557 
gender, gender identity, age, sexual orientation, dis-
ability, and ethnicity) of such populations; 
‘‘(3) provide information on evidence-based, cul-
turally and linguistically appropriate and adapted 
interventions and treatments; 
‘‘(4) ensure full participation of, and engage, 
both consumers and community members in the de-
velopment and implementation of materials; and 
‘‘(5) seek to broaden the perspective among 
both individuals in such communities and stake-
holders serving such communities to use a com-
prehensive public health approach to promoting be-
havioral health that addresses a holistic view of 
health by focusing on the intersection between be-
havioral and physical health. 
‘‘(b) REPORTS.—Beginning not later than 1 year 
after the date of the enactment of this section and annu-
ally thereafter, the Secretary, acting through the Assistant 
Secretary, shall submit to Congress, and make publicly 
available, a report on the extent to which the strategy de-
veloped and implemented under subsection (a) increased 
behavioral and mental health outcomes associated with 
mental health conditions and substance abuse among 
Asian American, Native Hawaiian, Pacific Islander, and 
Hispanic and Latino populations. 
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‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$300,000 for fiscal year 2021.’’. 
SEC. 608. MENTAL HEALTH IN SCHOOLS. 
(a) PURPOSE.—It is the purpose of this section to— 
(1) revise, increase funding for, and expand the 
scope of the Project AWARE State Educational 
Agency Grant Program carried out by the Secretary 
of Health and Human Services, in order to provide 
access to more comprehensive school-based mental 
health services and supports; 
(2) provide for comprehensive staff development 
for school and community service personnel working 
in the school; 
(3) provide for comprehensive training to im-
prove health and academic outcomes for children 
with, or at risk for, mental health conditions, for 
parents or guardians, siblings, and other family 
members of such children, and for concerned mem-
bers of the community; 
(4) provide for comprehensive, universal, evi-
dence-based screening to identify children and ado-
lescents with potential mental health conditions or 
unmet emotional health needs; 
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(5) recognize best practices for the delivery of 
mental health care in school-based settings, includ-
ing school-based health centers; 
(6) provide for comprehensive training for par-
ents or guardians, siblings, other family members, 
and concerned members of the community on behalf 
of children and adolescents experiencing mental 
health trauma, disorder, or disability; and 
(7) establish formal working relationships be-
tween health, human service, and educational enti-
ties that support the mental and emotional health of 
children and adolescents in the school setting. 
(b) TECHNICAL AMENDMENTS.—The second part G 
(relating to services provided through religious organiza-
tions) of title V of the Public Health Service Act (42 
U.S.C. 290kk et seq.) is amended— 
(1) by redesignating such part as part J; and 
(2) by redesignating sections 581 through 584 
as sections 596 through 596C, respectively. 
(c) SCHOOL-BASED MENTAL HEALTH AND CHIL-
DREN AND VIOLENCE.—Section 581 of the Public Health 
Service Act (42 U.S.C. 290hh) is amended to read as fol-
lows: 
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‘‘SEC. 581. SCHOOL-BASED MENTAL HEALTH; CHILDREN 
AND ADOLESCENTS AND TRAUMA. 
‘‘(a) IN GENERAL.—The Secretary, in collaboration 
with the Secretary of Education, shall, directly or through 
grants, contracts, or cooperative agreements awarded to 
eligible entities described in subsection (c), assist local 
communities and schools (including schools funded by the 
Bureau of Indian Education) in applying a public health 
approach to mental health services both in schools and in 
the community. Such approach should provide comprehen-
sive developmentally appropriate services and supports, 
that are linguistically and culturally appropriate and trau-
ma-informed, and incorporate developmentally appropriate 
strategies of positive behavioral interventions and sup-
ports. A comprehensive school mental health program 
funded under this section shall assist children in dealing 
with traumatic experiences, grief, bereavement, risk of sui-
cide, violence, and individual and community trauma that 
children may experience, and shall be implemented with 
a focus on positive youth development. Causes of trauma 
for children may include but are not limited to exposure 
to multiple forms of violence and abuse, structural racism 
and discrimination, family housing instability, family job 
loss, and climate-related disasters. 
‘‘(b) ACTIVITIES.—Under the program under sub-
section (a), the Secretary may— 
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‘‘(1) provide financial support to enable local 
communities to implement a comprehensive cul-
turally and linguistically appropriate, trauma-in-
formed, and developmentally appropriate, school- 
based mental health program that— 
‘‘(A) builds awareness of multiple forms of 
trauma, individual trauma, and intergenera-
tional, continuum of impacts of trauma, on pop-
ulations; 
‘‘(B) trains appropriate staff and edu-
cators to identify, and screen for, signs of trau-
ma exposure, mental health conditions, or risk 
of suicide; and 
‘‘(C) incorporates positive behavioral inter-
ventions, family engagement, student treatment, 
and multi-generational supports to foster the 
health and development of children, prevent 
mental health conditions, and ameliorate the 
impacts of trauma; 
‘‘(2) provide technical assistance to local com-
munities with respect to the development of pro-
grams described in paragraph (1); 
‘‘(3) provide assistance to local communities in 
the development of policies to address child and ado-
lescent trauma and mental health conditions; 
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‘‘(4) facilitate community partnerships among 
families, students, law enforcement agencies, edu-
cation agencies, mental health and substance use 
disorder systems, family-based mental health service 
systems, child welfare agencies, health care providers 
(including primary care physicians, mental health 
professionals, and other professionals who specialize 
in children’s mental health such as child and adoles-
cent psychiatrists), institutions of higher education, 
faith-based programs, trauma networks, public 
health, youth development and recreation, youth em-
ployment organizations, and other community-based 
systems; and 
‘‘(5) establish and promote trauma-informed, 
culturally based, and supportive mechanisms for 
children and adolescents to share their experiences 
of individual and community trauma, including their 
exposure to violence, with trusted adults. 
‘‘(c) REQUIREMENTS.— 
‘‘(1) IN GENERAL.—To be eligible for a grant, 
contract, or cooperative agreement under subsection 
(a), an entity shall— 
‘‘(A) be a partnership that includes— 
‘‘(i) a State educational agency (as 
defined in section 8101 of the Elementary 
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and Secondary Education Act of 1965) in 
coordination with one or more local edu-
cational agencies (as defined in section 
8101 of such Act) or a consortium of enti-
ties described in subparagraph (B), (C), 
(D), or (E) of the definition of a local edu-
cational agency in section 8101 of such 
Act; and 
‘‘(ii) in accordance with paragraph 
(2)(A)(i), appropriate public or private en-
tities that employ interventions that are 
evidence-based (as defined in section 8101 
of the Elementary and Secondary Edu-
cation Act of 1965); and 
‘‘(B) submit an application, endorsed by 
all members of the partnership, that— 
‘‘(i) specifies which members will 
serve as the lead partners; and 
‘‘(ii) contains the assurances described 
in paragraph (2). 
‘‘(2) REQUIRED ASSURANCES.—An application 
under paragraph (1) shall contain assurances as fol-
lows: 
‘‘(A) The eligible entity will ensure that, in 
carrying out activities under this section, the el-
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igible entity will enter into a memorandum of 
understanding— 
‘‘(i) with at least 2 entities from the 
following 
categories: 
community-based, 
public or private mental-health providers, 
health care entities, public health entities, 
law enforcement or juvenile justice entities, 
child welfare agencies, family-based mental 
health entities, trauma networks, commu-
nity-based entities, or other entities as de-
termined by the Secretary (which may in-
clude a human services agency or institu-
tion of higher education); and 
‘‘(ii) that clearly states— 
‘‘(I) the responsibilities of each 
partner with respect to the activities 
to be carried out, including how fam-
ily and community engagement will be 
incorporated in the activities; 
‘‘(II) how school-employed and 
school-based mental health profes-
sionals will be utilized for carrying out 
such responsibilities; 
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‘‘(III) how each such partner will 
be accountable for carrying out such 
responsibilities; and 
‘‘(IV) the amount of non-Federal 
funding or in-kind contributions that 
each such partner will contribute in 
order to sustain the program. 
‘‘(B) The comprehensive school-based men-
tal health program carried out under this sec-
tion supports the flexible use of funds to ad-
dress— 
‘‘(i) universal prevention, through the 
promotion of the social, emotional, mental, 
and behavioral health of all students in an 
environment that is conducive to learning; 
‘‘(ii) the reduction in the likelihood of 
at-risk students developing social, emo-
tional, or behavioral health problems, or 
substance use disorders; 
‘‘(iii) the screening for, and early 
identification of, social, emotional, mental, 
and behavioral problems, or substance use 
disorders and the provision of early inter-
vention services; 
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‘‘(iv) the treatment or referral for 
treatment of students with existing social, 
emotional, and mental behavioral health 
problems, or substance use disorders; 
‘‘(v) the development and implementa-
tion of evidence-based programs (including 
program curricula, school supports, and 
after-school programs) to assist children 
who are experiencing or have been exposed 
to individual and community trauma or ex-
posed to multiple forms of violence; and 
‘‘(vi) the development and implemen-
tation of evidence-based programs to assist 
children who are grieving, which may in-
clude training for school personnel on the 
impact of trauma and bereavement on chil-
dren, and services to provide support to 
grieving children. 
‘‘(C) The comprehensive school-based men-
tal health program carried out under this sec-
tion will provide for in-service training of all 
school personnel, including ancillary staff and 
volunteers, in— 
‘‘(i) the techniques and supports need-
ed to promote early identification of chil-
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dren with trauma histories, children who 
are grieving, and children with a mental 
health condition or at risk of developing a 
mental health condition, or who are at risk 
of suicide; 
‘‘(ii) the use of referral mechanisms 
that effectively link such children to appro-
priate prevention, treatment, and interven-
tion services in the school and in the com-
munity and to follow up when services are 
not available; 
‘‘(iii) strategies that promote a school- 
wide positive environment, including strat-
egies to prevent bullying, which includes 
cyber-bullying; 
‘‘(iv) strategies for promoting the so-
cial, emotional, mental, and behavioral 
health of all students; 
‘‘(v) strategies for promoting the so-
cial, emotional, mental, and behavioral 
health of all students; and 
‘‘(vi) strategies to increase the knowl-
edge and skills of school and community 
leaders about the impact of individual and 
community trauma and exposure to mul-
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tiple forms of violence on the application of 
a public health approach to comprehensive 
school-based mental health programs. 
‘‘(D) The comprehensive school-based men-
tal health program carried out under this sec-
tion will include comprehensive training for par-
ents or guardians, siblings, and other family 
members of children with mental health condi-
tions, and for concerned members of the com-
munity, in— 
‘‘(i) the techniques and supports need-
ed to promote early identification of chil-
dren with trauma histories, children who 
are grieving, children with a mental health 
condition or at risk of developing a mental 
health condition, and children who are at 
risk of suicide; 
‘‘(ii) the use of referral mechanisms 
that effectively link such children to appro-
priate prevention, treatment, and interven-
tion services in the school and in the com-
munity and followup when such services 
are not available; and 
‘‘(iii) strategies that promote a school- 
and community-wide positive environment, 
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including strategies to prevent bullying, in-
cluding cyber-bullying. 
‘‘(E) The comprehensive school-based men-
tal health program carried out under this sec-
tion will demonstrate the measures to be taken 
to sustain the program (which may include 
seeking funding for the program under a State 
Medicaid plan under title XIX of the Social Se-
curity Act or a waiver of such a plan, or under 
a State plan under subpart 1 of part B or part 
E of title IV of the Social Security Act). 
‘‘(F) The eligible entity is supported by the 
State agency with primary responsibility for be-
havioral health to ensure that comprehensive 
school-based mental health program carried out 
under this section will be sustainable after 
funding under this section terminates. 
‘‘(G) The comprehensive school-based men-
tal health program carried out under this sec-
tion will be coordinated with early intervening 
activities carried out under the Individuals with 
Disabilities Education Act or activities funded 
under part A of title IV of the Elementary and 
Secondary Education Act of 1965. 
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‘‘(H) 
The 
comprehensive 
school-based 
mental health program carried out under this 
section will be coordinated with early inter-
vening activities carried out under the Individ-
uals with Disabilities Education Act. 
‘‘(I) The comprehensive school-based men-
tal health program carried out under this sec-
tion will be trauma informed, evidence based, 
and developmentally, culturally, and linguis-
tically appropriate. 
‘‘(J) The comprehensive school-based men-
tal health program carried out under this sec-
tion will include a broad needs assessment of 
youth who drop out or are expelled from school 
due to policies of ‘zero tolerance’ with respect 
to drugs, alcohol, or weapons and an inability 
to obtain appropriate services. 
‘‘(K) The mental health services provided 
through the comprehensive school-based mental 
health program carried out under this section 
will be provided by qualified mental and behav-
ioral health professionals who are— 
‘‘(i) certified, credentialed, or licensed 
by the State involved in compliance with 
applicable Federal and State law; and 
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‘‘(ii) practicing within their area of 
expertise. 
‘‘(L) The comprehensive school-based men-
tal health program carried out under this sec-
tion will permit students to self-refer to the pro-
gram for mental health care and self-consent 
for mental health crisis care to the extent per-
mitted by State or other applicable law. 
‘‘(3) COORDINATOR.—Any entity that is a 
member of a partnership described in paragraph 
(1)(A) may serve as the coordinator of funding and 
activities under the grant if all members of the part-
nership agree. 
‘‘(4) COMPLIANCE
WITH
HIPAA.—A grantee 
under this section shall be deemed to be a covered 
entity for purposes of compliance with the regula-
tions promulgated under section 264(c) of the 
Health Insurance Portability and Accountability Act 
of 1996 with respect to any patient records devel-
oped through activities under the grant. 
‘‘(5) COMPLIANCE WITH FERPA.—Section 444 
of the General Education Provisions Act (commonly 
known as the ‘Family Educational Rights and Pri-
vacy Act of 1974’) shall apply to any entity that is 
a member of the partnership in the same manner 
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that such section applies to an educational agency or 
institution (as that term is defined in such section). 
‘‘(d) GEOGRAPHICAL DISTRIBUTION.—The Secretary 
shall ensure that grants, contracts, or cooperative agree-
ments under subsection (a) will be distributed equitably 
among the regions of the country and among urban and 
rural areas. 
‘‘(e) DURATION OF AWARDS.—With respect to the 
award of a grant, contract, or cooperative agreement 
under subsection (a), the award shall be for a period of 
5 years and may be renewed for subsequent 5-year peri-
ods. 
‘‘(f) EVALUATION AND MEASURES OF OUTCOMES.— 
‘‘(1) DEVELOPMENT OF PROCESS.—The Assist-
ant Secretary shall develop a fiscally appropriate 
process for evaluating activities carried out under 
this section. Such process shall include— 
‘‘(A) the development of guidelines for the 
submission of program data by grant, contract, 
or cooperative agreement recipients; 
‘‘(B) the development of measures of out-
comes (in accordance with paragraph (2)) to be 
applied by such recipients in evaluating pro-
grams carried out under this section; and 
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‘‘(C) the submission of annual reports by 
such recipients concerning the effectiveness of 
programs carried out under this section. 
‘‘(2) MEASURES OF OUTCOMES.— 
‘‘(A) IN
GENERAL.—The Assistant Sec-
retary shall develop measures of outcomes to be 
applied by recipients of assistance under this 
section, and the Assistant Secretary, in evalu-
ating the effectiveness of programs carried out 
under this section. Such measures shall include 
student and family measures as provided for in 
subparagraph (B) and local educational meas-
ures as provided for under subparagraph (C). 
‘‘(B) STUDENT AND FAMILY MEASURES OF 
OUTCOMES.—The measures of outcomes devel-
oped under paragraph (1)(B) relating to stu-
dents and families shall, with respect to activi-
ties and interventions carried out under a pro-
gram under this section, at a minimum include 
provisions to evaluate whether the program is 
effective in— 
‘‘(i) enhancing the social skills and 
emotional resilience of all students, as well 
as providing support to students who expe-
rience peer-inflicted bullying and isolation; 
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‘‘(ii) improving academic outcomes, 
including as measured by proficiency on 
the annual assessments under section 
1111(b)(2) of the Elementary and Sec-
ondary Education Act of 1965; 
‘‘(iii) reducing the incidence of behav-
iors that harm the self or others, or other-
wise disrupt the learning environment of 
other students, when such behavior cannot 
be reduced by the presence of reasonable 
accommodations; 
‘‘(iv) improving participation and en-
gagement in classroom activities in chil-
dren with mental health conditions; 
‘‘(v) reducing substance use disorders; 
‘‘(vi) reducing rates of suicide; 
‘‘(vii) reducing suspensions, truancy, 
expulsions, and violence; 
‘‘(viii) increasing high school gradua-
tion rates, calculated using the four-year 
adjusted cohort graduation rate or the ex-
tended-year adjusted cohort graduation 
rate (as such terms are defined in section 
8101 of the Elementary and Secondary 
Education Act of 1965); and 
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‘‘(ix) improving attendance rates and 
rates of chronic absenteeism; 
‘‘(x) improving access to care for men-
tal health conditions, including access to 
mental health services that are trauma-in-
formed, and developmentally, linguistically, 
and culturally appropriate; 
‘‘(xi) improving health outcomes; and 
‘‘(xii) decreasing disparities among 
vulnerable and protected populations in 
outcomes described in clauses (i) through 
(xi). 
