458 
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). 
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 2016’’. 
(b) FINDINGS.—Congress finds the following: 
(1) Approximately 5,300,000 Americans are 
chronically infected with the hepatitis B virus (re-
ferred to in this section as ‘‘HBV’’), the hepatitis C 
virus (referred to in this section as ‘‘HCV’’), or 
both. 
(2) In the United States, chronic HBV and 
HCV are the most common cause of liver cancer, 
one of the most lethal and fastest growing cancers 
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in this country. It is the most common cause of 
chronic liver disease, liver cirrhosis, and the most 
common indication for liver transplantation. At least 
21,000 deaths per year in the United States can be 
attributed to chronic HBV and HCV. Chronic HCV 
is also a leading cause of death in Americans 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 easily transmitted and is 100 times 
more infectious than HIV. According to the CDC, 
HBV is transmitted through contact with infectious 
blood, semen, or other body fluids. HCV is trans-
mitted by contact with infectious blood, particularly 
through percutaneous exposures (i.e. puncture 
through the skin). 
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(5) The CDC conservatively estimates that in 
2013 approximately 29,700 Americans were newly 
infected with HCV and more than 19,800 Americans 
were newly infected with HBV. These estimates 
could be much higher due to many reasons, includ-
ing lack of screening education and awareness, and 
perceived marginalization of the populations at risk. 
(6) In 2012, CDC released new guidelines rec-
ommending every person born between 1945 and 
1965 receive a one-time test. Among the estimated 
102 million (1.6 million chronically HCV-infected) 
eligible for screening, birth-cohort screening leads to 
84,000 fewer cases of decompensated cirrhosis, 
46,000 fewer cases of hepatocellular carcinoma, 
10,000 fewer liver transplants, and 78,000 fewer 
HCV-related deaths gained versus risk-based screen-
ing. 
(7) In 2013, the United States Preventive Serv-
ices Task Force (USPSTF) issued a Grade B rating 
for screening for the hepatitis C virus (HCV) infec-
tion in persons at high risk for infection and adults 
born between 1945 and 1965. In 2014, the 
USPSTF issued a Grade B for screening for the 
hepatitis B virus (HBV) in persons at high-risk of 
hepatitis B infection. In 2009, the USPSTF issued 
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a Grade A for screening pregnant women for the 
hepatitis B virus (HBV) during their first prenatal 
visit. 
(8) There were 44 outbreaks (23 of HBV, 22 
of HCV) reported to CDC for investigation from 
2008 through 2014 related to health care acquired 
infection of HBV and HCV, 42 of which occurred in 
nonhospital settings. There were more than 101,100 
patients 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. 
(10) HBV and HCV disproportionately affect 
certain populations in the United States. Although 
representing only 6 percent of the population, Asian- 
Americans and Pacific Islanders account for over 
half of the 1,400,000 domestic chronic HBV cases. 
Baby boomers (those born between 1945 and 1965) 
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account for approximately 75 percent of domestic 
chronic hepatitis C cases. In addition, African-Amer-
icans, Latinos (Latinas), and American Indian/Na-
tive Alaskans are among the groups which have dis-
proportionately high rates of HBV and/or HCV in-
fections in the United States. 
(11) For both chronic HBV and chronic HCV, 
behavioral changes 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 vaccination 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-
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-
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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. The treatment of chronic HBV can 
effectively suppress viral replication in the over-
whelming majority (over 80 percent) of those treat-
ed, thereby reducing the risk of transmission and 
progression to liver scarring or liver cancer, even 
though a complete cure is much less common than 
for HCV. 
(15) To combat the viral hepatitis epidemic in 
the United States, in May 2011, the Department of 
Health and Human Services released ‘‘Combating 
the Silent Epidemic of Viral Hepatitis: Action Plan 
for the Prevention, Care & Treatment of Viral Hepa-
titis’’ (hereafter referred to as the HHS Action 
Plan). The Institute of Medicine (IOM) of the Na-
tional Academies produced a 2010 report on the 
Federal response to HBV and HCV titled: ‘‘Hepa-
titis and Liver Cancer: A National Strategy for Pre-
vention and Control of Hepatitis B and C’’. These 
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recommendations and guidelines provide a frame-
work for HBV and HCV prevention, education, con-
trol, research, and medical management programs. 
(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 
$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 
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the Federal Government invests in effective mecha-
nisms to avoid documented cost drivers. 
(17) According to the IOM report in 2010 (de-
scribed in paragraph (15)), 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 per-
sonal and economic burdens. Existing grants are not 
sufficient for the scale of the health burden pre-
sented by HBV and HCV. 
(18) Screening and testing for HBV and HCV 
is aligned with the Healthy People 2020 goal to in-
crease 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 
in reducing the morbidity and mortality of these 
epidemics. 
