
Sec. 433. Access for Native Americans under PPACA. 
TITLE V—IMPROVING HEALTH OUTCOMES FOR WOMEN, 
CHILDREN, AND FAMILIES 
Sec. 501. Grants to promote positive health behaviors in women and children. 
Sec. 502. Removing barriers to health care and nutrition assistance for chil-
dren, pregnant women, and lawfully present individuals. 
Sec. 503. Repeal of denial of benefits. 
Sec. 504. Birth defects prevention, risk reduction, and awareness. 
Sec. 505. Uniform State maternal mortality review committees on pregnancy- 
related deaths. 
Sec. 506. Eliminating disparities in maternity health outcomes. 
Sec. 507. Decreasing the risk factors for sudden unexpected infant death and 
sudden unexplained death in childhood. 
Sec. 508. Reducing teenage pregnancies. 
Sec. 509. Gestational diabetes. 
Sec. 510. Emergency contraception education and information programs. 
Sec. 511. Supporting healthy adolescent development. 
TITLE VI—MENTAL HEALTH 
Sec. 601. Coverage of marriage and family therapist services and mental health 
counselor services under part B of the Medicare program. 
Sec. 602. Community Mental Health and Addiction Safety Net Equity Act. 
Sec. 603. Minority Fellowship Program. 
Sec. 604. Integrated Health Care Demonstration Program. 
Sec. 605. Addressing racial and ethnic minority mental health disparities re-
search gaps. 
TITLE VII—ADDRESSING HIGH IMPACT MINORITY DISEASES 
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Subtitle A—Cancer 
Sec. 701. Lung Cancer Mortality Reduction Program. 
Sec. 702. Expanding prostate cancer research, outreach, screening, testing, ac-
cess, and treatment effectiveness. 
Sec. 703. Improved Medicaid coverage for certain breast and cervical cancer pa-
tients in the territories. 
Sec. 704. Cancer prevention and treatment demonstration for ethnic and racial 
minorities. 
Sec. 705. Reducing cancer disparities within Medicare. 
Subtitle B—Viral Hepatitis and Liver Cancer Control and Prevention 
Sec. 711. Viral hepatitis and liver cancer control and prevention. 
Subtitle C—Acquired Bone Marrow Failure Diseases 
Sec. 721. Acquired Bone Marrow Failure Diseases. 
Subtitle D—Cardiovascular Disease, Chronic Disease, and Other Disease 
Issues 
Sec. 731. Guidelines for disease screening for minority patients. 
Sec. 732. Coverage of the shingles vaccine under the Medicare program. 
Sec. 733. CDC Wisewoman Screening Program. 
Sec. 734. Report on cardiovascular care for women and minorities. 
Sec. 735. Coverage of comprehensive tobacco cessation services in Medicaid. 
Sec. 736. Clinical research funding for oral health. 
Subtitle E—HIV/AIDS 
Sec. 741. Findings. 
Sec. 742. Addressing HIV/AIDS in communities of color. 
Sec. 743. HIV/AIDS reduction in racial and ethnic minority communities. 
Sec. 744. Repealing ineffective and incomplete abstinence-only education pro-
gram. 
Sec. 745. Dental Education Loan Repayment Program. 
Sec. 746. Report on the implementation of the national HIV/AIDS strategy. 
Sec. 747. Addressing HIV/AIDS in the African-American community. 
Sec. 748. National Black Clergy for the Elimination of HIV/AIDS. 
Sec. 749. Reducing the spread of sexually transmitted infections in correctional 
facilities. 
Sec. 750. Stop AIDS in prison. 
Sec. 751. Services to reduce HIV/AIDS in racial and ethnic minority commu-
nities. 
Sec. 752. Health care professionals treating individuals with HIV/AIDS. 
Sec. 753. Report on impact of HIV/AIDS in racial and ethnic minority commu-
nities. 
Sec. 754. Study on status of HIV/AIDS epidemic among African-Americans. 
Subtitle F—Diabetes 
Sec. 755. Treatment of diabetes in minority communities. 
Sec. 756. Eliminating disparities in diabetes prevention access and care. 
Subtitle G—Lung Disease 
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Sec. 761. Expansion of the National Asthma Education and Prevention Pro-
gram. 
Sec. 762. Asthma-related activities of the centers for disease control and pre-
vention. 
Sec. 763. Influenza and pneumonia vaccination campaign. 
Sec. 764. Chronic obstructive pulmonary disease action plan. 
TITLE VIII—HEALTH INFORMATION TECHNOLOGY 
Subtitle A—Reducing Health Disparities Through Health IT 
Sec. 801. HRSA assistance to health centers for promotion of Health IT. 
Sec. 802. Assessment of impact of Health IT on racial and ethnic minority 
communities; outreach and adoption of Health IT in such com-
munities. 
Subtitle B—Modifications to Achieve Parity in Existing Programs 
Sec. 811. Extending funding to strengthen the Health IT infrastructure in ra-
cial and ethnic minority communities. 
Sec. 812. Prioritizing regional extension center assistance to racial and ethnic 
minority groups. 