‘‘(C) LOCAL EDUCATIONAL OUTCOMES.— 
The outcome measures developed under para-
graph (1)(B) relating to local educational sys-
tems shall, with respect to activities carried out 
under a program under this section, at a min-
imum include provisions to evaluate— 
‘‘(i) the effectiveness of comprehensive 
school mental health programs established 
under this section; 
‘‘(ii) the effectiveness of formal part-
nership linkages among child and family 
serving institutions, community support 
systems, and the educational system; 
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‘‘(iii) the progress made in sustaining 
the program once funding under the grant 
has expired; 
‘‘(iv) the effectiveness of training and 
professional development programs for all 
school personnel that incorporate indica-
tors that measure cultural and linguistic 
competencies under the program in a man-
ner that incorporates appropriate cultural 
and linguistic training; 
‘‘(v) the improvement in perception of 
a safe and supportive learning environment 
among school staff, students, and parents; 
‘‘(vi) the improvement in case-finding 
of students in need of more intensive serv-
ices and referral of identified students to 
early intervention and clinical services; 
‘‘(vii) the improvement in the imme-
diate availability of clinical assessment and 
treatment services within the context of 
the local community to students posing a 
danger to themselves or others; 
‘‘(viii) the increased successful matric-
ulation to postsecondary school; 
‘‘(ix) reduced suicide rates; 
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‘‘(x) referrals to juvenile justice; and 
‘‘(xi) increased educational equity. 
‘‘(3) SUBMISSION OF ANNUAL DATA.—An eligi-
ble entity described in subsection (c) that receives a 
grant, contract, or cooperative agreement under this 
section shall annually submit to the Assistant Sec-
retary a report that includes data to evaluate the 
success of the program carried out by the entity 
based on whether such program is achieving the pur-
poses of the program. Such reports shall utilize the 
measures of outcomes under paragraph (2) in a rea-
sonable manner to demonstrate the progress of the 
program in achieving such purposes. 
‘‘(4) EVALUATION BY ASSISTANT SECRETARY.— 
Based on the data submitted under paragraph (3), 
the Assistant Secretary shall annually submit to 
Congress a report concerning the results and effec-
tiveness of the programs carried out with assistance 
received under this section. 
‘‘(5) LIMITATION.—An eligible entity shall use 
not more than 20 percent of amounts received under 
a grant under this section to carry out evaluation 
activities under this subsection. 
‘‘(g) INFORMATION
AND
EDUCATION.—The Sec-
retary shall establish comprehensive information and edu-
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cation programs to disseminate the findings of the knowl-
edge development and application under this section to the 
general public and to health care professionals. 
‘‘(h) AMOUNT OF GRANTS AND AUTHORIZATION OF 
APPROPRIATIONS.— 
‘‘(1) AMOUNT OF GRANTS.—A grant under this 
section shall be in an amount that is not more than 
$2,000,000 for each of the first 5 fiscal years fol-
lowing the date of enactment of the Mental Health 
Services for Students Act of 2019. The Secretary 
shall determine the amount of each such grant based 
on the population of children up to age 21 of the 
area to be served under the grant. 
‘‘(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this section $200,000,000 for each of the first 5 fis-
cal years following the date of enactment of the Im-
migrants’ Mental Health Act of 2020.’’. 
(d) CONFORMING AMENDMENT.—Part G of title V 
of the Public Health Service Act (42 U.S.C. 290hh et 
seq.), as amended by this section, is further amended by 
striking the part heading and inserting the following: 
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‘‘PART G—SCHOOL-BASED MENTAL HEALTH’’. 
SEC. 609. BUILDING AN EFFECTIVE WORKFORCE IN MEN-
TAL HEALTH. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, in coordination with the Assistant Sec-
retary for Mental Health and Substance Use, the Adminis-
trator of the Health Resources and Services Administra-
tion, and the Secretary of Labor, shall, in coordination 
with advocacy and behavioral and mental health organiza-
tions serving people of color— 
(1) develop, strengthen, and implement strate-
gies to bolster career pathways for mental health 
professionals; and 
(2) identify the breadth of settings where men-
tal and behavioral health care can take place. 
(b) CONTENTS.—Strategies under subsection (a) 
shall include— 
(1) the variety of settings where mental health 
professionals are needed, including community-based 
organizations, women’s centers, shelters, organiza-
tions focused on youth development, workforce agen-
cies, job placement and development centers, emer-
gency rooms, the special supplemental nutrition pro-
gram for women, infants, and children under section 
17 of the Child Nutrition Act of 1966 (42 U.S.C. 
1786), food banks, legal aid, and benefit issuers as 
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defined in section 3 of the Food and Nutrition Act 
of 2008 (7 U.S.C. 2012); 
(2) defining career pathways in mental and be-
havioral health, to help communities understand the 
variety of careers in mental health that are avail-
able; 
(3) building career pathways in mental and be-
havioral health as part of the curriculum at the 
postsecondary education level; 
(4) providing accessible training and certifi-
cation pathways for lay health workers such as com-
munity health workers and other peer support indi-
viduals to ensure that careers pay a living wage; 
(5) creating incentives for students in the fields 
of occupational therapy, social work, medicine, and 
nursing to learn more about mental health, and to 
include a mental health rotation as a part of the 
health professional curricula; 
(6) including training and education for teach-
ers about the basics of section 504 of the Rehabilita-
tion Act of 1973 (29 U.S.C. 794) and individualized 
education programs (as defined in section 614(d) of 
the Individuals with Disabilities in Education Act 
(20 U.S.C. 1414(d)); 
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(7) researching, developing, and implementing 
programs for mental and behavioral health profes-
sionals to prevent burnout; 
(8) finding better and increased avenues to en-
sure equity by providing better loan forgiveness pro-
grams, including a focus area within the National 
Health Service Corps focused on community trauma. 
SEC. 610. MENTAL HEALTH AT THE BORDER. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Immigrants’ Mental Health Act of 2020’’. 
(b) TRAINING FOR CERTAIN CBP PERSONNEL IN 
MENTAL HEALTH ISSUES.— 
(1) TRAINING TO IDENTIFY RISK FACTORS AND 
WARNING SIGNS IN IMMIGRANTS AND REFUGEES.— 
(A) IN GENERAL.—The Commissioner of 
U.S. Customs and Border Protection, in con-
sultation with the Assistant Secretary for Men-
tal Health and Substance Use, the Adminis-
trator of the Health Resources and Services Ad-
ministration, and nongovernmental experts in 
the delivery of health care in humanitarian cri-
ses and in the delivery of health care to chil-
dren, shall develop and implement a training 
curriculum for U.S. Customs and Border Pro-
tection agents and officers assigned to U.S. 
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Customs and Border Protection facilities to en-
able such agents and officers to identify the 
risk factors and warning signs in immigrants 
and refugees of mental health issues relating to 
trauma. 
(B) REQUIREMENTS.—The training cur-
riculum described in subparagraph (A) shall— 
(i) apply to all U.S. Customs and 
Border Protection agents and officers 
working at U.S. Customs and Border Pro-
tection facilities; 
(ii) provide for crisis intervention 
using a trauma-informed approach; and 
(iii) 
provide 
for 
mental 
health 
screenings for immigrants and refugees ar-
riving at the border in their preferred lan-
guage or with appropriate language assist-
ance. 
(2) TRAINING TO ADDRESS MENTAL HEALTH 
AND WELLNESS OF CBP AGENTS AND OFFICERS.— 
(A) IN GENERAL.—The Commissioner of 
U.S. Customs and Border Protection, in con-
sultation with the Assistant Secretary for Men-
tal Health and Substance Use, the Adminis-
trator of the Health Resources and Services Ad-
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ministration, and nongovernmental experts in 
the delivery of mental health care, shall develop 
and implement a training curriculum for U.S. 
Customs and Border Protection agents and offi-
cers assigned to U.S. Customs and Border Pro-
tection facilities to address the mental health 
and wellness of individuals working at such fa-
cilities. 
(B) REQUIREMENT.—The training cur-
riculum described in subparagraph (A) shall be 
designed to help U.S. Customs and Border Pro-
tection agents and officers working at U.S. 
Customs and Border Protection facilities to— 
(i) better manage their own stress and 
the stress of their coworkers; and 
(ii) be more aware of the psychological 
pressures experienced during their jobs. 
(3) ANNUAL REVIEW OF TRAINING.—Beginning 
with respect to fiscal year 2022, the Assistant Sec-
retary for Mental Health and Substance Use shall— 
(A) conduct an annual review of the train-
ing implemented pursuant to paragraphs (1) 
and (2); and 
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(B) submit the results of each such review, 
including any recommendations for improve-
ment of such training, to— 
(i) the Commissioner of U.S. Customs 
and Border Protection; and 
(ii) the Committees on Appropria-
tions, Energy and Commerce, Homeland 
Security, and the Judiciary of the House 
of Representatives and the Committees on 
Appropriations, Health, Education, Labor, 
and Pensions, and Homeland Security and 
Governmental Affairs of the Senate. 
(4) AUTHORIZATION OF APPROPRIATIONS.—To 
carry out this subsection, there is authorized to be 
appropriated— 
(A) for fiscal year 2021, $50,000 to de-
velop the training under paragraphs (1) and 
(2); and 
(B) for each of fiscal years 2022 through 
2026— 
(i) $20,000 to implement such train-
ing pursuant to paragraphs (1) and (2); 
and 
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(ii) such sums as may be necessary to 
review and make recommendations for 
such training pursuant to paragraph (3). 
(c) STAFFING BORDER FACILITIES AND DETENTION 
CENTERS.— 
(1) IN GENERAL.—To adequately evaluate the 
mental health needs of immigrants, refugees, border 
patrol agents, and staff, the Commissioner of U.S. 
Customs and Border Protection shall assign at least 
one qualified mental or behavioral health expert to 
each U.S. Customs and Border Protection facility. 
(2) QUALIFICATIONS.—To be qualified for pur-
poses of paragraph (1), a mental or behavioral 
health expert shall be— 
(A) bilingual; 
(B) well-versed in culturally appropriate 
and trauma-informed interventions; and 
(C) have particular expertise in child or 
adolescent mental health or family mental 
health. 
(3) AUTHORIZATION OF APPROPRIATIONS.—To 
carry out this subsection, there is authorized to be 
appropriated $3,000,000 for each of fiscal years 
2021 through 2025. 
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(d) NO SHARING OF DEPARTMENT OF HEALTH AND 
HUMAN SERVICES MENTAL HEALTH INFORMATION FOR 
ASYLUM DETERMINATIONS, IMMIGRATION HEARINGS, OR 
DEPORTATION PROCEEDINGS.—The officers, employees, 
and agents of the Department of Health and Human Serv-
ices, including the Office of Refugee Resettlement, may 
not share with the Department of Homeland Security, and 
the officers, employees, and agents of the Department of 
Homeland Security may not request or receive from the 
Department of Health and Human Services, for the pur-
poses of an asylum determination, immigration hearing, 
or deportation proceeding, any information or record 
that— 
(1) concerns the mental health of an alien; and 
(2) was obtained or produced by a mental or 
behavioral health professional while the alien was in 
a shelter or otherwise in the custody of the Federal 
Government. 
(e) DEFINITIONS.—In this section: 
(1) The term ‘‘U.S. Customs and Border Pro-
tection facility’’ means any of the following facilities 
that typically detain migrants on behalf of U.S. Cus-
toms and Border Protection: 
(A) U.S. Border Patrol stations. 
(B) Ports of entry. 
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(C) Checkpoints. 
(D) Forward operating bases. 
(E) Secondary inspection areas. 
(F) Short-term custody facilities. 
(2) The term ‘‘forward operating base’’ means 
a permanent facility established by U.S. Customs 
and Border Protection in forward or remote loca-
tions, and designated as such by U.S. Customs and 
Border Protection. 
TITLE VII—ADDRESSING HIGH- 
IMPACT MINORITY DISEASES 
Subtitle A—Cancer 
SEC. 701. LUNG CANCER MORTALITY REDUCTION. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Lung Cancer Mortality Reduction Act of 2020’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) Lung cancer is the leading cause of cancer 
death for both men and women, accounting for 25 
percent of all cancer deaths. 
(2) Lung cancer kills more people annually 
than breast cancer, prostate cancer, colon cancer, 
liver cancer, melanoma, and kidney cancer combined. 
(3) Since the National Cancer Act of 1971 
(Public Law 92–218; 85 Stat. 778), coordinated and 
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comprehensive research has raised the 5-year sur-
vival rates for breast cancer to 90 percent, for pros-
tate cancer to 99 percent, and for colon cancer to 
64 percent. 
(4) The 5-year survival rate for lung cancer is 
still only 18 percent, and a similar coordinated and 
comprehensive research effort is required to achieve 
increases in lung cancer survivability rates. 
(5) Sixty percent of lung cancer cases are now 
diagnosed in nonsmokers or former smokers. 
(6) Two-thirds of nonsmokers diagnosed with 
lung cancer are women. 
(7) Certain minority populations, such as Afri-
can-American males, have disproportionately high 
rates of lung cancer incidence and mortality, despite 
their smoking rate being similar to other racial 
groups. 
(8) Members of the Baby Boomer Generation 
are entering their 60s, the most common age at 
which people develop lung cancer. 
(9) Tobacco addiction and exposure to other 
lung cancer carcinogens such as Agent Orange and 
other herbicides and battlefield emissions are serious 
problems among military personnel and war vet-
erans. 
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(10) Significant and rapid improvements in 
lung cancer mortality can be expected through great-
er use and access to lung cancer screening tests for 
at-risk individuals. 
(11) Recent research has shown that screening 
with low-dose computed tomography scan reduced 
lung cancer death mortality by 20 percent for those 
with a high risk of lung cancer through early detec-
tion. The Centers for Medicare & Medicaid Services 
supports annual lung cancer screening for high-risk 
patients with low-dose computed tomography. 
(12) Additional strategies are necessary to fur-
ther enhance the existing tests and therapies avail-
able to diagnose and treat lung cancer in the future. 
(13) The August 2001 Report of the Lung 
Cancer Progress Review Group of the National Can-
cer Institute stated that funding for lung cancer re-
search was ‘‘far below the levels characterized for 
other common malignancies and far out of propor-
tion to its massive health impact’’. 
(14) The Report of the Lung Cancer Progress 
Review Group identified as its ‘‘highest priority’’ the 
creation of integrated, multidisciplinary, multi-insti-
tutional research consortia organized around the 
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problem of lung cancer rather than around specific 
research disciplines. 
(15) The United States must enhance its re-
sponse to the issues raised in the Report of the 
Lung Cancer Progress Review Group, and this can 
be accomplished through the establishment of a co-
ordinated effort designed to reduce the lung cancer 
mortality rate by 50 percent by 2020 and targeted 
funding to support this coordinated effort. 
(c) SENSE OF CONGRESS CONCERNING INVESTMENT 
IN LUNG CANCER RESEARCH.—It is the sense of the Con-
gress that— 
(1) lung cancer mortality reduction should be 
made a national public health priority; and 
(2) a comprehensive mortality reduction pro-
gram coordinated by the Secretary of Health and 
Human Services is justified and necessary to ade-
quately address and reduce lung cancer mortality. 
(d) LUNG CANCER MORTALITY REDUCTION PRO-
GRAM.— 
(1) IN GENERAL.—Subpart 1 of part C of title 
IV of the Public Health Service Act (42 U.S.C. 285 
et seq.) is amended by adding at the end the fol-
lowing: 
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‘‘SEC. 417H. LUNG CANCER MORTALITY REDUCTION PRO-
GRAM. 
‘‘(a) IN GENERAL.—Not later than 6 months after 
the date of the enactment of the Health Equity and Ac-
countability Act of 2020, the Secretary, in consultation 
with the Secretary of Defense, the Secretary of Veterans 
Affairs, the Director of the National Institutes of Health, 
the Director of the Centers for Disease Control and Pre-
vention, the Commissioner of Food and Drugs, the Admin-
istrator of the Centers for Medicare & Medicaid Services, 
the Director of the National Institute on Minority Health 
and Health Disparities, and other members of the Lung 
Cancer Advisory Board established under section 701 of 
the Health Equity and Accountability Act of 2020, shall 
implement a comprehensive program, to be known as the 
Lung Cancer Mortality Reduction Program, to achieve a 
reduction of at least 25 percent in the mortality rate of 
lung cancer by 2020. 
‘‘(b) REQUIREMENTS.—The Program shall include at 
least the following: 
‘‘(1) With respect to the National Institutes of 
Health— 
‘‘(A) a strategic review and prioritization 
by the National Cancer Institute of research 
grants to achieve the goal of the Lung Cancer 
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Mortality Reduction Program in reducing lung 
cancer mortality; 
‘‘(B) the provision of funds to enable the 
Airway Biology and Disease Branch of the Na-
tional Heart, Lung, and Blood Institute to ex-
pand its research programs to include pre-
dispositions to lung cancer, the interrelationship 
between lung cancer and other pulmonary and 
cardiac disease, and the diagnosis and treat-
ment of those interrelationships; 
‘‘(C) the provision of funds to enable the 
National Institute of Biomedical Imaging and 
Bioengineering to expedite the development of 
computer-assisted diagnostic, surgical, treat-
ment, and drug-testing innovations to reduce 
lung cancer mortality, such as through expan-
sion of the Institute’s Quantum Grant Program 
and Image-Guided Interventions programs; and 
‘‘(D) the provision of funds to enable the 
National Institute of Environmental Health 
Sciences to implement research programs rel-
ative to the lung cancer incidence. 
‘‘(2) With respect to the Food and Drug Ad-
ministration— 
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‘‘(A) activities under section 529B of the 
Federal Food, Drug, and Cosmetic Act; and 
‘‘(B) activities under section 561 of the 
Federal Food, Drug, and Cosmetic Act to ex-
pand access to investigational drugs and devices 
for the diagnosis, monitoring, or treatment of 
lung cancer. 
‘‘(3) With respect to the Centers for Disease 
Control and Prevention, the establishment of an 
early disease research and management program 
under section 1511. 