(20) The Secretary of Health and Human Serv-
ices has the discretion to carry out this Act directly 
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and through whichever of the agencies of the Public 
Health Service the Secretary determines to be ap-
propriate, which may (in the Secretary’s discretion) 
include the Centers for Disease Control and Preven-
tion, the Health Resources and Services Administra-
tion, the Substance Abuse and Mental Health Serv-
ices Administration, the National Institutes of 
Health (including the National Institute on Minority 
Health and Health Disparities), and other agencies 
of such Service. 
(21) The Centers for Disease Control and Pre-
vention reported a 151 percent increase in hepatitis 
C cases from 2010–2013, stemming from the opioid, 
heroin, and overdose epidemics affecting commu-
nities nationwide. 
(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.) is 
amended— 
(1) by striking section 317N (42 U.S.C. 247b– 
15); and 
(2) by adding at the end the following: 
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‘‘PART W—BIENNIAL ASSESSMENT OF HHS HEPA-
TITIS B AND HEPATITIS C PREVENTION, EDU-
CATION, RESEARCH, AND MEDICAL MANAGE-
MENT PLAN 
‘‘SEC. 399NN. 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); 
‘‘(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 
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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. 
‘‘SEC. 399NN–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 399NN(a), shall implement pro-
grams to increase awareness and enhance knowledge and 
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understanding of hepatitis B and hepatitis C. Such pro-
grams shall include— 
‘‘(1) the conduct of culturally and language ap-
propriate health education in primary and secondary 
schools, college campuses, public awareness cam-
paigns, and community outreach activities (especially 
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 knowl-
edge about the value of hepatitis A and hepatitis B 
immunization, risk factors, the 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 treat-
ment of chronic hepatitis B and chronic hepatitis C; 
‘‘(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; 
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‘‘(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 hep-
atitis B and hepatitis C, such as the importance of 
prevention and early intervention, regular moni-
toring, the recognition of psychosocial needs, appro-
priate treatment, and liver cancer screening) for in-
dividuals providing hepatitis B and hepatitis C coun-
seling; and 
‘‘(7) support for the implementation curricula 
described in paragraph (6) by State and local public 
health agencies. 
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‘‘(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 
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 
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Services Task Force under section 915(a) of 
the Public Health Service Act to review its rec-
ommendation 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-
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. 
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‘‘(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; 
‘‘(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 
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‘‘(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 country 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— 
‘‘(i) ensuring continued funding for 
hepatitis B vaccination for all children 19 
years of age or younger through the Vac-
cines for Children Program; 
‘‘(ii) ensuring that the recommenda-
tions of the Advisory Committee on Immu-
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nization Practices are followed regarding 
the birth dose of hepatitis B vaccinations 
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 susceptible 
adults to protect them from becoming 
acutely or chronically infected, including 
ethnic and other populations with high 
prevalence rates of chronic hepatitis B in-
fection; 
‘‘(v) expanding the availability of hep-
atitis B vaccination for all susceptible 
adults, particularly those in their reproduc-
tive age (women and 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 
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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 
‘‘(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 
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drug and alcohol abuse treatment where 
appropriate. 
‘‘(4) INCREASED SUPPORT FOR ADULT VIRAL 
HEPATITIS PREVENTION COORDINATORS.—The Sec-
retary, acting through the Director of the Centers 
for Disease Control and Prevention, shall provide in-
creased support to adult viral hepatitis prevention 
coordinators in State, local, territorial, and tribal 
health departments in order to enhance the addi-
tional management, networking, and technical exper-
tise needed to ensure successful integration of hepa-
titis B and hepatitis C prevention and control activi-
ties 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 
acute hepatitis B and hepatitis C surveillance pro-
gram, in order to identify— 
‘‘(A) trends in the incidence of acute and 
chronic hepatitis B and acute and chronic hepa-
titis C; 
‘‘(B) trends in the prevalence of acute and 
chronic hepatitis B and acute and chronic hepa-
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titis C infection among groups that may be dis-
proportionately affected; and 
‘‘(C) trends in liver cancer and end-stage 
liver disease incidence and deaths, caused by 
chronic hepatitis B and chronic hepatitis C in 
the high-risk ethnic populations. 
‘‘(2) SEROPREVALENCE
AND
LIVER
CANCER 
STUDIES.—The Secretary, acting through the Direc-
tor of the Centers for Disease Control and Preven-
tion, shall prepare a report outlining the population- 
based seroprevalence studies currently underway, fu-
ture planned studies, the criteria involved in deter-
mining which seroprevalence studies to conduct, 
defer, or suspend, and the scope of those studies, the 
economic and clinical impact of hepatitis B and hep-
atitis C, and the impact of chronic hepatitis B and 
chronic hepatitis C infections on the quality of life. 