Sec. 813. Extending competitive grants for the development of loan programs 
to facilitate adoption of certified EHR technology by providers 
serving racial and ethnic minority groups. 
Subtitle C—Additional Research and Studies 
Sec. 831. Data collection and assessments conducted in coordination with mi-
nority-serving institutions. 
Sec. 832. IOM study and report on privacy concerns of certain minority popu-
lations. 
Sec. 833. Study of health information technology in medically underserved com-
munities. 
Subtitle D—Closing Gaps in Funding To Adopt Certified EHRs 
Sec. 841. Application of Medicare HITECH payments to hospitals in Puerto 
Rico. 
Sec. 842. Extending Medicaid EHR incentive payments to long-term care facili-
ties and home health agencies. 
Sec. 843. Extending physician assistant eligibility for Medicaid electronic health 
record incentive payments. 
TITLE IX—ACCOUNTABILITY AND EVALUATION 
Sec. 901. Prohibition on discrimination in Federal assisted health care services 
and research programs on the basis of sex, race, color, national 
origin, sexual orientation, gender identity, or disability status. 
Sec. 902. Treatment of Medicare payments under Title VI of the Civil Rights 
Act of 1964. 
Sec. 903. Accountability and transparency within the Department of Health 
and Human Services. 
Sec. 904. United States Commission on Civil Rights. 
Sec. 905. Sense of Congress concerning full funding of activities to eliminate 
racial and ethnic health disparities. 
Sec. 906. GAO and NIH reports. 
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TITLE X—ADDRESSING SOCIAL DETERMINANTS AND IMPROVING 
ENVIRONMENTAL JUSTICE 
Sec. 1001. Codification of Executive Order 12898. 
Sec. 1002. Implementation of recommendations by Environmental Protection 
Agency. 
Sec. 1003. Grant program. 
Sec. 1004. Additional research on the relationship between the built environ-
ment and the health of community residents. 
Sec. 1005. Environment and public health restoration. 
Sec. 1006. Healthy Food Financing Initiative. 
Sec. 1007. GAO report on health effects of Deepwater Horizon oil rig explosion 
in the Gulf Coast. 
SEC. 3. FINDINGS. 
The Congress finds as follows: 
(1) The population of racial and ethnic minori-
ties is expected to increase over the next few dec-
ades, yet racial and ethnic minorities have the poor-
est health status and face substantial cultural, so-
cial, and economic barriers to obtaining quality 
health care. 
(2) Health disparities are a function of not only 
access to health care, but also the social deter-
minants of health—including the environment, the 
physical structure of communities, nutrition and 
food options, educational attainment, employment, 
race, ethnicity, sex, geography, language preference, 
immigrant or citizenship status, sexual orientation, 
gender identity, socioeconomic status, or disability 
status—that directly and indirectly affect the health, 
health care, and wellness of individuals and commu-
nities. 
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(3) By 2020, the Nation will face a shortage of 
health care providers and allied health workers and 
this shortage disproportionately affects health pro-
fessional shortage areas where many racial and eth-
nic minority populations reside. 
(4) All efforts to reduce health disparities and 
barriers to quality health services require better and 
more consistent data. 
(5) A full range of culturally and linguistically 
appropriate health care and public health services 
must be available and accessible in every community. 
(6) Racial and ethnic minorities and under-
served populations must be included early and equi-
tably in health reform innovations. 
(7) Efforts to improve minority health have 
been limited by inadequate resources in funding, 
staffing, stewardship and accountability. Targeted 
investments that are focused on disparities elimi-
nation must be made in providing care and services 
that are community-based, including prevention and 
policies addressing social determinants of health. 
(8) In 2011, the Department of Health and 
Human Services developed the HHS Action Plan to 
Reduce Racial and Ethnic Health Disparities and 
the National Stakeholder Strategy for Achieving 
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Health Equity, two strategic plans that represent 
the country’s first coordinated roadmap to reducing 
health disparities. Along with the National Preven-
tion Strategy and the National Health Care Quality 
Strategy, these comprehensive plans will work to in-
crease the number of Americans who are healthy at 
every stage of life. 
(9) The Department of Health and Human 
Services also developed other strategic planning doc-
uments to combat disease disparities with a high im-
pact on minority populations including the National 
HIV/AIDS Strategy, and the Action Plan for the 
Prevention, Care and Treatment of Viral Hepatitis. 
(10) The Patient Protection and Affordable 
Care Act, as amended by the Health Care and Edu-
cation Reconciliation Act, represents the biggest ad-
vancement for minority health in the last 40 years. 
TITLE I—DATA COLLECTION 
AND REPORTING 
SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE 
ACT. 
(a) PURPOSE.—It is the purpose of this section to 
promote data collection, analysis, and reporting by race, 
ethnicity, sex, primary language, sexual orientation, dis-
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ability status, gender identity, and socioeconomic status 
among federally supported health programs. 
(b) AMENDMENT.—Title XXXIV of the Public 
Health Service Act, as amended by titles II and III of 
this Act, is further amended by inserting after subtitle A 
the following: 
‘‘Subtitle 
B—Strengthening 
Data 
Collection, 
Improving 
Data 
Analysis, and Expanding Data 
Reporting 
‘‘SEC. 3431. HEALTH DISPARITY DATA. 