‘‘(4) With respect to the Agency for Healthcare 
Research and Quality, the conduct of a biannual re-
view of lung cancer screening, diagnostic, and treat-
ment protocols, and the issuance of updated guide-
lines. 
‘‘(5) The promotion (including education) of 
lung cancer screening within minority and rural pop-
ulations and the study of the effectiveness of efforts 
to increase such screening. 
‘‘(6) The cooperation and coordination of all 
minority and health disparity programs within the 
Department of Health and Human Services to en-
sure that all aspects of the Lung Cancer Mortality 
Reduction Program under this section adequately 
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address the burden of lung cancer on minority and 
rural populations. 
‘‘(7) The cooperation and coordination of all to-
bacco control and cessation programs within agen-
cies of the Department of Health and Human Serv-
ices to achieve the goals of the Lung Cancer Mor-
tality Reduction Program under this section with 
particular emphasis on the coordination of drug and 
other cessation treatments with early detection pro-
tocols.’’. 
(2) FEDERAL
FOOD, DRUG, AND
COSMETIC 
ACT.—Subchapter B of chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa et 
seq.) is amended by adding at the end the following: 
‘‘SEC. 529B. DRUGS RELATING TO LUNG CANCER. 
‘‘(a) IN GENERAL.—The provisions of this sub-
chapter shall apply to a drug described in subsection (b) 
to the same extent and in the same manner as such provi-
sions apply to a drug for a rare disease or condition. 
‘‘(b) QUALIFIED DRUGS.—A drug described in this 
subsection is— 
‘‘(1) a chemoprevention drug for precancerous 
conditions of the lung; 
‘‘(2) a drug for targeted therapeutic treat-
ments, including any vaccine, for lung cancer; or 
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‘‘(3) a drug to curtail or prevent nicotine addic-
tion. 
‘‘(c) BOARD.—The Board established under section 
701 of the Health Equity and Accountability Act of 2020 
shall monitor the program implemented under this sec-
tion.’’. 
(3) ACCESS TO UNAPPROVED THERAPIES.—Sec-
tion 561(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb(e)) is amended by in-
serting before the period the following: ‘‘and shall 
include expanding access to drugs under section 
529B, with substantial consideration being given to 
whether the totality of information available to the 
Secretary regarding the safety and effectiveness of 
an investigational drug, as compared to the risk of 
morbidity and death from the disease, indicates that 
a patient may obtain more benefit than risk if treat-
ed with the drug’’. 
(4) CDC.—Title XV of the Public Health Serv-
ice Act (42 U.S.C. 300k et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 1511. EARLY DISEASE RESEARCH AND MANAGEMENT 
PROGRAM. 
‘‘The Secretary shall establish and implement an 
early disease research and management program targeted 
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at the high incidence and mortality rates of lung cancer 
among minority and low-income populations.’’. 
(e) DEPARTMENT OF DEFENSE AND THE DEPART-
MENT OF VETERANS AFFAIRS.—The Secretary of Defense 
and the Secretary of Veterans Affairs, each in coordina-
tion with the Secretary of Health and Human Services, 
shall engage— 
(1) in the implementation within the Depart-
ment of Defense and the Department of Veterans 
Affairs of an early detection and disease manage-
ment research program for military personnel and 
veterans whose smoking history and exposure to car-
cinogens during active duty service has increased 
their risk for lung cancer; and 
(2) in the implementation of coordinated care 
programs for military personnel and veterans diag-
nosed with lung cancer. 
(f) LUNG CANCER ADVISORY BOARD.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall convene a Lung Cancer Advi-
sory Board (referred to in this section as the 
‘‘Board’’)— 
(A) to monitor the programs established 
under this section (and the amendments made 
by this section); and 
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(B) to provide annual reports to the Con-
gress concerning benchmarks, expenditures, 
lung cancer statistics, and the public health im-
pact of such programs. 
(2) COMPOSITION.—The Board shall be com-
prised of— 
(A) the Secretary of Health and Human 
Services; 
(B) the Secretary of Defense; 
(C) the Secretary of Veterans Affairs; and 
(D) 2 representatives each from the fields 
of clinical medicine focused on lung cancer, 
lung cancer research, imaging, drug develop-
ment, and lung cancer advocacy, to be ap-
pointed by the Secretary of Health and Human 
Services. 
(g) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN
GENERAL.—To carry out this section 
(and the amendments made by this section), there 
are authorized to be appropriated $75,000,0000 for 
fiscal year 2021 and such sums as may be necessary 
for each of fiscal years 2022 through 2025. 
(2) LUNG CANCER MORTALITY REDUCTION PRO-
GRAM.—The amounts appropriated under paragraph 
(1) shall be allocated as follows: 
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(A) $25,000,000 for fiscal year 2021, and 
such sums as may be necessary for each of fis-
cal years 2022 through 2025, for the activities 
described in section 417H(b)(1)(B) of the Pub-
lic Health Service Act, as added by subsection 
(d); 
(B) $25,000,000 for fiscal year 2021, and 
such sums as may be necessary for each of fis-
cal years 2022 through 2025, for the activities 
described in section 417H(b)(1)(C) of the Pub-
lic Health Service Act; 
(C) $10,000,000 for fiscal year 2021, and 
such sums as may be necessary for each of fis-
cal years 2022 through 2025, for the activities 
described in section 417H(b)(1)(D) of the Pub-
lic Health Service Act; and 
(D) $15,000,000 for fiscal year 2021, and 
such sums as may be necessary for each of fis-
cal years 2022 through 2025, for the activities 
described in section 417H(b)(3) of the Public 
Health Service Act. 
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SEC. 702. EXPANDING PROSTATE CANCER RESEARCH, OUT-
REACH, SCREENING, TESTING, ACCESS, AND 
TREATMENT EFFECTIVENESS. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Prostate Research, Outreach, Screening, Testing, Access, 
and Treatment Effectiveness Act of 2020’’ or the ‘‘PROS-
TATE Act’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) Prostate cancer is the second leading cause 
of cancer death among men. 
(2) In 2018, an estimated 164,690 men will be 
diagnosed with prostate cancer and more than 
29,000 will die from this disease. 
(3) Roughly 2,000,000 to 3,000,000 people in 
the United States are living with a diagnosis of pros-
tate cancer and its consequences. 
(4) While prostate cancer generally affects older 
individuals, younger men are also at risk for the dis-
ease, and when prostate cancer appears in early 
middle age, it frequently takes on a more aggressive 
form. 
(5) There are significant racial and ethnic dis-
parities that demand attention; African Americans 
have prostate cancer mortality rates that are more 
than double those in the White population. 
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(6) Underserved rural populations have higher 
rates of mortality compared to their urban counter-
parts, and innovative and cost-efficient methods to 
improve rural access to high-quality care should take 
advantage of advances in telehealth to diagnose and 
treat prostate cancer when appropriate. 
(7) Certain veterans populations may have 
nearly twice the incidence of prostate cancer as the 
general population of the United States. 
(8) Urologists may constitute the specialists 
who diagnose and treat the vast majority of prostate 
cancer patients. 
(9) Although much basic and translational re-
search has been completed and much is currently 
known, there are still many unanswered questions, 
such as the extent to which known disparities are at-
tributable to disease etiology, access to care, or edu-
cation and awareness in the community. 
(10) Causes of prostate cancer are not known. 
There is not good information regarding how to dif-
ferentiate accurately, early on, between aggressive 
and indolent forms of the disease. As a result, there 
is significant overtreatment in prostate cancer. 
There are no treatments that can durably arrest 
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growth or cure prostate cancer once it has metasta-
sized. 
(11) A significant proportion (about 23 to 54 
percent) of cases may be clinically indolent and 
‘‘overdiagnosed’’, resulting in significant overtreat-
ment. More accurate tests will allow men and their 
families to face less physical, psychological, financial, 
and emotional trauma, and billions of dollars could 
be saved in private and public health care systems 
in an area that has been identified by the Medicare 
program under title XVIII of the Social Security Act 
(42 U.S.C. 1395 et seq.) as one of 8 high-volume, 
high-cost areas in the Resource Utilization Report 
Program established under the Medicare Improve-
ments for Patients and Providers Act of 2008 (Pub-
lic Law 110–275). 
(12) Prostate cancer research and health care 
programs across Federal agencies should be coordi-
nated to improve accountability and actively encour-
age the translation of research into practice, to iden-
tify and implement best practices, in order to foster 
an integrated and consistent focus on effective pre-
vention, diagnosis, and treatment of this disease. 
(c) PROSTATE CANCER COORDINATION AND EDU-
CATION.— 
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(1) INTERAGENCY PROSTATE CANCER COORDI-
NATION AND EDUCATION TASK FORCE.—Not later 
than 180 days after the date of the enactment of 
this section, the Secretary of Veterans Affairs, in co-
operation with the Secretary of Defense and the Sec-
retary of Health and Human Services, shall estab-
lish an Interagency Prostate Cancer Coordination 
and Education Task Force (in this section referred 
to as the ‘‘Prostate Cancer Task Force’’). 
(2) DUTIES.—The Prostate Cancer Task Force 
shall— 
(A) develop a summary of advances in 
prostate cancer research supported or con-
ducted by Federal agencies relevant to the diag-
nosis, prevention, and treatment of prostate 
cancer, including psychosocial impairments re-
lated to prostate cancer treatment, and compile 
a list of best practices that warrant broader 
adoption in health care programs; 
(B) consider establishing, and advocating 
for, a guidance to enable physicians to allow 
screening of men who are over age 74, on a 
case-by-case basis, taking into account quality 
of life and family history of prostate cancer; 
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(C) share and coordinate information on 
Federal research and health care program ac-
tivities, including activities related to— 
(i) determining how to improve re-
search and health care programs, including 
psychosocial impairments related to pros-
tate cancer treatment; 
(ii) identifying any gaps in the overall 
research inventory and in health care pro-
grams; 
(iii) identifying opportunities to pro-
mote translation of research into practice; 
and 
(iv) maximizing the effects of Federal 
efforts by identifying opportunities for col-
laboration and leveraging of resources in 
research and health care programs that 
serve individuals who are susceptible to or 
diagnosed with prostate cancer; 
(D) develop a comprehensive interagency 
strategy and advise relevant Federal agencies in 
the solicitation of proposals for collaborative, 
multidisciplinary research and health care pro-
grams, including proposals to evaluate factors 
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that may be related to the etiology of prostate 
cancer, that would— 
(i) result in innovative approaches to 
study emerging scientific opportunities or 
eliminate knowledge gaps in research to 
improve the prostate cancer research port-
folio of the Federal Government; 
(ii) outline key research questions, 
methodologies, and knowledge gaps; and 
(iii) ensure consistent action, as out-
lined by section 402(b) of the Public 
Health Service Act; 
(E) develop a coordinated message related 
to screening and treatment for prostate cancer 
to be reflected in educational and beneficiary 
materials for Federal health programs as such 
documents are updated; and 
(F) not later than 2 years after the date 
of the establishment of the Prostate Cancer 
Task Force, submit to the Expert Advisory 
Panel to be reviewed and returned within 30 
days, and then within 90 days submitted to 
Congress recommendations— 
(i) regarding any appropriate changes 
to research and health care programs, in-
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cluding recommendations to improve the 
research portfolio of the Department of 
Veterans Affairs, the Department of De-
fense, National Institutes of Health, and 
other Federal agencies to ensure that sci-
entifically based strategic planning is im-
plemented in support of research and 
health care program priorities; 
(ii) designed to ensure that the re-
search and health care programs and ac-
tivities of the Department of Veterans Af-
fairs, the Department of Defense, the De-
partment of Health and Human Services, 
and other Federal agencies are free of un-
necessary duplication; 
(iii) regarding public participation in 
decisions relating to prostate cancer re-
search and health care programs to in-
crease the involvement of patient advo-
cates, community organizations, and med-
ical associations representing a broad geo-
graphical area; 
(iv) on how to best disseminate infor-
mation on prostate cancer research and 
progress achieved by health care programs; 
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(v) about how to expand partnerships 
between public entities, including Federal 
agencies, and private entities to encourage 
collaborative, cross-cutting research and 
health care delivery; 
(vi) assessing any cost savings and ef-
ficiencies realized through the efforts iden-
tified and supported in this section and 
recommending expansion of those efforts 
that have proved most promising while also 
ensuring against any conflicts in directives 
from other congressional or statutory man-
dates or enabling statutes; 
(vii) identifying key priority action 
items from among the recommendations; 
and 
(viii) with respect to the level of fund-
ing needed by each agency to implement 
the recommendations contained in the re-
port. 
(3) MEMBERS OF THE PROSTATE CANCER TASK 
FORCE.—The Prostate Cancer Task Force described 
in this subsection shall be comprised of representa-
tives from such Federal agencies, as each head of 
such applicable agencies determines necessary, to co-
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(v) The Centers for Disease Control 
and Prevention. 
(vi) The Agency for Healthcare Re-
search and Quality. 
(vii) The Health Resources and Serv-
ices Administration. 
(4) APPOINTING EXPERT ADVISORY PANELS.— 
The Prostate Cancer Task Force shall appoint ex-
pert advisory panels, as such task force determines 
appropriate, to provide input and concurrence from 
individuals and organizations from the medical, 
prostate cancer patient and advocate, research, and 
delivery communities with expertise in prostate can-
cer diagnosis, treatment, and research, including 
practicing urologists, primary care providers, and 
others and individuals with expertise in education 
and outreach to underserved populations affected by 
prostate cancer. 
(5) MEETINGS.—The Prostate Cancer Task 
Force shall convene not less than twice a year, or 
more frequently as the Secretary of Veterans Affairs 
determines to be appropriate. 
(6) FEDERAL ADVISORY COMMITTEE ACT.— 
(A) IN GENERAL.—Except as provided in 
subparagraph (B), the Federal Advisory Com-
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mittee Act (5 U.S.C. App.) shall apply to the 
Prostate Cancer Task Force. 
(B) EXCEPTION.—Section 14(a)(2)(B) of 
such Act (relating to the termination of advi-
sory committees) shall not apply to the Prostate 
Cancer Task Force. 
(7) SUNSET DATE.—The Prostate Cancer Task 
Force shall terminate on September 30, 2025. 
(d) PROSTATE CANCER RESEARCH.— 
(1) RESEARCH COORDINATION.—The Secretary 
of Veterans Affairs, in coordination with the Sec-
retary of Defense and the Secretary of Health and 
Human Services, shall establish and carry out a pro-
gram to coordinate and intensify prostate cancer re-
search. Such research program shall— 
(A) develop advances in diagnostic and 
prognostic methods and tests, including bio-
markers and an improved prostate cancer 
screening blood test, including improvements or 
alternatives to the prostate specific antigen test 
and additional tests to distinguish indolent from 
aggressive disease; 
(B) develop better understanding of the 
etiology of the disease (including an analysis of 
lifestyle factors proven to be involved in higher 
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rates of prostate cancer, such as obesity and 
diet, and in different ethnic, racial, and socio-
economic groups, such as the African-American, 
Latino or Hispanic, and American Indian popu-
lations and men with a family history of pros-
tate cancer) to improve prevention efforts; 
(C) expand basic research into prostate 
cancer, including studies of fundamental molec-
ular and cellular mechanisms; 
(D) identify and provide clinical testing of 
novel agents for the prevention and treatment 
of prostate cancer; 
(E) establish clinical registries for prostate 
cancer; 
(F) use the National Institute of Bio-
medical Imaging and Bioengineering and the 
National Cancer Institute for assessment of ap-
propriate imaging modalities; and 
(G) address such other matters relating to 
prostate cancer research as may be identified by 
the Federal agencies participating in the pro-
gram under this subsection. 
(2) PROSTATE
CANCER
ADVISORY
BOARD.— 
There is established in the Office of the Chief Sci-
entist of the Food and Drug Administration a Pros-
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tate Cancer Scientific Advisory Board. Such board 
shall be responsible for accelerating real-time shar-
ing of the latest research data and accelerating 
movement of new medicines to patients. 
(3) UNDERSERVED
MINORITY
GRANT
PRO-
GRAM.—In carrying out such program, the Secretary 
shall— 
(A) award grants to eligible entities to 
carry out components of the research outlined 
in paragraph (1); 
(B) integrate and build upon existing 
knowledge gained from comparative effective-
ness research; and 
(C) recognize and address— 
(i) the racial and ethnic disparities in 
the incidence and mortality rates of pros-
tate cancer and men with a family history 
of prostate cancer; 
(ii) any barriers in access to care and 
participation in clinical trials that are spe-
cific to racial, ethnic, and other under-
served minorities and men with a family 
history of prostate cancer; 
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(iii) outreach and educational efforts 
to raise awareness among the populations 
described in clause (ii); and 
(iv) appropriate access and utilization 
of imaging modalities. 
(e) TELEHEALTH
AND
RURAL
ACCESS
PILOT 
PROJECTS.— 
(1) IN GENERAL.—The Secretary of Veterans 
Affairs, in cooperation with the Secretary of Defense 
and the Secretary of Health and Human Services 
(referred to in this section collectively as the ‘‘Secre-
taries’’) shall establish 4-year telehealth pilot 
projects for the purpose of analyzing the clinical out-
comes and cost-effectiveness associated with tele-
health services in a variety of geographic areas that 
contain high proportions of medically underserved 
populations, including African Americans, Latinos or 
Hispanics, American Indians or Alaska Natives, and 
those in rural areas. Such projects shall promote ef-
ficient use of specialist care through better coordina-
tion of primary care and physician extender teams 
in underserved areas and more effectively employ 
tumor boards to better counsel patients. 
(2) ELIGIBLE ENTITIES.— 
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(A) IN
GENERAL.—The Secretaries shall 
select eligible entities to participate in the pilot 
projects under this section. 