Not later than one year after the date of the enact-
ment of this part, the Secretary shall submit the re-
port to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate. 
‘‘(3) CONFIDENTIALITY.—The Secretary shall 
not disclose any individually identifiable information 
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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; 
‘‘(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-
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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. 399NN–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-
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. 
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‘‘SEC. 399NN–3. AUTHORIZATION OF APPROPRIATIONS. 
‘‘There are authorized to be appropriated to carry out 
this part $90,000,000 for fiscal year 2017, $90,000,000 
for fiscal year 2018, $110,000,000 for fiscal year 2019, 
$130,000,000 for fiscal year 2020, and $150,000,000 for 
fiscal year 2021.’’. 
(d) ENHANCING SAMHSA’S ROLE IN HEPATITIS AC-
TIVITIES.—Paragraph (6) of section 501(d) of the Public 
Health Service Act (42 U.S.C. 290aa(d)) is amended by 
striking ‘‘HIV or tuberculosis’’ and inserting ‘‘HIV, tuber-
culosis, or hepatitis’’. 
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 2016’’. 
(b) FINDINGS.—The Congress finds the following: 
(1) Between 20,000 and 30,000 Americans are 
diagnosed each year with myelodysplastic syndromes, 
aplastic 
anemia, 
paroxysmal 
nocturnal 
hemo-
globinuria, and other acquired bone marrow failure 
diseases. 
(2) Acquired bone marrow failure diseases have 
a debilitating and often fatal impact on those diag-
nosed with these diseases. 
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(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. 
(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. 
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(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.—Part B of the Public Health Service 
Act (42 U.S.C. 311 et seq.) is amended by inserting after 
section 317W, as added, the following: 
‘‘SEC. 317X. 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— 
‘‘(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-
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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— 
‘‘(A) shall identify the incidence and preva-
lence of acquired bone marrow failure diseases 
in the United States; 
‘‘(B) shall be used to collect and store data 
on acquired bone marrow failure diseases, in-
cluding data concerning— 
‘‘(i) the age, race or ethnicity, general 
geographic location, sex, and family history 
of individuals who are diagnosed with ac-
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-
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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) shall 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 
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-
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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; 
‘‘(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— 
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‘‘(i) diagnosing or treating acquired 
bone marrow failure diseases; and 
‘‘(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-
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. 
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‘‘(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 (MDS); 
‘‘(2) aplastic anemia; 
‘‘(3) 
paroxysmal 
nocturnal 
hemoglobinuria 
(PNH); 
‘‘(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 2017 through 2021.’’. 
(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 Adminis-
trator of the Agency for Toxic Substances and Dis-
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ease Registry, shall conduct pilot studies to deter-
mine which environmental factors, including expo-
sure to toxins, may cause acquired bone marrow fail-
ure 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. 274j) 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 2017 
through 2021. 
(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: 
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‘‘MINORITY-FOCUSED PROGRAMS ON ACQUIRED BONE 
MARROW FAILURE DISEASES 
‘‘SEC. 1707B. (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— 
‘‘(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, 
at the National Minority Health Resource Center 
supported under section 1707(b)(8) (including by 
means of the Center’s Web site, through appropriate 
locations such as the Center’s knowledge center, and 
through appropriate programs such as the Center’s 
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resource persons network) and through minority 
health consultants located at each Department of 
Health and Human Services regional office. 
‘‘(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-
retary for Minority Health, shall award grants to, or 
enter into cooperative agreements with, entities to 
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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 317X(d). 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section 
$2,000,000 for each of fiscal years 2017 through 2021.’’. 
(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-
tices and quality of care with respect to patients 
with acquired bone marrow failure diseases. 
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(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There is authorized to be appropriated to carry out 
this section $2,000,000 for each of fiscal years 2017 
through 2021. 
(g) DEFINITION.—In this section, the term ‘‘acquired 
bone marrow failure disease’’ means— 
(1) myelodysplastic syndromes (MDS); 
(2) aplastic anemia; 
(3) 
paroxysmal 
nocturnal 
hemoglobinuria 
(PNH); 
(4) pure red cell aplasia; 
(5) acute myeloid leukemia that progressed 
from myelodysplastic syndromes; or 
(6) large granular lymphocytic leukemia. 
Subtitle 
D—Cardiovascular 
Dis-
ease, 
Chronic 
Disease, 
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 
which have a higher than average risk for many chronic 
diseases and cancers. 
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(b) PARTICIPANTS.—In convening meetings under 
subsection (a), the Secretary shall ensure that meeting 
participants include representatives of— 
(1) professional societies and associations; 
(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 determined appropriate by the 
Secretary. 
(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; 
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(8) diabetes; 
(9) kidney diseases; 
(10) eye diseases and disorders, including glau-
coma; 
(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 24 months 
after the date of enactment of this title, the Secretary 
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shall publish and disseminate to health care provider orga-
nizations the guidelines developed under subsection (a). 
