(2) A Hispanic-serving institution, as defined in 
section 502 of such Act (20 U.S.C. 1101a). 
(3) A Tribal College or University, as defined in 
section 316 of such Act (20 U.S.C. 1059c). 
(4) An Asian American and Native American 
Pacific Islander-serving institution, as defined in 
section 371(c) of such Act (20 U.S.C. 1067q(c)). 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal years 2021 
through 2025. 
SEC. 108. STANDARDS FOR MEASURING SEXUAL ORIENTA-
TION, 
GENDER 
IDENTITY, 
AND 
SOCIO-
ECONOMIC 
STATUS 
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, socioeconomic status,’’ 
before ‘‘and disability status’’; 
(2) in paragraph (1)(C), by inserting ‘‘sexual 
orientation, gender identity, socioeconomic status,’’ 
before ‘‘and disability status’’; and 
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(3) in paragraph (2)(B), by inserting ‘‘sexual 
orientation, gender identity, socioeconomic status,’’ 
before ‘‘and disability status’’. 
SEC. 109. 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 505F the following: 
‘‘SEC. 505G. 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 
ethnic background as to the safety or effectiveness of a 
drug or biological product, then— 
‘‘(1)(A) in the case of a drug, the investigations 
required under section 505(b)(1)(A) shall include 
adequate and well-controlled investigations of the 
disparity; or 
‘‘(B) in the case of a biological product, the evi-
dence required under section 351(a) of the Public 
Health Service Act for approval of a biologics license 
application for the biological product shall include 
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adequate and well-controlled investigations of the 
disparity; and 
‘‘(2) if the investigations described in subpara-
graph (A) or (B) of paragraph (1) confirm that 
there is such a disparity, the labeling of the drug or 
biological product shall include appropriate informa-
tion 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 of this Act or of a biological prod-
uct for which there is an approved license under sec-
tion 351 of the Public Health Service Act, the Sec-
retary may by order require the holder of the ap-
proved application or license to conduct, by a date 
specified by the Secretary, postmarket studies to in-
vestigate the disparity. 
‘‘(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 or biological product shall include appro-
priate information about the disparity. 
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‘‘(3) STUDY DESIGN.—The Secretary may, in 
an order under paragraph (1), specify all aspects of 
the design of the postmarket studies required under 
such paragraph for a drug or biological product, in-
cluding the number of studies and study partici-
pants, and the other demographic characteristics of 
the study participants. 
‘‘(4) MODIFICATIONS OF STUDY DESIGN.—The 
Secretary may, by order and as necessary, modify 
any aspect of the design of a postmarket study re-
quired in an order under paragraph (1) after issuing 
such order. 
‘‘(5) STUDY
RESULTS.—The results from a 
study required under paragraph (1) shall be sub-
mitted to the Secretary as a supplement to the drug 
application or biologics license application. 
‘‘(c) APPLICATIONS UNDER SECTION 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-
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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 
section 505(j)(5)(F). 
‘‘(2) LABELING.—Notwithstanding paragraph 
(1), the Secretary may require that the labeling of 
a drug approved under section 505(j) that 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 include a statement of any ap-
propriate contraindications, warnings, or precautions 
related to the disparity that the Secretary considers 
necessary. 
‘‘(d) DEFINITION.—The term ‘evidence that there 
may be a disparity on the basis of racial or ethnic back-
ground as to the safety or effectiveness’, with respect to 
a drug or biological product, includes— 
‘‘(1) evidence that there is a disparity on the 
basis of racial or ethnic background as to safety or 
effectiveness of a drug or biological product in the 
same chemical class as the drug or biological prod-
uct; 
‘‘(2) evidence that there is a disparity on the 
basis of racial or ethnic background in the way the 
drug or biological product is metabolized; and 
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‘‘(3) other evidence as the Secretary may deter-
mine appropriate.’’. 
(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: 
‘‘(ee) 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 505G.’’. 
(c) DRUG FEES.—Section 736(a)(1)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h(a)(1)(A)(ii)) is amended by inserting after ‘‘are not 
required’’ the following: ‘‘, including postmarket studies 
required under section 505G’’. 
SEC. 110. IMPROVING HEALTH DATA REGARDING NATIVE 
HAWAIIANS AND OTHER PACIFIC ISLANDERS. 
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 317U the following: 
‘‘SEC. 317V. NATIVE HAWAIIAN AND OTHER PACIFIC IS-
LANDER HEALTH DATA. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) COMMUNITY GROUP.—The term ‘commu-
nity group’ means a group of NHOPI who are orga-
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nized at the community level, and may include a 
church group, social service group, national advocacy 
organization, or cultural group. 
‘‘(2) NONPROFIT, NONGOVERNMENTAL ORGANI-
ZATION.—The term ‘nonprofit, nongovernmental or-
ganization’ means a group of NHOPI with a dem-
onstrated history of addressing NHOPI issues, in-
cluding a NHOPI coalition. 