(B) PRIORITY.—In selecting eligible enti-
ties to participate in the pilot projects under 
this section, the Secretaries shall give priority 
to such entities located in medically under-
served areas, particularly those that include Af-
rican Americans, Latinos and Hispanics, and 
facilities of the Indian Health Service, including 
Indian Health Service-operated facilities, trib-
ally operated facilities, and Urban Indian Clin-
ics, and those in rural areas. 
(3) 
EVALUATION.—The 
Secretaries 
shall, 
through the pilot projects, evaluate— 
(A) the effective and economic delivery of 
care in diagnosing and treating prostate cancer 
with the use of telehealth services in medically 
underserved and Tribal areas including collabo-
rative uses of health professionals and integra-
tion of the range of telehealth and other tech-
nologies; 
(B) the effectiveness of improving the ca-
pacity of nonmedical providers and nonspecial-
ized medical providers to provide health services 
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for prostate cancer in medically underserved 
and Tribal areas, including the exploration of 
innovative medical home models with collabora-
tion between urologists, other relevant medical 
specialists, including oncologists, radiologists, 
and primary care teams and coordination of 
care through the efficient use of primary care 
teams and physician extenders; and 
(C) the effectiveness of using telehealth 
services to provide prostate cancer treatment in 
medically underserved areas, including the use 
of tumor boards to facilitate better patient 
counseling. 
(4) REPORT.—Not later than 1 year after the 
completion of the pilot projects under this sub-
section, the Secretaries shall submit to Congress a 
report describing the outcomes of such pilot projects, 
including any cost savings and efficiencies realized, 
and providing recommendations, if any, for expand-
ing the use of telehealth services. 
(f) EDUCATION AND AWARENESS.— 
(1) IN GENERAL.—The Secretary of Veterans 
Affairs (referred to in this subsection as the ‘‘Sec-
retary’’) shall develop a national education campaign 
for prostate cancer. Such campaign shall involve the 
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use of written educational materials and public serv-
ice announcements consistent with the findings of 
the Prostate Cancer Task Force under subsection 
(c), that are intended to encourage men to seek 
prostate cancer screening when appropriate. 
(2) RACIAL DISPARITIES AND THE POPULATION 
OF
MEN
WITH
A
FAMILY
HISTORY
OF
PROSTATE 
CANCER.—In developing the national campaign 
under paragraph (1), the Secretary shall ensure that 
such educational materials and public service an-
nouncements are more readily available in commu-
nities experiencing racial disparities in the incidence 
and mortality rates of prostate cancer and by men 
of any race classification with a family history of 
prostate cancer. 
(3) GRANTS.—In carrying out the national 
campaign under this section, the Secretary shall 
award grants to nonprofit private entities to enable 
such entities to test alternative outreach and edu-
cation strategies. 
(g) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN GENERAL.—There is authorized to be 
appropriated to carry out this section for the period 
of fiscal years 2021 through 2025 an amount equal 
to the savings described in paragraph (2). 
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(2) CORRESPONDING REDUCTION.—The savings 
described in this paragraph is the amount author-
ized to be appropriated by provisions of law other 
than this section for the period of fiscal years 2021 
through 2025 for Federal research and health care 
program activities related to prostate cancer, re-
duced by the amount of Federal savings projected to 
be achieved over such period by implementation of 
this section. 
SEC. 703. PROSTATE RESEARCH, IMAGING, AND MEN’S EDU-
CATION (PRIME). 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Prostate Research, Imaging, and Men’s Education Act 
of 2020’’ or the ‘‘PRIME Act of 2020’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) Prostate cancer has reached epidemic pro-
portions, particularly among African-American men, 
and strikes and kills men in numbers comparable to 
the number of women who lose their lives from 
breast cancer. 
(2) Life-saving breakthroughs in screening, di-
agnosis, and treatment of breast cancer resulted 
from the development of advanced imaging tech-
nologies led by the Federal Government. 
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(3) Men should have accurate and affordable 
prostate cancer screening exams and minimally 
invasive treatment tools, similar to what women have 
for breast cancer. 
(4) While it is important for men to take ad-
vantage of current prostate cancer screening tech-
niques, a recent NCI-funded study demonstrated 
that the most common available methods of detect-
ing prostate cancer (PSA blood test and physical 
exams) are not foolproof, causing numerous false 
alarms and false reassurances. 
(5) The absence of advanced imaging tech-
nologies for prostate cancer causes the lack of accu-
rate information critical for clinical decisions, result-
ing in missed cancers and lost lives, as well as un-
necessary and costly medical procedures, with re-
lated complications. 
(6) With prostate imaging tools, men and their 
families would face less physical, psychological, fi-
nancial and emotional trauma and billions of dollars 
could be saved in private and public health care sys-
tems. 
(c) RESEARCH AND DEVELOPMENT OF PROSTATE 
CANCER IMAGING TECHNOLOGIES.— 
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(1) EXPANSION OF RESEARCH.—The Secretary 
of Health and Human Services (referred to in this 
section as the ‘‘Secretary’’), acting through the Di-
rector of the National Institutes of Health and the 
Administrator of the Health Resources and Services 
Administration, and in consultation with the Sec-
retary of Defense, shall carry out a program to ex-
pand and intensify research to develop innovative 
advanced imaging technologies for prostate cancer 
detection, diagnosis, and treatment comparable to 
state-of-the-art mammography technologies. 
(2) 
EARLY
STAGE
RESEARCH.—In 
imple-
menting the program under paragraph (1), the Sec-
retary, acting through the Administrator of the 
Health Resources and Services Administration, shall 
carry out a grant program to encourage the early 
stages of research in prostate imaging to develop 
and implement new ideas, proof of concepts, and 
pilot studies for high-risk technologic innovation in 
prostate cancer imaging that would have a high po-
tential impact for improving patient care, including 
individualized care, quality of life, and cost-effective-
ness. 
(3) LARGE-SCALE LATER STAGE RESEARCH.— 
In implementing the program under paragraph (1), 
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the Secretary, acting through the Director of the 
National Institutes of Health, shall utilize the Na-
tional Institute of Biomedical Imaging and Bio-
engineering and the National Cancer Institute for 
advanced stages of research in prostate imaging, in-
cluding technology development and clinical trials for 
projects determined by the Secretary to have dem-
onstrated promising preliminary results and proof of 
concept. 
(4) INTERDISCIPLINARY PRIVATE-PUBLIC PART-
NERSHIPS.—In developing the program under para-
graph (1), the Secretary, acting through the Admin-
istrator of the Health Resources and Services Ad-
ministration, shall establish interdisciplinary private- 
public partnerships to develop and implement re-
search strategies for expedited innovation in imaging 
and image-guided treatment and to conduct such re-
search. 
(5) RACIAL
DISPARITIES.—In developing the 
program under paragraph (1), the Secretary shall 
recognize and address— 
(A) the racial disparities in the incidences 
of prostate cancer and mortality rates with re-
spect to such disease; and 
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(B) any barriers in access to care and par-
ticipation in clinical trials that are specific to 
racial minorities. 
(6) AUTHORIZATION OF APPROPRIATIONS.— 
(A) IN
GENERAL.—Subject to subpara-
graph (B), there is authorized to be appro-
priated to carry out this section $100,000,000 
for each of the fiscal years 2021 through 2025. 
(B) 
SPECIFIC
ALLOCATIONS.—Of 
the 
amount authorized to be appropriated under 
subparagraph (A) for each of the fiscal years 
described in such paragraph— 
(i) no less than 10 percent may be ap-
propriated to carry out the grant program 
under paragraph (2); and 
(ii) no more than 1 percent may be 
appropriated to carry out paragraph (4). 
(d) PUBLIC AWARENESS
AND EDUCATION CAM-
PAIGN.— 
(1) NATIONAL CAMPAIGN.—The Secretary shall 
carry out a national campaign to increase the aware-
ness and knowledge of Americans with respect to the 
need for prostate cancer screening and for improved 
detection technologies. 
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(2) REQUIREMENTS.—The national campaign 
conducted shall include— 
(A) roles for the Health Resources Services 
Administration, the Office on Minority Health 
of the Department of Health and Human Serv-
ices, the Centers for Disease Control and Pre-
vention, and the Office of Minority Health of 
the Centers for Disease Control and Prevention; 
and 
(B) the development and distribution of 
written educational materials, and the develop-
ment and placing of public service announce-
ments, that are intended to encourage men to 
seek prostate cancer screening and to create 
awareness of the need for improved imaging 
technologies for prostate cancer screening and 
diagnosis, including in-vitro blood testing and 
imaging technologies. 
(3) RACIAL
DISPARITIES.—In developing the 
national campaign under paragraph (1), the Sec-
retary shall recognize and address— 
(A) the racial disparities in the incidences 
of prostate cancer and mortality rates with re-
spect to such disease; and 
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(B) any barriers in access to care and par-
ticipation in clinical trials that are specific to 
racial minorities. 
(4) GRANTS.—The Secretary shall establish a 
program to award grants to nonprofit private enti-
ties to enable such entities to test alternative out-
reach and education strategies to increase the 
awareness and knowledge of Americans with respect 
to the need for prostate cancer screening and im-
proved imaging technologies. 
(5) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this section $10,000,000 for each of the fiscal years 
2021 through 2025. 
(e) IMPROVING
PROSTATE
CANCER
SCREENING 
BLOOD TESTS.— 
(1) IN GENERAL.—The Secretary, in coordina-
tion with the Secretary of Defense, shall carry out 
research to develop an improved prostate cancer 
screening blood test using in-vitro detection. 
(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this section, $20,000,000 for each of fiscal years 
2021 through 2025. 
(f) REPORTING AND COMPLIANCE.— 
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(1) REPORT AND STRATEGY.—Not later than 
12 months after the date of the enactment of this 
Act, the Secretary shall submit to Congress a report 
that details the strategy of the Secretary for imple-
menting the requirements of this section and the 
status of such efforts. 
(2) FULL
COMPLIANCE.—Not later than 36 
months after the date of the enactment of this Act, 
and annually thereafter, the Secretary shall submit 
to Congress a report that— 
(A) describes the research and development 
and public awareness and education campaigns 
funded under this section; 
(B) provides evidence that projects involv-
ing high-risk, high-impact technologic innova-
tion, proof of concept, and pilot studies are 
prioritized; 
(C) provides evidence that the Secretary 
recognizes and addresses any barriers in access 
to care and participation in clinical trials that 
are specific to racial minorities in the imple-
mentation of this section; 
(D) contains assurances that all the other 
provisions of this section are fully implemented; 
and 
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(E) certifies compliance with the provisions 
of this section, or in the case of a Federal agen-
cy that has not complied with any of such pro-
visions, an explanation as to such failure to 
comply. 
SEC. 704. PROSTATE CANCER DETECTION RESEARCH AND 
EDUCATION. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Prostate Cancer Detection Research and Education 
Act’’. 
(b) PLAN TO DEVELOP AND VALIDATE A TEST OR 
TESTS FOR PROSTATE CANCER.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’), acting through the Director of the Na-
tional Institutes of Health, shall establish an advi-
sory council on prostate cancer (referred to in this 
section as the ‘‘advisory council’’) to draft a plan for 
the development and validation of an accurate test 
or tests, such as biomarkers or imaging, to detect 
and diagnose prostate cancer. 
(2) ADVISORY COUNCIL.— 
(A) MEMBERSHIP.— 
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(i) FEDERAL
MEMBERS.—The advi-
sory council shall be comprised of the fol-
lowing experts: 
(I) A designee of the Centers for 
Disease Control and Prevention. 
(II) A designee of the Centers for 
Medicare & Medicaid Services. 
(III) A designee of the Office of 
the Director of the National Cancer 
Institute. 
(IV) A designee of the Director 
of the Department of Defense Con-
gressionally Directed Medical Re-
search Program. 
(V) A designee of the Director of 
the National Institute of Biomedical 
Imaging and Bioengineering. 
(VI) A designee of the Director 
of the National Institute of General 
Medical Sciences. 
(VII) A designee of the Director 
of the National Institute on Minority 
Health and Health Disparities. 
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(VIII) A designee of the Office of 
the Director of the National Institutes 
of Health. 
(IX) A designee of the Food and 
Drug Administration. 
(X) A designee of the Agency for 
Healthcare Research and Quality. 
(XI) A designee of the Director 
of the Telemedicine and Advanced 
Technology Research Center of the 
Department of Defense. 
(ii) NON-FEDERAL MEMBERS.—In ad-
dition to the members described in clause 
(i), the advisory council shall include 8 ex-
pert members from outside the Federal 
Government to be appointed by the Sec-
retary, which shall include— 
(I) 2 prostate cancer patient ad-
vocates; 
(II) 2 health care providers with 
a range of expertise and experience in 
prostate cancer; and 
(III) 4 leading researchers with 
prostate cancer-related expertise in a 
range of clinical disciplines. 
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(B) MEETINGS.—The advisory council 
shall meet quarterly and such meetings shall be 
open to the public. 
(C) ADVICE.—The advisory council shall 
advise the Secretary or the Secretary’s des-
ignee. 
(D) ANNUAL REPORT.—Not later than 1 
year after the date of enactment of this Act, the 
advisory council shall provide to the Secretary, 
or the Secretary’s designee, and Congress— 
(i) an initial evaluation of all federally 
funded efforts in prostate cancer research 
relating to the development and validation 
of an accurate test or tests to detect and 
diagnose prostate cancer; 
(ii) a plan for the development and 
validation of a reliable test or tests for the 
detection and accurate diagnosis of pros-
tate cancer; and 
(iii) a set of standards for prostate 
cancer screening, developed in coordination 
with the United States Preventive Services 
Task Force, to ensure that any tools for 
screening, detection, and diagnosis devel-
oped in accordance with the plan under 
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clause (ii) will meet the requirements of 
the Task Force for recommendation as a 
proven preventive or diagnostic service. 
(E) TERMINATION.—The advisory council 
shall terminate on December 31, 2024. 
(3) FUNDING.—The Secretary may make avail-
able $1,000,000 from amounts appropriated to the 
National Institutes of Health for each of fiscal years 
2021 through 2025 to carry out this subsection. 
(c) COORDINATION AND INTENSIFICATION OF PROS-
TATE CANCER RESEARCH.— 
(1) IN GENERAL.—The Director of the National 
Institutes of Health, in consultation with the Sec-
retary of Defense, shall coordinate and intensify re-
search in accordance with the plan, with particular 
attention provided to leveraging existing research to 
develop and validate a test or tests, such as bio-
markers or imaging, to detect and accurately diag-
nose prostate cancer in order to improve quality of 
life for millions of Americans, and decrease health 
care system costs. 
(2) FUNDING.—The Secretary may make avail-
able $30,000,000 from amounts appropriated to the 
National Institutes of Health for each of fiscal years 
2022 through 2026 to carry out this subsection. 
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(d) PUBLIC AWARENESS
AND EDUCATION CAM-
PAIGN.— 
(1) NATIONAL CAMPAIGN.—The Secretary, in 
coordination with the Director of the National Insti-
tutes of Health and the Director of the Centers for 
Disease Control and Prevention, shall carry out a 
national campaign to increase the awareness and 
knowledge of prostate cancer. 
(2) REQUIREMENTS.—The national campaign 
conducted under paragraph (1) shall include— 
(A) roles for the National Cancer Institute, 
the National Institute on Minority Health and 
Health Disparities, the Office on Minority 
Health of the Department of Health and 
Human Services, and the Office of Minority 
Health of the Centers for Disease Control and 
Prevention; and 
(B) the development and distribution of 
written educational materials, and the develop-
ment and placing of public service announce-
ments, that are intended to encourage men to 
seek prostate cancer screening when symptoms 
are present, when they have a family history of 
prostate cancer, or if they belong to a high-risk 
population. 
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(3) RACIAL
DISPARITIES.—In developing the 
national campaign under paragraph (1), the Sec-
retary shall recognize and address— 
(A) the racial disparities in the incidences 
of prostate cancer and mortality rates with re-
spect to such disease; and 
(B) any barriers in access to patient care 
and participation in clinical trials that are spe-
cific to racial minorities. 
(4) GRANTS.—The Secretary shall establish a 
program to award grants to nonprofit private enti-
ties to enable such entities to test alternative out-
reach and education strategies to increase the 
awareness and knowledge of Americans with respect 
to prostate cancer. 
(5) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this subsection $5,000,000 for each of fiscal years 
2021 through 2025. 
SEC. 705. NATIONAL PROSTATE CANCER COUNCIL. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘National Prostate Cancer Plan Act’’. 
(b) NATIONAL PROSTATE CANCER COUNCIL.— 
(1) ESTABLISHMENT.—There is established in 
the Office of the Secretary of Health and Human 
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Services (referred to in this section as the ‘‘Sec-
retary’’) the National Prostate Cancer Council on 
Screening, Early Detection, Assessment, and Moni-
toring of Prostate Cancer (referred to in this section 
as the ‘‘Council’’). 
(2) PURPOSE OF THE COUNCIL.—The Council 
shall— 
(A) develop and implement a national stra-
tegic plan for the accelerated creation, advance-
ment, and testing of diagnostic tools to improve 
screening, early detection, assessment, and 
monitoring of prostate cancer, including— 
(i) early detection of aggressive pros-
tate cancer to save lives; 
(ii) monitoring of tumor response to 
treatment, including recurrence and pro-
gression; and 
(iii) accurate assessment and surveil-
lance of indolent disease to reduce unnec-
essary biopsies and treatment; 
(B) provide information and coordination 
of prostate cancer research and services across 
all Federal agencies; 
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(C) review diagnostic tools and their over-
all effectiveness at screening, detecting, assess-
ing, and monitoring of prostate cancer; 
(D) evaluate all programs in prostate can-
cer that are in existence on the date of enact-
ment of this Act, including Federal budget re-
quests and approvals and public-private part-
nerships; 
(E) submit an annual report to the Sec-
retary and Congress on the creation and imple-
mentation of the national strategic plan under 
subparagraph (A); and 
(F) ensure the inclusion of men at high 
risk for prostate cancer, including men from 
ethnic and racial populations and men who are 
least likely to receive care, in clinical, research, 
and service efforts, with the purpose of decreas-
ing health disparities. 