‘‘(a) REQUIREMENTS.— 
‘‘(1) IN
GENERAL.—Each health-related pro-
gram operated by or that receives funding or reim-
bursement, in whole or in part, either directly or in-
directly from the Department of Health and Human 
Services shall— 
‘‘(A) require the collection, by the agency 
or program involved, of data on the race, eth-
nicity, sex, primary language, sexual orienta-
tion, disability status, gender identity, and so-
cioeconomic status of each applicant for and re-
cipient of health-related assistance under such 
program— 
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‘‘(2) from all inappropriate internal use by any 
entity that collects, stores, or receives the data, in-
cluding use of such data in determinations of eligi-
bility (or continued eligibility) in health plans, and 
from other inappropriate uses, as defined by the 
Secretary. 
‘‘(c) NATIONAL PLAN OF THE DATA COUNCIL.—The 
Secretary shall develop and implement a national plan to 
ensure the collection of data in a culturally appropriate 
and competent manner, to improve the collection, analysis, 
and reporting of racial, ethnic, sex, primary language, sex-
ual orientation, disability status, gender identity, and so-
cioeconomic status data at the Federal, State, territorial, 
tribal, and local levels, including data to be collected under 
subsection (a), and to ensure that data collection activities 
carried out under this section are in compliance with the 
standards developed under section 3101. The Data Coun-
cil of the Department of Health and Human Services, in 
consultation with the National Committee on Vital Health 
Statistics, the Office of Minority Health, Office on Wom-
en’s Health, and other appropriate public and private enti-
ties, shall make recommendations to the Secretary con-
cerning the development, implementation, and revision of 
the national plan. Such plan shall include recommenda-
tions on how to— 
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‘‘(1) implement subsection (a) while minimizing 
the cost and administrative burdens of data collec-
tion and reporting; 
‘‘(2) expand awareness among Federal agencies, 
States, territories, Indian tribes, health providers, 
health plans, health insurance issuers, and the gen-
eral public that data collection, analysis, and report-
ing by race, ethnicity, primary language, sexual ori-
entation, disability status, gender identity, and socio-
economic status is legal and necessary to assure eq-
uity and nondiscrimination in the quality of health 
care services; 
‘‘(3) ensure that future patient record systems 
have data code sets for racial, ethnic, primary lan-
guage, sexual orientation, disability status, gender 
identity, and socioeconomic status identifiers and 
that such identifiers can be retrieved from clinical 
records, including records transmitted electronically; 
‘‘(4) improve health and health care data collec-
tion and analysis for more population groups if such 
groups can be aggregated into the minimum race 
and ethnicity categories, including exploring the fea-
sibility of enhancing collection efforts in States for 
racial and ethnic groups that comprise a significant 
proportion of the population of the State; 
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‘‘(5) provide researchers with greater access to 
racial, ethnic, primary language, sexual orientation, 
disability status, gender identity, and socioeconomic 
status data, subject to privacy and confidentiality 
regulations; and 
‘‘(6) safeguard and prevent the misuse of data 
collected under subsection (a). 
‘‘(d) COMPLIANCE WITH STANDARDS.—Data col-
lected under subsection (a) shall be obtained, maintained, 
and presented (including for reporting purposes) in ac-
cordance with the 1997 Office of Management and Budget 
Standards for Maintaining, Collecting, and Presenting 
Federal Data on Race and Ethnicity (at a minimum). 
‘‘(e) TECHNICAL ASSISTANCE FOR THE COLLECTION 
AND REPORTING OF DATA.— 
‘‘(1) IN GENERAL.—The Secretary may, either 
directly or through grant or contract, provide tech-
nical assistance to enable a health care program or 
an entity operating under such program to comply 
with the requirements of this section. 
‘‘(2) TYPES OF ASSISTANCE.—Assistance pro-
vided under this subsection may include assistance 
to— 
‘‘(A) enhance or upgrade computer tech-
nology that will facilitate racial, ethnic, primary 
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language, sexual orientation, disability status, 
gender identity, and socioeconomic status data 
collection and analysis; 
‘‘(B) improve methods for health data col-
lection and analysis including additional popu-
lation groups beyond the Office of Management 
and Budget categories if such groups can be 
aggregated into the minimum race and ethnicity 
categories; 
‘‘(C) develop mechanisms for submitting 
collected data subject to existing privacy and 
confidentiality regulations; and 
‘‘(D) develop educational programs to in-
form health insurance issuers, health plans, 
health providers, health-related agencies, and 
the general public that data collection and re-
porting by race, ethnicity, primary language, 
sexual orientation, disability status, gender 
identity, and socioeconomic status are legal and 
essential for eliminating health and health care 
disparities. 