(e) AUTHORIZATION
OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section, 
such sums as may be necessary for each of fiscal years 
2017 through 2021. 
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 
2017, 
$25,300,000 for fiscal year 2018, $27,800,000 for 
fiscal year 2019, $30,800,000 for fiscal year 2020, 
and $34,000,000 for fiscal year 2021.’’. 
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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.) is amended by adding at the end 
the following: 
‘‘SEC. 399V–6. REPORT ON CARDIOVASCULAR CARE FOR 
WOMEN AND MINORITIES. 
‘‘Not later than September 30, 2017, and annually 
thereafter, the Secretary shall prepare and submit to the 
Congress 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 IN ACA 
ESSENTIAL HEALTH BENEFITS . 
(a) REQUIRING COVERAGE
OF COUNSELING
AND 
PHARMACOTHERAPY
FOR
CESSATION
OF
TOBACCO 
USE.—Section 1905 of the Social Security Act (42 U.S.C. 
1396d) is amended— 
(1) in subsection (a)(4)(D), is amended by 
striking ‘‘by pregnant women’’; and 
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(2) in subsection (bb)— 
(A) by striking ‘‘by pregnant women’’ each 
place it appears; 
(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 by striking ‘‘in the 
case of pregnant women’’. 
(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. 1395a(a)), as amended by section 450(c), is 
amended— 
(1) by striking ‘‘and’’ at the end of paragraph 
(81); 
(2) by striking the period at the end of para-
graph (82) and inserting ‘‘; and’’; and 
(3) by inserting after paragraph (82) the fol-
lowing new paragraph: 
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‘‘(83) provide for the State to monitor and pro-
mote the use of comprehensive tobacco cessation 
services under the State plan;’’. 
(d) REMOVAL OF COST SHARING FOR COUNSELING 
AND PHARMACOTHERAPY FOR CESSATION OF TOBACCO 
USE UNDER MEDICAID.— 
(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)) and 
covered outpatient drugs (as defined in sub-
section (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-
mote, tobacco cessation by pregnant women in 
accordance with the Guideline referred to in 
section 1905(bb)(2)(A)’’ each place it appears; 
and 
(B) in each of subsections (a)(2)(D) and 
(b)(2)(D) by inserting ‘‘and counseling and 
pharmacotherapy for cessation of tobacco use 
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(as defined in section 1905(bb)) and covered 
outpatient 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 pro-
mote, tobacco cessation in accordance with the 
Guideline 
referred 
to 
in 
section 
1905(bb)(2)(A),’’ 
after 
‘‘section 
1905(a)(4)(C),’’. 
(2) APPLICATION TO ALTERNATIVE COST SHAR-
ING.—Section 1916A(b)(3)(B) of such Act (42 
U.S.C. 
1396o–1(b)(3)(B)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 
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501 
(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 1905(bb)(2)(A).’’. 
(e) COMPREHENSIVE COVERAGE UNDER ACA ES-
SENTIAL HEALTH BENEFITS.— 
(1) COVERAGE.—Section 1302(b)(1) of the Pa-
tient Protection and Affordable Care Act (42 U.S.C. 
18022(b)(1)) is amended by adding at the end the 
following new subparagraph: 
‘‘(K) Comprehensive tobacco cessation 
services and medications, including all evidence- 
based tobacco cessation counseling and all 
medications for tobacco cessation approved by 
the Food and Drug Administration.’’. 
(2) NO COST SHARING.—Section 1302(c) of the 
Patient Protection and Affordable Care Act (42 
U.S.C. 18022(c)) is amended by inserting after 
paragraph (1) the following new paragraph: 
‘‘(2) NO COST SHARING OR PRIOR AUTHORIZA-
TION
FOR
COMPREHENSIVE
TOBACCO
CESSATION 
COVERAGE.—There shall be no cost sharing or prior 
authorization requirement imposed with respect to 
services described in subsection (b)(1)(K).’’. 
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(f) EFFECTIVE DATE.—The amendments made by 
this section shall apply to items and services furnished on 
or after January 1, 2017. 
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 
(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. 
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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. 
‘‘(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 
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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 
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 
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‘‘(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 
their participation in such trial would be appro-
priate. 
‘‘(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 
such form satisfies the requirements estab-
lished under such subparagraph, with such 
process to include establishment and oper-
ation of a 24-hour, toll-free telephone num-
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ber and e-mail address to provide for expe-
dited communication. 
‘‘(ii) FAILURE
TO
RESPOND.—If an 
individual or the referring health care pro-
vider does not receive a response or re-
quest for additional information from the 
State agency following the 48-hour period 
described in clause (i), the information 
provided in the form may be presumed to 
satisfy the requirements established under 
this paragraph. 