(3) MEMBERSHIP.— 
(A) FEDERAL
MEMBERS.—The Council 
shall be led by the Secretary or designee and 
comprised of the following experts: 
(i) Two representatives of the Na-
tional Institutes of Health, including 1 rep-
resentative of the National Institute of 
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Biomedical Imaging and Bioengineering 
and 1 representative of the National Can-
cer Institute. 
(ii) A representative of the Centers 
for Disease Control and Prevention. 
(iii) A representative of the Centers 
for Medicare & Medicaid Services. 
(iv) A designee of the Director of the 
Department of Defense Congressionally 
Directed Medical Research Program. 
(v) A designee of the Director of the 
Office of Minority Health. 
(vi) A representative of the Food and 
Drug Administration. 
(vii) A representative of the Agency 
for Healthcare Research and Quality. 
(B) NON-FEDERAL
MEMBERS.—In addi-
tion to the members described in subparagraph 
(A), the Council shall include 14 expert mem-
bers from outside the Federal Government, 
which shall include— 
(i) 6 prostate cancer patient advo-
cates, including— 
(I) 2 patient-survivors; 
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(II) 2 caregivers of prostate can-
cer patients; and 
(III) 2 representatives from na-
tional prostate cancer disease organi-
zations that fund research or have 
demonstrated experience in providing 
assistance to patients, families, and 
medical professionals, including infor-
mation on health care options, edu-
cation, and referral; and 
(ii) 8 health care stakeholders with 
specific expertise in prostate cancer re-
search in the critical areas of clinical ex-
pertise, including medical oncology, radi-
ology, radiation oncology, urology, and pa-
thology. 
(4) MEETINGS.—The Council shall meet quar-
terly and meetings shall be open to the public. 
(5) ADVICE.—The Council shall advise the Sec-
retary, or the Secretary’s designee. 
(6) ANNUAL REPORT.—The Council shall sub-
mit annual reports, beginning not later than 1 year 
after the date of enactment of this Act, to the Sec-
retary or the Secretary’s designee and to Congress. 
The annual report shall include— 
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(A) in the first year— 
(i) an evaluation of all federally fund-
ed efforts in prostate cancer research and 
gaps relating to the development and vali-
dation of diagnostic tools for prostate can-
cer; and 
(ii) recommendations for priority ac-
tions to expand, eliminate, coordinate, or 
condense programs based on the perform-
ance, mission, and purpose of the pro-
grams; and 
(B) annually thereafter for 5 years— 
(i) an outline for the development and 
implementation of a national research plan 
for creation and validation of accurate di-
agnostic tools to improve prostate cancer 
care in accordance with paragraph (1); 
(ii) roles for the National Cancer In-
stitute, National Institute on Minority 
Health and Health Disparities, and the Of-
fice on Minority Health of the Department 
of Health and Human Services; 
(iii) an analysis of the disparities in 
the incidence and mortality rates of pros-
tate cancer in men at high risk of the dis-
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ease, including individuals with family his-
tory, increasing age, or African-American 
heritage; and 
(iv) a review of the progress towards 
the realization of the proposed strategic 
plan. 
(7) TERMINATION.—The Council shall termi-
nate on December 31, 2025. 
SEC. 706. IMPROVED MEDICAID COVERAGE FOR CERTAIN 
BREAST AND CERVICAL CANCER PATIENTS 
IN THE TERRITORIES. 
(a) ELIMINATION OF FUNDING LIMITATIONS.— 
(1) IN GENERAL.—Section 1108(g)(4) of the 
Social Security Act (42 U.S.C. 1308(g)(4)) is 
amended by adding at the end the following: ‘‘With 
respect to fiscal years beginning with fiscal year 
2021, payment for medical assistance for individuals 
who are eligible for such assistance only on the basis 
of section 1902(a)(10)(A)(ii)(XVIII) shall not be 
taken into account in applying subsection (f) (as in-
creased in accordance with paragraphs (1), (2), (3), 
and (5) of this subsection) to Puerto Rico, the Vir-
gin Islands, Guam, the Northern Mariana Islands, 
or American Samoa for such fiscal year.’’. 
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(2) TECHNICAL AMENDMENT.—Such section is 
further amended by striking ‘‘(3), and (4)’’ and in-
serting ‘‘(3), and (5)’’. 
(b) APPLICATION OF ENHANCED FMAP FOR HIGH-
EST STATE.—Section 1905(b) of such Act (42 U.S.C. 
1396d(b)) is amended by adding at the end the following: 
‘‘Notwithstanding the first sentence of this subsection, 
with respect to medical assistance described in clause (4) 
of such sentence that is furnished in Puerto Rico, the Vir-
gin Islands, Guam, the Northern Mariana Islands, or 
American Samoa in a fiscal year, the Federal medical as-
sistance percentage is equal to the highest such percentage 
applied under such clause for such fiscal year for any of 
the 50 States or the District of Columbia that provides 
such medical assistance for any portion of such fiscal 
year.’’ 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to payment for medical assistance 
for items and services furnished on or after October 1, 
2021. 
SEC. 707. CANCER PREVENTION AND TREATMENT DEM-
ONSTRATION FOR ETHNIC AND RACIAL MI-
NORITIES. 
(a) DEMONSTRATION.— 
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(1) IN GENERAL.—The Secretary of Health and 
Human Services (referred to in this section as the 
‘‘Secretary’’) shall conduct demonstration projects 
for the purpose of developing models and evaluating 
methods that— 
(A) improve the quality of items and serv-
ices provided to target individuals in order to 
facilitate reduced disparities in early detection 
and treatment of cancer; 
(B) improve clinical outcomes, satisfaction, 
quality of life, appropriate use of items and 
services covered under the Medicare program 
under title XVIII of the Social Security Act (42 
U.S.C. 1395 et seq.), and referral patterns with 
respect to target individuals with cancer; 
(C) eliminate disparities in the rate of pre-
ventive cancer screening measures, such as Pap 
smears, prostate cancer screenings, colon cancer 
screenings, breast cancer screenings, and com-
puted tomography scans, for lung cancer among 
target individuals; 
(D) promote collaboration with community- 
based organizations to ensure cultural com-
petency of health care professionals and lin-
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guistic access for target individuals who are 
persons with limited English proficiency; and 
(E) encourage the incorporation of commu-
nity health workers to increase the efficiency 
and appropriateness of cancer screening pro-
grams. 
(2) COMMUNITY HEALTH WORKER DEFINED.— 
In this section, the term ‘‘community health worker’’ 
includes a community health advocate, a lay health 
worker, a community health representative, a peer 
health promoter, a community health outreach work-
er, and a promotore de salud, who promotes health 
or nutrition within the community in which the indi-
vidual resides. 
(3) TARGET
INDIVIDUAL
DEFINED.—In this 
section, the term ‘‘target individual’’ means an indi-
vidual of a racial and ethnic minority group, as de-
fined in section 1707(g)(1) of the Public Health 
Service Act (42 U.S.C. 300u–6(g)(1)), who is enti-
tled to benefits under part A, and enrolled under 
part B, of title XVIII of the Social Security Act. 
(b) PROGRAM DESIGN.— 
(1) INITIAL DESIGN.—Not later than 1 year 
after the date of the enactment of this Act, the Sec-
retary shall evaluate best practices in the private 
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sector, community programs, and academic research 
of methods that reduce disparities among individuals 
of racial and ethnic minority groups in the preven-
tion and treatment of cancer and shall design the 
demonstration projects based on such evaluation. 
(2) NUMBER AND PROJECT AREAS.—Not later 
than 2 years after the date of the enactment of this 
Act, the Secretary shall implement at least 9 dem-
onstration projects, including the following: 
(A) Two projects, each of which shall tar-
get different ethnic subpopulations, for each of 
the 4 following major racial and ethnic minority 
groups: 
(i) American Indians and Alaska Na-
tives, Eskimos, and Aleuts. 
(ii) Asian Americans. 
(iii) Blacks and African Americans. 
(iv) Latinos and Hispanics. 
(v) Native Hawaiians and other Pa-
cific Islanders. 
(B) One project within the Pacific Islands 
or United States insular areas. 
(C) At least one project in a rural area. 
(D) At least one project in an inner-city 
area. 
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(3) EXPANSION
OF
PROJECTS; IMPLEMENTA-
TION OF DEMONSTRATION PROJECT RESULTS.—The 
Secretary shall continue the existing demonstration 
projects and may expand the number of demonstra-
tion projects if the initial report under subsection (c) 
contains 
an 
evaluation 
that 
demonstration 
projects— 
(A) reduce expenditures under the Medi-
care program under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.); or 
(B) do not increase expenditures under 
such Medicare program and reduce racial and 
ethnic health disparities in the quality of health 
care services provided to target individuals and 
increase satisfaction of Medicare beneficiaries 
and health care providers. 
(c) REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date the Secretary implements the initial dem-
onstration projects, and biannually thereafter, the 
Secretary shall submit to Congress a report regard-
ing the demonstration projects. 
(2) CONTENT OF REPORT.—Each report under 
paragraph (1) shall include the following: 
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(A) A description of the demonstration 
projects. 
(B) An evaluation of— 
(i) the cost-effectiveness of the dem-
onstration projects; 
(ii) the quality of the health care serv-
ices provided to target individuals under 
the demonstration projects; and 
(iii) beneficiary and health care pro-
vider satisfaction under the demonstration 
projects. 
(C) Any other information regarding the 
demonstration projects that the Secretary de-
termines to be appropriate. 
(d) WAIVER AUTHORITY.—The Secretary shall waive 
compliance with the requirements of title XVIII of the So-
cial Security Act (42 U.S.C. 1395 et seq.) to such extent 
and for such period as the Secretary determines is nec-
essary to conduct demonstration projects. 
SEC. 708. REDUCING CANCER DISPARITIES WITHIN MEDI-
CARE. 
(a) DEVELOPMENT OF MEASURES OF DISPARITIES 
IN QUALITY OF CANCER CARE.— 
(1) DEVELOPMENT OF MEASURES.—The Sec-
retary of Health and Human Services (in this sec-
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tion referred to as the ‘‘Secretary’’) shall enter into 
an agreement with an entity that specializes in de-
veloping quality measures for cancer care under 
which the entity shall develop a uniform set of meas-
ures to evaluate disparities in the quality of cancer 
care and annually update such set of measures. 
(2) MEASURES TO BE INCLUDED.—Such set of 
measures shall include, with respect to the treatment 
of cancer, measures of patient outcomes, the process 
for delivering medical care related to such treat-
ment, patient counseling and engagement in deci-
sionmaking, patient experience of care, resource use, 
and practice capabilities, such as care coordination. 
(b) ESTABLISHMENT OF REPORTING PROCESS.— 
(1) IN GENERAL.—The Secretary shall establish 
a reporting process that requires and provides for a 
method for health care providers specified under 
paragraph (2) to submit to the Secretary and make 
public data on the performance of such providers 
during each reporting period through use of the 
measures developed pursuant to subsection (a). Such 
data shall be submitted in a form and manner and 
at a time specified by the Secretary. 
(2) SPECIFICATION OF PROVIDERS TO REPORT 
ON
MEASURES.—The Secretary shall specify the 
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classes of Medicare providers of services and sup-
pliers, including hospitals, cancer centers, physi-
cians, primary care providers, and specialty pro-
viders, that will be required under such process to 
publicly report on the measures specified under sub-
section (a). 
(3) ASSESSMENT
OF
CHANGES.—Under such 
reporting process, the Secretary shall establish a for-
mat that assesses changes in both the absolute and 
relative disparities in cancer care over time. These 
measures shall be presented in an easily comprehen-
sible format, such as those presented in the final 
publications relating to Healthy People 2010 or the 
National Healthcare Disparities Report. 
(4) INITIAL IMPLEMENTATION.—The Secretary 
shall implement the reporting process under this 
subsection for reporting periods beginning not later 
than 6 months after the date that measures are first 
established under subsection (a). 
SEC. 709. CANCER CLINICAL TRIALS. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Henrietta Lacks Enhancing Cancer Research Act of 
2020’’. 
(b) FINDINGS.—Congress finds as follows: 
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(1) Only a small percent of patients participate 
in cancer clinical trials, even though most express an 
interest in clinical research. There are several obsta-
cles that restrict individuals from participating in-
cluding lack of available local trials, restrictive eligi-
bility criteria, transportation to trial sites, taking 
time off from work, and potentially increased med-
ical and nonmedical costs. Ultimately, about 1 in 5 
cancer clinical trials fail because of lack of patient 
enrollment. 
(2) Groups that are generally underrepresented 
in clinical trials include racial and ethnic minorities 
and older, rural, and lower-income individuals. 
(3) Henrietta Lacks, an African-American 
woman, was diagnosed with cervical cancer at the 
age of 31, and despite receiving painful radium 
treatments, passed away on October 4, 1951. 
(4) Medical researchers took samples of Hen-
rietta Lacks’ tumor during her treatment and the 
HeLa cell line from her tumor proved remarkably 
resilient. 
(5) HeLa cells were the first immortal line of 
human cells. Henrietta Lacks’ cells were unique, 
growing by the millions, commercialized and distrib-
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uted worldwide to researchers, resulting in advances 
in medicine. 
(6) Henrietta Lacks’ prolific cells continue to 
grow and contribute to remarkable advances in med-
icine, including the development of the polio vaccine, 
as well as drugs for treating the effects of cancer, 
HIV/AIDS, hemophilia, leukemia, and Parkinson’s 
disease. These cells have been used in research that 
has contributed to our understanding of the effects 
of radiation and zero gravity on human cells. These 
immortal cells have informed research on chromo-
somal conditions, cancer, gene mapping, and preci-
sion medicine. 
(7) Henrietta Lacks and her immortal cells 
have made a significant contribution to global 
health, scientific research, quality of life, and patient 
rights. 
(8) For more than 20 years, the advances made 
possible by Henrietta Lacks’ cells were without her 
or her family’s consent, and the revenues they gen-
erated were not known to or shared with her family. 
(9) Henrietta Lacks and her family’s experience 
is fundamental to modern and future bioethics poli-
cies and informed consent laws that benefit patients 
nationwide by building patient trust; promoting eth-
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ical research that benefits all individuals, including 
traditionally underrepresented populations; and pro-
tecting research participants. 
(c) GAO STUDY ON BARRIERS TO PARTICIPATION IN 
FEDERALLY FUNDED CANCER CLINICAL TRIALS BY POP-
ULATIONS THAT HAVE BEEN TRADITIONALLY UNDER-
REPRESENTED IN SUCH TRIALS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act, the Comptroller 
General of the United States shall— 
(A) complete a study that— 
(i) reviews what actions Federal agen-
cies have taken to help to address barriers 
to participation in federally funded cancer 
clinical trials by populations that have 
been traditionally underrepresented in such 
trials, and identifies challenges, if any, in 
implementing such actions; and 
(ii) identifies additional actions that 
can be taken by Federal agencies to ad-
dress barriers to participation in federally 
funded cancer clinical trials by populations 
that have been traditionally underrep-
resented in such trials; and 
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(B) submit a report to the Congress on the 
results of such study, including recommenda-
tions on potential changes in practices and poli-
cies to improve participation in such trials by 
such populations. 
(2) INCLUSION
OF
CLINICAL
TRIALS.—The 
study under paragraph (1)(A) should include review 
of cancer clinical trials that are largely funded by 
Federal agencies, including the National Institutes 
of Health, the Department of Defense, the Depart-
ment of Veterans Affairs, the Agency for Health Re-
search and Quality, the Food and Drug Administra-
tion, and such other Federal agencies as the Comp-
troller General of the United States may identify. 
Subtitle 
B—Viral 
Hepatitis 
and 
Liver Cancer Control and Pre-
vention 
SEC. 711. VIRAL HEPATITIS AND LIVER CANCER CONTROL 
AND PREVENTION. 
(a) SHORT TITLE.—This subtitle may be cited as the 
‘‘Viral Hepatitis and Liver Cancer Control and Prevention 
Act of 2020’’. 
(b) FINDINGS.—Congress finds the following: 
(1) In the United States, nearly 5,000,000 per-
sons are living with the hepatitis B virus (referred 
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to in this section as ‘‘HBV’’) or the hepatitis C virus 
(referred to in this section as ‘‘HCV’’). 
(2) In the United States, chronic HBV and 
HCV are the most common causes of liver cancer, 
the second deadliest and fastest growing cancer in 
this country. Such viruses are the most common 
cause of chronic liver disease, liver cirrhosis, and the 
most common indications for liver transplantation. 
At least 21,000 deaths per year in the United States 
can be attributed to chronic HBV and HCV. Chron-
ic HCV is also a leading cause of death in Ameri-
cans living with HIV/AIDS; many of those living 
with HIV/AIDS are coinfected with chronic HBV, 
chronic HCV, or both. 
(3) According to the Centers for Disease Con-
trol and Prevention (referred to in this section as 
the ‘‘CDC’’), approximately 2 percent of the popu-
lation of the United States is living with chronic 
HBV, chronic HCV, or both. The CDC has recog-
nized HCV as the Nation’s most common chronic 
bloodborne virus infection and HBV as the deadliest 
vaccine-preventable disease. 
(4) HBV is transmitted through contact with 
infectious blood, semen, or other bodily fluids and is 
100 times more infectious than HIV. HCV is trans-
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mitted by contact with infectious blood, particularly 
through percutaneous exposures (such as puncture 
through the skin). 