‘‘(f) ANALYSIS OF HEALTH DISPARITY DATA.—The 
Secretary, acting through the Director of the Agency for 
Healthcare Research and Quality and in coordination with 
the Administrator of the Centers for Medicare & Medicaid 
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Services, shall provide technical assistance to agencies of 
the Department of Health and Human Services in meeting 
Federal standards for health disparity data collection and 
for analysis of racial and ethnic disparities in health and 
health care in public programs by— 
‘‘(1) identifying appropriate quality assurance 
mechanisms to monitor for health disparities; 
‘‘(2) specifying the clinical, diagnostic, or thera-
peutic measures which should be monitored; 
‘‘(3) developing new quality measures relating 
to racial and ethnic disparities and their overlap 
with other disparity factors in health and health 
care; 
‘‘(4) identifying the level at which data analysis 
should be conducted; and 
‘‘(5) sharing data with external organizations 
for research and quality improvement purposes. 
‘‘(g) DEFINITION.—In this section, the term ‘health- 
related program’ mean a program— 
‘‘(1) under the Social Security Act (42 U.S.C. 
301 et seq.) that pays for health care and services; 
and 
‘‘(2) under this Act that provides Federal finan-
cial assistance for health care, biomedical research, 
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or health services research and or is designed to im-
prove the public’s health. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section, 
such sums as may be necessary for each of fiscal years 
2012 through 2017. 
‘‘SEC. 3432. PROVISIONS RELATING TO NATIVE AMERICANS. 
‘‘(a) ESTABLISHMENT
OF
EPIDEMIOLOGY
CEN-
TERS.—The Secretary shall establish an epidemiology cen-
ter in each service area to carry out the functions de-
scribed in subsection (b). Any new center established after 
the date of the enactment of the Health Equity and Ac-
countability Act of 2011 may be operated under a grant 
authorized by subsection (d), but funding under such a 
grant shall not be divisible. 
‘‘(b) FUNCTIONS OF CENTERS.—In consultation with 
and upon the request of Indian tribes, tribal organizations, 
and urban indian organizations, each service area epidemi-
ology center established under this subsection shall, with 
respect to such service area— 
‘‘(1) collect data relating to, and monitor 
progress made toward meeting, each of the health 
status objectives of the service, the Indian tribes, 
tribal organizations, and urban indian organizations 
in the service area; 
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‘‘(2) evaluate existing delivery systems, data 
systems, and other systems that impact the improve-
ment of Indian health; 
‘‘(3) assist Indian tribes, tribal organizations, 
and urban indian organizations in identifying their 
highest priority health status objectives and the 
services needed to achieve such objectives, based on 
epidemiological data; 
‘‘(4) make recommendations for the targeting 
of services needed by the populations served; 
‘‘(5) make recommendations to improve health 
care delivery systems for Indians and urban Indians; 
‘‘(6) provide requested technical assistance to 
Indian tribes, tribal organizations, and urban indian 
organizations in the development of local health 
service priorities and incidence and prevalence rates 
of disease and other illness in the community; and 
‘‘(7) provide disease surveillance and assist In-
dian tribes, tribal organizations, and urban Indian 
organizations to promote public health. 
‘‘(c) TECHNICAL ASSISTANCE.—The Director of the 
Centers for Disease Control and Prevention shall provide 
technical assistance to the centers in carrying out the re-
quirements of this subsection. 
‘‘(d) GRANTS FOR STUDIES.— 
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‘‘(1) IN GENERAL.—The Secretary may make 
grants to Indian tribes, tribal organizations, urban 
indian organizations, and eligible intertribal con-
sortia to conduct epidemiological studies of Indian 
communities. 
‘‘(2) ELIGIBLE INTERTRIBAL CONSORTIA.—An 
intertribal consortium is eligible to receive a grant 
under this subsection if— 
‘‘(A) the intertribal consortium is incor-
porated for the primary purpose of improving 
Indian health; and 
‘‘(B) the intertribal consortium is rep-
resentative of the Indian tribes or urban Indian 
communities in which the intertribal consortium 
is located. 
‘‘(3) APPLICATIONS.—An application for a 
grant under this subsection shall be submitted in 
such manner and at such time as the Secretary shall 
prescribe. 
‘‘(4) REQUIREMENTS.—An applicant for a 
grant under this subsection shall— 
‘‘(A) demonstrate the technical, adminis-
trative, and financial expertise necessary to 
carry out the functions described in paragraph 
(5); 
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‘‘(B) consult and cooperate with providers 
of related health and social services in order to 
avoid duplication of existing services; and 
‘‘(C) demonstrate cooperation from Indian 
tribes or urban Indian organizations in the area 
to be served. 
‘‘(5) USE OF FUNDS.—A grant awarded under 
paragraph (1) may be used— 
‘‘(A) to carry out the functions described 
in subsection (b); 
‘‘(B) to provide information to and consult 
with tribal leaders, urban Indian community 
leaders, and related health staff on health care 
and health service management issues; and 
‘‘(C) in collaboration with Indian tribes, 
tribal organizations, and urban Indian commu-
nities, to provide the service with information 
regarding ways to improve the health status of 
Indians. 