‘‘(b) ENCOURAGEMENT OF PARTICIPATION IN AP-
PROVED CLINICAL TRIALS.— 
‘‘(1) REASONABLY
ACCESSIBLE
PROVIDER.— 
For purposes of participation in an approved clinical 
trial by an individual eligible for medical assistance 
under this title, the State agency administering the 
State plan shall make reasonable efforts to ensure 
that the individual is provided with access to a pro-
vider who is— 
‘‘(A) participating in the approved clinical 
trial; 
‘‘(B) located not more than 25 miles from 
the residence of the individual (or, if no such 
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provider is available, as close as possible to the 
residence of the individual); and 
‘‘(C) a participating provider under the 
State plan or has been deemed to be a partici-
pating provider under the State plan for pur-
poses of providing medical assistance to the in-
dividual during their participation in the ap-
proved clinical trial. 
‘‘(2) INFORMATIONAL MATERIALS.—The State 
agency administering the plan approved under this 
title shall develop informational materials and pro-
grams to encourage participating providers to make 
appropriate referrals to physicians and other appro-
priate health care professionals who can provide in-
dividuals with access to approved clinical trials. 
‘‘(c) DEFINITION OF APPROVED CLINICAL TRIAL.— 
The term ‘approved clinical trial’ has the same meaning 
as provided under section 2709(d) of the Public Health 
Service Act.’’. 
(b) CONFORMING AMENDMENT.—Section 1902(a) of 
the Social Security Act (42 U.S.C. 1396a(a)) is amended 
by inserting after paragraph (77) the following new para-
graph: 
‘‘(78) provide that participation in an approved 
clinical trial and coverage of routine patient costs 
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associated with such trial for an individual eligible 
for medical assistance under this title is conducted 
in accordance with the requirements under section 
1944;’’. 
(c) EFFECTIVE DATE.— 
(1) IN GENERAL.—Except as provided in para-
graph (2), the amendments made by this section 
shall apply to calendar quarters beginning on or 
after October 1, 2016. 
(2) DELAY
PERMITTED
FOR
STATE
PLAN 
AMENDMENT.—In the case of a State plan for med-
ical assistance under title XIX of the Social Security 
Act which the Secretary of Health and Human Serv-
ices determines requires State legislation (other than 
legislation appropriating funds) in order for the plan 
to meet the additional requirements imposed by the 
amendments made by this section, the State plan 
shall not be regarded as failing to comply with the 
requirements of such title solely on the basis of its 
failure to meet these additional requirements before 
the first day of the first calendar quarter beginning 
after the close of the first regular session of the 
State legislature that begins after the date of enact-
ment of this Act. For purposes of the previous sen-
tence, in the case of a State that has a 2-year legis-
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lative session, each year of such session shall be 
deemed to be a separate regular session of the State 
legislature. 
Subtitle E—HIV/AIDS 
SEC. 741. STATEMENT OF POLICY. 
It is the policy of the United States to achieve an 
AIDS-free generation, and to— 
(1) expand access to lifesaving antiretroviral 
therapy for people living with HIV/AIDS and imme-
diately link people to continuous and coordinated 
high-quality care when they learn they are infected 
with HIV; 
(2) expand targeted efforts to prevent HIV in-
fection using a combination of effective, evidence- 
based approaches, including routine HIV screening, 
and universal access to HIV prevention tools in the 
communities where HIV/AIDS is most heavily con-
centrated, particularly communities of color; 
(3) ensure laws, policies, and regulations do not 
impede access to prevention, treatment, and care for 
people living with HIV/AIDS or at risk for acquiring 
HIV; 
(4) accelerate research for more efficacious HIV 
prevention and treatments tools, a cure, and a vac-
cine; and 
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(5) respect the human rights and dignity of 
persons living with HIV/AIDS. 
SEC. 742. FINDINGS. 
The Congress finds the following: 
(1) Over one million people are estimated to be 
living with HIV in the United States according to 
the Centers for Disease Control and Prevention, 16 
percent of whom are unaware of their HIV-positive 
status. 
(2) Annually there are over 50,000 new HIV in-
fections and 20,000 deaths in people with an HIV 
diagnoses in 50 States and 6 dependent areas of the 
United States. 
(3) The Centers for Disease Control and Pre-
vention estimates that in 2010 there were approxi-
mately 47,500 people newly diagnosed with HIV. 
Though this number seems to be staying relatively 
stable, the number of new infections is rapidly in-
creasing among certain populations especially among 
young African-American men who have sex with men 
(MSM). CDC data show that since 2006, HIV inci-
dence has increased among Black and Latino gay 
men/MSM, notably those aged 13 to 24 years. Even 
more concerning is that there are more new HIV in-
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fections among young African American gay men/ 
MSM than any other subgroup of gay men/MSM. 