‘‘(3) DESIGNATED
ORGANIZATION.—The term 
‘designated organization’ means an entity estab-
lished to represent NHOPI populations and which 
has statutory responsibilities to provide, or has com-
munity support for providing, health care. 
‘‘(4) 
GOVERNMENT
REPRESENTATIVES
OF 
NHOPI POPULATIONS.—The term ‘government rep-
resentatives of NHOPI populations’ means rep-
resentatives from Hawaii, American Samoa, the 
Commonwealth of the Northern Mariana Islands, 
the Federated States of Micronesia, Guam, the Re-
public of Palau, and the Republic of the Marshall Is-
lands. 
‘‘(5) NATIVE HAWAIIANS AND OTHER PACIFIC 
ISLANDERS (NHOPI).—The term ‘Native Hawaiians 
and Other Pacific Islanders’ or ‘NHOPI’ means peo-
ple having origins in any of the original peoples of 
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American Samoa, the Commonwealth of the North-
ern Mariana Islands, the Federated States of Micro-
nesia, Guam, Hawaii, the Republic of the Marshall 
Islands, the Republic of Palau, or any other Pacific 
Island. 
‘‘(6) INSULAR AREA.—The term ‘insular area’ 
means Guam, the Commonwealth of Northern Mar-
iana Islands, American Samoa, the United States 
Virgin Islands, the Federated States of Micronesia, 
the Republic of Palau, or the Republic of the Mar-
shall Islands. 
‘‘(b) NATIONAL STRATEGY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the National Center for 
Health Statistics (referred to in this section as 
‘NCHS’) of the Centers for Disease Control and 
Prevention, and other agencies within the Depart-
ment of Health and Human Services as the Sec-
retary determines appropriate, shall develop and im-
plement an ongoing and sustainable national strat-
egy for identifying and evaluating the health status 
and health care needs of NHOPI populations living 
in the continental United States, Hawaii, American 
Samoa, the Commonwealth of the Northern Mariana 
Islands, the Federated States of Micronesia, Guam, 
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the Republic of Palau, and the Republic of the Mar-
shall Islands. 
‘‘(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 
enactment of the Health Equity and Accountability 
Act of 2020, the Secretary— 
‘‘(A) shall consult with representatives of 
community groups, designated organizations, 
and nonprofit, nongovernmental organizations 
and with government representatives of NHOPI 
populations; and 
‘‘(B) may solicit the participation of rep-
resentatives from other Federal departments. 
‘‘(c) PRELIMINARY HEALTH SURVEY.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of NCHS, shall conduct a pre-
liminary health survey in order to identify the major 
areas and regions in the continental United States, 
Hawaii, American Samoa, the Commonwealth of the 
Northern Mariana Islands, the Federated States of 
Micronesia, Guam, the Republic of Palau, and the 
Republic of the Marshall Islands in which NHOPI 
people reside. 
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‘‘(2) CONTENTS.—The health survey described 
in paragraph (1) shall include health data and any 
other data the Secretary determines to be— 
‘‘(A) useful in determining health status 
and health care needs; or 
‘‘(B) required for developing or imple-
menting a national strategy. 
‘‘(3) METHODOLOGY.—Methodology for the 
health survey described in paragraph (1), including 
plans for designing questions, implementation, sam-
pling, and analysis, shall be developed in consulta-
tion with community groups, designated organiza-
tions, nonprofit, nongovernmental organizations, and 
government representatives of NHOPI populations, 
as determined by the Secretary. 
‘‘(4) TIMEFRAME.—The survey required under 
this subsection shall be completed not later than 18 
months after the date of enactment of the Health 
Equity and Accountability Act of 2020. 
‘‘(d) PROGRESS REPORT.—Not later than 2 years 
after the date of enactment of the Health Equity and Ac-
countability Act of 2020, the Secretary shall submit to 
Congress a progress report, which shall include the na-
tional strategy described in subsection (b)(1). 
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‘‘(e) STUDY AND REPORT BY THE HEALTH AND 
MEDICINE DIVISION.— 
‘‘(1) IN GENERAL.—The Secretary shall enter 
into an agreement with the Health and Medicine Di-
vision of the National Academies of Sciences, Engi-
neering, and Medicine to conduct a study, with input 
from stakeholders in insular areas, on each of the 
following: 
‘‘(A) The standards and definitions of 
health care applied to health care systems in in-
sular areas and the appropriateness of such 
standards and definitions. 
‘‘(B) The status and performance of health 
care systems in insular areas, evaluated based 
upon standards and definitions, as the Sec-
retary determines appropriate. 
‘‘(C) The effectiveness of donor aid in ad-
dressing health care needs and priorities in in-
sular areas. 
‘‘(D) The progress toward implementation 
of recommendations of the Committee on 
Health Care Services in the United States—As-
sociated Pacific Basin that are set forth in the 
1998 report entitled ‘Pacific Partnerships for 
Health: Charting a New Course’. 