(5) The CDC estimates that in 2016, more 
than 41,000 people in the United States were newly 
infected with HCV and nearly 21,000 people in the 
United States were newly infected with HBV. These 
estimates could be much higher due to many rea-
sons, including lack of screening education and 
awareness, and perceived marginalization of the pop-
ulations at risk. 
(6) In 2012, CDC released new guidelines rec-
ommending every person born between 1945 and 
1965 receive a one-time test for HCV. Among the 
estimated 102,000,000 (1,600,000 chronically HCV- 
infected) eligible for screening, birth-cohort screen-
ing leads to 84,000 fewer cases of decompensated 
cirrhosis, 46,000 fewer cases of hepatocellular car-
cinoma, 10,000 fewer liver transplants, and 78,000 
fewer HCV-related deaths gained versus risk-based 
screening. 
(7) In 2013, the United States Preventive Serv-
ices Task Force (referred to in this section as the 
‘‘USPSTF’’) issued a Grade B rating for screening 
for HCV infection in persons at high risk for infec-
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tion and adults born between 1945 and 1965. In 
2014, the USPSTF issued a Grade B for screening 
for HBV in persons at high risk of hepatitis B infec-
tion. In 2009, the USPSTF issued a Grade A for 
screening pregnant women for HBV during their 
first prenatal visit, and in 2019, reaffirmed this 
grade. 
(8) There were 59 outbreaks (24 of HBV and 
36 of HCV, including one of both HBV and HCV) 
reported to CDC for investigation from 2008 
through 2016 related to health care-associated infec-
tion of HBV and HCV, 56 of which occurred in non- 
hospital settings. There were more than 115,983 pa-
tients potentially exposed to one of the viruses. 
(9) Chronic HBV and chronic HCV usually do 
not cause symptoms early in the course of the dis-
ease, but after many years of a clinically ‘‘silent’’ 
phase, CDC estimates show more than 33 percent of 
infected individuals will develop cirrhosis, end-stage 
liver disease, or liver cancer. Since most individuals 
with chronic HBV, HCV, or both are unaware of 
their infection, they do not know to take precautions 
to prevent the spread of their infection and can un-
knowingly exacerbate their own disease progression. 
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(10) HBV and HCV disproportionately affect 
certain populations in the United States. Although 
representing only about 6 percent of the population, 
Asian Americans and Pacific Islanders account for 
half of all chronic HBV cases in the United States. 
Baby Boomers (those born between 1945 and 1965) 
account for approximately 75 percent of domestic 
chronic HCV cases. In addition, African Americans, 
Latinos, and American Indian and Native Alaskans 
are among the groups which have disproportionately 
high rates of HBV or HCV infections in the United 
States. 
(11) For both chronic HBV and chronic HCV, 
behavioral changes and appropriate medical care can 
slow disease progression if diagnosis is made early. 
Early diagnosis, which is determined through simple 
blood tests, can reduce the risk of transmission and 
disease progression through education and vaccina-
tion of household members and other susceptible 
persons at risk. 
(12) Advancements have led to the development 
of improved diagnostic tests for viral hepatitis. 
These tests, including rapid, point-of-care testing 
and others in development, can facilitate testing, no-
tification of results and post-test counseling, and re-
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ferral to care at the time of the testing visit. In par-
ticular, these tests are also advantageous because 
they can be used simultaneously with HIV rapid 
testing for persons at risk for both HCV and HIV 
infections. 
(13) For those chronically infected with HBV 
or HCV, regular monitoring can lead to the early de-
tection of liver cancer at a stage where a cure is still 
possible. Liver cancer is the second deadliest cancer 
in the United States; however, liver cancer has re-
ceived little funding for research, prevention, or 
treatment. 
(14) Treatment for chronic HCV can eradicate 
the disease in approximately 90 percent of those cur-
rently treated. While there is no cure for chronic 
HBV, available treatments can effectively suppress 
viral replication in the overwhelming majority of 
those treated, thereby reducing the risk of trans-
mission and progression to liver scarring or liver 
cancer. 
(15) To combat the viral hepatitis epidemic in 
the United States, in February 2017, the Depart-
ment of Health and Human Services released its 
‘‘National Viral Hepatitis Action Plan 2017–2020’’ 
(referred to in this section as the ‘‘HHS Action 
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Plan’’). In March 2017, the National Academies of 
Sciences, Engineering, and Medicine released a re-
port entitled, ‘‘A National Strategy for the Elimi-
nation of Hepatitis B and C: Phase Two Report’’ 
(referred to in this section as the ‘‘NAS report’’), 
recommending specific actions to eliminate viral hep-
atitis as public health problems in the United States 
by 2030. 
(16) The annual health care costs attributable 
to HBV and HCV in the United States are signifi-
cant. For HBV, it is estimated to be approximately 
$2,500,000,000 ($2,000 per infected person). In 
2000, the lifetime cost of HBV—before the avail-
ability of most current therapies—was approximately 
$80,000 per chronically infected person, totaling 
more than $100,000,000,000. For HCV, medical 
costs for patients are expected to increase from 
$30,000,000,000 in 2009 to over $85,000,000,000 
in 2024. Avoiding these costs by screening and diag-
nosing individuals earlier—and connecting them to 
appropriate treatment and care, will save lives and 
critical health care dollars. Currently, without a 
comprehensive screening, testing, and diagnosis pro-
gram, most patients are diagnosed too late when 
they need a liver transplant costing at least 
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$314,000 for uncomplicated cases or when they have 
liver cancer or end-stage liver disease which costs 
$30,980 to $110,576 per hospital admission. As 
health care costs continue to grow, it is critical that 
the Federal Government invests in effective mecha-
nisms to avoid documented cost drivers. 
(17) According to the NAS report in 2010, 
chronic HBV and HCV infections cause substantial 
morbidity and mortality despite being preventable 
and treatable. Deficiencies in the implementation of 
established guidelines for the prevention, diagnosis, 
and medical management of chronic HBV and HCV 
infections perpetuate personal and economic bur-
dens. Existing grants are not sufficient for the scale 
of the health burden presented by HBV and HCV. 
(18) Screening and testing for HBV and HCV 
is aligned with the goal of Healthy People 2020 to 
increase immunization rates and reduce preventable 
infectious diseases. Awareness of disease and access 
to prevention and treatment remain essential compo-
nents for reducing infectious disease transmission. 
(19) Federal support is necessary to increase 
knowledge and awareness of HBV and HCV and to 
assist State and local prevention and control efforts 
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in reducing the morbidity and mortality of these 
epidemics. 
(20) The Centers for Disease Control and Pre-
vention reported a 233 percent increase in hepatitis 
C cases from 2010 to 2016, stemming from the 
opioid, heroin, and overdose epidemics affecting com-
munities nationwide. From 2014 to 2015, the num-
ber of reported cases of acute hepatitis B infection 
in the United States rose for the first time since 
2006, increasing by 20.7 percent, which is also 
largely attributable to the opioid epidemic. 
(21) The Secretary of Health and Human Serv-
ices has the discretion to carry out this subtitle (in-
cluding the amendments made by this subtitle) di-
rectly and through whichever of the agencies of the 
Public Health Service the Secretary determines to be 
appropriate, which may (in the Secretary’s discre-
tion) include the Centers for Disease Control and 
Prevention, the Health Resources and Services Ad-
ministration, the Substance Abuse and Mental 
Health Services Administration, the National Insti-
tutes of Health (including the National Institute on 
Minority Health and Health Disparities), and other 
agencies of such Service. 
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(c) BIENNIAL ASSESSMENT OF HHS HEPATITIS B 
AND HEPATITIS C PREVENTION, EDUCATION, RESEARCH, 
AND MEDICAL MANAGEMENT PLAN.—Title III of the 
Public Health Service Act (42 U.S.C. 241 et seq.), as 
amended by title V, is further amended— 
(1) by striking section 317N (42 U.S.C. 247b– 
15); and 
(2) by adding after part W, as added by section 
508, the following: 
‘‘PART X—BIENNIAL ASSESSMENT OF HHS HEPA-
TITIS B AND HEPATITIS C PREVENTION, EDU-
CATION, RESEARCH, AND MEDICAL MANAGE-
MENT PLAN 
‘‘SEC. 399PP. BIENNIAL UPDATE OF THE PLAN. 
‘‘(a) IN GENERAL.—The Secretary shall conduct a bi-
ennial assessment of the Secretary’s plan for the preven-
tion, control, and medical management of, and education 
and research relating to, hepatitis B and hepatitis C, for 
the purposes of— 
‘‘(1) incorporating into such plan new knowl-
edge or observations relating to hepatitis B and hep-
atitis C (such as knowledge and observations that 
may be derived from clinical, laboratory, and epide-
miological research and disease detection, preven-
tion, and surveillance outcomes); 
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‘‘(2) addressing gaps in the coverage or effec-
tiveness of the plan; and 
‘‘(3) evaluating and, if appropriate, updating 
recommendations, guidelines, or educational mate-
rials of the Centers for Disease Control and Preven-
tion or the National Institutes of Health for health 
care providers or the public on viral hepatitis in 
order to be consistent with the plan. 
‘‘(b) PUBLICATION OF NOTICE OF ASSESSMENTS.— 
Not later than October 1 of the first even-numbered year 
beginning after the date of the enactment of this part, 
and October 1 of each even-numbered year thereafter, the 
Secretary shall publish in the Federal Register a notice 
of the results of the assessments conducted under para-
graph (1). Such notice shall include— 
‘‘(1) a description of any revisions to the plan 
referred to in subsection (a) as a result of the as-
sessment; 
‘‘(2) an explanation of the basis for any such 
revisions, including the ways in which such revisions 
can reasonably be expected to further promote the 
original goals and objectives of the plan; and 
‘‘(3) in the case of a determination by the Sec-
retary that the plan does not need revision, an expla-
nation of the basis for such determination. 
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‘‘SEC. 399PP–1. ELEMENTS OF PROGRAM. 
‘‘(a) EDUCATION AND AWARENESS PROGRAMS.—The 
Secretary, acting through the Director of the Centers for 
Disease Control and Prevention, the Administrator of the 
Health Resources and Services Administration, and the 
Administrator of the Substance Abuse and Mental Health 
Services Administration, and in accordance with the plan 
referred to in section 399PP(a), shall implement programs 
to increase awareness and enhance knowledge and under-
standing of hepatitis B and hepatitis C. Such programs 
shall include— 
‘‘(1) the conduct of culturally and linguistically 
appropriate health education in primary and sec-
ondary schools, college campuses, public awareness 
campaigns, and community outreach activities (espe-
cially to the ethnic communities with high rates of 
chronic hepatitis B and chronic hepatitis C and 
other high-risk groups) to promote public awareness 
and knowledge about the value of hepatitis A and 
hepatitis B immunization; risk factors, transmission, 
and prevention of hepatitis B and hepatitis C; the 
value of screening for the early detection of hepatitis 
B and hepatitis C; and options available for the 
treatment of chronic hepatitis B and chronic hepa-
titis C; 
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‘‘(2) the promotion of immunization programs 
that increase awareness and access to hepatitis A 
and hepatitis B vaccines for susceptible adults and 
children; 
‘‘(3) the training of health care professionals 
regarding the importance of vaccinating individuals 
infected with hepatitis C and individuals who are at 
risk for hepatitis C infection against hepatitis A and 
hepatitis B; 
‘‘(4) the training of health care professionals 
regarding the importance of vaccinating individuals 
chronically infected with hepatitis B and individuals 
who are at risk for chronic hepatitis B infection 
against the hepatitis A virus; 
‘‘(5) the training of health care professionals 
and health educators to make them aware of the 
high rates of chronic hepatitis B and chronic hepa-
titis C in certain adult ethnic populations, and the 
importance of prevention, detection, and medical 
management of hepatitis B and hepatitis C and of 
liver cancer screening; 
‘‘(6) the development and distribution of health 
education curricula (including information relating 
to the special needs of individuals infected with or 
at risk of hepatitis B and hepatitis C, such as the 
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importance of prevention and early intervention, reg-
ular monitoring, the recognition of psychosocial 
needs, appropriate treatment, and liver cancer 
screening) for individuals providing hepatitis B and 
hepatitis C counseling; and 
‘‘(7) support for the implementation curricula 
described in paragraph (6) by State and local public 
health agencies. 
‘‘(b) IMMUNIZATION, PREVENTION, AND CONTROL 
PROGRAMS.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall support the integra-
tion of activities described in paragraph (3) into ex-
isting clinical and public health programs at State, 
local, territorial, and Tribal levels (including commu-
nity health clinics, programs for the prevention and 
treatment of HIV/AIDS, sexually transmitted infec-
tions, and substance abuse, and programs for indi-
viduals in correctional settings). 
‘‘(2) COORDINATION
OF
DEVELOPMENT
OF 
FEDERAL SCREENING GUIDELINES.— 
‘‘(A) REFERENCES.—For purposes of this 
subsection, the term ‘CDC Director’ means the 
Director of the Centers for Disease Control and 
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Prevention, and the term ‘AHRQ Director’ 
means 
the 
Director 
of 
the 
Agency 
for 
Healthcare Research and Quality. 
‘‘(B) AGENCY
FOR
HEALTHCARE
RE-
SEARCH
AND
QUALITY.—Due to the rapidly 
evolving standard of care associated with diag-
nosing and treating viral hepatitis infection, the 
AHRQ Director shall convene the Preventive 
Services Task Force under section 915(a) to re-
view its recommendation for screening for HBV 
and HCV infection every 3 years. 
‘‘(3) ACTIVITIES.— 
‘‘(A) VOLUNTARY TESTING PROGRAMS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall establish a mechanism by which to 
support and promote the development of 
State, local, territorial, and tribal vol-
untary hepatitis B and hepatitis C testing 
programs to screen the high-prevalence 
populations to aid in the early identifica-
tion of chronically infected individuals. 
‘‘(ii) CONFIDENTIALITY OF THE TEST 
RESULTS.—The Secretary shall prohibit 
the use of the results of a hepatitis B or 
hepatitis C test conducted by a testing pro-
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gram developed or supported under this 
subparagraph for any of the following: 
‘‘(I) Issues relating to health in-
surance. 
‘‘(II) To screen or determine 
suitability for employment. 
‘‘(III) To discharge a person 
from employment. 
‘‘(B) COUNSELING REGARDING VIRAL HEP-
ATITIS.—The Secretary shall support State, 
local, territorial, and tribal programs in a wide 
variety of settings, including those providing 
primary and specialty health care services in 
nonprofit private and public sectors, to— 
‘‘(i) provide individuals with ongoing 
risk factors for hepatitis B and hepatitis C 
infection with client-centered education 
and counseling which concentrates on— 
‘‘(I) promoting testing of individ-
uals that have been exposed to their 
blood, family members, and their sex-
ual partners; and 
‘‘(II) changing behaviors that 
place individuals at risk for infection; 
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‘‘(ii) provide individuals chronically in-
fected with hepatitis B or hepatitis C with 
education, health information, and coun-
seling to reduce their risk of— 
‘‘(I) dying from end-stage liver 
disease and liver cancer; and 
‘‘(II) transmitting viral hepatitis 
to others; and 
‘‘(iii) provide women chronically in-
fected with hepatitis B or hepatitis C who 
are pregnant or of childbearing age with 
culturally and linguistically appropriate 
health information, such as how to prevent 
hepatitis B perinatal infection, and to al-
leviate fears associated with pregnancy or 
raising a family. 
‘‘(C) IMMUNIZATION.—The Secretary shall 
support State, local, territorial, and tribal ef-
forts to expand the current vaccination pro-
grams to protect every child in the Nation and 
all susceptible adults, particularly those infected 
with hepatitis C and high-prevalence ethnic 
populations and other high-risk groups, from 
the risks of acute and chronic hepatitis B infec-
tion by— 
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‘‘(i) ensuring continued funding for 
hepatitis B vaccination for all children 18 
years of age or younger through the Vac-
cines for Children program; 
‘‘(ii) ensuring that the recommenda-
tions of the Advisory Committee on Immu-
nization Practices of the Centers for Dis-
ease Control and Prevention are followed 
regarding the birth dose of hepatitis B vac-
cinations for newborns; 
‘‘(iii) requiring proof of hepatitis B 
vaccination for entry into public or private 
daycare, preschool, elementary school, sec-
ondary school, and institutions of higher 
education; 
‘‘(iv) expanding the availability of 
hepatitis B vaccination for all adults to 
protect them from becoming acutely or 
chronically infected, including ethnic and 
other populations with high prevalence 
rates of chronic hepatitis B infection; 
‘‘(v) expanding the availability of hep-
atitis B vaccination for all adults, particu-
larly those of reproductive age (women and 
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men less than 45 years of age), to protect 
them from the risk of hepatitis B infection; 
‘‘(vi) ensuring the vaccination of indi-
viduals infected, or at risk for infection, 
with hepatitis C against hepatitis A, hepa-
titis B, and other infectious diseases, as 
appropriate, for which such individuals 
may be at increased risk; and 
‘‘(vii) ensuring the vaccination of indi-
viduals infected, or at risk for infection, 
with hepatitis B against hepatitis A virus 
and other infectious diseases, as appro-
priate, for which such individuals may be 
at increased risk. 
‘‘(D) MEDICAL REFERRAL.—The Secretary 
shall support State, local, territorial, and tribal 
programs that support— 
‘‘(i) referral of persons chronically in-
fected with hepatitis B or hepatitis C— 
‘‘(I) for medical evaluation to de-
termine 
the 
appropriateness 
for 
antiviral treatment to reduce the risk 
of progression to cirrhosis and liver 
cancer; and 
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‘‘(II) for ongoing medical man-
agement including regular monitoring 
of liver function and screening for 
liver cancer; and 
‘‘(ii) referral of persons infected with 
acute or chronic hepatitis B infection or 
acute or chronic hepatitis C infection for 
drug and alcohol abuse treatment where 
appropriate. 