(4) HIV disproportionately affects certain popu-
lations in the United States. Though African-Ameri-
cans represent approximately 14 percent of the pop-
ulation, African-Americans account for almost half 
(44 percent) of all people living with HIV in the 
United States. Men who have sex with men (MSM) 
make up approximately 4 percent of the population, 
but account for 78 percent of all new HIV infections 
and are the only risk group in which HIV infections 
continue to increase. 
(5) Disparities exist among Latinos/Hispanics; 
they make up 16 percent of the United States popu-
lation and 21 percent of new infections (2010). 
(6) Though American Indians/Alaska Natives 
represent less than 2 percent of the total number of 
HIV/AIDS cases, American Indians and Alaska Na-
tives rank fifth in rates of HIV/AIDS diagnosis, still 
higher than their White counterparts. 
(7) While Asian-Americans, Native Hawaiians, 
and Pacific Islanders HIV/AIDS cases account for 
approximately 1 percent of cases nationally, between 
2010 and 2011, the rate of new HIV diagnoses in-
creased for Asian-Americans by 22 percent. 
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(8) The latest data from the CDC (2013) indi-
cate that women account for 1 in 5 (20 percent) new 
HIV infections in the United States. Women of 
color, particularly Black women, have been especially 
hard hit and represent the majority of women living 
with the disease and women newly infected. In addi-
tion, Black women accounted for nearly two-thirds 
(64 percent) of all estimated new HIV infections 
among women, while only accounting for 13 percent 
of the female population; White women accounted 
for 18 percent and Latinas 15 percent of new infec-
tions among women. 
(9) The history of HIV shows that culturally 
relevant and gender-responsive supportive services, 
including psychosocial support, treatment literacy, 
case management, and transportation are necessary 
strategies to reach and engage women and girls in 
medical care. 
(10) The limited data available on transgender 
individuals point to a disproportionate burden of 
HIV infection. 
(11) Stigma and discrimination contribute to 
these disparities. 
(12) The Centers for Disease Control and Pre-
vention has determined that increasing the propor-
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tion of people who know their HIV status is an es-
sential component of comprehensive HIV/AIDS 
treatment and prevention efforts and that early di-
agnosis is critical in order for people with HIV/ 
AIDS to receive life-extending therapy. Additionally, 
the Centers for Disease Control and Prevention rec-
ommend routine HIV screening in health care set-
tings for all patients aged 13 to 64, regardless of 
risk. 
(13) In 1998, Congress created the National 
Minority AIDS Initiative to provide technical assist-
ance, build capacity, and strengthen outreach efforts 
among local institutions and community-based orga-
nizations that serve racial and ethnic minorities liv-
ing with or vulnerable to HIV/AIDS. 
(14) To combat the HIV epidemic in the United 
States, the National HIV/AIDS Strategy (NHAS) 
from the White House Office of National AIDS Pol-
icy provides a framework of increasing access to 
care, reducing new infections, and eliminating HIV- 
related health disparities. The vision of NHAS is 
‘‘The United States will become a place where new 
HIV infections are rare and when they do occur, 
every person, regardless of age, gender, race/eth-
nicity, 
gender 
identity, 
or 
socioeconomic 
cir-
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cumstance, will have unfettered access to high qual-
ity, life-extending care, free from stigma and dis-
crimination.’’. 
(15) In recent years, several thousand people 
across the country were waiting to receive AIDS 
treatment through the AIDS Drug Assistance Pro-
gram authorized by the provisions popularly known 
as the Ryan White CARE Act. 
(16) At present, 32 States and 2 United States 
territories have criminal statutes based on ‘‘expo-
sure’’ to HIV. Most of these laws were adopted be-
fore the availability of effective antiretroviral treat-
ment for HIV/AIDS. 
(17) Although the cost of education, treatment 
and care, and research are not inconsequential, they 
are substantially less than the annual health care 
cost attributable to HIV in the United States. The 
lifetime cost of HIV care and treatment was esti-
mated to be $326,500 to $435,000 dollars in a life-
time. Preventing 50,000 new infections in the 
United States each year could save $22 billion. 
(18) According to the Centers for Disease Con-
trol and Prevention (CDC), latex condoms, when 
used consistently and correctly, are highly effective 
in preventing the transmission of HIV. Latex 
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condoms also reduce the risk of other STIs. Despite 
the effectiveness of condoms in reducing the spread 
of STIs, the Bureau of Prisons does not recommend 
their use in correctional facilities. 
(19) The distribution of condoms in correctional 
facilities is currently legal in certain parts of the 
United States and the world. The States of Vermont 
and Mississippi, the District of Columbia, and the 
cities of New York, San Francisco, Los Angeles, 
Washington, DC, and Philadelphia allow condom 
distribution in their correctional facilities. However, 
these States and cities operate fewer than 1 percent 
of all correctional facilities. 