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‘‘(2) REPORT.—An agreement described in 
paragraph (1) shall require the Health and Medicine 
Division to submit to the Secretary and to Congress, 
not later than 2 years after the date of the enact-
ment of the Health Equity and Accountability Act of 
2020, a report containing a description of the results 
of the study conducted under paragraph (1), includ-
ing the conclusions and recommendations of the 
Health and Medicine Division for each of the items 
described in subparagraphs (A) through (D) of such 
paragraph. 
‘‘(f) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated such sums as may be necessary for fiscal years 
2021 through 2025.’’. 
SEC. 111. CLARIFICATION OF SIMPLIFIED ADMINISTRATIVE 
REPORTING REQUIREMENT. 
Section 11(a) of the Food and Nutrition Act of 2008 
(7 U.S.C. 2020(a)) is amended by adding at the end the 
following: 
‘‘(5) SIMPLIFIED ADMINISTRATIVE REPORTING 
REQUIREMENT.—With respect to any obligation of a 
State agency to comply with the notification require-
ment under paragraph (2) of section 421(e) of the 
Personal Responsibility and Work Opportunity Rec-
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onciliation Act of 1996 (8 U.S.C. 1631(e)), notwith-
standing the requirement to include in that notifica-
tion the names of the sponsor and the sponsored 
alien involved, the State agency shall be considered 
to have complied with the notification requirement if 
the State agency submits to the Attorney General a 
report that includes the aggregate number of excep-
tions granted by the State agency under paragraph 
(1) of that section.’’. 
TITLE II—CULTURALLY AND LIN-
GUISTICALLY 
APPROPRIATE 
HEALTH AND HEALTH CARE 
SEC. 201. DEFINITIONS; FINDINGS. 
(a) DEFINITIONS.—In this title, the definitions in 
section 3400 of the Public Health Service Act, as added 
by section 204, shall apply. 
(b) FINDINGS.—Congress finds the following: 
(1) Effective communication is essential to 
meaningful access to quality physical and mental 
health care. 
(2) Research indicates that the lack of appro-
priate language services creates language barriers 
that result in increased risk of misdiagnosis, ineffec-
tive treatment plans, and poor health outcomes for 
individuals with limited English proficiency and indi-
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viduals with communication disabilities such as cog-
nitive, hearing, vision, or print impairments. 
(3) The number of limited English speaking 
residents in the United States who speak English 
less than very well and, therefore, cannot effectively 
communicate with health and social service providers 
continues to increase significantly. 
(4) The responsibility to fund language services 
in the provision of health care and health-care-re-
lated services to individuals with limited English 
proficiency and individuals with communication dis-
abilities such as cognitive hearing, vision, or print 
impairments is a societal one that cannot fairly be 
placed solely upon the health care, public health, or 
social services community. 
(5) Title VI of the Civil Rights Act of 1964 (42 
U.S.C. 2000d et seq.) prohibits discrimination based 
on the grounds of race, color, or national origin by 
any entity receiving Federal financial assistance. In 
order to avoid discrimination on the grounds of na-
tional origin, all programs or activities administered 
by the Federal Government must take adequate 
steps to ensure that their policies and procedures do 
not deny or have the effect of denying individuals 
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with limited English proficiency with equal access to 
benefits and services for which such persons qualify. 
(6) Both the Americans with Disabilities Act of 
1990 (42 U.S.C. 12101 et seq.) and the Rehabilita-
tion Act of 1973 (29 U.S.C. 701 et seq.) prohibit 
discrimination on the basis of disability and require 
the provision of appropriate auxiliary aids and serv-
ices necessary to ensure effective communication 
with individuals with disabilities. The type of auxil-
iary aid or service necessary to ensure effective com-
munication will vary in accordance with the method 
of communication used by the individual; the nature, 
length, and complexity of the communication in-
volved; and the context in which the communication 
is taking place. A public accommodation should con-
sult with individuals with disabilities whenever pos-
sible to determine what type of auxiliary aid is need-
ed to ensure effective communication. The public ac-
commodation should use the person’s preferred 
method of communication whenever possible, unless 
it would be an undue burden to the public accommo-
dation and an alternative would provide an equally 
effective means of communication. The ultimate de-
cision as to what measures to take rests with the 
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public accommodation, provided that the method 
chosen results in effective communication. 
(7) Section 1557 of the Patient Protection and 
Affordable Care Act (42 U.S.C. 18116) builds on 
Title VI of the Civil Rights Act of 1964 (42 U.S.C. 
2000d et seq.) and the Rehabilitation Act of 1973 
(29 U.S.C. 701 et seq.), prohibits discrimination on 
the basis of race, color, national origin, disability, 
sex, and age, requires the provision of language serv-
ices to ensure effective communication with individ-
uals with limited English proficiency, and requires 
the provision of appropriate auxiliary aids and serv-
ices necessary to ensure effective communication 
with individuals with disabilities. 