‘‘(e) ACCESS
TO INFORMATION.—An epidemiology 
center operated by a grantee pursuant to a grant awarded 
under subsection (d) shall be treated as a public health 
authority for purposes of the Health Insurance Portability 
and Accountability Act of 1996 (Public Law 104–191; 110 
Stat. 2033), as such entities are defined in part 164.501 
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of title 45, Code of Federal Regulations (or a successor 
regulation). The Secretary shall grant such grantees ac-
cess to and use of data, data sets, monitoring systems, 
delivery systems, and other protected health information 
in the possession of the Secretary.’’. 
SEC. 102. ELIMINATION OF PREREQUISITE OF DIRECT AP-
PROPRIATIONS FOR DATA COLLECTION AND 
ANALYSIS. 
Section 3101 of the Public Health Service Act (42 
U.S.C. 300kk) is amended— 
(1) by striking subsection (h); and 
(2) by redesignating subsection (i) as subsection 
(h). 
SEC. 103. COLLECTION OF RACE AND ETHNICITY DATA BY 
THE SOCIAL SECURITY ADMINISTRATION. 
Part A of title XI of the Social Security Act (42 
U.S.C. 1301 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 1150C. COLLECTION OF RACE AND ETHNICITY DATA 
BY THE SOCIAL SECURITY ADMINISTRATION. 
‘‘(a) REQUIREMENT.—The Commissioner of Social 
Security, in consultation with the Administrator of the 
Centers for Medicare & Medicaid Services, shall— 
‘‘(1) require the collection of data on the race, 
ethnicity, primary language, and disability status of 
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all applicants for Social Security account numbers or 
benefits under title II or part A of title XVIII and 
all individuals with respect to whom the Commis-
sioner maintains records of wages and self-employ-
ment income in accordance with reports received by 
the Commissioner or the Secretary of the Treas-
ury— 
‘‘(A) using, at a minimum, the standards 
for data collection on race, ethnicity, primary 
language, and disability status developed under 
section 3101 of the Public Health Service Act; 
‘‘(B) where practicable, collecting data for 
additional population groups if such groups can 
be aggregated into the minimum race and eth-
nicity categories; and 
‘‘(C) additionally referring, where prac-
ticable, to the standards developed by the Insti-
tute of Medicine in ‘Race, Ethnicity, and Lan-
guage Data: Standardization for Health Care 
Quality Improvement’ (released August 31, 
2009); 
‘‘(2) with respect to the collection of the data 
described in paragraph (1) for applicants who are 
under 18 years of age or otherwise legally incapaci-
tated, require that— 
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‘‘(A) such data be collected from the par-
ent or legal guardian of such an applicant; and 
‘‘(B) the primary language of the parent 
or legal guardian of such an applicant or recipi-
ent be used; 
‘‘(3) require that such data be uniformly ana-
lyzed and reported at least annually to the Commis-
sioner of Social Security; 
‘‘(4) be responsible for storing the data re-
ported under paragraph (3); 
‘‘(5) ensure transmission to the Centers for 
Medicare & Medicaid Services and other Federal 
health agencies; 
‘‘(6) provide such data to the Secretary on at 
least an annual basis; and 
‘‘(7) ensure that the provision of assistance to 
an applicant is not denied or otherwise adversely af-
fected because of the failure of the applicant to pro-
vide race, ethnicity, primary language, and disability 
status data. 
‘‘(b) PROTECTION OF DATA.—The Commissioner of 
Social Security shall ensure (through the promulgation of 
regulations or otherwise) that all data collected pursuant 
to subsection (a) are protected— 
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‘‘(1) under the same privacy protections as the 
Secretary applies to health data under the regula-
tions promulgated under section 264(c) of the 
Health Insurance Portability and Accountability Act 
of 1996 (Public Law 104–191; 110 Stat. 2033) re-
lating to the privacy of individually identifiable 
health information and other protections; and 
‘‘(2) from all inappropriate internal use by any 
entity that collects, stores, or receives the data, in-
cluding use of such data in determinations of eligi-
bility (or continued eligibility) in health plans, and 
from other inappropriate uses, as defined by the 
Secretary. 
‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to permit the use of information 
collected under this section in a manner that would ad-
versely affect any individual providing any such informa-
tion. 
‘‘(d) TECHNICAL ASSISTANCE.—The Secretary may, 
either directly or by grant or contract, provide technical 
assistance to enable any health entity to comply with the 
requirements of this section. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section, 
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such sums as may be necessary for each of fiscal years 
2012 through 2017.’’. 
SEC. 104. REVISION OF HIPAA CLAIMS STANDARDS. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall revise the regulations promulgated 
under part C of title XI of the Social Security Act (42 
U.S.C. 1320d et seq.), relating to the collection of data 
on race, ethnicity, and primary language in a health-re-
lated transaction, to require— 
(1) the use, at a minimum, of the standards for 
data collection on race, ethnicity, primary language, 
disability, and sex developed under section 3101 of 
the Public Health Service Act (42 U.S.C. 300kk); 
and 
(2) the designation of the racial, ethnic, pri-
mary language, disability, and sex code sets as re-
quired for claims and enrollment data. 