(20) Many correctional facilities in the United 
States do not provide comprehensive testing and 
treatment programs to reduce the spread of STIs. 
Fewer than half of correctional facilities provide 
counseling to HIV-positive incarcerated persons. 
(21) Incarcerated individuals living with HIV/ 
AIDS who are eligible for Medicaid would benefit 
from prompt and automatic enrollment upon their 
release in order to ensure their continued ability to 
access health services, including antiretroviral treat-
ment. 
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(22) Research shows that stable housing leads 
to better health outcomes for those living with HIV. 
Inadequate or unstable housing is not only a barrier 
to effective treatment, but also increases the likeli-
hood of engaging in risky behaviors leading to HIV 
infection. Insecure housing puts people with HIV/ 
AIDS at risk of premature death from exposure to 
other diseases, poor nutrition, and lack of medical 
care. 
(23) Due to advances in treatment, many peo-
ple living with HIV/AIDS (PLWHA) today are liv-
ing healthy lives and have the ability and desire to 
fully participate in all aspects of community life, in-
cluding employment. Research associates being em-
ployed with tremendous economic, social, and health 
benefits for many people living with HIV/AIDS. 
(24) The common benefits associated with em-
ployment include income, autonomy, productivity, 
and status within society, daily structure, making a 
contribution to one’s community, and increased skills 
and self-esteem. Research also indicates that many 
people with disabilities, including PLWHA, report 
perceiving themselves as being less disabled or not 
disabled at all, when working. Furthermore, some 
studies link working with better physical and mental 
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health outcomes for PLWHA when compared to 
those who are not working. Preliminary data also 
suggest that transitioning to employment is associ-
ated with reduced HIV-related health risk behavior 
for many people. 
(25) On July 16, 2012, the Food and Drug Ad-
ministration approved the first drug to reduce the 
risk of HIV infection in uninfected individuals who 
are at high risk of HIV infection and who may en-
gage in sexual activity with HIV-infected partners. 
SEC. 743. ADDITIONAL FUNDING FOR AIDS DRUG ASSIST-
ANCE PROGRAM TREATMENTS. 
Section 2623 of the Public Health Service Act (42 
U.S.C. 300ff–31b) is amended by adding at the end the 
following: 
‘‘(c) ADDITIONAL FUNDING FOR AIDS DRUG AS-
SISTANCE
PROGRAM
TREATMENTS.—In addition to 
amounts otherwise authorized to be appropriated for car-
rying out this subpart, there are authorized to be appro-
priated such sums as may be necessary to carry out sec-
tions 2612(b)(3)(B) and 2616 for each of fiscal years 
2017 through 2020.’’. 
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SEC. 744. ENHANCING THE NATIONAL HIV SURVEILLANCE 
SYSTEM. 
(a) GRANTS.—The Secretary of Health and Human 
Services, acting through the Director of the Centers for 
Disease Control and Prevention, shall make grants to 
States to support integration of public health surveillance 
systems into all electronic health records in order to allow 
rapid communications between the clinical setting and 
health departments, by means that include— 
(1) providing technical assistance and policy 
guidance to State and local health departments, clin-
ical providers, and other agencies serving individuals 
with HIV to improve the interoperability of data sys-
tems relevant to monitoring HIV care and sup-
portive services; 
(2) capturing longitudinal data pertaining to 
the initiation and ongoing prescription or dispensing 
of antiretroviral therapy for individuals diagnosed 
with HIV (such as through pharmacy-based report-
ing); 
(3) obtaining information— 
(A) on a voluntary basis, on sexual orienta-
tion and gender identity; and 
(B) on sources of coverage (or the lack 
thereof) for medical treatment (including cov-
erage through Medicaid, Medicare, the program 
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under title XXVI of the Public Health Service 
Act (42 U.S.C. 300ff–11 et seq.; commonly re-
ferred to as the ‘‘Ryan White HIV/AIDS Pro-
gram’’), other public funding, private insurance, 
and health maintenance organizations); and 
(4) obtaining and using current geographic 
markers of residence (such as current address, zip 
code, partial zip code, and census block). 
(b) PRIVACY AND SECURITY SAFEGUARDS.—In car-
rying out this section, the Secretary of Health and Human 
Services shall ensure that appropriate privacy and security 
safeguards are met to prevent unauthorized disclosure of 
protected health information and compliance with the 
HIPAA privacy and security law (as defined in section 
3009 of the Public Health Service Act (42 U.S.C. 300jj– 
19)) and other relevant laws and regulations. 
(c) PROHIBITION
AGAINST
IMPROPER
USE
OF 
DATA.—No grant under this section may be used to allow 
or facilitate the collection or use of surveillance or clinical 
data or records— 
(1) for punitive measures of any kind, civil or 
criminal, against the subject of such data or records; 
or 
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(2) for imposing any requirement or restriction 
with respect to an individual without the individual’s 
written consent. 