(8) Linguistic diversity in the health care and 
health-care-related services workforce is important 
for providing all patients the environment most con-
ducive to positive health outcomes. 
(9) All members of the health care and health- 
care-related services community should continue to 
educate their staff and constituents about limited 
English proficient and disability communication 
issues and help them identify resources to improve 
access to quality care for individuals with limited 
English proficiency and individuals with communica-
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tion disabilities such as cognitive, hearing, vision, or 
print impairments. 
(10) Access to English as a second language, 
foreign language, and sign language interpreters, 
translated and alternative format documents, read-
ers, and other auxiliary aids and services, are essen-
tial to ensure effective communication and eliminate 
the language barriers that impede access to health 
care. 
(11) Competent language services in health care 
settings should be available as a matter of course. 
SEC. 202. IMPROVING ACCESS TO SERVICES FOR INDIVID-
UALS WITH LIMITED ENGLISH PROFICIENCY. 
(a) PURPOSE.—Consistent with the goals provided in 
Executive Order 13166 (42 U.S.C. 2000d–1 note; relating 
to improving access to services for persons with limited 
English proficiency), it is the purpose of this section— 
(1) to improve Federal agency performance re-
garding access to federally conducted and federally 
assisted programs and activities for individuals with 
limited English proficiency; 
(2) to require each Federal agency to examine 
the services it provides and develop and implement 
a system by which individuals with limited English 
proficiency can obtain culturally competence services 
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and meaningful access to those services consistent 
with, and without substantially burdening, the fun-
damental mission of the agency; 
(3) to require each Federal agency to ensure 
that recipients of Federal financial assistance pro-
vide culturally competence services and meaningful 
access to applicants and beneficiaries that are indi-
viduals with limited English proficiency; 
(4) to ensure that recipients of Federal finan-
cial assistance take reasonable steps, consistent with 
the guidelines set forth in the ‘‘Guidance to Federal 
Financial Assistance Recipients Regarding Title VI 
Prohibition Against National Origin Discrimination 
Affecting Limited English Proficient Persons (67 
Fed. Reg. 41455 (June 18, 2002))’’, to ensure cul-
turally and linguistically appropriate access to their 
programs and activities by individuals with limited 
English proficiency; and 
(5) to ensure compliance with title VI of the 
Civil Rights Act of 1964 (42 U.S.C. 2000d et seq.) 
and section 1557 of the Patient Protection and Af-
fordable Care Act (42 U.S.C. 18116) as published in 
the Federal Register on May 18, 2016, that health 
care providers and organizations do not discriminate 
in the provision of services. 
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(b) FEDERALLY CONDUCTED PROGRAMS AND AC-
TIVITIES.— 
(1) IN
GENERAL.—Not later than 120 days 
after the date of enactment of this Act, each Federal 
agency providing financial assistance to, or admin-
istering, a health program or activity described in 
section 203(a) shall prepare a plan or update their 
current plan to improve culturally and linguistically 
appropriate access to such program or activity with 
respect to individuals with limited English pro-
ficiency. Not later than 1 year after the date of en-
actment of this title, each such Federal agency shall 
ensure that such plan is fully implemented. 
(2) PLAN
REQUIREMENT.—Each plan under 
paragraph (1) shall include— 
(A) the steps the agency will take to en-
sure that individuals with limited English pro-
ficiency have access to each health program or 
activity supported or administered by the agen-
cy; 
(B) the policies and procedures for identi-
fying, assessing, and meeting the culturally and 
linguistically appropriate language needs of its 
beneficiaries that are individuals with limited 
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English proficiency served by such program or 
activity; 
(C) the steps the agency will take for such 
program or activity to be culturally and linguis-
tically appropriate by providing a range of lan-
guage assistance options, notice to individuals 
with limited English proficiency of the right to 
competent language services, periodic training 
of staff, monitoring and quality assessment of 
the language services and, in appropriate cir-
cumstances, the translation of written mate-
rials; 
(D) the steps the agency will take for such 
program or activity to provide reasonable ac-
commodations necessary for individuals with 
limited English proficiency and communication 
disabilities to understand communications from 
the agency; 
(E) the steps the agency will take to en-
sure that applications, forms, and other rel-
evant documents for such program or activity 
are competently translated into the primary 
language of a client that is an individual with 
limited English proficiency where such mate-
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rials are needed to improve access of such client 
to such program or activity; 
(F) the resources the agency will provide 
to improve cultural and linguistic appropriate-
ness to assist recipients of Federal funds to im-
prove access to health-care-related programs 
and activities for individuals with limited 
English proficiency; 
(G) the resources the agency will provide 
to ensure that competent language assistance is 
provided to patients that are individuals with 
limited English proficiency by interpreters or 
trained bilingual staff; and 
(H) the resources the agency will provide 
to ensure that family, particularly minor chil-
dren, and friends are not used to provide inter-
pretation services, except as permitted under 
regulations implementing section 1557 of the 
Patient Protection and Affordable Care Act (42 
U.S.C. 18116) as published in the Federal Reg-
ister on May 18, 2016. 