(b) DISSEMINATION.—The Secretary of Health and 
Human Services shall disseminate the new standards de-
veloped under subsection (a) to all health entities that are 
subject to the regulations described in such subsection and 
provide technical assistance with respect to the collection 
of the data involved. 
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(c) COMPLIANCE.—The Secretary of Health and 
Human Services shall require that health entities comply 
with the new standards developed under subsection (a) not 
later than 2 years after the final promulgation of such 
standards. 
SEC. 105. NATIONAL CENTER FOR HEALTH STATISTICS. 
Section 306(n) of the Public Health Service Act (42 
U.S.C. 242k(n)) is amended— 
(1) in paragraph (1), by striking ‘‘2003’’ and 
inserting ‘‘2016’’; 
(2) in paragraph (2), in the first sentence, by 
striking ‘‘2003’’ and inserting ‘‘2016’’; and 
(3) in paragraph (3), by striking ‘‘2002’’ and 
inserting ‘‘2016’’. 
SEC. 106. OVERSAMPLING OF ASIAN-AMERICANS, NATIVE 
HAWAIIANS, OR PACIFIC ISLANDERS AND 
OTHER 
UNDERREPRESENTED 
GROUPS 
IN 
FEDERAL HEALTH SURVEYS. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317T the following: 
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‘‘SEC. 317U. OVERSAMPLING OF ASIAN-AMERICANS, NATIVE 
HAWAIIANS, OR PACIFIC ISLANDERS AND 
OTHER 
UNDERREPRESENTED 
GROUPS 
IN 
FEDERAL HEALTH SURVEYS. 
‘‘(a) NATIONAL STRATEGY.— 
‘‘(1) IN GENERAL.—The Secretary of Health 
and Human Services, acting through the Director of 
the National Center for Health Statistics (referred 
to in this section as ‘NCHS’) of the Centers for Dis-
ease Control and Prevention, and other agencies 
within the Department of Health and Human Serv-
ices as the Secretary determines appropriate, shall 
develop and implement an ongoing and sustainable 
national strategy for oversampling Asian-Americans, 
Native Hawaiians, or Pacific Islanders, and other 
underrepresented populations as determined appro-
priate by the Secretary in Federal health surveys. 
‘‘(2) CONSULTATION.—In developing and imple-
menting a national strategy, as described in para-
graph (1), not later than 180 days after the date of 
the enactment of the this section, the Secretary— 
‘‘(A) shall consult with representatives of 
community groups, nonprofit organizations, 
nongovernmental organizations, and govern-
ment agencies working with Asian-Americans, 
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Native Hawaiians, or Pacific Islanders, and 
other underrepresented populations; and 
‘‘(B) may solicit the participation of rep-
resentatives from other Federal departments 
and agencies. 
‘‘(b) PROGRESS REPORT.—Not later than 2 years 
after the date of the enactment of this section, the Sec-
retary shall submit to the Congress a progress report, 
which shall include the national strategy described in sub-
section (a)(1). 
‘‘(c) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for fiscal years 
2012 through 2017.’’. 
SEC. 107. GEO-ACCESS STUDY. 
The Administrator of the Substance Abuse and Men-
tal Health Services Administration shall— 
(1) conduct a study to— 
(A) determine which geographic areas of 
the United States have shortages of specialty 
mental health providers; and 
(B) assess the preparedness of speciality 
mental health providers to deliver culturally and 
linguistically appropriate, affordable, and acces-
sible services; and 
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(2) submit a report to the Congress on the re-
sults of such study. 
SEC. 108. RACIAL, ETHNIC, AND LINGUISTIC DATA COL-
LECTED BY THE FEDERAL GOVERNMENT. 
(a) COLLECTION; SUBMISSION.—Not later than 90 
days after the date of the enactment of this Act, and Jan-
uary 31 of each year thereafter, each department, agency, 
and office of the Federal Government that has collected 
racial, ethnic, or linguistic data during the preceding cal-
endar year shall submit such data to the Secretary of 
Health and Human Services. 
(b) ANALYSIS; PUBLIC AVAILABILITY; REPORTING.— 
Not later than April 30, 2012, and each April 30 there-
after, the Secretary of Health and Human Services, acting 
through the Director of the National Institute on Minority 
Health and Health Disparities and the Deputy Assistant 
Secretary for Minority Health, shall— 
(1) collect and analyze the racial, ethnic, and 
linguistic data submitted under subsection (a) for 
the preceding calendar year; 
(2) make publicly available such data and the 
results of such analysis; and 
(3) submit a report to the Congress on such 
data and analysis. 
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SEC. 109. DATA COLLECTION AND ANALYSIS GRANTS TO MI-
NORITY-SERVING INSTITUTIONS. 
(a) AUTHORITY.—The Secretary of Health and 
Human Services, acting through the National Institute on 
Minority Health and Health Disparities and the Office of 
Minority Health, may award grants to access and analyze 
racial and ethnic, and where possible other health dis-
parity data, to monitor and report on progress to reduce 
and eliminate disparities in health and health care. 