(d) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for each of fiscal years 
2017 through 2021. 
SEC. 745. EVIDENCE-BASED STRATEGIES FOR IMPROVING 
LINKAGE TO AND RETENTION IN APPRO-
PRIATE CARE. 
(a) STRATEGIES.—The Secretary of Health and 
Human Services, in collaboration with the Director of the 
Centers for Disease Control and Prevention, the Adminis-
trator of the Substance Abuse and Mental Health Services 
Administration, the Director of the Office of AIDS Re-
search, the Administrator of the Health Resources and 
Services Administration, and the Administrator of the 
Centers for Medicare & Medicaid Services, shall— 
(1) identify evidence-based strategies most ef-
fective at addressing the multifaceted issues that im-
pede disease status awareness and linkage to and re-
tention in appropriate care, taking into consideration 
health care systems issues, clinic and provider 
issues, and individual psychosocial, environmental, 
and other contextual factors; 
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(2) support the wide-scale implementation of 
the evidence-based strategies identified pursuant to 
paragraph (1), including through incorporating such 
strategies into health care coverage supported by the 
Medicaid program under title XIX of the Social Se-
curity Act (42 U.S.C. 1396 et seq.), the program 
under title XXVI of the Public Health Service Act 
(42 U.S.C. 300ff–11 et seq.; commonly referred to 
as the ‘‘Ryan White HIV/AIDS Program’’), and 
health plans purchased through an American Health 
Benefit Exchange established pursuant to section 
1311 of the Patient Protection and Affordable Care 
Act (42 U.S.C. 18031); and 
(3) not later than 12 months after the date of 
the enactment of this Act, submit a report to the 
Congress on the status of activities under para-
graphs (1) and (2). 
(b) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out this section, there are authorized to be appropriated 
such sums as may be necessary for fiscal years 2017 
through 2021. 
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SEC. 746. IMPROVING ENTRY INTO AND RETENTION IN 
CARE AND ANTIRETROVIRAL ADHERENCE 
FOR PERSONS WITH HIV. 
(a) SENSE OF CONGRESS.—It is the sense of the Con-
gress that AIDS research has led to scientific advance-
ments that have— 
(1) saved the lives of millions of people with 
HIV/AIDS; 
(2) prevented millions of people from being in-
fected; and 
(3) had broad benefits that extend far beyond 
helping people at risk for or living with HIV. 
(b) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Director of the Na-
tional Institutes of Health, shall expand, intensify, and co-
ordinate operational and translational research and other 
activities of the National Institutes of Health regarding 
methods— 
(1) to increase adoption of evidence-based ad-
herence strategies within HIV care and treatment 
programs; 
(2) to increase HIV testing and case detection 
rates; 
(3) to reduce HIV-related health disparities; 
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529 
terest on the individual’s professional education 
loans. 
(2) Upon completion by the physician, nurse 
practitioner, or physician assistant of the second 
year of such service, the Secretary shall pay another 
30 percent of the principal of and the interest on 
such loans. 
(3) Upon completion by that individual of a 
third year of such service, the Secretary shall pay 
another 25 percent of the principal of and the inter-
est on such loans. 
(c) APPLICABILITY OF CERTAIN PROVISIONS.—The 
provisions of subpart III of part D of title III of the Public 
Health Service Act (42 U.S.C. 254l et seq.) shall, except 
as inconsistent with this section, apply to the program car-
ried out under this section in the same manner and to 
the same extent as such provisions apply to the National 
Health Service Corps Loan Repayment Program. 
(d) REPORTS.—Not later than 18 months after the 
date of the enactment of this Act, and annually thereafter, 
the Secretary shall prepare and submit to the Congress 
a report describing the program carried out under this sec-
tion, including statements regarding the following: 
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(1) The number of physicians, nurse practi-
tioners, and physician assistants enrolled in the pro-
gram. 
(2) The number and amount of loan repay-
ments. 
(3) The placement location of loan repayment 
recipients at facilities described in subsection (a)(1). 
(4) The default rate and actions required. 
(5) The amount of outstanding default funds. 
(6) To the extent that it can be determined, the 
reason for the default. 
(7) The demographics of individuals partici-
pating in the program. 
(8) An evaluation of the overall costs and bene-
fits of the program. 
(e) DEFINITIONS.—In this section: 
(1) The term ‘‘HIV/AIDS’’ means human im-
munodeficiency virus and acquired immune defi-
ciency syndrome. 
(2) The term ‘‘nurse practitioner’’ means a reg-
istered nurse who has completed an accredited grad-
uate degree program in advanced nurse practice and 
has successfully passed a national certification exam. 
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