(3) SUBMISSION OF PLAN TO DOJ.—Each agen-
cy that is required to prepare a plan under para-
graph (1) shall send a copy of such plan to the At-
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torney General, which shall serve as the central re-
pository of all such plans. 
SEC. 203. ENSURING STANDARDS FOR CULTURALLY AND 
LINGUISTICALLY APPROPRIATE SERVICES IN 
HEALTH CARE. 
(a) APPLICABILITY.—This section shall apply to any 
health program or activity, any part of which is receiving 
Federal financial assistance, including credits, subsidies, 
or contracts of insurance, or any program or activity that 
is administered by an executive agency or any entity estab-
lished under title I of the Patient Protection and Afford-
able Care Act (42 U.S.C. 18001 et seq.) (or amendments 
made thereby). 
(b) STANDARDS.—Each program or activity de-
scribed in subsection (a)— 
(1) shall implement strategies to recruit, retain, 
and promote individuals at all levels to maintain a 
diverse staff and leadership that can provide cul-
turally and linguistically appropriate health care to 
patient populations of the service area of the pro-
gram or activity; 
(2) shall educate and train governance, leader-
ship, and workforce at all levels and across all dis-
ciplines of the program or activity in culturally and 
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linguistically appropriate policies and practices on an 
ongoing basis at least yearly; 
(3) shall offer and provide language assistance, 
including trained and competent bilingual staff and 
interpreter services, to individuals with limited 
English proficiency or who have other communica-
tion needs, at no cost to the individual at all points 
of contact, and during all hours of operation, to fa-
cilitate timely access to health care services and 
health-care-related services; 
(4) shall for each language group consisting of 
individuals with limited English proficiency that con-
stitutes 5 percent or 500 individuals, whichever is 
less, of the population of persons eligible to be 
served or likely to be affected or encountered in the 
service area of the program or activity, make avail-
able at a fifth grade reading level— 
(A) easily understood patient-related mate-
rials, including print and multimedia materials, 
in the language of such language group; 
(B) information or notices about termi-
nation of benefits in such language; 
(C) signage; and 
(D) any other documents or types of docu-
ments designated by the Secretary; 
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(5) shall develop and implement clear goals, 
policies, operational plans, and management, ac-
countability, and oversight mechanisms to provide 
culturally and linguistically appropriate services and 
infuse them throughout the planning and operations 
of the program or activity; 
(6) shall conduct initial and ongoing organiza-
tional assessments of culturally and linguistically ap-
propriate services-related activities and integrate 
valid linguistic, competence-related National Stand-
ards for Culturally and Linguistically Appropriate 
Services (CLAS) measures into the internal audits, 
performance improvement programs, patient satis-
faction assessments, continuous quality improvement 
activities, and outcomes-based evaluations of the 
program or activity and develop ways to standardize 
the assessments, and such assessments must occur 
at least yearly; 
(7) shall ensure that, consistent with the pri-
vacy protections provided for under the regulations 
promulgated under section 264(c) of the Health In-
surance Portability and Accountability Act of 1996 
(42 U.S.C. 1320–2 note), data on an individual re-
quired to be collected pursuant to section 3101, in-
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cluding the individual’s alternative format pref-
erences and policy modification needs, are— 
(A) collected in health records; 
(B) integrated into the management infor-
mation systems of the program or activity; and 
(C) periodically updated; 
(8) shall maintain a current demographic, cul-
tural, and epidemiological profile of the community, 
conduct regular assessments of community health 
assets and needs, and use the results of such assess-
ments to accurately plan for and implement services 
that respond to the cultural and linguistic character-
istics of the service area of the program or activity; 
(9) shall develop participatory, collaborative 
partnerships with communities and utilize a variety 
of formal and informal mechanisms to facilitate 
community and patient involvement in designing, 
implementing, and evaluating policies and practices 
to ensure culturally and linguistically appropriate 
service-related activities; 
(10) shall ensure that conflict and grievance 
resolution processes are culturally and linguistically 
appropriate and capable of identifying, preventing, 
and resolving cross-cultural conflicts or complaints 
by patients; 
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(11) shall regularly make available to the public 
information about their progress and successful in-
novations in implementing the standards under this 
section and provide public notice in their commu-
nities about the availability of this information; and 
(12) shall, if requested, regularly make avail-
able to the head of each Federal entity from which 
Federal funds are provided, information about the 
progress and successful innovations of the program 
or activity in implementing the standards under this 
section as required by the head of such entity. 