(b) ELIGIBLE ENTITY.—In this section, the term ‘‘el-
igible entity’’ means a historically Black college or univer-
sity, an Hispanic-serving institution, a tribal college or 
university, or an Asian-American, Native American, or Pa-
cific Islander-serving institution with an accredited public 
health, health policy, or health services research program. 
SEC. 110. STANDARDS FOR MEASURING SEXUAL ORIENTA-
TION AND GENDER IDENTITY IN COLLECTION 
OF HEALTH DATA. 
Section 3101(a) of the Public Health Service Act (42 
U.S.C. 300kk(a)) is amended— 
(1) in paragraph (1)(A), by inserting ‘‘sexual 
orientation, gender identity,’’ before ‘‘and disability 
status’’; 
(2) in paragraph (1)(C), by inserting ‘‘sexual 
orientation, gender identity,’’ before ‘‘and disability 
status’’; and 
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(3) in paragraph (2)(B), by inserting ‘‘sexual 
orientation, gender identity,’’ before ‘‘and disability 
status’’. 
SEC. 111. OPTIONAL COLLECTION OF HEALTH DATA ON IM-
MIGRANTS 
AND 
INDIVIDUALS 
IN 
THEIR 
HOUSEHOLDS. 
Section 3101(a) of the Public Health Service Act (42 
U.S.C. 300k(a)) is amended by adding at the end the fol-
lowing: 
‘‘(4) OPTIONAL
UNIFORM
CATEGORIES.—Not 
later than 12 months after the date of the enact-
ment of this paragraph, the Secretary shall— 
‘‘(A) enter into an arrangement with the 
Institute of Medicine of the National Academies 
(or, if the Institute of Medicine declines to 
enter into such an arrangement, another appro-
priate entity) to— 
‘‘(i) conduct a study and develop rec-
ommended standards for the optional col-
lection of data on immigrants, as well as 
citizens living within immigrant households 
(mixed-status households), in order to 
measure disparities in health coverage, 
health care access and quality, and health 
status among these populations, and 
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‘‘(ii) include ensuing recommendations 
and results in a report to the Secretary 
that includes best practices to protect the 
privacy of respondents to the full extent of 
applicable law; 
‘‘(B) promulgate standards based on the 
recommendations and results of subparagraph 
(A) for the optional collection of data in major 
health surveys and research; and 
‘‘(C) provide clear guidance that immi-
grant and mixed-status households are optional 
uniform categories and data concerning such 
households shall— 
‘‘(i) not be required to be collected by 
the standards under subparagraph (B); 
‘‘(ii) be collected only in accordance 
with— 
‘‘(I) the ‘Tri-Agency Guidance’ 
issued by the Food and Nutrition 
Service of the Department of Agri-
culture, the Centers for Medicare & 
Medicaid Services, the Administration 
for Children and Families, and Office 
for Civil Rights; and 
‘‘(II) other applicable law; and 
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‘‘(iii) not be collected for program ap-
plication and enrollment processes beyond 
statutory requirements.’’. 
SEC. 112. STANDARDS FOR MEASURING SOCIOECONOMIC 
STATUS IN COLLECTION OF HEALTH DATA. 
Section 3101(a) of the Public Health Service Act (42 
U.S.C. 300kk(a)), as amended, is amended— 
(1) in paragraph (1)(A), by inserting ‘‘socio-
economic status,’’ before ‘‘and disability status’’; 
(2) in paragraph (1)(C), by inserting ‘‘socio-
economic status,’’ before ‘‘and disability status’’; and 
(3) in paragraph (2)(B), by inserting ‘‘socio-
economic status,’’ before ‘‘and disability status’’. 
SEC. 113. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding after section 505D the following: 
‘‘SEC. 505E. SAFETY AND EFFECTIVENESS OF DRUGS WITH 
RESPECT TO RACIAL AND ETHNIC BACK-
GROUND. 
‘‘(a) PREAPPROVAL STUDIES.—If there is evidence 
that there may be a disparity on the basis of racial or 
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ethnic background as to the safety or effectiveness of a 
drug, then— 
‘‘(1)(A) the investigations required under sec-
tion 505(b)(1)(A) shall include adequate and well- 
controlled investigations of the disparity; or 
‘‘(B) the evidence required under section 351(a) 
of the Public Health Service Act for approval of a 
biologics license application for the drug shall in-
clude adequate and well-controlled investigations of 
the disparity; and 
‘‘(2) if the investigations confirm that there is 
a disparity, the labeling of the drug shall include ap-
propriate information about the disparity. 
‘‘(b) POSTMARKET STUDIES.— 
‘‘(1) IN GENERAL.—If there is evidence that 
there may be a disparity on the basis of racial or 
ethnic background as to the safety or effectiveness 
of a drug for which there is an approved application 
under section 505 or a license under section 351 of 
the Public Health Service Act, the Secretary may by 
order require the holder of the approved application 
or license to conduct, by a date specified by the Sec-
retary, postmarketing studies to investigate the dis-
parity. 
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‘‘(2) LABELING.—If the Secretary determines 
that the postmarket studies confirm that there is a 
disparity described in paragraph (1), the labeling of 
the drug shall include appropriate information about 
the disparity. 