‘‘(4) INCREASED SUPPORT FOR ADULT VIRAL 
HEPATITIS PREVENTION COORDINATORS.—The Sec-
retary, acting through the CDC Director, shall pro-
vide increased support to adult viral hepatitis pre-
vention coordinators in State, local, territorial, and 
tribal health departments in order to enhance the 
additional management, networking, and technical 
expertise needed to ensure successful integration of 
hepatitis B and hepatitis C prevention and control 
activities into existing public health programs. 
‘‘(c) EPIDEMIOLOGICAL SURVEILLANCE.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, shall support the establish-
ment and maintenance of a national chronic and 
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ment of this part, the Secretary shall submit the re-
port to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representa-
tives. 
‘‘(3) CONFIDENTIALITY.—The Secretary shall 
not disclose any individually identifiable information 
identified under paragraph (1) or derived through 
studies under paragraph (2). 
‘‘(d) RESEARCH.—The Secretary, acting through the 
Director of the Centers for Disease Control and Preven-
tion, the Director of the National Cancer Institute, and 
the Director of the National Institutes of Health, shall— 
‘‘(1) conduct epidemiologic and community- 
based research to develop, implement, and evaluate 
best practices for hepatitis B and hepatitis C pre-
vention especially in the ethnic populations with high 
rates of chronic hepatitis B and chronic hepatitis C 
and other high-risk groups; 
‘‘(2) conduct research on hepatitis B and hepa-
titis C natural history, pathophysiology, improved 
treatments and prevention (such as the hepatitis C 
vaccine), and noninvasive tests that help to predict 
the risk of progression to liver cirrhosis and liver 
cancer; 
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‘‘(3) conduct research that will lead to better 
noninvasive or blood tests to screen for liver cancer, 
and more effective treatments of liver cancer caused 
by chronic hepatitis B and chronic hepatitis C; and 
‘‘(4) conduct research comparing the effective-
ness of screening, diagnostic, management, and 
treatment approaches for chronic hepatitis B, chron-
ic hepatitis C, and liver cancer in the affected com-
munities. 
‘‘(e) UNDERSERVED AND DISPROPORTIONATELY AF-
FECTED POPULATIONS.—In carrying out this section, the 
Secretary shall provide expanded support for individuals 
with limited access to health education, testing, and health 
care services and groups that may be disproportionately 
affected by hepatitis B and hepatitis C. 
‘‘(f) EVALUATION
OF PROGRAM.—The Secretary 
shall develop benchmarks for evaluating the effectiveness 
of the programs and activities conducted under this sec-
tion and make determinations as to whether such bench-
marks have been achieved. 
‘‘SEC. 399PP–2. GRANTS. 
‘‘(a) IN GENERAL.—The Secretary may award grants 
to, or enter into contracts or cooperative agreements with, 
States, political subdivisions of States, territories, Indian 
tribes, or nonprofit entities that have special expertise re-
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lating to hepatitis B, hepatitis C, or both, to carry out 
activities under this part. 
‘‘(b) APPLICATION.—To be eligible for a grant, con-
tract, or cooperative agreement under subsection (a), an 
entity shall prepare and submit to the Secretary an appli-
cation at such time, in such manner, and containing such 
information as the Secretary may require. 
‘‘SEC. 399PP–3. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated to carry out 
this part $90,000,000 for fiscal year 2021, $90,000,000 
for fiscal year 2022, $110,000,000 for fiscal year 2023, 
$130,000,000 for fiscal year 2024, and $150,000,000 for 
fiscal year 2025.’’. 
Subtitle C—Acquired Bone Marrow 
Failure Diseases 
SEC. 721. ACQUIRED BONE MARROW FAILURE DISEASES. 
(a) SHORT TITLE.—This subtitle may be cited as the 
‘‘Bone Marrow Failure Disease Research and Treatment 
Act of 2020’’. 
(b) FINDINGS.—The Congress finds the following: 
(1) Between 20,000 and 30,000 people in the 
United States are diagnosed each year with 
myelodysplastic syndromes, aplastic anemia, parox-
ysmal nocturnal hemoglobinuria, and other acquired 
bone marrow failure diseases. 
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(2) Acquired bone marrow failure diseases have 
a debilitating and often fatal impact on those diag-
nosed with these diseases. 
(3) While some treatments for acquired bone 
marrow failure diseases can prolong and improve the 
quality of patients’ lives, there is no single cure for 
these diseases. 
(4) The prevalence of acquired bone marrow 
failure diseases in the United States will continue to 
grow as the general public ages. 
(5) Evidence exists suggesting that acquired 
bone marrow failure diseases occur more often in 
minority populations, particularly in Asian-American 
and Latino or Hispanic populations. 
(6) The National Heart, Lung, and Blood Insti-
tute and the National Cancer Institute have con-
ducted important research into the causes of and 
treatments for acquired bone marrow failure dis-
eases. 
(7) The National Marrow Donor Program Reg-
istry has made significant contributions to the fight 
against bone marrow failure diseases by connecting 
millions of potential marrow donors with individuals 
and families suffering from these conditions. 
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(8) Despite these advances, a more comprehen-
sive Federal strategic effort among numerous Fed-
eral agencies is needed to discover a cure for ac-
quired bone marrow failure disorders. 
(9) Greater Federal surveillance of acquired 
bone marrow failure diseases is needed to gain a bet-
ter understanding of the causes of acquired bone 
marrow failure diseases. 
(10) The Federal Government should increase 
its research support for and engage with public and 
private organizations in developing a comprehensive 
approach to combat and cure acquired bone marrow 
failure diseases. 
(c) NATIONAL ACQUIRED BONE MARROW FAILURE 
DISEASE REGISTRY.—Title III of the Public Health Serv-
ice Act (42 U.S.C. 241 et seq.) is amended by inserting 
after section 317V (as added by section 110) the following: 
‘‘SEC. 317W. NATIONAL ACQUIRED BONE MARROW FAILURE 
DISEASE REGISTRY. 
‘‘(a) ESTABLISHMENT OF REGISTRY.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of the enactment of this section, the 
Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall— 
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‘‘(A) develop a system to collect data on 
acquired bone marrow failure diseases; and 
‘‘(B) establish and maintain a national and 
publicly available registry, to be known as the 
National Acquired Bone Marrow Failure Dis-
ease Registry, in accordance with paragraph 
(3). 
‘‘(2) RECOMMENDATIONS
OF
ADVISORY
COM-
MITTEE.—In carrying out this subsection, the Sec-
retary shall take into consideration the recommenda-
tions of the Advisory Committee on Acquired Bone 
Marrow Failure Diseases established under sub-
section (b). 
‘‘(3) PURPOSES OF REGISTRY.—The National 
Acquired Bone Marrow Failure Disease Registry 
shall— 
‘‘(A) identify the incidence and prevalence 
of acquired bone marrow failure diseases in the 
United States; 
‘‘(B) be used to collect and store data on 
acquired bone marrow failure diseases, includ-
ing data concerning— 
‘‘(i) the age, race or ethnicity, general 
geographic location, sex, and family history 
of individuals who are diagnosed with ac-
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quired bone marrow failure diseases, and 
any other characteristics of such individ-
uals determined appropriate by the Sec-
retary; 
‘‘(ii) the genetic and environmental 
factors that may be associated with devel-
oping acquired bone marrow failure dis-
eases; 
‘‘(iii) treatment approaches for deal-
ing with acquired bone marrow failure dis-
eases; 
‘‘(iv) outcomes for individuals treated 
for acquired bone marrow failure diseases, 
including outcomes for recipients of stem 
cell therapeutic products as contained in 
the database established pursuant to sec-
tion 379A; and 
‘‘(v) any other factors pertaining to 
acquired bone marrow failure diseases de-
termined appropriate by the Secretary; and 
‘‘(C) be made available— 
‘‘(i) to the general public; and 
‘‘(ii) to researchers to facilitate fur-
ther research into the causes of, and treat-
ments for, acquired bone marrow failure 
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diseases in accordance with standard prac-
tices of the Centers for Disease Control 
and Preventions. 
‘‘(b) ADVISORY COMMITTEE.— 
‘‘(1) ESTABLISHMENT.—Not later than 6 
months after the date of the enactment of this sec-
tion, the Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, 
shall establish an advisory committee, to be known 
as the Advisory Committee on Acquired Bone Mar-
row Failure Diseases. 
‘‘(2) MEMBERS.—The members of the Advisory 
Committee on Acquired Bone Marrow Failure Dis-
eases shall be appointed by the Secretary, acting 
through the Director of the Centers for Disease 
Control and Prevention, and shall include at least 
one representative from each of the following: 
‘‘(A) A national patient advocacy organiza-
tion with experience advocating on behalf of pa-
tients suffering from acquired bone marrow 
failure diseases. 
‘‘(B) The National Institutes of Health, in-
cluding at least one representative from each 
of— 
‘‘(i) the National Cancer Institute; 
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‘‘(ii) the National Heart, Lung, and 
Blood Institute; and 
‘‘(iii) the Office of Rare Diseases. 
‘‘(C) The Centers for Disease Control and 
Prevention. 
‘‘(D) Clinicians with experience in— 
‘‘(i) diagnosing or treating acquired 
bone marrow failure diseases; or 
‘‘(ii) medical data registries. 
‘‘(E) Epidemiologists who have experience 
with data registries. 
‘‘(F) Publicly or privately funded research-
ers who have experience researching acquired 
bone marrow failure diseases. 
‘‘(G) The entity operating the C.W. Bill 
Young Cell Transplantation Program estab-
lished pursuant to section 379 and the entity 
operating the C.W. Bill Young Cell Transplan-
tation Program Outcomes Database. 
‘‘(3) RESPONSIBILITIES.—The Advisory Com-
mittee on Acquired Bone Marrow Failure Diseases 
shall provide recommendations to the Secretary on 
the establishment and maintenance of the National 
Acquired Bone Marrow Failure Disease Registry, in-
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cluding recommendations on the collection, mainte-
nance, and dissemination of data. 
‘‘(4) PUBLIC
AVAILABILITY.—The Secretary 
shall make the recommendations of the Advisory 
Committee on Acquired Bone Marrow Failure Dis-
ease publicly available. 
‘‘(c) GRANTS.—The Secretary, acting through the 
Director of the Centers for Disease Control and Preven-
tion, may award grants to, and enter into contracts and 
cooperative agreements with, public or private nonprofit 
entities for the management of, as well as the collection, 
analysis, and reporting of data to be included in, the Na-
tional Acquired Bone Marrow Failure Disease Registry. 
‘‘(d) DEFINITION.—In this section, the term ‘ac-
quired bone marrow failure disease’ means— 
‘‘(1) myelodysplastic syndromes; 
‘‘(2) aplastic anemia; 
‘‘(3) paroxysmal nocturnal hemoglobinuria; 
‘‘(4) pure red cell aplasia; 
‘‘(5) acute myeloid leukemia that has pro-
gressed from myelodysplastic syndromes; or 
‘‘(6) large granular lymphocytic leukemia. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$3,000,000 for each of fiscal years 2021 through 2025.’’. 
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(d) PILOT STUDIES THROUGH THE AGENCY FOR 
TOXIC SUBSTANCES AND DISEASE REGISTRY.— 
(1) PILOT STUDIES.—The Secretary of Health 
and Human Services, acting through the Director of 
the Agency for Toxic Substances and Disease Reg-
istry, shall conduct pilot studies to determine which 
environmental factors, including exposure to toxins, 
may cause acquired bone marrow failure diseases. 
(2) COLLABORATION WITH THE RADIATION IN-
JURY TREATMENT NETWORK.—In carrying out the 
directives of this section, the Secretary may collabo-
rate with the Radiation Injury Treatment Network 
of the C.W. Bill Young Cell Transplantation Pro-
gram established pursuant to section 379 of the 
Public Health Service Act (42 U.S.C. 274k) to— 
(A) augment data for the pilot studies au-
thorized by this section; 
(B) access technical assistance that may be 
provided by the Radiation Injury Treatment 
Network; or 
(C) perform joint research projects. 
(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this section $1,000,000 for each of fiscal years 2021 
through 2025. 
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(e) MINORITY-FOCUSED PROGRAMS ON ACQUIRED 
BONE MARROW FAILURE DISEASES.—Title XVII of the 
Public Health Service Act (42 U.S.C. 300u et seq.) is 
amended by inserting after section 1707A the following: 
‘‘SEC. 
1707B. 
MINORITY-FOCUSED 
PROGRAMS 
ON 
AC-
QUIRED BONE MARROW FAILURE DISEASE. 
‘‘(a) INFORMATION AND REFERRAL SERVICES.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of the enactment of this section, the 
Secretary, acting through the Deputy Assistant Sec-
retary for Minority Health, shall establish and co-
ordinate outreach and informational programs tar-
geted to minority populations affected by acquired 
bone marrow failure diseases. 
‘‘(2) PROGRAM
REQUIREMENTS.—Minority-fo-
cused outreach and informational programs author-
ized by this section at the National Minority Health 
Resource Center supported under section 1707(b)(8) 
(including by means of the Center’s website, through 
appropriate locations such as the Center’s knowledge 
center, and through appropriate programs such as 
the Center’s resource persons network) and through 
minority health consultants located at each Depart-
ment of Health and Human Services regional of-
fice— 
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‘‘(A) shall make information about treat-
ment options and clinical trials for acquired 
bone marrow failure diseases publicly available; 
and 
‘‘(B) shall provide referral services for 
treatment options and clinical trials. 
‘‘(b) HISPANIC AND ASIAN-AMERICAN AND PACIFIC 
ISLANDER OUTREACH.— 
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Deputy Assistant Secretary for Minority 
Health, shall undertake a coordinated outreach ef-
fort to connect Hispanic, Asian-American, and Pa-
cific Islander communities with comprehensive serv-
ices focused on treatment of, and information about, 
acquired bone marrow failure diseases. 
‘‘(2) COLLABORATION.—In carrying out this 
subsection, the Secretary may collaborate with public 
health agencies, nonprofit organizations, community 
groups, and online entities to disseminate informa-
tion about treatment options and clinical trials for 
acquired bone marrow failure diseases. 
‘‘(c) GRANTS AND COOPERATIVE AGREEMENTS.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of the enactment of this section, the 
Secretary, acting through the Deputy Assistant Sec-
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retary for Minority Health, shall award grants to, or 
enter into cooperative agreements with, entities to 
perform research on acquired bone marrow failure 
diseases. 
‘‘(2) REQUIREMENT.—Grants and cooperative 
agreements authorized by this subsection shall be 
awarded or entered into on a competitive, peer-re-
viewed basis. 
‘‘(3) SCOPE OF RESEARCH.—Research funded 
under this section shall examine factors affecting the 
incidence of acquired bone marrow failure diseases 
in minority populations. 
‘‘(d) DEFINITION.—In this section, the term ‘ac-
quired bone marrow failure disease’ has the meaning given 
to such term in section 317W(d). 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$2,000,000 for each of fiscal years 2021 through 2025.’’. 
(f) DIAGNOSIS
AND QUALITY
OF CARE
FOR AC-
QUIRED BONE MARROW FAILURE DISEASES.— 
(1) GRANTS.—The Secretary of Health and 
Human Services, acting through the Director of the 
Agency for Healthcare Research and Quality, shall 
award grants to entities to improve diagnostic prac-
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tices and quality of care with respect to patients 
with acquired bone marrow failure diseases. 
(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this section $2,000,000 for each of fiscal years 2021 
through 2025. 
(g) DEFINITION.—In this section, the term ‘‘acquired 
bone marrow failure disease’’ has the meaning given such 
term in section 317W(d) of the Public Health Service Act, 
as added by subsection (c). 
Subtitle 
D—Cardiovascular 
Dis-
ease, Chronic Disease, Obesity, 
and Other Disease Issues 
SEC. 731. GUIDELINES FOR DISEASE SCREENING FOR MI-
NORITY PATIENTS. 
(a) IN GENERAL.—The Secretary, acting through the 
Director of the Agency for Healthcare Research and Qual-
ity, shall convene a series of meetings to develop guidelines 
for disease screening for minority patient populations that 
have a higher than average risk for many chronic diseases 
and cancers. 
(b) PARTICIPANTS.—In convening meetings under 
subsection (a), the Secretary shall ensure that meeting 
participants include representatives of— 
(1) professional societies and associations; 
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(2) minority health organizations; 
(3) health care researchers and providers, in-
cluding those with expertise in minority health; 
(4) Federal health agencies, including the Of-
fice of Minority Health, the National Institute on 
Minority Health and Health Disparities, and the 
National Institutes of Health; and 
(5) other experts as the Secretary determines 
appropriate. 
(c) DISEASES.—Screening guidelines for minority 
populations shall be developed as appropriate under sub-
section (a) for— 
(1) hypertension; 
(2) hypercholesterolemia; 
(3) diabetes; 
(4) cardiovascular disease; 
(5) cancers, including breast, prostate, colon, 
cervical, and lung cancer; 
(6) other pulmonary problems including sleep 
apnea; 
(7) asthma; 
(8) diabetes; 
(9) kidney diseases; 
(10) eye diseases and disorders, including glau-
coma; 
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(11) HIV/AIDS and sexually transmitted infec-
tions; 
(12) uterine fibroids; 
(13) autoimmune disease; 
(14) mental health conditions; 
(15) dental health conditions and oral diseases, 
including oral cancer; 
(16) environmental and related health illnesses 
and conditions; 
(17) sickle cell disease and sickle cell trait; 
(18) violence and injury prevention and control; 
(19) genetic and related conditions; 
(20) heart disease and stroke; 
(21) tuberculosis; 
(22) chronic obstructive pulmonary disease; 
(23) musculoskeletal diseases, arthritis, and 
obesity; and 
(24) other diseases determined appropriate by 
the Secretary. 