(c) COMMENTS ACCEPTED THROUGH NOTICE AND 
COMMENT RULEMAKING.—An agency carrying out a pro-
gram described in subsection (a) shall ensure that com-
ments with respect to such program that are accepted 
through notice and comment rulemaking be accepted in 
all languages, may not require such comments to be sub-
mitted only in English, and must ensure these comments 
are considered equally as comments submitted in English 
during the agency’s review of comments submitted. 
SEC. 204. CULTURALLY AND LINGUISTICALLY APPRO-
PRIATE 
HEALTH 
CARE 
IN 
THE 
PUBLIC 
HEALTH SERVICE ACT. 
The Public Health Service Act (42 U.S.C. 201 et 
seq.) is amended by adding at the end the following: 
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‘‘TITLE 
XXXIV—CULTURALLY 
AND LINGUISTICALLY APPRO-
PRIATE HEALTH CARE 
‘‘SEC. 3400. DEFINITIONS. 
‘‘(a) IN GENERAL.—In this title: 
‘‘(1) BILINGUAL.—The term ‘bilingual’, with 
respect to an individual, means a person who has 
sufficient degree of proficiency in 2 languages. 
‘‘(2) CULTURAL.—The term ‘cultural’ means 
relating to integrated patterns of human behavior 
that include the language, thoughts, communica-
tions, actions, customs, beliefs, values, and institu-
tions of racial, ethnic, religious, or social groups, in-
cluding lesbian, gay, bisexual, transgender, queer, 
and questioning individuals, and individuals with 
physical and mental disabilities. 
‘‘(3) CULTURALLY
AND
LINGUISTICALLY
AP-
PROPRIATE.—The term ‘culturally and linguistically 
appropriate’ means being respectful of and respon-
sive to the cultural and linguistic needs of all indi-
viduals. 
‘‘(4) EFFECTIVE COMMUNICATION.—The term 
‘effective communication’ means an exchange of in-
formation between the provider of health care or 
health-care-related services and the recipient of such 
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services who is limited in English proficiency, or has 
a communication impairment such as a hearing, vi-
sion, speaking, or learning impairment, that enables 
access to, understanding of, and benefit from health 
care or health-care-related services, and full partici-
pation in the development of their treatment plan. 
‘‘(5) GRIEVANCE RESOLUTION PROCESS.—The 
term ‘grievance resolution process’ means all aspects 
of dispute resolution including filing complaints, 
grievance and appeal procedures, and court action. 
‘‘(6) HEALTH CARE GROUP.—The term ‘health 
care group’ means a group of physicians organized, 
at least in part, for the purposes of providing physi-
cian services under the Medicaid program under title 
XIX of the Social Security Act, the State Children’s 
Health Insurance Program under title XXI of such 
Act, or the Medicare program under title XVIII of 
such Act and may include a hospital and any other 
individual or entity furnishing services covered under 
any such program that is affiliated with the health 
care group. 
‘‘(7) HEALTH
CARE
SERVICES.—The term 
‘health care services’ means services that address 
physical as well as mental health conditions in all 
care settings. 
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‘‘(8) HEALTH-CARE-RELATED
SERVICES.—The 
term ‘health-care-related services’ means human or 
social services programs or activities that provide ac-
cess, referrals, or links to health care. 
‘‘(9) HEALTH
EDUCATOR.—The term ‘health 
educator’ includes a professional with a bacca-
laureate degree who is responsible for designing, im-
plementing, and evaluating individual and population 
health promotion and chronic disease prevention pro-
grams. 
‘‘(10) INDIAN; INDIAN TRIBE.—The terms ‘In-
dian’ and ‘Indian Tribe’ have the meanings given 
such terms in section 4 of the Indian Self-Deter-
mination and Education Assistance Act. 
‘‘(11) INDIVIDUAL
WITH
A
DISABILITY.—The 
term ‘individual with a disability’ means any indi-
vidual who has a disability as defined for the pur-
pose of section 504 of the Rehabilitation Act of 
1973. 
‘‘(12) INDIVIDUAL
WITH
LIMITED
ENGLISH 
PROFICIENCY.—The term ‘individual with limited 
English proficiency’ means an individual whose pri-
mary language for communication is not English 
and who has a limited ability to read, write, speak, 
or understand English. 
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‘‘(13) INTEGRATED
HEALTH
CARE
DELIVERY 
SYSTEM.—The term ‘integrated health care delivery 
system’ means an interdisciplinary system that 
brings together providers from the primary health, 
mental health, substance use disorder, and related 
disciplines to improve the health outcomes of an in-
dividual. Such providers may include hospitals, 
health, mental health, or substance use disorder clin-
ics and providers, home health agencies, ambulatory 
surgery centers, skilled nursing facilities, rehabilita-
tion centers, and employed, independent, or con-
tracted physicians. 
‘‘(14) INTERPRETING; INTERPRETATION.—The 
terms ‘interpreting’ and ‘interpretation’ mean the 
transmission of a spoken, written, or signed message 
from one language or format into another, faithfully, 
accurately, and objectively. 