‘‘(3) STUDY
DESIGN.—The Secretary may 
specify all aspects of study design, including the 
number of studies and study participants, and the 
other demographic characteristics of study partici-
pants included, in the order requiring postmarket 
studies of the drug. 
‘‘(4) MODIFICATIONS OF STUDY DESIGN.—The 
Secretary may by order modify any aspect of the 
study design as necessary after issuing an order 
under paragraph (1). 
‘‘(5) STUDY RESULTS.—The results from stud-
ies required under paragraph (1) shall be submitted 
to the Secretary as supplements to the drug applica-
tion or biological license application. 
‘‘(c) DISPARITY.—The term ‘evidence that there may 
be a disparity on the basis of racial or ethnic background 
for adult and pediatric populations as to the safety or ef-
fectiveness of a drug’ includes— 
‘‘(1) evidence that there is a disparity on the 
basis of racial or ethnic background as to safety or 
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effectiveness of a drug in the same chemical class as 
the drug; 
‘‘(2) evidence that there is a disparity on the 
basis of racial or ethnic background in the way the 
drug is metabolized; and 
‘‘(3) other evidence as the Secretary may deter-
mine. 
‘‘(d) APPLICATIONS UNDER SECTIONS 505(b)(2) 
AND 505(j).— 
‘‘(1) IN GENERAL.—A drug for which an appli-
cation has been submitted or approved under section 
505(j) shall not be considered ineligible for approval 
under that section or misbranded under section 502 
on the basis that the labeling of the drug omits in-
formation relating to a disparity on the basis of ra-
cial or ethnic background as to the safety or effec-
tiveness of the drug, whether derived from investiga-
tions or studies required under this section or de-
rived from other sources, when the omitted informa-
tion is protected by patent or by exclusivity under 
clause (iii) or (iv) of section 505(j)(5)(B). 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of section 505(j)(5)(B), the Secretary may 
require that the labeling of a drug approved under 
section 505(j) that omits information relating to a 
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disparity on the basis of racial or ethnic background 
as to the safety or effectiveness of the drug include 
a statement of any appropriate contraindications, 
warnings, or precautions related to the disparity 
that the Secretary considers necessary.’’. 
(b) ENFORCEMENT.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(aa) If it is a drug and the holder of the approved 
application under section 505 or license under section 351 
of the Public Health Service Act for the drug has failed 
to complete the investigations or studies, or comply with 
any other requirement, of section 505E.’’. 
(c) DRUG FEES.—Section 736(a)(1)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) 
is amended by adding after ‘‘are required’’ the following: 
‘‘, including supplements required under section 505E’’. 
SEC. 114. GAO STUDY ON COMPLIANCE WITH EXISTING FDA 
REQUIREMENTS TO PRESENT DRUG AND DE-
VICE SAFETY AND EFFECTIVENESS DATA BY 
SEX, AGE, AND RACIAL AND ETHNIC SUB-
GROUPS. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study investigating the ex-
tent to which sponsors of clinical studies of investigational 
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‘‘(E) the resources the agency will provide 
to improve cultural competence to assist recipi-
ents of Federal funds to improve access to 
health care or health-care-related programs and 
activities for limited-English-proficient individ-
uals. 
Each agency shall send a copy of such plan to the 
Department of Justice, which shall serve as the cen-
tral repository of the Agency’s plans. 
‘‘(c) FEDERALLY ASSISTED PROGRAMS AND ACTIVI-
TIES.— 
‘‘(1) IN GENERAL.—Not later than 120 days 
after the date of enactment of this title, each Fed-
eral agency providing health-care-related Federal fi-
nancial assistance shall ensure that the guidance for 
recipients of Federal financial assistance developed 
by the agency to ensure compliance with title VI of 
the Civil Rights Act of 1964 (42 U.S.C. 2000d et 
seq.) is specifically tailored to the recipients of such 
assistance. Each agency shall send a copy of such 
guidance to the Department of Justice which shall 
serve as the central repository of the Agency’s plans. 
After approval by the Department of Justice, each 
agency shall publish its guidance document in the 
Federal Register for public comment. 
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‘‘(ii) such State or locality releases 
such a copy and any such information to 
the Secretary. 
‘‘(C) TIMELY ACTION ON APPLICATION.— 
The Secretary shall determine, within 210 days 
after the date the Secretary receives an applica-
tion by a private accrediting organization, 
State, or locality whether the process of the pri-
vate accrediting organization, State, or locality 
meets the requirements with respect to training, 
assessment, or certification standards for inter-
preters or translators with respect to which 
standards the application is made. The Sec-
retary may not deny an application on the basis 
that it seeks to meet the requirements with re-
spect to only one, or more than one, training, 
assessment, or certification standards for inter-
preters or translators. 
‘‘(D) DISCLOSURE
OF
ACCREDITATION 
SURVEY.—The Secretary may not disclose any 
accreditation survey made and released to him 
by the National Council on Interpreting in 
Health Care or any State or locality of an ac-
credited organization or individual, except that 
the Secretary may disclose such a survey and 
VerDate Mar 15 2010 
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