(d) DISSEMINATION.—Not later than 2 years after 
the date of enactment of this Act, the Secretary shall pub-
lish and disseminate to health care provider organizations 
the guidelines developed under subsection (a). 
(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 
2021 through 2025. 
SEC. 732. CDC WISEWOMAN SCREENING PROGRAM. 
Section 1509 of the Public Health Service Act (42 
U.S.C. 300n–4a) is amended— 
(1) in subsection (a)— 
(A) by striking the heading and inserting 
‘‘IN GENERAL.—’’; and 
(B) in the matter preceding paragraph (1), 
by striking ‘‘may make grants’’ and all that fol-
lows through ‘‘purpose’’ and inserting the fol-
lowing: ‘‘may make grants to such States for 
the purpose’’; and 
(2) in subsection (d)(1), by striking ‘‘there are 
authorized’’ and all that follows through the period 
and inserting ‘‘there are authorized to be appro-
priated 
$23,000,000 
for 
fiscal 
year 
2021, 
$25,300,000 for fiscal year 2022, $27,800,000 for 
fiscal year 2023, $30,800,000 for fiscal year 2024, 
and $34,000,000 for fiscal year 2025.’’. 
SEC. 733. REPORT ON CARDIOVASCULAR CARE FOR WOMEN 
AND MINORITIES. 
Part P of title III of the Public Health Service Act 
(42 U.S.C. 280g et seq.), as amended by section 531, is 
further amended by adding at the end the following: 
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‘‘SEC. 399V–8. REPORT ON CARDIOVASCULAR CARE FOR 
WOMEN AND MINORITIES. 
‘‘Not later than September 30, 2021, and annually 
thereafter, the Secretary shall prepare and submit to Con-
gress a report on the quality of and access to care for 
women and minorities with heart disease, stroke, and 
other cardiovascular diseases. The report shall contain rec-
ommendations for eliminating disparities in, and improv-
ing the treatment of, heart disease, stroke, and other car-
diovascular diseases in women, racial and ethnic minori-
ties, those for whom English is not their primary lan-
guage, and individuals with disabilities.’’. 
SEC. 734. COVERAGE OF COMPREHENSIVE TOBACCO CES-
SATION SERVICES IN MEDICAID AND PRI-
VATE HEALTH INSURANCE. 
(a) REQUIRING MEDICAID COVERAGE
OF COUN-
SELING AND PHARMACOTHERAPY FOR CESSATION OF TO-
BACCO USE.—Section 1905 of the Social Security Act (42 
U.S.C. 1396d) is amended— 
(1) in subsection (a)(4)(D), by striking ‘‘by 
pregnant women’’; and 
(2) in subsection (bb)— 
(A) by striking ‘‘by pregnant women’’ each 
place it appears; 
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(B) in paragraph (1), in the matter before 
subparagraph (A), by inserting ‘‘by individuals’’ 
before ‘‘who use tobacco’’; and 
(C) in paragraph (2)(A), by striking ‘‘with 
respect to pregnant women’’. 
(b) EXCEPTION
FROM
OPTIONAL
RESTRICTION 
UNDER MEDICAID PRESCRIPTION DRUG COVERAGE.— 
Section 1927(d)(2)(F) of the Social Security Act (42 
U.S.C. 1396r–8(d)(2)(F)) is amended— 
(1) by striking ‘‘in the case of pregnant 
women’’; and 
(2) by striking ‘‘under the over-the-counter 
monograph process’’. 
(c) STATE MONITORING AND PROMOTING OF COM-
PREHENSIVE TOBACCO CESSATION SERVICES UNDER 
MEDICAID.—Section 1902(a) of the Social Security Act 
(42 U.S.C. 1396a(a)), as amended by section 462(a), is 
amended— 
(1) by striking ‘‘and’’ at the end of paragraph 
(85); 
(2) by striking the period at the end of para-
graph (86) and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (86) the fol-
lowing new paragraph: 
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‘‘(87) provide for the State to monitor and pro-
mote the use of comprehensive tobacco cessation 
services under the State plan, including conducting 
an outreach campaign to increase awareness of, and 
the benefits of using, such services among— 
‘‘(A) individuals entitled to medical assist-
ance under the State plan who use tobacco 
products; and 
‘‘(B) clinicians and others who provide 
services to individuals entitled to medical assist-
ance under the State plan.’’. 
(d) FEDERAL REIMBURSEMENT FOR MEDICAID OUT-
REACH CAMPAIGN TO INCREASE AWARENESS.—Section 
1903(a) of the Social Security Act (42 U.S.C. 1396b(a)) 
is amended— 
(1) by striking the period at the end of para-
graph (7) and inserting ‘‘; plus’’; and 
(2) by inserting after paragraph (7) the fol-
lowing new paragraph: 
‘‘(8) an amount equal to 90 percent of the 
sums expended during each quarter which are attrib-
utable to the development, implementation, and eval-
uation of an outreach campaign to— 
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‘‘(A) increase awareness of comprehensive 
tobacco cessation services covered in the State 
plan among— 
‘‘(i) individuals who are likely to be el-
igible for medical assistance under the 
State plan; and 
‘‘(ii) clinicians and others who provide 
services to individuals who are likely to be 
eligible for medical assistance under the 
State plan; and 
‘‘(B) increase awareness of the benefits of 
using comprehensive tobacco cessation services 
covered in the State plan among— 
‘‘(i) individuals who are likely to be el-
igible for medical assistance under the 
State plan; and 
‘‘(ii) clinicians and others who provide 
services to individuals who are likely to be 
eligible for medical assistance under the 
State plan about the benefits of using com-
prehensive tobacco cessation services.’’. 
(e) REMOVAL OF COST SHARING FOR COUNSELING 
AND PHARMACOTHERAPY FOR CESSATION OF TOBACCO 
USE UNDER MEDICAID.— 
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691 
(1) GENERAL COST SHARING LIMITATIONS.— 
Section 1916 of the Social Security Act (42 U.S.C. 
1396o) is amended— 
(A) in subsections (a)(2)(B) and (b)(2)(B), 
by striking ‘‘and counseling and pharmacother-
apy for cessation of tobacco use by pregnant 
women (as defined in section 1905(bb) of this 
title) and covered outpatient drugs (as defined 
in subsection (k)(2) of section 1927 and includ-
ing nonprescription drugs described in sub-
section (d)(2) of such section) that are pre-
scribed for purposes of promoting, and when 
used to promote, tobacco cessation by pregnant 
women in accordance with the Guideline re-
ferred to in section 1905(bb)(2)(A)’’ each place 
it appears; and 
(B) in each of subsections (a)(2)(B) and 
(b)(2)(B) by inserting ‘‘and counseling and 
pharmacotherapy for cessation of tobacco use 
(as defined in section 1905d(bb) of this title) 
and covered outpatient drugs (as defined in 
subsection (k)(2) of section 1927 and including 
nonprescription drugs described in subsection 
(d)(2) of such section) that are prescribed for 
purposes of promoting, and when used to pro-
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692 
mote, tobacco cessation in accordance with the 
Guideline 
referred 
to 
in 
section 
1905(bb)(2)(A)’’ after ‘‘(or at the option of the 
State, any services furnished to pregnant 
women’’. 
(2) APPLICATION TO ALTERNATIVE COST SHAR-
ING.—Section 1916A(b)(3)(B) of such Act (42 
U.S.C. 1396o–1(b)(3)(B)) is amended— 
(A) in clause (iii), by striking ‘‘, and coun-
seling and pharmacotherapy for cessation of to-
bacco use by pregnant women (as defined in 
section 1905(bb))’’; and 
(B) by adding at the end the following: 
‘‘(xi) Counseling and pharmacothera-
py for cessation of tobacco use (as defined 
in section 1905(bb)) and covered out-
patient drugs (as defined in subsection 
(k)(2) of section 1927 and including non-
prescription drugs described in subsection 
(d)(2) of such section) that are prescribed 
for purposes of promoting, and when used 
to promote, tobacco cessation in accord-
ance with the Guideline referred to in sec-
tion 1396d (bb)(2)(A) of this title.’’. 
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693 
(f) NO PRIOR AUTHORIZATION FOR TOBACCO CES-
SATION DRUGS UNDER MEDICAID.—Section 1927(d) of 
the Social Security Act (42 U.S.C. 1396r–8) is amended— 
(1) by striking in paragraph (1)(A) ‘‘A State’’ 
and inserting ‘‘Except as otherwise provided in para-
graph (6), a State’’; 
(2) by redesignating paragraphs (6) and (7) as 
paragraphs (7) and (8), respectively; and 
(3) by inserting after paragraph (5) the fol-
lowing: 
‘‘(6) NO PRIOR AUTHORIZATION PROGRAMS FOR 
TOBACCO CESSATION DRUGS.—A State plan under 
this title shall not require, as a condition of coverage 
or payment for a covered outpatient drug for which 
Federal financial participation is available in accord-
ance with this section, the approval of an agent 
when used to promote smoking cessation, including 
agents approved by the Food and Drug Administra-
tion for the purposes of promoting, and when used 
to promote, tobacco cessation.’’. 
(g) COMPREHENSIVE COVERAGE OF TOBACCO CES-
SATION COVERAGE IN PRIVATE HEALTH INSURANCE.— 
Section 2713 of the Public Health Service Act (42 U.S.C. 
300gg–3) is amended by adding at the end the following: 
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694 
‘‘(d) NO PRIOR AUTHORIZATION.—A group health 
plan and a health insurance issuer offering group or indi-
vidual health insurance coverage shall not impose any 
prior authorization requirement for tobacco cessation 
counseling and pharmacotherapy that has in effect a rat-
ing of ‘A’ or ‘B’ in the current recommendations of the 
United States Preventive Services Task Force.’’. 
(h) EFFECTIVE DATE.—The amendments made by 
this section shall apply to items and services furnished on 
or after January 1, 2021. 
SEC. 
735. 
CLINICAL 
RESEARCH 
FUNDING 
FOR 
ORAL 
HEALTH. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services shall expand and intensify the conduct 
and support of the research activities of the National In-
stitutes of Health and the National Institute of Dental 
and Craniofacial Research to improve the oral health of 
the population through the prevention and management 
of oral diseases and conditions. 
(b) INCLUDED RESEARCH ACTIVITIES.—Research 
activities under subsection (a) shall include— 
(1) comparative effectiveness research and clin-
ical disease management research addressing early 
childhood caries and oral cancer; and 
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695 
(2) awarding of grants and contracts to support 
the training and development of health services re-
searchers, comparative effectiveness researchers, and 
clinical researchers whose research improves the oral 
health of the population. 
SEC. 736. PARTICIPATION BY MEDICAID BENEFICIARIES IN 
APPROVED CLINICAL TRIALS. 
(a) IN GENERAL.—Title XIX of the Social Security 
Act (42 U.S.C. 1396 et seq.) is amended by inserting after 
section 1943 the following new section: 
‘‘SEC. 1944. PARTICIPATION IN AN APPROVED CLINICAL 
TRIAL. 
‘‘(a) COVERAGE OF ROUTINE PATIENT COSTS ASSO-
CIATED WITH APPROVED CLINICAL TRIALS.— 
‘‘(1) INCLUSION.—Subject to paragraph (2), 
routine patient costs shall include all items and serv-
ices consistent with the medical assistance provided 
under the State plan that would otherwise be pro-
vided to the individual under such State plan if such 
individual was not enrolled in an approved clinical 
trial, including any items or services related to the 
prevention, detection, and treatment of any medical 
complications that arise as a result of participation 
in the approved clinical trial. 
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696 
‘‘(2) EXCLUSION.—For purposes of paragraph 
(1), routine patient costs does not include— 
‘‘(A) the investigational item, device, or 
service itself; 
‘‘(B) items and services that are provided 
solely to satisfy data collection and analysis 
needs and that are not used in the direct clin-
ical management of the patient; or 
‘‘(C) a service that is clearly inconsistent 
with widely accepted and established standards 
of care for a particular diagnosis. 
‘‘(3) 
INFORMATION
CONCERNING
CLINICAL 
TRIALS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Secretary, in consultation with 
relevant stakeholders, shall develop a single 
standardized electronic form for use by the indi-
vidual or the referring health care provider to 
submit to the State agency administering the 
State plan in order to verify that the clinical 
trial meets the conditions established for an ap-
proved clinical trial (as defined in subsection 
(c)). 
‘‘(B) EXCLUDED INFORMATION.—For pur-
poses of subparagraph (A) or any such request 
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by the State agency for information regarding 
a clinical trial, an individual or referring health 
care provider shall not be required to submit— 
‘‘(i) the clinical protocol document for 
the clinical trial; or 
‘‘(ii) subject to subparagraph (C), any 
additional information other than such in-
formation as is required pursuant to the 
form described in subparagraph (A). 
‘‘(C) OPTIONAL INFORMATION.—For pur-
poses of subparagraphs (A) and (B)(ii), the 
form may include a requirement that the refer-
ring health care provider attest that the indi-
vidual is eligible to participate in the clinical 
trial pursuant to the trial protocol and that in-
dividual participation in such trial would be ap-
propriate. 
‘‘(D) REVIEW OF INFORMATION.— 
‘‘(i) IN
GENERAL.—A State plan 
under this title shall establish a process for 
timely review by the State agency of the 
form and information submitted pursuant 
to subparagraph (A) and, not later than 
48 hours after receipt of such form, con-
firmation that the information provided in 
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748 
governmental organizations and, if applicable, 
any contractors, including with respect to non-
governmental organizations, the type of tech-
nical assistance provided, and an evaluation of 
the impact of such assistance on eligible State 
and local entities; and 
(D) a summary and description of eligible 
State and local entities, State and local public 
health departments, and eligible nongovern-
mental 
organizations 
receiving 
assistance 
through this subsection, including if applicable, 
a summary and description of any contractors 
selected to assist in implementing such assist-
ance. 
(5) DEFINITIONS.—For the purposes of this 
subsection: 
(A) ELIGIBLE
STATE
AND
LOCAL
ENTI-
TIES.—The term ‘‘eligible State and local enti-
ties’’ means the relevant individuals, offices, or 
organizations that directly participate in the de-
velopment, dissemination, or implementation of 
State laws, policies, regulations, or judicial deci-
sions, including— 
(i) State governments, including State 
attorneys general, State departments of 
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749 
justice, and State National Guards, or 
their equivalents; 
(ii) State judicial and court systems, 
including trial courts, appellate courts, 
State supreme courts and courts of appeal, 
and State correctional facilities, or their 
equivalents; and 
(iii) local governments, including city 
and county governments, district attorneys, 
and local law enforcement departments, or 
their equivalents. 
(B) STATE AND LOCAL PUBLIC HEALTH 
DEPARTMENTS.—The term ‘‘State and local 
public health departments’’ means the fol-
lowing: 
(i) State public health departments, or 
their equivalents, including the chief officer 
of such departments and infectious disease 
and communicable disease specialists with-
in such departments. 
(ii) Local public health departments, 
or their equivalents, including city and 
county public health departments, the chief 
officer of such departments, and infectious 
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750 
disease and communicable disease special-
ists within such departments. 
(iii) Public health departments or offi-
cials, or their equivalents, within State or 
local correctional facilities. 
(iv) Public health departments or offi-
cials, or their equivalents, within State Na-
tional Guards. 
(v) Any other recognized State or 
local public health organization or entity 
charged with carrying out official State or 
local public health duties. 
(C) ELIGIBLE NONGOVERNMENTAL ORGA-
NIZATIONS.—The term ‘‘eligible nongovern-
mental organizations’’ means the following: 
(i) Nongovernmental organizations, 
including trade organizations or associa-
tions that represent— 
(I) State attorneys general, or 
their equivalents; 
(II) State public health officials, 
or their equivalents; 
(III) State judicial and court offi-
cers, including judges, district attor-
neys, prosecutors, defense attorneys, 
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751 
law enforcement, and correctional offi-
cers; 
(IV) State National Guards; 
(V) people living with HIV; 
(VI) legal advocacy and HIV 
service organizations that work with 
people living with HIV; and 
(VII) nongovernmental health or-
ganizations that work on behalf of 
people living with HIV. 
(ii) Nongovernmental organizations, 
including trade organizations or associa-
tions that demonstrate a public-health ori-
ented, evidence-based, medically accurate, 
and contemporary understanding of— 
(I) the multiple factors that lead 
to HIV transmission; 
(II) the relative risk of HIV 
transmission routes; 
(III) the current health implica-
tions of living with HIV; 
(IV) the associated benefits of 
treatment and support services for 
people living with HIV; 
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(ii) purchase sexual barrier protection 
devices; 
(iii) purchase sexual barrier protection 
devices at a reduced cost; or 
(iv) obtain sexual barrier protection 
devices without cost. 
(C) INCIDENCE OF SEXUAL VIOLENCE.— 
The incidence of sexual violence and assault 
committed by incarcerated persons and by cor-
rectional facility staff. 
(D) PREVENTION EDUCATION OFFERED.— 
The type of prevention education, information, 
or training offered to incarcerated persons and 
correctional facility staff regarding sexual vio-
lence and the spread of STIs, including whether 
such education, information, or training— 
(i) constitutes comprehensive sexuality 
education; 
(ii) is compulsory for new incarcerated 
persons and for new staff; and 
(iii) is offered on an ongoing basis. 
(E) STI TESTING.—Whether the correc-
tional facility tests incarcerated persons for 
STIs or gives them the option to undergo such 
testing— 
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