‘‘(15) LANGUAGE ACCESS.—The term ‘language 
access’ means the provision of language services to 
an individual with limited English proficiency or an 
individual with communication disabilities designed 
to enhance that individual’s access to, understanding 
of, or benefit from health care services or health- 
care-related services. 
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‘‘(16) LANGUAGE ASSISTANCE SERVICES.—The 
term ‘language assistance services’ includes— 
‘‘(A) oral language assistance, including in-
terpretation in non-English languages provided 
in-person or remotely by a qualified interpreter 
for an individual with limited English pro-
ficiency, and the use of qualified bilingual or 
multilingual staff to communicate directly with 
individuals with limited English proficiency; 
‘‘(B) written translation, performed by a 
qualified and competent translator, of written 
content in paper or electronic form into lan-
guages other than English; and 
‘‘(C) taglines. 
‘‘(17) MINORITY.— 
‘‘(A) IN GENERAL.—The terms ‘minority’ 
and ‘minorities’ refer to individuals from a mi-
nority group. 
‘‘(B) POPULATIONS.—The term ‘minority’, 
with respect to populations, refers to racial and 
ethnic minority groups, members of sexual and 
gender minority groups, and individuals with a 
disability. 
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‘‘(18) MINORITY GROUP.—The term ‘minority 
group’ has the meaning given the term ‘racial and 
ethnic minority group’. 
‘‘(19) ONSITE
INTERPRETATION.—The term 
‘onsite interpretation’ means a method of inter-
preting or interpretation for which the interpreter is 
in the physical presence of the provider of health 
care services or health-care-related services and the 
recipient of such services who is limited in English 
proficiency or has a communication impairment such 
as an impairment in hearing, vision, or learning. 
‘‘(20) QUALIFIED
INDIVIDUAL
WITH
A
DIS-
ABILITY.—The term ‘qualified individual with a dis-
ability’ means, with respect to a health program or 
activity, an individual with a disability who, with or 
without reasonable modifications to policies, prac-
tices, or procedures, the removal of architectural, 
communication, or transportation barriers, or the 
provision of auxiliary aids and services, meets the es-
sential eligibility requirements for the receipt of aids, 
benefits, or services offered or provided by the health 
program or activity. 
‘‘(21) QUALIFIED INTERPRETER FOR AN INDI-
VIDUAL WITH A DISABILITY.—The term ‘qualified 
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interpreter for an individual with a disability’, for an 
individual with a disability— 
‘‘(A) means an interpreter who by means 
of a remote interpreting service or an onsite ap-
pearance— 
‘‘(i) adheres to generally accepted in-
terpreter ethics principles, including client 
confidentiality; and 
‘‘(ii) is able to interpret effectively, ac-
curately, and impartially, both receptively 
and expressively, using any necessary spe-
cialized vocabulary, terminology, and phra-
seology; and 
‘‘(B) may include sign language inter-
preters, oral transliterators (individuals who 
represent or spell in the characters of another 
alphabet), and cued language transliterators 
(individuals who represent or spell by using a 
small number of handshapes). 
‘‘(22) QUALIFIED INTERPRETER FOR AN INDI-
VIDUAL
WITH
LIMITED
ENGLISH
PROFICIENCY.— 
The term ‘qualified interpreter for an individual with 
limited English proficiency’ means an interpreter 
who via a remote interpreting service or an onsite 
appearance— 
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cialized vocabulary, terminology, and phrase-
ology. 
‘‘(24) RACIAL AND ETHNIC MINORITY GROUP.— 
The term ‘racial and ethnic minority group’ means 
Indians and Alaska Natives, African Americans (in-
cluding Caribbean Blacks, Africans, and other 
Blacks), Asian Americans, Hispanics (including 
Latinos), and Native Hawaiians and other Pacific 
Islanders. 
‘‘(25) 
SEXUAL
AND
GENDER
MINORITY 
GROUP.—The term ‘sexual and gender minority 
group’ encompasses lesbian, gay, bisexual, and 
transgender populations, as well as those whose sex-
ual orientation, gender identity and expression, or 
reproductive development varies from traditional, so-
cietal, cultural, or physiological norms. 
‘‘(26) SIGHT TRANSLATION.—The term ‘sight 
translation’ means the transmission of a written 
message in one language into a spoken or signed 
message in another language, or an alternative for-
mat in English or another language. 
‘‘(27) STATE.—Notwithstanding section 2, the 
term ‘State’ means each of the several States, the 
District of Columbia, the Commonwealth of Puerto 
Rico, the United States Virgin Islands, Guam, 
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American Samoa, and the Commonwealth of the 
Northern Mariana Islands. 
‘‘(28) 
TELEPHONIC
INTERPRETATION.—The 
term ‘telephonic interpretation’ (also known as ‘over 
the phone interpretation’ or ‘OPI’) means, with re-
spect to interpretation for an individual with limited 
English proficiency, a method of interpretation in 
which the interpreter is not in the physical presence 
of the provider of health care services or health-care- 
related services and such individual receiving such 
services, but the interpreter is connected via tele-
phone. 
‘‘(29) TRANSLATION.—The term ‘translation’ 
means the transmission of a written message in one 
language into a written or signed message in an-
other language, and includes translation into an-
other language or alternative format, such as large 
print font, Braille, audio recording, or CD. 
‘‘(30) VIDEO
REMOTE
INTERPRETING
SERV-
ICES.—The term ‘video remote interpreting services’ 
means the provision, in health care services or 
health-care-related services, through a qualified in-
terpreter for an individual with limited English pro-
ficiency, of video remote interpreting services that 
are— 
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‘‘(A) in real-time, full-motion video, and 
audio over a dedicated high-speed, wide-band-
width video connection or wireless connection 
that delivers high-quality video images that do 
not produce lags, choppy, blurry, or grainy im-
ages, or irregular pauses in communication; and 
‘‘(B) in a sharply delineated image that is 
large enough to display. 
‘‘(31) VITAL DOCUMENT.—The term ‘vital doc-
ument’ includes applications for government pro-
grams that provide health care services, medical or 
financial consent forms, financial assistance docu-
ments, letters containing important information re-
garding patient instructions (such as prescriptions, 
referrals to other providers, and discharge plans) 
and participation in a program (such as a Medicaid 
managed care program), notices pertaining to the 
reduction, denial, or termination of services or bene-
fits, notices of the right to appeal such actions, and 
notices advising individuals with limited English pro-
ficiency with communication disabilities of the avail-
ability of free language services, alternative formats, 
and other outreach materials. 
‘‘(b) REFERENCE.—In any reference in this title to 
a regulatory provision applicable to a ‘handicapped indi-
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vidual’, the term ‘handicapped individual’ in such provi-
sion shall have the same meaning as the term ‘individual 
with a disability’ as defined in subsection (a). 
‘‘Subtitle A—Resources and Innova-
tion for Culturally and Linguis-
tically Appropriate Health Care 
‘‘SEC. 3401. ROBERT T. MATSUI CENTER FOR CULTURALLY 
AND LINGUISTICALLY APPROPRIATE HEALTH 
CARE. 
‘‘(a) 
ESTABLISHMENT.—The 
Secretary, 
acting 
through the Director of the Agency for Healthcare Re-
search and Quality, shall establish and support a center 
to be known as the ‘Robert T. Matsui Center for Cul-
turally and Linguistically Appropriate Health Care’ (re-
ferred to in this section as the ‘Center’) to carry out each 
of the following activities: 
‘‘(1) INTERPRETATION SERVICES.—The Center 
shall provide resources via the internet to identify 
and link health care providers to competent inter-
preter and translation services. 
‘‘(2) TRANSLATION OF WRITTEN MATERIAL.— 
‘‘(A) VITAL
DOCUMENTS.—The Center 
shall provide, directly or through contract, vital 
documents from competent translation services 
for providers of health care services and health- 
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care-related services at no cost to such pro-
viders. Such documents may be submitted by 
covered entities (as defined in section 92.4 of 
title 42, Code of Federal Regulations, as in ef-
fect on May 16, 2016) for translation into non- 
English languages or alternative formats at a 
fifth-grade reading level. Such translation serv-
ices shall be provided in a timely and reason-
able manner. The quality of such translation 
services shall be monitored and reported pub-
licly. 
‘‘(B) FORMS.—For each form developed or 
revised by the Secretary that will be used by in-
dividuals with limited English proficiency in 
health care or health-care-related settings, the 
Center shall translate the form, at a minimum, 
into the top 15 non-English languages in the 
United States according to the most recent data 
from the American Community Survey or its re-
placement. The translation shall be completed 
within 45 calendar days of the Secretary receiv-
ing final approval of the form from the Office 
of Management and Budget. The Center shall 
post all translated forms on its website so that 
other entities may use the same translations. 
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lations including people with disabilities and the 
Lesbian, gay, bisexual, transgender, queer, 
questioning, 
questioning 
and 
intersex 
(LGBTQIA) community, shall be counted to-
ward the determination of full-time equiva-
lency.’’. 
(b) 
INDIRECT
MEDICAL
EDUCATION.—Section 
1886(d)(5)(B) of the Social Security Act (42 U.S.C. 
1395ww(d)(5)(B)) is amended— 
(1) by redesignating the clause (x) added by 
section 5505(b) of the Patient Protection and Af-
fordable Care Act as clause (xi); and 
(2) by adding at the end the following new 
clause: 
‘‘(xii) The provisions of subparagraph (L) of 
subsection (h)(4) shall apply under this subpara-
graph in the same manner as they apply under such 
subsection.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall apply with respect to pay-
ments made to hospitals on or after the date that is one 
year after the date of the enactment of this Act. 
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